1
DEPARTMENT
OF
AGRICULTURE
Agricultural
Marketing
Service
7
CFR
Part
205
[
Docket
Number:
TMD­
00­
02­
FR]

RIN:
0581­
AA40
National
Organic
Program
AGENCY:
Agricultural
Marketing
Service,
USDA.

ACTION:
Final
Rule
with
request
for
comments.

SUMMARY:
This
final
rule
establishes
the
National
Organic
Program
(
NOP
or
program)
under
the
direction
of
the
Agricultural
Marketing
Service
(
AMS),
an
arm
of
the
United
States
Department
of
Agriculture
(
USDA).
This
national
program
will
facilitate
domestic
and
international
marketing
of
fresh
and
processed
food
that
is
organically
produced
and
assure
consumers
that
such
products
meet
consistent,
uniform
standards.
This
program
establishes
national
standards
for
the
production
and
handling
of
organically
produced
products,
including
a
National
List
of
substances
approved
for
and
prohibited
from
use
in
organic
production
and
handling.
This
final
rule
establishes
a
national­
level
accreditation
program
to
be
administered
by
AMS
for
State
officials
and
private
persons
who
want
to
be
accredited
as
certifying
agents.

Under
the
program,
certifying
agents
will
certify
production
and
handling
operations
in
compliance
with
the
requirements
of
this
regulation
and
initiate
compliance
actions
to
enforce
program
requirements.
The
final
rule
includes
requirements
for
labeling
products
as
organic
and
containing
organic
ingredients.
This
final
rule
also
provides
for
importation
of
organic
agricultural
products
from
foreign
programs
determined
to
have
equivalent
organic
program
2
requirements.
This
program
is
authorized
under
the
Organic
Foods
Production
Act
of
1990,
as
amended.

EFFECTIVE
DATE:
This
rule
becomes
effective
[
60
days
after
publication
in
the
Federal
Register].

Comments:
Comments
on
specified
aspects
of
the
final
regulations
must
be
submitted
on
or
before
[
90
days
after
publication
in
the
Federal
Register].

ADDRESSES:
Interested
persons
are
invited
to
submit
written
comments
on
specified
aspects
of
the
final
regulation
to:
Keith
Jones,
Program
Manager,
National
Organic
Program,
USDA­

AMSTMP
NOP,
Room
2945­
So.,
Ag
Stop
0275,
P.
O.
Box
96456,
Washington,
DC
20090­
6456.

Comments
may
also
be
filed
via
the
Internet
through
the
National
Organic
Program's
homepage
at:
www.
ams.
usda.
gov/
nop.
Written
comments
on
specified
aspects
of
the
final
regulations
should
be
identified
with
the
docket
number
TMD­
00­
02­
FR.
To
facilitate
the
timely
scanning
and
posting
of
comments
to
the
NOP
homepage,
multiple­
page
comments
submitted
by
regular
mail
should
not
be
stapled
or
clipped.

It
is
our
intention
to
have
all
comments
to
this
final
rule,
whether
mailed
or
submitted
via
the
Internet,
available
for
viewing
on
the
NOP
homepage
in
a
timely
manner.
Comments
submitted
in
response
to
this
final
rule
will
be
available
for
viewing
at
USDA­
AMS,

Transportation
and
Marketing
Programs,
Room
2945­
South
Building,
14th
and
Independence
Avenue,
SW,
Washington,
DC,
from
9:
00
a.
m.
to
12:
00
noon
and
from
1:
00
p.
m.
to
4:
00
p.
m.,

Monday
through
Friday
(
except
for
official
Federal
holidays).
Persons
wanting
to
visit
the
USDA
South
Building
to
view
comments
received
in
response
to
this
final
rule
are
requested
to
make
an
appointment
in
advance
by
calling
(
202)
720­
3252.
3
FOR
FURTHER
INFORMATION
CONTACT:
Richard
Mathews,
Senior
Agricultural
Marketing
Specialist,
USDA­
AMS­
TMP­
NOP,
Room
2510­
So.,
P.
O.
Box
96456,
Washington,

DC
20090­
6456;
Telephone:
(
202)
205­
7806;
Fax:
(
202)
205­
7808.

SUPPLEMENTARY
INFORMATION:

Prior
Documents
in
this
Proceeding
This
final
rule
is
issued
pursuant
to
the
Organic
Food
Production
Act
of
1990
(
Act
or
OFPA),
as
amended
(
7
U.
S.
C.
6501
et
seq.).
This
final
rule
replaces
the
proposed
rule
published
in
the
Federal
Register
March
13,
2000.
The
public
submitted
40,774
comments
on
the
proposed
rule.
Comments
to
the
proposed
rule
were
considered
in
the
preparation
of
this
final
rule.

The
following
notices
related
to
the
National
Organic
Standards
Board
(
NOSB)
and
the
development
of
this
proposed
regulation
have
been
published
in
the
Federal
Register.
Six
notices
of
nominations
for
membership
on
the
NOSB
were
published
between
April
1991
and
June
2000
(
56
FR
15323,
59
FR
43807,
60
FR
40153,
61
FR
33897,
64
FR
33240,
65
FR
35317).
Two
notices
of
extension
of
time
for
submitting
nominations
were
published
on
September
22,
1995,

and
September
23,
1996
(
60
FR
49246,
61
FR
49725).
Twenty
notices
of
meetings
of
the
NOSB
were
published
between
March
1992
and
November
2000
(
57
FR
7094,
57
FR
27017,
57
FR
36974,
58
FR
85,
58
FR
105,
58
FR
171,
59
FR
58,
59
FR
26186,
59
FR
49385,
60
FR
51980,

60
FR
15532,
61
FR
43520,
63
FR
7389,
63
FR
64451,
64
FR
3675,
64
FR
28154,
64
FR
54858,

65
FR
11758,
65
FR
33802,
65
FR
64657).
One
notice
of
public
hearings
on
organic
livestock
and
livestock
products
was
published
on
December
30,
1993
(
58
FR
69315).
Two
notices
specifying
a
procedure
for
submitting
names
of
substances
for
inclusion
on
or
removal
from
the
National
List
of
Approved
and
Prohibited
Substances
were
published
on
March
27,
1995
(
60
FR
4
15744),
and
July
13,
2000
(
65
FR
43259.
A
rule
proposing
the
NOP
was
published
on
December
16,
1997
(
62
FR
65850).
An
extension
of
the
time
period
for
submitting
comments
to
the
proposed
rule
was
published
on
February
9,
1998
(
63
FR
6498).
One
request
for
comments
on
Issue
Papers
was
published
on
October
28,
1998
(
63
FR
57624).
A
notice
of
a
program
to
assess
organic
certifying
agencies
was
published
on
June
9,
1999
(
64
FR
30861).
A
rule
proposing
the
NOP
was
published
on
March
13,
2000
(
65
FR
13512).
A
notice
of
public
meeting
and
request
for
comments
on
organic
production
and
handling
of
aquatic
animals
to
be
labeled
as
organic
was
published
on
March
23,
2000
(
65
FR
15579).
One
advance
notice
of
proposed
rulemaking
and
request
for
comments
on
reasonable
security
for
private
certifying
agents
was
published
on
August
9,
2000
(
65
FR
48642).

This
preamble
includes
a
discussion
of
the
final
rule
and
supplementary
information,

including
the
Regulatory
Impact
Assessment,
Unfunded
Mandates
Reform
Act
Statement,

Regulatory
Flexibility
Act
Analysis,
Federalism
Impact
Statement,
and
Civil
Justice
Impact
Statement.
The
Civil
Rights
Impact
Analysis
is
not
included
as
an
attachment
but
may
be
obtained
by
writing
to
the
address
provided
above
or
via
the
Internet
through
the
National
Organic
Program's
homepage
at:
http://
www.
ams.
usda.
gov/
nop.

Approval
of
Paperwork
Reduction
Act
Requirements
for
this
Final
Rule
The
reporting
requirements
and
recordkeeping
burden
imposed
by
this
rule
were
published
in
the
March
13,
2000,
Federal
Register
for
public
comment.
The
Agency
addressed
these
comments
in
the
final
rule
to
ensure
that
the
least
amount
of
the
burden
is
placed
on
the
public.

The
information
collection
and
recordkeeping
requirements
have
been
reviewed
and
approved
by
the
Office
of
Management
and
Budget
under
OMB
Number
0581­
0191,
National
Organic
5
Program.

National
Organic
Program
Overview
Subpart
A
­
Definitions
Description
of
Regulations
This
subpart
defines
various
terms
used
in
this
part.
These
definitions
are
intended
to
enhance
conformance
with
the
regulatory
requirements
through
a
clear
understanding
of
the
meaning
of
key
terms.

We
have
amended
terms
and
definitions
carried
over
from
the
proposed
rule
where
necessary
to
make
their
wording
consistent
with
the
language
used
in
this
final
rule.
We
have
revised
the
definitions
of
the
following
words
for
greater
clarity:
person,
practice
standard,
inert
ingredient,
processing,
tolerance.
We
have
removed
the
definitions
for
the
following
terms
because
the
terms
are
not
used
in
this
final
rule
or
have
been
determined
to
be
unnecessary:

accredited
laboratory,
estimated
national
mean,
system
of
organic
production
and
handling.
We
received
comments
on
some
of
these
definitions
that
have
been
deleted.
We
have
not
addressed
those
comments
here
because
the
relevant
definitions
have
been
deleted.

Definitions
­
Changes
Based
on
Comments
This
subpart
differs
from
the
proposed
rule
in
several
respects
as
follows:

(
1)
Many
commenters
requested
changes
to
the
definition
of
"
excluded
methods."

Comments
included
requests
to
use
the
more
common
term,
"
genetically
modified
organisms(
GMO)";
to
include
the
products
of
excluded
methods/
GMO's
in
the
definition;
to
more
closely
follow
the
NOSB
definition
by
adding
gene
deletion,
doubling,
introduction
of
a
foreign
gene,
and
changing
gene
position;
to
include
that
excluded
methods
are
prohibited
by
the
6
Act
and
by
the
regulations
in
this
part;
to
change
the
wording
of
the
reference
to
"
recombinant
DNA";
and
to
add
that
the
definition
of
excluded
methods
only
covers
"
intentional
use."

We
have
accepted
some
of
the
comments
and
have
modified
the
definition
accordingly.

Specifically,
we
have
included
reference
to
the
"
methods"
 
gene
deletion,
gene
doubling,
changing
positions
of
genes,
and
introducing
foreign
genes
 
that
were
included
in
the
original
NOSB
definition.
This
will
make
the
definition
even
more
closely
parallel
the
NOSB
recommendation.

We
also
refer
to
recombinant
DNA
technology,
which
is
technically
more
accurate
than
the
proposed
rules
reference
to
recombinant
DNA
as
a
"
method."

We
have
not
accepted
the
comments
that
requested
adding
the
products
of
excluded
methods
to
the
definition.
The
emphasis
and
basis
of
these
standards
is
on
process,
not
product.

We
have
specifically
structured
the
provisions
relating
to
excluded
methods
to
refer
to
the
use
of
methods.
Including
the
products
of
excluded
methods
in
the
definition
would
not
be
consistent
with
this
approach
to
organic
standards
as
a
process­
based
system.
For
the
same
reason,
we
have
retained
the
term,
"
excluded
methods,"
to
reinforce
that
process­
based
approach.

We
have
also
rejected
comments
requesting
that
we
include
the
prohibition
on
excluded
methods
in
the
definition
and,
likewise,
those
requesting
that
we
refer
to
"
intentional
use"
of
excluded
methods.
The
final
rule
maintains
and
clarifies
the
prohibition
on
the
use
of
excluded
methods
in
organic
production
systems.
The
prohibition
is
most
properly
addressed
in
the
appropriate
provisions
of
the
regulations,
particularly
in
Section
205.105,
and
not
in
the
definition.
Similarly,
although
we
recognize
that
a
distinction
between
intentional
and
unintentional
use
of
excluded
methods
may
be
meaningful,
particularly
as
it
pertains
to
issues
of
drift,
this
is
an
issue
that
is
best
handled
in
the
sections
of
the
regulation
governing
use
of
7
excluded
methods,
not
in
the
definition.
The
definition
for
"
excluded
methods"
now
reads:

A
variety
of
methods
used
to
genetically
modify
organisms
or
influence
their
growth
and
development
by
means
that
are
not
possible
under
natural
conditions
or
processes
and
are
not
considered
compatible
with
organic
production.
Such
methods
include
cell
fusion,

microencapsulation
and
macroencapsulation,
and
recombinant
DNA
technology
(
including
gene
deletion,
gene
doubling,
introducing
a
foreign
gene,
and
changing
the
position
of
genes
when
achieved
by
recombinant
DNA
technology).
Such
methods
do
not
include
the
use
of
traditional
breeding,
conjugation,
fermentation,
hybridization,
in
vitro
fertilization,
or
tissue
culture."

(
2)
Many
commenters
objected
to
the
definition
of
"
compost"
in
the
proposed
rule
because
it
required
that
compost
must
be
produced
in
a
facility
that
was
in
compliance
with
the
Natural
Resource
Conservation
Service's
(
NRCS)
practice
standard
for
a
composting
facility.

We
agree
with
these
commenters
and
removed
the
requirement
to
comply
with
the
NRCS
practice
standard.
However,
the
final
rule
incorporates
new
requirements
for
the
production
of
compost
that
are
included
in
the
definition.
The
final
rule
requires
that
compost
must
be
produced
through
a
process
that
combines
plant
and
animal
materials
with
an
initial
C:
N
ratio
of
between
25:
1
and
40:
1.
Furthermore,
producers
using
an
in­
vessel
or
static
aerated
pile
system
must
maintain
the
composting
materials
at
a
temperature
of
between
131
E
F
and
170
E
F
for
3
days.

Producers
using
a
windrow
system
must
maintain
the
composting
materials
at
a
temperature
between
131
E
F
and
170
E
F
for
15
days,
during
which
time,
the
materials
must
be
turned
a
minimum
of
five
times.
We
developed
the
requirements
in
the
final
rule
for
producing
an
allowed
composted
material
by
integrating
standards
used
by
the
Environmental
Protection
Agency
(
EPA)

and
USDA's
Natural
Resources
Conservation
Service
(
NRCS).
The
requirements
for
the
carbon­
8
to­
nitrogen
(
C:
N)
ratio
for
composting
materials
is
the
same
as
that
found
in
the
NRCS
practice
standard
for
a
composting
facility.
The
time
and
temperature
requirements
for
in­
vessel,
static
aerated
pile,
and
window
composting
systems
are
consistent
with
those
which
EPA
regulates
under
40
CFR
503
for
the
production
of
Class
A
sewage
sludge.
Additionally,
AMS
reviewed
these
compost
production
requirements
with
USDA's
Agricultural
Research
Service
(
ARS).
This
subject
is
discussed
further
under
subpart
C,
Crop
Production,
Changes
Based
on
Comment.

(
3)
Some
commenters
stated
that
allowing
nonagricultural
or
synthetic
substances
as
feed
supplements
contradicted
the
definition
for
"
feed
supplement"
in
the
proposed
rule.
These
commenters
stated
that
the
definition
stipulated
that
a
feed
supplement
must,
itself,
be
a
feed
material
and
that
the
proposed
definition
for
"
feed"
did
not
include
nonagricultural
or
synthetic
substances.
These
commenters
stated
that
the
definition
of
"
feed
supplement"
needed
to
be
amended
to
accommodate
nonagricultural
or
synthetic
substances,
or
such
substances
should
not
be
allowed.
We
agree
with
these
commenters
and
amended
the
definition
for
"
feed
supplement"

to
read
"
a
combination
of
feed
nutrients
added
to
livestock
feed
to
improve
the
nutritional
balance
or
performance
of
the
total
ration."
One
commenter
recommended
modifying
the
definition
of
"
feed
additive"
to
"
a
substance
added
to
feed
in
micro
quantities
to
fulfill
a
specific
nutritional
need;
i.
e.,
essential
nutrients
in
the
form
of
amino
acids,
vitamins,
and
minerals."
We
agree
that
this
modification
provides
a
more
precise
description
of
"
feed
additive"
and
have
included
the
change.
The
changes
to
the
definitions
for
"
feed
supplement"
and
"
feed
additive"
are
further
discussed
under
item
(
4)
of
Livestock
Production
­
Changes
Based
on
Comments.

(
4)
One
commenter
stated
that
the
definition
for
"
forage"
inaccurately
described
it
as
"
vegetable
matter,"
and
suggested
that
"
vegetative
matter"
was
a
more
suitable
description.
We
9
agree
with
the
suggestion
and
have
incorporated
the
change.

(
5)
Some
commenters
stated
that
the
definition
for
"
mulch"
implied
that
all
mulch
materials
must
either
be
organic
or
included
on
the
National
List.
These
commenters
maintained
that,
if
this
was
the
intent
of
the
proposed
rule,
the
provision
was
too
restrictive.
They
recommended
revising
the
definition
to
clarify
that
natural
but
nonorganic
plant
and
animal
materials,
if
managed
to
prevent
contamination
from
prohibited
substances,
could
be
used
as
mulch
without
being
added
to
the
National
List.
This
was
the
intent
in
the
proposed
rule,
and
we
have
modified
the
definition
to
make
this
provision
clearer.

(
6)
Many
commenters
stated
that
the
final
rule
should
include
a
definition
of
"
organic
production"
that
required
that
certified
operations
must
preserve
or
protect
biodiversity.
These
commenters
stated
that
the
preservation
of
biodiversity
is
a
requirement
in
many
existing
organic
certification
standards,
including
the
Codex
guidelines.
They
also
stated
that
the
NOSB
had
included
the
requirement
to
preserve
biodiversity
in
its
definition
of
organic.
We
agree
with
the
intent
of
these
comments
but
prefer
the
term,
"
conserve,"
to
"
preserve"
because
it
reflects
a
more
dynamic,
interactive
relationship
between
the
operation
and
biodiversity
over
time.
We
included
a
definition
for
organic
production
as
"
a
production
system
that
is
managed
in
accordance
with
the
Act
and
regulations
in
this
part
to
respond
to
site­
specific
conditions
by
integrating
cultural,

biological,
and
mechanical
practices
that
foster
cycling
of
resources,
promote
ecological
balance,

and
conserve
biodiversity."
We
deleted
the
definition
for
"
organic
system
of
production
and
handling"
in
the
final
rule.

(
7)
Several
commenters,
including
the
NOSB,
were
concerned
that
the
definition
for
"
planting
stock"
as
"
any
plant
or
plant
tissue,
including
rhizomes,
shoots,
leaf
or
stem
cuttings,
10
roots,
or
tubers,
used
in
plant
production
or
propagation"
was
sufficiently
broad
to
be
applied
to
annual
seedlings.
We
agree
that
it
is
important
to
establish
that
annual
seedlings
are
not
covered
by
the
definition
of
"
planting
stock"
and
amended
the
definition
to
exclude
them.
The
definition
for
planting
stock
in
the
final
rule
states
"
any
plant
or
plant
tissue
other
than
annual
seedlings
but
including
rhizomes,
shoots,
leaf
or
stem
cuttings,
roots,
or
tubers,
used
in
plant
production
or
propagation."
The
final
rule
retains
the
definition
for
"
annual
seedling
"
from
the
proposed
rule.

(
8)
Several
commenters
recommended
that
the
definition
of
"
processing"
should
be
amended
to
include
"
distilling"
as
an
allowed
practice.
We
agree
with
this
comment
and
added
distilling
as
an
allowed
processing
practice.

(
9)
Several
commenters
recommended
that
the
final
rule
include
a
definition
for
"
processing
aid"
that
is
consistent
with
the
definition
proposed
by
the
NOSB
and
used
by
the
Food
and
Drug
Administration
(
FDA).
We
agree
with
these
commenters
and
have
included
a
definition
for
processing
aid
that
is
the
same
as
the
definition
used
by
FDA
and
found
in
21
CFR
Part
101.100(
a)(
3)(
ii).

(
10)
Many
commenters
questioned
whether
the
term,
"
State
organic
certification
program,"
in
the
proposed
rule
included
organic
programs
from
States
that
did
not
offer
certification
services.
These
commenters
stated
that
the
final
rule
should
include
provisions
for
all
State
organic
programs
regardless
of
whether
they
functioned
as
certifying
agents.
We
agree
with
these
commenters
and
have
amended
the
final
rule
by
incorporating
the
term,
"
State
organic
program,"
as
"
a
State
program
that
meets
the
requirements
of
section
6506
of
the
Act,
is
approved
by
the
Secretary,
and
is
designed
to
ensure
that
a
product
that
is
sold
or
labeled
as
organically
produced
under
the
Act
is
produced
and
handled
using
organic
methods."
The
term,
11
"
State
organic
program,"
encompasses
such
programs
whether
they
offer
certification
services
or
not.

(
11)
One
commenter
stated
that
the
definition
for
"
wild
crop"
only
referred
to
a
plant
or
part
of
a
plant
that
was
harvested
from
"
an
area
of
land."
This
commenter
was
concerned
that
the
definition
would
preclude
the
certification
of
operations
that
produce
wild
aquatic
crops,
such
as
seaweed,
and
stated
that
the
OFPA
does
allow
for
certifying
such
operations.
We
agree
with
this
commenter
and
changed
the
definition
to
refer
to
a
plant
or
part
of
a
plant
harvested
from
a
"
site."

(
12)
Many
commenters
stated
that
the
soil
fertility
and
crop
nutrient
management
practice
standard
lacked
a
definition
for
"
manure."
These
commenters
maintained
that
the
different
provisions
contained
in
the
practice
standard
for
"
manure"
and
"
compost"
would
be
difficult
to
enforce
without
clear
definitions
to
differentiate
between
the
two
materials.
We
agree
with
these
comments
and
added
a
definition
for
manure
as
"
feces,
urine,
other
excrement,
and
bedding
produced
by
livestock
that
has
not
been
composted."

(
13)
Some
commenters
stated
that
the
National
List
in
the
final
rule
should
include
an
annotation
for
narrow
range
oils
to
limit
their
use
to
a
specific
subset
of
such
materials
recommended
by
the
NOSB.
We
agree
with
this
comment
but,
rather
than
add
an
annotation,
we
have
included
the
specifications
recommended
by
the
NOSB
in
a
new
definition
for
narrow
range
oils.
Narrow
range
oils
are
defined
as
"
petroleum
derivatives,
predominately
of
paraffinic
and
napthenic
fractions
with
a
50­
percent
boiling
point
(
10
mm
Hg)
between
415
E
F
and
440
E
F.

(
14)
Many
commenters
maintained
that
the
final
rule
needed
a
definition
of
the
term,

"
pasture,"
to
describe
the
relationship
between
ruminants
and
the
land
they
graze.
These
commenters
stated
that
a
meaningful
definition
of
"
pasture"
must
incorporate
the
nutritional
12
component
that
it
provides
livestock,
as
well
as
the
necessity
to
manage
the
land
in
a
manner
that
protects
the
natural
resources
of
the
operation.
We
agree
with
these
commenters
and
have
added
a
definition
of
"
pasture"
as
"
land
used
for
livestock
grazing
that
is
managed
to
provide
feed
value
and
maintain
or
improve
soil,
water,
and
vegetative
sources."

(
15)
Many
commenters
stated
that
a
definition
for
"
split
operation"
was
necessary
to
prevent
commingling
between
organic
and
nonorganic
commodities
on
operations
that
produced
or
handled
both
forms
of
a
commodity.
We
agree
with
these
comments
and
have
included
a
definition
for
"
split
operation"
as
"
an
operation
that
produces
or
handles
both
organic
and
nonorganic
agricultural
products."

Definitions
­
Changes
Requested
But
Not
Made
This
subpart
retains
from
the
proposed
rule
terms
and
their
definitions
on
which
we
received
comments
as
follows:

(
1)
Many
commenters
objected
to
the
definition
of
"
sewage
sludge"
because
it
excluded
ash
generated
in
a
sewage
sludge
incinerator
and
grit
and
screenings
generated
during
preliminary
treatment
of
domestic
sewage
in
treatment
works.
We
have
not
changed
the
definition
for
"
sewage
sludge"
because
it
provides
the
most
comprehensive
and
enforceable
description
of
the
types
of
materials
that
commenters
wanted
to
prohibit.
The
definition
for
"
sewage
sludge"
in
the
proposed
rule
arose
in
response
to
significant
public
comment
on
the
first
proposed
rule
for
national
organic
standards
(
62
Federal
Register,
No.
241)
that
recommended
prohibiting
biosolids
in
organic
production.
When
incorporating
those
comments
into
the
proposed
rule,
we
did
not
use
the
term,
"
biosolids,"
because
it
does
not
have
a
standardized
definition
under
Federal
regulations.
The
term,
"
biosolids,"
is
commonly
used
to
refer
to
"
sewage
sludge,"
which
is
the
13
regulatory
term
established
in
40
CFR
Part
503.
We
incorporated
the
precise
definition
from
40
CFR
Part
503,
even
though
it
does
not
include
ash,
grit,
or
screenings,
because
it
provided
the
clearest
description
of
the
types
of
materials
identified
in
public
comment.

While
commenters
are
correct
that
ash,
grit,
or
screenings
from
the
production
of
sewage
sludge
are
not
prohibited
by
this
definition,
these
materials
are
prohibited
elsewhere
in
the
regulation.
The
soil
fertility
and
crop
nutrient
management
practice
standard
in
section
205.203
establishes
the
universe
of
allowed
materials
and
practices.
These
allowed
materials
and
practices
are
crop
rotations,
cover
crops,
plant
and
animal
materials
(
including
their
ash),
nonagricultural,

natural
materials,
and,
under
appropriate
conditions,
mined
substances
of
low
and
high
solubility
and
synthetic
materials
included
on
the
National
List.
Ash,
grit,
or
screenings
from
the
production
of
sewage
sludge
cannot
be
included
in
any
of
these
categories
and,
therefore,
cannot
be
used
in
organic
production.
We
retained
the
definition
of
"
sewage
sludge"
because
it
most
clearly
conveys
the
wide
array
of
commercially
available
soil
amendments
that
might
be
considered
for
organic
production
but
that
the
final
rule
expressly
prohibits.
We
have
not
added
specific
exclusions
for
sewage
sludge,
ash,
grit,
or
screenings
because
these
materials
are
prohibited
through
other
provisions
in
the
practice
standard.

(
2)
The
proposed
rule
prohibited
the
handler
of
an
organic
handling
operation
from
using
ionizing
radiation
for
any
purpose.
The
vast
majority
of
commenters
agreed
with
this
prohibition
and
further
recommended
that
the
term,
"
ionizing
radiation,"
should
be
defined
to
identify
the
specific
applications
that
are
prohibited.
Most
commenters
supported
a
definition
based
on
the
FDA
requirements
in
21
CFR
part
179.26
for
the
treatment
or
processing
of
food
using
ionizing
radiation.
While
agreeing
with
the
prohibition
on
ionizing
radiation,
these
commenters
favored
14
allowing
certain
forms
of
irradiation
such
as
the
use
of
X­
rays
to
inspect
for
debris
such
as
stones
that
were
inadvertently
commingled
with
organically
handled
food.
Other
commenters
recommended
a
prohibition
on
all
forms
of
irradiation,
which
would
include
X­
rays
for
inspection
purposes,
ultraviolet
light,
and
microwaves
in
addition
to
ionizing
radiation.
Finally,
a
number
of
commenters
stated
that
ionizing
radiation
is
a
safe
and
effective
process
for
handling
food
and,

therefore,
should
not
be
prohibited
in
organic
handling.

We
have
not
added
a
definition
for
"
ionizing
radiation"
to
the
final
rule
because
we
have
incorporated
specific
references
to
the
applications
that
are
prohibited
in
the
regulatory
text.
The
final
rule
prohibits
the
handler
of
an
organic
handling
operation
from
using
ionizing
radiation
as
specified
under
21
CFR
part
179.26.
These
are
the
FDA­
approved
uses
of
ionizing
radiation
that
commenters
most
frequently
recommended
that
we
prohibit
in
organic
handling
operations.
They
include
the
use
of
cobalt­
60,
cesium­
137,
and
other
sources
of
radiation
for
the
purpose
of
controlling
microbial
contaminants,
pathogens,
and
pests
in
food
or
to
inhibit
the
growth
and
maturation
of
fresh
foods.
At
its
June
2000
meeting,
the
NOSB
recommended
prohibiting
ionizing
radiation
for
the
purpose
of
controlling
microbial
contaminants,
pathogens,
parasites,
and
pests
in
food,
preserving
a
food,
or
inhibiting
physiological
processes
such
as
sprouting
or
ripening.
The
final
rule
does
not
prohibit
the
handler
of
an
organic
handling
operation
from
using
the
FDA­
approved
applications
of
X­
rays
for
inspecting
food.
The
prohibition
on
ionizing
radiation
in
the
final
rule
is
based
solely
on
consumer
preference
as
reflected
in
the
overwhelming
public
comment
stating
that
organically
handled
foods
should
not
be
treated
in
that
manner.

(
3)
Some
commenters
recommend
that
the
final
rule
incorporate
definitions
for
the
terms,

"
food
additives,"
"
extraction
methods,"
"
incidental
additive,"
and
"
substantially
transform."
15
However,
these
terms
are
not
used
in
the
final
rule
and
do
not
require
a
definition.

Definitions
­
Clarifications
Following
our
review
of
the
definitions
provisions
in
the
proposed
rule,
we
decided
to
further
clarify
the
following
provision
in
the
final
rule:

We
were
concerned
that
"
State
entity,"
the
meaning
of
which
encompasses
both
domestic
and
foreign
political
subdivisions,
may
be
confused
with
"
State,"
the
meaning
of
which
is
limited
to
the
States
of
the
United
States,
its
territories,
the
District
of
Columbia,
and
Puerto
Rico.
To
avoid
any
possible
confusion
as
to
which
provisions
in
this
final
rule
apply
to
States
and
which
apply
to
the
broader
political
subdivisions,
we
have
replaced
the
term,
"
State
entity,"
with
the
term,
"
governmental
entity,"
while
retaining
the
same
definition
language
in
the
proposed
rule.

Subpart
B
­
Applicability
This
subpart
provides
an
overview
of
what
has
to
be
certified
under
the
National
Organic
Program
(
NOP);
describes
exemptions
and
exclusions
from
certification;
addresses
use
of
the
term,
"
organic";
addresses
recordkeeping
by
certified
production
and
handling
operations;
and
addresses
allowed
and
prohibited
substances,
methods,
and
ingredients
in
organic
production
and
handling.

Description
of
Regulations
Except
for
exempt
and
excluded
operations,
each
production
or
handling
operation
or
specified
portion
of
a
production
or
handling
operation
that
produces
or
handles
crops,
livestock,

livestock
products,
or
other
agricultural
products
that
are
intended
to
be
sold,
labeled,
or
represented
as
"
100
percent
organic,"
"
organic,"
or
"
made
with
organic
(
specified
ingredients
or
food
group(
s))"
must
be
certified.
Certified
operations
must
meet
all
applicable
requirements
of
16
these
regulations.

This
final
rule
becomes
effective
60
days
after
its
publication
in
the
Federal
Register
and
will
be
fully
implemented
18
months
after
its
effective
date.
Eighteen
months
after
the
effective
date,
all
agricultural
products
that
are
sold,
labeled,
or
represented
as
"
100
percent
organic,"

"
organic,"
or
"
made
with..."
must
be
produced
and
handled
in
compliance
with
these
regulations.

Products
entering
the
stream
of
commerce
prior
to
the
effective
date
will
not
have
to
be
relabeled.

The
U.
S.
Department
of
Agriculture
(
USDA)
seal
may
not
be
affixed
to
any
"
100
percent
organic"
or
"
organic"
product
until
18
months
after
the
final
rule's
effective
date.

We
anticipate
that
certifying
agents
and
production
and
handling
operations
will
move
as
quickly
as
possible
after
the
effective
date
of
the
final
rule
to
begin
operating
under
the
national
organic
standards.
Certifying
agents
must
begin
certifying
organic
production
and
handling
operations
to
the
national
standards
upon
receipt
of
their
accreditation
from
the
Administrator.

Any
production
or
handling
operation
or
specified
portion
of
a
production
or
handling
operation
that
has
been
already
certified
by
a
certifying
agent
on
the
date
that
the
certifying
agent
receives
its
accreditation
under
this
part
shall
be
deemed
to
be
certified
under
the
Act
until
the
operation's
next
anniversary
date
of
certification.
We
have
taken
this
approach
because
we
believe
that
such
certifying
agents
will,
upon
the
effective
date
of
the
final
rule,
demonstrate
their
eligibility
for
accreditation
by
applying
the
national
standards
to
the
certification
and
renewal
of
certification
of
their
clients.
We
also
believe
this
approach
will
provide
relief
to
certified
operations
which
might
otherwise
have
to
be
certified
twice
within
a
12­
month
period
(
prior
to
their
certifying
agent's
accreditation
and
again
following
their
certifying
agent's
accreditation).
This
relief
will
only
be
available
to
those
certified
operations
certified
by
a
certifying
agent
that
receives
its
accreditation
17
within
18
months
from
the
effective
date
of
the
final
rule.

Certifying
agents
can
apply
for
accreditation
anytime
after
the
effective
date
of
the
rule.

Applications
will
be
processed
on
a
first­
come,
first­
served
basis.
Those
certifying
agents
who
apply
for
accreditation
within
the
first
6
months
after
the
effective
date
of
the
final
rule
and
are
determined
by
the
Administrator
to
meet
the
requirements
for
accreditation
will
be
notified
of
their
status
approximately
12
months
after
the
final
rule's
effective
date.
This
approach
is
being
taken
because
of
the
market
advantage
that
could
be
realized
by
accredited
certifying
agents
if
USDA
did
not
announce
the
accreditations
simultaneously.

Exempt
and
Excluded
Operations
This
regulation
establishes
several
categories
of
exempt
or
excluded
operations.
An
exempt
or
excluded
operation
does
not
need
to
be
certified.
However,
operations
that
qualify
as
exempt
or
excluded
operations
can
voluntarily
choose
to
be
certified.
A
production
or
handling
operation
that
is
exempt
or
excluded
from
obtaining
certification
still
must
meet
other
regulatory
requirements
contained
in
this
rule
as
explained
below.

Exempt
Operations
(
1)
A
production
or
handling
operation
that
has
$
5,000
or
less
in
gross
annual
income
from
organic
sales
is
exempt
from
certification.
This
exemption
is
primarily
designed
for
those
producers
who
market
their
product
directly
to
consumers.
It
will
also
permit
such
producers
to
market
their
products
direct
to
retail
food
establishments
for
resale
to
consumers.
The
exemption
is
not
restricted
to
U.
S.
producers.
However,
as
a
practical
matter,
we
do
not
envision
any
significant
use
of
the
exemption
by
foreign
producers
because:
(
1)
the
products
from
such
operations
cannot
be
used
as
ingredients
identified
as
organic
in
processed
products
produced
by
18
another
handling
operation,
and
(
2)
it
is
unlikely
that
such
operations
will
be
selling
their
products
directly
to
consumers
in
the
United
States.

An
exempt
producer
or
handler
must
comply
with
the
labeling
requirements
of
section
205.310
and
the
organic
production
and
handling
requirements
applicable
to
its
type
of
operation.

For
example,
a
producer
of
organic
vegetables
that
performs
no
handling
functions
would
have
to
comply
with
the
labeling
requirements
of
section
205.310
and
the
applicable
production
requirements
in
sections
205.202
through
205.207.
The
labeling
and
production
and
handling
requirements
protect
the
integrity
of
organically
produced
products.

(
2)
A
retail
food
establishment
or
portion
of
a
retail
food
establishment
that
handles
organically
produced
agricultural
products
but
does
not
process
them
is
exempt
from
all
of
the
requirements
in
these
regulations.

(
3)
A
handling
operation
or
portion
of
a
handling
operation
that
handles
only
agricultural
products
containing
less
than
70
percent
organic
ingredients
by
total
weight
of
the
finished
product
(
excluding
water
and
salt)
is
exempt
from
the
requirements
in
these
regulations,
except
the
recordkeeping
provisions
of
section
205.101(
c);
the
provisions
for
prevention
of
contact
of
organic
products
with
prohibited
substances
in
section
205.272;
and
the
labeling
regulations
in
sections
205.305
and
205.310.
The
recordkeeping
provisions
maintain
an
audit
trail
for
organic
products.
The
prevention
of
contact
with
prohibited
substances
and
the
labeling
requirements
protect
the
integrity
of
organically
produced
products.

(
4)
A
handling
operation
or
portion
of
a
handling
operation
that
uses
the
word,
"
organic,"

only
on
the
information
panel
is
exempt
from
the
requirements
in
these
regulations,
except
the
recordkeeping
provisions
of
section
205.101(
c);
the
provisions
for
prevention
of
contact
of
19
organic
products
with
prohibited
substances
as
provided
in
section
205.272;
and
the
labeling
regulations
in
sections
205.305
and
205.310.
The
recordkeeping
provisions
maintain
an
audit
trail
for
organic
products.
The
prevention
of
contact
with
prohibited
substances
and
labeling
requirements
protect
the
integrity
of
organically
produced
products.

As
noted
above,
exempt
handling
operations
producing
multiingredient
products
must
maintain
records
as
required
by
section
205.101(
c).
This
would
include
records
sufficient
to:
(
1)

prove
that
ingredients
identified
as
organic
were
organically
produced
and
handled
and
(
2)
verify
quantities
produced
from
such
ingredients.
Such
records
must
be
maintained
for
no
less
than
3
years,
and
the
operation
must
allow
representatives
of
the
Secretary
and
the
applicable
State
program's
governing
State
official
access
to
the
records
during
normal
business
hours
for
inspection
and
copying
to
determine
compliance
with
the
applicable
regulations.

Excluded
Operations
(
1)
A
handling
operation
or
portion
of
a
handling
operation
that
sells
organic
agricultural
products
labeled
as
"
100
percent
organic,"
"
organic,"
or
"
made
with..."
that
are
packaged
or
otherwise
enclosed
in
a
container
prior
to
being
received
or
acquired
by
the
operation,
remain
in
the
same
package
or
container,
and
are
not
otherwise
processed
while
in
the
control
of
the
handling
operation
is
excluded
from
the
requirements
in
these
regulations,
except
for
the
provisions
for
prevention
of
commingling
and
contact
of
organic
products
with
prohibited
substances
in
section
205.272.
The
requirements
for
the
prevention
of
commingling
and
contact
with
prohibited
substances
protect
the
integrity
of
organically
produced
products.

This
exclusion
will
avoid
creating
an
unnecessary
barrier
for
handlers
who
distribute
nonorganic
products
and
who
want
to
offer
a
selection
of
organic
products.
20
(
2)
A
retail
food
establishment
or
portion
of
a
retail
food
establishment
that
processes
on
the
premises
of
the
retail
food
establishment
raw
and
ready­
to­
eat
food
from
certified
agricultural
products
labeled
as
"
100
percent
organic,"
"
organic,"
or
"
made
with..."
is
excluded
from
the
requirements
in
these
regulations,
except
for
the
provisions
for
prevention
of
contact
of
organic
products
with
prohibited
substances
as
provided
in
section
205.272
and
the
labeling
regulations
in
section
205.310.
The
prevention
of
commingling
and
contact
with
prohibited
substances
and
labeling
requirements
protect
the
integrity
of
organically
produced
products.

Excluded
retail
food
establishments
include
restaurants;
delicatessens;
bakeries;
grocery
stores;
or
any
retail
outlet
with
an
in­
store
restaurant,
delicatessen,
bakery,
salad
bar,
or
other
eatin
or
carry­
out
service
of
processed
or
prepared
raw
and
ready­
to­
eat
food.

There
is
clearly
a
great
deal
of
public
concern
regarding
the
handling
of
organic
products
by
retail
food
establishments.
We
have
not
required
certification
of
retail
food
establishments
at
this
time
because
of
a
lack
of
consensus
as
to
whether
retail
food
establishments
should
be
certified,
a
lack
of
consensus
on
retailer
certification
standards,
and
a
concern
about
the
capacity
of
existing
certifying
agents
to
certify
the
sheer
volume
of
such
businesses.
Retail
food
establishments,
not
exempt
under
the
Act,
could
at
some
future
date
be
subject
to
regulation
under
the
NOP.
Any
such
regulation
would
be
preceded
by
rulemaking
with
an
opportunity
for
public
comment.

No
retailer,
regardless
of
this
exclusion
and
the
exceptions
found
in
the
definitions
for
"
handler"
or
"
handling
operation,"
may
sell,
label,
or
provide
market
information
on
a
product
unless
such
product
has
been
produced
and
handled
in
accordance
with
the
Act
and
these
regulations.
Any
retailer
who
knowingly
sells
or
labels
a
product
as
organic,
except
in
accordance
21
with
the
Act
and
these
regulations,
will
be
subject
to
a
civil
penalty
of
not
more
than
$
10,000
per
violation
under
this
program.

Recordkeeping
Requirements
for
Certified
Operations
A
certified
operation
must
maintain
records
concerning
the
production
and
handling
of
agricultural
products
that
are
sold,
labeled,
or
represented
as
"
100
percent
organic,"
"
organic,"
or
"
made
with..."
sufficient
to
demonstrate
compliance
with
the
Act
and
regulations.
Such
records
must
be
adapted
to
the
particular
business
that
the
certified
operation
is
conducting,
fully
disclose
all
activities
and
transactions
of
the
certified
operation
in
sufficient
detail
to
be
readily
understood
and
audited,
be
maintained
for
not
less
than
5
years
beyond
their
creation,
and
be
sufficient
to
demonstrate
compliance
with
the
Act
and
regulations.
Certified
operations
must
make
the
records
required
by
this
regulation
available
for
inspection
by
authorized
representatives
of
the
Secretary,
the
applicable
State
organic
program's
(
SOP)
governing
State
official,
and
the
certifying
agent.
Access
to
such
records
must
be
provided
during
normal
business
hours.

Examples
of
Records
Each
exempt,
excluded,
and
certified
operation
should
maintain
the
records
which
demonstrate
compliance
with
the
Act
and
the
regulations
applicable
to
it
and
which
it
believes
establish
an
audit
trail
sufficient
to
prove
to
the
Secretary,
the
applicable
SOP's
governing
State
official,
and
the
certifying
agent
that
the
exempt,
excluded,
or
certified
operation
is
and
has
been
in
compliance
with
the
Act
and
regulations.

Examples
of
records
include:
application
and
supporting
documents
for
certification;

organic
system
plan
and
supporting
documents;
purchased
inputs,
including
seeds,
transplants,

livestock,
and
substances
(
fertilizers,
pesticides,
and
veterinary
biologics
consistent
with
the
22
livestock
provisions
of
subpart
C),
cash
purchase
receipts,
receiving
manifests
(
bills
of
lading),

receiving
tickets,
and
purchase
invoices;
field
records
(
planting,
inputs,
cultivation,
and
harvest);

storage
records
(
bin
register,
cooler
log);
livestock
records,
including
feed
(
cash
purchase
receipts,
receiving
manifests
(
bills
of
lading),
receiving
tickets,
purchase
invoices,
copies
of
grower
certificates),
breeding
records
(
calendar,
chart,
notebook,
veterinary
documents),

purchased
animals
documentation
(
cash
purchase
receipts,
receiving
manifests
(
bills
of
lading),

receiving
tickets,
purchase
invoices,
copies
of
grower
certificates),
herd
health
records
(
calendar,

notebook,
card
file,
veterinary
records),
and
input
records
(
cash
purchase
receipts,
written
records,
labels);
producer
invoice;
producer
contract;
receiving
manifests
(
bills
of
lading);

transaction
certificate;
producer
certificate;
handler
certificate;
weigh
tickets,
receipts,
and
tags;

receiving
tickets;
cash
purchase
receipts;
raw
product
inventory
reports
and
records;
finished
product
inventory
reports
and
records;
daily
inventories
by
lot;
records
as
to
reconditioning,

shrinkage,
and
dumping;
production
reports
and
records;
shipping
reports;
shipping
manifests
(
bills
of
lading);
paid
freight
and
other
bills;
car
manifests;
broker's
contracts;
broker's
statements;

warehouse
receipts;
inspection
certificates;
residue
testing
reports;
soil
and
water
testing
reports;

cash
receipt
journals;
general
ledgers
and
supporting
documents;
sales
journals;
accounts
payable
journals;
accounts
receivable
journals;
cash
disbursement
journals;
purchase
invoices;
purchase
journals;
receiving
tickets;
producer
and
handler
contracts;
cash
sales
receipts;
cash
purchase
journals;
sales
invoices,
statements,
journals,
tickets,
and
receipts;
account
sales
invoices;
ledgers;

financial
statements;
bank
statements;
records
of
deposit;
canceled
checks;
check
stubs;
cash
receipts;
tax
returns;
accountant's
or
other
work
papers;
agreements;
contracts;
purchase
orders;

confirmations
and
memorandums
of
sales;
computer
data;
computer
printouts;
and
compilations
23
of
data
from
the
foregoing.

Allowed
and
Prohibited
Substances
A
certified
operation
must
only
use
allowed
substances,
methods,
and
ingredients
for
the
production
and
handling
of
agricultural
products
that
are
sold,
labeled,
or
represented
as
"
100
percent
organic,"
"
organic,"
or
made
with..."
for
these
products
to
be
in
compliance
with
the
Act
and
the
NOP
regulations.
Use
of
ionizing
radiation,
sewage
sludge,
and
excluded
methods
are
prohibited
in
the
production
and
handling
of
organic
agricultural
products.

Applicability
­
Changes
Based
on
Comments
This
subpart
differs
from
the
proposal
in
several
respects
as
follows:

(
1)
Violations
of
the
Act
or
Regulations.
We
have
amended
section
205.100
by
adding
a
new
paragraph
(
c),
which
addresses
violations
of
the
Act
and
these
regulations.
A
number
of
commenters
advocated
for
provisions
within
the
final
rule
describing
what
legal
proceedings
USDA
would
conduct
against
operations
or
persons
that
violate
the
NOP.
We
agree
that
this
rule
should
include
provisions
addressing
violations
of
the
Act
and
these
regulations.
Accordingly,
we
have
added
at
section
205.100
the
misuse
of
label
provisions
and
false
statement
provisions
of
section
2120
(
7
U.
S.
C.
6519)
of
the
Act.
Specifically,
section
205.100(
c)
provides
that
persons
not
in
compliance
with
the
labeling
requirements
of
the
Act
or
these
regulations
are
subject
to
a
civil
penalty
of
not
more
than
$
10,000
per
violation
and
that
persons
making
false
statements
under
the
Act
to
the
Secretary,
a
governing
State
official,
or
an
accredited
certifying
agent
shall
be
subject
to
the
provisions
of
section
1001
of
Title
18,
United
States
Code.
The
provisions
of
the
Act
and
these
regulations
apply
to
all
operations
or
persons
that
sell,
label,
or
represent
their
agricultural
product
as
organic.
24
(
2)
Prohibition
on
Use
of
Excluded
Methods.
We
have
moved
section
205.600
from
subpart
G,
Administrative,
to
subpart
B,
Applicability,
and
replaced
paragraph
(
d),
which
referred
the
reader
to
section
205.301,
with
new
paragraphs
(
d)
through
(
g).
As
amended,
this
section,

redesignated
as
section
205.105,
includes
all
of
the
provisions
covered
under
old
section
205.600.

The
vast
majority
of
commenters
strongly
supported
the
prohibition
on
the
use
of
excluded
methods
in
organic
production
and
handling
but
raised
concerns
that
they
could
not
point
to
one
provision
that
prohibited
use
of
excluded
methods
in
all
aspects
of
organic
production
and
handling.
To
close
what
they
perceived
to
be
"
loopholes"
in
the
prohibition,

commenters
made
several
suggestions
for
inclusion
of
new
provisions
prohibiting
use
of
excluded
methods
in
particular
aspects
of
organic
production
and
handling
that
they
believed
were
not
covered
in
the
proposed
rule.
Other
commenters
pointed
to
inconsistencies
in
the
way
the
prohibition
on
use
of
excluded
methods
was
described
in
different
sections,
raising
concerns
that
these
apparent
inconsistencies
may
create
confusion
for
organic
operations,
certifiers,
and
consumers.

Although
we
intended
that
use
of
excluded
methods
would
be
prohibited
in
all
aspects
of
organic
production
and
handling,
the
structure
of
the
proposed
rule
may
not
have
made
that
clear.

We
also
share
the
concerns
that,
in
attempting
to
identify
all
aspects
of
organic
production
and
handling
where
excluded
methods
might
be
used,
we
may
inadvertently
have
left
out
some
provisions,
creating
confusion
for
organic
operations,
certifying
agents,
and
consumers
and
creating
doubt
as
to
the
scope
of
the
prohibition
on
use
of
excluded
methods.
Similarly,
to
the
extent
that
the
prohibition
on
excluded
methods
may
have
been
described
differently
in
various
sections
of
the
proposed
rule,
we
also
share
the
concern
that
these
inconsistencies
could
create
25
confusion.

As
a
result
of
these
concerns,
we
have
created
a
new
provision
in
section
205.105
that
prohibits
the
use
of
excluded
methods
(
and
ionizing
radiation
and
sewage
sludge)
generally.
This
provision
should
alleviate
perceptions
that
some
areas
of
organic
production
may
not
have
been
covered
by
the
prohibitions
in
the
proposed
rule.
It
also
allows
us
to
eliminate
from
the
regulation
most
of
the
individual
references
to
the
prohibition
on
use
of
these
methods,
thereby
eliminating
any
potential
confusion
where
these
provisions
may
have
appeared
inconsistent.

These
changes
do
not
lift
the
prohibition
on
use
of
these
methods
in
those
sections.
In
fact,
the
purpose
of
this
new
provision
is
to
make
clear
that
use
of
these
methods
is
prohibited
in
the
production
and
handling
of
organic
products.

(
3)
Animal
Vaccines.
The
proposed
rule
specifically
asked
for
public
comment
on
the
potential
impact
of
the
prohibition
on
use
of
excluded
methods
as
it
relates
to
animal
vaccines.
A
number
of
commenters
raised
concerns
that
there
may
be
some
critical
vaccines
that
are
only
available
in
forms
produced
using
excluded
methods.
Several
commenters
requested
that
we
prohibit
use
of
animal
vaccines
produced
using
excluded
methods
but
that
we
provide
for
a
temporary
exemption
until
such
time
as
vaccines
produced
without
using
excluded
methods
are
approved
for
use
on
the
National
List.
Other
commenters
requested
that
we
prohibit
use
of
vaccines
produced
using
excluded
methods
without
exception.

We
have
concluded
that
the
potential
impact
of
prohibiting
vaccines
produced
using
excluded
methods
on
animal
production
systems
is
still
unknown.
We
do
not
know
of
any
critical
animal
vaccine
that
is
only
available
in
a
form
produced
using
excluded
methods,
but
it
is
unclear
whether
producers
and
certifying
agents
are
tracking
the
possible
use
of
such
vaccines.
There
26
also
appears
to
be
no
international
consensus
on
the
use
in
organic
production
systems
of
animal
vaccines
produced
using
excluded
methods,
although
there
is
precedent
for
such
an
exemption.

European
Union
regulations,
for
example,
allow
for
use
of
animal
vaccines
produced
using
excluded
methods.

Based
on
comments
received
and
because
the
potential
impact
of
the
prohibition
on
use
of
excluded
methods
is
still
uncertain,
we
have
created
the
possibility
at
section
205.105(
e)
for
the
NOSB
to
exercise
one
very
narrow
exception
to
allow
use
of
animal
vaccines
produced
using
excluded
methods
but
only
if
they
are
explicitly
approved
on
the
National
List.
We
believe
the
issue
of
animal
vaccines
requires
further
deliberation
and
that
it
is
most
appropriate
to
consider
it
through
the
National
List
process,
which
mandates
review
by
the
NOSB
and
Technical
Advisory
Panels.
Consideration
of
animal
vaccines
produced
using
excluded
methods
is
appropriate
for
the
National
List
review
process
because
animal
vaccines,
we
believe,
are
most
appropriately
considered
synthetic
materials.
That
is
why
the
provision
is
structured
so
that
vaccines
produced
using
excluded
methods
could
only
be
used
in
organic
production
if
they
are
affirmatively
included
on
the
National
List.
We
do
not
believe
that
a
broad­
based
exemption
of
the
type
suggested
in
some
comments,
even
if
only
temporary,
is
appropriate.

The
Act
allows
use
of
animal
vaccines
in
organic
livestock
production.
Given
the
general
prohibition
on
the
use
of
excluded
methods,
however,
we
believe
that
animal
vaccines
produced
using
excluded
methods
should
not
be
allowed
without
an
explicit
consideration
of
such
materials
by
the
NOSB
and
without
an
affirmative
determination
from
the
NOSB
that
they
meet
the
criteria
for
inclusion
on
the
National
List.
It
is
for
that
reason
that
we
have
not
granted
this
request
of
commenters
but,
rather,
provided
an
opportunity
for
review
of
this
narrow
range
of
materials
27
produced
using
excluded
methods
through
the
National
List
process.

It
is
important
to
make
clear,
however,
that
this
provision
does
not
open
all
potential
applications
of
excluded
methods
to
a
case­
by­
case
review
in
the
context
of
the
National
List,
nor
are
we
proposing
that
any
particular
vaccines
be
reviewed
for
inclusion
on
the
National
List
at
this
time.
The
prohibition
on
use
of
excluded
methods
applies
across
the
board
to
all
phases
of
organic
production
and
handling.
We
are
simply
responding
to
comments
suggesting
that
a
narrow
exception
for
animal
vaccines
may
be
appropriate
and
providing
for
the
possibility
that
such
an
exception
could
be
invoked
upon
thorough
review
and
recommendation
by
the
NOSB
Applicability
­
Changes
Requested
But
Not
Made
This
subpart
retains
from
the
proposed
rule
regulations
on
which
we
received
comments
as
follows:

(
1)
Exemption
of
Handling
Operations
Producing
Multiingredient
Products.
Some
commenters
asserted
that
only
certified
handling
operations
should
be
allowed
to
identify
ingredients
in
multiingredient
products
as
organic.
These
commenters
believe
that
consumers
will
be
misled
if
noncertified
handling
operations
are
allowed
to
identify
ingredients
as
organic
even
if
the
organic
claim
is
limited
to
the
information
panel.
We
do
not
agree
with
these
assertions
and
have
retained
the
proposed
rule
provisions
that
do
not
require
handler
certification
when
a
product
only
identifies
ingredients
as
organic
within
the
information
panel.
Although
handling
operations
only
making
organic
claims
on
the
information
panel
are
exempt
from
certification,

these
operations
are
required
to
use
organic
product
from
certified
operations.
They
are
also
required
to
prevent
contact
of
organic
products
with
prohibited
substances
as
set
forth
in
section
205.272,
adhere
to
the
labeling
provisions
of
sections
205.305
and
205.310,
and
maintain
records
28
in
accordance
with
section
205.101(
c).
We
believe
consumers
will
understand
the
distinction
between
products
that
have
the
organic
nature
of
the
product
stated
on
the
principal
display
panel
and
those
that
merely
identify
an
ingredient
as
organic
on
the
information
panel.

(
2)
Retailer
Exclusion
from
Certification.
Many
commenters
objected
to
the
provisions
of
section
205.101(
b)(
2)
which
exclude
retail
food
establishments
from
certification.
These
commenters
assert
that
only
final
retailers
that
do
not
process
agricultural
products
should
be
excluded
from
certification.
There
is
clearly
a
great
deal
of
public
concern
regarding
the
handling
of
organic
products
by
retail
food
establishments.
We
have
not
required
certification
of
retail
food
establishments
at
this
time
because
of
a
lack
of
consensus
as
to
whether
retail
food
establishments
should
be
certified,
a
lack
of
condenses
on
retailer
certification
standards,
and
a
concern
about
the
capacity
of
existing
certifying
agents
to
certify
the
sheer
volume
of
such
businesses.
In
addition,
most
existing
certification
programs
do
not
include
retail
food
establishments,
and
we
do
not
believe
there
is
sufficient
consensus
to
institute
such
a
significant
expansion
in
the
scope
of
certification
at
this
time.
However,
since
a
few
States
have
established
procedures
for
certifying
retail
food
establishments,
we
will
assess
their
experience
and
continue
to
seek
consensus
on
this
issue
of
establishing
retailer
provisions
under
the
NOP.
Any
such
change
would
be
preceded
by
rulemaking
with
an
opportunity
for
public
comment.
The
exclusion
of
nonexempt
retail
food
establishments
from
this
final
rule
does
not
prevent
a
State
from
developing
an
organic
retail
food
establishment
program
as
a
component
of
its
SOP.
However,
as
with
any
component
of
an
SOP,
the
Secretary
will
review
such
components
on
a
case­
by­
case
basis.

(
3)
Producer
Exemption
Level.
Several
commenters
advocated
for
an
increase
in
the
29
producer
exemption
level
above
the
$
5,000
limit.
Comments
supporting
the
exemption
suggested
increasing
the
statutory
limit
for
qualifying
for
the
exemption
to
as
high
as
$
75,000.
Other
commenters
stated
that
all
producers
should
be
certified
and
opposed
the
exemption
even
though
it
is
required
by
the
Act.
These
commenters
were
concerned
about
maintaining
the
integrity
of
the
organic
product
and
about
the
lack
of
verification
of
the
exempt
operations.

We
have
not
increased
or
removed
the
$
5,000
producer
exemption
because
the
exemption
is
mandated
by
section
2106(
d)
(
7
U.
S.
C.
6505(
d))
of
the
Act.
Our
purpose
is
to
limit
the
financial
burdens
of
certification
on
such
operations
but
not
to
exempt
them
from
the
standards
for
organic
production
and
handling.
Accordingly,
exempt
production
and
handling
operations
must
comply
with
the
applicable
organic
production
and
handling
requirements
of
subpart
C
and
the
labeling
requirements
of
section
205.310.

Some
of
the
commenters
wanting
a
change
in
the
producer
exemption
level
suggested
that
the
NOP
add
provisions
for
restricting
these
producers
to
marketing
at
farmers
markets
or
roadside
stands.
We
disagree
with
these
comments.
While
we
believe
that
most
producers
qualifying
for
the
exemption
are
indeed
likely
to
be
small
producers
who
market
their
products
directly
to
consumers,
we
do
not
believe
it
is
in
the
best
interest
of
these
producers
to
restrict
their
market
opportunity
to
a
specific
sales
method.

A
few
comments
suggested
that
we
establish
a
sliding­
scale
certification
fee
based
upon
either
the
size
of
the
operation
or
sales
of
agricultural
product
instead
of
the
exemption.
The
NOP
does
not
establish
fees
for
certification.
Certifying
agents
may
establish
a
sliding­
scale
system
as
long
as
their
fees
are
reasonable
and
applied
in
a
consistent
and
nondiscriminatory
manner.
30
Finally,
some
commenters
expressed
concern
that
exempt
operations
were
forbidden
from
certification.
This
interpretation
is
not
correct.
Any
production
or
handling
operation,
including
an
exempt
operation,
which
makes
application
for
certification
as
an
organic
operation
and
meets
the
requirements
for
organic
certification
may
be
certified.

(
4)
Handler
exemption.
Many
commenters
disagreed
with
the
proposed
rule
provision
providing
for
an
exemption
of
$
5,000
to
handlers.
These
commenters
asked
the
NOP
to
remove
the
phrase,
"
or
handlers,"
from
the
exemption
provision.
The
commenters
argue
that
the
handler
exemption
is
not
authorized
by
the
Act.
We
disagree
with
the
commenters,
and
we
have
retained
the
handler
exemption
in
the
final
rule.
The
Act
states
that
the
exemption
is
available
to
"
persons"

selling
not
more
than
$
5,000
annually
in
value
of
agricultural
products.
The
Act's
definition
of
"
persons"
includes
handlers.
Thus,
handlers
grossing
$
5,000
or
less
qualify
for
the
exemption.

(
5)
Categories
of
Income
to
Qualify
for
an
Exemption.
Some
commenters
want
the
$
5,000
producer/
handler
exemption
to
include
all
sales
of
agricultural
products,
not
just
sales
of
organic
agricultural
products.
These
commenters
perceive
this
provision
to
be
a
loophole
for
large,
split
operations.
We
disagree
with
these
commenters,
and
we
have
retained
the
$
5,000
producer/
handler
exemption
based
upon
total
sales
of
organic
agricultural
products.
We
do
not
believe
there
is
a
significant
number
of
split
operations
which
only
gross
$
5,000
in
annual
sales
of
organic
products
and,
therefore,
qualify
for
this
exemption.
In
setting
the
exemption
levels,
the
Department
sought
to
maximize
the
benefits
to
small
producers
afforded
by
the
Act
while
setting
a
threshold
level
that
minimizes
the
potential
of
product
mislabeling.

(
6)
Limiting
Handler
Exclusions.
Many
commenters
argued
that
brokers,
distributors,

warehousers,
and
transporters
should
not
be
excluded
from
certification.
We
do
not
agree
with
31
these
commenters.
Brokers,
distributors,
warehousers
and
transporters
do
not
alter
the
product
and,
in
many
cases,
do
not
take
title
to
the
product.
Certifying
these
handlers
would
be
an
unnecessary
burden
on
the
industry.
Traditionally,
distributors
and
trucking
companies
have
been
excluded
from
State
and
private
certification
requirements.

(
7)
Recordkeeping
Requirements
for
Excluded
Operations.
Several
commenters
argued
that
excluded
operations
should
be
required
to
comply
with
the
same
recordkeeping
requirements
as
exempt
operations.
Some
commenters
expressed
concern
over
the
inability
to
verify
compliance
for
either
exempt
or
excluded
operations
and
asked
that
exempt
or
excluded
operations
be
subject
to
additional
recordkeeping
requirements.
We
disagree
with
these
commenters
and
have
retained
the
provisions
from
the
proposed
rule
on
recordkeeping
for
excluded
operations.
Given
the
nature
of
these
excluded
operations,
for
example,
operations
that
only
sell
prepackaged
organic
products,
we
believe
that
extensive
recordkeeping
requirements
would
be
an
unwarranted
regulatory
burden.

(
8)
Recordkeeping
Burden
on
Small
Certified
Operations.
Some
commenters
questioned
whether
small
certified
operations
have
the
ability
to
implement
a
recordkeeping
system
which
complies
with
the
provisions
of
section
205.103.
These
commenters
argue
that
recordkeeping
requirements
must
be
tailored
to
the
scale
of
the
operation.
We
do
not
believe
that
the
recordkeeping
requirements
as
described
in
section
205.103
conflict
with
the
suggestions
of
the
commenters.
The
recordkeeping
requirements
provide
that
the
records
must
be
adapted
to
the
particular
business
that
the
certified
operation
is
conducting
and
be
sufficient
to
demonstrate
compliance
with
the
Act
and
regulations.
It
is
USDA's
intent
that
each
production
and
handling
operation
decide
for
itself
what
recordkeeping
scheme
is
appropriate,
given
the
complexity
and
32
scope
of
the
individual
business.
These
provisions
provide
considerable
latitude
for
each
production
and
handling
operation
to
decide
what
records
are
necessary
to
demonstrate
its
compliance
with
the
Act
and
the
NOP
regulations.

(
9)
Public
Access
to
Records.
Several
commenters
asked
that
the
public
have
full
access
to
any
certifying
agent
record
on
organic
production
and/
or
handling
operations.
Other
commenters
expressed
concerns
about
certifying
agents
divulging
confidential
business
information
and
asked
that
records
containing
confidential
business
information
not
be
taken
from
the
business'
physical
location.

We
have
not
changed
this
provision.
The
recordkeeping
requirements
are
designed
to
seek
a
balance
between
the
pubic's
right
to
know
and
a
business's
right
to
retain
confidential
business
information.
Certifying
agents
must
have
access
to
certain
records
during
their
review
of
the
operation
to
determine
the
operation's
compliance
with
the
NOP.
However,
certifying
agents
are
required
to
protect
an
operation's
confidential
business
information.
Requiring
full
public
access
could
compromise
a
business'
competitive
position
and
place
an
unfair
burden
on
the
organic
industry.

(
10)
Fair
Labor
Practices
on
Organic
Farms.
Many
commenters
asked
the
NOP
to
develop
fair
labor
practice
standards
as
a
part
of
the
final
rule.
We
have
not
adopted
these
comments.
Other
statutes
cover
labor
and
worker
safety
standards.
The
Act
does
not
provide
the
authority
to
include
them
in
these
regulations.
However,
these
regulations
do
not
prohibit
certifying
agents
from
developing
a
voluntary
certification
program,
separate
from
organic
certification,
that
address
fair
labor
and
worker
safety
standards.

(
11)
"
Transitional
Organic"
Label.
Several
commenters
requested
that
the
NOP
adopt
33
regulations
on
the
conversion
of
operations
to
organic
production
and
create
a
"
transitional
organic"
label.
We
have
not
included
provisions
within
the
final
rule
that
provide
for
"
transitional
organic"
labeling.
Although
many
commenters
requested
that
we
provide
for
transition
labeling,

there
does
not
appear
to
be
sufficient
consensus
to
establish
such
a
standard
at
this
time.
Given
this
lack
of
consensus,
it
is
unclear
what
marketplace
value
such
a
label
might
have,
and
we
are
concerned
that
allowing
such
a
label
at
this
point
might
lead
to
greater
consumer
confusion
rather
than
providing
clarity.

Applicability
­
Clarifications
Clarification
is
given
on
the
following
issues
raised
by
commenters
as
follows:

(
1)
"
Genetic"
drift.
Many
commenters
raised
issues
regarding
drift
of
the
products
of
excluded
methods
onto
organic
farms.
These
commenters
were
concerned
that
pollen
drifting
from
near­
by
farms
would
contaminate
crops
on
organic
operations
and
that,
as
a
result,
organic
farmers
could
lose
the
premium
for
their
organic
products
through
no
fault
of
their
own.
Many
commenters
argued
that
we
should
use
this
rule
to
somehow
shift
the
burden
to
the
technology
providers
who
market
the
products
of
excluded
methods
or
the
nonorganic
farming
operations
that
use
their
products.
Some,
for
example,
suggested
that
this
regulation
should
require
that
the
nonorganic
operations
using
genetically
engineered
varieties
plant
buffer
strips
or
take
other
steps
to
avoid
drift
onto
organic
farms.
Others
suggested
that
the
regulation
could
provide
for
citizens'

right
to
sue
in
cases
of
drift.

While
we
understand
the
concerns
that
commenters
have
raised,
the
kind
of
remedies
they
suggested
are
outside
the
scope
of
the
Act
and
this
regulation.
The
Act
only
provides
for
the
regulation
of
organic
operations.
We
cannot
use
this
regulation
to
impose
restrictions,
such
as
34
requiring
buffer
strips
or
other
measures,
on
operations
that
are
not
covered
by
the
Act.

Similarly,
while
citizens
may
have
the
ability
to
bring
suit
under
other
laws,
the
Act
itself
does
not
provide
for
the
right
to
bring
suit
as
a
Federal
cause
of
action,
and
we
could
not
grant
it
through
this
regulation.

Drift
has
been
a
difficult
issue
for
organic
producers
from
the
beginning.
Organic
operations
have
always
had
to
worry
about
the
potential
for
drift
from
neighboring
operations,

particularly
drift
of
synthetic
chemical
pesticides.
As
the
number
of
organic
farms
increases,
so
does
the
potential
for
conflict
between
organic
and
nonorganic
operations.

It
has
always
been
the
responsibility
of
organic
operations
to
manage
potential
contact
of
organic
products
with
other
substances
not
approved
for
use
in
organic
production
systems,

whether
from
the
nonorganic
portion
of
a
split
operation
or
from
neighboring
farms.
The
organic
system
plan
must
outline
steps
that
an
organic
operation
will
take
to
avoid
this
kind
of
unintentional
contact.

When
we
are
considering
drift
issues,
it
is
particularly
important
to
remember
that
organic
standards
are
process
based.
Certifying
agents
attest
to
the
ability
of
organic
operations
to
follow
a
set
of
production
standards
and
practices
that
meet
the
requirements
of
the
Act
and
the
regulations.
This
regulation
prohibits
the
use
of
excluded
methods
in
organic
operations.
The
presence
of
a
detectable
residue
of
a
product
of
excluded
methods
alone
does
not
necessarily
constitute
a
violation
of
this
regulation.
As
long
as
an
organic
operation
has
not
used
excluded
methods
and
takes
reasonable
steps
to
avoid
contact
with
the
products
of
excluded
methods
as
detailed
in
their
approved
organic
system
plan,
the
unintentional
presence
of
the
products
of
excluded
methods
should
not
affect
the
status
of
an
organic
product
or
operation.
35
Issues
of
pollen
drift
are
also
not
confined
to
the
world
of
organic
agriculture.
For
example,
plant
breeders
and
seed
companies
must
ensure
genetic
identity
of
plant
varieties
by
minimizing
any
cross­
pollination
that
might
result
from
pollen
drift.
Under
research
conditions,

small­
scale
field
tests
of
genetically
engineered
plants
incorporate
various
degrees
of
biological
containment
to
limit
the
possibility
of
gene
flow
to
other
sexually
compatible
plants.
Federal
regulatory
agencies
might
impose
specific
planting
requirements
to
limit
pollen
drift
in
certain
situations.
Farmers
planting
nonbiotechnology­
derived
varieties
may
face
similar
kinds
of
questions
if
cross­
pollination
by
biotechnology­
derived
varieties
alters
the
marketability
of
their
crop.
These
discussions
within
the
broader
agricultural
community
may
lead
to
new
approaches
to
addressing
these
issues.
They
are,
however,
outside
the
scope
of
this
regulation
by
definition.

(
2)
Additional
NOP
Standards
for
Specific
Production
Categories.
Many
commenters
asked
that
the
NOP
include
in
the
final
rule
certification
standards
for
apiculture,
greenhouses,

mushrooms,
aquatic
species,
culinary
herbs,
pet
food,
and
minor
animal
species
(
e.
g.,
rabbits)

food.
The
NOP
intends
to
provide
standards
for
categories
where
the
Act
provides
the
authority
to
promulgate
standards.
During
the
18­
month
implementation
period,
the
NOP
intends
to
publish
for
comment
certification
standards
for
apiculture,
mushrooms,
greenhouses
and
aquatic
animals.
These
standards
will
build
upon
the
existing
final
rule
and
will
address
only
the
unique
requirements
necessary
to
certify
these
specialized
operations.

Some
of
the
other
questions
raised
by
commenters
are
already
addressed
in
the
final
rule.

For
example,
feed
for
minor
species
is
covered
by
livestock
feed
provisions
within
subpart
C
and
the
livestock
feed
labeling
provisions
within
subpart
D.
The
production
and
utilization
of
culinary
herbs,
including
herbal
teas,
is
covered
by
the
provisions
of
the
final
rule.
We
do
not
envision
36
needing
to
do
additional
rulemaking
on
these
two
categories.

Other
requests
by
commenters
have
not
been
addressed.
We
have
not
addressed
the
labeling
of
pet
food
within
this
final
rule
because
of
the
extensive
consultation
that
will
be
required
between
USDA,
the
NOSB,
and
the
pet
food
industry
before
any
standards
on
this
category
could
be
considered.

(
3)
Standards
for
Cosmetics,
Body
Care
Products,
and
Dietary
Supplements.
A
few
commenters
asked
that
the
NOP
include
in
the
final
rule
certification
standards
for
cosmetics,

body
care
products,
and
dietary
supplements.
Producers
and
handlers
of
agricultural
products
used
as
ingredients
in
cosmetics,
body
care
products,
and
dietary
supplements
could
be
certified
under
these
regulations.
Producers
and
handlers
of
these
ingredients
might
find
an
increased
market
value
for
their
products
because
of
the
additional
assurance
afforded
by
certification.
The
ultimate
labeling
of
cosmetics,
body
care
products,
and
dietary
supplements,
however,
is
outside
the
scope
of
these
regulations.

(
4)
Private
Label
Products.
Many
commenters
asked
about
the
certification
status
of
so­
called
"
private
label
products."
Private
label
products
are
items
for
which
a
retailer
contracts
with
a
processor
to
produce
the
product
to
the
retailer's
specifications
and
to
be
sold
under
the
retailer's
name.
Commenters
believe
the
proposed
rule
was
unclear
on
the
certification
requirements
for
these
products.
Any
product
labeled
as
"
100
organic,"
"
organic,"
or
"
made
with..."
must
be
certified
regardless
of
the
business
arrangements
under
which
the
product
was
produced.
When
a
retail
operation
contracts
for
the
production,
packaging,
or
labeling
of
organic
product,
it
is
the
certified
production
or
handling
operation
that
is
responsible
for
complying
with
the
applicable
organic
production
or
handling
regulations.
37
(
5)
State
Oversight
of
Exempt
and
Excluded
Operations.
Many
commenters
asked
for
clarification
on
the
State's
enforcement
responsibility
for
exempt
and
excluded
operations.
The
NOP
is
ultimately
responsible
for
the
oversight
and
enforcement
of
the
program,
including
oversight
of
exempt
and
excluded
operations
and
cases
of
fraudulent
or
misleading
labeling.
We
expect,
however,
that
States
would
want
to
monitor
for
false
claims
or
misleading
labeling
under
these
regulations
and
would
forward
any
complaints
to
the
NOP.
States
that
have
an
approved
SOP
which
includes
regulation
of
operations
excluded
under
the
NOP
would
be
required
to
enforce
those
provisions.

(
6)
Nonedible
Fibers
Products
in
the
NOP.
Some
commenters
asked
the
NOP
to
clarify
the
certification
status
of
fibers
such
as
cotton
and
flax.
The
final
rule
allows
for
certification
of
organically
produced
fibers
such
as
cotton
and
flax.
However,
the
processing
of
these
fibers
is
not
covered
by
the
final
rule.
Therefore,
goods
that
utilize
organic
fibers
in
their
manufacture
may
only
be
labeled
as
a
"
made
with..."
product;
e.
g.,
a
cotton
shirt
labeled
"
made
with
organic
cotton."

(
7)
Recordkeeping
for
Operations
That
Produce
Organic
and
Nonorganic
Product.

Several
commenters
recommended
that
"
split
operations,"
which
are
operations
producing
organic
and
nonorganic
agricultural
products,
be
required
to
maintain
separate
records.
These
commenters
believe
that
the
proposed
rule
did
not
provide
adequate
provision
for
the
maintenance
of
separate
recordkeeping.
The
provisions
within
section
205.103(
b)(
1)
and
(
b)(
2)

do
indicate
that
operations
which
produce
both
organic
and
nonorganic
agricultural
products
must
maintain
a
recordkeeping
system
that
differentiates
the
organic
portion
of
the
operations
from
the
records
related
to
other
portions
of
operations.
38
(
8)
NOP
Program
Manual.
A
few
commenters,
particularly
States,
noted
that
the
proposed
rule
made
several
references
to
program
manuals
as
a
mechanism
for
further
clarifying
certain
portions
of
the
rule.
These
commenters
asked
whether
certifying
agents
should
consider
information
contained
in
these
manuals
as
enforceable
regulations.
NOP
program
manuals
cannot
be
and
are
not
intended
to
be
the
equivalent
of
regulations.
Rather,
the
NOP
envisions
development
of
a
program
manual
to
serve
as
guidance
for
certifying
agents
regarding
implementation­
and
certification­
related
issues.
Material
contained
within
the
program
manual
will
be
designed
to
address
the
organic
agriculture
principles
of
each
final
rule
section,
as
appropriate,
and
to
offer
information
that
certifying
agents
should
consider
in
making
certification
decisions
that
will
be
reliably
uniform
throughout
the
country.
The
use
of
program
manuals
as
guidance
to
assist
in
developing
uniform
certification
decisions
is
a
standard
industry
practice,
and
the
NOP
has
compiled
examples
of
program
manuals
from
both
large
and
small
certifiers.

Because
the
NOP
intends
to
use
the
examples
it
has
acquired
as
the
basis
for
any
NOP
guidance
manual,
we
believe
that
most
certifying
agents
will
find
such
NOP
manual,
when
developed,

familiar
and
useful.
Additionally,
we
will
use
the
NOSB
public
meeting
process
to
seek
guidance
from
industry
and
the
public
on
what
information
would
be
useful
in
a
program
manual
and
to
provide
input
on
the
program
manual
as
it
is
developed.
Of
course,
if
in
developing
program
guidance,
it
appears
that
modifications
or
changes
in
the
NOP
final
rule
are
required,
such
modifications
would
be
made
through
notice
and
comment
rulemaking.

(
9)
Use
of
Products
from
Exempt
Operations
as
Organic
Ingredients.
A
few
commenters
responded
to
the
question
in
the
proposed
rule
in
which
we
asked
whether
handlers
should
be
allowed
to
identify
organically
produced
products
produced
by
exempt
production
operations
as
39
organic
ingredients.
The
proposed
rule
provided
that
all
ingredients
identified
as
organic
in
a
multiingredient
product
must
have
been
produced
by
a
production
or
handling
operation
certified
by
an
accredited
certifying
agent.

The
commenters
supported
this
position.
These
commenters
believe
that
the
potential
for
mislabeling
outweighed
any
financial
benefit
that
might
accrue
to
exempt
producers
through
expanded
market
opportunities.
We
concur,
and,
therefore,
have
retained
the
prohibition
on
using
products
produced
by
an
exempt
production
or
handling
operation
as
organic
ingredients
(
10)
Exemption
of
Handling
Operations
Producing
Multiingredient
Products.
We
have
amended
section
205.101(
a)(
3)
by
changing
"
50
percent"
to
"
70
percent"
to
make
it
consistent
with
the
amendments
to
the
labeling
provisions.
We
have
also
edited
section
205.101(
a)(
4)
for
clarification
purposes.
Additionally,
we
amended
sections
205.101(
a)(
3)
and
205.101(
a)(
4)
by
citing
the
labeling
requirements
of
section
205.305.
These
amendments
have
been
made
to
clarify
that
handling
operations
exempted
under
these
sections
are
subject
to
the
labeling
requirements
of
section
205.305.

(
11)
Production
and
Handling
in
Compliance
with
Federal
Statutes.
We
have
amended
section
205.102
by
removing
paragraph
(
c).
This
paragraph
provided
that
any
agricultural
product
that
is
sold,
labeled,
or
represented
as
"
100
percent
organic,"
"
organic,"
or
"
made
with
organic
(
specified
ingredients)"
must
be
produced
and
handled
in
compliance
with
applicable
Federal
statutes
and
their
implementing
regulations.
We
have
taken
this
action
because
the
provision
is
an
identical
restatement
of
section
2120(
f)
(
7
U.
S.
C.
6519(
f))
of
the
Act.
The
Act
makes
clear
that
all
production
and
handling
operations
are
to
comply
with
all
applicable
Federal
statutes
and
their
implementing
regulations.
Therefore,
it
is
unnecessary
to
repeat
the
requirement
40
in
these
regulations.

(
12)
Foreign
Applicants.
We
have
removed
section
205.104,
which
provided
that
the
regulations
in
this
part,
as
applicable,
apply
equally
to
domestic
and
foreign
applicants
for
accreditation,
accredited
certifying
agents,
domestic
and
foreign
applicants
for
certification
as
organic
production
or
handling
operations,
and
certified
organic
production
and
handling
operations
unless
otherwise
specified.
These
regulations,
as
written,
apply
equally
to
all
applicants
for
accreditation,
accredited
certifying
agents,
applicants
for
organic
certification,
and
certified
organic
operations.
Accordingly,
we
have
determined
that
section
205.104
is
not
necessary.

Subpart
C
­
Organic
Crop,
Wild
Crop,
Livestock,
and
Handling
Requirements
Description
of
Regulations
General
Requirements
This
subpart
sets
forth
the
requirements
with
which
production
and
handling
operations
must
comply
in
order
to
sell,
label,
or
represent
agricultural
products
as
"
100
percent
organic,"

"
organic,"
or
"
made
with
organic
(
specified
ingredients
or
food
group(
s))."
The
producer
or
handler
of
an
organic
production
or
handling
operation
must
comply
with
all
applicable
provisions
of
subpart
C.
Any
production
practice
implemented
in
accordance
with
this
subpart
must
maintain
or
improve
the
natural
resources,
including
soil
and
water
quality,
of
the
operation.

Production
and
handling
operations
which
sell,
label,
or
represent
agricultural
products
as
organic
in
any
manner
and
which
are
exempt
or
excluded
from
certification
must
comply
with
the
requirements
of
this
subpart,
except
for
the
development
of
an
organic
system
plan.

Production
and
Handling
(
General)
41
The
Organic
Food
Production
Act
of
1990
(
OFPA
or
Act)
requires
that
all
crop,
wild
crop,
livestock,
and
handling
operations
requiring
certification
submit
an
organic
system
plan
to
their
certifying
agent
and,
where
applicable,
the
State
organic
program
(
SOP).
The
organic
system
plan
is
a
detailed
description
of
how
an
operation
will
achieve,
document,
and
sustain
compliance
with
all
applicable
provisions
in
the
OFPA
and
these
regulations.
The
certifying
agent
must
concur
that
the
proposed
organic
system
plan
fulfills
the
requirements
of
subpart
C,
and
any
subsequent
modification
of
the
organic
plan
by
the
producer
or
handler
must
receive
the
approval
of
the
certifying
agent.

The
organic
system
plan
is
the
forum
through
which
the
producer
or
handler
and
certifying
agent
collaborate
to
define,
on
a
site­
specific
basis,
how
to
achieve
and
document
compliance
with
the
requirements
of
certification.
The
organic
system
plan
commits
the
producer
or
handler
to
a
sequence
of
practices
and
procedures
resulting
in
an
operation
that
complies
with
every
applicable
provision
in
the
regulations.
Accreditation
qualifies
the
certifying
agent
to
attest
to
whether
an
organic
system
plan
comports
with
the
organic
standard.
The
organic
system
plan
must
be
negotiated,
enacted,
and
amended
through
an
informed
dialogue
between
certifying
agent
and
producer
or
handler,
and
it
must
be
responsive
to
the
unique
characteristics
of
each
operation.

An
organic
system
plan
contains
six
components.
First,
the
organic
system
plan
must
describe
the
practices
and
procedures
used,
including
the
frequency
with
which
they
will
be
used,

in
the
certified
operation.
Second,
it
must
list
and
characterize
each
substance
used
as
a
production
or
handling
input,
including
the
documentation
of
commercial
availability,
as
applicable.
Third,
it
must
identify
the
monitoring
techniques
which
will
be
used
to
verify
that
the
organic
plan
is
being
implemented
in
a
manner
which
complies
with
all
applicable
requirements.
42
Fourth,
it
must
explain
the
recordkeeping
system
used
to
preserve
the
identity
of
organic
products
from
the
point
of
certification
through
delivery
to
the
customer
who
assumes
legal
title
to
the
goods.
Fifth,
the
organic
system
plan
must
describe
the
management
practices
and
physical
barriers
established
to
prevent
commingling
of
organic
and
nonorganic
products
on
a
split
operation
and
to
prevent
contact
of
organic
production
and
handling
operations
and
products
with
prohibited
substances.
Finally,
the
organic
system
plan
must
contain
the
additional
information
deemed
necessary
by
the
certifying
agent
to
evaluate
site­
specific
conditions
relevant
to
compliance
with
these
or
applicable
State
program
regulations.
Producers
or
handlers
may
submit
a
plan
developed
to
comply
with
other
Federal,
State,
or
local
regulatory
programs
if
it
fulfills
the
requirements
of
an
organic
system
plan.

The
first
element
of
the
organic
system
plan
requires
a
narrative
or
other
descriptive
format
that
identifies
the
practices
and
procedures
to
be
performed
and
maintained,
including
the
frequency
with
which
they
will
be
performed.
Practices
are
tangible
production
and
handling
techniques,
such
as
the
method
for
applying
manure,
the
mechanical
and
biological
methods
used
to
prepare
and
combine
ingredients
and
package
finished
products,
and
the
measures
taken
to
exclude
pests
from
a
facility.
Procedures
are
the
protocols
established
for
selecting
appropriate
practices
and
materials
for
use
in
the
organic
system
plan,
such
as
a
procedure
for
locating
commercially
available,
organically
produced
seed.
Procedures
reflect
the
decision­
making
process
used
to
implement
the
organic
system
plan.

By
requiring
information
on
the
frequency
with
which
production
and
handling
practices
and
procedures
will
be
performed,
the
final
rule
requires
an
organic
system
plan,
to
include
an
implementation
schedule,
including
information
on
the
timing
and
sequence
of
all
relevant
43
production
and
handling
activities.
The
plan
will
include,
for
example,
information
about
planned
crop
rotation
sequences,
the
timing
of
any
applications
of
organic
materials,
and
the
timing
and
location
of
soil
tests.
Livestock
management
practices
might
describe
development
of
a
rotational
grazing
plan
or
addition
of
mineral
supplements
to
the
feed
supply.
A
handling
operation
might
identify
steps
involved
in
locating
and
contracting
with
farmers
who
could
produce
organic
ingredients
that
were
in
short
supply.

The
second
element
that
must
be
included
in
an
organic
system
plan
is
information
on
the
application
of
substances
to
land,
facilities,
or
agricultural
products.
This
requirement
encompasses
both
natural
and
synthetic
materials
allowed
for
use
in
production
and
handling
operations.
For
natural
materials
which
may
be
used
in
organic
operations
under
specific
restrictions,
the
organic
plan
must
detail
how
the
application
of
the
materials
will
comply
with
those
restrictions.
For
example,
farmers
who
apply
manure
to
their
fields
must
document
in
their
organic
system
plans
how
they
will
prevent
that
application
from
contributing
to
water
contamination.
A
producer
and
handler
who
bases
the
selection
of
seed
and
planting
stock
material
under
section
205.204
or
an
agricultural
ingredient
under
section
205.301
on
the
commercial
availability
of
that
substance
must
provide
documentation
in
the
organic
system
plan.

The
third
element
of
the
organic
system
plan
is
a
description
of
the
methods
used
to
evaluate
its
effectiveness.
Producers
and
handlers
are
responsible
for
identifying
measurable
indicators
that
can
be
used
to
evaluate
how
well
they
are
achieving
the
objectives
of
the
operation.
For
example,
production
objectives
could
be
measured
through
regular
tallies
of
bushels
or
pounds
of
product
sold
from
the
farm
or
in
numbers
of
cases
sold
from
a
handling
operation.
Indicators
that
can
identify
changes
in
quality
or
effectiveness
of
management
44
practices
could
be
relatively
simple,
such
as
the
information
contained
in
a
standard
soil
test.
The
specific
indicators
used
to
evaluate
a
given
organic
system
plan
will
be
determined
by
the
producer
or
handler
in
consultation
with
the
certifying
agent.
Thus,
if
the
organic
system
plan
calls
for
improvements
in
soil
organic
matter
content
in
a
particular
field,
it
would
include
provisions
for
analyzing
soil
organic
matter
levels
at
periodic
intervals.
If
herd
health
improvement
is
an
objective,
factors
such
as
somatic
cell
count
or
observations
about
changes
in
reproductive
patterns
might
be
used
as
indicators.

The
fourth
element
of
the
organic
system
plan
is
a
description
of
the
recordkeeping
system
used
to
verify
and
document
an
audit
trail,
as
appropriate
to
the
operation.
For
each
crop
or
wildcrop
harvested,
the
audit
trail
must
trace
the
product
from
the
field,
farm
parcel,
or
area
where
it
is
harvested
through
the
transfer
of
legal
title.
A
livestock
operation
must
trace
each
animal
from
its
entrance
into
through
removal
from
the
organic
operation.
A
handling
operation
must
trace
each
product
that
is
handled
and
sold,
labeled,
or
represented
as
organic
from
the
receipt
of
its
constituent
ingredients
to
the
sale
of
the
processed
product.

The
fifth
element
which
must
be
included
in
an
organic
system
plan
pertains
to
split
production
or
handling
operations.
This
provision
requires
an
operation
that
produces
both
organic
and
nonorganic
products
to
describe
the
management
practices
and
physical
barriers
established
to
prevent
commingling
of
organic
and
nonorganic
products.
This
requirement
addresses
contact
of
organic
products,
including
livestock,
organic
field
units,
storage
areas,
and
packaging
to
be
used
for
organic
products,
with
prohibited
substances.

The
specific
requirements
to
be
included
in
an
organic
system
plan
are
not
listed
here.
The
accreditation
process
provides
an
assurance
that
certifying
agents
are
competent
to
determine
the
45
specific
documentation
they
require
to
review
and
evaluate
an
operation's
organic
system
plan.

Section
205.200(
a)(
6)
allows
a
certifying
agent
to
request
additional
information
needed
to
determine
that
an
organic
system
plan
meets
the
requirements
of
this
subpart.
The
site­
specific
nature
of
organic
production
and
handling
necessitates
that
certifying
agents
have
the
authority
to
determine
whether
specific
information
is
needed
to
carry
out
their
function.

Crop
Production
Any
field
or
farm
parcel
used
to
produce
an
organic
crop
must
have
been
managed
in
accordance
with
the
requirements
in
sections
205.203
through
205.206
and
have
had
no
prohibited
substances
applied
to
it
for
at
least
3
years
prior
to
harvest
of
the
crop.
Such
fields
and
farm
parcels
must
also
have
distinct,
defined
boundaries
and
buffer
zones
to
prevent
contact
with
the
land
or
crop
by
prohibited
substances
applied
to
adjoining
land.

A
producer
of
an
organic
crop
must
manage
soil
fertility,
including
tillage
and
cultivation
practices,
in
a
manner
that
maintains
or
improves
the
physical,
chemical,
and
biological
condition
of
the
soil
and
minimizes
soil
erosion.
The
producer
must
manage
crop
nutrients
and
soil
fertility
through
rotations,
cover
crops,
and
the
application
of
plant
and
animal
materials.
The
producer
must
manage
plant
and
animal
materials
to
maintain
or
improve
soil
organic
matter
content
in
a
manner
that
does
not
contribute
to
contamination
of
crops,
soil,
or
water
by
plant
nutrients,

pathogenic
organisms,
heavy
metals,
or
residues
of
prohibited
substances.
Plant
and
animal
materials
include
raw
animal
manure,
composted
plant
and
animal
materials,
and
uncomposted
plant
materials.
Raw
animal
manure
must
either
be
composted,
applied
to
land
used
for
a
crop
not
intended
for
human
consumption,
or
incorporated
into
the
soil
at
least
90
days
before
harvesting
an
edible
product
that
does
not
come
into
contact
with
the
soil
or
soil
particles
and
at
46
least
120
days
before
harvesting
an
edible
product
that
does
come
into
contact
with
the
soil
or
soil
particles.
Composted
plant
or
animal
materials
must
be
produced
through
a
process
that
establishes
an
initial
carbon­
to­
nitrogen
(
C:
N)
ratio
of
between
25:
1
and
40:
1
and
achieves
a
temperature
between
131
E
F
and
170
E
F.
Composting
operations
that
utilize
an
in­
vessel
or
static
aerated
pile
system
must
maintain
a
temperature
within
that
range
for
a
minimum
of
3
days.

Composting
operations
that
utilize
a
windrow
composting
system
must
maintain
a
temperature
within
that
range
for
a
minimum
of
15
days,
during
which
time
the
materials
must
be
turned
five
times.

In
addition
to
these
practices
and
materials,
a
producer
may
apply
a
crop
nutrient
or
soil
amendment
included
on
the
National
List
of
synthetic
substances
allowed
in
crop
production.
The
producer
may
apply
a
mined
substance
of
low
solubility.
A
mined
substance
of
high
solubility
may
only
be
applied
if
the
substance
is
used
in
compliance
with
the
annotation
on
the
National
List
of
nonsynthetic
materials
prohibited
in
crop
production.
Ashes
of
untreated
plant
or
animal
materials
which
have
not
been
combined
with
a
prohibited
substance
and
which
are
not
included
on
the
National
List
of
nonsynthetic
substances
prohibited
for
use
in
organic
crop
production
may
be
used
to
produce
an
organic
crop.
A
plant
or
animal
material
that
has
been
chemically
altered
by
a
manufacturing
process
may
be
used
only
if
it
is
included
on
the
National
List
of
synthetic
substances
allowed
for
use
in
organic
production.
The
producer
may
not
use
any
fertilizer
or
composted
plant
and
animal
material
that
contains
a
synthetic
substance
not
allowed
for
crop
production
on
the
National
List
or
use
sewage
sludge.
Burning
crop
residues
as
a
means
of
disposal
is
prohibited,
except
that
burning
may
be
used
to
suppress
the
spread
of
disease
or
to
stimulate
seed
germination.
47
The
producer
must
use
organically
grown
seeds,
annual
seedlings,
and
planting
stock.

The
producer
may
use
untreated
nonorganic
seeds
and
planting
stock
when
equivalent
organic
varieties
are
not
commercially
available,
except
that
organic
seed
must
be
used
for
the
production
of
edible
sprouts.
Seed
and
planting
stock
treated
with
substances
that
appear
on
the
National
List
may
be
used
when
an
organically
produced
or
untreated
variety
is
not
commercially
available.

Nonorganically
produced
annual
seedlings
may
be
used
when
a
temporary
variance
has
been
established
due
to
damage
caused
by
unavoidable
business
interruption,
such
as
fire,
flood,
or
frost.
Planting
stock
used
to
produce
a
perennial
crop
may
be
sold
as
organically
produced
planting
stock
after
it
has
been
maintained
under
a
system
of
organic
management
for
at
least
1
year.
Seeds,
annual
seedlings,
and
planting
stock
treated
with
prohibited
substances
may
be
used
to
produce
an
organic
crop
when
the
application
of
the
substance
is
a
requirement
of
Federal
or
State
phytosanitary
regulations.

The
producer
is
required
to
implement
a
crop
rotation,
including
but
not
limited
to
sod,

cover
crops,
green
manure
crops,
and
catch
crops.
The
crop
rotation
must
maintain
or
improve
soil
organic
matter
content,
provide
for
effective
pest
management
in
perennial
crops,
manage
deficient
or
excess
plant
nutrients,
and
control
erosion
to
the
extent
that
these
functions
are
applicable
to
the
operation.

The
producer
must
use
preventive
practices
to
manage
crop
pests,
weeds,
and
diseases,

including
but
not
limited
to
crop
rotation,
soil
and
crop
nutrient
management,
sanitation
measures,

and
cultural
practices
that
enhance
crop
health.
Such
cultural
practices
include
the
selection
of
plant
species
and
varieties
with
regard
to
suitability
to
site­
specific
conditions
and
resistance
to
prevalent
pests,
weeds,
and
diseases.
Mechanical
and
biological
methods
that
do
not
entail
48
application
of
synthetic
substances
may
be
used
as
needed
to
control
pest,
weed,
and
disease
problems
that
may
occur.
Pest
control
practices
include
augmentation
or
introduction
of
pest
predators
or
parasites;
development
of
habitat
for
natural
enemies;
and
nonsynthetic
controls
such
as
lures,
traps,
and
repellents.
Weed
management
practices
include
mulching
with
fully
biodegradable
materials;
mowing;
livestock
grazing;
hand
weeding
and
mechanical
cultivation;

flame,
heat,
or
electrical
techniques;
and
plastic
or
other
synthetic
mulches,
provided
that
they
are
removed
from
the
field
at
the
end
of
the
growing
or
harvest
season.
Disease
problems
may
be
controlled
through
management
practices
which
suppress
the
spread
of
disease
organisms
and
the
application
of
nonsynthetic
biological,
botanical,
or
mineral
inputs.
When
these
practices
are
insufficient
to
prevent
or
control
crop
pests,
weeds,
and
diseases,
a
biological
or
botanical
substance
or
a
synthetic
substance
that
is
allowed
on
the
National
List
may
be
used
provided
that
the
conditions
for
using
the
substance
are
documented
in
the
organic
system
plan.
The
producer
must
not
use
lumber
treated
with
arsenate
or
other
prohibited
materials
for
new
installations
or
replacement
purposes
that
comes
into
contact
with
soil
or
livestock.

A
wild
crop
that
is
to
be
sold,
labeled,
or
represented
as
"
100
percent
organic,"
"
organic,"

or
"
made
with
organic
(
specified
ingredients
or
food
group(
s))"
must
be
harvested
from
a
designated
area
that
has
had
no
prohibited
substances
applied
to
it
for
a
period
of
3
years
immediately
preceding
the
harvest
of
the
wild
crop.
The
wild
crop
must
also
be
harvested
in
a
manner
that
ensures
such
harvesting
or
gathering
will
not
be
destructive
to
the
environment
and
will
sustain
the
growth
and
production
of
the
wild
crop.

Livestock
Production
Any
livestock
product
to
be
sold,
labeled,
or
represented
as
organic
must
be
maintained
49
under
continuous
organic
management
from
the
last
third
of
gestation
or
hatching
with
three
exceptions.
Poultry
or
edible
poultry
products
must
be
from
animals
that
have
been
under
continuous
organic
management
beginning
no
later
than
the
second
day
of
life.
Milk
or
milk
products
must
be
from
animals
that
have
been
under
continuous
organic
management
beginning
no
later
than
1
year
prior
to
the
production
of
such
products,
except
for
the
conversion
of
an
entire,
distinct
herd
to
organic
production.
For
the
first
9
months
of
the
year
of
conversion,
the
producer
may
provide
the
herd
with
a
minimum
of
80­
percent
feed
that
is
either
organic
or
produced
from
land
included
in
the
organic
system
plan
and
managed
in
compliance
with
organic
crop
requirements.
During
the
final
3
months
of
the
year
of
conversion,
the
producer
must
provide
the
herd
feed
in
compliance
with
section
205.237.
Once
the
herd
has
been
converted
to
organic
production,
all
dairy
animals
shall
be
under
organic
management
from
the
last
third
of
gestation.
Livestock
used
as
breeder
stock
may
be
brought
from
a
nonorganic
operation
into
an
organic
operation
at
any
time,
provided
that,
if
such
livestock
are
gestating
and
the
offspring
are
to
be
organically
raised
from
birth,
the
breeder
stock
must
be
brought
into
the
organic
operation
prior
to
the
last
third
of
gestation.

Should
an
animal
be
brought
into
an
organic
operation
pursuant
to
this
section
and
subsequently
moved
to
a
nonorganic
operation,
neither
the
animal
nor
any
products
derived
from
it
may
be
sold,
labeled,
or
represented
as
organic.
Breeder
or
dairy
stock
that
has
not
been
under
continuous
organic
management
from
the
last
third
of
gestation
may
not
be
sold,
labeled,
or
represented
as
organic
slaughter
stock.
The
producer
of
an
organic
livestock
operation
must
maintain
records
sufficient
to
preserve
the
identity
of
all
organically
managed
livestock
and
all
edible
and
nonedible
organic
livestock
products
produced
on
his
or
her
operation.
50
Except
for
nonsynthetic
substances
and
synthetic
substances
included
on
the
National
List
that
may
be
used
as
feed
supplements
and
additives,
the
total
feed
ration
for
livestock
managed
in
an
organic
operation
must
be
composed
of
agricultural
products,
including
pasture
and
forage,

that
are
organically
produced.
Any
portion
of
the
feed
ration
that
is
handled
must
comply
with
organic
handling
requirements.
The
producer
must
not
use
animal
drugs,
including
hormones,
to
promote
growth
in
an
animal
or
provide
feed
supplements
or
additives
in
amounts
above
those
needed
for
adequate
growth
and
health
maintenance
for
the
species
at
its
specific
stage
of
life.

The
producer
must
not
feed
animals
under
organic
management
plastic
pellets
for
roughage
or
formulas
containing
urea
or
manure.
The
feeding
of
mammalian
and
poultry
slaughter
byproducts
to
mammals
or
poultry
is
prohibited.
The
producer
must
not
supply
animal
feed,
feed
additives,
or
feed
supplements
in
violation
of
the
Federal
Food,
Drug,
and
Cosmetic
Act.

The
producer
of
an
organic
livestock
operation
must
establish
and
maintain
preventive
animal
health
care
practices.
The
producer
must
select
species
and
types
of
livestock
with
regard
to
suitability
for
site­
specific
conditions
and
resistance
to
prevalent
diseases
and
parasites.
The
producer
must
provide
a
feed
ration
including
vitamins,
minerals,
protein,
and/
or
amino
acids,

fatty
acids,
energy
sources,
and,
for
ruminants,
fiber.
The
producer
must
establish
appropriate
housing,
pasture
conditions,
and
sanitation
practices
to
minimize
the
occurrence
and
spread
of
diseases
and
parasites.
Animals
in
an
organic
livestock
operation
must
be
maintained
under
conditions
which
provide
for
exercise,
freedom
of
movement,
and
reduction
of
stress
appropriate
to
the
species.
Additionally,
all
physical
alterations
performed
on
animals
in
an
organic
livestock
operation
must
be
conducted
to
promote
the
animals'
welfare
and
in
a
manner
that
minimizes
stress
and
pain.
51
The
producer
of
an
organic
livestock
operation
must
administer
vaccines
and
other
veterinary
biologics
as
needed
to
protect
the
well­
being
of
animals
in
his
or
her
care.
When
preventive
practices
and
veterinary
biologics
are
inadequate
to
prevent
sickness,
the
producer
may
administer
medications
included
on
the
National
List
of
synthetic
substances
allowed
for
use
in
livestock
operations.
The
producer
may
not
administer
synthetic
parasiticides
to
breeder
stock
during
the
last
third
of
gestation
or
during
lactation
if
the
progeny
is
to
be
sold,
labeled,
or
represented
as
organically
produced.
After
administering
synthetic
parasiticides
to
dairy
stock,

the
producer
must
observe
a
90­
day
withdrawal
period
before
selling
the
milk
or
milk
products
produced
from
the
treated
animal
as
organically
produced.
Every
use
of
a
synthetic
medication
or
parasiticide
must
be
incorporated
into
the
livestock
operation's
organic
system
plan
subject
to
approval
by
the
certifying
agent.

The
producer
of
an
organic
livestock
operation
must
not
treat
an
animal
in
that
operation
with
antibiotics,
any
synthetic
substance
not
included
on
the
National
List
of
synthetic
substances
allowed
for
use
in
livestock
production,
or
any
substance
that
contains
a
nonsynthetic
substance
included
on
the
National
List
of
nonsynthetic
substances
prohibited
for
use
in
organic
livestock
production.
The
producer
must
not
administer
any
animal
drug,
other
than
vaccinations,
in
the
absence
of
illness.
The
use
of
hormones
for
growth
promotion
is
prohibited
in
organic
livestock
production,
as
is
the
use
of
synthetic
parasiticides
on
a
routine
basis.
The
producer
must
not
administer
synthetic
parasiticides
to
slaughter
stock
or
administer
any
animal
drug
in
violation
of
the
Federal
Food,
Drug,
and
Cosmetic
Act.
The
producer
must
not
withhold
medical
treatment
from
a
sick
animal
to
maintain
its
organic
status.
All
appropriate
medications
and
treatments
must
be
used
to
restore
an
animal
to
health
when
methods
acceptable
to
organic
production
standards
52
fail.
Livestock
that
are
treated
with
prohibited
materials
must
be
clearly
identified
and
shall
not
be
sold,
labeled,
or
represented
as
organic.

A
livestock
producer
must
document
in
his
or
her
organic
system
plan
the
preventative
measures
he
or
she
has
in
place
to
deter
illness,
the
allowed
practices
he
or
she
will
employ
if
illness
occurs,
and
his
or
her
protocol
for
determining
when
a
sick
animal
must
receive
a
prohibited
animal
drug.
These
standards
will
not
allow
an
organic
system
plan
that
envisions
an
acceptable
level
of
chronic
illness
or
proposes
to
deal
with
disease
by
sending
infected
animals
to
slaughter.
The
organic
system
plan
must
reflect
a
proactive
approach
to
health
management,

drawing
upon
allowable
practices
and
materials.
Animals
with
conditions
that
do
not
respond
to
this
approach
must
be
treated
appropriately
and
diverted
to
nonorganic
markets.

The
producer
of
an
organic
livestock
operation
must
establish
and
maintain
livestock
living
conditions
for
the
animals
under
his
or
her
care
which
accommodate
the
health
and
natural
behavior
of
the
livestock.
The
producer
must
provide
access
to
the
outdoors,
shade,
shelter,

exercise
areas,
fresh
air,
and
direct
sunlight
suitable
to
the
species,
its
stage
of
production,
the
climate,
and
the
environment.
This
requirement
includes
access
to
pasture
for
ruminant
animals.

The
producer
must
also
provide
appropriate
clean,
dry
bedding,
and,
if
the
bedding
is
typically
consumed
by
the
species,
it
must
comply
with
applicable
organic
feed
requirements.
The
producer
must
provide
shelter
designed
to
allow
for
the
natural
maintenance,
comfort
level,
and
opportunity
to
exercise
appropriate
to
the
species.
The
shelter
must
also
provide
the
temperature
level,
ventilation,
and
air
circulation
suitable
to
the
species
and
reduce
the
potential
for
livestock
injury.
The
producer
may
provide
temporary
confinement
of
an
animal
because
of
inclement
weather;
the
animal's
stage
of
production;
conditions
under
which
the
health,
safety,
or
well­
being
53
of
the
animal
could
be
jeopardized;
or
risk
to
soil
or
water
quality.
The
producer
of
an
organic
livestock
operation
is
required
to
manage
manure
in
a
manner
that
does
not
contribute
to
contamination
of
crops,
soil,
or
water
by
plant
nutrients,
heavy
metals,
or
pathogenic
organisms
and
optimizes
nutrient
recycling.

Handling
Mechanical
or
biological
methods
can
be
used
to
process
an
agricultural
product
intended
to
be
sold,
labeled,
or
represented
as
"
100
percent
organic,"
"
organic,"
or
"
made
with
organic
ingredients"
for
the
purpose
of
retarding
spoilage
or
otherwise
preparing
the
agricultural
product
for
market.
Processed
multiingredient
products
labeled
"
100
percent
organic,"
may
only
use
wholly
organic
ingredients,
pursuant
to
paragraph
(
a)
of
section
205.301.
Nonagricultural
substances
that
are
allowed
for
use
on
the
National
List
and
nonorganically
produced
agricultural
products
may
be
used
in
or
on
"
organic"
and
"
made
with..."
products
pursuant
to
paragraphs
(
b)

and
(
c)
of
section
205.301,
respectively.
Documentation
of
commercial
availability
of
each
substance
to
be
used
as
a
nonorganic
ingredient
in
products
labeled
"
organic"
must
be
listed
in
the
organic
handling
system
plan
in
accordance
with
section
205.201.

Handlers
are
prohibited
from
using:
(
1)
ionizing
radiation
for
the
treatment
or
processing
of
foods;
(
2)
ingredients
produced
using
excluded
methods;
or
(
3)
volatile
synthetic
solvents
in
or
on
a
processed
product
or
any
ingredient
which
is
sold,
labeled,
or
represented
as
organic.
The
prohibition
on
ionizing
radiation
for
the
treatment
or
processing
of
foods
is
discussed
under
Applicability,
section
205.105.
This
rule
does
not
prohibit
an
organic
handling
operation
from
using
Food
and
Drug
Administration
(
FDA)­
approved
X­
rays
for
inspecting
packaged
foods
for
foreign
objects
that
may
be
inadvertently
commingled
in
the
packaged
product.
54
The
two
paragraphs
on
excluded
methods
and
ionizing
radiation
in
section
205.270(
c)
of
the
proposed
rule
are
replaced
with
new
paragraph
(
c)(
1)
which
cross­
references
those
practices
under
paragraphs
(
e)
and
(
f)
of
section
205.105.
New
section
205.105
clearly
specifies
that
ionizing
radiation
and
excluded
methods
are
two
practices
that
handlers
must
not
use
in
producing
organic
agricultural
products
and
ingredients.
The
prohibition
on
the
use
of
volatile
synthetic
solvents,
also
included
under
paragraph
(
c)
of
section
205.270
does
not
apply
to
nonorganic
ingredients
in
"
made
with..."
products.

The
practice
standard
for
facility
pest
management
under
section
205.271
requires
the
producer
or
handler
operating
a
facility
to
use
management
practices
to
control
and
prevent
pest
infestations.
Prevention
practices
in
paragraph
(
a)
include
removing
pest
habitats,
food
sources,

and
breeding
areas;
preventing
access
to
handling
facilities;
and
controlling
environmental
factors,

such
as
temperature,
light,
humidity,
atmosphere,
and
air
circulation,
to
prevent
pest
reproduction.
Permitted
pest
control
methods
in
paragraph
(
b)
include
mechanical
or
physical
controls,
such
as
traps,
light,
or
sound.
Lures
and
repellents
using
nonsynthetic
substances
may
be
used
as
pest
controls.
Lures
and
repellents
with
synthetic
substances
that
are
allowed
on
the
National
List
also
may
be
used.
Prevention
and
control
practices
in
paragraphs
(
a)
and
(
b)
may
be
used
concurrently.

If
the
practices
in
paragraphs
(
a)
and
(
b)
are
not
effective,
amended
paragraph
(
c)
provides
that
handlers
may
then
use
a
nonsynthetic
or
synthetic
substance
consistent
with
National
List.
If
the
measures
and
substances
provided
under
paragraphs
(
a),
(
b),
and
(
c)
are
not
effective,

synthetic
substances
not
on
the
National
List
may
be
used
to
control
pest
infestations.
Under
new
paragraph
(
d),
the
handler
and
the
operation's
certifying
agent,
prior
to
using
such
a
substance,
55
must
agree
on
the
substance
to
be
used
to
control
the
pest,
measures
to
be
taken
to
prevent
contact
with
organically
produced
product,
and
ingredients
that
may
be
in
the
handling
facility.

This
rule
recognizes
that
certain
local,
State,
and
Federal
laws
or
regulations
may
require
intervention
with
prohibited
substances
before
or
at
the
same
time
substances
allowed
in
paragraphs
(
b)
and
(
c)
are
used.
To
the
extent
that
this
occurs,
this
rule
permits
the
handler
to
follow
such
laws
and
regulations
to
market
a
product
as
organically
handled,
provided
that
the
product
does
not
come
into
contact
with
the
pest
control
substance
used.

The
extent
of
pest
infestation
cannot
be
foreseen
when
an
organic
plan
is
submitted
by
the
certified
operation
and
approved
by
the
certifying
agent.
A
handler
who
uses
any
nonsynthetic
or
synthetic
substance
to
control
facility
pests
must
update
its
organic
handling
system
plan
to
address
all
measures
taken
or
intended
to
be
taken
to
prevent
contact
between
the
substance
and
any
organically
produced
ingredient
or
finished
product.

Section
205.272
provides
additional
practice
standards
that
must
be
followed
by
an
organic
handling
operation
to
prevent
the
commingling
of
organic
and
nonorganic
products
and
to
protect
organic
products
from
contact
with
prohibited
substances.
An
organic
handling
operation
must
not
use
packaging
materials
and
storage
containers
or
bins
that
contain
a
synthetic
fungicide,

preservative,
or
fumigant
in
handling
an
organic
product.
The
operation
also
must
not
use
or
reuse
any
storage
bin
or
container
that
was
previously
in
contact
with
any
prohibited
substance
unless
the
reusable
bin
or
container
has
been
thoroughly
cleaned
and
poses
no
risk
of
prohibited
materials
contacting
the
organic
product.

Temporary
Variances
This
subpart
establishes
conditions
under
which
certified
organic
operations
may
receive
56
temporary
variances
from
the
production
and
handling
provisions
of
this
subpart.
The
Administrator
may
establish
temporary
variances
due
to:
(
1)
Natural
disasters
declared
by
the
Secretary;
(
2)
unavoidable
business
interruption
caused
by
natural
catastrophes
such
as
drought,

wind,
fire,
flood,
excessive
moisture,
hail,
tornado,
or
earthquake;
or
(
3)
to
conduct
research
on
organic
production
and
handling
techniques
or
inputs.
An
SOP's
governing
State
official
or
a
certifying
agent
may
recommend
that
the
Administrator
establish
a
temporary
variance
for
various
reasons
including
an
unavoidable
business
interruption.
The
Administrator
will
determine
how
long
a
temporary
variance
will
be
in
effect
at
the
time
it
is
established,
subject
to
such
extension
as
the
Administrator
deems
necessary.
Temporary
variances
may
not
be
issued
to
allow
use
of
any
practice,
material,
or
procedure
which
is
prohibited
under
section
205.105.

The
proposed
rule
inadvertently
omitted
the
SOP's
governing
State
official
as
having
authority
to
recommend
a
temporary
variance
to
the
Administrator.
We
have
added
that
authority
in
paragraph
(
b)
of
section
205.290.

Upon
notification
by
the
Administrator
that
a
temporary
variance
has
been
established,
the
certifying
agent
must
inform
each
production
and
handling
operation
it
certifies
that
may
be
affected
by
the
temporary
variance.
For
example,
if
a
drought
causes
a
severe
shortage
of
organically
produced
hay,
a
dairy
operation
may
be
permitted
to
substitute
some
nonorganic
hay
for
a
portion
of
the
herd's
diet
to
prevent
liquidation
of
the
herd.
The
producer
must
keep
records
showing
the
source
and
amount
of
the
nonorganic
hay
used
and
the
timeframe
needed
to
restore
the
total
feed
ration
to
organic
sources.
The
certifying
agent
may
require
that
the
next
organic
plan
include
contingency
measures
to
avoid
the
need
to
resort
to
nonorganic
feed
in
case
of
a
future
shortage.
57
General
­
Changes
Based
on
Comments
This
subpart
differs
from
the
proposal
in
several
respects
as
follows:

(
1)
Maintain
or
Improve
Provision
for
Production
Operations
Only.
A
number
of
commenters
questioned
whether
the
requirement
in
the
proposed
rule
that
an
operation
must
"
maintain
or
improve
the
natural
resources
of
the
operation,
including
soil
and
water
quality"

applied
to
handling
as
well
as
production
operations.
They
stated
that
handling
operations
are
not
integrated
into
natural
systems
the
way
that
production
systems
are.
As
a
result,
these
commenters
were
uncertain
how
handlers
could
fulfill
the
"
maintain
or
improve"
requirement.

The
"
maintain
or
improve"
requirement
addresses
the
impact
of
a
production
operation
on
the
natural
resource
base
that
sustains
it
and,
as
such,
does
not
apply
to
handling
operations.
We
have
modified
the
final
rule
in
section
205.200
by
limiting
the
"
maintain
or
improve"
requirement
to
production
practices.

(
2)
Management
Practices
and
Physical
Barriers
to
Prevent
Commingling.
Many
commenters,
including
numerous
certifying
agents,
stated
that
the
proposed
provisions
for
an
organic
system
plan
were
not
adequate
for
the
task
of
certifying
an
operation
that
produces
both
organic
and
nonorganic
products.
The
commenters
requested
that
the
final
rule
incorporate
the
provisions
established
in
the
OFPA
for
certifying
these
split
operations.
These
provisions
include
separate
recordkeeping
for
the
organic
and
nonorganic
operations
and
the
implementation
of
protective
practices
to
prevent
the
commingling
of
product
and
the
unintentional
contact
of
organic
product
with
prohibited
substances.
We
have
amended
the
provisions
for
an
organic
system
plan
in
section
205.201(
a)(
5)
to
require
greater
accountability
regarding
the
segregation
of
organic
and
nonorganic
products
in
a
split
operation.
The
changes
we
made
incorporate
language
58
from
the
OFPA
("
physical
facilities,
management
practices")
to
provide
clear
criteria
for
producers,
handlers
and
certifying
agents
to
agree
upon
an
organic
system
plan
that
protects
the
integrity
of
organic
product.

(
3)
Commercial
Availability.
The
proposed
rule
required
that
a
raw
or
processed
agricultural
product
sold,
labeled,
or
represented
as
organic
must
contain
not
less
than
95
percent
organically
produced
raw
or
processed
agricultural
product.
Additionally,
section
205.606
of
the
proposed
rule
allowed
any
nonorganically
produced
agricultural
product
to
be
used
in
the
5
percent
nonorganic
component
of
an
agricultural
product
sold,
labeled,
or
represented
as
organic.

Many
commenters
objected
to
these
provisions
and
recommended
that
nonorganically
produced
agricultural
products
should
only
be
allowed
in
an
organic
product
when
the
organically
produced
form
was
not
commercially
available.
Commenters
stated
that
allowing
nonorganically
produced
agricultural
products
within
the
5
percent
would
significantly
weaken
demand
for
many
organically
produced
commodities,
especially
herbs
and
spices.
These
commenters
stated
that
herbs
and
spices
often
constitute
less
than
5
percent
of
the
ingredients
in
a
raw
or
processed
agricultural
product
and
that
handlers
producing
an
organic
product
would
instinctively
seek
out
the
less
expensive
nonorganic
variety.
They
also
indicated
that
the
5
percent
component
is
an
important
market
for
many
products
produced
from
organically
produced
livestock,
such
as
milk
derivatives
and
meat
by­
products,
that
are
not
typically
marketed
directly
to
consumers.

Commenters
stated
that
the
preponderance
of
current
certification
programs
use
the
commercial
availability
criterion
when
determining
whether
a
nonorganically
produced
agricultural
product
may
be
used
within
the
5
percent
component.
Commenters
cited
the
National
Organic
Standards
Board's
(
NOSB)
recommendation
that
organic
agricultural
products
be
used
in
this
5
percent
59
component
unless
they
are
commercially
unavailable
and
requested
that
the
final
rule
incorporate
the
criteria
for
determining
commercial
availability
that
accompanied
that
NOSB
recommendation.

We
agree
with
commenters
that
a
preference
for
organically
produced
agricultural
commodities,
when
commercially
available,
can
benefit
organic
producers,
handlers,
and
consumers
in
a
variety
of
ways.
We
believe
that
the
commercial
availability
requirement
may
allow
consumers
to
have
confidence
that
processed
products
labeled
as
"
organic"
contain
the
highest
feasible
percentage
of
organic
ingredients.
Some
producers
may
benefit
from
any
market
incentive
to
supply
organically
produced
minor
ingredients
that
handlers
need
for
their
processed
products.
We
recognize
that
the
provision
does
impose
an
additional
requirement
on
handlers
who
must
ascertain
whether
the
agricultural
ingredients
they
use
are
commercially
available
in
organic
form.
The
NOSB
recommended
that
the
final
rule
contain
a
commercial
availability
provision
based
upon
the
guidelines
developed
by
the
American
Organic
Standards
project
of
the
Organic
Trade
Association.
For
these
reasons,
we
have
amended
the
final
rule
to
require
that
an
agricultural
commodity
used
as
an
ingredient
in
a
raw
or
processed
product
labeled
as
organic
must
be
organic
when
the
ingredient
is
commercially
available
in
an
organic
form.

While
recognizing
the
potential
benefits
of
applying
the
commercial
availability
standard
to
all
agricultural
ingredients
in
a
processed
product,
we
are
concerned
that
enforcing
this
provision
could
impose
an
excessive
burden
on
handlers.
Although
many
commenters
stated
that
some
existing
certifying
agents
apply
a
commercial
availability
standard,
we
do
not
have
complete
information
on
the
criteria
used
by
these
certifying
agents,
and
we
are
unsure
whether
a
consensus
exists
on
criteria
for
commercial
availability
within
the
organic
community.
Additionally,
we
are
60
concerned
that,
unless
the
standard
is
clearly
articulated
and
consistently
interpreted
and
enforced,

it
will
not
be
effective.
Disagreement
among
certifying
agents
regarding
when
and
under
what
circumstances
an
ingredient
is
commercially
available
would
undermine
our
intent
to
create
an
equitable
and
enforceable
standard.

AMS
is
soliciting
additional
comment
and
information
on
a
number
of
issues
concerning
the
development
of
standards
for
the
commercial
availability
of
organically
produced
agricultural
commodities
used
in
processed
products
labeled
as
"
organic."
On
the
basis
of
these
comments
and
information
and
additional
recommendations
that
the
NOSB
may
develop,
AMS
will
develop
a
commercial
availability
standard
for
use
in
implementing
the
final
rule.
AMS
intends
to
develop
the
commercial
availability
standard
and
incorporate
it
within
the
final
rule
prior
to
the
commencement
of
certification
activities
by
accredited
certifying
agents.
This
approach
will
provide
organic
handlers
and
certifying
agents
the
standard
necessary
to
incorporate
the
consideration
of
commercial
availability
of
ingredients
in
an
organic
system
plan
at
the
time
that
the
USDA
organic
standard
comes
into
use.
Specifically,
AMS
requests
comments
and
information
addressing
the
following
questions:

What
factors,
such
as
quantity,
quality,
consistency
of
supply,
and
expense
of
different
sources
of
an
ingredient,
should
be
factored
into
the
consideration
of
commercial
availability?

What
relative
importance
should
each
of
these
factors
possess,
and
are
there
circumstances
under
which
the
relative
importance
can
change?

What
activities
and
documentation
are
sufficient
to
demonstrate
that
a
handler
has
taken
appropriate
and
adequate
measures
to
ascertain
whether
an
ingredient
is
commercially
available?

How
can
AMS
ensure
the
greatest
possible
degree
of
consistency
in
the
application
of
the
61
commercial
availability
standard
among
multiple
certifying
agents?

Could
potentially
adverse
effects
of
a
commercial
availability
standard,
such
as
uncertainty
over
the
cost
and
availability
of
essential
ingredients,
impact
or
impede
the
development
of
markets
for
organically
processed
products?

What
economic
and
administrative
burdens
are
imposed
by
the
commercial
availability
standards
found
in
existing
organic
certification
programs?

How
would
producers
benefit
from
market
incentives
to
increase
use
of
organic
ingredients
that
result
from
a
commercial
availability
standard?

Would
lack
of
a
commercial
availability
standard
provide
a
disincentive
for
handlers
of
products
labeled
"
organic"
to
seek
out
additional
organic
minor
ingredients?
What
impacts
could
this
have
on
producers
of
minor
ingredients?

AMS
welcomes
any
new
or
unpublished
research
results
or
information
that
exists
concerning
a
commercial
availability
standard.
AMS
specifically
invites
comment
from
establishments
which
currently
operate
using
commercial
availability
or
a
comparable
provision
in
the
conduct
of
their
business.
AMS
will
receive
comment
on
this
issue
until
90
days
after
publication
of
the
final
rule.

(
4)
Conservation
of
Biodiversity.
Many
commenters
recommended
amending
the
definition
of
organic
production
to
include
the
requirement
that
an
organic
production
system
must
promote
or
enhance
biological
diversity
(
biodiversity).
Commenters
stated
that
the
definitions
for
organic
production
developed
by
the
NOSB
and
the
Codex
Commission
include
this
requirement.
We
agree
with
these
commenters
and
have
amended
the
definition
of
organic
production
to
require
that
a
producer
must
conserve
biodiversity
on
his
or
her
operation.
The
use
62
of
"
conserve"
establishes
that
the
producer
must
initiate
practices
to
support
biodiversity
and
avoid,
to
the
extent
practicable,
any
activities
that
would
diminish
it.
Compliance
with
the
requirement
to
conserve
biodiversity
requires
that
a
producer
incorporate
practices
in
his
or
her
organic
system
plan
that
are
beneficial
to
biodiversity
on
his
or
her
operation.

General
­
Changes
Requested
But
Not
Made
This
subpart
retains
from
the
proposed
rule
regulations
on
which
we
received
comments
as
follows:

Organic
Plan
Excessively
Restrictive.
One
organic
inspector
was
concerned
that
the
requirements
of
the
organic
system
plan
were
too
prescriptive
and
would
create
an
excessive
paper
work
burden
for
producers
and
handlers.
The
commenter
stated
that
the
excessive
specificity
of
certain
requirements
(
composition
and
source
of
every
substance
used),
combined
with
the
ambiguity
of
others
(
soil
and
tissue
testing
required
but
with
no
mention
of
the
frequency),
would
confuse
the
working
relationship
between
a
producer
or
handler
and
his
or
her
certifying
agent.
The
commenter
was
concerned
that
strict
adherence
to
the
specifications
in
the
organic
system
plan
would
compromise
the
ability
of
producers
and
handlers
to
run
their
businesses.
While
agreeing
that
flexibility
in
the
development
of
the
organic
system
plan
was
valuable,
the
commenter
stated
that
producers
and
handlers,
not
the
certifying
agent,
must
retain
the
primary
managerial
role
for
their
operation.
Other
commenters
maintained
that
the
organic
system
plan
requirements
were
too
ambiguous
and
would
inhibit
certifying
agents'
efforts
to
review
necessary
information.
For
example,
a
trade
association
commented
that
the
absence
of
specific
recordkeeping
requirements
for
livestock
feed
materials,
medications,
and
health
care
activities
would
impair
compliance
monitoring.
63
The
provisions
for
an
organic
system
plan
were
one
of
the
most
significantly
revised
components
of
the
proposed
rule,
and,
with
minor
changes
related
to
split
operations,
we
have
retained
them
in
the
final
rule.
These
provisions
provide
ample
discretion
for
producers,
handlers,

and
certifying
agents
to
perform
their
duties
while
recognizing
that
mutual
consent
is
a
prerequisite
for
them
to
meet
their
responsibilities.
The
organic
system
plan
enables
producers
and
handlers
to
propose
and
certifying
agents
to
approve
site
and
operation­
specific
practices
that
fulfill
all
applicable
program
requirements.
Producers
and
handlers
retain
the
authority
to
manage
their
operations
as
they
deem
necessary,
but
any
actions
they
undertake
that
modify
their
organic
system
plan
must
be
approved
by
the
certifying
agent.
With
regard
to
recordkeeping,
certifying
agents
are
authorized
to
require
the
additional
information,
such
as
the
livestock
records
mentioned
in
the
comment,
that
they
deem
necessary
to
evaluate
compliance
with
the
regulations.

One
certifying
agent
stated
that
the
requirement
to
maintain
or
improve
the
natural
resources
of
the
operation
was
worthy
in
principle
but
unreasonable
to
achieve.
This
commenter
stated
that
the
long­
term
consequences
of
an
organic
system
plan
could
not
be
foreseen
and
recommended
requiring
that
producers
"
must
endeavor"
to
maintain
or
improve
the
operation's
natural
resources.
We
have
not
changed
this
requirement
because
the
vast
majority
of
commenters
supported
an
organic
system
plan
that
mandated
the
"
maintain
or
improve"
principle.

A
good
working
relationship
between
the
producer
and
his
or
her
certifying
agent,
including
the
annual
inspection
and
accompanying
revisions
to
the
organic
system
plan,
can
rectify
the
unforeseen
and
unfavorable
conditions
that
arise.

Crop
Production
­
Changes
Based
on
Comments
This
subpart
differs
from
the
proposal
in
several
respects
as
follows:
64
(
1)
Crop
nutrient
management.
The
fundamental
requirement
of
the
soil
fertility
and
crop
nutrient
management
practice
standard,
that
tillage,
cultivation,
and
nutrient
management
practices
maintain
or
improve
the
physical,
chemical,
and
biological
condition
of
the
soil
and
minimize
erosion,
remains
unaltered.
The
proposed
rule
required
that
a
producer
budget
crop
nutrients
by
properly
utilizing
manure
or
other
animal
and
plant
materials,
mined
substances
of
low
or
high
solubility,
and
allowed
synthetic
amendments.
Many
commenters
disagreed
with
using
the
term,
"
budget,"
which
they
considered
too
limiting
to
characterize
nutrient
management
in
organic
systems.
These
commenters
recommended
that
the
practice
standard
instead
emphasize
the
diverse
practices
used
in
organic
systems
to
cycle
nutrients
over
extended
periods
of
time.

We
agree
with
these
commenters
and
have
amended
the
final
rule
to
require
that
producers
manage
crop
nutrients
and
soil
fertility
through
the
use
of
crop
rotations
and
cover
crops
in
addition
to
plant
and
animal
materials.
Additionally,
we
clarified
that
producers
may
manage
crop
nutrients
and
soil
fertility
by
applying
mined
substances
if
they
are
used
in
compliance
with
the
conditions
established
in
the
National
List.
Finally,
we
removed
the
word,

"
waste,"
from
our
description
of
animal
and
plant
materials
in
the
proposed
rule
to
emphasize
the
importance
of
these
resources
in
organic
soil
fertility
management.

(
2)
Compost
Practice
Standard.
The
proposed
rule
required
that
a
composted
material
used
on
an
organic
operation
must
be
produced
at
a
facility
in
compliance
with
the
Natural
Resource
Conservation
Service
(
NRCS)
practice
standard.
While
many
commenters
agreed
with
the
need
for
greater
oversight
of
the
feedstocks
and
procedures
used
to
produce
compost,
most
stated
that
the
NRCS
practice
standard
would
not
be
suitable
for
this
purpose.
Commenters
65
stated
that
the
requirements
in
the
NRCS
practice
standard
were
not
designed
for
organic
operations
and
would
prohibit
many
established,
effective
composting
systems
currently
used
by
organic
producers.
For
example,
adoption
of
the
NRCS
practice
standard
would
prevent
producers
from
using
nonfarm
wastes
as
compost
feedstocks.
Materials
such
as
food
processing
by­
products
and
leaves
from
curbside
collection
programs
have
long
been
used
with
beneficial
results.

Commenters
also
stated
that
the
minimum
acceptable
requirements
for
the
design,

construction,
and
operation
of
a
composting
facility
contained
in
the
practice
standard
were
appropriate
for
a
voluntary
cost
share
program
but
were
excessive
as
a
compliance
requirement
for
organic
certification.
Commenters
questioned
whether
producers
could
justify
the
investment
of
time
and
resources
needed
to
comply
with
the
multiple
design
and
operation
criteria
specified
in
the
NRCS
practice
standard.

We
agree
with
commenters
who
stated
that,
given
the
diversity
of
composting
systems
covered
by
a
national
organic
standard,
requiring
full
compliance
with
the
NRCS
practice
standard
would
be
overly
prescriptive.
We
maintain,
however,
that
implementation
of
the
OFPA
requires
a
rigorous,
quantitative
standard
for
the
production
of
compost.
The
OFPA
contains
significant
restrictions
on
applying
raw
manure
that
are
reflected
in
the
soil
fertility
and
crop
nutrient
management
practice
standard.
These
restrictions
pertain
to
raw
manure
and
do
not
apply
once
fresh
animal
materials
are
transformed
into
a
composted
material.
An
organic
producer
using
a
composted
material
containing
manure
must
comply
with
the
nutrient
cycling
and
soil
and
water
conservation
provisions
in
his
or
her
organic
system
plan
but
is
not
constrained
by
the
restrictions
that
apply
to
raw
manure.
Therefore,
producers
intending
to
apply
soil
66
amendments
will
require
clear
and
verifiable
criteria
to
differentiate
raw
manure
from
composted
material.
We
developed
the
requirements
in
the
final
rule
for
producing
an
allowed
composted
material
by
integrating
standards
used
by
the
Environmental
Protection
Agency
(
EPA)
and
USDA's
Natural
Resources
Conservation
Service
(
NRCS).
The
requirements
for
the
carbon­

tonitrogen
(
C:
N)
ratio
for
composting
materials
are
the
same
as
that
found
in
the
NRCS
practice
standard
for
a
composting
facility.
The
time
and
temperature
requirements
for
in­
vessel,
static
aerated
pile,
and
windrow
composting
systems
are
consistent
with
that
EPA
regulates
under
40
CFR
Part
503
for
the
production
of
Class
A
sewage
sludge.
Additionally,
AMS
reviewed
these
compost
production
requirements
with
USDA's
Agricultural
Research
Service
(
ARS).

The
conditions
in
the
final
rule
for
producing
an
allowed
composted
material
begin
with
the
selection
of
appropriate
feedstocks.
The
producer's
first
responsibility
is
to
identify
the
source
of
the
feedstocks
used
in
the
composting
system.
This
requirement
ensures
that
only
allowed
plant
and
animal
materials
are
included
in
the
composting
process,
that
they
are
not
contaminated
with
prohibited
materials,
and
that
they
are
incorporated
in
quantities
suitable
to
the
design
of
the
composting
system.
Certifying
agents
will
exercise
considerable
discretion
for
evaluating
the
appropriateness
of
potential
feedstock
materials
and
may
require
testing
for
prohibited
substances
before
allowing
their
use.
For
example,
a
certifying
agent
could
require
a
producer
to
monitor
off­
farm
inputs
such
as
leaves
collected
through
a
municipal
curbside
program
or
organic
wastes
from
a
food
processing
facility.
Monitoring
may
be
necessary
to
protect
against
contamination
from
residues
of
prohibited
substances,
such
as
motor
oil
or
heavy
metals,
or
gross
inert
materials
such
as
glass
shards
that
can
enter
the
organic
waste
stream.

The
final
rule
further
requires
that
the
producer
adhere
to
quantitative
criteria
when
67
combining
and
managing
the
plant
and
animal
materials
that
are
being
composted.
When
combining
feedstocks
to
initiate
the
process,
producers
must
establish
a
C:
N
ratio
of
between
25:
1
and
40:
1.
This
range
allows
for
very
diverse
combinations
of
feedstock
materials
while
ensuring
that,
when
properly
managed,
the
composting
process
will
yield
high
quality
material.

While
some
commenters
maintained
that
specifying
any
C:
N
ratio
in
the
final
rule
would
be
too
restrictive,
it
would
be
far
more
problematic
not
to
establish
a
range.
The
25:
1
to
40:
1
range
ensures
that
producers
will
establish
appropriate
conditions
under
which
the
additional
requirements
in
this
practice
standard,
most
notably
the
time
and
temperature
criteria,
can
be
achieved
with
minimal
producer
oversight.
Composting
operations
using
a
C:
N
ratio
lower
than
25:
1
require
increasingly
intensive
management
as
the
ratio
drops
due
to
the
risk
of
putrefaction.

Operations
in
excess
of
the
40:
1
range
may
achieve
the
minimum
temperature
but
are
likely
to
drop
off
quickly
and
result
in
a
finished
material
that
is
inadequately
mature
and
deficient
in
nitrogen.
The
producer
is
not
required
to
perform
a
physical
analysis
of
each
feedstock
component
if
he
or
she
can
demonstrate
that
an
estimated
value
is
reliable.
For
example,

estimates
of
the
carbon
and
nitrogen
content
in
specific
manures
and
plant
materials
are
generally
recognized.
Other
feedstocks
of
consistent
quality
may
be
tested
once
and
assumed
to
approximate
that
value.

The
producer
must
develop
in
his
or
her
organic
system
plan
the
management
strategies
and
monitoring
techniques
to
be
used
in
his
or
her
composting
system.
To
produce
an
allowed
composted
material,
the
producer
must
use
an
in­
vessel,
static
aerated
pile,
or
windrow
composting
system.
Producers
using
an
in­
vessel
or
static
aerated
pile
system
must
document
that
the
composting
process
achieved
a
temperature
between
131
E
F
and
170
E
F
and
maintained
68
that
level
for
a
minimum
of
3
days.
Producers
using
a
windrow
composting
system
must
document
that
the
composting
process
achieved
a
temperature
between
131
E
F
and
170
E
F
and
maintained
that
level
for
a
minimum
of
15
days.
Compost
produced
using
a
windrow
system
must
be
turned
five
times
during
the
process.
These
time
and
temperature
requirements
are
designed
to
minimize
the
risk
from
human
pathogens
contained
in
the
feedstocks,
degrade
plant
pathogens
and
weed
seeds,
and
ensure
that
the
plant
nutrients
are
sufficiently
stabilized
for
land
application.

The
final
rule
does
not
contain
provisions
for
the
use
of
materials
commonly
referred
to
as
"
compost
teas."
A
compost
tea
is
produced
by
combining
composted
plant
and
animal
materials
with
water
and
a
concentrated
nutrient
source
such
as
molasses.
The
moisture
and
nutrient
source
contribute
to
a
bloom
in
the
microbial
population
in
the
compost,
which
is
then
applied
in
liquid
form
as
a
crop
pest
or
disease
control
agent.
The
microbial
composition
of
compost
teas
are
difficult
to
ascertain
and
control
and
we
are
concerned
that
applying
compost
teas
could
impose
a
risk
to
human
health.
Regulation
of
compost
teas
was
not
addressed
in
the
proposed
rule.
The
National
Organic
Program
(
NOP)
will
request
additional
input
from
the
NOSB
and
the
agricultural
research
community
before
deciding
whether
these
materials
should
be
prohibited
in
organic
production
or
whether
restrictions
on
their
use
are
appropriate.

In
addition
to
managing
crop
nutrients
with
raw
manure
and
composted
plant
and
animal
materials,
a
producer
may
use
uncomposted
plant
materials.
These
are
materials
derived
exclusively
from
plant
sources
that
a
producer
manages
in
a
manner
that
makes
them
suitable
for
application
in
a
cropping
system.
For
example,
plant
materials
that
are
degraded
and
stabilized
through
a
vermicomposting
process
may
be
used
as
a
soil
fertility
and
crop
nutrient
amendment.

(
3)
Mined
Substances
of
High
Solubility.
The
proposed
rule
treated
mined
substances
of
69
high
solubility
as
a
single
category
of
soil
amendment
and
allowed
their
use
where
warranted
by
soil
and
crop
tissue
testing.
Many
commenters
objected
to
the
general
allowance
for
this
category
of
substances
and
were
particularly
disappointed
that
the
NOSB
annotations
on
two
such
materials,
sodium
(
Chilean)
nitrate
and
potassium
chloride,
were
not
included.
Commenters
cited
the
potential
detrimental
effects
of
these
highly
soluble
and
saline
substances
on
soil
quality
and
stated
that
several
international
organic
certification
programs
severely
prescribe
or
prohibit
their
use.
One
certifying
agent
recommended
that
natural
substances
of
high
solubility
and
salinity
be
handled
comparably
to
similar
synthetic
materials
such
as
liquid
fish
products
and
humic
acids
that
appear
on
the
National
List,
complete
with
their
original
NOSB
annotations.

At
its
June
2000
meeting,
the
NOSB
recommended
that
the
NOP
delete
general
references
to
mined
substances
of
high
solubility
from
the
final
rule,
and
incorporate
the
NOSB's
specific
annotations
for
materials
of
this
nature.
We
have
adopted
this
recommendation
by
retaining
a
place
for
mined
substances
of
high
solubility
in
the
soil
fertility
and
crop
nutrient
management
practice
standard
but
restricting
their
use
to
the
conditions
established
for
the
material
as
specified
on
the
National
List
of
prohibited
natural
substances.
Under
this
approach,
mined
substances
of
high
solubility
are
prohibited
unless
used
in
accordance
with
the
annotation
recommended
by
the
NOSB
and
added
by
the
Secretary
to
the
National
List.
We
deleted
the
provision
from
the
proposed
rule
that
use
of
the
substance
be
"
justified
by
soil
or
crop
tissue
analysis."
The
final
rule
contains
two
materials­­
sodium
nitrate
and
potassium
chloride­­
that
may
be
used
in
organic
crop
production
with
the
annotations
developed
the
NOSB.

While
"
mined
substances
of
high
solubility"
is
not
a
discrete,
recognized
category
such
as
crop
nutrients,
the
proposed
rule
mentioned
sodium
nitrate,
potassium
chloride,
potassium
nitrate
70
(
niter),
langbeinite
(
sulfate
of
potash
magnesia),
and
potassium
sulfate
in
this
context.
Based
on
the
recommendation
of
the
NOSB,
the
final
rule
would
prohibit
use
of
these
materials,
unless
the
NOSB
developed
recommendations
on
conditions
for
their
use
and
the
Secretary
added
them
to
the
National
List.
The
NOP
would
welcome
further
guidance
from
the
NOSB
on
these
materials.

(
4)
Burning
crop
residues.
The
proposed
rule
prohibited
burning
as
a
means
of
crop
disposal,
except
for
burning
prunings
from
perennial
crops
to
suppress
the
spread
of
disease.

Many
commenters
supported
the
principle
behind
the
prohibition
but
maintained
that
the
proposed
language
was
too
restrictive
and
would
preclude
certain
beneficial
agronomic
practices.

Several
producers
stated
that
the
proposed
rule
would
prevent
them
from
collecting
and
burning
residues
from
diseased
annual
crops,
which
they
felt
was
an
effective
and
beneficial
practice.

Other
producers
cited
their
use
of
prescriptive
burning
as
a
management
practice
for
certain
native
or
wild
crops.
As
evidenced
by
the
allowance
for
burning
to
suppress
disease
with
perennial
crops,
the
proposed
rule
was
not
designed
to
preclude
the
selective
use
of
fire
in
organic
production.
We
agree
with
the
commenters
that
a
more
flexible
allowance
for
the
practice
is
warranted,
and
we
have
amended
the
provision
to
allow
burning
of
annual
and
perennial
crop
residues
for
the
suppression
of
disease
and
to
stimulate
seed
germination.
Producers
must
establish
their
need
and
procedures
for
burning
in
their
organic
system
plan,
and
the
practice
cannot
be
used
solely
to
remove
crop
debris
from
fields.

(
5)
Requirement
for
Organic
Seed
in
Sprout
Production.
The
proposed
rule
allowed
nonorganically
produced
seeds
for
all
purposes,
including
sprout
production,
when
the
certifying
agent
concurred
with
the
producer
that
organically
produced
seeds
were
not
commercially
available.
While
commenters
predominately
supported
this
approach
with
seed
used
for
planting,
71
they
were
virtually
unanimous
in
stating
that
it
is
never
appropriate
to
allow
nonorganically
produced
and
handled
seeds
in
organic
sprout
production.
Commenters
cited
the
NOSB's
June
1994
recommendation
that
seed
used
for
the
production
of
edible
sprouts
shall
be
organically
produced
and
stated
that
existing
certification
standards
do
not
provide
an
exemption
based
on
commercial
availability.
We
agree
with
these
commenters
and
have
modified
the
final
rule
to
require
that
organic
seed
must
be
used
for
the
production
of
edible
sprouts.

(
6)
Mitigating
the
Effects
of
a
Biological,
Botanical,
or
Synthetic
Substance.
The
proposed
rule
required
that
producers
who
used
a
biological
or
botanical
substance
or
an
allowed
synthetic
substance
to
control
crop
pests,
weeds,
or
disease
evaluate
and
mitigate
the
effects
of
repetitive
use
of
the
same
or
similar
substances.
While
agreeing
that
pest
resistance
and
shifts
in
pest
populations
were
important
considerations,
commenters
stated
that
managing
these
issues
was
beyond
the
ability
of
individual
operations.
Commenters
recommended
that
the
NOP
develop
principles
and
practices
for
managing
pest
resistance
and
shifts
in
pest
types
that
would
apply
to
all
production
operations.
We
agree
with
these
comments
and
have
deleted
the
requirement
to
evaluate
and
mitigate
the
effects
of
using
the
same
or
similar
crop
pest,
weed,
or
disease
control
substances.
The
final
rule
requires
that
producers
document
the
use
of
such
substances
in
their
organic
systems
plans,
subject
to
the
approval
of
their
certifying
agent.

(
7)
Prohibition
on
Use
of
Treated
Lumber.
The
proposed
rule
did
not
specifically
address
the
use
of
lumber
that
had
been
treated
with
a
prohibited
substance,
such
as
arsenic,
in
organic
production.
Citing
the
explicit
prohibition
on
these
substances
in
existing
organic
standards,
many
commenters
felt
that
treated
lumber
should
be
excluded
in
the
final
rule.
Commenters
also
cited
the
NOSB's
recommendation
to
prohibit
the
use
of
lumber
treated
with
a
prohibited
substance
for
72
new
construction
and
replacement
purposes
effective
upon
publication
of
the
final
rule.
We
have
included
a
modified
version
of
the
NOSB's
recommendation
within
the
crop
pest,
weed,
and
disease
management
practice
standard.
This
provision
prohibits
the
use
of
lumber
treated
with
arsenate
or
other
prohibited
materials
for
new
installations
or
replacement
purposes
in
contact
with
an
organic
production
site.
We
included
this
modification
to
clarify
that
the
prohibition
applies
to
lumber
used
in
direct
contact
with
organically
produced
and
handled
crops
and
livestock
and
does
not
include
uses,
such
as
lumber
for
fence
posts
or
building
materials,
that
are
isolated
from
production.
The
prohibition
applies
to
lumber
used
in
crop
production,
such
as
the
frames
of
a
planting
bed,
and
for
raising
livestock,
such
as
the
boards
used
to
build
a
farrowing
house.

(
8)
Greater
Rigor
in
the
Wild
Harvest
Production
Organic
System
Plan.
A
number
of
commenters
stated
that
the
wild­
crop
harvesting
practice
standard
was
insufficiently
descriptive
and
that
the
proposed
rule
failed
to
apply
the
same
oversight
to
wild
harvest
operations
as
it
did
to
those
producing
crops
and
livestock.
Some
commenters
maintained
that
the
proposed
rule
did
not
require
a
wild
harvest
producer
to
operate
under
an
approved
organic
system
plan.
These
commenters
proposed
specific
items,
including
maps
of
the
production
area
that
should
be
required
in
a
wild
harvest
operation's
organic
system
plan.
One
commenter
recommended
that
the
definition
for
"
wild
crop"
be
modified
to
allow
the
harvest
of
plants
from
aquatic
environments.

We
amended
the
practice
standard
for
wild­
crop
harvesting
to
express
the
compliance
requirements
more
clearly.
Wild­
crop
producers
must
comply
with
the
same
organic
system
plan
requirements
and
conditions,
as
applicable
to
their
operation,
as
their
counterparts
who
produce
crops
and
livestock.
Wild
harvest
operations
are
production
systems,
and
they
must
satisfy
the
73
general
requirement
that
all
practices
included
in
their
organic
system
plan
must
maintain
or
improve
the
natural
resources
of
the
operation,
including
soil
and
water
quality.
We
modified
the
practice
standard
to
emphasize
that
wild
harvest
production
is
linked
to
a
designated
site
and
expect
that
a
certifying
agent
would
incorporate
mapping
and
boundary
conditions
into
the
organic
system
plan
requirements.
Finally,
we
changed
the
definition
of
"
wild
crop"
to
specify
that
harvest
takes
place
from
a
"
site"
instead
of
"
from
land,"
thereby
allowing
for
aquatic
plant
certification.

Crop
Production
­
Changes
Requested
But
Not
Made
This
subpart
retains
from
the
proposed
rule
regulations
on
which
we
received
comments
as
follows:

(
1)
Application
of
Raw
Manure.
The
soil
fertility
and
crop
nutrient
management
practice
standard
in
the
proposed
rule
permitted
the
application
of
raw
manure
to
crops
not
intended
for
human
consumption
and
established
restrictions
for
applying
it
to
crops
used
for
human
food.
For
human
food
crops,
the
proposed
rule
required
a
120­
day
interval
between
application
and
harvest
of
crops
whose
edible
portion
had
direct
contact
with
the
soil
or
soil
particles,
and
a
90­
day
interval
for
crops
that
did
not.
These
provisions
reflected
the
recommendations
developed
by
the
NOSB
at
its
June
1999
meeting.
The
practice
standard
also
required
that
raw
manure
must
be
applied
in
a
manner
that
did
not
contribute
to
the
contamination
of
crops,
soil,
or
water
by
plant
nutrients,
pathogenic
organisms,
heavy
metals,
or
residues
of
prohibited
substances.

The
majority
of
commenters
supported
the
provisions
for
applying
raw
manure.
Some
commenters
stated
that
the
provisions
effectively
balanced
the
benefits
of
applying
raw
manure
to
the
soil
with
the
environmental
and
human
health
risks
associated
with
its
use.
These
commenters
74
stated
that
the
lengthy
intervals
between
application
and
harvest
would
not
impose
an
unreasonable
or
unfeasible
burden
on
organic
producers.
The
NOSB
strongly
supported
the
provisions
in
the
proposed
rule,
emphasizing
that
raw
manure
contributed
significant
benefits
to
soil
nutrient,
structure,
and
biological
activity
that
other
soil
fertility
practices
and
materials
do
not
provide.
Other
commenters
stated
that
the
provisions
were
consistent
with
the
requirements
in
existing
organic
standards
and
added
that
the
restrictions
were
justifiable
because
they
reflected
responsible
management
practices.

For
differing
reasons,
a
number
of
commenters
disagreed
with
the
proposed
provisions.

Some
commenters
cited
the
human
health
risks
associated
with
pathogenic
organisms
found
in
raw
manure
and
stated
that
the
proposed
intervals
between
application
and
harvest
were
not
adequately
protective.
These
commenters
recommended
that
the
NOP
conduct
more
extensive
risk
assessment
procedures
before
determining
what,
if
any,
intervals
between
application
and
harvest
would
adequately
protect
human
health.
Some
of
these
commenters
identified
the
risk
assessment
methodology
and
pathogen
treatment
procedures
governing
the
production
and
use
of
sewage
sludge
as
the
most
suitable
precedent
for
guiding
the
additional
work
required
in
this
area.

Conversely,
a
number
of
commenters
stated
that
the
provisions
in
the
proposed
rule
were
excessive
because
they
exceeded
the
minimum
60­
day
interval
between
application
and
harvest
established
in
the
OFPA.
Many
of
these
commenters
recommended
eliminating
the
distinction
between
crops
that
come
into
contact
with
soil
or
soil
particles
and
those
that
don't
and
applying
a
uniform
60­
day
interval
between
harvest
and
application
for
any
crop
to
which
raw
manure
had
been
applied.
Some
commenters
stated
that
the
120­
day
interval
severely
limited
the
flexibility
of
producers
who
operated
in
regions
such
as
the
Northeast
where
the
growing
season
lasted
only
75
slightly
longer.
Other
commenters
maintained
that
the
practice
standard
did
not
address
specific
practices,
such
as
applying
raw
manure
to
frozen
fields,
that
they
maintained
should
be
expressly
prohibited.

The
responsibility
to
use
raw
manure
in
a
manner
that
is
protective
of
human
health
applies
to
all
producers,
whether
organic
or
not,
who
apply
such
materials.
We
acknowledge
the
commenters
who
noted
that
the
OFPA
cites
food
safety
concerns
relative
to
manure
use
and,

therefore,
that
food
safety
considerations
should
be
reflected
in
the
practice
standard
for
applying
raw
manure
in
the
final
rule.
Some
of
the
commenters
favored
more
extensive
risk
assessment
procedures
or
lengthening
the
interval
between
application
and
harvest.
We
have
not,
however,

changed
the
provisions
for
applying
raw
manure.

Although
public
health
officials
and
others
have
identified
the
use
of
raw
manure
as
a
potential
food
safety
concern,
at
the
present
time,
there
is
no
science­
based,
agreed­
upon
standard
for
regulating
the
use
of
raw
manure
in
crop
production.
The
standard
in
this
rule
is
not
a
public
health
standard.
The
determination
of
food
safety
demands
a
complex
risk
assessment
methodology,
involving
extensive
research,
peer
review,
and
field
testing
for
validation
of
results.

The
only
comparable
undertaking
in
Federal
rulemaking
has
been
EPA's
development
of
treatment
and
application
standards
for
sewage
sludge,
an
undertaking
that
required
years
of
dedicated
effort.
The
NOP
does
not
have
a
comparable
capacity
with
which
to
undertake
a
comprehensive
risk
assessment
of
the
safety
of
applying
raw
manure
to
human
food
crops.
To
delegate
the
authority
to
determine
what
constitutes
safe
application
of
raw
manure
to
certifying
agents
would
be
even
more
problematic.
A
certifying
agent
cannot
be
responsible
for
establishing
a
Federal
food
safety
standard.
Therefore,
the
standard
in
this
rule
is
a
reflection
of
AMS'
view
76
and
of
the
public
comments
that
this
standard
is
reasonable
and
consistent
with
current
organic
industry
practices
and
NOSB
recommendations
for
organic
food
crop
production.
Should
additional
research
or
Federal
regulation
regarding
food
safety
requirements
for
applying
raw
manure
emerge,
AMS
will
ensure
that
organic
production
practice
standards
are
revised
to
reflect
the
most
up­
to­
date
food
safety
standard.

Neither
the
identification
of
food
safety
as
a
consideration
in
the
OFPA
nor
the
inclusion
of
this
practice
standard
in
the
final
rule
should
be
construed
to
suggest
that
organically
produced
agricultural
products
are
any
safer
than
nonorganically
produced
ones.
USDA
has
consistently
stated
that
certification
is
a
process
claim,
not
a
product
claim,
and,
as
such,
cannot
be
used
to
differentiate
organic
from
nonorganic
commodities
with
regard
to
food
safety.
National
organic
standards
for
manure
use
cannot
be
used
to
establish
a
food
safety
standard
for
certified
commodities
in
the
absence
of
as
uniform
Federal
regulation
to
ensure
the
safety
of
all
human
food
crops
to
which
raw
manure
has
been
applied.
The
OFPA
was
designed
to
certify
a
process
for
informational
marketing
purposes.

Neither
have
we
changed
the
practice
standard
in
response
to
comments
that
the
requirement
in
the
final
rule
should
not
exceed
the
60­
day
interval
contained
in
the
OFPA.
The
OFPA
clearly
establishes
that
the
interval
must
be
no
less
than
60
days
and
does
not
preclude
a
longer
standard.
The
NOSB
has
strongly
supported
the
proposed
90­
and
120­
day
intervals,
and
the
vast
majority
of
commenters
indicated
that
these
provisions
would
be
feasible
for
virtually
all
organic
cropping
systems.
The
requirement
in
the
practice
standard
that
raw
manure
must
be
applied
in
a
manner
that
does
not
contribute
to
the
contamination
of
crops,
soil,
or
water
by
plant
nutrients,
pathogenic
organisms,
heavy
metals,
or
residues
of
prohibited
substances
provides
77
certifying
agents
the
discretion
to
prohibit
specific
practices
that
would
not
be
in
compliance.

With
this
discretion,
a
certifying
agent
could
prohibit
practices,
such
as
applying
manure
to
frozen
ground
or
too
close
to
water
resources,
that
many
commenters
stated
were
not
appropriate
for
organic
production.

(
2)
No
Prohibition
on
Manure
from
Nonorganic
Operations.
The
proposed
rule
identified
animal
and
plant
waste
materials
as
important
components
in
soil
fertility
and
crop
nutrient
management
without
providing
criteria
for
distinguishing
allowed
and
prohibited
sources.
A
large
number
of
commenters
objected
to
this
provision
and
stated
that
manure
from
nonorganic
sources
may
contain
residues
from
prohibited
substances,
including
animal
medications.
These
commenters
maintained
that
some
of
these
residues,
such
as
antibiotics,
may
remain
active
for
extended
intervals,
and
others,
such
as
heavy
metals,
could
accumulate
on
the
organic
operation.

Commenters
stated
that
if
either
or
both
conditions
prevailed,
the
integrity
of
the
organic
operation
would
be
jeopardized.
Many
producers
and
certifying
agents
emphasized
that
the
proposed
rule
conflicted
with
the
Codex
guidelines
that
prohibit
the
use
of
manure
from
factory
farms.
These
commenters
were
concerned
that
failure
to
restrict
the
use
of
manure
from
nonorganic
operations
would
put
their
products
at
a
competitive
disadvantage,
particularly
in
European
markets.
When
raising
this
issue,
most
commenters
requested
that
the
final
rule
either
prohibit
the
use
of
manure
from
factory
farms
or
state
that
certifying
agents
could
regulate
the
practice
by
requiring
residue
testing
and
restrictions
on
application.

We
have
not
changed
the
provisions
for
using
manure
from
nonorganic
operations
in
the
final
rule.
In
many
discussions
on
the
subject
throughout
the
years,
the
NOSB
has
never
recommended
that
manure
from
nonorganic
farms
be
prohibited.
Existing
organic
certification
78
standards
routinely
permit
the
use
of
manure
from
nonorganic
operations
with
appropriate
oversight,
and
the
final
rule
incorporates
a
similar
approach.
Under
the
final
rule,
a
certifying
agent
can
require
residue
testing
when
there
is
reasonable
concern
that
manure,
either
raw
or
as
a
component
of
compost,
contains
sufficient
quantities
of
prohibited
materials
to
violate
the
organic
integrity
of
the
operation.
Providing
certifying
agents
the
discretion
to
require
screening
for
prohibited
materials
will
minimize
the
risk
of
introducing
contaminants
while
maintaining
the
ecologically
important
practice
of
recycling
organic
material
from
nonorganic
operations.

Additionally,
the
final
rule
requires
that
producers
apply
manure
and
compost
in
a
manner
that
maintains
or
improves
the
soil
and
water
quality
of
their
operation.
This
provision
provides
an
additional
safeguard
that
certifying
agents
may
use
to
ensure
that
the
application
of
any
form
of
manure
protects
the
natural
resources
of
the
operation.

(
3)
Rotating
a
Field
in
and
out
of
Organic
Production.
Some
commenters
stated
that
a
producer
should
not
be
allowed
to
rotate
fields
on
their
operation
in
and
out
of
organic
production.
These
commenters
were
concerned
that
producers
could
apply
prohibited
substances
that
persisted
for
many
years,
such
as
soil
fumigants,
and
begin
harvesting
organically
produced
crops
after
3
years.
They
stated
that,
without
a
prohibition
on
the
rotation
of
fields
in
this
manner,
organic
producers
could
effectively
use
a
prohibited
substance
on
their
operation.

We
have
not
amended
the
final
rule
to
prohibit
the
rotation
of
a
field
on
an
operation
in
and
out
of
organic
production.
The
statutory
prohibition
on
the
application
of
a
prohibited
substance
is
3
years,
and
this
requirement
is
contained
in
section
205.202(
b).
This
prohibition
restricts
the
application
of
a
prohibited
substance,
not
its
residual
activity.
If
AMS
receives
evidence
that
the
rotation
of
fields
in
this
manner
threatens
to
compromise
organic
production,
the
79
NOP
and
NOSB
will
collaborate
on
developing
standards
to
remedy
it.

(
4)
Use
of
Seed
Treatments
on
the
National
List.
The
seed
and
planting
stock
practice
standard
in
the
proposed
rule
generated
a
very
diverse
array
of
responses
that,
while
largely
favorable,
highlighted
a
potentially
disruptive
impact
on
organic
producers.
The
practice
standard
favored
organic
seed
and
planting
stock
over
nonorganically
produced
but
untreated
varieties
and
nonorganically
produced,
untreated
seed
and
planting
stock
over
nonorganically
produced
seeds
and
planting
stock
treated
with
an
allowed
synthetic
substance.
Producers
could
use
the
less
preferable
seed
or
planting
stock
variety
if
they
demonstrated
to
their
certifying
agent
that
an
equivalent
variety
in
the
preferred
form
was
not
commercially
available.
Most
commenters
endorsed
the
principle
of
requiring
organic
seed
and
planting
stock
and
agreed
that
the
proposed
provisions
were
a
workable
approach
to
enforcement.
They
stated
that
the
provisions
created
an
incentive
for
seed
and
planting
stock
providers
to
develop
supplies
for
organic
markets,
yet
enabled
producers
who
made
a
good
faith
effort
but
failed
to
locate
seed
or
planting
stock
in
the
preferred
form
the
ability
to
continue
producing
organically.
Most
commenters
indicated
that
this
approach
would
support
the
existing
market
for
organic
seed
and
planting
stock
while
fostering
its
continued
development.

A
number
of
commenters,
however,
stated
that
the
seed
and
planting
stock
practice
standard
was
unreasonable
and
unworkable
and
would
adversely
affect
organic
producers.
These
effects
would
include
significantly
reduced
planting
options
due
to
the
nonavailability
of
seed
in
any
allowed
form
and
higher
seed
costs,
which
represent
a
significant
percentage
of
the
total
production
cost
for
some
commodities.
These
commenters
maintained
that
the
three
categories
of
seed
and
planting
stock
allowed
in
the
order
of
preference
could
not
reliably
provide
producers
80
with
many
commercial
varieties
currently
being
planted.
They
pointed
out
that
there
were
no
synthetic
seed
treatments
on
the
National
List
in
the
proposed
rule,
thereby
eliminating
the
use
of
treated
seed
in
organic
production.
Commenters
stated
that
producers
often
rely
upon
seed
and
planting
stock
varieties
that
are
uniquely
well
adapted
for
their
growing
conditions
or
marketing
requirements
and
that
these
particular
varieties
would
very
often
not
be
available
in
untreated
form.
These
commenters
concluded
that
the
proposed
practice
standard
would
compel
many
producers
to
abandon
many
tried
and
true
varieties
of
seed
and
planting
stock
and
perhaps
phase
out
organic
production
entirely.
One
commenter
maintained
that
the
proposed
rule's
stated
intention
of
using
the
practice
standard
to
stimulate
production
of
organic
seed
and
planting
stock
was
not
within
the
purpose
of
the
OFPA.

We
have
not
changed
the
seed
and
planting
stock
practice
standard
in
response
to
these
commenters
because
the
prohibition
on
using
synthetic
materials
not
on
the
National
List
is
a
requirement
of
the
OFPA.
The
final
rule
cannot
allow
producers
to
use
synthetic
seed
treatments
that
have
not
been
reviewed,
favorably
recommended
by
the
NOSB,
and
added
to
the
National
List
by
the
Secretary.
The
practice
standard
creates
incentives
for
producers
to
seek
out
seed
and
planting
stock
inputs
that
are
the
most
compatible
with
organic
production,
yet
includes
allowances
when
preferred
forms
are
not
commercially
available.
While
no
seed
treatments
are
included
on
the
National
List
in
the
final
rule,
individuals
may
petition
the
NOSB
for
review
of
such
substances.
Additionally,
the
practice
standard
creates
an
incentive
for
seed
and
planting
stock
producers
and
suppliers
to
develop
natural
treatments
suitable
for
organic
systems
that
would
not
need
to
appear
on
the
National
List.
The
objectives
of
spurring
production
of
organically
grown
seed
and
promoting
research
in
natural
seed
treatments
are
compatible
with
the
81
OFPA's
purpose
of
facilitating
commerce
in
organically
produced
and
processed
food.
We
designed
the
practice
standard
to
pursue
these
objectives
while
preventing
the
disruption
that
an
ironclad
requirement
for
organically
produced
seed
and
planting
stock
may
have
caused.

(
5)
Practice
Standard
for
Maple
Syrup.
Many
commenters
stated
that
the
proposed
rule
lacked
production
and
handling
standards
for
operations
that
produce
maple
syrup.
Commenters
stated
that
maple
syrup
production
is
a
significant
enterprise
for
many
organic
producers
and
that
the
absence
of
a
practice
standard
in
the
final
rule
would
adversely
affect
existing
markets
for
organic
products.
Many
commenters
recommended
that
the
final
rule
incorporate
the
maple
syrup
practice
standard
from
an
existing
certification
program
or
the
American
Organic
Standards.

We
have
not
included
a
practice
standard
for
the
production
and
handling
of
maple
syrup
because
the
final
rule
contains
sufficient
provisions
for
the
certification
of
these
types
of
operations.
After
reviewing
existing
practice
standards
for
maple
syrup,
we
determined
that
the
standards
in
the
final
rule
for
crop
production,
handling
operations,
and
allowed
and
prohibited
materials
on
the
National
List
provided
comparable
guidance.

Crop
Production
­
Clarifications
Clarification
is
given
on
the
following
issues
raised
by
commenters:

(
1)
Applicability
of
Crop
Rotation
Requirement
to
all
Operations.
One
State
program
commented
that
the
crop
rotation
practice
standard
in
the
proposed
rule
was
unreasonable
for
producers
who
operated
in
regions
where
limited
rainfall
and
irrigation
resources
or
unique
soil
conditions
made
cover
cropping
impractical.
This
commenter
stated
that
certain
dryland
cropping
systems,
such
as
aloe
vera
production,
function
as
"
semi­
perennial"
systems
that
do
not
include
82
rotations,
yet
fulfill
the
objectives
of
the
crop
rotation
practice
standard.
A
certifying
agent
expressed
a
similar
concern
by
suggesting
that
the
crop
rotation
practice
standard
be
changed
by
adding
"
may
include,
but
is
not
limited
to"
prior
to
the
list
of
allowed
management
practices.
This
commenter
felt
that
the
"
may
include"
clause
afforded
individual
growers
greater
discretion
by
acknowledging
that
not
every
allowed
management
practice
would
be
applicable
to
all
operations.

We
have
retained
the
language
from
the
proposed
rule
because
it
already
provides
the
flexibility
to
develop
site­
specific
crop
rotation
practices
requested
by
these
commenters.
The
regulation
as
originally
written
includes
the
"
but
not
limited
to"
clause
that
allows
producers
to
include
alternative
management
practices
in
their
organic
system
plan.
Additionally,
the
regulation
states
that
the
producer
must
implement
a
crop
rotation
that
provides
the
required
functions
"
that
are
applicable
to
the
operation."
This
further
establishes
that
the
crop
rotation
component
of
an
organic
system
plan
must
be
considered
within
the
context
of
site­
specific
environmental
conditions
including
climate,
hydrology,
soil
conditions,
and
the
crops
being
produced.
The
final
rule
requires
implementation
of
a
crop
rotation,
but
the
producer
and
certifying
agent
will
determine
the
specific
crops
and
the
frequency
and
sequencing
of
their
use
in
that
rotation.
Crop
rotations
must
fulfill
the
requirements
of
this
practice
standard­­
to
maintain
or
improve
soil
organic
matter
content,
provide
for
pest
management,
manage
deficient
or
excess
plant
nutrients,
and
control
erosion­­
and
are
not
obligated
to
use
any
specific
management
practice.
We
structured
this
and
other
practice
standards,
as
well
as
the
requirements
of
the
organic
system
plan,
to
enable
producers
and
certifying
agents
to
develop
organic
system
plans
adapted
to
natural
variation
in
environmental
conditions
and
production
systems.

(
2)
Excluding
Annual
Seedlings
from
Planting
Stock.
The
proposed
rule
allowed
a
83
producer
to
use
nonorganically
produced
seeds
and
planting
stock
if
organically
produced
equivalent
varieties
were
not
commercially
available.
Several
commenters,
including
the
NOSB,

were
concerned
that
the
definition
of
planting
stock
as
"
any
plant
or
plant
tissue,
including
rhizomes,
shoots,
leaf
or
stem
cuttings,
roots,
or
tubers,
used
in
plant
production
or
propagation"

was
sufficiently
broad
to
be
applied
to
annual
seedlings.
While
many
commenters,
including
the
NOSB,
supported
the
commercial
availability
exemption
in
the
case
of
seeds
and
planting
stock,

they
objected
to
extending
it
to
annual
seedlings.
The
proposed
rule
did
not
intend
to
include
annual
seedling
within
the
definition
of
planting
stock
and
included
a
separate
definition
of
"
annual
seedling"
as
"
a
plant
grown
from
seed
that
will
complete
its
life
cycle
or
produce
a
harvestable
crop
yield
within
the
same
crop
your
or
season
in
which
it
is
planted."
The
proposed
rule
addressed
annual
seedlings
as
a
distinct
category
within
the
seed
and
planting
stock
practice
standard.
There
was
no
allowance
for
using
nonorganically
produced
annual
seedlings
based
on
commercial
availability,
and
such
seedlings
can
only
be
used
when
a
temporary
variance
has
been
issued
due
to
a
catastrophic
business
interruption.
The
growth
of
markets
for
organically
produced
annual
seedlings,
unlike
those
for
seeds
and
planting
stock,
obviates
the
need
for
the
commercial
availability
provision.
We
have
retained
this
approach
in
the
final
rule.

Livestock
Production
­
Changes
Based
on
Comments
This
subpart
differs
from
the
proposal
in
several
respects
as
follows:

(
1)
Whole
Herd
Conversion.
The
proposed
rule
required
that
livestock
receive
1
year
of
continuous
organic
management
prior
to
the
milk
or
milk
products
they
produce
being
labeled
as
organic.
Based
on
the
feed
provisions
in
that
proposal,
producers
would
be
required
to
provide
a
100­
percent
organic
feed
ration
(
exclusive
of
National
List
substances
allowed
as
feed
84
supplements
and
additives)
for
that
entire
year.
Many
producers,
consumers,
State
certification
programs,
and
certifying
agents
commented
that
the
full
year
organic
feed
requirement
created
an
insurmountable
barrier
for
small
and
medium­
size
dairy
operations
wishing
to
convert
to
organic
production.
They
maintained
that
the
added
expense
of
a
full
year,
100­
percent
organic
feed
requirement
was
economically
prohibitive.
These
commenters
stated
that
"
new
entry"
or
"
whole
herd"
conversion
provisions
in
existing
certification
standards
have
been
instrumental
in
enabling
established
nonorganic
dairies
to
make
the
transition
to
organic
production.
Commenters
stated
that
these
provisions
typically
allow
producers
to
provide
livestock
80­
percent
organic
or
selfraised
feed
for
the
first
9
months
of
a
herd's
transition,
before
requiring
100­
percent
organic
feed
for
the
final
3
months.
Some
commenters
stated
that
many
current
organic
dairies
had
capitalized
on
this
whole
herd
conversion
provision
and
that
the
consistent
growth
in
demand
for
organic
milk
and
milk
products
reflected
consumer
acceptance
of
the
principle.

At
its
June
2000
meeting,
the
NOSB
reiterated
its
prior
endorsement
of
the
conversion
principle
for
operations
that
jointly
convert
dairy
herds
and
the
land
on
which
they
are
raised.
The
NOSB
recommended
allowing
a
producer
managing
an
entire,
distinct
herd
to
provide
80­
percent
organic
or
self­
raised
feed
during
the
first
9
months
of
the
final
year
of
conversion,
and
100­

percent
organic
feed
for
the
final
3
months.
The
recommendation
further
required
that
dairy
animals
brought
onto
an
organic
dairy
must
be
organically
raised
form
the
last
third
of
gestation,

except
that
feed
produced
on
land
managed
under
an
organic
system
plan
could
be
fed
to
young
stock
up
to
12
months
prior
to
milk
production.

While
the
preponderance
of
comments
supported
the
whole
herd
conversion
provision,
a
significant
number
of
individuals,
certifying
agents,
and
State
certification
programs
opposed
it.
85
Some
commenters
felt
that
requiring
less
than
1
full
year
of
100­
percent
organic
feed
would
not
satisfy
consumer
expectations
for
an
organically
managed
dairy.
Other
commenters
stated
that
the
whole
herd
conversion
merely
favored
one
segment
of
organic
producers
over
another.
They
maintained
that
the
full
year,
100­
percent
organic
feed
requirement
would
stimulate
markets
for
organically
produced
hay
and
grain,
thereby
rewarding
good
row
crop
rotation.
One
certifying
agent
was
concerned
that
the
conversion
provision
would
create
a
permanent
exemption
and
that
split
operation
dairies
could
use
it
repeatedly
to
bring
nonorganic
animals
into
the
organic
operation.

The
final
rule
contains
a
provision
for
whole
herd
conversion
that
closely
resembles
those
found
in
the
NOSB
recommendation
and
the
existing
certification
standards.
The
final
rule
requires
that
an
entire,
distinct
dairy
herd
must
be
under
organic
management
for
1
year
prior
to
the
production
of
organic
milk.
During
the
first
9
months
of
that
year,
the
producer
must
provide
a
feed
ration
containing
a
minimum
of
80­
percent
organic
feed
or
feed
that
is
raised
from
land
included
in
the
organic
system
plan
and
managed
in
compliance
with
organic
crop
requirements.

The
balance
of
the
feed
ration
may
be
nonorganically
produced,
but
it
must
not
include
prohibited
substances
including
antibiotics
or
hormones.
The
producer
must
provide
the
herd
100­
percent
organic
feed
for
the
final
3
months
before
the
production
of
organic
milk.
The
producer
must
comply
with
the
provisions
in
the
livestock
health
and
living
conditions
practice
standard
during
the
entire
year
of
conversion.
After
the
dairy
operation
has
been
certified,
animals
brought
on
to
the
operation
must
be
organically
raised
from
the
last
third
of
gestation.
We
did
not
incorporate
the
NOSB's
recommendation
to
provide
young
stock
with
nonorganic
feed
up
to
12
months
prior
to
the
production
of
certified
milk.
By
creating
an
ongoing
allowance
for
using
nonorganic
feed
86
on
a
certified
operation,
this
provision
would
have
undermined
the
principle
that
a
whole
herd
conversion
is
a
distinct,
one­
time
event.

We
anticipate
that
the
provisions
added
to
the
final
rule
will
address
the
concerns
of
commenters
who
objected
to
the
conversion
principle.
Consumers
have
embraced
milk
and
milk
products
from
dairies
certified
under
private
whole
herd
conversion
provisions
essentially
identical
to
that
in
the
final
rule.
While
the
conversion
provision
may
temporarily
reduce
demand
for
organic
feed
materials,
it
encourages
producers
to
develop
their
own
supplies
of
organic
feed.

The
conversion
provision
also
rewards
producers
for
raising
their
own
replacement
animals
while
still
allowing
for
the
introduction
of
animals
from
off
the
farm
that
were
organically
raised
from
the
last
third
of
gestation.
This
should
protect
existing
markets
for
organically
raised
heifers
while
not
discriminating
against
closed
herd
operations.
Finally,
the
conversion
provision
cannot
be
used
routinely
to
bring
nonorganically
raised
animals
into
an
organic
operation.
It
is
a
one­
time
opportunity
for
producers
working
with
a
certifying
agent
to
implement
a
conversion
strategy
for
an
established,
discrete
dairy
herd
in
conjunction
with
the
land
resources
that
sustain
it.

(
2)
Organic
Management
for
Livestock
from
the
Last
Third
of
Gestation.
The
proposed
rule
required
that
organically
managed
breeder
and
dairy
stock
sold,
labeled,
or
represented
as
organic
slaughter
stock
must
be
under
continuous
organic
management
from
birth.
Many
commenters
stated
that
this
requirement
was
an
inappropriate
relaxation
of
most
existing
organic
standards,
which
require
organic
management
for
all
slaughter
stock
from
the
last
third
of
gestation.
These
commenters
cited
the
NOSB's
1994
recommendation
that
all
slaughter
stock
must
be
the
progeny
of
breeder
stock
under
organic
management
from
the
last
third
of
gestation
or
longer.
Commenters
also
recommended
extending
the
organic
management
provision
to
cover
87
the
last
third
of
gestation
to
make
it
consistent
with
the
requirements
in
section
205.236(
a)(
4)
for
the
organically
raised
offspring
of
breeder
stock.
We
agree
with
the
argument
presented
by
commenters
and
have
changed
the
final
rule
to
require
that
breeder
or
dairy
stock
be
organically
raised
from
the
last
third
of
gestation
to
be
sold
as
organic
slaughter
stock.

(
3)
Conversion
Period
for
Nonedible
Livestock
Products.
The
proposed
rule
required
that
livestock
must
be
under
continuous
organic
management
for
a
period
not
less
than
1
year
before
the
nonedible
products
produced
from
them
could
be
sold
as
organic.
Several
commenters
questioned
the
basis
for
creating
different
origin
of
livestock
requirements
based
on
whether
the
operation
intended
to
produce
edible
or
nonedible
products.
These
commenters
stated
that
the
OFPA
does
not
sanction
such
a
distinction,
nor
is
it
contained
in
existing
certification
standards.

They
questioned
why
the
proposed
rule
created
such
a
provision
in
the
absence
of
a
favorable
NOSB
recommendation.
We
agree
that
the
creation
of
a
separate
origin
of
livestock
requirement
for
animals
intended
to
provide
nonedible
products
could
be
confusing.
We
have
changed
this
provision
in
the
final
rule
to
require
that
nonedible
products
be
produced
from
livestock
that
have
been
organically
managed
from
the
last
third
of
gestation.

(
4)
Provisions
for
Feed
Supplements
and
Feed
Additives.
The
proposed
rule
provided
that
nonagricultural
products
and
synthetic
substances
included
on
the
National
List
could
be
used
as
feed
additives
and
supplements.
Many
commenters
stated
that
allowing
nonagricultural
products
and
synthetic
substances
as
feed
supplements
contradicted
the
definition
for
"
feed
supplement"
found
in
the
proposed
rule.
That
definition
stipulated
that
a
feed
supplement
must,

itself,
be
a
feed
material,
and
the
definition
for
"
feed"
in
the
proposed
rule
precluded
using
nonagricultural
products
and
synthetic
substances.
These
commenters
requested
that
either
the
88
definition
of
"
feed
supplement"
be
changed
to
make
it
consistent
with
the
allowance
for
nonagricultural
products
and
synthetic
substances
or
else
that
the
term
be
dropped
from
the
final
rule.
The
Food
and
Drug
Administration
(
FDA)
recommended
modifying
the
definitions
for
"
feed
additive"
and
"
feed
supplement"
and
further
specifying
the
components
required
in
a
feed
ration
under
the
livestock
health
care
practice
standard.

We
amended
the
definition
in
the
final
rule
to
state
that
a
feed
supplement
is
"
a
combination
of
feed
nutrients
added
to
livestock
feed
to
improve
the
nutritional
balance
or
performance
of
the
total
ration."
We
retained
the
second
component
of
the
proposed
definition,

which
described
how
a
feed
supplement
could
be
offered
to
livestock.
We
amended
the
definition
of
"
feed
additive"
to
"
a
substance
added
to
feed
in
micro
quantities
to
fulfill
a
specific
nutritional
need;
i.
e.,
essential
nutrients
in
the
form
of
amino
acids,
vitamins,
and
minerals."
The
definitions
for
"
feed
supplement"
and
"
feed
additive"
in
the
proposed
rule
were
originally
recommended
by
the
NOSB.
While
our
intent
in
the
proposed
rule
was
to
codify
as
fully
as
possible
the
recommendations
of
the
NOSB,
we
agree
with
commenters
that
the
proposed
definitions
were
was
incompatible
with
the
overall
provisions
for
livestock
feed.
The
definitions
in
the
final
rule
are
consistent
with
the
NOSB's
objective
to
create
clear
distinctions
between
feed,
feed
supplements,
and
feed
additives
while
clarifying
the
role
for
each
within
an
organic
livestock
ration.
We
also
incorporated
FDA's
recommendation
to
include
protein
and/
or
amino
acids,
fatty
acids,
energy
sources,
and
fiber
for
ruminants
as
required
elements
of
a
feed
ration
in
the
livestock
health
care
practice
standard.
These
additions
make
the
livestock
health
care
practice
standard
more
consistent
with
the
National
Research
Council's
Committee
on
Animal
Nutrition's
Nutrient
Requirement
series,
which
we
cited
in
the
proposed
rule
as
the
basis
for
feed
requirements.
89
Many
commenters
addressed
provisions
in
the
proposed
rule
to
allow
or
prohibit
specific
materials
and
categories
of
materials
used
in
livestock
feed.
Among
these,
some
commenters
questioned
whether
enzymes
were
defined
as
a
feed
additive
and,
therefore,
allowed.
One
certifying
agent
requested
guidance
on
the
status
of
supplementing
livestock
feed
with
amino
acids.
At
its
October
1999
meeting,
the
NOSB
discussed
the
Technical
Advisory
Panel
(
TAP)

reviews
on
the
use
of
enzymes
and
amino
acids
in
livestock
feed.
The
NOSB
determined
that
natural
sources
of
enzymes
exist
and
that
their
use
should
be
allowed
in
organic
production.

Their
discussion
of
natural
sources
of
enzymes
concluded
that
enzymes
derived
from
edible,

nontoxic
plants
and
nonpathogenic
bacteria
or
fungi
that
had
not
been
genetically
engineered
should
be
allowed
as
a
nonorganic
feed
additive.
The
NOSB
did
not
take
a
position
on
amino
acids
during
this
meeting
but
indicated
that
it
would
revisit
the
subject
in
the
near
future.
Based
on
these
recommendations,
the
final
rule
allows
the
use
of
natural
enzymes
but
not
amino
acids
as
nonorganic
feed
additives.
The
NOSB's
recommendation
that
natural
sources
of
enzymes
existed
and
were
compatible
with
organic
livestock
production
supports
allowing
them
without
adding
them
to
the
National
List.
Some
commenters
discussed
the
animal
welfare
and
environmental
benefits
associated
with
providing
amino
acids
in
livestock
feed
and
supported
allowing
them.

However,
without
a
recommendation
from
the
NOSB
that
amino
acids
are
natural
or
should
be
added
to
the
National
List
as
a
synthetic,
the
final
rule
does
not
allow
their
use.

Commenters
questioned
whether
nonsynthetic
but
nonagricultural
substances,
such
as
ground
oyster
shells
and
diatomaceous
earth,
would
be
allowed
in
agricultural
feed.
In
1994,
the
NOSB
recommended
that
natural
feed
additives
can
be
from
any
source,
provided
that
the
additive
is
not
classified
as
a
prohibited
natural
on
the
National
List.
We
agree
with
this
90
recommendation
and
have
amended
the
final
rule
to
allow
such
materials
as
feed
additives
and
supplements.
The
only
additional
constraint
on
these
materials
is
that
every
feed,
feed
additive,

and
feed
supplement
be
used
in
compliance
with
the
Federal
Food,
Drug,
and
Cosmetic
Act,
as
stated
in
section
205.237(
b)(
6).

The
NOSB
recommended
that
ruminants
maintained
under
temporary
confinement
must
have
access
to
dry,
unchopped
hay.
Although
this
position
was
an
NOSB
recommendation
and
not
part
of
the
proposed
rule,
several
commenters
responded
to
it.
Most
of
these
commenters
stated
that
the
language
was
too
restrictive
and
could
preclude
the
use
of
many
suitable
forage
products.
One
dairy
producer
stated
that
the
requirement
would
not
be
practical
for
operations
that
mix
hay
with
other
feed
components.
We
agree
that
the
NOSB's
proposed
language
is
too
prescriptive
and
have
not
included
it
in
the
final
rule.

(
5)
Provisions
for
Confinement.
The
proposed
rule
established
the
health,
nutritional,
and
behavioral
needs
of
the
particular
species
and
breed
of
animal
as
the
primary
considerations
for
determining
livestock
living
conditions.
The
proposed
rule
also
identified
essential
components
of
the
practice
standard,
including
access
to
shade,
shelter,
exercise
areas,
fresh
air,
and
direct
sunlight,
while
stating
that
species­
specific
guidelines
would
be
developed
in
conjunction
with
future
NOSB
recommendations
and
public
comment.
Finally,
the
proposed
rule
outlined
the
conditions
pertaining
to
animal
welfare
and
environmental
protection
under
which
producers
could
temporarily
confine
livestock.

While
supportive
of
the
underlying
principles
of
this
practice
standard,
the
vast
majority
of
commenters
stated
that
the
actual
provisions
suffered
from
a
lack
of
clarity
and
specificity.
Many
commenters
were
concerned
that
the
proposed
rule
did
not
adequately
ensure
access
to
the
91
outdoors
for
all
animals.
While
supportive
of
the
access
to
pasture
requirement
for
ruminant
production,
commenters
stated
that
the
final
rule
needed
a
clear
definition
of
pasture
to
make
the
provision
meaningful.
Conversely,
some
commenters
supported
the
less
prescriptive
approach
adopted
in
the
proposed
rule.
The
NOSB
added
considerably
to
its
earlier
recommendations
on
livestock
living
conditions
during
its
June
2000
meeting.

Many
commenters
stated
that
the
criteria
identified
as
required
elements
in
the
provisions
for
livestock
living
conditions
did
not
specifically
include
access
to
the
outdoors.
One
commenter
stated
that
the
requirement
that
animals
receive
direct
sunlight
could
be
interpreted
to
simply
require
windows
in
livestock
confinement
facilities.
Commenters
were
virtually
unanimous
that,

except
for
the
limited
exceptions
for
temporary
confinement,
all
animals
of
all
species
must
be
afforded
access
to
the
outdoors.
Commenters
also
maintained
that
the
outdoor
area
must
accommodate
natural
livestock
behavior,
such
as
dust
wallows
for
poultry
and,
in
the
case
of
ruminants,
provide
substantial
nutrition.
Many
commenters
specifically
opposed
dry
lots
as
an
allowable
outdoor
environment.
The
NOSB
recommended
that
the
final
rule
state
that
all
livestock
shall
have
access
to
the
outdoors.
As
a
result
of
these
comments,
we
have
revised
the
final
rule
to
establish
that
access
to
the
outdoors
is
a
required
element
for
all
organically
raised
livestock.

We
further
amended
the
final
rule
to
include
a
definition
of
"
pasture."
The
definition
of
"
pasture"
we
included
emphasizes
that
livestock
producers
must
manage
their
land
to
provide
nutritional
benefit
to
grazing
animals
while
maintaining
or
improving
the
soil,
water,
and
vegetative
resources
of
the
operation.
The
producer
must
establish
and
maintain
forage
speciesappropriate
for
the
nutritional
requirements
of
the
species
using
the
pasture.
92
Numerous
commenters
requested
clarification
on
species­
specific
living
conditions,
such
as
the
use
of
cages
for
poultry
and
confinement
systems
for
veal
production.
The
use
of
continuous
confinement
systems
including
cages
for
poultry
and
veal
production
is
incompatible
with
the
requirement
that
organically
raised
livestock
receive
access
to
the
outdoors
and
the
ability
to
engage
in
physical
activity
appropriate
to
their
needs.
There
will
be
times
when
producers
must
temporarily
confine
livestock
under
their
care,
but
these
instances
must
be
supported
by
the
exemptions
to
the
outdoor
access
requirement
included
in
the
final
rule.
Other
commenters
requested
additional
guidance
on
whether
confinement
for
the
purpose
of
finishing
slaughter
stock
would
be
allowed,
and,
if
so,
how
long
that
confinement
could
last.
Commenters
who
supported
an
allowance
for
finishing
most
often
recommended
that,
in
the
case
of
cattle,

confinement
should
not
exceed
90
days.
The
final
rule
does
not
include
a
specific
length
of
time
that
cattle
or
other
species
may
be
confined
prior
to
slaughter.
We
will
seek
additional
input
from
the
NOSB
and
public
comment
before
developing
such
standards.

Several
commenters
questioned
whether
a
Federal,
State,
or
local
regulation
that
required
confinement
would
supersede
the
requirement
for
outdoor
access.
These
commenters
were
aware
of
county
ordinances
that
prohibited
free
ranging
livestock
production
to
protect
water
quality.

Organic
operations
must
comply
with
all
Federal,
State,
and
local
regulations.
At
the
same
time,

to
sell,
label,
or
represent
an
agricultural
commodity
as
"
100
percent
organic,"
"
organic,"
or
"
made
with...,"
the
producer
or
handler
must
comply
with
the
all
applicable
requirements
set
forth
in
this
regulation.
Federal,
State,
or
local
regulations
that
prohibit
a
required
practice
or
require
a
prohibited
one
will
essentially
preclude
organic
certification
of
the
affected
commodity
within
that
jurisdiction.
93
(
6)
Prohibition
on
Parasiticides
During
Lactation.
The
proposed
rule
provided
that
breeder
stock
could
receive
synthetic
parasiticides
included
on
the
National
List,
provided
that
the
treatment
occurred
prior
to
the
last
third
of
gestation
for
progeny
that
were
to
be
organically
managed.
Many
commenters
supported
this
principle
but
were
concerned
that
the
wording
would
allow
producers
to
administer
parasiticides
to
lactating
breeder
stock
while
the
offspring
were
still
nursing.
These
commenters
felt
that
such
an
allowance
violated
the
intent
of
the
provision
because
offspring
could
be
exposed
to
systemic
parasiticides
or
their
residues
through
their
mother's
milk.
The
NOSB
recommended
a
prohibition
on
using
allowed
synthetic
parasiticides
during
lactation
for
progeny
that
are
organically
managed.
We
agree
with
these
commenters
and
have
modified
the
final
rule
to
prohibit
the
treatment
of
organically
managed
breeder
stock
with
allowed
synthetic
parasiticides
during
the
last
third
of
gestation
or
lactation.

Livestock
Production
­
Changes
Requested
But
Not
Made
This
subpart
retains
from
the
proposed
rule
regulations
on
which
we
received
comments
as
follows:

(
1)
Prohibition
on
Factory
Farms.
Many
commenters
requested
that
the
final
rule
prohibit
the
certification
of
"
factory
farms."
These
commenters
stated
that
factory
farms
are
dependent
upon
practices
and
materials
that
are
inconsistent
with
or
expressly
prohibited
in
the
OFPA.
The
final
rule
does
not
contain
such
a
prohibition
because
commenters
did
not
provide
a
clear,

enforceable
definition
of
"
factory
farm"
for
use
in
the
final
rule.
All
organic
operations,
regardless
of
their
size
or
other
characteristics,
must
develop
and
adhere
to
an
approved
organic
system
plan
that
complies
with
these
regulations
in
order
to
be
certified.

(
2)
Nonorganic
Feed
Protocol.
The
proposed
rule
required
that,
except
for
94
nonagricultural
products
and
synthetic
substances
included
on
the
National
List,
a
producer
must
provide
livestock
with
a
total
feed
ration
composed
of
agricultural
feed
products,
including
pasture
and
forage,
that
is
organically
produced
and,
if
applicable,
handled.
It
also
included
provisions
for
temporary
variances
that,
under
very
limited
circumstances
and
with
the
approval
of
the
certifying
agent
and
the
Administrator,
would
provide
an
exemption
from
specific
production
and
handling
standards.
The
preamble
of
the
proposed
rule
described
an
emergency
resulting
in
the
unavailability
of
organic
agricultural
feed
products
as
an
example
of
a
situation
in
which
a
temporary
variance
could
be
issued.
Many
commenters
recommended
that
the
final
rule
require
a
producer
who
received
a
temporary
variance
for
a
feed
emergency
to
follow
the
order
of
preference
for
noncertified
organic
feed
developed
by
the
NOSB.
This
order
of
preference
requires
a
producer
to
procure
agricultural
feed
products
from
sources
that
are
as
close
to
complying
with
the
standards
for
organic
certification
as
possible.
Commenters
stated
that
adherence
to
the
order
of
preference
would
most
closely
conform
with
the
expectation
of
consumers
that
organically
raised
livestock
received
organic
feed
and
would
create
an
incentive
for
livestock
feed
producers
to
pursue
certification.

We
have
not
included
the
NOSB's
feed
emergency
order
of
preference
in
the
final
rule
because
it
would
be
too
prescriptive
and
difficult
to
enforce
during
an
emergency.
Receiving
a
temporary
variance
categorically
exempts
a
producer
from
the
provision
for
which
it
was
issued,

although
that
producer
may
not
substitute
any
practice,
material,
or
procedure
that
is
otherwise
prohibited,
although
that
producer
may
not
substitute
any
practice,
material,
or
procedure
that
is
otherwise
prohibited
under
section
205.105
.
Additionally,
certified
organic
feed
is
far
more
available
in
terms
of
quantity
and
affordability
than
when
the
NOSB
developed
its
order
of
95
preference
in
1994.
We
anticipate
that
producers
whose
original
supply
of
organic
agricultural
feed
products
is
interrupted
will
be
able
to
fill
the
shortfall
through
the
marketplace.

(
3)
Prohibition
on
Physical
Alterations.
The
proposed
rule
required
that
producers
perform
physical
alterations
as
needed
to
promote
animal
welfare
and
in
a
manner
that
minimizes
pain
and
stress.
This
provision
was
one
component
of
the
health
care
practice
standard
that
required
producers
to
establish
and
maintain
preventive
livestock
health
care
practices.
We
stated
in
the
preamble
that
there
was
insufficient
consensus
from
previous
public
comment
to
designate
specific
physical
alterations
as
allowed
or
prohibited
and
envisioned
working
with
producers,

certifying
agents,
and
consumers
to
achieve
that
goal.
We
requested
comment
on
techniques
to
measure
animal
stress
that
could
be
used
to
evaluate
whether
specific
physical
alterations
were
consistent
with
the
conditions
established
in
the
proposed
rule.

We
received
significant
numbers
of
comments
both
opposing
and
supporting
the
provision
in
the
proposed
rule
for
performing
physical
alterations.
Many
commenters
opposed
any
allowance
for
physical
alterations
and
argued
that
such
practices
are
cruel
and
debilitating
to
animals.
These
commenters
maintained
that
modifications
in
breed
selection,
stocking
densities,

and
the
configuration
of
living
conditions
could
achieve
results
similar
to
physical
alterations
without
harming
the
animal.
They
stated
that
by
adapting
their
production
systems
to
promote
the
physical
and
psychological
welfare
of
animals,
producers
could
obviate
the
need
for
physical
alterations.
In
particular,
commenters
cited
physical
alterations
to
the
beaks
and
feet
of
poultry
as
unnecessary
due
to
the
availability
of
alternative
production
systems.
Many
commenters
expressed
concern
that
the
allowance
for
physical
alterations
would
facilitate
the
certification
of
large
confinement
operations.
Commenters
also
stated
that
performing
physical
alterations
was
96
inconsistent
with
Codex
guidelines
and
objected
to
the
allowance
before
full
public
deliberation
on
the
subject
through
the
NOSB
process.

A
large
number
of
commenters
stated
that,
if
reasonable
guidelines
could
be
established,

the
allowance
for
physical
alterations
would
be
a
beneficial,
and
even
necessary,
condition
for
organic
livestock
production.
These
commenters
maintained
that
producers
engage
in
physical
alterations
for
the
overall
welfare
of
the
flock
or
herd
and
that
the
pain
and
stress
of
performing
them
must
be
weighed
against
the
pain
and
stress
of
not
doing
so.
For
example,
these
commenters
cited
the
traumatic
effect
of
cannibalism
on
poultry
flocks
that
had
not
undergone
beak
trimming
or
the
injuries
caused
by
animals
whose
horns
had
not
been
removed.
Many
of
these
commenters
stated
that
producers
could
reduce
but
not
eliminate
the
need
for
physical
alterations
through
alternative
production
practices
such
as
breed
selection
and
stocking
densities.

The
NOSB
supported
the
provision
as
written
in
the
proposed
rule,
stating
that
it
met
the
animal
welfare
requirements
while
allowing
practices
necessary
for
good
animal
husbandry.

We
have
retained
the
proposed
provision
for
physical
alterations
without
taking
any
further
position
on
whether
specific
practices
are
allowed
or
prohibited.
We
did
not
receive
substantial
new
guidance
on
techniques
to
measure
stress
in
animals
due
to
physical
alterations
and
have
made
no
revisions
in
that
regard.
The
final
rule
establishes
that,
when
appropriately
performed
and
within
the
context
of
an
overall
management
system,
specific
physical
alterations
are
allowed.

It
also
mandates
that,
as
an
element
of
a
preventative
health
care
program,
physical
alterations
must
benefit
the
ultimate
physical
and
psychological
welfare
of
the
affected
animal.

(
4)
Withdrawal
for
Synthetic
Parasiticides
in
Lactating
Livestock.
The
proposed
rule
required
a
90­
day
withdrawal
period
before
milk
and
milk
products
produced
from
livestock
97
treated
with
an
allowed
synthetic
parasiticide
could
be
labeled
as
organic.
Referencing
the
statement
in
the
preamble
to
the
proposed
rule
that
the
90­
day
withdrawal
period
was
attributable
to
"
consumer
expectations
of
organically
raised
animals,"
a
dairy
producer
commented
that
the
provision
ignored
animal
welfare
and
farm
economic
sustainability
considerations.
The
commenter
considered
the
90­
day
withdrawal
period
capricious
and
problematic
since,
for
bovine
dairy
operations,
it
would
compel
producers
to
either
shorten
an
animal's
natural
drying
off
period,
or
lose
30
days
of
organic
milk
production.
The
commenter
stated
that
the
optimal
extended
withdrawal
period
for
this
situation
would
be
60
days
since
this
is
the
approximate
duration
of
a
dairy
cow's
natural
dry
period.
Under
this
approach,
livestock
requiring
treatment
could
receive
an
allowed
synthetic
parasiticide
at
the
time
of
drying
off,
thus
allowing
the
withdrawal
period
to
coincide
with
the
natural
60­
day
period
when
the
livestock
were
not
lactating.
Livestock
could
complete
the
withdrawal
period
prior
to
the
birth
of
their
offspring
in
approximately
60
days,
at
which
time
the
mother's
milk
could
again
be
sold
as
organic.
The
commenter
maintained
that
the
60­
day
period
would
satisfy
consumer
expectation
for
an
extended
withdrawal
period
after
treatment
with
an
allowed
synthetic
parasiticide
without
imposing
an
unnecessary
constraint
on
the
producer.

We
have
retained
the
90­
day
withdrawal
period
in
the
final
rule.
The
provisions
in
the
final
rule
for
treating
livestock
with
an
allowed
synthetic
parasiticide
reflect
the
90­
day
withdrawal
period
recommended
by
the
NOSB
at
its
October
1999
meeting.
The
NOSB
has
the
authority
to
reconsider
this
issue
and
propose
an
alternative
annotation
for
the
Secretary's
consideration.

(
5)
Delineation
of
Space
Requirements
for
Animal
Confinement.
The
proposed
rule
did
not
establish
space
requirements
for
livestock
living
conditions
but
stated
that
a
producer
must
98
accommodate
the
health
and
natural
behavior
of
animals
under
his
or
her
care.
Some
commenters
stated
their
preference
for
space
requirements
because
they
are
more
uniform
and
enforceable.

These
commenters
stated
that
some
existing
certification
standards
include
space
requirements
in
standards
for
livestock
living
conditions
and
that
Codex
guidelines
support
this
approach.
While
not
disagreeing
that
space
requirements
could
be
an
effective
certification
tool
for
organic
livestock
production
systems,
we
have
not
incorporated
any
such
provisions
in
the
final
rule.
We
anticipate
that
additional
NOSB
recommendations
and
public
comment
will
be
necessary
for
the
development
of
space
requirements.
At
its
June
2000
meeting,
the
NOSB
agreed
that
it
would
be
premature
to
include
space
requirements
in
the
final
rule.

(
6)
Access
to
pasture
versus
pasture­
based.
Commenters
stated
that
the
proposed
rule's
requirement
that
ruminants
receive
"
access
to
pasture"
did
not
sufficiently
characterize
the
relationship
that
should
exist
between
ruminants
and
the
land
they
graze.
Many
of
these
commenters
recommended
that
the
final
rule
require
that
ruminant
production
be
"
pasture­
based."

Many
commenters
stated
that
the
final
rule
needed
a
more
explicit
description
of
the
relationship
between
livestock
and
grazing
land.
The
NOSB
shared
this
perspective
and
recommended
that
the
final
rule
require
that
ruminant
production
systems
be
"
pasture­
based."
In
contrast,
an
organic
dairy
producer
maintained
that
a
uniform,
prescriptive
definition
of
pasture
would
not
be
appropriate
in
a
final
rule.
This
commenter
stated
that
the
diversity
of
growing
seasons,

environmental
variables,
and
forage
and
grass
species
could
not
be
captured
in
a
single
definition
and
that
certifying
agents
should
define
pasture
on
a
case­
by­
case
basis.
This
commenter
also
disagreed
with
the
"
pasture­
based"
requirement,
stating
that
pasture
should
be
only
one
of
several
components
of
balanced
livestock
nutrition.
Singling
out
pasture
as
the
foundation
for
ruminant
99
management
would
distort
this
balance
and
deprive
other
producers
of
the
revenue
and
rotation
benefits
they
generate
by
growing
livestock
feed.

We
retained
the
"
access
to
pasture"
requirement
because
the
term,
"
pasture­
based,"
has
not
been
sufficiently
defined
to
use
for
implementing
the
final
rule.
The
final
rule
does
include
a
definition
for
pasture,
and
retention
of
the
"
access
to
pasture"
provision
provides
producers
and
certifying
agents
with
a
verifiable
and
enforceable
standard.
The
NOP
will
work
with
the
NOSB
to
develop
additional
guidance
for
managing
ruminant
production
operations.

(
7)
Stage
of
Production.
The
proposed
rule
contained
provisions
for
temporary
confinement,
during
which
time
livestock
would
not
receive
access
to
the
outdoors.
Many
commenters
were
concerned
that
the
stage­
of­
production
justification
for
temporary
confinement
could
be
used
to
deny
animals
access
to
the
outdoors
during
naturally
occurring
life
stages,

including
lactation.
Commenters
overwhelmingly
opposed
such
an
allowance
and
stated
that
the
stage
of
production
exemption
should
be
narrowly
applied.
One
commenter
stated
that
a
dairy
operation,
for
example,
might
have
seven
or
eight
distinct
age
groups
of
animals,
with
each
group
requiring
distinct
living
conditions.
Under
these
circumstances,
the
commenter
maintained
that
a
producer
should
be
allowed
to
temporarily
house
one
of
these
age
groups
indoors
to
maximize
use
of
the
whole
farm
and
the
available
pasture.
At
its
June
2000
meeting,
the
NOSB
stated
that
the
allowance
for
temporary
confinement
should
be
restricted
to
short­
term
events
such
as
birthing
of
newborn
or
finish
feeding
for
slaughter
stock
and
should
specifically
exclude
lactating
dairy
animals.

We
have
not
changed
the
provision
in
the
final
rule
for
the
stage­
of­
production
allowance
in
response
to
these
comments.
The
NOSB
has
supported
the
principle
of
a
stage­
of­
production
100
allowance
but
has
not
provided
sufficient
guidance
for
determining,
on
a
species­
specific
basis,

what
conditions
would
warrant
such
an
allowance.
Without
a
clearer
foundation
for
evaluating
practices,
we
have
not
identified
any
specific
examples
of
practices
that
would
or
would
not
warrant
a
stage­
of­
production
allowance.
We
will
continue
to
explore
with
the
NOSB
specific
conditions
under
which
certain
species
could
be
temporarily
confined
to
enhance
their
well­
being.

In
the
final
rule,
temporary
confinement
refers
to
the
period
during
which
livestock
are
denied
access
to
the
outdoors.
The
length
of
temporary
confinement
will
vary
according
to
the
conditions
on
which
it
is
based,
such
as
the
duration
of
inclement
weather.
The
conditions
for
implementing
temporary
confinement
for
livestock
do
not
minimize
the
producer's
ability
to
restrain
livestock
in
the
performance
of
necessary
production
practices.
For
example,
it
is
allowable
for
a
producer
to
restrain
livestock
during
the
actual
milking
process
or
under
similar
circumstances,
such
as
the
administration
of
medication,
when
the
safety
and
welfare
of
the
livestock
and
producer
are
involved.

Handling
­
Changes
Based
on
Comments
The
following
changes
are
made
based
on
comments
received.

(
1)
Commercial
Availability.
A
large
number
of
commenters,
including
organic
handlers
and
certifying
agents,
stated
that
"
commercial
availability"
must
be
included
as
a
requirement
for
the
5
percent
of
nonorganic
ingredients
that
are
used
in
products
labeled
"
organic."

We
agree
and
have
added
a
commercial
availability
requirement
as
part
of
a
handler's
organic
system
plan
under
section
205.201
of
this
subpart.
Up
to
5
percent
(
less
water
and
salt)

of
a
product
labeled
"
organic,"
may
be
nonorganic
agricultural
ingredients.
However,
handlers
must
document
that
organic
forms
of
the
nonorganic
ingredients
are
not
commercially
available
101
before
using
the
nonorganic
ingredients.

(
2)
Prohibited
Practices.
Commenters
were
unclear
about
the
extent
of
the
prohibition
on
use
of
excluded
methods
and
ionizing
radiation.
To
make
that
prohibition
clear,
we
have
moved
the
handling
prohibitions
in
proposed
rule
sections
205.270
(
c)
to
205.105,
Applicability,
subpart
B.
Paragraphs
(
c)(
1)
and
(
c)(
2)
which
listed
excluded
methods
and
ionizing
radiation
in
the
proposed
rule
are
combined
into
paragraph
(
c)(
1)
that
cross­
references
new
section
205.105.

(
3)
Use
of
Predator
Pests
and
Parasites.
Paragraph
(
b)(
1)
of
section
205.271
proposed
that
predator
pests
and
parasites
may
be
used
to
control
pests
in
handling
facilities.
Under
FDA's
Good
Manufacturing
Practice,
21
CFR
part
section
110.35(
c),
it
states
that
"
No
pests
shall
be
allowed
in
any
area
of
a
food
plant."
Some
commenters
believed
use
of
predator
pests
in
handling
facilities
is
prohibited
by
the
FDA
regulation.
Other
commenters
stated
that
predator
pests
could
be
used
in
certain
handling
facilities
under
the
FDA
regulation.
One
commenter
claimed
that
the
FDA
regulation
in
21
CFR
part
110.19
allows
exemptions
for
certain
establishments
that
only
harvest,
store,
or
distribute
raw
agricultural
product.
Another
commenter
suggested
that
use
of
predator
pests
should
be
allowed
when
FDA
does
not
prohibit
their
use.

We
do
not
intend
to
be
inconsistent
with
the
FDA
requirement
and,
thus,
have
removed
proposed
paragraph
(
b)(
1)
of
section
205.271.
Use
of
predator
pests
in
various
organic
handling
and
storage
areas
is
subject
to
FDA's
Good
Manufacturing
Practice.
Paragraphs
(
b)(
2)
and
(
b)(
3)

are
redesignated.

(
4)
Use
of
Synthetic
Pheromone
Lures.
Proposed
paragraph
(
b)(
3)
provided
for
use
of
nonsynthetic
lures
and
repellant.
A
few
handlers
and
certifying
agents
commented
that
nearly
all
pheromone
lures
use
synthetic
substances.
Because
pheromone
lures
do
not
come
into
contact
102
with
products
in
a
handling
facility,
commenters
argued
that
such
lures
should
be
allowed,

provided
that
the
synthetic
substance
used
is
on
the
National
List.

We
agree
and
have
added
"
synthetic
substances"
to
redesignated
paragraph
(
b)(
2)
for
use
in
lures
and
repellents.
The
synthetic
substances
used
must
be
consistent
with
the
National
List.

(
5)
Restrict
Initial
Use
of
Synthetics
to
National
List
Substances.
Paragraph
(
c)
in
the
proposed
rule
provided
for
use
of
any
synthetic
substance
to
prevent
or
control
pests.
Several
handlers
and
certifying
agents
stated
that
use
of
nonsynthetic
and
synthetic
substances
should
initially
be
limited
first
to
substances
which
are
allowed
on
the
National
List.
This
would
mean
that
substances
not
allowed
for
use
on
the
National
List
could
not
be
used
initially
to
control
or
prevent
pest
infestations.

We
agree
with
these
comments.
Use
of
allowed
substance
before
use
of
other
substances
is
a
fundamental
principle
of
organic
agriculture.
Therefore,
if
preferred
practices
under
paragraphs
(
a)
and
(
b)
are
not
successful
in
preventing
or
controlling
pest
infestations,
handlers
may
then
use,
under
amended
paragraph
(
c),
only
nonsynthetic
or
synthetic
substances
which
are
allowed
for
use
on
the
National
List.

We
have
removed
the
proviso
that
applications
of
a
pest
control
substance
must
be
consistent
with
the
product's
label
instructions.
This
requirement
is
readily
understood
and
does
not
need
to
be
explicitly
stated
in
the
regulations.

Because
paragraph
(
c)
now
provides
for
use
only
of
allowed
National
List
substances,
a
new
paragraph
(
d)
is
added
to
allow
for
use
of
other
synthetic
substances,
including
synthetic
substances
not
on
the
National
List,
to
prevent
or
control
pest
infestations.
These
substances
may
be
used
only
if
the
practices
in
paragraphs
(
a),
(
b),
and
(
c)
are
ineffective.
Before
the
substance
is
103
used,
the
handler
and
the
operation's
certifying
agent
must
agree
on
the
synthetic
substance
to
be
used
and
the
measures
to
be
taken
to
prevent
contact
of
the
substance
with
organic
products
and
ingredients
in
the
facility.
We
expect
that
this
communication
can
be
accomplished
with
telephone
calls
or
by
electronic
means.

This
regulation
does
not
preempt
Federal,
State,
or
local
health
and
sanitation
requirements.
We
recognize
that
inspectors
who
monitor
compliance
with
those
regulations
may
require
immediate
intervention
and
use
of
synthetic
substances,
not
on
the
National
List,
before
or
at
the
same
time
as
the
methods
specified
in
paragraphs
(
b)
and
(
c).
Therefore,
to
make
this
clear,

we
have
added
a
new
paragraph
(
f).
To
ensure
that
the
use
of
the
substances
does
not
destroy
a
product's
organic
integrity,
we
are
requiring
that
the
handler
take
appropriate
measures
to
prevent
contact
of
the
product
with
the
pest
control
substance
used.

(
6)
Preventing
Contact
with
Prohibited
Substances.
Commenters
recommended
that,
if
prohibited
substances
are
applied
by
fogging
or
fumigation,
the
organic
product
and
packaging
material
must
be
required
to
be
completely
removed
from
the
facility
and
reentry
of
the
product
or
packaging
be
delayed
for
a
period
three
times
longer
than
that
specified
on
the
pesticide
label.

Commenters
believed
removal
and
reentry
should
be
mandatory,
regardless
of
the
organic
product
or
container.

We
understand
the
commenters'
concerns.
However,
their
recommendations
are
not
appropriate
for
all
pest
infestations.
We
believe
that
measures
needed
to
be
taken
to
prevent
contact
with
a
synthetic
substance
must
be
determined
on
a
case­
by­
case
basis
by
the
handler
and
certifying
agent.
As
stated
earlier,
new
paragraph
(
d)
of
section
205.271
requires
a
handler
and
certifying
agent
to
agree
on
control
and
prevention
measures
prior
to
application
of
a
synthetic
104
substance.
We
believe
that
such
an
agreement
will
help
safeguard
a
product's
organic
integrity.

Use
of
a
synthetic
substance
in
fogging
or
fumigation
should
be
based
on,
among
other
things,

location
of
the
pest
relative
to
the
organic
products
in
the
facility;
the
extent
of
the
pest
infestation;
the
substance
and
application
method
to
be
used;
the
state
of
the
organically
produced
product
or
ingredient
(
raw,
unpackaged
bulk,
canned,
or
otherwise
sealed);
and
health
and
sanitation
requirements
of
local,
State,
and
Federal
authorities.

Paragraph
(
e)
is
changed
to
clarify
that
an
operation's
organic
handling
plan
must
be
updated
to
document
all
measures
taken
to
prevent
contact
between
synthetic
pest
control
substances
and
organically
produced
products
and
ingredients.

(
7)
Repetitive
Use
of
Pest
Control
Measures.
One
commenter
suggested
a
change
in
the
paragraph
(
e)
requirement
that
handlers'
organic
plans
must
include
"
an
evaluation
of
the
effects
of
repetitive
use"
of
pest
prevention
and
control
materials.
The
commenter
believed
that
the
requirement
was
excessive
and
beyond
what
should
be
expected
of
handlers.
The
commenter
indicated
that
handlers'
organic
plans
should
address
the
"
techniques
that
will
be
used
to
minimize"
the
negative
effects
of
repetitive
use
of
pest
control
materials.

We
agree
that
"
an
evaluation
of
the
effects
of
repetitive
use"
is
more
than
what
is
reasonable
to
expect
of
handlers
in
their
organic
plans.
We
do
not
agree,
however,
that
an
organic
plan
should
be
required
to
address
the
"
techniques"
used
to
minimize
the
effects
of
repetitive
use
of
pest
control
materials.
However,
we
believe
that
handlers
should
update
their
organic
handling
plans
to
account
for
the
use
of
pest
control
or
prevention
substances,
particularly
if
the
substances
are
prohibited
substances.
The
update
should
include
a
description
of
the
application
methods
used
and
the
measures
taken
to
prevent
contact
between
the
substance
used
105
and
the
organic
product.
We
have
added
these
requirements
in
redesignated
paragraph
(
e).

Proposed
paragraph
(
e)
of
section
205.271
is
removed.

Handling
­
Changes
Requested
But
Not
Made
(
1)
Exceptions
to
Handling
Processes.
A
commenter
stated
that
many
herbal
products
are
extracted
from
organically
produced
herbs
but
that
the
extraction
of
those
products
"
can
employ
significantly
different
methods
than
those
used
in
the
manufacture
of
more
traditional
foods."
To
be
labeled
as
"
organic"
ingredients,
substances
such
as
herbs,
spices,
flavorings,

colorings,
and
other
similar
substances,
must
be
derived
from
a
certified
organic
source
and
be
extracted
without
the
use
of
prohibited
substances.

(
2)
Allowed
Synthetics
Used
in
Packaging
Materials
and
Storage
Containers.
A
State
department
of
agriculture
commented
that
section
205.272(
b)(
1)
prohibits
use
of
synthetic
fungicides,
preservatives,
or
fumigants
in
packaging
materials
and
storage
containers
or
bins.
The
comment
stated
that
it
is
inconsistent
to
permit
use
of
allowed
substances
as
ingredients
in
processed
products
but
prohibit
their
use
as
a
preservative
or
fumigant
in
the
packaging
materials
and
storage
containers
and
bins.
The
commenter
suggested
that
paragraph
(
b)(
1)
be
amended
to
permit
use
of
National
List­
allowed
substances
in
section
205.605,
particularly
carbon
dioxide
and
ozone,
in
packaging
materials
and
storage
containers
or
bins.

We
understand
the
commenter's
concern.
However,
section
6510(
a)(
5)
of
the
Act
specifically
prohibits
use
of
any
packaging
materials,
storage
containers,
or
bins
that
contain
synthetic
fungicides,
preservatives,
or
fumigants.

(
3)
Additional
Measures
to
Prevent
Product
Contamination.
A
few
commenters
suggested
changing
paragraph
(
e)
of
section
205.271
to
require
that
handlers'
organic
handling
106
plans
specify
measures
that
would
be
taken
to
prevent
contact
between
a
pest
control
substance
and
"
packaging
materials."
This
would
be
in
addition
to
measures
preventing
contamination
of
"
any
ingredient
or
finished
product"
in
the
handling
facility.

We
understand
the
commenters'
objective.
However,
for
the
reasons
stated
earlier
in
regard
to
commenters'
request
that
mandatory
removal
of
product
during
pest
control
treatment
be
required,
we
believe
that
such
a
requirement
should
not
be
mandatory
for
all
packaging
materials.
Measures
to
prevent
contamination
of
packaging
material
should
be
left
to
the
handler
and
certifying
agent
to
specify
in
the
handling
plan.

Handling
­
Clarifications
Clarification
is
given
on
the
following
issues
raised
by
commenters.

(
1)
Use
of
Nonorganic
Ingredients
in
Processed
Products.
We
have
corrected
paragraph
(
c)
of
section
205.270
to
clarify
what
must
not
be
used
in
or
on
organically
produced
ingredients
and
nonorganically
produced
ingredients
used
in
processed
organic
products.
The
prohibition
on
use
of
ionizing
radiation,
excluded
methods,
and
volatile
synthetic
solvents
applies
to
all
organically
produced
ingredients.
The
5
percent
of
nonorganic
ingredients
in
products
labeled
"
organic,"
also
are
subject
to
the
three
prohibited
practices.
The
nonorganic
ingredients
in
products
labeled
"
made
with
organic
ingredients"
must
not
be
produced
using
ionizing
radiation
or
excluded
methods
but
may
be
produced
using
volatile
synthetic
solvents.
The
nonorganic
ingredients
in
products
containing
less
than
70
percent
organically
produced
ingredients
may
be
produced
and
processed
using
ionizing
radiation,
excluded
methods,
and
synthetic
solvents.

(
2)
Water
Quality
Used
in
Processing.
A
handler
questioned
whether
public
drinking
water
containing
approved
levels
of
chlorine,
pursuant
to
the
Safe
Drinking
Water
Act,
is
107
acceptable
for
use
in
processing
products
labeled
"
100
percent
organic."
Water
meeting
the
Safe
Drinking
Water
Act
may
be
used
in
processing
any
organically
produced
products.

Temporary
Variances
­
Changes
Based
on
Comments
Additional
Causes
for
Issuing
Temporary
Variance.
A
few
State
department
of
agriculture
commenters
suggested
that
"
drought"
should
be
added
to
the
regulatory
text
as
a
natural
disaster
warranting
a
temporary
variance
from
regulations.

We
agree
and
have
added
drought
to
the
regulatory
text
in
paragraph
(
a)(
2)
of
section
205.290.
We
have
also
added
"
hail"
as
a
natural
disaster
warranting
a
temporary
variance.
Both
drought
and
hail
were
mentioned
in
the
preamble
of
the
proposed
rule
but
were
unintentionally
left
out
of
the
regulatory
text.

Temporary
Variances
­
Changes
Requested
But
Not
Made
Allowance
of
Temporary
Variances.
A
few
commenters
suggested
that
SOP's
governing
State
officials
should
be
able
to
authorize
temporary
variances
due
to
local
natural
disasters
which
may
occur
in
a
State.
We
do
not
agree
that
with
these
comments.
For
consistency
of
application,

we
believe
that
only
the
Administrator
should
have
the
authority
to
grant
a
temporary
variance.

Citing
local
conditions,
an
SOP's
governing
State
official
and
certifying
agents
may
recommend
a
temporary
variance
to
the
Administrator.
We
are
committed
to
providing
quick
responses
to
such
recommendations.

Subpart
D
­
Labels,
Labeling,
and
Market
Information
The
Act
provides
that
a
person
may
sell
or
label
an
agricultural
product
as
organically
produced
only
if
the
product
has
been
produced
and
handled
in
accordance
with
provisions
of
the
Act
and
these
regulations.
This
subpart
sets
forth
labeling
requirements
for
organic
agricultural
108
products
and
products
with
organic
ingredients
based
on
their
percentage
of
organic
composition.

For
each
labeling
category,
this
subpart
establishes
what
organic
terms
and
references
can
and
cannot
be
displayed
on
a
product
package's
principal
display
panel
(
pdp),
information
panel,

ingredient
statement,
and
on
other
package
panels.
Labeling
requirements
also
are
established
for
organically
produced
livestock
feed,
for
containers
used
in
shipping
and
storing
organic
product,

and
for
denoting
organic
bulk
products
in
market
information
which
is
displayed
or
disseminated
at
the
point
of
retail
sale.
Restrictions
on
labeling
organic
product
produced
by
exempt
operations
are
established.
Finally,
this
subpart
provides
for
a
USDA
seal
and
regulations
for
display
of
the
USDA
seal
and
the
seals,
logos,
or
other
identifying
marks
of
certifying
agents.

The
intent
of
these
sections
is
to
ensure
that
organically
produced
agricultural
products
and
ingredients
are
consistently
labeled
to
aid
consumers
in
selection
of
organic
products
and
to
prevent
labeling
abuses.
These
provisions
cover
the
labeling
of
a
product
as
organic
and
are
not
intended
to
supersede
other
labeling
requirements
specified
in
other
Federal
labeling
regulations.

The
Food
and
Drug
Administration
(
FDA)
regulates
the
placement
of
information
on
food
product
packages
in
21
CFR
parts
1
and
101.
USDA's
Food
Safety
and
Inspection
Service's
(
FSIS)
Federal
Meat
Inspection
Act,
Poultry
Products
Inspection
Act,
and
Egg
Products
Inspection
Act
have
implementing
regulations
in
9
CFR
part
317
which
must
be
followed
in
the
labeling
of
meat,
poultry,
and
egg
products.
The
Federal
Trade
Commission
(
FTC)
regulations
under
the
Fair
Packaging
and
Labeling
Act
(
FLPA)
in
16
CFR
part
500
and
the
Alcohol
Tobacco
and
Firearms
(
ATF)
regulations
under
the
Federal
Alcohol
Administration
Act
(
FAA)
in
27
CFR
parts
4,
5,
and
7,
also
must
be
followed,
as
applicable
to
the
nature
of
the
product.
The
labeling
requirements
specified
in
this
subpart
must
be
implemented
in
a
manner
so
that
they
do
not
109
conflict
with
the
labeling
requirements
of
these
and
other
Federal
labeling
requirements.

While
this
regulation
does
not
require
labeling
of
an
organic
product
as
organic,
we
assume
that
producers
and
handlers
choose
to
label
their
organic
products
and
display
the
USDA
seal
to
the
extent
allowed
in
these
regulations.
They
do
this
to
improve
the
marketability
of
their
organic
product.

Under
the
National
Organic
Program
(
NOP),
the
assembly,
packaging,
and
labeling
of
multiingredient
organic
products
are
considered
handling
activities.
The
certification
of
handling
operations
is
covered
in
subpart
C
of
this
regulation.
No
claims,
statements,
or
marks
using
the
term,
"
organic,"
or
display
of
certification
seals,
other
than
as
provided
in
this
regulation,
may
be
used.
Based
on
comments
received,
several
important
labeling
changes
from
the
proposed
rule
are
made
in
this
final
rule.
(
1)
The
term,
"
organic,"
cannot
be
used
in
an
agricultural
product
name
if
it
modifies
an
ingredient
that
is
not
organically
produced
(
e.
g.,
"
organic
chocolate
ice
cream"
when
the
chocolate
flavoring
is
not
organically
produced).
(
2)
The
5
percent
or
less
of
nonorganic
ingredients
in
products
labeled
"
organic"
must
be
determined
not
"
commercially
available"
in
organic
form.
(
3)
Display
of
a
product's
organic
percentage
is
changed
from
required
to
optional
for
"
organic"
and
"
made
with
..."
products.
(
4)
The
minimum
organic
content
for
"
made
with..."
products
is
increased
from
50
percent
to
70
percent.
(
5)
In
addition
to
listing
individual
ingredients,
the
"
made
with..."
label
may
identify
a
food
group
on
the
label
("
made
with
organic
fruit").
(
6)
A
new
section
is
added
to
provide
labeling
of
livestock
feed
that
is
organically
produced.
(
7)
Finally,
a
revised
design
for
the
USDA
seal
is
established.
In
addition
to
these
changes,
we
have
made
a
few
changes
in
the
regulatory
text
for
clarity
and
consistency
purposes.
These
do
not
change
the
intent
of
the
regulation.
110
Once
a
handler
makes
a
decision
to
market
a
product
as
organic
or
containing
organic
ingredients,
the
handler
is
required
to
follow
the
provisions
in
this
subpart
regarding
use,
display,

and
location
of
organic
claims
and
certification
seals.
Handlers
who
produce
and
label
organic
ingredients
and/
or
assemble
multiingredient
products
composed
of
70
percent
or
more
organic
ingredients
must
be
certified
as
an
organic
handling
operation.
Handlers
of
products
of
less
than
70
percent
organic
ingredients
do
not
have
to
be
certified
unless
the
handler
actually
produces
one
or
more
of
the
organic
ingredients
used
in
the
product.
Repackers
who
purchase
certified
organic
product
from
other
entities
for
repackaging
and
labeling
must
be
certified
as
an
organic
operation.

Entities
which
simply
relabel
an
organic
product
package
are
subject
to
recordkeeping
requirements
which
show
proof
that
the
product
purchased
prior
to
relabeling
was,
indeed,

organically
produced
and
handled.
Distributors
which
receive
and
transport
labeled
product
to
market
are
not
subject
to
certification
or
any
labeling
requirements
of
this
regulation.

Many
commenters
appealed
for
"
transition"
or
"
conversion"
labeling.
This
issue
is
discussed
under
Applicability
in
subpart
B.
Transition
labeling
is
not
provided
for
in
the
Act
or
the
proposed
rule
and
is
not
provided
for
in
this
regulation.

Description
of
Regulations
General
Requirements
The
general
labeling
principle
employed
in
this
regulation
is
that
labeling
or
identification
of
the
organic
nature
of
a
product
increases
as
the
organic
content
of
the
product
increases.
In
other
words,
the
higher
the
organic
content
of
a
product,
the
more
prominently
its
organic
nature
can
be
displayed.
This
is
consistent
with
provisions
of
the
Act
which
establish
the
three
percentage
categories
for
organic
content
and
basic
labeling
requirements
in
those
categories.
111
Section
205.300
specifies
the
general
use
of
the
term,
"
organic,"
on
product
labels
and
market
information.
Paragraph
(
a)
establishes
that
the
term,
"
organic,"
may
be
used
only
on
labels
and
in
market
information
as
a
modifier
of
agricultural
products
and
ingredients
that
have
been
certified
as
produced
and
handled
in
accordance
with
these
regulations.
The
term,

"
organic,"
cannot
be
used
on
a
product
label
or
in
market
information
for
any
purpose
other
than
to
modify
or
identify
the
product
or
ingredient
in
the
product
that
is
organically
produced
and
handled.
Food
products
and
ingredients
that
are
not
organically
produced
and
handled
cannot
be
modified,
described,
or
identified
with
the
term,
"
organic,"
on
any
package
panel
or
in
market
information
in
any
way
that
implies
the
product
is
organically
produced.

Section
6519(
b)
of
the
Act
provides
the
Secretary
with
the
authority
to
review
use
of
the
term,
"
organic,"
in
agricultural
product
names
and
the
names
of
companies
that
produce
agricultural
products.
While
we
believe
that
the
term,
"
organic,"
in
a
brand
name
context
does
not
inherently
imply
an
organic
production
or
handling
claim
and,
thus,
does
not
inherently
constitute
a
false
or
misleading
statement,
we
intend
to
monitor
the
use
of
the
term
in
the
context
of
the
entire
label.
We
will
consult
with
the
FTC
and
FDA
regarding
product
and
company
names
that
may
misrepresent
the
nature
of
the
product
and
take
action
on
a
case­
by­
case
basis.

Categories
of
Organic
Content
Section
205.301
establishes
the
organic
content
requirements
for
different
labeling
provisions
specified
under
this
program.
The
type
of
labeling
and
market
information
that
can
be
used
and
its
placement
on
different
panels
of
consumer
packages
and
in
market
information
is
based
on
the
percentage
of
organic
ingredients
in
the
product.
The
percentage
must
reflect
the
actual
weight
or
fluid
volume
(
excluding
water
and
salt)
of
the
organic
ingredients
in
the
product.
112
Four
categories
of
organic
content
are
established:
100
percent
organic;
95
percent
or
more
organic;
70
to
95
percent
organic;
and
less
than
70
percent
organic.

100
Percent
Organic
For
labeling
and
market
information
purposes,
this
regulation
allows
a
"
100
percent
organic"
label
on:
(
1)
agricultural
products
that
are
composed
of
a
single
ingredient
such
as
raw,

organically
produced
fruits
and
vegetables
and
(
2)
products
composed
of
two
or
more
organically
produced
ingredients,
provided
that
the
individual
ingredients
are,
themselves,
wholly
organic
and
produced
without
any
nonorganic
ingredients
or
additives.
Only
processing
aids
which
are,

themselves,
organically
produced,
may
be
used
in
the
production
of
products
labeled
"
100
percent
organic."
With
the
exception
of
the
description
phrase
"
100
percent"
on
the
pdp,
the
labeling
requirements
for
"
100
percent
organic"
products
are
the
same
as
requirements
for
95
percent
organic
products
specified
in
section
205.303.

Organic
Products
labeled
or
represented
as
"
organic"
must
contain,
by
weight
(
excluding
water
and
salt),
at
least
95
percent
organically
produced
raw
or
processed
agricultural
product.
The
organic
ingredients
must
be
produced
using
production
and
handling
practices
pursuant
to
subpart
C.
Up
to
5
percent
of
the
ingredients
may
be
nonagricultural
substances
(
consistent
with
the
National
List)
and,
if
not
commercially
available
in
organic
form
pursuant
to
section
205.201,

nonorganic
agricultural
products
and
ingredients
in
minor
amounts
(
hereinafter
referred
to
as
minor
ingredients)
(
spices,
flavors,
colorings,
oils,
vitamins,
minerals,
accessory
nutrients,

incidental
food
additives).
The
nonorganic
ingredients
must
not
be
produced
using
excluded
methods,
sewage
sludge,
or
ionizing
radiation.
113
Made
with
Organic
Ingredients
For
labeling
and
market
information
purposes,
the
third
category
of
agricultural
products
are
multiingredient
products
containing
by
weight
or
fluid
volume
(
excluding
water
and
salt)

between
70
and
95
percent
organic
agricultural
ingredients.
The
organic
ingredients
must
be
produced
in
accordance
with
subpart
C
and
subpart
G.
Such
products
may
be
labeled
or
represented
as
"
made
with
organic
(
specified
ingredients
or
food
group(
s))."
By
"
specified,"
we
mean
the
name
of
the
agricultural
product(
s)
or
food
group(
s)
forming
the
organic
ingredient(
s).

Up
to
three
organically
produced
ingredients
or
food
groups
may
be
named
in
the
phrase.

If
one
or
more
food
groups
are
specified
in
the
phrase,
all
ingredients
in
the
product
which
belong
to
the
food
group(
s)
identified
on
the
label
must
be
organically
produced.
For
the
purposes
of
this
labeling,
the
following
food
groups
may
be
identified
as
organically
produced
on
a
food
package
label:
beans,
fish,
fruits,
grains,
herbs,
meats,
nuts,
oils,
poultry,
seeds,
spices,

sweeteners,
and
vegetables.
In
addition,
processed
milk
products
(
butter,
cheese,
yogurt,
milk,

sour
creams,
etc.)
also
may
be
identified
as
a
"
milk
products"
food
group.
For
instance,
a
vegetable
soup
made
with
85
percent
organically
produced
and
handled
potatoes,
tomatoes,

peppers,
celery,
and
onions
may
be
labeled
"
soup
made
with
organic
potatoes,
tomatoes,
and
peppers"
or,
alternatively,
"
soup
made
with
organic
vegetables."
In
the
latter
example,
the
soup
may
not
contain
nonorganic
vegetables.
For
the
purposes
of
this
labeling
provision,
tomatoes
are
classified,
according
to
food
use,
as
a
vegetable.

To
qualify
for
this
organic
labeling,
the
nonorganic
agricultural
ingredients
must
be
produced
and
handled
without
use
of
the
first
three
prohibited
practices
specified
in
paragraph
(
f)

of
section
205.301,
but
may
be
produced
or
handled
using
practices
prohibited
in
paragraphs
114
(
f)(
4)
through
(
f)(
7).

Because
of
the
length
of
the
labeling
phrase
"
made
with
organic
(
specified
ingredients
or
food
group(
s)),"
such
products
are
referred
to
in
this
preamble
as
"
made
with..."
products.
The
labeling
requirements
for
"
made
with..."
products
are
specified
in
section
205.304.

Product
With
Less
Than
70
Percent
Organic
Ingredients
The
final
labeling
category
covers
multiingredient
products
with
less
than
70
percent
organic
ingredients
(
by
weight
or
fluid
volume,
excluding
water
and
salt).
The
organic
ingredients
must
be
produced
in
accordance
with
subparts
C
and
G.
The
remaining
nonorganic
ingredients
may
be
produced,
handled,
and
assembled
without
regard
to
these
regulations
(
using
prohibited
substances
and
prohibited
production
and
handling
practices).
Organic
labeling
of
these
products
is
limited
to
the
information
panel
only
as
provided
in
section
205.305.

Products
that
fail
to
meet
the
requirements
for
one
labeling
category
may
be
eligible
for
a
lower
labeling
category.
For
example,
if
a
product
contains
wholly
organic
ingredients
but
the
product
formulation
requires
a
processing
aid
or
less
than
5
percent
of
a
minor
ingredient
that
does
not
exist
in
organic
form,
the
product
cannot
be
labeled
"
100
percent
organic"
and
must
be
labeled
as
"
organic."
If
a
multiingredient
product
is
95
percent
or
more
organic
but
contains
a
prohibited
substance
in
the
remaining
5
percent,
the
product
cannot
be
labeled
as
"
organic,"

because
of
the
presence
of
the
prohibited
substance,
but
may
be
labeled
as
a
"
made
with..."

product.
Further,
a
handler
who
produces
a
"
100
percent
organic"
or
"
organic"
product
but
chooses
not
to
be
certified
under
this
program
may
only
display
the
organic
percentage
on
the
information
panel
and
label
the
ingredients
as
"
organic"
on
the
ingredient
statement.
The
handler
must
comply
with
recordkeeping
requirements
in
subpart
E.
115
Livestock
feed
All
agricultural
ingredients
used
in
raw
and
processed
livestock
feed
that
is
labeled
as
"
100
percent
organic"
and
"
organic"
must
be
organically
produced
and
handled
in
accordance
with
the
requirements
of
these
regulations.
The
difference
between
the
two
labels
is
that
feed
labeled
as
"
100
percent
organic"
must
be
composed
only
of
organically
produced
agricultural
ingredients
and
may
not
contain
nonorganic
feed
additives
or
supplements.
The
agricultural
portion
of
livestock
feed
labeled
as
"
organic"
must
contain
only
organically
produced
raw
and
processed
agricultural
ingredients
and
may
contain
feed
additives
and
supplements
in
conformance
with
the
requirements
of
section
205.237.
Additionally,
labeling
of
livestock
feed
containers
must
follow
State
livestock
feed
labeling
laws.

Prohibited
Practices
The
labeling
of
whole
products
or
ingredients
as
organic
is
prohibited
if
those
products
or
ingredients
are
produced
using
any
of
the
following
production
or
handling
practices:
(
1)

ingredients
or
processing
aids
produced
using
excluded
methods;
(
2)
ingredients
that
have
been
produced
using
applications
of
sewage
sludge;
(
3)
ingredients
that
have
been
processed
with
ionizing
radiation;
(
4)
synthetic
substances
not
on
the
National
List;
(
5)
sulfites,
nitrates,
or
nitrites
added
to
or
used
in
processing
of
an
organic
product
in
addition
to
those
substances
occurring
naturally
in
a
commodity
(
except
the
use
of
sulfites
in
the
production
of
wine);
(
6)
use
of
the
phrase,
"
organic
when
available,"
or
similar
statement
on
labels
or
in
market
information
when
referring
to
products
composed
of
nonorganic
ingredients
used
in
place
of
specified
organic
ingredients;
and
(
7)
labeling
as
"
organic"
any
product
containing
both
organic
and
nonorganic
forms
of
an
ingredient
specified
as
"
organic"
on
the
label.
116
These
seven
prohibitions
apply
to
the
four
labeling
categories
of
products
and
are
not
individually
repeated
as
prohibited
practices
in
the
following
sections.
Table
1,
Prohibited
Production
and
Handling
Practices
for
Organic
Labeling,
shows
how
use
of
the
seven
prohibited
practices
affects
the
labeling
of
organically
produced
products
and
ingredients
used
in
those
products.
117
TABLE
1:
PROHIBITED
PRODUCTION
AND
HANDLING
PRACTICES
FOR
LABELING
CATEGORIES
Organic
and
use
label
Use
excluded
methods
Use
sewage
sludge
Use
ionizing
radiation
Use
substances
not
on
National
List
Contain
added
sulfites,
nitrates,
nitrites
Use
nonorganic
ingredients
and
label
"
when
available"
Use
both
organic
and
nonorganic
forms
of
same
ingredient
"
100
percent
organic"
Single/
multiingredients
completely
organic
NO
NO
NO
NO
NO
NO
NO
"
Organic"
Organic
ingredients
(
95%
or
more)
Nonorganic
ingredients
(
5%
or
less)
NO
NO
NO
NO
NO
NO
NO
NO
NO
NO
NO
NO
NO
NO
"
Made
with
organic
ingredients"
Organic
ingredients
(
70­
95%)
Nonorganic
ingredients
(
30%
or
less)
NO
NO
NO
NO
NO
NO
NO
OK
NO­
except
wine
OK
NO
NA*
NO
NA*

Less­
than
70%
organic
ingredients
Organic
Ingredients
(
30%
or
less)
Nonorganic
Ingredients
(
70%
or
more)
NO
OK
NO
OK
NO
OK
NO
OK
NO­
except
wine
OK
NO
NA*
NO
NA*

*
Not
applicable,
provided
that
the
nonorganic
ingredient
is
not
labeled
as
"
organic"
on
the
ingredient
statement
and
is
not
counted
in
the
calculation
of
the
product's
organic
percentage.
118
Calculating
the
Percentage
of
Organic
Ingredients
Section
205.302
specifies
procedures
for
calculating
the
percentage,
by
weight
or
fluid
volume,
of
organically
produced
ingredients
in
an
agricultural
product
labeled
or
represented
as
"
organic."
The
calculation
is
made
by
the
handler
at
the
time
the
finished
product
is
assembled.

The
organic
percentage
of
liquid
products
and
liquid
ingredients
is
determined
based
on
the
fluid
volume
of
the
product
and
ingredients
(
excluding
water
and
salt).
When
a
product
is
identified
on
the
pdp
or
the
information
panel
as
being
reconstituted
with
water
from
a
concentrate,
the
organic
content
is
calculated
on
the
basis
of
a
single­
strength
concentration.

For
products
that
contain
organically
produced
dry
and
liquid
ingredients,
the
percentage
of
total
organic
ingredients
is
based
on
the
combined
weight
of
the
dry
organic
ingredient(
s)
and
the
weight
of
the
liquid
organic
ingredient(
s)
(
excluding
water
and
salt).
For
example,
a
product
may
be
made
using
organically
produced
vegetable
oils
or
grain
oils
or
contain
organic
liquid
flavoring
extracts
in
addition
to
other
organic
and
nonorganic
ingredients.
In
such
cases,
the
weight
of
the
liquid
organic
oils
or
flavoring
extracts,
less
any
added
water
and
salt,
would
be
added
to
other
solid
organic
ingredients
in
the
product,
and
their
combined
weight
would
be
the
basis
for
calculating
the
percentage
of
organic
ingredients.

At
the
discretion
of
the
handler,
the
total
percentage
of
all
organic
ingredients
in
a
food
product
may
be
displayed
on
any
package
panel
of
the
product
with
the
phrase,
"
contains
X
percent
organic
ingredients,"
or
a
similar
phrase.
If
the
total
percentage
is
a
fraction,
it
must
be
rounded
down
to
the
nearest
whole
number.
The
percentage
of
each
organic
ingredient
is
not
required
to
be
displayed
in
the
ingredient
statement.

A
certified
operation
that
produces
organic
product
may
contract
with
another
operation
119
to
repackage
and/
or
relabel
the
product
in
consumer
packages.
In
such
cases,
the
repacker
or
relabeler
may
use
information
provided
by
the
certified
operation
to
determine
the
percentage
of
organic
ingredients
and
properly
label
the
organic
product
package
consistent
with
the
requirements
of
this
subpart.

Labeling
"
100
Percent
Organic"
and
"
Organic"
Products
Section
205.303
includes
optional,
required,
and
prohibited
practices
for
labeling
agricultural
products
that
are
"
100
percent
organic"
or
"
organic."
Products
that
are
composed
of
wholly
organic
ingredients
may
be
identified
with
the
label
statement,
"
100
percent
organic,"
on
any
package
panel.
Products
composed
of
between
95
and
100
percent
organic
ingredients
may
be
identified
with
the
label
statement
"
organic"
on
any
package
panel,
and
the
handler
must
identify
each
organic
ingredient
in
the
ingredient
statement.

The
handler
may
display
the
following
information
on
the
pdp,
the
information
panel,
and
any
other
part
of
the
package
and
in
market
information
representing
the
product:
(
1)
the
term,

"
100
percent
organic"
or
"
organic,"
as
applicable
to
the
content
of
the
product;
and
(
2)
for
products
labeled
"
organic,"
the
percentage
of
organic
ingredients
in
the
product.
The
size
of
the
percentage
statement
must
not
exceed
one­
half
the
size
of
the
largest
type
size
on
the
panel
on
which
the
statement
is
displayed.
It
also
must
appear
in
its
entirety
in
the
same
type
size,
style,

and
color
without
highlighting;
(
3)
the
USDA
seal;
and
(
4)
the
seal,
logo,
or
other
identifying
mark
of
the
certifying
agent
(
hereafter
referred
to
as
"
seal
or
logo")
which
certified
the
handler
of
the
finished
product.
The
seals
or
logos
of
other
certifying
agents
which
certified
organic
raw
materials
or
organic
ingredients
used
in
the
product
also
may
be
displayed,
at
the
discretion
of
the
finished
product
handler.
If
multiple
organic
ingredients
are
identified
on
the
ingredient
120
statement,
the
handler
of
the
finished
product
that
combined
the
various
organic
ingredients
must
maintain
documentation,
pursuant
to
subpart
B
of
this
regulation.

While
certifying
agent
identifications
can
appear
on
the
package
with
the
USDA
seal,
they
may
not
appear
larger
than
the
USDA
seal
on
the
package.
There
is
no
restriction
on
the
size
of
the
USDA
seal
as
it
may
appear
on
any
panel
of
a
packaged
product,
provided
that
display
of
the
Seal
conforms
with
the
labeling
requirements
of
FDA
and
FSIS.

If
a
product
is
labeled
as
"
100
percent
organic"
the
ingredients
may
be
identified
with
the
term,
"
organic,"
but
will
not
have
to
be
so
labeled
because
it
is
assumed
from
the
100
percent
label
that
all
ingredients
are
organic.
For
95
percent­
plus
products,
each
organically
produced
ingredient
listed
in
the
ingredient
statement
must
be
identified
with
the
term,
"
organic,"
or
an
asterisk
or
other
mark
to
indicate
that
the
ingredient
is
organically
produced.
Water
and
salt
cannot
be
identified
as
"
organic"
in
the
ingredient
statement.

The
handler
of
these
products
also
must
display
on
the
information
panel
the
name
of
the
certifying
agent
which
certified
the
handling
operation
that
produced
the
finished
product.
The
handler
may
include
the
business
address,
Internet
address,
or
telephone
number
of
the
certifying
agent.
This
information
must
be
placed
below
or
otherwise
near
the
manufacturer
or
distributor's
name.

Labeling
Products
"
Made
with
Organic
(
specified
ingredients
or
food
group(
s))"

With
regard
to
agricultural
products
"
made
with..."­­
those
products
containing
between
70
and
95
percent
organic
ingredients­­
this
rule
establishes,
in
section
205.304,
the
following
optional,
required,
and
prohibited
labeling
practices.

Under
optional
practices,
the
"
made
with..."
statement
is
used
to
identify
the
organically
121
produced
ingredients
in
the
product.
The
statement
may
be
placed
on
the
pdp
and
other
panels
of
the
package.
The
same
statement
can
also
be
used
in
market
information
representing
the
product.
However,
the
following
restrictions
are
placed
on
the
statement:
(
1)
the
statement
may
list
up
to
three
ingredients
or
food
group
commodities
that
are
in
the
product;
(
2)
the
individually
specified
ingredients
and
all
ingredients
in
a
labeled
food
group
must
be
organically
produced
and
must
be
identified
as
"
organic"
in
the
ingredient
statement
on
the
package's
information
panel;
(
3)

the
statement
cannot
appear
in
print
that
is
larger
than
one
half
(
50
percent)
of
the
size
of
the
largest
print
or
type
appearing
on
the
pdp;
and
(
4)
The
statement
and
optional
display
of
the
product's
organic
percentage
must
appear
in
their
entirety
in
the
same
type
size,
style,
and
color
without
highlighting.

The
following
food
groups
can
be
specified
in
the
"
made
with"
labeling
statement:
fish,

fruits,
grains,
herbs,
meats,
nuts,
oils,
poultry,
seeds,
spices,
sweeteners,
and
vegetables.
In
addition,
organically
produced
and
processed
butter,
cheeses,
yogurt,
milk,
sour
cream,
etc.,
may
be
identified
as
a
"
milk
products"
food
group.
For
the
purposes
of
this
labeling,
tomatoes
are
considered
as
vegetables,
based
on
their
use
in
a
product.
As
noted
immediately
above,
all
of
a
product's
ingredients
that
are
in
the
specified
food
group(
s)
must
be
organically
produced.

Display
of
the
"
made
with.."
statement
on
other
panels
must
be
similarly
consistent
with
the
size
of
print
used
on
those
panels.
These
restrictions
are
in
accordance
with
FDA
labeling
requirements
and
similar
to
the
recommendations
of
the
National
Organic
Standards
Board
(
NOSB).
This
provision
helps
assure
that
the
"
made
with..."
statement
is
not
displayed
in
such
a
manner
as
to
misrepresent
the
actual
organic
composition
of
the
product.

The
USDA
seal
may
not
be
displayed
on
the
pdp
of
products
labeled
"
made
with
organic
122
ingredients."
However,
at
the
handler's
option
and
consistent
with
any
contract
agreement
between
the
organic
producer
or
handler
and
the
certifying
agent,
the
certifying
agent's
seal
or
logo
may
be
displayed
on
the
pdp
and
other
package
panels.

Packages
of
"
made
with..."
products
may
display
on
the
pdp,
information
panel,
or
any
package
panel,
the
total
percentage
of
organic
ingredients
in
the
product.
Any
organically
produced
ingredient,
including
any
ingredient
that
is
a
member
of
a
food
group
listed
on
the
"
made
with..."
statement,
must
be
identified
in
the
ingredient
statement
with
the
term,
"
organic."

Alternatively,
an
asterisk
or
other
mark
may
be
placed
beside
each
organically
produced
ingredient
in
the
ingredients
statement
with
an
explanation
that
the
mark
indicates
the
ingredient
is
organically
produced.

The
name
of
the
certifying
agent
which
certified
the
handler
of
the
finished
product
must
be
displayed
below
or
otherwise
near
the
manufacturer
or
distributor's
name.
The
statement
may
include
the
phrase,
"
Certified
organic
by..."
or
"
Ingredients
certified
as
organically
produced
by...."
to
help
distinguish
the
certifying
agent
from
the
manufacturer
or
distributor.
The
handler
may
include
the
business
address,
Internet
address,
or
telephone
number
of
the
certifying
agent
which
certified
the
handler
of
the
finished
product.

If
the
percentage
of
organic
ingredients
in
the
product
is
displayed,
the
handler
who
affixes
the
label
to
the
product
package
is
responsible
for
determining
the
percentage.
The
handler
may
use
information
provided
by
the
certified
operation
in
determining
the
percentage.
As
part
of
the
certifying
agent's
annual
certification
of
the
handler,
the
certifier
must
verify
the
calculation
and
labeling
of
packages.

Labeling
Products
with
Less
Than
70
Percent
Organic
Ingredients
123
Section
205.305
covers
the
final
labeling
category
of
packaged
multiingredient
agricultural
products
containing
less
than
70
percent
organic
ingredients.

Handlers
of
"
less
than
70
percent"
multiingredient
products,
who
choose
to
declare
the
organic
nature
of
their
product,
may
do
so
only
in
the
ingredient
statement
by
identifying
the
organically
produced
ingredients
with
the
term,
"
organic,"
or
with
an
asterisk
or
other
mark.
If
the
handler
identifies
the
ingredients
that
are
organically
produced,
the
handler
also
may
declare
the
percentage
of
organic
content
in
the
product.
The
percentage
may
only
be
placed
on
the
information
panel
so
that
it
can
be
viewed
in
relation
to
the
ingredient
statement.

Processed
products
composed
of
less
than
70
percent
organic
content
cannot
display
the
USDA
seal
or
any
certifying
agent's
organic
certification
seal
or
logo
anywhere
on
the
product
package
or
in
market
information.

Handlers
of
such
products
are
subject
to
this
regulation
in
the
following
ways.
Those
handlers
who
only
purchase
organic
and
nonorganic
ingredients
and
assemble
a
finished
product
of
less
than
70
percent
organic
content
do
not
have
to
be
certified
as
organic
handlers.
However,

they
are
responsible
for
appropriate
handling
and
storage
of
the
organic
ingredients
(
section
205.101(
a)(
3))
and
for
maintaining
records
verifying
the
organic
certification
of
the
ingredients
used
in
the
product
(
section
205.101(
c)).
To
the
extent
that
the
packaging
process
includes
affixing
the
label
to
finished
product
package,
those
handlers
are
responsible
for
meeting
the
labeling
requirements
of
this
subpart.
The
nonorganic
ingredients
may
be
produced,
handled,
and
assembled
without
regard
to
the
requirements
of
this
part.

Table
2,
Labeling
Consumer
Product
Packages,
provides
a
summary
of
the
required
and
prohibited
labeling
practices
for
the
four
labeling
categories.
124
TABLE
2:
LABELING
CONSUMER
PRODUCT
PACKAGES
Labeling
category
Principle
display
panel
Information
panel
Ingredient
statement
Other
package
panels
"
100
percent
Organic"
(
Entirely
organic;
whole,
raw
or
processed
product)
"
100
percent
organic"
(
optional)

USDA
seal
and
certifying
agent
seal(
s)
(
optional)
"
100%
organic"
(
optional)

Certifying
agent
name
(
required);
business/
Internet
address,
tele.
#
(
optional)
If
multiingredient
product,
identify
each
ingredient
as
"
organic"
(
optional)
"
100
percent
organic"
(
optional)

USDA
seal
and
certifying
agent
seal(
s)
(
optional)

"
Organic"
(
95%
or
more
organic
ingredients)
"
Organic"
(
plus
product
name)
(
optional)
"
X%
organic"
(
optional)
USDA
seal
and
certifying
agent
seal(
s)
(
optional)
"
X
%
organic"
(
optional)

Certifying
agent
name
(
required);
business/
Internet
address,
tele.
#
(
optional)
Identify
organic
ingredients
as
"
organic"
(
required
if
other
organic
labeling
is
shown)
X%
organic"
(
optional)

USDA
seal
and
certifying
agent
seal(
s)
(
optional)

"
Made
with
Organic
Ingredients"
(
70
to
95%
organic
ingredients)
"
made
with
organic
(
ingredients
or
food
group(
s))"
(
optional)

"
X
%
organic"
(
optional)

Certifying
agent
seal
of
final
product
handler
(
optional)

Prohibited:
USDA
seal
"
X
%
organic
ingredients"
(
optional)

Certifying
agent
name
(
required);
business/
Internet
address,
tele.
#
(
optional)
Prohibited:
USDA
seal
Identify
organic
ingredients
as
"
organic"
(
required
if
other
organic
labeling
is
shown)
"
made
with
organic
(
ingredients
or
food
group(
s))"
(
optional)
"
X
%
organic"
(
optional)
Certifying
agent
seal
of
final
product
handler
(
optional)
Prohibited:
USDA
seal
Less­
than
70%
organic
ingredients
Prohibited:
Any
reference
to
organic
content
of
product
Prohibited:
USDA
seal
&
certifying
agent
seal
"
X
%
organic"
(
optional)

Prohibited:
USDA
seal
&
certifying
agent
seal
Identify
organic
ingredients
as
"
organic"
(
optional)
(
required
if
%
organic
is
displayed)
Prohibited:
USDA
seal
&
certifying
agent
seal
Misrepresentation
in
Labeling
of
Organic
Products.
The
labeling
requirements
of
this
final
rule
are
intended
to
assure
that
the
term,
"
organic,"
and
other
similar
terms
or
phrases
are
not
125
used
on
a
product
package
or
in
marketing
information
in
a
way
that
misleads
consumers
as
to
the
contents
of
the
package.
Thus,
we
intend
to
monitor
the
use
of
the
term,
"
organic,"
and
other
similar
terms
and
phrases.
If
terms
or
phrases
are
used
on
product
packages
to
represent
"
organic"
when
the
products
are
not
produced
to
the
requirements
of
this
regulation,
we
will
proceed
to
restrict
their
use.

Handlers
may
not
qualify
or
modify
the
term,
"
organic,"
using
adjectives
such
as,
"
pure"

or
"
healthy,"
e.
g.,
"
pure
organic
beef"
or
"
healthy
organic
celery."
The
term,
"
organic,"
is
used
in
labeling
to
indicate
a
certified
system
of
agricultural
production
and
handling.
Terms
such
as
"
pure,"
"
healthy,"
and
other
similar
adjectives
attribute
hygienic,
compositional,
or
nutritional
characteristics
to
products.
Use
of
such
adjectives
may
misrepresent
products
produced
under
the
organic
system
of
agriculture
as
having
special
qualities
as
a
result
of
being
produced
under
the
organic
system.
Furthermore,
use
of
such
adjectives
would
incorrectly
imply
that
products
labeled
in
this
manner
are
different
from
other
organic
products
that
are
not
so
labeled.

Moreover,
"
pure,"
"
healthy,"
and
other
similar
terms
are
regulated
by
FDA
and
FSIS.

These
terms
may
be
used
only
in
accordance
with
the
labeling
requirements
of
FDA
and
FSIS.

The
prohibition
on
use
of
these
terms
to
modify
"
organic"
does
not
otherwise
preclude
their
use
in
other
labeling
statements
as
long
as
such
statements
are
in
accordance
with
other
applicable
regulations.
Representations
made
in
market
information
for
organic
products
are
also
subject
to
the
requirements
and
restrictions
of
other
Federal
statutes
and
applicable
regulations,
including
the
Federal
Trade
Commission
Act,
15
U.
S.
C.
45
et
seq.

Labeling
Organically
Produced
Livestock
Feed
Products
New
section
205.306
is
added
to
provide
for
labeling
of
the
two
categories
of
livestock
126
feed
that
are
organically
produced
under
this
regulation.
Feed
labeled
"
100
percent
organic"
may
contain
only
organically
produced
agricultural
product.
Such
feed
must
not
contain
feed
additives,
supplements,
or
synthetic
substances.
Feed
labeled
"
organic"
must
contain
only
organically
produced
agricultural
products
and
may
contain
feed
additives
and
supplements
in
accordance
with
section
205.237,
Livestock
Feed,
and
section
205.603
of
the
National
List.
This
rule
does
not
limit
the
percentage
of
such
additives
and
supplements
in
organic
feed
products,

which
may
be
required
under
various
State
laws.

Livestock
feed
labeled
"
100
percent
organic"
and
"
organic"
may,
at
the
handler's
option,

display
the
USDA
seal
and
the
seal
or
logo
of
the
certifying
agent.
The
organic
ingredients
listed
on
the
ingredient
statement
may
be
identified
with
the
word,
"
organic,"
or
other
reference
mark.

The
name
of
the
certifying
agent
must
be
displayed
on
the
information
panel.
The
business
address,
Internet
address,
and
other
contact
information
for
the
certifying
agent
may
be
displayed.

These
are
the
only
labeling
options
to
indicate
that
livestock
feed
that
is
organically
produced.

Labeling
of
Products
Shipped
in
International
Markets
Domestically
produced
organic
products
intended
for
export
may
be
labeled
to
meet
the
requirements
of
the
country
of
destination
or
any
labeling
requirements
specified
by
a
particular
foreign
buyer.
For
instance,
a
product
label
may
require
a
statement
that
the
product
has
been
certified
to,
or
meets,
certain
European
Union
(
EU)
organic
standards.
Such
factual
statements
regarding
the
organic
nature
of
the
product
are
permitted.
However,
those
packages
must
be
exported
and
cannot
be
sold
in
the
United
States
with
such
a
statement
on
the
label
because
the
statement
indicates
certification
to
standards
other
than
are
required
under
this
program.
As
a
safeguard
for
this
requirement,
we
require
that
shipping
containers
and
bills
of
lading
for
such
127
exported
products
display
the
statement,
"
for
export
only,"
in
bold
letters.
Handlers
also
are
expected
to
maintain
records,
such
as
bills
of
lading
and
U.
S.
Customs
Service
documentation,

showing
export
of
the
products.
Only
products
which
have
been
certified
and
labeled
in
accordance
with
the
requirements
of
the
NOP
may
be
shipped
to
international
markets
without
marking
the
shipping
containers
"
for
export
only."

Organically
produced
products
imported
into
the
United
States
must
be
labeled
in
accordance
with
the
requirements
of
this
subpart.
Labeling
and
market
representation
of
the
product
cannot
imply
that
the
product
is
also
certified
to
other
organic
standards
or
requirements
that
differ
from
this
national
program.

Labeling
Nonretail
Containers
Section
205.307
provides
for
labeling
nonretail
containers
used
to
ship
or
store
raw
or
processed
organic
agricultural
products
that
are
labeled
"
100
percent
organic,"
"
organic,"
and
"
made
with
organic..."
Labeling
nonretail
containers
as
containing
organically
produced
product
should
provide
for
easy
identification
of
the
product
to
help
prevent
commingling
with
nonorganic
product
or
handling
of
the
product
which
would
destroy
the
organic
nature
of
the
product
(
fumigation,
etc.).
These
labeling
provisions
are
not
intended
for
shipping
or
storage
containers
that
also
are
used
in
displays
at
the
point
of
retail
sale.
Retail
containers
must
meet
labeling
provisions
specified
in
section
205.307.

Containers
used
only
for
shipping
and
storage
of
any
organic
product
labeled
as
containing
70
percent
or
more
organic
content
may,
at
the
handler's
discretion,
display
the
following
information:
(
1)
the
name
and
contact
information
of
the
certifying
agent
which
certified
the
handler
of
the
finished
product;
(
2)
the
term,
"
organic,"
modifying
the
product
name;
(
3)
any
128
special
handling
instructions
that
must
be
followed
to
maintain
the
organic
integrity
of
the
product;
and
(
4)
the
USDA
seal
and
the
appropriate
certifying
agent
seal.
This
information
is
available
to
handlers
if
they
believe
display
of
the
information
helps
ensure
special
handling
or
storage
practices
which
are
consistent
with
organic
practices.

Containers
used
for
shipping
and
storage
of
organic
product
must
display
a
production
lot
number
if
such
a
number
is
used
in
the
processing
and
handling
of
the
product.
Much
of
this
information
may
overlap
information
that
the
handler
normally
affixes
to
shipping
and
storage
containers
or
information
that
is
required
under
other
Federal
labeling
regulations.
There
are
no
restrictions
on
size
or
display
of
the
term,
"
organic,"
or
the
certifying
agent
seal
unless
required
by
other
Federal
or
State
statutes.

Labeling
Products
at
the
Point
of
Retail
Sale
Section
205.308
applies
to
organically
produced
"
100
percent
organic"
and
"
organic"

products
that
are
not
packaged
prior
to
sale
and
are
presented
in
a
manner
which
allows
the
consumer
to
select
the
quantity
of
the
product
purchased.

The
terms,
"
100
percent
organic"
and
"
organic,"
as
applicable,
may
be
used
to
modify
the
name
of
the
product
in
retail
displays,
labeling,
and
market
information.
The
ingredient
statement
of
a
product
labeled
"
organic"
displayed
at
retail
sale
must
identify
the
organic
ingredients.
If
the
product
is
prepared
in
a
certified
facility,
the
retail
materials
may
also
display
the
USDA
seal
and
the
seal
or
logo
of
the
certifying
agent.
If
shown,
the
certifying
agent
seal
must
not
be
larger
than
the
USDA
seal.

Section
205.309
addresses
"
made
with..."
products
that
are
not
packaged
prior
to
sale
and
are
presented
in
a
manner
which
allows
the
consumer
to
select
the
quantity
of
the
product
129
purchased.
These
products
include,
but
are
not
limited
to,
multiingredient
products
containing
between
70
and
95
percent
organic
ingredients.
The
"
made
with..."
label
may
be
used
to
modify
the
name
of
the
product
in
retail
displays,
labeling,
and
market
information.
Up
to
three
organic
ingredients
or
food
groups
may
be
identified
in
the
statement.
If
such
statement
is
declared
in
market
information
at
the
point
of
retail
sale,
the
ingredient
statement
and
market
information
must
identify
the
organic
ingredients.
Retail
display
and
market
information
of
bulk
products
cannot
display
the
USDA
seal
but
may,
if
the
product
is
prepared
in
a
certified
facility,
display
the
seal
or
logo
of
the
certifying
agent
which
certified
the
finished
product.
The
certifying
agent's
seal
or
logo
may
be
displayed
at
the
option
of
the
retail
food
establishment.

Products
containing
less
than
70
percent
organic
ingredients
may
not
be
identified
as
organic
or
containing
organic
ingredients
at
retail
sale.
The
USDA
seal
and
any
certifying
agent
seal
or
logo
may
not
be
displayed
for
such
products.

Labeling
Products
Produced
in
Exempt
or
Excluded
Operations
Section
205.310
provides
limited
organic
labeling
provisions
for
organic
product
produced
or
handled
on
exempt
and
excluded
operations.
Such
operations
would
include
retail
food
establishments,
certain
manufacturing
facilities,
and
production
and
handling
operations
with
annual
organic
sales
of
less
the
$
5,000.
These
operations
are
discussed
more
thoroughly
in
subpart
B,
Applicability.

Any
such
operation
that
is
exempt
or
excluded
from
certification
or
which
chooses
not
to
be
certified
may
not
label
its
organically
produced
products
in
a
way
which
indicates
that
the
operation
has
been
certified
as
organic.
Exempt
producers
may
market
whole,
raw
organic
product
directly
to
consumers,
for
example,
at
a
farmers
market
or
roadside
stand
as
"
organic
130
apples"
or
"
organic
tomatoes."
Exempt
producers
may
market
their
products
to
retail
food
establishments
for
resale
to
consumers.
However,
no
terms
may
be
used
which
indicate
that
such
products
are
"
certified"
as
organic.
Finally,
exempt
organic
producers
cannot
sell
their
product
to
a
handler
for
use
as
an
ingredient
or
for
processing
into
an
ingredient
that
is
labeled
as
organic
on
the
information
panel.

These
provisions
are
truth
in
labeling
provisions
because
display
of
a
certification
seal
indicates
that
the
product
has
been
certified.
We
believe
this
requirement
helps
differentiate
between
certified
and
uncertified
products
and
helps
maintain
the
integrity
of
certified
products
while
providing
organic
labeling
opportunities
for
exempt
and
excluded
operations.

USDA
Organic
Seal
This
final
rule
establishes
a
USDA
seal
that
can
be
placed
on
consumer
packages,

displayed
at
retail
food
establishments,
and
used
in
market
information
to
show
that
certified
organic
products
have
been
produced
and
handled
in
accordance
with
these
regulations.
The
USDA
seal
can
only
be
used
to
identify
raw
and
processed
products
that
are
certified
as
organically
produced.
It
cannot
be
used
for
products
labeled
as
"
made
with
organic
ingredients"

(
70
to
95
percent
organic
ingredients)
or
on
products
with
less
than
70
percent
organic
ingredients.

The
USDA
seal
is
composed
of
an
outer
circle
around
two
interior
half
circles
with
an
overlay
of
the
words
"
USDA
Organic."
When
used,
the
USDA
seal
must
be
the
same
form
and
design
as
shown
in
figure
1
of
section
205.311
of
this
regulation.
The
USDA
seal
must
be
printed
legibly
and
conspicuously.
On
consumer
packages,
retail
displays,
and
labeling
and
market
information,
the
USDA
seal
should
be
printed
on
a
white
background
in
earth
tones
with
a
131
brown
outer
circle
and
separate
interior
half
circles
of
white
(
upper)
and
green
(
lower).
The
term,

"
USDA,"
must
appear
in
green
on
the
white
half
circle.
The
term,
"
organic,"
must
appear
in
white
on
the
green
half
circle.
The
handler
may
print
the
USDA
seal
in
black
and
white,
using
black
in
the
place
of
green
and
brown.
Size
permitting,
the
green
(
or
black)
lower
half
circle
may
have
four
light
lines
running
from
left
to
right
and
disappearing
at
the
right
horizon,
to
resemble
a
cultivated
field.
The
choice
between
these
two
color
schemes
is
left
to
the
discretion
of
the
producer,
handler,
or
retail
food
establishment.

Labeling
­
Changes
Based
on
Comments
The
following
changes
are
made
based
on
comments
received.

(
1)
Use
of
"
Organic"
in
Product
Names.
The
NOSB,
State
organic
program
(
SOP)

managers,
certifying
agents,
and
a
large
number
of
individual
commenters
strongly
recommended
that
USDA
prohibit
use
of
the
term,
"
organic,"
to
modify
an
ingredient
in
a
product
name
if
the
ingredient,
itself,
is
not
produced
organically.
The
examples
offered
were
"
organic
chocolate
ice
cream"
and
"
organic
cherry
sweets"
in
which
the
ice
cream
and
candy
are
at
least
95
percent
organic
but
the
chocolate
and
cherry
flavoring
is
not
organically
produced.

We
agree
with
commenters
that
such
product
names
can
be
misleading
and
would
be
a
violation
of
section
205.300(
a).
In
the
examples,
the
word,
"
organic,"
precedes
the
words,

"
chocolate"
and
"
cherry,"
and
clearly
implies
that
those
ingredients
are
organically
produced.
The
chocolate
and
cherry
flavorings
must
be
organically
produced
to
be
used
in
this
way.
If
the
product
is
at
least
95
percent
organically
produced
but
the
flavoring
is
nonorganic,
the
word
sequence
must
be
reversed
or
the
word,
"
flavored,"
must
be
added
to
the
name;
e.
g.,
"
chocolate
organic
ice
cream"
or
"
chocolate
flavored
organic
ice
cream."
A
sentence
has
been
added
to
132
section
205.300(
a)
to
specify
that
the
term,
"
organic,"
may
not
be
used
in
a
product
name
to
identify
an
ingredient
that
is
not
organically
produced.

A
similar
comment
was
received
asking
how
a
single
product
with
two
separately
wrapped
components
can
be
labeled
if
one
of
the
components
is
organically
produced
and
the
other
is
not.

The
commenter's
example
was
a
carrot
and
dip
snack
pack
in
which
the
carrots
are
organically
produced
and
the
dip
is
a
conventional
product.
Another
example
is
ready­
to­
eat
tossed
green
salad
in
which
the
salad
greens
are
organically
produced
but
the
separately
pouched
salad
dressing
is
a
nonorganic
component
of
the
product.

Such
products
also
must
be
labeled
in
accordance
with
section
205.300(
a).
It
would
be
misleading
to
label
the
snack
pack
"
organic
carrots
and
dip"
or
"
organic
green
salad
and
ranch
dressing,"
if
the
dip
and
ranch
dressing
are
not
produced
with
organic
ingredients.
The
salad
may
be
labeled
"
organic
green
salad
with
ranch
dressing."

Section
6519(
b)
of
the
Act
provides
the
Secretary
with
the
authority
to
take
action
against
misuse
of
the
term,
"
organic."
USDA
will
monitor
use
of
the
term,
"
organic,"
in
product
names
and
will
restrict
use
of
the
term
in
names
that
are
determined
to
be
deliberately
misleading
to
consumers.
Such
determinations
must
be
made
on
a
case­
by­
cases
basis.

(
2)
Labeling
Livestock
Feed.
In
the
definition
of
"
agricultural
product,"
the
Act
includes
product
marketed
for
"
livestock
consumption."
This
means
that
NOP
regulations
have
applicability
to
livestock
feed
production.
The
Association
of
American
Feed
Control
Officials
(
AAFCO)
and
a
few
States
departments
of
agriculture
commented
that
the
proposed
provisions
conflict
with
widely
followed
standards
for
livestock
feed
labeling.
AAFCO's
"
Model
Bill
and
Regulation"
standards
are
incorporated
in
many
State
feed
laws.
The
commenters
claimed
that
133
the
requirement
to
identify
organic
ingredients
in
the
ingredient
statement
conflicts
with
feed
regulations
which
prohibit
reference
to
an
ingredient's
"
quality
or
grade."
They
also
claimed
that
the
percentage
of
organic
content
requirement
is
a
quantitative
claim
that
must
be
verified
by
independent
sources
(
e.
g.,
sources
other
than
the
certifying
agent).
The
commenters
suggested
that
a
provision
be
added
to
address
labeling
of
commercial
livestock
feed.

We
have
added
new
paragraph
(
e)
of
section
205.301
which
provides
for
two
kinds
of
feed
that
can
be
labeled
as
"
organic."
The
first
is
feed
that
contains
only
organically
produced
agricultural
ingredients
and
contains
no
added
nutrients
or
supplements.
The
second
organic
feed
category
also
must
contain
only
organically
produced
agricultural
ingredients
but
may
contain
feed
additives
and
supplements
that
are
needed
to
meet
the
nutritional
and
health
needs
of
the
livestock
for
which
the
feed
is
intended.
Feed
labeled
as
"
organic"
must
conform
with
the
requirements
of
section
205.237,
Livestock
feed.
That
section
provides
that
feed
additives
and
supplements
produced
in
conformity
with
section
205.603
of
the
National
List
may
be
used.
The
NOP
requires
that
livestock
under
organic
management
must
only
be
fed
organically
produced
agricultural
ingredients.

We
also
have
added
new
section
205.306
to
address
commenters'
labeling
concerns.
The
new
section
provides
for
optional
display
of
a
feed's
organic
percentage
and
optional
identification
of
the
feed
ingredients
that
are
organically
produced.
The
labeling
requirements
are
not
intended
to
supersede
the
general
feed
labeling
requirements
established
in
the
FFDCA
and
those
found
under
various
State
laws.
Handling
processes,
feed
formulations
and
recordkeeping
must
be
sufficient
to
meet
the
requirements
of
applicable
State
regulations.

We
believe
the
provisions
in
new
paragraph
(
e)
of
section
205.301
on
feed
content
and
134
new
section
205.306
on
labeling
will
allow
livestock
feed
producers
to
produce
and
label
organic
livestock
feed
that
is
in
accordance
with
these
regulations
and
State
requirements.

(
3)
Organic
Processing
Aids.
Several
industry
leaders
and
SOP
managers
questioned
whether
the
proposed
rule
intended
to
exclude
the
use
of
certified
organic
processing
aids
in
the
creation
of
"
100
percent
organic"
products.
Commenters
pointed
out
that
a
handler
should
be
able
to
use
organically
produced
processing
aids
to
create
products
that
are
labeled
as
"
100
percent
organic."
The
processing
aid
can
be
a
by­
product
of
an
organic
agricultural
product;
e.
g.,

a
filter
made
of
rice
hulls
from
organically
produced
rice.
AMS
concurs.
Accordingly,
a
change
is
made
in
paragraph
(
f)(
4)
of
section
205.301
to
provide
for
use
of
organically
produced
processing
aids
in
products
labeled
"
100
percent
organic."

To
help
clarify
this
and
correct
an
incomplete
reference
in
the
proposed
rule
preamble,
we
have
changed
the
column
heading
of
the
fourth
prohibited
practice
in
the
preamble
table
1.

(
4)
Content
of
"
100
Percent
Organic
Products."
Certifying
agents
and
several
industry
commenters
called
attention
to
the
regulatory
text
of
section
205.301(
a)
describing
100
percent
organic
products.
They
argued
that
the
proposed
rule
would
allow
products
with
one
or
more
95
percent­
plus
"
organic"
ingredients
to
be
combined
as
components
and
have
the
resulting
product
be
labeled
as
"
100
percent
organic."

We
did
not
intend
to
allow
any
ingredient
that
is
less
than
100
percent
organic
to
be
used
in
a
product
labeled
"
100
percent
organic."
To
leave
no
doubt
as
to
the
nature
of
any
product
labeled
"
100
percent
organic,"
we
have
changed
the
wording
of
paragraph
(
a)
of
section
205.301
to
clarify
that
a
multiingredient
"
100
percent
organic"
product
must
be
comprised
entirely
of
100
percent
organic
ingredients.
135
(
5)
Labeling
of
Organic
Percentage.
We
received
many
comments
requesting
clearer
display
of
a
product's
percentage
of
organic
content.
Most
suggested
that
any
product
containing
less
than
100
percent
organic
ingredients
should
be
required
to
display
the
organic
percentage
on
the
pdp.
They
argued
that
display
of
the
organic
percentage
on
the
front
of
the
package
would
enable
consumers
to
more
easily
determine
organic
content,
compare
competing
products,
and
make
better
purchase
decisions.
The
NOSB
did
not
recommend
display
of
organic
percentage
on
the
pdp
for
all
products
containing
organic
ingredients.

We
also
received
several
comments
from
handlers
concerned
that
the
required
display
of
a
product's
organic
percentage
can
be
a
burden
on
handlers.
They
stated
that,
to
save
packaging
and
printing
costs,
handlers
order
bulk
quantities
of
printed
packages,
labels,
and
other
printed
marketing
materials.
When
printed
in
advance
of
a
growing
season
and
harvest,
the
handler
may
not
be
able
to
assemble
a
product
that
is
exactly
consistent
with
the
preprinted
labeling
information,
particularly
the
percentage
of
organic
content.
One
commenter
representing
a
commodity
association
opposed
the
required
percentage
labeling
because
the
association
believes
consumers
will
not
understand
any
organic
claim
if
a
percentage
of
less
than
100
percent
is
displayed.

We
believe
that
display
of
the
percentage
of
organic
content
is
important
product
information
that
can
be
very
helpful
to
consumers
in
their
purchase
decisions.
We
also
believe
that
the
opportunity
to
display
the
percentage
content
of
organically
produced
ingredients
can
be
a
positive
factor
in
encouraging
handlers
to
use
more
organic
ingredients
in
their
multiingredient
products.
At
the
same
time,
we
understand
the
financial
commitment
involved
in
preprinting
bulk
quantities
of
packages
and
labels
well
in
advance
of
harvests,
which
determine
availability
of
136
needed
ingredients.

This
final
rule
implements
changes
in
sections
205.303
and
205.304
for
products
labeled
"
organic"
and
"
made
with
organic
ingredients."
The
requirement
to
display
the
percentage
of
organic
content
on
the
information
panel
is
removed.
That
requirement
is
replaced
with
optional
labeling
of
the
product's
organic
percentage
on
the
pdp
or
any
other
package
panels.
This
will
allow
those
handlers
to
display
the
percentage
of
their
product's
organically
produced
contents
on
the
pdp
where
it
will
be
most
immediately
visible
to
consumers.
Handlers
who
cannot,
with
certainty,
display
their
product's
organic
percentage
or
who
choose
not
to
display
the
percentage,

are
not
required
to
do
so.

This
revised
labeling
provision
also
removes
the
requirement
in
section
205.305
that
products
with
less
than
70
percent
organic
content
display
the
product's
organic
percentage
on
the
information
panel.
Under
this
final
rule,
that
percentage
labeling
is
optional
but
is
still
restricted
to
the
information
panel.
The
percentage
of
a
less
than
70
percent
organic
product
may
not
be
displayed
on
the
pdp
and
may
not
be
displayed
if
the
organic
ingredients
are
not
identified
in
the
ingredient
statement.

(
6)
Designation
of
Organically
Produced
Ingredients.
A
certifying
agent
suggested
that
identification
of
organic
ingredients
in
ingredient
statements
should
be
allowed
to
be
made
with
an
asterisk
or
similar
mark,
with
the
asterisk
defined
on
the
information
panel.
The
commenter
stated
that
the
repetitive
use
of
the
word,
"
organic,"
may
cause
space
problems
on
some
small
packages
and
that
use
of
a
mark
is
a
common
industry
practice.
We
agree
with
the
comment
and
have
changed
sections
205.303(
b)(
1),
205.304(
b)(
1),
and
205.305(
a)(
i)
of
the
regulatory
text
accordingly.
Thus,
organic
ingredients
may
be
identified
in
the
ingredient
statement
with
either
137
the
term,
"
organic,"
or
an
asterisk
or
other
mark,
provided
that
the
asterisk
or
other
mark
is
defined
on
the
information
panel
adjacent
to
the
ingredient
statement.

(
7)
Minimum
Organic
Percentage
for
Labeling.
In
the
proposed
rule's
preamble,
we
asked
for
public
comment
on
whether
the
50
percent
minimum
organic
content
for
pdp
labeling
should
be
increased.
The
50
percent
minimum
content
was
established
in
section
6505(
c)
of
the
Act.
However,
the
Act
also
provides
the
Secretary
with
the
authority
to
require
such
other
terms
and
conditions
as
are
necessary
to
implement
the
program.
Thus,
the
minimum
organic
content
level
for
pdp
labeling
could
be
changed
if
the
change
would
further
the
purposes
of
the
Act.

Comments
to
the
first
(
1997)
proposal
and
to
the
revised
proposed
rule
suggested
that
the
minimum
organic
content
for
labeling
purposes
should
be
increased.
All
comments
received,

including
comments
from
certifying
agents,
a
leading
organic
association,
the
EU
and
other
international
commenters
recommended
that
the
minimum
organic
content
to
qualify
for
pdp
labeling
should
be
raised
to
70
percent,
which
is
the
EU's
minimum.
All
comments
stated
that
the
increase
is
necessary
to
make
the
NOP
standards
consistent
with
international
organic
standards.

Commenters
also
pointed
to
advances
in
organic
production
and
processing
technologies
and
to
increases
in
the
availability
of
organically
produced
products
and
processed
ingredients.
These
factors
should
make
it
easier
for
handlers
to
assemble
food
products
with
higher
organic
content.

We
concur
with
the
comments.
We
view
this
as
a
tightening
of
labeling
requirements
in
that
pdp
labeling
now
requires
a
higher
percentage
of
organic
ingredients
and
makes
the
U.
S.

standard
consistent
with
international
norms.

In
the
proposed
rule's
preamble,
we
also
asked
for
specific
public
comment
on
whether
a
minimum
percentage
of
total
product
content
should
be
required
for
any
single
organic
ingredient
138
that
is
included
in
the
pdp
statement
"
made
with
organic
(
specified
ingredients)."
No
commenters
responded
to
this
question.
Therefore,
no
required
minimum
percentage
for
a
single
organic
ingredient
in
"
made
with..."
products
is
established.

(
8)
"
Made
With
Organic
(
Specified
Food
Groups)."
Several
industry
organizations
suggested
that,
as
an
alternative
to
listing
up
to
three
organic
ingredients
in
the
"
made
with..."

label,
the
rule
should
also
allow
for
identification
of
food
"
groups"
or
"
classes"
of
food
in
the
"
made
with"
label.
Commenters
suggested,
for
instance,
that
a
soup
(
with
70
percent
or
more
organic
ingredients,
less
water
and
salt)
containing
organically
produced
potatoes,
carrots,
and
onions
may
be
labeled
as
"
soup
made
with
organic
potatoes,
carrots,
and
onions"
or,
alternatively,

"
soup
made
with
organic
vegetables."

We
agree
that
this
label
option
offers
handlers
of
such
multiingredient
products
with
more
flexibility
in
their
labeling.
All
ingredients
in
the
identified
food
group
must
be
organically
produced
and
must
be
identified
in
the
ingredient
statement
as
"
organic."
In
the
above
example,
if
soup
also
contains
conventionally
produced
cauliflower,
only
"
soup
made
with
organic
potatoes,

carrots,
and
onions"
can
be
displayed.

We
also
believe
that
some
parameters
must
be
established
as
to
what
are
considered
as
food
groups
or
classes
of
food.
For
the
purposes
of
this
regulation,
products
from
the
following
food
groups
may
be
labeled
as
"
organic"
in
a
"
made
with..."
label:
beans,
fruits,
grains,
herbs,

meats,
nuts,
oils,
poultry,
seeds,
spices,
and
vegetables.
In
addition,
organically
produced
and
processed
butter,
cheeses,
yogurt,
milk,
sour
cream,
etc.
may
be
combined
in
a
product
and
identified
as
"
organic
milk
products."
Organically
produced
and
processed
sugar
cane,
sugar
beets,
corn
syrup,
maple
syrup,
etc.
may
be
used
in
a
product
and
identified
as
"
organic
139
sweeteners."

Finally,
to
be
consistent
with
the
"
made
with..."
labeling
for
individual
ingredients,
up
to
three
food
groups
can
be
identified
in
the
"
made
with..."
statement.
Section
205.304
is
changed
accordingly.

(
9)
Labeling
Products
from
Exempt
and
Excluded
Operations.
A
change
is
made
in
redesignated
section
205.310
which
provides
for
labeling
of
organic
products
produced
by
exempt
and
excluded
operations.
SOP
managers
and
an
organic
handler
pointed
out
that
the
preamble
suggested
restrictions
on
labeling
that
would
prevent
exempt
and
excluded
operations
from
identifying
their
products
as
"
organic."
After
review
of
the
proposed
rule,
we
have
revised
redesignated
section
205.310
to
more
clearly
specify
labeling
opportunities
for
exempt
operations.

The
regulatory
text
more
clearly
states
that
such
operations
may
not
label
or
represent
their
organic
products
as
being
"
certified"
as
organic
and
that
such
exempt
and
excluded
operations
must
comply
with
applicable
production
and
handling
provisions
of
subpart
C.
Labeling
must
be
consistent
with
the
four
labeling
categories
based
on
the
product's
organic
content.

A
State
organic
advisory
board
recommended
that
proposed
section
205.309
be
revised
to
apply
to
exempt
and
excluded
operations
which
choose
to
be
certified
under
this
program.
We
do
not
believe
it
is
necessary
to
provide
separate
regulatory
text
for
exempt
and
excluded
operations
that
are
certified.
An
exempt
operation
is
not
precluded
from
organic
certification,
if
qualified.

(
10)
Redesigned
USDA
Seal.
Leading
industry
members,
certifying
agents,
SOP
managers,
and
many
individual
commenters
opposed
the
proposed
wording
and
design
of
the
USDA
seal.
Comments
generally
stated
the
following
points:
(
1)
the
proposed
Seal
wording
indicates
that
USDA
is
the
certifying
agent
rather
than
accredited
certifiers;
(
2)
international
140
Organization
for
Standardization
(
ISO)
Guide
61
prohibits
government
bodies
from
acting
or
appearing
as
certifying
agents;
and
(
3)
The
shield
or
badge
design
indicates
a
certification
of
product
"
quality"
and
assurance
of
safety
which
is
inconsistent
with
the
NOP's
claim
to
be
a
certification
of
"
process"
only.
Commenters
suggested
several
alternative
seal
statements,

including:
"
Certified
Organic
­
USDA
Accredited,"
"
Certified
Organic
­
USDA
Approved,"

"
USDA
Certified
Organic
Production,"
"
Meets
USDA
Organic
Production
Requirements."

Based
on
comments
received,
we
are
implementing
a
revised
USDA
seal
which
is
shown
in
the
regulatory
text
under
section
301.311.
It
is
a
circular
design
with
the
words,
"
USDA
Organic."
The
color
scheme
is
a
white
background,
brown
outer
circle,
white
and
green
inner
semicircles,
and
green
and
white
words.
A
black
and
white
color
scheme
also
may
be
used
if
preferred
by
the
handler.

Some
commenters
suggested
changing
the
shape
of
the
USDA
seal
to
a
circle
or
triangle
which,
they
state,
is
more
in
keeping
with
recognized
recycling
and
sustainability
logos.
We
did
not
choose
a
triangle
design
because
processors
have
commented
that
triangle
designs
may
cause
tears
in
shrink
wrap
coverings
at
the
points
of
the
triangle.

Labeling
­
Changes
Requested
But
Not
Made
(
1)
"
Organic"
in
Company
Names.
Many
commenters
stated
that
the
term,
"
organic,"

must
not
be
used
as
part
of
a
company
name
if
the
company
does
not
market
organically
produced
foods.
They
are
concerned
that
the
term
in
a
company
name
would
incorrectly
imply
that
the
product,
itself,
is
organically
produced.

While
we
understand
commenter
concerns,
we
do
not
know
the
extent
of
the
problem.

We
do
not
believe
those
concerns
require
such
a
prohibition
in
the
regulations
at
this
time.
These
141
regulations
may
not
be
the
best
mechanism
to
address
the
issue.
Section
6519(
b)
of
the
Act
provides
the
Secretary
with
the
authority
to
take
action
against
misuse
of
the
term,
"
organic."

USDA
will
monitor
use
of
the
term,
"
organic,"
in
company
names
and
will
work
with
the
FTC
to
take
action
against
such
misuse
of
the
term.
These
determinations
must
be
made
on
a
case­

bycase
basis.
The
proposed
rule
did
not
specifically
address
this
issue.
We
have
added
a
sentence
to
paragraph
(
a)
of
section
205.300
to
this
effect.

(
2)
The
"
100
Percent
Organic"
Label.
A
large
number
of
commenters
opposed
the
"
100
percent
organic"
label
for
different
reasons.
A
few
claimed
that
the
label
is
not
authorized
under
the
Act.
Several
commenters
suggested
that
consumers
will
not
understand
the
difference
between
multiingredient
products
labeled
"
100
percent
organic"
and
"
organic."
Others
raised
the
concern
that
the
"
100
percent
organic"
phrase
to
modify
raw,
fresh
fruits
and
vegetables
in
produce
sections
and
farmers
markets
may
be
confusing
to
consumers.

Regarding
the
first
comment,
the
term
is
not
specifically
provided
for
in
the
Act.

However,
the
Secretary
has
the
authority
under
section
6506(
a)(
11)
to
require
other
terms
and
conditions
as
may
be
necessary
to
develop
a
national
organic
program.
When
a
product
is
wholly
organic,
pursuant
to
the
production
and
handling
requirements
of
the
NOP,
we
believe
the
handler
should
have
the
option
to
differentiate
it
from
products
which,
by
necessity,
are
less
than
100
percent
organic.
We
believe
the
label
meets
the
purposes
of
the
Act.

Regarding
consumer
confusion,
we
believe
consumers
will
understand
the
difference
between
the
two
kinds
of
organic
products
and
will
make
their
organic
purchases
accordingly.

Regarding
the
labeling
of
raw,
fresh
product
as
"
100
percent
organic,"
organically
produced
products
can
be
labeled
to
a
lower
labeling
category.
Raw,
fresh
fruits
and
vegetables
142
which
qualify
for
a
"
100
percent
organic"
label
may
be
labeled
simply
as
"
organic,"
if
the
producer
or
retail
operator
believes
that
label
is
best
for
marketing
purposes.

(
3)
Explain
Why
Product
Is
Not
100
Percent
Organic.
A
large
number
of
commenters
also
suggested
any
"
product
that
is
less
than
100
percent
organic
should
carry
that
information
on
the
main
display
panel..."
By
"
that
information,"
we
assume
the
commenters
are
referring
to
the
reasons
why
a
product
cannot
be
certified
as
"
100
percent
organic."

AMS
believes
such
a
labeling
requirement
is
impractical.
Products
may
fail
to
qualify
for
a
"
100
percent
organic"
label
for
very
technical,
or
little
understood,
reasons.
Contemporary
food
processing
often
uses
ingredients,
processing
technologies,
and
product
formulations
that
are
complicated,
technical,
and
probably
not
of
interest
to
the
general
organic
consumer.
Such
information
is
not
required
on
nonorganically
produced
products
for
the
simple
reason
that
it
is
not
considered
useful
to
consumers.
Explanations
of
the
different
processing
technologies
used
in
food
products
would
be
cumbersome
and
would
interfere
with
other
product
labeling.

We
believe
the
optional
display
of
the
organic
percentage
and
required
identification
of
organic
ingredients
on
the
information
panel
provides
sufficient
information
for
consumers
to
make
purchase
decisions.
Other
descriptive
information
regarding
processing
substances
and
procedures
may,
of
course,
be
provided
at
the
handler's
option
and
placed
in
accordance
with
other
Federal
labeling
requirements.

(
4)
Check
the
Appropriate
Organic
Category.
One
commenter
suggested
that
packages
of
organically
produced
product
display
a
small
box
listing
the
four
organic
label
categories
and
a
check
mark
beside
the
category
which
fits
the
product.

We
understand
the
simplicity
and
comparative
nature
of
such
a
standardized
organic
label
143
that
allows
easy
comparison
of
similar
products.
However,
we
believe
that
the
optional
display
of
the
product's
organic
percentage
and
required
identification
of
organic
ingredients
will
be
more
helpful
to
consumers
and
makes
the
grid
box
redundant.

(
5)
Nonorganic
Ingredients
in
Organic
Products.
A
large
number
of
comments
were
received
on
the
composition
and
use
of
nonorganic
ingredients
in
products
labeled
"
made
with..."

and
on
conventional
products
with
less
than
50
(
now
70)
percent
organic
ingredients.
Several
industry
commenters
suggested
that
nonorganic
ingredients
in
"
made
with..."
products
must
be
"
natural"
(
nonsynthetic
agricultural
substances)
and
not
be
artificially
produced.
Commenters
argued
that
all
ingredients
in
"
made
with..."
and
less
than
70
percent
products
should
be
produced
in
accordance
with
the
prohibited
practices
under
sections
205.105
and
205.301(
f).
A
significant
number
of
commenters
opposed
identification
of
organic
ingredients
in
what
they
called
"
natural
food"
products.

First,
we
do
not
agree
that
the
nonorganic
ingredients
in
"
made
with..."
products
must
be
restricted
to
only
"
natural"
products.
Such
restrictions
on
the
composition
of
nonorganic
ingredients
would
significantly
reduce
handlers'
options
in
producing
those
products
and,
thus,

reduce
consumers'
options
in
purchasing
products
with
organic
ingredients.

Regarding
prohibited
practices,
this
rule
implements
the
strong
industry
and
consumer
demand
that
the
prohibited
practices
found
under
section
205.105
(
excluded
methods,
irradiation,

and
sewage
sludge)
not
be
used
in
nonorganic
ingredients
in
"
made
with..."
products.
However,

we
do
not
believe
that
restrictions
on
use
of
the
other
prohibited
practices,
found
in
section
205.301(
f),
would
further
the
purposes
of
the
Act.
Application
of
all
prohibited
practices
on
the
nonorganic
ingredients
in
the
"
made
with..."
and
less­
than
70
percent
organic
products
would
144
essentially
require
that
those
products
be
organically
produced.
The
Act
allows
for
products
that
are
not
wholly
organic.
We
believe
the
"
made
with..."
label
and
the
labeling
restrictions
on
the
less­
than
70
percent
organic
products
clearly
states
to
consumers
that
only
some
of
the
ingredients
in
those
products
are
organically
produced.

If
accepted,
these
comments
would
unnecessarily
restrict
a
handler's
ability
to
truthfully
represent
and
market
a
conventionally
produced
agricultural
product
with
some
organic
ingredients.
A
handler
should
not
be
prohibited
from
making
a
truthful
claim
about
some
ingredients
in
a
less
than
70
percent
organic
product.

(
6)
Alternative
"
Made
With..."
Labels.
A
few
SOP
managers
commented
that
the
phrase,

"
made
with...,"
is
confusing.
They
stated
that
many
processed
foods
contain
at
least
50
percent
organic
ingredients
but
do
not
make
an
organic
claim
on
the
pdp.
They
believe
the
label
would
be
less
confusing
if
it
stated
a
minimum
organic
percentage
rather
than
identifying
the
organic
ingredients.
They
suggest
the
labeling
category
be
changed
to
"
contains
at
least
50
percent
organic
ingredients
(
or,
as
revised
in
this
rule,
"
contains
at
least
70
percent
organic
ingredients").

We
disagree.
Identification
of
up
to
three
organically
produced
ingredients
or
food
groups
on
the
pdp
gives
consumers
useful,
specific
information
about
the
product's
organic
ingredients.
This
label,
combined
with
the
optional
display
of
the
percentage
content
on
the
pdp
and
required
identification
of
organic
ingredients,
should
provide
enough
information
for
consumers
to
make
good
decisions.

A
few
commenters
contended
that
the
statement
"
made
with
organic
(
specified
ingredients)"
is
unclear
and
"
open
ended"
and
that
consumers
may
assume
the
entire
product
is
organically
produced.
The
"
made
with..."
labeling
claim
refers
only
to
the
organic
ingredients
and
145
not
to
the
whole
product.
We
do
not
believe
that
consumers
will
be
confused
by
the
label.

(
7)
Use
of
Other
Terms
as
Synonymous
for
"
Organic".
A
few
commenters
representing
international
organic
standards
suggested
that
use
of
the
terms,
"
biologic"
and
"
ecologic,"
which
are
synonymous
with
"
organic"
in
other
countries,
should
be
allowed
under
the
NOP.

Commenters
claimed
these
terms
are
approved
by
Codex
and
their
inclusion
in
this
regulation
would
facilitate
international
trade
and
equivalency
agreements.

These
terms
were
addressed
in
the
proposed
rule
and
are
not
accepted.
Under
the
NOP,

these
terms
may
be
used
as
eco­
labels
on
a
product
package
but
may
not
be
used
in
place
of
the
term,
"
organic."
Although
such
terms
may
be
considered
synonymous
with
"
organic"
in
other
countries,
they
are
not
widely
used
or
understood
in
this
country.
We
believe
their
use
as
synonymous
for
"
organic"
would
only
lend
to
consumer
confusion.
Regarding
the
Codex
labeling
standard,
we
point
out
that
Codex
also
provides
that
terms
commonly
used
in
a
country
may
be
used
in
place
of
"
biologic"
and
"
ecologic."
Thus,
the
use
of
"
organic"
in
the
United
States
is
consistent
with
Codex
standards.

With
regard
to
the
commenters'
claim
that
the
alternate
labels
would
facilitate
international
trade,
this
regulation
allows
alternative
labeling
of
products
which
are
being
shipped
to
international
markets.
Thus,
a
certified
organic
operation
in
the
United
States
may
produce
a
product
to
meet
contracted
organic
requirements
of
a
foreign
buyer,
label
the
product
as
"
biologic"
or
"
ecologic"
on
the
pdp
consistent
with
the
market
preferences
of
the
receiving
country,
and
ship
the
product
to
the
foreign
buyer.

Other
terms
were
suggested
by
commenters
as
alternatives
to
the
term,
"
organic,"

including
"
grown
by
age­
old,
natural
methods,"
"
grown
without
chemical
input,"
and
"
residue
146
Free."
These
phrases
may
be
consumer
friendly
but
clearly
do
not
convey
the
extensive
and
complex
nature
of
contemporary
organic
agriculture.
These
phrases
may
be
used
as
additional,

eco­
labels,
provided
they
are
truthful
labeling
statements.
They
are
not
permitted
as
replacements
for
the
term,
"
organic."

(
8)
Reconstituted
Organic
Concentrates.
A
certifying
agent
objected
to
paragraph
(
a)(
2)

of
section
205.302,
which
allows
labeling
of
an
organically
produced
concentrate
ingredient
which
is
reconstituted
with
water
during
assembly
of
the
processed
product.
The
commenter
claimed
that
this
provision
gives
consumers
the
message
that
reconstituted
juice
is
equivalent
to
fresh
juice
when,
the
commenter
claims,
it
is
not
the
same.

AMS
disagrees.
This
labeling
is
consistent
with
current
industry
practices.
The
Act
does
not
prohibit
such
labeling
of
concentrates.
We
believe
it
is
in
the
interest
of
the
program
to
allow
labeling
of
organically
produced
concentrates,
provided
that
the
process
to
produce
the
concentrate
and
the
reconstitution
process
is
consistent
with
organic
principles
and
the
National
List.

(
9)
Calculating
Reconstituted
Versus
Dehydrated
Weight.
Several
comments
were
received
regarding
specific
problems
encountered
in
the
calculation
of
the
percentage
of
organic
content
as
provided
under
section
295.302.
A
handler
claimed
the
reconstituted
weight
of
an
organically
produced
spice
should
be
counted
in
the
percentage
calculation
rather
than
the
dehydrated
weight
of
the
spice
used
in
the
formulation.
A
similar
comment
was
received
from
a
food
cooperative
suggesting
that,
if
an
organically
produced
concentrate
(
in
powdered
form)
is
added
to
the
same
organically
produced
ingredient
in
its
organic
liquid
form
(
not
from
concentrate),
then
the
product's
organic
percentage
should
be
calculated
based
on
the
147
concentrate's
single­
strength
reconstituted
weight
plus
the
weight
of
the
natural
organic
liquid.

AMS
disagrees
with
these
comments.
This
regulation
provides
for
an
ingredient's
weight
to
be
calculated,
excluding
added
water
and
salt.
If
an
organically
produced
spice
is
added
to
a
product
in
its
natural
form,
the
weight
of
the
spice
is
calculated.
If
the
spice
ingredient
is
in
dehydrated,
powdered
form
when
added
in
the
product
formulation,
the
dehydrated
weight
of
the
spice
must
be
the
basis
for
its
percentage
of
content
calculation.
If
an
organically
produced
dehydrated
spice
is
reconstituted
with
water
prior
to
product
assembly,
the
spice
must
still
be
calculated
at
its
dehydrated
weight
because
percentage
calculations
are
based
on
the
ingredient
weight,
excluding
water
and
salt.
It
would
be
misleading
to
calculate
the
weight
of
the
concentrate
ingredient
in
its
reconstituted
form.

Likewise,
if
a
powdered
ingredient
is
added
to
the
same
organically
produced
ingredient
in
its
natural,
liquid
form,
the
weight
of
the
powdered
ingredient
must
be
used.
Using
the
reconstituted
weight
of
the
powdered
ingredient
would
increase
the
percentage
of
the
ingredient
above
the
actual
weight
of
the
ingredient
in
the
product.
We
believe
that
if
the
comment
were
accepted,
the
handler
would
be
able
to
use
less
natural
organic
liquid
than
the
organic
percentage
and
ingredient
statement
indicates.

(
10)
Calculate
Organic
Percentage
in
Tenths
of
a
Percent.
A
trade
organization
suggested
that
the
organic
percentage
be
rounded
to
tenths
of
one
percent
to
accommodate
products
that
may
contain
a
minor
ingredient
or
additive
that
comprises
less
than
1
percent
of
the
product.
The
example
provided
was
Vitamin
D
in
milk.
The
comment
suggested
that
it
is
misleading
to
consumers
to
suggest
that
1
percent
of
a
milk
product
is
nonorganic
when
the
Vitamin
D
additive
may
be
comprise
only
a
few
tenths
of
one
percent
of
the
product.
148
AMS
disagrees.
Rounding
down
the
percentage
to
a
whole
number
is
sufficient
for
consumer
information
and
does
not
misrepresent
the
product's
organic
content.
A
handler
may
add
a
qualifying
statement
regarding
the
minor
ingredient's
weight
in
relation
to
the
whole
product
weight.

(
11)
Verifying
Calculations.
A
State
department
of
agriculture
comment
suggested
that
the
paragraph
(
c)
of
section
205.302
be
revised
slightly
to
provide
that
percentage
calculations
must
be
verified
"
to
the
satisfaction"
of
the
certifying
agent.
The
commenter
believes
that
the
suggested
language
allows
the
handler
the
flexibility
to
determine
the
number
calculations
that
need
to
be
checked
in
order
to
verify
that
the
organic
percentage
calculation
is
correct.

We
do
not
believe
the
suggested
change
is
necessary.
We
assume
that
any
use
of
a
certifying
agent's
seal
on
a
product
means
that
the
certifying
agent
has
checked
and
approves
of
the
method
of
calculating
the
product's
organic
percentage.
If
the
calculations
are
not
to
the
certifying
agent's
satisfaction,
the
agent
would
not
certify
the
handling
process.

While
we
appreciate
the
point
made
by
the
commenter,
we
do
not
believe
the
suggested
change
means
what
the
commenter
intends.
Paragraph
(
c)
of
section
205.302
does
not
specify
the
number
and
methods
of
calculations
that
need
to
be
carried
out
by
a
certifying
agent
because
that
will
depend
on
the
handling
process
being
certified
and
the
ingredients
in
the
product.
We
leave
that
to
the
discretion
of
the
certifying
agent.
Also,
the
basis
for
a
product's
organic
percentage
calculation
should
be
clarified
in
the
organic
plan.
It
is
assumed
that
the
certifying
agent
will
either
be
satisfied
that
the
methodology
for
calculating
organic
percentage
is
correct
or
the
methodology
will
be
changed.

(
12)
Labeling
Nonretail
Shipping
Containers.
A
few
State
departments
of
agriculture
149
commented
that
shipping
and
storage
containers
with
organic
products
should
be
required
to
be
labeled
as
containing
organic
product.
Other
commenters
recommended
that
shipping
containers
be
required
to
display
the
name
of
the
grower
and
the
certifying
agent.
They
cite
these
requirements
as
current
industry
practice.

This
regulation
does
not
require
organic
labeling
on
shipping
and
storage
containers
because
those
containers
are
not
used
in
the
marketplace.
The
only
information
required
by
the
NOP
is
the
production
lot
number
of
the
product,
if
a
lot
number
exists
for
the
particular
product.

Product
content
and
shipper
information
may
be
displayed,
as
required
by
other
Federal
or
State
regulations
or
at
the
discretion
of
the
handler.
Proper
identification
of
the
organic
nature
of
a
product
with
special
instructions
for
shipment
or
storage
could
prevent
exposure
to
prohibited
substances
that
would
lead
to
subsequent
loss
of
the
shipment
as
an
organic
product.

(
13)
Disclaimers
on
Organic
Products.
Several
commenters
complained
that
consumers
are
misled
by
the
organic
labeling
and
the
NOP.
They
claimed
that
when
science­
based
technologies
(
genetic
engineering,
irradiation,
chlorination,
etc.)
are
not
used
on
products,
the
food
is
less
safe
than
conventionally
produced
foods.
Some
of
the
commenters
suggested
that
a
disclaimer
regarding
food
safety
and
nutritional
value
be
required
on
packages
with
organic
labeling.

AMS
disagrees.
The
USDA
seal
indicates
only
that
the
product
has
been
certified
to
a
certain
production
and/
or
handling
"
process"
or
"
system."
The
seal
does
not
convey
a
message
of
food
safety
or
more
nutritional
value.
The
NOP
prohibitions
on
use
of
excluded
methods,

ionizing
radiation,
sewage
sludge,
and
some
substances
and
materials
are
not
intended
to
imply
that
conventionally
produced
products
made
by
those
methods
or
containing
those
prohibited
150
substances
are
less
safe
or
nutritious
than
organically
produced
products.
We
do
not
believe
that
organic
food
packages
or
labeling
should
carry
disclaimers
of
what
the
USDA
seal
or
a
certifying
agent's
seal
does
not
represent.
Other
Federal
and
State
seals
and
marketing
claims
are
placed
on
consumer
products,
including
food
products,
without
disclaimers
regarding
those
seals
and
claims.
A
disclaimer
displayed
in
relation
to
USDA
seal
or
a
certifying
agent's
seal
would
confuse
consumers.
Finally,
disclaimer
statements
also
would
present
space
problems
on
small
product
packages.

Labeling
­
Clarifications
Clarification
is
given
on
the
following
issues
raised
by
commenters:

(
1)
Certification
Is
to
an
Organic
Process,
Not
Organic
Product.
Several
commenters
suggested
that
the
final
rule
more
clearly
state
that
the
NOP
provides
for
certification
of
an
organic
process
or
system
of
agriculture
and
not
certification
of
products,
themselves,
as
"
organic."
They
stated
that
the
phrase
"...
contain
or
be
created
using..."
in
paragraphs
(
a),
(
b),

and
(
c)
of
section
205.301
implies
certification
of
the
product's
content
and
not
to
the
processedbased
organic
system
of
agriculture.

We
agree
and
have
revised
the
wording
in
those
paragraphs
to
clarify
that
such
products
must
be
organically
produced
in
accordance
with
organic
production
and
handling
requirement
of
this
regulation.

(
2)
Phasing
Out
Use
of
Old
Labels
and
Packages.
Citing
FDA
regulations,
the
NOSB,

certifying
agents,
and
some
State
agencies
suggested
a
minimum
18­
month
period
for
handlers
to
use
up
their
current
supplies
of
packages
and
labels
before
complying
with
the
new
labeling
requirements.
151
This
rule
provides
for
an
interim
period
of
18
months
between
publication
of
the
final
rule
and
the
implementation
date
of
the
program.
Publication
of
this
final
rule
serves
notice
to
certified
producers
and
handlers
that
they
should
begin
planning
for
phasing
out
use
of
labels
that
are
not
in
accordance
with
these
requirements.

The
implementation
process
is
discussed
in
Applicability,
subpart
B.
An
organic
operation
will
automatically
be
certified
under
this
program
when
its
certifying
agent
is
accredited
by
AMS.

At
that
time,
the
operation
may
begin
following
these
labeling
requirements
but
may
not
display
the
new
USDA
seal
until
the
implementation
date.
AMS
assumes
that
certifying
agents
and
their
client
certified
operations
will
maintain
frequent
contact
as
to
the
status
of
the
agent's
application
for
accreditation
so
that
the
certified
operation
may
schedule
the
phasing
out
of
old
labels
and
purchase
of
new
labels
and
packages.
AMS
expects
to
accredit
all
currently
operating
certifying
agents
by
the
implementation
date
of
this
regulation.
Stick­
on
labels
to
comply
with
the
new
requirements
are
acceptable.

Newly
established
organic
operations
certified
for
the
first
time
must
immediately
begin
using
labels
in
accordance
with
this
program.

(
3)
Labeling
of
Products
With
Minor
Ingredients.
Several
commenters
questioned
how
the
minor
ingredients
(
spices,
flavors,
colorings,
preservatives,
oils,
vitamins,
minerals,
accessory
nutrients,
processing
aids,
and
incidental
food
additives)
needed
for
formulation
or
processing
of
many
multiingredient
products
will
be
treated
under
the
"
100
percent
organic"
and
"
organic"

labeling
categories.
Because
minor
ingredients
may
not
exist
or
are
difficult
to
obtain
in
organic
form,
their
use
in
a
product
can
affect
the
labeling
of
the
product,
even
though
the
percentage
of
the
ingredient
is
extremely
small
compared
to
the
rest
of
the
product's
ingredients.
152
Minor
ingredients
and
processing
aids
must
be
treated
as
any
other
ingredient
or
substance
which
is
used
as
an
ingredient
in
or
in
the
processing
of
an
organically
produced
product.
To
be
added
as
an
ingredient
or
used
in
the
processing
of
a
product
labeled
"
100
percent
organic,"
a
minor
ingredient
must
be
extracted
from
a
certified
organic
source
without
the
use
of
chemicals
or
solvents.
To
be
added
as
an
ingredient
or
used
in
the
processing
of
a
product
labeled
"
organic,"
a
minor
ingredient
must
be
from
an
organic
agricultural
source,
if
commercially
available.
If
not
commercially
available,
the
ingredient
must
be
an
agricultural
product
or
a
substance
consistent
with
the
National
List.

(
4)
Reusing
Containers.
A
commenter
complained
that
small
producers
should
not
be
subjected
to
costly
packaging
and
labeling
requirements
when
their
products
are
sold
directly
to
the
public
at
farmers
markets
and
roadside
stands.
The
commenter
requested
that
small
producers
be
able
to
reuse
retail
boxes
and
labels.
The
commenter
did
not
specify
which
labeling
provisions
presented
burdensome
costs
on
small
entities.

We
agree
that
costs
for
exempt
operations,
indeed
all
organic
operations,
should
be
kept
to
a
minimum.
NOP
does
not
prohibit
reuse
of
containers
provided
their
labeling
does
not
misrepresent
product
and
does
not
allow
organic
product
to
come
into
contact
with
prohibited
substances
from
the
container's
previous
contents.

(
5)
Clarifying
Prohibited
Labeling
Practices.
Commenters
identified
a
few
inconsistencies
between
the
preamble
and
regulatory
text
regarding
the
seven
prohibited
production
and
processing
practices
now
specified
in
section
205.301(
f).
We
have
made
the
following
changes
to
clarify
the
intent
of
the
regulation.

A
commenter
correctly
pointed
out
that
the
regulatory
text
of
paragraph
(
f)
incorrectly
153
refers
only
to
ingredients
that
cannot
be
produced
using
the
seven
prohibited
production
and
handling
practices
listed
in
the
paragraph.
That
text
is
not
consistent
with
the
preamble,
which
correctly
states
that
whole
products,
as
well
as
ingredients,
labeled
as
"
organic"
cannot
be
produced
or
processed
using
the
seven
prohibited
practices.
The
term,
"
whole
products,"
is
added
to
the
introductory
sentence
of
new
section
205.301(
f).

A
few
commenters
pointed
out
that
all
seven
practices
are
prohibited
in
the
production
of
nonorganic
ingredients
used
in
products
labeled
as
"
organic."
The
second
sentence
of
proposed
paragraph
(
b)
of
section
205.301
(
products
labeled
"
organic")
incorrectly
listed
only
the
first
three
prohibited
practices.
A
phrase
is
added
to
the
introductory
sentence
of
new
paragraph
(
f)
to
specify
that
the
5
percent
or
less
of
nonorganic
ingredients
in
products
labeled
as
"
organic"
may
not
be
produced
or
handled
using
any
of
the
seven
prohibited
practices.

Finally,
with
the
addition
of
the
commercial
availability
requirement
in
section
205.201,
a
conforming
change
is
needed
in
section
205.301(
f)(
6)
regarding
use
of
nonorganic
ingredients
when
organically
produced
ingredients
are
available.

(
6)
Consistency
with
State
Labeling
Requirements.
One
State
organic
association
commented
that
the
State's
law
requires
identification
of
the
certifying
agent
if
the
term,
"
certified
organic,"
appears
on
the
label.
The
comment
was
not
clear
about
where
on
the
package
the
certifier
must
be
identified;
e.
g.,
with
the
"
certified
organic"
term
on
the
pdp
or
anywhere
on
the
package.
The
commenter
did
not
specifically
suggest
changing
the
labeling
provisions
to
include
the
certifying
agent
on
the
pdp.

This
regulation
allows
a
handler
the
option
of
displaying
the
certifying
agent's
seal
or
logo
on
the
pdp
for
products
with
70
percent
or
more
organically
produced
ingredients.
This
154
regulation
also
requires
identification
of
the
certifying
agent
on
the
information
panel
of
all
products
containing
70
percent
or
more
organically
produced
ingredients.
The
identification
must
include
an
address
or
contact
information
and
be
placed
adjacent
to
identification
of
the
manufacturer,
required
by
FDA.
We
believe
these
provisions
are
sufficient
to
meet
the
State's
labeling
requirements.
The
NOP
will
be
available
to
consult
with
States
regarding
alternative
labeling
required
to
be
used
in
the
State.

(
7)
Clarifying
Labeling
of
Products
in
Other
Than
Packaged
Form.
We
have
modified
sections
205.308
and
205.309
to
clarify
that
products
in
other
than
packaged
form
at
the
point
of
retail
sale
that
are
prepared
by
an
exempt
or
excluded
operation
may
be
labeled
as
"
100
percent
organic,"
"
organic,"
or
"
made
with..."
as
appropriate.
Consistent
with
the
general
restrictions
on
the
labeling
of
products
from
such
operations,
which
are
found
in
section
205.310,
such
products
may
not
display
the
USDA
seal
or
any
certifying
agent's
seal
or
other
identifying
mark
or
otherwise
be
represented
as
a
certified
organic
product.

Subpart
E
­
Certification
This
subpart
sets
forth
the
requirements
for
a
national
program
to
certify
production
and
handling
operations
as
certified
organic
production
or
handling
operations.
This
certification
process
will
be
carried
out
by
accredited
certifying
agents.

Description
of
Regulations
General
Requirements
Production
and
handling
operations
seeking
to
receive
or
maintain
organic
certification
must
comply
with
the
Act
and
applicable
organic
production
and
handling
regulations.
Such
operations
must
establish,
implement,
and
annually
update
an
organic
production
or
handling
155
system
plan
that
is
submitted
to
an
accredited
certifying
agent.
They
must
permit
on­
site
inspections
by
the
certifying
agent
with
complete
access
to
the
production
or
handling
operation,

including
noncertified
production
and
handling
areas,
structures,
and
offices.

As
discussed
in
subpart
B,
certified
operations
must
maintain
records
concerning
the
production
and
handling
of
agricultural
products
that
are
sold,
labeled,
or
represented
as
"
100
percent
organic,"
"
organic,"
or
"
made
with
organic
(
specified
ingredients
or
food
group(
s))"

sufficient
to
demonstrate
compliance
with
the
Act
and
regulations.
Records
applicable
to
the
organic
operation
must
be
maintained
for
not
less
than
5
years
beyond
their
creation.
Authorized
representatives
of
the
Secretary,
the
applicable
State
organic
program's
(
SOP)
governing
State
official,
and
the
certifying
agent
must
be
allowed
access
to
the
operation's
records
during
normal
business
hours.
Access
to
the
operation's
records
will
be
for
the
purpose
of
reviewing
and
copying
the
records
to
determine
compliance
with
the
Act
and
regulations.

Certified
operations
are
required
to
immediately
notify
the
certifying
agent
concerning
any
application,
including
drift,
of
a
prohibited
substance
to
any
field,
production
unit,
site,
facility,

livestock,
or
product
that
is
part
of
the
organic
operation.
They
must
also
immediately
notify
the
certifying
agent
concerning
any
change
in
a
certified
operation
or
any
portion
of
a
certified
operation
that
may
affect
its
compliance
with
the
Act
and
regulations.

Certification
Process
To
obtain
certification,
a
producer
or
handler
must
submit
an
application
for
certification
to
an
accredited
certifying
agent.
The
application
must
contain
descriptive
information
about
the
applicant's
business,
an
organic
production
and
handling
system
plan,
information
concerning
any
previous
business
applications
for
certification,
and
any
other
information
necessary
to
determine
156
compliance
with
the
Act.

Applicants
for
certification
and
certified
operations
must
submit
the
applicable
fees
charged
by
the
certifying
agent.
An
applicant
may
withdraw
its
application
at
anytime.
An
applicant
who
withdraws
its
application
will
be
liable
for
the
costs
of
services
provided
up
to
the
time
of
withdrawal
of
the
application.

The
certifying
agent
will
decide
whether
to
accept
the
applicant's
application
for
certification.
A
certifying
agent
must
accept
all
production
and
handling
applications
that
fall
within
its
area(
s)
of
accreditation
and
certify
all
qualified
applicants
to
the
extent
of
its
administrative
capacity
to
do
so.
In
other
words,
a
certifying
agent
may
decline
to
accept
an
application
for
certification
when
the
certifying
agent
is
not
accredited
for
the
area
to
be
certified
or
when
the
certifying
agent
lacks
the
resources
to
perform
the
certification.
However,
the
certifying
agent
may
not
decline
to
accept
an
application
on
the
basis
of
race,
color,
national
origin,
gender,
religion,
age,
disability,
political
beliefs,
sexual
orientation,
or
marital
or
family
status.

Upon
acceptance
of
an
application
for
certification,
a
certifying
agent
will
review
the
application
to
ensure
completeness
and
to
determine
whether
the
applicant
appears
to
comply
or
may
be
able
to
comply
with
the
applicable
production
or
handling
regulations.
As
part
of
its
review,
the
certifying
agent
will
verify
that
an
applicant
has
submitted
documentation
to
support
the
correction
of
any
noncompliances
identified
in
a
previously
received
notification
of
noncompliance
or
denial
of
certification.
We
anticipate
that
at
a
future
date
the
certifying
agent
will
also
review
any
available
U.
S.
Department
of
Agriculture
(
USDA)
data
on
production
and
handling
operations
for
information
concerning
the
applicant.
157
We
anticipate
using
data
collected
from
certifying
agents
to
establish
and
maintain
a
password­
protected
Internet
database
only
available
to
accredited
certifying
agents
and
USDA.

This
database
would
include
data
on
production
and
handling
operations
issued
a
notification
of
noncompliance,
noncompliance
correction,
denial
of
certification,
certification,
proposed
suspension
or
revocation
of
certification,
and
suspension
or
revocation
of
certification.
Certifying
agents
would
use
this
Internet
database
during
their
review
of
an
application
for
certification.

This
data
will
not
be
available
to
the
general
public
because
much
of
the
data
would
involve
ongoing
compliance
issues
inappropriate
for
release
prior
to
a
final
determination.

After
a
complete
review
of
the
application,
which
shall
be
conducted
within
a
reasonable
time,
the
certifying
agent
will
communicate
its
findings
to
the
applicant.
If
the
review
of
the
application
reveals
that
the
applicant
may
be
in
compliance
with
the
applicable
production
or
handling
regulations,
the
certifying
agent
will
schedule
an
on­
site
inspection
of
the
applicant's
operation
to
determine
whether
the
applicant
qualifies
for
certification.
The
initial
on­
site
inspection
must
be
conducted
within
a
reasonable
time
following
a
determination
that
the
applicant
appears
to
comply
or
may
be
able
to
comply
with
the
requirements
for
certification.

The
initial
inspection
may
be
delayed
for
up
to
6
months
to
comply
with
the
requirement
that
the
inspection
be
conducted
when
the
land,
facilities,
and
activities
that
demonstrate
compliance
or
capacity
to
comply
can
be
observed.

The
certifying
agent
will
conduct
an
initial
on­
site
inspection
of
each
production
unit,

facility,
and
site
that
produces
or
handles
organic
products
and
that
is
included
in
the
applicant's
operation.
As
a
benchmark,
certifying
agents
should
follow
auditing
guidelines
prescribed
by
the
International
Organization
for
Standardization
Guide
10011­
1,
"
Guidelines
for
auditing
quality
1
ISO
Guide
10011­
1
is
available
for
viewing
at
USDA­
AMS,
Transportation
and
Marketing
Programs,
Room
2945­
South
Building,
14th
and
Independence
Ave.,
SW,
Washington,
DC,
from
9:
00
a.
m.
to
4:
00
p.
m.,
Monday
through
Friday
(
except
official
Federal
holidays).
A
copy
may
be
obtained
from
the
American
National
Standards
Institute,
11
West
42d
Street,
New
York,
NY
10036;
Website:
www.
ansi.
org;
E­
mail:
ansionline@
ansi.
org;
Telephone:
212­
642­
4900;
Facsimile:
212­
398­
0023.

158
systems
­
Part
1:
Auditing"
(
ISO
Guide
10011­
1).
1
The
certifying
agent
will
use
the
on­
site
inspection
in
determining
whether
to
approve
the
request
for
certification
and
to
verify
the
operation's
compliance
or
capability
to
comply
with
the
Act
and
regulations.
Certifying
agents
will
conduct
on­
site
inspections
when
an
authorized
representative
of
the
operation
who
is
knowledgeable
about
the
operation
is
present.
An
on­
site
inspection
must
also
be
conducted
when
land,
facilities,
and
activities
that
demonstrate
the
operation's
compliance
with
or
capability
to
comply
with
the
applicable
production
or
handling
regulations
can
be
observed.

The
on­
site
inspection
must
verify
that
the
information
provided
to
the
certifying
agent
accurately
reflects
the
practices
used
or
to
be
used
by
the
applicant
or
certified
operation
and
that
prohibited
substances
have
not
been
and
are
not
being
applied
to
the
operation.
Certifying
agents
may
use
the
collection
and
testing
of
soil;
water;
waste;
plant
tissue;
and
plant,
animal,
and
processed
products
samples
as
tools
in
accomplishing
this
verification.

The
inspector
will
conduct
an
exit
interview
with
an
authorized
representative
of
the
operation
who
is
knowledgeable
about
the
inspected
operation
to
confirm
the
accuracy
and
completeness
of
inspection
observations
and
information
gathered
during
the
on­
site
inspection.

The
main
purpose
of
this
exit
interview
is
to
present
the
inspection
observations
to
those
in
charge
of
the
firm
in
such
a
manner
so
as
to
ensure
they
clearly
understand
the
results
of
the
inspection.

The
firm
is
not
required
to
volunteer
any
information
during
the
exit
interview
but
would
be
159
required
to
respond
to
questions
or
requests
for
additional
information.
The
inspector
will
raise
and
discuss
during
the
exit
interview
any
known
issues
of
concern,
taking
into
account
their
perceived
significance.
As
a
general
rule,
the
inspector
will
not
make
recommendations
for
improvements
to
the
operation
during
the
exit
interview.
However,
the
certifying
agent
will
have
the
discretion
to
decide
the
extent
to
which
an
inspector
may
discuss
any
compliance
issue.
At
the
time
of
the
inspection,
the
inspector
shall
provide
the
operation's
authorized
representative
with
a
receipt
for
any
samples
taken
by
the
inspector.
There
shall
be
no
charge
to
the
inspector
for
the
samples
taken.

The
certifying
agent
shall,
within
a
reasonable
time,
provide
the
inspected
operation
with
a
copy
of
the
on­
site
inspection
report,
as
approved
by
the
certifying
agent,
for
any
on­
site
inspection
performed
and
provide
the
operation
with
a
copy
of
the
test
results
for
any
samples
taken
by
an
inspector.

Notification
of
Approval
A
certifying
agent
will
review
the
on­
site
inspection
report,
the
results
of
any
analyses
for
substances,
and
any
additional
information
provided
by
the
applicant
within
a
reasonable
time
after
completion
of
the
initial
on­
site
inspection.
The
certifying
agent
will
grant
certification
upon
making
two
determinations:
(
1)
that
the
applicant's
operation,
including
its
organic
system
plan
and
all
procedures
and
activities,
is
in
compliance
with
the
Act
and
regulations
and
(
2)
that
the
applicant
is
able
to
conduct
operations
in
accordance
with
its
organic
systems
plan.

Upon
determining
the
applicant's
compliance
and
ability
to
comply,
the
agent
will
grant
certification
and
issue
a
"
certificate
of
organic
operation."
The
certification
may
include
requirements
for
the
correction
of
minor
noncompliances
within
a
specified
time
period
as
a
160
condition
of
continued
certification.
A
certificate
of
organic
operation
will
specify
the
name
and
address
of
the
certified
operation;
the
effective
date
of
certification;
the
categories
of
organic
operation,
including
crops,
wild
crops,
livestock,
or
processed
products
produced
by
the
certified
operation;
and
the
name,
address,
and
telephone
number
of
the
certifying
agent.
Once
certified,
a
production
or
handling
operation's
organic
certification
continues
in
effect
until
surrendered
by
the
organic
operation
or
suspended
or
revoked
by
the
certifying
agent,
the
SOP's
governing
State
official,
or
the
Administrator.

Denial
of
Certification
Should
the
certifying
agent
determine
that
the
applicant
is
not
able
to
comply
or
is
not
in
compliance
with
the
Act,
the
certifying
agent
will
issue
a
written
notification
of
noncompliance
to
the
applicant.
The
notification
of
noncompliance
will
describe
each
noncompliance,
the
facts
on
which
the
notification
is
based,
and
the
date
by
which
rebuttal
or
correction
of
each
noncompliance
must
be
made.
Applicants
who
receive
a
notification
of
noncompliance
may
correct
the
noncompliances
and
submit,
by
the
date
specified,
a
description
of
correction
and
supporting
documentation
to
the
certifying
agent.
As
an
alternative,
the
applicant
may
submit
a
new
application
to
another
certifying
agent,
along
with
the
notification
of
noncompliance
and
a
description
of
correction
of
the
noncompliances
and
supporting
documentation.
Applicants
may
also
submit,
by
the
date
specified,
written
information
to
the
issuing
certifying
agent
to
rebut
the
noncompliance
described
in
the
notification
of
noncompliance.
When
a
noncompliance
cannot
be
corrected,
a
notification
of
noncompliance
and
a
"
notification
of
denial
of
certification"
may
be
combined
in
one
notification.

The
certifying
agent
will
evaluate
the
applicant's
corrective
actions
taken
and
supporting
161
documentation
submitted
or
the
written
rebuttal.
If
necessary,
the
certifying
agent
will
conduct
a
followup
on­
site
inspection
of
the
applicant's
operation.
When
the
corrective
action
or
rebuttal
is
sufficient
for
the
applicant
to
qualify
for
certification,
the
certifying
agent
will
approve
certification.
When
the
corrective
action
or
rebuttal
is
not
sufficient
for
the
applicant
to
qualify
for
certification,
the
certifying
agent
will
issue
the
applicant
a
written
notice
of
denial
of
certification.
The
certifying
agent
will
also
issue
a
written
notice
of
denial
of
certification
when
an
applicant
fails
to
respond
to
the
notification
of
noncompliance.
The
notice
of
denial
of
certification
will
state
the
reasons
for
denial
and
the
applicant's
right
to
reapply
for
certification,

request
mediation,
or
file
an
appeal.

An
applicant
who
has
received
a
notification
of
noncompliance
or
notice
of
denial
of
certification
may
apply
for
certification
again
at
any
time
with
any
certifying
agent.
When
the
applicant
submits
a
new
application
to
a
different
certifying
agent,
the
application
must
include,

when
available,
a
copy
of
the
notification
of
noncompliance
or
notice
of
denial
of
certification.

The
application
must
also
include
a
description
of
the
actions
taken,
with
supporting
documentation,
to
correct
the
noncompliances
noted
in
the
notification
of
noncompliance.
When
a
certifying
agent
receives
such
an
application,
the
certifying
agent
will
treat
the
application
as
a
new
application
and
begin
a
new
application
process.

A
certifying
agent
has
limited
authority
to
deny
certification
without
first
issuing
a
notification
of
noncompliance.
This
authority
may
be
exercised
when
the
certifying
agent
has
reason
to
believe
that
an
applicant
for
certification
has
willfully
made
a
false
statement
or
otherwise
purposefully
misrepresented
its
operation
or
its
compliance
with
the
requirements
for
certification.
162
Continuation
of
Certification
Each
year,
the
certified
operation
must
update
its
organic
production
or
handling
system
plan
and
submit
the
updated
information
to
the
certifying
agent
and
pay
the
certification
fees
to
continue
certification.
The
updated
organic
system
plan
must
include
a
summary
statement,

supported
by
documentation,
detailing
deviations
from,
changes
to,
modifications
to,
or
other
amendments
to
the
previous
year's
organic
system
plan.
The
updated
organic
system
plan
must
also
include
additions
to
or
deletions
from
the
previous
year's
organic
system
plan,
intended
to
be
undertaken
in
the
coming
year.
The
certified
operation
must
update
the
descriptive
information
about
its
business
and
other
information
as
deemed
necessary
by
the
certifying
agent
to
determine
compliance
with
the
Act
and
regulations.
The
certified
operation
must
also
provide
an
update
on
the
correction
of
minor
noncompliances
previously
identified
by
the
certifying
agent
as
requiring
correction
for
continued
certification.

Following
receipt
of
the
certified
operation's
updated
information,
the
certifying
agent
will,
within
a
reasonable
time,
arrange
and
conduct
an
on­
site
inspection
of
the
certified
operation.

When
it
is
impossible
for
the
certifying
agent
to
conduct
the
annual
on­
site
inspection
following
receipt
of
the
certified
operation's
annual
update
of
information,
the
certifying
agent
may
allow
continuation
of
certification
and
issue
an
updated
certificate
of
organic
operation
on
the
basis
of
the
information
submitted
and
the
most
recent
on­
site
inspection
conducted
during
the
previous
12
months.
However,
the
annual
on­
site
inspection
must
be
conducted
within
the
first
6
months
following
the
certified
operation's
scheduled
date
of
annual
update.
As
a
benchmark,
certifying
agents
should
follow
auditing
guidelines
prescribed
by
ISO
Guide
10011­
1.
Upon
completion
of
the
inspection
and
a
review
of
updated
information,
the
certifying
agent
will
determine
whether
163
the
operation
continues
to
comply
with
the
Act
and
regulations.
If
the
certifying
agent
determines
that
the
operation
is
in
compliance,
certification
will
continue.
If
any
of
the
information
specified
on
the
certificate
of
organic
operation
has
changed,
the
certifying
agent
will
issue
an
updated
certificate
of
organic
operation.
If
the
certifying
agent
finds
that
the
operation
is
not
complying
with
the
Act
and
regulations,
a
written
notification
of
noncompliance
will
be
issued
as
described
in
section
205.662.

In
addition
to
annual
inspections,
a
certifying
agent
may
conduct
additional
on­
site
inspections
of
certified
operations
that
produce
or
handle
organic
products
to
determine
compliance
with
the
Act
and
regulations.
The
Administrator
or
SOP's
governing
State
official
may
also
require
that
additional
inspections
be
performed
by
the
certifying
agent
to
determine
compliance
with
the
Act
and
regulations.
Additional
inspections
may
be
announced
or
unannounced
and
would
be
conducted,
as
necessary,
to
obtain
information
needed
to
determine
compliance
with
identified
requirements.

Such
on­
site
inspections
would
likely
be
precipitated
by
reasons
to
believe
that
the
certified
operation
was
operating
in
violation
of
one
or
more
requirements
of
the
Act
or
these
regulations.
The
policies
and
procedures
regarding
additional
inspections,
including
how
the
costs
of
such
inspections
are
handled,
would
be
the
responsibility
of
each
certifying
agent.
Misuse
of
such
authority
would
be
subject
to
review
by
USDA
during
its
evaluation
of
a
certifying
agent
for
reaccreditation
and
at
other
times
in
response
to
complaints.
Certified
production
and
handling
operations
can
file
complaints
with
USDA
at
any
time
should
they
believe
a
certifying
agent
abuses
its
authority
to
perform
additional
inspections.

Certification
After
Suspension
or
Revocation
of
Certifying
Agent's
Accreditation
164
When
the
Administrator
revokes
or
suspends
a
certifying
agent's
accreditation,
affected
certified
operations
will
need
to
make
application
for
certification
with
another
accredited
certifying
agent.
The
certification
of
the
production
or
handling
operation
remains
in
effect
during
this
transfer
of
the
certification.
The
certified
production
or
handling
operation
may
seek
certification
by
any
qualified
certifying
agent
accredited
by
the
Administrator.
To
minimize
the
burden
of
obtaining
the
new
certification,
the
Administrator
will
oversee
transfer
of
the
original
certifying
agent's
file
on
the
certified
operation
to
the
operation's
new
certifying
agent.

Upon
initiation
of
suspension
or
revocation
of
a
certifying
agent's
accreditation
or
upon
suspension
or
revocation
of
a
certifying
agent's
accreditation,
the
Administrator
may
initiate
proceedings
to
suspend
or
revoke
the
certification
of
operations
certified
by
the
certifying
agent.

The
Administrator's
decision
to
suspend
or
revoke
a
producer's
or
handler's
certification
in
light
of
the
loss
of
its
certifying
agent's
accreditation
would
be
made
on
a
case­
by­
case
basis.
Actions
such
as
fraud,
bribery,
or
collusion
by
the
certifying
agent,
which
cause
the
Administrator
to
believe
that
the
certifying
agent's
clients
do
not
meet
the
standards
of
the
Act
or
these
regulations,
might
require
the
immediate
initiation
of
procedures
to
suspend
or
revoke
certification
from
some
or
all
of
its
client
base.
Removal
of
accreditation,
regardless
of
the
reason,
in
no
way
affects
the
appeals
rights
of
the
certifying
agent's
clients.
Further,
a
certified
operation's
certification
will
remain
in
effect
pending
the
final
resolution
of
any
proceeding
to
suspend
or
revoke
its
certification.

A
private­
entity
certifying
agent
must
furnish
reasonable
security
for
the
purpose
of
protecting
the
rights
of
operations
certified
by
such
certifying
agent.
This
security
is
to
ensure
the
performance
of
the
certifying
agent's
contractual
obligations.
As
noted
elsewhere
in
this
rule,
the
165
specific
amount
and
type
of
security
that
must
be
furnished
by
a
private
certifying
agent
will
be
the
subject
of
future
rulemaking
by
USDA.
We
anticipate
that
the
amount
of
the
security
will
be
tied
to
the
number
of
clients
served
by
the
certifying
agent
and
the
anticipated
costs
of
certification
that
may
be
incurred
by
its
clients
in
the
event
that
the
certifying
agent's
accreditation
is
suspended
or
revoked.
We
anticipate
that
the
security
may
be
in
the
form
of
cash,
surety
bonds,
or
other
financial
instrument
(
such
as
a
letter
of
credit)
administered
in
a
manner
comparable
to
cash
or
surety
bonds
held
under
the
Perishable
Agricultural
Commodities
Act.

Certification
­
Changes
Based
on
Comments
This
subpart
differs
from
the
proposal
in
several
respects
as
follows:

(
1)
Access
to
Production
and
Handling
Operation.
We
have
amended
section
205.400(
c)

by
changing
"
noncertified
areas
and
structures"
to
"
noncertified
production
and
handling
areas,

structures,
and
offices."
A
commenter
requested
that
section
205.400(
c)
be
amended
to
allow
for
access
to
farm­
related
structures
only.
The
commenter
believes
that
the
requirements
of
section
205.400(
c)
could
be
interpreted
as
giving
inspectors
access
to
residential
property.
We
agree
with
the
commenter
that
residential
privacy
should
be
maintained.
However,
if
a
certified
operation
conducts
business
from
or
stores
records
at
a
residential
property,
the
certified
operation
will
be
considered
to
be
maintaining
an
office
at
the
residential
property.
The
records
in
such
office
shall
be
made
accessible
for
review
and
copying.
Accordingly,
we
have
amended
section
205.400(
c)
to
further
clarify
which
areas
and
structures
are
to
be
made
accessible
during
an
on­
site
inspection.

(
2)
Application
for
Certification.
We
have
amended
the
first
paragraph
of
section
205.401
by
replacing
the
word,
"
request,"
each
time
it
occurred
with
the
word,
"
application."
A
166
commenter
recommended
that
we
amend
the
first
paragraph
of
section
205.401
by
replacing
the
word,
"
request,"
with
"
application."
We
have
accepted
the
commenter's
recommendation
because
the
amendment
makes
the
language
in
the
first
paragraph
consistent
with
the
title
and
the
requirements
of
the
section.

(
3)
Verification
of
Correction
of
Noncompliances.
To
make
section
205.402(
a)(
3)

consistent
with
section
205.401(
c)
we
have
amended
the
language
in
section
205.402(
a)(
3)
to
require
that
the
certifying
agent
verify
that
an
applicant
who
previously
applied
to
another
certifying
agent
and
received
a
notification
of
denial
of
certification
has
submitted
documentation
to
support
the
correction
of
any
noncompliances
identified
in
the
notification
of
denial
of
certification.
A
commenter
recommended
that
section
205.402(
a)(
3)
be
amended
by
inserting
"
or
denial
of
certification"
after
the
phrase,
"
notification
of
noncompliance."
We
have
accepted
the
commenter's
recommended
amendment
because
it
is
consistent
with
the
requirements
of
section
205.401(
c).
Section
205.401(
c)
requires
an
applicant
for
certification
to
include
the
name(
s)
of
any
organic
certifying
agent(
s)
to
which
application
has
previously
been
made,
the
year(
s)
of
application,
and
the
outcome
of
the
application(
s)
submission.
The
applicant
is
also
required
to
include,
when
available,
a
copy
of
any
notification
of
noncompliance
or
denial
of
certification
issued
to
the
applicant
for
certification.
The
words,
"
when
available,"
have
been
added
to
this
requirement
in
this
final
rule
to
satisfy
concerns
regarding
the
status
of
applicants
who
cannot
find
or
no
longer
have
a
copy
of
any
notification
of
noncompliance
or
denial
of
certification
previously
received.
We
see
no
down
side
to
relaxing
this
requirement
since
the
applicant
must
still
comply
with
each
of
the
other
provisions
in
section
205.401(
c),
including
the
requirement
that
the
applicant
include
a
description
of
the
actions
taken
to
correct
the
noncompliances
noted
in
any
167
notification
of
noncompliance
or
denial
of
certification,
including
evidence
of
such
correction.

Further,
the
certifying
agent
will
be
using
USDA's
database
of
certification
actions
during
its
review
of
an
application
for
certification.

(
4)
Timely
Communication
to
the
Applicant.
We
have
amended
section
205.402(
b),
by
requiring
at
paragraph
(
b)(
1)
that
the
certifying
agent,
within
a
reasonable
time,
review
the
application
materials
received
and
communicate
its
findings
to
the
applicant.
A
commenter
requested
that
we
amend
section
205.402(
b)
which
required
a
certifying
agent
to
communicate
to
the
applicant
its
findings
on
the
review
of
application
materials
submitted
by
the
applicant.

Specifically,
the
commenter
requested
that
section
205.402(
b)
be
amended
by
adding
to
the
end
thereof,
"
in
a
timely
manner
so
as
to
prevent
the
avoidable
tillage
of
native
habitat
that
had
been
identified
in
the
application
as
lands
for
organic
production."

We
concur
that
certification
decisions
should
be
timely.
There
are
many
reasons
(
e.
g.,

financial
and
contractual)
for
why
certification
must
be
timely.
It
would
be
impractical,
however,

to
attempt
to
address
all
of
the
reasons
for
timely
certification
in
these
regulations.
We
have,

therefore,
amended
section
205.402(
b)
as
noted
above.
This
amendment
is
consistent
with
the
requirement
in
section
205.402(
a)
that
the
certifying
agent,
upon
acceptance
of
an
application
for
certification,
review
the
application
for
completeness,
determine
by
a
review
of
the
application
materials
whether
the
applicant
appears
to
comply
or
may
be
able
to
comply
with
the
requirements
for
certification,
and
schedule
an
on­
site
inspection.
The
"
upon
acceptance"

requirement
necessitates
that
the
certifying
agent
review
the
application
for
certification
and
provide
feedback
to
the
applicant
in
a
timely
manner.

(
5)
On­
site
Inspections.
We
have
amended
section
205.403(
a)(
1)
by
specifying
that
the
168
initial
and
annual
on­
site
inspections
of
each
production
unit,
facility,
and
site
in
an
operation
applies
to
those
units,
facilities,
and
sites
that
produce
or
handle
organic
products.
A
commenter
recommended
that
section
205.403(
a)(
1)
be
amended
to
specify
that
on­
site
inspections
of
each
production
unit,
facility,
and
site
will
include
just
those
that
produce
or
handle
organic
products.

The
commenter
stated
that
this
change
was
necessary
because
some
retail
corporations
choose
to
certify
all
store
locations
regardless
of
whether
the
location
sells
organic
products.
The
commenter
went
on
to
say
that,
if
a
location
does
not
stock
any
organic
products,
the
certifying
agent
should
have
the
discretion
to
modify
the
inspection
requirement.

We
have
excluded
all
retail
food
establishments
from
certification.
The
exclusion
is
found
in
section
205.101(
b)(
2).
Accordingly,
the
commenter's
recommendation
is
not
applicable
to
retail
food
establishments.
We
have,
however,
made
the
recommended
amendment
to
section
205.403(
a)(
1)
because
of
its
potential
applicability
to
other
operations
which
may
apply
for
certification.

(
6)
Scheduling
Initial
On­
site
Inspection.
We
have
amended
section
205.403(
b)
to
provide
that
the
initial
inspection
may
be
delayed
for
up
to
6
months
to
comply
with
the
requirement
that
the
inspection
be
conducted
when
the
land,
facilities,
and
activities
that
demonstrate
compliance
or
capacity
to
comply
with
the
organic
production
and
handling
requirements
can
be
observed.
We
received
a
comment
stating
that
if
an
application
is
received
in
January
for
a
crop
that
will
be
planted
in
May,
it
would
be
necessary
to
delay
the
inspection
until
late
May
or
June
to
observe
the
crop
in
the
field.
The
commenter
went
on
to
say
that
the
alternative
would
be
to
conduct
the
initial
inspection
before
the
crop
is
planted,
in
order
to
meet
the
"
within
a
reasonable
time"
requirement,
and
then
conduct
a
reinspection
during
the
growing
169
season.
The
commenter
recommended
amending
section
205.403(
b)
to
allow
the
certifying
agent
to
delay
the
initial
on­
site
inspection
until
the
land,
facilities,
and
activities
that
demonstrate
compliance
or
capacity
to
comply
can
be
observed.

We
have
accepted
the
recommendation
because
there
may
be
situations
where
a
later
onsite
inspection
will
prove
mutually
beneficial
to
the
certifying
agent
and
the
operation
to
be
inspected.
However,
certifying
agents
are
reminded
that
the
operation
may
be
certified
following
a
demonstration
that
the
operation
is
able
to
comply
with
the
organic
production
and
handling
requirements
found
in
subpart
C
of
these
regulations.
Accordingly,
certifying
agents
should
not
unnecessarily
delay
the
certification
of
an
organic
production
or
handling
operation
by
insisting
that
the
inspection
only
be
performed
when
the
operation
can
demonstrate
its
actual
compliance
with
the
organic
production
and
handling
requirements.
Applicants
who
believe
that
the
certifying
agent
is
abusing
its
authority
to
delay
the
on­
site
inspection
may
file
a
complaint
with
the
Administrator.

We
have
also
amended
the
second
sentence
in
section
205.403(
b)
by
inserting
the
word,

"
all,"
and
removing
both
references
to
"
applicant"
to
clarify
that
the
provision
applies
to
all
onsite
inspections.

(
7)
Exit
Interview.
We
have
amended
section
205.403(
d)
by
requiring
that
the
inspector
conduct
an
exit
interview
with
"
an
authorized
representative
of
the
operation
who
is
knowledgeable
about
the
inspected
operation"
rather
than
"
an
authorized
representative
of
the
inspected
operation"
as
required
in
the
proposed
rule.
This
amendment
is
consistent
with
the
requirement
in
section
205.403(
b)
that
an
on­
site
inspection
be
conducted
when
an
authorized
representative
of
the
operation
who
is
knowledgeable
about
the
operation
is
present.
170
A
commenter
requested
that
we
define
"
authorized
representative."
Another
commenter
recommended
changing
the
term,
"
authorized
representative,"
to
"
responsible
executive."
Our
amendment
of
section
205.403(
d)
responds
to
both
of
these
comments
by
clarifying
the
qualifications
of
an
authorized
representative.

A
third
commenter
stated
that
an
exit
interview
is
not
a
practical
requirement
and
that
an
initial
interview
is
often
preferred.
The
commenter
stressed
that
verification
that
the
inspector
has
correctly
understood
what
is
presented
is
ongoing.
This
commenter
also
expressed
the
belief
that
there
may
be
times
when
it
may
not
be
appropriate
for
the
inspector
to
address
issues
of
concern
and
that
such
issues
may
be
best
left
to
the
certifying
agent.
The
commenter
recommended
that
the
requirement
for
an
exit
interview
be
deleted
or
presented
as
an
option.
Another
commenter
suggested
that
issues
of
concern
are
often
identified
and
discussed
with
the
operation's
representative
during
the
course
of
the
inspection.
This
commenter
believes
that
it
is
unnecessarily
confrontational
to
require
an
exit
interview
during
which
these
issues
of
concern
are
repeated.
This
commenter
recommended
replacing
the
required
exit
interview
with
a
communications
provision
that
would
require
the
inspector
to
discuss
the
need
for
any
additional
information
as
well
as
any
issues
of
concern.
The
recommended
provision
would
also
authorize
the
certifying
agent
to
provide
the
applicant
with
a
summary
of
the
inspector's
areas
of
concern.

While
we
agree
that
the
language
in
section
205.403(
d)
needed
clarification,
we
do
not
agree
that
the
exit
interview
is
impractical
or
unnecessarily
confrontational.
The
exit
interview
is
intended
to
give
the
inspector
an
opportunity
to
confirm
the
accuracy
and
completeness
of
inspection
observations
and
information
gathered
during
the
on­
site
inspection,
to
request
any
additional
information
necessary
to
establish
eligibility
for
certification,
and
to
raise
and
discuss
171
any
known
issues
of
concern.
Issues
of
concern
that
may
involve
compliance
issues
will
be
handled
as
authorized
by
the
certifying
agent.
The
exit
interview
is
also
intended
to
give
the
inspected
operation's
authorized
representative
general
information
concerning
the
inspector's
observations.
Such
exit
interviews
are
required
under
ISO
Guide
10011­
1.
Accordingly,

requiring
exit
interviews
is
consistent
with
ISO
standards
and
our
expectation,
as
stated
earlier
in
this
preamble,
that
certifying
agents
benchmark
their
on­
site
inspection
procedures
to
ISO
Guide
10011­
1.

(
8)
On­
site
Inspection
Documentation.
We
have
amended
section
205.402(
b)
by
adding
the
requirements
that
the
certifying
agent:
(
1)
provide
the
applicant
with
a
copy
of
the
on­
site
inspection
report,
as
approved
by
the
certifying
agent,
for
any
on­
site
inspection
performed
and
(
2)
provide
the
applicant
with
a
copy
of
the
test
results
for
any
samples
taken
by
an
inspector.

We
have
also
amended
section
205.403
by
adding
a
new
paragraph
(
e)
that
requires
the
inspector,

at
the
time
of
the
inspection,
to
provide
the
operation's
authorized
representative
with
a
receipt
for
any
samples
taken
by
the
inspector.
This
new
paragraph
also
addresses
the
requirement
that
the
certifying
agent
provide
the
operation
inspected
with
a
copy
of
the
inspection
report
and
any
test
results.
Having
the
certifying
agent
issue
the
on­
site
inspection
report
to
the
operation
inspected
is
consistent
with
ISO
Guide
65,
section
11(
b).

Several
commenters
recommended
that
section
205.403
be
amended
to
require
that
the
inspector
issue
a
copy
of
the
on­
site
inspection
report
to
the
operation
at
the
exit
interview.
They
also
recommended
that
the
inspector
be
required
to
provide
the
operation
with
a
receipt
for
samples
collected
for
testing.
The
commenters,
further,
recommended
that
the
certifying
agent
be
required
to
provide
the
operation
with
a
written
report
on
the
results
of
the
testing
performed
on
172
the
samples
taken.
A
commenter
also
recommended
that
the
operation
be
paid
for
any
samples
taken.
One
of
the
commenters
recommended
that
section
205.403
be
amended
by
adding
protocol
for
an
exit
interview.

We
concur
that
the
applicant
for
certification
and
certified
operations
should
be
provided
with
a
copy
of
the
on­
site
inspection
report,
a
receipt
for
samples
taken,
and
a
copy
of
the
test
results
for
samples
taken.
Accordingly,
we
have
amended
sections
205.402(
b)
and
205.403
as
noted
above.

The
protocol
for
an
exit
interview
will
be
set
forth
in
the
certifying
agent's
procedures
to
be
used
to
evaluate
certification
applicants,
make
certification
decisions,
and
issue
certification
certificates.
The
NOP
is
available
to
respond
to
questions
and
to
assist
certifying
agents
in
the
development
of
these
procedures
which
are
required
under
section
205.504(
b)(
1).
Accordingly,

AMS
is
not
amending
the
section
to
include
a
protocol
for
exit
interviews.
AMS
is
also
not
including
a
requirement
that
the
certifying
agent
pay
the
applicant
for
samples
taken,
since
such
charges
would
just
be
charged
back
to
the
applicant
as
a
cost
for
processing
the
applicant's
application
for
certification.

(
9)
Granting
Certification.
We
have
amended
the
last
sentence
of
section
205.404(
a)
by
removing
the
word,
"
restrictions,"
and
replacing
it
with
"
requirements
for
the
correction
of
minor
noncompliances
within
a
specified
time
period."
A
commenter
suggested
that
the
last
sentence
of
section
205.404(
a)
be
amended
to
read:
"
The
approval
may
include
restrictions
or
requirements
as
a
condition
of
continued
certification,
which
includes
a
time
line
for
fulfilling
the
requirement."

Another
commenter
requested
that
we
define
"
restrictions."
This
commenter
also
recommended
amending
section
205.404(
a)
to
clarify
the
meaning
of
"
restrictions"
and
to
require
corrective
173
action
by
the
operator
within
a
specific
time
period.
We
agree
with
the
commenters
that
the
last
sentence
of
section
205.404(
a)
was
in
need
of
further
clarification.
We
also
agree
that
it
is
appropriate
for
the
regulations
to
require
that
the
requirements
for
correction
include
a
specified
time
period
within
which
the
corrections
must
be
made.
Accordingly,
we
amended
section
205.404(
a)
as
noted
above.
The
certifying
agent
will
make
the
determination
of
whether
a
violation
of
the
Act
and
regulations
is
minor.
Minor
noncompliances
are
those
infractions
that,
by
themselves,
do
not
preclude
the
certification
or
continued
certification
of
an
otherwise
qualified
organic
producer
or
handler.
The
certifying
agent
would
be
free
to
modify
the
time
period
for
correction
should
it
believe
it
to
be
appropriate.

We
have
also
made
editorial
changes
to
section
205.404(
a)
consistent
with
suggestions
we
received
on
section
205.506.
In
the
title
to
section
205.404
we
have
replaced
"
Approval
of"
with
"
Granting."
In
section
205.404(
a)
we
have
replaced
"
approve"
with
"
grant"
and
"
approval"
with
"
certification."
This
change
makes
the
language
in
section
205.404
consistent
with
ISO
Guide
65,

section
4.6,
which
addresses
the
granting
of
certification.

(
10)
Payment
of
Fees.
We
have
amended
the
introductory
statement
within
section
205.406(
a)
by
adding
the
requirement
that,
to
continue
certification,
a
certified
operation
annually
pay
the
certifying
agent's
certification
fees.
A
commenter
recommended
amending
section
205.404(
c)
by
adding
a
sentence
providing
that
a
certified
operation's
failure
to
pay
the
certifying
agent's
certification
fees
may
be
a
cause
for
suspension
or
revocation
of
certification.
We
agree
that
the
issue
of
payment
of
fees
should
be
addressed
but
not
in
section
205.404(
c),
which
deals
with
the
duration
of
a
certified
operation's
certification.
We
believe
the
issue
of
payment
of
certification
fees
is
more
appropriately
addressed
in
section
205.406,
which
deals
with
174
continuation
of
certification.
Accordingly,
we
have
amended
section
205.406(
a)
to
require
payment
of
the
certifying
agent's
fees
as
a
condition
of
continued
certification.
This
addition
would
allow
a
certifying
agent
to
initiate
suspension
or
revocation
proceedings
against
any
operation
that
fails
to
pay
the
required
fees.
The
certifying
agent
is
not
required
to
initiate
suspension
or
revocation
proceedings
for
failure
to
pay
the
fees.
In
fact,
the
certifying
agent
is
encouraged
to
use
one
or
more
of
the
legal
debt
collection
alternatives
available
to
it.

(
11)
Denial
of
Certification.
We
have
amended
section
205.405
to
include
noncompliance
and
resolution
provisions
originally
included
by
cross­
reference
to
section
205.662(
a).
We
have
made
this
amendment
in
response
to
a
comment
that
these
regulations
do
not
provide
an
opportunity
for
a
hearing
upon
denial
of
certification.
We
disagree
with
the
commenter's
assessment
but
have
amended
section
205.405(
a)
to
eliminate
confusion
that
may
result
from
the
cross­
reference
to
section
205.662(
a).
We
have
determined
that
section
205.662(
a)
may
cause
confusion
for
certification
applicants
because
the
section
does
not
specifically
address
applicants.

As
amended,
section
205.405(
a)
required
a
written
notification
of
noncompliance
that
describes
each
noncompliance,
the
facts
on
which
the
noncompliance
is
based,
and
the
date
by
which
the
applicant
must
rebut
or
correct
each
noncompliance
and
submit
supporting
documentation
of
each
such
correction
when
correction
is
possible.
Section
205.405(
b)
lists
the
options
available
to
the
applicant,
including
the
options
of
correcting
the
noncompliance
or
submitting
written
information
to
rebut
the
noncompliance.
Successful
correction
or
rebuttal
will
result
in
an
approval
of
certification.
When
the
corrective
action
or
rebuttal
is
not
sufficient
for
the
applicant
to
qualify
for
certification,
the
certifying
agent
will
issue
a
written
notice
of
denial
of
175
certification.
This
notice
will
state
the
reason(
s)
for
denial
and
the
applicant's
right
to
request
mediation
in
accordance
with
section
205.663
or
to
file
an
appeal
in
accordance
with
section
205.681.

(
12)
Rebuttal
of
a
Noncompliance.
We
have
amended
section
205.405(
b)(
3)
to
clarify
that
rebuttal
of
a
noncompliance
shall
be
submitted
to
the
certifying
agent
that
issued
the
notification
of
noncompliance.
We
made
this
amendment
in
response
to
a
commenter's
question
about
who
has
authority
to
evaluate
a
written
rebuttal.

(
13)
Correction
of
Minor
Noncompliances.
We
have
amended
section
205.406(
a)
by
adding
a
new
paragraph
(
3)
which
requires
the
certified
operation
to
include
with
its
annual
reporting
an
update
on
the
correction
of
minor
noncompliances
previously
identified
by
the
certifying
agent
as
requiring
correction
for
continued
certification.
A
commenter
recommended
adding
at
205.406(
a)
a
requirement
that
the
certified
operation
address
any
restrictions
that
have
been
applied
to
its
certification
under
205.404(
a).
We
agree
with
the
commenter
that
the
annual
reporting
by
the
certified
operation
should
include
an
update
addressing
the
certified
operation's
compliance
with
the
certifying
agent's
requirements
for
the
correction
of
minor
noncompliances.

Accordingly,
we
amended
section
205.406(
a)
as
noted
above
and
redesignated
paragraph
(
3)
as
paragraph
(
4).
The
certifying
agent
will
make
the
determination
of
whether
a
violation
of
the
Act
and
regulations
is
minor.
Minor
noncompliances
are
those
infractions
that,
by
themselves,
do
not
preclude
the
certification
or
continued
certification
of
an
otherwise
qualified
organic
producer
or
handler.

(
14)
Scheduling
Annual
On­
site
Inspections.
We
have
amended
section
205.406(
b)
to
provide
that,
when
it
is
impossible
for
the
certifying
agent
to
conduct
the
annual
on­
site
inspection
176
following
receipt
of
the
certified
operation's
annual
update
of
information,
the
certifying
agent
may
allow
continuation
of
certification
and
issue
an
updated
certificate
of
organic
operation
on
the
basis
of
the
information
submitted
and
the
most
recent
on­
site
inspection
conducted
during
the
previous
12
months.
The
annual
on­
site
inspection,
required
by
section
205.403,
must,
however,

be
conducted
within
the
first
6
months
following
the
certified
operation's
scheduled
date
of
annual
update.

A
commenter
expressed
the
belief
that
the
requirement
for
an
on­
site
inspection
after
receipt
of
the
certified
operation's
annual
update
of
information
would
have
required
that
all
annual
on­
site
inspections
be
performed
at
the
same
time
of
the
year.
The
commenter
went
on
to
express
the
belief
that,
to
avoid
inspecting
certified
operations
twice
a
year,
certifying
agents
would
have
to
schedule
the
annual
update
to
occur
during
the
growing
season
in
order
to
comply
with
the
requirement
for
timing
inspections
when
normal
production
activities
can
be
observed.

The
commenter
stated
that
certifying
agents
should
be
given
more
flexibility
for
scheduling
inspections
and
conducting
their
certification
programs
according
to
management
procedures
best
suited
to
their
agency.
The
commenter
recommended
amending
section
205.406(
b)
by
adding
to
the
end
thereof:
"
or
base
the
decision
regarding
eligibility
for
renewal
on
an
on­
site
inspection
conducted
during
the
previous
12
months."

We
agree
with
the
commenter
that
certifying
agents
should
be
given
more
flexibility
for
scheduling
on­
site
inspections
so
as
to
best
meet
the
management
needs
of
the
certifying
agent.

Accordingly,
we
have
amended
section
205.406(
b)
to
allow
continuation
of
certification
and
issuance
of
an
updated
certificate
of
organic
operation
on
the
basis
of
the
information
submitted
and
the
most
recent
on­
site
inspection
conducted
during
the
previous
12
months.
This
option
will
177
be
available
to
the
certifying
agent
when
renewal
is
scheduled
for
a
time
when
it
is
impossible
to
conduct
the
annual
on­
site
inspection
following
receipt
of
the
annual
update
and
at
a
time
when
land,
facilities,
and
activities
that
demonstrate
the
operation's
compliance
or
capability
to
comply
can
be
observed.
This
change
does
not
affect
the
requirement
in
section
205.403(
a)(
1)
that
the
certifying
agent
conduct
an
annual
on­
site
inspection
of
each
certified
operation.
Further,
the
annual
on­
site
inspection
must
be
conducted
within
the
first
6
months
following
the
certified
operation's
scheduled
date
of
annual
update.

Certification
­
Changes
Requested
But
Not
Made
This
subpart
retains
from
the
proposed
rule
regulations
on
which
we
received
comments
as
follows:

(
1)
Number
of
On­
site
Inspections.
A
commenter
recommended
that
section
205.403(
a)(
1)
be
amended
by
adding
a
requirement
that
production
operations
be
under
active
organic
management
for
the
last
year
of
the
3­
year
land
conversion
period
and
that
two
on­
site
inspections
be
performed
prior
to
organic
certification.

Section
205.403(
a)(
1)
provides
that
the
certifying
agent
must
conduct
an
initial
on­
site
inspection
of
each
production
unit,
facility,
and
site
that
produces
or
handles
organic
products
and
that
is
included
in
an
operation
for
which
certification
is
requested.
The
requirement
does
not
preclude
a
certifying
agent
from
conducting
additional
on­
site
inspections,
if
necessary,
to
establish
the
applicant's
eligibility
for
certification.
The
Act
requires
a
3­
year
period
immediately
preceding
harvest,
during
which
the
production
operation
must
be
free
from
the
application
of
prohibited
substances.
The
Act
does
not,
however,
require
that
land
be
under
active
organic
management
during
this
period,
and
we
do
not
believe
such
a
requirement
in
these
regulations
is
178
necessary.
Such
a
requirement,
for
example,
would
necessitate
some
process
for
verifying
that
an
operation
is
under
active
organic
management,
which
would,
in
effect,
require
a
certification­
type
decision
a
year
before
certification
is
granted
and
the
operation
can
begin
to
label
products
as
certified
organic.
Accordingly,
we
disagree
with
the
commenter's
recommendation
that
an
operation
be
under
active
organic
management
for
the
last
year
of
the
3­
year
land
conversion
and
that
two
on­
site
inspections
be
required.

(
2)
Unannounced
Inspections.
A
commenter
recommended
that
section
205.403(
a)(
2)(
iii)
be
amended
to
require
additional
unannounced
inspections
either
by
defining
the
circumstances
under
which
the
inspections
should
be
undertaken
or
by
setting
a
minimum
percentage
of
unannounced
inspections.
The
commenter
claimed
that
5
percent
is
a
common
percentage
adopted
by
certifying
agents
around
the
world.

Section
205.403
requires
an
initial
on­
site
inspection,
annual
on­
site
inspection,
and
additional
on­
site
inspections
to
determine
compliance
with
the
Act
and
regulations,
to
verify
that
information
provided
reflects
actual
practices,
and
to
verify,
through
testing
if
necessary,
that
prohibited
substances
are
not
used
by
the
operation.
Because
of
the
widely
disparate
nature
of
certified
operations,
we
believe
the
certifying
agent
is
in
the
best
position
to
determine
the
need
for
additional
on­
site
inspections.
Accordingly,
we
have
rejected
the
commenter's
request
that
the
regulations
require
additional
unannounced
visits
either
by
defining
the
circumstances
under
which
these
should
be
undertaken
or
by
setting
a
minimum
percentage.

(
3)
Timeliness
of
Certifying
Agent
Review
Information.
A
commenter
requested
that
section
205.404(
a)
be
amended
to
specify
a
timeframe
of
60
days
rather
than
"
Within
a
reasonable
time"
as
the
time
by
which
the
certifying
agent
must
review
the
on­
site
inspection
report,
the
179
results
of
any
analyses
for
substances,
and
any
additional
information
requested
from
or
supplied
by
the
applicant.

Section
205.404(
a)
requires
the
certifying
agent,
within
a
reasonable
time
after
completion
of
the
initial
on­
site
inspection,
to
review
the
on­
site
inspection
report,
the
results
of
any
analyses
for
substances
conducted,
and
any
additional
information
requested
from
or
supplied
by
the
applicant.
Section
205.504(
b)(
1)
requires
the
certifying
agent
to
submit
a
copy
of
the
procedures
to
be
used
to
evaluate
certification
applicants,
make
certification
decisions,
and
issue
certification
certificates.
Such
procedures
and
the
certifying
agent's
performance
in
making
timely
certification
decisions
will
be
subject
to
review
during
accreditation
and
reaccreditation
of
the
certifying
agent.
Certifying
agents
are
expected
to
make
timely
decisions
regarding
whether
to
certify
an
applicant
and
whether
a
certified
operation
is
in
compliance
with
the
Act
and
regulations.
Applicants
with
complaints
regarding
timeliness
of
service
could
forward
their
complaints
to
the
Administrator.
Accordingly,
timely
service
will
be
in
the
best
interest
of
certifying
agents
since
such
complaints
could
have
an
impact
on
their
reaccreditation
or
continued
accreditation.
Further,
our
original
position
is
consistent
with
those
commenters
requesting
flexibility
in
determining
what
constitutes
reasonable
time.
Accordingly,
we
have
not
amended
section
205.404(
a)
as
requested.

(
4)
Categories
of
Organic
Operation.
We
received
a
variety
of
comments
regarding
the
requirement
that
the
certifying
agent
issue
a
certificate
of
organic
operation
which
specifies
the
categories
of
organic
operation,
including
crops,
wild
crops,
livestock,
or
processed
products
produced
by
the
certified
operation.
One
commenter
recommended
that
section
205.404(
b)(
3)
be
amended,
with
regard
to
processing,
to
only
require
a
processing
category
to
be
specified
on
the
180
certificate,
such
as
food
processing
or
feed
processing.
The
commenter
stated
that
it
should
not
be
necessary
to
list
every
product
on
the
certificate.
Specifically,
the
commenter
recommended
amending
section
205.404(
b)(
3)
by
inserting
the
words,
"
general
categories
of,"
immediately
in
front
of
the
word,
"
processed."
Another
commenter
recommended
amending
section
205.404(
b)(
3)
to
require
the
identity
of
specific
crops
and
the
specific
processing
operations
certified.
Still
another
commenter
requested
that
section
205.404(
b)
be
amended
by
adding
a
new
paragraph
requiring
that
the
certificate
include
the
number
of
livestock
of
each
species
produced
on
the
certified
operation.
This
same
commenter
also
recommended
the
addition
of
a
new
paragraph
requiring
that
the
certificate
identify
the
specific
location
of
each
certified
organic
field
and
handling
operation.
We
also
received
support
for
section
205.404(
b)(
3)
as
written.
This
commenter
does
not
support
the
addition
of
information
regarding
the
number
of
livestock
or
the
location
of
fields.

We
disagree
with
the
suggestion
that
the
certificate
list
every
crop,
wild
crop,
livestock,
or
processed
product
produced
by
the
certified
operation.
We
believe
that
listing
categories
of
organic
operation
is
sufficient.
This
does
not,
however,
prevent
the
certifying
agent,
in
cooperation
with
the
certified
operation,
from
listing
specific
crops,
livestock,
or
processed
products
on
the
certificate.
Such
information
could
always
be
listed
on
the
certificate
when
requested
by
the
certified
operation.
We
also
disagree
with
the
commenter
who
requested
that
certifying
agents
display
the
number
of
livestock
of
each
species
produced
by
the
certified
operation
and
the
specific
location
of
each
certified
organic
field
and
handling
operation.
We
do
not
believe
it
is
necessary
to
list
the
quantity
of
product
to
be
produced
or
handled
at
a
certified
operation,
nor
do
we
believe
it
is
necessary
to
list
the
location
of
a
certified
operation's
fields
or
181
facilities.
Such
information
may,
however,
be
listed
on
the
certificate
upon
the
written
request
of
the
certified
operation.
By
requiring
the
name,
address,
and
telephone
number
of
the
certifying
agent,
the
certificate
would
provide
interested
persons
with
a
contact
for
obtaining
releasable
information
concerning
the
certified
operation.
Further,
the
certifying
agent
is
the
first
line
of
compliance
under
this
program
and,
as
such,
is
the
person
to
whom
all
questions
and
concerns
should
be
addressed
about
certified
operations.

(
5)
Annual
Renewal
of
Certification.
Numerous
commenters
requested
that
section
205.404(
b)(
2)
be
amended
to
provide
for
the
placement
of
an
expiration
date
on
the
certificate
of
organic
operation.
The
commenters
want
yearly
expiration
of
certification
and
yearly
expiration
of
the
certificate
of
organic
operation.
Commenters
also
requested
that
section
205.404(
c)
be
amended
to
provide
that
once
certified,
a
production
or
handling
operation's
organic
certification
continues
in
effect
until
the
expiration
date
on
the
certificate,
until
surrendered
by
the
organic
operation,
or
until
suspended
or
revoked
by
the
certifying
agent,
the
SOP's
governing
State
official,
or
the
Administrator.
Some
commenters
recommended
the
addition
of
a
new
paragraph
205.406(
e)
that
would
provide
for
automatic
suspension
of
a
certification
if
the
certified
operation
did
not
provide
the
information
required
in
paragraph
205.406(
a)
by
the
expiration
date
to
be
placed
on
the
certificate
of
organic
operation.

We
disagree
with
the
commenters
who
have
requested
annual
renewal
of
certification
and
that
the
certified
operation's
certification
and
its
certificate
of
organic
operation
expire
annually.

We
prefer
continuous
certification
due
to
the
very
real
possibility
that
the
renewal
process
might
not
always
be
completed
before
expiration
of
the
certification
period.
Expiration
of
the
certification
period
would
result
in
termination
of
the
operation's
certification.
Even
a
short
182
period
of
interruption
in
an
operation's
organic
status
could
have
severe
economic
ramifications.

Further,
we
believe
that
a
regular
schedule
of
expiration
of
certification
is
unnecessary
inasmuch
as
all
certified
operations
are
required
to
annually
update
their
organic
system
plan
and
submit
any
changes
to
their
certifying
agent.
More
importantly,
unlike
accreditation,
where
the
Act
provides
for
expiration
and
renewal,
the
Act
does
not
provide
for
an
expiration
or
renewal
of
certification.

Therefore,
it
is
also
our
position
that
once
granted
certification
the
production
or
handling
operation
retains
that
certification
until
voluntarily
surrendered
or
removed,
following
due
process,
for
violation
of
the
Act
or
these
regulations.

(
6)
Denial
of
Certification.
A
commenter
recommended
that
section
205.405(
e)
be
amended
to
place
a
time
restriction
on
reapplication
for
certification
after
denial
of
certification.

The
commenter
suggested
a
3­
year
period.
We
disagree
with
this
recommendation
because
the
reasons
for
denial
include
a
wide
range
of
noncompliances.
The
ability
to
correct
noncompliances
will
vary
as
will
the
time
needed
to
correct
the
noncompliances.

(
7)
Production
and
Handling
Operation
Certification
Following
Suspension
or
Revocation
of
Certifying
Agent
Accreditation.
A
few
commenters
requested
amendment
of
section
205.406
through
the
addition
of
a
new
paragraph
(
f).
Specifically,
the
commenters
requested
provisions
that
would
provide
for
USDA
notification
of
certified
operations
regarding
the
suspension
or
revocation
of
their
certifying
agent's
accreditation.
Some
of
these
commenters
requested
that
the
provisions
also
allow
the
affected
certified
operation
to
use
current
market
labels
for
a
maximum
period
of
12
months,
provided
the
certified
operation
made
application
for
certification
with
another
USDA­
accredited
certifying
agent
within
3
months
of
being
notified
of
their
certifying
agent's
suspension
or
revocation
of
accreditation.
Another
commenter
requested
that
the
new
183
paragraph
provide
that
the
affected
certified
operation
will
continue
to
operate
as
if
certified
by
the
USDA
and
will
be
allowed
to
use
current
market
labels
for
a
maximum
period
of
12
months.

The
commenter
stated
that
this
amendment
would
provide
the
certified
operation
with
the
time
needed
to
obtain
recertification
by
an
accredited
certifying
agent
and
to
prepare
new
labels.

We
disagree
with
the
recommendations.
USDA
does
not
perform
organic
certification
activities
under
any
circumstance,
including
upon
surrender,
suspension,
or
revocation
of
an
accredited
certifying
agent's
accreditation.
Operations
certified
by
a
certifying
agent
that
surrenders
or
loses
its
USDA
accreditation
will
be
notified
by
USDA
and
given
an
opportunity
to
immediately
begin
seeking
certification
by
the
USDA­
accredited
certifying
agent
of
their
choice.

Certified
operations
shall
not
affix
the
seal
or
other
representation
of
a
certifying
agent
to
any
product
that
they
produce
after
the
certifying
agent
has
surrendered
or
had
its
accreditation
revoked.
The
certified
operation
may
use
the
USDA
organic
seal.
In
the
case
of
suspension
of
the
certifying
agent,
the
reasons
for
the
suspension
and
the
terms
of
the
suspension
will
determine
whether
the
certifying
agent's
certified
operations
will
have
to
seek
recertification
or
stop
affixing
the
certifying
agent's
seal
or
other
representation
to
their
products.
USDA
will
announce
the
suspension
or
revocation
of
a
certifying
agent's
accreditation,
and
the
announcement
will
address
the
status
of
operations
certified
by
the
certifying
agent.

Certification
­
Clarifications
Clarification
is
given
on
the
following
issues
raised
by
commenters
as
follows:

(
1)
Recordkeeping.
A
commenter
stated
that
most
computerized
recordkeeping
systems
used
at
retail
and
wholesale
are
set
up
to
save
the
data
for
a
maximum
of
2
years;
adding
3
additional
years
to
that
requirement
would
be
extremely
costly
as
systems
modifications
and
184
additional
hardware
and
support
would
be
required
to
meet
the
mandate.
The
commenter
suggested
that
since
food
product
is
generally
sold
and
consumed
within
a
matter
of
months
(
if
not
weeks),
shortening
this
requirement
to
2
years
should
meet
the
goal
for
tracking
of
any
product
through
the
distribution
system.
This
commenter
was
referring
to
the
requirement
in
section
205.400(
d)
that
records
be
maintained
for
not
less
than
5
years
beyond
their
creation.

Section
205.103
requires
that
a
certified
operation
maintain
records;
that
the
records
be
adapted
to
the
particular
business
that
the
certified
operation
is
conducting,
fully
disclose
all
activities
and
transactions
of
the
certified
operation
in
sufficient
detail
as
to
be
readily
understood
and
audited,
be
maintained
for
not
less
than
5
years
beyond
their
creation,
and
be
sufficient
to
demonstrate
compliance
with
the
Act
and
the
regulations
in
this
part;
and
that
the
certified
operation
must
make
such
records
available
for
inspection
and
copying
during
normal
business
hours
by
authorized
representatives
of
the
Secretary,
the
applicable
SOP's
governing
State
official,
and
the
certifying
agent.
The
requirements
do
not
state
in
what
form
(
i.
e.,
paper,

electronic,
film)
that
the
records
must
be
maintained.
Therefore,
in
answer
to
the
commenter's
concern,
database
records
more
than
2
years
old
could
be
stored
in
any
form,
including
on
an
electronic
storage
device,
which
would
permit
retrieval
upon
request.

(
2)
Application
Fees.
A
commenter
recommended
that
section
205.401
be
amended
by
adding
a
new
paragraph
(
e)
which
would
require
an
applicant
for
certification
to
include,
along
with
the
other
required
application
information,
the
application
fees
required
by
the
certifying
agent.

The
requested
language
is
unnecessary
because
section
205.400(
e)
requires
submission
of
the
applicable
fees
charged
by
the
certifying
agent
as
a
general
requirement
for
certification.
185
(
3)
Applicant
Identification.
In
reference
to
section
205.401(
c)
a
commenter
stated
that
an
applicant
that
is
a
corporation
could
easily
change
the
name
of
the
corporation
in
order
to
avoid
having
to
report
applications
submitted
and
denied
under
the
previous
name.
The
commenter
went
on
to
state
that
there
must
be
a
database
available
to
certifying
agents
that
includes
names
and
location
addresses
of
operations
that
have
received
a
notification
of
noncompliance,
denial
of
certification,
or
a
suspension
or
revocation
of
certification.

Section
205.401(
b)
requires
the
applicant
to
include
in
its
application
the
name
of
the
person
completing
the
application;
the
applicant's
business
name,
address,
and
telephone
number;

and,
when
the
applicant
is
a
corporation,
the
name,
address,
and
telephone
number
of
the
person
authorized
to
act
on
the
applicant's
behalf.

As
we
stated
in
the
preamble
to
the
proposed
rule,
we
anticipate
using
the
data
collected
under
section
205.501(
a)(
15)
to
establish
and
maintain
two
Internet
databases.
The
first
Internet
database
would
be
accessible
to
the
general
public
and
would
include
the
names
and
other
appropriate
data
on
certified
organic
production
and
handling
operations.
The
second
Internet
database
would
be
password
protected
and
only
available
to
accredited
certifying
agents
and
USDA.
This
second
database
would
include
data
on
production
and
handling
operations
issued
a
notification
of
noncompliance,
noncompliance
correction,
denial
of
certification,
certification,

proposed
suspension
or
revocation
of
certification,
and
suspension
or
revocation
of
certification.

Certifying
agents
would
use
the
second
Internet
database
during
their
review
of
an
application
for
certification.

(
4)
Withdrawal
of
Application.
Several
commenters
expressed
the
belief
that
allowing
an
applicant
to
voluntarily
withdraw
its
application
will
be
used
as
a
tool
to
avoid
denial
of
186
certification.
They
expressed
concern
that
voluntary
withdrawal
before
denial
of
certification
will
allow
the
applicant
to
make
application
with
a
different
certifying
agent
with
a
clean
record.

These
commenters
were
responding
to
the
provision
in
section
205.402(
e)
which
allows
an
applicant
for
certification
to
withdraw
its
application
at
any
time.

We
continue
to
believe
that
operations
should
not
be
unnecessarily
stigmatized
because
they
applied
for
certification
before
the
operation
was
ready
to
meet
all
requirements
for
certification.
While
some
operations
may
use
voluntary
withdrawal
as
a
means
to
avoid
the
issuance
of
a
notification
of
noncompliance
or
a
notice
of
denial
of
certification,
this
should
not
adversely
affect
the
National
Organic
Program
(
NOP)
because
all
certifying
agents
are
responsible
for
using
qualified
personnel
in
the
certification
process
and
for
ensuring
an
applicant's
eligibility
for
certification.
Further,
all
applicants
for
certification
are
required
under
section
205.401(
c)
to
include
in
their
application
the
name(
s)
of
any
organic
certifying
agent(
s)
to
which
application
has
previously
been
made,
the
year(
s)
of
application,
and
the
outcome
of
the
application(
s)

submission.

(
5)
On­
site
Inspections.
Section
205.403(
a)(
2)(
ii)
provides
that
the
Administrator
or
SOP's
governing
State
official
may
require
that
additional
inspections
be
performed
by
the
certifying
agent
for
the
purpose
of
determining
compliance
with
the
Act
and
the
regulations
in
this
part.
In
commenting
on
this
provision,
a
commenter
asked,
"
Who
is
running
this
program:
State
or
Federal
officials?"

This
is
a
national
organic
program
administered
by
the
Agricultural
Marketing
Service
of
the
United
States
Department
of
Agriculture.
States
may
administer
their
own
organic
program.

However,
all
SOP's
are
subject
to
USDA
approval.
The
National
Organic
Standards
and
a
187
State's
organic
standards
under
a
USDA­
approved
SOP
are
the
National
Organic
Standards
for
that
State.
The
State,
under
USDA's
approval
of
the
SOP,
has
enforcement
responsibilities
for
the
Federal
and
State
components
of
the
organic
program
within
the
State.

(
6)
Verification
of
Information.
A
commenter
stated
that
section
205.403(
c)
is
insufficiently
comprehensive.
The
commenter
stated
that
organic
inspection
is
assessment
of
a
process
evaluated
against
comprehensive
standards
and,
as
such,
it
requires
specific
rules
to
provide
confidence
in
the
quality
of
the
inspection.
The
commenter
recommended
amending
section
205.403(
c)
by
including
requirements
on
minimum
verification
methods.

Section
205.403(
c)
identifies
what
must
be
verified
during
the
on­
site
inspection.
The
details
on
how
the
verification
will
be
accomplished
will
be
set
forth
in
the
certifying
agent's
procedures
to
be
used
to
evaluate
certification
applicants,
make
certification
decisions,
and
issue
certification
certificates
and
the
certifying
agent's
procedures
for
reviewing
and
investigating
certified
operation
compliance
with
the
Act
and
regulations.
The
NOP
is
available
to
respond
to
questions
and
to
assist
certifying
agents
in
complying
with
the
on­
site
inspection
requirements,

including
those
for
the
verification
of
information.

(
7)
Notifying
Customers
of
Change
in
Certification
Status.
A
commenter
stated
that
the
regulations
do
not
indicate
when
a
certified
organic
producer
must
stop
using
the
organic
seal
or
whether
they
must
notify
customers
of
their
denial
of
certification.
The
commenter
recommended
amending
section
205.405
to
include
a
provision
for
notifying
customers
of
a
certified
operation's
change
in
certification
status.

Any
producer
or
handler
who
plans
to
sell,
label,
or
represent
its
product
as
"
100
percent
organic,"
"
organic,"
or
"
made
with..."
must
be
certified
unless
exempted
under
the
small
188
operation
exemption
under
section
205.101(
a)(
1)
or
not
regulated
under
the
NOP
(
i.
e.,
a
producer
of
dog
food).
Only
certified
operations
may
represent
themselves
as
certified.

Operations
denied
certification
may
not
represent
their
products
as
"
100
percent
organic,"

"
organic,"
or
"
made
with..."
Operations
that
have
had
their
certification
suspended
or
revoked
will
be
subject
to
the
terms
and
conditions
of
their
suspension
or
revocation
relative
to
the
labeling
of
product
produced
prior
to
the
suspension
or
revocation.
No
product
produced
by
an
operation
after
suspension
or
revocation
of
certification
may
be
sold,
labeled,
or
represented
as
"
100
percent
organic,"
"
organic,"
or
"
made
with..."

Buyers
of
organic
product
can
request
to
see
the
producer's
or
handler's
certificate
of
organic
operation.
Operations
that
have
lost
their
organic
status
will
be
unable
to
obtain
an
updated
certificate.
Buyers
with
questions
regarding
an
operation's
organic
status
may
also
contact
the
certifying
agent
identified
on
a
certificate
of
organic
operation.
Further,
as
previously
noted,
we
anticipate
using
the
data
collected
under
section
205.501(
a)(
15)
to
establish
and
maintain
an
Internet
database
accessible
to
the
general
public
that
will
include
the
names
and
other
appropriate
data
on
certified
organic
production
and
handling
operations.

(
8)
Continuation
of
Certification.
A
few
commenters
recommended
amending
section
205.406
to
include
a
safety
net
for
producers
who
are
certified
by
a
certifying
agent
that
does
not
become
accredited
by
USDA.
They
stated
that
the
rule
must
clearly
state
that
a
certified
organic
producer
will
have
the
full
18­
month
implementation
period
starting
from
the
effective
date
of
the
final
rule
to
get
recertified
if
their
certifying
agent
is
not
accredited.
One
of
the
commenters
stated
that
because
the
NOP
anticipates
that
the
accreditation
process
will
require
12
months,

producers
will,
in
effect,
have
6
months
to
be
certified
by
a
new
certifying
agent
should
the
189
producer's
certifying
agent
not
be
accredited.

Certification
under
the
NOP
will
become
mandatory
18
months
after
the
effective
date
of
the
final
rule.
Applications
for
accreditation
will
be
processed
on
a
first­
come,
first­
served
basis.

Accreditations
will
be
announced
approximately
12
months
after
the
effective
date
of
the
final
rule
for
those
qualified
certifying
agents
who
apply
within
the
first
6
months
following
the
effective
date
and
for
any
other
applicants
that
AMS
determines
eligible.
Certifying
agents
will
begin
the
process
of
certifying
organic
production
and
handling
operations
to
the
national
standards
upon
receipt
of
their
USDA
accreditation.
All
production
and
handling
operations
certified
by
an
accredited
certifying
agent
will
be
considered
certified
to
the
national
standards
until
the
certified
operation's
anniversary
date
of
certification.
This
phase­
in
period
will
only
be
available
to
those
certified
operations
certified
by
a
certifying
agent
that
receives
its
accreditation
within
18
months
from
the
effective
date
of
the
final
rule.
We
anticipate
that
certifying
agents
and
production
and
handling
operations
will
move
as
quickly
as
possible
to
begin
operating
under
the
national
organic
standards.
Operations
certified
by
a
certifying
agent,
which
fails
to
apply
for
or
fails
to
meet
the
requirements
for
USDA
accreditation
under
the
NOP,
must
seek
and
receive
certification
by
a
USDA­
accredited
certifying
agent
before
they
can
sell,
label,
or
represent
their
products
as
organic,
effective
18
months
after
the
effective
date
of
the
final
rule.

Subpart
F
­
Accreditation
of
Certifying
Agents
This
subpart
sets
forth
the
requirements
for
a
national
program
to
accredit
State
and
private
entities
as
certifying
agents
to
certify
domestic
or
foreign
organic
production
or
handling
operations.
This
subpart
also
provides
that
USDA
will
accept
a
foreign
certifying
agent's
accreditation
to
certify
organic
production
or
handling
operations
if:
(
1)
USDA
determines,
upon
2
ISO/
IEC
Guide
65
is
available
for
viewing
at
USDA­
AMS,
Transportation
and
Marketing
Programs,
Room
2945­
South
Building,
14th
and
Independence
Ave.,
SW,
Washington,
DC,
from
9:
00
a.
m.
to
4:
00
p.
m.,
Monday
through
Friday
(
except
official
Federal
holidays).
A
copy
may
be
obtained
from
the
American
National
Standards
Institute,
11
West
42d
Street,
New
York,
NY
10036;
Website:
www.
ansi.
org;
E­
mail:
ansionline@
ansi.
org;
Telephone:
212­
642­
4900;
Facsimile:
212­
398­
0023.

190
the
request
of
a
foreign
government,
that
the
standards
under
which
the
foreign
government
authority
accredited
the
foreign
certifying
agent
meet
the
requirements
of
this
part;
or
(
2)
the
foreign
governmental
authority
that
accredited
the
certifying
agent
acted
under
an
equivalency
agreement
negotiated
between
the
United
States
Government
and
the
foreign
government.

This
National
Organic
Program
(
NOP)
accreditation
process
will
facilitate
national
and
international
acceptance
of
U.
S.
organically
produced
agricultural
commodities.
The
accreditation
requirements
in
these
regulations
will,
upon
announcement
of
the
first
group
of
accredited
certifying
agents,
replace
the
voluntary
fee­
for­
service
organic
assessment
program,

established
by
AMS
under
the
Agricultural
Marketing
Act
of
1946.
That
assessment
program
verifies
that
State
and
private
organic
certifying
agents
comply
with
the
requirements
prescribed
under
the
International
Organization
for
Standardization/
International
Electrotechnical
Commission
Guide
65,
"
General
Requirements
for
Bodies
Operating
Product
Certification
Systems"
(
ISO
Guide
65).
2
ISO
Guide
65
provides
the
general
requirements
that
a
certifying
agent
would
need
to
meet
to
be
recognized
as
competent
and
reliable.
That
assessment
program
was
originally
established
to
enable
organic
certifying
agents
in
the
absence
of
a
U.
S.
national
organic
program
to
comply
with
European
Union
(
EU)
requirements
beginning
on
June
30,
1999.

That
assessment
program
verifies
that
State
and
private
organic
certifying
agents
are
operating
third­
party
certification
systems
in
a
consistent
and
reliable
manner,
thereby
facilitating
191
uninterrupted
exports
of
U.
S.
organic
agricultural
commodities
to
the
EU.
ISO
Guide
65
was
used
as
a
benchmark
in
developing
the
accreditation
program
described
in
this
final
rule.

Certifying
agents
accredited
under
the
NOP
that
maintain
compliance
with
the
Act
and
these
regulations
will
meet
or
exceed
the
requirements
of
ISO
Guide
65;
therefore,
the
organic
assessment
program
is
no
longer
needed.

Participation
in
the
NOP
does
not
preclude
the
accredited
certifying
agent
from
conducting
other
business
operations,
including
the
certification
of
agricultural
products,

practices,
and
procedures
to
standards
that
do
not
make
an
organic
claim.
An
accredited
certifying
agent
may
not,
however,
engage
in
any
business
operations
or
activities
which
would
involve
the
agent
in
a
violation
of
or
in
a
conflict
of
interest
under
the
NOP.

Description
of
Regulations
The
Administrator
will
accredit
qualified
domestic
and
foreign
applicants
in
the
areas
of
crops,
livestock,
wild
crops,
or
handling
or
any
combination
thereof
to
certify
domestic
or
foreign
production
or
handling
operations
as
certified
organic
operations.
Qualified
applicants
will
be
accredited
for
5
years.

Application
Process
Certifying
agents
will
apply
to
the
Administrator
for
accreditation
to
certify
production
or
handling
operations
operating
under
the
NOP.
The
certifying
agent's
application
must
include
basic
business
information,
must
identify
each
area
of
operation
for
which
accreditation
is
requested
and
the
estimated
number
of
each
type
of
operation
to
be
certified
annually,
and
must
include
a
list
of
each
State
or
foreign
country
where
it
currently
certifies
production
or
handling
operations
and
where
it
intends
to
certify
such
operations.
Certifying
agents
must
also
submit
192
personnel,
administrative,
conflict
of
interest,
current
certification,
and
other
documents
and
information
to
demonstrate
their
expertise
in
organic
production
or
handling
techniques,
their
ability
to
comply
with
and
implement
the
organic
certification
program,
and
their
ability
to
comply
with
the
requirements
for
accreditation.
Certifying
agents
planning
to
certify
production
or
handling
operations
within
a
State
with
an
approved
State
organic
program
(
SOP)
must
demonstrate
their
ability
to
comply
with
the
requirements
of
the
SOP.

The
administrative
information
submitted
by
the
applicant
must
include
copies
of
its
procedures
for
certifying
operations,
for
ensuring
compliance
of
its
certified
operations
with
the
Act
and
regulations,
for
complying
with
recordkeeping
requirements,
and
for
making
information
available
to
the
public
about
certified
operations.
The
procedures
for
certifying
operations
encompass
the
processes
used
by
the
certifying
agent
to
evaluate
applicants,
make
certification
decisions,
issue
certification
certificates,
and
maintain
the
confidentiality
of
any
business
information
submitted
by
the
certified
operation.
The
procedures
for
ensuring
compliance
of
the
certified
operations
will
include
the
methods
used
to
review
and
investigate
certified
operations,

for
sampling
and
residue
testing,
and
to
report
violations.

The
personnel
information
submitted
with
the
application
must
demonstrate
that
the
applicant
uses
a
sufficient
number
of
adequately
trained
personnel
to
comply
with
and
implement
the
organic
certification
program.
The
certifying
agent
will
also
have
to
provide
evidence
that
its
responsibly
connected
persons,
employees,
and
contractors
with
inspection,
analysis,
and
decision­
making
responsibilities
have
sufficient
expertise
in
organic
production
or
handling
techniques
to
successfully
perform
the
duties
assigned.
They
must
also
show
that
all
persons
who
review
applications
for
certification
perform
on­
site
inspections,
review
certification
documents,
193
evaluate
qualifications
for
certification,
make
recommendations
concerning
certification,
or
make
certification
decisions
and
that
all
parties
responsibly
connected
to
the
certifying
agent
have
revealed
existing
or
potential
conflicts
of
interest.

Applicants
who
currently
certify
production
or
handling
operations
must
also
submit
a
list
of
the
production
and
handling
operations
currently
certified
by
them.
For
each
area
in
which
the
applicant
requests
accreditation,
the
applicant
should
furnish
copies
of
inspection
reports
and
certification
evaluation
documents
for
at
least
three
operations.
If
the
applicant
underwent
any
other
accrediting
process
in
the
year
previous
to
the
application,
the
applicant
should
also
submit
the
results
of
the
process.

Certifying
agents
are
prohibited
from
giving
advice
or
providing
consultancy
services
to
certification
applicants
or
certified
operations
for
overcoming
identified
barriers
to
certification.

This
requirement
does
not
apply
to
voluntary
education
programs
available
to
the
general
public
and
sponsored
by
the
certifying
agent.

The
Administrator
will
provide
oversight
of
the
fees
to
ensure
that
the
schedule
of
fees
filed
with
the
Administrator
is
applied
uniformly
and
in
a
nondiscriminatory
manner.
The
Administrator
may
inform
a
certifying
agent
that
its
fees
appear
to
be
unreasonable
and
require
that
the
certifying
agent
justify
the
fees.
The
Administrator
will
investigate
the
level
of
fees
charged
by
an
accredited
certifying
agent
upon
receipt
of
a
valid
complaint
or
under
compelling
circumstances
warranting
such
an
investigation.

Statement
of
Agreement.

Upon
receipt
of
the
certifying
agent's
application
for
accreditation,
the
Administrator
will
send
a
statement
of
agreement
to
the
person
responsible
for
the
certifying
agent's
day­
to­
day
194
operations
for
signature.
The
statement
of
agreement
affirms
that,
if
granted
accreditation
as
a
certifying
agent
under
this
subpart,
the
applicant
will
carry
out
the
provisions
of
the
Act
and
the
regulations
in
this
part.
Accreditation
will
not
be
approved
until
this
statement
is
signed
and
returned
to
the
Administrator.

The
statement
of
agreement
will
include
the
applicant's
agreement
to
accept
the
certification
decisions
made
by
another
certifying
agent
accredited
or
accepted
by
USDA
pursuant
to
section
205.500
and
the
applicant's
agreement
to
refrain
from
making
false
or
misleading
claims
about
its
accreditation
status,
the
USDA
accreditation
program,
or
the
nature
or
qualities
of
products
labeled
as
organically
produced.
Further,
the
statement
will
include
the
applicant's
agreement
to
pay
and
submit
the
fees
charged
by
AMS
and
to
comply
with,
implement,
and
carry
out
any
other
terms
and
conditions
determined
by
the
Administrator
to
be
necessary.
Applicants
are
also
required
to
affirm
through
this
statement
of
agreement
that
they
will:
(
1)
conduct
an
annual
performance
evaluation
of
all
persons
who
review
applications
for
certification,
perform
on­
site
inspections,
review
certification
documents,
evaluate
qualifications
for
certification,
make
recommendations
concerning
certification,
or
make
certification
decisions
and
implement
measures
to
correct
any
deficiencies
in
certification
services;
and
(
2)
have
an
annual
program
review
conducted
of
their
certification
activities
by
their
staff,
an
outside
auditor,
or
a
consultant
who
has
expertise
to
conduct
such
reviews
and
implement
measures
to
correct
any
noncompliances
with
the
Act
and
the
regulations
in
this
part
that
are
identified
in
the
evaluation.

A
private
entity
certifying
agent
must
additionally
agree
to
hold
the
Secretary
harmless
for
any
failure
on
the
agent's
part
to
carry
out
the
provisions
of
the
Act
and
regulations.
A
private
entity
certifying
agent's
statement
will
also
include
an
agreement
to
furnish
reasonable
security
for
195
the
purpose
of
protecting
the
rights
of
operations
certified
by
such
certifying
agent.
Such
security
will
be
in
an
amount
and
according
to
such
terms
as
the
Administrator
may
by
regulation
prescribe.
A
private
entity
certifying
agent
must
agree
to
transfer
all
records
or
copies
of
records
concerning
its
certification
activities
to
the
Administrator
if
it
dissolves
or
loses
its
accreditation.

This
requirement
for
the
transfer
of
records
does
not
apply
to
a
merger,
sale,
or
other
transfer
of
ownership
of
a
certifying
agent.
A
private
entity
certifying
agent
must
also
agree
to
make
such
records
available
to
any
applicable
SOP's
governing
State
official.

Granting
Accreditation.

Upon
receiving
all
the
required
information,
including
the
statement
of
agreement,
and
the
required
fee,
the
Administrator
will
determine
if
the
applicant
meets
the
requirements
for
accreditation.
The
Administrator's
determination
will
be
based
on
a
review
of
the
information
submitted
and,
if
necessary,
a
review
of
the
information
obtained
from
a
site
evaluation.
The
Administrator
will
notify
the
applicant
of
the
granting
of
accreditation
in
writing.
The
notice
of
accreditation
will
state
the
area(
s)
for
which
accreditation
is
given,
the
effective
date
of
the
accreditation,
any
terms
or
conditions
for
the
correction
of
minor
noncompliances,
and,
for
a
private­
entity
certifying
agent,
the
amount
and
type
of
security
that
must
be
established.

Certifying
agents
who
apply
for
accreditation
and
do
not
meet
the
requirements
for
accreditation
will
be
provided
with
a
notification
of
noncompliance
which
will
describe
each
noncompliance,
the
facts
on
which
the
notification
is
based,
and
the
date
by
which
the
applicant
must
rebut
or
correct
each
noncompliance
and
submit
supporting
documentation
of
each
such
correction
when
correction
is
possible.
If
the
applicant
is
successful
in
its
rebuttal
or
provides
acceptable
evidence
demonstrating
correction
of
the
noncompliances,
the
NOP
Program
Manager
196
will
send
the
applicant
a
written
notification
of
noncompliance
resolution
and
proceed
with
further
processing
of
the
application.
If
the
applicant
fails
to
correct
the
noncompliances,
fails
to
report
the
corrections
by
the
date
specified
in
the
notification
of
noncompliance,
fails
to
file
a
rebuttal
by
the
date
specified
in
the
notification
of
noncompliance,
or
is
unsuccessful
in
its
rebuttal,
the
Program
Manager
will
issue
a
written
notification
of
accreditation
denial
to
the
applicant.
An
applicant
who
has
received
written
notification
of
accreditation
denial
may
apply
for
accreditation
again
at
any
time
or
file
an
appeal
of
the
denial
of
accreditation
with
the
Administrator
by
the
date
specified
in
the
notification
of
accreditation
denial.

Once
accredited,
a
certifying
agent
may
establish
a
seal,
logo,
or
other
identifying
mark
to
be
used
by
certified
production
and
handling
operations.
However,
the
certifying
agent
may
not
require
use
of
its
seal,
logo,
or
other
identifying
mark
on
any
product
sold,
labeled,
or
represented
as
organically
produced
as
a
condition
of
certification.
The
certifying
agent
also
may
not
require
compliance
with
any
production
or
handling
practices
other
than
those
provided
for
in
the
Act
and
regulations
as
a
condition
for
use
of
its
identifying
mark.
However,
certifying
agents
certifying
production
or
handling
operations
within
a
State
with
more
restrictive
requirements,
approved
by
the
Administrator,
shall
require
compliance
with
such
requirements
as
a
condition
of
use
of
their
identifying
mark
by
such
operations.

Site
Evaluations.

One
or
more
representatives
of
the
Administrator
will
perform
site
evaluations
for
each
certifying
agent
in
order
to
examine
the
certifying
agent's
operations
and
to
evaluate
compliance
with
the
Act
and
regulations.
Site
evaluations
will
include
an
on­
site
review
of
the
certifying
agent's
certification
procedures,
decisions,
facilities,
administrative
and
management
systems,
and
197
production
or
handling
operations
certified
by
the
certifying
agent.
A
site
evaluation
of
an
accreditation
applicant
will
be
conducted
before
or
within
a
reasonable
time
after
issuance
of
the
applicant's
notification
of
accreditation.
Certifying
agents
will
be
billed
for
each
site
evaluation
conducted
in
association
with
an
initial
accreditation,
amendments
to
an
accreditation,
and
renewals
of
accreditation.
Certifying
agents
will
not
be
billed
by
USDA
for
USDA­
initiated
site
evaluations
conducted
to
determine
compliance
with
the
Act
and
regulations.

As
noted
above,
a
certifying
agent
may
be
accredited
prior
to
a
site
evaluation.
If
the
Program
Manager
finds,
following
the
site
evaluation,
that
an
accredited
certifying
agent
is
not
in
compliance
with
the
Act
or
regulations,
the
Program
Manager
will
issue
the
certifying
agent
a
written
notification
of
noncompliance.
If
the
certifying
agent
fails
to
correct
the
noncompliances,

report
the
corrections
by
the
date
specified
in
the
notification
of
noncompliance,
or
file
a
rebuttal
by
the
date
specified
in
the
notification
of
noncompliance,
the
Administrator
will
begin
proceedings
to
suspend
or
revoke
the
accreditation.
A
certifying
agent
that
has
had
its
accreditation
suspended
may
at
any
time,
unless
otherwise
stated
in
the
notification
of
suspension,

submit
a
request
to
the
Secretary
for
reinstatement
of
its
accreditation.
The
request
must
be
accompanied
by
evidence
demonstrating
correction
of
each
noncompliance
and
corrective
actions
taken
to
comply
with
and
remain
in
compliance
with
the
Act
and
regulations.
A
certifying
agent
whose
accreditation
is
revoked
will
be
ineligible
for
accreditation
for
a
period
of
not
less
than
3
years
following
the
date
of
such
determination.

Peer
Review
Panels.

The
Administrator
shall
establish
a
peer
review
panel
pursuant
to
the
Federal
Advisory
Committee
Act
(
FACA)
(
5
U.
S.
C.
App.
2
et
seq.).
The
peer
review
panel
shall
be
composed
of
3
ISO/
IEC
Guide
61
is
available
for
viewing
at
USDA­
AMS,
Transportation
and
Marketing
Programs,
Room
2945­
South
Building,
14th
and
Independence
Ave.,
SW,
Washington,
DC,
from
9:
00
a.
m.
to
4:
00
p.
m.,
Monday
through
Friday
(
except
official
Federal
holidays).
A
copy
may
be
obtained
from
the
American
National
Standards
Institute,
11
West
42d
Street,
New
York,
NY
10036;
Website:
www.
ansi.
org;
E­
mail:
ansionline@
ansi.
org;
Telephone:
212­
642­
4900;
Facsimile:
212­
398­
0023.

198
not
fewer
than
three
members
who
shall
annually
evaluate
the
NOP's
adherence
to
the
accreditation
procedures
in
subpart
F
of
these
regulations
and
ISO/
IEC
Guide
613,
General
requirements
for
assessment
and
accreditation
of
certification/
registration
bodies,
and
the
NOP's
accreditation
decisions.
This
will
be
accomplished
through
the
review
of:
(
1)
accreditation
procedures,
(
2)
document
review
and
site
evaluation
reports,
and
(
3)
accreditation
decision
documents
or
documentation.
The
peer
review
panel
shall
report
its
finding,
in
writing,
to
the
NOP
Program
Manager.

Continuing
Accreditation.

An
accredited
certifying
agent
must
submit
annually
to
the
Administrator,
on
or
before
the
anniversary
date
of
the
issuance
of
the
notification
of
accreditation,
the
following
reports
and
fees:

(
1)
a
complete
and
accurate
update
of
its
business
information,
including
its
fees,
and
information
evidencing
its
expertise
in
organic
production
or
handling
and
its
ability
to
comply
with
these
regulations;
(
2)
information
supporting
any
changes
requested
in
the
areas
of
accreditation;
(
3)
a
description
of
measures
implemented
in
the
previous
year
and
any
measures
to
be
implemented
in
the
coming
year
to
satisfy
any
terms
and
conditions
specified
in
the
most
recent
notification
of
accreditation
or
notice
of
renewal
of
accreditation;
(
4)
the
results
of
the
most
recent
performance
evaluations
and
annual
program
review
and
a
description
of
adjustments
to
the
certifying
agent's
operation
and
procedures
implemented
or
to
be
implemented
in
response
to
the
performance
199
evaluations
and
program
review;
and
(
5)
the
required
AMS
fees.

Certifying
agents
will
keep
the
Administrator
informed
of
their
certification
activities
by
providing
the
Administrator
with
a
copy
of:
(
1)
any
notice
of
denial
of
certification,
notification
of
noncompliance,
notification
of
noncompliance
correction,
notification
of
proposed
suspension
or
revocation,
and
notification
of
suspension
or
revocation
issued
simultaneously
with
its
issuance
and
(
2)
a
list,
on
January
2
of
each
year,
including
the
name,
address,
and
telephone
number
of
each
operation
granted
certification
during
the
preceding
year.

One
or
more
site
evaluations
will
occur
during
the
5­
year
period
of
accreditation
to
determine
whether
an
accredited
certifying
agent
is
complying
with
the
Act
and
regulations.

USDA
will
establish
an
accredited
certifying
agent
compliance
monitoring
program,
which
will
involve
no
less
than
one
randomly
selected
site
evaluation
of
each
certifying
agent
during
its
5­

year
period
of
accreditation.
Larger
and
more
diverse
operations,
operations
with
clients
marketing
their
products
internationally,
and
operations
with
a
history
of
problems
should
expect
more
frequent
site
evaluations
by
USDA.
Operations
with
clients
marketing
their
products
internationally
will
be
annually
site
evaluated
to
meet
the
ISO­
Guide
61
requirement
for
periodic
surveillance
of
accredited
certifying
agents.
USDA
may
also
conduct
site
evaluations
during
investigations
of
alleged
or
suspected
violations
of
the
Act
or
regulations
and
in
followup
to
such
investigations.
Such
investigations
will
generally
be
the
result
of
complaints
filed
with
the
Administrator
alleging
violations
by
the
certifying
agent.
Compliance
site
evaluations
may
be
announced
or
unannounced
at
the
discretion
of
the
Administrator.
Certifying
agents
will
not
be
billed
by
USDA
for
USDA­
initiated
site
evaluations
conducted
to
determine
compliance
with
the
Act
and
regulations.
200
An
accredited
certifying
agent
must
provide
sufficient
information
to
persons
seeking
certification
to
enable
them
to
comply
with
the
applicable
requirements
of
the
Act
and
these
regulations.
The
certifying
agent
must
maintain
strict
confidentiality
with
respect
to
its
clients
and
not
disclose
to
third
parties
(
with
the
exception
of
the
Secretary
or
the
applicable
SOP's
governing
State
official
or
their
authorized
representatives)
any
business­
related
information
concerning
any
client
obtained
while
implementing
these
regulations
except
as
authorized
by
regulation.
A
certifying
agent
must
make
the
following
information
available
to
the
public:
(
1)

certification
certificates
issued
during
the
current
and
3
preceding
calender
years;
(
2)
a
list
of
producers
and
handlers
whose
operations
it
has
certified,
including
for
each
the
name
of
the
operation,
type(
s)
of
operation,
products
produced,
and
the
effective
date
of
the
certification,

during
the
current
and
3
preceding
calender
years;
and
(
3)
the
results
of
laboratory
analyses
for
residues
of
pesticides
and
other
prohibited
substances
conducted
during
the
current
and
3
preceding
calender
years.
A
certifying
agent
may
make
other
business
information
available
to
the
public
if
permitted
in
writing
by
the
producer
or
handler.
This
information
will
be
made
available
to
the
public
at
the
public's
expense.

An
accredited
certifying
agent
must
maintain
records
according
to
the
following
schedule:

(
1)
records
obtained
from
applicants
for
certification
and
certified
operations
must
be
maintained
for
not
less
than
5
years
beyond
their
receipt;
(
2)
records
created
by
the
certifying
agent
regarding
applicants
for
certification
and
certified
operations
must
be
maintained
for
not
less
than
10
years
beyond
their
creation;
and
(
3)
records
created
or
received
by
the
certifying
agent
pursuant
to
the
accreditation
requirements,
excluding
any
records
covered
by
the
10­
year
requirement,
must
be
maintained
for
not
less
than
5
years
beyond
their
creation
or
receipt.
Examples
of
records
201
obtained
from
applicants
for
certification
and
certified
operations
include
organic
production
system
plans,
organic
handling
system
plans,
application
documents,
and
any
documents
submitted
to
the
certifying
agent
by
the
applicant/
certified
operation.
Examples
of
records
created
by
the
certifying
agent
regarding
applicants
for
certification
and
certified
operations
include
certification
certificates,
notices
of
denial
of
certification,
notification
of
noncompliance,

notification
of
noncompliance
correction,
notification
of
proposed
suspension
or
revocation,

notification
of
suspension
or
revocation,
correspondence
with
applicants
and
certified
operations,

on­
site
inspection
reports,
documents
concerning
residue
testing,
and
internal
working
papers
and
memorandums
concerning
applicants
and
certified
operations.
Examples
of
records
created
or
received
by
the
certifying
agent
pursuant
to
the
accreditation
requirements
include
operations
manuals;
policies
and
procedures
documents
(
personnel,
administrative);
training
records;
annual
performance
evaluations
and
supporting
documents;
conflict
of
interest
disclosure
reports
and
supporting
documents;
annual
program
review
working
papers,
memorandums,
letters,
and
reports;
fee
schedules;
annual
reports
of
operations
granted
certification;
application
materials
submitted
to
the
NOP;
correspondence
received
from
and
sent
to
USDA;
and
annual
reports
to
the
Administrator.

The
certifying
agent
must
make
all
records
available
for
inspection
and
copying
during
normal
business
hours
by
authorized
representatives
of
the
Secretary
and
the
applicable
SOP's
governing
State
official.
In
the
event
that
the
certifying
agent
dissolves
or
loses
its
accreditation,

it
must
transfer
to
the
Administrator
and
make
available
to
any
applicable
SOP's
governing
State
official
all
records
or
copies
of
records
concerning
its
certification
activities.
This
requirement
for
the
transfer
of
records
does
not
apply
to
a
merger,
sale,
or
other
transfer
of
ownership
of
a
202
certifying
agent.

Certifying
agents
are
also
required
to
prevent
conflicts
of
interest
and
to
require
the
completion
of
an
annual
conflict
of
interest
disclosure
report
by
all
persons
who
review
applications
for
certification,
perform
on­
site
inspections,
review
certification
documents,
evaluate
qualifications
for
certification,
make
recommendations
concerning
certification,
or
make
certification
decisions
and
all
parties
responsibly
connected
to
the
certifying
agent.
Coverage
of
the
conflict
of
interest
provisions
extends
to
immediate
family
members
of
persons
required
to
complete
an
annual
conflict
of
interest
disclosure
report.
A
certifying
agent
may
not
certify
a
production
or
handling
operation
if
the
certifying
agent
or
a
responsibly
connected
party
of
such
certifying
agent
has
or
has
held
a
commercial
interest
in
the
production
or
handling
operation,

including
an
immediate
family
interest
or
the
provision
of
consulting
services,
within
the
12­
month
period
prior
to
the
application
for
certification.
A
certifying
agent
may
certify
a
production
or
handling
operation
if
any
employee,
inspector,
contractor,
or
other
personnel
of
the
certifying
agent
has
or
has
held
a
commercial
interest,
including
an
immediate
family
interest
or
the
provision
of
consulting
services,
within
the
12­
month
period
prior
to
the
application
for
certification.
However,
such
persons
must
be
excluded
from
work,
discussions,
and
decisions
in
all
stages
of
the
certification
process
and
the
monitoring
of
the
entity
in
which
they
have
or
have
held
a
commercial
interest.
The
acceptance
of
payment,
gifts,
or
favors
of
any
kind,
other
than
prescribed
fees,
from
any
business
inspected
is
prohibited.
However,
a
certifying
agent
that
is
a
not­
for­
profit
organization
with
an
Internal
Revenue
Code
tax
exemption
or,
in
the
case
of
a
foreign
certifying
agent,
a
comparable
recognition
of
not­
for­
profit
status
from
its
government,

may
accept
voluntary
labor
from
certified
operations.
Certifying
agents
are
also
prohibited
from
203
giving
advice
or
providing
consultancy
services
to
certification
applicants
or
certified
operations
for
overcoming
identified
barriers
to
certification.
To
further
ensure
against
conflict
of
interest,

the
certifying
agent
must
ensure
that
the
decision
to
certify
an
operation
is
made
by
a
person
different
from
the
person
who
conducted
the
on­
site
inspection.

The
certifying
agent
must
reconsider
a
certified
operation's
application
for
certification
when
the
certifying
agent
determines,
within
12
months
of
certifying
the
operation,
that
a
person
participating
in
the
certification
process
and
covered
under
section
205.501(
c)(
11)(
ii)
has
or
had
a
conflict
of
interest
involving
the
applicant.
If
necessary,
the
certifying
agent
must
perform
a
new
on­
site
inspection.
All
costs
associated
with
a
reconsideration
of
an
application,
including
onsite
inspection
costs,
shall
be
borne
by
the
certifying
agent.
When
it
is
determined
that,
at
the
time
of
certification,
a
conflict
of
interest
existed
between
the
applicant
and
a
person
covered
under
section
205.501(
c)(
11)(
i),
the
certifying
agent
must
refer
the
certified
operation
to
a
different
accredited
certifying
agent
for
recertification.
The
certifying
agent
must
also
reimburse
the
operation
for
the
cost
of
the
recertification.

No
accredited
certifying
agent
may
exclude
from
participation
in
or
deny
the
benefits
of
the
NOP
to
any
person
due
to
discrimination
because
of
race,
color,
national
origin,
gender,

religion,
age,
disability,
political
beliefs,
sexual
orientation,
or
marital
or
family
status.
Accredited
certifying
agents
must
accept
all
production
and
handling
applications
that
fall
within
their
areas
of
accreditation
and
certify
all
qualified
applicants,
to
the
extent
of
their
administrative
capacity
to
do
so,
without
regard
to
size
or
membership
in
any
association
or
group.

Renewal
of
Accreditation.

To
avoid
a
lapse
in
accreditation,
certifying
agents
must
apply
for
renewal
of
accreditation
204
at
least
6
months
prior
to
the
fifth
anniversary
of
issuance
of
the
notification
of
accreditation
and
each
subsequent
renewal
of
accreditation.
The
Administrator
will
send
the
certifying
agent
a
notice
of
pending
expiration
of
accreditation
approximately
1
year
prior
to
the
scheduled
date
of
expiration.
The
accreditation
of
certifying
agents
who
make
timely
application
for
renewal
of
accreditation
will
not
expire
during
the
renewal
process.
The
accreditation
of
certifying
agents
who
fail
to
make
timely
application
for
renewal
of
accreditation
will
expire
as
scheduled
unless
renewed
prior
to
the
scheduled
expiration
date.
Certifying
agents
with
an
expired
accreditation
must
not
perform
certification
activities
under
the
Act
and
these
regulations.

Following
receipt
of
the
certifying
agent's
annual
report
and
fees
and
the
results
of
a
site
evaluation,
the
Administrator
will
determine
whether
the
certifying
agent
remains
in
compliance
with
the
Act
and
regulations
and
should
have
its
accreditation
renewed.
Upon
a
determination
that
the
certifying
agent
is
in
compliance
with
the
Act
and
regulations,
the
Administrator
will
issue
a
notice
of
renewal
of
accreditation.
The
notice
of
renewal
will
specify
any
terms
and
conditions
that
must
be
addressed
by
the
certifying
agent
and
the
time
within
which
those
terms
and
conditions
must
be
satisfied.
Renewal
of
accreditation
will
be
for
5
years.
Upon
a
determination
that
the
certifying
agent
is
not
in
compliance
with
the
Act
and
regulations,
the
Administrator
will
initiate
proceedings
to
suspend
or
revoke
the
certifying
agent's
accreditation.
Any
certifying
agent
subject
to
a
proceeding
to
suspend
or
revoke
its
accreditation
may
continue
to
perform
certification
activities
pending
resolution
of
the
proceedings
to
suspend
or
revoke
the
accreditation.

Amending
accreditation.

An
accredited
certifying
agent
may
request
amendment
to
its
accreditation
at
any
time.
205
The
application
for
amendment
must
be
sent
to
the
Administrator
and
must
contain
information
applicable
to
the
requested
change
in
accreditation,
a
complete
and
accurate
update
of
the
certifying
agent's
application
information
and
evidence
of
expertise
and
ability,
and
the
applicable
fees.

Accreditation
­
Changes
Based
on
Comments
This
subpart
differs
from
the
proposal
in
several
respects
as
follows:

(
1)
Advice
and
Consultancy
Services.
We
have
amended
section
205.501(
a)(
11)(
iv)
to
clarify
that
certifying
agents
are
to
prevent
conflicts
of
interest
by
not
giving
advice
or
providing
consultancy
services
to
applicants
for
certification
and
certified
operations
for
overcoming
identified
barriers
to
certification.
This
amendment
has
been
made
in
response
to
a
commenter
who
stated
that
the
provisions
of
section
205.501(
a)(
11)(
iv),
as
proposed,
seemed
to
preclude
the
providing
of
advice
and
educational
workshops
and
training
programs.
It
was
not
our
intent
to
prevent
certifying
agents
from
sponsoring
in­
house
publications,
conferences,
workshops,

informational
meetings,
and
field
days
for
which
participation
is
voluntary
and
open
to
the
general
public.
The
provisions
as
originally
proposed
and
as
amended
are
intended
to
prohibit
certifying
agents
from
telling
applicants
and
certified
operations
how
to
overcome
barriers
to
certification
identified
by
the
certifying
agent.
It
would
be
a
conflict
of
interest
for
a
certifying
agent
to
tell
an
operation
how
to
comply
inasmuch
as
the
certifying
agents
impartiality
and
objectivity
will
be
lost
should
the
advice
or
consultancy
prove
ineffective
in
resolving
the
noncompliance.
The
provisions
of
section
205.501(
a)(
11)(
iv)
are
consistent
with
ISO
Guide
61.

To
further
clarify
this
issue,
we
have
also
amended
section
205.501(
a)(
16)
by
adding
"
for
certification
activities"
after
the
word,
"
charges."
206
(
2)
Conflicts
of
Interest
­
Persons
Covered.
We
have
amended
section
205.501(
a)(
11)(
v)

to
limit
the
completion
of
annual
conflict
of
interest
disclosure
reports
to
all
persons
who
review
applications
for
certification,
perform
on­
site
inspections,
review
certification
documents,
evaluate
qualifications
for
certification,
make
recommendations
concerning
certification,
or
make
certification
decisions
and
all
parties
responsibly
connected
to
the
certifying
agent.
A
commenter
recommended
amending
section
205.501(
a)(
11)(
v)
to
have
it
apply
to
all
persons
with
direct
oversight
of
or
participation
in
the
certification
program
rather
than
all
persons
identified
in
section
205.504(
a)(
2).
Section
205.504(
a)(
2)
includes
all
personnel
to
be
used
in
the
certification
operation,
including
administrative
staff,
certification
inspectors,
members
of
any
certification
review
and
evaluation
committees,
contractors,
and
all
parties
responsibly
connected
to
the
certifying
agent.
We
have
decided
that
completion
of
annual
conflict
of
interest
disclosure
reports
by
persons
not
involved
in
the
certification
process
or
responsibly
connected
to
the
certifying
agent
is
unnecessary.
As
amended,
section
205.501(
a)(
11)(
v)
includes
all
persons
with
the
opportunity
to
influence
the
outcome
of
a
decision
on
whether
to
certify
a
specific
production
or
handling
operation.
Completed
conflict
of
interest
disclosure
reports
will
be
used
by
certifying
agents
to
identify
persons
with
interests
in
applicants
for
certification
and
certified
operations
that
may
affect
the
impartiality
of
such
persons.

(
3)
Reporting
Certifications
Granted.
We
have
amended
section
205.501(
a)(
15)(
ii)

(
formerly
section
205.501(
a)(
14)(
ii))
by
replacing
"
a
quarterly
calendar
basis"
with
"
January
2
of
each
year."
A
commenter
stated
that
the
requirement
that
certifying
agents
report
certifications
that
they
have
granted
on
a
quarterly
basis
to
the
Administrator
is
burdensome.
The
commenter
requested
that
section
205.501(
a)(
14)(
ii)
be
amended
to
require
a
midyear
or
end­
year
reporting.
207
Section
205.501(
a)(
15)(
ii)
now
requires
the
certifying
agent
to
submit
a
list,
on
January
2
of
each
year,
including
the
name,
address,
and
telephone
number
of
each
operation
granted
certification
during
the
preceding
year.
Certifying
agents
can
fulfill
this
requirement
by
providing
an
up­

todate
copy
of
the
list
of
producers
and
handlers
required
to
be
made
available
to
the
public
by
section
205.504(
b)(
5)(
ii).

(
4)
Notification
of
Inspector.
We
have
added
a
new
section
205.501(
a)(
18)
requiring
the
certifying
agent
to
provide
the
inspector,
prior
to
each
on­
site
inspection,
with
previous
on­
site
inspection
reports
and
to
notify
the
inspector
of
the
certifying
agent's
decision
relative
to
granting
or
denying
certification
to
the
applicant
site
inspected
by
the
inspector.
Such
notification
must
identify
any
requirements
for
the
correction
of
minor
noncompliances.
We
have
made
this
addition
because
we
agree
with
the
commenter
that
such
information
should
be
provided
to
the
inspector
and
because
the
requirements
are
consistent
with
ISO
Guide
61.

(
5)
Acceptance
of
Applications.
We
have
added
a
new
section
205.501(
a)(
19)
requiring
the
certifying
agent
to
accept
all
production
or
handling
applications
for
certification
that
fall
within
the
certifying
agent's
areas
of
accreditation
and
to
certify
all
qualified
applicants,
to
the
extent
of
their
administrative
capacity
to
do
so,
without
regard
to
size
or
membership
in
any
association
or
group.
We
have
made
this
addition
because
we
agree
with
the
many
commenters
who
requested
that
certifying
agents
be
required
to
certify
all
qualified
applicants.
We
recognize,

however,
that
there
may
be
times
when
the
certifying
agent's
workload
or
the
size
of
its
client
base
might
make
it
necessary
for
the
certifying
agent
to
decline
acceptance
of
an
application
for
certification
within
its
area
of
accreditation.
This
is
why
we
have
included
the
proviso,
"
to
the
extent
of
their
administrative
capacity
to
do
so."
We
have
included
"
without
regard
to
size
or
208
membership
in
any
association
or
group"
to
address
commenter
concerns
about
discrimination
in
the
providing
of
certification
services.
This
addition
is
consistent
with
ISO
Guide
61.

(
6)
Ability
to
Comply
with
SOP.
We
have
added
a
new
section
205.501(
a)(
20)
requiring
the
certifying
agent
to
demonstrate
its
ability
to
comply
with
an
SOP,
to
certify
organic
production
or
handling
operations
within
the
State.
This
change,
as
pointed
out
by
a
State
commenter,
is
necessary
to
clarify
that
a
certifying
agent
must
be
able
to
comply
with
an
SOP
to
certify
production
or
handling
operations
within
that
State.

(
7)
Performance
Evaluation.
We
have
amended
section
205.501(
a)(
6)
by
replacing
"
appraisal"
with
"
evaluation"
and
expanding
the
coverage
from
inspectors
to
persons
who
review
applications
for
certification,
perform
on­
site
inspections,
review
certification
documents,
evaluate
qualifications
for
certification,
make
recommendations
concerning
certification,
or
make
certification
decisions.
Corresponding
amendments
have
also
been
made
to
section
205.510(
a)(
4).
Further,
we
have
amended
section
205.501(
a)(
6)
to
clarify
that
the
deficiencies
to
be
corrected
are
deficiencies
in
certification
services.
We
changed
"
appraisal"
to
"
evaluation"
at
the
request
of
a
State
commenter
who
pointed
out
that
State
inspectors
generally
perform
other
duties
in
addition
to
the
inspection
of
organic
production
or
handling
operations.
We
concur
that
this
change
will
help
differentiate
between
the
State's
employee
performance
appraisal
for
all
duties
as
a
State
employee
and
the
evaluation
of
certification
services
provided
under
the
NOP.

Expanding
the
coverage
from
inspectors
to
all
persons
involved
in
the
certification
process
makes
the
regulation
consistent
with
ISO
Guide
61.
Sections
205.505(
a)(
3)
and
205.510(
a)(
4)
have
been
amended
to
make
their
language
consistent
with
the
changes
to
section
205.501(
a)(
6).

(
8)
Annual
Program
Evaluation.
We
have
amended
section
205.501(
a)(
7)
by
replacing
209
"
evaluation"
with
"
review"
and
by
replacing
"
evaluations"
with
"
reviews."
A
commenter
suggested
amending
section
205.501(
a)(
7)
by
replacing
the
requirement
of
an
annual
program
evaluation
with
an
annual
review
of
program
activities.
We
agree
that
"
review"
is
a
more
appropriate
term
than
"
evaluate"
since
to
review
is
to
examine,
report,
and
correct
while
evaluate
is
more
in
the
nature
of
assessing
value.
We
have
not,
however,
accepted
that
portion
of
the
commenter's
suggestion
which
would
have
removed
the
reference
to
the
review
being
conducted
by
the
certifying
agent's
staff,
an
outside
auditor,
or
a
consultant
who
has
the
expertise
to
conduct
such
reviews.
We
have
not
accepted
this
suggestion
because
the
comment
would
have
limited
the
review
to
being
conducted
by
the
certifying
agent
with
no
requirement
that
the
certifying
agent
be
qualified
to
conduct
the
review.
Another
commenter
wanted
to
change
the
requirement
to
an
annual
assessment
of
the
quality
of
the
inspection
system.
We
have
not
accepted
this
suggestion
because
it
can
be
interpreted
as
narrowing
the
scope
of
the
review
from
the
full
certification
program
to
just
the
inspection
component
of
the
certification
program.
This
commenter
would
also
have
limited
the
review
to
being
conducted
by
the
certifying
agent
with
no
requirement
that
the
certifying
agent
be
qualified
to
conduct
the
review.
We
believe
that
narrowing
the
scope
of
the
review
would
be
inconsistent
with
ISO
Guide
65.
It
is
also
inconsistent
with
our
intent
that
the
entire
certification
program
be
reviewed
annually.
We
also
received
a
comment
stating
that
it
is
a
violation
of
ISO
Guide
65
to
have
staff
perform
an
internal
review.
We
disagree
with
this
commenter.
ISO
Guide
65
provides
that
the
certification
body
shall
conduct
periodic
internal
audits
covering
all
procedures
in
a
planned
and
systematic
manner.
Sections
205.505(
a)(
4)
and
205.510(
a)(
4)
have
been
amended
to
make
their
language
consistent
with
the
changes
to
section
205.501(
a)(
7).
210
(
9)
Certification
Decision.
We
have
added
a
new
section
205.501(
a)(
11)(
vi)
that
requires
the
certifying
agent
to
ensure
that
the
decision
to
certify
an
operation
is
made
by
a
person
different
from
the
person
who
carried
out
the
on­
site
inspection.
Commenters
requested
that
this
provision
be
added
to
the
requirement
that
certifying
agents
prevent
conflicts
of
interest.
We
concur
with
the
request
because
it
clearly
separates
the
act
of
inspecting
an
organic
operation
from
the
act
of
granting
certification.
This
addition
is
also
consistent
with
ISO
Guide
65,
section
4.2(
f),
which
requires
that
the
certification
body
ensure
that
each
decision
on
certification
is
taken
by
a
person
different
from
those
who
carried
out
the
evaluation.

(
10)
Determination
of
Conflict
of
Interest.
We
have
added
a
new
section
205.501(
a)(
12)

addressing
situations
where
a
conflict
of
interest
present
at
the
time
of
certification
is
identified
after
certification.
Several
commenters
requested
the
addition
of
a
provision
that,
if
a
conflict
of
interest
is
identified
within
12
months
of
certification,
the
certifying
agent
must
reconsider
the
application
and
may
reinspect
the
operation
if
necessary.
We
agree
with
the
commenters
that
the
issue
of
conflicts
of
interest
present
at
the
time
of
certification
but
identified
after
certification
need
to
be
addressed
in
the
regulations.
Accordingly,
we
have
provided
that
an
entity
accredited
as
a
certifying
agent
must
reconsider
a
certified
operation's
application
for
certification
and,
if
necessary,
perform
a
new
on­
site
inspection
when
it
is
determined,
within
12
months
of
certifying
the
operation,
that
any
person
participating
in
the
certification
process
and
covered
under
section
205.501(
a)(
11)(
ii)
has
or
had
a
conflict
of
interest
involving
the
applicant.
Because
the
certifying
agent
is
responsible
for
preventing
conflicts
of
interest,
all
costs
associated
with
a
reconsideration
of
application,
including
onsite
inspection
costs,
must
be
borne
by
the
certifying
agent.
Further,
a
certifying
agent
must
refer
a
certified
operation
to
a
different
accredited
certifying
agent
for
211
recertification
when
it
is
determined
that
any
person
covered
under
section
205.501(
a)(
11)(
i)
at
the
time
of
certification
of
the
applicant
had
a
conflict
of
interest
involving
the
applicant.
Because
the
certifying
agent
is
responsible
for
preventing
conflicts
of
interest,
the
certifying
agent
must
reimburse
the
operation
for
the
cost
of
the
recertification.
Sections
205.501(
a)(
12)
through
205.501(
a)(
17)
have
been
redesignated
as
sections
205.501(
a)(
13)
through
205.501(
a)(
18),

respectively.

(
11)
Financial
Security.
We
published
an
advanced
notice
of
proposed
rulemaking
and
request
for
comments
regarding
financial
security
in
the
August
9,
2000,
issue
of
the
Federal
Register.
We
issued
a
news
release
announcing
the
Federal
Register
publication
on
August
9,

2000.
Numerous
commenters
expressed
concern
about
reasonable
security
relative
to
its
amount
and
impact
on
small
certifying
agents.
A
few
commenters
requested
a
definition
for
reasonable
security.
Others
stated
that
the
formula
for
determining
the
amount
of
security
should
be
published
in
the
Federal
Register.
The
March
13,
2000,
NOP
proposed
rule
stated
that
the
amount
and
terms
of
reasonable
financial
security
would
be
the
subject
of
additional
rulemaking.

The
August
9,
2000,
advanced
notice
of
proposed
rulemaking
solicited
comments
on
all
aspects
of
reasonable
security
and
protection
of
the
rights
of
program
participants.
We
requested
comments
from
any
interested
parties,
including
producers
and
handlers
of
organic
agricultural
products,
certifying
agents,
importers
and
exporters,
the
international
community,
and
any
other
person
or
group.
Six
questions
were
provided
to
facilitate
public
comment
on
the
advanced
notice
of
proposed
rulemaking.
Comments
addressing
other
relevant
issues
were
also
invited.

The
questions
posed
in
the
advanced
notice
of
proposed
rulemaking
were:

(
1)
From
what
risks
or
events
might
a
customer
of
a
private
certifying
agent
require
212
reasonable
security?

(
2)
What
are
the
financial
instrument(
s)
that
could
provide
the
reasonable
security
to
protect
customers
from
these
events?

(
3)
What
dollar
amounts
of
security
would
give
reasonable
protection
to
a
customer
of
a
private
certifying
agent?

(
4)
What
are
the
financial
costs
to
private
certifiers,
especially
small
certifiers,
of
providing
reasonable
security?

(
5)
Do
the
risks
or
events
provided
in
response
to
question
#
1
necessarily
require
financial
compensation?

(
6)
Are
there
situations
in
which
reasonable
security
is
not
needed?

Following
analysis
of
the
comments
received,
we
will
publish
a
proposed
rule
on
reasonable
security
in
the
Federal
Register.
The
public
will
again
be
invited
to
submit
comments.

The
proposed
rule
will
include
the
proposed
regulation,
an
explanation
of
the
decision­
making
process,
an
analysis
of
the
costs
and
benefits,
the
effects
on
small
businesses,
and
an
estimate
of
the
paperwork
burden
imposed
by
the
regulation.

(
12)
Use
of
Identifying
Mark.
We
have
amended
section
205.501(
b)(
2)
to
clarify
that
all
certifying
agents
(
private
and
State)
certifying
production
or
handling
operations
within
a
State
with
more
restrictive
requirements,
approved
by
the
Secretary,
shall
require
compliance
with
such
requirements
as
a
condition
of
use
of
their
identifying
mark
by
such
operations.
Numerous
commenters
stated
that
they
wanted
USDA
to
permit
higher
production
standards
by
private
certifying
agents.
See
also
item
17
under
Accreditation
­
Changes
Requested
But
Not
Made.

This
amendment
is
intended
to
further
clarify
our
position
that
no
certifying
agent
(
State
or
213
private)
may
establish
or
require
compliance
with
its
own
organic
standards.
It
is
an
SOP,
not
a
State
certifying
agent,
that
receives
approval
from
the
Secretary
for
more
restrictive
requirements.

See
also
item
7
under
Accreditation
­
Clarifications.

(
13)
Transfer
of
Records.
To
address
the
issues
of
a
merger,
sale,
or
other
transfer
of
ownership,
we
have
added
the
following
to
the
end
of
section
205.501(
c)(
3);
"
Provided,
That,

such
transfer
shall
not
apply
to
a
merger,
sale,
or
other
transfer
of
ownership
of
a
certifying
agent."
Commenters
suggested
amending
section
205.501(
c)(
3)
to
provide
for
the
transfer
of
records
accumulated
from
the
time
of
accreditation
to
the
Administrator
or
his
or
her
designee,

another
accredited
certifying
agent,
or
an
SOP's
governing
State
official
in
a
State
where
such
official
exists.
It
was
also
stated
that
this
section
needs
to
take
into
account
a
certifying
agent's
decision
to
merge
or
transfer
accounts
to
another
certifying
agent
in
the
case
of
loss
of
accreditation.
Under
the
NOP,
should
a
certifying
agent
dissolve
or
lose
its
accreditation,
its
certified
operations
will
be
free
to
seek
certification
with
the
accredited
certifying
agent
of
their
choice.
Accordingly,
it
would
be
inappropriate
to
automatically
transfer
an
operation's
records
to
another
certifying
agent
as
requested
by
the
commenters.
However,
in
analyzing
the
comments,

we
realized
that
a
provision
was
needed
for
a
merger,
sale,
or
other
transfer
of
ownership
of
a
certifying
agent;
thus,
the
amendment
to
section
205.501(
c)(
3).
Section
205.505(
b)(
3)
has
been
amended
to
make
its
language
consistent
with
the
changes
to
section
205.501(
c)(
3).

(
14)
Fees
for
Information.
We
have
amended
section
205.504(
b)(
5)
by
inserting
"
including
any
fees
to
be
assessed"
after
the
word,
"
used."
This
change
is
made
in
response
to
the
question
of
whether
fees
may
be
charged
for
making
information
available
to
the
public.
It
is
our
intent
that
certifying
agents
may
charge
reasonable
fees
for
document
search
time,
duplication,
214
and,
when
applicable,
review
costs.
We
anticipate
that
review
costs
will
most
likely
be
incurred
when
the
information
requested
is
located
within
documents
which
may
contain
confidential
business
information.

(
15)
Information
Available
to
the
Public.
We
have
amended
section
205.504(
b)(
5)(
ii)
by
adding
products
produced
to
the
information
to
be
released
to
the
public.
This
addition
responds
in
an
alternate
way
to
commenters
who
wanted
the
information
included
on
certificates
of
organic
operation.
That
request
was
denied;
see
item
4,
Changes
Requested
But
Not
Made,
under
subpart
E,
Certification.
This
addition
is
consistent
with
ISO
Guide
61.

(
16)
Equivalency
of
Certification
Decisions
and
Statement
of
Agreement.
We
have
amended
sections
205.501(
a)(
12)
(
redesignated
as
205.501(
a)(
13))
and
205.505(
a)(
1)
by
deleting
the
words,
"
USDA
accredited"
and
"
as
equivalent
to
its
own,"
and
adding
to
the
end
thereof:

"
accredited
or
accepted
by
USDA
pursuant
to
section
205.500."
We
have
made
this
amendment
to
clarify
that
the
provision
applies
to
certification
decisions
by
domestic
certifying
agents
as
well
as
foreign
certifying
agents
accredited
or
accepted
by
USDA
pursuant
to
section
205.500.

There
were
many
comments
in
support
of
section
205.501(
a)(
12)
as
written.
However
some
did
not
agree
that
certifying
agents
should
have
to
recognize
another
agent's
decision
as
equivalent
to
their
own.
These
commenters
want
to
maintain
the
right
and
ability
not
to
use
their
seal
on
a
product
that
does
not
meet
their
standards.
The
most
strongly
voiced
comment
stated:

"
delete
section
205.501(
a)(
12)
and
section
205.505(
a)(
1).
The
requirements
constitute
a
"
taking"

in
violation
of
the
Fifth
Amendment
and
are
unnecessary
to
accomplish
the
goal
of
establishing
a
consistent
standard
and
facilitating
trade."

We
do
not
concur
with
the
commenters
who
want
to
change
sections
205.501(
a)(
12)
and
215
205.505(
a)(
1).
We
also
do
not
agree
with
the
comment
that
sections
205.501(
a)(
12)
and
205.505(
a)(
1)
constitute
a
taking
in
violation
of
the
Fifth
Amendment
and
are
unnecessary
to
accomplish
the
goal
of
establishing
a
consistent
standard
and
facilitating
trade.
We
believe
that,

to
accomplish
the
goal
of
establishing
a
consistent
standard
and
to
facilitate
trade,
it
is
vital
that
an
accredited
certifying
agent
accept
the
certification
decisions
made
by
another
certifying
agent
accredited
or
accepted
by
USDA
pursuant
to
section
205.500.
All
domestic
organic
production
and
handling
operations,
unless
exempted
or
excluded
under
section
205.101,
must
be
certified
to
these
national
standards
and,
when
applicable,
any
State
standards
approved
by
the
Secretary.
All
domestic
certified
operations
must
be
certified
by
a
certifying
agent
accredited
by
the
Administrator.
No
USDA­
accredited
certifying
agent,
domestic
or
foreign,
may
establish
or
require
compliance
with
its
own
organic
standards.
Certifying
agents
are
not
required
to
have
an
identifying
mark
for
use
under
the
NOP.
However,
if
a
certifying
agent
is
going
to
use
an
identifying
mark
under
the
NOP,
the
use
of
such
mark
must
be
voluntary
and
available
to
all
of
the
certifying
agent's
clients
certified
under
the
NOP.
Accordingly,
we
have
not
changed
the
requirement
that
a
certifying
agent
accept
the
certification
decisions
made
by
another
USDAaccredited
certifying
agent.
We
have,
however,
as
noted
above,
amended
both
sections
to
require
that
USDA­
accredited
certifying
agents
accept
the
certification
decisions
made
by
another
certifying
agent
accredited
or
accepted
by
USDA
pursuant
to
section
205.500.

(
17)
Granting
Accreditation.
We
have
made
editorial
changes
to
section
205.506
consistent
with
the
suggestion
that
we
replace
"
approval
of
accreditation"
with
"
granting
of
accreditation."
In
the
title
to
section
205.506,
we
have
replaced
"
Approval
of"
with
"
Granting."

In
section
205.506(
a),
we
have
replaced
"
approved"
with
"
granted,"
and
in
section
205.506(
b),
216
we
have
replaced
"
approval"
with
"
the
granting."
We
have
made
these
change
because,
under
the
NOP,
we
grant
accreditation
rather
than
approve
accreditation.

(
18)
Correction
of
Minor
Noncompliances.
We
have
added
a
new
section
205.506(
b)(
3)

providing
that
the
notification
granting
accreditation
will
state
any
terms
and
conditions
for
the
correction
of
minor
noncompliances.
Commenters
requested
the
addition
of
language
to
section
205.506(
b)
which
would
clarify
that
the
Administrator
may
accredit
with
required
corrective
actions
for
minor
noncompliances.
In
the
proposed
rule,
we
addressed
accreditation
subject
to
the
correction
of
minor
noncompliances
at
section
205.510(
a)(
3).
We
agree
with
commenters
that,
for
the
purposes
of
clarity,
this
issue
should
also
be
addressed
in
section
205.506
on
the
granting
of
accreditation.
Accordingly,
we
have
added
new
section
205.506(
b)(
3)
as
noted
above.
We
have
also
retained
the
provisions
of
section
205.510(
a)(
3),
which
requires
certifying
agents
to
annually
report
on
actions
taken
to
satisfy
any
terms
and
conditions
addressed
in
the
most
recent
notification
of
accreditation
or
notice
of
renewal
of
accreditation.
Section
205.506(
b)(
3)
has
been
redesignated
as
section
205.506(
b)(
4).

(
19)
Denial
of
Accreditation.
We
have
amended
section
205.507
to
include
noncompliance
and
resolution
provisions
originally
included
by
cross­
reference
to
section
205.665(
a).
This
cross­
reference
created
confusion
for
commenters,
regarding
section
205.665'
s
applicability
to
applicants
for
accreditation
because
the
section
does
not
specifically
address
applicants.
Rather
than
specifically
identifying
applicants
within
section
205.665,
we
believe
the
issue
is
best
clarified
by
addressing
noncompliance
and
resolution
within
section
205.507.
As
amended,
section
205.507
now
states
in
paragraph
(
a)
that
the
written
notification
of
noncompliance
must
describe
each
noncompliance,
the
facts
on
which
the
notification
is
based,
217
and
the
date
by
which
the
applicant
must
rebut
or
correct
each
noncompliance
and
submit
supporting
documentation
of
each
such
correction
when
correction
is
possible.
This
rewrite
of
paragraph
(
a)
also
enabled
us
to
eliminate
paragraph
(
b)
since
its
provisions
are
addressed
in
amended
paragraph
(
a).
The
section
also
provides,
at
new
paragraph
(
b),
that
when
each
noncompliance
has
been
resolved,
the
Program
Manager
will
send
the
applicant
a
written
notification
of
noncompliance
resolution
and
proceed
with
further
processing
of
the
application.

We
have
also
clarified
the
applicant's
appeal
rights
by
adding
"
or
appeal
the
denial
of
accreditation
in
accordance
with
section
205.681
by
the
date
specified
in
the
notification
of
accreditation
denial"
to
the
end
of
paragraph
(
c).

(
20)
Reinstatement
of
Accreditation.
We
have
amended
section
205.507(
d)
by
removing
the
requirement
that
a
certifying
agent
that
has
had
its
accreditation
suspended
reapply
for
accreditation
in
accordance
with
section
205.502.
In
its
place,
we
provide
that
the
certifying
agent
may
request
reinstatement
of
its
accreditation.
Such
request
may
be
submitted
at
any
time
unless
otherwise
stated
in
the
notification
of
suspension.
Amended
section
205.507(
d)
also
provides
that
the
certifying
agent's
request
must
be
accompanied
by
evidence
demonstrating
correction
of
each
noncompliance
and
corrective
actions
taken
to
comply
with
and
remain
in
compliance
with
the
Act
and
the
regulations
in
this
part.
We
have
made
this
change
because
unlike
revocation,
suspension
does
not
terminate
a
certifying
agent's
accreditation.
Accordingly,

requiring
a
new
application
for
accreditation
is
unnecessary
and
burdensome
on
the
certifying
agent.
This
change
is
consistent
with
changes
to
sections
205.662(
f)
and
205.665(
g)(
1),
which
were
made
based
on
comments
received
on
section
205.662(
f).

(
21)
Ineligible
for
accreditation.
We
have
amended
section
205.507(
d)
by
deleting
218
"
private
entity"
from
the
third
sentence.
The
amended
sentence
provides
that
"
A
certifying
agent
whose
accreditation
is
revoked
will
be
ineligible
for
accreditation
for
a
period
of
not
less
than
3
years
following
the
date
of
such
determination."
Several
commenters
recommended
deletion
of
"
private
entity"
so
that
private
certifying
agents
would
be
regulated
on
an
equivalent
basis
with
State
certifying
agents.
It
is
our
intent
to
regulate
private
and
State
certifying
agents
on
an
equivalent
basis.
Accordingly,
we
made
the
recommended
change.

(
22)
Peer
Review.
We
have
amended
section
205.509.
As
amended,
the
section
requires
that
the
Administrator
establish
a
peer
review
panel
pursuant
to
FACA
(
5
U.
S.
C.
App.
2
et
seq.).

The
peer
review
panel
will
be
composed
of
not
less
than
3
members
who
will
annually
evaluate
the
NOP's
adherence
to
the
accreditation
procedures
in
subpart
F
of
these
regulations
and
ISO/
IEC
Guide
61,
General
requirements
for
assessment
and
accreditation
of
certification/
registration
bodies,
and
the
NOP's
accreditation
decisions.
This
will
be
accomplished
through
the
review
of
accreditation
procedures,
document
review
and
site
evaluation
reports,
and
accreditation
decision
documents
and
documentation.
The
peer
review
panel
will
report
its
finding,
in
writing,
to
the
NOP's
Program
Manager.
We
developed
this
approach
to
peer
review
as
a
means
of
addressing
the
suggestions
of
the
commenters
and
the
need
for
administration
of
an
effective
and
timely
accreditation
program.

Many
commenters
wanted
the
opening
language
in
the
first
sentence
of
section
205.509
changed
from
"
The
Administrator
may"
to
the
"
The
Administrator
shall"
establish
a
peer
review
panel
to
assist
in
evaluating
applicants
for
accreditation,
amendment
to
an
accreditation,
and
renewal
of
accreditation
as
certifying
agents.
One
of
the
most
frequent
comments,
including
a
comment
by
the
NOSB,
was
that
peer
reviewers
should
be
compensated
for
their
time
and
219
expenses.
Many
commenters
believe
also
that
the
peer
review
process
should
be
collaborative.

Some
commenters
who
wanted
this
change
recognized
that
a
collaborative
process
where
confidential
information
was
shared
could
run
into
problems
because
FACA
(
P.
L.
92­
463,
5
U.
S.
C.
App.)
meetings
are
open
to
the
public.
They
advised
creating
a
FACA
panel
but
restricting
public
access
during
discussion
of
confidential
business
information
based
on
5
U.
S.
C.

Section
522b(
c)(
4)
of
the
Government
in
the
Sunshine
Act.

As
requested,
amended
section
205.509
requires
the
formation
of
a
peer
review
panel.

Also
as
requested,
peer
reviewers,
who
will
serve
as
a
FACA
committee,
will
be
reimbursed
for
their
travel
and
per
diem
expenses.
The
reviewers
will
also
work
collaboratively.
We
have
not,

however,
provided
for
collaborative
review
of
each
applicant
for
accreditation
by
the
peer
review
panel
because
of
the
administrative
burden
that
an
outside
collaborative
review
process
would
place
on
the
NOP.
Currently,
there
are
36
private
and
13
State
certifying
agencies.
It
is,

therefore,
likely
that
USDA
will
receive
approximately
50
applications
for
accreditation
the
first
year
of
the
program.
Given
the
need
to
make
accreditation
decisions
in
a
timely,
organized
fashion,
it
would
be
infeasible
to
convene
a
panel
of
peers
for
each
applicant
for
accreditation
prior
to
rendering
a
decision
on
accreditation.
However,
as
noted
above,
we
have
provided
that
a
peer
review
panel
will
annually
evaluate
the
NOP's
adherence
to
the
accreditation
procedures
in
subpart
F
of
these
regulations
and
ISO/
IEC
Guide
61,
General
requirements
for
assessment
and
accreditation
of
certification/
registration
bodies,
and
validate
the
NOP's
accreditation
decisions.

We
have
also
amended
current
section
205.510(
c)(
3)
by
removing
the
reference
to
reports
submitted
by
a
peer
review
panel
to
make
that
section
consistent
with
the
rewrite
of
section
205.509.
220
(
23)
Expiration
of
accreditation.
We
have
added
a
new
section
205.510(
c)(
1)
which
provides
that
the
Administrator
shall
send
the
accredited
certifying
agent
a
notice
of
pending
expiration
of
accreditation
approximately
1
year
prior
to
the
scheduled
date
of
expiration.
A
commenter
suggested
USDA
notification
of
certifying
agents
at
least
1
year
prior
to
the
scheduled
expiration
of
accreditation.
We
have
made
the
suggested
change
because
we
believe
notification
about
1
year
prior
to
expiration
will
facilitate
the
timely
receipt
of
applications
for
renewal.
We
have
redesignated
sections
205.510(
c)(
1)
and
205.510(
c)(
2)
as
205.510(
c)(
2)
and
205.510(
c)(
3),

respectively.

(
24)
Amendments
to
Accreditation.
We
have
added
a
new
section
205.510(
f)
to
provide
that
an
amendment
to
an
accreditation
may
be
requested
at
any
time.
The
application
for
amendment
must
be
sent
to
the
Administrator
and
must
contain
information
applicable
to
the
requested
change
in
accreditation.
The
application
for
amendment
must
also
contain
a
complete
and
accurate
update
of
the
information
submitted
in
accordance
with
section
205.503,
Applicant
information;
and
section
205.504,
Evidence
of
expertise
and
ability.
The
applicant
must
also
submit
the
applicable
fees
required
in
section
205.640.
We
have
added
this
new
section
because
we
agree
with
the
commenter
who
expressed
concern
that
the
regulations
were
not
clear
regarding
amendments
to
accreditation.
This
addition
is
consistent
with
section
205.510(
a)(
2)

which
allows
certifying
agents
to
request
amendment
of
their
accreditation
as
part
of
their
annual
report
to
the
Administrator.

Accreditation
­
Changes
Requested
But
Not
Made
This
subpart
retains
from
the
proposed
rule,
regulations
on
which
we
received
comments
as
follows:
221
(
1)
Accreditation
by
USDA.
A
commenter
stated
that
ISO/
IEC
Guide
61
specifies,
but
the
proposed
rule
did
not
specify,
the
requirements
for
USDA
to
assess
and
accredit
certifying
agents.
The
commenter
questioned
USDA's
acceptance
internationally
as
a
competent
accreditation
body.
A
few
commenters
requested
that
USDA
provide
certifying
agents
with
assurance
of
international
trade
acceptance
of
the
USDA's
accreditation
program
prior
to
implementation
of
the
final
rule.
We
do
not
believe
that
it
is
necessary
to
include
in
these
regulations
detailed
procedures
by
which
USDA
will
operate
its
accreditation
program.
USDA
has
developed
its
accreditation
and
certification
programs
with
the
intent
that
they
meet
or
exceed
international
guidelines.
Every
country
will
make
its
own
decision
regarding
acceptance
of
this
accreditation
program.
Accordingly,
while
we
do
not
anticipate
problems
with
acceptance
of
our
accreditation
program,
we
cannot
provide
assurance
against
problems
as
requested
by
the
commenters.

(
2)
Equivalency
at
the
European
Community
(
EC)
Level.
A
commenter
requested
confirmation
that
an
equivalency
agreement
would
be
negotiated
at
the
EC
level
since
the
EC
legislation
provides
for
the
basic
rules
while
accreditation
of
certifying
agents
is
a
task
for
each
member
state.
Another
commenter
pointed
out
that
because
Switzerland
has
the
same
regulations
as
the
EC,
equivalency
would
have
to
be
done
in
close
coordination
with
the
EC.
The
commenter
went
on
to
say
that
according
to
Swiss
and
European
practice,
not
only
the
organic
product,
but
also
the
bodies
involved
will
be
mutually
accepted.
This
commenter
also
stated
that,
due
to
Swiss
import
provisions,
brokers
must
be
subject
to
a
certain
control.
Equivalency
will
be
negotiated
between
the
United
States
and
the
foreign
government
authority
seeking
the
equivalency
agreement.
222
(
3)
Period
of
Accreditation.
It
was
suggested
that
accreditation
should
be
for
a
4­
year
period
with
full
reevaluation
occurring
once
every
4
years
and
annual
surveillance
visits
in
the
intervening
years.
We
do
not
concur
with
changing
the
period
of
accreditation
from
5
years
to
4
years
as
suggested.
The
5­
year
period
that
we
have
provided
that
accreditation
is
consistent
with
the
Act,
which
provides
that
accreditation
shall
be
for
a
period
of
not
to
exceed
5
years.
The
commenter
claims
that
the
international
norm
is
for
full
reevaluations
to
take
place
once
every
4
years
with
annual
surveillance
visits
in
the
intervening
years.
ISO
Guide
61,
section
3.5.1,

provides
that
the
accreditation
body
shall
have
an
established
documented
program,
consistent
with
the
accreditation
granted,
for
carrying
out
periodic
surveillance
and
reassessment
at
sufficiently
close
intervals
to
verify
that
its
accredited
body
continues
to
comply
with
the
accreditation
requirements.
We
believe
that
accreditation
for
5
years
is
a
reasonable
period
of
time.
Further,
we
believe
that
a
5­
year
period
of
accreditation
is
consistent
with
ISO
Guide
61
inasmuch
as
we
require
an
annual
evaluation
of
the
certification
program;
annual
review
of
persons
associated
with
the
certification
process,
including
inspectors;
annual
reporting
with
a
complete
and
accurate
update
of
information
required
for
accreditation;
and
one
or
more
site
evaluations
during
the
period
of
accreditation
in
addition
to
the
initial
site
evaluation
for
the
period
of
accreditation.
Accordingly,
we
have
not
made
the
recommended
change.

(
4)
Accreditation
by
Private­
Sector
Accreditation
Bodies.
Numerous
commenters
wanted
language
added
to
section
205.500(
c)
that
would
allow
private
sector
accreditation
bodies
to
accredit
foreign
certifying
agents.
For
example,
several
commenters
suggested
adding
a
provision
reading
as
follows:
"
The
foreign
certifying
agent
is
accredited
by
a
private
accreditation
body
recognized
by
the
USDA
as
defined
by
an
equivalency
agreement
negotiated
between
the
223
USDA
and
the
accreditation
body."
Commenters
also
wanted
us
to
amend
section
205.502(
a)
to
recognize
accreditation
by
private
accreditation
programs.

USDA
is
the
accrediting
body
for
all
accreditations
under
the
NOP.
USDA
will
not
recognize
nongovernmental
accrediting
bodies.
USDA
will
recognize
foreign
certifying
agents
accredited
by
a
foreign
government
authority
when
USDA
determines
that
the
foreign
government's
standards
meet
the
requirements
of
the
NOP
or
when
an
equivalency
agreement
has
been
negotiated
between
the
United
States
and
a
foreign
government.

(
5)
Requirements
for
Accreditation.
Some
commenters
requested
more
specificity
in
the
requirements
for
accreditation.
For
example,
one
recommended
that
section
205.501(
a)(
1)
should
include
the
requirement
that
inspectors
demonstrate
completion
of
a
specified
training
program
or
internship
or
ongoing
education
and/
or
licensing.
Another
commenter
wanted
baseline
criteria
for
denying
an
application
due
to
expertise.
Still
others
wanted
a
definition
for
(
1)
"
experience
and
training
pertaining
to
organic/
sustainable
agricultural
methods
and
their
implementation
on
farm
or
in
processing
facilities,"
(
2)
"
trained
certifying
agent
personnel,"
and
(
3)
"
reasonable
time."

Finally,
one
wanted
recordkeeping
and
evaluative
parameters.
AMS
does
not
believe
that
it
is
necessary
to
present
the
requirements
for
accreditation
to
the
extent
of
detail
requested
by
the
commenters.
The
intent
is
to
provide
flexibility
to
the
certifying
agents
such
that
they
can
tailor
their
policies
and
procedures
to
the
nature
and
scope
of
their
operation.
The
NOP
is
available
to
respond
to
questions
and
to
assist
certifying
agents
in
complying
with
the
requirements
for
accreditation.

(
6)
Volunteer
Board
Members.
Some
commenters
suggested
amending
section
205.501(
a)(
5)
to
include
a
reference
to
committees
and
to
expand
"
sufficient
expertise"
to
224
"
sufficient
balance
of
interests
and
expertise."
The
commenters
proposed
the
amendment
to
create
a
firewall
between
those
persons
involved
in
decision
making
and
the
volunteer
board
members.
However,
the
purpose
of
section
205.501(
a)(
5)
is
to
ensure
that
the
persons
used
by
the
certifying
agent
to
assume
inspection,
analysis,
and
decision­
making
responsibilities
have
sufficient
expertise
in
organic
production
or
handling
techniques
to
successfully
perform
the
duties
assigned.
Therefore,
we
have
not
made
the
suggested
changes.
Conflict
of
interest
guidelines
are
found
at
section
205.501(
a)(
11).

(
7)
Confidentiality.
A
commenter
stated
that
Texas
law
prevents
the
Texas
Department
of
Agriculture
from
guaranteeing
confidentiality
to
its
clients.
Accordingly,
the
commenter
requested
that
section
205.501(
a)(
10)
be
amended
by
adding
to
the
end
thereof:
"
or
as
required
by
State
statutes."
We
have
not
made
the
suggested
change
because
the
Act
requires
that
the
certifying
agent
maintain
strict
confidentiality
with
respect
to
its
clients
under
the
NOP
and
not
disclose
any
business­
related
information
concerning
such
client
obtained
while
implementing
the
Act.
To
be
accredited
under
the
NOP,
certifying
agents
must
fully
comply
with
the
requirements
of
the
Act
and
these
regulations.
Further,
no
SOP
will
be
approved
which
does
not
comply
with
the
NOP.

(
8)
Certifying
Agent
Fees.
Several
commenters
requested
that
the
regulations
prohibit
royalty
formulas
(
i.
e.,
fees
from
every
certified
sale)
for
certifying
agent
fees.
It
is
not
our
intent
to
regulate
how
a
certifying
agent
sets
its
fees
beyond
their
being
reasonable
and
nondiscriminatory.

(
9)
Conflicts
of
Interest.
We
received
numerous
comments
stating
that
section
205.501(
a)(
11)(
i)
was
too
restrictive
and
unnecessary
due
to
the
provisions
of
section
225
205.501(
a)(
11)(
ii)
to
prevent
conflicts
of
interest.
Some
argued
that
these
conflict
of
interest
provisions
are
beyond
ISO
requirements
and
place
an
undue
burden
on
membership
based
certifying
agents
and
the
entities
they
serve.
They
requested
a
conflict
of
interest
policy
enabling
membership­
based
certification
organizations
to
continue
operating.
A
commenter
suggested
that
section
205.501(
a)(
11)
be
amended
to
require
that
a
certifying
agent's
board
members
sign
an
affidavit
listing
potential
conflicts
of
interest,
identify
issues
where
an
organization
decision
might
help
them
personally,
and
exclude
themselves
from
decision­
making
that
would
assist
them
personally.
This
commenter
proposed
the
amendment
for
the
purpose
of
creating
a
firewall
between
those
persons
involved
in
certification
decision­
making
and
the
volunteer
board
members.

We
do
not
believe
that
the
conflict
of
interest
provisions
are
too
restrictive.
These
provisions
are
very
similar
to
conflict
of
interest
provisions
under
other
USDA
programs
involving
public­
private
partnerships
(
e.
g.,
grain
inspection).
The
certifying
agent
and
its
responsibly
connected
parties,
including
volunteer
board
members,
hold
positions
of
influence
over
the
certifying
agent's
employees
and
persons
with
whom
the
certifying
agent
contracts
for
such
services
as
inspection,
sampling,
and
residue
testing.
Therefore,
we
continue
to
believe
that
avoiding
such
conflicts
of
interest
is
necessary
to
maintain
the
integrity
of
the
organic
certification
process.

(
10)
Conflicts
of
Interest
and
Prohibition
on
Certification.
A
commenter
requested
that
we
include
an
"
or"
between
sections
205.501(
a)(
11)(
i)
and
205.501(
a)(
11)(
ii).
We
have
not
made
the
recommended
change
because
both
sections
must
be
complied
with;
they
are
not
mutually
exclusive.
Section
205.501(
a)(
11)(
i)
prohibits
the
certification
of
an
applicant
when
the
certifying
226
agent
or
a
responsibly
connected
party
of
such
certifying
agent
has
or
has
held
a
commercial
interest
in
the
applicant
for
certification,
including
an
immediate
family
interest
or
the
provision
of
consulting
services,
within
the
12­
month
period
prior
to
the
application
for
certification.
When
the
certifying
agent
and
its
responsibly
connected
persons
are
free
of
any
conflict
of
interest
involving
the
applicant
for
certification,
the
applicant
may
be
certified
if
qualified.
However,

section
205.501(
a)(
11)(
ii)
requires
the
certifying
agent
to
exclude
any
person
(
employees
and
contractors
who
do
not
meet
the
definition
of
responsibly
connected),
including
contractors,
with
conflicts
of
interest
from
work,
discussions,
and
decisions
in
all
stages
of
the
certification
process
and
the
monitoring
of
certified
production
or
handling
operations
for
all
entities
in
which
such
person
has
or
has
held
a
commercial
interest,
including
an
immediate
family
interest
or
the
provision
of
consulting
services,
within
the
12­
month
period
prior
to
the
application
for
certification.

(
11)
Gifts
and
Contributions.
Commenters
recommended
that
section
205.501(
a)(
11)(
iii)

be
amended
to
allow
not­
for­
profit
organizations
to
accept
gifts
and
contributions
from
certified
operations
for
those
programs
not
directly
related
to
the
certifying
agent's
organic
certification
activities.
They
also
wanted
it
clarified
that
not­
for­
profit
organizations
can
accept
voluntary
labor
from
certified
operations
for
those
programs
not
directly
related
to
the
certifying
agent's
organic
certification
activities.
We
have
not
made
the
requested
changes.
First,
the
acceptance
of
gifts
and
contributions
would
constitute
a
conflict
of
interest
and
would
be
contrary
to
ISO
Guide
61.
Certifying
agents
must
have
the
financial
stability
and
resources
to
perform
their
certification
duties
without
relying
on
gifts
and
contributions
from
those
they
serve.
Second,
we
have
not
added
the
requested
provision
on
voluntary
labor
because
section
205.501(
a)(
11)(
iii)
already
227
addresses
the
acceptance
of
voluntary
labor
by
not­
for­
profit
organizations
from
certified
operations.

(
12)
Conflicts
of
Interest
­
Determination
Period.
Commenters
wanted
to
increase
the
conflict
determination
period
from
12
months
to
24
months.
Some
also
wanted
the
period
to
extend
for
2
years
after,
with
the
exception
of
those
who
have
left
the
employ
of
the
certifying
agent
or
are
no
longer
under
contract
with
the
certifying
agent.

We
disagree
with
the
recommendations
calling
for
a
longer
precertification
conflict
of
interest
prohibition
period.
We
continue
to
believe
that
12
months
is
a
sufficient
period
to
ensure
that
any
previous
commercial
interest
would
not
create
a
conflict
of
interest
situation
for
two
reasons.
First,
this
time
period
is
consistent
with
similar
provisions
governing
conflicts
of
interest
for
government
employees.
Second,
section
205.501(
a)(
11)(
v)
requires
the
completion
of
an
annual
conflict
of
interest
disclosure
report
by
all
personnel
designated
to
be
used
in
the
certification
operation,
including
administrative
staff,
certification
inspectors,
members
of
any
certification
review
and
program
evaluation
committees,
contractors,
and
all
parties
responsibly
connected
to
the
certification
operation.
This
requirement
will
assist
certifying
agents
in
complying
with
the
requirements
to
prevent
conflicts
of
interest.
We
also
continue
to
believe
that
a
longer
prohibition
period
would
have
the
effect
of
severely
curtailing
most
certifying
agents'

ability
to
comply
with
the
Act's
requirement
that
they
employ
persons
with
sufficient
expertise
to
implement
the
applicable
certification
program.
Accordingly,
we
have
not
made
the
recommended
change.

The
change
recommended
by
the
commenters
who
requested
that
the
conflict
of
interest
determination
period
extend
for
2
years
after
certification
is
unnecessary.
Certifying
agents
and
228
their
responsibly
connected
parties,
employees,
inspectors,
contractors,
and
other
personnel
are
prohibited
from
engaging
in
activities
or
associations
at
any
time
during
their
affiliation
with
the
certifying
agent
which
would
result
in
a
conflict
of
interest.
While
associated
with
the
certifying
agent,
all
employees,
inspectors,
contractors,
and
other
personnel
are
expected
to
disclose
to
the
certifying
agent
any
offer
of
employment
they
have
received
and
not
immediately
refused.
They
are
also
expected
to
disclose
any
employment
they
are
seeking
and
any
arrangement
they
have
concerning
future
employment
with
an
applicant
for
certification
or
a
certified
operation.
The
certifying
agent
would
then
have
to
exclude
that
person
from
work,
discussions,
and
decisions
in
all
stages
of
the
certification
or
monitoring
of
the
operation
making
the
employment
offer.
If
a
certifying
agent
or
a
responsibly
connected
party
of
the
certifying
agent
has
received
and
not
immediately
refused
an
offer
of
employment,
is
seeking
employment,
or
has
an
arrangement
concerning
future
employment
with
an
applicant
for
certification,
the
certifying
agent
may
not
accept
or
process
the
application.
Further,
certifying
agents
and
responsibly
connected
parties
may
not
seek
employment
or
have
an
arrangement
concerning
future
employment
with
an
operation
certified
by
the
certifying
agent
while
associated
with
that
certifying
agent.
Certifying
agents
and
responsibly
connected
parties
must
sever
their
association
with
the
certifying
agent
when
such
person
does
not
immediately
refuse
an
offer
of
employment
from
a
certified
operation.

Accordingly,
we
have
decided
not
to
include
a
postcertification
prohibition
period
in
this
final
rule.

(
13)
False
and
Misleading
Claims.
A
commenter
asked
who
will
determine
what
is
a
misleading
claim
about
the
nature
or
qualities
of
products
labeled
as
organically
produced.
This
same
commenter
recommended
amending
section
205.501(
a)(
13)
by
removing
the
prohibition
229
against
making
false
or
misleading
claims
about
the
nature
or
qualities
of
products
labeled
as
organically
produced.

We
disagree
with
this
recommendation.
Claims
regarding
accreditation
status,
the
USDA
accreditation
program
for
certifying
agents,
and
the
nature
and
quality
of
products
labeled
as
organically
produced
all
fall
under
the
authority
of
the
Act.
Accordingly,
USDA
will
determine
what
is
a
misleading
claim.
We
believe
that
the
requirements
are
needed
to
prevent
the
dissemination
of
inaccurate
or
misleading
information
to
consumers
about
organically
produced
products.
We
further
believe
that
the
change
suggested
by
the
commenter
would
undermine
the
goal
of
a
uniform
NOP
by
allowing
certifying
agents
to
make
claims
that
would
state
or
imply
that
organic
products
produced
by
operations
that
they
certify
are
superior
to
those
of
operations
certified
by
other
certifying
agents.
These
requirements
would
not
prohibit
certifying
agents
from
sharing
factual
information
with
consumers,
farmers,
processors,
and
other
interested
parties
regarding
verifiable
attributes
of
organic
food
and
organic
production
systems.
Accordingly,
we
have
not
made
the
recommended
change
to
what
is
now
section
205.501(
a)(
14).

(
14)
Certifying
Agent
Compliance
With
Terms
and
Conditions
Deemed
Necessary.
A
commenter
recommended
that
we
remove
section
205.501(
a)(
17).
This
section
requires
that
certifying
agents
comply
with
and
implement
other
terms
and
conditions
deemed
necessary
by
the
Secretary.
This
requirement
is
consistent
with
section
6515(
d)(
2)
of
the
Act,
which
requires
a
certifying
agent
to
enter
into
an
agreement
with
the
Secretary
under
which
such
agent
shall
agree
to
such
other
terms
and
conditions
as
the
Secretary
determines
appropriate.
Accordingly,
we
have
not
accepted
the
commenter's
recommendation.
This
requirement
is
located
at
current
section
205.501(
a)(
21).
230
(
15)
Limitations
on
the
Use
of
Certifying
Agent's
Marks.
Numerous
commenters
stated
that
they
wanted
USDA
to
permit
higher
production
standards
by
private
certifying
agents.
A
common
argument
for
allowing
higher
standards
was
that
practitioners
must
be
allowed
to
"
raise
the
bar"
through
superior
ecological
on­
farm
practices
or
pursuit
of
other
social
and
ecological
goals.
Some
commenters
recommended
that
the
language
in
section
205.501(
b)(
2)
be
replaced
with
provisions
that
would
allow
certifying
agents
to
issue
licensing
agreements
with
contract
specifications
that
clearly
establish
conditions
for
use
of
the
certifying
agent's
identifying
mark.

We
believe
the
positions
advocated
by
the
commenters
are
inconsistent
with
section
6501(
2)
of
the
Act,
which
provides
that
a
stated
purpose
of
the
Act
is
to
assure
consumers
that
organically
produced
products
meet
a
consistent
national
standard.
We
believe
that,
to
accomplish
the
goal
of
establishing
a
consistent
standard
and
to
facilitate
trade,
it
is
vital
that
an
accredited
certifying
agent
accept
the
certification
decisions
made
by
another
certifying
agent
accredited
or
accepted
by
USDA
pursuant
to
section
205.500.
All
organic
production
and
handling
operations,
unless
exempted
or
excluded
under
section
205.101
or
not
regulated
under
the
NOP
(
i.
e.,
a
producer
of
dog
food),
must
be
certified
to
these
national
standards
and,
when
applicable,
any
State
standards
approved
by
the
Secretary.
All
certified
operations
must
be
certified
by
a
certifying
agent
accredited
by
the
Administrator.
No
accredited
certifying
agent
may
establish
or
require
compliance
with
its
own
organic
standards.
Accredited
certifying
agents
may
establish
other
standards
outside
of
the
NOP.
They
may
not,
however,
refer
to
them
as
organic
standards
nor
require
that
applicants
for
certification
under
the
NOP
or
operations
certified
under
the
NOP
comply
with
such
standards
as
a
requirement
for
certification
under
the
NOP.
Use
of
the
certifying
agent's
identifying
mark
must
be
voluntary
and
available
to
all
of
its
231
clients
certified
under
the
NOP.
However,
a
certifying
agent
may
withdraw
a
certified
operation's
authority
to
use
its
identifying
mark
during
a
compliance
process.
The
certifying
agent,
however,

accepts
full
liability
for
any
such
action.

The
national
standards
implemented
by
this
final
rule
can
be
amended
as
needed
to
establish
more
restrictive
national
standards.
Anyone
may
request
that
a
provision
of
these
regulations
be
amended
by
submitting
a
request
to
the
NOP
Program
Manager
or
the
Chairperson
of
the
NOSB.
Requests
for
amendments
submitted
to
the
NOP
Program
Manager
will
be
forwarded
to
the
NOSB
for
its
consideration.
The
NOSB
will
consider
the
requested
amendments
and
make
its
recommendations
to
the
Administrator.
When
appropriate,
the
NOP
will
conduct
rulemaking
on
the
recommended
amendment.
Such
rulemaking
will
include
an
opportunity
for
public
comment.

(
16)
Evidence
of
Expertise
and
Ability.
A
commenter
stated
that
section
205.504,
which
addresses
the
documentation
necessary
to
establish
evidence
of
expertise
and
abilities,
requires
too
much
paperwork.
We
believe
the
amount
of
paperwork
is
appropriate
for
the
task
at
hand,

verifying
a
certifying
agent's
expertise
in
and
eligibility
for
accreditation
to
certify
organic
production
and
handling
operations
to
the
NOP.
We
further
believe
that
the
level
of
paperwork
is
necessary
to
meet
international
guidelines
for
determining
whether
an
applicant
is
qualified
for
accreditation
as
a
certifying
agent.

(
17)
Procedures
for
Making
Information
Available
to
the
Public.
Comments
on
section
205.504(
b)(
5)
were
mixed.
Some
commenters
felt
that
the
proposal
fell
short
of
the
OFPA
requirement
to
"
Provide
for
public
access
to
certification
documents
and
lab
analysis."
Others
thought
that
too
much
confidential
information
would
be
released.
232
The
Act
requires
public
access,
at
section
2107(
a)(
9),
to
certification
documents
and
laboratory
analyses
pertaining
to
certification.
Accordingly,
we
disagree
with
those
commenters
who
requested
that
such
documents
not
be
released
to
the
public.
We
also
disagree
with
the
commenters
who
contend
that
the
requirement
for
public
disclosure
falls
short
of
what
is
required
by
the
Act.
Section
205.504(
b)(
5)
meets
the
requirements
of
the
Act
by
requiring
the
release
of
those
documents
cited
in
section
2107(
a)(
9)
of
the
Act.
The
section
also
authorizes
the
release
of
other
business
information
as
authorized
in
writing
by
the
producer
or
handler.

(
18)
Accreditation
Prior
to
Site
Evaluation.
Numerous
commenters
recommended
that
we
require
site
visits
prior
to
accreditation.
Some
commenters
cited
ISO
Guide
61,
section
2.3.1,

in
their
arguments
for
site
visits
prior
to
accreditation.
ISO
Guide
61,
section
2.3.1.,
provides
that
the
decision
on
whether
to
accredit
a
body
shall
be
made
on
the
basis
of
the
information
gathered
during
the
accreditation
process
and
any
other
relevant
information.
Section
3.3.2
of
ISO
Guide
61
provides
that
the
accreditation
body
shall
witness
fully
the
on­
site
activities
of
one
or
more
assessments
or
audits
conducted
by
an
applicant
body
before
an
initial
accreditation
is
granted.

We
do
not
concur
with
the
commenters.
These
regulations
provide
for
assessment
of
the
applicant's
qualifications
and
capabilities
through
a
rigorous
review
of
the
application
and
supporting
documentation.
Following
this
review,
an
initial
site
evaluation
shall
be
conducted
before
or
within
a
reasonable
period
of
time
after
issuance
of
the
applicant's
"
notification
of
accreditation."
In
cases
where
the
document
review
raises
concerns
regarding
the
applicant's
qualifications
and
capabilities
and
the
Administrator
deems
it
necessary,
a
preapproval
site
evaluation
will
be
conducted.
We
have
further
provided
that
a
site
evaluation
shall
be
conducted
233
after
application
for
renewal
of
accreditation
but
prior
to
renewal
of
accreditation.

Our
purpose
in
allowing
for
initial
accreditation
prior
to
a
site
evaluation
is
to
facilitate
implementation
of
the
NOP
and
to
provide
a
means
for
newly
established
certifying
agents
to
obtain
a
client
base
to
demonstrate
that
they
can
meet
the
requirements
of
the
NOP
regulations.

We
believe
this
is
consistent
with
the
intent
of
ISO
Guide
61,
section
2.3.1.
and
fits
within
its
"
and
any
other
relevant
information"
provision.
Accordingly,
we
restate
our
position
that
accreditation
approval
without
a
site
evaluation
is
appropriate,
necessary
in
the
case
of
established
certifying
agents
that
may
need
to
make
adjustments
in
their
operations
to
comply
with
the
NOP
regulations,
and
necessary
in
the
case
of
newly
established
certifying
agents
who
will
have
to
obtain
a
client
base
to
demonstrate
beyond
the
paperwork
that
they
can
meet
the
requirements
of
the
NOP
regulations.

(
19)
Ineligibility
After
Revocation
of
Accreditation.
Section
205.507(
d)
provides
that
a
certifying
agent
whose
accreditation
is
revoked
will
be
ineligible
for
accreditation
for
a
period
of
not
less
than
3
years
following
the
date
of
such
determination.
A
commenter
stated
that
the
3­

year
period
of
ineligibility
is
overly
long
and
effectively
puts
the
certifying
agent
out
of
business.

The
commenter
suggested
that
a
6­
to
12­
month
period
might
be
reasonable.
We
have
not
accepted
the
suggested
6­
to
12­
month
ineligibility
period
because
the
Act
requires
a
period
of
ineligibility
of
not
less
than
3
years
following
revocation
of
accreditation.

(
20)
Qualifications
of
the
Site
Evaluator.
A
commenter
recommended
amending
section
205.508(
a)
to
indicate
the
required
qualifications
of
the
site
evaluator.
We
have
not
accepted
the
recommendation.
We
do
not
believe
that
it
is
necessary
to
specify
the
required
qualifications
of
site
evaluators
in
these
regulations.
All
USDA
employees
who
will
perform
site
evaluations
under
234
the
NOP
are
quality
systems
auditors
trained
in
accordance
with
internationally
recognized
protocols.

(
21)
Complaint
Process.
A
commenter
recommended
that
section
205.510
include
a
complaint
process
for
complaints
by
certified
operations
regarding
the
performance
of
a
certifying
agent
or
inspector.
The
commenter
also
recommended
that
section
205.510
include
a
complaint
process
for
the
public
should
they
feel
that
a
certifying
agent
is
not
in
compliance.

We
do
not
believe
that
it
is
necessary
to
include
a
complaint
process
in
the
regulations.

All
interested
parties
are
free
to
file
a
complaint
with
an
accredited
certifying
agent,
SOP's
governing
State
official,
or
the
Administrator
at
any
time.
We
will
provide
guidance
to
accredited
certifying
agents
and
SOP's
governing
State
officials
regarding
the
type
of
information
to
gather
when
receiving
a
complaint.
SOP's
governing
State
officials
will
include
in
their
request
for
approval
of
their
SOP
information
on
their
collection
of
complaint
information.
Certifying
agents
will
include
details
regarding
the
collection
of
complaint
information
and
the
investigation
of
complaints
involving
certified
operations
in
their
procedures
for
reviewing
and
investigating
certified
operation
compliance
(
section
205.504(
b)(
2)).
This
will
include
maintaining
records
of
complaints
and
remedial
actions
relative
to
certification
as
well
as
documentation
of
followup
actions.
Further,
certifying
agents
will
include
details
regarding
the
collection
of
complaint
information
and
the
investigation
of
complaints
involving
inspectors
and
other
personnel
employed
by
or
contracted
by
the
certifying
agents
in
their
policies
and
procedures
for
training,

evaluating,
and
supervising
personnel
(
section
205.504(
a)(
1)).

(
22)
Recordkeeping
by
Certifying
Agents.
A
commenter
stated
that
the
10­
year
recordkeeping
requirement
of
section
205.510(
b)(
2)
for
records
created
by
the
certifying
agent
235
regarding
applicants
for
certification
and
certified
operations
is
excessive.
The
commenter
recommended
a
5­
year
retention
period.
We
have
not
accepted
the
recommended
5­
year
records
retention
period
for
records
created
by
the
certifying
agent
regarding
applicants
for
certification
and
certified
operations
because
the
Act
requires
the
retention
of
such
records
for
10
years.

(
23)
Reaccreditation.
A
commenter
recommended
that
section
205.510(
c)(
1)
be
amended
to
require
reaccreditation
every
3
years.
We
have
provided
that
accreditation
will
be
for
a
period
of
5
years.
This
is
consistent
with
the
Act
which
provides
that
accreditation
shall
be
for
a
period
of
not
to
exceed
5
years.
The
commenter
believes
that
a
5­
year
period
is
not
consistent
with
ISO
Guide
61,
section
3.5.1,
which
provides
that
the
accreditation
body
shall
have
an
established
documented
program,
consistent
with
the
accreditation
granted,
for
carrying
out
periodic
surveillance
and
reassessment
at
sufficiently
close
intervals
to
verify
that
its
accredited
body
continues
to
comply
with
the
accreditation
requirements.
We
believe
that
accreditation
for
5
years
is
a
reasonable
period
of
time.
Further,
we
believe
that
a
5­
year
period
of
accreditation
is
consistent
with
ISO
Guide
61
inasmuch
as
we
require
an
annual
evaluation
of
the
certification
program;
annual
review
of
persons
associated
with
the
certification
process,
including
inspectors;

annual
reporting
with
a
complete
and
accurate
update
of
information
required
for
accreditation;

and
one
or
more
site
evaluations
during
the
period
of
accreditation
in
addition
to
the
initial
site
evaluation
for
the
period
of
accreditation.
Accordingly,
we
have
not
made
the
recommended
change.
This
requirement
is
located
at
current
section
205.510(
c)(
2).

(
24)
Notice
of
Renewal
of
Accreditation.
A
commenter
recommended
that
section
205.510(
d)
be
amended
to
include
a
timeframe
within
which
the
Administrator
must
notify
an
applicant
of
its
renewal
of
accreditation.
We
believe
that
a
mandated
timeframe
for
notifying
the
236
applicant
of
renewal
of
accreditation
is
inappropriate.
We
plan
to
process
all
applications
for
renewal
of
accreditation
in
the
order
in
which
they
are
received,
to
confirm
the
receipt
of
each
application,
and
to
establish
a
dialog
with
the
applicant
upon
confirmation
of
receipt
of
an
application
for
renewal
of
accreditation.
The
length
of
the
renewal
process
will
depend
in
large
part
on
the
nature
of
the
operation
seeking
renewal
of
accreditation.
To
minimize
the
chances
that
an
accreditation
will
expire
during
the
renewal
process,
we
have:
(
1)
provided
that
the
Administrator
shall
send
the
accredited
certifying
agent
a
notice
of
pending
expiration
of
accreditation
approximately
1
year
before
the
date
of
expiration
of
the
certifying
agent's
accreditation,
(
2)
required
that
an
application
for
renewal
of
accreditation
must
be
received
at
least
6
months
prior
to
expiration
of
the
certifying
agent's
accreditation,
and
(
3)
provided
that
the
accreditation
of
a
certifying
agent
who
makes
timely
application
for
renewal
of
accreditation
will
not
expire
during
the
renewal
process.
Accordingly,
we
have
not
made
the
recommended
amendment.

Accreditation
­
Clarifications
Clarification
is
given
on
the
following
issues
raised
by
commenters
as
follows:

(
1)
Accreditation
of
Foreign
Certifying
Agents.
A
commenter
suggested
that
section
205.500
be
amended
to
provide
that
if
there
is
a
government
system
operating
in
a
foreign
country
then
the
government
is
the
appropriate
pathway
for
that
country
to
apply
for
accreditation.

USDA
will
accept
an
application
for
accreditation
to
perform
certification
activities
under
the
NOP
from
any
private
entity
or
governmental
entity
certifying
agent
and
accredit
such
applicant
upon
proof
of
qualification
for
accreditation.
USDA
will
provide
for
USDA
237
accreditation
of
certifying
agents
and
acceptance
of
a
foreign
government's
accreditation
of
certifying
agent
within
the
same
country.
This
maximizes
opportunity
for
certifying
agents
without
the
potential
for
confusion
and
overlap
in
documentation.
Further,
we
believe
these
requirements
facilitate
world
trade.

(
2)
State
Approval
of
Product
From
Foreign
Countries.
A
commenter
stated
that
any
product
making
claims
of
organic
agricultural
ingredients
to
be
sold
in
California
shall
fall
under
the
jurisdiction
of
the
California
Organic
Program
for
enforcement,
inspection,
and
certification
direction.
The
commenter
further
stated
that,
should
any
foreign
certifying
agents
be
accepted,

they
too
shall
be
subject
to
the
sovereign
rights
of
the
State
of
California
to
protect
and
enforce
the
laws
of
the
State
of
California
and
to
protect
agricultural
claims
in
this
State.

Any
organic
program
administered
by
a
State
will
have
to
be
approved
by
the
Secretary.

Approval
of
an
SOP
will
be
contingent
upon
the
State's
agreeing
to
accept
the
certification
decisions
made
by
certifying
agents
accredited
or
accepted
by
USDA
pursuant
to
section
205.500.

(
3)
Equivalency.
A
commenter
stated
that
USDA
should
declare
in
section
205.500
that
there
are
no
alternative
methods
of
production
that
meet
the
Congressional
purpose
"
to
assure
consumers
that
organically
produced
products
meet
a
consistent
standard."
The
commenter
went
on
to
state
that,
if
USDA
proceeds
with
equivalency
then
the
regulations
should
be
amended
to
provide
for:
(
1)
no
importing
until
final
determination,
(
2)
no
final
determination
until
Federal
Register
publication
and
public
comment,
(
3)
audit
of
foreign
agency
and
production
sites,
and
(
4)

revocation
of
accreditation
for
violations.
The
commenter
also
recommended
that
foreign
certifying
agents
be
reviewed
with
the
same
frequency
as
State
certifying
agents.

We
disagree
that
there
are
no
alternative
methods
of
production
that
assure
consumers
238
that
organically
produced
products
meet
a
consistent
standard.
Accordingly,
we
will
negotiate
equivalency
agreements
with
foreign
governments.
A
final
equivalency
agreement
will
be
required
before
affected
product
may
be
imported
into
the
United
States
and
sold,
labeled,
or
represented
as
organic.
Equivalency
agreements
will
be
announced
to
the
public
through
a
notice
in
the
Federal
Register
and
a
news
release.
Site
evaluations
are
a
possibility.
Foreign
certifying
agents
that
receive
USDA
accreditation,
rather
than
recognition
through
their
government,
will
have
to
fully
comply
with
the
NOP
and
will
be
treated
the
same
as
domestic
accredited
certifying
agents.

(
4)
Evaluation
of
Equivalency.
Commenters
asked
how
equivalency
would
be
evaluated
and
recommended
basing
equivalency,
not
on
a
check
of
formalities,
but
on
the
finding
of
substantive
equivalence
and
equivalent
effectiveness
of
certifying
systems.

The
negotiation
of
an
equivalency
agreement
will
involve
meetings
between
representatives
of
the
foreign
government
seeking
equivalency
and
representatives
of
USDA's
Agricultural
Marketing
Service
and
Foreign
Agricultural
Service.
Support
will
be
provided
by
the
Office
of
the
U.
S.
Trade
Representative.
The
process
will
also
include
the
review
of
documents
and
possibly
one
or
more
site
evaluations.
Equivalency
agreements
will
be
announced
to
the
public
through
a
notice
in
the
Federal
Register
and
a
news
release.

(
5)
Treatment
of
Certifying
Agents
Operating
in
More
Than
One
Country.
A
few
commenters
requested
that
we
amend
section
205.500(
c)
by
adding
a
provision
to
clarify
the
issue
of
how
the
international
activities
of
foreign
or
domestic
certifying
agents
will
be
treated
when
they
operate
in
more
than
one
country.

We
believe
that
the
requested
provision
is
unnecessary.
Certifying
agents,
domestic
and
239
foreign,
accredited
under
the
NOP
will
be
expected
to
comply
fully
with
the
requirements
of
the
NOP
regardless
of
where
they
operate.
The
only
exception
would
be
when
they
operate
in
a
country
in
which
the
Secretary
has
negotiated
an
equivalency
agreement.

(
6)
Accreditation
of
Foreign
Certifying
Agents.
A
commenter
requested
that
we
amend
section
205.500(
c)
to
exempt
foreign
applicants
from
having
to
be
accredited
certifying
agents
in
USDA's
program
if
the
exporting
country's
national
organic
program
meets
international
standards;
e.
g,
Codex
guidelines.

We
have
provided
for
USDA
accreditation
of
qualified
foreign
certifying
agents
upon
application.
We
have
also
provided
that
USDA
will
accept
a
foreign
certifying
agent's
accreditation
to
certify
organic
production
or
handling
operations
if
it
determines,
upon
the
request
of
a
foreign
government,
that
the
standards
under
which
the
foreign
government
authority
accredited
the
foreign
certifying
agent
meet
the
requirements
of
this
part.
We
have
further
provided
that
USDA
will
accept
a
foreign
certifying
agent's
accreditation
to
certify
organic
production
or
handling
operations
if
the
foreign
government
authority
that
accredited
the
foreign
certifying
agent
acted
under
an
equivalency
agreement
negotiated
between
the
United
States
and
the
foreign
government.
These
recognitions
of
foreign
government
programs,
however,
do
not
extend
to
international
standards
such
as
Codex
guidelines.
In
either
case,
we
are
recognizing
the
ability
of
a
foreign
government's
program
to
meet
U.
S.
standards,
not
some
other
international
standard.

(
7)
States
with
an
Organic
Statute.
A
commenter
stated
that
a
State
with
an
organic
statute
or
regulations
that
does
not
certify
organic
producers
or
organic
handlers
should
not
have
to
be
accredited.
240
The
NOP
requires
the
Secretary's
approval
of
SOP's
whether
or
not
the
State
has
a
State
certifying
agent.
A
State
may
have
an
SOP
but
not
have
a
State
certifying
agent.
In
this
case
the
SOP
must
be
approved
by
the
Secretary.
A
State
may
have
a
State
certifying
agent
but
no
SOP.

In
this
case,
the
State
certifying
agent
must
apply
for
and
receive
accreditation
to
certify
organic
production
or
handling
operations.
Finally,
a
State
may
have
an
SOP
and
a
State
certifying
agent.

In
this
case,
the
SOP
must
be
approved
by
the
Secretary,
and
the
State
certifying
agent
must
apply
for
and
receive
accreditation
to
certify
organic
production
or
handling
operations.

(
8)
Nondiscriminatory
Services.
A
commenter
wanted
the
addition
of
a
provision
in
section
205.501(
a)
requiring
certifying
agents
to
provide
nondiscriminatory
services.
We
have
not
included
the
suggested
addition
in
this
final
rule
because
the
provision
already
exists
in
section
205.501(
d).

(
9)
Release
of
Information.
A
few
commenters
requested
that
we
amend
section
205.501(
a)(
10)
to
include
a
general
exclusion
allowing
the
release
of
any
information
with
the
client's
permission.
We
have
not
included
the
suggested
addition
in
this
final
rule
because
section
205.504(
b)(
5)(
iv)
already
addresses
the
allowed
release
of
other
business
information
as
permitted
in
writing
by
the
producer
or
handler.

(
10)
Use
of
the
Term,
"
Certified
Organic."
In
commenting
on
section
205.501(
b)(
1),
a
commenter
stated
that
if
the
term,
"
certified
organic,"
is
included
on
a
label,
it
must
state
by
whom,
according
to
Maine
State
law.
We
do
not
believe
that
the
requirements
of
section
205.501(
b)(
1)
would
preclude
a
certified
operation
from
complying
with
a
State
law
requiring
identification
of
the
certifying
agent
on
a
product
sold,
labeled,
or
represented
as
"
certified
organic."
Further,
these
regulations
do
not
require
a
certified
operation
to
use
the
word,
241
"
certified,"
on
its
label.

(
11)
Holding
the
Secretary
Harmless.
In
commenting
on
the
requirements
of
section
205.501(
c)(
1),
a
commenter
stated
that
certifying
agents
are
responsible
for
representing
USDA
but
seem
to
have
no
recourse.
Another
commenter
asked,
what
happens
if
a
certifying
agent
is
found
in
violation
of
the
Act
but
the
violation
was
due
to
information
or
direction
that
came
from
USDA?

Under
the
NOP,
accredited
certifying
agents
are
required
to
comply
with
and
carry
out
the
requirements
of
the
Act
and
these
regulations.
If
they
fail
to
do
so,
they
are
responsible
for
their
actions
or
failures
to
act.
This
would
not
be
true
if
the
action
or
failure
to
act
was
at
the
direction
of
the
Secretary.

(
12)
Self­
evaluation
of
Ability
to
Comply.
A
commenter
requested
that
section
205.504
be
amended
to
provide
clarity
on
the
baseline
requirements
that
would
allow
a
certifying
agent
to
conduct
a
self­
evaluation
to
determine
its
ability
to
comply.
The
commenter
stated
that
there
should
be
some
type
of
baseline
acceptance
of
expertise
and
ability.
The
commenter
wants
details
regarding
the
"
training"
or
"
experience"
requirements
necessary
to
qualify
for
accreditation.
This
commenter
also
stated
that
criteria
for
inspector
and
reviewer
training
should
be
added
and
enlarged.

We
do
not
believe
that
it
is
necessary
to
present
the
requirements
for
accreditation
to
the
extent
of
detail
requested
by
the
commenter.
The
intent
is
to
provide
flexibility
to
the
certifying
agents
such
that
they
can
tailor
their
policies
and
procedures
to
the
nature
and
scope
of
their
operation.
The
NOP
is
available
to
respond
to
questions
and
to
assist
certifying
agents
in
complying
with
the
requirements
for
accreditation.
242
(
13)
Evidence
of
Expertise
and
Ability.
Commenters
stated
that
important
elements
of
ISO
Guide
65
are
missing
from
section
205.504.
They
cite
the
maintenance
of
a
complaints
register
and
a
register
of
precedents
and
provisions
for
subcontracting
and
a
documents
control
policy
or
a
document
register.

Certifying
agents
grant
certification,
deny
certification,
and
take
enforcement
action
against
a
certified
operation's
certification.
Certifying
agents
are
required
to
maintain
records
applicable
to
all
such
actions
and
to
report
such
actions
to
the
Administrator.
Certifying
agents
may
contract
with
qualified
individuals
for
the
performance
of
services
such
as
inspection,

sampling,
and
residue
testing.
Certifying
agents
are
required
to
submit
personnel
information
(
employed
and
contracted)
and
administrative
policies
and
procedures
to
the
Administrator.
All
such
documents
must
be
updated
annually.
The
regulations
also
require
the
maintenance
of
records
according
to
specified
retention
periods.
All
of
these
factors
will
be
considered
in
granting
or
denying
accreditation.
We
believe
these
requirements
meet
or
exceed
the
ISO
Guide
65
guidelines.

(
14)
Personnel
Evidence
of
Expertise.
A
commenter
inquired
about
the
frequency
at
which
the
personnel
information,
required
by
section
205.504(
a)
and
used
to
establish
evidence
of
expertise
and
ability,
is
to
be
updated.
Section
205.510
requires
that
the
certifying
agent
annually
submit
a
complete
and
accurate
update
of
the
information
required
in
section
205.504.

(
15)
Responsibly
Connected.
A
commenter
stated
that
the
term,
"
responsibly
connected,"

as
used
in
section
205.504(
a)(
2)
is
a
broad
sweep.
The
commenter
believes
the
term
would
include
everyone
they
do
business
with.

Section
205.504(
a)(
2)
requires
the
certifying
agent
to
provide
the
name
and
position
243
description
of
all
personnel
to
be
used
in
the
certification
operation.
The
section
assists
the
certifying
agent
in
meeting
the
requirement
by
identifying
categories
of
persons
covered
by
the
requirement
including
persons
responsibly
connected
to
the
certifying
agent.
Responsibly
connected
does
not
include
everyone
that
the
certifying
agent
does
business
with.
Responsibly
connected
is
defined
in
the
Definitions
subpart
of
this
final
rule
as
"
any
person
who
is
a
partner,

officer,
director,
holder,
manager,
or
owner
of
10
percent
or
more
of
the
voting
stock
of
an
applicant
or
a
recipient
of
certification
or
accreditation."
This
definition
has
not
changed.

(
16)
Independent
Third­
Party
Inspectors.
A
commenter
recommended
amending
section
205.504(
a)(
3)(
I)
to
provide
for
the
use
of
independent
third­
party
inspectors.
We
believe
that
this
recommended
amendment
is
unnecessary
since
nothing
in
these
regulations
precludes
a
certifying
agent
from
contracting
with
independent
third
parties
for
inspection
services.

(
17)
Response
to
Accreditation
Applicant.
A
commenter
requested
that
section
205.506(
a)(
3)
be
amended
to
provide
a
timeframe
within
which
the
Administrator
has
to
respond
to
the
accreditation
application.
While
section
205.506(
a)(
3)
identifies
the
information
to
be
reviewed
by
the
Administrator
prior
to
the
granting
of
accreditation,
we
assume
the
commenter
is
seeking
a
specific
time
limit
by
which
the
Administrator
will
acknowledge
receipt
of
an
application
for
accreditation.
In
the
alternative,
the
commenter
may
have
been
seeking
a
specific
time
limit
by
which
the
Administrator
must
grant
or
deny
accreditation.
We
believe
that
a
regulation­
mandated
timeframe
for
notifying
the
applicant
of
receipt
of
an
application
or
for
granting
or
denying
accreditation
is
unnecessary.
We
plan
to
process
all
applications
in
the
order
in
which
they
are
received,
to
confirm
the
receipt
of
each
application
upon
receipt,
and
to
establish
a
dialog
with
the
applicant
upon
confirmation
of
receipt
of
an
application
for
accreditation.
We
will
work
with
244
each
applicant
to
complete
the
accreditation
process
as
expeditiously
as
possible.
A
firm
timeframe,
however,
cannot
be
set
for
granting
or
denying
accreditation
due
to
the
anticipated
uniqueness
of
each
applicant
and
its
application
for
accreditation.

(
18)
Duration
of
Accreditation
and
Certification.
A
commenter
asked,
"
How
can
certification
be
essentially
in
perpetuity
and
accreditation
have
a
time
restraint?"
The
commenter's
question
does
not
indicate
a
preference
for
certification
or
accreditation
longevity.
The
commenter
correctly
points
out
that
certification
and
accreditation,
both
of
which
must
be
updated
annually,
are
granted
for
different
time
periods.
The
Act
limits
the
period
of
accreditation
to
5
years
but
does
not
establish
a
limit
to
the
period
of
certification.
We
believe
the
requirement
that
the
certified
operation
submit
an
annual
update
of
its
organic
plan
negates
the
need
for
a
certification
expiration
date.

(
19)
Denial
of
Accreditation.
In
commenting
on
section
205.507,
a
commenter
stated
that
the
regulations
need
to
address
what
happens
to
a
certifying
agent's
clients
when
the
certifying
agent
fails
to
qualify
for
accreditation
on
its
first
attempt.

Section
205.507(
c)
provides
that
an
applicant
who
has
received
written
notification
of
accreditation
denial
may
apply
for
accreditation
again
at
any
time
in
accordance
with
section
205.502.
Upon
implementation
of
the
certification
requirements
of
the
NOP,
production
and
handling
operations
planning
to
sell,
label,
or
represent
their
products
as
organic
must
be
certified
by
a
USDA­
accredited
certifying
agent
before
selling,
labeling,
or
representing
their
products
as
organic.
If
a
producer's
or
handler's
choice
of
certifying
agents
does
not
receive
USDA
accreditation,
the
producer
or
handler
must
seek
and
receive
certification
under
the
NOP
from
a
USDA­
accredited
certifying
agent
before
selling,
labeling,
or
representing
their
products
as
245
organic.
Producers
and
handlers
not
so
certified
may
not
sell,
label,
or
represent
their
products
as
organic.
Any
producer
or
handler
who
violates
this
requirement
will
be
subject
to
prosecution
under
section
2120
of
the
Act.

(
20)
Loss
of
Accreditation
After
Initial
Site
Visit.
Commenting
on
section
205.508(
b),
a
commenter
stated
the
belief
that
accreditation
before
a
site
visit
may
cause
problems
if
the
certifying
agent
does
not
meet
the
requirements
and,
subsequently,
loses
its
accreditation.
We
believe
the
problems
will
be
no
greater
than
will
occur
at
any
other
time
when
it
becomes
necessary
to
revoke
a
certifying
agent's
accreditation,
including
when
it
becomes
necessary
to
initiate
proceedings
to
suspend
or
revoke
the
certification
of
one
or
more
of
the
certifying
agent's
certified
operations.
However,
just
because
revocation
of
a
certifying
agent's
accreditation
may
be
justified,
it
may
not
be
necessary
to
suspend
or
revoke
the
certification
of
one
or
more
of
its
clients.
An
operation
certified
by
a
certifying
agent
that
has
lost
its
accreditation
must
make
application
with
a
new
certifying
agent
if
it
is
going
to
continue
to
sell,
label,
or
represent
its
products
as
organic.

(
21)
Prohibition
on
Certification
After
Expiration
of
Accreditation.
A
commenter
stated
that,
"
USDA
should
allow
certifying
agents
to
apply
the
same
provisions
to
expiration
of
certification
of
a
certified
operation."
The
provision
referenced
by
the
commenter
is
the
section
205.510(
c)(
1)
(
current
section
205.510(
c)(
2))
requirement
that
certifying
agents
with
an
expired
accreditation
must
not
perform
certification
activities
under
the
Act
and
these
regulations.
We
have
not
accepted
the
commenter's
request
that
the
same
prohibition
be
applied
to
production
and
handling
operations
with
an
expired
certification
because
certification
does
not
expire.

(
22)
Expiration
of
Accreditation.
Many
commenters
requested
that
we
amend
section
246
205.510(
c)(
1)
to
require
annual
reports
and
"
minivisits."
The
commenters
cited
ISO
Guide
61,

section
3.5.1.
We
do
not
believe
that
annual
"
minivisits"
are
necessary
to
meet
the
requirements
of
ISO
Guide
61
or
to
assure
compliance
with
the
NOP.
One
or
more
site
evaluations
will
be
conducted
during
the
period
of
accreditation.
The
certifying
agent's
annual
report
will
be
used
as
a
determining
factor
in
whether
to
conduct
a
site
evaluation.
A
request
for
amendment
to
a
certifying
agent's
area
of
accreditation
will
also
result
in
a
site
evaluation.
This
requirement
is
located
at
current
section
205.510(
c)(
2).

(
23)
Update
and
Review
of
Inspector
Lists.
In
commenting
on
section
205.510(
c)(
1)

(
current
section
205.510(
c)(
2))
several
commenters
stated
that
updating
and
review
of
inspector
lists
must
occur
more
frequently
than
every
5
years.
They
cited
ISO
Guide
61,
section
3.5.1.

Section
205.510(
a)(
1)
requires
that
the
certifying
agent
annually
update
the
information
required
in
section
205.504.
This
includes
the
inspector
information
required
by
paragraphs
205.504(
a)(
2)
and
205.504(
a)(
3)(
i).

Subpart
G
Administrative
The
National
List
of
Allowed
and
Prohibited
Substances
Description
of
Regulations
General
Requirements
This
subpart
contains
criteria
for
determining
which
substances
and
ingredients
are
allowed
or
prohibited
in
products
to
be
sold,
labeled,
or
represented
as
"
organic"
or
"
made
with
organic
(
specified
ingredients
or
food
group(
s))."
It
establishes
the
National
List
of
Allowed
and
Prohibited
Substances
(
National
List)
and
identifies
specific
substances
which
may
or
may
not
be
used
in
organic
production
and
handling
operations.
Sections
6504,
6510,
6517,
and
6518
of
the
247
Organic
Foods
Production
Act
(
OFPA)
of
1990
provide
the
Secretary
with
the
authority
to
develop
the
National
List.
The
contents
of
the
National
List
are
based
upon
a
Proposed
National
List,
with
annotations,
as
recommended
to
the
Secretary
by
the
National
Organic
Standards
Board
(
NOSB).
The
NOSB
is
established
by
the
OFPA
to
advise
the
Secretary
on
all
aspects
of
the
National
Organic
Program
(
NOP).
The
OFPA
prohibits
synthetic
substances
in
the
production
and
handling
of
organically
produced
agricultural
products
unless
such
synthetic
substances
are
placed
on
the
National
List.

Substances
appearing
on
the
National
List
are
designated
using
the
following
classifications:

1.
Synthetic
substances
allowed
for
use
in
organic
crop
production
2.
Nonsynthetic
substances
prohibited
for
use
in
organic
crop
production
3.
Synthetic
substances
allowed
for
use
in
organic
livestock
production
4.
Nonsynthetic
substances
prohibited
for
use
in
organic
livestock
production
5.
Nonagricultural
(
nonorganic)
substances
allowed
as
ingredients
in
or
on
processed
products
labeled
as
"
organic"
or
"
made
with
organic
(
specified
ingredients
or
food
group(
s))

6.
Nonorganically
produced
agricultural
products
allowed
as
ingredients
in
or
on
processed
products
labeled
as
organic"
or
"
made
with
organic
(
specified
ingredients
or
food
group(
s))

This
subpart
also
outlines
procedures
through
which
an
individual
may
petition
the
Secretary
to
evaluate
substances
for
developing
proposed
National
List
amendments
and
deletions.

The
NOSB
is
responsible
for
making
the
recommendation
of
whether
a
substance
is
248
suitable
for
use
in
organic
production
and
handling.
The
OFPA
allows
the
NOSB
to
develop
substance
recommendations
and
annotations
and
forward
to
the
Secretary
a
Proposed
National
List
and
any
subsequent
proposed
amendments.
We
have
made
every
effort
to
ensure
the
National
List
in
this
final
rule
corresponds
to
the
recommendations
on
allowed
and
prohibited
substances
made
by
the
NOSB.
In
developing
their
recommendations,
the
NOSB
evaluates
synthetic
substances
for
the
National
List
utilizing
the
criteria
stipulated
by
the
Act.
Additionally,

criteria
for
evaluating
synthetic
processing
ingredients
have
been
implemented
by
the
NOSB.

These
criteria
are
an
interpretation
and
application
of
the
general
evaluation
criteria
for
synthetic
substances
contained
in
the
OFPA
that
the
NOSB
will
apply
to
processing
aids
and
adjuvants.

The
NOSB
adopted
these
criteria
as
internal
guidelines
for
evaluating
processing
aids
and
adjuvants.
The
adopted
criteria
do
not
supersede
the
criteria
contained
in
the
OFPA
or
replace
the
Food
and
Drug
Administration's
(
FDA)
regulations
related
to
food
additives
and
generally
recognized
as
safe
(
GRAS)
substances.
The
NOSB
has
also
provided
recommendations
for
the
use
of
synthetic
inert
ingredients
in
formulated
pesticide
products
used
as
production
inputs
in
organic
crop
or
livestock
operations.
The
Environmental
Protection
Agency
(
EPA)
regulates
and
maintains
the
EPA
Lists
of
Inert
ingredients
used
for
pesticide.
In
this
final
rule,
EPA
Inerts
List
1
and
2
are
prohibited,
EPA
List
3
is
also
prohibited
unless
specifically
recommended
as
allowed
by
the
NOSB,
and
EPA
List
4
Inerts
are
allowed
unless
specifically
prohibited.

In
this
final
rule,
only
EPA
List
4
Inerts
are
allowed
as
ingredients
in
formulated
pesticide
products
used
in
organic
crop
and
livestock
production.
The
allowance
for
EPA
List
4
Inerts
only
applies
to
pesticide
formulations.
Synthetic
ingredients
in
any
formulated
products
used
as
organic
production
inputs,
including
pesticides,
fertilizers,
animal
drugs,
and
feeds,
must
be
249
included
on
the
National
List.
As
sanctioned
by
OFPA,
synthetic
substances
can
be
used
in
organic
production
and
handling
as
long
as
they
appear
on
the
National
List.
The
organic
industry
should
clearly
understand
that
NOSB
evaluation
of
the
wide
variety
of
inert
ingredients
and
other
nonactive
substances
will
require
considerable
coordination
between
the
NOP,
the
NOSB,
and
industry.
Materials
review
can
be
anticipated
as
one
of
the
NOSB's
primary
activities
during
NOP
implementation.
Considering
the
critical
nature
of
this
task,
the
organic
industry
should
make
a
collaborative
effort
to
prioritize
for
NOSB
review
those
substances
that
are
essential
to
organic
production
and
handling.
The
development
and
maintenance
of
the
National
List
has
been
and
will
be
designed
to
allow
the
use
of
a
minimal
number
of
synthetic
substances
that
are
acceptable
to
the
organic
industry
and
meet
the
OFPA
criteria.

We
expect
the
maintenance
of
the
National
List
to
be
a
dynamic
process.
We
anticipate
that
decisions
on
substance
petitions
for
the
inclusion
on
or
deletion
from
the
National
List
will
be
made
on
an
annual
basis.
Any
person
seeking
a
change
in
the
National
List
should
request
a
copy
of
the
petition
procedures
that
were
published
in
the
Federal
Register
(
65
Fed
Reg
43259
­

43261)
on
July
13,
2000,
from
the
NOP.
The
National
List
petition
process
contact
information
is:
Program
Manager,
National
Organic
Program,
USDA/
AMS/
TMP/
NOP,
Room
2945­
S,
Ag
Stop
0268,
P.
O.
Box
96456,
Washington,
DC
20090­
6456
or
visit
the
NOP
website:

www.
ams.
usda.
gov/
nop.
Substances
petitioned
for
inclusion
on
the
National
List
will
be
reviewed
by
the
NOSB,
which
will
forward
a
recommendation
to
the
Secretary.
Any
amendments
to
the
National
List
will
require
rulemaking
and
must
be
published
for
comment
in
the
Federal
Register.

Nothing
in
this
subpart
alters
the
authority
of
other
Federal
agencies
to
regulate
250
substances
appearing
on
the
National
List.
FDA
issues
regulations
for
the
safe
use
of
substances
in
food
production
and
processing.
USDA's
Food
Safety
and
Inspection
Service
(
FSIS)
has
the
authority
to
determine
efficacy
and
suitability
regarding
the
production
and
processing
of
meat,

poultry,
and
egg
products.
FDA
and
FSIS
restrictions
on
use
or
combinations
of
food
additives
or
GRAS
substances
take
precedence
over
the
approved
and
prohibited
uses
specified
in
this
final
rule.
In
other
words,
any
combinations
of
substances
in
food
processing
not
already
addressed
in
FDA
and
FSIS
regulations
must
be
approved
by
FDA
and
FSIS
prior
to
use.
FDA
and
FSIS
regulations
can
be
amended
from
time
to
time
under
their
rulemaking
procedures,
and
conditions
of
safe
use
of
food
additives
and
GRAS
substances
can
be
revised
by
the
amendment.
It
is
important
that
certified
organic
producers
and
handlers
of
both
crop
and
livestock
products
consult
with
FDA
regulations
in
21
CFR
parts
170
through
199
and
FSIS
regulations
in
this
regard.
All
feeds,
feed
ingredients,
and
additives
for
feeds
used
in
the
production
of
livestock
in
an
organic
operation
must
comply
with
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA).

Animal
feed
labeling
requirements
are
published
in
21
CFR
Part
501,
and
new
animal
drug
requirements
and
a
listing
of
approved
animal
drugs
are
published
in
21
CFR
Parts
510­
558.

Food
(
feed)
additive
requirements,
a
list
of
approved
food
(
feed)
additives
generally
recognized
as
safe
substances,
substances
affirmed
as
GRAS,
and
substances
prohibited
from
use
in
animal
food
or
feed
are
published
in
21
CFR
570­
571,
21
CFR
573,
21
CFR
582,
21
CFR
584,
and
21
CFR
589,
respectively.
Furthermore,
the
Food
and
Drug
Administration
has
worked
closely
with
the
Association
of
American
Feed
Control
Officials
(
AAFCO)
and
recognizes
the
list
of
additives
and
feedstuffs
published
in
the
AAFCO
Official
Publication,
which
is
updated
annually.

Under
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
FIFRA),
EPA
regulates
251
the
use
of
all
pesticide
products,
including
those
that
may
be
approved
for
use
in
the
NOP.
In
registering
a
pesticide
under
FIFRA,
EPA
approves
the
uses
of
each
pesticide
product.
It
is
a
violation
of
FIFRA
to
use
a
registered
product
in
a
manner
inconsistent
with
its
labeling.
The
fact
that
a
substance
is
on
the
National
List
does
not
authorize
use
or
a
pesticide
product
for
that
use
if
the
pesticide
product
label
does
not
include
that
use.
If
the
National
List
and
the
pesticide
labeling
conflict,
the
pesticide
labeling
takes
precedence
and
may
prohibit
a
practice
allowed
on
the
National
List.

National
List
­
Changes
Based
On
Comments
This
subpart
differs
from
the
proposal
in
several
respects
as
follows:

(
1)
Comprehensive
Prohibition
on
Excluded
Methods.
Many
commenters
supported
a
comprehensive
prohibition
on
the
use
of
excluded
methods
in
organic
production
and
handling.

These
commenters
stated
that
the
proposed
language
on
excluded
methods
could
have
allowed
some
uses
since
the
general
prohibition
described
in
section
205.301
of
the
proposed
rule
could
be
interpreted
as
applying
only
to
multiingredient
products.
In
order
to
provide
a
comprehensive
prohibition
on
the
use
of
excluded
methods,
we
incorporated
a
new
provision
within
section
205.105.
A
more
comprehensive
discussion
of
this
issue
is
found
in
subpart
B,
Applicability.

(
2)
Substance
Evaluation
Criteria
for
the
National
List.
Commenters
stated
that
the
final
rule
should
include
in
the
regulation
text
the
evaluation
criteria
utilized
by
the
NOSB
for
the
development
of
substance
recommendations.
We
agree,
and
we
have
inserted
the
substance
evaluation
criteria
developed
by
the
NOSB
for
processing
ingredients
and
cited
the
criteria
within
the
Act
(
7
U.
S.
C.
6518(
m))
for
crops
and
livestock
production
as
new
provisions
for
section
205.600,
which
is
now
entitled
"
Evaluation
criteria
for
allowed
and
prohibited
substances,
252
methods,
and
ingredients."

(
3)
Substances
Approved
for
Inclusion
on
the
National
List.
Commenters
stated
that
the
National
List
did
not
contain
all
of
the
substances
recommended
by
the
NOSB
for
inclusion
on
the
National
List
of
Allowed
and
Prohibited
Substances.
We
agree
and
have
added
the
following
substances
consistent
with
the
most
recent
NOSB
recommendations:

Crop
Production:

Lime
sulfur
as
a
plant
disease
control
substance
Elemental
sulfur
as
a
plant
or
soil
amendment
Copper
as
a
plant
or
soil
micronutrient
Streptomycin
sulfate
as
plant
disease
control
substances
with
the
annotation
"
for
fire
blight
control
in
apples
and
pears
only"

Terramycin
(
oxytetracycline
calcium
complex)
as
a
plant
disease
control
substance
with
the
annotation
"
for
fire
blight
control
only"

Magnesium
sulfate
as
a
plant
or
soil
amendment
with
the
annotation
"
allowed
with
a
documented
soil
deficiency"

Ethylene
as
a
plant
growth
regulator,
with
the
annotation
"
for
regulation
of
pineapple
flowering"

We
have
added
sodium
nitrate
and
potassium
chloride
to
the
National
List
as
nonsynthetic
substances
prohibited
for
use
in
crop
production
unless
used
in
accordance
with
the
substance
annotations.
Sodium
nitrate
is
prohibited
unless
use
is
restricted
to
no
more
than
20
percent
of
the
crop's
total
nitrogen
requirement.
Potassium
chloride
is
prohibited
unless
derived
from
a
mined
source
and
applied
in
a
manner
that
minimizes
chloride
accumulation
in
the
soil.
These
253
additions
are
discussed
further
in
item
3
under
Changes
Based
on
Comments,
subpart
C.

Livestock
Production:

Oxytocin
with
the
annotation
"
for
use
in
postparturition
therapeutic
applications"

EPA
List
4
inert
ingredients
as
synthetic
inert
ingredients
for
use
with
nonsynthetic
substances
or
synthetic
substances
allowed
in
organic
livestock
production.

Several
commenters
recommended
that
the
final
rule
should
specify
which
nonsynthetic
substances
are
prohibited
for
use
in
livestock
production.
These
commenters
stated
that
the
proposed
rule
prohibited
six
such
substances
for
use
in
crop
production
and
maintained
that
an
analogous
list
for
livestock
operations
would
be
beneficial.
Of
the
six
nonsynthetic
substances
in
the
proposed
rule
prohibited
for
use
in
crop
production,
four
were
based
on
NOSB
recommendations
(
strychnine,
tobacco
dust,
sodium
fluoaluminate
(
mined),
and
ash
from
burning
manure)
and
two
were
based
on
statutory
provisions
in
the
OFPA
(
arsenic
and
lead
salts).
After
reviewing
these
substances
and
the
NOSB
recommendations,
we
determined
that
the
prohibition
for
one,
strychnine,
also
applies
to
livestock
production.
Individuals
may
petition
the
NOSB
to
have
additional
nonsynthetic
substances
prohibited
for
use
in
organic
crop
and
livestock
production.

Organic
Handling
(
Processing):

Tribasic
calcium
phosphate
Nonsynthetic
colors
Flavors,
with
the
annotation
"
nonsynthetic
sources
only
and
must
not
be
produced
using
synthetic
solvents
and
carrier
systems
or
any
artificial
preservatives"

Nonsynthetic
waxes,
carnauba
wax,
wood
resin
254
Cornstarch
(
native),
gums,
kelp,
lecithin
and
pectin
were
moved
from
section
205.605
to
section
205.606
(
4)
Substance
Removed
from
the
National
List.
Commenters
stated
that
certain
substances
on
the
National
List
in
the
proposed
rule
had
not
been
recommended
by
the
NOSB.

We
agree
with
the
comment
that
the
NOSB
did
not
recommend
that
magnesium
should
be
allowed
as
a
plant
or
soil
micronutrient
and
have
removed
it
from
the
National
List.

(
5)
Changes
in
Substance
Annotations
on
the
National
List.
Commenters
stated
that
certain
annotations
in
the
proposed
rule
did
not
capture
the
precise
recommendations
of
the
NOSB.
We
agree
and
have
amended
the
annotations
within
the
National
List
as
follows:

The
annotation
for
hydrated
lime
as
a
plant
disease
control
substance
now
states,
"
must
be
used
in
a
manner
that
minimizes
accumulation
of
copper
in
the
soil."

The
annotation
for
horticultural
oils
as
an
insecticide
substance
and
as
a
plant
disease
control
substance
now
states,
"
Narrow
range
oils
as
dormant,
suffocating,
and
summer
oils."

The
annotation
for
hydrated
lime
in
livestock
production
now
states,
"
not
permitted
for
soil
application
or
to
cauterize
physical
alterations
or
deodorize
animal
wastes."

The
annotation
for
the
allowed
synthetic
parasiticide
Ivermectin
has
been
modified
to
state
that
the
substance
may
not
be
used
during
the
lactation
period
of
breeding
stock.

The
annotation
for
trace
minerals
and
vitamins
allowed
as
feed
additives
has
been
modified
and
now
states,
"
used
for
enrichment
or
fortification
when
FDA
approved."

The
annotation
for
magnesium
sulfate
in
organic
handling
now
states,
"
nonsynthetic
sources
only."

The
annotation
for
EPA
List
4
Inerts
allowed
in
crop
and
livestock
production
has
been
255
modified
to
state,
"...
for
use
with
nonsynthetic
substances
or
synthetic
substances
listed
in
this
section..."

(
6)
Sulfur
Dioxide
for
Organic
Wines.
Many
commenters
recommended
that
this
final
rule
should
allow
for
the
use
of
sulfur
dioxide
in
wine
labeled
"
made
with
organic
grapes."
They
argued
that
sulfur
dioxide
is
necessary
in
organic
wine
production
and
that
prohibiting
its
use
would
have
a
negative
impact
on
organic
grape
production
and
wineries
that
produce
wine
labeled
"
made
with
organic
grapes."
The
prohibition
on
the
use
of
sulfur
dioxide
in
the
proposed
rule
was
based
upon
the
requirement
in
the
Act
that
prohibited
the
addition
of
sulfites
to
organically
produced
foods.
However,
a
change
in
the
Act
now
allows
the
use
of
sulfites
in
wine
labeled
as
"
made
with
organic
grapes."
Therefore,
we
have
added
sulfur
dioxide
to
the
National
List
with
the
annotation,
"
for
use
only
in
wine
labeled
`
made
with
organic
grapes,'
Provided,

That,
total
sulfite
concentration
does
not
exceed
100
ppm."
The
label
for
the
wine
must
indicate
the
presence
of
sulfites.
This
addition
to
the
National
List
is
also
in
agreement
with
the
NOSB
recommendation
for
allowing
the
use
of
sulfur
dioxide
in
producing
wine
to
be
labeled
as
"
made
with
organic
grapes."

National
List
­
Changes
Requested
But
Not
Made
This
subpart
retains
from
the
proposed
rule
regulations
on
which
we
received
comments
as
follows:

(
1)
Restructuring
the
National
List.
Commenters
requested
a
restructuring
of
the
National
List
to
improve
its
clarity
and
ease
of
use.
Some
of
the
commenters
asked
for
minor
changes
involving
the
wording
of
section
titles.
Other
commenters
were
opposed
to
the
categories
used
in
the
National
List
because
the
categories
are
not
in
compliance
with
the
Act.
In
256
its
June
2000
meeting,
the
NOSB
asked
the
NOP
to
review
a
proposal
from
a
research
institute
proposing
that
processing
materials
for
the
National
List
be
categorized
according
to
industry
standards.
This
proposal
recommended
including
new
sections
for
substances
used
in
"
made
with..."
and
substances
used
in
the
5­
percent
nonorganic
portion
of
"
organic"
multiingredient
products.
We
agree
that
the
present
structure
of
the
National
List
may
not
have
optimum
clarity
and
ease
of
use.
However,
extensive
restructuring
of
the
National
List
without
additional
NOSB
consideration
and
public
discussion
would
be
a
significant
variation
from
the
policy
that
established
the
National
List
for
this
final
rule.
The
NOP
will
work
with
the
NOSB
and
the
public
to
refine
the
National
list
consistent
with
industry
norms
and
public
expectations.

(
2)
Use
of
EPA
List
4
Inerts.
The
proposed
rule
allowed
EPA
List
4
Inerts
to
be
used
as
synthetic
inert
ingredients
with
allowed
synthetic
active
ingredients
in
crop
production.
Some
commenters
stated
that
certain
substances
among
the
EPA
List
4
inerts
should
not
be
allowed
in
organic
production.
Some
commenters
went
further
and
recommended
that
the
allowance
for
synthetic
inert
ingredients
should
be
limited
to
the
subset
of
materials
that
the
EPA
designates
as
List
4A.
We
do
not
agree
with
these
commenters
and
have
retained
the
allowance
for
all
inerts
included
on
EPA
List
4.
List
4
inerts
are
classified
by
EPA
as
those
of
"
minimal
concern"
and,

after
continuing
consultation
with
EPA,
we
believe
there
is
no
justification
for
a
further
restriction
to
List
4A.
If
commenters
believe
that
a
particular
List
4
inert
should
not
be
allowed
in
formulated
products
used
in
organic
production,
they
can
petition
the
NOSB
to
have
that
substance
prohibited.

(
3)
Removing
Vaccines
from
the
National
List.
Some
commenters
asserted
that
vaccines
should
not
be
included
on
the
National
List
because
the
NOSB
had
never
favorably
recommended
257
their
use
in
livestock
production.
However,
the
OFPA
authorizes
the
use
of
vaccines,
and
in
1995,
the
NOSB
recommended
allowing
their
use.
The
NOSB
stated
that
use
of
vaccines
may
be
necessary
to
ensure
the
health
of
the
animal
and
to
remain
in
compliance
with
Federal,
State,
or
regional
regulations.
We
agree
with
the
NOSB's
recommendation
and
have
retained
vaccines
as
an
allowed
substance
in
livestock
medication.

(
4)
Adding
Amino
Acids
to
the
National
List.
Some
commenters
recommended
that
amino
acids
should
be
added
to
the
National
List
as
allowed
synthetic
substances
for
livestock
production.
We
have
not
added
amino
acids
to
the
National
List
because
the
NOSB
has
not
recommended
that
they
should
be
allowed.
This
subject
is
discussed
further
in
item
4,
Livestock
­

Changes
Based
on
Comments,
subpart
C.

(
5)
Creating
a
Category
for
Prohibited
Nonsynthetic
Seed
Treatments.
A
commenter
stated
that
the
National
List
of
nonsynthetic
substances
prohibited
for
use
in
crop
production
should
include
provisions
for
seed
treated
with
a
nonsynthetic
substance.
This
commenter
stated
that
the
final
rule
should
acknowledge
that
a
nonsynthetic
seed
treatment
could
be
prohibited
on
the
National
List.
We
do
not
believe
it
is
necessary
to
include
a
separate
category
for
seed
treatments
under
the
prohibited
nonsynthetic
section
of
the
National
List.
An
individual
may
petition
the
NOSB
to
have
a
particular
nonsynthetic
seed
treatments
placed
on
the
prohibited
list
without
creating
a
new
category
for
seed
treatments.

(
6)
Creating
a
Category
for
Treated
Seed
and
Toxins
Derived
from
Bacteria.

Commenters
stated
that
the
National
List
of
synthetic
substances
allowed
in
crop
production
should
include
categories
for
treated
seed
and
toxins
derived
from
bacteria.
These
commenters
stated
that
these
categories
are
sanctioned
by
the
OFPA,
and
failure
to
consider
them
would
place
258
a
significant
burden
on
organic
producers.
We
believe
it
is
unnecessary
to
include
these
categories
on
the
National
List.
Specific
substances
from
these
categories
could
be
incorporated
in
existing
categories
that
reflect
their
function,
such
as
plant
disease
control
or
insecticide.
An
individual
may
submit
petitions
to
the
NOSB
to
have
specific
substances
from
these
categories
considered
for
inclusion
on
the
National
List.

(
7)
Remove
Categories
for
Feed
Supplements.
A
commenter
stated
that
it
was
inappropriate
for
the
National
List
of
synthetic
substances
allowed
in
livestock
production
to
contain
categories
for
feed
supplements
and
feed
additives
because
they
are
not
authorized
in
the
OFPA.
We
disagree
with
this
commenter
because
the
identification
of
categories
on
the
National
List
does
not
mean
that
all
substances
within
that
category
are
allowed.
The
categories
help
to
clarify
which
types
of
materials
may
be
included
on
the
National
List.
The
substances
included
under
the
categories
of
feed
supplements
and
feed
additives
were
recommended
by
the
NOSB
and
added
to
the
National
List
with
the
Secretary's
approval.

(
8)
Neurotoxic
Substances
on
the
National
List.
Many
commenters
requested
that
the
NOP
remove
particular
substances
from
section
205.605
of
the
National
List.
They
stated
these
substances
were
sources
of
neurotoxic
compounds
that
negatively
effect
human
health.
The
substances
cited
were
yeast
(
autolysate
and
brewers),
carrageenan,
and
enzymes.
Moreover,

these
commenters
argued
against
including
on
the
National
List
some
amino
acids
or
their
derivatives
which
the
commenters
claim
have
neurotoxic
side
effects.
These
commenters
requested
that
amino
acids
should
be
prohibited
from
the
National
List
due
to
the
possibility
that
neurotoxic
substances
could
be
utilized
for
either
organic
agricultural
production
or
handling.

We
do
not
agree
with
the
requests
of
the
commenters
and
we
have
not
made
the
requested
259
changes.
There
are
no
amino
acids
currently
on
the
National
List;
therefore,
synthetic
sources
of
amino
acids
are
prohibited.
Unless
recommended
for
use
by
the
NOSB,
synthetic
amino
acids
will
not
be
included
on
the
National
List.
The
NOP
has
established
a
petition
process
for
substances
to
be
evaluated
for
inclusion
on
or
removal
from
the
National
List
of
Allowed
and
Prohibited
Substances
in
organic
production
and
handling.
Anyone
seeking
to
have
a
particular
substance
removed
from
the
National
List
may
file
a
substance
petition
to
amend
the
National
List.

(
9)
EPA
List
4
Inerts
for
Organic
Processing.
A
few
commenters
recommended
that
substances
in
EPA
List
4
inerts
that
are
allowed
for
use
in
crop
production
also
be
allowed
for
use
as
processing
materials.
We
do
not
agree,
and
we
have
not
included
EPA
List
4
Inerts
on
the
National
List
for
organic
handling.
Inerts
listed
on
EPA
List
4
have
been
evaluated
and
approved
for
use
in
pesticide
formulations,
not
for
use
as
processing
materials.
Inerts
that
are
included
on
EPA
List
4
would
have
to
be
further
evaluated
to
determine
whether
such
materials
meet
the
criteria
for
inclusion
on
the
National
List.

(
10)
Modifying
Annotations
of
Organic
Processing
Substances.
One
commenter
requested
that
the
Department
modify
the
annotation
for
phosphoric
acid
to
include
its
use
as
a
processing
aid.
We
have
not
made
the
suggested
change.
Any
change
in
the
annotation
of
a
substance
can
only
occur
through
an
NOSB
recommendation.
Individuals
or
groups
can
use
the
petition
process
to
submit
substance
petitions
to
the
NOSB
for
the
evaluation
to
be
included
on
or
removed
from
the
National
List.

(
11)
Nutritional
Supplementation
of
Organic
Foods.
Some
commenters
asserted
that
21
CFR
104.20
is
not
an
adequate
stand­
alone
reference
for
nutritional
supplementation
of
organic
foods.
As
a
result,
these
commenters
recommended
that
the
final
rule
include
as
additional
cites
260
21
CFR
101.9(
c)(
8)
for
FDA­
regulated
foods
and
9
CFR
317.30(
c),
318.409(
c)(
8)
for
foods
regulated
by
FSIS
to
support
21
CFR
104.20.
We
did
not
implement
the
suggested
changes
of
the
commenters.
Section
205.605(
b)(
20)
in
the
proposed
rule
allowed
the
use
of
synthetic
nutrient
vitamins
and
minerals
to
be
used
in
accordance
with
21
CFR
104.20,
Nutritional
Quality
Guidelines
For
Foods,
as
ingredients
in
processed
products
to
be
sold
as
"
organic"
or
"
made
with..."
The
commenters
recommended
cites,
21
CFR
101.9(
c)(
8)
for
FDA­
regulated
foods
and
9
CFR
317.30(
c);
section
318.409(
c)(
8)
did
not
provide
provisions
for
nutritional
supplementation
of
foods.
Instead,
these
suggested
cites
were
particularly
aimed
toward:
(
1)
the
declaration
of
nutrition
information
on
the
label
and
in
labeling
of
a
food;
(
2)
labeling,
marking
devices,
and
containers;
(
3)
entry
into
official
establishments;
and
(
4)
reinspection
and
preparation
of
products.
The
NOP,
in
consultation
with
FDA,
considers
21
CFR
104.20
to
be
the
most
appropriate
reference
regarding
nutritional
supplementation
for
organic
foods.

(
12)
National
List
Petition
Process
as
Part
of
the
Final
Rule.

Commenters
have
requested
that
the
National
List
Petition
Process,
approved
by
the
NOSB
at
its
June
2000
meeting
(
and
published
in
the
Federal
Register
on
July
13,
2000),
be
included
in
the
final
rule.
We
do
not
agree
with
the
commenters,
and
we
have
retained
the
National
List
Petition
Process
regulation
language
from
the
proposed
rule.
We
have
separated
the
specific
petition
process
from
the
regulation
to
provide
for
maximum
flexibility
to
change
and
clarify
the
petition
process
to
accommodate
new
considerations
developed
during
the
NOP
implementation.
If
this
process
were
part
of
this
final
rule,
updates
to
the
petition
process
would
require
notice
and
comment
rulemaking.
Any
changes
in
the
National
List
that
may
be
a
result
of
the
petition
process,
however,
would
require
notice
and
comment
rulemaking.
261
(
13)
Nonapproved
Substance
Amendments
to
the
National
List.
Commenters
also
requested
to
have
many
substances
that
are
not
on
the
National
List
and
that
have
not
be
recommended
by
the
NOSB
for
use
in
organic
production
and
handling
be
added
to
the
National
List.
We
do
not
agree.
Amendments
to
the
National
List
must
be
petitioned
for
NOSB
consideration,
must
have
an
NOSB
recommendation,
and
must
be
published
for
public
comment
in
the
Federal
Register.

National
List
­
Clarifications
Clarification
is
given
on
the
following
issues
raised
by
commenters
as
follows:

(
1)
Inerts
Use
in
Botanical
or
Microbial
Pesticides.
Commenters
expressed
concern
that
the
prohibition
on
the
use
of
EPA
List
3
inerts
would
prevent
organic
producers
from
using
certain
botanical
or
microbial
formulated
products
that
are
currently
allowed
under
some
certification
programs.
These
commenters
requested
that
the
NOP
and
the
NOSB
expedite
the
evaluation
of
List
3
inerts
used
in
nonsynthetic
formulated
products
to
prevent
the
loss
of
certain
formulated
products.
The
prohibition
of
List
3
inerts
was
based
on
the
recommendation
of
the
NOSB
to
add
only
those
substances
from
List
4
to
the
National
List.
The
NOSB
also
recommended
that
individual
inert
substances
included
on
List
3
could
be
petitioned
for
addition
to
the
National
List.
The
NOP
has
requested
that
the
NOSB
identify
for
expedited
review
those
List
3
inerts
that
are
most
important
in
formulated
products
used
in
organic
production.

Individuals
may
petition
to
have
these
inerts
considered
for
inclusion
on
the
National
List.

Additionally,
the
NOP
will
work
with
the
EPA
and
the
registrants
of
formulated
products
to
expedite
review
of
List
3
inerts
currently
included
in
formulated
products
used
in
organic
production.
Unless
List
3
inerts
are
moved
to
List
4
or
individually
added
to
the
National
List,
262
they
are
prohibited
for
use
in
organic
production.

(
2)
Prohibiting
Ash,
Grit,
and
Screenings
Derived
from
Sewage
Sludge.
Many
commenters
recommended
that
the
ash,
grit,
and
screenings
derived
from
the
production
of
sewage
sludge
should
be
added
to
the
National
List
as
nonsynthetic
materials
prohibited
for
use
in
crop
production.
While
the
use
of
sewage
sludge,
including
ash,
grit,
and
screenings,
is
prohibited
in
organic
production,
we
did
not
add
them
to
the
National
List
as
prohibited
nonsynthetic
substances.
This
subject
is
discussed
further
under
subpart
A,
Definitions
­
Changes
Requested
But
Not
Made.

(
3)
Allowed
Uses
for
Pheromones.
Some
commenters
were
concerned
that
the
annotation
for
using
pheromones
as
"
insect
attractants"
was
too
limiting
and
would
not
include
uses
such
as
mating
disruption,
trapping,
and
monitoring.
The
annotation
for
pheromones
does
not
preclude
any
use
for
a
pheromone
that
is
otherwise
allowed
by
Federal,
State,
or
local
regulation.

(
4)
Nonagricultural
Products
as
Livestock
Feed
Ingredients.
Some
commenters
questioned
whether
nonsynthetic,
nonagricultural
substances
such
as
fishmeal
and
crushed
oyster
shell
needed
to
be
added
to
the
National
List
to
be
used
in
livestock
feed.
Nonsynthetic
substances
do
not
have
to
appear
on
the
National
List
and
may
be
used
in
organic
livestock
feed,

provided
that
they
are
used
in
compliance
with
the
FFDCA.
This
subject
is
discussed
further
under
item
4,
Livestock
­
Changes
Based
on
Comments,
subpart
C.

(
5)
Chlorine
Disinfectant
Limit
Annotation
for
Organic
Production
and
Handling.
Some
commenters
requested
clarification
on
the
annotation
for
using
chlorine
materials
as
an
allowed
synthetic
substance
in
crop
and
handling
operations.
The
annotation
in
the
proposed
rule,
which
263
has
been
retained
in
the
final
rule,
stated
that
"
residual
chlorine
levels
in
the
water
shall
not
exceed
the
maximum
residual
disinfectant
limit
under
the
Safe
Water
Drinking
Act."
With
this
annotation,
the
residual
chlorine
levels
at
the
point
where
the
waste
water
stream
leaves
the
production
or
handling
operation
must
meet
limits
under
the
Safe
Drinking
Water
Act.

(
6)
Tobacco
Use
in
Organic
Production.
One
commenter
questioned
whether
forms
of
tobacco
other
than
tobacco
dust,
such
as
water
extracts
or
smoke,
were
prohibited
nonsynthetic
substances.
The
technical
advisory
panel
(
TAP)
review
on
which
the
NOSB
based
its
recommendation
to
prohibit
tobacco
dust
identified
nicotine
sulfate
as
the
active
ingredient.

Therefore,
any
substance
containing
nicotine
sulfate
as
an
active
ingredient
is
prohibited
in
crop
production.

(
7)
Nonsynthetic
Agricultural
Processing
Aids
on
the
National
List.
A
commenter
requested
clarification
from
the
NOP
on
whether
processing
aids
(
e.
g.,
defoaming
agents),
which
are
nonsynthetic
and
nonorganic
agricultural
substances
(
e.
g.,
soybean
oil),
must
appear
on
the
National
List
when
used
in
processing.
In
the
this
regulation,
a
nonsynthetic
and
nonorganic
agricultural
product,
such
as
soybean
oil,
used
as
a
processing
aid
does
not
have
to
appear
on
the
National
List.
Such
products
are
included
in
the
provision
in
section
205.606
that
nonorganically
produced
agricultural
products
may
be
used
in
accordance
with
any
applicable
restrictions
when
the
substance
is
not
commercially
available
in
organic
form.

(
8)
Transparency
of
the
National
List
Petition
Process.
Some
commenters
stated
the
petition
process
for
amending
the
National
List
appears
to
have
limited
public
access
and
should
be
more
transparent.
These
commenters
advocate
that
any
amendments
to
the
National
List
should
be
subject
to
notice
and
comment.
They
also
requested
clarity
on
how
petitions
are
264
prioritized
and
reviewed
and
the
timeframes
for
review.
Additionally,
these
commenters
asked
the
NOP
to
expedite
the
review
of
materials
for
the
National
List.
On
July
13,
2000,
AMS
published
in
the
Federal
Register
(
Vol.
65,
43259­
43261)
guidelines
for
submitting
petitions
for
the
evaluations
of
substances
for
the
addition
to
or
removal
from
the
National
List.
In
this
notice,

the
NOP
stated
that
most
petition
information
is
available
for
public
inspection
with
the
exception
of
information
considered
to
be
"
confidential
business
information."
The
notice
also
specified
that
any
changes
to
the
National
List
must
be
published
in
the
Federal
Register
for
public
comment.

The
published
petition
notice
has
also
provided
an
indication
to
the
industry
about
the
urgency
of
the
need
for
substance
review
and
that
the
industry
should
provide
pertinent
information
to
the
NOSB
to
expedite
the
review
of
materials
not
on
the
National
List.

State
Organic
Programs
The
Act
provides
that
each
State
may
implement
an
organic
program
for
agricultural
products
that
have
been
produced
and
handled
within
the
State,
using
organic
methods
that
meet
the
requirements
of
the
Act
and
these
regulations.
The
Act
further
provides
that
a
State
organic
program
(
SOP)
may
contain
more
restrictive
requirements
for
organic
products
produced
and
handled
within
the
State
than
are
contained
in
the
National
Organic
Program
(
NOP).
All
SOP's
and
subsequent
amendments
thereto
must
be
approved
by
the
Secretary.

A
State
may
have
an
SOP
but
not
have
a
State
certifying
agent.
A
State
may
have
a
State
certifying
agent
but
no
SOP.
Finally,
a
State
may
have
an
SOP
and
a
State
certifying
agent.
In
all
cases,
the
SOP's
must
be
approved
by
the
Secretary.
In
all
cases,
the
State
certifying
agent
must
apply
for
and
receive
accreditation
to
certify
organic
production
or
handling
operations
pursuant
to
subpart
F.
265
In
States
with
an
approved
SOP,
the
SOP's
governing
State
official
is
responsible
for
administering
a
compliance
program
for
enforcement
of
the
NOP
and
any
more
restrictive
requirements
contained
in
the
SOP.
The
SOP
governing
State
officials
may
review
and
investigate
complaints
of
noncompliance
involving
organic
production
or
handling
operations
operating
within
their
State
and,
when
appropriate,
initiate
suspension
or
revocation
of
certification.
The
SOP
governing
State
officials
may
also
review
and
investigate
complaints
of
noncompliance
involving
accredited
certifying
agents
operating
within
their
State.
They
must
report
the
findings
of
any
review
and
investigation
of
a
certifying
agent
to
the
NOP
Program
Manager
along
with
any
recommendations
for
appropriate
action.
States
that
do
not
have
an
SOP
will
not
be
responsible
for
compliance
under
the
NOP,
except
that
an
accredited
State
certifying
agent
operating
within
such
State
will
have
compliance
responsibilities
under
the
NOP
as
a
condition
of
its
accreditation.

The
sections
covering
SOP's,
beginning
with
section
205.620,
establish:
(
1)
the
requirements
for
an
SOP
and
amending
such
a
program
and
(
2)
the
process
for
approval
of
an
SOP
and
amendments
to
the
SOP's.
Review
and
approval
of
an
SOP
will
occur
not
less
than
once
during
each
5­
year
period.
Review
related
to
compliance
matters
may
occur
at
any
time.

Description
of
Regulations
State
Organic
Program
Requirements
A
State
may
establish
an
SOP
for
production
and
handling
operations
within
the
State
that
produces
and
handles
organic
agricultural
products.
The
SOP
and
supporting
documentation
must
demonstrate
that
the
SOP
meets
the
requirements
for
organic
programs
specified
in
the
Act.

An
SOP
may
contain
more
restrictive
requirements
governing
the
production
and
handling
266
of
organic
products
within
the
State.
Such
requirements
must
be
based
on
environmental
conditions
or
specific
production
or
handling
practices
particular
to
the
State
or
region
of
the
United
States,
which
necessitates
the
more
restrictive
requirement.
More
restrictive
requirements
must
be
justified
and
shown
to
be
consistent
with
and
to
further
the
purposes
of
the
Act
and
the
regulations
in
this
part.
Requirements
necessitated
by
an
environmental
condition
that
is
limited
to
a
specific
geographic
area
of
the
State
should
only
be
required
of
organic
production
and
handling
operations
operating
within
the
applicable
geographic
area.
If
approved
by
the
Secretary,
the
more
restrictive
requirements
will
become
the
NOP
regulations
for
organic
producers
and
handlers
in
the
State
or
applicable
geographical
area
of
the
State.
All
USDAaccredited
certifying
agents
planning
to
operate
within
a
State
with
an
SOP
will
be
required
to
demonstrate
their
ability
to
comply
with
the
SOP's
more
restrictive
requirements.

No
provision
of
an
SOP
shall
discriminate
against
organic
agricultural
products
produced
by
production
or
handling
operations
certified
by
certifying
agents
accredited
or
accepted
by
USDA
pursuant
to
section
205.500.
Specifically,
an
SOP
may
not
discriminate
against
agricultural
commodities
organically
produced
in
other
States
in
accordance
with
the
Act
and
the
regulations
in
this
part.
Further,
an
SOP
may
not
discriminate
against
agricultural
commodities
organically
produced
by
production
or
handling
operations
certified
by
foreign
certifying
agents
operating
under:
(
1)
standards
determined
by
USDA
to
meet
the
requirements
of
this
part
or
(
2)

an
equivalency
agreement
negotiated
between
the
United
States
and
a
foreign
government.

To
receive
approval
of
its
SOP,
a
State
must
assume
enforcement
obligations
in
the
State
for
the
requirements
of
this
part
and
any
more
restrictive
requirements
included
in
the
SOP
and
approved
by
the
Secretary.
Specifically,
the
State
must
ensure
compliance
with
the
Act,
the
267
regulations
in
this
part,
and
the
provisions
of
the
SOP
by
certified
production
and
handling
operations
operating
within
the
State.
The
SOP
must
include
compliance
and
appeals
procedures
equivalent
to
those
provided
for
under
the
NOP.

An
SOP
and
any
amendments
thereto
must
be
approved
by
the
Secretary
prior
to
implementation
by
the
State.

State
Organic
Program
Approval
Process
An
SOP
and
subsequent
amendments
thereto
must
be
submitted
to
the
Secretary
by
the
SOP's
governing
State
official
for
approval
prior
to
implementation.
A
request
for
approval
of
an
SOP
must
contain
supporting
materials
that
include
statutory
authorities,
program
descriptions,

documentation
of
environmental
or
ecological
conditions
or
specific
production
and
handling
practices
particular
to
the
State
which
necessitate
more
restrictive
requirements
than
the
requirements
of
this
part,
and
other
information
as
may
be
required
by
the
Secretary.
A
request
for
amendment
of
an
approved
SOP
must
contain
supporting
materials
that
include
an
explanation
and
documentation
of
the
environmental
or
ecological
conditions
or
specific
production
practices
particular
to
the
State
or
region,
which
necessitate
the
proposed
amendment.
Supporting
material
also
must
explain
how
the
proposed
amendment
furthers
and
is
consistent
with
the
purposes
of
the
Act
and
the
regulations
in
this
part.

Each
request
for
approval
of
an
SOP
or
amendment
to
an
SOP
and
its
supporting
materials
and
documentation
will
be
reviewed
for
compliance
with
the
Act
and
these
regulations.

Within
6
months
of
receiving
the
request
for
approval,
the
Secretary
will
notify
the
SOP's
governing
State
official
of
approval
or
disapproval.
A
disapproval
will
include
the
reasons
for
disapproval.
A
State
receiving
a
notice
of
disapproval
of
its
SOP
or
amendment
to
its
SOP
may
268
submit
a
revised
SOP
or
amendment
to
its
SOP
at
any
time.

Review
of
State
Organic
Programs
SOP's
will
be
reviewed
at
least
once
every
5
years
by
the
Secretary
as
required
by
section
6507(
c)(
1)
of
the
Act.
The
Secretary
will
notify
the
SOP's
governing
State
official
of
approval
or
disapproval
of
the
program
within
6
months
after
initiation
of
the
review.

State
Organic
Programs
­
Changes
Based
on
Comments
This
portion
of
subpart
G
differs
from
the
proposal
in
several
respects
as
follows:

(
1)
Publication
of
SOP's
and
Consideration
of
Public
Comments.
Some
commenters
assert
that
the
USDA
should
not
publish
SOP
provisions
for
public
comment
in
the
Federal
Register.
These
commenters
argued
that
it
is
not
appropriate
for
the
NOP
to
have
nonresidents
commenting
on
a
particular
State
program
as
nearly
all
States
have
a
mechanism
to
ensure
full
public
participation
in
their
regulation
promulgation.
They
believe
the
comment
process
set
forth
in
the
proposed
rule
is
a
redundant
and
unacceptable
intrusion
on
State
sovereignty.

We
will
not
publish
for
public
comment
the
provisions
of
SOP's
under
review
by
the
Secretary
in
the
Federal
Register.
We
have
removed
the
provision
from
this
final
rule,
described
in
section
205.621(
b),
requiring
the
Secretary
to
publish
in
the
Federal
Register
for
public
comment
a
summary
of
the
SOP
and
a
summary
of
any
amendment
to
such
a
program.

Alternatively,
we
will
announce
which
SOP's
are
being
reviewed
through
the
NOP
website.
The
NOP
will
issue
public
information
notices
that
will
announce
each
approved
SOP
and
any
approved
amendments
to
an
existing
State
program.
The
notices
will
identify
the
characteristics
of
the
approved
State
program
that
warranted
the
more
restrictive
organic
production
or
handling
requirements.
We
also
will
include
a
summary
of
the
new
program
on
the
NOP
website.
269
(
2)
NOP
Oversight
of
SOP's.
Several
commenters
stated
that,
in
the
proposed
rule,
the
provisions
did
not
provide
a
comprehensive
description
of
organic
programs
operated
by
States
that
would
be
under
NOP
authority.
Some
commenters
implied
that
the
proposed
rule
would
only
include
States
with
organic
certification
programs,
while
other
commenters
inquired
whether
the
sections
205.620
to
205.622
included
other
SOP
activities
beyond
certification.

To
address
the
commenters'
concerns,
we
have
modified
the
section
heading
by
adding
the
term,
"
organic,"
and
removing
the
term,
"
certification,"
from
the
description
and
definition
of
SOP's.
We
have
taken
this
action
to
clarify
that,
while
certification
is
one
component
of
the
requirements,
it
does
not
define
the
extent
of
evaluation
of
State
programs
that
will
be
conducted
by
the
NOP.
SOP's
can
choose
not
to
conduct
certification
activities
under
their
existing
organic
program.
State
programs
whose
provisions
fall
within
the
scope
of
the
eleven
general
provisions
described
in
the
Act
(
7
U.
S.
C.
6506)
will
require
Departmental
review.

States
may
conduct
other
kinds
of
organic
programs
that
will
not
need
review
and
approval
by
the
NOP.
Examples
of
these
other
programs
may
include:
organic
promotion
and
research
projects,
marketing;
transition
assistance
or
cost
share
programs,
registration
of
State
organic
production
and
handling
operations,
registration
of
certifying
agents
operating
within
the
State,
or
a
consumer
referral
program.
The
NOP
will
not
regulate
such
State
activities.
Such
programs
may
not
advertise,
promote,
or
otherwise
infer
that
the
State's
organic
products
are
more
organic
or
better
than
organic
product
produced
in
other
States.
Such
programs
and
projects
would
be
beyond
the
scope
of
this
national
program
and
will
not
be
subject
to
the
Secretary's
review.

State
Organic
Programs
­
Changes
Requested
But
Not
Made
270
(
1)
Limitations
on
SOP
More
Restrictive
Requirements.
Commenters
expressed
concern
that
limiting
a
State's
ability
to
craft
a
regulation
designated
as
a
more
restrictive
requirement
to
environmental
conditions
or
specific
production
and
handling
practices
would
hinder
the
ongoing
development
of
SOP's.
They
were
concerned
that
any
State
legislation
modifying
the
SOP
would
need
to
be
preapproved
by
the
Secretary.

We
have
retained
the
provision
limiting
the
scope
of
more
restrictive
requirements
States
can
include
in
their
organic
program
as
described
in
section
205.620(
c).
We
believe
the
language
contained
in
the
provision
is
broad
enough
to
facilitate
the
development
of
SOP's
without
hindering
development
or
State
program
implementation
and
enforcement.
Section
6507(
b)(
1)
of
the
Act
provides
that
States
may
establish
more
restrictive
organic
certification
requirements;

paragraph
(
b)(
2)
establishes
parameters
for
those
requirements.
More
restrictive
SOP
requirements
must:
further
the
purposes
of
the
Act,
be
consistent
with
the
Act,
not
discriminate
against
other
State's
agricultural
commodities,
and
be
approved
by
the
Secretary
before
becoming
effective.
We
expect
that
a
State's
more
restrictive
requirements
are
likely
to
cover
specific
organic
production
or
handling
practices
to
address
a
State's
specific
environmental
conditions.

The
Secretary
will
approve
State's
requests
for
more
restrictive
State
requirements
that
are
consistent
with
the
purposes
of
the
Act.
However,
we
believe
requests
from
States
for
more
restrictive
requirements
will
be
rare.
Although
SOP's
can
impose
additional
requirements,
we
believe
States
will
be
reluctant
to
put
their
program
participants
at
a
competitive
disadvantage
when
compared
to
producers
and
handlers
in
other
States
absent
compelling
environmental
conditions
or
a
compelling
need
for
special
production
and
handling
practices.
While
preapproval
of
State
legislation
modifying
an
existing
SOP
is
not
required,
the
NOP
envisions
a
close
271
consultation
with
States
with
existing
programs
to
ensure
consistency
with
the
final
rule.

(
2)
SOP
Enforcement
Obligations.
Some
commenters
expressed
concern
about
States
having
adequate
resources
available
to
implement
enforcement
activities
that
they
are
obligated
to
conduct
under
the
NOP.
A
few
of
these
commenters
argue
that
the
enforcement
obligation
will
result
in
their
State
programs
being
discontinued.
A
few
commenters
cited
a
lack
of
federal
funding
to
support
State
enforcement
obligations
and
suggested
the
NOP
provide
funding
for
enforcement
activities.

The
proposed
rule
indicated
that
States
with
organic
programs
must
assume
enforcement
obligations
for
this
regulation
within
their
State.
We
have
retained
this
enforcement
obligation
in
section
205.620(
d).
Many
States
currently
have
organic
programs
with
the
kind
of
comprehensive
enforcement
and
compliance
mechanisms
necessary
for
implementing
any
State
regulatory
program.
Assuming
those
enforcement
activities
are
consistent
with
the
NOP,
this
final
rule
adds
no
additional
regulatory
burden
to
the
SOP's.
The
costs
associated
with
the
enforcement
activities
of
an
approved
SOP
should
be
similar
to
the
enforcement
costs
associated
with
the
existing
State
program.
Additional
clarification
of
SOP
enforcement
obligations
is
in
the
Accreditation,
Appeals,
and
Compliance
preamble
discussions.

(
3)
SOP
Evaluation
Notification
Period.
A
few
commenters
indicated
that
the
SOP
review
and
decision
notification
period
described
in
section
205.621(
b)
of
the
proposed
rule
could
hinder
a
State's
ability
to
develop
or
implement
an
SOP.
These
commenters
cited
potential
cases
in
which
particular
States
have
requirements
for
regulatory
promulgation
that
must
occur
within
6
months
under
a
State
legislative
session
that
is
held
once
every
2
years.
These
commenters
suggested
the
NOP
should
reduce
the
notification
time
to
1
to
3
months.
272
We
disagree
with
the
commenters.
In
the
proposed
rule
in
section
205.621(
b),
the
Secretary
is
required
to
notify
the
SOP's
governing
State
official
within
6
months
of
receipt
of
submission
of
documents
and
information
regarding
the
approval
of
the
SOP.
We
have
retained
this
time
period.
We
will
review
SOP
applications
as
quickly
as
possible
and
will
endeavor
to
make
decisions
in
less
than
6
months
whenever
possible.
However,
some
SOP's
may
be
very
complex
and
require
more
review
time.
The
NOP
envisions
working
closely
with
the
States
and
State
officials
to
ensure
a
smooth
transition
to
the
requirements
of
this
final
rule.

State
Organic
Programs
­
Clarifications
(
1)
Discrimination
Against
Organic
Products.
Several
commenters
requested
the
addition
of
a
provision
prohibiting
an
SOP
from
discriminating
against
agricultural
commodities
organically
produced
in
other
States.
Discrimination
by
a
State
against
organically
produced
agricultural
products
produced
in
another
State
is
prevented
in
two
ways.
First,
any
organic
program
administered
by
a
State
must
meet
the
requirements
for
organic
programs
specified
in
the
Act
and
be
approved
by
the
Secretary.
Finally,
a
USDA­
accredited
certifying
agent
must
accept
the
certification
decisions
made
by
another
USDA­
accredited
certifying
agent
as
its
own.

(
2)
Potential
Duplication
Between
the
Accreditation
and
SOP
Review
Process.
Some
commenters
asked
about
possible
duplication
between
the
process
for
reviewing
SOP's
and
the
process
of
accreditation
review.
These
commenters
have
asked
the
NOP
to
eliminate
any
duplication
that
may
exist
between
the
two
review
processes.
The
NOP
will
be
conducting
a
review
process
for
SOP's
and
a
separate
review
process
for
accrediting
State
and
private
certifying
agents.
The
two
reviews
are
different.
The
SOP
review
is
the
evaluation
of
SOP
compliance
with
the
Act
and
the
NOP
regulations.
If
approved,
the
SOP
becomes
the
NOP
273
standards
for
the
particular
State
with
which
all
certifying
agents
operating
in
that
State
must
comply.
Approved
SOP's
must
be
in
compliance
with
the
Act
and
the
NOP
regulations.
They
cannot
have
weaker
standards
than
the
NOP.
States
can
have
more
restrictive
requirements
than
the
NOP
if
approved
by
the
Secretary.

The
accreditation
review
is
an
evaluation
of
the
ability
of
certifying
agents
to
carry
out
their
responsibilities
under
the
NOP.
This
review
is
a
measure
of
the
competency
of
certifying
agents
to
evaluate
compliance
to
national
organic
standards.
Certifying
agents
will
not
be
unilaterally
establishing
regulations
or
standards
related
to
the
certification
of
organic
products.

They
will
only
provide
an
assessment
of
compliance.

Thus,
SOP
reviews
and
accreditation
reviews
are
separate
evaluations
of
different
procedures.
We
acknowledge
some
of
the
information
for
the
two
evaluations
may
be
similar;

e.
g.,
compliance
procedures.
The
reviews
do
not
duplicate
the
same
requirements.
However,
the
NOP
envisions
working
with
States
to
ensure
documentation
is
not
duplicated.

(
3)
Scope
of
Enforcement
by
States.
A
number
of
State
commenters
have
requested
clarification
on
the
proposed
rule
provision
specifying
that
approved
SOP's
must
assume
enforcement
obligations
in
their
State
for
the
requirements
of
the
NOP
and
any
additional
requirements
approved
by
the
Secretary.
These
commenters
have
indicated
that
they
remain
uncertain
as
to
what
is
expected
by
the
term,
"
enforcement
obligation."

Approved
SOP's
will
have
to
administer
and
provide
enforcement
of
the
requirements
of
the
Act
and
the
regulations
of
the
NOP.
The
administrative
procedures
used
by
the
State
in
administering
the
approved
SOP
should
have
the
same
force
and
effect
as
the
procedures
use
by
AMS
in
administering
this
program.
This
final
rule
specifies
that
the
requirements
for
274
environmental
conditions
or
for
special
production
and
handling
practices
are
necessary
for
establishing
more
restrictive
requirements.
These
factors
establish
our
position
that
a
State
must
agree
to
incurring
increased
enforcement
responsibilities
and
obligations
to
be
approved
as
an
SOP
under
the
NOP.
For
instance,
a
State
with
an
approved
organic
program
will
oversee
compliance
and
appeals
procedures
for
certified
organic
operations
in
the
State.
Those
procedures
must
provide
due
process
opportunities
such
as
rebuttal,
mediation,
and
correction
procedures.
Once
approved
by
the
Secretary,
the
State
governing
official
of
the
SOP
must
administer
the
SOP
in
a
manner
that
is
consistent
and
equitable
for
the
certified
parties
involved
in
compliance
actions.

(
4)
SOP's
That
Do
not
Certify
and
NOP
Oversight.
A
few
commenters
requested
that
the
NOP
develop
new
provisions
to
include
State
programs
that
have
organic
regulations
but
do
not
conduct
certification
activities.
These
commenters
argue
that
any
SOP
that
has
a
regulatory
impact
on
organic
producers,
regardless
of
whether
or
not
the
program
includes
certification,
be
approved
by
the
Secretary.

This
regulation,
in
section
205.620(
b),
provides
for
NOP
oversight
of
SOP's
that
do
not
conduct
certification
activities.

(
5)
State's
Use
of
Private
Certifying
Agents.
Some
commenters
have
requested
that
the
NOP
provide
clarification
of
the
proposed
rule
sections
205.620
through
205.622
on
how
these
sections
will
affect
States
that
delegate
certification
activities
to
private
certifying
agents.
These
commenters
asked
how
the
NOP
intends
to
oversee
this
type
of
State
activity.

The
NOP
intends
to
give
considerable
latitude
to
States
in
choosing
the
most
appropriate
system
or
procedures
to
structure
their
programs.
This
may
include
a
State
establishing
its
own
275
certifying
agent
or
relying
on
private
certifying
agents.
However,
States
will
not
be
accrediting
certifying
agents
operating
in
their
State.
Accreditation
of
all
certifying
agents
operating
in
the
United
States
is
the
responsibility
of
USDA.
Establishment
of
a
single
national
accreditation
program
is
an
essential
part
of
the
NOP.
As
stated
elsewhere
in
this
final
rule,
any
accreditation
responsibilities
of
a
State's
current
organic
program
will
cease
with
implementation
of
this
program.
Pursuant
to
the
Compliance
provisions
of
this
subpart,
the
governing
State
official
charged
with
compliance
oversight
under
the
SOP
may
investigate
and
notify
the
NOP
of
possible
compliance
violations
on
the
part
of
certifying
agents
operating
in
the
State.
However,
the
State
may
not
pursue
compliance
actions
or
remove
accreditation
of
any
certifying
agent
accredited
by
the
Secretary.
That
authority
is
the
sole
responsibility
of
the
Secretary.
If
more
restrictive
State
requirements
are
approved
by
the
Secretary,
we
will
review
certifying
agent
qualifications
in
the
State,
as
provided
by
section
205.501(
a)(
20),
and
determine
whether
they
are
able
to
certify
to
the
approved,
more
restrictive
requirements.
Our
accreditation
responsibilities
include
oversight
of
both
State
and
private
certifying
agents,
including
any
foreign
certifying
agents
that
may
operate
in
a
State.

Subpart
G
­
Fees
This
portion
of
subpart
G
sets
forth
the
regulations
on
fees
and
other
charges
to
be
assessed
for
accreditation
and
certification
services
under
the
National
Organic
Program
(
NOP).

These
regulations
address
the
kinds
of
fees
and
charges
to
be
assessed
by
the
U.
S.
Department
of
Agriculture
(
USDA)
for
the
accreditation
of
certifying
agents,
the
level
of
such
fees
and
charges,

and
the
payment
of
such
fees
and
charges.
These
regulations
also
address
general
requirements
to
be
met
by
certifying
agents
in
assessing
fees
and
other
charges
for
the
certification
of
producers
276
and
handlers
as
certified
organic
operations.
Finally,
these
regulations
address
the
Secretary's
oversight
of
a
certifying
agent's
fees
and
charges
for
certification
services.

Description
of
Regulation
Fees
and
Other
Charges
for
Accreditation
Fees
and
other
charges
will
be
assessed
and
collected
from
applicants
for
initial
accreditation
and
accredited
certifying
agents
submitting
annual
reports
or
seeking
renewal
of
accreditation.
Such
fees
will
be
equal
as
nearly
as
may
be
to
the
cost
of
the
accreditation
services
rendered
under
these
regulations.
Fees­
for­
service
will
be
based
on
the
time
required
to
render
the
service
provided
calculated
to
the
nearest
15­
minute
period.
Activities
to
be
billed
on
the
basis
of
time
used
include
the
review
of
applications
and
accompanying
documents
and
information,
evaluator
travel,
the
conduct
of
on­
site
evaluations,
review
of
annual
reports
and
updated
documents
and
information,
and
the
preparation
of
reports
and
any
other
documents
in
connection
with
the
performance
of
service.
The
hourly
rate
will
be
the
same
as
that
charged
by
the
Agricultural
Marketing
Service
(
AMS),
through
its
Quality
System
Certification
Program,
to
certification
bodies
requesting
conformity
assessment
to
the
International
Organization
for
Standardization
"
General
Requirements
for
Bodies
Operating
Product
Certification
Systems"

(
ISO
Guide
65).

Applicants
for
initial
accreditation
and
accredited
certifying
agents
submitting
annual
reports
or
seeking
renewal
of
accreditation
during
the
first
18
months
following
the
effective
date
of
subpart
F
will
receive
service
without
incurring
an
hourly
charge
for
such
service.

Applicants
for
initial
accreditation
and
renewal
of
accreditation
must
pay
at
the
time
of
application,
effective
18
months
following
the
effective
date
of
subpart
F,
a
nonrefundable
fee
of
277
$
500.00.
This
fee
will
be
applied
to
the
applicant's
fees­
for­
service
account.

When
service
is
requested
at
a
place
so
distant
from
the
evaluator's
headquarters
that
a
total
of
one­
half
hour
or
more
is
required
for
the
evaluator(
s)
to
travel
to
such
a
place
and
back
to
the
headquarters
or
from
a
place
of
prior
assignment
on
circuitous
routing
requiring
a
total
of
one­
half
hour
or
more
to
travel
to
the
next
place
of
assignment
on
the
circuitous
routing,
the
charge
for
such
service
will
include
all
applicable
travel
charges.
Travel
charges
may
include
a
mileage
charge
administratively
determined
by
USDA,
travel
tolls,
or,
when
the
travel
is
made
by
public
transportation
(
including
hired
vehicles),
a
fee
equal
to
the
actual
cost
thereof.
If
the
service
is
provided
on
a
circuitous
routing,
the
travel
charges
will
be
prorated
among
all
the
applicants
and
certifying
agents
furnished
the
service
involved.
Travel
charges
will
become
effective
for
all
applicants
for
initial
accreditation
and
accredited
certifying
agents
on
the
effective
date
of
subpart
F.
The
applicant
or
certifying
agent
will
not
be
charged
a
new
mileage
rate
without
notification
before
the
service
is
rendered.

When
service
is
requested
at
a
place
away
from
the
evaluator's
headquarters,
the
fee
for
such
service
shall
include
a
per
diem
charge
if
the
employee(
s)
performing
the
service
is
paid
per
diem
in
accordance
with
existing
travel
regulations.
Per
diem
charges
to
applicants
and
certifying
agents
will
cover
the
same
period
of
time
for
which
the
evaluator(
s)
receives
per
diem
reimbursement.
The
per
diem
rate
will
be
administratively
determined
by
USDA.
Per
diem
charges
shall
become
effective
for
all
applicants
for
initial
accreditation
and
accredited
certifying
agents
on
the
effective
date
of
subpart
F.
The
applicant
or
certifying
agent
will
not
be
charged
a
new
per
diem
rate
without
notification
before
the
service
is
rendered.

When
costs,
other
than
fees­
for­
service,
travel
charges,
and
per
diem
charges,
are
278
associated
with
providing
the
services,
the
applicant
or
certifying
agent
will
be
charged
for
these
costs.
Such
costs
include
but
are
not
limited
to
equipment
rental,
photocopying,
delivery,

facsimile,
telephone,
or
translation
charges
incurred
in
association
with
accreditation
services.

The
amount
of
the
costs
charged
will
be
determined
administratively
by
USDA.
Such
costs
will
become
effective
for
all
applicants
for
initial
accreditation
and
accredited
certifying
agents
on
the
effective
date
of
subpart
F.

Payment
of
Fees
and
Other
Charges
Applicants
for
initial
accreditation
and
renewal
of
accreditation
must
remit
the
nonrefundable
fee
along
with
their
application.
Remittance
must
be
made
payable
to
the
Agricultural
Marketing
Service,
USDA,
and
mailed
to:
Program
Manager,

USDA­
AMS­
TMP­
NOP,
Room
2945­
South
Building,
P.
O.
Box
96456,
Washington,
DC
20090­
6456
or
such
other
address
as
required
by
the
Program
Manager.
All
other
payments
for
fees
and
other
charges
must
be
received
by
the
due
date
shown
on
the
bill
for
collection,
made
payable
to
the
Agricultural
Marketing
Service,
USDA,
and
mailed
to
the
address
provided
on
the
bill
for
collection.
The
Administrator
will
assess
interest,
penalties,
and
administrative
costs
on
debts
not
paid
by
the
due
date
shown
on
a
bill
for
collection
and
collect
delinquent
debts
or
refer
such
debts
to
the
Department
of
Justice
for
litigation.

Fees
and
Other
Charges
for
Certification
Fees
charged
by
a
certifying
agent
must
be
reasonable,
and
a
certifying
agent
may
charge
applicants
for
certification
and
certified
production
and
handling
operations
only
those
fees
and
charges
that
it
has
filed
with
the
Administrator.
The
certifying
agent
must
provide
each
applicant
with
an
estimate
of
the
total
cost
of
certification
and
an
estimate
of
the
annual
cost
of
updating
279
the
certification.
The
certifying
agent
may
require
applicants
for
certification
to
pay
at
the
time
of
application
a
nonrefundable
fee
that
must
be
applied
to
the
applicant's
fees­
for­
service
account.
A
certifying
agent
may
set
the
nonrefundable
portion
of
certification
fees;
however,
the
nonrefundable
portion
of
certification
fees
must
be
explained
in
the
fee
schedule
submitted
to
the
Administrator.
The
fee
schedule
must
explain
what
fee
amounts
are
nonrefundable
and
at
what
stage
during
the
certification
process
the
respective
fees
become
nonrefundable.
The
certifying
agent
must
provide
all
persons
inquiring
about
the
application
process
with
a
copy
of
its
fee
schedule.

Fees
­
Changes
Based
on
Comments
This
subpart
differs
from
the
proposal
in
the
following
respects:

Nonrefundable
Portion
of
Certification
Fees.
Commenters
were
not
satisfied
with
the
provision
in
section
205.642
that
stated,
"
The
certifying
agent
may
require
applicants
for
certification
to
pay
at
the
time
of
application
a
nonrefundable
fee
of
no
more
than
$
250.00,
which
shall
be
applied
to
the
applicant's
fee
for
service
account."
Some
commenters
believed
we
were
requiring
the
certifying
agents
to
bill
fees
for
inspection
services
separately.
One
State
agency
expressed
a
concern
that
we
were
placing
a
limit
on
the
initial
fee
the
certifying
agent
could
collect.
As
a
result,
the
State
agency
commented
that
by
not
being
allowed
to
collect
the
full
certification
fee
at
the
time
of
application,
the
certifying
agent,
in
effect,
would
be
extending
credit
to
the
applicant.
Commenters
reported
that
some
State
agencies
are
prevented
by
statute
from
extending
credit
and
are
required
to
collect
all
fees
at
the
time
of
application.
Several
commenters
stated
that
the
amount
of
$
250.00
was
too
low
and
would
not
cover
the
costs
the
certifying
agents
could
incur
during
the
certification
process.
One
organization
noted
that
we
should
280
consider
prorating
the
amount
of
the
of
the
fee
to
be
refunded
when
an
applicant
for
certification
withdraws
before
the
completion
of
the
certification
process.
The
organization
recommended
that
the
amount
of
the
prorated
fee
should
be
based
on
how
far
along
in
the
certification
process
the
applicant
had
progressed
before
withdrawal.
Another
commenter
believed
it
was
inappropriate
for
USDA
to
set
any
fees
for
private
certification
programs
and
that
the
fees
should
be
market
driven.

It
was
not
our
intent
to
limit
the
initial
amount
that
certifying
agents
could
collect
from
the
applicant
for
certification.
Our
intent
was
to
limit
the
portion
of
the
fee
that
would
be
nonrefundable
in
order
to
reduce
the
potential
liability
for
the
small
producer/
handler
who
may
need
to
withdraw
prematurely
from
the
certification
process.
However,
we
acknowledge
that
this
provision
could
be
misinterpreted.
We
also
realize
that
certifying
agents
may
incur
initial
costs
during
the
preliminary
stage
of
the
certification
process
that
may
be
more
or
less
than
the
$
250.00
application
rate
proposed.
As
a
result,
we
have
removed
the
provision
that
stated
certifying
agents
could
collect
a
nonrefundable
fee
of
not
more
than
$
250.00
at
the
time
of
application
from
applicants
for
certification.

Certifying
agents
may
set
the
nonrefundable
portion
of
their
certification
fees.
However,

the
nonrefundable
portion
of
their
certification
fees
must
be
explained
in
the
fee
schedule
submitted
to
the
Administrator.
The
fee
schedule
must
explain
what
fee
amounts
are
nonrefundable
and
at
what
stage
during
the
certification
process
the
respective
fees
become
nonrefundable.
Certifying
agents
will
also
provide
all
persons
inquiring
about
the
application
process
with
a
copy
of
its
fee
schedule.

Fees
­
Changes
Requested
But
Not
Made
281
This
subpart
retains
from
the
proposed
rule
regulations
on
which
we
received
comments
as
follows:

(
1)
Farm
Subsidy/
Transition
Program.
Many
commenters
asked
that
USDA
subsidize
or
develop
a
cost­
share
program
for
small
farmers/
producers
who
are
certified
or
who
are
in
transition
to
organic
farming.
Some
commenters
wanted
these
costs
to
be
fully
subsidized;
a
few
commenters
suggested
that
USDA
pay
for
any
extra
site
visit
costs;
and
many
others
wanted
USDA
to
pay
premium
prices
to
farmers
for
their
products
during
the
period
of
transition
to
organic
production.
In
addition,
many
commenters
argued
that
USDA
should
fully
fund
certification
costs.
Finally,
many
commenters
suggested
that
the
USDA
should
provide
additional
financial
support
to
the
organic
industry
because
the
industry
is
relatively
young
and
composed
of
a
large
number
of
small,
low­
resource
businesses.

We
have
considered
the
commenters
requests
but
have
not
made
the
suggested
changes.

The
NOP
under
AMS
is
primarily
a
user­
fee­
based
Federal
program.
Section
2107(
a)(
10)
of
the
Organic
Food
Production
Act
of
1990
(
OFPA)
requires
that
the
NOP
provide
for
the
collection
of
reasonable
fees
from
producers,
certifying
agents,
and
handlers
who
participate
in
activities
to
certify,
produce,
or
handle
agricultural
products
as
organically
produced.
Therefore,
under
the
statutory
authority
of
OFPA,
it
is
outside
of
the
scope
of
the
NOP
to
provide
for
the
subsidization
of
producers,
handlers,
and
certifying
agents
as
desired
by
some
commenters.
We
have,
however,

established
provisions
in
this
part
that
we
believe
will
minimize
the
economic
impact
of
the
NOP
on
producers,
handlers,
and
certifying
agents.

(
2)
Small
Farmer
Exemption
Versus
Lower
Certification
Fees.
Many
commenters
suggested
that
certification
fees
be
lowered
or
based
on
a
sliding
scale
rather
than
instituting
an
282
exemption
from
certification
for
small
farmers
and
handlers.

We
have
not
accepted
the
commenters'
suggestion.
We
cannot
remove
the
small
farmer
exemption
because
section
2106(
d)
of
the
Act
requires
that
small
farmers
be
provided
an
exemption
from
organic
certification
if
they
sell
no
more
than
$
5,000
annually
in
value
of
agricultural
products.
Also,
certification
fees
cannot
be
lowered
by
USDA
because
NOP
under
AMS
is
primarily
a
user­
fee­
based
Federal
agency.
It
is
not
our
goal
or
objective
to
make
a
profit
on
our
accreditation
activities.
However,
our
fees
associated
with
the
accreditation
process
are
targeted
toward
recovering
costs
incurred
during
the
accreditation
process.
Commenters
expressed
a
concern
that
the
accreditation
fees
charged
by
USDA
would
have
an
impact
on
the
certification
fees
prescribed
by
certifying
agents
to
operations
seeking
organic
certification.
We
understand
the
commenters'
concern
that
accreditation
fees
charged
to
certifying
agents
will
most
likely
be
calculated
into
the
fees
that
certifiers
charge
their
clients.
However,
we
believe
that
our
provision
to
waive
the
hourly
service
charges
for
accreditation
during
the
first
18
months
of
implementation
of
the
NOP
should
help
reduce
accreditation
costs
of
the
certifying
agent
and
should,
therefore,
result
lower
certification
fee
charged
by
certifying
agents.
As
provided
by
the
Act
and
the
regulations
in
this
part,
fees
charged
by
certifying
agents
must
be
reasonable.
Also,

certifying
agents
must
submit
their
fee
schedule
to
the
Administrator
and
may
only
charge
those
fees
and
charges
filed
with
the
Administrator.
In
addition,
certifiers
are
required
to
provide
their
approved
fee
schedules
to
applicants
for
certification.
Therefore,
applicants
for
certification
will
be
able
to
base
their
selection
of
a
certifying
agent
on
price
if
they
choose.
Moreover,
there
are
no
provisions
in
the
regulations
that
preclude
certifying
agents
from
pricing
their
services
on
a
sliding
scale,
as
long
as
their
fees
are
consistent
and
nondiscriminatory
and
are
approved
during
283
the
accreditation
process.

(
3)
Accreditation
Fees.
Many
industry
commenters
suggested
that
we
reevaluate
our
accreditation
fee
structure.
They
believe
the
hourly
accreditation
rate
proposed
is
unacceptable.

Commenters
were
concerned
that
high
accreditation
costs
would
lead
to
high
certification
costs,

which
would
have
a
greater
impact
on
small
operations.
Some
industry
commenters
also
noted
that
we
should
be
required
to
provide
a
fee
schedule
such
as
the
certifiers
are
required
to
do.

They
stated
that
unless
USDA
provided
a
fee
schedule
that
included
travel
costs,
they
would
not
be
able
to
accurately
budget
for
these
costs.
A
few
commenters
wanted
USDA
to
forgo
charging
travel
costs
or
not
charge
travel
time
at
the
full
rate.
Several
commenters
also
stated
that
the
hourly
rate
stated
in
the
proposal
is
much
higher
than
what
the
people
who
actually
perform
the
accreditations
will
earn.
However,
a
large
majority
of
the
commenters
favored
the
18­
month
period
in
which
AMS
will
not
charge
the
hourly
accreditation
rate
to
applicants.

As
stated
in
the
proposal,
the
hourly
rate
will
be
the
same
as
that
of
AMS'
Quality
Systems
Certification
Program.
Due
to
the
fact
that
AMS'
Quality
Systems
Certification
Program
publishes
one
rate
that
is
readily
available
to
the
public,
it
is
our
belief
that
it
is
unnecessary
for
the
NOP
to
set
up
a
separate
fee
schedule.
The
NOP
will
notify
accredited
certifying
agents
and
applicants
for
accreditation
of
any
proposed
rate
changes
and
final
actions
on
such
rates
by
AMS.

We
will
also
periodically
report
the
status
of
fees
to
the
National
Organic
Standards
Board.

Those
applicants
and
certifying
agents
who
need
accreditation
cost
estimates,
including
travel,
for
budgetary
or
other
reasons
may
notify
the
NOP.
The
NOP
staff
will
provide
the
applicant
with
a
cost
estimate,
based
on
information
provided
by
the
applicant.
As
stated
in
an
earlier
response
((
2)
­
Changes
Requested
But
Not
Made),
the
objective
of
the
fee
that
is
charged
284
to
accredit
certifying
agents
is
not
to
gain
a
profit
for
accreditation
activities
but
to
recover
costs
incurred
during
the
accreditation
process.
As
such,
these
costs
include
but
are
not
limited
to
salaries,
benefits,
clerical
help,
equipment,
supplies,
etc.

Compliance
This
portion
of
subpart
G
sets
forth
the
enforcement
procedures
for
the
National
Organic
Program
(
NOP).
These
procedures
describe
the
compliance
responsibilities
of
the
NOP
Program
Manager,
State
organic
programs'
(
SOP)
governing
State
officials,
and
State
and
private
certifying
agents.
These
provisions
also
address
the
rights
of
certified
production
and
handling
operations
and
accredited
certifying
agents
operating
under
the
NOP.
The
granting
and
denial
of
certification
and
accreditation
are
addressed
under
subparts
E
and
F.

Description
of
Regulations
The
Secretary
is
required
under
the
Act
to
review
the
operations
of
SOP's,
accredited
certifying
agents,
and
certified
production
or
handling
operations
for
compliance
with
the
Act
and
these
regulations.
The
Program
Manager
of
the
NOP
may
carry
out
compliance
proceedings
and
provide
oversight
of
compliance
proceedings
on
behalf
of
the
Secretary
and
the
Administrator.

The
Program
Manager
will
initiate
proceedings
to
suspend
or
revoke
a
certified
operation's
certification
if
a
certifying
agent
or
SOP's
governing
State
official
fails
to
take
appropriate
enforcement
action.
The
Program
Manager
may
also
initiate
proceedings
to
suspend
or
revoke
a
certified
operation's
certification
if
the
operation
is
found
to
have
been
erroneously
certified
by
a
certifying
agent
whose
accreditation
has
been
suspended
or
revoked.
We
anticipate,
however,

that
most
investigations,
reviews,
and
analyses
of
certification
noncompliance
and
initiation
of
suspension
or
revocation
will
be
conducted
by
the
certified
operation's
certifying
agent.
With
285
regard
to
certifying
agents,
the
Program
Manager
will,
when
appropriate,
initiate
proceedings
to
suspend
or
revoke
the
accreditation
of
a
certifying
agent
for
noncompliance
with
the
Act
and
these
regulations.

In
States
with
an
approved
SOP,
the
SOP's
governing
State
official
is
responsible
for
administering
a
compliance
program
for
enforcement
of
the
NOP/
SOP.
SOP's
governing
State
officials
may
review
and
investigate
complaints
of
noncompliance
involving
organic
production
or
handling
operations
operating
within
their
State
and,
when
appropriate,
initiate
suspension
or
revocation
of
certification.
SOP's
governing
State
officials
may
also
review
and
investigate
complaints
of
noncompliance
involving
accredited
certifying
agents
operating
within
their
State.

They
must
report
the
findings
of
any
review
and
investigation
of
a
certifying
agent
to
the
Program
Manager
along
with
any
recommendations
for
appropriate
action.

The
compliance
provisions
of
the
NOP
are
consistent
with
the
requirements
of
the
Administrative
Procedure
Act
(
APA)
(
5
U.
S.
C.
553­
559)
in
that
this
program
provides
for
due
process
including
an
opportunity
for
hearing,
appeal
procedures,
written
notifications
of
noncompliance,
and
opportunities
to
demonstrate
or
achieve
compliance
before
any
suspension
or
revocation
of
organic
certification
or
accreditation
is
invoked.
A
compliance
action
regarding
certification
carried
out
under
an
approved
SOP's
compliance
procedures
will
have
the
same
force
and
effect
as
a
certification
compliance
action
carried
out
under
these
NOP
compliance
procedures.
The
notification
process
for
denying
certification
and
accreditation
is
laid
out
in
subparts
E
and
F,
respectively.

Each
notification
of
noncompliance,
rejection
of
mediation,
noncompliance
resolution,

proposed
suspension
or
revocation,
and
suspension
or
revocation
issued
under
these
regulations
286
must
be
sent
to
the
recipient's
place
of
business
via
a
delivery
service
which
provides
return
receipts.
Certified
operations
and
certifying
agents
must
respond
to
all
compliance
notifications
via
a
delivery
service
which
provides
return
receipts.

Noncompliance
Procedure
for
Certified
Operations
The
Act
provides
for
the
enforcement
of
certification
requirements.
Statutory
oversight
of
production
and
handling
operations
by
certifying
agents
includes
review
of
organic
plans,
on­
site
inspections,
residue
and
tissue
testing,
authority
to
conduct
investigations
and
initiate
suspension
or
revocation
actions,
and
responsibility
to
report
violations.

Notification
of
Noncompliance
A
written
notification
of
noncompliance
will
be
sent
to
the
certified
operation
when
an
inspection,
review,
or
investigation
reveals
any
noncompliance
with
the
Act
or
these
regulations.

A
noncompliance
notification
may
encompass
the
entire
operation
or
a
portion
of
the
operation.

For
instance,
a
violation
at
one
farm
may
not
warrant
loss
of
certification
at
other
farms
of
the
certified
operation
not
affected
by
the
violation.
The
notification
of
noncompliance
will
provide:

(
1)
a
description
of
each
condition,
action,
or
item
of
noncompliance;
(
2)
the
facts
upon
which
the
notification
is
based;
and
(
3)
the
date
by
which
the
certified
operation
must
rebut
the
notification
or
correct
the
noncompliance
and
submit
supporting
documentation
of
the
correction.
A
certified
operation
may
continue
to
sell
its
product
as
organic
upon
receiving
a
notification
of
noncompliance
and
throughout
the
compliance
proceeding
and
any
appeal
procedure
which
might
follow
the
compliance
proceeding
unless
otherwise
notified
by
a
State
or
Federal
government
agency.

If
a
certified
operation
believes
the
notification
of
noncompliance
is
incorrect
or
not
well­
287
founded,
the
certified
operation
may
submit
a
rebuttal
to
the
certifying
agent
or
SOP's
governing
State
official,
as
applicable,
providing
supporting
data
to
refute
the
facts
stated
in
the
notification.

The
opportunity
for
rebuttal
is
provided
to
allow
certifying
agents
and
certified
operations
to
informally
resolve
noncompliance
issues.
The
rebuttal
process
should
be
helpful
in
resolving
differences
which
may
be
the
result
of
misinterpretation
of
requirements,
misunderstandings,
or
incomplete
information.
Alternatively,
the
certified
operation
may
correct
the
identified
noncompliances
and
submit
proof
of
such
corrections.
When
the
certified
operation
demonstrates
that
each
noncompliance
has
been
corrected
or
otherwise
resolved,
the
certifying
agent
or
SOP's
governing
State
official,
as
applicable,
will
send
the
certified
operation
a
written
notification
of
noncompliance
resolution.

Proposed
Suspension
or
Revocation
of
Certification
If
the
noncompliance
is
not
resolved
or
is
not
in
the
process
of
being
resolved
by
the
date
specified
in
the
notification
of
noncompliance,
the
certifying
agent
or
SOP's
governing
State
official
will
send
the
certified
operation
a
written
notification
of
proposed
suspension
or
revocation
of
certification
for
the
entire
operation
or
a
portion
of
the
operation
affected
by
the
noncompliance.
The
notification
will
state:
(
1)
the
reasons
for
the
proposed
suspension
or
revocation;
(
2)
the
proposed
effective
date
of
the
suspension
or
revocation;
(
3)
the
impact
of
the
suspension
or
revocation
on
the
certified
operation's
future
eligibility
for
certification;
and
(
4)
that
the
certified
operation
has
a
right
to
request
mediation
or
to
file
an
appeal.
The
impact
of
a
proposed
suspension
or
revocation
may
include
the
suspension
or
revocation
period
or
whether
the
suspension
or
revocation
applies
to
the
entire
operation
or
to
a
portion
or
portions
of
the
operation.
288
If
a
certifying
agent
or
SOP's
governing
State
official
determines
that
correction
of
a
noncompliance
is
not
possible,
the
notification
of
noncompliance
and
the
proposed
suspension
or
revocation
of
certification
may
be
combined
in
one
notification
of
proposed
suspension
or
revocation.
The
certified
operation
will
have
an
opportunity
to
appeal
the
proposed
suspension
or
revocation.

If
a
certifying
agent
or
SOP's
governing
State
official
has
reason
to
believe
that
a
certified
operation
has
willfully
violated
the
Act
or
regulations,
a
notification
of
proposed
suspension
or
revocation
will
be
sent
to
the
certified
operation.
The
proposed
suspension
or
revocation
will
be
for
the
entire
operation
or
a
portion
of
the
operation.
This
notification,
because
it
involves
a
willful
violation,
will
be
sent
without
first
issuing
a
notification
of
noncompliance.

Mediation
A
production
or
handling
operation
may
request
mediation
of
any
dispute
regarding
denial
of
certification
or
proposed
suspension
or
revocation
of
certification.
Mediation
is
not
required
prior
to
filing
an
appeal
but
is
offered
as
an
option
which
may
resolve
the
dispute
more
quickly
than
the
next
step,
which
is
filing
an
appeal.
When
mediation
is
requested,
it
must
be
requested
in
writing
to
the
applicable
certifying
agent.
The
certifying
agent
will
have
the
option
of
accepting
or
rejecting
the
request
for
mediation.
If
the
certifying
agent
rejects
the
request
for
mediation,
the
certifying
agent
must
provide
written
notification
to
the
applicant
for
certification
or
certified
operation.
The
written
notification
must
advise
the
applicant
for
certification
or
certified
operation
of
the
right
to
request
an
appeal
in
accordance
with
section
205.681.
Any
such
appeal
must
be
requested
within
30
days
of
the
date
of
the
written
notification
of
rejection
of
the
request
for
mediation.
If
mediation
is
accepted
by
the
certifying
agent,
such
mediation
must
be
conducted
289
by
a
qualified
mediator
mutually
agreed
upon
by
the
parties
to
the
mediation.
If
an
SOP
is
in
effect,
the
mediation
procedures
established
in
the
SOP,
as
approved
by
the
Secretary,
must
be
followed.
The
parties
to
the
mediation
will
have
no
more
than
30
days
to
reach
an
agreement
following
a
mediation
session.
If
mediation
is
unsuccessful,
the
production
or
handling
operation
will
have
30
days
from
termination
of
mediation
to
appeal
the
denial
of
certification
or
proposed
suspension
or
revocation
in
accordance
with
the
appeal
procedures
in
section
205.681.

Any
agreement
reached
during
or
as
a
result
of
the
mediation
process
must
be
in
compliance
with
the
Act
and
these
regulations.
The
Secretary
reserves
the
right
to
review
any
mediated
agreement
for
conformity
to
the
Act
and
these
regulations
and
to
reject
any
agreement
or
provision
not
in
conformance
with
the
Act
or
these
regulations
Suspension
or
Revocation
The
certifying
agent
or
SOP's
governing
State
official
will
suspend
or
revoke
the
certified
operation's
certification
when
the
operation
fails
to
resolve
the
issue
through
rebuttal
or
mediation,
fails
to
complete
needed
corrections,
or
does
not
file
an
appeal.
The
operation
will
be
notified
of
the
suspension
or
revocation
by
written
notification.
The
certifying
agent
or
SOP's
governing
State
official
must
not
send
a
notification
of
suspension
or
revocation
to
a
certified
operation
that
has
requested
mediation
or
filed
an
appeal
while
final
resolution
of
either
is
pending.

The
decision
to
suspend
or
revoke
certification
will
be
based
on
the
seriousness
of
the
noncompliance.
Such
decisions
must
be
made
on
a
case­
by­
case
basis.
Section
6519
of
the
Act
establishes
that
willful
violations
include
making
a
false
statement,
knowingly
affixing
a
false
label,

or
otherwise
violating
the
purposes
of
the
Act.
290
In
addition
to
suspension
or
revocation,
a
certified
operation
that
knowingly
sells
or
labels
a
product
as
organic,
except
in
accordance
with
the
Act,
will
be
subject
to
a
civil
penalty
of
not
more
than
$
10,000
per
violation.
Further,
a
certified
operation
that
makes
a
false
statement
under
the
Act
to
the
Secretary,
an
SOP's
governing
State
official,
or
a
certifying
agent
will
be
subject
to
the
provisions
of
section
1001
of
title
18,
United
States
Code.

A
certified
operation
whose
certification
has
been
suspended
under
this
section
may
at
any
time,
unless
otherwise
stated
in
the
notification
of
suspension,
submit
a
request
to
the
Secretary
for
reinstatement
of
its
certification.
The
request
must
be
accompanied
by
evidence
demonstrating
correction
of
each
noncompliance
and
corrective
actions
taken
to
comply
with
and
remain
in
compliance
with
the
Act
and
the
NOP.

A
certified
operation
or
a
person
responsibly
connected
with
an
operation
that
has
had
its
certification
revoked
will
be
ineligible
to
receive
certification
for
an
operation
in
which
such
operation
or
person
has
an
interest
for
5
years
following
the
date
of
revocation.
Accordingly,
an
operation
will
be
ineligible
for
organic
certification
if
one
of
its
responsibly
connected
parties,
was
a
responsibly
connected
party
of
an
operation
that
had
its
certification
revoked.
The
Secretary
may,
when
in
the
best
interest
of
the
certification
program,
reduce
or
eliminate
the
period
of
ineligibility.

Noncompliance
Procedure
for
Certifying
Agents
The
Program
Manager,
on
behalf
of
the
Secretary,
may
initiate
a
compliance
action
against
an
accredited
certifying
agent
who
violates
the
Act
or
these
regulations.
Compliance
proceedings
may
be
initiated
as
a
result
of
annual
reviews
for
continuation
of
accreditation,
site
evaluations,
or
investigations
initiated
in
response
to
complaints
of
noncompliant
activities.
291
Compliance
proceedings
also
may
be
initiated
on
recommendation
of
an
SOP's
governing
State
official.

A
written
notification
of
noncompliance
will
be
sent
by
the
Program
Manager
to
an
accredited
certifying
agent
when
an
inspection,
review,
or
investigation
of
such
person
reveals
any
noncompliance
with
the
Act
or
these
regulations.
A
notification
of
noncompliance
will
provide
a
description
of
each
noncompliance
found
and
the
facts
upon
which
the
notification
is
based.

Additionally,
the
notification
will
provide
the
date
by
which
the
certifying
agent
must
rebut
or
correct
each
noncompliance
described
and
submit
supporting
documentation
of
each
correction.

When
documentation
received
by
the
Program
Manager
demonstrates
that
each
noncompliance
has
been
resolved,
the
Program
Manager
will
send
the
certifying
agent
a
written
notification
of
noncompliance
resolution.

If
a
noncompliance
is
not
resolved
by
rebuttal
or
correction,
the
Program
Manager
will
issue
a
notification
of
proposed
suspension
or
revocation
of
accreditation.
The
notification
will
state
whether
the
suspension
or
revocation
will
be
for
the
certifying
agent's
entire
accreditation,

that
portion
of
the
accreditation
applicable
to
a
particular
field
office,
or
a
specific
area
of
accreditation.
For
instance,
if
a
certifying
agent
with
field
offices
in
different
geographic
areas
is
cited
for
a
compliance
violation
at
one
field
office,
the
Program
Manager
could
determine
that
only
that
portion
of
the
accreditation
applicable
to
the
noncompliant
field
office
should
be
suspended
or
revoked.

If
the
Program
Manager
determines
that
the
noncompliance
cannot
be
immediately
or
easily
corrected,
the
Program
Manager
may
combine
the
notification
of
noncompliance
and
the
proposed
suspension
or
revocation
in
one
notification.
292
The
notification
of
proposed
suspension
or
revocation
of
accreditation
will
state
the
reasons
and
effective
date
for
the
proposed
suspension
or
revocation.
Such
notification
will
also
state
the
impact
of
a
suspension
or
revocation
on
future
eligibility
for
accreditation
and
the
certifying
agent's
right
to
file
an
appeal.

If
the
Program
Manager
has
reason
to
believe
that
a
certifying
agent
has
willfully
violated
the
Act
or
regulations,
the
Program
Manager
will
issue
a
notification
of
proposed
suspension
or
revocation
of
accreditation.
The
proposed
suspension
or
revocation
may
be
for
the
certifying
agent's
entire
accreditation,
that
portion
of
the
accreditation
applicable
to
a
particular
field
office,

or
a
specified
area
of
accreditation.
This
notification,
because
it
involves
a
willful
violation,
will
be
sent
without
first
issuing
a
notification
of
noncompliance.

The
certifying
agent
may
file
an
appeal
of
the
Program
Manager's
determination
pursuant
to
section
205.681.
If
the
certifying
agent
fails
to
file
an
appeal
of
the
proposed
suspension
or
revocation,
the
Program
Manager
will
suspend
or
revoke
the
certifying
agent's
accreditation.
The
certifying
agent
will
be
notified
of
the
suspension
or
revocation
by
written
notification.

A
certifying
agent
whose
accreditation
is
suspended
or
revoked
must
cease
all
certification
activities
in
each
area
of
accreditation
and
in
each
State
for
which
its
accreditation
is
suspended
or
revoked.
Any
certifying
agent
whose
accreditation
has
been
suspended
or
revoked
must
transfer
to
the
Secretary
all
records
concerning
its
certification
activities
that
were
suspended
or
revoked.

The
certifying
agent
must
also
make
such
records
available
to
any
applicable
SOP's
governing
State
official.
The
records
will
be
used
to
determine
whether
operations
certified
by
the
certifying
agent
may
retain
their
organic
certification.

A
certifying
agent
whose
accreditation
is
suspended
by
the
Secretary
may
at
any
time,
293
unless
otherwise
stated
in
the
notification
of
suspension,
submit
a
request
to
the
Secretary
for
reinstatement
of
its
accreditation.
Such
request
must
be
accompanied
by
evidence
demonstrating
correction
of
each
noncompliance
and
actions
taken
to
comply
with
and
remain
in
compliance
with
the
Act
and
regulations.
A
certifying
agent
whose
accreditation
is
revoked
by
the
Secretary
will
be
ineligible
to
be
accredited
as
a
certifying
agent
under
the
Act
and
regulations
for
a
period
of
not
less
than
3
years
following
the
date
of
revocation.

State
Organic
Programs'
Compliance
Procedures
An
SOP's
governing
State
official
may
initiate
noncompliance
proceedings
against
certified
organic
operations
operating
in
the
State.
Such
proceedings
may
be
initiated
for
failure
of
a
certified
operation
to
meet
the
production
or
handling
requirements
of
this
part
or
the
State's
more
restrictive
requirements,
as
approved
by
the
Secretary.

The
SOP's
governing
State
official
must
promptly
notify
the
Program
Manager
of
commencement
of
noncompliance
proceedings
initiated
against
certified
operations
and
forward
to
the
Program
Manager
a
copy
of
each
notice
issued.
A
noncompliance
proceeding,
brought
by
an
SOP's
governing
State
official
against
a
certified
operation
may
be
appealed
in
accordance
with
the
appeal
procedures
of
the
SOP.
There
will
be
no
subsequent
rights
of
appeal
to
the
Secretary.
Final
decisions
of
a
State
may
be
appealed
to
the
United
States
District
Court
for
the
district
in
which
such
certified
operation
is
located.

An
SOP's
governing
State
official
may
review
and
investigate
complaints
of
noncompliance
with
the
Act
or
regulations
concerning
accreditation
of
certifying
agents
operating
in
the
State.
When
such
review
or
investigation
reveals
any
noncompliance,
the
SOP's
governing
State
official
must
send
a
written
report
of
noncompliance
to
the
Program
Manager.
The
SOP's
294
governing
State
official's
report
must
provide
a
description
of
each
noncompliance
and
the
facts
upon
which
the
noncompliance
is
based.

Compliance
­
Changes
Based
On
Comments
This
portion
of
subpart
G
differs
from
the
proposal
in
several
respects
as
follows:

(
1)
Written
Notifications.
We
have
added
a
new
paragraph
(
d)
to
section
205.660.
The
preamble
to
the
proposed
rule
stated
that
all
written
notifications
sent
by
certifying
agents
and
SOP's
governing
State
officials,
as
well
as
rebuttals,
requests
for
mediation,
and
notices
of
correction
of
noncompliances
sent
by
certified
operations,
will
be
sent
to
the
addressee's
place
of
business
by
a
delivery
service
which
provides
dated
return
receipts.
The
assurance
of
completed
communications
and
timely
compliance
procedures
was
given
as
the
reason
for
delivery
by
a
service
which
provides
dated
return
receipts.
The
addition
of
paragraph
(
d)
at
section
205.660
is
one
of
the
actions
that
we
have
taken
in
response
to
requests
from
commenters
that
we
further
clarify
the
compliance
process.
Paragraph
(
d)
requires
that
each
notification
of
noncompliance,

rejection
of
mediation,
noncompliance
resolution,
proposed
suspension
or
revocation,
and
suspension
or
revocation
issued
in
accordance
with
sections
205.662,
205.663,
and
205.665
and
each
response
to
such
notification
must
be
sent
to
the
recipient's
place
of
business
via
a
delivery
service
which
provides
return
receipts.
This
action
will
facilitate
the
effective
administration
of
the
compliance
process
by
assuring
a
verifiable
time
line
on
the
issuance
and
receipt
of
compliance
documents
and
the
response
given
to
each
such
document.

(
2)
Determination
of
Willful.
The
preamble
statement
that
"
only
the
Program
Manager
or
governing
State
official
may
make
the
final
determination
that
a
violation
is
willful"
was
incorrect
and
inconsistent
with
the
regulatory
language
in
section
205.662(
d).
Section
205.662(
d)
provides
295
that,
"
if
a
certifying
agent
or
State
organic
program's
governing
State
official
has
reason
to
believe
that
a
certified
operation
has
willfully
violated
the
Act
or
regulations
in
this
part,
the
certifying
agent
or
State
organic
program's
governing
State
official
shall
send
the
certified
operation
a
notification
of
proposed
suspension
or
revocation
of
certification
of
the
entire
operation
or
a
portion
of
the
operation,
as
applicable
to
the
noncompliance."
Accordingly,
as
recommended
by
a
commenter,
the
incorrect
statement
has
been
deleted
from
the
preamble
to
this
final
rule.

(
3)
Proposed
Suspension
or
Revocation.
We
have
amended
sections
205.662(
c)
and
205.665(
c)
by
removing
the
redundant
phrase
"
or
is
not
adequate
to
demonstrate
that
each
noncompliance
has
been
corrected"
from
the
first
sentence
of
each
section.

(
4)
Suspension
or
Revocation.
We
have
amended
section
205.662(
e)(
2)
by
adding
"
while
final
resolution
of
either
is
pending"
to
the
end
thereof.
The
language
of
section
205.662(
e)(
2)

now
reads:
"
A
certifying
agent
or
State
organic
program's
governing
State
official
must
not
send
a
notification
of
suspension
or
revocation
to
a
certified
operation
that
has
requested
mediation
pursuant
to
section
205.663
or
filed
an
appeal
pursuant
to
section
205.681
while
final
resolution
of
either
is
pending."
We
have
made
this
change
because
we
agree
with
those
commenters
who
expressed
the
belief
that
section
205.662(
e)(
2)
needed
to
be
amended
to
clarify
the
duration
of
the
stay
on
the
issuance
of
a
notification
of
suspension
or
revocation
when
mediation
is
requested
or
an
appeal
is
filed.
Several
commenters
stated
that
section
205.662(
e)(
2)
needed
to
be
amended
to
clarify
that
requesting
mediation
or
filing
an
appeal
does
not
indefinitely
stop
the
suspension
or
revocation
process.

(
5)
Eligibility
After
Suspension
or
Revocation
of
Certification.
We
have
amended
section
296
205.662(
f)
such
that
it
now
parallels
section
205.665(
g)
which
addresses
suspension
and
revocation
of
certifying
agents.
We
have
also
changed
the
title
of
section
205.662(
f)
from
"
Ineligibility"
to
"
Eligibility"
to
parallel
section
205.665(
g).
A
few
commenters
referred
to
the
provisions
in
section
205.665(
g),
which
addresses
eligibility
after
suspension
or
revocation
of
accreditation,
and
requested
clarification
of
the
difference
between
suspension
and
revocation
of
certification.
Upon
reviewing
section
205.662(
f),
we
decided
that
amendment
was
needed
to
clarify
the
difference
between
suspension
and
revocation
of
certification
relative
to
eligibility
for
certification.
Accordingly,
we
added
a
new
paragraph
(
1)
which
provides
that
a
certified
operation
whose
certification
has
been
suspended
under
this
section
may
at
any
time,
unless
otherwise
stated
in
the
notification
of
suspension,
submit
a
request
to
the
Secretary
for
reinstatement
of
its
certification.
The
paragraph
also
provides
that
the
request
must
be
accompanied
by
evidence
demonstrating
correction
of
each
noncompliance
and
corrective
actions
taken
to
comply
with
and
remain
in
compliance
with
the
Act
and
the
regulations
in
this
part.
We
also
amended
what
is
now
paragraph
(
2)
of
section
205.662(
f)
to
clarify
that
the
period
of
ineligibility
following
revocation
of
certification
is
5
years
unless
reduced
or
eliminated
by
the
Secretary.

Further,
we
have
amended
section
205.665(
g)(
1)
to
clarify
that
a
certifying
agent
that
has
had
its
accreditation
suspended
may
request
reinstatement
of
its
accreditation
rather
than
submit
a
new
request
for
accreditation.
The
amendment
also
clarifies
that
the
reinstatement
may
be
requested
at
any
time
unless
otherwise
stated
in
the
notification
of
suspension.
This
amendment
makes
section
205.665(
g)(
1)
similar
to
new
paragraph
(
1)
of
section
205.662(
f).
This
amendment
is
also
consistent
with
commenter
desires
that
the
noncompliance
procedures
for
certified
297
operations
and
accredited
certifying
agents
be
similar.

(
6)
Penalties
for
Violations
of
the
Act.
We
have
amended
section
205.662
by
adding
a
new
paragraph
(
g)
which
incorporates
therein
the
provisions
of
paragraphs
(
a)
and
(
b)
of
section
2120,
7
U.
S.
C.
6519,
Violations
of
Title,
of
the
Act.
Specifically,
paragraph
(
g)
provides
that,
in
addition
to
suspension
or
revocation,
any
certified
operation
that
knowingly
sells
or
labels
a
product
as
organic,
except
in
accordance
with
the
Act,
shall
be
subject
to
a
civil
penalty
of
not
more
than
$
10,000
per
violation.
This
paragraph
also
provides
that
any
certified
operation
that
makes
a
false
statement
under
the
Act
to
the
Secretary,
an
SOP's
governing
State
official,
or
a
certifying
agent
shall
be
subject
to
the
provisions
of
section
1001
of
title
18,
United
States
Code.

Commenters
requested
regulatory
language
citing
section
2120,
7
USC
6519,
Violations
of
Title,

of
the
Act.
Commenters
also
requested
a
clearer
description
of
enforcement.
Specifically,
they
want
provisions
describing
how
USDA
will
deal
with
operations
that
make
false
claims
or
do
not
meet
the
NOP
requirements.
Further,
numerous
commenters
expressed
concern
that
there
are
no
penalties
in
the
regulations
other
than
suspension
and
revocation.
The
European
Community
stated
that
it
did
not
find,
in
the
proposal,
requirements
for
penalties
to
be
applied
by
certifying
agents
when
irregularities
or
infringements
are
found.
The
European
Community
went
on
to
say
that
the
European
Union
requires
such
penalties.

The
Act
provides
for
suspension
and
revocation
of
certification
and
the
civil
and
criminal
penalties
addressed
in
7
U.
S.
C.
6519.
Certified
operations
are
also
required
through
the
compliance
program
set
forth
in
these
regulations,
to
correct
all
noncompliances
with
the
Act
or
regulations
as
a
condition
of
retaining
their
certification.
Furthermore,
to
get
a
suspended
certification
reinstated,
an
operation
must
submit
a
request
to
the
Secretary.
The
request
must
be
298
accompanied
by
evidence
demonstrating
correction
of
each
noncompliance
and
corrective
actions
taken
to
comply
with
and
remain
in
compliance
with
the
Act
and
the
regulations
in
this
part.
An
operation
or
a
person
responsibly
connected
with
an
operation
whose
certification
has
been
revoked
will
be
ineligible
to
receive
certification
for
a
period
of
not
more
than
5
years.

We
believe
adding
paragraph
(
g)
will
help
clarify
that
there
are
penalties
which
may
be
imposed
on
certified
operations
that
violate
the
Act
and
these
regulations
in
addition
to
suspension
or
revocation.

The
provisions
of
the
Act
and
these
regulations
apply
to
all
persons
who
sell,
label,
or
represent
their
agricultural
product
as
organic.
Accordingly,
persons
who
falsely
sell,
label,
or
represent
their
product
as
organic,
are
subject
to
the
provisions
of
paragraphs
(
a)
and
(
b)
of
section
2120,
7
USC
6519,
of
the
Act.
To
clarify
this,
we
have
added
a
new
paragraph
(
c)
to
section
205.100
of
the
Applicability
subpart.

Certifying
agents,
SOP's
governing
State
officials,
and
USDA
will
receive
complaints
alleging
violations
of
the
Act
or
these
regulations.
Certifying
agents
will
review
all
complaints
that
they
receive
to
determine
if
the
complaint
involves
one
of
their
clients.
If
the
complaint
involves
a
client
of
the
certifying
agent,
the
agent
will
handle
the
complaint
in
accordance
with
its
procedures
for
reviewing
and
investigating
certified
operation
compliance.
If
the
complaint
involves
a
person
who
is
not
a
client
of
the
certifying
agent,
the
certifying
agent
will
refer
the
complaint
to
the
SOP's
governing
State
official,
when
applicable,
or,
in
the
absence
of
an
applicable
SOP's
governing
State
official,
the
Administrator.
SOP's
governing
State
officials
will
review
all
complaints
that
they
receive
in
accordance
with
their
procedures
for
reviewing
and
investigating
alleged
violations
of
the
NOP
and
SOP.
The
SOP's
governing
State
official's
299
review
of
the
complaint
could
result
in
referral
of
the
complaint
to
a
certifying
agent
when
the
complaint
involves
a
client
of
the
certifying
agent,
dismissal,
or
investigation
by
the
SOP's
governing
State
official.
SOP's
governing
State
officials
will,
as
appropriate,
investigate
allegations
of
violations
of
the
Act
by
noncertified
operations
operating
within
their
State.
USDA
will
review
all
complaints
that
it
receives
in
accordance
with
its
procedures
for
reviewing
and
investigating
alleged
violations
of
the
NOP.
USDA
will
refer
complaints
alleging
violations
of
the
NOP/
SOP
to
the
applicable
SOP's
governing
State
official,
who
may,
in
turn,
refer
the
complaint
to
the
applicable
certifying
agent.
In
States
without
an
approved
SOP,
USDA
will
refer
complaints
to
the
applicable
certifying
agent.
USDA
will,
as
appropriate,
investigate
allegations
of
violations
of
the
Act
by
noncertified
operations
operating
in
States
where
there
is
no
approved
SOP.

(
7)
Mediation.
We
have
amended
section
205.663
by
providing
that
a
dispute
with
respect
to
proposed
suspension
or
revocation
of
certification
may,
rather
than
shall,
be
mediated.

We
have
also
provided
that
mediation
must
be
requested
in
writing
to
the
applicable
certifying
agent.
The
certifying
agent
will
have
the
option
of
accepting
or
rejecting
the
request
for
mediation.
If
the
certifying
agent
rejects
the
request
for
mediation,
the
certifying
agent
must
provide
written
notification
to
the
applicant
for
certification
or
certified
operation.
The
written
notification
must
advise
the
applicant
for
certification
or
certified
operation
of
the
right
to
request
an
appeal
within
30
days
of
the
date
of
the
written
notification
of
rejection
of
the
request
for
mediation.
If
mediation
is
accepted
by
the
certifying
agent,
such
mediation
must
be
conducted
by
a
qualified
mediator
mutually
agreed
upon
by
the
parties
to
the
mediation.

Several
commenters
wanted
section
205.663
amended
to
provide
that
disputes
"
may,"
300
rather
than
"
shall,"
be
mediated.
The
commenters
advocated
allowing
the
certifying
agent
to
determine
when
mediation
is
a
productive
option.
Several
State
commenters
wanted
to
amend
the
second
sentence
to
read
as
follows:
"
If
a
State
organic
program
is
in
effect,
the
mediation
procedures
established
in
the
State
orgnic
program,
as
approved
by
the
Secretary,
will
be
followed
for
cases
involving
the
State
organic
program
and
its
applicants
or
certified
parties."

Another
commenter
wanted
to
retain
the
requirement
that
disputes
"
shall"
be
mediated
but
wanted
disputes
mediated
in
accordance
with
7
CFR
Part
11
and
section
205.681
of
these
regulations.

We
concur
that
certifying
agents
should
be
authorized
to
reject
a
request
for
mediation,

especially
when
they
believe
that
the
noncompliance
issue
is
not
conducive
to
mediation.

Accordingly,
we
amended
section
205.663
as
noted
above.
We
disagree,
however,
with
the
State
commenters
who
want
to
amend
the
second
sentence.
We
believe
that
the
recommended
change
would
exclude
the
clients
of
private­
sector
certifying
agents
operating
within
the
State.
USDA
approval
of
an
SOP
will
require
that
all
certified
operations
operating
within
the
State
have
the
same
opportunities
for
mediation,
regardless
of
whether
they
are
certified
by
a
private
or
State
certifying
agent.
If
an
approved
SOP
provides
for
mediation,
such
mediation
must
be
available
to
all
certified
operations
operating
within
the
State.
We
also
disagree
with
the
commenter
who
requested
that
disputes
be
mediated
in
accordance
with
7
CFR
Part
11
and
section
205.681
of
these
regulations.
First,
we
believe
that
States
with
an
approved
SOP
must
be
allowed
to
establish
their
own
mediation
program
and
procedures.
Second,
the
Act
and
its
implementing
regulations
are
subject
to
the
APA
for
adjudication.
The
provisions
of
the
APA
generally
applicable
to
agency
adjudication
are
not
applicable
to
proceedings
under
7
CFR
Part
11,
National
301
Appeals
Division
Rules
of
Procedure.
Even
if
7
CFR
Part
11
were
applicable,
it
does
not
address
mediation
procedures.
Mediation
is
merely
addressed
in
7
CFR
Part
11
as
an
available
dispute
resolution
method
along
with
its
impact
on
the
filing
of
an
appeal.

(
8)
Noncompliance
Procedure
for
Certifying
Agents.
We
have
amended
section
205.665(
a)(
3)
to
clarify
that,
like
certified
operations,
certifying
agents
must
submit
supporting
documentation
of
each
correction
of
a
noncompliance
identified
in
a
notification
of
noncompliance.
This
amendment
to
section
205.665(
a)(
3)
was
made
in
response
to
commenter
concerns
that
the
noncompliance
procedures
for
certified
operations
and
certifying
agents
be
similar.
It
had
been
our
intent
that
certifying
agents
would
have
to
document
their
correction
of
noncompliances
and
that
the
noncompliance
procedures
for
certified
operations
and
certifying
agents
would
be
similar.

Compliance
­
Changes
Requested
But
Not
Made
This
subpart
retains
from
the
proposed
rule,
regulations
on
which
we
received
comments
as
follows:

(
1)
Funding
for
Enforcement.
Several
commenters
stated
that
USDA
should
provide
funding
to
the
States
for
the
cost
of
performing
enforcement
activities.
Others
asked
who
should
fund
investigations
and
enforcement
actions
if
certifying
agents
(
State
and
private)
are
enforcing
compliance
with
a
Federal
law.
Numerous
commenters
requested
information
on
how
enforcement
will
be
funded.
The
National
Organic
Standards
Board
(
NOSB)
recommended
that
the
NOP
examine
existing
models
for
capturing
enforcement
fees
such
as
the
State
of
California's
registration
program
for
all
growers,
handlers,
and
processors
who
use
the
word,
"
organic,"
in
marketing
their
products.
302
We
disagree
with
the
commenters
who
stated
that
USDA
should
fund
enforcement
activities
(
State
and
private).
Costs
for
compliance
under
the
NOP
will
be
borne
by
USDA,

States
with
approved
SOP's,
and
accredited
certifying
agents.
Each
of
the
entities
will
bear
the
cost
of
their
own
enforcement
activities
under
the
NOP.
AMS
anticipates
that
States
will
consider
the
cost
of
enforcing
their
SOP's
prior
to
seeking
USDA
approval
of
such
programs.

We
also
anticipate
that
certifying
agents
will
factor
the
cost
of
compliance
into
their
certification
fee
schedules.

We
agree
that
there
may
be
alternatives,
such
as
the
State
of
California's
registration
program,
available
to
raise
funds
for
enforcing
the
NOP.
We
will
help
identify
existing
models
and
potential
options
that
may
be
available
in
the
future
at
the
Federal,
State,
or
certifying
agent
level.
In
the
interim,
we
believe
that
SOP's
should
explore
funding
options
at
their
level
and
that
certifying
agents
should
factor
the
cost
of
enforcement
into
their
certification
fees
structure.

(
2)
Stop
Sale.
A
number
of
commenters
requested
that
the
regulations
include
the
ability
to
stop
sales
or
recall
misbranded
or
fraudulently
produced
products.
The
Act
does
not
authorize
the
NOP
to
stop
sales
or
recall
misbranded
or
fraudulently
produced
product.
Accordingly,

USDA
cannot
authorize
stop
sales
or
the
recall
of
product.
We
also
believe
that
the
certified
operation's
right
to
due
process
precludes
a
stop
sale
or
recall
prior
to
full
adjudication
of
the
alleged
noncompliance.
However,
the
Food
and
Drug
Administration
(
FDA)
and
the
USDA's
Food
Safety
Inspection
Service
(
FSIS)
have
stop
sale
authority
that
may
be
used
in
certain
organic
noncompliance
cases.
Further,
States
may,
at
their
discretion,
be
able
to
provide
for
stop
sale
or
recall
of
misbranded
or
fraudulently
produced
products
produced
within
their
State.
While
the
Act
does
not
provide
for
stop
sale
or
recall,
it
does
provide
at
7
U.
S.
C.
6519
that
any
person
303
who:
(
1)
knowingly
sells
or
labels
a
product
as
organic,
except
in
accordance
with
the
Act,
shall
be
subject
to
a
civil
penalty
of
not
more
than
$
10,000
and
(
2)
makes
a
false
statement
under
the
Act
to
the
Secretary,
an
SOP's
governing
State
official,
or
a
certifying
agent
shall
be
subject
to
the
provisions
of
section
1001
of
title
18,
United
States
Code.

(
3)
Notification
of
Proposed
Suspension
or
Revocation.
A
commenter
recommended
replacing
"
notification
of
proposed
suspension
or
revocation"
in
section
205.662(
d)
with
"
notification
of
suspension
or
revocation."
Certification
cannot
be
suspended
or
revoked
without
due
process.
Accordingly,
the
issuance
of
a
written
notification
of
proposed
suspension
or
revocation
is
necessary
to
provide
the
certified
operation
with
information
regarding
the
alleged
noncompliance(
s)
and
its
right
to
answer
the
allegations.
For
this
reason
we
have
not
accepted
the
commenter's
recommendation.

(
4)
Mediation
for
Certifying
Agents.
Several
commenters
recommended
amending
section
205.665(
c)(
4)
to
provide
for
mediation
between
a
certifying
agent
and
the
Program
Manager
when
a
proposed
suspension
or
revocation
is
disputed
by
the
certifying
agent.
We
have
not
accepted
the
recommendation.
USDA
uses
7
CFR
Part
1,
Rules
of
Practice
Governing
Formal
Adjudicatory
Proceedings
Instituted
by
the
Secretary
Under
Various
Statutes,
for
adjudicatory
proceedings
involving
the
denial,
suspension,
and
revocation
of
accreditation.

(
5)
Revocation
of
Accreditation.
A
commenter
stated
that
revocation
of
accreditation
for
3
years
is
excessive.
The
commenter
stated
that
a
period
of
6
to
12
months
might
be
reasonable.

We
have
not
amended
section
205.665(
g)(
2)
because
the
Act
requires
that
the
period
of
revocation
for
certifying
agents,
who
violate
the
Act
and
these
regulations,
be
for
not
less
than
3
years.
Suspension
is
available
to
the
Secretary
to
address
less
egregious
noncompliances.
A
304
certifying
agent
whose
accreditation
is
suspended
may
at
any
time,
unless
otherwise
stated
in
the
notification
of
suspension,
submit
a
request
to
the
Secretary
for
reinstatement
of
its
accreditation.

The
request
must
be
accompanied
by
evidence
demonstrating
correction
of
each
noncompliance
and
corrective
actions
taken
to
comply
with
and
remain
in
compliance
with
the
Act
and
these
regulations.

(
6)
Appeals
Under
SOP's.
Several
commenters
recommended
amending
205.668(
b)
by
adding
at
the
end
thereof:
"
unless
the
State
program's
appeals
procedures
include
judicial
review
through
the
State
District
Court."
Another
commenter
wanted
205.668(
b)
amended
by
removing
"
of
the
State
organic
certification
program.
There
shall
be
no
subsequent
rights
of
appeal
to
the
Secretary.
Final
decisions
of
a
State
may
be
appealed
to
the
United
States
District
Court
for
the
district
in
which
such
certified
operation
is
located,"
and
inserting
in
its
place
"
at
7
CFR
part
11
and
205.681
of
this
chapter."
We
have
not
accepted
the
recommendations
because
the
Act
at
7
U.
S.
C.
6520
provides
that
a
final
decision
of
the
Secretary
may
be
appealed
to
the
United
States
District
Court
for
the
district
in
which
the
person
is
located.
We
consider
an
approved
SOP
to
be
the
NOP
for
that
State.
As
such,
we
consider
the
SOP's
governing
State
official
of
such
approved
SOP
to
be
the
equivalent
of
a
representative
of
the
Secretary
for
the
purposes
of
the
appeals
procedures
under
the
NOP.
Accordingly,
the
final
decision
of
the
SOP's
governing
State
official
of
an
approved
SOP
is
considered
the
final
decision
of
the
Secretary
and,
as
such,
is
appealable
to
the
United
States
District
Court
for
the
district
in
which
the
person
is
located,
not
a
State's
District
Court.

We
also
disagree
with
the
commenter
who
wanted
all
appeals
to
be
made
to
the
National
Appeals
Division
under
the
provisions
at
7
CFR
Part
11
and
section
205.681
of
these
regulations.
305
First,
we
believe
that
States
with
an
approved
SOP
must
be
allowed
to
establish
their
own
appeal
procedures.
Such
procedures
would
have
to
comply
with
the
Act,
be
equivalent
to
the
procedures
of
USDA,
and
be
approved
by
the
Secretary.
Second,
as
noted
elsewhere
in
this
preamble,
the
Act
and
its
implementing
regulations
are
subject
to
the
APA
for
adjudication.
The
provisions
of
the
APA
generally
applicable
to
agency
adjudication
are
not
applicable
to
proceedings
under
7
CFR
Part
11.

Compliance
­
Clarifications
Clarification
is
given
on
the
following
issues
raised
by
commenters:

(
1)
Complaints,
Investigations,
Stop
Sales,
and
Penalties.
Many
commenters
wanted
USDA
to
spell
out
the
responsibilities
and
authorities
of
States,
State
and
private
certifying
agents,
Federal
agencies,
and
citizens
to
make
complaints,
investigate
violations,
halt
the
sale
of
products,
and
impose
penalties.
Anyone
may
file
a
complaint,
with
USDA,
an
SOP's
governing
State
official,
or
certifying
agent,
alleging
violation
of
the
Act
or
these
regulations.
Certifying
agents,
SOP's
governing
State
officials,
and
USDA
will
receive,
review,
and
investigate
complaints
alleging
violations
of
the
Act
or
these
regulations
as
described
in
item
6
above
under
Changes
Based
on
Comments.
Citizens
have
no
authority
under
the
NOP
to
investigate
complaints
alleging
violation
of
the
Act
or
these
regulations.

As
noted
elsewhere
in
this
preamble,
the
Act
does
not
authorize
USDA
to
stop
the
sale
of
product.
Accordingly,
USDA
cannot
authorize
stop
sales
by
accredited
certifying
agents.
We
also
believe
that
the
certified
operation's
right
to
due
process
precludes
a
stop
sale
prior
to
full
adjudication
of
the
alleged
noncompliance.
However,
FDA
and
FSIS
have
stop
sale
authority
that
may
be
used
in
the
event
of
food
safety
concerns.
Further,
States
may,
at
their
discretion,
be
able
306
to
provide
for
stop
sale
of
product
produced
within
their
State.
Citizens
have
no
authority
under
the
NOP
to
stop
the
sale
of
a
product.

The
Act
and
these
regulations
provide
for
suspension
or
revocation
of
certification
by
certifying
agents,
SOP's
governing
State
officials,
and
the
Secretary.
Only
USDA
may
suspend
or
revoke
a
certifying
agent's
accreditation.
All
proposals
to
suspend
or
revoke
a
certification
or
accreditation
are
subject
to
appeal
as
provided
in
section
205.681.
The
Act
provides
at
7
U.
S.
C.

6519
that
any
person
who:
(
1)
knowingly
sells
or
labels
a
product
as
organic,
except
in
accordance
with
the
Act,
shall
be
subject
to
a
civil
penalty
of
not
more
than
$
10,000
and
(
2)

makes
a
false
statement
under
the
Act
to
the
Secretary,
an
SOP's
governing
State
official,
or
a
certifying
agent
shall
be
subject
to
the
provisions
of
section
1001
of
title
18,
United
States
Code.

Only
USDA
may
bring
an
action
under
7
U.
S.
C.
6519.

(
2)
Certifying
Agent's
Identifying
Mark.
The
NOSB
reaffirmed
its
recommendation
which
would
allow
private
certifying
agents
to
prevent
the
use
of
their
service
mark
(
seal)
upon
written
notification
that:
(
1)
certification
by
the
private
certifying
agent
has
been
terminated,
and
(
2)
the
certifying
agent
has
30
days
to
appeal
the
certifying
agent's
decision
to
the
Secretary
of
Agriculture.
We
will
neither
prohibit
nor
approve
a
certifying
agent's
actions
to
withdraw
a
certified
operation's
authority
to
use
the
certifying
agent's
identifying
mark
for
alleged
violations
of
the
Act
or
regulations.
We
stand
fast
in
our
position
that
all
certified
operations
are
to
be
given
due
process
prior
to
the
suspension
or
revocation
of
their
certification.
The
reader
is
also
reminded
that
the
certifying
agent
cannot
terminate,
suspend,
or
revoke
a
certification
if
the
certified
operation
files
an
appeal
with
an
SOP's
governing
State
official,
when
applicable,
or
the
Administrator
as
provided
for
in
the
notification
of
proposed
suspension
or
revocation.
The
307
certifying
agent
accepts
full
liability
for
any
action
brought
as
a
result
of
the
withdrawal
of
a
certified
operation's
authority
to
use
the
certifying
agent's
identifying
mark.

(
3)
Loss
of
Certification.
A
commenter
posed
several
questions
regarding
the
loss
of
certification.
The
commenter's
questions
and
our
responses
are
as
follows.

How
will
consumers
and
affected
regulatory
agencies
know
if
a
grower
or
handler
loses
its
certification?
We
will
provide
public
notification
of
suspensions
and
revocations
of
certified
operations
through
means
such
as
the
NOP
website.

What
will
the
effect
of
a
lost
certification
be?
Suspension
or
revocation
of
a
producer's
or
handler's
certification
will
require
that
the
producer
or
handler
immediately
cease
its
sale,
labeling,

and
representation
of
agricultural
products
as
organically
produced
or
handled
as
provided
in
the
suspension
or
revocation
order.
A
production
or
handling
operation
or
a
person
responsibly
connected
with
an
operation
whose
certification
has
been
suspended
may
at
any
time,
unless
otherwise
stated
in
the
notification
of
suspension,
submit
a
new
request
for
certification
in
accordance
with
section
205.401.
The
request
must
be
accompanied
by
evidence
demonstrating
correction
of
each
noncompliance
and
corrective
actions
taken
to
comply
with
and
remain
in
compliance
with
the
Act
and
the
regulations
in
this
part.
An
operation
or
a
person
responsibly
connected
with
an
operation
whose
certification
has
been
revoked
will
be
ineligible
to
receive
certification
for
a
period
of
not
more
than
5
years
following
the
date
of
such
revocation,
as
determined
by
the
Secretary.
Any
producer
or
handler
who
sells,
labels,
or
represents
its
product
as
organic
contrary
to
the
provisions
of
the
suspension
or
revocation
order
would
be
subject
to
prosecution
under
7
U.
S.
C.
6519
of
the
Act.

Will
the
certifying
agent
give
a
future
effective
date
for
loss
of
certification,
or
could
the
308
loss
of
certification
be
immediate
or
even
retroactive?
Suspension
or
revocation
will
become
effective
as
specified
in
the
suspension
or
revocation
order
once
it
becomes
final
and
effective.

The
operation,
upon
suspension
or
revocation,
will
be
prohibited
from
selling,
labeling,
and
representing
its
product
as
organic
per
the
provisions
of
the
suspension
or
revocation
order.

If
organic
products
already
on
the
market
were
grown
or
handled
by
someone
whose
certification
is
revoked
or
suspended,
would
USDA
require
that
the
products
be
recalled
and
relabeled?
USDA
will
not,
unless
the
noncompliance
involves
a
food
safety
issue
under
FSIS,

require
the
recall
or
relabeling
of
product
in
the
channels
of
commerce
prior
to
the
issuance
of
a
suspension
or
revocation
order.
First,
at
the
time
the
product
was
produced,
it
may
have
been
produced
in
compliance
with
the
Act
and
these
regulations.
Second,
USDA
does
not
have
the
authority,
under
the
Act,
to
issue
a
stop
sale
order
for
product
sold,
labeled,
or
represented
as
organic
and
placed
in
the
channels
of
commerce
prior
to
suspension
or
revocation
of
a
certified
operation's
certification.
The
Act,
however,
provides
at
7
U.
S.
C.
6519(
a)
for
the
prosecution
of
any
person
who
knowingly
sells
or
labels
a
product
as
organic,
except
in
accordance
with
the
Act.

Such
persons
shall
be
subject
to
a
civil
penalty
of
not
more
than
$
10,000
per
violation.

(
4)
Investigations.
A
commenter
suggested
that
we
amend
section
205.661(
a)
to
require
that
all
complaints
must
be
investigated
in
accordance
with
the
certifying
agent's
complaints
policy.
The
commenter
also
stated
that
the
Administrator
should
know
which
complaints
were
not
investigated.
We
disagree
that
all
complaints
must
be
investigated
since,
upon
review
of
the
alleged
noncompliance,
some
complaints
may
lack
grounds
for
investigation.
For
example,
a
concerned
citizen
could
allege
that
an
organic
producer
was
seen
applying
a
pesticide
to
a
specific
field.
Upon
review
of
the
allegation,
the
certifying
agent
could
determine
that
the
producer
in
309
question
was
a
split
operation
and
that
the
field
in
question
was
part
of
the
conventional
side
of
the
production
operation.
Accordingly,
there
would
be
no
need
for
an
investigation.
However,

the
certifying
agent
will
be
expected
to:
(
1)
take
each
allegation
seriously,
(
2)
review
each
complaint
received,
(
3)
make
a
determination
as
to
whether
there
may
be
a
basis
for
conducting
an
investigation,
(
4)
investigate
all
allegations
when
it
is
believed
that
there
may
be
a
basis
for
conducting
the
investigation,
and
(
5)
maintain
a
detailed
log
of
all
complaints
received
and
their
disposition.
The
actions
taken
by
the
certifying
agent
must
be
in
conformance
with
the
certifying
agent's
procedures
for
reviewing
and
investigating
certified
operation
compliance.

(
5)
Deadline
for
the
Correction
of
a
Noncompliance.
Several
commenters
requested
that
205.662(
a)(
3)
be
amended
by
adding:
"
The
deadline
for
correction
of
the
noncompliance
may
be
extended
at
the
discretion
of
the
certifier
if
substantial
progress
has
been
made
to
correct
the
noncompliance."
We
believe
that
the
requested
amendment
is
unnecessary.
Section
205.662(
a)(
3)
requires
that
the
notification
of
noncompliance
include
a
date
by
which
the
certified
operation
must
rebut
or
correct
each
noncompliance
and
submit
supporting
documentation
of
each
correction
when
correction
is
possible.
There
is
no
prohibition
preventing
the
certifying
agent
from
extending
the
deadline
specified
when
the
certifying
agent
believes
that
the
certified
operation
has
made
a
good
faith
effort
at
correcting
each
noncompliance.

(
6)
Compliance
with
SOP.
Several
States
requested
that
section
205.665
be
amended
to
clarify
how
States
may
handle
a
private
certifying
agent
found
to
be
in
noncompliance
with
SOP's
approved
by
the
Secretary.
A
majority
of
these
commenters
also
asked
if
NOP
intends
to
suspend
or
revoke
the
accreditation
of
certifying
agents
on
a
State­
by­
State
basis.
Section
205.668(
c)

authorizes
an
SOP's
governing
State
official
to
review
and
investigate
complaints
of
310
noncompliance
with
the
Act
or
regulations
concerning
accreditation
of
certifying
agents
operating
in
the
State.
When
such
review
or
investigation
reveals
any
noncompliance,
the
SOP's
governing
State
official
shall
send
a
written
report
of
noncompliance
to
the
NOP
Program
Manager.
The
report
shall
provide
a
description
of
each
noncompliance
and
the
facts
upon
which
the
noncompliance
is
based.
The
NOP
Program
Manager
will
then
employ
the
noncompliance
procedures
for
certifying
agents
as
found
in
section
205.665.
This
may
include
additional
investigative
work
by
AMS.
Only
USDA
may
suspend
or
revoke
a
certifying
agent's
accreditation.

SOP's
must
meet
the
general
requirements
for
organic
programs
specified
in
the
Act
and
be
at
least
equivalent
to
these
regulations.
Accordingly,
noncompliances
worthy
of
suspension
or
revocation
would
in
all
probability
be
worthy
of
national
suspension
or
revocation
of
accreditation
for
one
or
more
areas
of
accreditation.
Therefore,
USDA
does
not
anticipate
suspending
or
revoking
accreditations,
or
areas
of
accreditation,
on
a
State­
by­
State
basis.
It
is
possible,

however,
that
the
Secretary
may
decide
to
only
suspend
or
revoke
a
certifying
agent's
accreditation
or
an
area
of
accreditation
to
certify
producers
or
handlers
within
a
given
State.

Such
a
decision
would
in
all
probability
be
tied
to
a
State's
more
restrictive
requirements.

Inspection
and
Testing,
Reporting,
and
Exclusion
from
Sale
This
portion
of
subpart
G
sets
forth
the
inspection
and
testing
requirements
for
agricultural
products
that
have
been
produced
on
organic
production
operations
or
handled
through
organic
handling
operations.

Residue
testing
plays
an
important
role
in
organic
certification
by
providing
a
means
for
monitoring
compliance
with
the
National
Organic
Program
(
NOP)
and
by
discouraging
the
311
mislabeling
of
agricultural
products.
This
testing
program
provides
State
organic
programs'

(
SOP)
governing
State
officials
and
certifying
agents
with
a
tool
for
ensuring
compliance
with
three
areas
for
testing:
(
1)
preharvest
residue
testing,
(
2)
postharvest
residue
testing,
and
(
3)

testing
for
unavoidable
residual
environmental
contamination
levels.

Description
of
Regulations
General
Requirements
Under
the
residue
testing
requirements
of
the
NOP,
all
agricultural
products
sold,
labeled,

or
represented
as
organically
produced
must
be
available
for
inspection
by
the
Administrator,

SOP's
governing
State
official,
or
certifying
agent.
Organic
farms
and
handling
operations
must
be
made
available
for
inspection
under
subpart
E,
Certification.
In
addition,
products
from
the
aforementioned
organic
operations
may
be
required
by
the
SOP's
governing
State
official
or
certifying
agent
to
undergo
preharvest
or
postharvest
testing
when
there
is
reason
to
believe
that
agricultural
inputs
used
in
organic
agriculture
production
or
agricultural
products
to
be
sold
or
labeled
as
organically
produced
have
come
into
contact
with
prohibited
substances
or
have
been
produced
using
excluded
methods.
The
cost
of
such
testing
will
be
borne
by
the
applicable
certifying
agent
and
is
considered
a
cost
of
doing
business.
Accordingly,
certifying
agents
should
make
provisions
for
the
cost
of
preharvest
or
postharvest
residue
testing
when
structuring
certification
fees.

Preharvest
and
Postharvest
Residue
Testing
The
main
objectives
of
the
residue
testing
program
are
to:
(
1)
ensure
that
certified
organic
production
and
handling
operations
are
in
compliance
with
the
requirements
set
forth
in
this
final
rule
and
(
2)
serve
as
a
means
for
monitoring
drift
and
unavoidable
residue
contamination
of
312
agricultural
products
to
be
sold
or
labeled
as
organically
produced.
Any
detectable
residues
of
a
prohibited
substance
or
a
product
produced
using
excluded
methods
found
in
or
on
samples
during
analysis
will
serve
as
a
warning
indicator
to
the
certifying
agent.

The
Administrator,
SOP's
governing
State
official,
or
certifying
agent
may
require
preharvest
or
postharvest
testing
of
any
agricultural
input
used
in
organic
agricultural
production
or
any
agricultural
product
to
be
sold
or
labeled
as
"
100
percent
organic,"
"
organic,"
or
"
made
with
organic
(
specified
ingredients
or
food
group(
s))."
It
is
based
on
the
Administrator's,
SOP's
governing
State
official's,
or
certifying
agent's
belief
that
an
agricultural
product
or
agricultural
input
has
come
into
contact
with
one
or
more
prohibited
substances
or
has
been
produced
using
excluded
methods.
Certifying
agents
do
not
have
to
conduct
residue
tests
if
they
do
not
have
reason
to
believe
that
there
is
a
need
for
testing.
Certifying
agents
must
ensure,
however,
that
certified
organic
operations
are
operating
in
accordance
with
the
Act
and
the
regulations
set
forth
in
this
part.

The
"
reason
to
believe"
could
be
triggered
by
various
situations,
for
example:
(
1)
the
applicable
authority
receiving
a
formal,
written
complaint
regarding
the
practices
of
a
certified
organic
operation;
(
2)
an
open
container
of
a
prohibited
substance
found
on
the
premises
of
a
certified
organic
operation;
(
3)
the
proximity
of
a
certified
organic
operation
to
a
potential
source
of
drift;
(
4)
suspected
soil
contamination
by
historically
persistent
substances;
or
(
5)
the
product
from
a
certified
organic
operation
being
unaffected
when
neighboring
fields
or
crops
are
infested
with
pests.
These
situations
do
not
represent
all
of
the
possible
occurrences
that
would
trigger
an
investigation.
Preharvest
or
postharvest
residue
testing
will
occur
on
a
case­
by­
case
basis.

In
each
case,
an
inspector
representing
the
Administrator,
SOP's
governing
State
official,
313
or
certifying
agent
or
will
conduct
sampling.
According
to
subpart
F,
Accreditation,
private
or
State
entities
accredited
as
certifying
agents
under
the
NOP
must
ensure
that
its
responsibly
connected
persons,
employees,
and
contractors
with
inspection,
analysis,
and
decision­
making
responsibilities
have
sufficient
expertise
to
successfully
perform
the
duties
assigned.
Therefore,
all
inspectors
employed
by
certifying
agents
to
conduct
sampling
must
have
sufficient
expertise
in
methods
of
chain­
of­
custody
sampling.
Moreover,
testing
for
chemical
residues
must
be
performed
in
an
accredited
laboratory.
When
conducting
chemical
analyses,
the
laboratory
must
incorporate
the
analytical
methods
described
in
the
most
current
edition
of
the
Official
Methods
of
Analysis
of
the
AOAC
International
or
other
current
applicable
validated
methodology
for
determining
the
presence
of
contaminants
in
agricultural
products.
Results
of
all
analyses
and
tests
performed
under
section
205.670
must
be
promptly
provided
to
the
Administrator,
except,

that,
where
an
SOP
exists,
all
test
results
and
analyses
should
be
provided
to
the
SOP's
governing
State
official
by
the
applicable
certifying
party
that
requested
testing.
Residue
test
results
and
analyses
must
also
be,
according
to
section
205.403(
e)(
2),
provided
to
the
owner
of
the
certified
organic
operation
whose
product
was
tested.
All
other
parities
desiring
to
obtain
such
information
must
request
it
from
the
applicable
certifying
agent.

OFPA
requires
certifying
agents,
to
the
extent
of
their
awareness,
to
report
violations
of
applicable
laws
relating
to
food
safety
to
appropriate
health
agencies
such
as
EPA
and
FDA.

When
residue
testing
indicates
that
an
agricultural
product
contains
pesticide
residues
or
environmental
contaminants
that
exceed
either
the
EPA
tolerance
level
or
FDA
action
level,
as
applicable,
the
certifying
agent
must
promptly
report
data
revealing
such
information
to
the
Federal
agency
whose
regulatory
tolerance
or
action
level
has
been
exceeded.
314
Residue
Testing
and
Monitoring
Tools
When
testing
indicates
that
an
agricultural
product
to
be
sold
or
labeled
as
organically
produced
contains
residues
of
prohibited
substances,
certifying
agents
will
compare
the
level
of
detected
residues
with
5
percent
of
the
Environmental
Protection
Agency
(
EPA)
tolerance
for
the
specific
residue
detected
on
the
agricultural
product
intended
to
be
sold
as
organically
produced.

This
compliance
measure,
5
percent
of
EPA
tolerance
for
the
detected
prohibited
residue,
will
serve
as
a
standard
for
the
Administrator,
SOP's
governing
State
officials,
and
certifying
agents
to
assist
in
monitoring
for
illegal
use
violations.

In
addition,
we
intend
to
establish
levels
of
unavoidable
residual
environmental
contamination
(
UREC)
for
crop­
and
site­
specific
agricultural
commodities
to
be
sold,
labeled,
or
represented
as
"
100
percent
organic,"
"
organic,"
or
"
made
with..."
These
levels
will
represent
limits
at
which
USDA
may
take
compliance
action
to
suspend
the
use
of
a
contaminated
area
for
organic
agricultural
production.
Currently,
USDA
is
seeking
scientifically
sound
principles
and
measures
by
which
it
can
establish
UREC
levels
to
most
effectively
address
issues
of
unavoidable
residual
environmental
contamination
with
respect
to
this
rule.
However,
in
the
interim,
UREC
will
be
defined
as
the
Food
and
Drug
Administration's
(
FDA)
action
levels
for
poisonous
or
deleterious
substances
in
human
food
or
animal
feed.
UREC
levels
will
be
initially
set
for
persistent
prohibited
substances
(
aldrin,
dieldrin,
chlordane,
DDE,
etc.)
in
the
environment.
They
may
become
more
inclusive
of
prohibited
residues
as
additional
information
becomes
available.

Unavoidable
residual
environmental
contamination
levels
will
be
based
on
the
unavoidability
of
the
chemical
substances
and
do
not
represent
permissible
levels
of
contamination
where
it
is
avoidable.
315
Analyses
and
test
results
will
be
available
for
public
access
unless
the
residue
testing
is
part
of
an
ongoing
compliance
investigation.
Information
relative
to
an
ongoing
compliance
investigation
will
be
confidential
and
restricted
to
the
public.

Detection
of
Prohibited
Substances
or
Products
Derived
from
Excluded
Methods
In
the
case
of
residue
testing
and
the
detection
of
prohibited
substances
in
or
on
agricultural
products
to
be
sold,
labeled,
or
represented
as
"
100
percent
organic,"
"
organic,"
or
"
made
with...,"
products
with
detectable
residues
of
prohibited
substances
that
exceed
5
percent
of
the
EPA
tolerance
for
the
specific
residue
or
UREC
cannot
be
sold
or
labeled
as
organically
produced.
When
such
an
agricultural
crop
is
in
violation
of
these
requirements,
the
certification
of
that
crop
will
be
suspended
for
the
period
that
the
crop
is
in
production.
Certifying
agents
must
follow
the
requirements
specified
in
sections
205.662
and
205.663
of
subpart
G,

Compliance.

The
"
5
percent
of
EPA
tolerance"
standard
is
considered
a
level
above
which
an
agricultural
product
cannot
be
sold
as
organic,
regardless
of
how
the
product
may
have
come
into
contact
with
a
potential
prohibited
substance.
This
standard
has
been
established
to:
(
1)
satisfy
consumer
expectations
that
organic
agricultural
products
will
contain
minimal
chemical
residues
and
(
2)
respond
to
the
organic
industry's
request
to
implement
a
standard
comparable
to
current
industry
practices.
However,
the
"
5
percent
of
EPA
tolerance"
standard
cannot
be
used
to
automatically
qualify
agricultural
products
as
organically
produced,
even
if
the
level
of
chemical
residues
detected
on
an
agricultural
product
is
below
5
percent
of
the
EPA
tolerance
for
the
respective
prohibited
substance.
This
final
rule
is
a
comprehensive
set
of
standards
and
regulations
that
determines
whether
a
product
can
or
cannot
be
considered
to
carry
the
specified
316
organic
labeling
terms
in
subpart
D,
Labeling.
Therefore,
in
addition
to
this
section
of
subpart
G,

Administrative,
all
other
requirements
of
this
part
must
be
met
by
certified
organic
operations
to
have
an
agricultural
product
considered
"
organically
produced."

When
residue
testing
detects
the
presence
of
any
prohibited
substance,
whether
above
or
below
5
percent
of
the
EPA
tolerance
for
the
specific
pesticide
or
UREC,
the
SOP's
governing
State
official
or
certifying
agent
may
conduct
an
investigation
of
the
certified
organic
operation
to
determine
the
cause
of
the
prohibited
substance
or
product
in
or
on
the
agricultural
product
to
be
sold
or
labeled
as
organically
produced.
The
same
shall
occur
if
testing
detects
a
product
produced
using
excluded
methods.
If
the
investigation
reveals
that
the
presence
of
the
prohibited
substance
or
product
produced
using
excluded
methods
in
or
on
an
agricultural
product
intended
to
be
sold
as
organically
produced
is
the
result
of
an
intentional
application
of
a
prohibited
substance
or
use
of
excluded
methods,
the
certified
organic
operation
shall
be
subject
to
suspension
or
revocation
of
its
organic
certification.
In
addition,
any
person
who
knowingly
sells,

labels,
or
represents
an
agricultural
product
as
organically
produced
in
violation
of
the
Act
or
these
regulations
shall
be
subject
to
a
civil
penalty
of
not
more
than
$
10,000
per
violation.

Emergency
Pest
or
Disease
Treatment
Programs
When
a
prohibited
substance
is
applied
to
an
organic
production
or
handling
operation
due
to
a
Federal
or
State
emergency
pest
or
disease
treatment
program
and
the
organic
handling
or
production
operation
otherwise
meets
the
requirements
of
this
final
rule,
the
certification
status
of
the
operation
shall
not
be
affected
as
a
result
of
the
application
of
the
prohibited
substance,
except
that:
(
1)
any
harvested
crop
or
plant
part
to
be
harvested
that
has
contact
with
a
prohibited
substance
applied
as
the
result
of
a
Federal
or
State
emergency
pest
or
disease
treatment
program
317
cannot
be
sold,
labeled,
or
represented
as
"
100
percent
organic,"
"
organic,"
or
"
made
with..."
and
(
2)
any
livestock
that
are
treated
with
a
prohibited
substance
applied
as
the
result
of
a
Federal
or
State
emergency
pest
or
disease
treatment
program
or
product
derived
from
such
treated
livestock
cannot
be
sold,
labeled,
or
represented
as
"
100
percent
organic,"
"
organic,"
or
"
made
with..."

However,
milk
or
milk
products
may
be
labeled
or
sold
as
organically
produced
beginning
12
months
following
the
last
date
that
the
dairy
animal
was
treated
with
the
prohibited
substance.

Additionally,
the
offspring
of
gestating
mammalian
breeder
stock
treated
with
a
prohibited
substance
may
be
considered
organic
if
the
breeder
stock
was
not
in
the
last
third
of
gestation
on
the
date
that
the
breeder
stock
was
treated
with
the
prohibited
substance.

Residue
Testing
­
Changes
Based
on
Comments
This
portion
of
subpart
G
differs
from
our
proposal
in
several
respects
as
follows:

(
1)
Reporting
Requirements.
Commenters
were
not
satisfied
with
the
language
in
section
205.670(
d)(
1)
that
required
results
of
all
analyses
and
tests
performed
under
section
205.670
to
be
provided
to
the
Administrator
promptly
upon
receipt.
They
asked
that
the
paragraph
be
amended
to
include
that:
(
1)
results
of
all
analyses
and
tests
performed
under
section
205.670
be
provided
by
the
Administrator
to
the
appropriate
SOP's
governing
State
official
and
(
2)
test
results
be
made
immediately
available
to
the
owner
of
the
material
sampled.
They
stated
that
since
State
organic
certification
programs
are
responsible
for
enforcement
within
their
State,

results
of
residue
tests
conducted
by
certifying
agents
must
be
provided
to
the
SOP's
governing
State
official
for
routine
monitoring
and
for
investigating
possible
violations
of
the
Act.

We
agree
with
the
commenters
and
have
responded
to
their
concerns
accordingly.
To
318
ensure
that
SOP's
receive
results
of
all
tests
and
analyses
conducted
under
the
inspection
and
testing
requirements
of
subpart
G,
section
205.670(
d)
has
been
amended
to
include
that
the
results
of
all
analyses
and
residue
tests
must
be
provided
to
the
Administrator
promptly
upon
receipt;
Except:
That
where
an
SOP
exists,
all
test
results
and
analyses
should
be
provided
to
the
SOP's
governing
State
official.

In
regard
to
the
commenters'
request
that
certified
organic
operations
be
provided
with
a
copy
of
test
results
from
samples
taken
by
an
inspector,
an
additional
paragraph,
section
205.403(
e)(
2),
has
been
added
to
subpart
E,
Certification,
that
assures
that
such
information
is
provided
to
the
owners
of
certified
organic
operations
by
the
certifying
agents.

(
2)
Integrity
Of
Organic
Samples.
We
have
modified
language
in
section
205.670(
c)
to
clarify
our
intent
regarding
the
maintenance
of
sample
integrity.
The
proposed
rule
stated
that
"
sample
integrity
must
be
maintained
in
transit,
and
residue
testing
must
be
performed
in
an
accredited
laboratory."
During
the
final
rulemaking
process,
we
did
not
believe
that
our
intent
was
clear
on
this
subject.
Our
intent
is
to
ensure
that
sample
integrity
is
maintained
throughout
the
entire
chain
of
custody
during
the
residue
testing
process.
Proposed
language
only
suggests
that
sample
integrity
be
maintained
in
transit.
Therefore,
the
we
have
changed
the
second
sentence
in
section
205.670(
c)
to
state
that
"
sample
integrity
must
be
maintained
throughout
the
chain
of
custody,
and
residue
testing
must
be
performed
in
an
accredited
laboratory."

(
3)
Reporting
Residue
and
Other
Food
Safety
Violations
to
Appropriate
Health
Agencies.

In
the
proposed
rule,
section
205.671(
b)
under
Exclusion
from
Organic
Sale
states,
"
If
test
results
indicate
a
specific
agricultural
product
contains
pesticide
residues
or
environmental
contaminants
that
exceed
the
FDA's
or
the
EPA's
regulatory
tolerances,
the
data
must
be
reported
promptly
to
319
the
appropriate
public
health
agencies."
During
the
final
rulemaking
process,
a
group
of
commenters
suggested
that
we
move
section
205.671(
b)
into
section
205.670
as
paragraph
(
e).

They
recommended
that
we
move
section
205.671(
b)
because
it
does
not
specifically
address
the
sale
of
organically
produced
products,
as
indicated
by
the
section
heading.
They
recommended
that
section
205.671(
b)
be
placed
under
section
205.670
as
paragraph
(
e)
because
it
dealt
with
the
reporting
of
residues
that
exceed
Federal
regulatory
tolerances.
The
commenters
further
stated
that,
while
section
205.671(
b)
creates
a
duty
to
report,
it
is
not
specific
as
to
who
must
report.

We
have
accepted
the
suggestions
of
the
commenters
and
have
responded
accordingly.

We
have
removed
section
205.671(
b)
and
relocated
it
under
section
205.670
as
paragraph
(
e).

We
have
also
modified
the
regulatory
text
of
paragraph
(
e)
to
include
language
that
instructs
certifying
agents
to
report,
when
residue
testing
indicates
that
an
agricultural
product
contains
pesticide
residues
or
environmental
contaminants
that
exceed
either
the
EPA
tolerance
level
or
FDA
action
level,
as
applicable,
data
reveling
such
information
to
the
Federal
agency
whose
regulatory
tolerance
or
action
level
has
been
exceeded.

(
4)
Exclusion
from
Organic
Sale.
We
have
reviewed
section
205.671(
a),
removed
the
requirement
to
implement
the
Pesticide
Data
Program
(
pdp)
estimated
national
mean
as
a
compliance
tool
in
monitoring
for
the
presence
of
unacceptable
levels
of
prohibited
substances
in
agricultural
products
intended
to
be
sold
as
organic,
and
added
the
"
5
percent
of
EPA
tolerance"

standard.

Commenters
voiced
the
opinion
that
the
estimated
national
mean
would
be
a
difficult
standard
in
organic
agricultural
production
for
several
reasons.
Some
stated
that
the
estimated
national
mean
was
a
new
concept
that
would
confuse
producers
and
handlers
because
they
would
320
not
know
the
exact
definition
of
"
estimated
national
mean"
and
how
it
would
be
determined.

Others
stated
that
the
PDP
was
too
limited
in
scope
to
employ
an
estimated
national
mean
for
all
commodity/
pesticide
combinations.
Commenters
reasoned
that
PDP
data
were
limited
in
terms
of
the
agricultural
commodities
that
are
sampled
and
tested.

Another
group
of
commenters
stated
that
PDP
data
would
be
unfair
to
use
in
the
NOP's
residue
testing
plan.
They
argued
PDP
data
should
not
be
used
to
set
maximum
residue
levels
for
organic
agricultural
products
because
PDP
samples
its
products
as
close
to
the
point
of
consumption
as
possible.
As
a
result,
commenters
believe
that
PDP
data
may
not
be
totally
reflective
of
residue
levels
of
agricultural
products
at
the
farmgate
level.
Since
most
residue
testing
in
organic
agricultural
production
takes
place
at
the
farmgate,
these
commenters
argued
that
it
would
be
an
inappropriate
standard
for
organic
agricultural
production.

As
a
result,
a
large
number
of
commenters
suggested
that
we
reconsider
using
the
estimated
national
mean
as
a
standard
for
the
maximum
allowable
residues
on
organically
produced
products.
Instead,
commenters
recommended
that
the
NOP
incorporate
the
National
Organic
Standards
Board's
(
NOSB)
recommendation
and
current
industry
practice
of
using
5
percent
of
the
EPA
tolerance
as
a
maximum
level
of
pesticide
residue
on
organic
agricultural
products.
Commenters
argued
that
using
5
percent
of
the
EPA
tolerance
provides
a
sense
of
confidence
to
the
consumers
of
organic
agricultural
products.

In
many
respects,
we
agree
with
the
commenters.
We
have
revisited
using
PDP
data
to
establish
an
estimated
national
mean
for
commodity/
pesticide
combinations
and
for
setting
a
maximum
level
of
pesticide
residue
that
could
exclude
agricultural
products
from
being
sold,

labeled,
or
represented
as
organic.
As
a
result,
we
have
concluded
that
such
an
approach
may
be
321
somewhat
underdeveloped
to
incorporate
into
the
NOP.
We
have
reached
this
conclusion
based
on
many
of
the
same
arguments
presented
by
commenters
(
i.
e.,
limited
scope
of
agricultural
products
tested
under
PDP,
product
sampling
based
upon
market
availability,
testing
near
the
point
of
consumption,
etc.).
Also,
we
estimated
that
there
would
be
a
considerable
time
lag
between
the
implementation
of
the
NOP
and
defining
a
comprehensive
list
of
estimated
national
means
for
all
commodity/
pesticide
combinations.
Thus,
we
have
decided
not
to
use
the
estimated
national
mean
as
a
tool
for
monitoring
organic
agricultural
products
for
the
presence
of
prohibited
substances
and
as
a
standard
to
exclude
agricultural
products
from
being
sold,
labeled,
or
represented
as
organically
produced.

Instead,
we
have
decided
to
follow
the
recommendation
of
the
commenters
by
replacing
the
estimated
national
mean
for
specific
commodity/
pesticide
pairs
with
5
percent
of
the
EPA
tolerance
for
the
specific
pesticide.
Therefore,
when
residue
testing
detects
prohibited
substances
at
levels
that
are
greater
than
5
percent
of
the
EPA
tolerance
for
the
specific
pesticide
detected
on
the
particular
product
samples,
the
agricultural
product
must
not
be
sold
or
labeled
as
organically
produced.

We
fully
understand
that
the
EPA
tolerance
is
defined
as
the
maximum
legal
level
of
a
pesticide
residue
in
or
on
a
raw
or
processed
agricultural
commodity.
We
also
acknowledge
that
the
EPA
tolerance
is
a
health­
based
standard.
We
are
not
trying
to
employ
the
5
percent
standard
in
a
manner
similar
to
that
of
EPA.
As
mentioned
in
our
proposal,
the
national
organic
standards,
including
provisions
governing
prohibited
substances,
are
based
on
the
method
of
production,
not
the
content
of
the
product.
The
primary
purpose
of
the
residue
testing
approach
described
in
this
final
rule,
then,
is
to
provide
an
additional
tool
for
SOP's'
governing
State
322
officials
and
certifying
agents
to
use
in
monitoring
and
ensuring
compliance
with
the
NOP.

(
5)
Unavoidable
Residual
Environmental
Contamination.
We
have
defined,
as
an
interim
measure,
UREC
as
the
FDA
action
levels
for
poisonous
or
deleterious
substances
in
human
food
or
animal
feed.

Section
205.671
proposed
the
use
of
UREC
to
serve
as
a
residue
testing
tool
for
compliance.
Commenters
believed
UREC
levels,
as
prescribed
in
section
205.671
of
the
proposed
rule,
would
be
problematic
as
a
standard
because
they
were
undefined.
Commenters
argued
that
it
would
be
impractical
and
very
expensive
to
establish
UREC
levels
for
every
organic
crop
and
region
in
the
United
States.
They
suggested
that
UREC
levels
be
managed
as
a
practice
standard
or
program
manual
issue.
They
also
expressed
the
concern
that
inconsistent
application
of
UREC
levels
could
create
difficulties
for
certifying
agents
and
certified
operations.

We
agree
that
UREC
levels
should
be
defined.
We
are
seeking
scientifically
sound
principles
and
measures
by
which
we
can
establish
UREC
levels
to
most
effectively
address
issues
of
unavoidable
residual
contamination
with
respect
to
this
rule.
However,
in
the
interim,
the
ability
to
implement
an
undefined
standard
would
be
difficult
for
certifying
agents.
Therefore,
we
have
included
language
in
the
preamble
that
temporarily
defines
UREC
as
the
FDA
action
levels
for
poisonous
or
deleterious
substances
in
human
food
or
animal
feed.
When
residue
testing
detects
the
presence
of
a
prohibited
substance
on
an
agricultural
product
greater
than
such
levels
mentioned,
the
agricultural
product
cannot
be
sold
as
organic.
We
have
decided
to
use
FDA
action
levels
for
UREC
because
they
encompass
many
of
the
toxic,
persistent
chemicals
and
heavy
metals
that
are
present
in
the
environment
and
may
be
found
on
food
and
animal
feed.
As
mentioned
earlier,
the
FDA
action
levels
are
being
employed
in
this
part
as
temporary
measures
323
for
compliance.
We
will
continue
to
seek
scientifically
sound
principles
and
measures
by
which
to
establish
UREC
levels
that
more
appropriately
satisfy
the
purposes
of
this
part.

Residue
Testing
­
Changes
Requested
But
Not
Made
This
subpart
retains
from
the
proposed
rule
regulations
on
which
we
received
comments
as
follows:

(
1)
Residue
Testing
Responsibility.
Commenters
petitioned
that
we
remove
the
requirement
in
section
205.670(
b)
that
states
residue
tests
must
be
conducted
by
the
applicable
SOP's
governing
State
official
or
the
certifying
agent
at
the
official's
or
certifying
agent's
own
expense.
The
commenters
expressed
the
opinion
that
we
were
practicing
"
micromanagement."

They
also
said
that
there
was
no
need
for
the
proposal
to
be
so
detailed
with
respect
to
who
pays
for
residue
testing.
Based
on
the
commenters'
responses,
residue
analyses
are
reportedly
paid
by
producers,
buyers,
brokers,
certifiers,
and
government
residue
testing
programs.

We
have
not
adopted
the
suggestion
of
the
commenters.
In
the
proposal,
we
stated
that
conducting
residue
tests
was
considered
a
cost
of
doing
business
for
certifying
agents.
Our
position
has
not
changed.
Certifying
agents
can
factor
residue
testing
costs
into
certification
fees.

It
is
not
our
intention
to
"
micromanage"
the
way
that
certifying
agents
conduct
business.
Section
2107(
a)(
6)
of
the
Act
requires
that
certifying
agents
conduct
residue
testing
of
agricultural
products
that
have
been
produced
on
certified
organic
farms
and
handled
through
certified
organic
handling
operations.
OFPA
also
requires,
under
section
2112(
a)
through
(
c),
that
certifying
agents
enforce
its
provisions
by
implementing
a
system
of
residue
testing
to
test
products
sold
or
labeled
as
organically
produced.
In
addition,
subpart
E,
Certification,
authorizes
certifying
agents
to
conduct
on­
site
inspections,
which
may
include
residue
testing,
of
certified
324
organic
operations
to
verify
that
the
operation
is
complying
with
the
provisions
in
the
Act
and
the
regulations
in
this
part.
Certifying
agents
are
responsible
for
monitoring
organic
operations
for
the
presence
of
prohibited
substances;
we
view
residue
testing
as
a
cost
of
doing
business.

Therefore,
we
believe
that
certifying
agents
should
factor
monitoring
costs
associated
with
implementing
the
provisions
in
the
Act
and
Rule
into
their
certification
fees.

(
2)
Reporting
to
Federal
Regulatory
Agencies.
Commenters
disagree
with
section
205.671(
b)
of
the
proposed
rule
which
states
that
if
test
results
indicate
a
specific
agricultural
product
contains
pesticide
residues
or
environmental
contaminants
that
exceed
the
FDA
action
level
or
EPA
tolerance,
the
data
must
be
reported
promptly
to
appropriate
public
health
agencies.

Commenters
believe
that
since
results
of
all
analyses
and
tests
must
be
provided
to
the
Administrator,
USDA
should
be
responsible
for
communicating
such
test
results
to
other
Federal
agencies
such
as
FDA
or
EPA
if
regulatory
tolerances
or
action
levels
are
exceeded.
They
also
suggested
that
section
205.671(
b)
be
removed
from
the
national
regulations.
Commenters
expressed
the
view
that
such
a
requirement
is
not
related
to
organic
certification.

We
do
not
agree
with
the
commenters.
It
is
not
our
intent
to
create
additional
responsibility
for
the
certifying
agent.
Section
205.671(
b),
redesignated
as
section
205.670(
e),
is
a
statutory
requirement.
Section
2107(
a)(
6)
of
the
Organic
Food
Production
Act
of
1990
requires
certifying
agents,
to
the
extent
of
their
awareness,
to
report
violations
of
applicable
laws
relating
to
food
safety
to
appropriate
health
agencies
such
as
EPA
and
FDA.
Therefore,
due
to
section
2107
of
the
Act,
section
205.670(
e)
has
been
included
in
the
national
regulations.

(
3)
"
Threshold"
for
Genetic
Contamination.
Many
commenters
suggested
that
we
establish
a
"
threshold"
for
the
unintended
or
adventitious
presence
of
products
of
excluded
325
methods
in
organic
products.
Some
commenters
argued
that
a
threshold
is
necessary
because,

without
the
mandatory
labeling
of
biotechnology­
derived
products,
organic
operations
and
certifying
agents
could
not
be
assured
that
products
of
excluded
methods
were
not
being
used.

Others
argued
that,
without
an
established
threshold,
the
regulations
would
constitute
a
"
zero
tolerance"
for
products
of
excluded
methods,
which
would
be
impossible
to
achieve.

We
do
not
believe
there
is
sufficient
consensus
upon
which
to
establish
such
a
standard
at
this
time.
Much
of
the
basic,
baseline
information
about
the
prevalence
of
genetically
engineered
products
in
the
conventional
agricultural
marketplace
that
would
be
necessary
to
set
such
a
threshold
 
e.
g.,
the
effects
of
pollen
drift
where
it
may
be
a
factor,
the
extent
of
mixing
at
various
points
throughout
the
marketing
chain,
the
adventitious
presence
of
genetically
engineered
seed
in
nonengineered
seed
lots
 
is
still
largely
unknown.
Our
understanding
of
how
the
use
of
biotechnology
in
conventional
agricultural
production
might
affect
organic
crop
production
is
even
less
well
developed.

Also,
as
was
pointed
out
in
some
comments,
the
testing
methodology
for
the
presence
of
products
of
excluded
methods
has
not
yet
been
fully
validated.
Testing
methods
for
some
biotechnology
traits
in
some
commodities
are
becoming
commercially
available.
Without
recognized
methods
of
testing
for
and
quantifying
of
all
traits
in
a
wide
range
of
food
products,

however,
it
would
be
very
difficult
to
establish
a
reliable
numerical
tolerance.

There
are
publicly
and
privately
funded
research
projects
underway
that
may
provide
useful
baseline
information.
Efforts
of
Federal
agencies
to
clarify
the
marketing
and
labeling
of
biotechnology­
and
nonbiotechnology­
derived
crops
may
also
help
address
these
concerns.
FDA,

for
example,
is
developing
guidance
for
food
producers
who
voluntarily
chose
to
label
326
biotechnology­
and
nonbiotechnology­
derived
foods.
USDA
is
also
preparing
a
Federal
Register
Notice
to
seek
public
comment
on
the
appropriate
role,
if
any,
that
it
can
play
in
facilitating
the
marketing
of
agricultural
products
through
the
development
of
"
quality
assurance"
type
programs
that
help
to
preserve
the
identity
of
agricultural
commodities.
USDA,
in
cooperation
with
the
technology
providers,
is
also
working
to
validate
testing
procedures
and
laboratories
for
some
commodities.

All
of
these
efforts
may
help
to
provide
information
on
this
issue.
Practices
for
preserving
product
identity,
including
segregating
genetically
engineered
and
nongenetically
engineered
products,
are
evolving
in
some
conventional
markets.
As
we
discussed
in
the
preamble
to
the
proposed
rule,
we
anticipate
that
these
evolving
industry
best
practices
and
standards
will
become
the
standards
for
implementing
the
provisions
in
this
regulation
relating
to
the
use
of
excluded
methods.
As
was
also
discussed
in
the
proposed
rule,
these
regulations
do
not
establish
a
"
zero
tolerance"
standard.
As
with
other
substances
not
approve
for
use
in
organic
production
systems,

a
positive
detection
of
a
product
of
excluded
methods
would
trigger
an
investigation
by
the
certifying
agent
to
determine
if
a
violation
of
organic
production
or
handling
standards
occurred.

The
presence
of
a
detectable
residue
alone
does
not
necessarily
indicate
use
of
a
product
of
excluded
methods
that
would
constitute
a
violation
of
the
standards.

(
4)
Certification
Status
After
Emergency
Pest
or
Disease
Treatment.
We
have
not
modified
language
in
section
205.672
that
would
affect
the
certification
status
of
a
certified
organic
operation
if
the
operation
had
been
subjected
to
a
Federal
or
State
emergency
pest
or
disease
treatment
program.

Section
205.672
states
that
when
a
prohibited
substance
is
applied
to
a
certified
operation
327
due
to
a
Federal
or
State
emergency
pest
or
disease
treatment
program
and
the
certified
operation
otherwise
meets
the
requirements
of
this
part,
the
certification
status
of
the
operation
shall
not
be
affected
as
a
result
of
the
application
of
the
prohibited
substance:
Provided,
That,
the
certified
operation
adheres
to
certain
requirements
prescribed
by
the
NOP.
One
group
of
commenters
informed
us
that
they
did
not
support
maintaining
the
organic
status
of
an
operation
that
has
been
directly
treated
with
prohibited
substances,
regardless
of
the
reason
for
treatment.
They
believe
that
Federal
and
State
emergency
pest
or
disease
treatment
programs
should
provide
alternatives
for
organic
operations
whenever
feasible.
If
no
alternative
measure
is
feasible,
the
organic
operation
should
choose
between
voluntary
surrender
of
their
organic
status
on
targeted
parts
of
the
operation
or
destruction
of
the
crop
to
eliminate
pest
habitat.
The
commenters
also
suggested
that
compensation
should
be
provided
to
organic
producers
whose
crops
must
be
destroyed
to
eliminate
habitat.
They
feel
that
allowing
the
application
of
prohibited
materials
to
certified
organic
land
without
affecting
the
certification
status
violates
the
trust
consumers
place
in
organic
certification.

We
disagree
with
the
position
of
the
commenters.
Historically,
residues
from
emergency
pest
or
disease
treatment
programs
have
been
treated
as
drift
cases
by
certifiers.
In
these
cases,

the
specific
crop
may
not
be
sold
as
organic,
but
the
organic
status
of
future
crop
years
are
not
affected.
We
intend
to
handle
such
cases
in
a
similar
manner.
We
understand
that
commenters
would
like
us
to
remove
the
certification
of
an
organic
operation
that
has
been
treated
with
a
prohibited
substance,
but
organic
certification
is
a
production
claim,
not
a
content
claim.
We,

along
with
the
commenters,
are
concerned
with
consumers
trusting
organic
certification.
At
the
same
time,
we
are
concerned
with
the
welfare
of
certified
organic
operations.
We
have
tried
to
328
include
language
in
section
205.672
that
would
address
both
issues.
We
believe
that,
if
a
certified
organic
grower
has
been
a
good
steward
of
his/
her
land
and
has
managed
the
production
of
his/
her
product(
s)
in
accordance
with
all
regulations
in
the
Act
and
other
requirements
in
this
part,

the
certification
status
of
the
operation
should
not
be
affected.
The
application
of
a
prohibited
substance
as
part
of
a
Federal
or
State
emergency
pest
or
disease
treatment
program
is
outside
the
control
of
the
certified
operation.
We
also
believe
that
maintaining
consumer
trust
is
important.

Thus,
section
205.672
states
that
any
harvested
crop
or
plant
part
to
be
harvested
that
has
been
treated
with
a
prohibited
substance
as
part
of
a
Federal
or
State
emergency
pest
or
disease
treatment
program
cannot
be
sold
as
organically
produced.
Therefore,
the
certified
organic
operation
can
retain
its
certification
status,
and
the
consumer
can
be
assured
that
a
product
from
a
certified
organic
operation
that
has
been
in
contact
with
a
prohibited
substance
as
the
result
of
a
Federal
or
State
pest
or
disease
treatment
program
will
not
enter
the
organic
marketplace.

Accordingly,
we
have
not
made
the
change
to
section
205.672
as
proposed
by
the
commenters.

(
5)
Emergency
Pest
or
Disease
Treatment
Programs.
Commenters
suggested
that
the
Department
add
a
new
paragraph
to
section
205.672
that
states
"
the
certifying
agent
must
monitor
production
operations
that
have
been
subjected
to
a
Federal
or
State
emergency
pest
or
disease
treatment
program,
and
may
require
testing
of
following
crops,
or
an
extended
transition
period
for
affected
production
sites,
if
residue
test
results
indicate
the
presence
of
a
prohibited
substance."
Commenters
said
the
language
in
the
proposed
rule
did
not
clearly
establish
that
a
transition
period
could
be
needed
after
contamination
of
a
certified
organic
operation
by
a
government­
mandated
spray
program.
They
felt
that
there
may
be
a
need
for
a
case­
by­
case
determination
by
the
certifying
agent
as
to
when
it
would
be
best
for
a
certified
organic
operation
329
to
begin
selling
its
products
as
organically
produced
after
it
has
been
subject
to
a
government
mandated
spray
program.

We
understand
that
commenters
would
like
USDA
to
mandate
certifying
agents
to
monitor
operations
that
have
been
subject
to
Federal
or
State
emergency
pest
or
disease
treatment
programs;
however,
we
do
not
see
a
need
to
prescribe
such
a
provision.
Based
on
the
responsibilities
of
being
a
USDA­
accredited
certifier,
it
is
our
belief
that
certifying
agents
would
monitor
a
certified
organic
operation
that
has
been
subjected
to
a
Federal
or
State
emergency
pest
or
disease
treatment
program
to
make
sure
that
product
being
produced
for
organic
sale
is
actually
being
produced
in
accordance
with
the
Act
and
the
regulations
in
this
part.
Certifying
agents
have
been
granted
the
authority
to
conduct
additional
on­
site
inspections
of
certified
organic
operations
to
determine
compliance
with
the
Act
and
national
standards
under
subpart
E,

section
205.403.
Commenters
requested
that
we
include
language
that
would
allow
certifying
agents
to
recommend
an
extended
transition
period
for
affected
production
sites
if
residue
tests
indicate
the
presence
of
a
prohibited
substance.
Again,
we
understand
the
commenters'
concern,

but
we
are
not
aware
of
comprehensive
soil
residue
data
that
could
guide
certifying
agents
in
determining
appropriate
withdrawal
intervals
for
operations
that
have
been
subjected
to
emergency
pest
or
disease
treatment
programs.

Residue
Testing
­
Clarifications
Clarification
is
given
on
the
following
issues
raised
by
commenters
as
follows:

(
1)
Sampling
and
Testing.
Commenters
stated
that
the
purpose
of
residue
testing
under
the
Act
is
to
assure
that
organically
produced
agricultural
products
that
are
sold
as
organic
do
not
contain
pesticide
residues
or
residues
of
other
prohibited
substances
that
exceed
levels
as
specified
330
by
the
NOP.
Based
on
language
in
section
205.670(
b)
of
the
proposed
rule,
commenters
expressed
the
opinion
that
the
Agricultural
Marketing
Service
(
AMS)
was,
not
only
requiring
residue
testing
of
organic
agricultural
products,
but
also
of
"
any"
agricultural
input
used
or
agricultural
product
intended
to
be
sold
as
"
100
percent
organic,"
"
organic,"
or
"
made
with..."

when
there
is
reason
to
believe
that
the
agricultural
input
or
product
has
come
into
contact
with
a
prohibited
substance.
Commenters
believe
that
organic
certifying
agents
may
be
required
to
test
many
nonorganic
agricultural
inputs
(
such
as
seeds,
compost,
straw,
sawdust,
and
plastic)
and
nonorganic
agricultural
products
and
ingredients
used
in
products
labeled
as
"
made
with...".

They
also
argued
that
such
testing
would
be
unnecessary,
burdensome,
and
expensive
because
such
materials
are
more
likely
to
have
come
into
contact
with
a
prohibited
substance.
Therefore,

commenters
suggested
that
we
amend
section
205.670(
b)
by
deleting
"
agricultural
inputs"
and
replacing
"
agricultural
product"
with
"
organically
produced
agricultural
product."
They
also
recommended
that
we
replace
the
second
occurrence
of
"
product"
with
"
organic
product."
Thus
section
205.670(
b)
would
suggest
that
only
organic
agricultural
products
could
be
required
to
be
tested
by
the
certifying
agent.

We
understand
the
concerns
of
the
commenters
but
believe
that
the
commenters
have
misinterpreted
the
intent
of
section
205.670(
b).
It
is
not
our
intent
to
mandate
residue
testing
of
all
inputs
and
ingredients
used
in
the
production
of
organic
agricultural
products.
Neither
is
it
our
intent
for
certifying
agents
to
abuse
residue
testing
responsibility
by
conducting
residue
tests
of
certified
organic
operations
without
reason
to
believe
that
the
agricultural
input
or
product
intended
to
be
sold
as
organic
has
come
into
contact
with
prohibited
substances.
Our
intent
is
to
make
it
clear
that
certifying
agents
have
the
authority
to
test
any
agricultural
input
used
or
331
agricultural
product
intended
to
be
sold
as
organically
produced
when
there
is
reason
to
believe
that
the
agricultural
input
or
product
has
come
into
contact
with
a
prohibited
substance.
Section
205.670(
b)
allows
for
testing
of
inputs
and
agricultural
products,
but
it
does
not
require
that
all
inputs
of
a
product
intended
to
be
sold
as
organically
produced
must
be
tested.
However,

certifying
agents
must
be
able
to
ensure
that
certified
organic
operations
are
operating
in
accordance
with
the
Act
and
the
regulations
set
forth
in
this
part.
To
assure
that
certifying
agents
have
established
fair
and
effective
procedures
for
enforcing
residue
testing
requirements,
section
205.504(
b)(
6)
provides
that
they
must
submit
to
USDA
a
copy
of
the
procedures
to
be
used
for
sampling
and
residue
testing
pursuant
to
section
205.670.

(
2)
Chain
Of
Custody
Training.
A
commenter
suggested
that
section
205.670(
c)
address
chain
of
custody
training
for
inspectors
that
will
be
performing
preharvest
or
postharvest
tissue
test
sample
collection
on
behalf
of
the
Administrator,
SOP's
governing
State
official,
or
certifying
agent.
The
commenter
proposed
that
all
inspectors
should
be
trained
to
handle
chain
of
custody
samples
in
order
to
maintain
the
integrity
of
the
samples.

We
agree
that
inspectors
should
be
appropriately
trained
to
handle
chain­
of­
custody
samples
in
order
to
maintain
the
integrity
of
the
samples
taken
from
a
certified
organic
operation.

However,
we
do
not
believe
that
the
language
in
section
205.670(
c)
must
be
modified
to
address
such
an
issue.
As
a
USDA­
accredited
body,
a
private
or
State
entity
operating
as
a
certifying
agent
must
ensure
that
its
responsibly
connected
persons,
employees,
and
contractors
with
inspection,
analysis,
and
decision­
making
responsibilities
have
sufficient
expertise
in
organic
production
or
handling
techniques
to
successfully
perform
the
duties
assigned.
The
certifying
agent
must
also
submit
a
description
of
the
training
that
has
been
provided
or
intends
to
be
332
provided
to
personnel
to
ensure
that
they
comply
with
and
implement
the
requirements
of
the
Act
and
the
regulations
in
this
part.
In
addition,
certifying
agents
must
submit
a
copy
of
the
procedure
to
be
used
for
sampling
and
residue
testing
for
approval
by
the
Administrator.
Through
the
accreditation
process,
therefore,
we
will
be
able
to
assess
the
expertise
of
the
individuals
employed
by
the
certifying
agent
and
provide
guidance
in
areas
where
additional
training
is
needed
to
comply
with
the
requirements
of
the
Act
and
the
regulations
in
this
part.

(
3)
Exclusion
from
Organic
Sale.
Commenters
expressed
that
section
205.671(
a)
could
be
easily
misinterpreted.
They
said
that
section
205.671(
a)
did
not
make
clear
that
residue
testing
may
not
be
used
to
qualify
crops
to
be
sold
as
organic
if
a
direct
application
of
prohibited
materials
occurred.
Commenters
suggested
that
section
205.671(
a)
include:
"
Any
crop
or
product
to
which
prohibited
materials
have
been
directly
applied
shall
not
be
sold,
labeled,
or
represented
as
organically
produced."

We
do
not
believe
this
additional
language
is
necessary.
Residue
testing
cannot
be
used
to
qualify
any
agricultural
crop
or
product
to
which
a
prohibited
material
has
been
purposefully/
directly
applied.
The
presence
of
any
prohibited
substance
on
an
agricultural
product
to
be
sold
as
organic
warrants
an
investigation
as
to
why
the
detected
prohibited
substance
is
present
on
the
agricultural
product.
It
does
not
matter
if
the
product
has
come
into
contact
with
a
prohibited
substance
through
means
of
drift
or
intentional
application.
If
the
outcome
of
the
investigation
reveals
that
the
presence
of
the
detected
prohibited
substance
is
the
result
of
an
intentional
application,
the
certified
operation
will
be
subject
to
suspension
or
revocation
of
its
organic
certification
and/
or
a
civil
penalty
of
not
more
than
$
10,000
if
he/
she
knowingly
sells
the
product
as
organic.
The
use
of
prohibited
substances
is
not
allowed
in
the
Act
333
or
this
final
rule.
Residue
testing
is
not
a
means
of
qualifying
a
crop
or
product
as
organic
if
a
prohibited
substance
has
been
intentionally/
directly
applied.
It
is
a
tool
for
monitoring
compliance
with
the
regulations
set
forth
in
the
Act
and
in
this
part.

(
4)
Emergency
Pest
or
Disease
Treatment
Programs.
Commenters
requested
that
we
make
a
clear
distinction
between
crops
or
agricultural
products
that
have
had
prohibited
substances
directly
applied
to
them
and
those
that
have
come
into
contact
with
prohibited
substances
through
chemical
drift.
They
have
proposed
that
we
amend
section
205.672(
a)
to
address
this
issue.
Section
205.672(
a)
of
the
proposal
states
that
any
harvested
crop
or
plant
part
to
be
harvested
that
has
had
contact
with
a
prohibited
substance
applied
as
the
result
of
a
Federal
or
State
emergency
pest
or
disease
treatment
program
cannot
be
sold
as
organically
produced.

Commenters
did
not
find
this
language
acceptable
because
it
did
not
distinguish
between
the
two
types
of
ways
that
products
can
come
into
contact
with
prohibited
substances
(
drift
and
direct/
intentional
application)
and
how
each
situation
would
be
addressed
with
respect
to
the
national
organic
standards.
Commenters
believed
that
section
205.672(
a)
was
fairly
ambiguous
and
open
for
misinterpretation.
Commenters
requested
that
we
amend
language
in
section
205.672(
a)
to
include
that
"
Any
harvested
crop
or
plant
part
to
be
harvested
that
has
contact
with
a
prohibited
substance
directly
applied
to
the
crop
as
the
result
of
a
Federal
or
State
emergency
pest
or
disease
treatment
program
cannot
be
sold,
labeled,
or
represented
as
organically
produced."

We
do
not
accept
the
commenters'
request
and
believe
that
the
commenters
have
misinterpreted
section
205.672
of
the
proposed
rule.
Section
205.672
specifically
addresses
certified
organic
operations
that
have
had
prohibited
substances
applied
to
them
due
to
a
Federal
334
or
State
pest
or
disease
treatment
program.
Section
205.672
does
not
include
those
organic
operations
that
may
have
been
drifted
upon
by
prohibited
substances
that
have
been
applied
to
a
neighboring
farm
as
a
result
of
a
Federal
or
State
emergency
pest
or
disease
treatment
program.

Any
potential
drift
from
a
mandatory
pest
and
disease
treatment
program
will
be
treated
in
the
same
manner
as
drift
from
any
other
source.

Adverse
Action
Appeal
Process
This
portion
of
subpart
G
sets
forth
the
procedures
for
appealing
adverse
actions
under
the
National
Organic
Program
(
NOP).
These
procedures
will
be
used
by:
(
1)
producers
and
handlers
appealing
denial
of
certification
and
proposed
suspension
or
revocation
of
certification
decisions;
and
(
2)
certifying
agents
appealing
denial
of
accreditation
and
proposed
suspension
or
revocation
of
accreditation
decisions.
The
Act
and
the
Administrative
Procedure
Act
(
APA)
(
5
U.
S.
C.
553­
559)
provides
affected
persons
with
the
right
to
appeal
any
adverse
actions
taken
against
their
application
for
certification
or
accreditation
or
their
certification
or
accreditation.

The
Administrator
will
handle
certification
appeals
from
operations
in
States
that
do
not
have
an
approved
State
organic
program
(
SOP).
The
Administrator
will
also
handle
appeals
of
accreditation
decisions
of
the
NOP
Program
Manager.
The
Administrator
will
issue
decisions
to
sustain
or
deny
appeals.
If
an
appeal
is
denied,
the
Administrator
will
initiate
a
formal
adjudicatory
proceeding
to
deny,
suspend,
or
revoke
certification
or
accreditation.
Such
proceedings
will
be
conducted
pursuant
to
USDA's
Rules
of
Practice
Governing
Formal
Adjudicatory
Proceedings
Instituted
by
the
Secretary
Under
Various
Statutes,
7
CFR
1.130
through
1.151.
Under
these
rules
of
practice,
if
the
Administrative
Law
Judge
denies
the
appeal,

the
appellant
may
appeal
the
Administrative
Law
Judge's
decision
to
the
Judicial
Officer.
If
the
335
Judicial
Officer
denies
the
appeal,
the
appellant
may
appeal
the
Judicial
Officer's
decision
to
the
United
States
District
Court
for
the
district
in
which
the
appellant
is
located.

In
States
with
approved
SOP's,
the
SOP
will
oversee
certification
compliance
proceedings
and
handle
appeals
from
certified
operations
in
the
State.
An
SOP's
appeal
procedures
and
rules
of
procedure
must
be
approved
by
the
Secretary
and
must
be
equivalent
to
those
of
the
NOP
and
USDA.
The
final
decision
on
an
appeal
under
the
SOP
may
be
appealed
by
the
appellant
to
United
States
District
Court
for
the
district
in
which
the
appellant
is
located.

Description
of
Regulations
These
appeal
procedures
provide
that:
(
1)
persons,
subject
to
the
Act,
who
believe
they
are
adversely
affected
by
a
noncompliance
decision
of
the
NOP's
Program
Manager
may
appeal
such
decision
to
the
Administrator;
(
2)
persons,
subject
to
the
Act,
who
believe
they
are
adversely
affected
by
a
noncompliance
decision
of
an
SOP
may
appeal
such
decision
to
the
SOP's
governing
State
official
who
will
initiate
handling
of
the
appeal
in
accordance
with
the
appeal
procedures
approved
by
the
Secretary;
and
(
3)
persons,
subject
to
the
Act,
who
believe
they
are
adversely
affected
by
a
noncompliance
decision
of
a
certifying
agent
may
appeal
such
decision
to
the
Administrator
unless
the
person
is
subject
to
an
approved
SOP,
in
which
case
the
appeal
must
be
made
to
the
SOP.

All
written
communications
between
parties
involved
in
appeal
proceedings
must
be
sent
to
the
recipient's
place
of
business
by
a
delivery
service
which
provides
dated
return
receipts.
All
appeals
filed
under
these
procedures
will
be
reviewed,
heard,
and
decided
by
persons
not
involved
with
the
decision
being
appealed.

Certification
Appeals
336
Applicants
for
certification
may
appeal
a
certifying
agent's
notice
of
denial
of
certification.

Certified
operations
may
appeal
a
notification
of
proposed
suspension
or
revocation
of
their
certification
issued
by
their
certifying
agent.
Such
appeals
will
be
made
to
the
Administrator
unless
the
person
is
subject
to
an
approved
SOP,
in
which
case
the
appeal
must
be
made
to
the
SOP.

If
the
Administrator
or
SOP
sustains
an
appeal,
the
applicant
or
certified
operation
will
be
granted
certification
or
continued
certification,
as
applicable
to
the
operation's
status.
The
act
of
sustaining
the
appeal
will
not
be
considered
an
adverse
action
and
may
not
be
appealed
by
the
certifying
agent
which
issued
the
notice
of
denial
of
certification
or
notification
of
proposed
suspension
or
revocation
of
certification.

If
the
Administrator
or
SOP
denies
an
appeal,
a
formal
administrative
proceeding
will
be
initiated
to
deny,
suspend,
or
revoke
the
certification.
Such
proceeding
will
be
conducted
in
accordance
with
USDA's
Uniform
Rules
of
Practice
or
the
SOP's
rules
of
procedure.

Accreditation
Appeals
Applicants
for
accreditation
may
appeal
the
Program
Manager's
notification
of
accreditation
denial.
Accredited
certifying
agents
may
appeal
a
notification
of
proposed
suspension
or
revocation
of
their
accreditation
issued
by
the
Program
Manager.
Such
appeals
will
be
made
to
the
Administrator.
If
the
Administrator
sustains
an
appeal,
the
applicant
or
certifying
agent
will
be
granted
accreditation
or
continued
accreditation,
as
applicable
to
the
operation's
status.
If
the
Administrator
denies
an
appeal,
a
formal
administrative
proceeding
will
be
initiated
to
deny,
suspend,
or
revoke
the
accreditation.
Such
proceeding
will
be
conducted
in
accordance
with
USDA's
Uniform
Rules
of
Practice.
337
Filing
Period
An
appeal
of
a
noncompliance
decision
must
be
filed
within
the
time
period
provided
in
the
letter
of
notification
or
within
30
days
from
the
date
of
receipt
of
the
notification,
whichever
occurs
later.
The
appeal
will
be
considered
"
filed"
on
the
date
received
by
the
Administrator
or,

when
applicable,
the
SOP.
Unless
appealed
in
a
timely
manner,
a
notification
to
deny,
suspend,
or
revoke
a
certification
or
accreditation
will
become
final.
The
applicant,
certified
operation,
or
certifying
agent
that
does
not
file
an
appeal
in
the
time
period
provided
waives
the
right
to
further
appeal
of
the
compliance
proceeding.

Where
and
What
to
File
Appeals
to
the
Administrator
must
be
filed
in
writing
and
sent
to:
Administrator,

USDAAMS
Room
3071­
S,
P.
O.
Box
96456,
Washington,
DC
20090­
6456.
Appeals
to
the
SOP
must
be
filed
in
writing
to
the
address
and
person
identified
in
the
letter
of
notification.
All
appeals
must
include
a
copy
of
the
adverse
decision
to
be
reviewed
and
a
statement
of
the
appellant's
reasons
for
believing
that
the
decision
was
not
proper
or
made
in
accordance
with
applicable
program
regulations,
policies,
or
procedures.

Appeals
­
Changes
Based
On
Comments
This
portion
of
subpart
G
differs
from
the
proposal
in
several
respects
as
follows:

(
1)
To
Whom
an
Appeal
Is
Made.
We
have
amended
section
205.680
to
clarify
to
whom
an
appeal
is
made
when
the
noncompliance
decision
is
made
by
the
NOP's
Program
Manager,
an
SOP,
or
a
certifying
agent.
Several
commenters
requested
that
we
amend
section
205.680
to
make
it
consistent
with
the
provision
providing
that
appeals
to
the
Administrator
are
not
allowed
in
the
case
of
an
SOP
decision,
because
such
appeals
have
to
be
made
to
the
SOP's
governing
338
State
official.

We
agree
that
section
205.680
did
not
convey
sufficient
explanation
of
to
whom
an
appeal
is
made.
Accordingly,
we
have
amended
the
language
in
section
205.680
to
clarify
through
paragraphs
(
a),
(
b),
and
(
c)
that:
(
1)
persons,
subject
to
the
Act,
who
believe
they
are
adversely
affected
by
a
noncompliance
decision
of
the
NOP's
Program
Manager
may
appeal
such
decision
to
the
Administrator;
(
2)
persons,
subject
to
the
Act,
who
believe
they
are
adversely
affected
by
a
noncompliance
decision
of
an
SOP
may
appeal
such
decision
to
the
SOP's
governing
State
official
who
will
initiate
handling
of
the
appeal
pursuant
to
appeal
procedures
approved
by
the
Secretary;

and
(
3)
persons,
subject
to
the
Act,
who
believe
they
are
adversely
affected
by
a
noncompliance
decision
of
a
certifying
agent
may
appeal
such
decision
to
the
Administrator
unless
the
person
is
subject
to
an
approved
SOP,
in
which
case
the
appeal
must
be
made
to
the
SOP.

(
2)
Written
Communications.
We
have
added
a
new
paragraph
(
d)
to
section
205.680,

which
provides
that
all
written
communications
between
parties
involved
in
appeal
proceedings
must
be
sent
to
the
recipient's
place
of
business
by
a
delivery
service
which
provides
dated
return
receipts.
We
have
taken
this
action
to
further
clarify
the
appeals
process.
This
addition
to
section
205.680
implements
the
same
requirements
for
appeal
documents
as
our
addition
of
new
paragraph
(
d)
to
section
205.660
stipulates
for
compliance
documents.

(
3)
Who
Shall
Handle
Appeals.
We
have
added
a
new
paragraph
(
e)
to
section
205.680,

which
provides
that
all
appeals
must
be
reviewed,
heard,
and
decided
by
persons
not
involved
with
the
decision
being
appealed.
This
provision
was
added
to
section
205.680
to
allay
the
fears
of
commenters
that
the
person
making
the
decision
would
be
the
person
deciding
the
appeal.
A
couple
of
commenters
recommended
that
an
appeal
be
heard
by
persons
other
than
those
who
339
made
the
decision
being
appealed.
Specifically,
they
want
the
appeal
conducted
by
independent
hearing
officers
who
are
not
responsible
for
implementation
or
administration
of
the
NOP.
They
also
want
the
final
decision­
making
authority
in
the
administrative
review
process
placed
in
the
hands
of
the
Secretary.

Under
the
NOP,
once
the
compliance
procedures
are
completed
at
the
certifying
agent
level,
the
certified
operation
may
appeal
the
decision
of
the
certifying
agent
to
the
Administrator
or
to
the
SOP
when
the
certified
operation
is
located
within
a
State
with
an
approved
SOP.
The
Administrator
or
the
SOP
will
review
the
case
and
render
an
opinion
on
the
appeal.
When
the
appeal
is
sustained,
the
certified
operation
and
certifying
agent
are
notified
and
the
case
ends.

However,
if
the
appeal
is
denied
the
certified
operation
and
certifying
agent
are
notified
and
the
certified
operation
is
given
an
opportunity
to
appeal
the
decision
of
the
Administrator
or
SOP.

Appeals
of
decisions
made
by
the
Administrator
will
be
heard
by
an
Administrative
Law
Judge.
If
the
Administrative
Law
Judge
rules
against
the
certified
operation,
the
Administrative
Law
Judge's
decision
may
be
appealed
by
the
certified
operation
to
the
Judicial
Officer.
The
Judicial
Officer
is
the
USDA
official
delegated
authority
by
the
Secretary
as
the
final
deciding
officer
in
adjudication
proceedings.
If
the
Judicial
Officer
rules
against
the
certified
operation,
the
Judicial
Officer's
decision
may
be
appealed
by
the
certified
operation
to
the
United
States
District
Court
for
the
district
in
which
the
certified
operation
is
located.
For
additional
information
see
USDA's
Uniform
Rules
of
Practice
found
at
7
CFR
Part
1,
subpart
H.

Appeals
of
decisions
made
by
an
SOP
will
follow
procedures
comparable
to
those
just
described
for
an
appeal
of
a
decision
made
by
the
Administrator.
As
with
a
final
decision
of
USDA,
a
final
decision
of
the
State
that
goes
against
the
certified
operation
may
be
appealed
to
340
the
United
States
District
Court
for
the
district
in
which
the
certified
operation
is
located.

(
4)
Filing
Period.
We
have
amended
the
first
sentence
of
section
205.681(
c)
by
replacing
"
at
least"
with
"
within"
and
by
adding
the
words,
"
whichever
occurs
later,"
to
the
end
thereof.

This
amendment
has
been
made
to
clarify
our
intent
that
persons
affected
by
a
noncompliance
proceeding
decision
receive
not
less
than
30
days
in
which
to
file
their
appeal
of
the
decision.

(
5)
Where
To
File
an
Appeal.
We
have
amended
section
205.681(
d)
to
clarify
where
appeals
are
to
be
filed.
First,
we
have
amended
what
is
now
paragraph
(
1)
by
removing
the
requirement
that
the
appellant
send
a
copy
of
the
appeal
to
the
certifying
agent.
This
action
shifts
the
responsibility
of
notifying
the
certifying
agent
of
the
appeal
from
the
appellant
to
USDA
or,

when
applicable,
the
SOP.
Second,
we
have
added
language
at
paragraph
(
2)
which
clarifies
that
appeals
to
the
SOP
must
be
filed
in
writing
to
the
address
and
person
identified
in
the
letter
of
notification.
Finally,
we
have
amended
what
is
now
paragraph
(
3)
of
section
205.681
by
replacing
"
position"
with
"
reasons
for
believing"
to
clarify
the
intended
scope
and
purpose
of
the
appellant's
appeal
statement.
Clarification
of
section
205.681(
d)
was
prompted
by
a
commenter
who
stated
that
it
is
discriminatory
to
require
clients
of
private
certifying
agents
to
appeal
to
USDA
in
Washington,
when
State
program
clients
can
appeal
locally.

There
are
various
levels
of
appeal
within
the
NOP.
Clients
of
certifying
agents
(
State
and
private)
are
provided
with
an
opportunity
to
rebut
the
noncompliance
findings
of
the
certifying
agent.
Once
the
certified
operation
has
exhausted
its
options
at
the
certifying
agent
level,
the
certified
operation
may
appeal
the
decision
of
the
certifying
agent
to
the
Administrator
or
to
the
SOP
when
the
certified
operation
is
located
within
a
State
with
an
approved
SOP.

The
Administrator
will
review
the
case
and
render
an
opinion
on
the
appeal.
This
level
of
341
appeal
will
not
require
the
certified
operation's
representative
to
travel
to
the
Administrator.
An
appeal
of
a
decision
made
by
the
Administrator
will
be
heard
by
an
Administrative
Law
Judge
as
near
as
possible
to
the
certified
operation's
representative's
place
of
business
or
residence.
An
appeal
of
a
decision
made
by
the
Administrative
Law
Judge
will
be
heard
by
the
Judicial
Officer.

Again
the
certified
operation's
representative
will
not
be
required
to
travel
outside
of
the
representative's
place
of
business
or
residence.
If
the
certified
operation
appeals
the
decision
of
the
Judicial
Officer,
the
appeal
would
be
heard
by
the
United
States
District
Court
for
the
district
in
which
the
certified
operation
is
located.

Appeals
of
decisions
made
by
an
SOP
will
follow
procedures
comparable
to
those
just
described
for
an
appeal
of
a
decision
made
by
the
Administrator.
As
with
a
final
decision
of
USDA,
a
final
decision
of
the
State
that
goes
against
the
certified
operation
may
be
appealed
to
the
United
States
District
Court
for
the
district
in
which
the
certified
operation
is
located.

(
6)
Appeal
Reports.
We
will
submit
an
annual
report
on
appeals
to
the
National
Organic
Standards
Board
(
NOSB),
which
will
include
nonconfidential
compliance
information.
A
commenter
requested
that
we
report
quarterly
to
the
NOSB
on
appeals
(
number,
outcome,
kinds,

and
problems).
We
agree
that
it
would
be
appropriate
for
the
NOP
to
submit
an
appeals
report
to
the
NOSB.
We
will
compile
appeal
data
such
as
the
number,
outcome,
kinds,
and
problems
encountered.
We
will
maintain
this
information
under
the
compliance
program
to
be
developed
within
the
NOP.
We
do
not
believe
that
it
is
necessary
to
put
this
type
of
detail
or
activity
into
the
regulations.
Further,
we
do
not
believe,
at
this
time,
that
reporting
more
frequently
than
annually
will
be
needed.
The
NOP,
however,
will
work
closely
with
the
NOSB
to
provide
it
with
the
information
it
may
need
to
recommend
program
amendments
designed
to
address
compliance
342
and
appeal
issues.

(
7)
Availability
of
Appeal
Information.
We
will
develop
and
distribute
appeal
information.
A
commenter
requested
that
section
205.680
be
amended
to
require
the
distribution
of
an
appeal
information
brochure
to
any
applicant
for
accreditation
or
certification.
We
agree
that
the
development
and
distribution
of
such
information
is
a
good
idea.
We
do
not
believe,

however,
that
it
is
necessary
or
appropriate
to
put
this
type
of
detail
or
activity
into
the
regulations.
We
plan
to
provide
program
information,
including
appeals
and
related
issues,
on
the
NOP
website.

Appeals
­
Changes
Requested
But
Not
Made
This
portion
of
subpart
G
retains
from
the
proposed
rule,
regulations
on
which
we
received
comments
as
follows:

(
1)
National
Appeals
Division.
Several
commenters
recommend
amending
sections
205.680
and
205.681
to
provide
for
appeals
to
the
National
Appeals
Division
under
the
provisions
at
7
CFR
Part
11.
We
disagree
with
the
request
that
the
NOP
use
the
National
Appeals
Division
Rules
of
Procedure.
The
Act
and
its
implementing
regulations
are
subject
to
the
APA
for
rulemaking
and
adjudication.
The
provisions
of
the
APA
generally
applicable
to
agency
adjudication
are
not
applicable
to
proceedings
under
7
CFR
Part
11,
National
Appeals
Division
Rules
of
Procedure.
USDA
uses
7
CFR
Part
1,
Rules
of
Practice
Governing
Formal
Adjudicatory
Proceedings
Instituted
by
the
Secretary
Under
Various
Statutes,
for
adjudicatory
proceedings
involving
the
denial,
suspension,
and
revocation
of
certification
and
accreditation.

Appeals
­
Clarifications
Clarification
is
given
on
the
following
issues
raised
by
commenters:
343
(
1)
Appeals.
A
commenter
stated
that
appeals
of
certification
decisions
should
always
be
taken
first
to
the
certifying
agent
to
provide
an
opportunity
to
rectify
any
possible
error.
Another
commenter
requested
an
appeals
process
that
includes
private
certifying
agents.

Section
205.662(
a)
requires
a
written
notification
of
noncompliance
with
opportunity
to
rebut
or
correct.
When
the
noncompliance
has
been
resolved
due
to
rebuttal
or
correction,
a
written
notification
of
noncompliance
resolution
is
issued
in
accordance
with
section
205.662(
b).

When
rebuttal
is
unsuccessful
or
correction
of
the
noncompliance
is
not
completed
within
the
prescribed
time
period,
a
written
notification
of
proposed
suspension
or
revocation
will
be
issued
in
accordance
with
section
205.662(
c).
This
notification
will
advise
the
certified
operation
of
its
right
to
request
mediation
or
file
an
appeal
with
the
Administrator
or,
when
applicable,
an
SOP.

We
believe
this
process
of
providing
a
notification
of
noncompliance
with
opportunity
to
rebut
or
correct,
followed
by
a
notification
of
proposed
suspension
or
revocation,
provides
ample
opportunity
for
the
certified
operation
to
work
with
its
certifying
agent
to
resolve
issues
of
noncompliance.

(
2)
Timely
Notification.
A
few
commenters
requested
that
we
amend
section
205.680
to
include
mandatory
procedures
for
timely
written
notice
of
an
adverse
decision,
the
reasons
for
the
decision,
the
person's
appeal
rights,
and
the
procedures
for
filing
an
appeal.
We
recognize
that
all
compliance
activities
need
to
be
carried
out
as
quickly
and
expeditiously
as
possible
within
the
confines
of
due
process.
We
believe
that
the
commenters'
concerns
are
addressed
through
various
sections
of
these
regulations.
Section
205.402(
a)
requires
review
of
an
application
upon
acceptance
of
the
application.
Section
205.405,
on
denial
of
certification,
requires
a
notification
of
noncompliance,
followed,
as
applicable,
by
a
notice
of
denial
of
certification.
In
accordance
344
with
section
205.405(
d),
the
notice
of
denial
of
certification
will
state
the
reasons
for
denial
and
the
applicant's
right
to
request
mediation
or
appeal
the
decision.
Section
205.507
on
denial
of
accreditation
requires
a
notification
of
noncompliance,
followed,
as
applicable,
by
a
denial
of
accreditation.
The
notification
of
accreditation
denial
will
state
the
reasons
for
denial
and
the
applicant's
right
to
appeal
the
decision.
Compliance
sections
205.662
for
certified
operations
and
205.665
for
certifying
agents
require
a
notification
of
noncompliance
with
an
opportunity
to
correct
or
rebut
the
noncompliance(
s).
Sections
205.662
and
205.665,
when
applicable,
require
the
issuance
of
a
notification
of
proposed
suspension
or
revocation.
Such
notice
must
describe
the
noncompliance
and
the
entity's
right
to
an
appeal.
Section
205.681
provides
the
procedures
for
filling
an
appeal.

Miscellaneous
Section
205.690
provisions
the
Office
of
Management
and
Budget
control
number
assigned
to
the
information
collection
requirements
of
these
regulations.
Sections
205.691
through
205.699
are
reserved.

List
of
Subjects
in
7
CFR
Part
205
Administrative
practice
and
procedure,
Agriculture,
Animals,
Archives
and
records,

Imports,
Labeling,
Organically
produced
products,
Plants,
Reporting
and
recordkeeping
requirements,
Seals
and
insignia,
Soil
conservation.

For
the
reasons
set
forth
in
the
preamble,
it
is
proposed
that
Title
7,
Chapter
I
of
the
Code
of
Federal
Regulations
be
amended
as
follows:

1.
Parts
205
through
209,
which
are
currently
reserved
in
subchapter
K
(
Federal
Seed
Act),
are
removed.
345
2.
A
new
subchapter
M
consisting
of
part
205
through
209
is
added
to
read
as
follows:

SUBCHAPTER
M­­
ORGANIC
FOODS
PRODUCTION
ACT
PROVISIONS
PART
205
­
NATIONAL
ORGANIC
PROGRAM
Subpart
A
­
Definitions
Sec.

205.1
Meaning
of
words.

205.2
Terms
defined.

Subpart
B
­
Applicability
205.100
What
has
to
be
certified.

205.101
Exemptions
and
exclusions
from
certification.

205.102
Use
of
the
term,
"
organic."

205­
103
Recordkeeping
by
certified
operations.

205.104
[
Reserved]

205.105
Allowed
and
prohibited
substances,
methods,
and
ingredients
in
organic
production
and
handling.

205.106­
205.199
[
Reserved]

Subpart
C
­
Organic
Crop,
Wild
Crop,
Livestock,
and
Handling
Requirements
205.200
General.

205.201
Organic
production
and
handling
system
plan.

205.202
Land
requirements.

205.203
Soil
fertility
and
crop
nutrient
management
practice
standard.

205.204
Seeds
and
planting
stock
practice
standard.
346
205.205
Crop
rotation
practice
standard.

205.206
Crop
pest,
weed,
and
disease
management
practice
standard.

205.207
Wild­
crop
harvesting
practice
standard.

205.208­
205.235
[
Reserved]

205.236
Origin
of
livestock.

205.237
Livestock
feed.

205.238
Livestock
health
care
practice
standard.

205.239
Livestock
living
conditions.

205.240­
205.269
[
Reserved]

205.270
Organic
handling
requirements.

205.271
Facility
pest
management
practice
standard.

205.272
Commingling
and
contact
with
prohibited
substance
prevention
practice
standard.

205.273­
205.289
[
Reserved]

205.290
Temporary
variances.

205.291­
205.299
[
Reserved]

Subpart
D
­
Labels,
Labeling,
and
Market
Information
205.300
Use
of
the
term,
"
organic."

205.301
Product
composition.

205.302
Calculating
the
percentage
of
organically
produced
ingredients.

205.303
Packaged
products
labeled
"
100
percent
organic"
or
"
organic."

205.304
Packaged
products
labeled
"
made
with
organic
(
specified
ingredients
or
food
group(
s))."
347
205.305
Multiingredient
packaged
products
with
less
that
70
percent
organically
produced
ingredients.

205.306
Labeling
of
livestock
feed.

205.307
Labeling
of
nonretail
containers
used
for
only
shipping
or
storage
of
raw
or
processed
agricultural
products
labeled
as
"
100
percent
organic,"
"
organic,"
or
"
made
with
organic
(
specified
ingredients
or
food
group(
s))."

205.308
Agricultural
products
in
other
than
packaged
form
at
the
point
of
retail
sale
that
are
sold,
labeled,
or
represented
as
"
100
percent
organic"
or
"
organic."

205.309
Agricultural
products
in
other
than
packaged
form
at
the
point
of
retail
sale
that
are
sold,
labeled,
or
represented
as
"
made
with
organic
(
specified
ingredients
or
food
group(
s))."

205.310
Agricultural
products
produced
on
an
exempt
production
operation.

205.311
USDA
Seal.

205.312­
205.399
[
Reserved]

Subpart
E
­
Certification
205.400
General
requirements
for
certification.

205.401
Application
for
certification.

205.402
Review
of
application.

205.403
On­
site
inspections.

205.404
Granting
certification.

205.405
Denial
of
certification.

205.406
Continuation
of
certification.
348
205.407­
205.499
[
Reserved]

Subpart
F
­
Accreditation
of
Certifying
Agents
205.500
Areas
and
duration
of
accreditation.

205.501
General
requirements
for
accreditation.

205.502
Applying
for
accreditation.

205.503
Applicant
information.

205.504
Evidence
of
expertise
and
ability.

205.505
Statement
of
agreement.

205.506
Granting
accreditation.

205.507
Denial
of
accreditation.

205.508
Site
evaluations.

205.509
Peer
review
panel.

205.510
Annual
report,
recordkeeping,
and
renewal
of
accreditation.

205.511­
205.599
[
Reserved]

Subpart
G
­
Administrative
The
National
List
of
Allowed
and
Prohibited
Substances
205.600
Evaluation
criteria
for
allowed
and
prohibited
substances,
methods,
and
ingredients.

205.601
Synthetic
substances
allowed
for
use
in
organic
crop
production.

205.602
Nonsynthetic
substances
prohibited
for
use
in
organic
crop
production.

205.603
Synthetic
substances
allowed
for
use
in
organic
livestock
production.

205.604
Nonsynthetic
substances
prohibited
for
use
in
organic
livestock
production.
349
205.605
Nonagricultural
(
nonorganic)
substances
allowed
as
ingredients
in
or
on
processed
products
labeled
as
"
organic,"
or
"
made
with
organic
(
specified
ingredients
or
food
group(
s))."

205.606
Nonorganically
produced
agricultural
products
allowed
as
ingredients
in
or
on
processed
products
labeled
as
"
organic"
or
"
made
with
organic
(
specified
ingredients
or
food
group(
s))."

205.607
Amending
the
National
List.

205.608­
205.619
[
Reserved]

State
Programs
205.620
Requirements
of
State
organic
programs.

205.621
Submission
and
determination
of
proposed
State
organic
programs
and
amendments
to
approved
State
organic
programs.

205.622
Review
of
approved
State
organic
programs.

205.623­
205.639
[
Reserved]

Fees
205.640
Fees
and
other
charges
for
accreditation.

205.641
Payment
of
fees
and
other
charges.

205.642
Fees
and
other
charges
for
certification.

205.643­
205.649
[
Reserved]

Compliance
205.660
General.

205.661
Investigation
of
certified
operations.
350
205.662
Noncompliance
procedure
for
certified
operations.

205.663
Mediation.

205.664
[
Reserved]

205.665
Noncompliance
procedure
for
certifying
agents.

205.666­
205.667
[
Reserved]

205.668
Noncompliance
procedures
under
State
Organic
Programs.

205.699
[
Reserved]

Inspection
and
Testing,
Reporting,
and
Exclusion
from
Sale
205.670
Inspection
and
testing
of
agricultural
product
to
be
sold
or
labeled
"
organic."

205.671
Exclusion
from
organic
sale.

205.672
Emergency
pest
or
disease
treatment.

205.673­
205.679
[
Reserved]

Adverse
Action
Appeal
Process
205.680
General.

205.681
Appeals.

205.682­
205.689
[
Reserved]

Miscellaneous
205.690
OMB
control
number.

205.691­
205.699
[
Reserved]

Authority:
7
U.
S.
C.
6501­
6522
Subpart
A
­
Definitions
§
205.1
Meaning
of
words.
351
For
the
purpose
of
the
regulations
in
this
subpart,
words
in
the
singular
form
shall
be
deemed
to
impart
the
plural
and
vice
versa,
as
the
case
may
demand.

§
205.2
Terms
defined.

Accreditation.
A
determination
made
by
the
Secretary
that
authorizes
a
private,
foreign,

or
State
entity
to
conduct
certification
activities
as
a
certifying
agent
under
this
part.

Act.
The
Organic
Foods
Production
Act
of
1990,
as
amended
(
7
U.
S.
C.
6501
et
seq.).

Action
level.
The
limit
at
or
above
which
the
Food
and
Drug
Administration
will
take
legal
action
against
a
product
to
remove
it
from
the
market.
Action
levels
are
based
on
unavoidability
of
the
poisonous
or
deleterious
substances
and
do
not
represent
permissible
levels
of
contamination
where
it
is
avoidable.

Administrator.
The
Administrator
for
the
Agricultural
Marketing
Service,
United
States
Departure
of
Agriculture,
or
the
representative
to
whom
authority
has
been
delegated
to
act
in
the
stead
of
the
Administrator.

Agricultural
inputs.
All
substances
or
materials
used
in
the
production
or
handling
of
organic
agricultural
products.

Agricultural
product.
Any
agricultural
commodity
or
product,
whether
raw
or
processed,

including
any
commodity
or
product
derived
from
livestock,
that
is
marketed
in
the
United
States
for
human
or
livestock
consumption.

Allowed
synthetic.
A
substance
that
is
included
on
the
National
List
of
synthetic
substances
allowed
for
use
in
organic
production
or
handling.

Agricultural
Marketing
Service
(
AMS).
The
Agricultural
Marketing
Service
of
the
United
States
Department
of
Agriculture.
352
Animal
drug.
Any
drug
as
defined
in
section
201
of
the
Federal
Food,
Drug,
and
Cosmetic
Act,
as
amended
(
21
U.
S.
C.
321),
that
is
intended
for
use
in
livestock,
including
any
drug
intended
for
use
in
livestock
feed
but
not
including
such
livestock
feed.

Annual
seedling.
A
plant
grown
from
seed
that
will
complete
its
life
cycle
or
produce
a
harvestable
yield
within
the
same
crop
year
or
season
in
which
it
was
planted.

Area
of
operation.
The
types
of
operations:
crops,
livestock,
wild­
crop
harvesting
or
handling,
or
any
combination
thereof
that
a
certifying
agent
may
be
accredited
to
certify
under
this
part.

Audit
trail.
Documentation
that
is
sufficient
to
determine
the
source,
transfer
of
ownership,
and
transportation
of
any
agricultural
product
labeled
as
"
100
percent
organic,"
the
organic
ingredients
of
any
agricultural
product
labeled
as
"
organic"
or
"
made
with
organic
(
specified
ingredients)"
or
the
organic
ingredients
of
any
agricultural
product
containing
less
than
70
percent
organic
ingredients
identified
as
organic
in
an
ingredients
statement.

Biodegradable.
Subject
to
biological
decomposition
into
simpler
biochemical
or
chemical
components.

Biologics.
All
viruses,
serums,
toxins,
and
analogous
products
of
natural
or
synthetic
origin,
such
as
diagnostics,
antitoxins,
vaccines,
live
microorganisms,
killed
microorganisms,
and
the
antigenic
or
immunizing
components
of
microorganisms
intended
for
use
in
the
diagnosis,

treatment,
or
prevention
of
diseases
of
animals.

Breeder
stock.
Female
livestock
whose
offspring
may
be
incorporated
into
an
organic
operation
at
the
time
of
their
birth.

Buffer
zone.
An
area
located
between
a
certified
production
operation
or
portion
of
a
353
production
operation
and
an
adjacent
land
area
that
is
not
maintained
under
organic
management.

A
buffer
zone
must
be
sufficient
in
size
or
other
features
(
e.
g.,
windbreaks
or
a
diversion
ditch)
to
prevent
the
possibility
of
unintended
contact
by
prohibited
substances
applied
to
adjacent
land
areas
with
an
area
that
is
part
of
a
certified
operation.

Bulk.
The
presentation
to
consumers
at
retail
sale
of
an
agricultural
product
in
unpackaged,
loose
form,
enabling
the
consumer
to
determine
the
individual
pieces,
amount,
or
volume
of
the
product
purchased.

Certification
or
certified.
A
determination
made
by
a
certifying
agent
that
a
production
or
handling
operation
is
in
compliance
with
the
Act
and
the
regulations
in
this
part,
which
is
documented
by
a
certificate
of
organic
operation.

Certified
operation.
A
crop
or
livestock
production,
wild­
crop
harvesting
or
handling
operation,
or
portion
of
such
operation
that
is
certified
by
an
accredited
certifying
agent
as
utilizing
a
system
of
organic
production
or
handling
as
described
by
the
Act
and
the
regulations
in
this
part.

Certifying
agent.
Any
entity
accredited
by
the
Secretary
as
a
certifying
agent
for
the
purpose
of
certifying
a
production
or
handling
operation
as
a
certified
production
or
handling
operation.

Certifying
agent's
operation.
All
sites,
facilities,
personnel,
and
records
used
by
a
certifying
agent
to
conduct
certification
activities
under
the
Act
and
the
regulations
in
this
part.

Claims.
Oral,
written,
implied,
or
symbolic
representations,
statements,
or
advertising
or
other
forms
of
communication
presented
to
the
public
or
buyers
of
agricultural
products
that
relate
to
the
organic
certification
process
or
the
term,
"
100
percent
organic,"
"
organic,"
or
"
made
354
with
organic
(
specified
ingredients
or
food
group(
s)),"
or,
in
the
case
of
agricultural
products
containing
less
than
70
percent
organic
ingredients,
the
term,
"
organic,"
on
the
ingredients
panel.

Commercially
available.
The
ability
to
obtain
a
production
input
in
an
appropriate
form,

quality,
or
quantity
to
fulfill
an
essential
function
in
a
system
of
organic
production
or
handling,
as
determined
by
the
certifying
agent
in
the
course
of
reviewing
the
organic
plan.

Commingling.
Physical
contact
between
unpackaged
organically
produced
and
nonorganically
produced
agricultural
products
during
production,
processing,
transportation,

storage
or
handling,
other
than
during
the
manufacture
of
a
multiingredient
product
containing
both
types
of
ingredients.

Compost.
The
product
of
a
managed
process
through
which
microorganisms
break
down
plant
and
animal
materials
into
more
available
forms
suitable
for
application
to
the
soil.
Compost
must
be
produced
through
a
process
that
combines
plant
and
animal
materials
with
an
initial
C:
N
ratio
of
between
25:
1
and
40:
1.
Producers
using
an
in­
vessel
or
static
aerated
pile
system
must
maintain
the
composting
materials
at
a
temperature
between
131
E
F
and
170
E
F
for
3
days.

Producers
using
a
windrow
system
must
maintain
the
composting
materials
at
a
temperature
between
131
E
F
and
170
E
F
for
15
days,
during
which
time,
the
materials
must
be
turned
a
minimum
of
five
times.

Control.
Any
method
that
reduces
or
limits
damage
by
populations
of
pests,
weeds,
or
diseases
to
levels
that
do
not
significantly
reduce
productivity.

Crop.
A
plant
or
part
of
a
plant
intended
to
be
marketed
as
an
agricultural
product
or
fed
to
livestock.

Crop
residues.
The
plant
parts
remaining
in
a
field
after
the
harvest
of
a
crop,
which
355
include
stalks,
stems,
leaves,
roots,
and
weeds.

Crop
rotation.
The
practice
of
alternating
the
annual
crops
grown
on
a
specific
field
in
a
planned
pattern
or
sequence
in
successive
crop
years
so
that
crops
of
the
same
species
or
family
are
not
grown
repeatedly
without
interruption
on
the
same
field.
Perennial
cropping
systems
employ
means
such
as
alley
cropping,
intercropping,
and
hedgerows
to
introduce
biological
diversity
in
lieu
of
crop
rotation.

Crop
year.
That
normal
growing
season
for
a
crop
as
determined
by
the
Secretary.

Cultivation.
Digging
up
or
cutting
the
soil
to
prepare
a
seed
bed;
control
weeds;
aerate
the
soil;
or
work
organic
matter,
crop
residues,
or
fertilizers
into
the
soil.

Cultural
methods.
Methods
used
to
enhance
crop
health
and
prevent
weed,
pest,
or
disease
problems
without
the
use
of
substances;
examples
include
the
selection
of
appropriate
varieties
and
planting
sites;
proper
timing
and
density
of
plantings;
irrigation;
and
extending
a
growing
season
by
manipulating
the
microclimate
with
green
houses,
cold
frames,
or
wind
breaks.

Detectable
residue.
The
amount
or
presence
of
chemical
residue
or
sample
component
that
can
be
reliably
observed
or
found
in
the
sample
matrix
by
current
approved
analytical
methodology.

Disease
vectors.
Plants
or
animals
that
harbor
or
transmit
disease
organisms
or
pathogens
which
may
attack
crops
or
livestock.

Drift.
The
physical
movement
of
prohibited
substances
from
the
intended
target
site
onto
an
organic
operation
or
portion
thereof.

Emergency
pest
or
disease
treatment
program.
A
mandatory
program
authorized
by
a
Federal,
State,
or
local
agency
for
the
purpose
of
controlling
or
eradicating
a
pest
or
disease.
356
Employee.
Any
person
providing
paid
or
volunteer
services
for
a
certifying
agent.

Excluded
methods.
A
variety
of
methods
used
to
genetically
modify
organisms
or
influence
their
growth
and
development
by
means
that
are
not
possible
under
natural
conditions
or
processes
and
are
not
considered
compatible
with
organic
production.
Such
methods
include
cell
fusion,
microencapsulation
and
macroencapsulation,
and
recombinant
DNA
technology
(
including
gene
deletion,
gene
doubling,
introducing
a
foreign
gene,
and
changing
the
positions
of
genes
when
achieved
by
recombinant
DNA
technology).
Such
methods
do
not
include
the
use
of
traditional
breeding,
conjugation,
fermentation,
hybridization,
in
vitro
fertilization,
or
tissue
culture.

Feed.
Edible
materials
which
are
consumed
by
livestock
for
their
nutritional
value.
Feed
may
be
concentrates
(
grains)
or
roughages
(
hay,
silage,
fodder).
The
term,
"
feed,"
encompasses
all
agricultural
commodities,
including
pasture
ingested
by
livestock
for
nutritional
purposes.

Feed
additive.
A
substance
added
to
feed
in
micro
quantities
to
fulfill
a
specific
nutritional
need;
i.
e.,
essential
nutrients
in
the
form
of
amino
acids,
vitamins,
and
minerals.

Feed
Supplement.
A
combination
of
feed
nutrients
added
to
livestock
feed
to
improve
the
nutrient
balance
or
performance
of
the
total
ration
and
intended
to
be:

(
1)
Diluted
with
other
feeds
when
fed
to
livestock;

(
2)
Offered
free
choice
with
other
parts
of
the
ration
if
separately
available;
or
(
3)
Further
diluted
and
mixed
to
produce
a
complete
feed.

Fertilizer.
A
single
or
blended
substance
containing
one
or
more
recognized
plant
nutrient(
s)
which
is
used
primarily
for
its
plant
nutrient
content
and
which
is
designed
for
use
or
claimed
to
have
value
in
promoting
plant
growth.
357
Field.
An
area
of
land
identified
as
a
discrete
unit
within
a
production
operation.

Forage.
Vegetative
material
in
a
fresh,
dried,
or
ensiled
state
(
pasture,
hay,
or
silage),

which
is
fed
to
livestock.

Governmental
entity.
Any
domestic
government,
tribal
government,
or
foreign
governmental
subdivision
providing
certification
services.

Handle.
To
sell,
process,
or
package
agricultural
products,
except
such
term
shall
not
include
the
sale,
transportation,
or
delivery
of
crops
or
livestock
by
the
producer
thereof
to
a
handler.

Handler.
Any
person
engaged
in
the
business
of
handling
agricultural
products,
including
producers
who
handle
crops
or
livestock
of
their
own
production,
except
such
term
shall
not
include
final
retailers
of
agricultural
products
that
do
not
process
agricultural
products.

Handling
operation.
Any
operation
or
portion
of
an
operation
(
except
final
retailers
of
agricultural
products
that
do
not
process
agricultural
products)
that
receives
or
otherwise
acquires
agricultural
products
and
processes,
packages,
or
stores
such
products.

Immediate
family.
The
spouse,
minor
children,
or
blood
relatives
who
reside
in
the
immediate
household
of
a
certifying
agent
or
an
employee,
inspector,
contractor,
or
other
personnel
of
the
certifying
agent.
For
the
purpose
of
this
part,
the
interest
of
a
spouse,
minor
child,
or
blood
relative
who
is
a
resident
of
the
immediate
household
of
a
certifying
agent
or
an
employee,
inspector,
contractor,
or
other
personnel
of
the
certifying
agent
shall
be
considered
to
be
an
interest
of
the
certifying
agent
or
an
employee,
inspector,
contractor,
or
other
personnel
of
the
certifying
agent.

Inert
ingredient.
Any
substance
(
or
group
of
substances
with
similar
chemical
structures
if
358
designated
by
the
Environmental
Protection
Agency)
other
than
an
active
ingredient
which
is
intentionally
included
in
any
pesticide
product
(
40
CFR
152.3(
m)).

Information
panel.
That
part
of
the
label
of
a
packaged
product
that
is
immediately
contiguous
to
and
to
the
right
of
the
principal
display
panel
as
observed
by
an
individual
facing
the
principal
display
panel,
unless
another
section
of
the
label
is
designated
as
the
information
panel
because
of
package
size
or
other
package
attributes
(
e.
g.,
irregular
shape
with
one
usable
surface).

Ingredient.
Any
substance
used
in
the
preparation
of
an
agricultural
product
that
is
still
present
in
the
final
commercial
product
as
consumed.

Ingredients
statement.
The
list
of
ingredients
contained
in
a
product
shown
in
their
common
and
usual
names
in
the
descending
order
of
predominance.

Inspector.
Any
person
retained
or
used
by
a
certifying
agent
to
conduct
inspections
of
certification
applicants
or
certified
production
or
handling
operations.

Inspection.
The
act
of
examining
and
evaluating
the
production
or
handling
operation
of
an
applicant
for
certification
or
certified
operation
to
determine
compliance
with
the
Act
and
the
regulations
in
this
part.

Label.
A
display
of
written,
printed,
or
graphic
material
on
the
immediate
container
of
an
agricultural
product
or
any
such
material
affixed
to
any
agricultural
product
or
affixed
to
a
bulk
container
containing
an
agricultural
product,
except
for
package
liners
or
a
display
of
written,

printed,
or
graphic
material
which
contains
only
information
about
the
weight
of
the
product.

Labeling.
All
written,
printed,
or
graphic
material
accompanying
an
agricultural
product
at
any
time
or
written,
printed,
or
graphic
material
about
the
agricultural
product
displayed
at
359
retail
stores
about
the
product.

Livestock.
Any
cattle,
sheep,
goat,
swine,
poultry,
or
equine
animals
used
for
food
or
in
the
production
of
food,
fiber,
feed,
or
other
agricultural­
based
consumer
products;
wild
or
domesticated
game;
or
other
nonplant
life,
except
such
term
shall
not
include
aquatic
animals
or
bees
for
the
production
of
food,
fiber,
feed,
or
other
agricultural­
based
consumer
products.

Lot.
Any
number
of
containers
which
contain
an
agricultural
product
of
the
same
kind
located
in
the
same
conveyance,
warehouse,
or
packing
house
and
which
are
available
for
inspection
at
the
same
time.

Manure.
Feces,
urine,
other
excrement,
and
bedding
produced
by
livestock
that
has
not
been
composted.

Market
information.
Any
written,
printed,
audiovisual,
or
graphic
information,
including
advertising,
pamphlets,
flyers,
catalogues,
posters,
and
signs,
distributed,
broadcast,
or
made
available
outside
of
retail
outlets
that
are
used
to
assist
in
the
sale
or
promotion
of
a
product.

Mulch.
Any
nonsynthetic
material,
such
as
wood
chips,
leaves,
or
straw,
or
any
synthetic
material
included
on
the
National
List
for
such
use,
such
as
newspaper
or
plastic
that
serves
to
suppress
weed
growth,
moderate
soil
temperature,
or
conserve
soil
moisture.

Narrow
range
oils.
Petroleum
derivatives,
predominately
of
paraffinic
and
napthenic
fractions
with
50
percent
boiling
point
(
10
mm
Hg)
between
415
E
F
and
440
E
F.

National
List.
A
list
of
allowed
and
prohibited
substances
as
provided
for
in
the
Act.

National
Organic
Program
(
NOP).
The
program
authorized
by
the
Act
for
the
purpose
of
implementing
its
provisions.

National
Organic
Standards
Board
(
NOSB).
A
board
established
by
the
Secretary
under
7
360
U.
S.
C.
6518
to
assist
in
the
development
of
standards
for
substances
to
be
used
in
organic
production
and
to
advise
the
Secretary
on
any
other
aspects
of
the
implementation
of
the
National
Organic
Program.

Natural
resources
of
the
operation.
The
physical,
hydrological,
and
biological
features
of
a
production
operation,
including
soil,
water,
wetlands,
woodlands,
and
wildlife.

Nonagricultural
substance.
A
substance
that
is
not
a
product
of
agriculture,
such
as
a
mineral
or
a
bacterial
culture,
that
is
used
as
an
ingredient
in
an
agricultural
product.
For
the
purposes
of
this
part,
a
nonagricultural
ingredient
also
includes
any
substance,
such
as
gums,
citric
acid,
or
pectin,
that
is
extracted
from,
isolated
from,
or
a
fraction
of
an
agricultural
product
so
that
the
identity
of
the
agricultural
product
is
unrecognizable
in
the
extract,
isolate,
or
fraction.

Nonsynthetic
(
natural).
A
substance
that
is
derived
from
mineral,
plant,
or
animal
matter
and
does
not
undergo
a
synthetic
process
as
defined
in
section
6502(
21)
of
the
Act
(
7
U.
S.
C.

6502(
21)).
For
the
purposes
of
this
part,
nonsynthetic
is
used
as
a
synonym
for
natural
as
the
term
is
used
in
the
Act.

Nontoxic.
Not
known
to
cause
any
adverse
physiological
effects
in
animals,
plants,

humans,
or
the
environment.

Nonretail
container.
Any
container
used
for
shipping
or
storage
of
an
agricultural
product
that
is
not
used
in
the
retail
display
or
sale
of
the
product.

Organic.
A
labeling
term
that
refers
to
an
agricultural
product
produced
in
accordance
with
the
Act
and
the
regulations
in
this
part.

Organic
matter.
The
remains,
residues,
or
waste
products
of
any
organism.

Organic
production.
A
production
system
that
is
managed
in
accordance
with
the
Act
and
361
regulations
in
this
part
to
respond
to
site­
specific
conditions
by
integrating
cultural,
biological,

and
mechanical
practices
that
foster
cycling
of
resources,
promote
ecological
balance,
and
conserve
biodiversity.

Organic
system
plan.
A
plan
of
management
of
an
organic
production
or
handling
operation
that
has
been
agreed
to
by
the
producer
or
handler
and
the
certifying
agent
and
that
includes
written
plans
concerning
all
aspects
of
agricultural
production
or
handling
described
in
the
Act
and
the
regulations
in
subpart
C
of
this
part.

Pasture.
Land
used
for
livestock
grazing
that
is
managed
to
provide
feed
value
and
maintain
or
improve
soil,
water,
and
vegetative
resources.

Peer
review
panel.
A
panel
of
individuals
who
have
expertise
in
organic
production
and
handling
methods
and
certification
procedures
and
who
are
appointed
by
the
Administrator
to
assist
in
evaluating
applicants
for
accreditation
as
certifying
agents.

Person.
An
individual,
partnership,
corporation,
association,
cooperative,
or
other
entity.

Pesticide.
Any
substance
which
alone,
in
chemical
combination,
or
in
any
formulation
with
one
or
more
substances
is
defined
as
a
pesticide
in
section
2(
u)
of
the
Federal
Insecticide,

Fungicide,
and
Rodenticide
Act
(
7
U.
S.
C.
136(
u)
et
seq).

Petition.
A
request
to
amend
the
National
List
that
is
submitted
by
any
person
in
accordance
with
this
part.

Planting
stock.
Any
plant
or
plant
tissue
other
than
annual
seedlings
but
including
rhizomes,
shoots,
leaf
or
stem
cuttings,
roots,
or
tubers,
used
in
plant
production
or
propagation.

Practice
standard.
The
guidelines
and
requirements
through
which
a
production
or
handling
operation
implements
a
required
component
of
its
production
or
handling
organic
system
362
plan.
A
practice
standard
includes
a
series
of
allowed
and
prohibited
actions,
materials,
and
conditions
to
establish
a
minimum
level
performance
for
planning,
conducting,
and
maintaining
a
function,
such
as
livestock
health
care
or
facility
pest
management,
essential
to
an
organic
operation.

Principal
display
panel.
That
part
of
a
label
that
is
most
likely
to
be
displayed,
presented,

shown,
or
examined
under
customary
conditions
of
display
for
sale.

Private
entity.
Any
domestic
or
foreign
nongovernmental
for­
profit
or
not­
for­
profit
organization
providing
certification
services.

Processing.
Cooking,
baking,
curing,
heating,
drying,
mixing,
grinding,
churning,

separating,
extracting,
slaughtering,
cutting,
fermenting,
distilling,
eviscerating,
preserving,

dehydrating,
freezing,
chilling,
or
otherwise
manufacturing
and
includes
the
packaging,
canning,

jarring,
or
otherwise
enclosing
food
in
a
container.

Processing
aid.
(
a)
substance
that
is
added
to
a
food
during
the
processing
of
such
food
but
is
removed
in
some
manner
from
the
food
before
it
is
packaged
in
its
finished
form;
(
b)
a
substance
that
is
added
to
a
food
during
processing,
is
converted
into
constituents
normally
present
in
the
food,
and
does
not
significantly
increase
the
amount
of
the
constituents
naturally
found
in
the
food;
and
(
c)
a
substance
that
is
added
to
a
food
for
its
technical
or
functional
effect
in
the
processing
but
is
present
in
the
finished
food
at
insignificant
levels
and
does
not
have
any
technical
or
functional
effect
in
that
food.

Producer.
A
person
who
engages
in
the
business
of
growing
or
producing
food,
fiber,

feed,
and
other
agricultural­
based
consumer
products.

Production
lot
number/
identifier.
Identification
of
a
product
based
on
the
production
363
sequence
of
the
product
showing
the
date,
time,
and
place
of
production
used
for
quality
control
purposes.

Prohibited
substance.
A
substance
the
use
of
which
in
any
aspect
of
organic
production
or
handling
is
prohibited
or
not
provided
for
in
the
Act
or
the
regulations
of
this
part.

Records.
Any
information
in
written,
visual,
or
electronic
form
that
documents
the
activities
undertaken
by
a
producer,
handler,
or
certifying
agent
to
comply
with
the
Act
and
regulations
in
this
part.

Residue
testing.
An
official
or
validated
analytical
procedure
that
detects,
identifies,
and
measures
the
presence
of
chemical
substances,
their
metabolites,
or
degradations
products
in
or
on
raw
or
processed
agricultural
products.

Responsibly
connected.
Any
person
who
is
a
partner,
officer,
director,
holder,
manager,

or
owner
of
10
percent
or
more
of
the
voting
stock
of
an
applicant
or
a
recipient
of
certification
or
accreditation.

Retail
food
establishment.
A
restaurant;
delicatessen;
bakery;
grocery
store;
or
any
retail
outlet
with
an
in­
store
restaurant,
delicatessen,
bakery,
salad
bar,
or
other
eat­
in
or
carry­
out
service
of
processed
or
prepared
raw
and
ready­
to­
eat­
food.

Routine
use
of
parasiticide.
The
regular,
planned,
or
periodic
use
of
parasiticides.

Secretary.
The
Secretary
of
Agriculture
or
a
representative
to
whom
authority
has
been
delegated
to
act
in
the
Secretary's
stead.

Sewage
sludge.
A
solid,
semisolid,
or
liquid
residue
generated
during
the
treatment
of
domestic
sewage
in
a
treatment
works.
Sewage
sludge
includes
but
is
not
limited
to:
domestic
septage;
scum
or
solids
removed
in
primary,
secondary,
or
advanced
wastewater
treatment
364
processes;
and
a
material
derived
from
sewage
sludge.
Sewage
sludge
does
not
include
ash
generated
during
the
firing
of
sewage
sludge
in
a
sewage
sludge
incinerator
or
grit
and
screenings
generated
during
preliminary
treatment
of
domestic
sewage
in
a
treatment
works.

Slaughter
stock.
Any
animal
that
is
intended
to
be
slaughtered
for
consumption
by
humans
or
other
animals.

Split
operation.
An
operation
that
produces
or
handles
both
organic
and
nonorganic
agricultural
products.

Soil
and
water
quality.
Observable
indicators
of
the
physical,
chemical,
or
biological
condition
of
soil
and
water,
including
the
presence
of
environmental
contaminants.

State.
Any
of
the
several
States
of
the
United
States
of
America,
its
territories,
the
District
of
Columbia,
and
the
Commonwealth
of
Puerto
Rico.

State
certifying
agent.
A
certifying
agent
accredited
by
the
Secretary
under
the
National
Organic
Program
and
operated
by
the
State
for
the
purposes
of
certifying
organic
production
and
handling
operations
in
the
State.

State
organic
program
(
SOP).
A
State
program
that
meets
the
requirements
of
section
6506
of
the
Act,
is
approved
by
the
Secretary,
and
is
designed
to
ensure
that
a
product
that
is
sold
or
labeled
as
organically
produced
under
the
Act
is
produced
and
handled
using
organic
methods.

State
organic
program's
governing
State
official.
The
chief
executive
official
of
a
State
or,

in
the
case
of
a
State
that
provides
for
the
statewide
election
of
an
official
to
be
responsible
solely
for
the
administration
of
the
agricultural
operations
of
the
State,
such
official
who
administers
a
State
organic
certification
program.

Synthetic.
A
substance
that
is
formulated
or
manufactured
by
a
chemical
process
or
by
a
365
process
that
chemically
changes
a
substance
extracted
from
naturally
occurring
plant,
animal,
or
mineral
sources,
except
that
such
term
shall
not
apply
to
substances
created
by
naturally
occurring
biological
processes.

Tolerance.
The
maximum
legal
level
of
a
pesticide
chemical
residue
in
or
on
a
raw
or
processed
agricultural
commodity
or
processed
food.

Transplant.
A
seedling
which
has
been
removed
from
its
original
place
of
production,

transported,
and
replanted.

Unavoidable
residual
environmental
contamination
(
UREC).
Background
levels
of
naturally
occurring
or
synthetic
chemicals
that
are
present
in
the
soil
or
present
in
organically
produced
agricultural
products
that
are
below
established
tolerances.

Wild
crop.
Any
plant
or
portion
of
a
plant
that
is
collected
or
harvested
from
a
site
that
is
not
maintained
under
cultivation
or
other
agricultural
management.

Subpart
B
­
Applicability
§
205.100
What
has
to
be
certified.

(
a)
Except
for
operations
exempt
or
excluded
in
§
205.101,
each
production
or
handling
operation
or
specified
portion
of
a
production
or
handling
operation
that
produces
or
handles
crops,
livestock,
livestock
products,
or
other
agricultural
products
that
are
intended
to
be
sold,

labeled,
or
represented
as
"
100
percent
organic,"
"
organic,"
or
"
made
with
organic
(
specified
ingredients
or
food
group(
s))"
must
be
certified
according
to
the
provisions
of
subpart
E
of
this
part
and
must
meet
all
other
applicable
requirements
of
this
part.

(
b)
Any
production
or
handling
operation
or
specified
portion
of
a
production
or
handling
operation
that
has
been
already
certified
by
a
certifying
agent
on
the
date
that
the
certifying
agent
366
receives
its
accreditation
under
this
part
shall
be
deemed
to
be
certified
under
the
Act
until
the
operation's
next
anniversary
date
of
certification.
Such
recognition
shall
only
be
available
to
those
operations
certified
by
a
certifying
agent
that
receives
its
accreditation
within
18
months
from
the
effective
date
of
this
final
rule.

(
c)
Any
operation
that:

(
1)
Knowingly
sells
or
labels
a
product
as
organic,
except
in
accordance
with
the
Act,

shall
be
subject
to
a
civil
penalty
of
not
more
than
$
10,000
per
violation.

(
2)
Makes
a
false
statement
under
the
Act
to
the
Secretary,
a
governing
State
official,
or
an
accredited
certifying
agent
shall
be
subject
to
the
provisions
of
section
1001
of
title
18,
United
States
Code.

§
205.101
Exemptions
and
exclusions
from
certification.

(
a)
Exemptions.

(
1)
A
production
or
handling
operation
that
sells
agricultural
products
as
"
organic"
but
whose
gross
agricultural
income
from
organic
sales
totals
$
5,000
or
less
annually
is
exempt
from
certification
under
subpart
E
of
this
part
and
from
submitting
an
organic
system
plan
for
acceptance
or
approval
under
§
205.201
but
must
comply
with
the
applicable
organic
production
and
handling
requirements
of
subpart
C
of
this
part
and
the
labeling
requirements
of
§
205.310.

The
products
from
such
operations
shall
not
be
used
as
ingredients
identified
as
organic
in
processed
products
produced
by
another
handling
operation.

(
2)
A
handling
operation
that
is
a
retail
food
establishment
or
portion
of
a
retail
food
establishment
that
handles
organically
produced
agricultural
products
but
does
not
process
them
is
exempt
from
the
requirements
in
this
part.
367
(
3)
A
handling
operation
or
portion
of
a
handling
operation
that
only
handles
agricultural
products
that
contain
less
than
70
percent
organic
ingredients
by
total
weight
of
the
finished
product
(
excluding
water
and
salt)
is
exempt
from
the
requirements
in
this
part,
except:

(
i)
The
provisions
for
prevention
of
contact
of
organic
products
with
prohibited
substances
set
forth
in
§
205.272
with
respect
to
any
organically
produced
ingredients
used
in
an
agricultural
product;

(
ii)
The
labeling
provisions
of
§
§
205.305
and
205.310;
and
(
iii)
The
recordkeeping
provisions
in
paragraph
(
c)
of
this
section.

(
4)
A
handling
operation
or
portion
of
a
handling
operation
that
only
identifies
organic
ingredients
on
the
information
panel
is
exempt
from
the
requirements
in
this
part,
except:

(
i)
The
provisions
for
prevention
of
contact
of
organic
products
with
prohibited
substances
set
forth
in
§
205.272
with
respect
to
any
organically
produced
ingredients
used
in
an
agricultural
product;

(
ii)
The
labeling
provisions
of
§
§
205.305
and
205.310;
and
(
iii)
The
recordkeeping
provisions
in
paragraph
(
c)
of
this
section.

(
b)
Exclusions.

(
1)
A
handling
operation
or
portion
of
a
handling
operation
is
excluded
from
the
requirements
of
this
part,
except
for
the
requirements
for
the
prevention
of
commingling
and
contact
with
prohibited
substances
as
set
forth
in
§
205.272
with
respect
to
any
organically
produced
products,
if
such
operation
or
portion
of
the
operation
only
sells
organic
agricultural
products
labeled
as
"
100
percent
organic,"
"
organic,"
or
"
made
with
organic
(
specified
ingredients
or
food
group(
s))"
that:
368
(
i)
Are
packaged
or
otherwise
enclosed
in
a
container
prior
to
being
received
or
acquired
by
the
operation;
and
(
ii)
Remain
in
the
same
package
or
container
and
are
not
otherwise
processed
while
in
the
control
of
the
handling
operation.

(
2)
A
handling
operation
that
is
a
retail
food
establishment
or
portion
of
a
retail
food
establishment
that
processes,
on
the
premises
of
the
retail
food
establishment,
raw
and
ready­

toeat
food
from
agricultural
products
that
were
previously
labeled
as
"
100
percent
organic,"

"
organic,"
or
"
made
with
organic
(
specified
ingredients
or
food
group(
s))"
is
excluded
from
the
requirements
in
this
part,
except:

(
i)
The
requirements
for
the
prevention
of
contact
with
prohibited
substances
as
set
forth
in
§
205.272;
and
(
ii)
The
labeling
provisions
of
§
205.310.

(
c)
Records
to
be
maintained
by
exempt
operations.

(
1)
Any
handling
operation
exempt
from
certification
pursuant
to
paragraph
(
a)(
3)
or
(
a)(
4)
of
this
section
must
maintain
records
sufficient
to:

(
i)
Prove
that
ingredients
identified
as
organic
were
organically
produced
and
handled;

and
(
ii)
Verify
quantities
produced
from
such
ingredients.

(
2)
Records
must
be
maintained
for
no
less
than
3
years
beyond
their
creation
and
the
operations
must
allow
representatives
of
the
Secretary
and
the
applicable
State
organic
programs'

governing
State
official
access
to
these
records
for
inspection
and
copying
during
normal
business
hours
to
determine
compliance
with
the
applicable
regulations
set
forth
in
this
part.
369
§
205.102
Use
of
the
term,
"
organic."

Any
agricultural
product
that
is
sold,
labeled,
or
represented
as
"
100
percent
organic,"

"
organic,"
or
"
made
with
organic
(
specified
ingredients
or
food
group(
s))"
must
be:

(
a)
Produced
in
accordance
with
the
requirements
specified
in
§
205.101
or
§
§
205.202
through
205.207
or
§
§
205.236
through
205.239
and
all
other
applicable
requirements
of
part
205;
and
(
b)
Handled
in
accordance
with
the
requirements
specified
in
§
205.101
or
§
§
205.270
through
205.272
and
all
other
applicable
requirements
of
this
part
205.

§
205.103
Recordkeeping
by
certified
operations.

(
a)
A
certified
operation
must
maintain
records
concerning
the
production,
harvesting,

and
handling
of
agricultural
products
that
are
or
that
are
intended
to
be
sold,
labeled,
or
represented
as
"
100
percent
organic,"
"
organic,"
or
"
made
with
organic
(
specified
ingredients
or
food
group(
s))."

(
b)
Such
records
must:

(
1)
Be
adapted
to
the
particular
business
that
the
certified
operation
is
conducting;

(
2)
Fully
disclose
all
activities
and
transactions
of
the
certified
operation
in
sufficient
detail
as
to
be
readily
understood
and
audited;

(
3)
Be
maintained
for
not
less
than
5
years
beyond
their
creation;
and
(
4)
Be
sufficient
to
demonstrate
compliance
with
the
Act
and
the
regulations
in
this
part.

(
c)
The
certified
operation
must
make
such
records
available
for
inspection
and
copying
during
normal
business
hours
by
authorized
representatives
of
the
Secretary,
the
applicable
State
program's
governing
State
official,
and
the
certifying
agent.
370
§
205.104
[
Reserved]

§
205.105
Allowed
and
prohibited
substances,
methods,
and
ingredients
in
organic
production
and
handling.

To
be
sold
or
labeled
as
"
100
percent
organic,"
"
organic,"
or
"
made
with
organic
(
specified
ingredients
or
food
group(
s)),"
the
product
must
be
produced
and
handled
without
the
use
of:

(
a)
Synthetic
substances
and
ingredients,
except
as
provided
in
§
205.601
or
§
205.603;

(
b)
Nonsynthetic
substances
prohibited
in
§
205.602
or
§
205.604;

(
c)
Nonagricultural
substances
used
in
or
on
processed
products,
except
as
otherwise
provided
in
§
205.605;

(
d)
Nonorganic
agricultural
substances
used
in
or
on
processed
products,
except
as
otherwise
provided
in
§
205.606;

(
e)
Excluded
methods,
except
for
vaccines,
Provided,
That,
the
vaccines
are
approved
in
accordance
with
§
205.600(
a);

(
f)
Ionizing
radiation,
as
described
in
Food
and
Drug
Administration
regulation,
21
CFR
179.26;
and
(
g)
Sewage
sludge.

§
§
205.106­
205.199
[
Reserved]

Subpart
C
­
Organic
Production
and
Handling
Requirements
§
205.200
General.
The
producer
or
handler
of
a
production
or
handling
operation
intending
to
sell,
label,
or
represent
agricultural
products
as
"
100
percent
organic,"
"
organic,"
or
"
made
with
organic
(
specified
ingredients
or
food
group(
s))"
must
comply
with
the
applicable
provisions
of
371
this
subpart.
Production
practices
implemented
in
accordance
with
this
subpart
must
maintain
or
improve
the
natural
resources
of
the
operation,
including
soil
and
water
quality.

§
205.201
Organic
production
and
handling
system
plan.

(
a)
The
producer
or
handler
of
a
production
or
handling
operation,
except
as
exempt
or
excluded
under
§
205.101,
intending
to
sell,
label,
or
represent
agricultural
products
as
"
100
percent
organic,"
"
organic,"
or
"
made
with
organic
(
specified
ingredients
or
food
group(
s))"
must
develop
an
organic
production
or
handling
system
plan
that
is
agreed
to
by
the
producer
or
handler
and
an
accredited
certifying
agent.
An
organic
system
plan
must
meet
the
requirements
set
forth
in
this
section
for
organic
production
or
handling.
An
organic
production
or
handling
system
plan
must
include:

(
1)
A
description
of
practices
and
procedures
to
be
performed
and
maintained,
including
the
frequency
with
which
they
will
be
performed;

(
2)
A
list
of
each
substance
to
be
used
as
a
production
or
handling
input,
indicating
its
composition,
source,
location(
s)
where
it
will
be
used,
and
documentation
of
commercial
availability,
as
applicable;

(
3)
A
description
of
the
monitoring
practices
and
procedures
to
be
performed
and
maintained,
including
the
frequency
with
which
they
will
be
performed,
to
verify
that
the
plan
is
effectively
implemented;

(
4)
A
description
of
the
recordkeeping
system
implemented
to
comply
with
the
requirements
established
in
§
205.103;

(
5)
A
description
of
the
management
practices
and
physical
barriers
established
to
prevent
commingling
of
organic
and
nonorganic
products
on
a
split
operation
and
to
prevent
contact
of
372
organic
production
and
handling
operations
and
products
with
prohibited
substances;
and
(
6)
Additional
information
deemed
necessary
by
the
certifying
agent
to
evaluate
compliance
with
the
regulations.

(
b)
A
producer
may
substitute
a
plan
prepared
to
meet
the
requirements
of
another
Federal,
State,
or
local
government
regulatory
program
for
the
organic
system
plan:
Provided,

That,
the
submitted
plan
meets
all
the
requirements
of
this
subpart.

§
205.202
Land
requirements.

Any
field
or
farm
parcel
from
which
harvested
crops
are
intended
to
be
sold,
labeled,
or
represented
as
"
organic,"
must:

(
a)
Have
been
managed
in
accordance
with
the
provisions
of
§
§
205.203
through
205.206;

(
b)
Have
had
no
prohibited
substances,
as
listed
in
§
205.105,
applied
to
it
for
a
period
of
3
years
immediately
preceding
harvest
of
the
crop;
and
(
c)
Have
distinct,
defined
boundaries
and
buffer
zones
such
as
runoff
diversions
to
prevent
the
unintended
application
of
a
prohibited
substance
to
the
crop
or
contact
with
a
prohibited
substance
applied
to
adjoining
land
that
is
not
under
organic
management.

§
205.203
Soil
fertility
and
crop
nutrient
management
practice
standard.

(
a)
The
producer
must
select
and
implement
tillage
and
cultivation
practices
that
maintain
or
improve
the
physical,
chemical,
and
biological
condition
of
soil
and
minimize
soil
erosion.

(
b)
The
producer
must
manage
crop
nutrients
and
soil
fertility
through
rotations,
cover
crops,
and
the
application
of
plant
and
animal
materials.

(
c)
The
producer
must
manage
plant
and
animal
materials
to
maintain
or
improve
soil
373
organic
matter
content
in
a
manner
that
does
not
contribute
to
contamination
of
crops,
soil,
or
water
by
plant
nutrients,
pathogenic
organisms,
heavy
metals,
or
residues
of
prohibited
substances.
Animal
and
plant
materials
include:

(
1)
Raw
animal
manure,
which
must
be
composted
unless
it
is:

(
i)
Applied
to
land
used
for
a
crop
not
intended
for
human
consumption;

(
ii)
Incorporated
into
the
soil
not
less
than
120
days
prior
to
the
harvest
of
a
product
whose
edible
portion
has
direct
contact
with
the
soil
surface
or
soil
particles;
or
(
iii)
Incorporated
into
the
soil
not
less
than
90
days
prior
to
the
harvest
of
a
product
whose
edible
portion
does
not
have
direct
contact
with
the
soil
surface
or
soil
particles;

(
2)
Composted
plant
and
animal
materials
produced
though
a
process
that
(
i)
established
an
initial
C:
N
ratio
of
between
25:
1
and
40:
1;
and
(
ii)
maintained
a
temperature
of
between
131
E
F
and
170
E
F
for
3
days
using
an
in­
vessel
or
static
aerated
pile
system;
or
(
iii)
maintained
a
temperature
of
between
131
E
F
and
170
E
F
for
15
days
using
a
windrow
composting
system,
during
which
period,
the
materials
must
be
turned
a
minimum
of
five
times.

(
3)
Uncomposted
plant
materials.

(
d)
A
producer
may
manage
crop
nutrients
and
soil
fertility
to
maintain
or
improve
soil
organic
matter
content
in
a
manner
that
does
not
contribute
to
contamination
of
crops,
soil,
or
water
by
plant
nutrients,
pathogenic
organisms,
heavy
metals,
or
residues
of
prohibited
substances
by
applying:

(
1)
A
crop
nutrient
or
soil
amendment
included
on
the
National
List
of
synthetic
substances
allowed
for
use
in
organic
crop
production;
374
(
2)
A
mined
substance
of
low
solubility;

(
3)
A
mined
substance
of
high
solubility,
Provided,
That,
the
substance
is
used
in
compliance
with
the
conditions
established
on
the
National
List
of
nonsynthetic
materials
prohibited
for
crop
production;

(
4)
Ash
obtained
from
the
burning
of
a
plant
or
animal
material,
except
as
prohibited
in
paragraph
(
e)
of
this
section:
Provided,
That,
the
material
burned
has
not
been
treated
or
combined
with
a
prohibited
substance
or
the
ash
is
not
included
on
the
National
List
of
nonsynthetic
substances
prohibited
for
use
in
organic
crop
production;
and
(
5)
A
plant
or
animal
material
that
has
been
chemically
altered
by
a
manufacturing
process:
Provided,
That,
the
material
is
included
on
the
National
List
of
synthetic
substances
allowed
for
use
in
organic
crop
production
established
in
§
205.601.

(
e)
The
producer
must
not
use:

(
1)
Any
fertilizer
or
composted
plant
and
animal
material
that
contains
a
synthetic
substance
not
included
on
the
National
List
of
synthetic
substances
allowed
for
use
in
organic
crop
production;

(
2)
Sewage
sludge
(
biosolids)
as
defined
in
40
CFR
Part
503;
and
(
3)
Burning
as
a
means
of
disposal
for
crop
residues
produced
on
the
operation:
Except,

That,
burning
may
be
used
to
suppress
the
spread
of
disease
or
to
stimulate
seed
germination.

§
205.204
Seeds
and
planting
stock
practice
standard.

(
a)
The
producer
must
use
organically
grown
seeds,
annual
seedlings,
and
planting
stock:

Except,
That,

(
1)
Nonorganically
produced,
untreated
seeds
and
planting
stock
may
be
used
to
produce
375
an
organic
crop
when
an
equivalent
organically
produced
variety
is
not
commercially
available,

Except,
That,
organically
produced
seed
must
be
used
for
the
production
of
edible
sprouts;

(
2)
Nonorganically
produced
seeds
and
planting
stock
that
have
been
treated
with
a
substance
included
on
the
National
List
of
synthetic
substances
allowed
for
use
in
organic
crop
production
may
be
used
to
produce
an
organic
crop
when
an
equivalent
organically
produced
or
untreated
variety
is
not
commercially
available;

(
3)
Nonorganically
produced
annual
seedlings
may
be
used
to
produce
an
organic
crop
when
a
temporary
variance
has
been
granted
in
accordance
with
§
205.290(
a)(
2);

(
4)
Nonorganically
produced
planting
stock
to
be
used
to
produce
a
perennial
crop
may
be
sold,
labeled,
or
represented
as
organically
produced
only
after
the
planting
stock
has
been
maintained
under
a
system
of
organic
management
for
a
period
of
no
less
than
1
year;
and
(
5)
Seeds,
annual
seedlings,
and
planting
stock
treated
with
prohibited
substances
may
be
used
to
produce
an
organic
crop
when
the
application
of
the
materials
is
a
requirement
of
Federal
or
State
phytosanitary
regulations.

§
205.205
Crop
rotation
practice
standard.

The
producer
must
implement
a
crop
rotation
including
but
not
limited
to
sod,
cover
crops,
green
manure
crops,
and
catch
crops
that
provide
the
following
functions
that
are
applicable
to
the
operation:

(
a)
Maintain
or
improve
soil
organic
matter
content;

(
b)
Provide
for
pest
management
in
annual
and
perennial
crops;

(
c)
Manage
deficient
or
excess
plant
nutrients;
and
(
d)
Provide
erosion
control.
376
§
205.206
Crop
pest,
weed,
and
disease
management
practice
standard.

(
a)
The
producer
must
use
management
practices
to
prevent
crop
pests,
weeds,
and
diseases
including
but
not
limited
to:

(
1)
Crop
rotation
and
soil
and
crop
nutrient
management
practices,
as
provided
for
in
§
§
205.203
and
205.205;

(
2)
Sanitation
measures
to
remove
disease
vectors,
weed
seeds,
and
habitat
for
pest
organisms;
and
(
3)
Cultural
practices
that
enhance
crop
health,
including
selection
of
plant
species
and
varieties
with
regard
to
suitability
to
site­
specific
conditions
and
resistance
to
prevalent
pests,

weeds,
and
diseases.

(
b)
Pest
problems
may
be
controlled
through
mechanical
or
physical
methods
including
but
not
limited
to:

(
1)
Augmentation
or
introduction
of
predators
or
parasites
of
the
pest
species;

(
2)
Development
of
habitat
for
natural
enemies
of
pests;

(
3)
Nonsynthetic
controls
such
as
lures,
traps,
and
repellents.

(
c)
Weed
problems
may
be
controlled
through:

(
1)
Mulching
with
fully
biodegradable
materials;

(
2)
Mowing;

(
3)
Livestock
grazing;

(
4)
Hand
weeding
and
mechanical
cultivation;

(
5)
Flame,
heat,
or
electrical
means;
or
(
6)
Plastic
or
other
synthetic
mulches:
Provided,
That,
they
are
removed
from
the
field
at
377
the
end
of
the
growing
or
harvest
season.

(
d)
Disease
problems
may
be
controlled
through:

(
1)
Management
practices
which
suppress
the
spread
of
disease
organisms;
or
(
2)
Application
of
nonsynthetic
biological,
botanical,
or
mineral
inputs.

(
e)
When
the
practices
provided
for
in
paragraphs
(
a)
through
(
d)
of
this
section
are
insufficient
to
prevent
or
control
crop
pests,
weeds,
and
diseases,
a
biological
or
botanical
substance
or
a
substance
included
on
the
National
List
of
synthetic
substances
allowed
for
use
in
organic
crop
production
may
be
applied
to
prevent,
suppress,
or
control
pests,
weeds,
or
diseases:

Provided,
That,
the
conditions
for
using
the
substance
are
documented
in
the
organic
system
plan.

(
f)
The
producer
must
not
use
lumber
treated
with
arsenate
or
other
prohibited
materials
for
new
installations
or
replacement
purposes
in
contact
with
soil
or
livestock.

§
205.207
Wild­
crop
harvesting
practice
standard.

(
a)
A
wild
crop
that
is
intended
to
be
sold,
labeled,
or
represented
as
organic
must
be
harvested
from
a
designated
area
that
has
had
no
prohibited
substance,
as
set
forth
in
§
205.105,

applied
to
it
for
a
period
of
3
years
immediately
preceding
the
harvest
of
the
wild
crop.

(
b)
A
wild
crop
must
be
harvested
in
a
manner
that
ensures
that
such
harvesting
or
gathering
will
not
be
destructive
to
the
environment
and
will
sustain
the
growth
and
production
of
the
wild
crop.

§
§
205.208
­
205.235
[
Reserved]

§
205.236
Origin
of
livestock.

(
a)
Livestock
products
that
are
to
be
sold,
labeled,
or
represented
as
organic
must
be
from
livestock
under
continuous
organic
management
from
the
last
third
of
gestation
or
hatching:
378
Except,
That,
(
1)
Poultry.
Poultry
or
edible
poultry
products
must
be
from
poultry
that
has
been
under
continuous
organic
management
beginning
no
later
than
the
second
day
of
life;

(
2)
Dairy
animals.
Milk
or
milk
products
must
be
from
animals
that
have
been
under
continuous
organic
management
beginning
no
later
than
1
year
prior
to
the
production
of
the
milk
or
milk
products
that
are
to
be
sold,
labeled,
or
represented
as
organic,
Except,
That,
when
an
entire,
distinct
herd
is
converted
to
organic
production,
the
producer
may:

(
i)
For
the
first
9
months
of
the
year,
provide
a
minimum
of
80­
percent
feed
that
is
either
organic
or
raised
from
land
included
in
the
organic
system
plan
and
managed
in
compliance
with
organic
crop
requirements;
and
(
ii)
provide
feed
in
compliance
with
§
205.237
for
the
final
3
months.

(
iii)
Once
an
entire,
distinct
herd
has
been
converted
to
organic
production,
all
dairy
animals
shall
be
under
organic
management
from
the
last
third
of
gestation.

(
3)
Breeder
stock.
Livestock
used
as
breeder
stock
may
be
brought
from
a
nonorganic
operation
onto
an
organic
operation
at
any
time:
Provided,
That,
if
such
livestock
are
gestating
and
the
offspring
are
to
be
raised
as
organic
livestock,
the
breeder
stock
must
be
brought
onto
the
facility
no
later
than
the
last
third
of
gestation.

(
b)
The
following
are
prohibited:

(
1)
Livestock
or
edible
livestock
products
that
are
removed
from
an
organic
operation
and
subsequently
managed
on
a
nonorganic
operation
may
be
not
sold,
labeled,
or
represented
as
organically
produced.

(
2)
Breeder
or
dairy
stock
that
has
not
been
under
continuous
organic
management
since
the
last
third
of
gestation
may
not
be
sold,
labeled,
or
represented
as
organic
slaughter
stock.
379
(
c)
The
producer
of
an
organic
livestock
operation
must
maintain
records
sufficient
to
preserve
the
identity
of
all
organically
managed
animals
and
edible
and
nonedible
animal
products
produced
on
the
operation.

§
205.237
Livestock
feed.

(
a)
The
producer
of
an
organic
livestock
operation
must
provide
livestock
with
a
total
feed
ration
composed
of
agricultural
products,
including
pasture
and
forage,
that
are
organically
produced
and,
if
applicable,
organically
handled:
Except,
That,
nonsynthetic
substances
and
synthetic
substances
allowed
under
§
205.603
may
be
used
as
feed
additives
and
supplements.

(
b)
The
producer
of
an
organic
operation
must
not:

(
1)
Use
animal
drugs,
including
hormones,
to
promote
growth;

(
2)
Provide
feed
supplements
or
additives
in
amounts
above
those
needed
for
adequate
nutrition
and
health
maintenance
for
the
species
at
its
specific
stage
of
life;

(
3)
Feed
plastic
pellets
for
roughage;

(
4)
Feed
formulas
containing
urea
or
manure;

(
5)
Feed
mammalian
or
poultry
slaughter
by­
products
to
mammals
or
poultry;
or
(
6)
Use
feed,
feed
additives,
and
feed
supplements
in
violation
of
the
Federal
Food,
Drug,

and
Cosmetic
Act.

§
205.238
Livestock
health
care
practice
standard.

(
a)
The
producer
must
establish
and
maintain
preventive
livestock
health
care
practices,

including:

(
1)
Selection
of
species
and
types
of
livestock
with
regard
to
suitability
for
site­
specific
conditions
and
resistance
to
prevalent
diseases
and
parasites;
380
(
2)
Provision
of
a
feed
ration
sufficient
to
meet
nutritional
requirements,
including
vitamins,
minerals,
protein
and/
or
amino
acids,
fatty
acids,
energy
sources,
and
fiber
(
ruminants);

(
3)
Establishment
of
appropriate
housing,
pasture
conditions,
and
sanitation
practices
to
minimize
the
occurrence
and
spread
of
diseases
and
parasites;

(
4)
Provision
of
conditions
which
allow
for
exercise,
freedom
of
movement,
and
reduction
of
stress
appropriate
to
the
species;

(
5)
Performance
of
physical
alterations
as
needed
to
promote
the
animal's
welfare
and
in
a
manner
that
minimizes
pain
and
stress;
and
(
6)
Administration
of
vaccines
and
other
veterinary
biologics.

(
b)
When
preventive
practices
and
veterinary
biologics
are
inadequate
to
prevent
sickness,

a
producer
may
administer
synthetic
medications:
Provided,
That,
such
medications
are
allowed
under
§
205.603.
Parasiticides
allowed
under
§
205.603
may
be
used
on
(
1)
Breeder
stock,
when
used
prior
to
the
last
third
of
gestation
but
not
during
lactation
for
progeny
that
are
to
be
sold,
labeled,
or
represented
as
organically
produced;
and
(
2)
Dairy
stock,
when
used
a
minimum
of
90
days
prior
to
the
production
of
milk
or
milk
products
that
are
to
be
sold,
labeled,
or
represented
as
organic.

(
c)
The
producer
of
an
organic
livestock
operation
must
not:

(
1)
Sell,
label,
or
represent
as
organic
any
animal
or
edible
product
derived
from
any
animal
treated
with
antibiotics,
any
substance
that
contains
a
synthetic
substance
not
allowed
under
§
205.603,
or
any
substance
that
contains
a
nonsynthetic
substance
prohibited
in
§
205.604.

(
2)
Administer
any
animal
drug,
other
than
vaccinations,
in
the
absence
of
illness;

(
3)
Administer
hormones
for
growth
promotion;
381
(
4)
Administer
synthetic
parasiticides
on
a
routine
basis;

(
5)
Administer
synthetic
parasiticides
to
slaughter
stock;

(
6)
Administer
animal
drugs
in
violation
of
the
Federal
Food,
Drug,
and
Cosmetic
Act;
or
(
7)
Withhold
medical
treatment
from
a
sick
animal
in
an
effort
to
preserve
its
organic
status.
All
appropriate
medications
must
be
used
to
restore
an
animal
to
health
when
methods
acceptable
to
organic
production
fail.
Livestock
treated
with
a
prohibited
substance
must
be
clearly
identified
and
shall
not
be
sold,
labeled,
or
represented
as
organically
produced.

§
205.239
Livestock
living
conditions.

(
a)
The
producer
of
an
organic
livestock
operation
must
establish
and
maintain
livestock
living
conditions
which
accommodate
the
health
and
natural
behavior
of
animals,
including:

(
1)
Access
to
the
outdoors,
shade,
shelter,
exercise
areas,
fresh
air,
and
direct
sunlight
suitable
to
the
species,
its
stage
of
production,
the
climate,
and
the
environment;

(
2)
Access
to
pasture
for
ruminants;

(
3)
Appropriate
clean,
dry
bedding.
If
the
bedding
is
typically
consumed
by
the
animal
species,
it
must
comply
with
the
feed
requirements
of
§
205.237;

(
4)
Shelter
designed
to
allow
for:

(
i)
Natural
maintenance,
comfort
behaviors,
and
opportunity
to
exercise;

(
ii)
Temperature
level,
ventilation,
and
air
circulation
suitable
to
the
species;
and
(
iii)
Reduction
of
potential
for
livestock
injury;

(
b)
The
producer
of
an
organic
livestock
operation
may
provide
temporary
confinement
for
an
animal
because
of:

(
1)
Inclement
weather;
382
(
2)
The
animal's
stage
of
production;

(
3)
Conditions
under
which
the
health,
safety,
or
well
being
of
the
animal
could
be
jeopardized;
or
(
4)
Risk
to
soil
or
water
quality.

(
c)
The
producer
of
an
organic
livestock
operation
must
manage
manure
in
a
manner
that
does
not
contribute
to
contamination
of
crops,
soil,
or
water
by
plant
nutrients,
heavy
metals,
or
pathogenic
organisms
and
optimizes
recycling
of
nutrients.

§
§
205.240
­
205.269
[
Reserved]

§
205.270
Organic
handling
requirements.

(
a)
Mechanical
or
biological
methods,
including
but
not
limited
to
cooking,
baking,

curing,
heating,
drying,
mixing,
grinding,
churning,
separating,
distilling,
extracting,
slaughtering,

cutting,
fermenting,
eviscerating,
preserving,
dehydrating,
freezing,
chilling,
or
otherwise
manufacturing,
and
the
packaging,
canning,
jarring,
or
otherwise
enclosing
food
in
a
container
may
be
used
to
process
an
organically
produced
agricultural
product
for
the
purpose
of
retarding
spoilage
or
otherwise
preparing
the
agricultural
product
for
market.

(
b)
Nonagricultural
substances
allowed
under
§
205.605
and
nonorganically
produced
agricultural
products
allowed
under
§
205.606
may
be
used:

(
1)
In
or
on
a
processed
agricultural
product
intended
to
be
sold,
labeled,
or
represented
as
"
organic,"
pursuant
to
§
205.301(
b),
if
not
commercially
available
in
organic
form.

(
2)
In
or
on
a
processed
agricultural
product
intended
to
be
sold,
labeled,
or
represented
as
"
made
with
organic
(
specified
ingredients
or
food
group(
s)),"
pursuant
to
§
205.301(
c).

(
c)
The
handler
of
an
organic
handling
operation
must
not
use
in
or
on
agricultural
383
products
intended
to
be
sold,
labeled,
or
represented
as
"
100
percent
organic,"
"
organic,"
or
"
made
with
organic
(
specified
ingredients
or
food
group(
s)),"
or
in
or
on
any
ingredients
labeled
as
organic:

(
1)
Practices
prohibited
under
paragraphs
(
e)
and
(
f)
of
§
205.105.

(
2)
A
volatile
synthetic
solvent
or
other
synthetic
processing
aid
not
allowed
under
§
205.605,
Except,
That,
nonorganic
ingredients
in
products
labeled
"
made
with
organic
(
specified
ingredients
or
food
group(
s))"
are
not
subject
to
this
requirement.

§
205.271
Facility
pest
management
practice
standard.

(
a)
The
producer
or
handler
of
an
organic
facility
must
use
management
practices
to
prevent
pests,
including
but
not
limited
to:

(
1)
Removal
of
pest
habitat,
food
sources,
and
breeding
areas;

(
2)
Prevention
of
access
to
handling
facilities;
and
(
3)
Management
of
environmental
factors,
such
as
temperature,
light,
humidity,

atmosphere,
and
air
circulation,
to
prevent
pest
reproduction.

(
b)
Pests
may
be
controlled
through:

(
1)
Mechanical
or
physical
controls
including
but
not
limited
to
traps,
light,
or
sound;
or
(
2)
Lures
and
repellents
using
nonsynthetic
or
synthetic
substances
consistent
with
the
National
List.

(
c)
If
the
practices
provided
for
in
paragraphs
(
a)
and
(
b)
of
this
section
are
not
effective
to
prevent
or
control
pests,
a
nonsynthetic
or
synthetic
substance
consistent
with
the
National
List
may
be
applied.

(
d)
If
the
practices
provided
for
in
paragraphs
(
a),
(
b),
and
©
of
this
section
are
not
384
effective
to
prevent
or
control
facility
pests,
a
synthetic
substance
not
on
the
National
List
may
be
applied,
Provided,
That,
the
handler
and
certifying
agent
agree
on
the
substance,
method
of
application,
and
measures
to
be
taken
to
prevent
contact
of
the
organically
produced
products
or
ingredients
with
the
substance
used.

(
e)
The
handler
of
an
organic
handling
operation
who
applies
a
nonsynthetic
or
synthetic
substance
to
prevent
or
control
pests
must
update
the
operation's
organic
handling
plan
to
reflect
the
use
of
such
substances
and
methods
of
application.
The
updated
organic
plan
must
include
a
list
of
all
measures
taken
to
prevent
contact
of
the
organically
produced
products
or
ingredients
with
the
substance
used.

(
f)
Notwithstanding
the
practices
provided
for
in
paragraphs
(
a),
(
b),
(
c),
and
(
d)
of
this
section,
a
handler
may
otherwise
use
substances
to
prevent
or
control
pests
as
required
by
Federal,
State,
or
local
laws
and
regulations,
Provided,
That,
measures
are
taken
to
prevent
contact
of
the
organically
produced
products
or
ingredients
with
the
substance
used.

§
205.272
Commingling
and
contact
with
prohibited
substance
prevention
practice
standard.

(
a)
The
handler
of
an
organic
handling
operation
must
implement
measures
necessary
to
prevent
the
commingling
of
organic
and
nonorganic
products
and
protect
organic
products
from
contact
with
prohibited
substances.

(
b)
The
following
are
prohibited
for
use
in
the
handling
of
any
organically
produced
agricultural
product
or
ingredient
labeled
in
accordance
with
subpart
D
of
this
part:

(
1)
Packaging
materials,
and
storage
containers,
or
bins
that
contain
a
synthetic
fungicide,

preservative,
or
fumigant;
385
(
2)
The
use
or
reuse
of
any
bag
or
container
that
has
been
in
contact
with
any
substance
in
such
a
manner
as
to
compromise
the
organic
integrity
of
any
organically
produced
product
or
ingredient
placed
in
those
containers,
unless
such
reusable
bag
or
container
has
been
thoroughly
cleaned
and
poses
no
risk
of
contact
of
the
organically
produced
product
or
ingredient
with
the
substance
used.

§
§
205.273
­
205.289
[
Reserved]

§
205.290
Temporary
variances.

(
a)
Temporary
variances
from
the
requirements
in
§
§
205.203
through
205.207,
205.236
through
205.239,
and
205.270
through
205.272
may
be
established
by
the
Administrator
for
the
following
reasons:

(
1)
Natural
disasters
declared
by
the
Secretary;

(
2)
Damage
caused
by
drought,
wind,
flood,
excessive
moisture,
hail,
tornado,

earthquake,
fire,
or
other
business
interruption;
and
(
3)
Practices
used
for
the
purpose
of
conducting
research
or
trials
of
techniques,
varieties,

or
ingredients
used
in
organic
production
or
handling.

(
b)
A
State
organic
program's
governing
State
official
or
certifying
agent
may
recommend
in
writing
to
the
Administrator
that
a
temporary
variance
from
a
standard
set
forth
in
subpart
C
of
this
part
for
organic
production
or
handling
operations
be
established:
Provided,

That,
such
variance
is
based
on
one
or
more
of
the
reasons
listed
in
paragraph
(
a)
of
this
section.

(
c)
The
Administrator
will
provide
written
notification
to
certifying
agents
upon
establishment
of
a
temporary
variance
applicable
to
the
certifying
agent's
certified
production
or
handling
operations
and
specify
the
period
of
time
it
shall
remain
in
effect,
subject
to
extension
as
386
the
Administrator
deems
necessary.

(
d)
A
certifying
agent,
upon
notification
from
the
Administrator
of
the
establishment
of
a
temporary
variance,
must
notify
each
production
or
handling
operation
it
certifies
to
which
the
temporary
variance
applies.

(
e)
Temporary
variances
will
not
be
granted
for
any
practice,
material,
or
procedure
prohibited
under
§
205.105.

§
§
205.291­
205.299
[
Reserved]

Subpart
D
­
Labels,
Labeling,
and
Market
Information
§
205.300
Use
of
the
term,
"
organic."

(
a)
The
term,
"
organic,"
may
only
be
used
on
labels
and
in
labeling
of
raw
or
processed
agricultural
products,
including
ingredients,
that
have
been
produced
and
handled
in
accordance
with
the
regulations
in
this
part.
The
term,
"
organic,"
may
not
be
used
in
a
product
name
to
modify
a
nonorganic
ingredient
in
the
product.

(
b)
Products
for
export,
produced
and
certified
to
foreign
national
organic
standards
or
foreign
contract
buyer
requirements,
may
be
labeled
in
accordance
with
the
organic
labeling
requirements
of
the
receiving
country
or
contract
buyer:
Provided,
That,
the
shipping
containers
and
shipping
documents
meet
the
labeling
requirements
specified
in
§
205.307(
c).

(
c)
Products
produced
in
a
foreign
country
and
exported
for
sale
in
the
United
States
must
be
certified
pursuant
to
subpart
E
of
this
part
and
labeled
pursuant
to
this
subpart
D.

(
d)
Livestock
feeds
produced
in
accordance
with
the
requirements
of
this
part
must
be
labeled
in
accordance
with
the
requirements
of
§
205.306.

§
205.301
Product
composition.
387
(
a)
Products
sold,
labeled,
or
represented
as
"
100
percent
organic."
A
raw
or
processed
agricultural
product
sold,
labeled,
or
represented
as
"
100
percent
organic"
must
contain
(
by
weight
or
fluid
volume,
excluding
water
and
salt)
100
percent
organically
produced
ingredients.

If
labeled
as
organically
produced,
such
product
must
be
labeled
pursuant
to
§
205.303.

(
b)
Products
sold,
labeled,
or
represented
as
"
organic."
A
raw
or
processed
agricultural
product
sold,
labeled,
or
represented
as
"
organic"
must
contain
(
by
weight
or
fluid
volume,

excluding
water
and
salt)
not
less
than
95
percent
organically
produced
raw
or
processed
agricultural
products.
Any
remaining
product
ingredients
must
be
organically
produced,
unless
not
commercially
available
in
organic
form,
or
must
be
nonagricultural
substances
or
nonorganically
produced
agricultural
products
produced
consistent
with
the
National
List
in
subpart
G
of
this
part.
If
labeled
as
organically
produced,
such
product
must
be
labeled
pursuant
to
§
205.303.

(
c)
Products
sold,
labeled,
or
represented
as
"
made
with
organic
(
specified
ingredients
or
food
group(
s))."
Multiingredient
agricultural
product
sold,
labeled,
or
represented
as
"
made
with
organic
(
specified
ingredients
or
food
group(
s))"
must
contain
(
by
weight
or
fluid
volume,

excluding
water
and
salt)
at
least
70
percent
organically
produced
ingredients
which
are
produced
and
handled
pursuant
to
requirements
in
subpart
C
of
this
part.
No
ingredients
may
be
produced
using
prohibited
practices
specified
in
paragraphs
(
1),
(
2),
and
(
3)
of
§
205.301(
f).
Nonorganic
ingredients
may
be
produced
without
regard
to
paragraphs
(
4),
(
5),
(
6),
and
(
7)
of
§
205.301(
f).

If
labeled
as
containing
organically
produced
ingredients
or
food
groups,
such
product
must
be
labeled
pursuant
to
§
205.304.

(
d)
Products
with
less
than
70
percent
organically
produced
ingredients.
The
organic
388
ingredients
in
multiingredient
agricultural
product
containing
less
than
70
percent
organically
produced
ingredients
(
by
weight
or
fluid
volume,
excluding
water
and
salt)
must
be
produced
and
handled
pursuant
to
requirements
in
subpart
C
of
this
part.
The
nonorganic
ingredients
may
be
produced
and
handled
without
regard
to
the
requirements
of
this
part.
Multiingredient
agricultural
product
containing
less
than
70
percent
organically
produced
ingredients
may
represent
the
organic
nature
of
the
product
only
as
provided
in
§
205.305.

(
e)
Livestock
feed:

(
1)
A
raw
or
processed
livestock
feed
product
sold,
labeled,
or
represented
as
"
100
percent
organic"
must
contain
(
by
weight
or
fluid
volume,
excluding
water
and
salt)
not
less
than
100
percent
organically
produced
raw
or
processed
agricultural
product.

(
2)
A
raw
or
processed
livestock
feed
product
sold,
labeled,
or
represented
as
"
organic"

must
be
produced
in
conformance
with
§
205.237.

(
f)
All
products
labeled
as
"
100
percent
organic"
or
"
organic"
and
all
ingredients
identified
as
"
organic"
in
the
ingredient
statement
of
any
product
must
not:

(
1)
Be
produced
using
excluded
methods,
pursuant
to
§
201.105(
e);

(
2)
Be
produced
using
sewage
sludge,
pursuant
to
§
201.105(
f);

(
3)
Be
processed
using
ionizing
radiation,
pursuant
to
§
201.105(
g);

(
4)
Be
processed
using
processing
aids
not
approved
on
the
National
List
of
Allowed
and
Prohibited
Substances
in
subpart
G
of
this
part:
Except,
That,
products
labeled
as
"
100
percent
organic,"
if
processed,
must
be
processed
using
organically
produced
processing
aids;

(
5)
Contain
sulfites,
nitrates,
or
nitrites
added
during
the
production
or
handling
process,

Except,
That,
wine
containing
added
sulfites
may
be
labeled
"
made
with
organic
grapes";
389
(
6)
Be
produced
using
nonorganic
ingredients
when
organic
ingredients
are
available;
or
(
7)
Include
organic
and
nonorganic
forms
of
the
same
ingredient.

§
205.302
Calculating
the
percentage
of
organically
produced
ingredients.

(
a)
The
percentage
of
all
organically
produced
ingredients
in
an
agricultural
product
sold,

labeled,
or
represented
as
"
100
percent
organic,"
"
organic,"
or
"
made
with
organic
(
specified
ingredients
or
food
group(
s)),"
or
that
include
organic
ingredients
must
be
calculated
by:

(
1)
Dividing
the
total
net
weight
(
excluding
water
and
salt)
of
combined
organic
ingredients
at
formulation
by
the
total
weight
(
excluding
water
and
salt)
of
the
finished
product.

(
2)
Dividing
the
fluid
volume
of
all
organic
ingredients
(
excluding
water
and
salt)
by
the
fluid
volume
of
the
finished
product
(
excluding
water
and
salt)
if
the
product
and
ingredients
are
liquid.
If
the
liquid
product
is
identified
on
the
principal
display
panel
or
information
panel
as
being
reconstituted
from
concentrates,
the
calculation
should
be
made
on
the
basis
of
singlestrength
concentrations
of
the
ingredients
and
finished
product.

(
3)
For
products
containing
organically
produced
ingredients
in
both
solid
and
liquid
form,
dividing
the
combined
weight
of
the
solid
ingredients
and
the
weight
of
the
liquid
ingredients
(
excluding
water
and
salt)
by
the
total
weight
(
excluding
water
and
salt)
of
the
finished
product.

(
b)
The
percentage
of
all
organically
produced
ingredients
in
an
agricultural
product
must
be
rounded
down
to
the
nearest
whole
number.

(
c)
The
percentage
must
be
determined
by
the
handler
who
affixes
the
label
on
the
consumer
package
and
verified
by
the
certifying
agent
of
the
handler.
The
handler
may
use
information
provided
by
the
certified
operation
in
determining
the
percentage.
390
§
205.303
Packaged
products
labeled
"
100
percent
organic"
or
"
organic."

(
a)
Agricultural
products
in
packages
described
in
§
205.301(
a)
and
(
b)
may
display,
on
the
principal
display
panel,
information
panel,
and
any
other
panel
of
the
package
and
on
any
labeling
or
market
information
concerning
the
product,
the
following:

(
1)
The
term,
"
100
percent
organic"
or
"
organic,"
as
applicable,
to
modify
the
name
of
the
product;

(
2)
For
products
labeled
"
organic,"
the
percentage
of
organic
ingredients
in
the
product;

(
The
size
of
the
percentage
statement
must
not
exceed
one­
half
the
size
of
the
largest
type
size
on
the
panel
on
which
the
statement
is
displayed
and
must
appear
in
its
entirety
in
the
same
type
size,

style,
and
color
without
highlighting.)

(
3)
The
term,
"
organic,"
to
identify
the
organic
ingredients
in
multiingredient
products
labeled
"
100
percent
organic";

(
4)
The
USDA
seal;
and/
or
(
5)
The
seal,
logo,
or
other
identifying
mark
of
the
certifying
agent
which
certified
the
production
or
handling
operation
producing
the
finished
product
and
any
other
certifying
agent
which
certified
production
or
handling
operations
producing
raw
organic
product
or
organic
ingredients
used
in
the
finished
product:
Provided,
That,
the
handler
producing
the
finished
product
maintain
records,
pursuant
to
this
part,
verifying
organic
certification
of
the
operations
producing
such
ingredients,
and:
Provided
further,
That,
such
seals
or
marks
are
not
individually
displayed
more
prominently
than
the
USDA
seal.

(
b)
Agricultural
products
in
packages
described
in
§
205.301(
a)
and
(
b)
must:

(
1)
For
products
labeled
"
organic,"
identify
each
organic
ingredient
in
the
ingredient
391
statement
with
the
word,
"
organic,"
or
with
an
asterisk
or
other
reference
mark
which
is
defined
below
the
ingredient
statement
to
indicate
the
ingredient
is
organically
produced.
Water
or
salt
included
as
ingredients
cannot
be
identified
as
organic.

(
2)
On
the
information
panel,
below
the
information
identifying
the
handler
or
distributor
of
the
product
and
preceded
by
the
statement,
"
Certified
organic
by...,"
or
similar
phrase,
identify
the
name
of
the
certifying
agent
that
certified
the
handler
of
the
finished
product
and
may
display
the
business
address,
Internet
address,
or
telephone
number
of
the
certifying
agent
in
such
label.

§
205.304
Packaged
products
labeled
"
made
with
organic
(
specified
ingredients
or
food
group(
s))."

(
a)
Agricultural
products
in
packages
described
in
§
205.301(
c)
may
display
on
the
principal
display
panel,
information
panel,
and
any
other
panel
and
on
any
labeling
or
market
information
concerning
the
product:

(
1)
The
statement:

(
i)
"
Made
with
organic
(
specified
ingredients)":
Provided,
That,
the
statement
does
not
list
more
than
three
organically
produced
ingredients;
or
(
ii)
"
Made
with
organic
(
specified
food
groups)":
Provided,
That,
the
statement
does
not
list
more
than
three
of
the
following
food
groups:
beans,
fish,
fruits,
grains,
herbs,
meats,
nuts,

oils,
poultry,
seeds,
spices,
sweeteners,
and
vegetables
or
processed
milk
products;
and,
Provided
Further,
That,
all
ingredients
of
each
listed
food
group
in
the
product
must
be
organically
produced;
and
(
iii)
Which
appears
in
letters
that
do
not
exceed
one­
half
the
size
of
the
largest
type
size
on
the
panel
and
which
appears
in
its
entirety
in
the
same
type
size,
style,
and
color
without
392
highlighting.

(
2)
The
percentage
of
organic
ingredients
in
the
product.
The
size
of
the
percentage
statement
must
not
exceed
one­
half
the
size
of
the
largest
type
size
on
the
panel
on
which
the
statement
is
displayed
and
must
appear
in
its
entirety
in
the
same
type
size,
style,
and
color
without
highlighting.

(
3)
The
seal,
logo,
or
other
identifying
mark
of
the
certifying
agent
that
certified
the
handler
of
the
finished
product.

(
b)
Agricultural
products
in
packages
described
in
§
205.301(
c)
must:

(
1)
In
the
ingredient
statement,
identify
each
organic
ingredient
with
the
word,
"
organic,"

or
with
an
asterisk
or
other
reference
mark
which
is
defined
below
the
ingredient
statement
to
indicate
the
ingredient
is
organically
produced.
Water
or
salt
included
as
ingredients
cannot
be
identified
as
organic.

(
2)
On
the
information
panel,
below
the
information
identifying
the
handler
or
distributor
of
the
product
and
preceded
by
the
statement,
"
Certified
organic
by...,"
or
similar
phrase,
identify
the
name
of
the
certifying
agent
that
certified
the
handler
of
the
finished
product:
Except,
That,

the
business
address,
Internet
address,
or
telephone
number
of
the
certifying
agent
may
be
included
in
such
label.

(
c)
Agricultural
products
in
packages
described
in
§
205.301(
c)
must
not
display
the
USDA
seal.

§
205.305
Multiingredient
packaged
products
with
less
than
70
percent
organically
produced
ingredients.

(
a)
An
agricultural
product
with
less
than
70
percent
organically
produced
ingredients
393
may
only
identify
the
organic
content
of
the
product
by:

(
1)
Identifying
each
organically
produced
ingredient
in
the
ingredient
statement
with
the
word,
"
organic,"
or
with
an
asterisk
or
other
reference
mark
which
is
defined
below
the
ingredient
statement
to
indicate
the
ingredient
is
organically
produced,
and
(
2)
If
the
organically
produced
ingredients
are
identified
in
the
ingredient
statement,

displaying
the
product's
percentage
of
organic
contents
on
the
information
panel.

(
b)
Agricultural
products
with
less
than
70
percent
organically
produced
ingredients
must
not
display:

(
1)
The
USDA
seal;
and
(
2)
Any
certifying
agent
seal,
logo,
or
other
identifying
mark
which
represents
organic
certification
of
a
product
or
product
ingredients.

§
205.306
Labeling
of
livestock
feed.

(
a)
Livestock
feed
products
described
in
§
205.301(
e)(
1)
and
(
e)(
2)
may
display
on
any
package
panel
the
following
terms:

(
1)
The
statement,
"
100
percent
organic"
or
"
organic,"
as
applicable,
to
modify
the
name
of
the
feed
product;

(
2)
The
USDA
seal;

(
3)
The
seal,
logo,
or
other
identifying
mark
of
the
certifying
agent
which
certified
the
production
or
handling
operation
producing
the
raw
or
processed
organic
ingredients
used
in
the
finished
product,
Provided,
That,
such
seals
or
marks
are
not
displayed
more
prominently
than
the
USDA
seal;

(
4)
The
word,
"
organic,"
or
an
asterisk
or
other
reference
mark
which
is
defined
on
the
394
package
to
identify
ingredients
that
are
organically
produced.
Water
or
salt
included
as
ingredients
cannot
be
identified
as
organic.

(
b)
Livestock
feed
products
described
in
§
205.301(
e)(
1)
and
(
e)(
2)
must:

(
i)
On
the
information
panel,
below
the
information
identifying
the
handler
or
distributor
of
the
product
and
preceded
by
the
statement,
"
Certified
organic
by...,"
or
similar
phrase,
display
the
name
of
the
certifying
agent
that
certified
the
handler
of
the
finished
product.
The
business
address,
Internet
address,
or
telephone
number
of
the
certifying
agent
may
be
included
in
such
label.

(
ii)
Comply
with
other
Federal
agency
or
State
feed
labeling
requirements
as
applicable.

§
205.307
Labeling
of
nonretail
containers
used
for
only
shipping
or
storage
of
raw
or
processed
agricultural
products
labeled
as
"
100
percent
organic,"
"
organic,"
or
"
made
with
organic
(
specified
ingredients
or
food
group(
s))."

(
a)
Nonretail
containers
used
only
to
ship
or
store
raw
or
processed
agricultural
product
labeled
as
containing
organic
ingredients
may
display
the
following
terms
or
marks:

(
1)
The
name
and
contact
information
of
the
certifying
agent
which
certified
the
handler
which
assembled
the
final
product;

(
2)
Identification
of
the
product
as
organic;

(
3)
Special
handling
instructions
needed
to
maintain
the
organic
integrity
of
the
product;

(
4)
The
USDA
seal;

(
5)
The
seal,
logo,
or
other
identifying
mark
of
the
certifying
agent
that
certified
the
organic
production
or
handling
operation
that
produced
or
handled
the
finished
product.

(
b)
Nonretail
containers
used
to
ship
or
store
raw
or
processed
agricultural
product
395
labeled
as
containing
organic
ingredients
must
display
the
production
lot
number
of
the
product
if
applicable.

(
c)
Shipping
containers
of
domestically
produced
product
labeled
as
organic
intended
for
export
to
international
markets
may
be
labeled
in
accordance
with
any
shipping
container
labeling
requirements
of
the
foreign
country
of
destination
or
the
container
labeling
specifications
of
a
foreign
contract
buyer:
Provided,
That,
the
shipping
containers
and
shipping
documents
accompanying
such
organic
products
are
clearly
marked
"
For
Export
Only"
and:
Provided
further,
That,
proof
of
such
container
marking
and
export
must
be
maintained
by
the
handler
in
accordance
with
recordkeeping
requirements
for
exempt
and
excluded
operations
under
§
205.101.

§
205.308
Agricultural
products
in
other
than
packaged
form
at
the
point
of
retail
sale
that
are
sold,
labeled,
or
represented
as
"
100
percent
organic"
or
"
organic."

(
a)
Agricultural
products
in
other
than
packaged
form
may
use
the
term,
"
100
percent
organic"
or
"
organic,"
as
applicable,
to
modify
the
name
of
the
product
in
retail
display,
labeling,

and
display
containers:
Provided,
That,
the
term,
"
organic,"
is
used
to
identify
the
organic
ingredients
listed
in
the
ingredient
statement.

(
b)
If
the
product
is
prepared
in
a
certified
facility,
the
retail
display,
labeling,
and
display
containers
may
use:

(
1)
The
USDA
seal;
and
(
2)
The
seal,
logo,
or
other
identifying
mark
of
the
certifying
agent
that
certified
the
production
or
handling
operation
producing
the
finished
product
and
any
other
certifying
agent
which
certified
operations
producing
raw
organic
product
or
organic
ingredients
used
in
the
396
finished
product:
Provided,
That,
such
seals
or
marks
are
not
individually
displayed
more
prominently
than
the
USDA
seal.

§
205.309
Agricultural
products
in
other
than
packaged
form
at
the
point
of
retail
sale
that
are
sold,
labeled,
or
represented
as
"
made
with
organic
(
specified
ingredients
or
food
group(
s))."

(
a)
Agricultural
products
in
other
than
packaged
form
containing
between
70
and
95
percent
organically
produced
ingredients
may
use
the
phrase,
"
made
with
organic
(
specified
ingredients
or
food
group(
s)),"
to
modify
the
name
of
the
product
in
retail
display,
labeling,
and
display
containers.

(
1)
Such
statement
must
not
list
more
than
three
organic
ingredients
or
food
groups,
and
(
2)
In
any
such
display
of
the
product's
ingredient
statement,
the
organic
ingredients
are
identified
as
"
organic."

(
b)
If
prepared
in
a
certified
facility,
such
agricultural
products
labeled
as
"
made
with
organic
(
specified
ingredients
or
food
group(
s))"
in
retail
displays,
display
containers,
and
market
information
may
display
the
certifying
agent's
seal,
logo,
or
other
identifying
mark.

§
205.310
Agricultural
products
produced
on
an
exempt
or
excluded
operation.

(
a)
An
agricultural
product
organically
produced
or
handled
on
an
exempt
or
excluded
operation
must
not:

(
1)
Display
the
USDA
seal
or
any
certifying
agent's
seal
or
other
identifying
mark
which
represents
the
exempt
or
excluded
operation
as
a
certified
organic
operation,
or
(
2)
Be
represented
as
a
certified
organic
product
or
certified
organic
ingredient
to
any
buyer.
397
(
b)
An
agricultural
product
organically
produced
or
handled
on
an
exempt
or
excluded
operation
may
be
identified
as
an
organic
product
or
organic
ingredient
in
a
multiingredient
product
produced
by
the
exempt
or
excluded
operation.
Such
product
or
ingredient
must
not
be
identified
or
represented
as
"
organic"
in
a
product
processed
by
others.

(
c)
Such
product
is
subject
to
requirements
specified
in
paragraph
(
a)
of
§
205.300,
and
paragraphs
(
f)(
1)
through
(
f)(
7)
of
§
205.301.

§
205.311
USDA
Seal.

(
a)
The
USDA
seal
described
in
paragraphs
(
b)
and
(
c)
of
this
section
may
be
used
only
for
raw
or
processed
agricultural
products
described
in
paragraphs
(
a),
(
b),
(
e)(
1),
and
(
e)(
2)
of
§
205.301.

(
b)
The
USDA
seal
must
replicate
the
form
and
design
of
the
example
in
figure
1
and
must
be
printed
legibly
and
conspicuously:

(
1)
On
a
white
background
with
a
brown
outer
circle
and
with
the
term,
"
USDA,"
in
green
overlaying
a
white
upper
semicircle
and
with
the
term,
"
organic,"
in
white
overlaying
the
green
lower
half
circle;
or
(
2)
On
a
white
or
transparent
background
with
black
outer
circle
and
black
"
USDA"
on
a
white
or
transparent
upper
half
of
the
circle
with
a
contrasting
white
or
transparent
"
organic"
on
the
black
lower
half
circle.

(
3)
The
green
or
black
lower
half
circle
may
have
four
light
lines
running
from
left
to
right
and
disappearing
at
the
point
on
the
right
horizon
to
resemble
a
cultivated
field.
398
§
§
205.312­
205.399
[
Reserved]

Subpart
E
­
Certification
§
205.400
General
requirements
for
certification.

A
person
seeking
to
receive
or
maintain
organic
certification
under
the
regulations
in
this
part
must:

(
a)
Comply
with
the
Act
and
applicable
organic
production
and
handling
regulations
of
this
part;

(
b)
Establish,
implement,
and
update
annually
an
organic
production
or
handling
system
plan
that
is
submitted
to
an
accredited
certifying
agent
as
provided
for
in
§
205.200;

(
c)
Permit
on­
site
inspections
with
complete
access
to
the
production
or
handling
operation,
including
noncertified
production
and
handling
areas,
structures,
and
offices
by
the
certifying
agent
as
provided
for
in
§
205.403;

(
d)
Maintain
all
records
applicable
to
the
organic
operation
for
not
less
than
5
years
beyond
their
creation
and
allow
authorized
representatives
of
the
Secretary,
the
applicable
State
organic
program's
governing
State
official,
and
the
certifying
agent
access
to
such
records
during
normal
business
hours
for
review
and
copying
to
determine
compliance
with
the
Act
and
the
regulations
in
this
part,
as
provided
for
in
§
205.104;
399
(
e)
Submit
the
applicable
fees
charged
by
the
certifying
agent;
and
(
f)
Immediately
notify
the
certifying
agent
concerning
any:

(
1)
Application,
including
drift,
of
a
prohibited
substance
to
any
field,
production
unit,

site,
facility,
livestock,
or
product
that
is
part
of
an
operation;
and
(
2)
Change
in
a
certified
operation
or
any
portion
of
a
certified
operation
that
may
affect
its
compliance
with
the
Act
and
the
regulations
in
this
part.

§
205.401
Application
for
Certification.

A
person
seeking
certification
of
a
production
or
handling
operation
under
this
subpart
must
submit
an
application
for
certification
to
a
certifying
agent.
The
application
must
include
the
following
information:

(
a)
An
organic
production
or
handling
system
plan,
as
required
in
§
205.200;

(
b)
The
name
of
the
person
completing
the
application;
the
applicant's
business
name,

address,
and
telephone
number;
and,
when
the
applicant
is
a
corporation,
the
name,
address,
and
telephone
number
of
the
person
authorized
to
act
on
the
applicant's
behalf;

(
c)
The
name(
s)
of
any
organic
certifying
agent(
s)
to
which
application
has
previously
been
made;
the
year(
s)
of
application;
the
outcome
of
the
application(
s)
submission,
including,

when
available,
a
copy
of
any
notification
of
noncompliance
or
denial
of
certification
issued
to
the
applicant
for
certification;
and
a
description
of
the
actions
taken
by
the
applicant
to
correct
the
noncompliances
noted
in
the
notification
of
noncompliance,
including
evidence
of
such
correction;

and
(
d)
Other
information
necessary
to
determine
compliance
with
the
Act
and
the
regulations
in
this
part.
400
§
205.402
Review
of
application.

(
a)
Upon
acceptance
of
an
application
for
certification,
a
certifying
agent
must:

(
1)
Review
the
application
to
ensure
completeness
pursuant
to
§
205.401;

(
2)
Determine
by
a
review
of
the
application
materials
whether
the
applicant
appears
to
comply
or
may
be
able
to
comply
with
the
applicable
requirements
of
subpart
C
of
this
part;

(
3)
Verify
that
an
applicant
who
previously
applied
to
another
certifying
agent
and
received
a
notification
of
noncompliance
or
denial
of
certification,
pursuant
to
§
205.405,
has
submitted
documentation
to
support
the
correction
of
any
noncompliances
identified
in
the
notification
of
noncompliance
or
denial
of
certification,
as
required
in
§
205.405(
e);
and
(
4)
Schedule
an
on­
site
inspection
of
the
operation
to
determine
whether
the
applicant
qualifies
for
certification
if
the
review
of
application
materials
reveals
that
the
production
or
handling
operation
may
be
in
compliance
with
the
applicable
requirements
of
subpart
C
of
this
part.

(
b)
The
certifying
agent
shall
within
a
reasonable
time:
(
1)
Review
the
application
materials
received
and
communicate
its
findings
to
the
applicant;

(
2)
Provide
the
applicant
with
a
copy
of
the
on­
site
inspection
report,
as
approved
by
the
certifying
agent,
for
any
on­
site
inspection
performed;
and
(
3)
Provide
the
applicant
with
a
copy
of
the
test
results
for
any
samples
taken
by
an
inspector.

(
c)
The
applicant
may
withdraw
its
application
at
any
time.
An
applicant
who
withdraws
its
application
shall
be
liable
for
the
costs
of
services
provided
up
to
the
time
of
withdrawal
of
its
application.
An
applicant
that
voluntarily
withdrew
its
application
prior
to
the
issuance
of
a
notice
401
of
noncompliance
will
not
be
issued
a
notice
of
noncompliance.
Similarly,
an
applicant
that
voluntarily
withdrew
its
application
prior
to
the
issuance
of
a
notice
of
certification
denial
will
not
be
issued
a
notice
of
certification
denial.

§
205.403
On­
site
inspections.

(
a)
On­
site
inspections.
(
1)
A
certifying
agent
must
conduct
an
initial
on­
site
inspection
of
each
production
unit,
facility,
and
site
that
produces
or
handles
organic
products
and
that
is
included
in
an
operation
for
which
certification
is
requested.
An
on­
site
inspection
shall
be
conducted
annually
thereafter
for
each
certified
operation
that
produces
or
handles
organic
products
for
the
purpose
of
determining
whether
to
approve
the
request
for
certification
or
whether
the
certification
of
the
operation
should
continue.

(
2)
(
i)
A
certifying
agent
may
conduct
additional
on­
site
inspections
of
applicants
for
certification
and
certified
operations
to
determine
compliance
with
the
Act
and
the
regulations
in
this
part.

(
ii)
The
Administrator
or
State
organic
program's
governing
State
official
may
require
that
additional
inspections
be
performed
by
the
certifying
agent
for
the
purpose
of
determining
compliance
with
the
Act
and
the
regulations
in
this
part.

(
iii)
Additional
inspections
may
be
announced
or
unannounced
at
the
discretion
of
the
certifying
agent
or
as
required
by
the
Administrator
or
State
organic
program's
governing
State
official.

(
b)
Scheduling.
(
1)
The
initial
on­
site
inspection
must
be
conducted
within
a
reasonable
time
following
a
determination
that
the
applicant
appears
to
comply
or
may
be
able
to
comply
with
the
requirements
of
subpart
C
of
this
part:
Except,
That,
the
initial
inspection
may
be
402
delayed
for
up
to
6
months
to
comply
with
the
requirement
that
the
inspection
be
conducted
when
the
land,
facilities,
and
activities
that
demonstrate
compliance
or
capacity
to
comply
can
be
observed.

(
2)
All
on­
site
inspections
must
be
conducted
when
an
authorized
representative
of
the
operation
who
is
knowledgeable
about
the
operation
is
present
and
at
a
time
when
land,
facilities,

and
activities
that
demonstrate
the
operation's
compliance
with
or
capability
to
comply
with
the
applicable
provisions
of
subpart
C
of
this
part
can
be
observed,
except
that
this
requirement
does
not
apply
to
unannounced
on­
site
inspections.

(
c)
Verification
of
information.
The
on­
site
inspection
of
an
operation
must
verify:

(
1)
The
operation's
compliance
or
capability
to
comply
with
the
Act
and
the
regulations
in
this
part;

(
2)
That
the
information,
including
the
organic
production
or
handling
system
plan,

provided
in
accordance
with
§
§
205.401,
205.406,
and
205.200,
accurately
reflects
the
practices
used
or
to
be
used
by
the
applicant
for
certification
or
by
the
certified
operation;

(
3)
That
prohibited
substances
have
not
been
and
are
not
being
applied
to
the
operation
through
means
which,
at
the
discretion
of
the
certifying
agent,
may
include
the
collection
and
testing
of
soil;
water;
waste;
seeds;
plant
tissue;
and
plant,
animal,
and
processed
products
samples.

(
d)
Exit
interview.
The
inspector
must
conduct
an
exit
interview
with
an
authorized
representative
of
the
operation
who
is
knowledgeable
about
the
inspected
operation
to
confirm
the
accuracy
and
completeness
of
inspection
observations
and
information
gathered
during
the
onsite
inspection.
The
inspector
must
also
address
the
need
for
any
additional
information
as
well
as
403
any
issues
of
concern.

(
e)
Documents
to
the
inspected
operation.
(
1)
At
the
time
of
the
inspection,
the
inspector
shall
provide
the
operation's
authorized
representative
with
a
receipt
for
any
samples
taken
by
the
inspector.
There
shall
be
no
charge
to
the
inspector
for
the
samples
taken.

(
2)
A
copy
of
the
on­
site
inspection
report
and
any
test
results
will
be
sent
to
the
inspected
operation
by
the
certifying
agent.

§
205.404
Granting
certification.

(
a)
Within
a
reasonable
time
after
completion
of
the
initial
on­
site
inspection,
a
certifying
agent
must
review
the
on­
site
inspection
report,
the
results
of
any
analyses
for
substances
conducted,
and
any
additional
information
requested
from
or
supplied
by
the
applicant.
If
the
certifying
agent
determines
that
the
organic
system
plan
and
all
procedures
and
activities
of
the
applicant's
operation
are
in
compliance
with
the
requirements
of
this
part
and
that
the
applicant
is
able
to
conduct
operations
in
accordance
with
the
plan,
the
agent
shall
grant
certification.
The
certification
may
include
requirements
for
the
correction
of
minor
noncompliances
within
a
specified
time
period
as
a
condition
of
continued
certification.

(
b)
The
certifying
agent
must
issue
a
certificate
of
organic
operation
which
specifies
the:

(
1)
Name
and
address
of
the
certified
operation;

(
2)
Effective
date
of
certification;

(
3)
Categories
of
organic
operation,
including
crops,
wild
crops,
livestock,
or
processed
products
produced
by
the
certified
operation;
and
(
4)
Name,
address,
and
telephone
number
of
the
certifying
agent.

(
c)
Once
certified,
a
production
or
handling
operation's
organic
certification
continues
in
404
effect
until
surrendered
by
the
organic
operation
or
suspended
or
revoked
by
the
certifying
agent,

the
State
organic
program's
governing
State
official,
or
the
Administrator.

§
205.405
Denial
of
certification.

(
a)
When
the
certifying
agent
has
reason
to
believe,
based
on
a
review
of
the
information
specified
in
§
205.402
or
§
205.404,
that
an
applicant
for
certification
is
not
able
to
comply
or
is
not
in
compliance
with
the
requirements
of
this
part,
the
certifying
agent
must
provide
a
written
notification
of
noncompliance
to
the
applicant.
When
correction
of
a
noncompliance
is
not
possible,
a
notification
of
noncompliance
and
a
notification
of
denial
of
certification
may
be
combined
in
one
notification.
The
notification
of
noncompliance
shall
provide:

(
1)
A
description
of
each
noncompliance;

(
2)
The
facts
upon
which
the
notification
of
noncompliance
is
based;
and
(
3)
The
date
by
which
the
applicant
must
rebut
or
correct
each
noncompliance
and
submit
supporting
documentation
of
each
such
correction
when
correction
is
possible.

(
b)
Upon
receipt
of
such
notification
of
noncompliance,
the
applicant
may:

(
1)
Correct
noncompliances
and
submit
a
description
of
the
corrective
actions
taken
with
supporting
documentation
to
the
certifying
agent;

(
2)
Correct
noncompliances
and
submit
a
new
application
to
another
certifying
agent:

Provided,
That,
the
applicant
must
include
a
complete
application,
the
notification
of
noncompliance
received
from
the
first
certifying
agent,
and
a
description
of
the
corrective
actions
taken
with
supporting
documentation;
or
(
3)
Submit
written
information
to
the
issuing
certifying
agent
to
rebut
the
noncompliance
described
in
the
notification
of
noncompliance.
405
(
c)
After
issuance
of
a
notification
of
noncompliance,
the
certifying
agent
must:

(
1)
Evaluate
the
applicant's
corrective
actions
taken
and
supporting
documentation
submitted
or
the
written
rebuttal,
conduct
an
on­
site
inspection
if
necessary,
and
(
i)
When
the
corrective
action
or
rebuttal
is
sufficient
for
the
applicant
to
qualify
for
certification,
issue
the
applicant
an
approval
of
certification
pursuant
to
§
205.404;
or
(
ii)
When
the
corrective
action
or
rebuttal
is
not
sufficient
for
the
applicant
to
qualify
for
certification,
issue
the
applicant
a
written
notice
of
denial
of
certification.

(
2)
Issue
a
written
notice
of
denial
of
certification
to
an
applicant
who
fails
to
respond
to
the
notification
of
noncompliance.

(
3)
Provide
notice
of
approval
or
denial
to
the
Administrator,
pursuant
to
§
205.501(
a)(
14).

(
d)
A
notice
of
denial
of
certification
must
state
the
reason(
s)
for
denial
and
the
applicant's
right
to:

(
1)
Reapply
for
certification
pursuant
to
§
§
205.401
and
205.405(
e);

(
2)
Request
mediation
pursuant
to
§
205.663
or,
if
applicable,
pursuant
to
a
State
organic
program;
or
(
3)
File
an
appeal
of
the
denial
of
certification
pursuant
to
§
205.681
or,
if
applicable,

pursuant
to
a
State
organic
program.

(
e)
An
applicant
for
certification
who
has
received
a
written
notification
of
noncompliance
or
a
written
notice
of
denial
of
certification
may
apply
for
certification
again
at
any
time
with
any
certifying
agent,
in
accordance
with
§
§
205.401
and
205.405(
e).
When
such
applicant
submits
a
new
application
to
a
certifying
agent
other
than
the
agent
who
issued
the
406
notification
of
noncompliance
or
notice
of
denial
of
certification,
the
applicant
for
certification
must
include
a
copy
of
the
notification
of
noncompliance
or
notice
of
denial
of
certification
and
a
description
of
the
actions
taken,
with
supporting
documentation,
to
correct
the
noncompliances
noted
in
the
notification
of
noncompliance.

(
f)
A
certifying
agent
who
receives
a
new
application
for
certification,
which
includes
a
notification
of
noncompliance
or
a
notice
of
denial
of
certification,
must
treat
the
application
as
a
new
application
and
begin
a
new
application
process
pursuant
to
§
205.402.

(
g)
Notwithstanding
paragraph
(
a)
of
this
section,
if
a
certifying
agent
has
reason
to
believe
that
an
applicant
for
certification
has
willfully
made
a
false
statement
or
otherwise
purposefully
misrepresented
the
applicant's
operation
or
its
compliance
with
the
certification
requirements
pursuant
to
this
part,
the
certifying
agent
may
deny
certification
pursuant
to
paragraph
(
c)(
1)(
ii)
of
this
section
without
first
issuing
a
notification
of
noncompliance.

§
205.406
Continuation
of
certification.

(
a)
To
continue
certification,
a
certified
operation
must
annually
pay
the
certification
fees
and
submit
the
following
information,
as
applicable,
to
the
certifying
agent:

(
1)
An
updated
organic
production
or
handling
system
plan
which
includes:

(
i)
A
summary
statement,
supported
by
documentation,
detailing
any
deviations
from,

changes
to,
modifications
to,
or
other
amendments
made
to
the
previous
year's
organic
system
plan
during
the
previous
year;
and
(
ii)
Any
additions
or
deletions
to
the
previous
year's
organic
system
plan,
intended
to
be
undertaken
in
the
coming
year,
detailed
pursuant
to
§
205.200;

(
2)
Any
additions
to
or
deletions
from
the
information
required
pursuant
to
§
205.401(
b);
407
(
3)
An
update
on
the
correction
of
minor
noncompliances
previously
identified
by
the
certifying
agent
as
requiring
correction
for
continued
certification;
and
(
4)
Other
information
as
deemed
necessary
by
the
certifying
agent
to
determine
compliance
with
the
Act
and
the
regulations
in
this
part.

(
b)
Following
the
receipt
of
the
information
specified
in
paragraph
(
a)
of
this
section,
the
certifying
agent
shall
within
a
reasonable
time
arrange
and
conduct
an
on­
site
inspection
of
the
certified
operation
pursuant
to
§
205.403:
Except,
That,
when
it
is
impossible
for
the
certifying
agent
to
conduct
the
annual
on­
site
inspection
following
receipt
of
the
certified
operation's
annual
update
of
information,
the
certifying
agent
may
allow
continuation
of
certification
and
issue
an
updated
certificate
of
organic
operation
on
the
basis
of
the
information
submitted
and
the
most
recent
on­
site
inspection
conducted
during
the
previous
12
months:
Provided,
That,
the
annual
on­
site
inspection,
required
pursuant
to
§
205.403,
is
conducted
within
the
first
6
months
following
the
certified
operation's
scheduled
date
of
annual
update.

(
c)
If
the
certifying
agent
has
reason
to
believe,
based
on
the
on­
site
inspection
and
a
review
of
the
information
specified
in
§
205.404,
that
a
certified
operation
is
not
complying
with
the
requirements
of
the
Act
and
the
regulations
in
this
part,
the
certifying
agent
shall
provide
a
written
notification
of
noncompliance
to
the
operation
in
accordance
with
§
205.662.

(
d)
If
the
certifying
agent
determines
that
the
certified
operation
is
complying
with
the
Act
and
the
regulations
in
this
part
and
that
any
of
the
information
specified
on
the
certificate
of
organic
operation
has
changed,
the
certifying
agent
must
issue
an
updated
certificate
of
organic
operation
pursuant
to
§
205.404(
b).

§
§
205.407­
205.499
[
Reserved]
408
Subpart
F
­
Accreditation
of
Certifying
Agents
§
205.500
Areas
and
duration
of
accreditation.

(
a)
The
Administrator
shall
accredit
a
qualified
domestic
or
foreign
applicant
in
the
areas
of
crops,
livestock,
wild
crops,
or
handling
or
any
combination
thereof
to
certify
a
domestic
or
foreign
production
or
handling
operation
as
a
certified
operation.

(
b)
Accreditation
shall
be
for
a
period
of
5
years
from
the
date
of
approval
of
accreditation
pursuant
to
§
205.506.

(
c)
In
lieu
of
accreditation
under
paragraph
(
a)
of
this
section,
USDA
will
accept
a
foreign
certifying
agent's
accreditation
to
certify
organic
production
or
handling
operations
if:

(
1)
USDA
determines,
upon
the
request
of
a
foreign
government,
that
the
standards
under
which
the
foreign
government
authority
accredited
the
foreign
certifying
agent
meet
the
requirements
of
this
part;
or
(
2)
The
foreign
government
authority
that
accredited
the
foreign
certifying
agent
acted
under
an
equivalency
agreement
negotiated
between
the
United
States
and
the
foreign
government.

§
205.501
General
requirements
for
accreditation.

(
a)
A
private
or
governmental
entity
accredited
as
a
certifying
agent
under
this
subpart
must:

(
1)
Have
sufficient
expertise
in
organic
production
or
handling
techniques
to
fully
comply
with
and
implement
the
terms
and
conditions
of
the
organic
certification
program
established
under
the
Act
and
the
regulations
in
this
part;

(
2)
Demonstrate
the
ability
to
fully
comply
with
the
requirements
for
accreditation
set
409
forth
in
this
subpart;

(
3)
Carry
out
the
provisions
of
the
Act
and
the
regulations
in
this
part,
including
the
provisions
of
§
§
205.402
through
205.406
and
§
205.670;

(
4)
Use
a
sufficient
number
of
adequately
trained
personnel,
including
inspectors
and
certification
review
personnel,
to
comply
with
and
implement
the
organic
certification
program
established
under
the
Act
and
the
regulations
in
subpart
E
of
this
part;

(
5)
Ensure
that
its
responsibly
connected
persons,
employees,
and
contractors
with
inspection,
analysis,
and
decision­
making
responsibilities
have
sufficient
expertise
in
organic
production
or
handling
techniques
to
successfully
perform
the
duties
assigned.

(
6)
Conduct
an
annual
performance
evaluation
of
all
persons
who
review
applications
for
certification,
perform
on­
site
inspections,
review
certification
documents,
evaluate
qualifications
for
certification,
make
recommendations
concerning
certification,
or
make
certification
decisions
and
implement
measures
to
correct
any
deficiencies
in
certification
services;

(
7)
Have
an
annual
program
review
of
its
certification
activities
conducted
by
the
certifying
agent's
staff,
an
outside
auditor,
or
a
consultant
who
has
expertise
to
conduct
such
reviews
and
implement
measures
to
correct
any
noncompliances
with
the
Act
and
the
regulations
in
this
part
that
are
identified
in
the
evaluation;

(
8)
Provide
sufficient
information
to
persons
seeking
certification
to
enable
them
to
comply
with
the
applicable
requirements
of
the
Act
and
the
regulations
in
this
part;

(
9)
Maintain
all
records
pursuant
to
§
205.510(
b)
and
make
all
such
records
available
for
inspection
and
copying
during
normal
business
hours
by
authorized
representatives
of
the
Secretary
and
the
applicable
State
organic
program's
governing
State
official;
410
(
10)
Maintain
strict
confidentiality
with
respect
to
its
clients
under
the
applicable
organic
certification
program
and
not
disclose
to
third
parties
(
with
the
exception
of
the
Secretary
or
the
applicable
State
organic
program's
governing
State
official
or
their
authorized
representatives)

any
business­
related
information
concerning
any
client
obtained
while
implementing
the
regulations
in
this
part,
except
as
provided
for
in
§
205.504(
b)(
5);

(
11)
Prevent
conflicts
of
interest
by:
(
i)
Not
certifying
a
production
or
handling
operation
if
the
certifying
agent
or
a
responsibly
connected
party
of
such
certifying
agent
has
or
has
held
a
commercial
interest
in
the
production
or
handling
operation,
including
an
immediate
family
interest
or
the
provision
of
consulting
services,
within
the
12­
month
period
prior
to
the
application
for
certification;

(
ii)
Excluding
any
person,
including
contractors,
with
conflicts
of
interest
from
work,

discussions,
and
decisions
in
all
stages
of
the
certification
process
and
the
monitoring
of
certified
production
or
handling
operations
for
all
entities
in
which
such
person
has
or
has
held
a
commercial
interest,
including
an
immediate
family
interest
or
the
provision
of
consulting
services,

within
the
12­
month
period
prior
to
the
application
for
certification;

(
iii)
Not
permitting
any
employee,
inspector,
contractor,
or
other
personnel
to
accept
payment,
gifts,
or
favors
of
any
kind,
other
than
prescribed
fees,
from
any
business
inspected,

Except,
That,
a
certifying
agent
that
is
a
not­
for­
profit
organization
with
an
Internal
Revenue
Code
tax
exemption
or,
in
the
case
of
a
foreign
certifying
agent,
a
comparable
recognition
of
notfor
profit
status
from
its
government,
may
accept
voluntary
labor
from
certified
operations;

(
iv)
Not
giving
advice
or
providing
consultancy
services,
to
certification
applicants
or
certified
operations,
for
overcoming
identified
barriers
to
certification;
411
(
v)
Requiring
all
persons
who
review
applications
for
certification,
perform
on­
site
inspections,
review
certification
documents,
evaluate
qualifications
for
certification,
make
recommendations
concerning
certification,
or
make
certification
decisions
and
all
parties
responsibly
connected
to
the
certifying
agent
to
complete
an
annual
conflict
of
interest
disclosure
report;
and
(
vi)
Ensuring
that
the
decision
to
certify
an
operation
is
made
by
a
person
different
from
those
who
conducted
the
review
of
documents
and
on­
site
inspection.

(
12)
(
i)
Reconsider
a
certified
operation's
application
for
certification
and,
if
necessary,

perform
a
new
on­
site
inspection
when
it
is
determined,
within
12
months
of
certifying
the
operation,
that
any
person
participating
in
the
certification
process
and
covered
under
§
205.501(
a)(
11)(
ii)
has
or
had
a
conflict
of
interest
involving
the
applicant.
All
costs
associated
with
a
reconsideration
of
application,
including
onsite
inspection
costs,
shall
be
borne
by
the
certifying
agent.

(
ii)
Refer
a
certified
operation
to
a
different
accredited
certifying
agent
for
recertification
and
reimburse
the
operation
for
the
cost
of
the
recertification
when
it
is
determined
that
any
person
covered
under
§
205.501(
a)(
11)(
i)
at
the
time
of
certification
of
the
applicant
had
a
conflict
of
interest
involving
the
applicant.

(
13)
Accept
the
certification
decisions
made
by
another
certifying
agent
accredited
or
accepted
by
USDA
pursuant
to
§
205.500;

(
14)
Refrain
from
making
false
or
misleading
claims
about
its
accreditation
status,
the
USDA
accreditation
program
for
certifying
agents,
or
the
nature
or
qualities
of
products
labeled
as
organically
produced;
412
(
15)
Submit
to
the
Administrator
a
copy
of:
(
i)
Any
notice
of
denial
of
certification
issued
pursuant
to
§
205.405,
notification
of
noncompliance,
notification
of
noncompliance
correction,
notification
of
proposed
suspension
or
revocation,
and
notification
of
suspension
or
revocation
sent
pursuant
to
§
205.662
simultaneously
with
its
issuance
and
(
ii)
A
list,
on
January
2
of
each
year,
including
the
name,
address,
and
telephone
number
of
each
operation
granted
certification
during
the
preceding
year;

(
16)
Charge
applicants
for
certification
and
certified
production
and
handling
operations
only
those
fees
and
charges
for
certification
activities
that
it
has
filed
with
the
Administrator;

(
17)
Pay
and
submit
fees
to
AMS
in
accordance
with
§
205.640;

(
18)
Provide
the
inspector,
prior
to
each
on­
site
inspection,
with
previous
on­
site
inspection
reports
and
notify
the
inspector
of
its
decision
regarding
certification
of
the
production
or
handling
operation
site
inspected
by
the
inspector
and
of
any
requirements
for
the
correction
of
minor
noncompliances;

(
19)
Accept
all
production
or
handling
applications
that
fall
within
its
area(
s)
of
accreditation
and
certify
all
qualified
applicants,
to
the
extent
of
its
administrative
capacity
to
do
so
without
regard
to
size
or
membership
in
any
association
or
group;
and
(
20)
Demonstrate
its
ability
to
comply
with
a
State's
organic
program
to
certify
organic
production
or
handling
operations
within
the
State.

(
21)
Comply
with,
implement,
and
carry
out
any
other
terms
and
conditions
determined
by
the
Administrator
to
be
necessary.

(
b)
A
private
or
governmental
entity
accredited
as
a
certifying
agent
under
this
subpart
may
establish
a
seal,
logo,
or
other
identifying
mark
to
be
used
by
production
and
handling
413
operations
certified
by
the
certifying
agent
to
indicate
affiliation
with
the
certifying
agent:

Provided,
That,
the
certifying
agent:

(
1)
Does
not
require
use
of
its
seal,
logo,
or
other
identifying
mark
on
any
product
sold,

labeled,
or
represented
as
organically
produced
as
a
condition
of
certification
and
(
2)
Does
not
require
compliance
with
any
production
or
handling
practices
other
than
those
provided
for
in
the
Act
and
the
regulations
in
this
part
as
a
condition
of
use
of
its
identifying
mark:
Provided,
That,
certifying
agents
certifying
production
or
handling
operations
within
a
State
with
more
restrictive
requirements,
approved
by
the
Secretary,
shall
require
compliance
with
such
requirements
as
a
condition
of
use
of
their
identifying
mark
by
such
operations.

(
c)
A
private
entity
accredited
as
a
certifying
agent
must:
(
1)
Hold
the
Secretary
harmless
for
any
failure
on
the
part
of
the
certifying
agent
to
carry
out
the
provisions
of
the
Act
and
the
regulations
in
this
part;

(
2)
Furnish
reasonable
security,
in
an
amount
and
according
to
such
terms
as
the
Administrator
may
by
regulation
prescribe,
for
the
purpose
of
protecting
the
rights
of
production
and
handling
operations
certified
by
such
certifying
agent
under
the
Act
and
the
regulations
in
this
part;
and
(
3)
Transfer
to
the
Administrator
and
make
available
to
any
applicable
State
organic
program's
governing
State
official
all
records
or
copies
of
records
concerning
the
person's
certification
activities
in
the
event
that
the
certifying
agent
dissolves
or
loses
its
accreditation;

Provided,
That,
such
transfer
shall
not
apply
to
a
merger,
sale,
or
other
transfer
of
ownership
of
a
certifying
agent.

(
d)
No
private
or
governmental
entity
accredited
as
a
certifying
agent
under
this
subpart
414
shall
exclude
from
participation
in
or
deny
the
benefits
of
the
National
Organic
Program
to
any
person
due
to
discrimination
because
of
race,
color,
national
origin,
gender,
religion,
age,

disability,
political
beliefs,
sexual
orientation,
or
marital
or
family
status.

§
205.502
Applying
for
accreditation.

(
a)
A
private
or
governmental
entity
seeking
accreditation
as
a
certifying
agent
under
this
subpart
must
submit
an
application
for
accreditation
which
contains
the
applicable
information
and
documents
set
forth
in
§
§
205.503
through
205.505
and
the
fees
required
in
§
205.640
to:

Program
Manager,
USDA­
AMS­
TMP­
NOP,
Room
2945­
South
Building,
PO
Box
96456,

Washington,
DC
20090­
6456.

(
b)
Following
the
receipt
of
the
information
and
documents,
the
Administrator
will
determine,
pursuant
to
§
205.506,
whether
the
applicant
for
accreditation
should
be
accredited
as
a
certifying
agent.

§
205.503
Applicant
information.

A
private
or
governmental
entity
seeking
accreditation
as
a
certifying
agent
must
submit
the
following
information:

(
a)
The
business
name,
primary
office
location,
mailing
address,
name
of
the
person(
s)

responsible
for
the
certifying
agent's
day­
to­
day
operations,
contact
numbers
(
telephone,

facsimile,
and
Internet
address)
of
the
applicant,
and,
for
an
applicant
who
is
a
private
person,
the
entity's
taxpayer
identification
number;

(
b)
The
name,
office
location,
mailing
address,
and
contact
numbers
(
telephone,
facsimile,

and
Internet
address)
for
each
of
its
organizational
units,
such
as
chapters
or
subsidiary
offices,

and
the
name
of
a
contact
person
for
each
unit;
415
(
c)
Each
area
of
operation
(
crops,
wild
crops,
livestock,
or
handling)
for
which
accreditation
is
requested
and
the
estimated
number
of
each
type
of
operation
anticipated
to
be
certified
annually
by
the
applicant
along
with
a
copy
of
the
applicant's
schedule
of
fees
for
all
services
to
be
provided
under
these
regulations
by
the
applicant;

(
d)
The
type
of
entity
the
applicant
is
(
e.
g.,
government
agricultural
office,
for­
profit
business,
not­
for­
profit
membership
association)
and
for:

(
1)
A
governmental
entity,
a
copy
of
the
official's
authority
to
conduct
certification
activities
under
the
Act
and
the
regulations
in
this
part,

(
2)
A
private
entity,
documentation
showing
the
entity's
status
and
organizational
purpose,
such
as
articles
of
incorporation
and
by­
laws
or
ownership
or
membership
provisions,

and
its
date
of
establishment;
and
(
e)
A
list
of
each
State
or
foreign
country
in
which
the
applicant
currently
certifies
production
and
handling
operations
and
a
list
of
each
State
or
foreign
country
in
which
the
applicant
intends
to
certify
production
or
handling
operations.

§
205.504
Evidence
of
expertise
and
ability.

A
private
or
governmental
entity
seeking
accreditation
as
a
certifying
agent
must
submit
the
following
documents
and
information
to
demonstrate
its
expertise
in
organic
production
or
handling
techniques;
its
ability
to
fully
comply
with
and
implement
the
organic
certification
program
established
in
§
§
205.100
and
205.101,
§
§
205.201
through
205.203,
§
§
205.300
through
205.303,
§
§
205.400
through
205.406,
and
§
§
205.661
and
205.662;
and
its
ability
to
comply
with
the
requirements
for
accreditation
set
forth
in
§
205.501:

(
a)
Personnel.
(
1)
A
copy
of
the
applicant's
policies
and
procedures
for
training,
416
evaluating,
and
supervising
personnel;

(
2)
The
name
and
position
description
of
all
personnel
to
be
used
in
the
certification
operation,
including
administrative
staff,
certification
inspectors,
members
of
any
certification
review
and
evaluation
committees,
contractors,
and
all
parties
responsibly
connected
to
the
certifying
agent;

(
3)
A
description
of
the
qualifications,
including
experience,
training,
and
education
in
agriculture,
organic
production,
and
organic
handling,
for:

(
i)
Each
inspector
to
be
used
by
the
applicant
and
(
ii)
Each
person
to
be
designated
by
the
applicant
to
review
or
evaluate
applications
for
certification;
and
(
4)
A
description
of
any
training
that
the
applicant
has
provided
or
intends
to
provide
to
personnel
to
ensure
that
they
comply
with
and
implement
the
requirements
of
the
Act
and
the
regulations
in
this
part.

(
b)
Administrative
policies
and
procedures.
(
1)
A
copy
of
the
procedures
to
be
used
to
evaluate
certification
applicants,
make
certification
decisions,
and
issue
certification
certificates;

(
2)
A
copy
of
the
procedures
to
be
used
for
reviewing
and
investigating
certified
operation
compliance
with
the
Act
and
the
regulations
in
this
part
and
the
reporting
of
violations
of
the
Act
and
the
regulations
in
this
part
to
the
Administrator;

(
3)
A
copy
of
the
procedures
to
be
used
for
complying
with
the
recordkeeping
requirements
set
forth
in
§
205.501(
a)(
9);

(
4)
A
copy
of
the
procedures
to
be
used
for
maintaining
the
confidentiality
of
any
business­
related
information
as
set
forth
in
§
205.501(
a)(
10);
417
(
5)
A
copy
of
the
procedures
to
be
used,
including
any
fees
to
be
assessed,
for
making
the
following
information
available
to
any
member
of
the
public
upon
request:

(
i)
Certification
certificates
issued
during
the
current
and
3
preceding
calender
years;

(
ii)
A
list
of
producers
and
handlers
whose
operations
it
has
certified,
including
for
each
the
name
of
the
operation,
type(
s)
of
operation,
products
produced,
and
the
effective
date
of
the
certification,
during
the
current
and
3
preceding
calender
years;

(
iii)
The
results
of
laboratory
analyses
for
residues
of
pesticides
and
other
prohibited
substances
conducted
during
the
current
and
3
preceding
calender
years;
and
(
iv)
Other
business
information
as
permitted
in
writing
by
the
producer
or
handler;
and
(
6)
A
copy
of
the
procedures
to
be
used
for
sampling
and
residue
testing
pursuant
to
§
205.670.

(
c)
Conflicts
of
interest.
(
1)
A
copy
of
procedures
intended
to
be
implemented
to
prevent
the
occurrence
of
conflicts
of
interest,
as
described
in
§
205.501(
a)(
11).

(
2)
For
all
persons
who
review
applications
for
certification,
perform
on­
site
inspections,

review
certification
documents,
evaluate
qualifications
for
certification,
make
recommendations
concerning
certification,
or
make
certification
decisions
and
all
parties
responsibly
connected
to
the
certifying
agent,
a
conflict
of
interest
disclosure
report,
identifying
any
food­
or
agriculturerelated
business
interests,
including
business
interests
of
immediate
family
members,
that
cause
a
conflict
of
interest.

(
d)
Current
certification
activities.
An
applicant
who
currently
certifies
production
or
handling
operations
must
submit:
(
1)
A
list
of
all
production
and
handling
operations
currently
certified
by
the
applicant;
418
(
2)
Copies
of
at
least
3
different
inspection
reports
and
certification
evaluation
documents
for
production
or
handling
operations
certified
by
the
applicant
during
the
previous
year
for
each
area
of
operation
for
which
accreditation
is
requested;
and
(
3)
The
results
of
any
accreditation
process
of
the
applicant's
operation
by
an
accrediting
body
during
the
previous
year
for
the
purpose
of
evaluating
its
certification
activities.

(
e)
Other
information.
Any
other
information
the
applicant
believes
may
assist
in
the
Administrator's
evaluation
of
the
applicant's
expertise
and
ability.

§
205.505
Statement
of
agreement.

(
a)
A
private
or
governmental
entity
seeking
accreditation
under
this
subpart
must
sign
and
return
a
statement
of
agreement
prepared
by
the
Administrator
which
affirms
that,
if
granted
accreditation
as
a
certifying
agent
under
this
subpart,
the
applicant
will
carry
out
the
provisions
of
the
Act
and
the
regulations
in
this
part,
including:

(
1)
Accept
the
certification
decisions
made
by
another
certifying
agent
accredited
or
accepted
by
USDA
pursuant
to
section
205.500;

(
2)
Refrain
from
making
false
or
misleading
claims
about
its
accreditation
status,
the
USDA
accreditation
program
for
certifying
agents,
or
the
nature
or
qualities
of
products
labeled
as
organically
produced;

(
3)
Conduct
an
annual
performance
evaluation
of
all
persons
who
review
applications
for
certification,
perform
on­
site
inspections,
review
certification
documents,
evaluate
qualifications
for
certification,
make
recommendations
concerning
certification,
or
make
certification
decisions
and
implement
measures
to
correct
any
deficiencies
in
certification
services;

(
4)
Have
an
annual
internal
program
review
conducted
of
its
certification
activities
by
419
certifying
agent
staff,
an
outside
auditor,
or
a
consultant
who
has
the
expertise
to
conduct
such
reviews
and
implement
measures
to
correct
any
noncompliances
with
the
Act
and
the
regulations
in
this
part;

(
5)
Pay
and
submit
fees
to
AMS
in
accordance
with
§
205.640;
and
(
6)
Comply
with,
implement,
and
carry
out
any
other
terms
and
conditions
determined
by
the
Administrator
to
be
necessary.

(
b)
A
private
entity
seeking
accreditation
as
a
certifying
agent
under
this
subpart
must
additionally
agree
to:

(
1)
Hold
the
Secretary
harmless
for
any
failure
on
the
part
of
the
certifying
agent
to
carry
out
the
provisions
of
the
Act
and
the
regulations
in
this
part;

(
2)
Furnish
reasonable
security,
in
an
amount
and
according
to
such
terms
as
the
Administrator
may
by
regulation
prescribe,
for
the
purpose
of
protecting
the
rights
of
production
and
handling
operations
certified
by
such
certifying
agent
under
the
Act
and
the
regulations
in
this
part;
and
(
3)
Transfer
to
the
Administrator
and
make
available
to
the
applicable
State
organic
program's
governing
State
official
all
records
or
copies
of
records
concerning
the
certifying
agent's
certification
activities
in
the
event
that
the
certifying
agent
dissolves
or
loses
its
accreditation;
Provided,
That
such
transfer
shall
not
apply
to
a
merger,
sale,
or
other
transfer
of
ownership
of
a
certifying
agent.

§
205.506
Granting
accreditation.

(
a)
Accreditation
will
be
granted
when:
(
1)
The
accreditation
applicant
has
submitted
the
information
required
by
§
§
205.503
through
205.505;
420
(
2)
The
accreditation
applicant
pays
the
required
fee
in
accordance
with
§
205.640(
c);

and
(
3)
The
Administrator
determines
that
the
applicant
for
accreditation
meets
the
requirements
for
accreditation
as
stated
in
§
205.501,
as
determined
by
a
review
of
the
information
submitted
in
accordance
with
§
§
205.503
through
205.505
and,
if
necessary,
a
review
of
the
information
obtained
from
a
site
evaluation
as
provided
for
in
§
205.508.

(
b)
On
making
a
determination
to
approve
an
application
for
accreditation,
the
Administrator
will
notify
the
applicant
of
the
granting
of
accreditation
in
writing,
stating:

(
1)
The
area(
s)
for
which
accreditation
is
given;

(
2)
The
effective
date
of
the
accreditation;

(
3)
Any
terms
and
conditions
for
the
correction
of
minor
noncompliances;
and
(
4)
For
a
certifying
agent
who
is
a
private
entity,
the
amount
and
type
of
security
that
must
be
established
to
protect
the
rights
of
production
and
handling
operations
certified
by
such
certifying
agent.

(
c)
The
accreditation
of
a
certifying
agent
shall
continue
in
effect
until
such
time
as
the
certifying
agent
fails
to
renew
accreditation
as
provided
in
§
205.510(
c),
the
certifying
agent
voluntarily
ceases
its
certification
activities,
or
accreditation
is
suspended
or
revoked
pursuant
to
§
205.665.

§
205.507
Denial
of
accreditation.

(
a)
If
the
Program
Manager
has
reason
to
believe,
based
on
a
review
of
the
information
specified
in
§
§
205.503
through
205.505
or
after
a
site
evaluation
as
specified
in
§
205.508,
that
an
applicant
for
accreditation
is
not
able
to
comply
or
is
not
in
compliance
with
the
requirements
421
of
the
Act
and
the
regulations
in
this
part,
the
Program
Manager
shall
provide
a
written
notification
of
noncompliance
to
the
applicant.
Such
notification
shall
provide:

(
1)
A
description
of
each
noncompliance;

(
2)
The
facts
upon
which
the
notification
of
noncompliance
is
based;
and
(
3)
The
date
by
which
the
applicant
must
rebut
or
correct
each
noncompliance
and
submit
supporting
documentation
of
each
such
correction
when
correction
is
possible.

(
b)
When
each
noncompliance
has
been
resolved,
the
Program
Manager
will
send
the
applicant
a
written
notification
of
noncompliance
resolution
and
proceed
with
further
processing
of
the
application.

(
c)
If
an
applicant
fails
to
correct
the
noncompliances,
fails
to
report
the
corrections
by
the
date
specified
in
the
notification
of
noncompliance,
fails
to
file
a
rebuttal
of
the
notification
of
noncompliance
by
the
date
specified,
or
is
unsuccessful
in
its
rebuttal,
the
Program
Manager
will
provide
the
applicant
with
written
notification
of
accreditation
denial.
An
applicant
who
has
received
written
notification
of
accreditation
denial
may
apply
for
accreditation
again
at
any
time
in
accordance
with
§
205.502,
or
appeal
the
denial
of
accreditation
in
accordance
with
§
205.681
by
the
date
specified
in
the
notification
of
accreditation
denial.

(
d)
If
the
certifying
agent
was
accredited
prior
to
the
site
evaluation
and
the
certifying
agent
fails
to
correct
the
noncompliances,
fails
to
report
the
corrections
by
the
date
specified
in
the
notification
of
noncompliance,
or
fails
to
file
a
rebuttal
of
the
notification
of
noncompliance
by
the
date
specified,
the
Administrator
will
begin
proceedings
to
suspend
or
revoke
the
certifying
agent's
accreditation.
A
certifying
agent
who
has
had
its
accreditation
suspended
may
at
any
time,
unless
otherwise
stated
in
the
notification
of
suspension,
submit
a
request
to
the
Secretary
422
for
reinstatement
of
its
accreditation.
The
request
must
be
accompanied
by
evidence
demonstrating
correction
of
each
noncompliance
and
corrective
actions
taken
to
comply
with
and
remain
in
compliance
with
the
Act
and
the
regulations
in
this
part.
A
certifying
agent
whose
accreditation
is
revoked
will
be
ineligible
for
accreditation
for
a
period
of
not
less
than
3
years
following
the
date
of
such
determination.

§
205.508
Site
evaluations.

(
a)
Site
evaluations
of
accredited
certifying
agents
shall
be
conducted
for
the
purpose
of
examining
the
certifying
agent's
operations
and
evaluating
its
compliance
with
the
Act
and
the
regulations
of
this
part.
Site
evaluations
shall
include
an
on­
site
review
of
the
certifying
agent's
certification
procedures,
decisions,
facilities,
administrative
and
management
systems,
and
production
or
handling
operations
certified
by
the
certifying
agent.
Site
evaluations
shall
be
conducted
by
a
representative(
s)
of
the
Administrator.

(
b)
An
initial
site
evaluation
of
an
accreditation
applicant
shall
be
conducted
before
or
within
a
reasonable
period
of
time
after
issuance
of
the
applicant's
"
notification
of
accreditation."

A
site
evaluation
shall
be
conducted
after
application
for
renewal
of
accreditation
but
prior
to
the
issuance
of
a
notice
of
renewal
of
accreditation.
One
or
more
site
evaluations
will
be
conducted
during
the
period
of
accreditation
to
determine
whether
an
accredited
certifying
agent
is
complying
with
the
general
requirements
set
forth
in
§
205.501.

§
205.509
Peer
review
panel.

The
Administrator
shall
establish
a
peer
review
panel
pursuant
to
the
Federal
Advisory
Committee
Act
(
FACA)
(
5
U.
S.
C.
App.
2
et
seq.).
The
peer
review
panel
shall
be
composed
of
not
less
than
3
members
who
shall
annually
evaluate
the
National
Organic
Program's
adherence
to
423
the
accreditation
procedures
in
subpart
F
of
these
regulations
and
ISO/
IEC
Guide
61,
General
requirements
for
assessment
and
accreditation
of
certification/
registration
bodies,
and
the
National
Organic
Program's
accreditation
decisions.
This
shall
be
accomplished
through
the
review
of
accreditation
procedures,
document
review
and
site
evaluation
reports,
and
accreditation
decision
documents
or
documentation.
The
peer
review
panel
shall
report
its
finding,
in
writing,
to
the
National
Organic
Program's
Program
Manager.

§
205.510
Annual
report,
recordkeeping,
and
renewal
of
accreditation.

(
a)
Annual
report
and
fees.
An
accredited
certifying
agent
must
submit
annually
to
the
Administrator,
on
or
before
the
anniversary
date
of
the
issuance
of
the
notification
of
accreditation,
the
following
reports
and
fees:

(
1)
A
complete
and
accurate
update
of
information
submitted
pursuant
to
§
§
205.503
and
205.504;

(
2)
Information
supporting
any
changes
being
requested
in
the
areas
of
accreditation
described
in
§
205.500;

(
3)
A
description
of
the
measures
implemented
in
the
previous
year
and
any
measures
to
be
implemented
in
the
coming
year
to
satisfy
any
terms
and
conditions
determined
by
the
Administrator
to
be
necessary,
as
specified
in
the
most
recent
notification
of
accreditation
or
notice
of
renewal
of
accreditation;

(
4)
The
results
of
the
most
recent
performance
evaluations
and
annual
program
review
and
a
description
of
adjustments
to
the
certifying
agent's
operation
and
procedures
implemented
or
to
be
implemented
in
response
to
the
performance
evaluations
and
program
review;
and
(
5)
The
fees
required
in
§
205.640(
a).
424
(
b)
Recordkeeping.
Certifying
agents
must
maintain
records
according
to
the
following
schedule:

(
1)
Records
obtained
from
applicants
for
certification
and
certified
operations
must
be
maintained
for
not
less
than
5
years
beyond
their
receipt;

(
2)
Records
created
by
the
certifying
agent
regarding
applicants
for
certification
and
certified
operations
must
be
maintained
for
not
less
than
10
years
beyond
their
creation;
and
(
3)
Records
created
or
received
by
the
certifying
agent
pursuant
to
the
accreditation
requirements
of
this
subpart
F,
excluding
any
records
covered
by
§
§
205.510(
b)(
2),
must
be
maintained
for
not
less
than
5
years
beyond
their
creation
or
receipt.

(
c)
Renewal
of
accreditation.
(
1)
The
Administrator
shall
send
the
accredited
certifying
agent
a
notice
of
pending
expiration
of
accreditation
approximately
1
year
prior
to
the
scheduled
date
of
expiration.

(
2)
An
accredited
certifying
agent's
application
for
accreditation
renewal
must
be
received
at
least
6
months
prior
to
the
fifth
anniversary
of
issuance
of
the
notification
of
accreditation
and
each
subsequent
renewal
of
accreditation.
The
accreditation
of
certifying
agents
who
make
timely
application
for
renewal
of
accreditation
will
not
expire
during
the
renewal
process.
The
accreditation
of
certifying
agents
who
fail
to
make
timely
application
for
renewal
of
accreditation
will
expire
as
scheduled
unless
renewed
prior
to
the
scheduled
expiration
date.

Certifying
agents
with
an
expired
accreditation
must
not
perform
certification
activities
under
the
Act
and
these
regulations.

(
3)
Following
receipt
of
the
information
submitted
by
the
certifying
agent
in
accordance
with
paragraph
(
a)
of
this
section
and
the
results
of
a
site
evaluation,
the
Administrator
will
425
determine
whether
the
certifying
agent
remains
in
compliance
with
the
Act
and
the
regulations
of
this
part
and
should
have
its
accreditation
renewed.

(
d)
Notice
of
renewal
of
accreditation.
Upon
a
determination
that
the
certifying
agent
is
in
compliance
with
the
Act
and
the
regulations
of
this
part,
the
Administrator
will
issue
a
notice
of
renewal
of
accreditation.
The
notice
of
renewal
will
specify
any
terms
and
conditions
that
must
be
addressed
by
the
certifying
agent
and
the
time
within
which
those
terms
and
conditions
must
be
satisfied.

(
e)
Noncompliance.
Upon
a
determination
that
the
certifying
agent
is
not
in
compliance
with
the
Act
and
the
regulations
of
this
part,
the
Administrator
will
initiate
proceedings
to
suspend
or
revoke
the
certifying
agent's
accreditation.

(
f)
Amending
accreditation.
Amendment
to
scope
of
an
accreditation
may
be
requested
at
any
time.
The
application
for
amendment
shall
be
sent
to
the
Administrator
and
shall
contain
information
applicable
to
the
requested
change
in
accreditation,
a
complete
and
accurate
update
of
the
information
submitted
pursuant
to
§
§
205.503
and
205.504,
and
the
applicable
fees
required
in
§
205.640.

§
§
205.511­
205.599
[
Reserved]

Subpart
G
 
Administrative
The
National
List
of
Allowed
and
Prohibited
Substances
§
205.600
Evaluation
criteria
for
allowed
and
prohibited
substances,
methods,
and
ingredients.

The
following
criteria
will
be
utilized
in
the
evaluation
of
substances
or
ingredients
for
the
organic
production
and
handling
sections
of
the
National
List:
426
(
a)
Synthetic
and
nonsynthetic
substances
considered
for
inclusion
on
or
deletion
from
the
National
List
of
allowed
and
prohibited
substances
will
be
evaluated
using
the
criteria
specified
in
the
Act
(
7
U.
S.
C.
6517
and
6518).

(
b)
In
addition
to
the
criteria
set
forth
in
the
Act,
any
synthetic
substance
used
as
a
processing
aid
or
adjuvant
will
be
evaluated
against
the
following
criteria:

(
1)
The
substance
cannot
be
produced
from
a
natural
source
and
there
are
no
organic
substitutes;

(
2)
The
substance's
manufacture,
use,
and
disposal
do
not
have
adverse
effects
on
the
environment
and
are
done
in
a
manner
compatible
with
organic
handling;

(
3)
The
nutritional
quality
of
the
food
is
maintained
when
the
substance
is
used,
and
the
substance,
itself,
or
its
breakdown
products
do
not
have
an
adverse
effect
on
human
health
as
defined
by
applicable
Federal
regulations;

(
4)
The
substance's
primary
use
is
not
as
a
preservative
or
to
recreate
or
improve
flavors,

colors,
textures,
or
nutritive
value
lost
during
processing,
except
where
the
replacement
of
nutrients
is
required
by
law;

(
5)
The
substance
is
listed
as
generally
recognized
as
safe
(
GRAS)
by
Food
and
Drug
Administration
(
FDA)
when
used
in
accordance
with
FDA's
good
manufacturing
practices
(
GMP)
and
contains
no
residues
of
heavy
metals
or
other
contaminants
in
excess
of
tolerances
set
by
FDA;
and
(
6)
The
substance
is
essential
for
the
handling
of
organically
produced
agricultural
products.

(
c)
Nonsynthetics
used
in
organic
processing
will
be
evaluated
using
the
criteria
specified
427
in
the
Act
(
7
U.
S.
C.
6517
and
6518).

§
205.601
Synthetic
substances
allowed
for
use
in
organic
crop
production.

In
accordance
with
restrictions
specified
in
this
section,
the
following
synthetic
substances
may
be
used
in
organic
crop
production:

(
a)
As
algicide,
disinfectants,
and
sanitizer,
including
irrigation
system
cleaning
systems
(
1)
Alcohols
(
i)
Ethanol
(
ii)
Isopropanol
(
2)
Chlorine
materials
­
Except,
That,
residual
chlorine
levels
in
the
water
shall
not
exceed
the
maximum
residual
disinfectant
limit
under
the
Safe
Drinking
Water
Act.

(
i)
Calcium
hypochlorite
(
ii)
Chlorine
dioxide
(
iii)
Sodium
hypochlorite
(
3)
Hydrogen
peroxide
(
4)
Soap­
based
algicide/
demisters
(
b)
As
herbicides,
weed
barriers,
as
applicable.

(
1)
Herbicides,
soap­
based
­
for
use
in
farmstead
maintenance
(
roadways,
ditches,
right
of
ways,
building
perimeters)
and
ornamental
crops
(
2)
Mulches
(
i)
Newspaper
or
other
recycled
paper,
without
glossy
or
colored
inks.

(
ii)
Plastic
mulch
and
covers
(
petroleum­
based
other
than
polyvinyl
chloride
(
PVC))

(
c)
As
compost
feedstocks
428
Newspapers
or
other
recycled
paper,
without
glossy
or
colored
inks
(
d)
As
animal
repellents
Soaps,
ammonium
­
for
use
as
a
large
animal
repellant
only,
no
contact
with
soil
or
edible
portion
of
crop
(
e)
As
insecticides
(
including
acaricides
or
mite
control)

(
1)
Ammonium
carbonate
­
for
use
as
bait
in
insect
traps
only,
no
direct
contact
with
crop
or
soil
(
2)
Boric
acid
­
structural
pest
control,
no
direct
contact
with
organic
food
or
crops
(
3)
Elemental
sulfur
(
4)
Lime
sulfur
­
including
calcium
polysulfide
(
5)
Oils,
horticultural
­
narrow
range
oils
as
dormant,
suffocating,
and
summer
oils.

(
6)
Soaps,
insecticidal
(
7)
Sticky
traps/
barriers
(
f)
As
insect
attractants
Pheromones
(
g)
As
rodenticides
(
1)
Sulfur
dioxide
­
underground
rodent
control
only
(
smoke
bombs)

(
2)
Vitamin
D3
(
h)
As
slug
or
snail
bait
<
None>

(
i)
As
plant
disease
control
(
1)
Coppers,
fixed
­
copper
hydroxide,
copper
oxide,
copper
oxychloride,
includes
429
products
exempted
from
EPA
tolerance,
Provided,
That,
copper­
based
materials
must
be
used
in
a
manner
that
minimizes
accumulation
in
the
soil
and
shall
not
be
used
as
herbicides.

(
2)
Copper
sulfate
­
Substance
must
be
used
in
a
manner
that
minimizes
accumulation
of
copper
in
the
soil.

(
3)
Hydrated
lime
­
must
be
used
in
a
manner
that
minimizes
copper
accumulation
in
the
soil.

(
4)
Hydrogen
peroxide
(
5)
Lime
sulfur
(
6)
Oils,
horticultural,
narrow
range
oils
as
dormant,
suffocating,
and
summer
oils.

(
7)
Potassium
bicarbonate
(
8)
Elemental
sulfur
(
9)
Streptomycin,
for
fire
blight
control
in
apples
and
pears
only
(
10)
Tetracycline
(
oxytetracycline
calcium
complex),
for
fire
blight
control
only
(
j)
As
plant
or
soil
amendments.

(
1)
Aquatic
plant
extracts
(
other
than
hydrolyzed)
­
Extraction
process
is
limited
to
the
use
of
potassium
hydroxide
or
sodium
hydroxide;
solvent
amount
used
is
limited
to
that
amount
necessary
for
extraction.

(
2)
Elemental
sulfur
(
3)
Humic
acids
­
naturally
occurring
deposits,
water
and
alkali
extracts
only
(
4)
Lignin
sulfonate
­
chelating
agent,
dust
suppressant,
floatation
agent
(
5)
Magnesium
sulfate
­
allowed
with
a
documented
soil
deficiency
(
6)
Micronutrients
­
not
to
be
used
as
a
defoliant,
herbicide,
or
desiccant.
Those
made
430
from
nitrates
or
chlorides
are
not
allowed.
Soil
deficiency
must
be
documented
by
testing.

(
i)
Soluble
boron
products
(
ii)
Sulfates,
carbonates,
oxides,
or
silicates
of
zinc,
copper,
iron,
manganese,

molybdenum,
selenium,
and
cobalt,

(
7)
Liquid
fish
products
­
can
be
pH
adjusted
with
sulfuric,
citric
or
phosphoric
acid.
The
amount
of
acid
used
shall
not
exceed
the
minimum
needed
to
lower
the
pH
to
3.5
(
8)
Vitamins,
B1,
C,
and
E
(
k)
As
plant
growth
regulators
Ethylene
­
for
regulation
of
pineapple
flowering
(
l)
As
floating
agents
in
postharvest
handling
(
1)
Lignin
sulfonate
(
2)
Sodium
silicate
­
for
tree
fruit
and
fiber
processing
(
m)
As
synthetic
inert
ingredients
as
classified
by
the
Environmental
Protection
Agency
(
EPA),
for
use
with
nonsynthetic
substances
or
synthetic
substances
listed
in
this
section
and
used
as
an
active
pesticide
ingredient
in
accordance
with
any
limitations
on
the
use
of
such
substances.

(
1)
EPA
List
4
­
Inerts
of
Minimal
Concern
(
n)­(
z)
[
Reserved]

§
205.602
Nonsynthetic
substances
prohibited
for
use
in
organic
crop
production.

The
following
nonsynthetic
substances
may
not
be
used
in
organic
crop
production:

(
a)
Ash
from
manure
burning
(
b)
Arsenic
(
c)
Lead
salts
431
(
d)
Sodium
fluoaluminate
(
mined)

(
e)
Strychnine
(
f)
Tobacco
dust
(
nicotine
sulfate)

(
g)
Potassium
chloride
­
unless
derived
from
a
mined
source
and
applied
in
a
manner
that
minimizes
chloride
accumulation
in
the
soil.

(
h)
Sodium
nitrate
­
unless
use
is
restricted
to
no
more
than
20%
of
the
crop's
total
nitrogen
requirement.

(
i)­(
z)
[
Reserved]

§
205.603
Synthetic
substances
allowed
for
use
in
organic
livestock
production.

In
accordance
with
restrictions
specified
in
this
section
the
following
synthetic
substances
may
be
used
in
organic
livestock
production:

(
a)
As
disinfectants,
sanitizer,
and
medical
treatments
as
applicable
(
1)
Alcohols
(
i)
Ethanol
­
disinfectant
and
sanitizer
only,
prohibited
as
a
feed
additive
(
ii)
Isopropanol
­
disinfectant
only
(
2)
Aspirin
­
approved
for
health
care
use
to
reduce
inflammation
(
3)
Chlorine
materials
­
disinfecting
and
sanitizing
facilities
and
equipment.
Residual
chlorine
levels
in
the
water
shall
not
exceed
the
maximum
residual
disinfectant
limit
under
the
Safe
Drinking
Water
Act
(
i)
Calcium
hypochlorite
(
ii)
Chlorine
dioxide
(
iii)
Sodium
hypochlorite
432
(
4)
Chlorohexidine
­
Allowed
for
surgical
procedures
conducted
by
a
veterinarian.

Allowed
for
use
as
a
teat
dip
when
alternative
germicidal
agents
and/
or
physical
barriers
have
lost
their
effectiveness
(
5)
Electrolytes
­
without
antibiotics
(
6)
Glucose
(
7)
Glycerin
­
Allowed
as
a
livestock
teat
dip,
must
be
produced
through
the
hydrolysis
of
fats
or
oils
(
8)
Iodine
(
9)
Hydrogen
peroxide
(
10)
Magnesium
sulfate
(
11)
Oxytocin
­
use
in
postparturition
therapeutic
applications
(
12)
Parasiticides
Ivermectin
­
prohibited
in
slaughter
stock,
allowed
in
emergency
treatment
for
dairy
and
breeder
stock
when
organic
system
plan­
approved
preventive
management
does
not
prevent
infestation.
Milk
or
milk
products
from
a
treated
animal
cannot
be
labeled
as
provided
for
in
subpart
D
of
this
part
for
90
days
following
treatment.
In
breeder
stock,
treatment
cannot
occur
during
the
last
third
of
gestation
if
the
progeny
will
be
sold
as
organic
and
must
not
be
used
during
the
lactation
period
of
breeding
stock.

(
13)
Phosphoric
acid
­
allowed
as
an
equipment
cleaner,
Provided,
That,
no
direct
contact
with
organically
managed
livestock
or
land
occurs.

(
14)
Biologics
Vaccines
433
(
b)
As
topical
treatment,
external
parasiticide
or
local
anesthetic
as
applicable.

(
1)
Iodine
(
2)
Lidocaine
­
as
a
local
anesthetic.
Use
requires
a
withdrawal
period
of
90
days
after
administering
to
livestock
intended
for
slaughter
and
7
days
after
administering
to
dairy
animals
(
3)
Lime,
hydrated
­
(
bordeaux
mixes),
not
permitted
to
cauterize
physical
alterations
or
deodorize
animal
wastes.

(
4)
Mineral
oil
­
for
topical
use
and
as
a
lubricant
(
5)
Procaine
­
as
a
local
anesthetic,
use
requires
a
withdrawal
period
of
90
days
after
administering
to
livestock
intended
for
slaughter
and
7
days
after
administering
to
dairy
animals
(
6)
Copper
sulfate
(
c)
As
feed
supplements
Milk
replacers
­
without
antibiotics,
as
emergency
use
only,
no
nonmilk
products
or
products
from
BST
treated
animals
(
d)
As
feed
additives
(
1)
Trace
minerals,
used
for
enrichment
or
fortification
when
FDA
approved,
including:

(
i)
Copper
sulfate
(
ii)
Magnesium
sulfate
(
2)
Vitamins,
used
for
enrichment
or
fortification
when
FDA
approved
(
e)
As
synthetic
inert
ingredients
as
classified
by
the
Environmental
Protection
Agency
(
EPA),
for
use
with
nonsynthetic
substances
or
a
synthetic
substances
listed
in
this
section
and
used
as
an
active
pesticide
ingredient
in
accordance
with
any
limitations
on
the
use
of
such
substances.
434
EPA
List
4
­
Inerts
of
Minimal
Concern.

(
f)­(
z)
[
Reserved]

§
205.604
Nonsynthetic
substances
prohibited
for
use
in
organic
livestock
production.

The
following
nonsynthetic
substances
may
not
be
used
in
organic
livestock
production:

(
a)
Strychnine
(
b)­(
z)
[
Reserved]

§
205.605
Nonagricultural
(
nonorganic)
substances
allowed
as
ingredients
in
or
on
processed
products
labeled
as
"
organic"
or
"
made
with
organic
(
specified
ingredients
or
food
group(
s))."

The
following
nonagricultural
substances
may
be
used
as
ingredients
in
or
on
processed
products
labeled
as
"
organic"
or
"
made
with
organic
(
specified
ingredients
or
food
group(
s))"

only
in
accordance
with
any
restrictions
specified
in
this
section.

(
a)
Nonsynthetics
allowed:

(
1)
Acids
(
i)
Alginic
(
ii)
Citric
­
produced
by
microbial
fermentation
of
carbohydrate
substances
(
iii)
Lactic
(
2)
Bentonite
(
3)
Calcium
carbonate
(
4)
Calcium
chloride
(
5)
Colors,
nonsynthetic
sources
only
(
6)
Dairy
cultures
435
(
7)
Diatomaceous
earth
­
food
filtering
aid
only
(
8)
Enzymes
­
must
be
derived
from
edible,
nontoxic
plants,
nonpathogenic
fungi,
or
nonpathogenic
bacteria
(
9)
Flavors,
nonsynthetic
sources
only
and
must
not
be
produced
using
synthetic
solvents
and
carrier
systems
or
any
artificial
preservative.

(
10)
Kaolin
(
11)
Magnesium
sulfate,
nonsynthetic
sources
only
(
12)
Nitrogen
­
oil­
free
grades
(
13)
Oxygen
­
oil­
free
grades
(
14)
Perlite
­
for
use
only
as
a
filter
aid
in
food
processing
(
15)
Potassium
chloride
(
16)
Potassium
iodide
(
17)
Sodium
bicarbonate
(
18)
Sodium
carbonate
(
19)
Waxes
­
nonsynthetic
(
i)
Carnauba
wax
(
ii)
Wood
resin
(
20)
Yeast
­
nonsynthetic,
growth
on
petrochemical
substrate
and
sulfite
waste
liquor
is
prohibited
(
i)
Autolysate
(
ii)
Bakers
(
iii)
Brewers
436
(
iv)
Nutritional
(
v)
Smoked
­
nonsynthetic
smoke
flavoring
process
must
be
documented.

(
b)
Synthetics
allowed:

(
1)
Alginates
(
2)
Ammonium
bicarbonate
­
for
use
only
as
a
leavening
agent
(
3)
Ammonium
carbonate
­
for
use
only
as
a
leavening
agent
(
4)
Ascorbic
acid
(
5)
Calcium
citrate
(
6)
Calcium
hydroxide
(
7)
Calcium
phosphates
(
monobasic,
dibasic,
and
tribasic)

(
8)
Carbon
dioxide
(
9)
Chlorine
materials
­
disinfecting
and
sanitizing
food
contact
surfaces,
Except,
That,

residual
chlorine
levels
in
the
water
shall
not
exceed
the
maximum
residual
disinfectant
limit
under
the
Safe
Drinking
Water
Act.

(
i)
Calcium
hypochlorite
(
ii)
Chlorine
dioxide
(
iii)
Sodium
hypochlorite
(
10)
Ethylene
­
allowed
for
postharvest
ripening
of
tropical
fruit
(
11)
Ferrous
sulfate
­
for
iron
enrichment
or
fortification
of
foods
when
required
by
regulation
or
recommended
(
independent
organization)

(
12)
Glycerides
(
mono
and
di)
­
for
use
only
in
drum
drying
of
food
(
13)
Glycerin
­
produced
by
hydrolysis
of
fats
and
oils
437
(
14)
Hydrogen
peroxide
(
15)
Lecithin
­
bleached
(
16)
Magnesium
carbonate
­
for
use
only
in
agricultural
products
labeled
"
made
with
organic
(
specified
ingredients
or
food
group(
s)),"
prohibited
in
agricultural
products
labeled
"
organic"

(
17)
Magnesium
chloride
­
derived
from
sea
water
(
18)
Magnesium
stearate
­
for
use
only
in
agricultural
products
labeled
"
made
with
organic
(
specified
ingredients
or
food
group(
s)),"
prohibited
in
agricultural
products
labeled
"
organic"

(
19)
Nutrient
vitamins
and
minerals,
in
accordance
with
21
CFR
104.20,
Nutritional
Quality
Guidelines
For
Foods
(
20)
Ozone
(
21)
Pectin
(
low­
methoxy)

(
22)
Phosphoric
acid
­
cleaning
of
food­
contact
surfaces
and
equipment
only
(
23)
Potassium
acid
tartrate
(
24)
Potassium
tartrate
made
from
tartaric
acid
(
25)
Potassium
carbonate
(
26)
Potassium
citrate
(
27)
Potassium
hydroxide
­
prohibited
for
use
in
lye
peeling
of
fruits
and
vegetables
(
28)
Potassium
iodide
­
for
use
only
in
agricultural
products
labeled
"
made
with
organic
(
specified
ingredients
or
food
group(
s)),"
prohibited
in
agricultural
products
labeled
"
organic"

(
29)
Potassium
phosphate
­
for
use
only
in
agricultural
products
labeled
"
made
with
438
organic
(
specific
ingredients
or
food
group(
s)),"
prohibited
in
agricultural
products
labeled
"
organic"

(
30)
Silicon
dioxide
(
31)
Sodium
citrate
(
32)
Sodium
hydroxide
­
prohibited
for
use
in
lye
peeling
of
fruits
and
vegetables
(
33)
Sodium
phosphates
­
for
use
only
in
dairy
foods
(
34)
Sulfur
dioxide
­
for
use
only
in
wine
labeled
"
made
with
organic
grapes,"
Provided,

That,
total
sulfite
concentration
does
not
exceed
100
ppm.

(
35)
Tocopherols
­
derived
from
vegetable
oil
when
rosemary
extracts
are
not
a
suitable
alternative
(
36)
Xanthan
gum
(
c)­(
z)
[
Reserved]

§
205.606
Nonorganically
produced
agricultural
products
allowed
as
ingredients
in
or
on
processed
products
labeled
as
organic
or
made
with
organic
ingredients.

The
following
nonorganically
produced
agricultural
products
may
be
used
as
ingredients
in
or
on
processed
products
labeled
as
"
organic"
or
"
made
with
organic
(
specified
ingredients
or
food
group(
s))"
only
in
accordance
with
any
restrictions
specified
in
this
section.

Any
nonorganically
produced
agricultural
product
may
be
used
in
accordance
with
the
restrictions
specified
in
this
section
and
when
the
product
is
not
commercially
available
in
organic
form.

(
a)
Cornstarch
(
native)

(
b)
Gums
­
water
extracted
only
(
arabic,
guar,
locust
bean,
carob
bean)
439
(
c)
Kelp
­
for
use
only
as
a
thickener
and
dietary
supplement
(
d)
Lecithin
­
unbleached
(
e)
Pectin
(
high­
methoxy)

§
205.607
Amending
the
National
List.

(
a)
Any
person
may
petition
the
National
Organic
Standard
Board
for
the
purpose
of
having
a
substance
evaluated
by
the
Board
for
recommendation
to
the
Secretary
for
inclusion
on
or
deletion
from
the
National
List
in
accordance
with
the
Act.

(
b)
A
person
petitioning
for
amendment
of
the
National
List
should
request
a
copy
of
the
petition
procedures
from
the
USDA
at
the
address
in
§
205.607(
c).

(
c)
A
petition
to
amend
the
National
List
must
be
submitted
to:
Program
Manager,

USDA/
AMS/
TMP/
NOP,
Room
2945,
South
Building,
P.
O.
Box
96456,
Washington,
DC
20090­

6456.

State
Organic
Programs
§
205.620
Requirements
of
State
organic
programs.

(
a)
A
State
may
establish
a
State
organic
program
for
production
and
handling
operations
within
the
State
which
produce
and
handle
organic
agricultural
products.

(
b)
A
State
organic
program
must
meet
the
requirements
for
organic
programs
specified
in
the
Act.

(
c)
A
State
organic
program
may
contain
more
restrictive
requirements
because
of
environmental
conditions
or
the
necessity
of
specific
production
or
handling
practices
particular
to
the
State
or
region
of
the
United
States.

(
d)
A
State
organic
program
must
assume
enforcement
obligations
in
the
State
for
the
440
requirements
of
this
part
and
any
more
restrictive
requirements
approved
by
the
Secretary.

(
e)
A
State
organic
program
and
any
amendments
to
such
program
must
be
approved
by
the
Secretary
prior
to
being
implemented
by
the
State.

§
205.621
Submission
and
determination
of
proposed
State
organic
programs
and
amendments
to
approved
State
organic
programs.

(
a)
A
State
organic
program's
governing
State
official
must
submit
to
the
Secretary
a
proposed
State
organic
program
and
any
proposed
amendments
to
such
approved
program.

(
1)
Such
submission
must
contain
supporting
materials
that
include
statutory
authorities,

program
description,
documentation
of
the
environmental
conditions
or
specific
production
and
handling
practices
particular
to
the
State
which
necessitate
more
restrictive
requirements
than
the
requirements
of
this
part,
and
other
information
as
may
be
required
by
the
Secretary.

(
2)
Submission
of
a
request
for
amendment
of
an
approved
State
organic
program
must
contain
supporting
materials
that
include
an
explanation
and
documentation
of
the
environmental
conditions
or
specific
production
and
handling
practices
particular
to
the
State
or
region,
which
necessitates
the
proposed
amendment.
Supporting
material
also
must
explain
how
the
proposed
amendment
furthers
and
is
consistent
with
the
purposes
of
the
Act
and
the
regulations
of
this
part.

(
b)
Within
6
months
of
receipt
of
submission,
the
Secretary
will:
Notify
the
State
organic
program's
governing
State
official
of
approval
or
disapproval
of
the
proposed
program
or
amendment
of
an
approved
program
and,
if
disapproved,
the
reasons
for
the
disapproval.

(
c)
After
receipt
of
a
notice
of
disapproval,
the
State
organic
program's
governing
State
official
may
submit
a
revised
State
organic
program
or
amendment
of
such
a
program
at
any
time.

§
205.622
Review
of
approved
State
organic
programs.
441
The
Secretary
will
review
a
State
organic
program
not
less
than
once
during
each
5­
year
period
following
the
date
of
the
initial
program
approval.
The
Secretary
will
notify
the
State
organic
program's
governing
State
official
of
approval
or
disapproval
of
the
program
within
6
months
after
initiation
of
the
review.

Fees
§
205.640
Fees
and
other
charges
for
accreditation.

Fees
and
other
charges
equal
as
nearly
as
may
be
to
the
cost
of
the
accreditation
services
rendered
under
the
regulations,
including
initial
accreditation,
review
of
annual
reports,
and
renewal
of
accreditation,
shall
be
assessed
and
collected
from
applicants
for
initial
accreditation
and
accredited
certifying
agents
submitting
annual
reports
or
seeking
renewal
of
accreditation
in
accordance
with
the
following
provisions:

(
a)
Fees­
for­
Service.
(
1)
Except
as
otherwise
provided
in
this
section,
fees­
for­
service
shall
be
based
on
the
time
required
to
render
the
service
provided
calculated
to
the
nearest
15­

minute
period,
including
the
review
of
applications
and
accompanying
documents
and
information,
evaluator
travel,
the
conduct
of
on­
site
evaluations,
review
of
annual
reports
and
updated
documents
and
information,
and
the
time
required
to
prepare
reports
and
any
other
documents
in
connection
with
the
performance
of
service.
The
hourly
rate
shall
be
the
same
as
that
charged
by
the
Agricultural
Marketing
Service,
through
its
Quality
Systems
Certification
Program,
to
certification
bodies
requesting
conformity
assessment
to
the
International
Organization
for
Standardization
"
General
Requirements
for
Bodies
Operating
Product
Certification
Systems"
(
ISO
Guide
65).

(
2)
Applicants
for
initial
accreditation
and
accredited
certifying
agents
submitting
annual
442
reports
or
seeking
renewal
of
accreditation
during
the
first
18
months
following
the
effective
date
of
subpart
F
of
this
part
shall
receive
service
without
incurring
an
hourly
charge
for
service.

(
3)
Applicants
for
initial
accreditation
and
renewal
of
accreditation
must
pay
at
the
time
of
application,
effective
18
months
following
the
effective
date
of
subpart
F
of
this
part,
a
nonrefundable
fee
of
$
500.00
which
shall
be
applied
to
the
applicant's
fees­
for­
service
account.

(
b)
Travel
charges.
When
service
is
requested
at
a
place
so
distant
from
the
evaluator's
headquarters
that
a
total
of
one­
half
hour
or
more
is
required
for
the
evaluator(
s)
to
travel
to
such
place
and
back
to
the
headquarters
or
at
a
place
of
prior
assignment
on
circuitous
routing
requiring
a
total
of
one­
half
hour
or
more
to
travel
to
the
next
place
of
assignment
on
the
circuitous
routing,
the
charge
for
such
service
shall
include
a
mileage
charge
administratively
determined
by
the
U.
S.
Department
of
Agriculture
and
travel
tolls,
if
applicable,
or
such
travel
prorated
among
all
the
applicants
and
certifying
agents
furnished
the
service
involved
on
an
equitable
basis
or,
when
the
travel
is
made
by
public
transportation
(
including
hired
vehicles),
a
fee
equal
to
the
actual
cost
thereof.
Travel
charges
shall
become
effective
for
all
applicants
for
initial
accreditation
and
accredited
certifying
agents
on
the
effective
date
of
subpart
F
of
this
part.

The
applicant
or
certifying
agent
will
not
be
charged
a
new
mileage
rate
without
notification
before
the
service
is
rendered.

(
c)
Per
diem
charges.
When
service
is
requested
at
a
place
away
from
the
evaluator's
headquarters,
the
fee
for
such
service
shall
include
a
per
diem
charge
if
the
employee(
s)

performing
the
service
is
paid
per
diem
in
accordance
with
existing
travel
regulations.
Per
diem
charges
to
applicants
and
certifying
agents
will
cover
the
same
period
of
time
for
which
the
evaluator(
s)
receives
per
diem
reimbursement.
The
per
diem
rate
will
be
administratively
443
determined
by
the
U.
S.
Department
of
Agriculture.
Per
diem
charges
shall
become
effective
for
all
applicants
for
initial
accreditation
and
accredited
certifying
agents
on
the
effective
date
of
subpart
F
of
this
part.
The
applicant
or
certifying
agent
will
not
be
charged
a
new
per
diem
rate
without
notification
before
the
service
is
rendered.

(
d)
Other
costs.
When
costs,
other
than
costs
specified
in
paragraphs
(
a),
(
b),
and
(
c)
of
this
section,
are
associated
with
providing
the
services,
the
applicant
or
certifying
agent
will
be
charged
for
these
costs.
Such
costs
include
but
are
not
limited
to
equipment
rental,

photocopying,
delivery,
facsimile,
telephone,
or
translation
charges
incurred
in
association
with
accreditation
services.
The
amount
of
the
costs
charged
will
be
determined
administratively
by
the
U.
S.
Department
of
Agriculture.
Such
costs
shall
become
effective
for
all
applicants
for
initial
accreditation
and
accredited
certifying
agents
on
the
effective
date
of
subpart
F
of
this
part.

§
205.641
Payment
of
fees
and
other
charges.

(
a)
Applicants
for
initial
accreditation
and
renewal
of
accreditation
must
remit
the
nonrefundable
fee,
pursuant
to
§
205.640(
a)(
3),
along
with
their
application.
Remittance
must
be
made
payable
to
the
Agricultural
Marketing
Service,
USDA,
and
mailed
to:
Program
Manager,

USDA­
AMS­
TMP­
NOP,
Room
2945­
South
Building,
P.
O.
Box
96456,
Washington,
DC
20090­

6456
or
such
other
address
as
required
by
the
Program
Manager.

(
b)
Payments
for
fees
and
other
charges
not
covered
under
paragraph
(
a)
of
this
section
must
be:

(
1)
Received
by
the
due
date
shown
on
the
bill
for
collection;

(
2)
Made
payable
to
the
Agricultural
Marketing
Service,
USDA;
and
(
3)
Mailed
to
the
address
provided
on
the
bill
for
collection.
444
(
c)
The
Administrator
shall
assess
interest,
penalties,
and
administrative
costs
on
debts
not
paid
by
the
due
date
shown
on
a
bill
for
collection
and
collect
delinquent
debts
or
refer
such
debts
to
the
Department
of
Justice
for
litigation.

§
205.642
Fees
and
other
charges
for
certification.

Fees
charged
by
a
certifying
agent
must
be
reasonable,
and
a
certifying
agent
shall
charge
applicants
for
certification
and
certified
production
and
handling
operations
only
those
fees
and
charges
that
it
has
filed
with
the
Administrator.
The
certifying
agent
shall
provide
each
applicant
with
an
estimate
of
the
total
cost
of
certification
and
an
estimate
of
the
annual
cost
of
updating
the
certification.
The
certifying
agent
may
require
applicants
for
certification
to
pay
at
the
time
of
application
a
nonrefundable
fee
which
shall
be
applied
to
the
applicant's
fees­
for­
service
account.

The
certifying
agent
may
set
the
nonrefundable
portion
of
certification
fees;
however,
the
nonrefundable
portion
of
certification
fees
must
be
explained
in
the
fee
schedule
submitted
to
the
Administrator.
The
fee
schedule
must
explain
what
fee
amounts
are
nonrefundable
and
at
what
stage
during
the
certification
process
fees
become
nonrefundable.
The
certifying
agent
shall
provide
all
persons
inquiring
about
the
application
process
with
a
copy
of
its
fee
schedule.

§
§
205.643­
205.659
[
Reserved]

Compliance
§
205.660
General.

(
a)
The
National
Organic
Program's
Program
Manager,
on
behalf
of
the
Secretary,
may
inspect
and
review
certified
production
and
handling
operations
and
accredited
certifying
agents
for
compliance
with
the
Act
or
regulations
in
this
part.

(
b)
The
Program
Manager
may
initiate
suspension
or
revocation
proceedings
against
a
445
certified
operation:

(
1)
When
the
Program
Manager
has
reason
to
believe
that
a
certified
operation
has
violated
or
is
not
in
compliance
with
the
Act
or
regulations
in
this
part;
or
(
2)
When
a
certifying
agent
or
a
State
organic
program's
governing
State
official
fails
to
take
appropriate
action
to
enforce
the
Act
or
regulations
in
this
part.

(
c)
The
Program
Manager
may
initiate
suspension
or
revocation
of
a
certifying
agent's
accreditation
if
the
certifying
agent
fails
to
meet,
conduct,
or
maintain
accreditation
requirements
pursuant
to
the
Act
or
this
part.

(
d)
Each
notification
of
noncompliance,
rejection
of
mediation,
noncompliance
resolution,

proposed
suspension
or
revocation,
and
suspension
or
revocation
issued
pursuant
to
§
205.662,
§
205.663,
and
§
205.665
and
each
response
to
such
notification
must
be
sent
to
the
recipient's
place
of
business
via
a
delivery
service
which
provides
dated
return
receipts.

§
205.661
Investigation
of
certified
operations.

(
a)
A
certifying
agent
may
investigate
complaints
of
noncompliance
with
the
Act
or
regulations
of
this
part
concerning
production
and
handling
operations
certified
as
organic
by
the
certifying
agent.
A
certifying
agent
must
notify
the
Program
Manager
of
all
compliance
proceedings
and
actions
taken
pursuant
to
this
part.

(
b)
A
State
organic
program's
governing
State
official
may
investigate
complaints
of
noncompliance
with
the
Act
or
regulations
in
this
part
concerning
organic
production
or
handling
operations
operating
in
the
State.

§
205.662
Noncompliance
procedure
for
certified
operations.

(
a)
Notification.
When
an
inspection,
review,
or
investigation
of
a
certified
operation
by
446
a
certifying
agent
or
a
State
organic
program's
governing
State
official
reveals
any
noncompliance
with
the
Act
or
regulations
in
this
part,
a
written
notification
of
noncompliance
shall
be
sent
to
the
certified
operation.
Such
notification
shall
provide:

(
1)
A
description
of
each
noncompliance;

(
2)
The
facts
upon
which
the
notification
of
noncompliance
is
based;
and
(
3)
The
date
by
which
the
certified
operation
must
rebut
or
correct
each
noncompliance
and
submit
supporting
documentation
of
each
such
correction
when
correction
is
possible.

(
b)
Resolution.
When
a
certified
operation
demonstrates
that
each
noncompliance
has
been
resolved,
the
certifying
agent
or
the
State
organic
program's
governing
State
official,
as
applicable,
shall
send
the
certified
operation
a
written
notification
of
noncompliance
resolution.

(
c)
Proposed
suspension
or
revocation.
When
rebuttal
is
unsuccessful
or
correction
of
the
noncompliance
is
not
completed
within
the
prescribed
time
period,
the
certifying
agent
or
State
organic
program's
governing
State
official
shall
send
the
certified
operation
a
written
notification
of
proposed
suspension
or
revocation
of
certification
of
the
entire
operation
or
a
portion
of
the
operation,
as
applicable
to
the
noncompliance.
When
correction
of
a
noncompliance
is
not
possible,
the
notification
of
noncompliance
and
the
proposed
suspension
or
revocation
of
certification
may
be
combined
in
one
notification.
The
notification
of
proposed
suspension
or
revocation
of
certification
shall
state:

(
1)
The
reasons
for
the
proposed
suspension
or
revocation;

(
2)
The
proposed
effective
date
of
such
suspension
or
revocation;

(
3)
The
impact
of
a
suspension
or
revocation
on
future
eligibility
for
certification;
and
(
4)
The
right
to
request
mediation
pursuant
to
§
205.663
or
to
file
an
appeal
pursuant
to
447
§
205.681.

(
d)
Willful
violations.
Notwithstanding
paragraph
(
a)
of
this
section,
if
a
certifying
agent
or
State
organic
program's
governing
State
official
has
reason
to
believe
that
a
certified
operation
has
willfully
violated
the
Act
or
regulations
in
this
part,
the
certifying
agent
or
State
organic
program's
governing
State
official
shall
send
the
certified
operation
a
notification
of
proposed
suspension
or
revocation
of
certification
of
the
entire
operation
or
a
portion
of
the
operation,
as
applicable
to
the
noncompliance.

(
e)
Suspension
or
revocation.
(
1)
If
the
certified
operation
fails
to
correct
the
noncompliance,
to
resolve
the
issue
through
rebuttal
or
mediation,
or
to
file
an
appeal
of
the
proposed
suspension
or
revocation
of
certification,
the
certifying
agent
or
State
organic
program's
governing
State
official
shall
send
the
certified
operation
a
written
notification
of
suspension
or
revocation.

(
2)
A
certifying
agent
or
State
organic
program's
governing
State
official
must
not
send
a
notification
of
suspension
or
revocation
to
a
certified
operation
that
has
requested
mediation
pursuant
to
§
205.663
or
filed
an
appeal
pursuant
to
§
205.681,
while
final
resolution
of
either
is
pending.

(
f)
Eligibility.
(
1)
A
certified
operation
whose
certification
has
been
suspended
under
this
section
may
at
any
time,
unless
otherwise
stated
in
the
notification
of
suspension,
submit
a
request
to
the
Secretary
for
reinstatement
of
its
certification.
The
request
must
be
accompanied
by
evidence
demonstrating
correction
of
each
noncompliance
and
corrective
actions
taken
to
comply
with
and
remain
in
compliance
with
the
Act
and
the
regulations
in
this
part.

(
2)
A
certified
operation
or
a
person
responsibly
connected
with
an
operation
whose
448
certification
has
been
revoked
will
be
ineligible
to
receive
certification
for
a
period
of
5
years
following
the
date
of
such
revocation,
Except,
That,
the
Secretary
may,
when
in
the
best
interest
of
the
certification
program,
reduce
or
eliminate
the
period
of
ineligibility.

(
g)
Violations
of
Act.
In
addition
to
suspension
or
revocation,
any
certified
operation
that:

(
1)
Knowingly
sells
or
labels
a
product
as
organic,
except
in
accordance
with
the
Act,

shall
be
subject
to
a
civil
penalty
of
not
more
than
$
10,000
per
violation.

(
2)
Makes
a
false
statement
under
the
Act
to
the
Secretary,
a
State
organic
program's
governing
State
official,
or
a
certifying
agent
shall
be
subject
to
the
provisions
of
section
1001
of
title
18,
United
States
Code.

§
205.663
Mediation.

Any
dispute
with
respect
to
denial
of
certification
or
proposed
suspension
or
revocation
of
certification
under
this
part
may
be
mediated
at
the
request
of
the
applicant
for
certification
or
certified
operation
and
with
acceptance
by
the
certifying
agent.
Mediation
shall
be
requested
in
writing
to
the
applicable
certifying
agent.
If
the
certifying
agent
rejects
the
request
for
mediation,

the
certifying
agent
shall
provide
written
notification
to
the
applicant
for
certification
or
certified
operation.
The
written
notification
shall
advise
the
applicant
for
certification
or
certified
operation
of
the
right
to
request
an
appeal,
pursuant
to
§
205.681,
within
30
days
of
the
date
of
the
written
notification
of
rejection
of
the
request
for
mediation.
If
mediation
is
accepted
by
the
certifying
agent,
such
mediation
shall
be
conducted
by
a
qualified
mediator
mutually
agreed
upon
by
the
parties
to
the
mediation.
If
a
State
organic
program
is
in
effect,
the
mediation
procedures
established
in
the
State
organic
program,
as
approved
by
the
Secretary,
will
be
followed.
The
449
parties
to
the
mediation
shall
have
no
more
than
30
days
to
reach
an
agreement
following
a
mediation
session.
If
mediation
is
unsuccessful,
the
applicant
for
certification
or
certified
operation
shall
have
30
days
from
termination
of
mediation
to
appeal
the
certifying
agent's
decision
pursuant
to
§
205.681.
Any
agreement
reached
during
or
as
a
result
of
the
mediation
process
shall
be
in
compliance
with
the
Act
and
these
regulations.
The
Secretary
may
review
any
mediated
agreement
for
conformity
to
the
Act
and
these
regulations
and
may
reject
any
agreement
or
provision
not
in
conformance
with
the
Act
or
these
regulations.

§
205.664
[
Reserved]

§
205.665
Noncompliance
procedure
for
certifying
agents.

(
a)
Notification.
When
an
inspection,
review,
or
investigation
of
an
accredited
certifying
agent
by
the
Program
Manager
reveals
any
noncompliance
with
the
Act
or
regulations
in
this
part,

a
written
notification
of
noncompliance
shall
be
sent
to
the
certifying
agent.
Such
notification
shall
provide:

(
1)
A
description
of
each
noncompliance;

(
2)
The
facts
upon
which
the
notification
of
noncompliance
is
based;
and
(
3)
The
date
by
which
the
certifying
agent
must
rebut
or
correct
each
noncompliance
and
submit
supporting
documentation
of
each
correction
when
correction
is
possible.

(
b)
Resolution.
When
the
certifying
agent
demonstrates
that
each
noncompliance
has
been
resolved,
the
Program
Manager
shall
send
the
certifying
agent
a
written
notification
of
noncompliance
resolution.

(
c)
Proposed
suspension
or
revocation.
When
rebuttal
is
unsuccessful
or
correction
of
the
noncompliance
is
not
completed
within
the
prescribed
time
period,
the
Program
Manager
shall
450
send
a
written
notification
of
proposed
suspension
or
revocation
of
accreditation
to
the
certifying
agent.
The
notification
of
proposed
suspension
or
revocation
shall
state
whether
the
certifying
agent's
accreditation
or
specified
areas
of
accreditation
are
to
be
suspended
or
revoked.
When
correction
of
a
noncompliance
is
not
possible,
the
notification
of
noncompliance
and
the
proposed
suspension
or
revocation
may
be
combined
in
one
notification.
The
notification
of
proposed
suspension
or
revocation
of
accreditation
shall
state:

(
1)
The
reasons
for
the
proposed
suspension
or
revocation;

(
2)
The
proposed
effective
date
of
the
suspension
or
revocation;

(
3)
The
impact
of
a
suspension
or
revocation
on
future
eligibility
for
accreditation;
and
(
4)
The
right
to
file
an
appeal
pursuant
to
§
205.681.

(
d)
Willful
violations.
Notwithstanding
paragraph
(
a)
of
this
section,
if
the
Program
Manager
has
reason
to
believe
that
a
certifying
agent
has
willfully
violated
the
Act
or
regulations
in
this
part,
the
Program
Manager
shall
send
a
written
notification
of
proposed
suspension
or
revocation
of
accreditation
to
the
certifying
agent.

(
e)
Suspension
or
revocation.
When
the
accredited
certifying
agent
fails
to
file
an
appeal
of
the
proposed
suspension
or
revocation
of
accreditation,
the
Program
Manager
shall
send
a
written
notice
of
suspension
or
revocation
of
accreditation
to
the
certifying
agent.

(
f)
Cessation
of
certification
activities.
A
certifying
agent
whose
accreditation
is
suspended
or
revoked
must:

(
1)
Cease
all
certification
activities
in
each
area
of
accreditation
and
in
each
State
for
which
its
accreditation
is
suspended
or
revoked.

(
2)
Transfer
to
the
Secretary
and
make
available
to
any
applicable
State
organic
451
program's
governing
State
official
all
records
concerning
its
certification
activities
that
were
suspended
or
revoked.

(
g)
Eligibility.
(
1)
A
certifying
agent
whose
accreditation
is
suspended
by
the
Secretary
under
this
section
may
at
any
time,
unless
otherwise
stated
in
the
notification
of
suspension,

submit
a
request
to
the
Secretary
for
reinstatement
of
its
accreditation.
The
request
must
be
accompanied
by
evidence
demonstrating
correction
of
each
noncompliance
and
corrective
actions
taken
to
comply
with
and
remain
in
compliance
with
the
Act
and
the
regulations
in
this
part.

(
2)
A
certifying
agent
whose
accreditation
is
revoked
by
the
Secretary
shall
be
ineligible
to
be
accredited
as
a
certifying
agent
under
the
Act
and
the
regulations
in
this
part
for
a
period
of
not
less
than
3
years
following
the
date
of
such
revocation.

§
§
205.666
and
205.667
[
Reserved]

§
205.668
Noncompliance
procedures
under
State
organic
programs.

(
a)
A
State
organic
program's
governing
State
official
must
promptly
notify
the
Secretary
of
commencement
of
any
noncompliance
proceeding
against
a
certified
operation
and
forward
to
the
Secretary
a
copy
of
each
notice
issued.

(
b)
A
noncompliance
proceeding,
brought
by
a
State
organic
program's
governing
State
official
against
a
certified
operation,
shall
be
appealable
pursuant
to
the
appeal
procedures
of
the
State
organic
program.
There
shall
be
no
subsequent
rights
of
appeal
to
the
Secretary.
Final
decisions
of
a
State
may
be
appealed
to
the
United
States
District
Court
for
the
district
in
which
such
certified
operation
is
located.

(
c)
A
State
organic
program's
governing
State
official
may
review
and
investigate
complaints
of
noncompliance
with
the
Act
or
regulations
concerning
accreditation
of
certifying
452
agents
operating
in
the
State.
When
such
review
or
investigation
reveals
any
noncompliance,
the
State
organic
program's
governing
State
official
shall
send
a
written
report
of
noncompliance
to
the
Program
Manager.
The
report
shall
provide
a
description
of
each
noncompliance
and
the
facts
upon
which
the
noncompliance
is
based.

§
205.669
[
Reserved]

Inspection
and
Testing,
Reporting,
and
Exclusion
from
Sale
§
205.670
Inspection
and
testing
of
agricultural
product
to
be
sold
or
labeled
"
organic."

(
a)
All
agricultural
products
that
are
to
be
sold,
labeled,
or
represented
as
"
100
percent
organic,"
"
organic,"
or
"
made
with
organic
(
specified
ingredients
or
food
group(
s))"
must
be
made
accessible
by
certified
organic
production
or
handling
operations
for
examination
by
the
Administrator,
the
applicable
State
organic
program's
governing
State
official,
or
the
certifying
agent.

(
b)
The
Administrator,
applicable
State
organic
program's
governing
State
official,
or
the
certifying
agent
may
require
preharvest
or
postharvest
testing
of
any
agricultural
input
used
or
agricultural
product
to
be
sold,
labeled,
or
represented
as
"
100
percent
organic,"
"
organic,"
or
"
made
with
organic
(
specified
ingredients
or
food
group(
s))"
when
there
is
reason
to
believe
that
the
agricultural
input
or
product
has
come
into
contact
with
a
prohibited
substance
or
has
been
produced
using
excluded
methods.
Such
tests
must
be
conducted
by
the
applicable
State
organic
program's
governing
State
official
or
the
certifying
agent
at
the
official's
or
certifying
agent's
own
expense.

(
c)
The
preharvest
or
postharvest
tissue
test
sample
collection
pursuant
to
paragraph
(
b)

of
this
section
must
be
performed
by
an
inspector
representing
the
Administrator,
applicable
State
453
organic
program's
governing
State
official,
or
certifying
agent.
Sample
integrity
must
be
maintained
throughout
the
chain
of
custody,
and
residue
testing
must
be
performed
in
an
accredited
laboratory.
Chemical
analysis
must
be
made
in
accordance
with
the
methods
described
in
the
most
current
edition
of
the
Official
Methods
of
Analysis
of
the
AOAC
International
or
other
current
applicable
validated
methodology
determining
the
presence
of
contaminants
in
agricultural
products.

(
d)
Results
of
all
analyses
and
tests
performed
under
this
section:
(
1)
Must
be
promptly
provided
to
the
Administrator;
Except,
That,
where
a
State
organic
program
exists,
all
test
results
and
analyses
shall
be
provided
to
the
State
organic
program's
governing
State
official
by
the
applicable
certifying
party
that
requested
testing;
and
(
2)
Will
be
available
for
public
access,
unless
the
testing
is
part
of
an
ongoing
compliance
investigation.

(
e)
If
test
results
indicate
a
specific
agricultural
product
contains
pesticide
residues
or
environmental
contaminants
that
exceed
the
Food
and
Drug
Administration's
or
the
Environmental
Protection
Agency's
regulatory
tolerences,
the
certifying
agent
must
promptly
report
such
data
to
the
Federal
health
agency
whose
regulatory
tolerance
or
action
level
has
been
exceeded.

§
205.671
Exclusion
from
organic
sale.

When
residue
testing
detects
prohibited
substances
at
levels
that
are
greater
than
5
percent
of
the
Environmental
Protection
Agency's
tolerance
for
the
specific
residue
detected
or
unavoidable
residual
environmental
contamination,
the
agricultural
product
must
not
be
sold,

labeled,
or
represented
as
organically
produced.
The
Administrator,
the
applicable
State
organic
454
program's
governing
State
official,
or
the
certifying
agent
may
conduct
an
investigation
of
the
certified
operation
to
determine
the
cause
of
the
prohibited
substance.

§
205.672
Emergency
pest
or
disease
treatment.

When
a
prohibited
substance
is
applied
to
a
certified
operation
due
to
a
Federal
or
State
emergency
pest
or
disease
treatment
program
and
the
certified
operation
otherwise
meets
the
requirements
of
this
part,
the
certification
status
of
the
operation
shall
not
be
affected
as
a
result
of
the
application
of
the
prohibited
substance:
Provided,
That:

(
a)
Any
harvested
crop
or
plant
part
to
be
harvested
that
has
contact
with
a
prohibited
substance
applied
as
the
result
of
a
Federal
or
State
emergency
pest
or
disease
treatment
program
cannot
be
sold,
labeled,
or
represented
as
organically
produced;
and
(
b)
Any
livestock
that
are
treated
with
a
prohibited
substance
applied
as
the
result
of
a
Federal
or
State
emergency
pest
or
disease
treatment
program
or
product
derived
from
such
treated
livestock
cannot
be
sold,
labeled,
or
represented
as
organically
produced:
Except,
That:

(
1)
Milk
or
milk
products
may
be
sold,
labeled,
or
represented
as
organically
produced
beginning
12
months
following
the
last
date
that
the
dairy
animal
was
treated
with
the
prohibited
substance;
and
(
2)
The
offspring
of
gestating
mammalian
breeder
stock
treated
with
a
prohibited
substance
may
be
considered
organic:
Provided,
That,
the
breeder
stock
was
not
in
the
last
third
of
gestation
on
the
date
that
the
breeder
stock
was
treated
with
the
prohibited
substance.

§
§
205.673­
205.679
[
Reserved]

Adverse
Action
Appeal
Process
§
205.680
General.
455
(
a)
Persons
subject
to
the
Act
who
believe
they
are
adversely
affected
by
a
noncompliance
decision
of
the
National
Organic
Program's
Program
Manager
may
appeal
such
decision
to
the
Administrator.

(
b)
Persons
subject
to
the
Act
who
believe
that
they
are
adversely
affected
by
a
noncompliance
decision
of
a
State
organic
program
may
appeal
such
decision
to
the
State
organic
program's
governing
State
official
who
will
initiate
handling
of
the
appeal
pursuant
to
appeal
procedures
approved
by
the
Secretary.

(
c)
Persons
subject
to
the
Act
who
believe
that
they
are
adversely
affected
by
a
noncompliance
decision
of
a
certifying
agent
may
appeal
such
decision
to
the
Administrator,

Except,
That,
when
the
person
is
subject
to
an
approved
State
organic
program,
the
appeal
must
be
made
to
the
State
organic
program.

(
d)
All
written
communications
between
parties
involved
in
appeal
proceedings
must
be
sent
to
the
recipient's
place
of
business
by
a
delivery
service
which
provides
dated
return
receipts.

(
e)
All
appeals
shall
be
reviewed,
heard,
and
decided
by
persons
not
involved
with
the
decision
being
appealed.

§
205.681
Appeals.

(
a)
Certification
appeals.
An
applicant
for
certification
may
appeal
a
certifying
agent's
notice
of
denial
of
certification,
and
a
certified
operation
may
appeal
a
certifying
agent's
notification
of
proposed
suspension
or
revocation
of
certification
to
the
Administrator,
Except,

That,
when
the
applicant
or
certified
operation
is
subject
to
an
approved
State
organic
program
the
appeal
must
be
made
to
the
State
organic
program
which
will
carry
out
the
appeal
pursuant
to
the
State
organic
program's
appeal
procedures
approved
by
the
Secretary.
456
(
1)
If
the
Administrator
or
State
organic
program
sustains
a
certification
applicant's
or
certified
operation's
appeal
of
a
certifying
agent's
decision,
the
applicant
will
be
issued
organic
certification,
or
a
certified
operation
will
continue
its
certification,
as
applicable
to
the
operation.

The
act
of
sustaining
the
appeal
shall
not
be
an
adverse
action
subject
to
appeal
by
the
affected
certifying
agent.

(
2)
If
the
Administrator
or
State
organic
program
denies
an
appeal,
a
formal
administrative
proceeding
will
be
initiated
to
deny,
suspend,
or
revoke
the
certification.
Such
proceeding
shall
be
conducted
pursuant
to
the
U.
S.
Department
of
Agriculture's
Uniform
Rules
of
Practice
or
the
State
organic
program's
rules
of
procedure.

(
b)
Accreditation
appeals.
An
applicant
for
accreditation
and
an
accredited
certifying
agent
may
appeal
the
Program
Manager's
denial
of
accreditation
or
proposed
suspension
or
revocation
of
accreditation
to
the
Administrator.

(
1)
If
the
Administrator
sustains
an
appeal,
an
applicant
will
be
issued
accreditation,
or
a
certifying
agent
will
continue
its
accreditation,
as
applicable
to
the
operation.

(
2)
If
the
Administrator
denies
an
appeal,
a
formal
administrative
proceeding
to
deny,

suspend,
or
revoke
the
accreditation
will
be
initiated.
Such
proceeding
shall
be
conducted
pursuant
to
the
U.
S.
Department
of
Agriculture's
Uniform
Rules
of
Practice,
7
CFR
Part
1,

Subpart
H.

(
c)
Filing
period.
An
appeal
of
a
noncompliance
decision
must
be
filed
within
the
time
period
provided
in
the
letter
of
notification
or
within
30
days
from
receipt
of
the
notification,

whichever
occurs
later.
The
appeal
will
be
considered
"
filed"
on
the
date
received
by
the
Administrator
or
by
the
State
organic
program.
A
decision
to
deny,
suspend,
or
revoke
461
certification
or
accreditation
will
become
final
and
nonappealable
unless
the
decision
is
appealed
in
a
timely
manner.

(
d)
Where
and
what
to
file.
(
1)
Appeals
to
the
Administrator
must
be
filed
in
writing
and
addressed
to
Administrator,
USDA­
AMS,
Room
3071­
S,
P.
O.
Box
96456,
Washington,
DC
20090­
6456.

(
2)
Appeals
to
the
State
organic
program
must
be
filed
in
writing
to
the
address
and
person
identified
in
the
letter
of
notification.

(
3)
All
appeals
must
include
a
copy
of
the
adverse
decision
and
a
statement
of
the
appellant's
reasons
for
believing
that
the
decision
was
not
proper
or
made
in
accordance
with
applicable
program
regulations,
policies,
or
procedures.

§
§
205.682­
205.689
[
Reserved]

Miscellaneous
§
205.690
OMB
control
number.

The
control
number
assigned
to
the
information
collection
requirements
in
this
part
by
the
Office
of
Management
and
Budget
pursuant
to
the
Paperwork
Reduction
Act
of
1995,
44
U.
S
C.

Chapter
35,
is
OMB
number
0581­
0181.

§
§
205.691­
205.699
[
Reserved]

PARTS
206­
209
[
Reserved]

Dated:
December
13,
2000
Kathleen
A.
Merrigan
Administrator
Agricultural
Marketing
Service
Appendixes
to
Preamble
462
Appendix
A.­­
Regulatory
Impact
Assessment
for
Final
Rule
Implementing
the
Organic
Foods
Production
Act
of
1990
The
following
regulatory
assessment
is
provided
to
fulfill
the
requirements
of
Executive
Order
12866.
This
assessment
consists
of
a
statement
of
the
need
for
national
organic
standards,

a
description
of
the
baseline
for
the
analysis,
a
summary
of
the
provisions
of
the
final
U.
S.

Department
of
Agriculture
(
USDA)
rule
and
the
alternative
approaches
that
were
examined,
and
an
analysis
of
the
benefits
and
costs.
Much
of
the
analysis
is
necessarily
descriptive
of
the
anticipated
effects
of
the
final
rule.
Because
basic
market
data
on
the
prices
and
quantities
of
organic
goods
and
the
costs
of
organic
production
are
limited,
it
is
not
possible
to
provide
quantitative
estimates
of
all
benefits
and
costs
of
the
final
rule.
The
cost
of
fees
and
recordkeeping
in
the
final
USDA
rule
are
quantified,
but
the
anticipated
benefits
and
other
costs
are
not.
Consequently,
the
analysis
does
not
estimate
the
magnitude
or
the
direction
(
positive
or
negative)
of
net
benefits.

Under
the
final
rule,
USDA
will
implement
a
program
of
uniform
standards
of
production
and
certification,
as
mandated
by
the
Organic
Foods
Production
Act
of
1990
(
OFPA).
The
primary
benefits
from
implementation
of
USDA's
National
Organic
Program
(
NOP)
are
standardizing
the
definitions
and
the
manner
in
which
organic
product
information
is
presented
to
consumers,
which
may
reduce
the
cost
associated
with
enforcement
actions
in
consumer
fraud
cases,
and
improved
access
to
domestic
and
international
markets
from
harmonizing
the
various
State
and
private
organic
standards
and
elevating
reciprocity
negotiations
to
the
national
level.

The
costs
of
this
rule
are
the
direct
costs
for
accreditation
and
the
costs
of
complying
with
the
specific
standards
in
the
proposal,
including
the
reporting
and
recordkeeping
requirements.
463
Certifiers
will
be
charged
fees
based
on
the
actual
costs
of
the
accreditation
work
done
by
USDA
staff.
Smaller
certifiers
with
less
complex
programs
are
expected
to
pay
somewhat
lower
fees.

Organic
farmers,
ranchers,
wild­
crop
harvesters,
and
handlers
will
have
to
pay
fees
for
organic
certification
from
a
State
or
private
certifier
but
will
not
be
charged
any
additional
fees
by
USDA.

The
direct
accreditation
costs
to
an
estimated
59
certifying
agents
(
including
all
49
current
U.
S.

certifiers
and
an
estimated
10
foreign
agents)
during
the
first
18
months
following
the
final
rule
are
estimated
to
be
approximately
$
92,000
to
$
124,000
and
are
being
subsidized
with
appropriated
funds
derived
from
the
taxpayers.
In
addition,
USDA
will
use
appropriated
funds
to
cover
approximately
$
270,000­$
448,000
in
hourly
charges
for
site
evaluation
during
this
period
and
for
other
costs
associated
with
starting
up
the
NOP.
The
magnitude
of
other
compliance
costs
for
adhering
to
this
regulation
 
including
the
costs
of
becoming
familiar
with
and
adopting
the
national
standards
 
have
not
been
measured.
For
organic
farmers
who
adhere
to
State
regulations
or
undergo
third­
party
inspection
and
certification,
the
compliance
cost
may
not
be
large.
For
those
who
don't,
the
costs
may
be
more
substantial.
The
impact
of
this
regulation
on
small
certifying
agents
and
other
small
businesses
has
also
not
been
measured
but
may
be
significant.

To
account
for
significant
rule
changes
from
the
proposal
and
to
reflect
more
up­
to­
date
information,
we
revised
some
estimates
of
benefits
and
costs.
We
have
raised
our
estimates
of
current
certification
fees
and
USDA
accreditation
fees.
Also,
we
now
project
higher
USDA
accreditation
fees
after
the
18­
month
implementation
period.
We
revised
our
estimates
of
the
certification
fees
charged
by
a
representative
set
of
public
and
private
certifiers
in
the
U.
S.
based
on
new
data,
and
our
new
estimates
are
about
25
percent
higher
for
small
and
midsized
farmers.
464
Small
and
midsized
farmers
are
now
estimated
to
pay
$
579
and
$
1,414
for
their
first­
year
certification,
respectively.
Accreditation
costs
after
the
18­
month
implementation
period
are
substantially
above
those
estimated
in
the
proposed
rule,
reflecting
a
slight
increase
in
the
government
per
diem
travel
allowance
since
the
proposed
rule
was
published
and
a
change
in
the
projected
number
of
reviewers
needed
for
site
evaluations
and
renewals
after
the
18­
month
implementation
period.
In
the
proposed
rule,
USDA
had
projected
that
only
one
reviewer
would
be
needed
for
site
evaluations
and
renewals
that
took
place
after
the
18­
month
implementation
period
but
has
changed
that
projection
to
two
reviewers
based
on
additional
experience
with
the
International
Organization
for
Standardization
(
ISO
Guide
65)
program.
We
estimate
that
initial
accreditation
costs
after
the
18­
month
implementation
period
will
range
from
$
6,120
to
$
9,700,

approximately
double
our
estimate
in
the
March
2000
proposed
rule.

Marginal
changes
have
been
made
in
the
final
rule,
in
response
to
comments
on
the
March
2000
proposal,
which
generally
clarify
or
add
flexibility
to
producer
and
handler
provisions
or
make
them
better
reflect
current
industry
standards.
One
key
change
was
to
raise
the
threshold
for
labeling
products
as
"
made
with
organic
ingredients"
from
50
percent
organic
content
to
70
percent
to
be
consistent
with
international
industry
standards.
Although
not
quantified,
we
believe
that
this
will
increase
the
cost
of
the
rule.
Another
key
change
was
to
reduce
the
transition
period
for
a
dairy
operation
to
make
a
whole­
herd
conversion
to
organic
production
in
order
to
make
conversion
affordable
for
a
wider
range
of
dairy
farms,
including
smaller
operations.
Although
not
quantified,
we
believe
that
this
will
decrease
the
cost
of
the
rule.

The
Need
for
National
Standards
465
Over
the
last
several
decades,
as
market
demand
has
grown
from
a
handful
of
consumers
bargaining
directly
with
farmers
to
millions
of
consumers
acquiring
goods
from
supermarket
shelves
as
well
as
market
stalls,
a
patchwork
of
State
and
private
institutions
has
evolved
to
set
standards
and
verify
label
claims.
Organically
produced
food
cannot
be
distinguished
visually
from
conventional
food
and
cannot
necessarily
be
distinguished
by
taste;
therefore,
consumers
must
rely
on
labels
and
other
advertising
tools
for
product
information.
Farmers,
food
handlers,

and
other
businesses
that
produce
and
handle
organically
grown
food
have
a
financial
incentive
to
advertise
that
information
because
consumers
have
been
willing
to
pay
a
price
premium
for
these
goods.
However,
consumers
face
difficulties
in
discerning
the
organic
attributes
of
a
product,
and
many
producers
and
handlers
have
sought
third­
party
certification
of
organic
claims.

State
and
private
initiatives
have
resulted
in
a
fairly
robust
system
of
standards
and
certification,
and
the
difficulties
in
consumer
verification
have
been
partially
overcome
by
these
initiatives.
Private
organizations,
mostly
nonprofits,
began
developing
certification
standards
in
the
early
1970'
s
as
a
way
to
support
organic
farming,
as
well
as
to
strengthen
legitimate
product
claims.
The
first
organization
to
offer
third­
party
certification,
California
Certified
Organic
Farmers,
was
formed
in
the
early
1970'
s,
and
the
first
State
regulations
and
laws
on
organic
labeling
were
also
passed
in
the
1970'
s.
Currently,
13
State
and
36
private
certification
programs
are
operating
in
the
United
States,
and
about
half
the
States
currently
have
some
form
of
regulation.
While
most
States
still
do
not
mandate
third­
party
certification
and
many
organic
producers
still
market
goods
without
certification,
large
food
processors,
grain
traders,
and
retailers
are
increasingly
requiring
certification,
and
many
growers
have
turned
to
certification
as
a
marketing
tool.
466
However,
even
with
increasing
pressure
for
growers
to
use
third­
party
certification
services
and
increasing
availability
of
these
services
from
State
and
private
certifiers,
the
discrepancies
between
the
certifiers
on
organic
standards
and
between
the
States
on
certification
requirements
have
resulted
in
several
impediments
to
market
development.
The
patchwork
of
variable
standards
has
made
producer
access
to
organic
markets,
international
and
domestic,

uneven.
The
recent
emergence
of
the
industry­
developed
standards
may
have
mitigated
some
domestic
access
problems,
but
two
important
impediments
remain.
They
are:
multiingredient
certification
disputes
and
barriers
to
foreign
markets.

Difficulty
Certifying
Multiingredient
Products
Although
the
State
and
private
organic
standards
that
have
developed
over
the
last
several
decades
have
many
areas
of
overlap,
particularly
for
crop
production,
the
differences
have
caused
disagreements
among
certifying
agents
over
whose
standards
apply
to
multiingredient
organic
processed
products.
These
disagreements
have
created
sourcing
problems
for
food.

Disagreements
about
standards
also
create
sourcing
problems
for
handlers
of
these
multiingredient
products.
Certifying
agents
are
able
to
negotiate
and
maintain
reciprocity
agreements
at
some
cost.
These
reciprocity
agreements
specify
the
conditions
under
which
certifying
agents
recognize
each
other's
standards.
Although
new
organic
product
offerings
have
emerged
at
a
fast
pace
during
the
1990'
s,
this
pace
could
eventually
slow,
assuming
that
the
need
for
costly
reciprocity
agreements
will
continue
to
persist
in
the
absence
of
national
standards.

Barriers
to
Foreign
Organic
Markets
In
the
absence
of
a
national
standard,
U.
S.
producers
have
taken
on
costs
of
private
accreditation
or
shipment­
by­
shipment
certification
required
to
gain
access
to
some
foreign
467
markets
such
as
the
European
Union
(
EU).
However,
even
with
these
actions,
U.
S.
organic
products
may
have
had
some
difficulties
entering
other
foreign
markets
due
to
high
information
and
search
costs
on
the
part
of
foreign
buyers.
Some
foreign
buyers
of
U.
S.
organic
products
may
incur
costs
to
determine
the
compatibility
of
standards.
Such
costs
may
have
discouraged
purchases
of
U.
S.
organic
products.

Congress
passed
the
OFPA
 
Title
XXI
of
the
Food,
Agriculture,
Conservation
and
Trade
Act
of
1990,
U.
S.
C.
Title
7
 
largely
to
address
these
marketing
problems.
The
OFPA
mandates
that
the
Secretary
of
Agriculture
develop
a
national
organic
program,
and
USDA's
statutory
responsibility
is
the
primary
reason
why
USDA
has
carried
out
this
rulemaking
process.
The
OFPA
requires
the
Secretary
to
establish
an
organic
certification
program
for
farmers,
wild­
crop
harvesters,
and
handlers
of
agricultural
products
that
have
been
produced
using
organic
methods
as
provided
for
in
the
OFPA.
This
legislation
requires
the
Secretary
to
establish
and
implement
a
program
to
accredit
a
State
program
official
or
any
private
person
who
meets
the
requirements
of
the
Act
as
a
certifying
agent
to
certify
that
farm,
wild­
crop
harvesting,
or
handling
operations
are
in
compliance
with
the
standards
set
out
in
the
regulation.
As
stated
by
the
OFPA
in
section
6501,
the
regulations
are
for
the
following
purposes:
(
1)
to
establish
national
standards
governing
the
marketing
of
certain
agricultural
products
as
organically
produced
products,
(
2)
to
assure
consumers
that
organically
produced
products
meet
a
consistent
standard,
and
(
3)
to
facilitate
interstate
commerce
in
fresh
and
processed
food
that
is
organically
produced.

Baseline
After
struggling
to
build
market
recognition
and
supply
capacity
for
many
decades,
the
organic
farming
industry
became
one
the
fastest
growing
segments
of
U.
S.
agriculture
during
the
468
last
decade.
Certified
organic
cropland
more
than
doubled
in
the
United
States
between
1992
and
1997,
and
two
organic
livestock
sectors
 
eggs
and
dairy
 
grew
even
faster
(
Greene,
2000a).

USDA's
Economic
Research
Service
estimates
that
over
1.3
million
acres
of
U.
S.
farmland
were
certified
in
1997,
and
more
recent
data
from
some
of
the
certifiers
indicate
that
this
momentum
is
continuing
(
Greene,
2000b).
Although
national
estimates
of
the
amount
of
uncertified
organic
acreage
are
not
available,
data
from
California,
the
largest
U.
S.
producer
of
organic
specialty
crops,
indicates
that
most
of
the
State's
organic
acreage
and
about
half
of
the
growers
were
certified
during
the
1997/
98
crop
year
(
Klonsky
et
al.,
2000).

Growth
in
U.
S.
sales
of
organic
products
during
the
1990'
s
mirrors
the
growth
in
acreage
devoted
to
producing
these
goods.
According
to
industry
data,
total
organic
product
sales
more
than
doubled
between
1992
and
1996
to
$
3.5
billion
in
sales
(
table
1).
More
recent
industry
data
on
organic
sales
through
natural
product
stores,
the
largest
outlet
for
organic
products,
show
annual
sales
growth
continuing
in
the
general
range
of
20­
25
percent
annually.

The
recent
growth
in
organic
production
and
sales
has
taken
place
in
the
absence
of
national
organic
standards
but
with
industry
expectation
that
these
standards
were
forthcoming.

While
the
U.
S.
organic
industry
is
characterized
by
an
array
of
certification,
production,

processing,
and
marketing
practices,
there
are
commonalities
throughout
the
industry.

Certification
The
number
of
U.
S.
certification
groups
has
fluctuated
between
40
and
50
during
the
last
decade.
Currently,
49
organizations
 
36
private
and
13
State
 
are
advertising
that
they
provide
certification
services
to
farmers,
handlers
(
a
category
that
USDA
defines
to
include
processors),

retailers,
or
other
segments
of
the
food
industry.
Some
certifiers
provide
services
to
multiple
469
segments
of
the
food
industry.
Private
certifying
agents
range
from
small
nonprofit
associations
that
certify
only
a
few
growers
to
large
for­
profit
businesses
operating
in
numerous
States
and
certifying
hundreds
of
producers.
Typically,
certifying
agents
review
organic
production
plans,

inspect
the
farm
fields
and
facilities
to
be
certified,
periodically
reinspect,
and
may
conduct
soil
tests
and
tests
for
residues
of
prohibited
substances.
In
some
cases,
certifying
agents
negotiate
reciprocity
agreements
with
other
agents.

State
laws
vary
widely
on
organic
certification
and
registration.
Some
States,
such
as
California,
require
only
that
an
organic
producer
register
and
make
certification
voluntary.
Other
States,
including
Texas,
require
certification
by
the
State's
own
agents,
while
Minnesota
and
others
accept
certification
by
a
private
certifying
agent.
Approximately
half
of
the
States
have
laws
that
regulate
organic
production
and
processing.
In
many
States
producers
may
claim
their
product
is
organic
but
operate
without
certification
or
well­
defined
standards.
Many
organic
producers
in
States
with
no
State
programs
voluntarily
secure
third­
party
certification
to
welldefined
standards.
Certification
costs
vary
with
farm
size
and
across
certifying
agents.
Illustrative
certification
costs
are
presented
in
tables
2A
and
2B.

Very
few
certifying
agents
operate
with
an
external
accreditation
for
the
following
reasons.
There
is
no
law
which
requires
them
to
be
accredited:
the
price
may
be
unacceptably
high
in
relation
to
expected
benefits;
the
certifying
agent
may
be
unable
to
find
an
accrediting
party
willing
to
accredit
the
particular
organic
program
the
certifying
agent
is
marketing;
and
State
programs
may
believe
that
their
status
as
a
government
entity
obviates
the
need
for
external
accreditation.

In
1999,
USDA
began
accrediting
certifying
agents
as
meeting
ISO
Guide
65.
It
is
a
470
valuable
recognition
that
the
certifying
entity
satisfies
the
business
capacity
standards
of
ISO
Guide
65.
EU
authorities
have
accepted
verification
of
certifying
agents
to
ISO
Guide
65
as
an
interim
measure
to
facilitate
exports
pending
the
establishment
of
a
national
organic
program.

Organic
Crop
and
Livestock
Production
In
1997,
farmers
in
49
States
used
organic
production
systems
and
third­
party
organic
certification
services
on
over
a
million
acres
of
farmland
and
were
raising
certified
organic
livestock
production
in
nearly
half
the
States,
according
to
USDA
data
(
Greene,
2000a).

Twothirds
of
the
farmland
was
used
for
growing
crops,
with
Idaho,
California,
North
Dakota,

Montana,
Minnesota,
Wisconsin,
Iowa,
and
Florida
as
the
top
producers.
Colorado
and
Alaska
had
the
most
organic
pasture
and
rangeland.
California
overwhelmingly
had
the
most
certified
organic
fruit
and
vegetable
acreage
in
1997,
but
farmers
were
growing
small
plots
of
certified
organic
vegetables
for
direct
marketing
to
consumers
in
over
half
the
States.
About
2
percent
of
the
U.
S.
apple,
grape,
lettuce,
and
carrot
crops
were
certified
organic
in
1997,
while
only
onetenth
of
1
percent
of
the
U.
S.
corn
and
soybean
crops
were
grown
under
certified
organic
farming
systems.
USDA
has
not
estimated
the
amount
of
acreage
devoted
to
organic
production
systems
that
has
not
been
certified,
although
data
from
California
suggest
that
a
large
number
of
farmers,

mostly
those
with
small
operations,
produce
and
market
organic
goods
without
third­
party
certification.

Key
production
practices
followed
by
certified
organic
producers
include:
abstaining
from
use
of
certain
crop
chemicals
and
animal
drugs;
ecologically
based
pest
and
nutrient
management;

segregation
of
organic
fields
and
animals
from
nonorganic
fields
and
animals;
following
an
organic
system
plan
with
multiple
goals,
including
sustainability;
and
recordkeeping
to
document
practices
471
and
progress
toward
the
plan's
goals.
Specific
elements
of
organic
production
vary,
but
organic
systems
generally
share
a
core
set
of
practices.
For
example,
the
certification
standards
of
virtually
all
State
and
private
U.
S.
certifying
agents
prohibit
the
use
of
synthetic
chemical
pesticides
or
animal
growth
hormones.
And
most
certification
standards
include
a
3­
year
ban
on
the
use
of
prohibited
substances
on
cropland
before
production
can
be
certified
as
organic.

On
the
other
hand,
certification
standards
for
organic
livestock
production
have
been
more
variable
for
pasture,
feed,
and
other
practices.
Until
1999,
the
USDA
Food
Safety
and
Inspection
Service
(
FSIS)
withheld
approval
for
the
use
of
organic
labels
on
meat
and
poultry
products
pending
the
outcome
of
this
rulemaking.
However,
the
Secretary
announced
a
change
in
policy
in
January
1999.
Meat
and
poultry
products
may
be
labeled
"
certified
organic
by
(
name
of
the
certifying
agent)"
if
handlers
obtain
prior
label
approval
from
FSIS
and
the
claim
meets
certain
basic
criteria.
Organic
labels
have
been
permitted
on
eggs
and
dairy
products
 
which
are
regulated
by
the
Food
and
Drug
Administration
(
FDA)
 
throughout
the
1990'
s,
but
most
certifiers
have
not
yet
offered
certification
services
for
these
products.

We
provide
a
summary
of
the
New
Hampshire
organic
program
to
highlight
the
similarities
in
the
core
set
of
practices.
It
is
important
to
note
that
this
discussion
is
intended
to
highlight
the
conceptual
similarities
between
State
and
private
programs
and
is
not
intended
to
suggest
that
these
programs
are
identical
to
each
other
or
to
the
NOP.
Production
standards
include:
a
written
rotation
plan;
tillage
systems
that
incorporate
organic
matter
wastes
into
the
topsoil;
compliance
with
limits
on
the
sources
of
manure
and
the
timing
of
its
application;

prohibitions
on
the
use
of
certain
substances
(
e.
g.,
sewage
sludge,
synthetic
sources
of
nitrates,

synthetic
growth
regulators,
and
anhydrous
ammonia);
a
list
of
accepted
and
prohibited
weed
and
472
pest
control
practices;
segregation
of
organic
and
nonorganic
production;
recordkeeping
regarding
fertilization,
cropping,
and
pest
management
histories;
separate
sales
records
for
organic
and
nonorganic
production;
and
records
of
all
laboratory
analyses.
Residue
testing
may
be
required
if
USDA
believes
that
the
products
or
soil
used
for
producing
certified
products
may
have
become
contaminated
with
prohibited
substances.

The
New
Hampshire
program
requires
growers
to
pay
a
$
100
annual
inspection
fee
and
to
provide
a
written
description
of
their
farm
operation,
including
the
size
of
the
farm;
a
field
map;
a
3­
year
history
of
crop
production,
pest
control,
and
fertilizer
use;
a
crop
rotation
and
a
soil
management
plan;
and
a
description
of
postharvest
storage
and
handling
methods.
Applicants
for
certification
must
also
agree
to
comply
with
regulations
controlling
the
use
of
the
New
Hampshire
certified
organic
logo.

Organic
Food
Handling
In
addition
to
growers,
who
actually
produce
and
harvest
products
to
be
marketed
as
organic,
there
are
handlers
who
transform
and
resell
the
organic
products.
Not
all
certifiers
have
standards
for
handling
organic
products.
And
some
certifiers
have
standards
for
parts
of
the
food
marketing
system,
such
as
restaurants,
which
are
not
explicitly
covered
by
the
OFPA
nor
encompassed
by
this
final
regulation.

Definitions
of
processing
and
handling
differ
across
certifying
agents
and
State
laws.

Some
States,
such
as
Washington,
distinguish
between
a
processor
and
a
handler,
specifying
21
actions
which
constitute
processing
and
defining
a
handler
as
anyone
who
sells,
distributes,
or
packs
organic
products.
Other
States
do
not
distinguish
between
food
processors
and
handlers.

Under
the
final
rule,
the
term,
"
handler,"
includes
processors
but
not
final
retailers
of
agricultural
473
products
that
do
not
process
agricultural
products.

Organic
Product
Marketing
The
two
largest
marketing
outlets
for
organically
produced
goods
are
natural
foods
stores
and
direct
markets
 
which
include
farmers
markets,
roadside
stands,
and
`
community
supported
agriculture'
arrangements
 
according
to
industry
data.
USDA
does
not
have
official
national
level
statistics
on
organic
retail
sales,
but
an
industry
trade
publication,
the
Natural
Foods
Merchandiser
(
NFM),
reported
estimates
of
total
retail
sales
of
organic
foods
for
years
1990­
96
and
continues
to
report
estimates
of
natural
product
stores
sales
(
table
1).
The
last
NFM
estimate
of
total
organic
sales
through
all
marketing
outlets
was
$
3.5
billion
in
1996
($
3.7
billion
in
1999
dollars),
less
than
one
percent
of
total
food
expenditures
by
families
and
individuals
that
year.

Natural
foods
stores
increased
in
size
and
presence
in
the
United
States
during
the
1990'
s
 
many
are
now
the
size
of
conventional
supermarkets
 
and
about
two­
thirds
of
estimated
total
organic
sales
during
the
1990'
s
were
through
this
outlet
(
table
1).
Natural
foods
supermarkets,
which
are
similar
to
conventional
in
the
breadth
of
supermarket
offerings
and
amount
of
total
sales,
accounted
for
close
to
1
percent
of
total
supermarket
sales
by
1997
(
Kaufman
1998).
Organic
product
sales
through
the
natural
foods
stores
outlet,
alone,
in
1999
were
estimated
at
$
4
billion,
and
sales
through
this
outlet
increased
about
20­
25
percent
annually
through
the
1990'
s.

Direct­
to­
consumer
market
sales
ranged
from
$
270
to
$
390
million
during
the
early
1990'
s,
accounting
for
between
17
and
22
percent
of
total
organic
sales
during
this
period,

according
to
NFM
estimates
(
table
1).
Conventional
food
stores
(
mass
markets)
accounted
for
6­

7
percent
of
total
sales
during
this
period,
and
export
sales
accounted
for
3­
8
percent
of
the
total.
474
A
draft
report
on
the
U.
S.
organic
export
market,
partly
funded
by
USDA,
indicates
that
current
U.
S.
export
sales
are
under
5
percent
of
total
organic
product
sales
(
Fuchshofen
and
Fuchshofen
2000).

The
United
States
is
both
an
importer
and
an
exporter
of
organic
foods.
The
United
States
does
not
restrict
imports
of
organic
foods.
In
fact,
U.
S.
Customs
accounts
do
not
distinguish
between
organic
and
conventional
products.
The
largest
markets
for
organic
foods
outside
the
United
States
are
in
Europe,
Japan,
and
Canada.
There
is
increasing
pressure,

particularly
in
Europe
and
Japan,
for
U.
S.
exports
to
demonstrate
that
they
meet
a
national
standard
rather
than
a
variety
of
private
and
State
standards.
France,
for
example,
has
indicated
to
USDA
that
it
prefers
to
negotiate
with
a
single
national
organic
program,
rather
than
the
dozens
of
different
State
and
private
certifying
programs
currently
operating
in
the
U.
S.

The
EU
is
the
largest
market
for
organic
food
outside
the
United
States.
The
organic
food
market
in
the
EU
was
estimated
to
be
worth
$
5.2
billion
in
1997
(
International
Trade
Centre
UNCTAD/
WTO
1999).
The
largest
organic
retail
sales
markets
in
the
EU
in
1997
were
Germany
($
1.8
billion),
France
($
720
million),
and
Italy
($
750
million).
Large
organic
markets
outside
the
EU
include
Canada
and
Australia,
with
approximately
$
60
million
and
$
68
million,
respectively,
in
organic
retail
sales
in
1997
(
Lohr
1998).
Import
share
of
the
organic
food
market
in
Europe
ranged
from
10
percent
in
France
to
70
percent
in
the
United
Kingdom,
was
80
percent
in
Canada,
and
varied
from
0
to
13
percent
in
various
Australian
States.

Japan
is
another
important
market
for
U.
S.
organic
products.
Currently,
Japan
has
voluntary
labeling
guidelines
for
6
categories
of
nonconventional
agricultural
products:
organic,

transitional
organic,
no
pesticide,
reduced
pesticide,
no
chemical
fertilizer,
and
reduced
chemical
475
fertilizer.
Total
sales,
including
foods
marketed
as
"
no
chemical"
and
"
reduced
chemical,"
are
forecast
to
jump
15
percent
in
1999
to
almost
$
3
billion.
Imports
of
organic
agricultural
products
were
valued
at
$
90
million
in
1998.
Given
Japan's
limited
agricultural
acreage,
imports
will
likely
provide
an
increasingly
significant
share
of
Japan's
organic
food
supply
(
USDA
FAS
1999a).

Recently,
these
markets
have
adopted
or
are
considering
adoption
of
procedures
that
may
impede
the
importing
of
organic
food.
The
EU
regulations
establishing
the
basis
for
equivalency
in
organic
production
among
EU
members
and
for
imports
from
outside
the
EU
were
adopted
in
1991
(
Council
Regulation
2092/
91).
The
EU
regulations
only
allow
imports
from
non­
EU
countries
whose
national
standards
have
been
recognized
as
equivalent
to
the
EU
standards
(
Commission
Regulation
94/
92).

The
Ministry
of
Agriculture,
Forestry,
and
Fisheries
(
MAFF)
in
Japan
recently
announced
proposed
standards
and
third­
party
certification
requirements.
Under
Japan's
proposed
standards,

certifying
agents
from
countries
without
national
organic
standards
administered
by
a
federal
government
will
face
additional
financial
and
administrative
costs.

Requirements
of
the
Final
Rule
The
final
rule
follows
the
structure
established
in
the
OFPA.
By
adopting
this
alternative,

the
Department
is
following
the
legislative
direction
in
the
OFPA.
All
products
marketed
as
organic
will
have
to
be
produced
and
handled
as
provided
in
the
OFPA
and
these
regulations.

Compared
to
current
organic
practices,
the
final
rule
sets
a
somewhat
more
stringent
system
of
requirements.

Among
many
alternatives,
two
alternatives
to
the
final
rule
are
discussed
in
this
section:

continuation
of
the
status
quo
and
use
of
industry­
developed
standards.
Given
the
statutory
476
responsibility,
USDA
is
implementing
the
requirements
of
the
OFPA.
However,
under
the
status
quo
alternative,
there
would
be
no
national
standard
or
national
program
of
accreditation
and
certification.
No
Federal
funds
would
be
used,
there
would
be
no
transfer
from
Federal
taxpayers
at
large
to
organic
market
participants,
and
there
would
be
no
Federal
regulatory
barriers
to
entry
into
organic
production
and
handling.
However,
growers
and
handlers
would
still
not
have
level
access,
under
uniform
standards,
to
the
domestic
market,
and
there
may
be
significant
enforcement
gaps
at
the
State
level.
International
pressure
for
additional
verification
would
continue
to
build
and
would
be
likely
to
lead
to
an
increased
use
of
public
and
private
verification
and
accreditation
services,
which
are
provided
on
a
user­
fee
basis
with
full
cost
recovery.

Establishing
reciprocity
between
certifying
agents
in
the
domestic
organic
market
would
continue
to
be
costly
and
may
stifle
growth
in
trade
of
organic
products,
although
the
magnitude
of
these
costs
and
their
effects
on
growth
are
unknown.
Without
further
analysis
that
includes
quantification
and
monetization
of
benefits
and
costs,
it
is
not
clear
whether
the
net
benefits
associated
with
this
alternative
are
greater
or
less
than
those
associated
with
the
final
rule.

Under
the
other
industry­
developed
standards
alternative,
USDA
could
eliminate
the
costs
associated
with
establishing
reciprocity
in
the
domestic
market
and
establish
equivalency
for
access
to
international
markets,
but
it
would
be
difficult
for
industry
to
develop
consensus
standards.
For
example,
the
industry­
developed
standards
recently
proposed
by
the
Organic
Trade
Association
were
developed
with
significant
industry
input
but
with
little
public
comment.

In
contrast,
several
hundred
thousand
comments
have
been
submitted
in
the
course
of
the
USDA
rulemaking
process.
In
addition,
the
OFPA
mandated
an
advisory
role
for
a
15­
member
National
Organic
Standards
Board
(
NOSB),
which
has
wide
representation
from
the
organic
community
477
and
includes
members
who
are
farmers,
handlers,
retailers,
environmentalists,
consumers,

scientists,
and
certifiers.
The
NOSB
has
assisted
in
developing
the
standards
promulgated
in
this
final
rule
and
will
play
an
advisory
role
for
the
NOP
even
after
the
final
rule
is
in
place.
Without
further
analysis
that
includes
quantification
and
monetization
of
benefits
and
costs,
it
is
not
clear
whether
the
net
benefits
associated
with
this
alternative
are
greater
or
less
than
those
associated
with
the
final
rule.

USDA's
final
rule
will
be
implemented
by
the
NOP
staff
in
the
Agricultural
Marketing
Service
(
AMS).
Major
features
of
the
NOP
include:

Accreditation
and
Certification
The
rule
specifies
the
accreditation
and
certification
process.
Persons
providing
certification
services
for
organic
production
and
handling
must
be
accredited
by
USDA
through
the
NOP.
Applicants
for
accreditation
must
document
their
abilities
to
certify
according
to
the
national
standards
and
to
oversee
their
client's
compliance
with
the
requirements
of
the
OFPA
and
NOP
regulations.
Producers
and
handlers
of
organic
products
must
be
certified
by
an
accredited
certifying
agent.
Producers
and
handlers
are
required
to
document
their
organic
plans
and
procedures
to
ensure
compliance
with
the
OFPA.

All
certifying
agents
would
have
to
be
accredited,
and
certification
by
producers
and
handlers
would
be
mandatory.
The
exceptions
are:
(
1)
growers
and
handlers
with
gross
organic
sales
of
$
5,000
or
less
would
be
exempt
from
certification,
and
(
2)
a
handling
operation
may
be
exempt
or
excluded
from
certification
according
to
provisions
described
in
the
rule's
subpart
B,

Applicability.

USDA
will
charge
applicants
for
accreditation
and
accreditation
renewal
(
required
every
5
478
years)
a
$
500
fee
at
the
time
of
application.
USDA
will
also
charge
applicants
for
costs
over
$
500
for
site
evaluation
of
the
applicant's
business.
The
applicant
would
be
charged
for
travel
costs,
per
diem
expenses,
and
any
miscellaneous
costs
incurred
with
a
site
evaluation.
USDA
will
also
charge
accredited
certifiers
at
an
hourly
rate
to
review
their
annual
reports.

Producers
and
handlers
will
not
pay
certification
fees
to
USDA.
Certification
fees
will
be
established
by
the
accredited
certifying
agents.
USDA
will
not
set
fees.
The
rule
requires
certifying
agents
to
submit
a
copy
of
their
fee
schedules
to
USDA,
post
their
fees,
and
provide
applicants
estimates
of
the
costs
for
initial
certification
and
for
renewal
of
certification.

Production
and
Handling
The
rule
establishes
standards
for
organic
production
of
crops
and
livestock
and
handling
of
organic
products.
These
standards
were
developed
from
specific
requirements
in
the
OFPA,

recommendations
from
the
NOSB,
review
of
existing
organic
industry
practices
and
standards,

public
comments
received
on
the
1997
proposal
and
subsequent
issue
papers,
public
meetings,

and
comments
received
on
the
2000
proposal.

The
final
rule
establishes
a
number
of
requirements
for
producers
and
handlers
of
organic
food.
These
requirements
will
affect
farming
operations,
packaging
operations,
processing
operations
and
retailers.
Some
of
the
major
provisions
are:
(
1)
land
requirements,
(
2)
crop
nutrient
requirements,
(
3)
crop
rotation
requirements,
(
4)
pest
management
requirements,
(
5)

livestock
management
requirements,
(
6)
processing
and
handling
requirements,
and
(
7)

commingling
requirements.

National
List
The
National
List
lists
allowed
synthetic
substances
and
prohibited
nonsynthetic
479
substances
that
may
or
may
not
be
used
in
organic
production
and
handling
operations.
The
list
identifies
those
synthetic
substances,
which
would
otherwise
be
prohibited,
that
may
be
used
in
organic
production
based
on
the
recommendations
of
the
NOSB.
Only
those
synthetic
substances
on
the
National
List
may
be
used.
The
National
List
also
identifies
those
natural
substances
that
may
not
be
used
in
organic
production,
as
determined
by
the
Secretary
based
on
the
NOSB
recommendations.

Testing
When
certifying
agents
have
reason
to
believe
organic
products
contain
a
prohibited
substance,
they
may
conduct
residue
tests.

Labeling
The
rule
also
states
how
organic
products
may
be
labeled
and
permitted
uses
of
the
USDA
organic
seal.
In
addition
to
the
USDA
seal
and
the
certifying
agent's
seal,
information
on
organic
food
content
may
be
displayed.
Small
businesses
that
are
certified
may
use
the
USDA
seal.

Recordkeeping
The
rule
requires
certifying
agents,
producers,
and
handlers
to
keep
certain
records.

Certifying
agents
are
required
to
file
periodic
reports
with
USDA.
Producers
and
handlers
are
required
to
notify
and
submit
reports
to
their
certifying
agent.
While
recordkeeping
is
a
standard
practice
in
conventional
and
organic
farming,
the
final
rule
adds
recordkeeping
and
reporting
requirements
that
do
not
exist
for
growers
and
handlers
operating
without
certification.
Similarly,

certifying
agents
would
face
additional
recordkeeping
and
reporting
requirements,
particularly
those
certifying
agents
operating
without
external
accreditation.
The
rule
permits
certifying
agent
logos
and
requires
the
name
of
the
certifying
agent
on
processed
organic
foods.
480
Enforcement
Organic
operations
that
falsely
sell
or
label
a
product
as
organic
will
be
subject
to
civil
penalties
of
up
to
$
10,000
per
violation.
The
provisions
of
the
final
regulation
apply
to
all
persons
who
sell,
label,
or
represent
their
agricultural
product
as
organic,
including
operations
that
aren't
certified,
and
the
civil
penalties
of
up
to
$
10,000
apply
to
these
operations
as
well.

Certifying
agents,
State
organic
programs'
governing
State
officials,
and
USDA
will
receive
complaints
alleging
violations
of
the
Act
or
these
regulations.
In
States
where
there
is
no
State
organic
program,
USDA
will
investigate
allegations
of
violations
of
the
Act.

Number
of
Affected
Parties
and
Projections
In
assessing
the
impacts
of
the
rule,
we
have
attempted
to
determine
the
number
of
certifying
agents,
private
and
State,
that
are
currently
operating
and
considered
the
factors
likely
to
affect
the
number
of
certifying
agents
after
the
rule
is
implemented.
We
have
attempted
to
determine
the
number
of
currently
operating
producers
and
handlers
that
would
be
affected.
And,

we
have
considered
the
factors
that
might
affect
the
number
of
producers
and
handlers
after
the
program
has
been
implemented.

For
the
analysis,
USDA
assumes
the
following:

1.
Forty­
nine
domestic
certifying
agents
and
ten
foreign
certifying
agents
will
be
affected
by
the
regulation.

2.
Approximately
13,650
certified
and
noncertified
organic
producers
will
be
affected
by
the
regulation.
With
the
assumed
growth
rate
of
14
percent
for
certified
organic
producers
and
approximately
8
percent
for
noncertified
organic
producers,
the
number
of
organic
producers
will
grow
to
17,150
in
2002.
481
3.
Approximately
1,600
handlers
of
organic
food
will
be
affected
by
the
regulation.
This
number
will
grow
to
2,250
by
2002.

Certifying
Entities
We
place
the
number
of
certifying
agents
currently
operating
at
49,
including
13
State
programs.
The
number
of
certifying
agents
has
remained
fairly
stable,
between
40
and
50,
for
some
years,
with
entries
and
exits
tending
to
offset
each
other.
For
purposes
of
estimating
the
paperwork
burden
described
elsewhere,
we
assume
no
growth
in
the
number
of
domestic
certifying
agents
but
project
10
foreign
certifying
agents
will
seek
and
receive
USDA
accreditation
in
the
first
3
years
of
the
program.

Organic
Producers
While
some
USDA
data
on
the
number
of
certified
organic
producers
in
the
United
States
exist,
no
national
data
have
been
collected
on
the
number
of
producers
that
produce
and
market
organic
goods
without
third­
party
certification.
Organic
farming
was
not
distinguished
from
conventional
agriculture
in
the
last
Census
of
Agriculture
in
1997.
USDA
and
Organic
Farming
Research
Foundation
(
OFRF)
data
were
used
in
the
Regulatory
Impact
Analysis
(
RIA)
of
the
March
2000
proposed
rule
to
help
estimate
the
number
of
certified
U.
S.
growers
affected
by
the
regulation.
California
Department
of
Food
and
Agriculture
(
CDFA)
data
were
used
to
help
estimate
the
number
of
uncertified
U.
S.
growers
affected
by
the
regulation.
All
three
of
these
data
sources
have
updated
their
estimates
of
the
number
of
certified
and
uncertified
organic
producers
since
the
RIA
of
the
proposed
rule
was
published
earlier
this
year.
However,
the
updated
numbers
do
not
indicate
trends
that
would
fundamentally
alter
the
assumptions
used
in
the
RIA
of
the
proposed
rule
to
calculate
the
number
of
affected
growers,
and
the
estimates
made
482
for
the
March
2000
RIA
are
retained
in
this
assessment
of
the
final
rule.

USDA
datum
indicates
the
average
annual
growth
rate
in
the
number
of
U.
S.
certified
organic
growers
between
1991
and
1994
was
about
14
percent
(
Dunn
1995b).
In
April
2000,

USDA's
Economic
Research
Service
estimated
that
5,021
certified
organic
growers
operated
1.347
million
acres
of
U.
S.
farmland
in
1997,
indicating
that
the
increase
in
acreage
had
outpaced
the
increase
in
growers,
and
showing
only
an
8
percent
annual
growth
rate
in
growers
between
1994
and
1997
(
Greene,
2000b).
However,
USDA's
study
indicated
that
the
pace
of
growth
in
certified
acreage
had
quickened
considerably
since
1997,
with
the
amount
of
certified
acreage
increasing
38
to
150
percent
between
1997
and
1999
by
several
large
certifying
organizations
across
the
U.
S.
And
a
nonprofit
organic
research
foundation,
OFRF,
estimates
that
the
number
of
certified
organic
producers
in
the
certification
organizations
that
they
track
 
the
ones
that
will
release
data
to
them
 
grew
over
20
percent
annually
between
1997
and
1999,
from
4,638
to
6,600
(
OFRF
2000).
Also,
one
certifier,
Washington
State,
responded
to
our
request
for
data
on
the
growth
rate,
indicating
that
the
number
of
certified
organic
producers
has
increased
an
average
of
17
percent
per
year
between
1994
and
1999
in
that
State
and
noting
that
certification
became
mandatory
by
State
law
in
1993.

In
the
March
2000
RIA,
USDA
estimated
that
the
number
of
certified
U.
S.
organic
producers
potentially
affected
by
this
legislation
is
approximately
9,350
in
2000
and
will
be
approximately12,150
in
2002,
based
on
a
straight
line
projection
of
the
14­
percent
annual
growth
rate
trend
shown
by
USDA
data
for
1991­
1994.
The
period,
2000­
2002,
was
chosen
for
analysis
because
it
encompasses
both
the
period
of
final
rulemaking
and
the
18­
month
implementation
period.
Congress
passed
the
OFPA
in
1990,
and
the
14­
percent
growth
rate
in
certified
growers
483
during
the
1991­
1994
period
reflects
their
expectation
that
national
organic
regulations
were
forthcoming.
Since
the
recent
estimates
of
industry
growth
during
the
1990'
s
are
uneven
and
the
actual
growth
rate
in
the
number
of
growers
who
will
become
certified
after
this
legislation
is
implemented
is
uncertain,
the
March
2000
estimates
are
retained
in
this
assessment
of
the
final
rule.

The
March
2000
RIA
also
estimated
the
number
of
producers
who
are
practicing
organic
agriculture
but
who
are
currently
uncertified
that
would
be
affected
by
the
rule.
In
California,

where
organic
growers
are
required
to
register
with
the
State
but
not
to
be
certified,
a
large
proportion
of
growers
are
uncertified.
The
most
recent
State
data,
for
the
1997/
98
crop
year,

indicate
that
1,526
growers
registered
as
organic,
but
only
41
percent
of
them
obtained
thirdparty
certification
(
Klonsky
et
al.,
2000).
While
only
a
small
percentage
of
growers
in
the
lowest
organic
sales
category
(
0­$
10,000),
where
the
largest
number
of
growers
were
clustered,
obtained
certification,
three­
quarters
or
more
of
the
growers
earning
at
least
$
50,000
obtained
certification,

and
all
of
the
growers
in
the
highest
sales
class
were
certified.
USDA
did
not
use
the
California
ratios
of
certified
to
uncertified
growers
in
the
March
2000
RIA
to
estimate
the
number
of
uncertified
growers
because
the
farming
structure
of
California
may
not
be
representative
of
the
Nation.
For
example,
California
sells
at
least
three
times
more
specialty
crops
that
any
other
State
in
the
United
States
 
and
has
an
unusual
registration
program
that
many
growers
use
instead
of
certification.

USDA
made
two
assumptions
about
uncertified
production
for
the
March
2000
estimate.

The
first
assumption
was
that
the
rate
of
growth
in
uncertified
production
is
less
than
the
rate
for
certified
farms
because
certification
has
value
and
organic
producers
would
be
expected
to
take
484
advantage
of
the
marketing
advantages
of
certification.
This
assumption
is
consistent
with
California
data
that
showed
an
increase
in
the
percent
of
organic
farmers
obtaining
certification
between
1996/
97
and
1997/
98
in
virtually
every
sales
class
(
Klonsky
et
al.
2000).
Second,
the
emergence
of
State
certification
programs
with
lower
certification
fees
than
private
certification
entities
may
have
encouraged
more
organic
producers
to
be
certified.
Based
on
these
assumptions,
USDA
assumed
that
the
number
of
uncertified
organic
producers
is
about
4,300
in
2000
and
will
be
about
5,000
in
2002,
making
the
total
number
of
farms
potentially
affected
by
the
rule
about
13,650
in
2000
and
17,150
in
2002.

Organic
Handlers
Little
information
exists
on
the
number
of
organic
product
handlers,
such
as
organic
soup
manufacturers,
organic
food
packaging
operations,
organic
food
wholesalers,
and
feed
millers.

USDA
has
estimated
that
there
were
600
entities
in
this
category
in
1994
(
Dunn
1995b).
AMS
estimated
that
the
growth
rate
was
11
percent
from
1990
through
1994
(
Dunn
1995b).
More
recent
data
from
CDFA
registration
records
suggest
a
growth
rate
of
about
28
percent
(
California
Department
of
Health
Services
1999).
For
projection
purposes,
we
use
a
growth
rate
of
20
percent
and
estimate
there
are
about
1,600
in
2000
and
there
will
be
about
2,250
handlers
in
2002.
Reasons
for
growth
include
the
general
increase
in
organic
production
and
growth
in
the
market
for
processed
organic
foods,
including
multiingredient
products.
Again,
these
projections
are
based
on
limited
data
from
the
early
1990'
s,
and
growth
may
have
slowed
or
increased.
These
estimates
of
organic
product
handlers
are
slightly
higher
that
the
estimates
made
in
the
March
2000
RIA
because
they
include
about
100
feed
millers
that
were
not
included
in
the
earlier
calculation.
485
Retail
Food
Establishments
Retailers
of
organic
food
are
grocery
stores,
bakeries
and
other
establishments
that
process
or
prepare
raw
and
ready­
to­
eat
food.
Most
are
not
currently
subject
to
either
voluntary
practices
or
mandatory
standards
of
the
organic
industry.
Although
they
are
excluded
from
the
certification
requirements
under
the
final
rule,
they
are
subject
to
other
processing,
handling,
and
other
production
related
requirements
of
the
final
rule.
Some
of
the
grocery
stores
in
the
United
States,
particularly
the
natural
foods
stores,
sell
processed
or
prepared
organic
foods
and
will
be
affected
by
the
these
requirements.
USDA
does
not
have
an
estimate
of
the
number
of
entities
affected.

Foreign
Entities
In
addition
to
domestic
certifying
agents,
foreign
certifying
agents
may
also
apply
for
accreditation
under
the
NOP.
At
this
time,
we
have
no
information
regarding
the
number
of
foreign
certifying
agents
that
may
seek
USDA
accreditation.
Foreign
applicants
will
face
the
same
base
costs
for
accreditation
as
domestic
applicants
but
the
overall
levels
of
cost
are
expected
to
be
higher
due
to
the
generally
higher
costs
of
foreign
travel
and
per
diem
expenses
for
site
evaluation
and
miscellaneous
costs
such
as
for
translation
of
documents.
For
purposes
of
estimating
the
paperwork
burden
described
elsewhere,
we
assume
10
foreign
certifying
agents
will
seek
and
obtain
accreditation
during
the
first
3
years
of
the
program.

Benefits
of
the
Final
Rule
The
benefits
of
implementing
national
uniform
standards
of
production
and
certification
include:
(
1)
providing
a
common
set
of
definitions
on
organic
attributes
and
standardizing
the
manner
in
which
the
product
information
is
presented,
which
may
reduce
the
cost
associated
with
486
enforcement
actions
in
consumer
fraud
cases;
(
2)
reduced
administrative
costs;
and
(
3)
improved
access
to
organic
markets.
Not
all
benefits
that
may
arise
from
the
rule
are
quantifiable.
Where
economic
data
are
available,
they
may
relate
to
costs
and
are
generally
not
adequate
to
quantify
economic
benefits.
The
regulatory
changes
in
the
final
rule
are
not
expected
to
reduce
the
benefits
from
those
described
under
the
March
2000
proposed
rule.

Information
Potential
benefits
to
consumers
as
a
result
of
the
final
rule
include
providing
a
common
set
of
definitions
on
organic
attributes
and
standardizing
the
manner
in
which
the
product
information
is
presented.
This
standardization
may
reduce
the
cost
associated
with
enforcement
actions
in
consumer
fraud
cases.

Organic
products
cannot
be
distinguished
from
conventionally
produced
products
by
sight
inspection,
and
consumers
rely
on
verification
methods
such
as
certification
to
ensure
that
organic
claims
are
true.
Self­
policing
by
certifiers
of
growers
and
handlers
that
are
certified
has
been
difficult
because
some
certifiers
have
been
under
pressure
to
use
weak
standards
and
lax
enforcement
procedures
in
order
to
keep
their
producer
and
processor
clients
from
taking
their
business
to
other
certifiers
(
Scowcroft
1998).

Anecdotal
evidence
suggests
that
consumer
fraud
involving
organic
food
does
occur,
and
several
States
successfully
pursued
civil
and
criminal
prosecution
of
these
cases
during
the
1990'
s.

The
Attorney
General
of
Minnesota
successfully
prosecuted
felony
charges
in
1997
against
the
president
of
Glacial
Ridge
Foods,
a
wholesale
supplier
of
beans
and
grains,
for
repackaging
conventionally
produced
product
and
selling
approximately
$
700,000
worth
labeled
as
certified
organic
(
Mergentime
1997).
The
San
Diego
City
Attorney's
office
successfully
prosecuted
felony
487
charges
against
Petrou
Foods,
Inc.,
an
organic
oil
and
vinegar
distributor,
for
misbranding
conventional
product,
based
on
an
investigation
by
the
California
Department
of
Health
Services
(
Scott
1997).
Also
the
California
Department
of
Food
and
Agriculture
conducted
spot
checks
of
51
uncertified
organic
growers
during
the
mid­
1990'
s,
based
on
complaints,
and
found
32
violations
of
California's
organic
standards
(
Farmers
Market
Outlook).
However,
only
about
half
of
the
States
have
any
organic
legislation,
and
few
of
those
States
have
laws
with
enough
teeth
to
permit
prosecution
of
organic
fraud.
In
States
without
similar
laws,
the
costs
associated
with
remedies
via
the
tort
system
may
be
high.
The
NOP
established
in
this
final
rule
is
expected
to
fill
in
important
State
and
regional
gaps
in
enforcement
in
organic
fraud
cases.

The
USDA
organic
seal
will
also
provide
consumers
a
quick
tool
to
verify
that
goods
offered
for
sale
as
organic
are
in
fact
organic.

Reduced
Administrative
Costs
The
rule
addresses
the
problem
of
existing
certifying
agents
using
different
standards
and
not
granting
reciprocity
to
other
certifying
agents.
By
accrediting
certifying
agents,
the
rule
establishes
the
requirements
and
enforcement
mechanisms
that
would
reduce
inconsistent
certification
services
and
lack
of
reciprocity
between
certifying
agents.
In
the
current
system,
the
certifying
agent
of
a
final
product
is
not
required
to
recognize
the
certification
of
an
intermediate
product.
Both
primary
farmers
and
food
handlers
may
face
a
risk
of
being
unable
to
sell
a
certified
organic
product
when
more
than
one
certifying
agent
is
involved.
By
imposing
a
uniform
standard
of
certification
and
production,
the
costs
associated
with
establishing
reciprocity
between
certifying
agents
will
be
eliminated,
and
the
market
dampening
effects
that
these
costs
impose
will
be
eliminated.
Industry­
wide
training
costs
may
also
decrease.
USDA's
uniform
488
standards
of
production
and
certification
should
enable
organic
inspectors
to
move
more
easily
from
one
certifying
agent
to
another
than
under
the
current
system.

Domestic
and
International
Markets
The
final
rule
is
expected
to
improve
access
to
domestic
and
foreign
markets
for
organically
produced
goods.
The
current
patchwork
of
differing
State
certification
requirements
and
variable
State
and
private
standards
has
given
producers
and
handlers
uneven
access
to
the
domestic
organic
market
and
to
the
price
premiums
associated
with
this
market.
Livestock
producers,
in
particular,
may
have
limited
their
organic
production
because
they
lacked
access
to
a
State
or
private
organic
livestock
certification
program
or
were
uncertain
about
the
standards
that
would
be
implemented
under
the
NOP.

The
final
rule
could
also
improve
access
to
EU
and
other
foreign
markets
for
U.
S.
organic
products.
For
example,
the
EU
may
determine
that
the
NOP
is
acceptable
vis­
a­
vis
EU
regulation
2092/
91.
Article
11
of
EU
Reg.
2092/
91
establishes
the
conditions
under
which
organic
products
may
be
imported
from
third
countries
and
addresses
the
framework
for
equivalency.
The
NOP
is
a
national
program
that
should
be
acceptable
to
the
EU
and
other
governments.
Foreign
acceptance
of
the
U.
S.
national
standard
would
reduce
costs
of
negotiating
and
documenting
shipment
by
shipment.
Reducing
these
transaction
costs
may
reduce
entry
costs
for
U.
S.

producers
to
foreign
organic
markets.
These
benefits
would
not
accrue
until
after
negotiations
for
an
equivalency
agreement
have
been
held
and
completed
successfully,
which
could
be
a
lengthy
process.

An
estimated
5
percent
of
total
U.
S.
sales
are
from
exports.
Currently,
despite
restricted
access
to
the
European
market,
the
United
States
is
the
most
important
non­
EU
supplier
of
489
organic
products
to
EU
countries
(
Foreign
Agriculture
Service
(
FAS),
1995).
Import
authorizations
have
been
granted
for
a
number
of
raw
and
processed
commodities,
including
sunflowers,
buckwheat,
beans,
sugar,
and
apples.
Demand
is
strong
throughout
the
European
market,
and
the
organic
market
share
was
1­
2
percent
of
total
food
sales
in
1997
(
Collins
1999).

Medium­
term
growth
rate
forecasts
range
from
5­
10
percent
for
Germany
to
30­
40
percent
for
Denmark,
and
is
20­
30
percent
in
most
of
the
EU
countries,
according
to
the
International
Trade
Centre
UNCTAD/
WTO.
However,
most
analysts
are
basing
their
projected
future
growth
rates
on
straight­
line
extrapolations
of
current
sales
and
growth
rates
without
understanding
the
underlying
market
mechanisms
and
price
elasticities
(
Lohr
1998).

Costs
of
the
Final
Rule
The
costs
of
the
regulation
are
the
direct
costs
of
complying
with
the
specific
standards.

It
is
important
to
note
that
while
some
costs
associated
with
accreditation
and
certification
are
quantified,
costs
stemming
from
other
provisions
of
the
final
regulations
are
not.
In
addition,
this
is
a
short­
run
analysis.
The
analysis
examines
the
costs
that
may
be
incurred
through
2002.
It
is
not
possible
at
this
time
to
conduct
a
longer
run
analysis
because
we
do
not
know
enough
about
the
fundamental
supply
and
demand
relationships
to
make
economically
sound
long­
run
projections.

Accreditation
Costs
USDA
has
identified
36
private
certifying
agents
and
13
State
programs
providing
certification
in
the
United
States.
These
49
entities
are
considered
likely
applicants
during
the
first
18
months
during
which
USDA
will
not
charge
application
fees
or
hourly
fees
for
accreditation.
An
unknown
number
of
new
entrants
to
the
certifying
business
may
also
apply.
490
However,
over
the
last
10
years,
the
number
of
certifying
agents
does
not
appear
to
have
grown
significantly,
with
the
net
effect
of
entries
and
exits
maintaining
a
population
of
certifying
agents
at
about
40­
50.

The
final
rule
allows
USDA
to
collect
fees
from
certifying
agents
for
USDA
accreditation.

The
first
proposal
would
have
permitted
USDA
to
collect
fees
from
producers
and
handlers
as
well,
but
USDA
decided
that
it
would
be
administratively
simpler
to
collect
fees
only
from
certifiers
and
would
enable
State
programs
that
want
to
keep
client
costs
low
to
be
able
to
do
so.

Applicants
for
accreditation
will
be
required
to
submit
a
nonrefundable
fee
of
$
500
at
the
time
of
application,
which
will
be
applied
to
the
applicant's
fees
for
service
account.
This
means
that
the
$
500
fee
paid
at
the
time
of
application
is
credited
against
any
subsequent
costs
of
accreditation
arising
from
the
initial
review
and
the
site
evaluation.
The
$
500
fee
is
the
direct
cost
to
applicants
who
are
denied
accreditation
based
on
the
initial
review
of
the
information
submitted
with
their
application.
Charges
for
the
site
evaluation
visit
will
cover
travel
costs
from
the
duty
station
of
USDA
employees,
per
diem
expenses
for
USDA
employees
performing
the
site
evaluation,
an
hourly
charge
(
per
each
employee)
for
services
during
normal
working
hours
(
higher
hourly
rates
will
be
charged
for
overtime
and
for
work
on
holidays),
and
other
costs
associated
with
providing
service
to
the
applicant
or
certifying
agent.

At
present,
the
base
per
diem
for
places
in
the
United
States
is
$
85
($
55
for
lodging
and
$
30
for
meals
and
incidental
expenses).
Per
diem
rates
are
higher
than
$
85
in
most
large
cities
and
urbanized
places,
but
over
half
of
the
current
U.
S.
certifiers
are
located
in
places
that
have
an
$
85
per
diem
rate,
and
that
is
the
rate
used
to
calculate
average
certifier
expenses
in
table
3.
A
review
of
domestic
travel
by
USDA
staff
during
fiscal
year
1999
indicates
transportation
costs
491
ranging
from
$
500
to
$
600
per
person.
Miscellaneous
costs
are
estimated
to
add
another
$
50
to
each
site
visit.

The
hourly
rate
that
USDA
anticipates
charging
for
accreditation
is
the
rate
that
USDA
currently
charges
for
services
under
the
Quality
Systems
Certification
Program
(
QSCP).
Our
preliminary
estimate
that
this
rate
will
be
no
more
than
$
95
per
hour
is
presented
to
give
the
public
some
indication
of
the
rate
that
will
be
charged
following
the
18­
month
transition
period.

QSCP
is
an
audit­
based
program
administered
by
AMS,
which
provides
meat
producers,
handlers
(
packers
and
processors),
and
other
businesses
in
the
livestock
and
meat
trade
with
the
opportunity
to
have
special
processes
or
documented
quality
management
systems
verified.
The
procedures
for
accreditation
evaluation
are
similar
to
those
used
to
certify
other
types
of
product
or
system
certification
programs
under
QSCP.

Accreditation
will
include
verification
of
adherence
to
ISO
Guide
65
and
the
regulations.

Although
much
of
the
site
evaluation
for
accreditation
will
involve
comparisons
against
ISO
Guide
65,
additional
hours
will
be
required
because
USDA
will
be
evaluating
additional
aspects
of
the
applicant's
operation
to
determine
if
the
applicant
is
qualified
to
perform
as
an
accredited
agent
for
the
NOP.
Based
on
experience
with
the
QSCP
and
more
limited
experience
performing
audits
verifying
that
certifying
agents
meet
ISO
Guide
65,
we
project
that
a
site
evaluation
visit
for
small
applicants
with
a
simple
business
structure
will
require
3
days
of
review,
and
for
those
large
applicants
with
more
complex
business
structure
will
require
5
days
of
review.

USDA
will
use
two
reviewers
for
each
site
evaluation
visit
during
the
18­
month
implementation
period,
as
well
as
for
new
applicants
after
that
period.
One
reviewer
will
come
from
the
QSCP
audit
staff
and
will
be
familiar
with
the
ISO
Guide
65
verification;
the
other
492
reviewer
will
come
from
the
NOP
staff
and
will
be
familiar
with
requirements
of
the
organic
program.
The
two
will
conduct
the
site
evaluation
jointly.
Two
reviewers
will
also
be
needed
for
the
site
evaluation
visits
for
the
accreditation
renewals,
which
will
take
place
every
5
years.
In
the
proposed
rule,
USDA
had
projected
that
only
one
reviewer
would
be
needed
for
site
evaluations
and
renewals
that
took
place
after
the
18­
month
implementation
period
but
has
changed
that
projection
based
on
additional
experience
with
the
ISO
Guide
65
program.

During
the
18­
month
implementation
period,
applicants
will
be
charged
for
travel
and
per
diem
costs
for
two
persons
and
for
miscellaneous
expenses
but
will
not
be
charged
application
fees
or
hourly
fees.
The
estimated
expenditures
for
these
initial
accreditations
is
$
1,560­$
2,100,

with
$
510­$
850
for
per
diem
expenses,
$
1,000­$
1,200
for
travel
expenses,
and
$
50
for
miscellaneous
expenses
(
table
3).
The
cost
of
initial
site
evaluation
visits
will
vary
with
the
cost
of
travel
from
the
USDA
reviewer's
duty
station
to
the
applicant's
place
of
business.
In
general,

more
distant
and
remote
locations
will
involve
higher
travel
costs.

USDA
estimates
the
costs
of
a
site
evaluation
visit
after
the
transition
period
may
average
$
6,120­$
9,700,
depending
on
the
characteristics
of
the
applicant,
including
$
4,500­$
7,600
for
the
hourly
site
evaluation
charges
that
are
not
billed
to
the
certifier
during
the
first
18
months
(
table
3).
USDA
has
received
appropriated
funds
to
pay
for
the
hourly
site
evaluation
charges
only
during
the
first
18
months
of
the
program.

Currently,
few
private
certifying
agents
are
operating
with
third­
party
accreditation.

Fetter
(
1999)
reports
that
in
a
sample
of
18
certification
programs,
four
programs
were
accredited,
and
one
had
accreditation
pending.
All
of
these
were
large,
private
certifying
agents.

Those
certifying
agents
currently
accredited
by
third
parties
will
likely
pay
less
for
USDA
493
accreditation.
In
its
first
proposal,
USDA
stated
at
FR
62:
65860,
"
We
are
aware
that
certifiers
currently
may
pay
in
excess
of
$
15,000
for
accreditation
by
a
private
organization."
Commenters
thought
this
figure
was
too
high.
One
commenter,
which
operates
the
International
Federation
of
Organic
Agriculture
Movements
(
IFOAM)
Accreditation
Programme
under
license
to
IFOAM,

stated,
"
It
is
possible
that
the
largest
programme
operating
a
chapter
system
with
activities
in
many
countries
(
which
is
included
in
their
IFOAM
evaluation)
paid
this
amount
in
their
first
year.

On
the
other
hand
the
average
cost
to
a
medium
sized
certifier
works
out
at
around
$
3000
to
$
4000
per
year."
Another
commenter
stated,
"
At
the
present
time
IFOAM
accreditation
costs
less
than
$
10,000/
year
for
the
largest
certifier
and
$
3­
5,000
for
smaller
certifiers."

The
18­
month
NOP
implementation
period
affects
the
distribution
of
program
costs
between
the
organic
industry
and
the
taxpayer.
Some
of
the
costs
of
accreditation
would
be
absorbed
by
the
NOP
operation
budget
appropriated
by
Congress.
In
effect,
the
taxpayers
are
subsidizing
the
organic
industry.
Without
this
subsidy,
the
total
cost
of
accreditation
would
approach
$
1
million.

The
direct
accreditation
costs
to
an
estimated
59
certifying
agents
(
including
all
49
current
U.
S.
certifiers
and
an
estimated
10
foreign
certifiers)
during
the
first
18
months
following
the
final
rule,
are
approximately
$
92,000
to
$
124,000.
This
figure
is
derived
from
the
per­
firm
costs
in
table
3.
In
addition,
USDA
will
use
appropriated
funds
to
cover
approximately
$
270,000­

$
448,000
in
hourly
charges
for
site
evaluation.
USDA
will
also
use
appropriated
funds
to
cover
the
costs
of
producing
and
publishing
an
accreditation
handbook
in
several
languages,
translating
USDA
reports
to
foreign
clients,
and
developing
and
funding
a
peer
review
panel
to
evaluate
NOP's
adherence
to
its
accreditation
procedures.
And
if
more
than
the
estimated
59
certifiers
494
apply
for
accreditation
during
the
first
18
months
of
the
program,
USDA
will
use
appropriated
funds
to
cover
additional
hourly
charges
for
site
evaluation.

Private
certifying
agents
and
State
programs
that
do
not
mirror
the
regulation
may
incur
additional
costs
to
change
their
programs
to
adopt
the
national
standards.
The
discussion
on
the
effect
of
the
regulation
on
existing
State
programs
is
in
"
State
Program
Costs."
The
cost
associated
with
changing
existing
private
certifying
programs
is
not
quantified.

Also,
certifying
agents
who
have
been
operating
without
third
party
accreditation
will
face
new
costs.
For
certifying
agents
who
currently
obtain
third­
party
accreditation,
the
direct
costs
of
USDA
accreditation,
which
are
only
incurred
every
5
years,
may
be
lower
on
an
annual
basis
compared
to
the
direct
costs
for
third­
party
certification
of
$
3,000­$
5,000
per
year
indicated
by
the
commenters.
The
direct
costs
for
certifying
agents
obtaining
accreditation
during
the
first
18
months,
when
USDA
will
not
impose
an
application
fee
or
hourly
charges,
will
be
limited
to
travel,
per
diem,
and
miscellaneous
expenses.

A
national
accreditation
program
may
shrink
the
market
for
a
third­
party
accreditation.

Certifying
agents
will
have
little
incentive
to
maintain
or
seek
a
second
accreditation
by
a
private
organization
unless
that
accreditation
sufficiently
enhances
the
market
value
of
the
certifying
agent's
services.
Thus,
the
market
will
determine
whether
other
accrediting
entities
continue
to
have
a
U.
S.
market
for
their
services.

Training
programs
are
currently
offered
by
the
Independent
Organic
Inspectors
Association
(
IOIA),
an
organization
of
approximately
165
organic
certification
inspectors,
and
by
some
of
the
larger
certifying
agents
(
IOIA).
Costs
to
existing
certifying
agents
to
provide
additional
training
to
other
staff
are
difficult
to
measure
in
the
absence
of
information
on
current
495
staff
skill
levels
or
the
existence
of
formal
training
other
than
inspector
training.
Some
agencies
rely
on
volunteer
staff
who
may
have
had
no
formal
training,
but
the
extent
of
this
practice
is
unknown.
AMS
intends
to
offer
assistance
to
certifying
agents,
producers,
and
handlers
by
providing
accreditation
training
for
certification
agents
and
other
printed
material
that
would
enable
participants
to
better
understand
the
regulations.
In
addition,
AMS
intends
to
continue
open
and
frequent
communication
with
certifying
agents
and
inspectors
to
provide
as
much
information
as
possible
to
aid
them
in
fulfilling
the
requirements
of
the
regulations.

The
OFPA
requires
that
private
certifying
agents
furnish
reasonable
security
for
the
purpose
of
protecting
the
rights
of
participants
in
the
organic
certification
program.
It
is
expected
that
there
will
be
costs
to
certifying
agents
from
these
requirements.

Implementation
of
the
final
rule
will
also
impose
a
less
tangible
cost
on
some
certifiers.

Some
private
certifiers
have
advertised
their
program
and
logo
as
representing
higher
standards
than
other
programs.
The
brand
value
associated
with
the
logos
of
these
certifiers
will
be
lost
when
uniform
standards
are
implemented
as
part
of
the
national
program.
However,
certifiers
will
still
be
able
to
distinguish
themselves
to
clients
based
on
the
quality
of
their
services
and
other
characteristics.

A
key
change
was
made
in
the
final
rule,
based
on
comments
to
the
March
2000
proposal,

to
make
the
standard
used
by
certifiers
to
determine
maximum
allowable
pesticide
residues
(
the
level
above
which
a
product
could
not
be
called
organic)
consistent
with
the
current
industry
standard
and
with
NOSB
recommendations.
In
the
final
rule,
the
standard
will
be
set
at
5
percent
of
the
pesticide
residue
tolerances
calculated
by
the
Environmental
Protection
Agency
(
EPA).

This
change
could
conceptually
reduce
costs,
but
the
magnitude
of
this
reduction
is
uncertain.
496
Certification
Costs
Under
the
final
rule,
USDA
will
not
impose
any
direct
fees
on
producers
and
handlers.

Certifying
agents
will
establish
a
fee
schedule
for
their
certification
services
that
will
be
filed
with
the
Secretary.
Certifying
agents
will
provide
all
persons
inquiring
about
the
application
process
with
a
copy
of
their
fees.
The
certifying
agent
will
provide
each
applicant
with
an
estimate
of
the
total
cost
of
certification
and
an
estimate
of
the
annual
costs
of
updating
the
certification.
Under
the
proposed
rule,
certifiers
could
charge
a
maximum
of
$
250
at
the
time
of
application,
but
under
the
final
rule,
certifiers
are
not
limited
in
the
amount
of
certification
fees
that
they
may
charge
at
the
time
of
application.

Some
States
charge
minimal
fees
for
certification
by
subsidizing
operating
costs
from
general
revenues.
The
majority
of
certifying
agents
structure
their
fee
schedules
on
a
sliding
scale
based
on
a
measure
of
size,
usually
represented
by
the
client's
gross
sales
of
organic
products
but
sometimes
based
on
the
acres
operated
(
Fetter
1999
and
Graf
and
Lohr
1999).
Some
certifying
agents
charge
an
hourly
rate
for
inspection
and
audit
services.

Graf
and
Lohr
have
applied
fee
schedules
provided
by
ten
certifying
agents
to
four
hypothetical
farms,
small,
medium,
large,
and
a
super
farm.
Tables
2A
and
2B
summarizes
the
fees
that
Graf
and
Lohr
found
by
applying
schedules
of
each
certifying
agent
to
hypothetical
farms.
Total
first­
year
costs
and
subsequent­
year
(
renewal)
costs
for
certification
are
shown.
The
average
cost
for
each
size
class
should
be
interpreted
with
care
because
it
is
not
weighted
by
the
number
of
clients
certified.
In
their
study,
the
Texas
Department
of
Agriculture
program
is
the
low­
cost
certifying
agent
for
all­
size
operations.
The
high­
cost
certifying
agent
differs
across
farm
sizes.
None
of
these
certification
programs
mentions
costs
for
residue
testing,
which
the
497
NOP
will
require
in
the
form
of
preharvest
testing
when
there
is
reason
to
believe
that
agricultural
products
have
come
into
contact
with
prohibited
substances.
Preharvest
testing
is
expected
to
be
infrequent.
Some
certifying
agents
currently
require
soil
nutrient
testing
and
water
quality
testing.

The
estimated
total
initial
costs
for
a
producer
or
handler
to
become
certified
are
presented
in
table
3.

We
have
not
extended
the
average
costs
reported
in
Tables
2A
and
2B
to
aggregate
certification
costs
for
all
organic
farms
because
the
number
of
organic
farms
is
not
known
with
precision,
nor
is
their
geographic
location,
and
there
are
no
data
to
distribute
the
population
of
organic
farms
across
size
classes.
The
data
from
California
suggest
that
a
large
number
of
small
farmers
produce
and
market
organic
goods
without
third­
party
certification,
but
those
data
may
not
be
representative
of
the
national
trend.
Although
many
of
the
smallest
farms
would
qualify
for
the
small
farm
exemption
from
certification,
if
consumers
accept
the
labeling
practices
required
by
this
final
rule,
small
farmers
may
obtain
certification
to
stay
in
the
organic
market,
which
may
involve
some
cost.

In
response
to
comments,
the
March
2000
proposal
was
changed
to
provide
that
if
a
conflict
of
interest
is
identified
within
12
months
of
certification,
the
certifying
agent
must
reconsider
the
application
and
may
reinspect
the
operation
if
necessary.
Additionally,
if
a
conflict
of
interest
is
identified,
the
certifying
agent
must
refer
the
operation
to
a
different
accredited
certifying
agent.
These
provisions
would
likely
increase
costs
to
certifiers;
however,
the
magnitude
of
this
increase
is
unknown.

Production
and
Handling
Costs
Producers
and
handlers
currently
active
in
the
organic
industry
may
bear
costs
under
the
498
national
standards.
We
believe
that
while
most
provisions
of
the
program
mirror
current
industry
practices,
there
are
some
differences.
In
addition
to
the
cost
associated
with
becoming
familiar
with
the
national
program,
any
adjustments
stemming
from
these
differences
will
result
in
costs.

These
costs
were
qualitatively
discussed
in
the
March
2000
RIA
for
major
provisions
of
the
rule
and
are
described
below.
The
March
2000
proposal
adhered
closely
to
recommendations
from
the
NOSB
and
largely
reflected
current
industry
standards.
Marginal
changes
have
been
made
in
the
final
rule
in
response
to
comments
on
the
March
2000
proposal.
These
changes
have
been
made
in
concert
with
NOSB
recommendations
and,
in
general,
have
been
made
to
clarify
or
add
flexibility
to
producer
and
handler
provisions
or
to
make
them
better
reflect
current
industry
standards.

Producers
Producers
of
organic
food
will
face
numerous
provisions
that
will
regulate
their
production
methods.
As
indicated
in
the
Baseline
section,
many
of
the
requirements
are
currently
followed
by
certified
organic
farmers.
Farming
operations
that
are
not
certified
but
are
registered
with
a
State
government,
such
as
California,
receive
copies
of
the
State
laws
to
which
they
must
comply.
The
costs
associated
with
adjusting
to
provisions
in
the
final
rule
may
be
minimal
for
certified
and
State­
registered
growers
but
may
be
more
substantial
for
noncertified
organic
producers
that
do
not
follow
a
specific
set
of
guidelines
or
regulations.
Some
organic
producers
are
neither
certified
nor
registered
and,
therefore,
may
not
practice
the
requirements
in
the
final
rule.
Major
provisions
of
the
final
rule
 
the
withdrawal
period
required
for
land
to
be
free
of
prohibited
substances,
National
List,
animal
drug
use,
and
residue
tests
 
are
discussed
to
illustrate
costs;
other
provisions
may
also
impose
additional
costs.
499
A
3­
year
withdrawal
period,
during
which
prohibited
materials
cannot
be
applied
to
a
field
to
be
certified
as
organic,
is
currently
required
by
most
private
and
State
organic
standards,
and
the
final
rule
also
specifies
a
3­
year
period.
The
effect
of
this
provision
on
the
currently
certified
organic
farming
operations
may
be
minimal,
but
the
effect
on
farming
operations
that
are
neither
certified
nor
registered
may
be
significant.
Farming
operations
that
have
completed
a
3­
year
withdrawal
period
will
not
be
affected
by
this
requirement.
To
stay
in
the
organic
industry,
those
who
have
not
completed
the
3­
year
period
must
comply
with
this
requirement.
They
may
incur
the
cost
of
organic
production
for
a
significant
length
of
time,
yet
not
be
allowed
to
sell
their
products
as
organic.
Hence,
some
small
organic
operations
may
exit
the
industry.

The
impact
of
the
National
List,
which
lists
allowed
synthetic
substances
and
prohibited
nonsynthetic
substances
that
may
or
may
not
be
used
in
organic
production
and
handling
operations,
will
be
determined
by
how
the
national
standards
differ
from
current
certification
standards
and
from
actual
practice.
Lists
of
approved
synthetic
materials,
including
soil
amendments
and
pesticides,
vary
from
one
certification
program
to
another,
but
a
detailed
analysis
of
specific
differences
in
the
various
existing
materials
lists
shows
them
to
be
overlapping
in
most
cases
with
each
other
and
with
the
National
List.
The
degree
of
overlap
should
mitigate
the
costs
for
certified
operations,
but
farming
operations,
particularly
those
that
aren't
certified,
may
need
to
make
some
adjustments
to
comply
with
the
list.
These
adjustments
will
impose
costs
on
these
operations.
The
magnitude
of
the
costs
resulting
from
these
adjustments
is
not
quantified.

Where
livestock
standards
have
been
adopted
by
existing
State
programs
and
by
private
certifying
agents,
most
prohibit
the
use
of
animal
drugs
except
for
the
treatment
of
a
specific
disease
condition,
and
use
of
animal
drugs
is
generally
prohibited
within
90
days
prior
to
the
sale
500
of
milk
or
eggs
as
organic.
Some
State
and
private
certifiers
allow
the
use
of
animal
drugs
in
animals
for
slaughter
under
certain
conditions,
while
others
prohibit
the
use
of
animal
drugs.
The
standards
in
the
final
rule
would
prohibit
the
sale
as
organic
of
edible
products
derived
from
an
animal
treated
with
antibiotics
or
other
unapproved
substances.
The
standards
may
not
differ
from
existing
State
or
private
standards
in
prohibiting
the
use
of
drugs
on
healthy
animals.

However,
the
effect
of
this
provision
may
differ
among
certified
and
registered
organic
farms.

The
effect
on
the
certified
farming
operations
is
unknown.
We
assume
that
this
provision
may
have
costs,
but
the
magnitude
of
these
costs
is
not
quantified.

Additional
costs
may
be
imposed
by
several
further
changes
to
the
March
2000
proposal.

These
changes
involve
the
use
of
treated
lumber,
confinement
requirements,
and
the
commercial
availability
of
ingredients
in
products
labeled
"
organic."

The
replacement
of
lumber
treated
with
prohibited
substances
that
comes
into
contact
with
soil,
crops,
or
livestock
under
organic
management
with
treated
lumber
is
now
specifically
prohibited
in
organic
systems.
Since
the
use
of
lumber
treated
with
prohibited
substances
for
the
purpose
of
preventing
degradation
is
not
a
common
practice
in
livestock
production,
this
prohibition
is
not
expected
to
increase
producer
costs
substantially.
The
exact
magnitude
of
any
increase
is
uncertain
and
mainly
dependent
upon
the
number
of
producers
seeking
organic
certification
that
currently
use
treated
lumber
in
their
operations
and
are
planning
to
replace
that
lumber.

The
confinement
provisions
in
the
March
2000
proposal
have
been
slightly
modified.

Access
to
the
outdoors
is
now
an
explicitly
required
element
for
all
organically
raised
livestock.

We
expect
this
change
to
have
a
minor
impact
on
overall
producer
costs,
since
we
assume
most
501
producers
raising
organic
livestock
already
provide
access
to
the
outdoors.
Additionally,
the
term,
"
pasture,"
has
been
defined
to
emphasize
that
livestock
producers
must
manage
their
land
to
provide
nutritional
benefit
to
grazing
animals
while
maintaining
or
improving
soil,
water,
and
vegetative
resources
of
the
operation.
To
the
extent
producers
desiring
to
raise
organic
livestock
do
not
currently
manage
pasture
in
this
manner,
we
expect
livestock
production
costs
to
increase.

The
organic
plan
now
requires
using
organically
produced
minor
agricultural
ingredients
unless
not
commercially
available.
This
applies
to
the
previously
allowed
5­
percent
nonorganic
agricultural
and
other
ingredients
in
products
labeled
"
organic."
Handlers
of
organically
produced
minor
ingredients,
especially
herbs
and
spices,
are
likely
to
benefit
from
this
market
incentive,

while
producers
of
nonorganic
minor
ingredients
will
likely
be
adversely
affected.
Producers
will
also
realize
a
burden
associated
with
providing
the
documentation
of
commercial
availability
for
ingredients
in
the
5­
percent
component.
Since
the
criteria
to
determine
commercial
availability
will
be
developed
after
additional
comments
and
information
are
considered,
the
magnitude
of
the
cost
and
benefit
implications
from
this
standard
are
currently
unquantifiable
but
will
likely
be
largely
dependent
upon
the
stringency
of
the
developed
criteria.

Producers
will
also
have
administrative
costs
for
reporting
and
recordkeeping,
although
producers
who
currently
are
active
in
the
organic
industry
already
perform
most
of
these
administrative
functions,
and
additional
costs
to
them
would
depend
upon
the
extent
to
which
their
current
practices
are
different
from
the
requirements
of
the
final
rule.
The
annual
reporting
and
recordkeeping
burden
on
producers
is
estimated
at
24
hours
for
certified
producers
and
1
hour
of
recordkeeping
for
small
producers
who
choose
to
operate
as
exempt
entities
and
is
valued
at
$
23
per
hour.
502
Other
provisions
of
the
final
rule,
such
as
those
on
residue
testing,
livestock
housing
and
feed,
and
health
care
practices,
may
vary
enough
from
those
followed
by
some
growers
that
they
may
impose
costs
due
to
the
variability
in
current
housing,
feed,
and
health
care
practices,
but
lacking
information,
we
have
not
quantified
these
costs.

There
were
also
several
key
changes
made
in
the
final
rule,
based
on
comments
to
the
March
2000
proposal,
that
will
add
flexibility
to
producer
standards.
A
specific
type
of
production
facility
was
required
for
composting
manure
in
the
proposal,
and
this
provision
has
been
modified
to
ensure
that
manure
is
adequately
composted
while
allowing
variation
in
the
type
of
facility
that
is
used.
Also,
the
transition
period
of
a
dairy
operation
to
make
a
whole­
herd
conversion
to
organic
production
has
been
reduced
in
order
to
make
conversion
affordable
for
a
wider
range
of
dairy
farms,
including
smaller
operations.
Finally,
the
requirement
that
slaughter
stock
sold,
labeled,
or
represented
as
organic
be
under
continuous
organic
management
from
birth
was
changed
to
require
continuous
organic
management
from
the
last
third
of
gestation.
This
change
is
also
expected
to
provide
possible
cost
savings
and
added
flexibility
for
producers.

Handlers
Handlers
of
organic
food
are
defined
and
regulated
differently
across
different
certifying
agents
and
States.
Due
to
this
variability,
handlers
may
incur
some
cost
associated
with
complying
with
the
requirements
of
the
regulation.
Several
key
changes
were
made
in
the
final
rule,
based
on
comments
to
the
March
2000
proposal,
to
make
handler
standards
more
consistent
with
current
industry
standards.
The
proposal
prohibited
the
addition
of
sulfites
to
wine
as
required
by
OFPA.
The
statute
has
been
changed
since
March,
and
the
final
rule
will
permit
added
sulfites
in
wine
labeled
"
made
with
organic
grapes,"
consistent
with
industry
standards
and
503
NOSB
recommendations.

Also,
the
March
proposal
required
products
labeled
"
made
with
organic
ingredients"
to
have
ingredients
that
were
at
least
50
percent
organic,
and
this
threshold
has
been
raised
to
70
percent
in
the
final
rule.
Some
certifiers
set
their
thresholds
at
50
percent,
others
at
70
percent,

while
others
restrict
labeling
to
individual
ingredients
only.
The
international
industry
standard
outside
the
United
States
is
set
at
70
percent.
The
threshold
is
set
at
70
percent
in
the
final
rule
inresponese
to
comments
received
on
the
proposal
and
to
be
consistent
with
international
standards,
which
will
help
ease
export
of
U.
S.
organic
product
into
those
markets.
Alternatively,

to
the
extent
handlers
do
not
currently
meet
the
70­
percent
threshold
to
label
products
"
made
with
organic
ingredients,"
handlers
may
incur
additional
costs
to
reach
the
threshold
or
exit
the
industry.
The
magnitude
of
those
effects
is
unknown.

In
addition
to
the
labeling
requirement,
a
handler's
current
use
of
nonsynthetic
and
synthetic
substances
may
change
in
response
to
the
final
rule.
The
March
2000
proposal
provided
for
the
use
of
any
prohibited
substance
to
prevent
or
control
pests.
This
provision
has
been
changed
to
first
limit
the
use
of
nonsynthetic
and
synthetic
substances
to
substances
which
are
on
the
National
List
before
allowing
the
use
of
any
synthetic
substance.
To
the
extent
to
which
handlers
are
now
required
to
consider
substances
on
the
National
List
before
using
a
prohibited
substance
and
these
substances
on
the
National
List
are
priced
differently
from
the
substance
otherwise
used,
handlers
may
incur
a
change
in
production
costs.
This
requirement
may
increase
costs
on
handlers,
but
the
magnitude
of
this
increase
is
unknown.

In
addition,
the
commercial
availability
requirement
in
the
final
rule,
described
in
the
producer
costs
section,
may
also
create
a
burden
on
handlers
to
consistently
apply
the
standard.
504
To
the
extent
to
which
sourcing
organically
produced
ingredients
in
excess
of
95
percent
of
the
finished
product
is
more
expensive
than
sourcing
nonorganically
produced
ingredients,
handlers
seeking
the
"
organic"
label
for
their
products
will
incur
additional
costs.
As
previously
described,

the
magnitude
of
the
cost
implications
from
this
standard
is
currently
unquantifiable
but
will
likely
be
largely
dependent
upon
the
stringency
of
the
standard
that
is
developed.

Handlers
will
also
have
administrative
costs
for
reporting
and
recordkeeping,
although
handlers
who
currently
are
active
in
the
organic
industry
already
perform
most
of
these
administrative
functions,
and
additional
costs
to
them
would
depend
upon
the
extent
to
which
their
current
practices
are
different
from
the
requirements
of
the
final
rule.
The
annual
reporting
and
recordkeeping
burden
on
handlers
is
estimated
at
63
hours
for
certified
handlers
and
1
hour
of
recordkeeping
for
small
handlers
who
choose
to
operate
as
exempt
entities
and
is
valued
at
$
23
per
hour.

Retail
Food
Establishments
Most
retailers
are
not
currently
subject
to
either
voluntary
practices
or
mandatory
standards
of
the
organic
industry.
Retailers
that
have
organic
processing
operations,
such
as
organic
food
delis
and
bakeries,
are
not
required
to
be
certified
in
the
final
rule.
However,

retailers
will
be
subject
to
requirements
such
as
prevention
of
contamination
of
organic
products
with
prohibited
substances,
and
commingling
organic
with
nonorganic
products.
Obtaining
certification
and
complying
with
these
provisions
will
incur
some
cost.

Labeling
Costs
Certified
handlers
will
have
to
comply
with
requirements
regarding
the
approved
use
of
labels.
In
addition,
any
producers,
handlers,
and
retailers
who
are
not
currently
certified
but
who
505
package
organic
products
are
also
subject
to
the
labeling
requirements.
The
estimated
annual
cost
for
handlers
to
determine
the
composition
of
20
products
to
be
reported
on
labels
is
$
1,647,000.

This
figure
is
based
on
an
average
of
1
hour
per
product
per
handler
and
an
hourly
cost
of
$
27.

Similarly,
certified
handlers
will
have
to
design
their
labels
to
comply
with
the
regulation.
This
is
expected
to
take
1
hour
per
label
at
$
27
per
hour
for
a
compliance
cost
of
$
1,647,000.
Total
label
costs
for
handlers
are
$
3.3
million.
Any
changes
to
existing
labels
and
new
labels
that
need
to
conform
to
the
regulation
will
incur
a
cost.
The
costs
associated
with
these
activities
are
not
quantified.
Hence,
the
lower
bound
on
the
labeling
cost
is
approximately
$
4
million.

State
Program
Costs
The
national
program
may
impose
additional
costs
on
States
by
requiring
changes
in
their
existing
programs.
The
rule
encompasses
most
of
the
principles
of
existing
State
programs.

However,
there
are
also
departures.

Where
State
standards
are
below
Federal
standards
or
where
elements
of
the
Federal
standards
are
missing
from
a
State
program,
these
States
would
be
required
to
make
changes
in
their
programs
that
they
might
otherwise
not
make.
Where
State
programs
have
standards
in
addition
to
the
Federal
standards
and
they
are
not
approved
by
the
Secretary,
States
also
would
be
required
to
make
changes
in
their
programs.
States
without
organic
standards
or
whose
current
standards
either
would
conform
to
those
of
the
national
program
or
would
be
approved
by
the
Secretary
would
not
incur
additional
costs
resulting
from
required
changes.
Currently,
USDA
cannot
predict
which
States
may
be
required
to
adjust
their
existing
programs.

States
that
conduct
certification
activities
will
be
charged
for
accreditation,
something
none
of
them
pay
for
now.
The
cost
associated
with
this
provision
is
discussed
in
the
506
Accreditation
section.

Enforcement
costs
Enforcement
costs
will
fall
upon
USDA's
NOP,
States
operating
State
organic
programs,

and
on
State
and
private
certifying
agents.
Certifying
agents
will
review
clients'
operations
and
will
notify
clients
of
deficiencies.
Certifying
agents
can
initiate
suspension
or
revocation
of
certification.
Certifying
agents
will
be
aware
of
these
overhead
costs,
and
we
assume
that
they
will
establish
fee
schedules
that
will
cover
these
costs.
Actual
costs
to
certifying
agents
for
enforcement
activities
will
depend
on
the
number
of
clients,
how
well
informed
clients
are
of
their
obligations,
and
client
conduct.
State
certifying
agents
will
face
the
same
obligations
and
types
of
costs
as
private
certifying
agents.

In
States
operating
State
organic
programs
(
SOP),
State
enforcement
costs
are
costs
associated
with
ensuring
that
certified
operations
fulfill
their
obligations.
These
States
will
bear
the
costs
of
investigating
complaints,
monitoring
use
of
the
State
organic
seal
and
organic
labeling,
and
taking
corrective
action
when
needed.
These
States
will
bear
costs
related
to
reviewing
an
applicant's
or
certified
operation's
appeal
and
for
administrative
proceedings.
Many
of
these
activities
are
already
a
routine
part
of
the
certification
program
in
States
that
have
programs,
and
USDA
will
fill
in
gaps
in
enforcement
in
States
that
choose
not
to
have
programs.

USDA's
enforcement
costs
are
costs
associated
with
ensuring
that
certifying
agents
fulfill
their
obligations.
In
States
without
an
organic
program,
USDA
will
bear
the
costs
of
investigating
complaints,
monitoring
use
of
the
USDA
organic
seal
and
organic
labeling,
and
taking
corrective
action
when
needed.
USDA
will
bear
costs
related
to
reviewing
an
applicant's
or
certified
or
accredited
operation's
appeal
and
for
administrative
proceedings.
USDA
expects
507
to
effectively
carry
out
its
enforcement
responsibilities
using
funds
that
are
already
allocated
for
operating
the
NOP.
To
the
extent
to
which
we
did
not
estimate
the
likely
noncompliance
rate,
the
cost
associated
with
enforcement
remains
unknown.

Reporting
and
Recordkeeping
Costs
The
Paperwork
Reduction
Act
of
1995
requires
an
estimate
of
the
annual
reporting
and
recordkeeping
burden
of
the
NOP.
The
estimated
annual
reporting
and
recordkeeping
burden
reported
is
approximately
$
13
million.
This
figure
should
be
understood
within
the
context
of
the
requirements
of
the
Paperwork
Reduction
Act.
The
Paperwork
Reduction
Act
requires
the
estimation
of
the
amount
of
time
necessary
for
participants
to
comply
with
the
regulation
in
addition
to
the
burden
they
currently
have.
Information
gathered
by
AMS
in
auditing
activities
in
conjunction
with
ISO
Guide
65
verifications
leads
us
to
believe
that
the
paperwork
burden
on
current
certifying
agents
and
certified
operators
will
be
10
to
15
percent
greater
than
their
current
business
practices
as
a
result
of
this
final
rule.

Certifying
Agents.
The
regulation
will
impose
administrative
costs
on
certifying
agents
for
reporting
and
recordkeeping.
The
actual
amount
of
the
additional
administrative
costs
that
would
be
imposed
by
the
rule
is
expected
to
be
different
for
those
entities
that
would
begin
their
activities
only
after
the
national
program
is
implemented.
Certifying
agents
that
currently
are
active
in
the
organic
industry
already
perform
most
of
these
administrative
functions;
therefore,

the
additional
costs
to
them
would
depend
upon
the
extent
to
which
their
current
practices
are
different
from
the
requirements
of
the
regulation.
An
estimate
of
the
cost
of
compliance
is
the
annual
reporting
and
recordkeeping
burden
documented
in
the
Paperwork
Reduction
Act
of
1995
analysis.
Table
4
shows
the
estimated
annual
costs
for
certifying
agents.
Certifying
agencies
each
508
have
an
estimated
burden
of
1,068
hours
valued
at
roughly
$
27,729.

The
following
list
describes
several
of
the
most
significant
administrative
requirements
or
optional
submissions
and
the
probable
resources
required
for
compliance.
Details
on
the
reporting
and
recordkeeping
burdens
estimated
for
each
item
are
in
the
paperwork
analysis.

1.
A
list
of
farmers,
wild­
crop
harvesters,
and
handlers
currently
certified.
This
information
can
be
compiled
from
existing
records.
After
implementation,
certifying
agents
will
be
required
to
submit
on
a
quarterly
basis
a
list
of
operations
certified
during
that
quarter.

2.
A
copy
of
procedures
used
for
certification
decisions,
complying
with
recordkeeping
requirements,
maintaining
confidentiality
of
client's
business­
related
information,
preventing
conflicts
of
interest,
sampling
and
residue
testing,
training
and
supervising
personnel,
and
public
disclosure
of
prescribed
information
concerning
operations
they
have
certified
and
laboratory
analyses.
These
policies
may
have
to
be
created
or
modified
to
conform
to
the
regulation.

3.
Documentation
on
the
qualifications
of
all
personnel
used
in
the
certification
operation,

annual
performance
appraisals
for
each
inspector
and
personnel
involved
in
the
certification,
and
an
annual
internal
program
evaluation.
Existing
certifying
agents
may
already
perform
these
operations.
New
certifying
agents
will
have
to
establish
procedures
to
achieve
these
things.

4.
Documentation
on
the
financial
capacity
and
compliance
with
other
administrative
requirements
(
e.
g.,
fee
structure,
reasonable
security
to
protect
the
rights
of
the
certifying
agent's
clients
as
provided
in
the
NOP,
and
business
relationships
showing
absence
of
conflicts
of
interest).
Some
of
this
information
can
be
compiled
from
existing
records,
e.
g.,
fee
schedules,
and
some
may
be
generated
from
other
sources.

5.
Copies
must
be
submitted
to
USDA
of
all
notices
that
are
issued
on
certification
denial,
509
noncompliance,
and
suspension
or
revocation
of
certification.
This
requirement
will
be
fulfilled
simultaneously
with
sending
notices
to
applicants
or
clients.

6.
An
annual
report
to
the
Administrator
including
an
update
of
previously
submitted
business
information,
information
supporting
any
requested
changes
in
the
areas
of
accreditation,

and
steps
taken
to
respond
to
previously
identified
concerns
of
the
Administrator
regarding
the
certifying
agent's
suitability
for
continued
accreditation.
The
annual
report
requirement
will
draw
on
records
created
in
the
normal
course
of
business.

7.
Retention
of
records
created
by
the
certifying
agent
regarding
applicants
and
certified
operations
for
not
less
than
10
years,
retention
of
records
obtained
from
applicants
and
certified
operations
for
not
less
than
5
years,
and
retention
of
other
records
created
or
received
for
USDA
accreditation
for
not
less
than
5
years.
This
activity
requires
records,
database
management
capabilities,
and
resources
(
storage
space,
file
cabinets,
electronic
storage,
etc.).
In
an
informal
inquiry,
AMS
found
that
most
existing
certifying
agents
currently
retain
records
for
at
least
10
years
and
use
both
electronic
and
paper
storage.
We
believe
that
this
requirement
will
not
pose
an
additional
burden
on
existing
certifying
agents.

8.
Public
access
to
certification
records,
such
as
a
list
of
certified
farmers
and
handlers,

their
dates
of
certification,
products
produced,
and
the
results
of
pesticide
residue
tests.
This
requirement
will
have
minimal
impact
given
the
requirements
for
retaining
records.

9.
Providing
program
information
to
certification
applicants.
To
comply
with
this
requirement,
certifying
agents
may
need
to
modify
existing
standards
and
practices.
The
criteria
for
qualified
personnel
in
the
rule
may
likely
result
in
an
increase
in
labor
costs
for
some
existing
certifying
agents
and,
initially,
an
increase
in
training
costs.
The
amount
of
additional
costs
to
510
these
certifying
agents
would
depend
on
the
level
of
expertise
among
current
certification
agency
staff,
the
extent
to
which
certifying
agents
currently
rely
on
volunteers,
and
the
current
costs
of
training
certification
staff.

Producers
and
Handlers.
The
regulation
will
impose
administrative
costs
on
producers
and
handlers
for
reporting
and
recordkeeping.
The
actual
amount
of
the
additional
administrative
costs
that
would
be
imposed
by
the
final
rule
is
expected
to
be
different
for
those
entities
that
would
begin
their
activities
only
after
the
national
program
is
implemented.
Producers
and
handlers
who
currently
are
active
in
the
organic
industry
already
perform
most
of
these
administrative
functions;
therefore,
the
additional
costs
to
them
would
depend
upon
the
extent
to
which
their
current
practices
are
different
from
the
requirements
of
the
final
regulation.
An
estimate
of
the
cost
of
compliance
is
the
annual
reporting
and
recordkeeping
burden
documented
in
the
Paperwork
Reduction
Act
of
1995
analysis.

The
following
list
describes
several
administrative
requirements
or
optional
submissions
and
the
probable
resources
required
for
compliance.

1.
Establish,
implement,
and
update
annually
an
organic
production
or
handling
plan.

Organic
plans
are
a
standard
feature
in
the
organic
industry
and
are
required
by
certifying
agents.

Thus,
producers
and
handlers
who
are
already
involved
in
organics
can
rely
on
their
current
plan
with
revisions
as
needed
to
meet
elements
of
the
national
program
which
are
new
to
them
or
differ
from
their
current
practice.
Although
producers
and
handlers
are
generally
aware
of
the
goals
of
organic
plans,
current
practice
may
fall
short
of
the
rigor
that
will
be
required
by
the
national
program.
New
producers
and
handlers
will
have
higher
costs
because
they
will
have
to
prepare
a
plan
from
scratch.
511
2.
Maintain
records
pertaining
to
their
organic
operation
for
at
least
5
years
and
allow
authorized
representatives
of
the
Secretary,
the
applicable
State
organic
program's
governing
State
official,
and
the
certifying
agent
access
to
records.
Existing
organic
producers
and
handlers
maintain
records.
New
producers
and
handlers
will
have
to
develop
records
systems.
Access
is
expected
to
be
infrequent,
will
require
little
time
of
the
certified
entity,
and
will
not
require
buildings
or
equipment
other
than
what
is
required
for
storing
records.

3.
Notify
the
certifying
agent
as
required
(
e.
g.,
when
drift
of
a
prohibited
substance
may
have
occurred)
and
complete
a
statement
of
compliance
with
the
provisions
of
the
NOP.

Notifications
are
expected
to
be
infrequent.

The
total
reporting
burden
includes
creation
and
submission
of
documents.
It
covers
the
greatest
amount
of
reporting
burden
that
might
occur
for
any
single
creation
or
submission
of
a
document
during
any
one
of
the
first
3
years
following
program
implementation;
i.
e.,
2000,
2001,

and
2002.
The
total
estimated
reporting
burden
reflects
the
average
burden
for
each
reporting
activity
that
might
occur
in
1
year
of
this
3­
year
period.

The
total
recordkeeping
burden
is
the
amount
of
time
needed
to
store
and
maintain
records.
For
the
purpose
of
measuring
the
recordkeeping
burden,
the
year
2002
is
used
as
the
reporting
year
for
which
the
largest
number
of
records
might
be
stored
and
maintained.

The
annual
reporting
and
recordkeeping
burden
on
producers,
handlers,
and
certifying
agents
is
summarized
in
table
4.
The
annual
burden
on
certified
producers
is
estimated
at
24
hours
and
$
552.
Certified
handlers
have
an
estimated
burden
of
63
hours
valued
at
$
1,449.
The
burden
on
small
producers
and
handlers
who
choose
to
operate
as
exempt
entities
is
minimal,
1
hour
of
recordkeeping
valued
at
$
23.
If
this
cost
is
applied
to
the
total
estimated
number
of
512
affected
producers,
the
reporting
and
recordkeeping
cost
would
be
$
5,260,100
in
2000
and
$
6,835,554
in
2002.
By
applying
this
cost
figure
to
the
estimated
total
number
of
affected
handlers,
the
reporting
and
recordkeeping
cost
would
be
$
2,143,002
in
2000
and
$
3,013,552
in
2002.

Barriers
to
Entry
­
Importers
of
Organic
Products
Currently,
there
are
no
Federal
restrictions
on
importing
organic
products
to
the
United
States
in
addition
to
those
regulations
applying
to
conventional
products.
If
the
imposition
of
the
NOP
decreases
the
importation
of
organic
food
into
the
United
States,
then
this
regulatory
action
may
result
in
some
cost.

Small
Business
Ramifications
USDA's
final
rule
has
an
18­
month
period
during
which
applicants
for
accreditation
would
not
be
billed
for
hourly
services.
The
rationale
for
this
transition
period
is
to
reduce
the
costs
to
certifying
agents
and,
thus,
increase
the
prospect
that
certifying
agents,
producers,
and
handlers
will
be
able
to
afford
to
participate
in
the
national
program.
The
choice
of
18
months
is
intended
to
provide
sufficient
time
for
parties
desiring
accreditation
to
submit
their
application
and
prepare
for
a
site
evaluation.

USDA
will
operate
the
program
partially
with
appropriated
funds,
in
effect
sharing
the
cost
of
the
program
between
taxpayers
and
the
organic
industry,
to
respond
to
public
concerns
regarding
the
effects
of
the
regulation
on
small
businesses.
Thousands
of
comments
were
received
opposing
the
first
proposal's
fee
provisions
with
most
focusing
on
the
substantial
impact
on
small
certifying
agents.

Congress
has
expressed
public
policy
concern
with
the
impacts
of
regulations
on
small
513
entities
generally
and
with
the
impacts
on
the
NOP
regulations
on
small
entities
particularly.
The
Small
Business
Regulatory
Enforcement
Fairness
Act
of
1996
and
the
Regulatory
Flexibility
Act
express
Congressional
concern
regarding
regulatory
burden
on
small
businesses.
The
Report
from
the
Committee
on
Appropriations
regarding
the
Agriculture,
Rural
Development,
Food
and
Drug
Administration,
and
Related
Agencies
Appropriations
Bill,
2000,
includes
the
following
language
(
U.
S.
Senate
1999):

"
The
Committee
continues
to
recognize
the
importance
of
organic
markets
for
small
farmers
and
fishermen.
The
Committee
expects
the
Secretary
to
construct
a
national
organic
program
that
takes
into
consideration
the
needs
of
small
farmers
and
fishermen.
...

Furthermore,
the
Committee
expects
that
of
the
funding
available
for
the
National
Organic
Program,
necessary
funds
should
be
used
to
offset
the
initial
costs
of
accreditation
services,
a
subsidy
necessary
due
to
the
lack
of
expertise
in
the
Department
of
Agriculture
in
the
areas
of
organic
accreditation
and
insufficient
data
on
the
industry."

Certifying
agents
applying
for
accreditation
during
the
first
18
months
following
the
final
regulation
will
face
lower
direct
costs
than
subsequent
applicants.
The
cost
for
later
applicants
for
accreditation
will
be
higher
because
they
will
have
to
pay
a
$
500
application
fee
and
hourly
charges
for
completing
their
site
evaluation.
The
requirement
for
accreditation
was
established
in
the
OFPA
in
1990
and
the
accreditation
program
was
part
of
the
1997
proposal.
Because
in
this
final
rule,
USDA
is
using
appropriated
funds
to
cover
some
of
the
costs
of
initial
accreditation
during
the
first
18
months
of
the
program,
certifying
agents
may
set
lower
fees
initially
benefiting
the
producers
and
handlers
who
are
certified
during
this
period.

It
is
important
to
note
that
many
small
organic
operations
may
not
be
certified
currently.
514
In
California,
for
example,
many
small
farms
are
registered
but
not
certified.
Even
if
certifying
agents
pass
on
the
cost
savings
of
the
18­
month
period
provision
to
applicants
for
certification,

the
cost
of
certification
may
be
higher
than
the
cost
of
registration.
Hence,
becoming
a
certified
operation
for
small
organic
producers
and
handlers
may
be
more
costly
than
the
current
practices.

The
costs
imposed
on
small
operations
may
be
mitigated
by
a
$
5000
certification
exemption
to
aid
the
smallest
organic
operations.
However,
these
operations
are
still
subject
to
other
requirements
of
the
regulation.
To
the
extent
that
these
requirements
differ
from
their
current
practices,
complying
with
the
national
standards
may
be
costly
for
exempt
operations.

In
addition,
the
certification
exemption
allowed
under
the
regulation
includes
limits
on
what
an
exempt
operation
may
do.
Without
the
certification,
small
organic
operations
may
not
display
the
USDA
seal
and
may
not
use
a
certifying
agent's
seal.
If
the
consumers
of
organic
food
view
the
seals
as
important
information
tools
on
organic
food;
that
is,
if
consumers
of
organic
products
insist
on
only
certified
organic
products,
the
inability
of
small
operations
to
display
these
seals
may
prevent
them
from
realizing
the
price
premiums
associated
with
certified
organic
products.

Industry
Composition
The
imposition
of
the
national
standards
may
change
the
composition
of
the
organic
industry.
Even
with
the
small
business
exemptions,
some
small
organic
operations
may
choose
to
exit
the
industry,
and
small
organic
operations
may
also
be
discouraged
from
entering
the
industry,
resulting
in
a
higher
concentration
of
larger
firms.
On
the
other
hand,
it
may
be
easier
for
small
operations
to
comply
with
certain
NOP
standards,
such
as
the
livestock
standards
that
prohibit
confinement
production
systems
and
require
100
percent
organic
feed.
And
State
and
515
Federal
certification
and
conservation
cost­
share
programs
and
other
government
programs
may
help
lower
the
impact
on
small
producers.

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Agr.
Econ.
Vol.
80,
No.
5:
1113­
1118.

Underhill,
S.
E.
and
E.
E.
Figueroa.
1993.
Consumer
Preferences
for
Non­
Conventionally
Grown
Produce.
Paper
presented
at
the
Valuing
Food
Safety
and
Nutrition
Conference,

organized
by
the
NE­
165
Regional
Research
Project.
Alexandria,
VA,
June
2­
4.

USDA
Foreign
Agricultural
Service.
1995.
Agricultural
Situation:
Agricultural
Highlights,

Winter
1995.
Report
from
Austria.
Code
24,
Sequence
No.
007.

USDA
Foreign
Agricultural
Service.
1995.
Agricultural
Situation:
Organic
Food.
Report
from
Germany.
Code
24,
Sequence
No.
011.

USDA
Foreign
Agricultural
Service.
1996.
Agricultural
Situation:
Organic
Food
Market
Potential
and
Regulations.
Report
from
France.
Code
24,
Sequence
No.
002.

USDA
Foreign
Agricultural
Service.
1999a.
Report
on
organic
agriculture
in
Japan.
Attache
report
JA91234.
October
5.

USDA
Foreign
Agricultural
Service.
1999b.
Report
on
organic
agriculture
in
France.
Attache
report
FR9070.
October
18.

U.
S.
Senate.
1999.
Report
106­
80.
Agriculture,
Rural
Development,
Food
and
Drug
Administration,
and
Related
Agencies
Appropriation
Bill
2000.
Committee
on
Appropriations.

Page
56.

Weaver,
Robert
D.,
David
J.
Evans,
and
A.
E.
Luloff.
1992.
Pesticide
Use
in
Tomato
Production:

Consumer
Concerns
and
Willingness­
to­
Pay.
Agribusiness,
Vol.
8
No.
2:
131­
142.
Table
1.
516
TABLE
1.
 
U.
S.
ORGANIC
PRODUCT
SALES,
1990­
99
($
billions)

Year
Export
Direct
Export/
Mass
Natural
Natural
Total
Total
Direct
Market
Foods
Foods
Sales
Sales
Subtotal
Stores
(
1999
$)
Stores
(
1999
$)

1990
­­
­­
­­
­­
­­
­­
1
1.27
1991
0.04
0.27
0.31
0.09
0.85
1.04
1.25
1.53
1992
0.07
0.32
0.39
0.12
1.03
1.22
1.54
1.83
1993
0.11
0.36
0.47
0.14
1.29
1.49
1.90
2.19
1994
0.20
0.39
0.60
0.17
1.54
1.73
2.31
2.60
1995
1/
1/
0.71
0.21
1.87
2.04
2.79
3.05
1996
­­
­­
1/
1/
1/
1/
3.5
3.72
1997
­­
­­
­­
­­
2/
­­
­­
­­

1998
­­
­­
­­
­­
3.28
3.35
­­
­­

1999
­­
­­
­­
­­
4.00
4.00
­­
­­

Source:
Natural
Foods
Merchandiser,
New
Hope
Communications
.
­­
=
Not
reported.

1/
New
Hope
Communications
reported
a
combined
estimate
for
export
and
direct
sales
in
1995
and
reported
a
different
set
of
subcategories
in
1996
and
has
reported
only
on
sales
in
natural
foods
stores
since
1996.

2/
New
Hope
Communications
did
not
estimate
natural
product
store
sales
in
1997,
but
the
Hartman
Group
estimated
these
sales
at
$
4.9
billion.
517
TABLE
2A.
 
FIRST­
YEAR
CERTIFICATION
COSTS,
FROM
GRAF
AND
LOHR
ANALYSIS
(
dollars)

Certifying
agent
Small
farm
Medium
farm
Large
farm
Super
farm
CCOF
850
1,750
4,850
51,250
FVO
698
1,737
5,214
51,550
FOG
810
1,860
4,860
51,210
NOFA­
VT
335
535
585
585
NC/
SCS
700
900
1,000
2,000
OGBA
1,290
3,300
12,300
33,296
OTCO­
In
608
1,603
2,517
150,300
OTCO­
Out
768
1,698
2,852
12,052
OCIA­
WI
315
1,590
6,090
75,090
OCIA­
VA
258
320
495
1,745
TDA
90
155
200
575
WSDA
480
1,555
3,040
12,480
Average
cost
579
1,414
3,623
33,276
Notes:
CCOF
 
California
Certified
Organic
Farmers
FVO
 
Farm
Verified
Organic
FOG
 
Florida
Certified
Organic
Growers
&
Consumers
NOFA­
VT
 
Northeast
Organic
Farming
Association
 
Vermont
NC/
SCS
 
NutriClean/
Scientific
Certification
Systems
OBBA
 
Organic
Growers
and
Buyers
Association
OTCO­
In
 
Oregon
Tilth
Certified
Organic,
inside
Oregon
OTCO­
Out
 
Oregon
Tilth
Certified
Organic,
outside
Oregon
OCIA­
WI
 
Organic
Crop
Improvement
Association,
Wisconsin
chapter
OCIA­
VA
 
Organic
Crop
Improvement
Association,
Virginia
chapter
TDA
 
Texas
Department
of
Agriculture
WSDA
 
Washington
State
Department
of
Agriculture
Small
farm
 
25
acres
with
annual
sales
of
$
30,000.
Medium
farm
 
150
acres
with
annual
sales
of
$
200,000.
Large
farm
 
500
acres
with
annual
sales
of
$
800,000.
Super
farm
 
3,000
acres
with
annual
sales
of
$
10,000,000.
518
TABLE
2B.
 
SUBSEQUENT­
YEAR
CERTIFICATION
COSTS,
FROM
GRAF
AND
LOHR
ANALYSIS
(
dollars)

Certifying
agent
Small
farm
Medium
farm
Large
farm
Super
farm
CCOF
425
1,300
4,350
50,550
FVO
510
1,499
4,851
51,187
FOG
325
845
2,525
25,525
NOFA­
VT
300
500
550
550
OTCO­
In
454
1,611
2,362
11,363
OTCO­
Out
424
1,353
2,207
11,208
OCIA­
WI
290
1,565
6,065
75,065
OCIA­
VA
233
295
470
1,720
TDA
90
155
200
515
WSDA
330
1,375
2,800
12,000
NC/
SCS
700
900
1,000
2,000
Average
cost
371
1,036
2,489
21,971
Notes:
CCOF
 
California
Certified
Organic
Farmers
FVO
 
Farm
Verified
Organic
FOG
 
Florida
Certified
Organic
Growers
&
Consumers
NOFA­
VT
 
Northeast
Organic
Farming
Association
 
Vermont
NC/
SCS
 
NutriClean/
Scientific
Certification
Systems
OBBA
 
Organic
Growers
and
Buyers
Association
OTCO­
In
 
Oregon
Tilth
Certified
Organic,
inside
Oregon
OTCO­
Out
 
Oregon
Tilth
Certified
Organic,
outside
Oregon
OCIA­
WI
 
Organic
Crop
Improvement
Association,
Wisconsin
chapter
OCIA­
VA
 
Organic
Crop
Improvement
Association,
Virginia
chapter
TDA
 
Texas
Department
of
Agriculture
WSDA
 
Washington
State
Department
of
Agriculture
Small
farm
 
25
acres
with
annual
sales
of
$
30,000.
Medium
farm
 
150
acres
with
annual
sales
of
$
200,000.
Large
farm
 
500
acres
with
annual
sales
of
$
800,000.
Super
farm
 
3,000
acres
with
annual
sales
of
$
10,000,000.
519
TABLE
3.
 
COSTS
OF
ACCREDITATION
AND
CERTIFICATION
Estimated
costs
to
certifying
agents
during
first
18
months
Application
fee
$
0
1
Site
evaluation
costs
(
two
person
team)

Per
diem
(
3
to
5
days
at
$
85/
day)

Travel
(
domestic)

Hourly
charges
(
not
billed
during
the
first
18
months)

Miscellaneous
charges
(
copying,
phone,
and
similar
costs)
$
510
to
$
850
$
1,000
to
$
1,200
$
0
$
50
Total
$
1,560
to
$
2,100
Estimated
costs
to
certifying
agents
for
initial
accreditation
after
first
18
months
Site
evaluation
costs
(
two
person
team)

Per
diem
(
3
to
5
days)
$
510
to
$
850
Travel
(
domestic)
$
1,000
to
$
1,200
Hourly
charges
(
24
to
40
hours
at
$
95/
hour))
$
4,560
to
$
7,600
Miscellaneous
charges
(
copying,
phone,
and
similar
costs)
$
50
Total
$
6,120
to
$
9,700
Annual
review
fees
for
certifying
agents
(
2
to
8
hours
at
$
95/
hour)
2
$
190
to
$
760
Estimated
costs
to
producers
for
certification
3
Certification
fee
(
renewals)
$
730
520
Estimated
costs
to
handlers
for
certification
4
Certification
fee
(
initial
certification)
$
2,337
Certification
fee
(
renewals)
$
1,665
Nonrefundable
fee
that
will
be
applied
to
the
applicant's
fee­
for­
service
account.
1
Certifying
agents
are
required
to
submit
annual
reports
to
USDA.
Review
of
these
2
reports
is
expected
to
range
from
2
to
8
hours
at
an
approximate
rate
of
$
95
per
hour.

Estimated
certification
fees
are
calculated
from
Graf
and
Lohr
1999
which,
for
a
3
selection
of
certification
agents,
provides
certification
costs
for
four
hypothetical
farm
sizes:
(
1)

small
farm
(
family
farm):
25
acres,
$
30,000
annual
sales,
5
hours
to
certify;
(
2)
medium
farm
(
cottage
industry):
150
acres,
$
200,000
annual
sales,
6
hours
to
certify;
(
3)
large
farm
(
commercial
farm):
500
acres,
$
800,000
annual
sales,
8
hours
to
certify;
and
(
4)
super
farm:

3,000
acres,
$
10,000,000
annual
sales,
16
hours
to
certify.
Our
estimated
certification
fees
only
include
those
charged
for
small
and
medium
farms
because
most
organic
producers
fall
into
these
categories
as
defined
by
Graf
and
Lohr.
In
the
1997
OFRF
survey,
90
percent
of
respondents
had
gross
organic
farming
income
of
less
than
$
250,000,
with
82
percent
less
than
$
100,000.

The
average
current
certification
cost
for
most
organic
producers
is
about
$
1,025
for
the
first
year
of
certification
($
579
for
small
and
$
1,414
for
medium
farms)
and
about
$
705
for
subsequent
years
($
371
for
small
and
$
1,036
for
medium
farms).
Approximately
$
25
is
added
to
cover
the
costs
associated
with
the
National
Organic
Program
for
an
estimated
first­
year
certification
fee
of
$
1,000
and
subsequent­
year
certification
fee
of
$
730
for
producers.
Larger
producers
could
expect
higher
fees.
521
Because
Graf
and
Lohr
do
not
estimate
certification
fees
for
handlers,
we
estimate
these
4
fees
by
applying
a
ratio
of
handler­
to­
producer
certification
fees
from
the
regulatory
impact
assessment
from
1997.
The
ratio
is
2:
28
and
results
in
estimated
fees
of
$
2,337
and
$
2,665,

respectively.

TABLE
4.
 
ESTIMATED
ANNUAL
REPORTING
AND
RECORDKEEPING
BURDEN
Type
of
respondent
Annual
hours
per
Hourly
rate
Annual
cost
respondent
Certified
producer
24
$
23
$
552
Certified
handler
63
$
23
$
1,449
Exempt
producers
and
handlers
1
$
23
$
23
Certifying
agency
1,068
$
27
$
27,729
Note:
Estimates
derived
from
Paperwork
Reduction
Act
of
1995
analysis.

Appendix
B.­­
Unfunded
Mandates
Reform
Act
This
rule
has
been
reviewed
under
the
Unfunded
Mandates
Reform
Act
(
P.
L.
104­
4).
The
Act
requires
that
agencies
prepare
a
qualitative
and
quantitative
assessment
of
the
anticipated
costs
and
benefits
before
issuing
any
rule
that
may
result
in
annual
expenditures
by
State,
local,

and
tribal
governments,
in
the
aggregate,
or
by
the
private
sector
of
$
100
million
(
adjusted
annually
for
inflation)
in
any
1
year.
According
to
the
Act,
the
term,
"
Federal
mandate,"
means
any
provision
in
legislation,
statute,
or
regulation
that
would
impose
an
enforceable
duty
upon
State,
local,
or
tribal
governments
or
the
private
sector,
except
a
duty
arising
from
participation
in
a
voluntary
Federal
program.
522
The
National
Organic
Foods
Production
Act
(
OFPA)
of
1990
mandates
that
the
Secretary
develop
a
national
organic
program
to
accredit
eligible
governing
State
officials
or
private
persons
as
certifying
agents
who
would
certify
producers
or
handlers
of
agricultural
products
that
have
been
produced
using
organic
methods
as
provided
for
in
the
OFPA.
The
OFPA
also
permits
a
governing
State
official
to
voluntarily
establish
a
State
organic
program
(
SOP)
if
the
program
is
approved
by
the
Secretary
and
meets
the
requirements
of
the
OFPA.
The
OFPA
does
not
require
that
States
establish
their
own
SOP's
or
that
State,
local,
or
tribal
governments
or
the
private
sector
become
accredited;
therefore,
the
OFPA
is
not
subject
to
the
Unfunded
Mandates
Reform
Act
because
it
is
a
voluntary
program.

Although
the
U.
S.
Department
of
Agriculture
has
determined
that
this
rule
is
not
subject
to
the
Unfunded
Mandates
Reform
Act,
USDA
has
sought
to
consider
the
rule's
impact
on
various
entities.
USDA
prepared
a
Regulatory
Impact
Assessment
(
RIA)
that
is
discussed
in
the
section
entitled
"
Executive
Order
12866"
(
also
attached
as
an
appendix
to
this
regulation).
The
RIA
consists
of
a
statement
of
the
need
for
the
action,
an
examination
of
alternative
approaches,

and
an
analysis
of
the
benefits
and
costs.
Much
of
the
analysis
is
necessarily
descriptive
of
the
anticipated
impacts
of
the
rule.
Because
basic
market
data
on
the
prices
and
quantities
of
organic
goods
and
services
and
the
costs
of
organic
production
are
limited,
it
is
not
possible
to
provide
quantitative
estimates
of
all
benefits
and
costs
of
the
rule.
The
cost
of
fees
and
recordkeeping
required
by
USDA
are
quantified,
but
the
anticipated
benefits
are
not.
Consequently,
the
analysis
does
not
contain
an
estimate
of
net
benefits.

The
analysis
employed
in
reaching
a
determination
that
this
rule
is
the
least
costly
and
least
burdensome
to
the
regulated
parties
is
discussed
in
the
sections
entitled
"
The
Regulatory
523
Flexibility
Act
and
the
Effects
on
Small
Businesses"
and
"
Paperwork
Reduction
Act
of
1995."

The
rule
has
been
designed
to
be
as
consistent
as
possible
with
existing
industry
practices,
while
satisfying
the
specific
requirements
of
the
OFPA.

We
have
had
numerous
occasions
during
which
to
communicate
with
various
entities
during
the
development
of
the
rule;
States,
for
example.
Currently,
there
are
32
States
with
some
standards
governing
the
production
or
handling
of
organic
food
and
13
States
with
organic
certifying
programs.
Representatives
of
State
governments
have
participated
in
public
meetings
with
the
National
Organic
Standards
Board,
while
the
NOP
staff
has
made
presentations,
received
comments,
and
consulted
with
States
and
local
and
regional
organic
conferences,
workshops,
and
trade
shows.
States
have
been
actively
involved
in
training
sessions
for
organic
inspectors;
public
hearings
concerning
standards
for
livestock
products
during
1994;
a
national
Organic
Certifiers
meeting
on
July
21,
1995;
a
USDA­
hosted
meeting
on
February
26,
1996;
a
State
certifiers
meeting
in
February
1999;
and
an
International
Organization
for
Standardization
(
ISO)
65
assessment
training
session
for
certifiers
in
April­
May
1999.
More
detail
about
contact
with
States
regarding
this
rule
is
in
the
Federalism
section.
It
is
unknown
at
this
time
how
many
States,
if
any,
might
voluntarily
establish
their
own
SOP's
pursuant
to
the
OFPA
and
the
regulations.

Appendix
C.­­
Final
Regulatory
Flexibility
Analysis
The
Regulatory
Flexibility
Act
(
5
U.
S.
C.
601
et
seq.)
requires
agencies
to
consider
the
economic
impact
of
each
rule
on
small
entities
and
evaluate
alternatives
that
would
accomplish
the
objectives
of
the
rule
without
unduly
burdening
small
entities
or
erecting
barriers
that
would
restrict
their
ability
to
compete
in
the
market.
The
purpose
is
to
fit
regulatory
actions
to
the
scale
524
of
businesses
subject
to
the
action.

1.
Need
for
and
objectives
of
the
National
Organic
Rule
Currently,
organic
certification
is
voluntary
and
self­
imposed.
Members
of
organic
industries
across
the
United
States
have
experienced
numerous
problems
marketing
their
organically
produced
and
handled
agricultural
products.
Inconsistent
and
conflicting
organic
production
standards
may
have
been
an
obstacle
to
the
effective
marketing
of
organic
products.

There
are
currently
36
private
and
13
State
organic
certification
agencies
(
certifying
agents)
in
the
United
States,
each
with
its
own
standards
and
identifying
marks.

Some
existing
private
certifying
agents
are
concerned
that
States
might
impose
registration
or
licensing
fees
which
would
limit
or
prevent
private
certification
activities
in
those
States.
Labeling
problems
have
confronted
manufacturers
of
multiingredient
organic
food
products
containing
ingredients
certified
by
different
certifying
agents
because
reciprocity
agreements
have
to
be
negotiated
between
certifying
agents.
Consumer
confusion
may
exist
because
of
the
variety
of
seals,
labels,
and
logos
used
by
certifying
agents
and
State
programs.

Also,
there
is
no
industrywide
agreement
on
an
accepted
list
of
substances
that
should
be
permitted
or
prohibited
for
use
in
organic
production
and
handling.
Finally,
a
lack
of
national
organic
standards
may
inhibit
organic
producers
and
handlers
in
taking
full
advantage
of
international
organic
markets
and
may
reduce
consumer
choices
in
the
variety
of
organic
products
available
in
the
marketplace.

To
address
these
problems
in
the
late
1980'
s,
the
organic
industry
attempted
to
establish
a
national
voluntary
organic
certification
program.
At
that
time,
the
industry
could
not
develop
consensus
on
the
standards
that
should
be
adopted,
so
Congress
was
petitioned
by
the
Organic
525
Trade
Association
to
establish
national
standards
for
organic
food
and
fiber
products.

In
1990,
Congress
enacted
the
Organic
Foods
Production
Act
of
1990,
as
amended
(
7
U.
S.
C.
6501
et
seq.)
(
OFPA).
The
OFPA
requires
all
agricultural
products
labeled
as
"
organically
produced"
to
originate
from
farms
or
handling
operations
certified
by
a
State
or
private
agency
that
has
been
accredited
by
USDA.

The
purposes
of
the
OFPA,
set
forth
in
section
2102
(
7
U.
S.
C.
6501),
are
to:
(
1)
establish
national
standards
governing
the
marketing
of
certain
agricultural
products
as
organically
produced
products;
(
2)
assure
consumers
that
organically
produced
products
meet
a
consistent
standard;
and
(
3)
facilitate
commerce
in
fresh
and
processed
food
that
is
organically
produced.

The
National
Organic
Program
(
NOP)
is
the
result
of
the
OFPA.

Recently,
the
Organic
Trade
Association
published
American
Organic
Standards,

Guidelines
for
the
Organic
Industry
(
AOS).
However,
not
all
participants
in
the
organic
industry
elected
to
participate
in
developing
the
AOS.
Many
certifying
agents
preferred
to
wait
for
implementation
of
the
national
standards,
and
some
certifying
agents
disagree
with
portions
of
the
AOS.
For
these
reasons,
USDA
will
implement
a
regulation
for
the
NOP.
.

2.
Summary
of
the
significant
issues
raised
by
public
comments
in
response
to
the
Initial
Regulatory
Flexibility
Analysis
(
IRFA),
a
summary
of
agency
assessment
of
such
issues,
and
a
statement
of
any
changes
made
in
the
final
rule
as
a
result
of
such
comments.

Although
we
received
many
individual
comments
in
reference
to
the
proposed
rule's
IRFA,

they
were,
for
the
most
part,
variations
of
several
form
letters.
Most
of
the
concern
on
the
part
of
commenters
regarded
the
fees
that
small
certifying
agents
would
be
subject
to
under
the
rule.

Comments
Accepted:
526
(
1)
We
received
numerous
comments
to
the
effect
that
the
fees,
recordkeeping,
and
paperwork
requirements
for
producer
and
handler
certification
must
be
kept
as
low
as
possible
while
still
offering
a
quality
certification
program.
We
believe
that
we
have
made
every
effort
in
this
rule
to
minimize
the
cost
and
paperwork
burden
to
certifiers
and
certified
operations
as
much
as
possible.
We
have
permitted
certifiers
and
certified
operations
to
develop
their
own
recordkeeping
and
reporting
systems
 
so
long
as
they
conform
to
the
needs
of
the
program.
For
the
most
part,
the
paperwork
and
recordkeeping
requirements
for
certified
operations
conform
to
the
requirements
that
they
presently
face
under
existing
certification
programs.
In
order
to
minimize
the
cost
to
the
industry
of
transitioning
to
a
system
where
certifying
agents
are
accredited
(
assuming
that
there
will
be
a
learning
curve
as
agents
familiarize
themselves
with
the
requirements
of
accreditation),
we
have
waived
the
per­
hour
cost
that
USDA
will
charge
to
conduct
an
accreditation
review
for
the
first
18
months
of
the
program.

(
2)
In
the
proposed
rule,
we
requested
comment
on
the
benefits
of
an
exemption
for
small
certifiers
similar
to
that
for
small
producers.
We
received
comments
in
opposition
to
such
an
exemption
because
commenters
wanted
to
maintain
documented
verification
of
standards
that
is
afforded
by
certification
and
accreditation.
They
felt
that
exemptions
weakened
the
organic
system
in
its
ability
to
assure
consumers
of
products
that
meet
a
consistent
standard.
We
concurred
with
this
comment
and
have
not
developed
an
exemption
for
certifiers
in
the
final
rule.

Comments
Rejected:

(
3)
We
received
comments
suggesting
that,
in
order
to
lower
the
direct
cost
of
accreditation
to
smaller
certifier
applicants,
we
should
eliminate
on­
site
visits
during
accreditation
or
extend
the
time
beyond
the
initial
on­
site
visit
for
a
subsequent
visit.
Although
eliminating
the
527
on­
site
visits
would
certainly
lower
the
applicant's
costs,
we
have
not
made
the
change
to
reduce
or
eliminate
on­
site
visits.
We
did
not
see
how
USDA
could
make
an
informed
decision
about
whether
or
not
to
continue
to
accredit
a
certifying
agent
without
complete
access
to
the
relevant
records
documenting
the
agent's
business
practices.
This
can
only
be
efficiently
done
through
a
site
visit.

(
4)
We
received
numerous
comments
that
the
fees
proposed
by
USDA
will
result
in
certification
fees
that
are
excessive
for
small
farming
operations.
The
commenters
suggested
that
USDA
impose
fees
on
a
sliding
scale
based
on
a
farmer's
income
so
as
not
to
drive
these
farmers
out
of
business
and
deprive
consumers
of
the
benefits
of
these
operations.
We
received
a
similar
comment
to
the
Fees
section
of
the
proposed
rule,
and
our
response
is
the
same.
Although
one
of
our
top
priorities
is
assisting
the
small
farmer,
AMS
is
primarily
a
user­
fee­
based
Federal
agency.

We
are
aware
that
our
accreditation
fees
will
figure
into
the
fees
that
certifiers
charge
their
clients.

However,
the
fee
we
will
charge
to
accredit
an
applicant
is
based
not
on
earning
profits,
but
on
recovery
of
costs.
In
addition,
our
waiver
of
the
hourly
service
charges
for
accreditation
during
the
first
18
months
of
the
program
should
help
to
keep
the
cost
of
accreditation
to
certifying
agents
down.
We
believe
the
requirements
that
fees
charged
by
a
certifying
agent
must
be
reasonable
and
that
certifiers
must
file
a
fee
schedule
for
approval
by
the
Administrator
will
help
to
keep
costs
under
control.
Since
certifiers
are
required
to
provide
their
approved
fee
schedules
to
applicants
for
certification,
the
applicants
will
be
able
to
base
their
selection
of
certifying
agent
on
price
if
the
applicants
so
choose.
In
addition,
nothing
in
the
regulations
precludes
certifying
agents
from
pricing
their
services
on
a
sliding
scale
so
long
as
their
fees
are
consistent
and
nondiscriminatory
and
are
approved
during
the
accreditation
process.
528
(
5)
Other
commenters
were
concerned
that
in
the
rule
USDA
neglects
to
establish
"
reasonable
fees"
annually
for
farm/
site/
wild
crop
production
and
handling
operation
certification.

Commenters
did
not
believe
that
a
valid
Regulatory
Flexibility
Act
analysis
could
be
made
without
the
annual
farm
and
handling
operation
fee
projection.
We
have
not
established
guidelines
for
what
constitutes
a
"
reasonable
fee"
in
the
final
rule.
Accredited
certifying
agents
will
be
required
to
submit
a
proposed
fee
schedule
as
a
part
of
their
application.
At
that
time,
we
will
work
with
applicants
for
accreditation
to
ensure
that
their
fees
are
appropriate.
In
addition,
certifying
agents
will
be
required
to
send
a
copy
of
their
fee
schedule
to
anyone
who
requests
one.
This
will
allow
operations
that
wish
to
be
certified
to
shop
around
and
will
provide
a
disincentive
for
accredited
agents
to
price
themselves
out
of
the
market.

3.
Description
of
and
an
estimate
of
the
number
of
small
entities
to
which
the
rule
will
apply.

Small
business
size
standards,
Standard
Industrial
Code
(
SIC)
(
13
CFR
part
121),
are
developed
by
an
interagency
group,
published
by
the
Office
of
Management
and
Budget,
and
used
by
the
Small
Business
Administration
(
SBA)
to
identify
small
businesses.
These
standards
represent
the
number
of
employees
or
annual
receipts
constituting
the
largest
size
that
a
for­
profit
enterprise
(
together
with
its
affiliates)
may
be
and
remain
eligible
as
a
small
business
for
various
SBA
and
other
Federal
Government
programs.

There
are
three
categories
of
operations
that
contain
small
business
entities
that
would
be
affected
by
this
rule:
certifying
agents,
organic
producers,
and/
or
organic
handlers.
The
term,

"
certifying
agent,"
means
the
chief
executive
officer
of
a
State
or,
in
the
case
of
a
State
that
provides
for
the
statewide
election
of
an
official
to
be
responsible
solely
for
the
administration
of
529
the
agricultural
operations
of
a
State,
such
official
and
any
person
(
including
private
entities)
who
is
accredited
by
the
Secretary
as
a
certifying
agent
for
the
purpose
of
certifying
a
farm
or
handling
operation
as
a
certified
organic
farm
or
handling
operation.

According
to
the
most
complete
data
available
to
USDA's
Agricultural
Marketing
Service
(
AMS),
there
are
49
certifying
agents
(
36
private
and
13
State)
in
the
United
States.
More
than
half
of
the
private
and
State
certifying
agents
certify
both
producers
and
handlers,
while
the
others
certify
only
producers.
Over
three­
fourths
of
private
and
State
certifying
agents
each
certify
fewer
than
150
producers
and
20
handlers.
The
number
of
certifying
agents
has
remained
fairly
stable,

between
40
and
50,
for
some
years,
with
entries
and
exits
tending
to
offset
each
other.
The
NOP
staff
anticipates
that,
in
addition
to
the
49
domestic
certifying
agents,
10
foreign
certifying
agents
may
seek
accreditation
during
the
initial
phase
of
the
program.

Small
businesses
in
the
agricultural
services
sector,
such
as
certifying
agents,
include
firms
with
average
annual
revenues
of
less
than
$
5
million
(
SIC
Division
A
Major
Group
7).
Based
on
SBA's
small
business
size
standards
for
the
agricultural
services
sector,
it
is
not
likely
that
many,
if
any,
of
the
49
domestic
certifying
agents
have
annual
revenue
greater
than
$
5
million.
All
private,

nonprofit
certifying
agents
would
be
considered
small
by
SBA's
standards.
Based
on
anecdotal
information,
only
a
few
private,
for­
profit,
certifying
agents
might
be
categorized
as
large
businesses.
In
addition,
the
13
State
certifying
agents,
although
not
exceeding
the
revenue
threshold,
would
not
be
considered
to
be
small
entities
under
the
Act
as
only
government
jurisdictions
with
populations
under
50,000
are
considered
to
be
small
entities
under
section
601(
5).
Therefore,
at
least
30
certifying
agents
would
qualify
as
a
small
business.

The
term,
"
producer,"
means
a
person
who
engages
in
the
business
of
growing
or
530
producing
food
or
feed.
It
is
more
difficult
to
establish
the
number
of
organic
producers.
Organic
farming
was
not
distinguished
from
conventional
agriculture
in
the
1997
Census
of
Agriculture.

There
are
sources
which
give
insight
into
the
number
of
producers.
The
Organic
Farming
Research
Foundation
(
OFRF),
a
California­
based
nonprofit
organization,
has
conducted
three
nationwide
surveys
of
certified
organic
producers
from
lists
provided
by
cooperating
certifying
agents.
The
most
recent
survey
applies
to
the
1997
production
year
(
1).
OFRF
sent
its
1997
survey
to
4,638
names
and
received
1,192
responses.
Because
OFRF
did
not
obtain
lists
from
all
certifying
organizations
or
their
chapters
(
55
out
of
a
total
of
64
identified
entities
provided
lists),

its
list
count
is
likely
an
understatement
of
the
number
of
certified
organic
producers.
Note
that
the
estimated
number
of
organic
producers
includes
only
certified
organic
farms.
Comments
filed
in
response
to
the
first
proposal
and
studies
indicate
that
the
total
number
of
organic
farms
is
higher.

Dunn
has
estimated
the
number
of
certified
organic
producers
in
the
United
States
(
2,
3)

Dunn's
1995
work,
a
USDA
study,
estimated
the
number
of
certified
producers
at
4,060
in
1994;

this
estimate
was
used
in
the
first
proposal.
Dunn's
1997
work
reported
4,060
certified
organic
farms
in
1994
and
4,856
in
1995.

Data
collected
by
AMS
indicate
that
the
number
of
organic
farmers
increased
about
12
percent
per
year
during
the
period
1990
to
1994.
OFRF
survey
efforts
indicate
that
growth
has
continued,
although
it
is
not
clear
whether
the
growth
rate
has
changed.
Similarly,
growth
in
retail
sales,
the
addition
of
meat
and
poultry
to
organic
production,
and
the
possibility
of
increased
exports
suggest
that
the
number
of
operations
has
continued
to
increase.
Lacking
an
alternative
estimate
of
the
growth
rate
for
the
number
of
certified
organic
producers,
we
use
the
average
531
growth
rate
of
about
14
percent
from
Dunn's
1997
study.
The
true
rate
of
growth
could
be
higher
or
lower.
Applying
the
14­
percent
growth
rate
to
Dunn's
estimate
of
certified
producers
in
1995
gives
an
estimate
of
8,200
organic
producers
for
1999.

An
adjustment
is
needed
to
account
for
the
number
of
producers
who
are
practicing
organic
agriculture
but
who
are
not
certified
and
who
would
be
affected
by
this
regulation.
We
assume
that
the
number
of
organic
but
not
certified
producers
in
1999
is
about
4,000.
This
assumption
is
based
on
very
limited
information
about
the
number
of
registered
but
not
certified
organic
producers
in
California
in
1995.
Thus,
the
total
number
of
certified
organic
producers
used
in
assessing
the
impact
of
the
rule
is
12,176.

Producers
with
crop
production
(
SIC
Division
A
Major
Group
1)
and
annual
average
revenues
under
$
500,000
are
small
businesses.
Producers
with
livestock
or
animal
specialities
are
also
considered
small
if
annual
average
revenues
are
under
$
500,000
(
SIC
Division
A
Major
Group
2),
with
the
exception
of
custom
beef
cattle
feedlots
and
chicken
eggs,
which
are
considered
small
if
annual
average
revenues
are
under
$
1,500,000.

Based
on
SBA's
small
business
size
standards
for
producers,
it
is
likely
that
almost
all
organic
producers
would
be
considered
small.
The
OFRF
survey
asked
for
the
producer's
total
gross
organic
farming
income
during
1997.
Only
35
(
less
than
3
percent)
of
the
survey
respondents
reported
gross
income
greater
than
$
500,000,
the
SBA's
cutoff
between
small
and
large
businesses.
Over
70
percent
reported
gross
income
of
less
than
$
50,000.
The
OFRF
survey
does
caution
readers
about
potential
survey
"
errors."
It
is
particularly
important
to
emphasize
potential
"
non­
response
error";
that
is,
it
is
unknown
if
those
who
responded
to
the
survey
accurately
represent
the
entire
population
of
certified
organic
growers.
Also,
some
producers
532
combine
organic
and
conventional
production
on
the
same
operation,
some
with
total
sales
that
may
exceed
$
500,000.
However,
it
is
likely
that
a
majority
of
organic
producers
would
be
considered
small.
We
have
estimated
that
there
would
be
12,176
producers
certified
in
the
first
year
and
of
those
97
percent,
or
11,811,
based
on
OFRF's
survey
results,
would
qualify
as
a
small
business.

The
term,
"
handler,"
means
any
person
engaged
in
the
business
of
handling
agricultural
products,
excluding
final
retailers
of
agricultural
products
that
do
not
process
agricultural
products.
Little
information
exists
on
the
numbers
of
handlers
and
processors.
USDA
has
estimated
that
there
were
600
entities
in
this
category
in
1994.
In
California,
there
were
208
registered
organic
processed
food
firms
in
1995
and
376
in
1999,
a
growth
rate
of
20
percent
(
4).

We
assume
that
this
growth
rate
is
applicable
to
the
U.
S.
and
project
2,077
certified
handlers
in
2001.
This
figure
includes
100
livestock
feed
handlers
who
would
become
certified
organic.

Again,
the
rate
of
growth
could
be
higher
or
lower.

In
handling
operations,
a
small
business
has
fewer
than
500
employees
(
SIC
Division
D
Major
Group
20).
It
is
also
likely
that
the
vast
majority
of
handlers
would
be
considered
small,

based
on
SBA's
small
business
size
standards
for
handlers.
Based
on
informal
conversations
with
organic
certifying
agents,
currently,
about
25
(
about
2
percent)
of
the
estimated
1,250
organic
handlers
in
1999
had
more
than
500
employees.
This
includes
firms
that
handle
or
process
both
organic
and
conventional
foods.
We
have
estimated
that
2,077
handlers
would
be
certified
organic
in
the
first
year.
Based
on
this
information,
98
percent
or
2,035
would
qualify
as
a
small
business.

4.
An
estimate
of
the
projected
reporting,
recordkeeping,
and
other
compliance
requirements
of
the
rule,
including
an
estimate
of
the
classes
of
small
entities
which
will
be
subject
533
to
the
requirement
and
the
type
of
professional
skills
necessary
for
preparation
of
the
report
or
record.

The
reporting,
recordkeeping,
and
compliance
requirements
of
the
rule
will
directly
affect
three
sectors
of
the
organic
industry
that
contain
small
business
entities:
accredited
certifying
agents,
organic
producers,
and
organic
handlers.
We
have
examined
the
requirements
of
the
rule
as
it
pertains
to
each
of
these
entities,
however
several
requirements
to
complete
this
Regulatory
Flexibility
Analysis
(
RFA)
overlap
with
the
Regulatory
Impact
Assessment
(
RIA)
and
the
Paperwork
Reduction
Act
(
PRA)
section.
In
order
to
avoid
duplication,
we
combine
some
analyses
as
allowed
in
section
605(
b)
of
the
Act.
This
RFA
provides
information
specific
to
small
entities,
while
the
RIA
or
PRA
should
be
referred
to
for
more
detail.
For
example,
the
RFA
requires
an
analysis
of
the
rule's
costs
to
small
entities.
The
RIA
provides
an
analysis
of
the
benefits
and
costs
of
this
regulation.
This
RFA
uses
the
RIA
information
to
estimate
the
impact
on
small
entities.
Likewise,
the
RFA
requires
a
description
of
the
projected
reporting,
recordkeeping,

and
other
compliance
requirements
of
the
final
rule.
The
PRA
section
estimates
the
reporting
and
recordkeeping
(
information
collection)
requirements
that
would
be
required
by
this
rule
from
individuals,
businesses,
other
private
institutions,
and
State
and
local
governments.
The
burden
of
these
requirements
is
measured
in
terms
of
the
amount
of
time
required
of
program
participants
and
its
cost.
This
RFA
uses
the
PRA
information
to
estimate
the
burden
on
small
entities.

Certifying
Agents
We
have
identified
36
private
certifying
agents
and
13
State
programs
providing
certification.
These
49
domestic
entities
are
considered
likely
applicants
during
the
first
12
months,
as
are
an
estimated
10
foreign
certifying
agents.
An
unknown
number
of
new
entrants
to
534
the
certifying
business
may
also
apply.
However,
over
the
last
10
years,
the
number
of
certifying
agents
does
not
appear
to
have
grown
significantly,
with
the
net
effect
of
entries
and
exits
maintaining
a
population
of
U.
S.­
based
certifying
agents
at
about
40
to
50.
Of
the
49
domestic
certifying
agents,
based
on
information
discussed
previously,
we
estimate
that
30
of
the
36
private
certifying
agents
are
small
businesses.

The
recordkeeping
and
paperwork
requirements
are
outlined
in
the
Paperwork
Reduction
Act
section.
The
requirements
for
small
and
large
certifying
agents
are
identical.
The
recordkeeping
and
paperwork
requirements
for
accreditation
will
be
a
new
burden
to
most
agents
as
the
majority
of
them
have
not
been
accredited
in
the
past.
However,
the
actual
amount
of
the
additional
administrative
costs
that
would
be
imposed
by
the
final
rule
is
expected
to
be
different
for
those
entities
that
would
begin
their
activities
only
after
the
national
program
is
implemented.

Certifying
agents
that
currently
are
active
in
the
organic
industry
already
perform
most
of
these
required
administrative
functions;
therefore,
the
additional
costs
to
them
would
depend
upon
the
extent
to
which
their
current
practices
are
different
from
the
requirements
of
the
final
regulation.

Because
the
rule
does
not
require
any
particular
system
or
technology,
it
does
not
discriminate
against
small
businesses.
The
ability
of
an
agent
to
carry
out
the
paperwork
and
recordkeeping
sections
of
the
rule
will
be
more
dependant
on
the
administrative
skill
and
capacity
of
their
particular
organization
than
their
size.
We
did
not
receive
significant
comments
about
the
paperwork
requirements
of
the
proposed
rule
that
would
indicate
that
they
will
be
onerous
for
small
certifying
agents.

Certifying
agents
will
be
the
front
line
in
monitoring
and
ensuring
that
certified
operations
stay
in
compliance
with
the
Act
and
the
regulations.
However,
most
of
the
compliance
535
requirements,
with
the
exception
of
some
reporting
requirements,
are
consistent
with
what
certifiers
are
currently
expected
to
do.
Like
the
paperwork
and
reporting
requirements,
the
additional
costs
to
an
agent
will
depend
on
how
different
their
current
practices
are
from
the
final
regulation.

The
final,
and
probably
most
significant,
area
in
which
certifying
agents
are
affected
by
the
rule
is
in
the
fees
that
they
must
pay
for
accreditation.
Certifying
agents
will
be
assessed
for
the
actual
time
and
travel
expenses
necessary
for
the
NOP
to
perform
accreditation
services,
including
initial
accreditations,
5­
year
renewals
of
accreditation,
review
of
annual
reports,
and
changes
to
accreditation.
Although
the
fees
have
not
been
set
yet,
we
are
using
as
a
starting
point
the
hourly
fees
that
are
charged
for
the
voluntary,
fee­
for­
service
program
provided
by
AMS
to
certification
bodies
requesting
conformity
assessment
to
the
ISO
Guide
65,
"
General
Requirements
for
Bodies
Operating
Product
Certification
Systems."
We
expect
that
at
the
time
the
NOP's
final
rule
is
implemented,
the
fees
will
be
approximately
$
95
per
hour
with
higher
overtime
and
holiday
rates.

Certifying
agents
will
also
be
charged
for
travel,
per
diem,
and
other
related
costs
associated
with
accreditation.
To
ease
the
financial
burden
of
accreditation
during
the
18
month
transition
period
after
the
NOP
has
been
implemented,
USDA
will
not
impose
hourly
charges
on
certifying
agents.

The
direct
costs
for
certifying
agents
to
obtain
accreditation
will
be
limited
to
per
diem
and
transportation
costs
to
the
site
evaluation.
Review
of
the
certifying
agent's
annual
report
is
anticipated
to
range
from
2
to
8
hours
at
the
ISO
Guide
65
hourly
rate.
Also,
if
certifying
agents
wish
to
become
accredited
in
additional
areas
for
which
they
were
not
accredited
previously,
a
site
evaluation
(
with
associated
fees)
will
be
necessary.
Detail
about
the
expected
costs
of
accreditation
can
be
found
in
the
RIA.
536
Several
factors
will
influence
the
amount
of
time
needed
to
complete
an
accreditation
audit.

An
operation
in
which
documents
are
well
organized
and
that
has
few
nonconformities
within
the
quality
system
will
require
less
time
for
an
audit
than
an
organization
in
which
documents
are
scattered
and
there
are
many
nonconformities
(
7).
Similarly,
in
a
followup
audit,
operations
that
lack
organization
in
their
documents
and
that
had
a
large
number
of
nonconformities
during
previous
audits
will
require
a
greater
amount
of
time.
The
scope
of
a
followup
audit
is
to
verify
the
correction
of
nonconformities
and
to
evaluate
the
effectiveness
of
the
corrections.
Certifying
agents
are
able
to
control
these
cost
factors
by
making
certain
that
documents
are
well
organized
and
by
educating
themselves
about
quality
systems.

The
complexity
of
a
certification
agency's
organization
also
will
affect
the
time
needed
to
complete
an
audit.
An
agency
with
a
central
office
in
which
all
certification
activities
take
place
will
require
less
time
for
document
review
and
site
evaluation
than
a
chapter
organization
or
a
business
structured
so
that
responsibility
for
making
certification
decisions
is
delegated
outside
of
the
central
office.
In
the
latter
cases,
the
auditors'
document
review
would
require
additional
time
and
site
evaluation
that
would
extend
from
the
central
office
to
one
or
more
of
the
chapters
or
to
the
site
to
which
the
certification
decision
making
is
delegated.

Other
factors
determine
the
amount
of
time
needed
to
complete
an
accreditation
audit.
For
an
agency
with
numerous
clients,
auditors
may
need
to
spend
more
time
reviewing
client
files
or
examining
business
operations
than
they
would
have
to
spend
for
a
smaller
agency.
Audit
of
an
agency
with
a
large
number
of
processor
clients
may
require
an
extended
amount
of
time
to
follow
audit
trails,
confirm
that
organic
ingredients
remain
segregated
from
nonorganic
ingredients,
and
establish
that
foreign­
produced
ingredients
originate
from
approved
entities.
Finally,
the
537
complexity
of
the
agricultural
practices
certified
could
influence
the
amount
of
time
necessary
to
complete
an
accreditation
audit.
An
agency
whose
certification
covers
only
producers
who
grow
and
harvest
one
crop
per
field
per
year,
such
as
wheat
or
sugar
beets,
could
quickly
be
audited.
An
agency
whose
producers
grow
several
different
crops
per
field
per
year
or
an
agency
that
certifies
producers
of
crops
and
livestock
as
well
as
handlers
would
require
a
greater
amount
of
time.

All
of
these
factors
will
affect
both
small
and
large
certifying
agents.
A
small
certifying
agent
could
be
assumed
to
have
a
less
complex
organization
or
have
fewer
clients,
and,
thus,

potentially
less
time
would
be
necessary
for
review.
However,
other
factors,
such
as
the
degree
of
paperwork
organization
or
the
complexity
of
the
agricultural
practices
certified,
may
influence
the
time
needed
for
review
for
any
size
of
business.

Currently,
relatively
few
certifying
agents
have
third­
party
accreditation
because
accreditation
of
certifying
agents
is
voluntary.
Fetter
reports
that
in
a
sample
of
18
certification
programs,
selected
to
include
six
large,
private
programs,
six
smaller
private
programs,
and
six
State
programs,
four
programs
were
accredited
and
one
had
accreditation
pending
(
8).
All
of
these
were
large
private
certifying
agents.
Three
of
the
certifying
agents
identified
by
Fetter
as
accredited
requested
ISO
Guide
65
assessments
by
USDA
and
have
been
approved
for
selling
organic
products
into
the
international
market.
Those
certifying
agents
currently
accredited
by
third
parties
will
likely
pay
less
for
USDA
accreditation
because
their
documents
are
organized
and
they
have
fewer
nonconformities.

It
is
expected
that
all
certifying
agents
will
set
their
fee
schedule
to
recover
costs
for
their
certification
services,
including
the
costs
of
accreditation.
The
larger
the
number
of
clients
per
certifying
agent,
the
more
fixed
costs
can
be
spread
out.
It
is
possible,
however,
that
small
538
certifying
agents
could
be
significantly
affected
by
this
final
rule
and
may
not
be
able
to
continue
in
business
from
a
financial
standpoint.

Costs
to
Producers
and
Handlers
The
OFPA
established
a
small
farmer
exemption
from
certification
and
submission
of
organic
plans
for
small
producers
with
a
maximum
of
$
5,000
in
gross
sales
of
organic
products.

For
purposes
of
the
exemption,
the
OFPA
defines
a
"
small
farmer"
as
those
who
sell
no
more
than
$
5,000
annually
in
value
of
agricultural
products.
In
this
rule,
we
have
clarified
that
the
exemption
applies
to
producers
and
handlers
who
sell
no
more
than
$
5,000
annually
in
value
of
organic
products
(
9).
In
addition,
handling
operations
are
exempt
if
they:
are
a
retail
food
establishment
that
handles
organically
produced
agricultural
products
but
does
not
process
them;
handles
agricultural
products
that
contain
less
than
70
percent
organic
ingredients
by
weight
of
finished
product;
or
does
not
use
the
word,
"
organic,"
on
any
package
panel
other
than
the
information
panel
if
the
agricultural
product
contains
at
least
70
percent
organic
ingredients
by
weight
of
finished
product.

A
handling
operation
or
specific
portion
of
a
handling
operation
is
excluded
from
certification
if
it
handles
packaged
certified
organic
products
that
were
enclosed
in
their
packages
or
containers
prior
to
being
acquired
and
remain
in
the
same
package
and
are
not
otherwise
processed
by
the
handler,
or
it
is
a
retail
food
establishment
that
processes
or
prepares
on
its
own
premises
raw
and
ready­
to­
eat
food
from
certified
organic
products.

According
to
the
OFRF
survey,
27
percent
of
currently
certified
farms
that
responded
to
the
survey
would
fall
under
the
producer
exemption.
This
percentage
does
not
take
into
account
those
organic
farms
that
are
not
currently
certified
by
a
private
or
State
certifying
agent.
A
study
539
of
California
organic
farms
found
that,
of
all
organic
farms
(
10)
in
1994­
95,
about
66
percent
have
revenues
less
than
$
10,000
(
11).
If
California
is
representative
and
the
distribution
within
the
sub­

$
10,000
category
is
uniform,
then
a
third
of
the
farms
would
be
classified
as
small
for
purposes
of
the
statutory
exemption
with
annual
sales
less
than
$
5,000.
Based
on
the
California
study
and
the
OFRF
survey
results,
we
estimate
that
between
25
and
33
percent
of
organic
producers
are
small
and
would
qualify
for
exemption
from
the
certification
requirements.

We
have
estimated
that
there
are
4,801
small
organic
producers
and
173
handlers
that
will
be
exempt
from
certification
(
this
figure
does
not
include
excluded
operations).
These
operations
would
be
required
to
comply
with
the
production
and
handling
standards
and
labeling
requirements
set
forth
under
the
NOP.
They
do
not
have
to
meet
the
paperwork
requirements
of
certification
and
they
must
only
keep
records
that
document
compliance
with
the
law
for
3
years
(
rather
than
5
for
certified
operations.
We
anticipate
that
this
exemption
will
be
used
primarily
by
small
market
gardeners
and
hobbyists
who
grow
and
process
produce
and
other
agricultural
products
for
sale
at
farmers
markets
and
roadside
stands
to
consumers
within
their
communities.

Exempt
producers
will
be
allowed
to
market
their
products
as
organically
produced
without
being
certified
by
a
certifying
agent.
Products
marketed
by
exempt
producers
cannot
be
represented
as
certified
organic
or
display
the
USDA
organic
seal.
Products
produced
or
handled
on
an
exempt
operation
may
be
identified
as
organic
ingredients
in
a
multiingredient
product
produced
by
the
exempt
operation,
but
they
may
not
be
identified
as
organic
in
a
product
processed
by
others.
These
limitations
may
discourage
some
small
producers
from
seeking
exemption,
who
instead
may
choose
to
become
certified.
In
this
case,
the
costs
of
certification
would
apply.
The
value
associated
with
having
organic
certification
may
outweigh
the
costs
of
540
certification.

As
with
accredited
certifying
agents,
the
regulation
will
impose
administrative
costs
on
certified
producers
and
handlers
for
reporting,
recordkeeping,
residue
testing,
and
other
compliance
requirements.
The
actual
amount
of
the
additional
administrative
costs
that
would
be
imposed
by
the
final
rule
is
expected
to
be
different
for
those
entities
that
become
certified
only
after
the
national
program
is
implemented.
Producers
and
handlers
who
currently
are
active
in
the
organic
industry
already
perform
most
of
these
administrative
functions;
therefore,
the
additional
costs
to
them
would
depend
upon
the
extent
to
which
their
current
practices
differ
from
the
requirements
of
the
final
regulation.
Projected
reporting,
recordkeeping,
and
other
compliance
requirements
of
certifying
agents
are
discussed
in
greater
detail
in
the
PRA
and
the
RIA.
The
only
distinction
made
in
the
final
rule
between
large
and
small
entities
for
reporting,
recordkeeping,
and
compliance
is
for
operators
who
produce
less
than
$
5000
per
year
in
organic
products
as
stated
above.

As
with
the
certifying
agents,
most
of
the
concern
this
rule
generated
for
small
certified
operations
revolves
around
fees.
Under
this
rule,
USDA
will
not
impose
any
direct
fees
on
producers
and
handlers.
Certifying
agents
will
establish
a
fee
schedule
for
their
certification
services
that
will
be
filed
with
the
Secretary
and
posted
in
a
place
accessible
to
the
public.

Certifying
agents
will
provide
all
persons
inquiring
about
the
application
process
with
a
copy
of
their
fees.
The
certifying
agent
may
only
charge
those
fees
that
it
has
filed
with
the
Secretary.

Furthermore,
the
certifying
agent
will
provide
each
applicant
with
an
estimate
of
the
total
cost
of
certification
and
an
estimate
of
the
annual
costs
of
updating
the
certification.

Currently,
supply
and
demand
for
certification
services
determine
the
fees
charged
in
most
541
areas.
Some
States
charge
minimal
fees
for
certification
and
instead
subsidize
operating
costs
from
general
revenues.
According
to
separate
studies
by
Fetter,
and
Graf
and
Lohr,
the
majority
of
certifying
agents
structure
their
fee
schedules
on
a
sliding
scale
based
on
a
measure
of
size,
usually
represented
by
the
client's
gross
sales
of
organic
products
but
sometimes
based
on
the
acres
operated.
Some
certifying
agents
charge
an
hourly
rate
for
inspection
and
audit
services.

Graf
and
Lohr's
study
indicates
that
even
small
farms
require
significant
time
for
the
certification
process,
and
this
time
does
not
increase
proportionately
as
farm
size
increases.
None
of
the
existing
certification
programs
mention
costs
for
residue
testing,
which
the
NOP
will
require
in
the
form
of
preharvest
testing
when
there
is
reason
to
believe
that
agricultural
products
have
come
into
contact
with
prohibited
substances.
Preharvest
testing
is
expected
to
be
infrequent.

Certifiers
will
recover
the
costs
of
preharvest
testing
through
explicit
charges
to
the
producer
whose
crop
is
tested
or
through
a
generally
higher
fee
structure
that
spreads
the
expected
costs
of
tests
over
all
clients.

This
rule
imposes
no
requirements
that
would
cause
certifying
agents
that
are
presently
using
a
sliding­
scale
type
fee
schedule
to
abandon
their
current
fee
system.
Certifying
agents
could
recover
their
net
additional
costs
by
increasing
their
flat­
fee
component,
their
incremental
charges,

or
both.
Because
accreditations
are
renewed
only
every
5
years,
certifying
agents
will
have
5
years
to
recover
their
net
new
costs.
Certifying
agents
who
become
accredited
during
the
first
year
of
the
program
would
have
fewer
direct
costs
to
recover
because
they
will
not
be
charged
the
application
fee
and
hourly
charges
for
accreditation
services.

Those
currently
receiving
voluntary
certification
will
likely
see
a
modest
increase
as
the
certifying
agent
passes
on
its
cost
incurred
under
the
NOP.
Those
not
currently
receiving
542
certification
and
producing
over
$
5,000
annually
in
organic
products
will
be
required
to
become
certified,
and
they
will
incur
the
actual
costs
of
certification.

Some
States,
such
as
Texas
and
Washington,
charge
producers
and
handlers
nominal
fees
for
certification,
and
it
is
possible
that
more
States
might
provide
certification
services
as
the
NOP
is
implemented.
Other
States,
such
as
Minnesota,
have
cost­
share
programs
to
help
offset
costs
for
organic
producers.

Conclusion
This
rule
will
primarily
affect
small
businesses.
We
have,
therefore,
attempted
to
make
the
paperwork,
recordkeeping,
and
compliance
provisions
as
flexible
as
possible
without
sacrificing
the
integrity
of
the
program.
We
are
not
requiring
specific
technologies
or
practices
and
with
the
18­

month
phase­
in
of
the
program
we
are
attempting
to
give
both
certifying
agents
and
certified
operators
an
opportunity
to
adapt
their
current
practices
to
conform
with
the
rule.
Because
we
have
attempted
to
make
the
rule
conform
with
existing
industry
standards,
including
ISO
guide
65
for
certification
and
ISO
guide
61
for
accreditation,
the
changes
for
most
organizations
and
operations
should
be
relatively
straightforward.

The
fees
required
for
accreditation
will
be
the
most
significant
change
faced
by
most
operations
 
and
this
was
apparent
in
the
comments
received.
While
we
understand
the
concerns
of
the
affected
organizations,
in
order
to
administer
an
accreditation
program,
it
is
necessary
that
we
recover
our
costs.
We
are
hoping
that
the
elimination
of
the
hourly
charges
in
the
first
round
of
accreditation
will
help
to
alleviate
some
of
this
burden.

1.
Organic
Farming
Research
Foundation.
1999.
Final
Results
of
the
Third
Biennial
National
Organic
Farmers'
Survey.
Santa
Cruz,
CA.
543
2.
Dunn,
Julie
Anton.
1995.
Organic
Food
and
Fiber:
An
Analysis
of
1994
Certified
Production
in
the
United
States.
U.
S.
Department
of
Agriculture,
Agricultural
Marketing
Service.

3.
Dunn,
Julie
Anton.
1997.
AgriSystems
International
Reports
Certified
Organic
Production
in
the
United
States:
Half
a
Decade
of
Growth.
AgriSystems
International:
Wind
Gap,
PA.

4.
California
Department
of
Health
Services
(
DHS).
1995.
Report
on
the
Registration
of
California
Organic
Processed
Food
Firms.
Sacramento:
State
of
California.
September
1999
figures
obtained
via
personal
communication
with
California
DHS.

5.
Graf,
Anita
and
Luanne
Lohr.
1999.
Analysis
of
certification
program
costs.
Working
Paper,
Fund
for
Rural
America
project,
Market
Development
for
Organic
Agriculture
Products,

Grant
No.
97­
36200­
5.

6.
During
the
first
18
months,
site
evaluation
for
initial
accreditation
will
be
conducted
jointly
by
two
reviewers.
Two
reviewers
offers:
(
1)
anticipated
faster
turn­
around;
(
2)
different
areas
of
expertise
­
one
reviewer
would
come
from
the
Quality
Systems
Certification
Program
audit
staff
and
would
be
familiar
with
ISO
Guide
65
verification,
while
the
other
reviewer
would
come
from
the
NOP
staff
and
would
be
familiar
with
the
requirements
of
the
program;
and
(
3)

consistency
with
the
organic
industry's
desire
to
have
reviewers
from
both
areas
of
expertise
during
ISO
Guide
65
assessments.
AMS
would
consider
sending
one
reviewer,
rather
than
two,
for
the
site
evaluation
of
small
certification
agents
if
an
individual
possessing
both
reviewing
skill
and
knowledged
of
the
NOP
is
available.
We
anticipate
only
one
reviewer
would
be
required
after
the
18­
month
transition
period.

7.
Adequate
advance
notice
will
be
given
to
certifying
agents
to
allow
them
the
opportunity
544
to
organize
their
records
prior
to
the
audit
and
minimize
the
costs
of
accreditation.

8.
Fetter,
Robert
T.
1999.
Economic
Impacts
of
Alternative
Scenarios
of
Organic
Products
Regulation.
Senior
Honors
Thesis.
University
of
Massachusetts,
Amherst,
MA.

9.
We
asked
for
comments
on
the
first
proposal
as
to
whether
the
current
statutory
limitation
of
$
5,000
for
exemption
from
certification
should
be
raised
to
$
10,000
or
to
another
amount
and
why
such
an
increased
monetary
limitation
for
exemption
from
certification
would
be
appropriate.
Few
commenters
offered
recommendations
as
to
a
maximum
sales
volume
to
exempt
producers.
Amounts
ranged
from
$
2,000
to
$
50,000,
with
a
few
suggesting
$
10,000
and
$
20,000
exemptions.
These
proposed
exemption
levels
and
justifications
in
comments
received
are
not
sufficiently
consistent
enough
for
us
to
recommend
changing
the
statute
requirement
of
the
$
5,000
maximum
sales
volume
exemption.

10.
California
State
law
requires
organic
farmers
to
register
with
the
State.
Certification
is
voluntary
at
the
current
time.

11.
Klonsky,
Karen,
and
Laura
Tourte.
1998.
Statistical
Review
of
California's
Organic
Agriculture,
1992­
95.
Report
prepared
for
the
California
Department
of
Food
and
Agriculture
Organic
Program.
Cooperative
Extension,
Department
of
Agricultural
Economics,
University
of
California,
Davis.

Appendix
D.­­
Executive
Order
12988,
Civil
Justice
Reform
Executive
Order
12988,
Civil
Justice
Reform,
instructs
each
executive
agency
to
adhere
to
certain
requirements
in
the
development
of
new
and
revised
regulations
in
order
to
avoid
unduly
burdening
the
court
system.
The
revised
proposal
was
reviewed
under
this
Executive
Order.
No
comments
were
received
on
that
review,
and
no
additional
related
information
has
been
obtained
545
since
then.
This
rule
is
not
intended
to
have
retroactive
effect.

States
and
local
jurisdictions
are
preempted
under
section
2115
of
the
Organic
Foods
Production
Act
(
OFPA)
(
7
U.
S.
C.
6514)
from
creating
programs
of
accreditation
for
private
persons
or
State
officials
who
want
to
become
certifying
agents
of
organic
farms
or
handling
operations.
A
governing
State
official
would
have
to
apply
to
USDA
to
be
accredited
as
a
certifying
agent,
as
described
in
section
2115(
b)
of
the
OFPA
(
7
U.
S.
C.
6514(
b)).
States
also
are
preempted
under
sections
2104
through
2108
of
the
OFPA
(
7
U.
S.
C.
6503
through
6507)
from
creating
certification
programs
to
certify
organic
farms
or
handling
operations
unless
the
State
programs
have
been
submitted
to,
and
approved
by,
the
Secretary
as
meeting
the
requirements
of
the
OFPA.

Pursuant
to
section
2108(
b)(
2)
of
the
OFPA
(
7
U.
S.
C.
6507(
b)(
2)),
a
State
organic
certification
program
may
contain
additional
requirements
for
the
production
and
handling
of
organically
produced
agricultural
products
that
are
produced
in
the
State
and
for
the
certification
of
organic
farm
and
handling
operations
located
within
the
State
under
certain
circumstances.

Such
additional
requirements
must:
(
a)
further
the
purposes
of
the
OFPA,
(
b)
not
be
inconsistent
with
the
OFPA,
(
c)
not
be
discriminatory
toward
agricultural
commodities
organically
produced
in
other
States,
and
(
d)
not
be
effective
until
approved
by
the
Secretary.

Pursuant
to
section
2120(
f)
of
the
OFPA
(
7
U.
S.
C.
6519(
f)),
this
regulation
would
not
alter
the
authority
of
the
Secretary
under
the
Federal
Meat
Inspection
Act
(
21
U.
S.
C.
601
et
seq.),

the
Poultry
Products
Inspections
Act
(
21
U.
S.
C.
451
et
seq.),
or
the
Egg
Products
Inspection
Act
(
21
U.
S.
C.
1031
et
seq.),
concerning
meat,
poultry,
and
egg
products,
nor
any
of
the
authorities
of
the
Secretary
of
Health
and
Human
Services
under
the
Federal
Food,
Drug
and
Cosmetic
Act
(
21
546
U.
S.
C.
301
et
seq.),
nor
the
authority
of
the
Administrator
of
the
Environmental
Protection
Agency
(
EPA)
under
the
Federal
Insecticide,
Fungicide
and
Rodenticide
Act
(
7
U.
S.
C.
136
et
seq.).

Section
2121
of
the
OFPA
(
7
U.
S.
C.
6520)
provides
for
the
Secretary
to
establish
an
expedited
administrative
appeals
procedure
under
which
persons
may
appeal
an
action
of
the
Secretary,
the
applicable
governing
State
official,
or
a
certifying
agent
under
this
title
that
adversely
affects
such
person
or
is
inconsistent
with
the
organic
certification
program
established
under
this
title.
The
Act
also
provides
that
the
U.
S.
District
Court
for
the
district
in
which
a
person
is
located
has
jurisdiction
to
review
the
Secretary's
decision.

Appendix
E.­­
Executive
Order
13132,
Federalism
This
final
rule
has
been
reviewed
under
Executive
Order
13132,
Federalism.
This
Order
requires
that
regulations
that
have
federalism
implications
provide
a
federalism
impact
statement
that:
(
1)
demonstrates
the
Agency
consulted
with
the
State
and
local
officials
before
developing
the
final
rule,
(
2)
summarizes
State
concerns,
(
3)
provides
the
Agency's
position
supporting
the
need
for
the
regulation,
and
(
4)
describes
how
the
concerns
of
State
officials
have
been
met.
The
Order
indicates
that,
where
National
standards
are
required
by
Federal
statutes,
Agencies
shall
consult
with
appropriate
State
and
local
officials
in
developing
those
standards.

The
Organic
Foods
Production
Act
(
OFPA)
of
1990
(
7
U.
S.
C.
6501
et
seq.)
establishes
national
standards
regarding
the
marketing
of
agricultural
products
as
organically
produced,

assures
consumers
that
organically
produced
products
meet
a
consistent
standard,
and
facilitates
interstate
commerce
in
fresh
and
processed
food
that
is
organically
produced.
There
has
been
a
great
deal
of
support
for
this
law
and
these
regulations
from
the
organic
community.
547
OFPA
and
these
regulations
do
preempt
State
statutes
and
regulations
related
to
organic
agriculture.
OFPA
establishes
national
standards
regarding
the
marketing
of
agricultural
products
as
organically
produced,
assures
consumers
that
organically
produced
products
meet
a
consistent
standard,
and
facilitates
interstate
commerce
in
fresh
and
processed
food
that
is
organically
produced.
Currently,
32
States
have
organic
statutes
on
their
books
and
have
implemented
them
to
various
degrees.
However,
the
Act
contemplates
a
significant
role
for
the
States
and,
in
fact,

envisions
a
partnership
between
the
States
and
the
Federal
Government
in
meeting
the
requirements
of
the
Statute.
The
Act
allows
the
States
to
determine
the
degree
to
which
they
are
involved
in
the
organic
program.
States
may
choose
to:
(
1)
carry
out
the
requirements
of
the
Act
by
establishing
a
State
organic
program
(
SOP)
and
becoming
accredited
to
certify
operations,
(
2)

establish
an
SOP
but
utilize
private
accredited
certifying
agents,
(
3)
become
accredited
to
certify
and
operate
under
the
National
Organic
Program
(
NOP)
as
implemented
by
the
Secretary,
or
(
4)

not
play
an
active
role
in
the
NOP.
7
U.
S.
C.
6507
provides
that
States
may
establish
an
SOP
consistent
with
the
national
program.
SOP's
may
contain
more
restrictive
requirements
than
the
NOP
established
by
the
Secretary
of
Agriculture.
To
be
more
restrictive,
SOP's
must:
further
the
purposes
of
the
Act,
be
consistent
with
the
Act,
not
discriminate
against
organic
products
of
another
State,
and
be
approved
by
the
Secretary.

Because
implementation
of
OFPA
will
have
a
significant
effect
on
many
States'
existing
State
statutes
and
programs,
the
U.
S.
Department
of
Agriculture
(
USDA)
has
reached
out
to
States
and
actively
sought
their
input
throughout
the
entire
process
of
developing
the
organic
rule.

On
publication
of
the
first
proposal
on
December
16,
1997,
an
announcement
and
information
packet
summarizing
the
proposal
was
sent
to
more
than
1,000
interested
parties,
including
State
548
governors
and
State
department
of
agriculture
secretaries,
commissioners,
or
directors.
Over
a
period
of
6
years,
numerous
meetings
were
held
to
provide
States
an
opportunity
to
provide
information
and
feedback
to
the
rule.
In
1994,
States
were
invited
to
participate
in
four
public
hearings
held
in
Washington,
DC;
Rosemont,
IL;
Denver,
CO;
and
Sacramento,
CA,
to
gather
information
to
guide
development
of
standards
for
livestock
products.
States
were
also
provided
the
opportunity
to
comment
specifically
on
State
issues
at
a
National
Organic
Certifiers
meeting
held
on
July
21,
1995.
They
were
invited
to
discuss
accreditation
issues
at
a
meeting
held
on
February
26,
1996.
Following
the
publication
of
the
first
proposal,
State
and
local
jurisdictions
had
the
opportunity
to
provide
input
at
four
listening
sessions
held
in
February
and
March
1998
in
Austin,
TX;
Ames,
IA;
Seattle,
WA;
and
New
Brunswick,
NJ.
A
meeting
to
discuss
the
role
of
States
in
the
NOP
was
held
in
February
1999.
A
State
organic
certifiers
meeting
to
discuss
State
issues
was
held
at
a
March
2000
meeting
with
the
National
Association
of
State
Organic
Programs.

USDA
also
drew
extensively
on
the
expertise
of
States
and
the
organic
industry
by
working
closely
with
the
National
Organic
Standards
Board.
The
Board
met
12
times
before
publication
of
the
proposed
rule
on
December
16,
1997,
and
met
five
times
during
1998
and
1999
and
two
times
in
2000.
States
were
invited
to
attend
each
of
these
meetings,
and
official
State
certifier
representatives
participated
in
Board
deliberations
in
meetings
held
in
July
1998,
July
1999,
and
March
2000.

Public
input
sessions
were
held
at
each
meeting
to
gather
information
from
all
interested
persons,
including
State
and
local
jurisdictions.
NOP
staff
also
received
comments
and
consulted
with
States
at
public
events.
They
made
presentations,
received
comments,
and
consulted
with
549
States
at
local
and
regional
organic
conferences
and
workshops
and
at
national
and
international
organic
and
natural
food
shows.
States
were
consulted
in
training
sessions
held
for
organic
inspectors,
as
well
as
numerous
question
and
answer
sessions
at
speaking
engagements
of
the
Agricultural
Marketing
Service
(
AMS)
Administrator,
the
NOP
Program
Manager,
and
NOP
staff.

In
addition,
during
August
and
September
2000,
the
Administrator
and
NOP
staff
engaged
in
extensive
efforts
to
discuss
the
proposed
rule.
While
many
organizations
declined
opportunities
for
these
briefings,
AMS
staff
did
meet
with
the
National
Conference
of
State
Legislatures
(
NCSL)

and,
at
their
request,
in
lieu
of
a
meeting,
provided
information
to
the
National
Governor's
Association
(
NGA).
NGA
and
NCSL
representatives
stated
they
were
aware
of
the
development
of
the
final
rule
but
offered
no
comments
during
these
consultations
beyond
those
submitted
by
the
individual
States
during
the
proposed
rule's
comment
period.
In
addition,
between
August
and
October
2000,
NOP
staff
had
telephone
or
e­
mail
contact
with
the
State
organic
program
directors
or
other
State
department
of
agriculture
representatives
in
25
States
to
determine
the
scope
and
status
of
each
State's
organic
program
in
the
context
of
the
issuance
of
the
final
rule.
These
State
representatives
stated
that
they
were
eagerly
awaiting
the
publication
of
the
final
rule
and
had
already
begun
adjusting
their
programs
to
conform
with
the
March
2000
proposed
rule
in
anticipation
of
the
publication
of
the
final
rule.
Finally,
States
have
had
the
opportunity
to
comment
on
two
proposed
rules.
More
than
275,000
comments
were
received
on
the
first
proposal,
and
40,000
on
the
second
proposed
rule
 
including
extensive
comments
from
twelve
State
departments
of
agriculture,
one
State
legislator,
two
members
of
Congress,
and
the
National
Association
of
State
Organic
Programs.
550
Through
this
outreach
and
consultation
process,
States
have
both
provided
general
feedback
to
the
rule
and
expressed
several
specific
concerns
about
how
this
rule
will
affect
State
programs.
Overwhelmingly,
States
were
extremely
supportive
of
the
March
2000
proposed
rule.

With
a
few
exceptions,
most
notably
who
should
bear
the
cost
of
enforcement
of
an
SOP,
States
are
supportive
of
the
Federal
legislation.
We
did
not
receive
a
single
comment
from
a
State
that
indicated
that
there
should
not
be
a
national
organic
program.

The
most
prevalent
issues
they
raised
regarding
the
March
2000
proposed
rule
as
to
how
this
rule
will
affect
organic
programs
in
their
States,
along
with
USDA's
response,
are
described
below.
We
received
no
direct
comments
from
States
on
the
Federalism
section
in
the
proposed
rule.
Many
of
these
concerns
and
others
are
addressed
in
more
detail
in
the
relevant
sections
of
the
rule.

Applicability
Regarding
section
205.100(
b),
five
States
currently
offer
a
"
transition
to
organic"
label
for
producers
who
are
in
the
process
of
becoming
certified.
Many
of
these
States
would
like
to
continue
to
offer
this
label.
However,
OFPA
does
not
authorize
a
"
transition
to
organic"
label.

Although
the
States
(
or
private
certifiers)
are
free
to
come
up
with
a
different
label
for
these
farmers,
they
cannot
utilize
the
term,
organic,"
in
any
seal
or
labeling
associated
with
the
conversion
period.
There
is
no
change
in
this
provision
from
the
proposed
rule.

Accreditation
Regarding
section
205.501(
a),
many
States
wanted
the
NOP
to
add
an
additional
subsection
to
the
Accreditation
section
requiring
certifiers
to
prove
that
they
can
carry
out
a
551
State's
more
restrictive
standards
in
order
to
be
accredited
to
certify
in
that
State.
AMS
concurs
with
this
suggestion
and
has
added
a
new
paragraph
205.502(
a)(
20)
requiring
the
certifying
agent
to
demonstrate
its
ability
to
comply
with
a
State's
additional
requirements.

Regarding
section
205.501(
b),
there
was
strong
support
by
all
of
the
States
for
the
provision
that
States
with
SOP's
are
able
to
have
higher
standards
than
the
NOP
for
operations
within
their
State.
However,
there
was
not
consensus
among
the
States
on
the
prohibition
on
private
certifiers
requiring
more
stringent
standards.

Although
most
supported
the
prohibition
on
private
certifiers
imposing
additional
requirements
as
a
condition
of
certification
because
they
perceived
that
it
lowered
barriers
to
farmers
and
processors
in
their
States,
three
States
were
strongly
opposed
to
this
provision.

Because
having
a
consistent
national
standard
is
one
of
the
primary
purposes
of
the
legislation,

there
is
no
change
in
this
provision
from
the
proposed
rule.

State
Programs
There
was
general
confusion
about
what
is
the
difference
between
a
State
organic
certification
program
and
an
SOP.
In
addition,
some
States
wanted
the
scope
of
the
NOP's
oversight
for
State
organic
activities
to
be
limited
to
certification.
A
State
organic
certification
program
is
equivalent
to
a
private
or
foreign
certification
program.
States
wishing
to
certify
operations
in
their
State
must
apply
to
the
NOP
for
accreditation.

An
SOP,
on
the
other
hand,
requires
the
State
to
submit
a
plan
to
the
NOP
for
approval
to,

in
effect,
administer
the
NOP
within
their
State.
Included
in
this
is
the
opportunity
to
include
requirements
that
differ
from
the
NOP.
In
creating
an
SOP,
a
State
is
also
agreeing
to
take
on
enforcement
activities
that
would
otherwise
be
the
responsibility
of
the
NOP.
One
exception
to
a
552
State's
enforcement
authority
is
that
States
with
SOP's
do
not
have
jurisdiction
over
the
accreditation
of
certifying
agents
and
cannot
revoke
accreditation.
They
can
investigate
and
report
accreditation
violations
to
the
NOP.
States
with
only
an
accredited
certification
program
are
only
responsible
for
the
level
of
enforcement
that
all
accredited
certifying
agents,
State,
private,
or
foreign,
are
required
to
take
on.

Regarding
section
205.620(
c),
several
States
want
broader
language
than
"
unique
environmental
conditions"
to
be
the
basis
for
a
State
to
have
the
right
to
establish
more
restrictive
requirements
under
an
SOP.
AMS
does
not
concur.
There
is
no
change
to
this
language
in
the
final
rule.
It
is
the
opinion
of
AMS
that
the
current
language
is
broad
enough
to
cover
the
scope
of
more
restrictive
requirements
as
authorized
by
OFPA.

Regarding
section
205.620(
d),
many
States
want
it
to
be
optional
for
States
with
SOP's
to
take
on
enforcement
obligations;
several
want
funding
from
USDA
for
enforcement
activities.

AMS
does
not
concur
with
this
change.
AMS
does
not
envision
that
participation
under
the
NOP
will
impose
additional
fiscal
costs
on
States
with
existing
organic
programs,
other
than
the
costs
of
accreditation.

Regarding
section
205.621(
b),
several
States
commented
that
States
with
SOP's
should
not
be
required
to
publish
proposed
changes
to
their
programs
in
the
Federal
Register
for
public
comment.
AMS
concurs
with
this
comment.
This
language
was
an
oversight
from
the
first
proposed
rule.

Fees
A
few
States
commented
that
the
proposed
fees
for
accreditation
could
cost
more
than
some
States
could
afford
to
pay.
They
made
some
suggestions
for
reducing
accreditation
fees,
553
ranging
from
no
fees
(
a
completely
federally
funded
program)
to
charging
reduced
rates
for
travel
or
eliminating
hourly
charges.
AMS
has
no
plans
to
change
the
fee
structure.
As
in
the
proposed
rule,
hourly
charges
for
accreditation
will
be
waived
for
all
applicants
in
the
first
18
months
of
the
program
to
facilitate
the
conversion
to
a
national
accreditation
system.

Compliance
Regarding
section
205.665,
several
States
wanted
to
know
what
their
authority
was
to
revoke
the
accreditation
of
private
certifiers
in
their
State
who
do
not
meet
additional
State
standards
under
an
SOP.
An
SOP's
governing
State
official
is
authorized
to
review
and
investigate
complaints
of
noncompliance
with
the
Act
or
regulations
concerning
accreditation
of
certifying
agents
operating
in
their
State.
If
they
discover
a
noncompliance,
they
shall
send
a
written
report
to
the
NOP
program
manager.
Because
accreditation
is
a
Federal
license,
States
do
not
have
the
authority
to
revoke
a
certifying
agent's
accreditation.
There
is
no
change
in
this
section
from
the
proposed
rule
Appeals
Regarding
section
205.668(
b),
several
State
commenters
want
appeals
from
SOP's
to
go
to
State
district
court
rather
than
Federal
district
court.
AMS
disagrees.
The
Act
provides
that
a
final
decision
of
the
Secretary
may
be
appealed
to
the
U.
S.
District
Court
for
the
district
in
which
the
person
is
located.
AMS
considers
an
approved
SOP
to
be
the
NOP
for
that
State.
As
such,

AMS
considers
the
governing
State
official
of
such
State
program
to
be
the
equivalent
of
a
representative
of
the
Secretary
for
the
purpose
of
the
appeals
procedures
under
the
NOP.
Because
the
final
decision
of
the
governing
State
official
is
considered
the
final
decision
of
the
Secretary,

under
the
Act
it
is
then
appealable
to
the
U.
S.
District
Court,
not
the
State
district
court.
554
Regarding
section
205.680,
State
commenters
want
a
process
by
which
people
who
feel
they
were
adversely
affected
by
the
organic
program
in
a
State
with
an
SOP
may
appeal
to
the
SOP's
governing
State
official,
rather
than
the
Administrator.
AMS
has
amended
the
language
in
section
205.680
to
clarify
to
whom
an
appeal
is
made
under
various
situations.
If
persons
believe
that
they
were
adversely
affected
by
a
decision
made
by
the
NOP
Program
Manager,
they
appeal
to
the
Administrator.
If
they
were
adversely
affected
by
a
decision
made
by
a
certifying
agent
(
State,

private,
or
foreign),
they
appeal
to
the
Administrator
unless
they
are
in
a
State
with
an
SOP,
in
which
case,
they
appeal
to
the
SOP's
governing
State
official.
If
persons
believe
that
they
were
adversely
affected
by
a
decision
made
by
a
representative
of
an
SOP,
they
appeal
such
decision
to
the
SOP's
governing
State
official
or
such
official's
designee.
