September
17,
2004
Page
1
SUPPORTING
STATEMENT
FOR
AN
INFORMATION
COLLECTION
REQUEST
(
ICR)

1.
IDENTIFICATION
OF
THE
INFORMATION
COLLECTION
1(
a)
Title
of
the
Information
Collection:

Data
Acquisition
for
Anticipated
Residue
and
Percent
of
Crop
Treated
OMB
No.:
2070­
0164;
EPA
No.:
1911.02
1(
b)
Short
Characterization/
Abstract
This
information
collection
request
(
ICR)
involves
an
information
collection
activity
related
to
the
statutorily
mandated
re­
evaluation
of
previous
Agency
decisions
regarding
the
establishment
of
a
tolerance
(
maximum
residue
limit)
for
pesticide
residues
on
food
or
feed
crops.

The
use
of
pesticides
to
increase
crop
production
often
results
in
pesticide
residues
in
or
on
the
crop.
To
protect
the
public
health
from
unsafe
pesticide
residues,
the
Environmental
Protection
Agency
(
EPA)
sets
limits
on
the
nature
and
level
of
residues
permitted
pursuant
to
section
408
of
the
Federal
Food,
Drug
and
Cosmetic
Act
(
FFDCA).
A
pesticide
may
not
be
used
on
food
or
feed
crops
unless
the
Agency
has
established
a
tolerance
for
the
pesticide
residues
on
that
crop,
or
established
an
exemption
from
the
requirement
to
have
a
tolerance.

It
is
EPA's
responsibility
to
ensure
that
the
maximum
residue
levels
likely
to
be
found
in
or
on
food/
feed
are
safe
for
human
consumption
through
a
careful
review
and
evaluation
of
residue
chemistry
and
toxicology
data.
In
addition
it
must
ensure
that
adequate
enforcement
of
the
tolerance
can
be
achieved
through
the
testing
of
submitted
analytical
methods.
Once
the
data
are
deemed
adequate
to
support
the
findings,
EPA
will
establish
the
tolerance
or
grant
an
exemption
from
the
requirement
of
a
tolerance.

This
ICR
will
enable
EPA's
Office
of
Pesticide
Programs
(
OPP)
to
obtain
information
needed
to
re­
evaluate
the
Agency's
original
tolerance
decisions
as
mandated
by
the
Food
Quality
Protection
Act
of
1996
(
FQPA),
which
amended
the
two
primary
statutes
regulating
pesticides,
i.
e.,
FFDCA
and
the
Federal
Insecticide,
Fungicide
and
Rodenticide
Act
(
FIFRA).
Among
other
things,
FQPA
amended
FFDCA
to
authorize
the
Agency
to
use
anticipated
or
actual
residue
(
ARs)
data
and
percent
crop
treated
(
PCT)
data
to
establish,
modify,
maintain,
or
revoke
a
tolerance
for
a
pesticide
residue.
However,
the
law
also
requires
that
tolerance
decisions
based
on
ARs
or
PCT
data
be
verified
to
ensure
that
residues
in
or
on
food
are
not
above
the
residue
levels
relied
on
for
establishing
the
tolerance.

In
order
to
conduct
the
required
re­
evaluation,
a
Pesticide
Registrant
may
be
required
to
submit
specific
data
necessary
to
demonstrate
that
residues
do
not
exceed
the
residue
levels
used
to
establish
the
tolerance.

The
burden
and
costs
associated
with
establishing
a
tolerance
or
an
exemption
from
a
tolerance
are
covered
under
ICR
number
2070­
0024,
Tolerance
Petitions
for
Pesticides
on
Food/
Feed
Crops
and
New
Inert
Ingredients.
This
ICR
only
addresses
the
burden
and
costs
September
17,
2004
Page
2
associated
with
the
information
collection
activities
related
to
the
re­
evaluation
of
tolerances
pursuant
to
FFDCA
section
408(
b)(
2)
(
Attachment
A).

2.
NEED
FOR
AND
USE
OF
THE
COLLECTION
2(
a)
Need/
Authority
for
the
Collection
FIFRA
sections
3(
a)
and
12(
a)(
1)
require
a
person
to
register
a
pesticide
product
with
the
EPA
before
that
product
may
be
lawfully
sold
or
distributed
in
the
United
States.
A
pesticide
registration
is
a
license
that
allows
a
pesticide
product
to
be
sold
and
distributed
for
specific
uses
under
specified
terms
and
conditions
such
as
use
instructions
and
precautions.
A
pesticide
product
may
be
registered
or
remain
registered
only
if
it
meets
the
statutory
standard
for
registration
given
in
FIFRA
section
3(
c)(
5).
Under
FFDCA
section
408,
before
a
pesticide
may
be
used
on
food
or
feed
crops,
the
Agency
must
establish
a
tolerance
for
the
pesticide
residues
on
that
crop
or
established
an
exemption
from
the
requirement
to
have
a
tolerance.

The
authority
for
the
information
collection
activities
contained
in
this
ICR
can
be
found
in
FFDCA
Section
408(
b)(
2)(
E)
and
(
F),
which
authorizes
the
Agency
to
use
anticipated
or
actual
residue
(
ARs)
data
and
percent
crop
treated
(
PCT)
data
to
establish,
modify,
maintain,
or
revoke
a
tolerance
for
a
pesticide.
The
FFDCA
requires
that
if
AR
data
are
used,
data
must
be
reviewed
five
years
after
a
tolerance
is
initially
established.
If
PCT
data
are
used,
the
FFDCA
affords
EPA
the
discretion
to
obtain
additional
data
if
any
or
all
of
several
conditions,
including
but
not
limited
to
the
following,
are
met:

°
the
existing
data
have
been
found
unreliable;
°
exposure
estimates
underestimate
exposures
for
any
significant
population
group;
°
dietary
exposure
must
be
re­
evaluated
periodically
As
noted
above,
when
re­
evaluating
tolerance
actions,
Section
408(
f)
of
FFDCA
generally
requires
EPA
to
issue
DCIs
whenever
ARs
data
have
been
relied
on,
and
affords
the
EPA
the
discretion
to
issue
DCIs
when
PCT
data
have
been
relied
on.
OPP
issues
a
DCI
to
affected
registrants
under
the
authority
of
FIFRA
section
3(
c)(
2)(
B)
(
Attachment
B).
The
data
obtained
from
the
DCIs
are
needed
to
reassess
the
risk
and
to
confirm
that
use
of
a
pesticide
is
not
likely
to
cause
unreasonable
adverse
effects
to
human
health
or
the
environment.

2(
b)
Practical
Utility/
Users
of
the
Data
OPP
will
evaluate
the
data
obtained
from
registrants
to
ensure
that
residues
in
or
on
food
are
not
above
the
residue
levels
relied
on
for
establishing
the
tolerance.
If
the
submitted
residue
data
demonstrates
that
the
residue
levels
are
above
the
levels
relied
on
for
establishing
the
tolerance,
EPA
will
take
appropriate
action
to
modify
or
revoke
the
tolerance.
September
17,
2004
Page
3
NON­
DUPLICATION,
CONSULTATIONS
AND
OTHER
COLLECTION
CRITERIA
3(
a)
Non­
duplication
OPP
supports
several
activities
to
eliminate
duplication
and
promote
efficiency
in
information
collection
efforts
for
registration.
Before
any
DCI
is
conducted,
internal
files
are
referenced
to
determine
whether
the
required
data
is
already
on
hand.
Since
much
of
the
percentcrop
treated
information
can
be
obtained
internally,
DCIs
will
only
be
issued
when
more
data
is
necessary.
The
data
for
anticipated
residues,
on
the
other
hand,
is
unique
to
the
requirements
of
FIFRA,
and,
therefore,
must
be
submitted
to
the
Agency.

OPP
also
publishes
a
list
of
data
submitters
and
encourages
the
industry
to
act
cooperatively
in
the
development
of
data
or
in
its
use.
OPP
allows
cost­
sharing
agreements
among
manufacturers
of
specific
pesticide
chemicals
in
order
to
minimize
the
duplication
of
laboratory
tests
conducted
for
this
program.
All
DCI
notices
explain
the
statutory
provisions
for
cost­
sharing
agreements
under
FIFRA.

3(
b)
Public
Notice
Required
Prior
to
ICR
Submission
to
OMB
In
preparing
to
renew
this
ICR,
EPA
published
a
notice
in
the
Federal
Register
which
provided
a
60­
day
public
notice
and
comment
period
on
the
draft
ICR(
see
FR
25079,
May
5,
2004).
The
Agency
did
not
receive
any
public
comments.

3(
c)
Consultations
Before
a
particular
DCI
is
issued
under
either
program,
the
procedures
for
both
programs
provide
several
opportunities
for
consultations
with
the
affected
registrants,
as
well
as
with
the
public
and
other
interested
parties.

In
the
initial
stage
of
AR/
PCT
reviews,
the
Agency
announces
its
intent
to
conduct
such
a
review
and
require
additional
studies.
Registrants
and
other
interested
parties
have
the
opportunity
to
comment
on
the
Agency's
intent.
Generally
the
Agency
consults
with
registrants
before
a
data
call­
in
notice
is
issued
to
discuss
the
Agency's
need
for
particular
information
and
the
protocol
to
be
used
to
conduct
the
study.
OPP
is
always
open
to
communications
with
registrants
concerning
any
issue
they
may
have
with
the
requirements
for
data.
As
mentioned,
registrants
may
request
waivers
of
data
requirements
if
they
believe
that
OPP
can
properly
evaluate
their
pesticide
without
additional
data.
The
Agency
may
modify
its
DCI
requirements
if
warranted
by
information
provided
by
registrants
or
the
public.
In
addition,
registrants
may
respond
to
the
DCI
by
requesting
waivers
of
data
requirements
if
they
believe
that
OPP
can
properly
evaluate
their
pesticide
without
additional
data.
The
Agency
has
already
on
several
occasions
discussed
the
statutory
requirements
and
data
requirements
for
the
AR/
PCT
reviews
with
the
stakeholders.

For
this
renewal,
EPA
consulted
with
five
organizations
that
might
have
a
specific
interest
in
this
ICR.
EPA
staff
contacted
the
representatives
listed
in
Attachment
J
by
telephone
and
email
and
asked
them
for
feedback
on
the
burden
and
cost
estimates
in
the
ICR.
The
solicitation
for
consultation
included
three
registrants
and
two
industry
trade
associations,
two
registrants
September
17,
2004
Page
4
replied.
The
Agency
did
not
receive
any
comments
to
the
proposed
ICR
during
the
first
public
comment
period.
While
the
Agency
provided
responses
to
the
comments
made
in
the
consultation
process
(
see
Attachment
K),
no
changes
to
the
burden
hours
or
cost
were
made
to
the
ICR
as
a
result
of
any
of
the
comments
received.

3(
d)
Effects
of
Less
Frequent
Collection
Information
is
collected
one
time
within
the
five
years
preceding
the
reliance
on
ARs
or
PCT
data.
This
one
time
collection
is
required
by
(
FFDCA
408(
b)(
2)(
E)(
I)
and
408(
b)(
2)(
F)
and
cannot
be
collected
less
frequently.

3(
e)
General
Guidelines
The
only
guideline
established
under
the
Paperwork
Reduction
Act
(
PRA)
that
is
exceeded
in
this
collection
is
the
time
period
for
retaining
records.
EPA
requirements
in
40
CFR
169.2(
k)
state
that
records
containing
research
data
relating
to
registered
pesticides
be
retained
as
long
as
the
registration
is
valid
and
the
producer
remains
in
business.
Registrations
are
valid
until
they
are
canceled
by
the
Agency,
either
by
request
of
the
registrant
or
on
the
initiative
of
EPA.
Since
most
pesticides
remain
on
the
market
for
15
to
30
years,
the
PRA
guidelines
specifying
that
data
other
than
health,
medical
or
tax
records
not
be
required
to
be
retained
for
more
than
three
years
is
exceeded
in
this
program.

The
forms
associated
with
this
ICR
are
also
used
for
other
information
collection
activities
that
are
approved
under
separate
OMB
Control
numbers,
e.
g.,
2070­
0057,
2070­
0060,
2070­
0107
and
2070­
0122.
Specifically,
Certification
of
Attempt
to
Enter
into
an
Agreement
with
Registrants
for
Development
of
Data
(
EPA
Form
8570­
32)
(
Attachment
E),
Certification
with
Respect
to
Citation
of
Data
(
in
Pesticide
Registration
(
PR)
Notice
98­
5)
(
EPA
Form
8570­
34)
(
Attachment
F),
Data
Matrix
(
also
in
PR
Notice
98­
5)
(
EPA
Form
8570­
35)
(
Attachment
G),
Data
Call­
In
Response
Form
(
EPA
Form
No.
pending)
(
Attachment
C),
and
the
Requirements
Status
and
Registrant's
Response
Form
(
EPA
Form
No.
pending)
(
Attachment
D).

When
EPA
submitted
the
previous
ICR
to
OMB
for
review
in
2000,
the
Agency
requested
permission,
in
accordance
with
5
CFR
1320.5(
a)(
1)(
iii)(
C),
to
discontinue
the
display
of
expiration
dates
on
these
forms
in
the
future
because
the
forms
had
not
changed
after
many
years
of
use
and
were
not
expected
to
change
in
the
future.
OMB
approved
that
ICR
request,
and
EPA
has
therefore
continued
to
omit
the
expiration
dates
on
these
forms.

The
Data
Call­
In
Response
Form
and
the
Requirements
Status
and
Registrant's
Response
Form
have
been
approved
with
DCI
related
ICRs
by
OMB
for
several
years,
although
no
official
EPA
Form
number
had
been
assigned
in
the
past.
These
two
forms
are
automatically
generated
by
EPA's
computer
databases
and
are
pre­
populated
with
information
that
is
specific
to
each
individual
registrant
that
receives
a
Data
Call­
In
notice
for
a
given
pesticide.
These
forms
will
not
be
widely
accessible
to
general
public
through
EPA's
Internet
site.
Instead,
EPA
will
continue
to
generate
the
pre­
populated,
registrant­
specific
forms
through
the
Agency's
computer
system
when
preparing
to
issue
Data
Call­
In
notices.
EPA
is
currently
assigning
official
form
numbers
for
these
forms
to
help
clarify
their
OMB
approval
status.
As
discussed
in
the
paragraph
above,
EPA
will
also
continue
to
omit
expiration
dates
for
these
forms.
September
17,
2004
Page
5
Also,
OMB's
regulations
require
agencies
to
provide
a
statement
indicating
whether
the
proposed
collection
of
information
involves
the
use
of
automated,
electronic,
mechanical,
or
other
technological
collection
techniques
or
other
forms
of
information
technology,
e.
g.,
permitting
electronic
submission
of
responses,
and
an
explanation
of
the
decision
(
5
CFR
1320.5(
a)(
iii)(
E)).
In
December
2001,
EPA
announced
that
registrants
now
have
the
option
to
electronically
submit
the
underlying
study
data
required
by
the
Agency
to
ensure
that
a
given
pesticide
will
not
pose
unreasonable
adverse
effects
to
human
health
and
the
environment.
At
this
time,
OPP
is
not
offering
a
fully
electronic
submission
option.
Additionally,
OPP
is
not
yet
prepared
to
accept
the
electronic
submission
of
any
forms
listed
in
this
ICR.
Forms­
based
submissions
likely
would
be
transmitted
via
the
World
Wide
Web
and
neither
OPP
nor
the
Agency's
Office
of
Environmental
Information
have
developed
the
information
technology
approaches
that
would
adequately
protect
FIFRA
Confidential
Business
Information
submitted
in
this
way.
Therefore,
the
public
should
note
that
the
electronic
submission
option
currently
applies
only
to
the
submission
of
studies
and
supplemental
files.

Ordinarily,
registrants
would
be
required
to
submit
3
paper
copies
of
study
data
to
EPA.
Under
this
hybrid
option,
registrants
need
only
submit
2
paper
copies
if
they
submit
the
required
study
data
in
Adobe
Acrobat
Portable
Document
Format
(
PDF)
on
a
compact
disc.
Once
EPA
staff
have
become
familiar
with
the
electronic
submission
process
and
the
technology,
OPP
believes
that
this
option
will
allow
the
Agency
to
achieve
operating
efficiencies
in
the
regulation
of
pesticides
through
the
promotion
and
facilitation
of
the
electronic
submission
process,
including
the
delivery,
review,
data
interchange
capability
and
archiving
of
data
supporting
national
pesticide
registration.
The
time
normally
required
for
OPP
to
complete
its
review
of
the
data
should
be
shortened,
thereby
allowing
faster
regulatory
decision­
making.
The
Agency
also
believes
that,
once
the
registrant
community
has
become
familiar
with
the
electronic
submission
process
and
the
technology,
registrants
would
be
able
to
prepare
their
data
submissions
in
less
time.
Registrant
submissions
of
study
data
are
often
voluminous.
Some
submitted
studies
may
be
several
thousand
pages
long.
OPP
expects
that
registrants
will
spend
less
time
and
money
preparing
copies
and
sending
their
submissions
using
the
hybrid
paperelectronic
submission
option,
and
stand
to
benefit
from
the
efficiencies
that
EPA
expects
to
experience
during
data
reviews.

Finally,
the
terms
of
clearance
outlined
by
OMB
when
this
ICR
was
approved
in
2001
required
that
EPA
not
issue
any
DCI
unless
it
had
first
been
approved
by
relevant
high­
level
management
in
the
Office
of
Pesticide
Programs,
as
well
as
reviewed
and
approved
by
OMB.
In
the
detailed
DCI
approval
request,
EPA
was
to
estimate
the
respondent
burden
and
costs
related
to
specific
DCIs
before
they
were
issued,
including
the
total
cost
for
performing
the
required
study(
s),
and
the
associated
paperwork
related
burden
and
costs.
OMB
would
then
review
the
information
collection
activities
associated
with
each
individual
DCI
to
ensure
that
the
collection
of
information
was
the
least
burdensome
necessary
for
the
proper
performance
of
the
agency's
functions
and
that
the
collection
of
information
was
not
duplicative
of
information
otherwise
accessible
to
the
agency.
If
OMB
raised
no
questions
during
the
15
work
day
review
period,
EPA
could
issue
the
DCIs.
During
the
last
3
year
approval
period
for
this
ICR,
the
Agency
did
not
need
to
seek
approval
for
any
specific
DCIs.

3(
f)
Confidentiality
September
17,
2004
Page
6
Except
as
provided
in
FIFRA
section
10(
d)(
1)(
A),
(
B)
or
(
C),
health
and
safety
data
submitted
by
registrants
under
FIFRA
must
be
made
available
by
the
Agency
upon
request
from
anyone
not
affiliated
with
a
multi­
national
pesticide
firm.
These
exceptions,
however,
specifically
prohibit
disclosure
of
the
inert
ingredients
in
a
pesticide,
or
of
it
manufacturing,
quality
control
processes,
sales
and
production
data,
or
trade
secrets.

Registrants
may
claim
at
the
time
of
submission
that
specific
data
are
subject
to
treatment
as
confidential
for
reasons
other
than
falling
within
the
exclusions
for
mandatory
release.
All
data
subject
to
such
claims,
or
falling
within
FIFRA
section
10(
d)(
1)(
A),
(
B),
or
(
C)
are
handled
strictly
in
accordance
with
the
provisions
of
the
FIFRA
Confidential
Business
Information
Security
Manual.
The
manual
requires
that
all
CBI
must
be
marked
or
flagged
as
such,
all
CBI
must
be
kept
in
secure
(
double­
locked)
areas,
and
all
CBI
intended
to
be
destroyed
must
be
cleared
by
a
Document
Control
Officer
and
shredded.

3(
g)
Sensitive
Questions
No
information
of
a
sensitive
or
private
nature
is
requested
in
conjunction
with
this
information
collection
activity,
and
this
information
collection
activity
complies
with
the
provisions
of
the
Privacy
Act
of
1974
and
OMB
Circular
A­
108.

4.
THE
RESPONDENTS
AND
THE
INFORMATION
REQUESTED
4(
a)
Respondents/
NAICS
Codes
The
North
American
Industrial
Classification
System
(
NAICS)
code
for
respondents
to
this
ICR
is
325320
(
Pesticide
and
other
Agricultural
Chemical
Manufacturing).

4(
b)
Information
Requested
(
i).
Data
items,
including
record
keeping
requirements
The
kinds
of
data
that
may
be
the
subject
of
a
DCI
under
this
ICR
may
include
one
or
more
of
the
following
data
items,
which
are
included
in
40
CFR
Part
158,
Data
Requirements
for
Pesticide
Registration:

1)
Monitoring
data
(
PDP,
FDA,
FSIS,
States,
special
monitoring
[
market
basket,
single
serving,
etc.])
2)
Field
trials,
3)
Processing
studies,
4)
Reduction
in
residue
data
(
washing,
peeling,
cooking,
etc.),
5)
Livestock
feeding
studies
6)
Metabolism
studies
7)
Percent
crop
treated
data
September
17,
2004
Page
7
SOURCE
OF
DATA
USED
I
N
A
NT
ICI
P
A
T
E
D
RESIDUES
DATA
NEEDED
TO
CONFIRM
ANTICIPATED
RESIDUES
5
YEARS
LATER
Monitoring
data
(
Pesticide
Data
Program
(
PDP),
FDA,
FSIS,
States,
special
monitoring
[
market
basket,
single
serving,
etc.])
Updated
monitoring
data
are
required.
The
registrant
may
use
any
of
the
publicly
available
sources
used
by
the
Agency.
Data
should
reflect
the
time
period
since
establishment
of
the
tolerance.
If
data
are
not
available
from
the
above
sources,
then
the
registrant
must
conduct
an
appropriately
designed
monitoring
study.
The
design
of
this
study
must
be
approved
by
the
Agency.

Field
trials
The
registrant
must
EITHER
verify
that
the
pesticide
formulations,
application
rates,
timing,
intervals,
geographic
distribution
of
use,
etc.,
have
not
changed
OR
provide
field
trial
data
that
reflect
any
changes
in
the
use
pattern
that
may
lead
to
increased
residues.

Processing
studies
Reduction
in
residue
data
(
washing,
peeling,
cooking,
etc.)
The
registrant
must
EITHER
certify
that
commercial
processing
practices
have
not
changed
significantly
OR
provide
new
processing
studies
reflecting
current
commercial
practices.
A
similar
requirement
applies
to
any
study
used
to
demonstrate
reduction
in
residues
between
farm
gate
and
consumption.

Livestock
feeding
studies
and
metabolism
studies
Registrant
must
EITHER
verify
that
the
dietary
burden
calculations
that
were
incorporated
in
the
original
AR
derivation
for
meat,
milk,
poultry
or
eggs
are
still
valid
OR
provide
a
new
animal
feeding
study
that
reflects
current
feeding
practices.
Dietary
burden
calculations
could
change
due
to
increased
residue
levels
on
feed
items
or
from
changes
in
the
relative
abundance
or
use
of
a
particular
feed
item
over
time.

EPA
has
published
guidelines
for
studies
listed
in
40
CFR
Part
158,
Data
Requirements.
Internal
guidelines
have
also
been
established
for
monitoring
studies
which
require
a
registrant
to
submit
and
obtain
approval
of
the
study
protocol
prior
to
initiating
a
study.
The
protocol
must
describe
crops
and
pesticides
to
be
covered
by
the
study.
After
approval,
the
applicant
must
adhere
to
the
protocol
or
seek
approval
for
major
deviations.
SOP
No.
HED
AR­
1
contains
the
specific
requirements
when
ARs
are
used
(
see
Attachment
H).

If
EPA
relies
on
ARs
data
when
establishing
or
reassessing
a
tolerance,
it
generally
must
issue
a
DCI,
and
if
the
EPA
used
the
percent
of
crop
treated
data
estimates
for
a
tolerance
action,
it
may
generally
issue
a
DCI.
A
DCI
is
a
letter
sent
to
the
registrant
that
explains
the
data
submission
requirement,
requests
specific
data,
sets
out
a
time
frame
for
a
response
to
EPA,
and
provides
applicable
forms
and
guidelines
to
assist
the
registrant
with
the
completion
of
the
DCI
request.
A
registrant
must
respond
within
90
days
of
receipt
of
the
DCI.
The
response
must
describe
plans
to
submit
the
required
data
in
accordance
with
the
time
frame
specified,
and,
if
September
17,
2004
Page
8
applicable,
contain
suggested
protocols
for
monitoring
studies.
Failure
to
generate
the
requested
data,
or
respond
to
the
DCI
in
a
timely
manner,
could
result
in
Agency
action
to
modify
or
revoke
the
tolerance.

There
are
two
main
categories
of
applications
for
this
collection:
those
requiring
submission
of
a
full
complement
of
supporting
data,
(
e.
g.,
new
chemicals,
and
biorationals);
and
those
requiring
submission
of
little
or
no
data,
(
e.
g.,
"
me­
too"
products)
for
previously
registered
chemicals
and
use
patterns.
Applicants
for
a
"
me­
too"
product
(
i.
e.,
a
pesticide
claimed
to
be
substantially
similar
in
composition
and
use
to
a
product
previously
registered
by
the
EPA)
may
be
required
only
to
use
EPA
Form
8570­
34,
Certification
with
Respect
to
Citation
of
Data
(
in
Pesticide
Registration
(
PR)
Notice
98­
5)
(
Attachment
F),
and
EPA
Form
8570­
35,
Data
Matrix
(
also
in
PR
Notice
98­
5)
(
Attachment
G),
to
certify
that
the
applicant
intends
to
rely
on
data
previously
submitted
to
the
EPA
by
another
producer,
the
applicant
has
contacted
the
appropriate
company
(
owning
the
data
that
the
applicant
is
referencing),
and
the
applicant
has
offered
to
pay
reasonable
compensation
for
the
use
of
the
data.

(
ii).
Respondent
Activities
A
registrant
must
take
the
following
actions
to
comply
with
a
DCI:

Read
instructions
Read
the
DCI
letter
to
understand
what
data
are
to
be
submitted;

Plan
activities
Plan
the
activities
necessary
to
comply
with
the
DCI.
These
may
include:
a)
request
a
waiver;
b)
agree
to
do
data;
c)
certify
offer
of
compensation
with
original
data
submitter;
d)
volunteer
to
cancel
the
registration
of
concern;
e)
claim
a
generic
data
exemption;

Create
information
Conduct
research,
administer
tests,
analyze
data
to
develop
studies,
perform
and
report
laboratory
analyses;

Gather
information
Search
for
existing
data
that
will
satisfy
the
DCI;

Compile
and
review
Assemble
and
evaluate
data
for
accuracy
and
appropriateness
for
compliance
with
the
DCI;

Complete
paperwork
Prepare
necessary
correspondence
documents
and
packages
for
submitting
data
to
EPA;
and
Submit
and
file
Transmit
the
data
and
other
information
to
EPA
and
catalog
in
company
files.
September
17,
2004
Page
9
5.
THE
INFORMATION
COLLECTED:
AGENCY
ACTIVITIES,
COLLECTION
METHODOLOGY,
AND
INFORMATION
MANAGEMENT
5(
a)
Agency
Activities
The
Agency
must
perform
the
following
actions
to
conduct
a
DCI:

Develop
DCI
notice
Determine
data
requirements
and
prepare
the
DCI
letter
identifying
all
data
needed
and
respondent's
options;
issue
DCI;

Answer
questions
Respond
to
any
questions
the
registrant
may
have
regarding
the
DCI;

Examine
responses
and
data
submissions;
archive
documents
Examine
responses
and
data
submissions
for
acceptability
and
responsiveness
to
DCI;
if
necessary,
clarify
or
seek
additional
information
from
registrant;
process,
catalog
and
archive
DCI
data
into
the
Pesticide
Document
Management
System
(
PDMS);
refer
nonresponders
to
the
Office
of
Enforcement
and
Compliance
and
Assurance
for
action;

Analyze
data
Conduct
scientific
reviews
of
the
data;
and
Record
and
store
DCI
data
Record
facts
of
the
submission
for
compliance
monitoring
and
archive
in
EPA
files.

5(
b)
Collection
Methodology
and
Management
OPP
tracks
DCIs
and
all
registrant
responses
through
the
Office
of
Pesticide
Programs
Information
Network
(
OPPIN),
OPP's
general
purpose
action
tracking
system.
Additionally,
the
Reference
Files
System
(
REFS)
is
used
if
the
registrant
voluntarily
cancels
a
product
in
response
to
a
DCI.
The
Pesticide
Data
Management
System
lists
the
bibliography
of
data
submitters
for
the
DCI
and
OPPIN
tracks
the
submissions.
All
correspondence
associated
with
the
issuance
and
response
to
the
DCI
is
filed
in
the
master
registration
file
or
`
registration
jacket'
of
affected
products.
Data
submitted
in
response
to
a
DCI
is
processed,
catalogued
and
archived
in
the
PDMS.
Failures
to
comply
with
DCI
requirements
are
referred
to
EPA's
Office
of
Enforcement
and
Compliance
Assurance
for
appropriate
follow­
up
actions.
Records
submitted
pursuant
to
a
DCI
are
subject
to
Freedom
of
Information
Act
(
FOIA)
requests.

5(
c)
Small
Entity
Flexibility
Currently,
pesticide
registrants
may
be
divided
into
two
groups.
Approximately
10
percent
of
the
total:
manufacture
or
import
chemical
active
ingredients
intended
for
use
as
pesticides,
sell
these
active
ingredients
to
other
firms
for
formulation
into
pesticide
products,
and/
or
make
the
end­
products
themselves.
The
second,
and
by
far
the
larger,
group
of
registrants
purchase
the
active
ingredients
in
their
pesticide
products
from
members
of
the
first
group,
and
combine
them
with
pesticide
inert
ingredients
or
sometimes
simply
repackage
them
to
make
their
end­
use
products.

This
second
group
is
primarily
comprised
of
small
businesses.
When
small
businesses
use
a
September
17,
2004
Page
10
registered
source
of
the
active
ingredient
to
formulate
their
products,
they
generally
are
exempt
from
generating
health
and
safety
data
for
pesticide
active
ingredients
("
generic
data").
Consequently,
they
usually
need
only
respond
to
a
DCI
for
active
ingredient
data
by
claiming
the
"
generic
data
exemption."
They
do
not
incur
any
other
information
burden
associated
with
the
generic
data
call­
in.

5(
d)
Collection
Schedule
DCIs
will
generally
be
issued
whenever
ARs
data
is
relied
upon,
either
to
establish
new
tolerances
or
reassess
existing
tolerances.
Registrants
have
five
years
before
data
must
generally
be
submitted
in
support
of
the
ARs
used.
Data
must
also
be
periodically
reviewed
when
PCT
estimates
are
relied
upon,
but
in
most
cases
the
Agency
will
be
able
to
internally
collect
or
generate
this
data.
In
cases
where
the
Agency
is
unable
to
get
the
information
itself,
the
registrant
must
submit
data
within
five
years
of
the
use
of
PCT
estimates.
A
registrant
must
respond
within
90
days
of
receipt
of
the
DCI.
The
response
must
describe
plans
to
submit
the
required
data
in
accordance
with
the
time
frame
specified,
and,
if
applicable,
contain
suggested
protocols
for
monitoring
studies.
Additional
time
is
provided
for
development
of
new
studies
appropriate
to
the
nature
of
the
studies
required.

6.
ESTIMATING
THE
BURDEN
AND
COST
OF
THE
COLLECTION
To
estimate
the
burden
and
costs
for
the
paperwork
related
activities
for
the
respondents
to
comply
with
DCIs
that
could
be
issued
under
this
ICR,
EPA
used
the
same
methodology
as
was
previously
used
to
estimate
DCI
related
paperwork
burden.
A
general
description
of
this
methodology
is
provided
in
Attachment
I.
In
short,
this
methodology
used
the
total
cost
of
the
test
required
by
the
DCI
to
generate
estimates
for
the
burden
and
cost
of
the
paperwork
related
activities
associated
with
DCIs.
The
following
estimates
represent
the
burden
and
costs
for
the
paperwork
related
activities,
and
therefore
includes
the
paperwork
burden
and
costs
related
to
the
creation
and
gathering
of
the
data.

6(
a)
Estimating
Respondent
Burden
The
annual
respondent
burden
for
the
collection
of
information
associated
with
this
activity
is
estimated
to
average
between
59
and
13,636
burden
hours
per
DCI,
depending
upon
the
type
of
response
requested.
The
total
estimated
burden
for
this
ICR
of
28,569
burden
hours
is
based
on
the
Agency's
estimate
of
the
potential
burden
and
number
of
responses
for
each
of
the
following
four
types
of
potential
DCIs:

1)
DCI
for
anticipated
residues
requiring
a
base
set
of
data
(
13,636
hrs.);
2)
DCI
for
anticipated
residues
requiring
minimum
data
(
69
hrs.);
3)
DCI
for
anticipated
residues
collected
from
publically
available
sources
(
137
hrs.);
and
4)
DCI
for
percent
crop
treated
using
existing
information
(
59
hrs.).

The
following
information
presents
the
Agency's
burden
estimates
for
each
type
of
DCI.

DCI
Type
1
­
DCI
for
anticipated
residues
requiring
a
base
set
of
data:

Respondent
burden
hours
for
generating
and
submitting
data
in
response
to
a
DCI
for
anticipated
residues
requiring
a
base
set
of
data
to
be
submitted
are
estimated
at
13,636
burden
hours
per
response.
September
17,
2004
Page
11
EPA
also
considered
the
typical
burden
for
reading
instructions,
planning
activities,
compiling
and
reviewing
the
submission,
submitting
the
data
to
EPA,
and
related
record
keeping
in
estimating
the
total
per
response
burden
and
costs.
Using
the
EPA
PDP
contracts
as
the
basis,
EPA
estimated
the
burden
for
conducting
a
monitoring
study
to
gather
the
necessary
data,
and
the
annual
respondent
cost
for
meeting
40
CFR
part
158
data
requirements
for
anticipated
residues.
See
Table
1.

Since,
in
most
cases,
registrants
will
be
able
to
get
the
information
from
federal
and
state
monitoring
programs,
EPA
estimates
that
no
more
than
2
registrants
might
generate
their
own
monitoring
data
in
response
to
the
DCI.
The
total
burden
for
this
type
of
DCI
is
therefore
estimated
to
be
27,272
hours
per
year
for
two
respondents.

TABLE
1
­
Annual
Respondent
Burden/
Cost
Estimates
for
Anticipated
Residues
Generating
Anticipated
Residue
Data
BURDEN
HOURS
(
per
year)
TOTAL
ACTIVITIES
Mgmt.
$
130
Tech.
$
88
Cler.
$
40
Hours
Costs
1)
Read
instructions
2
0
0
2
260
2)
Plan
activities
4
0
0
4
520
3)
Create
information
0
13,600
0
13,600
1,196,800
4)
Gather
information
0
16
0
16
1,408
5)
Compile
and
review
1
8
0
9
834
6)
Complete
paperwork
2
0
2
4
340
7)
Maintain
and
file
0
0
1
1
40
TOTAL
9
13,624
3
13,636
$
1,200,202
BURDEN:
13,636
hours
x
Average
of
2
responses
=
27,272
Total
Burden
Hours.

DCI
Type
2
­
DCI
for
anticipated
residues
requiring
minimum
data:

Minimum
data
captures
the
burden
for
cases
in
which
the
respondent
verifies
that
nothing
has
changed;
i.
e.,
the
formulation,
use
rate,
geographic
distribution
of
use,
etc.
have
not
changed
since
the
ARs
where
used
to
establish
or
reassess
the
tolerance.
Average
burden
hours
per
respondent
for
submitting
a
base
set
of
data
for
updating
use
information
is
estimated
at
69
burden
hours
per
year
per
response.
EPA
estimates
that
no
more
than
10
respondents
each
year
will
comply
with
a
DCI
by
submitting
a
base
set
of
data
for
updating
use
information.
As
such,
the
total
respondent
burden
hours
per
year
are
estimated
at
690
hours.
See
Table
2.
September
17,
2004
Page
12
TABLE
2
­
Annual
Respondent
Burden/
Cost
Estimates
for
Anticipated
Residues
Requiring
Minimum
Data
Burden
Hours
(
per
year)
Total
Collection
Activities
Mgmt.
$
130
Tech.
$
88
Cler.
$
40
Hours
Costs
1)
Read
Instructions
8
0
0
8
1,040
2)
Plan
Activities
16
0
0
16
2,080
3)
Create
Information
0
0
0
0
0
4)
Gather
Information
0
16
0
16
1,408
5)
Compile
and
Review
2
16
0
18
1,668
6)
Complete
Paperwork
2
0
8
10
580
7)
Submit
and
File
0
0
1
1
40
Total
28
32
9
69
$
6,816
BURDEN:
69
hours
x
Average
of
10
responses
=
690
Total
Hours.

DCI
Type
3
­
DCI
for
anticipated
residues
collected
from
publically
available
sources:

The
average
respondent
burden
for
submitting
a
base
set
of
data
for
updating
monitoring
information
is
estimated
at
137
burden
hours
per
year.
EPA
estimates
that
an
average
of
4
respondents
each
year
are
likely
to
be
able
to
comply
with
a
DCI
by
submitting
data
from
publically
available
sources.
As
such,
the
total
annual
respondent
burden
for
this
type
of
DCI
is
estimated
to
be
548
burden
hours.
See
Table
3.

TABLE
3
­
Annual
Respondent
Burden/
Cost
Estimates
for
Anticipated
Residues
Collected
from
Publicly
Available
Sources
Burden
Hours
(
per
year)
Total
Collection
Activities
Mgmt.
$
130
Tech.
$
88
Cler.
$
40
Hours
Costs
1)
Read
Instructions
8
0
0
8
1,040
2)
Plan
Activities
16
0
0
16
2,080
3)
Create
Information
0
0
0
0
0
4)
Gather
Information
0
60
0
60
5,280
5)
Compile
and
Review
2
40
0
42
3,780
6)
Complete
Paperwork
2
0
8
10
580
7)
Submit
and
File
0
0
1
1
40
Total
28
100
9
137
12,800
September
17,
2004
Page
13
BURDEN:
137
hours
x
Average
of
4
responses
=
548
Total
Hours.

DCI
Type
4
­
DCI
for
percent
crop
treated
using
existing
information:

The
annual
per
respondent
burden
for
generating
percent
crop
treated
estimates
using
existing
information
is
estimated
to
be
59
burden
hours.
Percent
crop
treated
estimates
are
generally
conducted
within
the
Agency,
and
only
in
rare
instances
would
a
registrant
need
to
gather
the
information;
one
per
year
may
be
an
overestimation.
The
estimated
costs
assume
that
cost
of
purchasing,
or
obtaining
percent
crop
treated
information
derived
from
existing,
contracted
data
sources.
See
Table
4.

TABLE
4
­
Annual
Respondent
Burden/
Cost
Estimates
for
Percent
Crop
Treated
Using
Existing
Information
Burden
Hours
(
per
year)
Total
Activities
Mgmt.
$
130
Tech.
$
88
Cler.
$
40
Hours
Costs
1)
Read
Instructions
1
1
0
2
218
2)
Plan
Activities
0
2
0
2
176
3)
Create
Information
0
8
0
8
704
4)
Gather
Information
0
22
0
22
1,936
5)
Compile
and
Review
1
20
0
21
1,890
6)
Complete
Paperwork
1
0
2
3
210
7)
Submit
and
File
0
0
1
1
40
Total
3
53
3
59
$
5,174
BURDEN:
59
hours
x
average
of
generating
1
response
=
59
Total
Hours
6(
b)
Estimating
Respondent
Costs
The
corresponding
estimated
respondent
cost
for
this
collection
is
$
2,524,938.
Respondent
costs
are
based
on
managerial,
technical
and
clerical
burden
hours
estimated
at
$
130,
$
88,
and
$
40
per
hour,
respectively.
EPA
has
calculated
the
estimated
labor
rates
for
respondents
to
the
requirements
of
this
ICR
factoring
in
an
inflation
cost
index
of
1.056
based
on
the
Gross
Domestic
Product.
These
labor
rates
are
fully
loaded
and
include
benefits
and
overhead
costs.

The
total
estimated
cost
for
this
collection
is
based
on
the
Agency's
estimate
of
the
potential
cost
and
number
of
responses
for
each
of
the
following
four
types
of
potential
DCIs:

1)
DCI
for
anticipated
residues
requiring
a
base
set
of
data
­
$
2,400,404
2)
DCI
for
anticipated
residues
requiring
minimum
data
­
$
68,160
3)
DCI
for
anticipated
residues
collected
from
publically
available
sources
­
$
51,200;
and
4)
DCI
for
percent
crop
treated
using
existing
information
­
$
5,174.
September
17,
2004
Page
14
6(
c)
Estimating
Agency
Burden
and
Costs
Annual
Agency
burden
for
managing
individual
information
from
Type
1,
2
or
3
DCIs
is
estimated
at
99
burden
hours
per
response.
The
hourly
rates
are
$
96,
$
70,
and
$
33
per
hour
for
management,
technical,
and
clerical
staff,
respectively.
Agency
labor
rates
are
based
on
Office
of
Personnel
Management
salary
tables
for
federal
employees
for
the
years
1999
through
2001
and
include
benefits
and
overhead
costs,
as
well
as
locality
pay
for
the
Washington,
DC­
Baltimore
area.
The
annual
Agency
cost
for
managing
an
individual
response
is
estimated
at
$
6,501
per
response.

Since
the
average
number
of
responses
each
year
for
these
DCIs
is
estimated
to
be
16,
the
total
annual
burden
for
the
Agency
activities
is
estimated
to
be
1,584
burden
hours,
with
an
associated
cost
of
$
104,016
per
year.
See
Table
5.

TABLE
5
­
Annual
Agency
Burden/
Cost
Estimates
for
Processing
DCI
Types
1­
3
Burden
Hours
(
per
year)
Total
Collection
Activities
Mgmt.
$
96
Tech.
$
70
Cler.
$
33
Hours
Costs
Develop
DCI
notice
1
0
2
3
162
Answer
Registrants'
questions
0
4
5
9
445
IN­
process
data
submissions
0
0
4
4
132
Analyze
data
1
80
0
81
5,696
Record
and
store
DCI
data
0
0
2
2
66
Total
2
84
13
99
$
6,501
BURDEN:
99
hours
x
16
responses
=
1,584
Total
Hours
COSTS:
$
6,501
x
16
responses
=
$
104,016
Total
Costs
The
annual
Agency
burden
for
managing
individual
DCI
information
for
percent
crop
treated
is
estimated
at
59
hours
per
response,
with
an
estimated
cost
of
$
3,701
per
response.
Since
the
Agency
estimates
no
more
than
1
response
each
year,
if
any,
the
total
annual
Agency
burden
and
cost
is
59
burden
hours,
and
$
3,701
See
Table
6.
September
17,
2004
Page
15
TABLE
6
­
Annual
Agency
Burden/
Cost
Estimates
for
Processing
DCI
Type
4
Burden
Hours
(
per
year)
Total
Collection
Activities
Mgmt.
$
96
Tech.
$
70
Cler.
$
33
Hours
Costs
Develop
DCI
notice
1
0
2
3
162
Answer
Registrants'
questions
0
4
5
9
445
IN­
process
data
submissions
0
0
4
4
132
Analyze
data
1
40
0
41
2,896
Record
and
store
DCI
data
0
0
2
2
66
Total
2
44
13
59
$
3,701
BURDEN:
59
hours
x
1
response
=
59
Total
Hours
COSTS:
$
3,701
x
1
responses
=
$
3,701
Total
Costs
6(
d)
Bottom
Line
Burden
Hours
and
Cost
Table
The
total
estimated
annual
respondent
burden
is
28,569
burden
hours
(
28,509
burden
hours
for
all
AR
DCI
submissions
+
59
burden
hours
for
Percent
Crop
Treated
DCI
submissions),
with
an
associated
cost
of
$
2,524,938
($
2,519,764
for
all
AR
DCI
submissions
+
$
5,174
for
Percent
Crop
Treated
DCI
submissions).
See
Table
7.

The
total
estimated
annual
Agency
burden
is
1,643
burden
hours
(
1,584
burden
hours
for
all
AR
DCI
submissions
+
59
burden
hours
for
Percent
Crop
Treated
DCI
submissions),
with
an
associated
cost
of
$
107,717
($
104,016
for
all
AR
DCI
submissions
+
$
3,701
for
Percent
Crop
Treated
DCI
submissions).

Key
Activities
Hours
Costs
Respondents
Total
respondent
burden/
costs
for
generating
anticipated
residue
data.
27,272
$
2,400,404
Total
respondent
burden/
costs
for
submitting
minimal
anticipated
residue
data.
690
$
68,160
Total
respondent
burden/
costs
for
submitting
anticipated
residue
data
from
publicly
available
sources.
548
$
51,200
Total
respondent
burden/
costs
for
submitting
percent
crop
treated
data
using
existing
information.
59
$
5,174
Total
estimated
respondent
burden/
costs.
28,569
$
2,524,938
Agency
Total
Agency
burden/
costs
for
managing
anticipated
residue
DCI's
1,584
$
104,016
September
17,
2004
Page
16
Total
Agency
burden/
costs
for
managing
percent
crop
treated
DCI's.
59
$
3,701
Total
Agency
burden/
costs.
1,643
$
107,717
6(
e)
Reasons
for
Change
in
Burden
In
the
previous
ICR,
OMB
approved
29,807
burden
hours,
with
a
cost
of
$
2,773,866.
This
ICR
renewal
request
reflects
a
decrease
of
approximately
1,238
burden
hours
for
an
annual
respondent
burden
of
28,569
hours
and
a
decrease
in
cost
of
$
248,928,
for
an
annual
respondent
cost
of
$
2,524,938.
These
reductions
are
adjustments
due
to
the
fact
that
the
Agency
expects
to
issue
fewer
data
call­
ins
under
this
program
than
originally
estimated.
Oftentimes,
data
can
be
acquired
more
efficiently
without
issuing
a
DCI.
For
example,
OPP
works
closely
with
USDA's
Pesticide
Data
Program
(
PDP)
which
generates
publically
available
monitoring
data.
OPP
can
get
the
PDP
monitoring
data
more
quickly
and
in
a
format
most
usable
to
the
Agency
by
requesting
the
data
directly
from
USDA.
This
would
eliminate
the
cost
to
the
pesticide
registrants
and
would
save
the
Agency
time
and
the
administrative
expense
associated
with
a
data­
call­
in.
Similarly,
data
on
changes
in
processing
practices
that
may
lead
to
increases
in
residues
can
more
efficiently
collected
in
cooperation
with
food
industry
associations.
Also,
in
many
cases
the
Agency
can
continue
to
stand
by
its
safety
finding
without
requiring
additional
data
because
the
risk
is
so
low
that
even
large
increases
in
exposure
would
not
create
a
risk
of
concern.

6(
f)
Burden
Statement
The
total
annual
respondent
burden
for
this
ICR
is
estimated
to
be
28,569
hours,
ranging
from
59
hours
to
13,636
hours
per
response,
depending
on
the
type
of
DCI.

According
to
the
Paperwork
Reduction
Act,
"
burden"
means
the
total
time,
effort,
or
financial
resources
expended
by
persons
to
generate,
maintain,
retain,
or
disclose
or
provide
information
to
or
for
a
Federal
agency.
For
this
collection,
it
is
the
time
reading
the
regulations,
planning
the
necessary
data
collection
activities,
conducting
tests,
analyzing
data,
generating
reports
and
completing
other
required
paperwork,
and
storing,
filing,
and
maintaining
the
data.

An
agency
may
not
conduct
or
sponsor,
and
a
person
is
not
required
to
respond
to,
a
collection
of
information
unless
it
displays
a
currently
valid
OMB
control
number.
The
OMB
control
numbers
for
EPA's
regulations
in
title
40
of
the
CFR,
after
appearing
in
the
Federal
Register,
are
listed
in
40
CFR
part
9,
and
included
on
the
related
collection
instrument
or
form,
if
applicable.

To
comment
on
EPA's
need
for
this
information,
the
accuracy
of
the
provided
burden
estimates,
and
any
suggested
methods
for
minimizing
respondent
burden,
including
the
use
of
automated
collection
techniques,
EPA
has
established
a
public
docket
for
this
ICR
under
Docket
ID
No.
OPP­
2004­
0109,
which
is
available
for
public
viewing
at
the
OPP
Docket
in
the
Public
Information
and
Records
Integrity
Branch,
Rm.
119,
Crystal
Mall
#
2,
1801
Bell
Street.,
Arlington,
VA.
This
docket
facility
is
open
from
8:
30
a.
m.
to
4:
00
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
docket
telephone
number
is
(
703)
305­
5805.

An
electronic
version
of
the
public
docket
for
this
ICR
renewal
is
available
through
EDOCKET
at
September
17,
2004
Page
17
http://
www.
epa.
gov/
edocket.
Use
EDOCKET
to
submit
or
view
public
comments,
access
the
index
listing
of
the
contents
of
the
public
docket,
and
to
access
those
documents
in
the
public
docket
that
are
available
electronically.
Once
in
the
system,
select
"
search,"
then
key
in
the
docket
ID
number
identified
above.
Also,
you
can
send
comments
to
the
Office
of
Information
and
Regulatory
Affairs,
Office
of
Management
and
Budget,
725
17th
Street,
NW,
Washington,
DC
20503,
Attention:
Desk
Officer
for
EPA.
Please
include
the
EPA
Docket
ID
No.
OPP­
2004­
0109
and
OMB
Control
No.
2070­
0164
in
any
correspondence.

ATTACHMENTS
TO
THE
SUPPORTING
STATEMENT
ATTACHMENT
A:
FFDCA
Section
408(
b)
­
Included
in
the
electronic
file
for
this
ICR
and
also
available
electronically
at
http://
www.
epa.
gov/
epahome/
laws.
htm.

ATTACHMENT
B:
FIFRA
Section
3(
c)(
2)(
B)
­
Included
in
the
electronic
file
for
this
ICR
and
also
available
electronically
at
http://
www.
epa.
gov/
oppfead1/
fqpa/
and
click
on
"
LAWS,"
then
click
on
the
available
PDF
file
for
FIFRA.

ATTACHMENT
C:
Data
Call­
In
Response
Form.
A
pdf
copy
is
available
electronically
through
EDOCKET.

ATTACHMENT
D:
Requirements
Status
and
Registrant's
Response
Form.
A
pdf
copy
is
available
electronically
through
EDOCKET.

ATTACHMENT
E:
Certification
of
Attempt
to
Enter
into
an
Agreement
with
Registrants
for
Development
of
Data
(
EPA
Form
8570­
32).
A
pdf
copy
is
available
electronically
through
EDOCKET
and
is
also
available
electronically
at
http://
www.
epa.
gov/
opprd001/
forms/
8570­
32.
pdf
ATTACHMENT
F:
Certification
with
Respect
to
Citation
of
Data
(
EPA
Form
8570­
34).
A
pdf
copy
is
available
electronically
through
EDOCKET
and
is
also
available
electronically
at
http://
www.
epa.
gov/
opprd001/
forms/
8570­
34.
pdf
ATTACHMENT
G:
Data
Matrix
(
EPA
Form
8570­
35).
A
pdf
copy
is
available
electronically
through
EDOCKET
and
is
also
available
electronically
at
http://
www.
epa.
gov/
opprd001/
forms/
8570­
35.
pdf
ATTACHMENT
H:
SOP
No.
HED
AR­
1,
Use
of
Anticipated
Residues
in
Risk
Assessment.
Included
in
the
electronic
file
for
this
ICR.

ATTACHMENT
I:
Estimating
the
Potential
Paperwork
Burden
and
Cost
for
DCIs.
Included
in
the
electronic
file
for
this
ICR.
September
17,
2004
Page
18
ATTACHMENT
J:
Consultation
Contacts
for
Data
Generation
for
Pesticide
Reregistration
Programs;
EPA
Questions
Asked
in
Consultations.
Included
in
the
electronic
file
for
this
ICR.

ATTACHMENT
K:
Comments
received
in
to
the
Consultation
Process;
EPA
Response
to
Specific
Consultation
Comments.
Included
in
the
electronic
file
for
this
ICR.
Data
Acquisition
for
Anticipated
Residue
and
Percent
of
Crop
Treated
OMB
No.
2070­
0164
EPA
No.
1911.02
Attachment
A
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA)
Section
408(
b)
­
Authority
and
Standard
for
Tolerance
September
17,
2004
Page
1
Attachment
A
­
FFDCA
§
408(
b)

Authority
and
standard
for
tolerance
(
1)
Authority
The
Administrator
may
issue
regulations
establishing,
modifying,
or
revoking
a
tolerance
for
a
pesticide
chemical
residue
in
or
on
a
food
­

(
A)
in
response
to
a
petition
filed
under
subsection
(
d);
or
(
B)
on
the
Administrator's
own
initiative
under
subsection
(
e).

As
used
in
this
section,
the
term
''
modify''
shall
not
mean
expanding
the
tolerance
to
cover
additional
foods.

(
2)
Standard
(
A)
General
rule
(
i)
Standard
The
Administrator
may
establish
or
leave
in
effect
a
tolerance
for
a
pesticide
chemical
residue
in
or
on
a
food
only
if
the
Administrator
determines
that
the
tolerance
is
safe.
The
Administrator
shall
modify
or
revoke
a
tolerance
if
the
Administrator
determines
it
is
not
safe.

(
ii)
Determination
of
safety
As
used
in
this
section,
the
term
''
safe'',
with
respect
to
a
tolerance
for
a
pesticide
chemical
residue,
means
that
the
Administrator
has
determined
that
there
is
a
reasonable
certainty
that
no
harm
will
result
from
aggregate
exposure
to
the
pesticide
chemical
residue,
including
all
anticipated
dietary
exposures
and
all
other
exposures
for
which
there
is
reliable
information.

(
iii)
Rule
of
construction
With
respect
to
a
tolerance,
a
pesticide
chemical
residue
meeting
the
standard
under
clause
(
i)
is
not
an
eligible
pesticide
chemical
residue
for
purposes
of
subparagraph
(
B).

(
B)
Tolerances
for
eligible
pesticide
chemical
residues
(
i)
Definition
­
As
used
in
this
subparagraph,
the
term
''
eligible
pesticide
chemical
residue''
means
a
pesticide
chemical
residue
as
to
which
­

(
I)
The
Administrator
is
not
able
to
identify
a
level
of
exposure
to
the
residue
at
which
the
residue
will
not
cause
or
contribute
to
a
known
or
anticipated
harm
to
human
health
(
referred
to
in
this
section
as
a
''
nonthreshold
effect'');

(
II)
the
lifetime
risk
of
experiencing
the
nonthreshold
effect
is
appropriately
assessed
by
quantitative
risk
assessment;
and
(
III)
with
regard
to
any
known
or
anticipated
harm
to
human
health
for
which
the
Administrator
is
able
to
identify
a
level
at
which
the
residue
will
not
cause
such
harm
(
referred
to
in
this
section
as
a
''
threshold
effect''),
the
Administrator
determines
that
the
level
of
aggregate
exposure
is
safe.

(
ii)
Determination
of
tolerance
­
Notwithstanding
subparagraph
(
A)(
i),
a
tolerance
for
an
eligible
pesticide
chemical
residue
may
be
left
in
effect
or
modified
under
this
September
17,
2004
Page
2
subparagraph
if
­

(
I)
at
least
one
of
the
conditions
described
in
clause
(
iii)
is
met;
and
(
II)
both
of
the
conditions
described
in
clause
(
iv)
are
met.

(
iii)
Conditions
regarding
use
­
For
purposes
of
clause
(
ii),
the
conditions
described
in
this
clause
with
respect
to
a
tolerance
for
an
eligible
pesticide
chemical
residue
are
the
following:

(
I)
Use
of
the
pesticide
chemical
that
produces
the
residue
protects
consumers
from
adverse
effects
on
health
that
would
pose
a
greater
risk
than
the
dietary
risk
from
the
residue.

(
II)
Use
of
the
pesticide
chemical
that
produces
the
residue
is
necessary
to
avoid
a
significant
disruption
in
domestic
production
of
an
adequate,
wholesome,
and
economical
food
supply.

(
iv)
Conditions
regarding
risk
­
For
purposes
of
clause
(
ii),
the
conditions
described
in
this
clause
with
respect
to
a
tolerance
for
an
eligible
pesticide
chemical
residue
are
the
following:

(
I)
The
yearly
risk
associated
with
the
nonthreshold
effect
from
aggregate
exposure
to
the
residue
does
not
exceed
10
times
the
yearly
risk
that
would
be
allowed
under
subparagraph
(
A)
for
such
effect.

(
II)
The
tolerance
is
limited
so
as
to
ensure
that
the
risk
over
a
lifetime
associated
with
the
nonthreshold
effect
from
aggregate
exposure
to
the
residue
is
not
greater
than
twice
the
lifetime
risk
that
would
be
allowed
under
subparagraph
(
A)
for
such
effect.

(
v)
Review
­
Five
years
after
the
date
on
which
the
Administrator
makes
a
determination
to
leave
in
effect
or
modify
a
tolerance
under
this
subparagraph,
and
thereafter
as
the
Administrator
deems
appropriate,
the
Administrator
shall
determine,
after
notice
and
opportunity
for
comment,
whether
it
has
been
demonstrated
to
the
Administrator
that
a
condition
described
in
clause
(
iii)(
I)
or
clause
(
iii)(
II)
continues
to
exist
with
respect
to
the
tolerance
and
that
the
yearly
and
lifetime
risks
from
aggregate
exposure
to
such
residue
continue
to
comply
with
the
limits
specified
in
clause
(
iv).
If
the
Administrator
determines
by
such
date
that
such
demonstration
has
not
been
made,
the
Administrator
shall,
not
later
than
180
days
after
the
date
of
such
determination,
issue
a
regulation
under
subsection
(
e)(
1)
of
this
section
to
modify
or
revoke
the
tolerance.

(
vi)
Infants
and
children
­
Any
tolerance
under
this
subparagraph
shall
meet
the
requirements
of
subparagraph
(
C).

(
C)
Exposure
of
infants
and
children
In
establishing,
modifying,
leaving
in
effect,
or
revoking
a
tolerance
or
exemption
for
a
pesticide
chemical
residue,
the
Administrator
­

(
i)
shall
assess
the
risk
of
the
pesticide
chemical
residue
based
on
­

(
I)
available
information
about
consumption
patterns
among
infants
and
children
that
are
likely
to
result
in
disproportionately
high
consumption
of
foods
containing
or
bearing
such
residue
among
infants
and
children
in
comparison
to
the
general
population;
September
17,
2004
Page
3
(
II)
available
information
concerning
the
special
susceptibility
of
infants
and
children
to
the
pesticide
chemical
residues,
including
neurological
differences
between
infants
and
children
and
adults,
and
effects
of
in
utero
exposure
to
pesticide
chemicals;
and
(
III)
available
information
concerning
the
cumulative
effects
on
infants
and
children
of
such
residues
and
other
substances
that
have
a
common
mechanism
of
toxicity;
and
(
ii)
shall
­

(
I)
ensure
that
there
is
a
reasonable
certainty
that
no
harm
will
result
to
infants
and
children
from
aggregate
exposure
to
the
pesticide
chemical
residue;
and
(
II)
publish
a
specific
determination
regarding
the
safety
of
the
pesticide
chemical
residue
for
infants
and
children.

The
Secretary
of
Health
and
Human
Services
and
the
Secretary
of
Agriculture,
in
consultation
with
the
Administrator,
shall
conduct
surveys
to
document
dietary
exposure
to
pesticides
among
infants
and
children.
In
the
case
of
threshold
effects,
for
purposes
of
clause
(
ii)(
I)
an
additional
tenfold
margin
of
safety
for
the
pesticide
chemical
residue
and
other
sources
of
exposure
shall
be
applied
for
infants
and
children
to
take
into
account
potential
pre­
and
post­
natal
toxicity
and
completeness
of
the
data
with
respect
to
exposure
and
toxicity
to
infants
and
children.
Notwithstanding
such
requirement
for
an
additional
margin
of
safety,
the
Administrator
may
use
a
different
margin
of
safety
for
the
pesticide
chemical
residue
only
if,
on
the
basis
of
reliable
data,
such
margin
will
be
safe
for
infants
and
children.

(
D)
Factors
In
establishing,
modifying,
leaving
in
effect,
or
revoking
a
tolerance
or
exemption
for
a
pesticide
chemical
residue,
the
Administrator
shall
consider,
among
other
relevant
factors
­

(
i)
the
validity,
completeness,
and
reliability
of
the
available
data
from
studies
of
the
pesticide
chemical
and
pesticide
chemical
residue;

(
ii)
the
nature
of
any
toxic
effect
shown
to
be
caused
by
the
pesticide
chemical
or
pesticide
chemical
residue
in
such
studies;

(
iii)
available
information
concerning
the
relationship
of
the
results
of
such
studies
to
human
risk;

(
iv)
available
information
concerning
the
dietary
consumption
patterns
of
consumers
(
and
major
identifiable
subgroups
of
consumers);

(
v)
available
information
concerning
the
cumulative
effects
of
such
residues
and
other
substances
that
have
a
common
mechanism
of
toxicity;

(
vi)
available
information
concerning
the
aggregate
exposure
levels
of
consumers
(
and
major
identifiable
subgroups
of
consumers)
to
the
pesticide
chemical
residue
and
to
other
related
substances,
including
dietary
exposure
under
the
tolerance
and
all
other
tolerances
in
effect
for
the
pesticide
chemical
residue,
and
exposure
from
other
non­
occupational
sources;
September
17,
2004
Page
4
(
vii)
available
information
concerning
the
variability
of
the
sensitivities
of
major
identifiable
subgroups
of
consumers;

(
viii)
such
information
as
the
Administrator
may
require
on
whether
the
pesticide
chemical
may
have
an
effect
in
humans
that
is
similar
to
an
effect
produced
by
a
naturally
occurring
estrogen
or
other
endocrine
effects;
and
(
ix)
safety
factors
which
in
the
opinion
of
experts
qualified
by
scientific
training
and
experience
to
evaluate
the
safety
of
food
additives
are
generally
recognized
as
appropriate
for
the
use
of
animal
experimentation
data.

(
E)
Data
and
information
regarding
anticipated
and
actual
residue
levels
(
i)
Authority
In
establishing,
modifying,
leaving
in
effect,
or
revoking
a
tolerance
for
a
pesticide
chemical
residue,
the
Administrator
may
consider
available
data
and
information
on
the
anticipated
residue
levels
of
the
pesticide
chemical
in
or
on
food
and
the
actual
residue
levels
of
the
pesticide
chemical
that
have
been
measured
in
food,
including
residue
data
collected
by
the
Food
and
Drug
Administration.

(
ii)
Requirement
If
the
Administrator
relies
on
anticipated
or
actual
residue
levels
in
establishing,
modifying,
or
leaving
in
effect
a
tolerance,
the
Administrator
shall
pursuant
to
subsection
(
f)(
1)
of
this
section
require
that
data
be
provided
five
years
after
the
date
on
which
the
tolerance
is
established,
modified,
or
left
in
effect,
and
thereafter
as
the
Administrator
deems
appropriate,
demonstrating
that
such
residue
levels
are
not
above
the
levels
so
relied
on.
If
such
data
are
not
so
provided,
or
if
the
data
do
not
demonstrate
that
the
residue
levels
are
not
above
the
levels
so
relied
on,
the
Administrator
shall,
not
later
than
180
days
after
the
date
on
which
the
data
were
required
to
be
provided,
issue
a
regulation
under
subsection
(
e)(
1)
of
this
section,
or
an
order
under
subsection
(
f)(
2)
of
this
section,
as
appropriate,
to
modify
or
revoke
the
tolerance.

(
F)
Percent
of
food
actually
treated
In
establishing,
modifying,
leaving
in
effect,
or
revoking
a
tolerance
for
a
pesticide
chemical
residue,
the
Administrator
may,
when
assessing
chronic
dietary
risk,
consider
available
data
and
information
on
the
percent
of
food
actually
treated
with
the
pesticide
chemical
(
including
aggregate
pesticide
use
data
collected
by
the
Department
of
Agriculture)
only
if
the
Administrator
­

(
i)
finds
that
the
data
are
reliable
and
provide
a
valid
basis
to
show
what
percentage
of
the
food
derived
from
such
crop
is
likely
to
contain
such
pesticide
chemical
residue;

(
ii)
finds
that
the
exposure
estimate
does
not
understate
exposure
for
any
significant
subpopulation
group;

(
iii)
finds
that,
if
data
are
available
on
pesticide
use
and
consumption
of
food
in
a
particular
area,
the
population
in
such
area
is
not
dietarily
exposed
to
residues
above
those
estimated
by
the
Administrator;
and
(
iv)
provides
for
the
periodic
reevaluation
of
the
estimate
of
anticipated
dietary
exposure.

(
3)
Detection
methods
(
A)
General
rule
September
17,
2004
Page
5
A
tolerance
for
a
pesticide
chemical
residue
in
or
on
a
food
shall
not
be
established
or
modified
by
the
Administrator
unless
the
Administrator
determines,
after
consultation
with
the
Secretary,
that
there
is
a
practical
method
for
detecting
and
measuring
the
levels
of
the
pesticide
chemical
residue
in
or
on
the
food.

(
B)
Detection
limit
A
tolerance
for
a
pesticide
chemical
residue
in
or
on
a
food
shall
not
be
established
at
or
modified
to
a
level
lower
than
the
limit
of
detection
of
the
method
for
detecting
and
measuring
the
pesticide
chemical
residue
specified
by
the
Administrator
under
subparagraph
(
A).

(
4)
International
standards
In
establishing
a
tolerance
for
a
pesticide
chemical
residue
in
or
on
a
food,
the
Administrator
shall
determine
whether
a
maximum
residue
level
for
the
pesticide
chemical
has
been
established
by
the
Codex
Alimentarius
Commission.
If
a
Codex
maximum
residue
level
has
been
established
for
the
pesticide
chemical
and
the
Administrator
does
not
propose
to
adopt
the
Codex
level,
the
Administrator
shall
publish
for
public
comment
a
notice
explaining
the
reasons
for
departing
from
the
Codex
level.
Data
Acquisition
for
Anticipated
Residue
and
Percent
of
Crop
Treated
OMB
No.
2070­
0164;
EPA
No.
1911.02
Attachment
B
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
FIFRA)
FIFRA
Section
3(
c)(
2)(
B)
September
17,
2004
Page
1
FIFRA
Section
3(
c)(
2)(
B)
 
Data
in
Support
of
Registration.­­
(
A)
In
General.­­
The
Administrator
shall
publish
guidelines
specifying
the
kinds
of
information
which
will
be
required
to
support
the
registration
of
a
pesticide
and
shall
revise
such
guidelines
from
time
to
time.
If
thereafter
the
Administrator
requires
any
additional
kind
of
information
under
subparagraph
(
B)
of
this
paragraph,
the
Administrator
shall
permit
sufficient
time
for
applicants
to
obtain
such
additional
information.
The
Administrator,
in
establishing
standards
for
data
requirements
for
the
registration
of
pesticides
with
respect
to
minor
uses,
shall
make
such
standards
commensurate
with
the
anticipated
extent
of
use,
pattern
of
use,
the
public
health
and
agricultural
need
for
such
minor
use,
and
the
level
and
degree
of
potential
beneficial
or
adverse
effects
on
man
and
the
environment.

The
Administrator
shall
not
require
a
person
to
submit,
in
relation
to
a
registration
or
reregistration
of
a
pesticide
for
minor
agricultural
use
under
this
Act,
any
field
residue
data
from
a
geographic
area
where
the
pesticide
will
not
be
registered
for
such
use.
In
the
development
of
these
standards,
the
Administrator
shall
consider
the
economic
factors
of
potential
national
volume
of
use,
extent
of
distribution,
and
the
impact
of
the
cost
of
meeting
the
requirements
on
the
incentives
for
any
potential
registrant
to
undertake
the
development
of
the
required
data.
Except
as
provided
by
section
10,
within
30
days
after
the
Administrator
registers
a
pesticide
under
this
Act
the
Administrator
shall
make
available
to
the
public
the
data
called
for
in
the
registration
statement
together
with
such
other
scientific
information
as
the
Administrator
deems
relevant
to
the
Administrator's
decision.

(
B)
Additional
Data.­­(
i)
If
the
Administrator
determines
that
additional
data
are
required
to
maintain
in
effect
an
existing
registration
of
a
pesticide,
the
Administrator
shall
notify
all
existing
registrants
of
the
pesticide
to
which
the
determination
relates
and
provide
a
list
of
such
registrants
to
any
interested
person.

(
ii)
Each
registrant
of
such
pesticide
shall
provide
evidence
within
ninety
days
after
receipt
of
notification
that
it
is
taking
appropriate
steps
to
secure
the
additional
data
that
are
required.

Two
or
more
registrants
may
agree
to
develop
jointly,
or
to
share
in
the
cost
of
developing,
such
data
if
they
agree
and
advise
the
Administrator
of
their
intent
within
ninety
days
after
notification.

Any
registrant
who
agrees
to
share
in
the
cost
of
producing
the
data
shall
be
entitled
to
examine
and
rely
upon
such
data
in
support
of
maintenance
of
such
registration.
The
Administrator
shall
issue
a
notice
of
intent
to
suspend
the
registration
of
a
pesticide
in
accordance
with
the
procedures
prescribed
by
clause
(
iv)
if
a
registrant
fails
to
comply
with
this
clause.

(
iii)
If,
at
the
end
of
sixty
days
after
advising
the
Administrator
of
their
agreement
to
develop
jointly,
or
share
in
the
cost
of
developing
data,
the
registrants
have
not
further
agreed
on
the
terms
of
the
data
development
arrangement
or
on
a
procedure
for
reaching
such
agreement,
any
of
such
registrants
may
initiate
binding
arbitration
proceedings
by
requesting
the
Federal
Mediation
and
Conciliation
Service
to
appoint
an
arbitrator
from
the
roster
of
arbitrators
maintained
by
such
Service.
The
procedure
and
rules
of
the
Service
shall
be
applicable
to
the
selection
of
such
arbitrator
and
to
such
arbitration
proceedings,
and
the
findings
and
determination
of
the
arbitrator
shall
be
final
and
conclusive,
and
no
official
or
court
of
the
United
States
shall
have
power
or
jurisdiction
to
review
any
such
findings
and
determination,
except
for
fraud,
misrepresentation,
or
other
misconduct
by
one
of
the
parties
to
the
arbitration
or
the
arbitrator
where
there
is
a
verified
complaint
with
supporting
affidavits
attesting
to
specific
instances
of
such
fraud,
misrepresentation,
or
other
misconduct.
All
parties
to
the
arbitration
shall
September
17,
2004
Page
2
share
equally
in
the
payment
of
the
fee
and
expenses
of
the
arbitrator.
The
Administrator
shall
issue
a
notice
of
intent
to
suspend
the
registration
of
a
pesticide
in
accordance
with
the
procedures
prescribed
by
clause
(
iv)
if
a
registrant
fails
to
comply
with
this
clause.

(
iv)
Notwithstanding
any
other
provision
of
this
Act,
if
the
Administrator
determines
that
a
registrant,
within
the
time
required
by
the
Administrator,
has
failed
to
take
appropriate
steps
to
secure
the
data
required
under
this
subparagraph,
to
participate
in
a
procedure
for
reaching
agreement
concerning
a
joint
data
development
arrangement
under
this
subparagraph
or
in
an
arbitration
proceeding
as
required
by
this
subparagraph,
or
to
comply
with
the
terms
of
an
agreement
or
arbitration
decision
concerning
a
joint
data
development
arrangement
under
this
subparagraph,
the
Administrator
may
issue
a
notice
of
intent
to
suspend
such
registrant's
registration
of
the
pesticide
for
which
additional
data
is
required.
The
Administrator
may
include
in
the
notice
of
intent
to
suspend
such
provisions
as
the
Administrator
deems
appropriate
concerning
the
continued
sale
and
use
of
existing
stocks
of
such
pesticide.
Any
suspension
proposed
under
this
subparagraph
shall
become
final
and
effective
at
the
end
of
thirty
days
from
receipt
by
the
registrant
of
the
notice
of
intent
to
suspend,
unless
during
that
time
a
request
for
hearing
is
made
by
a
person
adversely
affected
by
the
notice
or
the
registrant
has
satisfied
the
Administrator
that
the
registrant
has
complied
fully
with
the
requirements
that
served
as
a
basis
for
the
notice
of
intent
to
suspend.
If
a
hearing
is
requested,
a
hearing
shall
be
conducted
under
section
6(
d)
of
this
Act.
The
only
matters
for
resolution
at
that
hearing
shall
be
whether
the
registrant
has
failed
to
take
the
action
that
served
as
the
basis
for
the
notice
of
intent
to
suspend
the
registration
of
the
pesticide
for
which
additional
data
is
required,
and
whether
the
Administrator's
determination
with
respect
to
the
disposition
of
existing
stocks
is
consistent
with
this
Act.
If
a
hearing
is
held,
a
decision
after
completion
of
such
hearing
shall
be
final.
Notwithstanding
any
other
provision
of
this
Act,
a
hearing
shall
be
held
and
a
determination
made
within
seventy­
five
days
after
receipt
of
a
request
for
such
hearing.
Any
registration
suspended
under
this
subparagraph
shall
be
reinstated
by
the
Administrator
if
the
Administrator
determines
that
the
registrant
has
complied
fully
with
the
requirements
that
served
as
a
basis
for
the
suspension
of
the
registration.

(
v)
Any
data
submitted
under
this
subparagraph
shall
be
subject
to
the
provisions
of
paragraph
(
1)(
D).
Whenever
such
data
are
submitted
jointly
by
two
or
more
registrants,
an
agent
shall
be
agreed
on
at
the
time
of
the
joint
submission
to
handle
any
subsequent
data
compensation
matters
for
the
joint
submitters
of
such
data.

(
vi)
Upon
request
of
a
registrant
the
Administrator
shall,
in
the
case
of
a
minor
use,
extend
the
deadline
for
the
production
of
residue
chemistry
data
under
this
subparagraph
for
data
required
solely
to
support
that
minor
use
until
the
final
deadline
for
submission
of
data
under
section
4
for
the
other
uses
of
the
pesticide
established
as
of
the
date
of
enactment
of
the
Food
Quality
Protection
Act
of
1996,
if
 
(
I)
the
data
to
support
other
uses
of
the
pesticide
on
a
food
are
being
provided;

(
II)
the
registrant,
in
submitting
a
request
for
such
an
extension,
provides
a
schedule,
including
interim
dates
to
measure
progress,
to
assure
that
the
data
production
will
be
completed
before
the
expiration
of
the
extension
period;

(
III)
the
Administrator
has
determined
that
such
extension
will
not
significantly
delay
the
Administrator's
schedule
for
issuing
a
reregistration
eligibility
determination
required
under
section
4;
and
(
IV)
the
Administrator
has
determined
that
based
on
existing
data,
such
extension
would
September
17,
2004
1Indentation
of
the
following
sentences
of
this
clause
is
so
in
original
(
as
added
by
sec.
201(
c)(
1)
of
P.
L.
104­
170).
Probably
should
be
indented
to
the
same
as
flush
matter
of
this
clause.

Page
3
not
significantly
increase
the
risk
of
any
unreasonable
adverse
effect
on
the
environment.
1
If
the
Administrator
grants
an
extension
under
this
clause,
the
Administrator
shall
monitor
the
development
of
the
data
and
shall
ensure
that
the
registrant
is
meeting
the
schedule
for
the
production
of
the
data.
If
the
Administrator
determines
that
the
registrant
is
not
meeting
or
has
not
met
the
schedule
for
the
production
of
such
data,
the
Administrator
may
proceed
in
accordance
with
clause
(
iv)
regarding
the
continued
registration
of
the
affected
products
with
the
minor
use
and
shall
inform
the
public
of
such
action.
Notwithstanding
the
provisions
of
this
clause,
the
Administrator
may
take
action
to
modify
or
revoke
the
extension
under
this
clause
if
the
Administrator
determines
that
the
extension
for
the
minor
use
may
cause
an
unreasonable
adverse
effect
on
the
environment.
In
such
circumstance,
the
Administrator
shall
provide,
in
writing
to
the
registrant,
a
notice
revoking
the
extension
of
time
for
submission
of
data.
Such
data
shall
instead
be
due
in
accordance
with
the
date
established
by
the
Administrator
for
the
submission
of
the
data.

(
vii)
If
the
registrant
does
not
commit
to
support
a
specific
minor
use
of
the
pesticide,
but
is
supporting
and
providing
data
in
a
timely
and
adequate
fashion
to
support
uses
of
the
pesticide
on
a
food,
or
if
all
uses
of
the
pesticide
are
nonfood
uses
and
the
registrant
does
not
commit
to
support
a
specific
minor
use
of
the
pesticide
but
is
supporting
and
providing
data
in
a
timely
and
adequate
fashion
to
support
other
nonfood
uses
of
the
pesticide,
the
Administrator,
at
the
written
request
of
the
registrant,
shall
not
take
any
action
pursuant
to
this
clause
in
regard
to
such
unsupported
minor
use
until
the
final
deadline
established
as
the
date
of
enactment
of
the
Food
Quality
Protection
Act
of
1996,
for
the
submission
of
data
under
section
4
for
the
supported
uses
identified
pursuant
to
this
clause
unless
the
Administrator
determines
that
the
absence
of
the
data
is
significant
enough
to
cause
human
health
or
environmental
concerns.
On
the
basis
of
such
determination,
the
Administrator
may
refuse
the
request
for
extension
by
the
registrant.
Upon
receipt
of
the
request
from
the
registrant,
the
Administrator
shall
publish
in
the
Federal
Register
a
notice
of
the
receipt
of
the
request
and
the
effective
date
upon
which
the
uses
not
being
supported
will
be
voluntarily
deleted
from
the
registration
pursuant
to
section
6(
f)(
1).
If
the
Administrator
grants
an
extension
under
this
clause,
the
Administrator
shall
monitor
the
development
of
the
data
for
the
uses
being
supported
and
shall
ensure
that
the
registrant
is
meeting
the
schedule
for
the
production
of
such
data.
If
the
Administrator
determines
that
the
registrant
is
not
meeting
or
has
not
met
the
schedule
for
the
production
of
such
data,
the
Administrator
may
proceed
in
accordance
with
clause
(
iv)
of
this
subparagraph
regarding
the
continued
registration
of
the
affected
products
with
the
minor
and
other
uses
and
shall
inform
the
public
of
such
action
in
accordance
with
section
6(
f)(
2).
Notwithstanding
the
provisions
of
this
clause,
the
Administrator
may
deny,
modify,
or
revoke
the
temporary
extension
under
this
subparagraph
if
the
Administrator
determines
that
the
continuation
of
the
minor
use
may
cause
an
unreasonable
adverse
effect
on
the
environment.
In
the
event
of
modification
or
revocation,
the
Administrator
shall
provide,
in
writing,
to
the
registrant
a
notice
revoking
the
temporary
extension
and
establish
a
new
effective
date
by
which
the
minor
use
shall
be
deleted
from
the
registration.

(
viii)
(
I)
If
data
required
to
support
registration
of
a
pesticide
under
subparagraph
(
A)
is
requested
by
a
Federal
or
State
regulatory
authority,
the
Administrator
shall,
to
the
extent
practicable,
coordinate
data
requirements,
test
protocols,
timetables,
and
standards
of
review
and
reduce
burdens
and
redundancy
caused
to
the
registrant
by
multiple
requirements
on
the
registrant.

(
II)
The
Administrator
may
enter
into
a
cooperative
agreement
with
a
State
to
carry
out
September
17,
2004
Page
4
subclause
(
I).

(
III)
Not
later
than
1
year
after
the
date
of
enactment
of
this
clause,
the
Administrator
shall
develop
a
process
to
identify
and
assist
in
alleviating
future
disparities
between
Federal
and
State
data
requirements.

(
C)
Simplified
Procedures.­­
Within
nine
months
after
the
date
of
enactment
of
this
subparagraph,
the
Administrator
shall,
by
regulation,
prescribe
simplified
procedures
for
the
registration
of
pesticides,
which
shall
include
the
provisions
of
subparagraph
(
D)
of
this
paragraph.

(
D)
Exemption.­­
No
applicant
for
registration
of
a
pesticide
who
proposes
to
purchase
a
registered
pesticide
from
another
producer
in
order
to
formulate
such
purchased
pesticide
into
the
pesticide
that
is
the
subject
of
the
application
shall
be
required
to
 
(
i)
submit
or
cite
data
pertaining
to
such
purchased
product;
or
(
ii)
offer
to
pay
reasonable
compensation
otherwise
required
by
paragraph
(
1)(
D)
of
this
subsection
for
the
use
of
any
such
data.

(
E)
Minor
Use
Waiver.­­
In
handling
the
registration
of
a
pesticide
for
a
minor
use,
the
Administrator
may
waive
otherwise
applicable
data
requirements
if
the
Administrator
determines
that
the
absence
of
such
data
will
not
prevent
the
Administrator
from
determining­­

(
i)
the
incremental
risk
presented
by
the
minor
use
of
the
pesticide;
and
(
ii)
that
such
risk,
if
any,
would
not
be
an
unreasonable
adverse
effect
on
the
environment.
Data
Acquisition
for
Anticipated
Residue
and
Percent
of
Crop
Treated
OMB
No.
2070­
0164
EPA
No.
1911.02
Attachment
C
Data
Call­
in
(
DCI)
Response
Form
[
A
electronic
copy
is
available
through
EDOCKET.]
Data
Acquisition
for
Anticipated
Residue
and
Percent
of
Crop
Treated
OMB
No.
2070­
0164
EPA
No.
1911.02
Attachment
D
Requirements
Status
and
Registrant's
Response
Form
[
A
electronic
copy
is
available
through
EDOCKET.]
Data
Acquisition
for
Anticipated
Residue
and
Percent
of
Crop
Treated
OMB
No.
2070­
0164
EPA
No.
1911.02
Attachment
E
Certification
of
Attempt
to
Enter
into
an
Agreement
with
Registrants
for
Development
of
Data
(
EPA
Form
8570­
32)

[
A
electronic
copy
is
available
through
EDOCKET.]
Data
Acquisition
for
Anticipated
Residue
and
Percent
of
Crop
Treated
OMB
No.
2070­
0164
EPA
No.
1911.02
Attachment
F
Certification
with
Respect
to
Citation
for
Data
(
EPA
Form
8570­
34)

[
A
electronic
copy
is
available
through
EDOCKET.]
Data
Acquisition
for
Anticipated
Residue
and
Percent
of
Crop
Treated
OMB
No.
2070­
0164
EPA
No.
1911.02
Attachment
G
Data
Matrix
(
EPA
Form
8570­
35)

[
A
electronic
copy
is
available
through
EDOCKET.]
Data
Acquisition
for
Anticipated
Residue
and
Percent
of
Crop
Treated
OMB
No.
2070­
0164
EPA
No.
1911.02
Attachment
H
SOP
No.
HED
AR­
1,
Use
of
Anticipated
Residues
in
Risk
Assessment
Attachment
H:
SOP
No.
HED
AR­
1,
Use
of
Anticipated
Residues
in
Risk
Assessment
Revision
No.
Original
Effective
Date:
FEB­
15­
99
Page
1
1.0
Purpose
To
standardize
the
procedures
used
by
scientists
in
the
Health
Effects
Division
for
calculation
of
anticipated
residues.

2.0
Scope
This
procedure
shall
be
followed
by
all
HED
personnel
involved
in
the
manipulation
of
data
to
calculate
anticipated
residues
to
be
used
in
risk
assessment
estimates.

3.0
Outline
of
Procedures

Regulatory
Background

Interpretations
of
FFDCA

Definition
of
Terms
Used
in
this
Document

Dietary
Exposure

Data
Needed
to
Verify
Anticipated
Residues

Non­
Detects

Documentation
Requirements
4.0
References

Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA)


Federal
Insecticide,
Fungicide
and
Rodenticide
Act
(
FIFRA)


Food
Quality
Protection
Act
(
FQPA)


Residue
Chemistry
Guidelines
OPPTS
860.1500,
860.1520

Acute
Dietary
Exposure
Assessment
OPP
Policy,
June
1996

Chronic
Dietary
Exposure
Assessment
OPP
Policy,
???
1997

Chemistry
Science
Advisory
Council
(
CHEM
SAC)
Decisions
5.0
Specific
Procedures
5.1
Regulatory
Background
Section
408(
b)(
2)(
E)
of
FFDCA
as
amended
by
FQPA
requires
that
if
EPA
relies
on
anticipated
residues
(
ARs)
or
Actual
Residues
to
establish,
modify,
or
leave
in
effect
a
tolerance,
then
EPA
must
require
that
data
be
provided
five
years
after
the
tolerance
decision
is
made
to
demonstrate
that
such
residue
levels
have
not
changed.

Section
408(
b)(
2)(
F)
of
the
Act
states
that
the
Agency
may
use
data
on
the
actual
percent
of
food
treated
or
"
percent
crop
treated"
(
PCT)
in
chronic
dietary
risk
if
such
data
are
reliable
and
its
use
will
not
understate
exposure
for
any
significant
population
subgroup.

Section
408(
f)
of
FFDCA
"
Special
Data
Requirements"
states
that
if
EPA
requires
additional
data
Attachment
H:
SOP
No.
HED
AR­
1,
Use
of
Anticipated
Residues
in
Risk
Assessment
Revision
No.
Original
Effective
Date:
FEB­
15­
99
Page
2
or
information
to
support
a
tolerance
or
exemption,
it
shall
issue
(
a)
a
DCI,
(
b)
a
rule
requiring
testing
or
(
c)
an
order
in
the
FR.

5.2
Interpretations
of
FFDCA
5.2.1
408(
b)(
2)(
E)­­
If
EPA
relies
on
anticipated
or
actual
residue
levels
in
establishing,
modifying
or
leaving
in
effect
a
tolerance,
it
must
call
in
data
within
five
years
for
all
crops
for
which
AR's
were
used
for
a
pesticide.
Such
data
will
be
used
to
demonstrate
that
the
residue
levels
are
not
above
the
(
anticipated)
levels
relied
on.
If
the
residues
are
higher,
EPA
shall
reassess
the
risk
posed
by
the
pesticide
and
modify
or
revoke
the
tolerance
as
required
to
assure
no
adverse
health
concerns
result
from
the
pesticide.

5.2.2
408(
b)(
2)(
F)­­
Whenever
PCT
has
been
used,
EPA
will
obtain
data
through
its
usual
sources
(
i.
e.,
BEAD)
within
five
years
and
determine
whether
the
risks
have
increased
unacceptably.
EPA
will
not
issue
a
data­
call­
in
(
DCI).

5.2.3
408(
f)­­
EPA
may
use
three
methods
to
require
data,
but
will
use
DCIs.

No
rule
is
required
for
implementation
of
these
provisions
of
the
Act,
but
an
Information
Collection
Request
(
ICR)
covering
the
AR
DCI
data
must
be
cleared
through
the
Office
of
Management
and
Budget
(
OMB)
before
DCIs
can
be
issued.
A
PR
Notice
will
be
issued
to
notify
registrants
and
the
public
about
FQPA's
requirements
on
AR/
PCT
and
the
process
the
Agency
will
follow.

5.2.4
FIFRA
Section
18
Tolerances­­
Any
tolerances
established
in
conjunction
with
FIFRA
Section
18s
that
use
ARs
and/
or
PCT
are
subject
to
FQPA.
Data
or
information
required
to
verify
these
tolerances
are
required
to
be
submitted
five
years
after
their
issuance
unless
EPA
obtains
and
uses
new
information
that
either
corroborates
or
changes
the
initial
AR
data.
If
a
Section
18
tolerance
is
repeatedly
renewed
with
little
or
no
new
information,
data
must
be
called
in.

To
obtain
AR
data
for
Section
18
exemptions,
OPP
may:
(
a)
issue
a
letter
requesting
data
from
the
main
registrant
(
producer
of
the
technical)
at
the
same
time
that
the
Section
18
is
issued;
(
b)
place
a
notice
in
the
initial
Section
18
approval
telegram
(
and
in
subsequent
years)
indicating
that
data
are
required
to
be
submitted
five
years
later
or
else
a
Section
18
will
not
be
granted
and
the
tolerance
will
be
revoked
(
registrants
would
also
be
notified
by
letter
of
this
requirement);
or
(
c)
both.

5.3
Definition
of
Terms
Used
in
this
Document
5.3.1
Anticipated
Residues
are
estimates
of
the
level
of
residues
of
a
pesticide
likely
to
be
present
on
a
given
crop
and
are
generally
lower
than
tolerances.
Data
used
for
these
estimates
are
based
on:
Attachment
H:
SOP
No.
HED
AR­
1,
Use
of
Anticipated
Residues
in
Risk
Assessment
Revision
No.
Original
Effective
Date:
FEB­
15­
99
Page
3
1)
Field
Trial
Studies
designed
to
show
what
residue
levels
will
be
present
in
crops
at
harvest.
These
studies
are
conducted
at
maximum
label
rate
and
minimum
pre­
harvest
interval,
and
are
designed
to
show
the
maximum
residues
likely
to
be
present.
Field
trial
data
can
be
used
to
project
the
residue
amounts
on
treated
crops
and
how
various
factors
may
affect
those
levels.
Field
trial
data
can
therefore,
be
combined
with
percent
crop
treated
data
to
produce
a
more
realistic
estimate
of
human
exposure.

2)
Monitoring
Data
which
provide
measurements
of
actual
residues
in/
on
commodities
as
they
move
in
commerce.
Monitoring
data
or
actual
residue
data
are
collected
by
sampling
a
crosssection
of
a
crop
and
it
include
treated
and
untreated
commodities.
Actual
residue
data
reflects
both
the
processes
measured
by
field
trial
studies
and
the
percent
of
the
crop
actually
treated.
Therefore,
actual
residue
data
for
a
given
commodity
would
generally
not
be
combined
with
either
field
trials
data
or
percent
crop
treated
information
for
that
commodity
in
estimating
human
exposure.
Actual
residue
measurements
are
taken
on
samples
gathered
as
the
commodities
leave
the
farm
(
e.
g.,
FDA
Surveillance
samples
taken
as
close
as
possible
to
the
point
of
production),
when
the
food
is
in
the
general
channels
of
distribution
(
e.
g.,
USDA's
PDP
taken
at
food
distribution
centers),
or
at
the
retail
level
(
e.
g.,
EBDCs
market
basket
survey).
Actual
residues
are
provided
by:

a)
FDA
Programs­­
Surveillance/
Compliance
Monitoring
and
Total
Diet.
b)
USDA
Programs
 
AMS
Pesticide
Data
Program
and
FSIS
Monitoring
Program
(
meat
and
poultry).
c)
Special
Studies­­
FDA
Total
Diet
Survey
which
show
residues
after
consumer
preparation
or
cooking
of
foods.

3)
Processing
Studies
designed
to
determine
the
concentration
or
reduction
of
residues
when
the
raw
agricultural
commodity
is
processed
commercially.

4)
Degradation/
Decline
Studies
showing
the
degradation
rates
of
pesticide
residues.

5)
Livestock
Feeding
Studies
and
Nature
of
the
Residue
in
Livestock
to
identify
the
nature
of
the
residue
in
the
edible
tissue
of
livestock
and
the
transfer
of
these
residues
to
meat,
milk,
poultry,
and
eggs.
These
studies
are
required
when
a
pesticide
is
applied
directly
to
livestock,
to
crops
or
crop
parts
used
for
feed,
or
when
livestock
premises
are
to
be
treated.

5.3.2
Percent
Crop
Treated
means
the
scope
of
pesticide
treatment
for
a
crop
expressed
as
a
percentage.
Percent
crop
treated
information
is
useful
for
estimating
exposure
because
it
defines
what
segment
of
the
crop
is
pesticide
free.

5.4
Dietary
Exposure
Dietary
exposure
to
pesticides
in
foods
is
estimated
by
multiplying
the
daily
consumption
of
the
food
forms
of
a
given
commodity
by
the
amount
of
pesticide
residues
on
the
food
forms.
Exposures
based
on
tolerance
levels
are
Theoretical
Maximum
Residue
Contribution
(
TMRC)
Attachment
H:
SOP
No.
HED
AR­
1,
Use
of
Anticipated
Residues
in
Risk
Assessment
Revision
No.
Original
Effective
Date:
FEB­
15­
99
Page
4
estimates.
A
TMRC
is
considered
a
"
worst
case"
estimate
because
it
assumes
that
the
food
contains
residues
at
the
tolerance
level
and
that
100
percent
of
the
crop
is
treated.
If
the
TMRC
exceeds
the
reference
dose
or
poses
an
unacceptable
lifetime
cancer
risk,
EPA
attempts
to
derive
a
more
accurate
estimate
of
residues
likely
to
be
present
in
foods
(
anticipated
residues).

5.4.1
Tiered
Approach
to
Estimating
Dietary
Exposure:
In
an
attempt
to
conserve
resources,
the
Agency
developed
a
tiered
process
by
which
pesticide
tolerance
data
(
40
CFR
158.240)
are
refined
to
reflect
pesticide
residues
in
food
as
consumed
(
dinner­
plate).
This
tiered
approach
flows
from
conservative
to
more
refined
assumptions
as
the
risk
management
situation
dictates.
Dietary
exposure
estimates
based
on
tolerance
level
residues
(
farm­
gate)
reflect
a
Theoretical
Maximum
Residue
Contribution
(
TMRC)
which
overestimate
actual
dietary
exposure.
The
best
estimate
of
pesticide
residues
in
food,
as
consumed,
is
termed
the
Anticipated
Residue
(
AR)
estimate.
When
estimating
ARs
the
Agency
uses
all
available
data,
therefore,
reviewers
must
exercise
considerable
scientific
judgment
to
derive
anticipated
residue
estimates.

Attachment
1
summarizes
applicability
of
the
various
tiers
in
estimating
acute
and
chronic
exposures.

5.5
Data
Needed
to
Verify
Anticipated
Residues
Verification
of
the
anticipated
residues
used
in
establishing
a
tolerance
depends
on
the
data
source.
Table
1
below
addresses
specific
cases.

Table
1.
Data
Needed
to
Verify
Anticipated
Residue
Calculations
SOURCE
OF
DATA
USED
IN
ANTICIPATED
RESIDUES
DATA
NEEDED
TO
CONFIRM
ANTICIPATED
RESIDUES
5
YEARS
LATER
Monitoring
data
(
PDP,
FDA,
FSIS,
States,
special
monitoring
[
market
basket,
single
serving,
etc.])
Updated
monitoring
data
are
required.
The
registrant
may
use
any
of
the
publicly
available
sources
used
by
the
Agency.
Data
should
reflect
the
time
period
since
establishment
of
the
tolerance.
If
data
are
not
available
from
the
above
sources,
then
the
registrant
must
conduct
an
appropriately
designed
monitoring
study.
The
design
of
this
study
must
be
approved
by
the
Agency.

Field
Trials
The
registrant
must
EITHER
verify
that
the
pesticide
formulations,
application
rates,
timing,
intervals,
geographic
distribution
of
use,
etc.,
have
not
changed
OR
provide
field
trial
data
that
reflect
any
changes
in
the
use
pattern
that
may
lead
to
increased
residues.

Processing
studies
Reduction
in
residue
data
(
washing,
peeling,
cooking,
etc.)
The
registrant
must
EITHER
certify
that
commercial
processing
practices
have
not
changed
significantly
OR
provide
new
processing
studies
reflecting
current
commercial
practices.
A
similar
requirement
applies
to
any
study
used
to
demonstrate
reduction
in
residues
between
farm
gate
and
consumption.
Attachment
H:
SOP
No.
HED
AR­
1,
Use
of
Anticipated
Residues
in
Risk
Assessment
Revision
No.
Original
Effective
Date:
FEB­
15­
99
Page
5
Livestock
feeding
studies
and
metabolism
studies
Registrant
must
EITHER
verify
that
the
dietary
burden
calculations
that
were
incorporated
in
the
original
AR
derivation
for
meat,
milk,
poultry
or
eggs
are
still
valid
OR
provide
a
new
animal
feeding
study
that
reflects
current
feeding
practices.
Dietary
burden
calculations
could
change
due
to
increased
residue
levels
on
feed
items
or
from
changes
in
the
relative
abundance
or
use
of
a
particular
feed
item
over
time.

5.5.1
Hypothetical
Scenario:
A
tolerance
is
established
for
a
chemical
already
registered
for
use
on
ten
food
crops.
Anticipated
residues
are
developed
for
seven
of
ten
previously
registered
crops
to
support
registration
of
crop
11
as
shown
in
Table
2.

Table
2.
Data
Sources
Used
to
Support
the
Tolerance
for
"
New
Crop
11
TOLERANCES
DATA
SOURCE
RESIDUE
ESTIMATE
ANTICIPATED
RESIDUE?

Old
crop
1
Monitoring
Mean
Yes
Old
crop
2
Monitoring
Mean
Yes
Old
crop
3
Monitoring
Mean
Yes
Old
crop
4
Monitoring
Mean
Yes
Old
crop
5
Monitoring
Mean
Yes
Old
crop
6
Field
trials
Mean
Yes
Old
crop
7
Field
trials
Mean
Yes
Old
crop
8
Field
trials
Tolerance
No
Old
crop
9
Field
trials
Tolerance
No
Old
crop
10
Field
trials
Tolerance
No
estimated
residue
consumption
from
crops
1­
10
=
80%
of
RfD
New
crop
11
Field
trials
Tolerance
No
estimated
residue
consumption
from
crops
1­
11
=
90%
of
RfD
In
accordance
with
the
interpretation
in
Section
5.2
above,
the
registrant
has
to
verify
that
the
ARs
on
crops
1
through
7
still
support
the
tolerance
on
crop
11
after
5
years.
Each
individual
AR
for
crops
1
through
7
must
be
confirmed
with
data
similar
to
that
originally
used
to
derive
the
AR
for
that
crop
(
see
Table
1).
This
confirmation
will
be
on
a
crop
by
crop
basis.
If
the
anticipated
residue
for
any
commodity
exceeds
the
value
relied
on
previously
then
a
new
dietary
risk
assessment
will
be
necessary
to
determine
if
the
tolerance
on
crop
11
needs
to
be
altered
or
revoked.
Attachment
H:
SOP
No.
HED
AR­
1,
Use
of
Anticipated
Residues
in
Risk
Assessment
Revision
No.
Original
Effective
Date:
FEB­
15­
99
Page
6
5.6
Non­
Detects
There
are
two
possible
explanations
for
residues
reported
as
"
not
detected":
either
the
residues
are
for
all
practical
purposes
zero
(
e.
g.,
pesticide
was
not
applied)
or
the
residues
may
be
present
at
levels
lower
than
the
limit
of
detection
(
LOD)
of
the
analytical
method
used.
The
Chem
SAC
recommendations
for
handling
non­
detects
are
as
follows:

1.
A
true
zero
may
be
entered
for
non­
detects
if
the
percentage
of
samples
reported
as
non­
detects
is
equal
or
greater
than
the
percent
crop
not
treated.
The
number
of
samples
entered
as
zeros
should
be
directly
proportional
to
the
percent
crop
not
treated.
The
reviewer
should
work
closely
with
BEAD
in
selecting
the
appropriate
percent
crop
treated
figure
(
e.
g.,
maximum,
average,
or
other
PCT
figure).

2.
A
zero
may
be
used
to
represent
non­
detects
if
metabolism
studies,
data
at
shorter
PHIs,
exaggerated
rate
data,
etc.
support
this
decision.

3.
A
value
such
as
½
LOD
or
½
LOQ
or
the
Lower
Limit
of
Method
Validation
(
LLMV)
may
be
used.
[
LLMV:
lowest
concentration
at
which
the
method
was
validated.
A
LLMV
could
be
higher
than
true
LOQ.]

5.7
Documentation
Requirements
Estimation
of
anticipated
residues
must
be
thoroughly
documented.
All
HED
documents
transmitted
to
RD
or
SRRD
that
are
concerned
with
either
establishing,
modifying,
or
leaving
in
effect
a
tolerance
must
contain
the
following
information:

a.
Percent
Crop
Treated
(
PCT):
Indicate
whether
assumption
of
100
percent
crop
treated
is
made
or
actual
percent
crop
treated
data
were
used.
If
PCT
data
were
used,
include
the
source
of
these
data
(
e.
g.,
for
BEAD
data,
attach
transmittal
memorandum
documenting
years
the
PCT
represent
for
each
crop).
Describe
any
assumptions
made
and
actual
PCT
values
used.

b.
Dietary
Exposure
Assessment:
Must
contain
a
clear
and
complete
account
of
the
basis
for
estimating
dietary
exposure.
For
each
food
form
included
in
the
assessment,
indicate
whether
exposure
was
based
on
tolerance
level
residues
or
anticipated
residues
and
whether
PCT
data
were
used.

c.
Anticipated
Residues:
If
ARs
were
used,
list
actual
numerical
estimates
used
and
the
source
of
the
estimate
(
i.
e.,
FDA
monitoring
data,
field
trial
data,
processing
studies,
etc.)
Document
must
fully
describe
all
values,
assumptions,
and
data
manipulation
used
in
deriving
anticipated
residues
including
use
of
default
values
(
e.
g.,
½
LOD/
LOQ
for
non­
detects,
½
LOQ
for
BQLs,
etc.).
The
sources
of
all
data
must
be
documented
sufficiently
that
any
interested
party
could
repeat
the
calculations.

The
HED
recommended
format
for
documentation
of
anticipated
residues
derived
from
field
trials,
monitoring
data,
and
processing
studies
is
provided
in
examples
given
in
Attachment
2.
Attachment
H:
SOP
No.
HED
AR­
1,
Use
of
Anticipated
Residues
in
Risk
Assessment
Revision
No.
Original
Effective
Date:
FEB­
15­
99
Page
7
d.
Dietary
Exposure
Assessments:
Must
be
documented
in
the
form
of
a
memorandum
containing
all
of
the
elements
found
in
the
HED
DEEM
SOP
(
being
prepared
by
DRES
committee).
Each
memorandum
will
contain,
at
a
minimum,
a
description
of
the
following
information:

a.
Type
of
action
(
section
18,
reregistration,
new
use,
etc.).
b.
Toxicological
Information
(
RfD,
data
gaps,
uncertainty
factor,
NOEL,
carcinogenicity,
etc),
including
reference
to
HED
documents
containing
these
data.
c.
Residue
Information
(
CFR
references,
PCT,
AR
data,
concentration
factors,
etc.)
including
reference
to
HED
documents
containing
these
data.
d.
Results
and
Discussion
(
refinements
to
the
analysis,
TMRC
and
ARC
numbers,
changes
to
concentration
factors,
population
subgroups
exceeding
100%
RfD,
commodity
contribution
analysis
if
RfD
exceeds
100%.
e.
Names
of
preparer
and
reviewer,
date,
and
file
location.
f.
For
Monte
Carlo
runs
attach
input
and
output
files.
Attachment
H:
SOP
No.
HED
AR­
1,
Use
of
Anticipated
Residues
in
Risk
Assessment
Revision
No.
Original
Effective
Date:
FEB­
15­
99
Page
8
Attachment
1
Tiered
Approach
to
Estimating
Dietary
Exposure
*

Dietary
Assessment
Acute
Chronic
(
Carcinogenic
and
non­
carcinogenic)

Single
Serving
Blended
Single
Serving/
Blended
Tier
1

Tolerance

100%
CT

Tolerance

100%
CT

Tolerance

100%
CT
Tier
2

Tolerance

100%
CT

Average
residue
from
field
trials

100%
CT

Tolerance

Adjust
for
%
CT
Tier
3

Entire
distribution
of
data
from
field
trials

Adjust
for
%
CT

Average
residue
from
field
trials

Adjust
for
%
CT

Processing
factors
­
or­


Entire
distribution
of
monitoring
data

100
%
CT.


Processing
factors

Average
residue
from
field
trials

Adjust
for
%
CT

Processing
factors
­
or­


Average
residue
of
monitoring
data

Adjust
for
%
CT

Processing
factors
Tier
4

Single
Serving
Market
basket
survey

Cooking

Residue
decline

Residue
degradation

Use
monitoring
data
directly

Cooking

Residue
decline

Residue
degradation

Single
Serving
Market
basket
survey

Cooking

Residue
decline,


Residue
degradation
*
For
meat,
milk,
poultry,
and
eggs,
if
monitoring
data
are
not
available,
1)
calculate
the
dietary
burden
using
anticipated
residues
for
feedstuffs;
2)
extrapolate
from
livestock
feeding
studies
Attachment
H:
SOP
No.
HED
AR­
1,
Use
of
Anticipated
Residues
in
Risk
Assessment
Revision
No.
Original
Effective
Date:
FEB­
15­
99
Page
9
XYZ
(
Chemical
#
000001)­­
Anticipated
Residues
Derived
from
Monitoring
Data
Commodity
Data
Source
No.
of
Samples
No.
of
Detects
%
Detects
LOD
ppm
LOQ
ppm
%
Crop
Treated
Max.
Residue
Average
Residue
95th
Percentile
caneberries
blackberries
boysenberries
dewberries
loganberries
raspberries
FDA
92­
96
158
19
12
0.02
55
0.204
0.0089
0.02
blueberries
FDA
92­
96
176
10
5.7
0.02
80
0.08
0.0093
T
cranberries
FDA
92­
96
69
1
1.4
0.02
7
0.02
0.0008
ND
FODC
92­
96
111
0
0.0
0.02
7
ND
ND
grapes
PDP
95­
96
1215
0
0.0
0.023
1
ND
0.0001
ND
strawberries
FDA
92­
96
644
78
12.1
0.02
28
0.28
0.0133
0.08
Attachment
H:
SOP
No.
HED
AR­
1,
Use
of
Anticipated
Residues
in
Risk
Assessment
Revision
No.
Original
Effective
Date:
FEB­
15­
99
Page
10
XYZ
(
Chemical
#
000001)­­
Anticipated
Residues
Derived
from
Monitoring
Data
(
continued)

Commodity
Data
Source
No.
of
Samples
No.
of
Detects
%
Detects
LOD
ppm
LOQ
ppm
%
Crop
Treated
Max.
Residue
Average
Residue
95th
Percentile
grapefruit
FDA
92­
96
133
0
0.0
0.02
1
ND
0.0001
ND
orange
PDP
95­
96
1209
6
0.5
0.037
1
0.028
0.0002
ND
orange
juice
PDP
97
604
0
0.0
0.02
1
ND
0.0001
ND
apple
PDP
95­
96
1723
0
0.0
0.037
15
ND
0.003
ND
apple
juice
PDP
96
177
1
0.6
0.023
15
<
0.017
0.002
ND
tomatoes
PDP
96
174
0
0.0
0.030
2
ND
0.0003
ND
whole
grain
wheat
PDP
95­
96
940
275
29.3
0.01
100
2.874
0.065
0.305
wheat
flour
FDA
92­
96
113
79
69.9
0.02
100
1.056
0.0631
0.247
milk
PDP
96
558
0
0.0
0.0033
­­
ND
0.0017
ND
Attachment
H:
SOP
No.
HED
AR­
1,
Use
of
Anticipated
Residues
in
Risk
Assessment
Revision
No.
Original
Effective
Date:
FEB­
15­
99
Page
11
XYX
(
Chemical
#
000001)­­
Anticipated
Residues
Derived
from
Field
Trial
Studies
Crop
Average
Residue
Maximum
Residue
PCT
Anticipated
Residue
Source
of
Data
Review
Reference
Macadamia
nuts
0.05
0.1
6
0.00300
MRID
44076801
DP
Barcode
Chestnuts
0.261
0.632
100
1.00000
MRID
44478401
DP
Barcode
Walnuts
0.05
0.10
9
0.00450
MRID
44383301
DP
Barcode
Figs
0.203
0.387
6
0.01220
MRID
44061201
DP
Barcode
Guava
0.159
0.48
100
0.15900
MRID
44391501
DP
Barcode
Passion
Fruit
0.0564
0.121
100
0.05640
or
8??
MRID
44472801
DP
Barcode
Attachment
H:
SOP
No.
HED
AR­
1,
Use
of
Anticipated
Residues
in
Risk
Assessment
Revision
No.
Original
Effective
Date:
FEB­
15­
99
Page
12
XYZ
(
Chemical
#
000001)­­
Anticipated
Residues
Reflecting
Processing
Factors
Crop
Processed
Form
Concentration
or
Dilution
Factor
Source
of
Data
Review
Reference
Grapes
Juice
0.1X
MRIDXXXXXXX
DP
Barcode
Raisins
0.4X
MRIDXXXXXXX
DP
Barcode
Citrus
Fruits
Juice
0.06X
MRIDXXXXXXX
DP
Barcode
Apples
Juice
0.13X
MRIDXXXXXXX
DP
Barcode
Tomatoes
Juice
0.03X
MRIDXXXXXXX
DP
Barcode
Puree
0.6X
MRIDXXXXXXX
DP
Barcode
Catsup
0.8X
MRIDXXXXXXX
DP
Barcode
Rice
Milled
0.02X
MRIDXXXXXXX
DP
Barcode
Corn
Oil
0.01X
MRIDXXXXXXX
DP
Barcode
Cottonseed
Oil
0.007X
MRIDXXXXXXX
DP
Barcode
Meal
0.07X
MRIDXXXXXXX
DP
Barcode
Mint
Oil
12.7X
MRIDXXXXXXX
DP
Barcode
Attachment
H:
SOP
No.
HED
AR­
1,
Use
of
Anticipated
Residues
in
Risk
Assessment
Revision
No.
Original
Effective
Date:
FEB­
15­
99
Page
13
Methidathion
(
PC
Code
100301)­­
Anticipated
Residues
Derived
from
Monte
Carlo
Assessments
Crop/
Food
Form
Data
source
#
of
Samples
PCT
Residues
found
(
Total
non­
zeros)
Total
zeros
Value
Entered
for
NDs
Comments
orange
juice
PDP­
1997
692
100
10
­­
­­

apples
PDP­
1998
100
3
3
97
½
LOQ
pears
PDP­
1997
100
11
11
89
½
LOQ
apple
juice
PDP­
1997
683
100
­­
½
LOQ
apple
juice
PDP
­
1996
177
100
olives
FDA?
2
2
2
98
½
LOQ
oranges
Field
trial
11
11
11
89
­­
MRID#
44491001
also
used
for
citron
&

kumquats
maximum
value
3.4
ppm
Food
Form
(
RAC/
Processed)
year/

data
source
#
of
data
points
Conc.
Range
Average
Tolerance/

food/
feed
additive
#
of
nondetects
LOD
LOQ
Data
Handling
grapefruit
1996/
field
trials
10
0.76­
3.76
1.55
4
dried
pulp
8
Data
Acquisition
for
Anticipated
Residue
and
Percent
of
Crop
Treated
OMB
No.
2070­
0164
EPA
No.
1911.02
Attachment
I
Estimating
the
Potential
Paperwork
Burden
and
Cost
for
DCIs
Page
1
ATTACHMENT
I
Estimating
the
Potential
Paperwork
Burden
and
Cost
for
DCIs
The
following
is
a
general
description
of
the
methodology
used
by
the
Agency
to
estimate
the
potential
paperwork
burden
and
costs
for
respondents
to
comply
with
data
call­
ins
(
DCIs)
issued
by
EPA.
In
general,
the
ICRs
provided
an
estimate
of
the
potential
paperwork
burden
and
costs
related
to
a
typical
or
general
DCI
based
on
sample
DCIs
derived
from
previously
issued
DCIs.
Prior
to
issuing
a
specific
DCI,
pursuant
to
the
terms
of
clearance
for
the
ICRs,
EPA
calculated
the
paperwork
burden
and
costs
related
to
the
specific
DCI
using
the
general
method
described
here.

The
estimates
represent
the
burden
associated
with
completing
multi­
year
studies
and
submitting
the
study
results
to
EPA
in
response
to
a
DCI.
A
portion
of
the
total
cost
for
a
study
conducted
in
response
to
a
DCI
may
be
attributed
to
the
paperwork
related
requirements
that
EPA
imposes
on
the
pesticide
registrants.
The
potential
number
of
DCIs
that
might
be
issued
in
any
year,
the
type
of
data
requested,
and
the
number
of
respondents
potentially
affected
by
a
particular
DCI
vary,
and
remain
unknown
until
the
Agency
identifies
the
need
for
the
information.
To
help
estimate
potential
burden
under
these
circumstances,
EPA
reviewed
previously
issued
DCIs
to
develop
sample
DCIs
that
are
used
to
generate
burden
and
cost
estimates
for
the
anticipated
testing
that
would
be
requested
by
EPA,
from
which
EPA
also
calculates
the
paperwork
burden
and
costs.

1.
What
activities
are
included
in
the
estimated
paperwork
burden
and
cost
for
DCIs?

Under
the
Paperwork
Reduction
Act
(
PRA)
,
44
USC
3501
et
seq.,
and
the
implementing
regulations
at
5
CFR
1320
et
seq.,
"
burden"
means
the
total
time,
effort,
or
financial
resources
expended
by
persons
to
generate,
maintain,
retain,
or
disclose
or
provide
information
to
or
for
a
Federal
agency.
This
typically
includes
the
time
needed
to
review
instructions;
develop,
acquire,
install,
and
utilize
technology
and
systems
for
the
purposes
of
collecting,
validating,
and
verifying
information,
processing
and
maintaining
information,
and
disclosing
and
providing
information;
adjust
the
existing
ways
to
comply
with
any
previously
applicable
instructions
and
requirements;
train
personnel
to
be
able
to
respond
to
a
collection
of
information;
search
data
sources;
complete
and
review
the
collection
of
information;
and
transmit
or
otherwise
disclose
the
information.

In
the
case
of
DCIs,
a
responding
Registrant
may
be
required
to
engage
in
one
or
more
of
the
following
paperwork
related
activities:

1)
Read
DCI
&
test
requirements
(
includes
review
of
records
for
previously
unavailable
data
&
requesting
exemptions
or
waivers)

2)
Discuss
test
and
protocol
with
Agency
3)
Plan
activities
necessary
to
respond
to
DCI
4)
Create
&
gather
information
(
conduct
tests)

5)
Process,
compile,
review
information
for
accuracy
6)
Complete
written
forms
Page
2
7)
Submit
information
to
EPA
8)
Store,
file,
or
maintain
information
OPP
will
only
issue
a
DCI
for
a
pesticide
chemical
after
it
reviews
the
available
data
and
determines
that
the
available
information
is
not
sufficient
to
satisfy
the
statutory
requirements
for
reregistration.
Although
the
Agency
is
responsible
for
identifying
available
data,
the
registrant
may
have
data
that
is
not
generally
available.
In
such
a
case,
the
registrant
may
respond
to
a
DCI
by
simply
submitting
such
data
to
EPA.
In
addition,
even
after
OPP
has
completed
its
review
and
has
determined
that
additional
data
must
be
called­
in,
registrants
may
also
request
a
waiver
if
they
believe
that
OPP
can
properly
evaluate
the
risks
of
their
pesticide
chemicals
without
additional
data.
OPP
will
review
each
waiver
request
individually.
For
purposes
of
estimating
the
potential
paperwork
burden
and
costs,
EPA
assumes
that
registrants
do
not
have
any
such
data,
and
that
registrants
will
not
request
any
waivers.
Since
such
activities
are
likely
to
be
few,
the
estimates
provided
will
cover
these
activities
and
will
generally
result
in
an
over­
estimate
of
the
total
burden
and
costs
if
these
activities
occur
for
any
specific
DCI.

2.
How
did
EPA
estimate
the
potential
Respondent
paperwork
burden?

In
general,
the
estimates
for
the
total
burden
and
costs
associated
with
a
Pesticide
Registrant
responding
to
a
DCI
are
derived
from
the
total
costs
for
doing
the
tests
that
might
be
required
based
on
the
sample
DCIs.
The
average
potential
test
costs
were
derived
using
cost
information
for
individual
DCIs
previously
conducted
by
the
Agency.
Based
on
the
cost
information
available,
the
Agency
calculates
an
average
total
test
cost
for
the
sample
DCIs.
These
costs
then
form
the
basis
for
calculating
the
labor
costs
from
which
the
burden
hours
are
derived.

The
Agency
anticipates
that
multiple
respondents
for
a
given
chemical
will
establish
consortiums
to
share
in
the
burden
of
generating
the
data
and
that
the
burden
and
cost
will
be
distributed
proportionately
across
the
participating
members
of
that
consortium.
However,
for
purposes
of
this
ICR,
EPA
estimates
are
on
a
per­
registrant
basis,
without
considering
this
possibility
for
sharing
the
burden.

Basically
two
types
of
respondent
burden
are
considered
in
deriving
the
burden
estimates:
Administrative
Burden
and
Technical
Burden.
The
respondents'
Administrative
Burden
is
defined
as
the
time
spent
communicating
and
working
with
the
Agency
to
develop
and
agree
upon
data
requirements,
the
protocol,
the
field
site,
and
data
presentations,
and
includes
the
time
for
registrants
to
draft
and
summarize
the
results
of
studies
completed
by
an
individual
respondent
or
by
a
consortium
of
respondents
for
one
chemical.
The
Administrative
Burden
is
also
intended
to
include
time
spent
overseeing
any
contractor
activities
employed
by
the
respondent.
The
Technical
Burden
represents
the
labor
needed
to
actually
derive
the
data,
which
involves
designing
the
test,
performing
it,
analyzing
and
compiling
test
data
and
summarizing
the
results.

To
derive
the
Administrative
Burden,
the
Agency
estimated
the
amount
of
administrative
labor
cost
that
would
be
in
addition
to
the
total
test
cost
using
a
percentage
of
the
total
test
costs.
The
Agency
assumed
that
respondents
would
expend
approximately
two
percent
of
the
total
cost
2
This
percentage
represents
an
estimate
obtained
from
expert
opinion,
industry
sources,
and
proprietary
data.

3This
estimate
was
derived
from
an
assessment
of
the
test
data
cost
estimates
by
DPRA,
Inc.;
subcontract
with
W.
R.
Landis
Associates,
Inc.

4The
hourly
rates
are
based
on
EPA's
1993
RIA
supporting
the
proposed
plant
pesticide
rule
(
published
in
the
Federal
Register,
of
March
28,
1994,
indexed
to
1996
dollars.

5
Same
as
Footnote
2.

6
Same
as
Footnote
2.

Page
3
for
Administrative
Burden.
2
The
Agency
assumed
that
the
value
of
this
time
is
divided
proportionally
among
management
(
20%),
technical
staff
(
65%)
and
clerical
(
15%).
3
The
value
of
labor
per
hour
for
management,
technical,
and
clerical
is
$
130,
$
88,
and
$
40,
respectively.
4
The
hourly
rate
includes
overhead
and
benefits.
The
combination
of
the
proportional
distribution
of
cost
across
the
labor
mix
and
the
hourly
rate
for
the
labor
categories
are
then
used
to
determine
the
total
burden
hours
from
the
total
labor
cost
estimate.

To
derive
the
Technical
Burden,
the
Agency
assumes
that
one­
third
of
the
total
test
cost
represents
labor.
5
Management,
technical,
and
clerical
comprise
the
labor
staff.
The
same
proportional
labor
rate
approximations
and
hourly
rates
are
used
to
calculate
the
distribution
of
hours
across
the
labor
mix
from
the
total
labor
cost
estimate.

Since
it
is
anticipated
that
actual
DCI
requests
per
year
will
vary,
the
annual
estimated
burden
and
costs
is
distributed
evenly
across
the
three
year
duration
of
the
ICR
to
estimate
an
average
annual
burden
and
cost.

3.
How
did
EPA
estimate
the
potential
Respondent
paperwork
cost?

As
was
the
case
for
the
burden
hour
analysis
discussed
above,
two
types
of
costs
to
respondents
are
considered
for
developing
the
cost
associated
with
this
ICR:
Administrative
Cost
and
Technical
Cost.
The
definitions
of
these
costs
are
the
same
as
those
defined
for
the
burden
hours
with
the
exception
that
they
are
costs
not
hours.
The
Administrative
Costs
are
estimated
as
approximately
two
percent
of
the
total
test
cost
and
are
considered
additive
costs,
while
the
Technical
Costs
are
based
on
the
assumption
that
one­
third
of
the
total
test
cost
represents
labor
cost.
6
The
value
of
labor
is
divided
proportionally
among
management
(
20%),
technical
staff
(
65%)
and
clerical
(
15%).
The
value
of
labor
per
hour
for
management,
technical,
and
clerical
is
$
130,
$
88,
and
$
40,
respectively.

The
Agency
also
anticipates
that
multiple
respondents
for
a
given
chemical
will
establish
consortiums
to
share
in
the
burden
of
generating
the
data
and
that
the
burden
and
cost
will
be
distributed
proportionately
across
the
participating
members.
Data
Acquisition
for
Anticipated
Residue
and
Percent
of
Crop
Treated
OMB
No.
2070­
0164
EPA
No.
1911.02
Attachment
J
Consultation
Contacts
for
Data
Generation
for
Pesticide
Reregistration
Programs;
EPA
Questions
asked
in
Consultation
Page
1
ATTACHMENT
J
Data
Acquisition
for
Anticipated
Residue
and
Percent
of
Crop
Treated
(
OMB
2070­
0164)
Consultation
Contacts
for
Data
Generation
for
Pesticide
Reregistration
Programs
Registrant
Associations
Ray
McAlister,
Vice
President
202­
872­
3874
Science
and
Regulatory
Affairs
CropLife
America
Suite
400
1156
15th
Street
N.
W.
Washington,
DC
20005
Susan
Little,
Executive
Director
202­
833­
7315
Consumer
Specialty
Products
Association
900
17th
Street
N.
W.
Suite
300
Washington,
DC
20006
Registrants
Chris
Wible,
Manager
of
Regulatory
Issues
937­
644­
7012
The
Scotts
Company
14111
Scottslawn
Road
Maryville,
OH
43041
Eric
Mauer,
Federal
Registration
Manager
202­
872­
4682
Valent
U.
S.
A.
Corporation
1101
14th
Street
N.
W.
Washington,
DC
20005
John
Cummings,
Manager
of
Regulatory
Affairs
302­
366­
5293
DuPont
Crop
Protection
Stine­
Haskell
Research
Center
P.
O.
Box
30
Newark,
DE
19714­
0030
Page
2
ATTACHMENT
J
Data
Acquisition
for
Anticipated
Residue
and
Percent
of
Crop
Treated
(
OMB
2070­
0164)
EPA
Questions
asked
in
Consultation
(
1)
Publicly
Available
Data
°
Is
the
data
that
the
Agency
seeks
available
from
any
public
source,
or
already
collected
by
another
office
at
EPA
or
by
another
agency?

°
If
yes,
where
can
you
find
the
data?
(
Does
your
answer
indicate
a
true
duplication,
or
does
the
input
indicate
that
certain
data
elements
are
available,
but
that
they
don't
meet
our
data
needs
very
well?)

(
2)
Frequency
of
Collection
°
Can
the
Agency
collect
the
information
less
frequently
and
still
produce
the
same
outcome?

(
3)
Clarity
of
Instructions
°
The
ICR
is
intended
to
require
that
respondents
provide
certain
data
so
that
the
Agency
can
utilize
them.

°
Based
on
the
instructions
(
regulations,
PR
Notices,
etc.),
is
it
clear
what
you
are
required
to
do
and
how
to
submit
such
data?
If
not,
what
suggestions
do
you
have
to
clarify
the
instructions?

°
Do
you
understand
that
you
are
required
to
maintain
records?

°
Considering
that
there
is
no
required
submission
format,
is
it
difficult
to
submit
information
in
ways
that
are
clear,
logical
and
easy
to
complete?

°
Regarding
the
Voluntary
Incident
Reporting
Forms,
do
you
use
them?
Are
they
clear,
logical,
and
easy
to
complete?

(
4)
Electronic
Reporting
and
Record
keeping
The
Government
Paperwork
Elimination
Act
requires
agencies
make
available
to
the
public
electronic
reporting
alternatives
to
paper­
based
submissions
by
2003,
unless
there
is
a
strong
reason
for
not
doing
so.
One
such
reason
is
that,
at
the
present
time,
the
Agency
is
unable
to
ensure
the
security
of
CBI
that
might
be
transmitted
over
the
Internet.

°
What
do
you
think
about
electronic
alternatives
to
paper­
based
records
and
data
submissions?
Current
electronic
reporting
alternatives
include
the
use
of
"
web
forms"/
XML
based
submissions
via
the
Agency's
Internet
site
and
magnetic
mediabased
submissions,
e.
g.,
diskette,
CD­
ROM,
etc.
Would
you
be
interested
in
pursuing
electronic
reporting?
°
Are
you
keeping
your
records
electronically?
Page
3
°
Are
you
keeping
your
records
electronically?
If
yes,
in
what
format?

Although
the
Agency
does
not
offer
an
electronic
reporting
option
because
of
CBI­
related
security
concerns
at
this
time,

°
would
you
be
more
inclined
to
submit
CBI
on
diskette
than
on
paper?
°
what
benefits
would
electronic
submission
bring
you
in
terms
of
burden
reduction
or
greater
efficiency
in
compiling
the
information?

(
5)
Burden
and
Costs
°
Are
the
labor
rates
accurate?
°
The
Agency
assumes
there
are
no
capital
costs
associated
with
this
activity.
Is
that
correct?
°
Bearing
in
mind
that
the
burden
and
cost
estimates
include
only
burden
hours
and
costs
associated
with
the
paperwork
involved
with
this
ICR,
e.
g.,
the
ICR
does
not
include
estimated
burden
hours
and
costs
for
conducting
studies,
are
the
estimated
burden
hours
and
labor
rates
accurate?
If
you
provide
burden
and
cost
estimates
that
are
substantially
different
from
EPA's,
please
provide
an
explanation
of
how
you
arrived
at
your
estimates.
°
Are
there
other
costs
that
should
be
accounted
for
that
may
have
been
missed?
Data
Acquisition
for
Anticipated
Residue
and
Percent
of
Crop
Treated
OMB
No.
2070­
0164
EPA
No.
1911.02
Attachment
K
Comments
received
in
to
the
Consultation
Process;
EPA
Response
to
Specific
Consultation
Comments
Page
1
ATTACHMENT
K
Data
Acquisition
for
Anticipated
Residue
and
Percent
of
Crop
Treated
(
OMB
2070­
0164)
Comments
received
in
to
the
Consultation
Process
Respondent
#
1:
Chris
J.
Wible
The
Scotts
Company
937­
644­
7012
Chris.
Wible@
Scotts.
com
Date:
July
26,
2004
(
1)
Publicly
Available
Data
(
1)
Is
the
data
that
the
Agency
seeks
available
from
any
public
source,
or
already
collected
by
another
office
at
EPA
or
by
another
agency?
The
Scotts
Company
is
a
Formulator
and
does
not
submit
residue
data
to
EPA.

(
2)
If
yes,
where
can
you
find
the
data?
(
Does
your
answer
indicate
a
true
duplication,
or
does
the
input
indicate
that
certain
data
elements
are
available,
but
that
they
don't
meet
our
data
needs
very
well?)

(
2)
Frequency
of
Collection
Can
the
Agency
collect
the
information
less
frequently
and
still
produce
the
same
outcome?
No.

(
3)
Clarity
of
Instructions
(
1)
The
ICR
is
intended
to
require
that
respondents
provide
certain
data
so
that
the
Agency
can
utilize
them.

(
1)
Based
on
the
instructions
(
regulations,
PR
Notices,
etc.),
is
it
clear
what
you
are
required
to
do
and
how
to
submit
such
data?
The
Scotts
Company
does
not
have
any
experience
with
residue
data
submissions.

(
2)
If
not,
what
suggestions
do
you
have
to
clarify
the
instructions?

(
2)
Do
you
understand
that
you
are
required
to
maintain
records?
Yes,
as
registrants,
we
understand
our
data
retention
obligations.
Page
2
(
3)
Considering
that
there
is
no
required
submission
format,
is
it
difficult
to
submit
information
in
ways
that
are
clear,
logical
and
easy
to
complete?
N/
A
(
4)
Regarding
the
Voluntary
Incident
Reporting
Forms,
do
you
use
them?
Are
they
clear,
logical,
and
easy
to
complete?
(
N/
A
(
4)
Electronic
Reporting
and
Record
keeping
The
Government
Paperwork
Elimination
Act
requires
agencies
make
available
to
the
public
electronic
reporting
alternatives
to
paper­
based
submissions
by
2003,
unless
there
is
a
strong
reason
for
not
doing
so.
One
such
reason
is
that,
at
the
present
time,
the
Agency
is
unable
to
ensure
the
security
of
CBI
that
might
be
transmitted
over
the
Internet.

(
1)
What
do
you
think
about
electronic
alternatives
to
paper­
based
records
and
data
submissions?
Current
electronic
reporting
alternatives
include
the
use
of
"
web
forms"/
XML
based
submissions
via
the
Agency's
Internet
site
and
magnetic
media­
based
submissions,
e.
g.,
diskette,
CD­
ROM,
etc.
Would
you
be
interested
in
pursuing
electronic
reporting?
Electronic
submissions
generally
result
in
faster
processing
times,
both
with
the
registrant
and
the
Agency.
Many
PMs
in
RD
accept
electronic
label
submission,
which
we
find
beneficial.
We
have
not
submitted
DCI
submissions
electronically
to
date
but
will
likely
move
in
that
direction
in
the
future.

Are
you
keeping
your
records
electronically?
If
yes,
in
what
format?
Yes,
scanned
documents,
pdf,
Word,
XML
(
2)
Although
the
Agency
does
not
offer
an
electronic
reporting
option
because
of
CBI­
related
security
concerns
at
this
time
(
1)
would
you
be
more
inclined
to
submit
CBI
on
diskette
than
on
paper?
We
would
be
more
inclined
to
submit
CBI
on
paper
(
CSFs).

(
2)
what
benefits
would
electronic
submission
bring
you
in
terms
of
burden
reduction
or
greater
efficiency
in
compiling
the
information?
Electronic
submission
of
Toxicology,
Product
Chemistry,
and
Master
Labels
would
have
a
negligible
impact
on
burden
reduction.
Document
preparation
is
the
key
driver
as
opposed
to
printing/
burning/
mailing.
Page
3
(
5)
Burden
and
Costs
(
1)
Are
the
labor
rates
accurate?
The
labor
rates
are
acceptable
industry
averages
(
2)
The
Agency
assumes
there
are
no
capital
costs
associated
with
this
activity.
Is
that
correct?
This
is
not
correct.
If
all
activities
are
outsourced,
the
fees
include
capital
cost
of
the
service
provider.
If
activities
are
conducted
inhouse
capital
cost
are
incurred
(
examples
include
processing
equipment
for
preparation
of
Product
Chemistry
and
Acute
Tox
samples:
formulating,
analytical,
grinding,
etc)

(
3)
Bearing
in
mind
that
the
burden
and
cost
estimates
include
only
burden
hours
and
costs
associated
with
the
paperwork
involved
with
this
ICR,
e.
g.,
the
ICR
does
not
include
estimated
burden
hours
and
costs
for
conducting
studies,
are
the
estimated
burden
hours
and
labor
rates
accurate?
The
burden
hours
and
total
costs
appear
accurate
for
Formulators
but
are
likely
significant
underestimates
for
the
basic
AI
registrants.
The
estimate
in
accurate
for
registrants
utilizing
their
formulators
exemption.

If
you
provide
burden
and
cost
estimates
that
are
substantially
different
from
EPA's,
please
provide
an
explanation
of
how
you
arrived
at
your
estimates.

(
4)
Are
there
other
costs
that
should
be
accounted
for
that
may
have
been
missed?
Page
4
ATTACHMENT
K
Data
Acquisition
for
Anticipated
Residue
and
Percent
of
Crop
Treated
(
OMB
2070­
0164)
EPA
Response
to
Specific
Consultation
Comments
14)
Consultation
Comment
by
J.
G.
Cummings
(
DuPont
Crop
Protection)
to
Question
#
5(
1)
on
Burden
and
Costs:

Labor
rates
are
low
if
they
represent
labor
costs,
benefits,
and
overhead.
The
estimates
are
reasonable
if
they
represent
labor
cost
only.

EPA
Response:

The
labor
cost
estimates
are
meant
to
cover
the
burden
hours
and
not
overhead
costs,
such
as
office
IT.
However,
they
are
meant
to
include
indirect
labor
costs,
such
as
benefits.
Based
on
the
comment,
DuPont's
costs
may
be
somewhat
higher
than
the
central
tendency
values
used
in
the
draft
ICR.
The
Agency
did
not
modify
labor
cost
estimates
based
on
one
company's
estimates.

15)
Consultation
Comment
by
J.
G.
Cummings
(
DuPont
Crop
Protection)
to
Question
#
5(
3)
on
Burden
and
Costs:

Total
number
of
burden
hours
are
correct,
but
there
should
be
somewhat
more
hours
of
management
time
and
an
offsetting
reduction
in
technical
time
for
Type
1
DCIs.

EPA
Response:

No
specific
recommendation
for
modifying
the
labor
mix
was
provided
and
the
mix
required
can
vary
from
company
to
company,
so
the
Agency
did
not
modify
the
ICR.
