47246
Federal
Register
/
Vol.
68,
No.
153
/
Friday,
August
8,
2003
/
Rules
and
Regulations
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP
 
2003
 
0127;
FRL
 
7321
 
6]

2,6­
Diisopropylnaphthalene;
Temporary
Tolerances
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Final
rule.

SUMMARY:
This
regulation
establishes
a
temporary
tolerance
of
0.5
parts
per
million
(
ppm)
for
2,6­
Diisopropylnaphthalene
(
2,6­
DIPN)
in
or
on
potatoes,
and
3
ppm
in
or
on
potato
peels.
Platte
Chemical
Company
requested
this
tolerance
under
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
as
amended
by
the
Food
Quality
Protection
Act
of
1996
(
FQPA).
The
temporary
tolerance
will
expire
on
May
31,
2006.
DATES:
This
regulation
is
effective
August
8,
2003.
Objections
and
requests
for
hearings,
identified
by
docket
ID
number
OPP
 
2003
 
0127,
must
be
received
on
or
before
October
7,
2003.
ADDRESSES:
Written
objections
and
hearing
requests
may
be
submitted
electronically,
by
mail,
or
through
hand
delivery/
courier.
Follow
the
detailed
instructions
as
provided
in
Unit
VII.
of
the
SUPPLEMENTARY
INFORMATION.

FOR
FURTHER
INFORMATION
CONTACT:
Driss
Benmhend,
Biopesticides
and
Pollution
Prevention
Division
(
7511C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
308
 
9525;
e­
mail
address:
Benmhend.
driss@
epa.
gov.

SUPPLEMENTARY
INFORMATION:

I.
General
Information
A.
Does
this
Action
Apply
to
Me?

You
may
be
potentially
affected
by
this
action
if
you
are
an
agricultural
producer,
food
manufacturer,
or
pesticide
manufacturer.
Potentially
affected
categories
and
entities
may
include,
but
are
not
limited
to:
 
Crop
production
(
NAICS
111)
 
Animal
production
(
NAICS
112)
 
Food
manufacturing
(
NAICS
311)
 
Pesticide
manufacturing
(
NAICS
32532)
This
listing
is
not
intended
to
be
exhaustive,
but
rather
provides
a
guide
for
readers
regarding
entities
likely
to
be
affected
by
this
action.
Other
types
of
entities
not
listed
in
this
unit
could
also
be
affected.
The
North
American
Industrial
Classification
System
(
NAICS)
codes
have
been
provided
to
assist
you
and
others
in
determining
whether
this
action
might
apply
to
certain
entities.
If
you
have
any
questions
regarding
the
applicability
of
this
action
to
a
particular
entity,
consult
the
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.

B.
How
Can
I
Get
Copies
of
this
Document
and
Other
Related
Information?

1.
Docket.
EPA
has
established
an
official
public
docket
for
this
action
under
docket
identification
(
ID)
number
OPP
 
2003
 
0127.
The
official
public
docket
consists
of
the
documents
specifically
referenced
in
this
action,
any
public
comments
received,
and
other
information
related
to
this
action.
Although
a
part
of
the
official
docket,
the
public
docket
does
not
include
Confidential
Business
Information
(
CBI)
or
other
information
whose
disclosure
is
restricted
by
statute.
The
official
public
docket
is
the
collection
of
materials
that
is
available
for
public
viewing
at
the
Public
Information
and
Records
Integrity
Branch
(
PIRIB),
Rm.
119,
Crystal
Mall
#
2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA.
This
docket
facility
is
open
from
8:
30
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
docket
telephone
number
is
(
703)
305
 
5805.
2.
Electronic
access.
You
may
access
this
Federal
Register
document
electronically
through
the
EPA
Internet
under
the
``
Federal
Register''
listings
at
http://
www.
epa.
gov/
fedrgstr/.
A
frequently
updated
electronic
version
of
40
CFR
part
180
is
available
at
http://
www.
access.
gpo.
gov/
nara/
cfr/
cfrhtml__
00/
Title__
40/
40cfr180_
00.
html,
a
beta
site
currently
under
development.
To
access
the
OPPTS
Harmonized
Guidelines
referenced
in
this
document,
go
directly
to
the
guidelines
at
http://
www.
epa.
gov/
opptsfrs/
home/
guidelin.
htm.
An
electronic
version
of
the
public
docket
is
available
through
EPA's
electronic
public
docket
and
comment
system,
EPA
Dockets.
You
may
use
EPA
Dockets
at
http://
www.
epa.
gov/
edocket/
to
submit
or
view
public
comments,
access
the
index
listing
of
the
contents
of
the
official
public
docket,
and
to
access
those
documents
in
the
public
docket
that
are
available
electronically.
Although
not
all
docket
materials
may
be
available
electronically,
you
may
still
access
any
of
the
publicly
available
docket
materials
through
the
docket
facility
identified
in
Unit
I.
B.
1.
Once
in
the
system,
select
``
search,''
then
key
in
the
appropriate
docket
ID
number.
II.
Background
and
Statutory
Findings
Section
408(
b)(
2)(
A)(
i)
of
the
FFDCA
allows
EPA
to
establish
a
tolerance
(
the
legal
limit
for
a
pesticide
chemical
residue
in
or
on
a
food)
only
if
EPA
determines
that
the
tolerance
is
``
safe.''
Section
408(
b)(
2)(
A)(
ii)
of
the
FFDCA
defines
``
safe''
to
mean
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.''
This
includes
exposure
through
drinking
water
and
in
residential
settings,
but
does
not
include
occupational
exposure.
Section
408(
b)(
2)(
C)
of
the
FFDCA
requires
EPA
to
give
special
consideration
to
exposure
of
infants
and
children
to
the
pesticide
chemical
residue
in
establishing
a
tolerance
and
to
``
ensure
that
there
is
a
reasonable
certainty
that
no
harm
will
result
to
infants
and
children
from
aggregate
exposure
to
the
pesticide
chemical
residue.
.
.
.''
In
the
Federal
Register
of
September
21,
2001
(
66
FR
48677)
(
FRL
 
6798
 
3),
EPA
issued
a
notice
pursuant
to
section
408
of
the
FFDCA,
21
U.
S.
C.
346a,
as
amended
by
FQPA
(
Public
Law
104
 
170),
announcing
the
filing
of
a
pesticide
petition
(
PF
 
1043)
by
Platte
Chemical
Company,
7251
4th
Street,
Greely,
CO
80632.
This
notice
included
a
summary
of
the
petition
prepared
by
the
petitioner
Platte
Chemical
Company.
The
petition
requested
that
40
CFR
180.1208
be
amended
by
establishing
a
temporary
tolerance
for
residues
of
the
plant
growth
regulator
2,6­
DIPN,
in
or
on
potatoes
at
3
parts
per
million
(
ppm)
for
the
peels,
0.5
ppm
for
potato
(
whole).
The
tolerance
will
expire
on
May
31,
2006.
EPA
received
comments
on
this
petition
submitted
by
John
Forsythe,
General
Manager,
on
behalf
of
D­
I­
1­
4,
Inc.
(
Meridian,
ID).
The
issues
raised
by
Mr.
Forsythe
related
to
the
following:
(
1)
The
classification
of
2,6­
DIPN
as
a
biochemical
pesticide;
(
2)
the
lack
of
chronic
toxicity
data;
and
(
3)
the
public's
exposure
to
this
chemical
through
its
use
as
an
industrial
chemical.
Mr.
Forsythe's
comments
are
discussed
individually
below,
along
with
EPA's
response.
Comment
1.
Mr.
Forsythe
requested
that
the
Agency
re­
evaluate
the
biochemical
classification
determination
for
2,6­
DIPN
and
provide
any
publicly
available
information
regarding
the
natural
occurrence
of
2,6­
DIPN
in
any
food
source.
EPA
Response.
A
biochemical
pesticide,
by
definition,
is
a
naturally
occurring
substance
which
controls
target
pests
by
a
non­
toxic
mode
of
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47247
Federal
Register
/
Vol.
68,
No.
153
/
Friday,
August
8,
2003
/
Rules
and
Regulations
action.
However,
there
are
products
that
are
not
naturally
occurring,
yet
they
are
registered
by
the
Agency
as
``
biochemical­
like,''
insofar
as
data
requirements
are
concerned.
Thus,
while
2,
6­
DIPN,
is
synthetic
and
does
not
occur
naturally
in
any
food
or
nonfood
plants,
it
is
structurally
similar
to
three
compounds
(
1­
isopropyl­
4,6­
dimethylnaphthalene,
1­
methyl­
7­
isopropylnaphthalene,
and
4­
isopropyl­
1,6­
dimethylnaphthalene)
that
occur
naturally
in
potatoes,
and
2,6­
DIPN
is
functionally
identical
to
the
naturally
occurring
plant
growth
regulator
in
potatoes.
Comment
2.
Mr.
Forsythe
expressed
concern
that
the
Agency
had
not
presented
any
public
documentation
demonstrating
that
the
mode
of
action
of
2,6­
DIPN
is
non­
toxic.
EPA
Response.
The
new
active
ingredient,
2,6­
DIPN,
is
a
plant
growth
regulator
(
PGR)
intended
to
inhibit
sprouting
in
stored
potatoes.
PGRs
may
stimulate
or
retard
ripening,
maturity
of
whole
plants
and/
or
fruits,
enhance
growth,
yield,
enhance
or
counteract
the
activities
of
other
PGRs,
and/
or
change
plant
architecture
(
amongst
other
processes).
PGRs
are
not
toxic
to
the
target
plant,
especially
at
the
application
rate.
Tests
conducted
during
the
experimental
use
permit
showed
no
toxicity
to
potatoes.
None
of
these
actions
are
directly
lethal
to
the
plants
upon
which
they
are
applied,
which
supports
a
determination
that
2,
6­
DIPN
operates
through
a
non­
toxic
mode
of
action.
Diisopropylnapthalene
is
similar
in
molecular
structure,
and
functions
as
three
sprout
inhibiting
compounds
naturally
occurring
in
potatoes
(
1­
isopropyl­
4,6­
dimethylnaphthalene,
1­
methyl­
7­
isopropylnaphthalene,
and
4­
isopropyl­
1,6­
dimethylnaphthalene).
The
three
compounds
found
in
potatoes
and
2,6
DIPN
are
all
isopropyl
napthalene,
a
sprout
inhibitor
in
a
manner
comparable
to
natural
PGRs
found
in
potato
plants
(
as
described
above).
In
addition,
acute
toxicity
studies
conducted
on
animals
indicated
Toxicity
Category
IV
for
all
routes
of
exposure
and
chronic
studies
were
not
triggered
following
the
data
requirements
for
biochemical
pesticides
as
given
in
40
CFR
158.690(
c).
EPA
therefore
has
concluded
that
its
mode
of
action
can
be
classified
as
``
non­
toxic.''
Comment
3.
Mr.
Forsythe
expressed
concerns
regarding
dietary
intake
of
2,6­
DIPN,
due
to:
(
1)
The
synthetic
nature
of
the
compound;
and
(
2)
the
lack
of
toxicity
information
to
support
an
assessment
of
dietary
exposure
to
2,6­
DIPN.
EPA
Response.
As
discussed
in
the
previous
response,
the
data
support
the
classification
of
2,6­
DIPN
as
a
biochemical,
based
on
its
structural
similarity
to
naturally
occuring
PGRs.
In
addition,
the
registrant
has
conducted
a
series
of
toxicity
tests
according
to
the
requirements
listed
in
40
CFR
158.690,
in
support
of
experimental
use
permits
(
EUPs)
and
for
product
registration.
Dietary
exposure
estimates
were
based
on
the
assumption
that
100%
of
the
crop
will
be
treated,
and
other
worstcase
assumptions
were
applied
to
overestimate
the
typical
dietary
exposure
likely
under
normal
conditions
of
use.
A
90
 
day
oral
toxicity
study
(
MRID
450493­
01)
demonstrated
that
rats
did
not
exhibit
immune
system
effects,
demonstrated
by
no
changes
in
spleen
or
thymus
weights
and
absence
of
lesions
in
spleen,
thymus,
and
lymph
nodes.
The
90
 
day
oral
no
observable
adverse
effects
level
(
NOAEL)
was
100
milligrams/
kilogram/
day
(
mg/
kg/
day),
and
the
lowest
observable
adverse
effects
level
(
LOAEL)
was
200
mg/
kg/
day,
based
on
decreased
body
weight
gain
and
food
consumption.
In
a
developmental
toxicity
study
(
MRID
4500010
 
01)
in
rats,
the
test
animals
did
not
exhibit
increased
fetal
susceptibility
to
2,6­
DIPN
when
compared
to
untreated
animals.
The
prenatal
developmental
toxicity
NOAEL
was
150
mg/
kg/
day
and
the
LOAEL
was
500
mg/
kg/
day,
based
on
decreased
fetal
body
weight
and
a
possible
treatment­
related
cartilage
anomaly.
The
toxicity
data
on
2,6­
DIPN
does
not
indicate
extra
sensitivity
of
offspring
when
compared
with
that
of
adult
animals,
but
the
data
base
does
not
represent
a
complete
assessment
of
potential
age­
related
sensitivity
or
acute
effects
other
than
lethality.
The
absence
of
a
developmental
toxicity
study
in
a
second
species,
a
multigeneration
reproduction
toxicity
study,
or
a
range
of
doses
adequate
to
induce
a
full
range
of
toxic
responses,
especially
potential
acute
effects
in
any
of
the
available
studies,
required
that
the
FQPA
10­
fold
safety
factor
be
retained
in
defining
EPA's
level
of
concern.
Studies
submitted
to
test
the
potential
genotoxicity
or
mutagenicity
of
2,6­
DIPN
included
a
reverse
mutation
(
Ames)
assay
(
MRID
446141
 
11),
an
unscheduled
DNA
synthesis
assay
in
rat
primary
hepatocytes
(
MRID
446141
 
10),
and
a
mouse
micronucleus
assay
(
MRID
446141
 
12);
all
of
these
were
negative.
A
mouse
lymphoma
assay
(
MRID
454388
 
01)
was
positive
at
higher
concentrations
for
mutagenicity,
but
since
2,6­
DIPN
was
cytotoxic
(
killed
the
test
cells)
at
the
those
concentrations
where
the
positive
results
occurred
(
with
and
without
metabolic
activation),
the
test
results
are
considered
as
being
equivocal,
or
falsely
positive.
As
a
group,
these
four
studies
demonstrated
that
2,6­
DIPN
is
not
a
mutagen.
Information
supplied
by
the
commenter
(
Ref.
5)
noted
that
``
Di­
Isopropylnaphthalene(
s)
contained
no
chemical
groups
that
would
be
structurally
alerting
for
potential
mutagenicity.''
Additionally,
in
spite
of
the
equivocal
study
(
MRID
454388
 
01),
``
there
was
no
evidence
for
a
mutagenic
effect
in
other
in­
vitro
mutagenicity
tests
or
in
an
adequately
performed
in
vivo
micronucleus
assay
in
mice.
The
Committee
agreed
that
no
further
mutagenicity
testing
was
required.''
Based
on
the
absence
of
effects
on
the
immune
system
in
the
90
 
day
subchronic
study,
no
effects
on
developing
rats
at
doses
below
those
causing
maternal
effects,
and
no
genetic
toxicity,
Tier
II
and
Tier
III
toxicity
data
requirements
were
not
triggered.
The
Agency
does
not
require
any
additional
toxicity
studies
at
this
time
although
a
livestock
feeding
study
must
be
conducted
as
a
condition
of
registration
(
see
EPA
Response
to
Comment
4).
Comment
4.
Mr.
Forsythe
stated
that,
in
the
absence
of
any
chronic
toxicity
data,
``
it
would
be
inappropriate
to
disregard
the
safety
factor''
(
referring
to
the
FQPA
10­
fold
margin
of
safety
to
account
for
effects
on
sensitive
populations,
such
as
infants
and
children),
and
that
``
threshold
effects
cannot
be
fully
determined,
and
a
safety
factor
would
seem
appropriate
to
address
this
lack
of
a
complete
data
set
regarding
dietary
exposure
and
chronic
toxicity.''
EPA
Response.
As
stated
above,
the
Agency
has
retained
the
FQPA
safety
factor
in
its
assessment
of
the
dietary
exposure
to
2,6­
DIPN.
Comment
5:
Mr.
Forsythe
stated
that
the
Agency
should
consider
non­
dietary
and
non­
occupational
sources
of
human
exposure
to
2,6­
DIPN.
The
commenter
submitted
an
EPA
document
(
Ref.
5),
in
which
2,6­
DIPN
is
described
as
an
``
emerging
pollutant''
in
Lake
Michigan.
The
document
also
states
that
polychlorinated
biphenyl
(
PCB)
substitute
compounds
(
which
include
2,6­
DIPN),
are
``
detected
in
effluent,
sediment,
and
fish
in
the
basin;
bioaccumulative
and
toxic.''
Additionally,
the
commenter
provided
information
that
European
governments
have
expressed
concerns
regarding
public
exposure
to
DIPNs
via
the
paper
industry.
In
studies
conducted
by
the
United
Kingdom
Joint
Food
Safety
and
Standards
Group
(
JFSSG),
it
was
determined
that
DIPNs
could
be
present
in
recycled
food
packaging
and
in
packaged
food
(
Ref.
5).
DIPNs
were
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detected
in
30
of
34
samples
of
retail
packaging
at
up
to
44
mg/
kg,
and
in
6
of
10
food
samples
at
0.04
 
0.89
mg/
kg.
EPA
Response.
Section
408(
b)(
2)(
A)(
ii)
explicitly
requires
the
Agency
to
find
that
``
there
is
a
reasonable
certainty
that
no
harm
will
result
from
aggregate
exposures,
including
all
anticipated
dietary
exposures
and
all
other
exposures
for
which
there
is
reliable
information.''
(
emphasis
added).
As
discussed
below,
EPA
has
considered
all
available
information
on
non­
dietary
and
nonoccupational
exposures
in
establishing
this
temporary
tolerance.
EPA
reviewed
the
LaMP
study
(
Ref.
5),
and
found
that
these
``
emerging
pollutants''
were
only
included
in
a
list
of
chemical
stressors
in
the
lake
``
as
a
precautionary
measure,
either
because
of
their
widespread
use
in
the
basin,
the
fact
that
these
chemicals
are
beginning
to
show
up
in
monitoring
data,
or
both.''
The
list
of
emerging
pollutants
listed
includes:
Mineral
and
silicone
oils,
di(
2­
ethylhexyl)
phathalate
(
DEHP),
isopropylbiphenyls,
diphenylmethanes,
butylbiphenyls,
dichlorobenzyldichlorotoluene,
phenylxylyl
ethane,
and
diisopropylnaphthalene.
The
article
does
list
PCB
substitute
compounds
as
being
``
detected
in
effluent,
sediment,
and
fish
in
the
basin;
bioaccumulative
and
toxic''
(
Ref.
5).
According
to
the
Michigan
LaMP
(
Ref.
5),
``
Following
the
1979
restrictions
on
PCB
use,
[
these]
compounds
began
being
used
in
dielectric
fluids,
hydraulic
system
lubricants,
and
in
solvents
and
carriers
in
the
carbonless
paper
industry.
Little
was
known
about
the
potential
impact
of
these
(
PCB)
substitutes
on
the
basin;
therefore
(
they)
were
designated
an
emerging
pollutant
needing
further
evaluation.''
With
the
exception
of
DHEP,
the
Michigan
LaMP
goes
on
to
state
that
``
other
PCB
substitutes
(
such
as
DIPN)
have
not
been
extensively
studied;
therefore,
information
on
releases
to
the
environment
are
limited.''
The
article
further
states
that
information
regarding
the
actual
loading
of
PCB
substitutes
into
Lake
Michigan
and
their
impact
on
the
lake
ecosystem
were
unknown
(
Ref.
5).
An
environmental
sampling
study
(
Ref.
5),
indicated
that
DIPNs
and
three
other
PCB
substitutes
were
identified
in
effluent
from:
A
de­
inking/
recycling
paper
plant
and
a
wastewater
treatment
facility
that
received
waste
water
from
a
carbonless
paper
manufacturing
plant;
fish
collected
near
discharge
points;
and
sediments,
all
of
these
samples
were
collected
from
the
Fox
River
in
Wisconsin.
However,
it
is
unknown
whether
all
four
PCB
substitutes
were
found
nor
what
concentrations
were
measured
in
each,
and
the
study
lacked
environmental
fate
and
transport
data
for
DIPNs.
Based
on
the
statements
in
the
LaMP
study,
EPA
concluded
that
although
DIPNs
have
been
detected
in
a
few
environmental
matrices,
it
has
not
been
associated
with
any
adverse
effects
to
human
health
or
the
environment.
EPA
also
reviewed
the
JFSSG
Food
Surveillance
Information
Sheet,
No.
169,
January
1999.
The
conclusion
reached
by
the
JFSSG
was
that
although
varying
amounts
of
DIPNs
can
be
carried
through
the
papermaking
process
to
the
finished
product,
there
was
no
correlation
between
DIPN
levels
in
food
and
that
found
in
the
food
packaging
materials.
Data
was
reviewed
that
demonstrated
that
2,6­
DIPN
does
not
pose
any
significant
bioaccumulation
risk.
A
summary
of
metabolism
studies/
data
in
support
of
a
temporary
tolerance
exemption
on
stored
potatoes
(
PP
8G05008;
Ref.
3;
MRIDs
451632
 
01
and
451632
 
02)
was
submitted
by
the
registrant,
Platte
Chemical
Co.,
that
demonstrated
orally
administered
DIPNs
were
rapidly
metabolized
and
excreted
by
experimental
animals,
and
exhibited
little
potential
for
bioaccumulation
(
Ref.
5).
Additionally,
experimental
animals
exposed
to
DIPNs
via
inhalation
did
not
exhibit
any
clinical
signs
of
toxicity
or
mortality
(
Ref.
5).
Necropsies
were
negative
in
experimental
animals
dosed
with
DIPNs
in
all
of
the
aforementioned
studies.

III.
Aggregate
Risk
Assessment
and
Determination
of
Safety
EPA
performs
a
number
of
analyses
to
determine
the
risks
from
aggregate
exposure
to
pesticide
residues.
For
further
discussion
of
the
regulatory
requirements
of
section
408
of
the
FFDCA
and
a
complete
description
of
the
risk
assessment
process,
see
the
final
rule
on
Bifenthrin
Pesticide
Tolerances
(
62
FR
62961,
November
26,
1997;
FRL
 
5754
 
7).
Consistent
with
section
408(
b)(
2)(
D)
of
the
FFDCA,
EPA
has
reviewed
the
available
scientific
data
and
other
relevant
information
in
support
of
this
action.
EPA
has
sufficient
data
to
assess
the
hazards
of
and
to
make
a
determination
on
aggregate
exposure,
consistent
with
section
408(
b)(
2)
of
the
FFDCA,
for
a
tolerance
for
residues
of
2,6­
DIPN
on
potatoes
at
3
ppm
for
the
peels
and
0.5
ppm
for
potato
(
whole)
ppm.
EPA's
assessment
of
exposures
and
risks
associated
with
establishing
the
tolerance
follows.
A.
Toxicological
Profile
EPA
has
evaluated
the
available
toxicity
data
and
considered
its
validity,
completeness,
and
reliability
as
well
as
the
relationship
of
the
results
of
the
studies
to
human
risk.
EPA
has
also
considered
available
information
concerning
the
variability
of
the
sensitivities
of
major
identifiable
subgroups
of
consumers,
including
infants
and
children.
The
classification
of
2,6­
DIPN
as
a
biopesticide
was
based
on
its
structural
and
functional
similarity
to
1­
isopropyl­
4,6­
dimethylnaphthalene,
1­
methyl­
7­
isopropylnaphthalene,
and
4­
isopropyl­
1,6­
dimethylnaphthalene
which
are
naturally
occurring
plant
growth
regulators
found
in
plant
tissues.
In
addition,
2,6­
DIPN
is
a
sprout
inhibitor,
with
a
non­
toxic
mode
of
action.
Therefore,
the
toxicity
data
reviewed
include
acute
oral,
dermal
and
inhalation
toxicity
studies,
eye
and
skin
irritation
studies,
a
dermal
sensitization
study,
subchronic
feeding
and
developmental
toxicity
studies
and
genetic
toxicity
studies.
2,6­
DIPN
is
classified
in
Toxicity
Category
IV
for
mammalian
acute
oral
toxicity
(
lethal
dose
(
LD)
50
>
5,000
mg/
kg;
OPPTS
Harmonized
Guideline
870.1100;
152
 
10;
MRID
446141
 
04),
acute
dermal
toxicity
(
LD50
>
5,000
mg/
kg;
OPPTS
Harmonized
Guideline
870.1200;
152­
11;
MRID
446141
 
05),
and
acute
inhalation
toxicity
(
lethal
concentration
(
LC)
50
>
2.60
mg/
L;
OPPTS
Harmonized
Guideline
870.1300;
152
 
12;
MRID
446141
 
06),
eye
irritation
(
OPPTS
Harmonized
Guideline
870.2400;
152
 
13;
MRID
446141
 
07)
and
dermal
irritant
(
OPPTS
Harmonized
Guideline
870.2500;
152
 
14;
MRID
446141
 
08).
The
active
ingredient
was
not
allergenic
on
skin
(
not
a
dermal
sensitizer;
OPPTS
Harmonized
Guideline
870.2600;
152
 
15;
MRID
446141
 
09).
The
subchronic
toxicity
study
in
rats
(
OPPTS
Harmonized
Guideline
870.3100;
152­
20;
MRID
450493
 
01)
suggests
a
no
observed
effect
level
(
NOEL)
of
104
mg/
kg/
day
(
104
or
121
mg/
kg/
day
for
males
and
females,
respectively).
The
lowest
observed
adverse
effect
level
(
LOAEL)
is
208
mg/
kg/
day
(
208
and
245
mg/
kg/
day
for
males
and
females,
respectively),
based
on
minimal
decreases
in
body
weight
gains,
food
consumption,
adrenal
effects
(
including
increased
absolute
and
relative
organ
weights
and
adrenal
cortical
hypertrophy)
and
kidney
toxicity
(
evidence
of
tubular
nephrosis
in
male
rats).
In
the
rat
developmental
toxicity
study
(
OPPTS
Harmonized
Guideline
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870.3700;
152
 
23;
MRID
450001
 
01),
the
maternal
toxicity
LOAEL
is
150
mg/
kg/
day
based
on
reduced
body
weight
gains
and
food
consumption.
The
maternal
toxicity
NOAEL
is
50
mg/
kg/
day.
The
developmental
toxicity
LOAEL
is
500
mg/
kg/
day
based
on
reduced
fetal
body
weights
and
a
slightly
increased
incidence
of
a
skeletal
alteration
(
fusion
of
cartilaginous
bands
in
the
cervical
centra).
The
developmental
toxicity
NOAEL
is
150
mg/
kg/
day.
A
mouse
lymphoma
gene
mutation
assay
(
OPPTS
Harmonized
Guideline
870.5300;
152
 
17;
MRID
454388
 
01)
showed
that
2,6­
DIPN
might
be
mutagenic
without
metabolic
activation
at
doses
between
10
 
30
µ
g/
mL.
With
metabolic
activation,
the
results
were
equivocal
at
doses
between
25
 
90
µ
g/
mL.
Cytotoxicity
was
observed
in
tests
using
the
aforementioned
doses,
with
and
without
metabolic
activation.
No
genotoxicity
was
observed
in
other
acceptable
studies
including
a
reverse
mutation
(
Ames)
assay
(
OPPTS
870.5100;
152
 
17;
MRID
446141
 
11),
in
vivo/
in
vitro
unscheduled
DNA
synthesis
(
UDS)
assays
in
rat
primary
hepatocytes
(
OPPTS
870.5550;
152
 
17;
MRID
446141
 
10),
and
a
mouse
micronucleus
assay
(
OPPTS
870.5395;
152
 
17;
MRID
446141
 
12).
The
collective
data
from
the
four­
study
mutagenicity
battery
demonstrates
that
2,6­
DIPN
is
not
likely
to
be
mutagenic.

B.
Toxicological
Endpoints
1.
Acute
toxicity.
The
acute
toxicity
studies
were
acceptable
in
accordance
with
the
guidelines
as
discussed
in
Unit
III.
A.
All
studies
were
performed
at
a
single
limit
dose
with
no
observable
(
non­
lethal)
toxic
endpoints.
2.
Short­
term
and
intermediate­
term
toxicity.
Although
the
rat
developmental
toxicity
study
indicates
a
lower
maternal
NOEL
(
50
mg/
kg/
day)
for
similar
toxicity
than
the
subchronic
toxicity
study
(
reduced
body
weight,
weight
gain
and
food
consumption),
the
maternal
LOAEL
of
150
mg/
kg/
day
falls
between
the
subchronic
NOEL
of
104
 
121
mg/
kg/
day
and
the
subchronic
LOAEL
of
208
 
245
mg/
kg/
day.
The
maternal
NOEL
of
50
mg/
kg/
day
from
the
developmental
toxicity
study
may
be
appropriate
for
use
in
characterization
of
risks
for
the
subpopulation
of
women
13
 
49
years
of
(
child­
bearing)
age.
However,
the
104
mg/
kg/
day
NOEL
in
the
subchronic
study
was
selected
as
the
endpoint
for
short­
term
and
intermediate­
term
dietary
assessments
since
the
effects
observed
at
the
subchronic
LOAEL
(
208
 
245
mg/
kg/
day)
were
more
thoroughly
defined
than
the
developmental
effects
observed
at
the
LOAEL
(
500
mg/
kg/
day)
in
the
developmental
toxicity
study,
which
were
minimal.
A
reference
dose
(
RfD)
of
1
mg/
kg/
day
is
established
by
dividing
the
104
mg/
kg/
day
NOEL
by
a
100­
fold
uncertainty
factor
(
10X
for
interspecies
extrapolation
and
10X
for
intraspecies
variability).
Available
developmental
toxicity
data
on
2,6­
DIPN
does
not
indicate
extra
sensitivity
of
offspring
when
compared
with
that
of
adult
animals,
but
a
developmental
toxicity
study
in
a
second
species
and
a
multigeneration
reproduction
toxicity
study
are
needed
to
fully
determine
agerelated
differences
in
response.
In
addition,
residues
have
been
detected
in
treated
potatoes
under
laboratory
and
field
conditions.
Therefore,
the
default
safety
factor
of
10X
is
retained,
and
acute
and
chronic
population
adjusted
doses
(
aPAD
and
cPAD)
for
dietary
risk
characterizations
are
established
by
dividing
the
RfD
by
10X
(
accounting
for
age­
related
sensitivity
for
the
subpopulations
of
infants
and
children).
Therefore,
the
aPAD
and
cPAD
are
0.1
mg/
kg/
day.
3.
Chronic
toxicity.
An
extra
10­
fold
uncertainty
factor
for
the
absence
of
chronic
toxicity
data
were
not
applied
to
determine
a
RfD
because
2,6­
DIPN
has
been
classified
as
a
biochemical
pesticide
having
a
non­
toxic
mode
of
action
with
biological
activity
more
specific
to
plants
than
animals.
Acute
toxicity
studies
on
animals
indicated
Toxicity
Category
IV
for
all
routes
of
exposure.
Chronic
studies
are
not
required
to
support
registration
of
biochemical
pesticides
unless
all
of
the
following
are
true:
i.
Has
subchronic
toxicity.
ii.
Its
use
pattern
involves
a
significant
rate,
frequency
or
site
of
application.
iii.
The
frequency
and
level
of
human
exposure
are
significant
(
40
CFR
158.690(
c)).
These
criteria
were
evaluated
in
the
Agency's
risk
assessment
(
Refs.
1
and
2)
which
compared
the
cPAD
to
worst­
case
estimates
of
dietary
exposure.
The
use
pattern
and
exposure
associated
with
2,6­
DIPN
on
potatoes
in
storage
does
not
trigger
chronic
studies.
Since
the
conservative
exposure
estimates
did
not
result
in
risk
characterizations
exceeding
the
defined
level
of
concern
(
exposure
>
100%
of
the
cPAD).
4.
Carcinogenicity.
Based
on
the
90
 
day
oral
toxicity
study
and
the
genotoxicity/
mutagencity
studies,
there
were
no
results
to
indicate
potential
neoplastic
changes,
and
the
genetic
toxicity
studies
did
not
suggest
carcinogenic
potential
in
mammalian
cells.
C.
Exposure
Assessment
1.
Dietary
exposure
from
food
and
feed
uses.
There
is
a
potential
for
dietary
exposure
to
2,6­
DIPN,
which
can
occur
following
its
application
to
stored
potatoes.
According
to
the
label,
the
plant
growth
regulator
is
to
be
applied
at
a
rate
of
16.6
ppm
(
weight/
weight),
and
as
many
as
three
applications
can
be
used
in
a
storage
period
with
a
minimum
interval
between
application
and
use
of
the
treated
potatoes
of
30
days.
Residue
profile.
The
submitted
residue
chemistry
data
for
the
use
of
2,6­
DIPN
on
potatoes
is
limited,
and
important
factors
in
this
assessment
depend
on
default
assumptions
or
hypothetical
calculations
having
a
low
level
of
confidence.
For
purposes
of
this
rule,
the
regulated
residue
is
considered
to
be
2,6­
DIPN,
and
a
potential
for
some
accumulation
of
2,6­
DIPN
residues
in
body
and
subcutaneous
fat
was
observed.
These
results
and
the
possible
use
of
peels
with
residues
from
treated
potatoes
as
livestock
feed
(
processed
potato
wastes
are
used
for
this
purpose)
suggest
that
residues
of
2,6­
DIPN
may
occur
in
meat
and
milk;
however,
this
has
not
been
evaluated
in
a
livestock
metabolism
study.
Limited
field
and
laboratory
residue
data
suggested
tolerance
levels
as
high
as
0.5
ppm
in/
on
whole
potatoes,
3
ppm
on
potato
peels,
1.35
ppm
in
meat
and
meat
by­
products,
and
0.7
ppm
in
milk.
The
analytical
method
for
2,6­
DIPN
has
a
level
of
quantification
(
LOQ)
of
0.02
ppm
and
field
and
laboratory
studies
suggests
that
20
ppm
is
a
likely
maximum
commercial
application
rate
for
2,6­
DIPN.
Residue
levels
expressed
as
2,6­
DIPN
were
reported
at
3
ppm
in
potato
peels
and
0.5
ppm
in
whole
potatoes.
In
a
published
report
(
MRID
451632
 
01),
the
investigators
noted
that
DIPNs
could
accumulate
in
the
fat
of
treated
rats
suggesting
a
potential
for
secondary
residues
in
meat
and
milk
from
livestock
fed
treated
potatoes,
but
a
livestock
metabolism
study
was
not
submitted.
Worst­
case
estimates
of
secondary
residues
were
calculated
for
meat
(
1.35
ppm)
and
milk
(
0.7
ppm)
of
beef/
dairy
cattle
fed
waste
from
2,6­
DIPN­
treated
processed
potatoes.
Supplementary
metabolism
information
was
submitted
on
2,6­
DIPN
in
rats
from
two
published
articles
(
MRID
451632
 
01).
In
one
study,
rats
were
given
either
a
single
dose
or
30
daily
oral
doses,
at
100
mg
2,6­
DIPN
per
kg
body
weight.
Residues
of
2,6­
DIPN
were
detected
in
all
tissues
2
hours
after
receiving
the
test
dose.
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/
Rules
and
Regulations
exception
of
body
and
subcutaneous
fat,
DIPN
was
not
detected
48
hours
after
the
single
(
100
mg/
kg)
dose.
Peak
levels
in
body
and
subcutaneous
fat
were
found
24
hours
after
dosing
at
75
and
85
µ
g/
g
of
tissue,
respectively;
these
levels
declined
to
approximately
60
µ
g/
g
by
48
hours
following
the
single
dose.
Results
were
similar
in
rats
given
the
repeated
doses
with
the
peak
levels
in
body
and
subcutaneous
fat
reported
to
be
150
and
90
µ
g/
g,
respectively,
at
2
hours
following
administration
of
the
last
dose.
By
30
days
after
this
last
dose
was
given,
the
2,6­
DIPN
levels
in
fat
had
declined
to
5
µ
g/
g.
The
estimated
halflife
for
2,6­
DIPN
in
fat
was
approximately
7
days,
and
the
investigators
noted
that
DIPNs
had
a
small
potential
for
accumulation
in
fat
(
levels
increased
from
2
to
7%
over
those
found
after
a
single
dose
in
subcutaneous
and
body
fat,
respectively).
Worst­
case
estimates
of
secondary
residues
were
calculated
for
meat
(
1.35
ppm)
and
milk
(
0.7
ppm)
of
beef/
dairy
cattle
fed
waste
from
2,6­
DIPN­
treated
processed
potatoes.
These
tolerance
provide
a
reasonable
certainty
of
no
harm
and
livestock
feeding
studies
will
allow
further
refinement
of
these
estimates.
In
the
second
article,
it
was
noted
that
2,6­
DIPN
was
metabolized
in
rats
primarily
by
way
of
an
oxidative
pathway
involving
the
isopropyl
groups.
Five
metabolites
were
identified
in
urine
from
rats
given
an
oral
dose
of
240
mg
2,6­
DIPN
per
kg
body
weight,
and
the
majority
of
the
DIPN
residues
recovered
in
the
urine
(
23%
of
the
dose
at
24
hours)
was
represented
by
2­[
6(
1­
hydroxy­
1­
methyl)
ethylnaphthalen­
2­
yl]­
2­
hydroxypionic
acid
(
17.5%
of
the
dose).
This
study
did
not
explain
the
fate
of
the
remaining
77%
of
the
administered
dose.
The
livestock
feeding
study
should
determine
the
fate
of
the
administered
dose,
but
because
worst­
case
estimates
were
used
to
establish
the
tolerances,
there
is
a
reasonable
certainty
of
no
harm.
Acute
and
chronic
dietary
exposure
assessments
were
conducted
using
the
Dietary
Exposure
Evaluation
Model
software
(
DEEMTM
version
1.30)
which
incorporates
consumption
data
from
USDA's
Continuing
Surveys
of
Food
Intakes
by
Individuals
(
CSFII,
1994
 
1996/
1998).
For
acute
exposure
assessments,
individual
1­
day
food
consumption
data
define
an
exposure
distribution
which
is
expressed
as
a
percentage
of
the
aPAD
(
aPAD
is
0.1
mg/
kg).
For
chronic
exposure
and
risk
assessment,
an
estimate
of
the
residue
level
in
each
food
or
food­
form
on
the
commodity
residue
list
is
multiplied
by
the
average
daily
consumption
estimate
for
the
food/
food­
form.
The
resulting
residue
consumption
estimate
for
each
food/
food­
form
is
summed
with
the
residue
consumption
estimate
for
all
other
food/
food­
forms
on
the
commodity
residue
list
to
arrive
at
the
total
estimated
exposure.
Exposure
estimates
are
expressed
as
mg/
kg
body
weight/
day
and
as
a
percent
of
the
cPAD
(
0.1
mg/
kg/
day).
It
is
just
as
likely
that
the
exposure
estimates
are
appropriate,
given
that
it
is
not
uncommon
for
the
peels
to
be
eaten.
These
procedures
were
performed
for
each
population
subgroup.
As
a
condition
of
registration,
the
registrant
will
be
required
to
submit
livestock
feeding
studies
and
enforcement
analytical
methods
for
livestock
and
potatoes;
however,
EPA
believes
that
its
analyses,
which
rely
on
the
available
data,
supplemented
with
conservative
assumptions,
are
sufficient
to
support
a
tolerance
for
the
short
period
during
which
these
studies
are
conducted.
2.
Dietary
exposure
from
drinking
water.
Pesticide
residues
in
drinking
water
are
not
expected
to
result
from
this
use.
The
use
is
restricted
to
application
in
a
commercial
warehouse
to
stored
potatoes.
In
addition,
the
label
will
restrict
users
from
contaminating
water
supplies
when
cleaning
equipment
or
disposing
of
equipment
wash
waters.
3.
From
non­
dietary
exposure.
The
term
``
residential
exposure''
is
used
in
this
document
to
refer
to
nonoccupational
non­
dietary
exposure
(
e.
g.,
for
lawn
and
garden
pest
control,
indoor
pest
control,
termiticides,
and
flea
and
tick
control
on
pets).
2,6­
DIPN
is
not
registered
for
use
on
any
sites
that
would
result
in
residential
exposure,
but
is
restricted
to
use
in
commercial
warehouses.
4.
Cumulative
exposure
to
substances
with
a
common
mechanism
of
toxicity.
Section
408(
b)(
2)(
D)(
v)
of
the
FFDCA
requires
that,
when
considering
whether
to
establish,
modify,
or
revoke
a
tolerance,
the
Agency
consider
``
available
information''
concerning
the
cumulative
effects
of
a
particular
pesticide's
residues
and
``
other
substances
that
have
a
common
mechanism
of
toxicity.''
EPA
does
not
have,
at
this
time,
available
data
to
determine
whether
2,6­
DIPN
has
a
common
mechanism
of
toxicity
with
other
substances
or
how
to
include
this
pesticide
in
a
cumulative
risk
assessment.
Unlike
other
pesticides
for
which
EPA
has
followed
a
cumulative
risk
approach
based
on
a
common
mechanism
of
toxicity,
2,6­
DIPN
does
not
appear
to
produce
a
toxic
metabolite
produced
by
other
substances.
For
the
purposes
of
this
tolerance
action,
therefore,
EPA
has
not
assumed
that
2,6­
DIPN
has
a
common
mechanism
of
toxicity
with
other
substances.
For
information
regarding
EPA's
efforts
to
determine
which
chemicals
have
a
common
mechanism
of
toxicity
and
to
evaluate
the
cumulative
effects
of
such
chemicals,
see
the
final
rule
for
Bifenthrin
Pesticide
Tolerances
(
62
FR
62961,
November
26,
1997).

D.
Safety
Factor
for
Infants
and
Children
1.
In
general.
Section
408
of
the
FFDCA
provides
that
EPA
shall
apply
an
additional
ten­
fold
margin
of
safety
for
infants
and
children
in
the
case
of
threshold
effects
to
account
for
prenatal
and
postnatal
toxicity
and
the
completeness
of
the
data
base
on
toxicity
and
exposure
unless
EPA
determines
that
a
different
margin
of
safety
will
be
safe
for
infants
and
children.
Margins
of
safety
are
incorporated
into
EPA
risk
assessments
either
directly
through
use
of
a
MOE
analysis
or
through
using
uncertainty
(
safety)
factors
in
calculating
a
dose
level
that
poses
no
appreciable
risk
to
humans.
2.
Prenatal
and
postnatal
sensitivity.
The
toxicity
data
on
2,6­
DIPN
does
not
indicate
extra
sensitivity
of
offspring
when
compared
with
that
of
adult
animals,
but
the
data
base
does
not
represent
a
complete
assessment
of
potential
age­
related
sensitivity
or
acute
effects
other
than
lethality.
The
following
data
would
be
necessary
to
allow
for
a
complete
assessment:
A
developmental
toxicity
study
in
a
second
species,
a
multigeneration
reproduction
toxicity
study,
or
a
range
of
doses
adequate
to
induce
a
full
range
of
toxic
responses,
especially
potential
acute
effects
in
any
of
the
available
studies.
3.
Conclusion.
In
light
of
the
absence
of
a
developmental
toxicity
study
in
a
second
species,
a
multigeneration
reproduction
toxicity
study,
or
a
range
of
doses
adequate
to
induce
a
full
range
of
toxic
responses,
especially
potential
acute
effects
in
any
of
the
available
studies,
EPA
has
retained
the
default
10­
fold
safety
factor
IV.
Aggregate
Risks
and
Determination
of
Safety
for
U.
S.
Population,
Infants
and
Children
1.
Acute
risk.
Acute
dietary
exposure
estimates
were
based
on
the
available
residue
data
and
worst­
case
assumptions
(
Refs.
1
and
2).
For
the
U.
S.
population,
acute
dietary
exposure
was
estimated
to
be
0.023113
mg/
kg.
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Vol.
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153
/
Friday,
August
8,
2003
/
Rules
and
Regulations
values
represented
23.11%
of
the
aPAD.
The
subpopulation
with
the
highest
acute
dietary
exposure
estimate
was
children
1
to
6
years
of
age
(
0.053492
mg/
kg;
53.49%
of
the
aPAD).
The
acute
dietary
exposures
to
all
the
subpopulations
in
the
analysis
did
not
exceed
EPA's
level
of
concern
(>
100%
of
the
aPAD).
2.
Chronic
risk.
Using
the
exposure
assumptions
described
previously
for
chronic
exposure,
EPA
has
concluded
that
the
chronic
dietary
exposure
for
the
general
population
was
estimated
to
be
0.006939
mg/
kg/
day,
6.9%
of
the
cPAD.
The
subpopulation
with
the
highest
chronic
dietary
exposure
estimate
was
children
1
to
6
years
of
age,
with
estimated
exposures
of
0.023247
mg/
kg/
day,
which
constitutes
23.25%
of
the
cPAD.
3.
Determination
of
safety.
Based
on
these
risk
assessments,
EPA
concludes
that
there
is
a
reasonable
certainty
that
no
harm
will
result
to
the
general
population,
and
to
infants
and
children
from
aggregate
exposure
to
2,6­
DIPN
residues.
This
includes
all
anticipated
dietary
exposures
and
all
other
exposures
for
which
there
is
reliable
information.

V.
Other
Considerations
A.
Analytical
Enforcement
Methodology
A
liquid
chromatography
(
HPLC)
method
was
used
to
measure
the
levels
of
2,6­
DIPN
in
the
residue
study.
Adequate
enforcement
methodology
(
for
example,
gas
chromatography)
is
available
to
enforce
the
tolerance
expression.
The
method
may
be
requested
from:
Chief,
Analytical
Chemistry
Branch,
Environmental
Science
Center,
701
Mapes
Rd.,
Ft.
Meade,
MD
20755
 
5350;
telephone
number:
(
410)
305
 
2905;
e­
mail
address:
residuemethods@
epa.
gov.

B.
International
Residue
Limits
There
are
no
Codex
Alimentarius
Commission
(
Codex)
maximum
residue
levels
for
residues
of
2,6­
DIPN.

VI.
Conclusion
Based
upon
the
risk
assessment,
residue
data
and
use
pattern
described
above,
a
temporary
tolerance
is
established
for
residues
of
2,6­
DIPN
in
raw
potatoes
and
potato
peel
at
0.5
ppm
and
3
ppm
respectively.

VII.
Objections
and
Hearing
Requests
Under
section
408(
g)
of
the
FFDCA,
as
amended
by
the
FQPA,
any
person
may
file
an
objection
to
any
aspect
of
this
regulation
and
may
also
request
a
hearing
on
those
objections.
The
EPA
procedural
regulations
which
govern
the
submission
of
objections
and
requests
for
hearings
appear
in
40
CFR
part
178.
Although
the
procedures
in
those
regulations
require
some
modification
to
reflect
the
amendments
made
to
the
FFDCA
by
the
FQPA,
EPA
will
continue
to
use
those
procedures,
with
appropriate
adjustments,
until
the
necessary
modifications
can
be
made.
The
new
section
408(
g)
of
the
FFDCA
provides
essentially
the
same
process
for
persons
to
``
object''
to
a
regulation
for
an
exemption
from
the
requirement
of
a
tolerance
issued
by
EPA
under
new
section
408(
d)
of
the
FFDCA,
as
was
provided
in
the
old
sections
408
and
409
of
the
FFDCA.
However,
the
period
for
filing
objections
is
now
60
days,
rather
than
30
days.

A.
What
Do
I
Need
to
Do
to
File
an
Objection
or
Request
a
Hearing?

You
must
file
your
objection
or
request
a
hearing
on
this
regulation
in
accordance
with
the
instructions
provided
in
this
unit
and
in
40
CFR
part
178.
To
ensure
proper
receipt
by
EPA,
you
must
identify
docket
ID
number
OPP
 
2003
 
0127,
in
the
subject
line
on
the
first
page
of
your
submission.
All
requests
must
be
in
writing,
and
must
be
mailed
or
delivered
to
the
Hearing
Clerk
on
or
before
October
7,
2003.
1.
Filing
the
request.
Your
objection
must
specify
the
specific
provisions
in
the
regulation
that
you
object
to,
and
the
grounds
for
the
objections
(
40
CFR
178.25).
If
a
hearing
is
requested,
the
objections
must
include
a
statement
of
the
factual
issues(
s)
on
which
a
hearing
is
requested,
the
requestor's
contentions
on
such
issues,
and
a
summary
of
any
evidence
relied
upon
by
the
objector
(
40
CFR
178.27).
Information
submitted
in
connection
with
an
objection
or
hearing
request
may
be
claimed
confidential
by
marking
any
part
or
all
of
that
information
as
CBI.
Information
so
marked
will
not
be
disclosed
except
in
accordance
with
procedures
set
forth
in
40
CFR
part
2.
A
copy
of
the
information
that
does
not
contain
CBI
must
be
submitted
for
inclusion
in
the
public
record.
Information
not
marked
confidential
may
be
disclosed
publicly
by
EPA
without
prior
notice.
Mail
your
written
request
to:
Office
of
the
Hearing
Clerk
(
1900C),
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001.
You
may
also
deliver
your
request
to
the
Office
of
the
Hearing
Clerk
in
Rm.
104,
Crystal
Mall
#
2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA.
The
Office
of
the
Hearing
Clerk
is
open
from
8
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
telephone
number
for
the
Office
of
the
Hearing
Clerk
is
(
703)
603
 
0061.
2.
Tolerance
fee
payment.
If
you
file
an
objection
or
request
a
hearing,
you
must
also
pay
the
fee
prescribed
by
40
CFR
180.33(
i)
or
request
a
waiver
of
that
fee
pursuant
to
40
CFR
180.33(
m).
You
must
mail
the
fee
to:
EPA
Headquarters
Accounting
Operations
Branch,
Office
of
Pesticide
Programs,
P.
O.
Box
360277M,
Pittsburgh,
PA
15251.
Please
identify
the
fee
submission
by
labeling
it
``
Tolerance
Petition
Fees.''
EPA
is
authorized
to
waive
any
fee
requirement
``
when
in
the
judgement
of
the
Administrator
such
a
waiver
or
refund
is
equitable
and
not
contrary
to
the
purpose
of
this
subsection.''
For
additional
information
regarding
the
waiver
of
these
fees,
you
may
contact
James
Tompkins
by
phone
at
(
703)
305
 
5697,
by
e­
mail
at
tompkins.
jim@
epa.
gov,
or
by
mailing
a
request
for
information
to
Mr.
Tompkins
at
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001.
If
you
would
like
to
request
a
waiver
of
the
tolerance
objection
fees,
you
must
mail
your
request
for
such
a
waiver
to:
James
Hollins,
Information
Resources
and
Services
Division
(
7502C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001.
3.
Copies
for
the
Docket.
In
addition
to
filing
an
objection
or
hearing
request
with
the
Hearing
Clerk
as
described
in
Unit
VI.
A.,
you
should
also
send
a
copy
of
your
request
to
the
PIRIB
for
its
inclusion
in
the
official
record
that
is
described
in
Unit
I.
B.
1.
Mail
your
copies,
identified
by
docket
ID
number
OPP
 
2003
 
0127,
to:
Public
Information
and
Records
Integrity
Branch,
Information
Resources
and
Services
Division
(
7502C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001.
In
person
or
by
courier,
bring
a
copy
to
the
location
of
the
PIRIB
described
in
Unit
I.
B.
1.
You
may
also
send
an
electronic
copy
of
your
request
via
e­
mail
to:
oppdocket
epa.
gov.
Please
use
an
ASCII
file
format
and
avoid
the
use
of
special
characters
and
any
form
of
encryption.
Copies
of
electronic
objections
and
hearing
requests
will
also
be
accepted
on
disks
in
WordPerfect
6.1/
8.0
or
ASCII
file
format.
Do
not
include
any
CBI
in
your
electronic
copy.
You
may
also
submit
an
electronic
copy
of
your
request
at
many
Federal
Depository
Libraries.

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Rules
and
Regulations
B.
When
Will
the
Agency
Grant
a
Request
for
a
Hearing?

A
request
for
a
hearing
will
be
granted
if
the
Administrator
determines
that
the
material
submitted
shows
the
following:
There
is
a
genuine
and
substantial
issue
of
fact;
there
is
a
reasonable
possibility
that
available
evidence
identified
by
the
requestor
would,
if
established
resolve
one
or
more
of
such
issues
in
favor
of
the
requestor,
taking
into
account
uncontested
claims
or
facts
to
the
contrary;
and
resolution
of
the
factual
issues(
s)
in
the
manner
sought
by
the
requestor
would
be
adequate
to
justify
the
action
requested
(
40
CFR
178.32).

VIII.
References
1.
EPA
Memorandum.
Roger
Gardner
to
Manying
Xue.
``
Addendum
to
a
previous
review
of
a
petition
for
an
exemption
from
the
requirement
of
a
tolerance
(
PP#
1F06338)
for
2,6­
DIPN
(
PC
055803)
in/
on
stored
potatoes
(
EPA
File
Symbol
No.
34704
 
IUE;
DP
Barcodes
D276743
and
D276753;
Submission
Nos.
S601233
and
S601234).''
March
7,
2003.
2.
EPA
Memorandum.
Roger
Gardner
to
Driss
Benmhend.
``
Petition
for
an
exemption
from
the
requirement
of
a
tolerance
(
PP#
1F06338)
for
2,6­
DIPN
(
PC
055803)
in/
on
stored
potatoes
(
EPA
File
Symbol
No.
34704
 
IUE;
DP
Barcodes
D276743
and
D276753;
Submission
Nos.
S601233
and
S601234).''
December
10,
2002.
3.
EPA
Memorandum.
Russell
S.
Jones
to
Driss
Benmhend.
``
Renewal
Request
for
an
Experimental
Use
Permit
for
Amplify
 
Sprout
Inhibitor
(
EPA
Symbol
No.
034704
 
EUP
 
13),
containing
99.7%
2,6­
Diisopropylnapthlalene
[
2,6­
DIPN;
(
Chemical
No.
055803)]
as
its
Active
Ingredient;
and
a
Petition
to
Extend
the
Temporary
Exemption
from
the
Requirement
of
a
Tolerance
on
Stored
Potatoes
(
PP#
8G05008).
Review
of
Toxicity,
Metabolism,
and
Residue
Chemistry
Studies.
DP
Barcodes
D267369
and
D267587;
Case
Nos.
062532
and
290334;
Submission
Nos.
S581969
and
S582755;
MRIDs
451632
 
01
and
 
02.''
August
3,
2000.
4.
EPA
Memorandum.
Russell
S.
Jones
to
Driss
Benmhend.
``
Amplify
 
Sprout
Inhibitor
(
EPA
Symbol
No.
034704
 
EUP
 
13),
containing
99.7%
2,6­
Diisopropyl­
napthlalene
[
2,6­
DIPN;
(
Chemical
No.
055803)]
A
New
Active
Ingredient;
and
a
Petition
For
Exemption
from
the
Requirement
of
Tolerances
for
2,6­
DIPN
on
Food
Commodities
(
PP#
1F06338).
Response
to
Comments
Received
Following
Publication
of
an
FR
Notice
Regarding
a
Request
for
a
Tolerance
Exemption
for
2,6­
DIPN.
DP
Barcode
D278840;
Case
No.
070700;
Submission
No.
S601234;
No
MRID
Nos.''
August
7,
2000.
5.
Lake
Michigan
Lakewide
Management
Plan
(
LaMP
Study).
United
States
Environmental
Protection
Agency,
Office
of
Water,
Chapter
5
pp
5­
125.
April
2000.

IX.
Statutory
and
Executive
Order
Reviews
This
final
rule
establishes
a
temporary
tolerance
under
section
408(
d)
of
the
FFDCA
in
response
to
a
petition
submitted
to
the
Agency.
The
Office
of
Management
and
Budget
(
OMB)
has
exempted
these
types
of
actions
from
review
under
Executive
Order
12866,
entitled
Regulatory
Planning
and
Review
(
58
FR
51735,
October
4,
1993).
Because
this
rule
has
been
exempted
from
review
under
Executive
Order
12866
due
to
its
lack
of
significance,
this
rule
is
not
subject
to
Executive
Order
13211,
Actions
Concerning
Regulations
That
Significantly
Affect
Energy
Supply,
Distribution,
or
Use
(
66
FR
28355,
May
22,
2001).
This
final
rule
does
not
contain
any
information
collections
subject
to
OMB
approval
under
the
Paperwork
Reduction
Act
(
PRA),
44
U.
S.
C.
3501
et
seq.,
or
impose
any
enforceable
duty
or
contain
any
unfunded
mandate
as
described
under
Title
II
of
the
Unfunded
Mandates
Reform
Act
of
1995
(
UMRA)
(
Public
Law
104
 
4).
Nor
does
it
require
any
special
considerations
under
Executive
Order
12898,
entitled
Federal
Actions
to
Address
Environmental
Justice
in
Minority
Populations
and
Low­
Income
Populations
(
59
FR
7629,
February
16,
1994);
or
OMB
review
or
any
Agency
action
under
Executive
Order
13045,
entitled
Protection
of
Children
from
Environmental
Health
Risks
and
Safety
Risks
(
62
FR
19885,
April
23,
1997).
This
action
does
not
involve
any
technical
standards
that
would
require
Agency
consideration
of
voluntary
consensus
standards
pursuant
to
section
12(
d)
of
the
National
Technology
Transfer
and
Advancement
Act
of
1995
(
NTTAA),
Public
Law
104
 
113,
section
12(
d)
(
15
U.
S.
C.
272
note).
Since
tolerances
and
exemptions
that
are
established
on
the
basis
of
a
petition
under
section
408(
d)
of
the
FFDCA,
such
as
the
temporary
tolerance
in
this
final
rule,
do
not
require
the
issuance
of
a
proposed
rule,
the
requirements
of
the
Regulatory
Flexibility
Act
(
RFA)
(
5
U.
S.
C.
601
et
seq.)
do
not
apply.
In
addition,
the
Agency
has
determined
that
this
action
will
not
have
a
substantial
direct
effect
on
States,
on
the
relationship
between
the
national
government
and
the
States,
or
on
the
distribution
of
power
and
responsibilities
among
the
various
levels
of
government,
as
specified
in
Executive
Order
13132,
entitled
Federalism
(
64
FR
43255,
August
10,
1999).
Executive
Order
13132
requires
EPA
to
develop
an
accountable
process
to
ensure
``
meaningful
and
timely
input
by
State
and
local
officials
in
the
development
of
regulatory
policies
that
have
federalism
implications.''
``
Policies
that
have
federalism
implications''
is
defined
in
the
Executive
Order
to
include
regulations
that
have
``
substantial
direct
effects
on
the
States,
on
the
relationship
between
the
national
government
and
the
States,
or
on
the
distribution
of
power
and
responsibilities
among
the
various
levels
of
government.''
This
final
rule
directly
regulates
growers,
food
processors,
food
handlers
and
food
retailers,
not
States.
This
action
does
not
alter
the
relationships
or
distribution
of
power
and
responsibilities
established
by
Congress
in
the
preemption
provisions
of
section
408(
n)(
4)
of
the
FFDCA.
For
these
same
reasons,
the
Agency
has
determined
that
this
rule
does
not
have
any
``
tribal
implications''
as
described
in
Executive
Order
13175,
entitled
Consultation
and
Coordination
with
Indian
Tribal
Governments
(
65
FR
67249,
November
6,
2000).
Executive
Order
13175,
requires
EPA
to
develop
an
accountable
process
to
ensure
``
meaningful
and
timely
input
by
tribal
officials
in
the
development
of
regulatory
policies
that
have
tribal
implications.''
``
Policies
that
have
tribal
implications''
is
defined
in
the
Executive
Order
to
include
regulations
that
have
``
substantial
direct
effects
on
one
or
more
Indian
tribes,
on
the
relationship
between
the
Federal
Government
and
the
Indian
tribes,
or
on
the
distribution
of
power
and
responsibilities
between
the
Federal
Government
and
Indian
tribes.''
This
rule
will
not
have
substantial
direct
effects
on
tribal
governments,
on
the
relationship
between
the
Federal
Government
and
Indian
tribes,
or
on
the
distribution
of
power
and
responsibilities
between
the
Federal
Government
and
Indian
tribes,
as
specified
in
Executive
Order
13175.
Thus,
Executive
Order
13175
does
not
apply
to
this
rule.

X.
Congressional
Review
Act
The
Congressional
Review
Act,
5
U.
S.
C.
801
et
seq.,
as
added
by
the
Small
Business
Regulatory
Enforcement
Fairness
Act
of
1996,
generally
provides
that
before
a
rule
may
take
effect,
the
agency
promulgating
the
rule
must
submit
a
rule
report,
which
includes
a
copy
of
the
rule,
to
each
House
of
the
Congress
and
to
the
Comptroller
General
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153
/
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August
8,
2003
/
Rules
and
Regulations
of
the
United
States.
EPA
will
submit
a
report
containing
this
rule
and
other
required
information
to
the
U.
S.
Senate,
the
U.
S.
House
of
Representatives,
and
the
Comptroller
General
of
the
United
States
prior
to
publication
of
this
final
rule
in
the
Federal
Register.
This
final
rule
is
not
a
``
major
rule''
as
defined
by
5
U.
S.
C.
804(
2).

List
of
Subjects
in
40
CFR
Part
180
Environmental
protection,
Administrative
practice
and
procedure,
Agricultural
commodities,
Pesticides
and
pests,
Reporting
and
recordkeeping
requirements.

Dated:
July
31,2003.

James
Jones,

Director,
Office
of
Pesticide
Programs.


Therefore,
40
CFR
chapter
I
is
amended
as
follows:

PART
180
 
[
AMENDED]


1.
The
authority
citation
for
part
180
continues
to
read
as
follows:

Authority:
21
U.
S.
C.
321(
q),
346(
a)
and
371.


2.
Section
180.590
is
added
to
subpart
C
to
read
as
follows:

§
180.590
2,6­
Diisopropylnaphthalene
(
2,6­
DIPN);
tolerances
for
residues.

(
a)
General.
Tolerances
are
established
for
residues
of
2,6­
Diisopropylnaphthalene
(
2,6­
DIPN)
in
or
on
the
following
commodities:

Commodity
Parts
per
million
Expiration/
revocation
date
Meat
1.35
5/
31/
06
Meat
byproducts
1.35
5/
31/
06
Milk
0.7
5/
31/
06
Potatoes
(
peel)
3
5/
31/
06
Potatoes
(
whole)
0.5
5/
31/
06
(
b)
Section
18
emergency
exemptions.
[
Reserved]
(
c)
Tolerances
with
regional
registrations.
[
Reserved]
(
d)
Indirect
or
inadvertent
residues.
[
Reserved]

§
180.1208
[
Removed]


3.
Section
180.1208
is
removed.
[
FR
Doc.
03
 
20307
Filed
8
 
7
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
FEDERAL
COMMUNICATIONS
COMMISSION
47
CFR
Part
54
[
CC
Docket
No.
96
 
45;
FCC
03
 
188]

Federal­
State
Joint
Board
on
Universal
Service:
Children's
Internet
Protection
Act
AGENCY:
Federal
Communications
Commission.
ACTION:
Final
rule.

SUMMARY:
In
this
document,
the
Commission
adopts
measures
to
ensure
that
its
implementation
of
the
Children's
Internet
Protection
Act
(
CIPA)
complies
with
the
recent
decision
of
the
United
States
Supreme
Court.
CIPA
requires
schools
and
libraries
with
``
computer
Internet
access''
to
certify
that
they
have
Internet
safety
policies
and
technology
protection
measures,
e.
g.,
software
filtering
technology,
to
receive
discounts
for
Internet
access
and
internal
connections
under
the
schools
and
libraries
universal
service
support
mechanism
(
e­
rate).
DATES:
The
rule
and
the
revised
FCC
Forms
479
and
486
in
this
document
contain
collection
requirements
that
have
not
been
approved
by
OMB.
Upon
OMB
approval,
the
Commission
will
publish
a
document
in
the
Federal
Register
announcing
the
effective
date
of
the
rule
and
the
revised
FCC
Forms
479
and
486.

FOR
FURTHER
INFORMATION
CONTACT:
Jennifer
Schneider,
Attorney,
Wireline
Competition
Bureau,
Telecommunications
Access
Policy
Division,
(
202)
418
 
7400.

SUPPLEMENTARY
INFORMATION:
This
is
a
summary
of
the
Commission's
Order
in
CC
Docket
No.
96
 
45
released
on
July
24,
2003.
The
full
text
of
this
document
is
available
for
public
inspection
during
regular
business
hours
in
the
FCC
Reference
Center,
Room
CY
 
A257,
445
Twelfth
Street,
SW.,
Washington,
DC
20554.

I.
Introduction
1.
In
this
Order,
we
adopt
measures
to
ensure
that
our
implementation
of
the
Children's
Internet
Protection
Act
(
CIPA)
complies
with
the
recent
decision
of
the
United
States
Supreme
Court.
CIPA
requires
schools
and
libraries
with
``
computer
Internet
access''
to
certify
that
they
have
Internet
safety
policies
and
technology
protection
measures,
e.
g.,
software
filtering
technology,
to
receive
discounts
for
Internet
access
and
internal
connections
under
the
schools'
and
libraries'
universal
service
support
mechanism
(
e­
rate).
2.
Libraries
subject
to
CIPA's
filtering
requirements
that
are
not
currently
in
compliance
with
the
CIPA
filtering
requirements
must
undertake
efforts
in
Funding
Year
2003
to
comply
by
Funding
Year
2004
in
order
to
receive
e­
rate
funds.
Libraries
must
be
in
compliance
with
the
CIPA
requirements
by
Funding
Year
2004,
except
to
the
extent
such
libraries
are
eligible
for
and
receive
a
waiver
of
the
CIPA
requirements
pursuant
to
section
254(
h)(
6)(
E)(
ii)(
III).
We
direct
the
Administrator
in
consultation
with
the
Wireline
Competition
Bureau
(
Bureau)
to
implement
the
necessary
procedural
changes,
including
changes
to
the
current
CIPA­
related
certifications
required
of
applicants.
We
take
these
steps
to
respond
promptly
to
the
Supreme
Court's
decision
and
to
ensure
that
the
schools'
and
libraries'
universal
service
support
mechanism
continues
to
operate
in
accordance
with
federal
law.

II.
Discussion
3.
Consistent
with
the
Supreme
Court
decision,
as
of
the
effective
date
of
this
Order,
we
lift
the
suspension
of
enforcement
of
those
§
of
54.520
of
our
rules
which
implemented
the
section
254(
h)(
6)
requirement
that
libraries
have
Internet
filtering
technology
to
receive
discounts
for
Internet
access
and
internal
connections
under
e­
rate.
Specifically,
we
lift
the
suspension
of
enforcement
of
§
§
54.520(
c)(
2)(
i)
and
(
iii),
54.520(
c)(
3),
54.520(
d),
and
54.520(
g)(
1)
of
our
rules
as
applied
to
libraries.
In
addition,
we
modify
§
54.520(
f)
and
(
g)
to
conform
with
the
revised
timeline
for
the
implementation
of
section
254(
h)(
6)
of
the
Act.
4.
Consistent
with
the
implementation
framework
established
by
Congress,
libraries
receiving
e­
rate
discounts
for
Internet
access
or
internal
connections
shall
have
one
year
from
July
1,
2003,
which
is
the
start
of
Funding
Year
2003,
to
come
into
compliance
with
the
filtering
requirements
of
CIPA.
When
Congress
enacted
CIPA
in
2001,
it
recognized
that
it
may
take
libraries
a
significant
amount
of
time
to
procure
and
install
the
Internet
filtering
technology
required
to
comply
with
CIPA.
Accordingly,
CIPA
allows
libraries
either
to
certify
(
1)
that
they
are
in
compliance
with
CIPA
or
(
2)
that
they
are
``
undertaking
such
actions,
including
any
necessary
procurement
procedures,
to
put
in
place''
the
required
policy
measures
to
comply
with
CIPA
for
the
next
funding
year.
Given
that
the
Supreme
Court
decision
was
issued
on
June
23,
2003
and
will
be
effective
no
sooner
than
July
18,
2003,

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