Document ID: EPA-HQ-OPP-2002-0347-0001
Agency: epa
Document Type: Rule
Title: Pyrithiobac Sodium (sodium 2-chloro-6-(4,6-dimethoxyprimidin-2-yl) thio benzoate); Pesticide
Tolerance
Posted Date: 2002-12-04T05:00Z

72104
Federal
Register
/
Vol.
67,
No.
233
/
Wednesday,
December
4,
2002
/
Rules
and
Regulations
physically
appear
as
illustrated
in
§
1200.2,
with
no
alterations.
(
e)
Only
use
the
official
seal
for
the
time
period
designated
in
the
approval
letter
(
example:
for
the
duration
of
a
conference
or
exhibit).

Subpart
D
 
Penalties
for
Misuse
of
NARA
Seals
§
1200.16
Will
I
be
penalized
for
misusing
the
official
seals?

(
a)
If
you
falsely
make,
forge,
counterfeit,
mutilate,
or
alter
official
seals,
replicas,
reproductions
or
embossing
seals,
or
knowingly
use
or
possess
with
fraudulent
intent
any
altered
seal,
you
are
subject
to
penalties
under
18
U.
S.
C.
506.
(
b)
If
you
use
the
official
seals,
replicas,
reproductions,
or
embossing
seals
in
a
manner
inconsistent
with
the
provisions
of
this
part,
you
are
subject
to
penalties
under
18
U.
S.
C.
1017
and
to
other
provisions
of
law
as
applicable.

Dated:
November
26,
2002.
John
W.
Carlin,
Archivist
of
the
United
States.
[
FR
Doc.
02
 
30766
Filed
12
 
3
 
02;
8:
45
am]

BILLING
CODE
7515
 
01
 
P
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP
 
2002
 
0005;
FRL
 
7279
 
5]

Pyrithiobac
Sodium
(
sodium
2­
chloro­
6­[(
4,6­
dimethoxypyrimidin­
2­
yl)
thio]
benzoate);
Pesticide
Tolerance
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Final
rule.

SUMMARY:
This
regulation
establishes
a
tolerance
for
residues
of
pyrithiobac
sodium
(
sodium
2­
chloro­
6­[(
4,6­
dimethoxypyrimidin­
2­
yl)
thio]
benzoate)
in
or
on
cotton,
undelinted
seed
and
cotton
gin
byproducts.
DuPont
Agricultural
Products,
Wilmington,
DE
requested
this
tolerance
under
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
as
amended
by
the
Food
Quality
Protection
Act
(
FQPA)
of
1996.
DATES:
This
regulation
is
effective
December
4,
2002.
Objections
and
requests
for
hearings,
identified
by
docket
ID
number
OPP
 
2002
 
0005,
must
be
received
on
or
before
February
3,
2003.
ADDRESSES:
Written
objections
and
hearing
requests
may
be
submitted
by
mail,
in
person,
or
by
courier.
Please
follow
the
detailed
instructions
for
each
method
as
provided
in
Unit
VI.
of
the
SUPPLEMENTARY
INFORMATION.
To
ensure
proper
receipt
by
EPA,
your
objections
and
hearing
requests
must
identify
docket
ID
number
OPP
 
2002
 
0005
in
the
subject
line
on
the
first
page
of
your
response.
FOR
FURTHER
INFORMATION
CONTACT:
By
mail:
James
A.
Tompkins,
Product
Manager
(
PM)
25,
Registration
Division
7505C,
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460;
telephone
number:
(
703)
305
 
5697;
e­
mail
address:
tompkins.
jim@
epa.
gov.

SUPPLEMENTARY
INFORMATION:

I.
General
Information
A.
Does
this
Action
Apply
to
Me?
You
may
be
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:

Categories
NAICS
codes
Examples
of
potentially
affected
entities
Industry
111
Crop
production
112
Animal
production
311
Food
manufacturing
32532
Pesticide
manufacturing
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
the
table
could
also
be
affected.
The
North
American
Industrial
Classification
System
(
NAICS)
codes
have
been
provided
to
assist
you
and
others
in
determining
whether
or
not
this
action
might
apply
to
certain
entities.
If
you
have
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
Additional
Information,
Including
Copies
of
this
Document
and
Other
Related
Documents?
1.
Docket.
EPA
has
established
an
official
public
docket
for
this
action
under
docket
identification
(
ID)
number
OPP
 
2002
 
0005.
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/
4
0cfr180_
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
In
the
Federal
Register
of
September
24,
1997
(
62
FR
49979)
(
FRL
 
5745
 
8),
EPA
issued
a
notice
pursuant
to
section
408
of
the
FFDCA,
21
U.
S.
C.
346a,
as
amended
by
the
FQPA
of
1996
(
Public
Law
104
 
170),
announcing
the
filing
of
a
pesticide
petition
PP
4F4391
by
DuPont
Agricultural
Products,
Wilmington,
DE.
This
notice
included
a
summary
of
the
petition
prepared
by
DuPont
Agricultural
Products,
the
registrant.
There
were
no
comments
received
in
response
to
the
notice
of
filing.
The
petition
requested
that
40
CFR
180.487
be
amended
by
establishing
a
tolerance
for
residues
of
the
herbicide
pyrithiobac
sodium,
(
sodium
2­
chloro­
6­
[(
4,6­
dimethoxypyrimidin­
2­
yl)
thio]
benzoate),
in
or
on
cotton,
undelinted
seed
at
0.02
parts
per
million
(
ppm)
and
cotton
gin
byproducts
at
0.1
ppm.
The
Registrant
subsequently
amended
the
petition
by
VerDate
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14:
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72105
Federal
Register
/
Vol.
67,
No.
233
/
Wednesday,
December
4,
2002
/
Rules
and
Regulations
increasing
the
tolerance
request
for
cotton
gin
byproducts
to
0.15
ppm.
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.
.
.
.''
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
and
a
complete
description
of
the
risk
assessment
process,
see
the
final
rule
on
Bifenthrin
Pesticide
Tolerances
November
26,
1997,
(
62
FR
62961)
(
FRL
 
5754
 
7).

III.
Aggregate
Risk
Assessment
and
Determination
of
Safety
Consistent
with
section
408(
b)(
2)(
D),
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),
for
a
tolerance
for
residues
of
pyrithiobac
sodium
on
cotton,
undelinted
seed
at
0.02
ppm
and
cotton
gin
byproducts
at
0.15
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
nature
of
the
toxic
effects
caused
by
pyrithiobac
sodium
are
discussed
below.
This
discussion
refers
to
the
no
observed
effect
level
(
NOEL)
and
the
lowest
observed
effect
level
(
LOEL)
from
the
toxicity
studies
reviewed
rather
than
the
no
observed
adverse
effect
level
(
NOAEL)
and
the
lowest
observed
adverse
effect
level
(
LOAEL)
because
the
toxicity
studies
for
pyrithiobac
sodium
were
reviewed
prior
to
adoption
in
1998
of
the
NOAEL/
LOAEL
terminology
by
EPA's
Office
of
Pesticide
Programs
(
OPP)
and
its
Health
Effects
Division
(
HED).
At
the
time
of
the
switch
to
the
revised
terminology,
HED
noted
that
the
new
terminology
was
unlikely
to
have
any
substantive
effect
on
its
hazard
evaluations:
``
In
a
practical
sense,
the
terms
NOEL
and
NOAEL
have
been
used
interchangeably
in
OPP.
As
a
general
rule,
OPP
would
consider
as
appropriate
for
hazard
identification
and
risk
assessment
only
those
effects
which
are
adverse
or
potentially
adverse.
This
inclusion
of
the
term
NOAEL
should
not
change
any
of
our
hazard
endpoints
for
regulation
but
add
to
the
quality
of
the
risk
assessment.''
HED
Standard
Operating
Procedure
(
SOP)
98.3
1.
A
rat
acute
oral
study
with
a
LD50
of
3,300
milligrams/
kilogram
(
mg/
kg)
for
males
and
a
LD50
of
3,200
mg/
kg
for
females.
2.
A
90
 
day
rat
feeding
study
with
a
NOAEL
of
50
parts
per
million
(
ppm)
(
3.25
mg/
kg/
day
for
males
and
4.14
mg/
kg/
day
for
females)
and
a
LOAEL
of
500
ppm
(
31.8
mg/
kg/
day
for
males
and
40.5
mg/
kg/
day
for
females
based
on
decrease
body
weight
gains
and
increased
rate
of
hepatic
beta­
oxidation
in
males.
3.
A
90
 
day
mouse
feeding
study
with
a
NOAEL
of
500
ppm
(
83.1
mg/
kg/
day
for
males
and
112
mg/
kg/
day
for
females)
and
a
LOAEL
of
1,500
ppm
(
263
mg/
kg/
day
for
males
and
384
mg/
kg/
day
for
females)
based
on
increased
liver
weight
and
an
increased
incidence
of
hepatocellular
hypertrophy
in
males
and
decreased
neutrophil
count
in
females.
4.
A
3
 
month
dog
feeding
study
with
a
NOAEL
of
5,000
ppm
(
165
mg/
kg/
day)
and
a
LOAEL
of
20,000
ppm
(
626
mg/
kg/
day),
based
on
decrease
red
blood
cell
count,
hemoglobin,
and
hematocrit
in
females
and
increased
liver
weight
in
both
sexes.
5.
A
21
 
day
rat
dermal
study
with
a
Dermal
Irritation
NOAEL
of
50
mg/
kg/
day
and,
a
Dermal
Irritation
LOAEL
of
500
mg/
kg/
day
based
on
increased
incidence
of
erythema
and
edema,
and
with
a
Systemic
Dermal
NOAEL
of
500
mg/
kg/
day
and
a
Systemic
Dermal
LOAEL
of
1,200
mg/
kg/
day
based
on
body
weight
gain
inhibition.
6.
A
90
 
day
rat
neurotoxicity
screening
battery
with
a
Systemic
NOAEL
of
7,000
ppm
(
466
mg/
kg/
day
for
males
and
588
mg/
kg/
day
for
females)
and
a
Systemic
LOAEL
of
20,000
ppm
(
1,376
mg/
kg/
day
for
males
and
1,609
mg/
kg/
day
for
females),
based
on
deceased
hind
grip
strength
and
increased
foot
spay
in
males,
and
a
Neurotoxicity
NOAEL
of
20,000
ppm
highest
dose
tested
(
HDT).
7.
A
78
 
week
dietary
carcinogenicity
study
in
mice
with
a
NOAEL
of
1,500
ppm
217
mg/
kg/
day
(
males)
and
319
mg/
kg/
day
(
females)
and
a
LOAEL
of
5,000
ppm
745
mg/
kg/
day
(
males)
and
1,101
mg/
kg/
day
(
females)
based
on
decreased
body
weight
gain
in
both
sexes,
treatment
related
increase
in
the
incidence
of
foci/
focus
of
hepatocellular
alternation
in
males,
and
increased
incidence
of
glomerulonephropathy
(
murine)
in
both
sexes,
and
an
increased
incidence
of
infarct
in
the
kidney
and
keratopathy
of
the
eyes.
There
was
evidence
of
carcinogenicity
based
on
significant
differences
in
the
pair­
wise
comparisons
of
hepatocellular
adenomas
and
combined
adenoma/
carcinoma
in
the
150
ppm
and
1,500
ppm
dose
groups
(
but
not
at
the
high
dose
of
5,000
ppm)
with
the
controls.
The
carcinogenic
effects
observed
are
discussed
below.
8.
A
23
 
month
rat
chronic
toxicity/
carcinogenicity
study
with
a
Systemic
NOAEL
of
1,500
ppm
(
58.7
mg/
kg/
day)
for
males
and
5,000
ppm
(
278
mg/
kg/
day)
for
females,
and
with
a
Systemic
LOAEL
of
5,000
ppm
(
200
mg/
kg/
day)
for
males
and
15,000
ppm
(
918
mg/
kg/
day)
for
females,
based
on
deceased
body
weight,
body
weight
gain
and
food
efficiency
for
females,
the
increased
incidence
of
eye
lesions
in
both
sexes,
mild
changes
in
hematology
and
urinalysis
in
both
sexes,
clinical
signs
suggestive
of
urinary
tract
dysfunction
in
males
and
females,
increased
incidence
of
focal
cystic
degeneration
in
the
liver
in
males,
increased
rate
of
hepatic
peroxisomal
beta­
oxidation
in
males
and
an
increased
incidence
of
inflammatory
and
degenerative
lesions
in
the
kidney
in
females.
There
was
evidence
of
carcinogenicity
based
on
significant
dose­
related
increasing
trend
in
kidney
tubular
combined
adenoma/
carcinoma
in
male
rats
and
a
significant
dose
related
increasing
trend
in
kidney
tubular
bilateral
and/
or
unilateral
adenomas
in
females.
The
carcinogenic
effects
observed
are
discussed
further
below.
9.
A
1
 
year
dog
chronic
toxicity
study
with
a
NOAEL
of
5,000
ppm
(
143
mg/
kg/
day
for
males
and
166
mg/
kg/
day
for
females)
and
a
LOAEL
of
20,000
ppm
(
580
mg/
kg/
day
for
males
and
647
mg/
kg/
day
for
females)
based
on
decreases
in
body
weight
gain,
increase
thyroid
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Regulations
and
liver
weights,
and
microscopic
findings
in
the
liver
and
kidneys.
10.
A
2­
generation
reproduction
study
in
rats
with
a
NOAEL
for
maternal
toxicity
of
1,500
ppm
(
103
mg/
kg/
day)
and
a
maternal
LOAEL
of
7,500
ppm
(
508
mg/
kg/
day),
based
on
decreased
body
weight,
body
weight
gain
and
food
efficiency.
The
NOAEL
for
paternal
toxicity
is
1,500
ppm
(
86
mg/
kg/
day),
while
the
LOAEL
is
7,500
ppm
(
439
mg/
kg/
day),
based
on
decreased
body
weight,
body
weight
gain
and
food
efficiency.
The
NOAEL
for
reproductive
effects
can
be
set
at
7,500
ppm
(
508
mg/
kg/
day),
the
LOAEL
at
20,000
ppm
(
1,551
mg/
kg/
day),
based
on
decreased
pup
body
weight.
The
NOAEL
for
effects
on
offspring
is
7,500
ppm
(
508
mg/
kg/
day),
and
the
LOAEL
at
20,000
ppm
(
1,551
mg/
kg/
day),
based
on
decreased
pup
body
weight.
11.
A
13
 
day
dosing
(
gestation
days
7
 
19)
developmental
toxicity
study
in
rabbits
with
a
maternal
NOAEL
of
300
mg/
kg
and
a
maternal
LOAEL
of
1,000
mg/
kg
based
on
deaths,
decreased
body
weight
gain
and
feed
consumption,
and
an
increase
in
early
resorptions.
There
is
developmental
toxicity
observed
at
1,000
mg/
kg
based
on
decreased
fetal
body
weights.
12.
A
10
 
day
dosing
(
gestation
days
7
 
16)
developmental
toxicity
study
in
rats
wth
a
maternal
NOAEL
of
200
mg/
kg
and
maternal
LOAEL
of
600
mg/
kg
due
to
increased
incidence
of
peritoneal
staining.
The
developmental
NOAEL
is
600
mg/
kg
and
the
developmental
LOAEL
is
1,800
mg/
kg
based
on
the
increased
incidence
of
skeletal
variations.
13.
No
evidence
of
gene
mutation
was
observed
in
a
test
for
induction
of
forward
mutations
at
the
hypoxanthine
guanine
phophoribosyl
transferase
(
HGPRT)
locus
in
Chinese
hamster
ovary
cells.
No
evidence
was
observed
for
inducing
reverse
gene
mutation
in
two
independent
assays
with
Salmonella
typhimurium
with
and
without
mammalian
metabolic
activation.
Pyrithiobac
sodium
was
negative
for
the
induction
of
micronuclei
in
the
bone
marrow
cells
of
mice,
and
negative
for
induction
of
unscheduled
DNA
synthesis
in
rat
primary
hepatocytes.
Pyrithiobac
sodium
was
positive
for
inducing
chromosome
aberrations
assay
in
human
lymphocytes.
14.
A
rat
metabolism
study
showed
that
radio
labeled
pyrithiobac
sodium
is
excreted
in
urine
and
feces
with
>
90%
being
eliminated
within
48
hours.
A
sex
difference
was
observed
in
the
excretion
and
biotransformation.
Females
excreted
a
greater
amount
of
the
radiolabel
in
the
urine
than
males
following
all
regimens,
with
a
corresponding
lower
amount
being
eliminated
in
the
feces
compared
to
the
males.

B.
Toxicological
Endpoints
The
dose
at
which
the
NOAEL
from
the
toxicology
study
identified
as
appropriate
for
use
in
risk
assessment
is
used
to
estimate
the
toxicological
level
of
concern
(
LOC).
However,
the
LOAEL
at
which
effects
of
concern
are
identified
is
sometimes
used
for
risk
assessment
if
no
NOAEL
was
achieved
in
the
toxicology
study
selected.
An
uncertainty
factor
(
UF)
is
applied
to
reflect
uncertainties
inherent
in
the
extrapolation
from
laboratory
animal
data
to
humans
and
in
the
variations
in
sensitivity
among
members
of
the
human
population
as
well
as
other
unknowns.
An
UF
of
100
is
routinely
used,
10X
to
account
for
interspecies
differences
and
10X
for
intra
species
differences.
For
dietary
risk
assessment
(
other
than
cancer)
the
Agency
uses
the
UF
to
calculate
an
acute
or
chronic
reference
dose
(
acute
RfD
or
chronic
RfD)
where
the
RfD
is
equal
to
the
NOAEL
divided
by
the
appropriate
UF
(
RfD
=
NOAEL/
UF).
Where
an
additional
safety
factor
is
retained
due
to
concerns
unique
to
the
FQPA,
this
additional
factor
is
applied
to
the
RfD
by
dividing
the
RfD
by
such
additional
factor.
The
acute
or
chronic
Population
Adjusted
Dose
(
aPAD
or
cPAD)
is
a
modification
of
the
RfD
to
accommodate
this
type
of
FQPA
Safety
Factor.
For
non­
dietary
risk
assessments
(
other
than
cancer)
the
UF
is
used
to
determine
the
LOC.
For
example,
when
100
is
the
appropriate
UF
(
10X
to
account
for
interspecies
differences
and
10X
for
intraspecies
differences)
the
LOC
is
100.
To
estimate
risk,
a
ratio
of
the
NOAEL
to
exposures
(
margin
of
exposure
(
MOE)
=
NOEL/
exposure)
is
calculated
and
compared
to
the
LOC.
The
linear
default
risk
methodology
(
Q*)
is
the
primary
method
currently
used
by
the
Agency
to
quantify
carcinogenic
risk.
The
Q*
approach
assumes
that
any
amount
of
exposure
will
lead
to
some
degree
of
cancer
risk.
A
Q*
is
calculated
and
used
to
estimate
risk
which
represents
a
probability
of
occurrence
of
additional
cancer
cases
(
e.
g.,
risk
is
expressed
as
1
x
106
or
one
in
a
million).
Under
certain
specific
circumstances,
MOE
calculations
will
be
used
for
the
carcinogenic
risk
assessment.
In
this
non­
linear
approach,
a
``
point
of
departure''
is
identified
below
which
carcinogenic
effects
are
not
expected.
The
point
of
departure
is
typically
a
NOAEL
based
on
an
endpoint
related
to
cancer
effects
though
it
may
be
a
different
value
derived
from
the
dose
response
curve.
To
estimate
risk,
a
ratio
of
the
point
of
departure
to
exposure
(
MOEcancer
=
point
of
departure/
exposures)
is
calculated.
A
summary
of
the
toxicological
endpoints
for
pyrithiobac
sodium
used
for
human
risk
assessment
is
as
follows:
1.
Acute
toxicity.
EPA
has
concluded
that
no
endpoint
exists
to
suggest
any
evidence
of
significant
toxicity
from
1
 
day
or
single­
event
exposure.
2.
Short­
term
and
intermediate­
term
toxicity.
EPA
has
concluded
that
available
evidence
does
not
indicate
any
evidence
of
significant
toxicity
from
short­
term
and
intermediate­
term
exposure.
3.
Chronic
toxicity.
EPA
has
established
the
RfD
for
pyrithiobac
sodium
at
0.587
mg/
kg/
day.
This
RfD
is
based
on
the
systemic
NOAEL
of
58.7
mg/
kg/
day
for
males
in
the
rat
chronic
feeding
study
with
a
100­
fold
safety
factor
to
account
for
interspecies
extrapolation
and
intraspecies
variability.
4.
Carcinogenicity.
EPA
has
concluded
that
the
available
data
provide
limited
evidence
of
the
carcinogenicity
of
pyrithiobac
sodium
in
mice
and
rats
and
has
classified
pyrithiobac
sodium
as
a
Group
C
(
possible
human
carcinogen
with
limited
evidence
of
carcinogenicity
in
animals)
in
accordance
with
Agency
guidelines,
published
in
the
Federal
Register
of
(
September
24,
1986,
51
FR
33992)
and
recommended
that
for
the
purpose
of
risk
characterization
a
low
dose
extrapolation
model
should
be
applied
to
the
experimental
animal
tumor
data
for
quantification
for
human
risk
(
Q1*).
This
decision
was
based
on
liver
adenomas,
carcinomas
and
combined
adenoma/
carcinomas
in
the
male
mouse
and
rare
kidney
tubular
adenomas,
carcinomas
and
combined
adenoma/
carcinomas
in
male
rats.
The
unit
risk,
Q1*
(
mg/
kg/
day)­
1,
of
pyrithiobac
sodium
is
1.05
x
10
 
3
(
mg/
kg/
day)­
1
in
human
equivalents
based
on
male
kidney
tumors.

C.
Exposure
Assessment
1.
Dietary
exposure
from
food
and
feed
uses.
Permanent
tolerances
have
been
requested
to
replace
the
time
limited
tolerance
in/
on
cottonseed
40
CFR
180.487
at
0.02
ppm,
and
a
new
tolerance
for
the
residues
of
pyrithiobac
sodium,
in
or
on
cotton
gin
byproducts
at
0.1
ppm.
The
requested
tolerance
for
cotton
gin
byproducts
has
been
amended
to
0.15
ppm
based
on
the
results
of
the
submitted
field
residue
trials,
and
cottonseed
was
changed
to
cotton,
undelinted
seed.
Processing
studies
for
cotton
have
shown
that
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Rules
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Regulations
pyrithiobac
sodium
does
not
concentrate
in
cottonseed
processed
food/
feed
commodities.
No
requested
tolerances
were
necessary
for
meat,
milk,
and
eggs
because
detectible
residues
are
not
expected
in
these
commodities
from
this
use
on
cotton.
Risk
assessments
were
conducted
by
EPA
to
assess
dietary
exposures
from
pyrithiobac
sodium
in
food
as
follows:
i.
Acute
exposure.
Acute
dietary
risk
assessments
are
performed
for
a
fooduse
pesticide
if
a
toxicological
study
has
indicated
the
possibility
of
an
effect
of
concern
occurring
as
a
result
of
a
1
 
day
or
single
exposure.
EPA
has
concluded
that
no
endpoint
exists
to
suggest
any
evidence
of
significant
toxicity
from
one­
day
or
single­
event
exposure;
therefore,
an
acute
exposure
assessment
is
not
applicable.
ii.
Chronic
exposure.
In
conducting
this
chronic
dietary
risk
assessment
the
Dietary
Exposure
Evaluation
Model
(
DEEMTM
analysis
evaluated
the
individual
food
consumption
as
reported
by
respondents
in
the
Department
of
Argiculture
(
USDA)
1989
 
1992
nationwide
Continuing
Surveys
of
Food
Intake
by
Individuals
(
CSFII)
and
accumulated
exposure
to
the
chemical
for
each
commodity.
EPA
assumed
that
all
commodities
for
which
tolerances
exist
and
all
cotton
food
commodities
had
pyrithiobac
sodium
residues
at
the
appropriate
tolerance
level.
iii.
Cancer.
The
cancer
exposure
assessment
relied
upon
the
same
data
and
assumptions
as
the
chronic
exposure
assessment.
iv.
Anticipated
residue
and
percent
crop
treated
(
PCT)
information.
Tolerance
level
residues
and
treatment
of
100%
of
the
crop
was
assumed.
Anticipated
residues
and
PCT
information
was
not
used.
2.
Dietary
exposure
from
drinking
water.
The
Agency
lacks
sufficient
monitoring
exposure
data
to
complete
a
comprehensive
dietary
exposure
analysis
and
risk
assessment
for
pyrithiobac
sodium
in
drinking
water.
Because
the
Agency
does
not
have
comprehensive
monitoring
data,
drinking
water
concentration
estimates
are
made
by
reliance
on
simulation
or
modeling
taking
into
account
data
on
the
physical
characteristics
of
pyrithiobac
sodium.
The
Agency
uses
the
GENEEC
or
the
PRZM/
EXAMS
to
estimate
pesticide
concentrations
in
surface
water
and
SCIGROW
which
predicts
pesticide
concentrations
in
ground
water.
In
general,
EPA
will
use
GENEEC
(
a
tier
1
model)
before
using
PRZM/
EXAMS
(
a
tier
2
model)
for
a
screening­
level
assessment
for
surface
water.
The
GENEEC
model
is
a
subset
of
the
PRZM/
EXAMS
model
that
uses
a
specific
highend
runoff
scenario
for
pesticides.
GENEEC
incorporates
a
farm
pond
scenario,
while
PRZM/
EXAMS
incorporate
an
index
reservoir
environment
in
place
of
the
previous
pond
scenario.
The
PRZM/
EXAMS
model
includes
a
percent
crop
(
PC)
area
factor
as
an
adjustment
to
account
for
the
maximum
PC
coverage
within
a
watershed
or
drainage
basin.
None
of
these
models
include
consideration
of
the
impact
processing
(
mixing,
dilution,
or
treatment)
of
raw
water
for
distribution
as
drinking
water
would
likely
have
on
the
removal
of
pesticides
from
the
source
water.
The
primary
use
of
these
models
by
the
Agency
at
this
stage
is
to
provide
a
coarse
screen
for
sorting
out
pesticides
for
which
it
is
highly
unlikely
that
drinking
water
concentrations
would
ever
exceed
human
health
levels
of
concern.
Since
the
models
used
are
considered
to
be
screening
tools
in
the
risk
assessment
process,
the
Agency
does
not
use
estimated
environmental
concentrations
(
EECs)
from
these
models
to
quantify
drinking
water
exposure
and
risk
as
a
%
RfD
or
%
PAD.
Instead
drinking
water
levels
of
comparison
(
DWLOCs)
are
calculated
and
used
as
a
point
of
comparison
against
the
model
estimates
of
a
pesticide's
concentration
in
water.
DWLOCs
are
theoretical
upper
limits
on
pesticide's
concentration
in
drinking
water
in
light
of
total
aggregate
exposure
to
a
pesticide
in
food,
and
from
residential
uses.
Since
DWLOCs
address
total
aggregate
exposure
to
pyrithiobac
sodium
they
are
further
discussed
in
the
aggregate
risk
sections
in
Unit
E.
Based
on
the
GENEEC
and
SCI­
GROW
models
the
EECs
of
pyrithiobac
sodium
for
chronic
exposures
are
estimated
to
be
7.76
parts
per
billion
(
ppb)
for
surface
water
and
0.778
ppb
for
ground
water.
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).
Pyrithiobac
sodium
is
not
registered
for
use
on
any
sites
that
would
result
in
residential
exposure.
4.
Cumulative
exposure
to
substances
with
a
common
mechanism
of
toxicity.
Section
408(
b)(
2)(
D)(
v)
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
pyrithiobac
sodium
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,
pyrithiobac
sodium
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
pyrithiobac
sodium
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
(
November
26,
1997,
62
FR
62961).

D.
Safety
Factor
for
Infants
and
Children
1.
In
general.
FFDCA
section
408
provides
that
EPA
shall
apply
an
additional
tenfold
margin
of
safety
for
infants
and
children
in
the
case
of
threshold
effects
to
account
for
pre­
natal
and
post­
natal
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.
Pre­
natal
and
post­
natal
sensitivity.
In
a
preliminary
review,
EPA
concluded
that
data
do
not
indicate
that
there
is
a
significant
potential
for
reproductive
or
developmental
effects
from
pyrithiobac
sodium
as
tested.
3.
Conclusion.
There
is
a
complete
toxicity
data
base
for
pyrithiobac
sodium
and
exposure
data
are
complete
or
are
estimated
based
on
data
that
reasonably
accounts
for
potential
exposures.
Pyrithiobac
sodium
has
not
been
formally
reviewed
by
the
Agency
regarding
the
need
to
retain
the
additional
10X
safety
factor
for
the
protection
of
infants
and
children.
Thus,
despite
the
completeness
of
the
database
and
the
lack
of
any
indication
of
significant
potential
for
reproductive
or
developmental
effects,
EPA
has
retained
the
additional
10X
safety
factor
until
a
full
review
can
be
completed.
Retention
of
the
additional
safety
factor
yields
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Rules
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Regulations
cPAD
for
pyrithiobac
sodium
of
0.0587
mg/
kg/
day.

E.
Aggregate
Risks
and
Determination
of
Safety
To
estimate
total
aggregate
exposure
to
a
pesticide
from
food,
drinking
water,
and
residential
uses,
the
Agency
calculates
DWLOCs
which
are
used
as
a
point
of
comparison
against
the
model
estimates
of
a
pesticide's
concentration
in
water
(
EECs).
DWLOC
values
are
not
regulatory
standards
for
drinking
water.
DWLOCs
are
theoretical
upper
limits
on
a
pesticide's
concentration
in
drinking
water
in
light
of
total
aggregate
exposure
to
a
pesticide
in
food
and
residential
uses.
In
calculating
a
DWLOC,
the
Agency
determines
how
much
of
the
acceptable
exposure
(
i.
e.,
the
PAD)
is
available
for
exposure
through
drinking
water
e.
g.,
allowable
chronic
water
exposure
(
mg/
kg/
day)
=
cPAD
­
(
average
food
+
residential
exposure).
This
allowable
exposure
through
drinking
water
is
used
to
calculate
a
DWLOC.
A
DWLOC
will
vary
depending
on
the
toxic
endpoint,
drinking
water
consumption,
and
body
weights.
Default
body
weights
and
consumption
values
as
used
by
EPA
Office
of
Water
are
used
to
calculate
DWLOCs:
2L/
70
kg
(
adult
male),
2L/
60
kg
(
adult
female),
and
1L/
10
kg
(
child).
Default
body
weights
and
drinking
water
consumption
values
vary
on
an
individual
basis.
This
variation
will
be
taken
into
account
in
more
refined
screening­
level
and
quantitative
drinking
water
exposure
assessments.
Different
populations
will
have
different
DWLOCs.
Generally,
a
DWLOC
is
calculated
for
each
type
of
risk
assessment
used:
acute,
short­
term,
intermediate­
term,
chronic,
and
cancer.
When
EECs
for
surface
water
and
ground
water
are
less
than
the
calculated
DWLOCs,
EPA
concludes
with
reasonable
certainty
that
exposures
to
the
pesticide
in
drinking
water
(
when
considered
along
with
other
sources
of
exposure
for
which
EPA
has
reliable
data)
would
not
result
in
unacceptable
levels
of
aggregate
human
health
risk
at
this
time.
Because
OPP
considers
the
aggregate
risk
resulting
from
multiple
exposure
pathways
associated
with
a
pesticide's
uses,
levels
of
comparison
in
drinking
water
may
vary
as
those
uses
change.
If
new
uses
are
added
in
the
future,
EPA
will
reassess
the
potential
impacts
of
residues
of
the
pesticide
in
drinking
water
as
a
part
of
the
aggregate
risk
assessment
process.
Pyrithiobac
sodium
is
not
registered
for
use
on
any
sites
that
would
result
in
residential
exposure.
Therefore,
the
aggregate
risk
is
the
sum
of
the
risk
from
food
and
water.
1.
Acute
risk.
EPA
has
concluded
that
no
endpoint
exists
to
suggest
any
evidence
of
significant
toxicity
from
acute
exposures
from
the
use
of
pyrithiobac
sodium
on
cotton.
2.
Chronic
risk.
Using
the
exposure
assumptions
described
in
this
unit
for
chronic
exposure,
EPA
has
concluded
that
exposure
to
pyrithiobac
sodium
from
food
and
water
will
utilize
less
than
0.2%
of
the
cPAD
for
the
U.
S.
population,
and
less
than
0.2%
of
the
cPAD
for
children
1
to
6
years
at
greatest
exposure
to
both
food
and
water.
There
are
no
residential
uses
for
pyrithiobac
sodium
that
result
in
chronic
residential
exposure
to
pyrithiobac
sodium.
EPA
generally
has
no
concern
for
exposures
below
100%
of
the
cPAD
because
the
cPAD
represents
the
level
at
or
below
which
aggregate
dietary
exposure
over
a
lifetime
will
not
pose
appreciable
risks
to
human
health.
Due
to
the
low
exposure
for
the
U.
S.
population
(
less
than
0.2%)
and
for
children
1
to
6
years
(
less
than
0.2%)
for
both
food
and
water,
the
calculated
DWLOC
is
approximately
equal
to
the
cPAD.
3.
Short­
term
risk.
EPA
has
concluded
that
no
endpoint
exists
to
suggest
any
evidence
of
significant
toxicity
from
short­
term
exposures
from
the
use
of
pyrithiobac
sodium
on
cotton.
4.
Intermediate­
term
risk.
EPA
has
concluded
that
no
endpoint
exists
to
suggest
any
evidence
of
significant
toxicity
from
intermediate­
term
exposures
from
the
use
of
pyrithiobac
sodium
on
cotton.
5.
Aggregate
cancer
risk
for
U.
S.
population.
Based
on
the
upper
bound
potency
factor
(
Q*
1)
of
1.05
x
10
 
3
(
mg/
kg/
day)­
1,
the
aggregate
upper
bound
lifetime
cancer
risk
from
the
use
of
pyrithiobac
sodium
on
cotton
from
worst
case
estimates
of
residues
in
food
and
drinking
water
is
2.3
x
10
 
7.
6.
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
pyrithiobac
sodium
residues.

IV.
Other
Considerations
A.
Analytical
Enforcement
Methodology
Adequate
enforcement
methodology
high
performance
liquid
chromotography
using
ultra­
violent
detection
(
HPLC­
UV)
with
column
switching)
is
available
to
enforce
the
tolerance
expression.
The
method
may
be
requested
from:
Paul
Golden,
U.
S.
Environmental
Protection
Agency,
Office
of
Pesticide
Programs,
BEAD,
ACB,
Environmental
Science
Center,
701
Mapes
Road
Fort
Meade,
MD
20755
 
5350;
Telephone
(
410)
305
 
2960.

B.
International
Residue
Limits
There
are
no
established
Codex
maximum
residue
levels
(
MRLs)
for
pyrithiobac
sodium
on
cottonseed.
An
established
Mexican
tolerance
for
pyrithiobac
sodium
on
cottonseed
is
identical
to
the
U.
S.
tolerance.
Compatibility
of
tolerance
levels
is
not
an
issue
at
this
time.

C.
Conditions
There
are
no
conditions.
Adequate
residue
data
has
been
submitted
to
support
the
tolerances
established
in
this
Federal
Register
Notice.

V.
Conclusion
Therefore,
the
tolerance
is
established
for
residues
of
pyrithiobac
sodium,
(
sodium
2­
chloro­
6­[(
4,6­
dimethoxypyrimidin­
2­
yl)
thio]
benzoate),
in
or
on
cotton,
undelinted
seed
at
0.02
ppm
and
cotton
gin
byproducts
at
0.15
ppm.

VI.
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
of
1996,
EPA
will
continue
to
use
those
procedures,
with
appropriate
adjustments,
until
the
necessary
modifications
can
be
made.
The
new
section
408(
g)
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),
as
was
provided
in
the
old
FFDCA
sections
408
and
409.
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
 
2002
 
0005
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
February
3,
2003.

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4,
2002
/
Rules
and
Regulations
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
(
1900),
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460.
You
may
also
deliver
your
request
to
the
Office
of
the
Hearing
Clerk
in
Rm.
C400,
Waterside
Mall,
401
M
St.,
SW.,
Washington,
DC
20460.
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
(
202)
260
 
4865.
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.
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.
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.
2.
Mail
your
copies,
identified
by
docket
ID
number
OPP
 
2002
 
0005,
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.
In
person
or
by
courier,
bring
a
copy
to
the
location
of
the
PIRIB
described
in
Unit
I.
B.
2.
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.

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).

VII.
Regulatory
Assessment
Requirements
This
final
rule
establishes
a
tolerance
under
FFDCA
section
408(
d)
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,
entitledRegulatory
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
FFDCA
section
408(
d),
such
as
the
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
FFDCA
section
408(
n)(
4).
For
these
same
reasons,
the
Agency
has
determined
that
this
rule
does
not
have
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Federal
Register
/
Vol.
67,
No.
233
/
Wednesday,
December
4,
2002
/
Rules
and
Regulations
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
andIndian
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.

VIII.
Submission
to
Congress
and
the
Comptroller
General
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
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:
November
8,
2002.
Debra
Edwards,
Acting
Director,
Registration
Division,
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
374.
2.
Section
180.487
paragraph
(
a)
is
revised
to
read
as
follows:

§
180.487
Pyrithiobac
sodium;
tolerances
for
residues.

(
a)
General.
Tolerances
are
established
for
residues
of
the
herbicide,
pyrithiobac
sodium,
(
sodium
2­
chloro­
6­
[(
4,6­
dimethoxypyrimidin­
2­
yl)
thio]
benzoate),
resulting
from
the
application
of
the
pesticide
chemical
in
or
on
the
following
foods/
feeds:

Commodity
Parts
per
million
Cotton
gin
byproducts
..........................................................................................
0.15
Cotton,
undelinted
seed
.......................................................................................
0.02
*
*
*
*
*
[
FR
Doc.
02
 
30472
Filed
12
 
3
 
02;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
DEPARTMENT
OF
COMMERCE
National
Oceanic
and
Atmospheric
Administration
50
CFR
Part
300
[
I.
D.
112702C]

Notification
of
U.
S.
Fish
Quotas
and
an
Effort
Allocation
in
the
Northwest
Atlantic
Fisheries
Organization
(
NAFO)
Regulatory
Area
AGENCY:
National
Marine
Fisheries
Service
(
NMFS),
National
Oceanic
and
Atmospheric
Administration
(
NOAA),
Commerce.
ACTION:
Notification
of
U.
S.
fish
quotas
and
an
effort
allocation.

SUMMARY:
NMFS
announces
that
fish
quotas
and
an
effort
allocation
are
available
for
harvest
by
U.
S.
fishermen
in
the
NAFO
Regulatory
Area.
This
action
is
necessary
to
make
available
to
U.
S.
fishermen
a
fishing
privilege
on
an
equitable
basis.
DATES:
All
fish
quotas
and
the
effort
allocation
are
effective
January
1,
2003,
through
December
31,
2003.
Expressions
of
interest
regarding
U.
S.
fish
quota
allocations
for
all
species
except
3L
shrimp
will
be
accepted
throughout
2003.
Expressions
of
interest
regarding
the
U.
S.
3L
shrimp
quota
allocation
and
the
3M
shrimp
effort
allocation
will
be
accepted
through
January
3,
2004.

ADDRESSES:
Expressions
of
interest
regarding
the
U.
S.
effort
allocation
and
quota
allocations
should
be
made
in
writing
to
Patrick
E.
Moran
in
the
NMFS
Office
of
Sustainable
Fisheries,
at
1315
East­
West
Highway,
Silver
Spring,
MD
20910
(
phone:
301
 
713
 
2276,
fax:
301
 
713
 
2313,
e­
mail:
pat.
moran@
noaa.
gov).
Information
relating
to
NAFO
fish
quotas,
NAFO
Conservation
and
Enforcement
Measures,
and
the
High
Seas
Fishing
Compliance
Act
(
HSFCA)
Permit
is
available
from
Jennifer
L.
Anderson
at
the
NMFS
Northeast
Regional
Office
at
One
Blackburn
Drive,
Gloucester,
Massachusetts
01930
(
phone:
978
 
281
 
9226,
fax:
978
 
281
 
9394,
e­
mail:
jennifer.
anderson@
noaa.
gov)
and
from
NAFO
on
the
World
Wide
Web
at
http:/
/
www.
nafo.
ca.

FOR
FURTHER
INFORMATION
CONTACT:
Patrick
E.
Moran,
301
 
713
 
2276.

SUPPLEMENTARY
INFORMATION:
Background
NAFO
has
established
and
maintains
conservation
measures
in
its
Regulatory
Area
that
include
one
effort
limitation
fishery
as
well
as
fisheries
with
total
allowable
catches
(
TACs)
and
member
nation
quota
allocations.
The
principal
species
managed
are
cod,
flounder,
redfish,
American
plaice,
halibut,
capelin,
shrimp,
and
squid.
At
the
2002
NAFO
Annual
Meeting,
the
United
States
received
fish
quota
allocations
for
three
NAFO
stocks
and
an
effort
allocation
for
one
NAFO
stock
to
be
fished
during
2003.
The
species,
location,
and
allocation
(
in
metric
tons
or
effort)
of
these
U.
S.
fishing
opportunities
are
as
follows:
(
1)
Redfish
NAFO
Division
3M
69
mt
(
2)
Squid
NAFO
Subareas
3
&
4
453
mt
(
3)
Shrimp
NAFO
Division
3L
67
mt
(
4)
Shrimp
NAFO
Division
3M
1
vessel/
100
days
Additionally,
U.
S.
vessels
may
fish
any
portion
of
the
7,500
mt
TAC
of
oceanic
redfish
in
NAFO
Subarea
2
and
Divisions
1F
and
3K.
This
opportunity
is
available
only
to
members
of
NAFO
that
are
not
members
of
the
North
East
Atlantic
Fisheries
Commission,
on
a
first­
come,
first­
served
basis.
Allocations
are
also
available
to
U.
S.

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