Document ID: EPA-HQ-OPP-2002-0326-0001
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2002-12-09T05:00Z

72846
Federal
Register
/
Vol.
67,
No.
236
/
Monday,
December
9,
2002
/
Rules
and
Regulations
Federal
standard,
and
does
not
alter
the
relationship
or
the
distribution
of
power
and
responsibilities
established
in
the
Clean
Air
Act.
This
rule
also
is
not
subject
to
Executive
Order
13045
``
Protection
of
Children
from
Environmental
Health
Risks
and
Safety
Risks''
(
62
FR
19885,
April
23,
1997),
because
it
is
not
economically
significant.
In
reviewing
SIP
submissions,
EPA's
role
is
to
approve
state
choices,
provided
that
they
meet
the
criteria
of
the
Clean
Air
Act.
In
this
context,
in
the
absence
of
a
prior
existing
requirement
for
the
State
to
use
voluntary
consensus
standards
(
VCS),
EPA
has
no
authority
to
disapprove
a
SIP
submission
for
failure
to
use
VCS.
It
would
thus
be
inconsistent
with
applicable
law
for
EPA,
when
it
reviews
a
SIP
submission,
to
use
VCS
in
place
of
a
SIP
submission
that
otherwise
satisfies
the
provisions
of
the
Clean
Air
Act.
Thus,
the
requirements
of
section
12(
d)
of
the
National
Technology
Transfer
and
Advancement
Act
of
1995
(
15
U.
S.
C.
272
note)
do
not
apply.
This
rule
does
not
impose
an
information
collection
burden
under
the
provisions
of
the
Paperwork
Reduction
Act
of
1995
(
44
U.
S.
C.
3501
et
seq.).
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.
Section
804
exempts
from
section
801
the
following
types
of
rules:
(
1)
Rules
of
particular
applicability;
(
2)
rules
relating
to
agency
management
or
personnel;
and
(
3)
rules
of
agency
organization,
procedure,
or
practice
that
do
not
substantially
affect
the
rights
or
obligations
of
non­
agency
parties.
5
U.
S.
C.
804(
3).
EPA
is
not
required
to
submit
a
rule
report
regarding
this
action
under
section
801
because
this
is
a
rule
of
particular
applicability.
Under
section
307(
b)(
1)
of
the
Clean
Air
Act,
petitions
for
judicial
review
of
this
action
must
be
filed
in
the
United
States
Court
of
Appeals
for
the
appropriate
circuit
by
February
7,
2003.
Filing
a
petition
for
reconsideration
by
the
Administrator
of
this
final
rule
does
not
affect
the
finality
of
this
rule
for
the
purposes
of
judicial
review
nor
does
it
extend
the
time
within
which
a
petition
for
judicial
review
may
be
filed,
and
shall
not
postpone
the
effectiveness
of
such
rule
or
action.
This
action
may
not
be
challenged
later
in
proceedings
to
enforce
its
requirements.
(
See
section
307(
b)(
2).)

List
of
Subjects
in
40
CFR
Part
52
Environmental
protection,
Administrative
practice
and
procedure,
Air
pollution
control,
Incorporation
by
reference,
Intergovernmental
relations,
Particulate
matter,
Reporting
and
recordkeeping
requirements.

Dated:
November
7,
2002.
Bharat
Mathur,
Acting
Regional
Administrator,
Region
5.

For
the
reasons
stated
in
the
preamble,
part
52,
chapter
I,
title
40
of
the
Code
of
Federal
Regulations
is
amended
as
follows:

PART
52
 
[
AMENDED]

1.
The
authority
citation
for
part
52
continues
to
read
as
follows:

Authority:
42
U.
S.
C.
7401
et
seq.

Subpart
P
 
Indiana
2.
Section
52.770
is
amended
by
adding
paragraph
(
c)(
155)
to
read
as
follows:

§
52.770
Identification
of
plan.

(
c)
*
*
*
(
155)
On
October
17,
2002,
the
State
submitted
revised
particulate
matter
emission
limits
for
the
Knauf
Fiber
Glass
in
Shelby
County
for
incorporation
into
the
Indiana
SIP.
(
i)
Incoropration
by
reference.
(
A)
Indiana
Administrative
Code
Title
326:
Air
Pollution
Control
Board,
Article
11
Emission
Limitations
for
Specific
Types
of
Operations,
Rule
4
Fiberglass
Insulation
Manufacturing,
Paragraph
5
Shelby
County
(
326
IAC
11
 
4
 
5).
Adopted
by
the
Indiana
Air
Pollution
Control
Board
on
May
1,
2002.
Filed
with
the
Secretary
of
State
on
August
28,
2002.
Published
in
the
Indiana
Register,
Volume
26,
Number
1,
October
1,
2002,
effective
September
27,
2002.

[
FR
Doc.
02
 
30937
Filed
12
 
6
 
02;
8:
45
am]

BILLING
CODE
6560
 
50
 
P
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP
 
2002
 
0326;
FRL
 
7282
 
1]

Carboxin;
Pesticide
Tolerance
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Final
rule.

SUMMARY:
This
regulation
establishes
a
tolerance
for
combined
residues
of
carboxin
(
5,6­
dihydro­
2­
methyl­
Nphenyl
1,4­
oxathiin­
3­
carboxamide)
and
its
metabolite
5,6­
dihydro­
3­
carboxanilide­
2­
methyl­
1,4­
oxathiin­
4­
oxide
(
calculated
as
carboxin)
(
from
treatment
of
seed
prior
to
planting)
in
or
on
canola,
seed.
Gustafson
LLC
requested
this
tolerance
under
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA)
,
as
amended
by
the
Food
Quality
Protection
Act
of
1996
(
FQPA).

DATES:
This
regulation
is
effective
December
9,
2002.
Objections
and
requests
for
hearings,
identified
by
docket
ID
number
OPP
 
2002
 
0326,
must
be
received
on
or
before
February
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
VI.
of
the
SUPPLEMENTARY
INFORMATION.

FOR
FURTHER
INFORMATION
CONTACT:
Mary
Waller,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
308
 
9354;
e­
mail
address:
waller.
mary@
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
entities
may
include,
but
are
not
limited
to:
 
Crop
production
(
NAICS
Code
111)
 
Animal
production
(
NAICS
Code
112)
 
Food
manufacturing
(
NAICS
Code
311)
 
Pesticide
manufacturing
(
NAICS
Code
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.

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Federal
Register
/
Vol.
67,
No.
236
/
Monday,
December
9,
2002
/
Rules
and
Regulations
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
 
2002
 
0326.
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
In
the
Federal
Register
of
February
23,
2000
(
65
FR
8970)
(
FRL
 
6390
 
1),
EPA
issued
a
notice
pursuant
to
section
408
of
FFDCA,
21
U.
S.
C.
346a,
as
amended
by
FQPA
(
Public
Law
104
 
170),
announcing
the
filing
of
a
pesticide
petition
(
PP
9F6036)
by
Gustafson
LLC,
1400
Preston
Road,
Suite
400,
Plano,
Texas
75093.
That
notice
included
a
summary
of
the
petition
prepared
by
Gustafson,
LLC,
the
registrant.
There
were
no
comments
received
in
response
to
the
notice
of
filing.
The
petition
requested
that
40
CFR
180.301
be
amended
by
establishing
a
tolerance
for
combined
residues
of
the
fungicide
carboxin,
5,6­
dihydro­
2­
methyl­
1,4­
oxathiin­
3­
carboxanilide]
and
its
sulfoxide
metabolite
5,6­
dihydro­
3­
carboxanilide­
2­
methyl­
1,4­
oxathiin­
4­
oxide],
each
expressed
as
the
parent
compound],
in
or
on
canola,
seed
at
0.03
parts
per
million
(
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
of
the
FFDCA
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)
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
combined
residues
of
carboxin
(
5,6­
dihydro­
2­
methyl­
N­
phenyl­
1,4­
oxathiin­
3­
carboxamide)
and
its
metabolite
5,6­
dihydro­
3­
carboxanilide­
2­
methyl­
1,4­
oxathiin­
4­
oxide
(
calculated
as
carboxin)
(
from
treatment
of
seed
prior
to
planting)
on
canola,
seed
at
0.03
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
carboxin
are
discussed
in
Table
1
of
this
unit
as
well
as
the
no
observed
adverse
effect
level
(
NOAEL)
and
the
lowest
observed
adverse
effect
level
(
LOAEL)
from
the
toxicity
studies
reviewed.

TABLE
1.
 
SUBCHRONIC,
CHRONIC,
AND
OTHER
TOXICITY
Guideline
No.
Study
Type
Results
870.3100
90
 
Day
oral
toxicity
in
rats
NOAEL
=
Males:
not
identified;
Females:
10
mg/
kg/
day
LOAEL
=
Males:
10
mg/
kg/
day
based
on
chronic
nephritis,
increased
urea
nitrogen,
increased
creatinine;
Females:
40
mg/
kg/
day
based
on
chronic
nephritis
870.3200
21/
28
 
Day
dermal
toxicity
Not
available
870.3465
90
 
Day
inhalation
toxicity
Not
available
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/
Vol.
67,
No.
236
/
Monday,
December
9,
2002
/
Rules
and
Regulations
TABLE
1.
 
SUBCHRONIC,
CHRONIC,
AND
OTHER
TOXICITY
 
Continued
Guideline
No.
Study
Type
Results
870.3700
Prenatal
developmental
in
rats
Maternal
NOAEL
=
10
milligrams/
kilogram/
day
(
mg/
kg/
day)
LOAEL
=
90
mg/
kg/
day
based
on
decreased
body
weights
and
body
weight
gain,
decreased
food
consumption,
and
increased
hair
loss
Developmental
NOAEL
=
175
mg/
kg/
day
LOAEL
=
not
identified
870.3700
Prenatal
developmental
in
rabbits
Maternal
NOAEL
=
75
mg/
kg/
day
LOAEL
=
375
mg/
kg/
day
based
on
increased
abortions
Developmental
NOAEL
=
75
mg/
kg/
day
LOAEL
=
375
mg/
kg/
day
based
on
increased
abortions
870.3800
Reproduction
and
fertility
effects
in
rats
Parental
NOAEL
=
Males
and
Females:
1
mg/
kg/
day
LOAEL
=
Males:
10
mg/
kg/
day
based
on
decreased
body
weight
gains
in
F1
parents,
gross
and
histopathological
changes
in
kidneys;
Females:
15
mg/
kg/
day
based
on
equivocal
histopathological
changes
in
kidneys
Reproductive
NOAEL
=
Males:
10
mg/
kg/
day;
Females:
15
mg/
kg/
day
LOAEL
=
Males:
20
mg/
kg/
day;
Females:
30
mg/
kg/
day
based
on
decreased
fertility
indices
for
F1b
parents
due
to
decreased
number
of
pregnancies
for
F2b
generation
Offspring
NOAEL
=
Males:
10
mg/
kg/
day;
Females:
15
mg/
kg/
day
LOAEL
=
Males:
20
mg/
kg/
day;
Females:
30
mg/
kg/
day
based
on
decreased
body
weights
for
F2b
male
pups
870.4100
Chronic
toxicity
in
dogs
NOAEL
=
Males:
16
mg/
kg/
day;
Females:
1.3
mg/
kg/
day
LOAEL
=
Males:
158
mg/
kg/
day
based
on
decreased
RBC,
hematocrit
and
hemoglobin
increased
MCH
and
MCV,
increased
alkaline
phosphatase
and
cholesterol,
increased
liver
weights;
Females:
15
mg/
kg/
day
based
on
decreased
body
weight
gains
870.4300
Combined
Chronic/

Carcinogenicity
in
rats
NOAEL
=
Males:
0.8
mg/
kg/
day;
Females:
1.0
mg/
kg/
day
LOAEL
=
Males:
9
mg/
kg/
day
based
on
decreased
body
weight
and
body
weight
gain,
increased
urea
nitrogen
and
creatinine,
increased
water
consumption
and
urine
volume
decreased
urine
specific
gravity,
histopathological
changes
in
kidneys;
Females
16
mg/
kg/
day
based
on
histopathological
changes
in
kidneys
Negative
for
carcinogenicity
870.4200
Carcino­
genicity
in
mice
NOAEL
=
Males:
752
mg/
kg/
day;
Females:
9
mg/
kg/
day
LOAEL
=
Males:
not
identified;
Females:
451
mg/
kg/
day
based
on
increased
mortality
Negative
for
carcinogenicity
870.5100
Bacterial
reverse
mutation
assay
(
Ames
test)
Negative
with
or
without
S­
9
activation
at
5.000
µ
g/
plate
and
less
870.5375
In
vitro
mammalian
chromosome
aberration
(
CHO
cells)
Negative
without
S­
9
activation
Positive
with
S­
9
activation.
Highly
significant
increases
in
chromosomal
aberrations
at
several
toxic
dose
levels
ranging
from
400
to
1,400
Fg/
mL
870.5385
In
vivo
mammalian
chromosome
aberration
(
rat
bone
marrow)
Negative
at
all
dose
levels
up
to
48­
hours
post­
dosing
Study
is
unacceptable
due
to
lack
of
clinical
toxicity,
lack
of
a
multiple
dosing
schedule
and/
or
lack
of
evidence
of
transport
to
target
tissue
870.5385
In
vivo
mammalian
chromosome
aberration
(
rat
bone
marrow)
Negative
at
all
dose
levels
tested
870.5385
In
vivo
mammalian
chromosome
aberration
(
rat
bone
marrow)
Positive.
Dose­
related
statistically
significant
increased
percent
of
aberrant
cells
at
191
mg/
kg/
day
870.5450
Dominant
lethal
assay
in
rats
Not
available
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Rules
and
Regulations
TABLE
1.
 
SUBCHRONIC,
CHRONIC,
AND
OTHER
TOXICITY
 
Continued
Guideline
No.
Study
Type
Results
870.5550
UDS
in
primary
rat
hepatocytes
Positive.
Dose­
dependent
positive
responses
were
observed
at
treatment
levels
from
5.13
to
103
µ
g/
mL
in
the
absence
of
moderate
to
severe
toxicity
870.7485
Metabolism
and
pharmaco
kinetics
in
rats
Following
oral
treatment
of
rats
with
phenyl­
UL­
C14
carboxin,
approximately
78.3
 
81.1%
and
77.0
 
81.5%
of
the
low
and
high
doses,
respectively,
were
recovered.
Urine
was
the
major
route
of
excretion.
The
major
urinary
metabolites
were
4­
acetamidophenol
and
its
glucuronide,
acetanilide,
and
hydroxylated
carboxin
sulfoxide
B.
Toxicological
Endpoints
The
dose
at
which
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
lowest
dose
at
which
adverse
effects
of
concern
are
identified
the
LOAEL
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
factors
(
SF)
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
SF.
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)
=
NOAEL/
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
10­
6
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
carboxin
used
for
human
risk
assessment
is
shown
in
Table
2
of
this
unit:

TABLE
2.
 
SUMMARY
OF
TOXICOLOGICAL
DOSE
AND
ENDPOINTS
FOR
CARBOXIN
FOR
USE
IN
HUMAN
RISK
ASSESSMENT
Exposure
Scenario
Dose
Used
in
Risk
Assessment
UF
FQPA
SF*
and
Level
of
Concern
for
Risk
Assessment
Study
and
Toxicological
Effects
Acute
dietary
all
populations
Acute
RfD
=
not
required
No
toxicological
endpoint
attributable
to
a
single
exposure
was
identified
None
Chronic
dietary
all
populations
NOAEL
=
0.8
mg/
kg/
day
UF
=
100
Chronic
RfD
=
0.008
mg/
kg/
day
FQPA
SF
=
3
cPAD
=
chr
RfD
FQPA
SF
=
0.00267
mg/
kg/
day
Combined
chronic/
carcinogenicity
­
rat
LOAEL
=
Males:
9
mg/
kg/
day
based
on
decreased
body
weight
and
body
weight
gain,
increased
urea
nitrogen
and
creatinine
increased
water
consumption
and
urine
volume,
decreased
urine
specific
gravity,
histopathological
changes
in
kidneys
Females:
16
mg/
kg/
day
based
on
histopathological
changes
in
kidneys
Cancer
(
oral,
dermal,
inhalation
Not
likely
to
be
carcinogenic
to
humans
Negative
for
carcinogenicity
in
rats
and
mice
Combined
chronic/
carcinogenicity
­
rat
and
carcinogenicity
­
mouse
*
The
reference
to
the
FQPA
SF
refers
to
any
additional
SF
retained
due
to
concerns
unique
to
the
FQPA.

C.
Exposure
Assessment
1.
Dietary
exposure
from
food
and
feed
uses.
Tolerances
have
been
established
(
40
CFR
180.301)
for
the
combined
residues
of
carboxin
and
its
sulfoxide
metabolite,
in
or
on
a
variety
of
raw
agricultural
commodities
(
RAC).
Risk
assessments
were
conducted
by
EPA
to
assess
dietary
exposures
from
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Rules
and
Regulations
carboxin
and
its
sulfoxide
metabolite
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.
No
toxicological
endpoint
attributable
to
a
single
exposure
was
identified
in
the
available
toxicology
studies
on
carboxin.
As
a
result,
an
acute
endpoint
was
not
identified
and
an
acute
dietary
exposure
assessment
was
not
performed.
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
Agriculture
(
USDA)
1989
 
1992
nationwide
Continuing
Surveys
of
Food
Intake
by
Individuals
(
CSFII)
and
accumulated
exposure
to
the
chemical
for
each
commodity.
The
chronic
dietary
exposure
analysis
was
an
unrefined
assessment.
Tolerance
level
residues
and
100%
crop
treated
assumptions
were
used.
iii.
Cancer.
Carboxin
was
classified
as
``
not
likely
to
be
carcinogenic
to
humans.''
Therefore,
a
cancer
dietary
exposure
assessment
was
not
performed.
2.
Dietary
exposure
from
drinking
water.
The
Agency
lacks
sufficient
monitoring
exposure
data
to
complete
a
comprehensive
dietary
exposure
analysis
and
risk
assessment
for
carboxin
and
its
sulfoxide
metabolite]
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
carboxin
and
its
sulfoxide
metabolite.
The
Agency
uses
the
First
Index
Reservoir
Screening
Tool
(
FIRST)
or
the
Pesticide
Root
Zone/
Exposure
Analysis
Modeling
System
(
PRZM/
EXAMS),
to
produce
estimates
of
pesticide
concentrations
in
an
index
reservoir.
The
SCI­
GROW
model
is
used
to
predict
pesticide
concentrations
in
shallow
ground
water.
For
a
screening­
level
assessment
for
surface
water
EPA
will
use
FIRST
(
a
tier
1
model)
before
using
PRZM/
EXAMS
(
a
tier
2
model).
The
FIRST
model
is
a
subset
of
the
PRZM/
EXAMS
model
that
uses
a
specific
highend
runoff
scenario
for
pesticides.
While
both
FIRST
and
PRZM/
EXAMS
incorporate
an
index
reservoir
environment,
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
a
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
carboxin
and
its
sulfoxide
metabolite
they
are
further
discussed
in
the
aggregate
risk
sectionsin
Unit
E.
Based
on
the
FIRST
and
SCI­
GROW
models
the
estimated
environmental
concentrations
(
EECs)
of
carboxin
and
its
sulfoxide
metabolite
for
acute
exposures
are
estimated
to
be
29.6
parts
per
billion
(
ppb)
for
surface
water
and
0.09
ppb
for
ground
water.
The
EECs
for
chronic
exposures
are
estimated
to
be
0.63
ppb
for
surface
water
and
0.09
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).
Carboxin
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)
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
carboxin
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,
carboxin
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
carboxin
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
tenfold
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
database
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
developmental
toxicity
and
reproduction
studies
performed
with
carboxin
did
not
indicate
evidence
for
enhanced
susceptibility
to
the
fetuses/
offspring
of
rats
or
rabbits.
Neither
quantitative
nor
qualitative
increased
susceptibility
was
observed
in
the
developmental
toxicity
study
in
rats,
the
developmental
toxicity
study
in
rabbits,
or
the
2­
generation
reproduction
toxicity
study
in
rats.
In
none
of
the
toxicity
studies
on
carboxin
was
there
any
toxicologically
significant
evidence
of
treatment­
related
neurotoxicity.
A
developmental
neurotoxicity
study
in
rats
is
not
required.
There
is,
however,
a
concern
for
possible
germinal
cell
toxicity.
In
genotoxicity
studies,
carboxin
demonstrated
clear
evidence
of
clastogenic
potential.
It
was
also
noted
that
in
the
2­
generation
reproduction
study
in
rats,
treatment­
related
decreased
fertility
indices
for
the
F1b
male
and
female
parents
(
due
to
a
decreased
number
of
pregnancies
for
the
F2b
generation)
were
observed.
Based
on
these
considerations,
the
registrant
will
be
required
to
submit
a
germinal
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Regulations
cell
assay,
specifically
a
dominant
lethal
assay
in
rats,
to
the
Agency
in
order
to
evaluate
possible
interaction
between
carboxin
and
germinal
cell
targets.
3.
Conclusion.
Based
upon
clear
evidence
of
clastogenic
activity
and
the
requirement
for
a
dominant
lethal
study,
EPA
concluded
that
a
FQPA
safety
factor
of
3X
is
appropriate
for
this
risk
assessment.
The
safety
factor
of
10X
was
reduced
to
3X
because:
i.
There
is
no
indication
of
quantitative
or
qualitative
increased
susceptibility
of
rats
or
rabbits
to
in
utero
and/
or
postnatal
exposure;
ii.
A
developmental
neurotoxicity
study
is
not
required;
iii.
The
dietary
(
food
and
drinking
water)
exposure
assessments
will
not
underestimate
the
potential
for
exposures
to
infants
and
children;
and
iv.
There
are
no
registered
residential
uses
for
carboxin.

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
EECs
of
a
pesticide.
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
the
USEPA
Office
of
Water
are
used
to
calculate
DWLOCs:
2
liter
(
L)/
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
EPA
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.
1.
Acute
risk.
No
toxicological
endpoint
attributable
to
a
single
exposure
was
identified
in
the
available
toxicology
studies
on
carboxin.
As
a
result,
carboxin
is
not
expected
to
pose
an
acute
risk.
2.
Chronic
risk.
Using
the
exposure
assumptions
described
in
this
unit
for
chronic
exposure,
EPA
has
concluded
that
exposure
to
carboxin
and
its
sulfoxide
metabolite
from
food
will
utilize
41%
of
the
cPAD
for
the
U.
S.
population
and
92%
of
the
cPAD
for
children
1
 
6
years,
the
most
highly
exposed
population.
There
are
no
residential
uses
for
carboxin.
In
addition,
there
is
potential
for
chronic
dietary
exposure
to
carboxin
and
its
sulfoxide
metabolite
in
drinking
water.
After
calculating
DWLOCs
and
comparing
them
to
the
EECs
for
surface
and
ground
water,
EPA
does
not
expect
the
aggregate
exposure
to
exceed
100%
of
the
cPAD,
as
shown
in
the
following
Table
3:

TABLE
3.
 
AGGREGATE
RISK
ASSESSMENT
FOR
CHRONIC
(
NON­
CANCER)
EXPOSURE
TO
CARBOXIN
AND
ITS
SULFOXIDE
METABOLITE
Population
Subgroup
cPAD
mg/
kg/
day
%
cPAD
(
Food)
Surface
Water
EEC
(
ppb)
Ground
Water
EEC
(
ppb)
Chronic
DWLOC
(
ppb)

U.
S.
population
0.00267
41
0.63
0.09
56
Children
1
 
6
years
0.00267
92
0.63
0.09
2
3.
Short­
term
and
Intermediate­
term
risk.
Both
short­
term
aggregate
exposure
and
intermediate­
term
aggregate
exposure
take
into
account
residential
exposure
plus
chronic
exposure
to
food
and
water
(
considered
to
be
a
background
exposure
level).
Since
carboxin
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,
which
do
not
exceed
the
Agency's
level
of
concern
as
described
in
Table
3.
4.
Aggregate
cancer
risk
for
U.
S.
population.
Carboxin
was
classified
as
``
not
likely
to
be
carcinogenic
to
humans.''
Therefore,
carboxin
is
not
expected
to
pose
a
cancer
risk.
5.
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
residues
of
carboxin
and
its
sulfoxide
metabolite.

IV.
Other
Considerations
A.
Endocrine
Disruptor
Effects
FQPA
requires
EPA
to
develop
a
screening
program
to
determine
whether
certain
substances
(
including
all
pesticides
and
inerts
or
inactive
ingredients)
``
may
have
an
effect
in
humans
that
is
similar
to
an
effect
produced
by
a
naturally
occurring
estrogen,
or
such
other
endocrine
effect...''
EPA
has
been
working
with
interested
stakeholders
to
develop
a
screening
and
testing
program
as
well
as
a
priority
setting
scheme.
In
the
available
toxicity
studies
for
carboxin,
there
is
no
evidence
of
endocrine
disruptor
effects.
When
appropriate
screening
and/
or
testing
protocols
being
considered
under
the
Agency's
Endocrine
Disruptor
Screening
Program
have
been
developed,
carboxin
may
be
subjected
to
further
screening
and/
or
testing
to
better
characterize
effects
related
to
endocrine
disruption.

B.
Analytical
Enforcement
Methodology
The
current
available
enforcement
methods
for
tolerances
of
the
combined
residues
of
carboxin
and
its
carboxin
sulfoxide
metabolite
are
described
in
the
Pesticide
Analytical
Manual
(
PAM)

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Vol.
II.
Method
I
is
a
colorimetric
method
which
is
used
for
determination
of
residues
in
or
on
corn,
peanuts,
rice,
rice
straw,
sorghum,
soybeans,
eggs,
meat,
and
milk.
Method
II
and
its
modification,
Method
A,
are
gas
liquid
chromatography
(
GLC)
methods
which
are
used
for
wheat,
oats,
barley,
peanuts,
peanut
oil
and
meal,
sorghum,
cottonseed,
and
cottonseed
oil
and
meal.
Adequate
recovery
data
were
submitted
to
validate
the
methods
used
in
the
canola
field
trials.
Residues
in
canola
seeds
were
converted
to
aniline,
which
was
derivatized
with
heptafluorobutyric
anhydride
prior
to
gas
chromatography
mass
selective
detector
(
GC/
MSD)
analysis.
Recoveries
were
100
 
103%
for
0.025
ppm
fortifications
in
canola
seeds.
Adequate
enforcement
methodology
is
available
to
enforce
the
tolerance
expression.
The
method
may
be
requested
from:
Francis
Griffith,
Analytical
Chemistry
Branch,
Environmental
Science
Center,
U.
S.
Environmental
Protection
Agency,
701
Mapes
Road,
Fort
George
G.
Meade,
MD
20755
 
5350;
telephone
number:
(
410)
305
 
2905;
e­
mail
address:
griffith.
francis@
epa.
gov.

C.
International
Residue
Limits
There
are
no
CODEX,
Canadian,
or
Mexican
maximum
residue
levels
(
MRLs)
for
carboxin
in/
on
onion
seed.
As
a
result,
harmonization
of
tolerances
is
not
an
issue.

V.
Conclusion
Therefore,
the
tolerance
is
established
for
combined
residues
of
carboxin,
(
5,6
dihydro­
2­
methyl­
N­
phenyl­
1,4­
oxathiin­
3­
carboxamide)
and
its
metabolite
5,6­
dihydro­
3­
carboxanilide­
2­
methyl­
1,4­
oxathiin­
4­
oxide
(
calculated
as
carboxin)
(
from
treatment
of
seed
prior
to
planting)
insert
regulated
chemical,
in
or
on
canola,
seed
at
0.03
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,
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
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
 
2002
 
0326
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
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
 
2002
 
0326,
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.

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
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and
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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
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
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.

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
26,
2002.
Peter
Caulkins,
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
371.

2.
Section
180.301
is
amended
by
alphabetically
adding
the
commodity
``
canola,
seed''
to
the
table
in
paragraph
(
a)
to
read
as
follows:

§
180.301
Carboxin;
tolerances
for
residues.

(
a)
*
*
*

Commodity
Parts
per
million
*
*
*
*
*
Canola,
seed
0.03
*
*
*
*
*

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*
*
*
*
*
[
FR
Doc.
02
 
31010
Filed
12
 
6
 
02;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
721
[
OPPT
 
2002
 
0043;
FRL
 
7279
 
1]

RIN
2070
 
AD43
Perfluoroalkyl
Sulfonates;
Significant
New
Use
Rule
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Final
rule.

SUMMARY:
EPA
is
issuing
a
significant
new
use
rule
(
SNUR)
under
section
5(
a)(
2)
of
the
Toxic
Substances
Control
Act
(
TSCA)
for
75
substances
including
perfluorooctanesulfonic
acid
(
PFOSH)
and
certain
of
its
salts
(
PFOSS),
perfluorooctanesulfonyl
fluoride
(
POSF),
certain
higher
and
lower
homologues
of
PFOSH
and
POSF,
and
certain
other
chemical
substances,
including
polymers,
that
are
derived
from
PFOSH
and
its
homologues.
These
chemicals
are
collectively
referred
to
as
perfluoroalkyl
sulfonates,
or
PFAS.
This
rule
requires
manufacturers
and
importers
to
notify
EPA
at
least
90
days
before
commencing
the
manufacture
or
import
of
these
chemical
substances
for
the
significant
new
uses
described
in
this
document.
EPA
believes
that
this
action
is
necessary
because
the
PFOSH
component
of
these
chemical
substances
may
be
hazardous
to
human
health
and
the
environment.
The
required
notice
will
provide
EPA
with
the
opportunity
to
evaluate
an
intended
new
use
and
associated
activities
and,
if
necessary,
to
prohibit
or
limit
that
activity
before
it
occurs.
DATES:
This
final
rule
is
effective
on
January
8,
2003.
FOR
FURTHER
INFORMATION
CONTACT:
For
general
information
contact:
Barbara
Cunningham,
Acting
Director,
Environmental
Assistance
Division
(
7408M),
Office
of
Pollution
Prevention
and
Toxics,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
202)
554
 
1404;
e­
mail
address:
TSCA­
Hotline@
epa.
gov.
For
technical
information
contact:
Mary
Dominiak,
Chemical
Control
Division
(
7405M),
Office
of
Pollution
Prevention
and
Toxics,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
202)
564
 
8104;
e­
mail
address:
dominiak.
mary@
epa.
gov.

SUPPLEMENTARY
INFORMATION:

I.
General
Information
A.
Does
this
Action
Apply
to
Me?
You
may
be
potentially
affected
by
this
action
if
you
manufacture
(
defined
by
statute
to
include
import)
any
of
the
chemical
substances
that
are
listed
in
Table
1
of
this
unit.
Persons
who
intend
to
import
any
chemical
substance
governed
by
a
final
SNUR
are
subject
to
TSCA
section
13
(
15
U.
S.
C.
2612)
import
certification
requirements,
and
to
the
regulations
codified
at
19
CFR
12.118
through
12.127
and
12.728.
Those
persons
must
certify
that
they
are
in
compliance
with
the
SNUR
requirements.
The
EPA
policy
in
support
of
import
certification
appears
at
40
CFR
part
707,
subpart
B.
In
addition,
any
persons
who
export
or
intend
to
export
any
of
the
chemical
substances
listed
in
Table
1
are
subject
to
the
export
notification
provisions
of
TSCA
section
12(
b)
(
15
U.
S.
C.
2611(
b)),
and
must
comply
with
the
export
notification
requirements
in
40
CFR
721.20
and
40
CFR
part
707,
subpart
D.
Potentially
affected
entities
may
include,
but
are
not
limited
to:

 
Chemical
manufacturers
or
importers
(
NAICS
325),
e.
g.,
persons
who
manufacture
(
defined
by
statute
to
include
import)
one
or
more
of
the
subject
chemical
substances.

 
Chemical
exporters
(
NAICS
325),
e.
g.,
persons
who
export,
or
intend
to
export,
one
or
more
of
the
subject
chemical
substances.
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.
To
determine
whether
you
or
your
business
may
be
affected
by
this
action,
you
should
carefully
examine
the
applicability
provisions
in
40
CFR
721.5
for
SNUR­
related
obligations.
Also,
consult
Unit
II.
If
you
have
any
questions
regarding
the
applicability
of
this
action
to
a
particular
entity,
consult
the
technical
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.

TABLE
1.
 
CHEMICAL
SUBSTANCES
COVERED
BY
THIS
RULE
CAS
No./
PMN
CAS
Ninth
Collective
Index
Name
307
 
35
 
7
1­
Octanesulfonyl
fluoride,
1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8­
heptadecafluoro­

307
 
51
 
7
1­
Decanesulfonyl
fluoride,
1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,10­
heneicosafluoro­

376
 
14
 
7
2­
Propenoic
acid,
2­
methyl­,
2­[
ethyl[(
heptadecafluorooctyl)
sulfonyl]
amino]
ethyl
ester
383
 
07
 
3
2­
Propenoic
acid,
2­[
butyl[(
heptadecafluorooctyl)
sulfonyl]
amino]
ethyl
ester
423
 
50
 
7
1­
Hexanesulfonyl
fluoride,
1,1,2,2,3,3,4,4,5,5,6,6,6­
tridecafluoro­

423
 
82
 
5
2­
Propenoic
acid,
2­[
ethyl[(
heptadecafluorooctyl)
sulfonyl]
amino]
ethyl
ester
754
 
91
 
6
1­
Octanesulfonamide,
1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8­
heptadecafluoro­

1652
 
63
 
7
1­
Propanaminium,
3­[[(
heptadecafluorooctyl)
sulfonyl]
amino]­
N,
N,
N­
trimethyl­,
iodide
1691
 
99
 
2
1­
Octanesulfonamide,
N­
ethyl­
1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8­
heptadecafluoro­
N­(
2­
hydroxyethyl)­

1763
 
23
 
1
1­
Octanesulfonic
acid,
1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8­
heptadecafluoro­

2795
 
39
 
3
1­
Octanesulfonic
acid,
1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8­
heptadecafluoro­,
potassium
salt
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