Document ID: EPA-HQ-OPP-2002-0299-0001
Agency: epa
Document Type: Rule
Title: Acetamiprid; Pesticide Tolerance
Posted Date: 2003-09-03T04:00Z

52343
Federal
Register
/
Vol.
68,
No.
170
/
Wednesday,
September
3,
2003
/
Rules
and
Regulations
(
12)
Crystal
River
Nuclear
Power
Plant.
All
waters,
from
surface
to
bottom,
around
the
Florida
Power
Crystal
River
nuclear
power
plant
located
at
the
end
of
the
Florida
Power
Corporation
Channel,
Crystal
River,
Florida,
encompassed
by
a
line
connecting
the
following
points:
28
°
56.87 
N,
082
°
45.17 
W
(
Northwest
corner);
28
°
57.37 
N,
082
°
41.92 
W
(
Northeast
corner);
28
°
56.81 
N,
082
°
45.17 
W
(
Southwest
corner);
and
28
°
57.32 
N,
082
°
41.92 
W
(
Southeast
corner).
(
13)
Crystal
River
Demory
Gap
Channel.
All
waters,
from
surface
to
bottom,
in
the
Demory
Gap
Channel
in
Crystal
River,
Florida,
encompassed
by
a
line
connecting
the
following
points:
28
°
57.61 
N,
082
°
43.42 
W
(
Northwest
corner);
28
°
57.53 
N,
082
°
41.88 
W
(
Northeast
corner);
28
°
57.60 
N,
082
°
43.42 
W
(
Southwest
corner);
and
28
°
57.51 
N,
082
°
41.88 
W
(
Southeast
corner).
(
b)
Regulations.
(
1)
Entry
into
or
remaining
within
these
zones
is
prohibited
unless
authorized
by
the
Coast
Guard
Captain
of
the
Port,
Tampa,
Florida
or
that
officer's
designated
representative.
(
2)
Persons
desiring
to
transit
the
area
of
the
security
zone
may
contact
the
Captain
of
the
Port
at
telephone
number
813
 
228
 
2189/
91
or
on
VHF
channel
16
to
seek
permission
to
transit
the
area.
If
permission
is
granted,
all
persons
and
vessels
must
comply
with
the
instructions
of
the
Captain
of
the
Port
or
their
designated
representative.
(
c)
Definition.
As
used
in
this
section,
``
cruise
ship''
means
a
vessel
required
to
comply
with
33
CFR
Part
120.
(
d)
Authority.
In
addition
to
33
U.
S.
C.
1231
and
50
U.
S.
C.
191,
the
authority
for
this
section
includes
33
U.
S.
C.
1226.

Dated:
August
1,
2003.
James
M.
Farley,
Captain,
U.
S.
Coast
Guard,
Captain
of
The
Port,
Tampa,
Florida.
[
FR
Doc.
03
 
22370
Filed
9
 
2
 
03;
8:
45
am]

BILLING
CODE
4910
 
15
 
P
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP
 
2002
 
0299;
FRL
 
7324
 
1]

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

SUMMARY:
This
regulation
establishes
a
tolerance
for
residues
of
acetamiprid
in
or
on
canola
seed
and
mustard
seed.
Bayer
Corporation
requested
this
tolerance
under
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
as
amended
by
the
Food
Quality
Protection
Act
of
1996
(
FQPA).
The
ownership
of
this
petition
has
subsequently
been
transferred
to
Nippon
Soda
Company,
Ltd.

DATES:
This
regulation
is
effective
September
3,
2003.
Objections
and
requests
for
hearings,
identified
by
docket
ID
number
OPP
 
2002
 
0299,
must
be
received
on
or
before
November
3,
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:
Akiva
Abramovitch,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
308
 
8328;
email
address:
abramovitch.
akiva@
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
111)
 
Animal
Production
(
NAICS
112)
 
Food
Manufacturing
(
NAICS
311)
 
Pesticide
Manufacturing
(
NAICS
32532)
This
listing
is
not
intended
to
be
exhaustive,
but
rather
provides
a
guide
for
readers
regarding
entities
likely
to
be
affected
by
this
action.
Other
types
of
entities
not
listed
in
this
unit
could
also
be
affected.
The
North
American
Industrial
Classification
System
(
NAICS)
codes
have
been
provided
to
assist
you
and
others
in
determining
whether
this
action
might
apply
to
certain
entities.
If
you
have
any
questions
regarding
the
applicability
of
this
action
to
a
particular
entity,
consult
the
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.

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

1.
Docket.
EPA
has
established
an
official
public
docket
for
this
action
under
docket
identification
(
ID)
number
OPP
 
2002
 
0299.
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
May
30,
2001
(
66
FR
29313)
(
FRL
 
6782
 
9),
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
0F6082)
by
Bayer
Corporation,
P.
O.
Box
12014,
2
T.
W.
Alexander
Drive,
Research
Triangle
Park,
NC
27709.
That
notice
included
a
summary
of
the
petition
prepared
by
Bayer
Corporation,
the
registrant.
There
were
no
comments
received
in
response
to
the
notice
of
filing.
Subsequent
to
the
notice
of
filing,
the
ownership
of
this
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Federal
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/
Vol.
68,
No.
170
/
Wednesday,
September
3,
2003
/
Rules
and
Regulations
petition
was
transferred
to
Nippon
Soda
Company,
Ltd.,
220
East
42nd
Street,
Suite
3002,
New
York,
NY
10017.
The
petition
requested
that
40
CFR
180.578
be
amended
by
establishing
a
tolerance
for
residues
of
the
insecticide
acetamiprid,
N1­[(
6­
chloro­
3­
pyridyl)
methyl]­
N2­
cyano­
N1­
methylacetamidine,
in
or
on
canola
seed
and
mustard
seed
at
0.01
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
(
62
FR
62961,
November
26,
1997)
(
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
residues
of
acetamiprid
on
canola
seed
and
mustard
seed
at
0.01
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
acetamiprid
are
discussed
in
Table
1
of
this
unit
as
well
as
the
no­
observed­
adverse­
effect­
level
(
NOAEL)
and
the
lowest­
observedadverse
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:
12.4/
14.6
mg/
kg/
day
(
M/
F)
LOAEL:
50.8/
56.0
mg/
kg/
day
(
M/
F:
decreased
BW,
BW
gain
and
food
consumption).

870.3100
90
 
Day
oral
toxicity
in
mice
NOAEL:
106.1/
129.4
mg/
kg/
day
(
M/
F)
LOAEL:
211.1/
249.1
mg/
kg/
day
(
reduced
BW
and
BW
gain,
decreased
glucose
and
cholesterol
levels,
reduced
absolute
organ
weights).

870.3150
90
 
Day
oral
toxicity
in
dogs
NOAEL:
13/
14
mg/
kg/
day
(
M/
F)
LOAEL:
32
mg/
kg/
day
(
reduced
BW
gain
in
both
sexes).

870.3200
21
 
Day
dermal
toxicity
in
rabbits
NOAEL:
1,000
mg/
kg/
day
(
HDT)
LOAEL:
>
1,000
mg/
kg/
day
870.3700
Developmental
toxicity
in
rats
Maternal
NOAEL:
16
mg/
kg/
day
Maternal
LOAEL:
50
mg/
kg/
day
(
reduced
BW
and
BW
gain
and
food
consumption,
increased
liver
weights).
Developmental
NOAEL:
16
mg/
kg/
day
Developmental
LOAEL:
50
mg/
kg/
day
(
increased
incidence
of
shortening
of
the
13th
rib)

870.3700
Developmental
toxicity
in
rabbits
Maternal
NOAEL:
15
mg/
kg/
day
Maternal
LOAEL:
30mg/
kg/
day
(
BW
loss
and
decreased
food
consumption).
Developmental
NOAEL:
30
mg/
kg/
day
(
HDT)
Developmental
LOAEL:
>
30
mg/
kg/
day
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Federal
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/
Vol.
68,
No.
170
/
Wednesday,
September
3,
2003
/
Rules
and
Regulations
TABLE
1.
 
SUBCHRONIC,
CHRONIC,
AND
OTHER
TOXICITY
 
Continued
Guideline
No.
Study
Type
Results
870.3800
2
 
Generation
reproduction
in
rats
Parental
systemic
NOAEL:
17.9/
21.7
mg/
kg/
day
(
M/
F)
Parental
systemic
LOAEL:
51.0/
60.1
mg/
kg/
day
(
M/
F)
(
decreased
body
weight,
body
weight
gain
and
food
consumption
Offspring
systemic
NOAEL:
17.9/
21.7
mg/
kg/
day
(
M/
F)
Offspring
systemic
LOAEL:
51.0/
60.1
mg/
kg/
day
(
M/
F:
reductions
in
pup
weight,
litter
size,
viability
and
weaning
indices;
delay
in
age
to
attain
preputial
separation
and
vaginal
opening).
Reproductive
NOAEL:
17.9/
21.7
mg/
kg/
day
(
M/
F)
Reproductive
LOAEL:
51.0/
60.1
mg/
kg/
day
(
M/
F:
reductions
in
litter
weights
and
individual
pup
weights
on
day
of
delivery).

870.4100
Chronic
toxicity
dogs
NOAEL:
20/
21
mg/
kg/
day
(
M/
F)
LOAEL:
55/
61
mg/
kg/
day
(
M/
F:
initial
BW
loss
and
overall
reduction
in
BW
gain).

870.4200
Carcinogenicity
in
mice
NOAEL:
20.3/
75.9
mg/
kg/
day
(
M/
F)
LOAEL:
65.6/
214.6
mg/
kg/
day
(
M/
F:
decreased
BW
and
BW
gain
and
amyloidosis
in
numerous
organs
(
M)
and
decreased
BW
and
BW
gain
(
F)).
Not
oncogenic
under
conditions
of
study.

870.4300
Carcinogenicity
in
rats
NOAEL:
7.1/
8.8
mg/
kg/
day
(
M/
F)
LOAEL:
17.5/
22.6
mg/
kg/
day
(
M/
F,
decreases
in
mean
BW
and
BW
gain
(
F)
and
hepatocellular
vacuolation
(
M))
Evidence
of
treatment­
related
increase
in
mammary
tumors
There
was
an
absence
of
a
dose­
response
and
a
lack
of
a
statistically
significant
increase
in
the
mammary
adenocarcinoma
incidence
by
pair
with
comparison
of
the
mid­
and
high­
dose
groups
with
the
controls.
Although
the
incidence
exceeded
the
historical
control
data
from
the
same
lab,
it
was
within
the
range
of
values
from
the
supplier.

870.5100
Salmonella
typhimurium/
E.
coli
Reverse
gene
mutation
assay
Not
mutagenic
under
the
conditions
of
the
study.

870.5300
Mammalian
cells
in
culture
Forward
gene
mutation
assay
­
CHO
cells
Not
mutagenic
under
the
conditions
of
the
study.

870.5375
In
vitro
mammalian
chromosomal
aberrations
­
CHO
cells
Acetamiprid
is
a
clastogen
under
the
conditions
of
the
study.

870.5385
In
vivo
mammalian
chromosome
aberrations
­
rat
bone
marrow
Acetamiprid
did
not
induce
a
significant
increase
in
chromosome
aberrations
in
bone
marrow
cells
when
compared
to
the
vehicle
control
group.

870.5395
In
vivo
mammalian
cytogenetics
­
micronucleus
assay
in
mice
Acetamiprid
is
not
a
clastogen
in
the
mouse
bone
marrow
micronucleus
test.

870.5550
UDS
assay
in
primary
rat
hepatocytes/
mammalian
cell
culture
Acetamiprid
tested
negatively
for
UDS
in
mammalian
hepatocytes
in
vivo.

870.6200
Acute
neurotoxicity
in
rats
NOAEL:
10
mg/
kg
LOAEL:
30
mg/
kg
(
reduction
in
locomotor
activity).

870.6200
Subchronic
neurotoxicity
in
rats
NOAEL:
14.8/
16.3
mg/
kg/
day
(
M/
F)
LOAEL:
59.7/
67.6
mg/
kg/
day
(
M/
F:
reductions
in
BW,
BW
gain,
food
consumption
and
food
efficiency).

N/
A
28
 
Day
feeding
in
dogs
NOAEL:
16.7/
19.1
mg/
kg/
day
(
M/
F)
LOAEL:
28.0/
35.8
mg/
kg/
day
(
reduced
BW
gain).

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TABLE
1.
 
SUBCHRONIC,
CHRONIC,
AND
OTHER
TOXICITY
 
Continued
Guideline
No.
Study
Type
Results
870.7485
Metabolism
in
rats
Extensively
and
rapidly
metabolized.
Metabolizes
79
 
86%
of
administered
dose.
Profiles
similar
for
males
and
females
for
both
oral
and
intravenous
dosing.
Three
to
seven
percent
of
dose
recovered
in
urine
and
feces
as
unchanged
test
article.
Urinary
and
fecal
metabolites
from
15
 
day
repeat
dose
experiment
only
showed
minor
differences
from
single­
dose
test.
Initial
Phase
I
biotransformation
Demethylation
of
parent.
6­
chloronicotinic
acid
most
prevalent
metabolite.
Phase
II
metabolism
shown
by
increase
in
glycine
conjugate.

870.7485
Metabolism
in
mice,
rats,
and
rabbits
(
Special
study)
Male
mice,
rats
or
rabbits
were
administered
single
doses
of
acetamiprid
by
gavage,
intraperitoneal
injection
(
i.
p.)
or
intravenous
injection
(
i.
v.)
up
to
60
mg/
kg.
The
animals
were
assessed
for
a
variety
of
neurobehavioral
parameters
In
vitro
experiments
were
also
done
using
isolated
ileum
sections
from
guinea
pigs
to
assess
contractile
responses
in
the
absence
and
presence
of
agonists
(
acetylcholine,
histamine
diphosphate,
barium
chloride
and
nicotine
tartrate).
Acetamiprid
was
also
assessed
via
i.
v.
in
rabbits
for
effects
on
respiratory
rate,
heart
rate
and
blood
pressure;
via
gavage
in
mice
for
effects
on
gastrointestinal
motility;
and
via
i.
p.
in
rats
for
effects
on
water
and
electrolyte
balance
in
urine,
and
blood
coagulation,
hemolytic
potential
and
plasma
cholinesterase
activity.
Based
on
a
number
of
neuromuscular
behavioral
and
physiological
effects
of
acetamiprid
in
male
mice,
under
the
conditions
of
this
study,
a
overall
NOAEL
of
10
mg/
kg
(
threshold)
and
LOAEL
of
20
mg/
kg
could
be
estimated
for
a
single
dose
by
various
exposure
routes.

870.7600
Dermal
absorption
The
majority
of
the
dose
was
washed
off
with
the
percent
increasing
with
dose.
Skin
residue
was
the
next
largest
portion
of
the
dose
with
the
percent
decreasing
with
dose.
In
neither
case
was
there
evidence
of
an
exposure
related
pattern.
Absorption
was
small
and
increased
with
duration
of
exposure.
Since
there
are
no
data
to
demonstrate
that
the
residues
remaining
on
the
skin
do
not
enter
the
animal,
then
as
a
conservative
estimate
of
dermal
absorption,
residues
remaining
on
the
skin
will
be
added
to
the
highest
dermal
absorption
value.
The
potential
total
absorption
at
24
hours
could
be
approximately
30%.

B.
Toxicological
Endpoints
The
dose
at
which
no
adverse
effects
are
observed
(
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
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
intraspecies
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
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
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Rules
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Regulations
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
acetamiprid
used
for
human
risk
assessment
is
shown
in
the
following
Table
2
of
this
unit:

TABLE
2.
 
SUMMARY
OF
TOXICOLOGICAL
DOSE
AND
ENDPOINTS
FOR
ACETAMIPRID
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
(
general
population
including
infants
and
children)
NOAEL
=
10
mg/
kg/
day
UF
=
100
Acute
RfD
=
0.10
mg/
kg/
day
FQPA
SF
=
1X
aPAD
=
acute
RfD/
FQPA
SF
=
0.10
mg/
kg/
day
Acute
neurotoxicity
study
LOAEL
=
30
mg/
kg/
day
based
on
decrease
in
locomotor
activity
in
males.

Chronic
dietary
(
all
populations)
NOAEL=
7.1
mg/
kg/
day
UF
=
100
Chronic
RfD
=
0.07
mg/
kg/
day
FQPA
SF
=
1X
cPAD
=
chronic
RfD/
FQPA
SF
=
0.07
mg/
kg/
day
Chronic
feeding/
oncology
study
in
rats.
LOAEL
=
17.5
mg/
kg/
day
based
on
decrease
in
body
weight/
body
weight
gain
and
hepatocellular
vacuolation.

Short­
term
(
1
to
30
days)
and
intermediate­
term
(
1
to
6
months)
Incidental
Oral
NOAEL=
15
mg/
kg/
day
LOC
for
MOE
=
100
(
Residential
13
 
Week
feeding
study
in
rats;
subchronic
neurotoxicity
in
rats;
developmental
toxicity
in
rats.
LOAEL
=
50
mg/
kg/
day
based
on
decrease
in
body
weight/
body
weight
gain,
food
consumption
and
food
efficiency.

Short­
term
(
1
to
30
days)
and
intermediate­
erm
(
1
to
6
months)
dermal
Oral
NOAEL
=
17.9
mg/
kg/
day
(
dermal
absorption
factor
=
30%)
LOC
for
MOE
=
100
(
Residential
LOC
for
MOE
=
100
(
Occupational
2
 
Generation
reproduction
study.
LOAEL
=
51
mg/
kg/
day
based
on
delay
in
preputial
separation,
vaginal
opening,
eye
opening
and
pinna
unfolding;
reduced
litter
size,
viability
and
weaning
indices
in
offspring

Long­
term
dermal
(>
6
months)
Oral
NOAEL=
mg/
kg/
day
(
dermal
absorption
factor
=
30%)
LOC
for
MOE
=
100
(
Residential
LOC
for
MOE
=
100
(
Occupational
Chronic
feeding/
oncology
study
in
rats.
LOAEL
=
17.5
mg/
kg/
day
based
on
decrease
in
body
weight/
body
weight
gain
and
hepatocellular
vacuolation.

Short­
term
(
1
to
30
days)
and
intermediate­
term
(
1
to
6
months)
Inhalation
Oral
NOAEL
=
17.9
mg/
kg/
day
(
inhalation
absorption
factor
=
100%)
LOC
for
MOE
=
100
(
Residential
LOC
for
MOE
=
100
(
Occupational
2
 
Generation
reproduction
study.
LOAEL
=
51
mg/
kg/
day
based
on
delay
in
preputial
separation,
vaginal
opening,
eye
opening
and
pinna
unfolding;
reduced
litter
size,
viability
and
weaning
indices
in
offspring

Long­
term
inhalation
(>
6
months)
Oral
NOAEL
=
7.1
mg/
kg/
day
(
inhalation
absorption
factor
=
100%)
LOC
for
MOE
=
100
(
Residential
LOC
for
MOE
=
100
(
Occupational
Chronic
feeding/
oncology
study
in
rats.
LOAEL
=
17.5
mg/
kg/
day
based
on
decrease
in
body
weight/
body
weight
gain
and
hepatocellular
vacuolation.

Cancer
(
oral,
dermal,
inhalation)
­
Not
likely
to
be
carcinogenic.

*
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
180.578)
for
the
residues
of
acetamiprid,
in
or
on
a
variety
of
raw
agricultural
commodities.
Tolerances
for
acetamiprid
range
from
0.2
to
20
ppm
in
plant
commodities
and
range
from
0.01
to
0.2
ppm
in
livestock
commodities.
Risk
assessments
were
conducted
by
EPA
to
assess
dietary
exposures
from
acetamiprid
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
one
day
or
single
exposure.
The
Dietary
Exposure
Evaluation
Model
(
DEEMTM)
analysis
evaluated
the
individual
food
consumption
as
reported
by
respondents
in
the
USDA
1989
 
1992
nationwide
Continuing
Surveys
of
Food
Intake
by
Individuals
(
CSFII)
and
accumulated
exposure
to
the
chemical
for
each
commodity.
The
following
assumptions
were
made
for
the
acute
exposure
assessments:
The
assessment
assumed
that
100%
of
the
proposed
crops
and
all
other
crops
having
acetamiprid
tolerances
were
treated
and
that
all
treated
crops
and
livestock
had
residues
of
concern
at
the
tolerance
level.
The
general
U.
S.
population
and
all
population
subgroups
have
exposure
and
risk
estimates
which
are
below
EPA's
LOC
(
i.
e.,
the
aPADs
are
all
below
100%).
The
most
highly
exposed
subgroup
is
children
1
to
6
years
of
age,
which
utilizes
40%
of
the
aPAD.
ii.
Chronic
exposure.
In
conducting
this
chronic
dietary
risk
assessment
the
DEEMTM
analysis
evaluated
the
individual
food
consumption
as
reported
by
respondents
in
the
USDA
1989
 
1992
nationwide
CSFII
and
accumulated
exposure
to
the
chemical
for
each
commodity.
The
following
assumptions
were
made
for
the
chronic
exposure
assessments:
The
assessment
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/
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and
Regulations
assumed
that
100%
of
the
proposed
crops
and
all
other
crops
having
acetamiprid
tolerances
were
treated
and
that
all
treated
crops
and
livestock
had
residues
of
concern
at
the
tolerance
level.
The
general
U.
S.
population
and
all
population
subgroups
have
exposure
and
risk
estimates
which
are
below
EPA's
LOC
(
i.
e.,
the
cPADs
are
all
below
100%).
The
most
highly
exposed
subgroup
is
children
1
to
6
years
of
age,
which
utilizes
21%
of
the
cPAD.
iii.
Cancer.
EPA
has
determined
that
acetamiprid
is
not
likely
to
be
a
human
carcinogen
and
EPA,
therefore,
does
not
expect
it
to
pose
a
cancer
risk.
As
a
result,
a
quantitative
cancer
dietary
exposure
analysis
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
acetamiprid
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
acetamiprid.
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
Screening
Concentrations
in
Ground
Water
(
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
high­
end
runoff
scenario
for
pesticides.
While
both
FIRST
and
PRZM/
EXAMS
incorporate
an
index
reservoir
environment,
the
PRZM/
EXAMS
model
includes
a
percent
crop
area
factor
as
an
adjustment
to
account
for
the
maximum
percent
crop
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
acetamiprid
they
are
further
discussed
in
the
aggregate
risk
sections
in
Unit
III.
E.
Based
on
the
FIRST
and
SCI­
GROW
models
the
EECs
of
acetamiprid
for
acute
exposures
are
estimated
to
be
17
parts
per
billion
(
ppb)
for
surface
water
and
0.0008
ppb
for
ground
water.
The
EECs
for
chronic
exposures
are
estimated
to
be
4
ppb
for
surface
water
and
0.0008
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).
Acetamiprid
is
currently
registered
for
use
on
the
following
residential
nondietary
sites:
As
an
outdoor
insecticide
on
ornamentals,
flowers,
vegetable
gardens,
and
fruit
trees.
The
risk
assessment
was
conducted
using
the
following
residential
exposure
assumptions:
Residential
handlers
(
homeowners)
are
assumed
to
make
the
maximum
number
of
applications
at
maximum
use
rates
with
little
use
of
any
protective
equipment.
Potential
dermal
and
inhalation
doses
that
homeowners
may
receive
during
applications
of
pesticides
to
the
garden,
around
walkways,
driveways,
foundations,
vegetables,
and
ornamentals
were
considered;
therefore,
exposures
and
risks
are
calculated
for
both
dermal
and
inhalation
exposures.
This
scenario
assumes
that
pesticides
are
available
for
inhalation
or
have
the
potential
to
come
in
contact
with
the
skin
of
adults
and
youths
during
the
mixing/
loading
and
application
of
pesticides
used
around
the
garden.
The
short­
and
intermediate­
term
handler
MOEs
for
the
residential
uses
of
acetamiprid
for
both
age
groups
of
adults
and
youth
are
at
or
greater
than
120,000
for
all
exposure
scenarios,
and
therefore
represent
risks
that
are
below
EPA's
level
of
concern.
Postapplication
exposures
were
calculated
assuming
dermal
exposure
to
adults
and
children
while
working
in
treated
gardens
or
with
various
fruit
trees
and
ornamentals.
Inhalation
exposure
was
not
quantitatively
addressed
because
exposure
by
inhalation
is
considered
minimal
due
to
the
air
exchange
that
occurs
in
outdoor
scenarios.
In
addition,
toddlers
are
not
expected
to
spend
a
significant
amount
of
time
in
a
home
garden
and
any
resulting
incidental
oral
exposures
would
be
minimal
and
not
quantifiable;
therefore,
EPA
does
not
believe
that
incidental
oral
exposure
from
the
registered
homeowner
uses
will
result
in
significant
incidental
oral
exposures
to
children.
This
scenario
assumes
that
pesticide
residues
are
transferred
to
the
skin
of
adults
and
youth
who
enter
treated
gardens
for
gardening
or
other
homeowner
activities.
The
short­
and
intermediate­
term
postapplication
MOEs
for
the
residential
uses
of
acetamiprid
for
both
age
groups
of
adults
and
youth
are
at
or
greater
than
18,000
for
all
exposure
scenarios,
and
therefore
represent
risks
that
are
below
EPA's
level
of
concern.
4.
Cumulative
effects
from
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
acetamiprid
has
a
common
mechanism
of
toxicity
with
other
substances.
Unlike
other
pesticides
for
which
EPA
has
followed
a
cumulative
risk
approach
based
on
a
common
mechanism
of
toxicity,
EPA
has
not
made
a
common
mechanism
of
toxicity
finding
as
to
acetamiprid
and
any
other
substances,
and
acetamiprid
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
acetamiprid
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
policy
statements
released
by
EPA's
Office
of
Pesticide
Programs
concerning
common
mechanism
determinations
and
procedures
for
cumulating
effects
from
substances
found
to
have
a
common
mechanism
on
EPA's
website
at
http://
www.
epa.
gov/
pesticides/
cumulative.

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/
Rules
and
Regulations
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
data
base
on
toxicity
and
exposure
unless
EPA
determines
that
a
different
margin
of
safety
will
be
safe
for
infants
and
children.
Margins
of
safety
are
incorporated
into
EPA
risk
assessments
either
directly
through
use
of
a
MOE
analysis
or
through
using
uncertainty
(
safety)
factors
in
calculating
a
dose
level
that
poses
no
appreciable
risk
to
humans.
2.
Prenatal
and
postnatal
sensitivity.
Neither
quantitative
nor
qualitative
evidence
of
increased
susceptibility
of
fetuses
to
in
utero
exposure
to
acetamiprid
was
observed
in
the
developmental
toxicity
studies
in
rats
and
rabbits.
In
the
multigeneration
reproductive
study,
qualitative
evidence
of
increased
susceptibility
of
rat
pups
is
observed
since
the
offspring
effects
are
considered
to
be
more
severe
than
the
parental
effects.
However,
quantitative
evidence
of
increased
susceptibility
of
rat
pups
was
not
observed
since
the
parental
and
offspring
NOAELs
and
LOAELs
are
at
the
same
doses.
Since
there
is
qualitative
evidence
of
increased
susceptibility
of
the
young
following
exposure
to
acetamiprid
in
the
rat
reproduction
study,
EPA
performed
a
Degree
of
Concern
analysis
to
determine
the
level
of
concern
for
the
effects
observed
when
considered
in
the
context
of
all
available
toxicity
data,
and
to
identify
any
residual
uncertainties
after
establishing
toxicity
endpoints
and
traditional
uncertainty
factors
to
be
used
in
the
risk
assessment
of
this
chemical.
If
residual
uncertainties
are
identified,
EPA
examines
whether
these
residual
uncertainties
can
be
addressed
by
a
special
FQPA
safety
factor
and,
if
so,
the
size
of
the
factor
needed.
The
multigeneration
reproduction
study
in
rats
was
used
for
the
Degree
of
Concern
analysis.
In
that
rat
reproduction
study,
qualitative
susceptibility
was
evidenced
as
significant
reductions
in
pup
weights
in
both
generations,
reductions
in
litter
size,
and
viability
and
weaning
indices
among
F2
offspring
as
well
as
significant
delays
in
the
age
to
attain
vaginal
opening
and
preputial
separation
in
the
presence
of
lesser
maternal
toxicity
(
reductions
in
body
weight,
body
weight
gain
and
food
consumption)
at
the
highest
dose
tested.
Considering
the
overall
toxicity
profile
and
the
doses
and
endpoints
selected
for
risk
assessment
for
acetamiprid,
the
EPA
characterized
the
degree
of
concern
for
the
effects
observed
in
this
study
as
low,
noting
that
there
is
a
clear
NOAEL
for
the
offspring
effects
observed
and
that
these
effects
occurred
in
the
presence
of
parental
toxicity
and
only
at
the
highest
dose
tested.
No
residual
uncertainties
were
identified.
The
NOAEL
for
offspring
effects
in
this
reproduction
study
(
17.9
mg/
kg/
day)
is
used
as
the
basis
for
short­
and
intermediate­
term
dermal
and
inhalation
exposure
scenarios.
For
all
other
toxicity
endpoints
established
for
acetamiprid,
a
NOAEL
lower
than
this
offspring
NOAEL
is
used.
For
the
reasons
stated
above,
EPA
has
concluded
that
there
is
low
concern
for
prenatal
and/
or
postnatal
toxicity
resulting
from
exposure
to
acetamiprid.
3.
Conclusion.
The
toxicology
data
base
is
not
complete
for
FQPA
purposes.
EPA
has
determined
that
a
developmental
neurotoxicity
study
in
rats
should
be
conducted.
The
need
for
a
developmental
neurotoxicity
study
is
based
on
the
consideration
that
clinical
signs
of
neurotoxicity
were
observed
on
the
day
of
dosing
in
the
acute
neurotoxicity
study
in
rats.
In
addition,
acetapmiprid
is
structurally
related
to
thiamethoxam
and
imidacloprid,
both
of
which
are
neonicotinoids.
Imidacloprid
is
a
chloronicotinyl
compound
and
is
an
analog
to
nicotine.
Studies
in
the
published
literature
suggest
that
nicotine,
when
administered
causes
developmental
toxicity,
including
functional
deficits,
in
animals
and/
or
humans
that
are
exposed
in
utero.
With
imidacloprid,
there
is
evidence
that
administration
causes
clinical
signs
of
neurotoxicity
following
a
single
oral
dose
in
the
acute
study
and
alterations
in
brain
weight
in
rats
in
the
2
 
year
carcinogenicity
study.
With
thiamethoxam,
there
was
also
evidence
of
clinical
signs
of
neurotoxicity
in
the
acute
neurotoxicity
study.
There
are
also
indications
that
thiamethoxam
may
affect
the
endocrine
system.
Recently,
EPA
has
received
objections
to
tolerances
for
residues
of
acetamiprid
from
the
Natural
Resources
Defense
Council
(
NRDC).
NRDC
asserted
that
EPA
is
missing
data
bearing
on
oral
exposure
to
acetamiprid
from
residential
uses
of
the
pesticide.
The
Federal
Register
notice
on
the
contested
acetamiprid
tolerance
notes
that
``
incidental
oral
exposure
is
an
insignificant
pathway
of
exposure''
for
acetamiprid
(
67
FR
14649,
14657;
March
27,
2002).
As
noted
above,
little
or
no
incidental
oral
exposure
is
expected
since
acetamiprid's
residential
uses
are
limited
to
ornamentals,
flowers,
vegetable
gardens,
and
fruit
trees.
Incidental
oral
exposure
to
pesticides
can
occur
when
young
children
engage
in
``
mouthing''
behavior
(
i.
e.
repeatedly
placing
their
hands
or
other
objects
in
their
mouth)
in
a
location
where
a
pesticide
is
present.
EPA
assumes
that
incidental
oral
exposure
to
a
pesticide
may
occur
when
a
pesticide
is
used
to
treat
a
home
lawn
because
young
children
frequently
play
on
home
lawns.
EPA,
however,
considers
it
unlikely
that
young
children
would
spend
an
extended
time
in
flower,
vegetable,
or
ornamental
gardens,
and
thus
treatment
of
such
gardens
with
a
pesticide
is
not
likely
to
lead
to
a
significant
exposure
to
children
by
the
incidental
oral
route.
The
NRDC
also
claimed
that
a
10X
safety
factor
should
be
used
to
account
for
the
lack
of
the
developmental
neurotoxicity
study.
However,
it
has
been
noted
that
reliable
developmental
neurotoxicity
data
received
and
reviewed
for
other
structurally­
related
compounds
in
this
chemical
class
(
neonicotinoids),
including
thiacloprid,
clothianidin,
and
imidacloprid,
demonstrated
that
the
developmental
neurotoxicity
had
no
effect
on
the
regulatory
endpoint
for
those
pesticides.
Therefore,
EPA
believes
that
the
results
of
the
required
developmental
neurotoxicity
study
will
not
likely
impact
the
regulatory
doses
selected
for
acetamiprid.
It
is
further
noted
that
the
requirement
of
a
developmental
neurotoxicity
study
is
not
based
on
criteria
reflecting
special
concern
for
the
developing
fetuses
or
young
(
e.
g.,
neuropathy
in
adult
animals;
CNS
malformations
following
prenatal
exposure;
brain
weight
or
sexual
maturation
changes
in
offspring;
and/
or
functional
changes
in
offspring).
On
this
basis,
EPA
concluded
that
a
data
base
uncertainty
factor
is
not
needed
to
account
for
the
lack
of
the
developmental
neurotoxicity
study
with
acetamiprid,
and
that
reliable
data
support
removing
the
additional
safety
factor
for
the
protection
of
infants
and
children.

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
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/
Rules
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Regulations
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,
OPP
concludes
with
reasonable
certainty
that
exposures
to
the
pesticide
in
drinking
water
(
when
considered
along
with
other
sources
of
exposure
for
which
OPP
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,
OPP
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.
Using
the
exposure
assumptions
discussed
in
this
unit
for
acute
exposure,
the
acute
dietary
exposure
from
food
to
acetamiprid
will
occupy
17%
of
the
aPAD
for
the
U.
S.
population,
11%
of
the
aPAD
for
females
13
years
and
older,
38%
of
the
aPAD
for
infants
less
than
1
year
of
age
and
40%
of
the
aPAD
for
children
1
to
6
years
of
age.
In
addition,
there
is
potential
for
acute
dietary
exposure
to
acetamiprid
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
aPAD,
as
shown
in
the
following
Table
3
of
this
unit:

TABLE
3.
 
AGGREGATE
RISK
ASSESSMENT
FOR
ACUTE
EXPOSURE
TO
ACETAMIPRID
Population
Subgroup
aPAD
(
mg/
kg)
%
aPAD
(
Food)
Surface
Water
EEC
(
ppb)
Ground
Water
EEC
(
ppb)
Acute
DWLOC
(
ppb)

U.
S.
population
0.10
17
17
0.0008
2,900
All
Infants
(<
1
year)
0.10
38
17
0.0008
620
Children
1
to
6
years
0.10
40
17
0.0008
600
Females
13
to
50
years
0.10
11
17
0.0008
2,700
2.
Chronic
risk.
Using
the
exposure
assumptions
described
in
this
unit
for
chronic
exposure,
EPA
has
concluded
that
exposure
to
acetamiprid
from
food
will
utilize
8%
of
the
cPAD
for
the
U.
S.
population,
15%
of
the
cPAD
for
infants
less
than
1
year
of
age
and
21%
of
the
cPAD
for
children
1
to
6
years
of
age.
Based
upon
the
use
pattern,
chronic
residential
exposure
to
residues
of
acetamiprid
is
not
expected.
In
addition,
there
is
potential
for
chronic
dietary
exposure
to
acetamiprid
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
4
of
this
unit:

TABLE
4.
 
AGGREGATE
RISK
ASSESSMENT
FOR
CHRONIC
(
NON­
CANCER)
EXPOSURE
TO
ACETAMIPRID
Population
Subgroup
cPAD
mg/
kg/
day
%
cPAD
(
Food)
Surface
Water
EEC
(
ppb)
Ground
Water
EEC
(
ppb)
Chronic
DWLOC
(
ppb)

U.
S.
population
0.07
8
4
0.0008
2,260
All
infants
(<
1
year)
0.07
15
4
0.0008
600
Children
1
to
6
years
0.07
21
4
0.0008
550
3.
Short­
and
intermediate­
term
risk.
Short­
and
intermediate­
term
aggregate
exposure
takes
into
account
residential
exposure
plus
chronic
exposure
to
food
and
water
(
considered
to
be
a
background
exposure
level).
Acetamiprid
is
currently
registered
for
use
that
could
result
in
short­
and
intermediate­
term
residential
exposure
and
the
Agency
has
determined
that
it
is
appropriate
to
aggregate
chronic
food
and
water
and
short­
and
intermediateterm
exposures
for
acetamiprid.
Using
the
exposure
assumptions
described
in
this
unit
for
short­
and
intermediate­
term
exposures,
EPA
has
concluded
that
food
and
residential
exposures
aggregated
result
in
aggregate
MOEs
of
18,000
for
U.
S.
population
and
23,000
for
children
7
to
12
years
of
age.
These
aggregate
MOEs
do
not
exceed
the
Agency's
level
of
concern
for
aggregate
exposure
to
food
and
residential
uses.
In
addition,
short­
and
intermediate­
term
DWLOCs
were
calculated
and
compared
to
the
EECs
for
chronic
exposure
of
acetamiprid
in
ground
and
surface
water.
After
calculating
DWLOCs
and
comparing
them
to
the
EECs
for
surface
and
ground
water,
EPA
does
not
expect
short­
and
intermediate­
term
aggregate
exposure
to
exceed
the
Agency's
level
of
concern,
as
shown
in
the
following
Table
5
of
this
unit:

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TABLE
5.
 
AGGREGATE
RISK
ASSESSMENT
FOR
SHORT­
AND
INTERMEDIATE­
TERM
EXPOSURE
TO
ACETAMIPRID
Population
Subgroup
Aggregate
MOE
(
Food
+
Residential
Aggregate
Level
of
Concern
(
LOC)
Surface
Water
EEC
(
ppb)
Ground
Water
EEC
(
ppb)
Short­/
Intermediate
Term
DWLOC
(
ppb)

U.
S.
population
18,000
100
4
0.0008
1,500
Children
7
to
12
years
23,000
100
4
0.0008
400
5.
Aggregate
cancer
risk
for
U.
S.
population.
Acetamiprid
has
been
classified
as
a
``
not
likely
human
carcinogen.''
Therefore,
it
is
not
expected
to
pose
a
cancer
risk.
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
acetamiprid
residues.

IV.
Other
Considerations
A.
Analytical
Enforcement
Methodology
Adequate
enforcement
methodology
(
solvent
extraction
followed
by
gas
chromatography/
electron
capture
detection
(
GC/
ECD)
determination
of
residues)
is
available
to
enforce
the
tolerance
expression.
The
method
may
be
requested
from:
Chief,
Analytical
Chemistry
Branch,
Environmental
Science
Center,
701
Mapes
Rd.,
Ft.
Meade,
MD
20755
 
5350;
telephone
number:
(
410)
305
 
2905;
e­
mail
address:
residuemethods@
epa.
gov.

B.
International
Residue
Limits
No
Codex,
Canadian,
or
Mexican
maximum
residue
levels
(
MRLs)
have
been
established
for
residues
of
acetamiprid.

V.
Conclusion
Therefore,
the
tolerance
is
established
for
residues
of
acetamiprid,
N1­[(
6­
chloro­
3­
pyridyl)
methyl]­
N2­
cyano­
N1­
methylacetamidine,
in
or
on
canola
seed
and
mustard
seed
at
0.01
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
 
0299
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
November
3,
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
 
0299,
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
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and
Regulations
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.
Statutory
and
Executive
Order
Reviews
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.
Congressional
Review
Act
The
Congressional
Review
Act,
5
U.
S.
C.
801
et
seq.,
as
added
by
the
Small
Business
Regulatory
Enforcement
Fairness
Act
of
1996,
generally
provides
that
before
a
rule
may
take
effect,
the
agency
promulgating
the
rule
must
submit
a
rule
report,
which
includes
a
copy
of
the
rule,
to
each
House
of
the
Congress
and
to
the
Comptroller
General
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:
August
22,
2003.
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
180.578
is
amended
by
alphabetically
adding
commodities
to
the
table
in
paragraph
(
a)(
1)
to
read
as
follows:

§
180.578
Acetamiprid;
tolerances
for
residues.

(
a)
*
*
*
(
1)
*
*
*

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Federal
Register
/
Vol.
68,
No.
170
/
Wednesday,
September
3,
2003
/
Rules
and
Regulations
Commodity
Parts
per
million
Canola,
seed
0.010
*
*
*
*
*
Mustard,
seed
0.010
*
*
*
*
*

*
*
*
*
*

[
FR
Doc.
03
 
22313
Filed
9
 
2
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP
 
2003
 
0288;
FRL
 
7323
 
9]

Bifenthrin;
Pesticide
Tolerance
for
Emergency
Exemption;
Technical
Amendment
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Final
rule;
technical
amendment.

SUMMARY:
EPA
issued
a
final
rule
in
the
Federal
Register
of
September
27,
2001,
to
establish
a
time­
limited
tolerance
for
residues
of
bifenthrin
in
or
on
sweet
potato.
This
action
was
in
response
to
EPA's
granting
of
an
emergency
exemption
under
section
18
of
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
authorizing
use
of
the
pesticide
on
sweet
potato.
This
document
is
being
issued
to
correct
typographical
errors
in
that
original
document.

DATES:
This
document
is
effective
on
September
3,
2003.

FOR
FURTHER
INFORMATION
CONTACT:
Andrea
Conrath,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
308
 
9356;
e­
mail
address:
conrath.
andrea@
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:
 
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
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
Copies
of
this
Document
and
Other
Related
Information?
1.
Docket.
EPA
has
established
an
official
public
docket
for
this
action
under
docket
identification
(
ID)
number
OPP
 
2003
 
0288.
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.
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.
Once
in
the
system,
select
``
search,''
then
key
in
the
appropriate
docket
ID
number.

II.
What
Does
this
Technical
Amendment
Do?
EPA
issued
a
final
rule
in
the
Federal
Register
of
September
27,
2001
(
66
FR
49300)(
FRL
 
6801
 
5),
to
establish
a
time­
limited
tolerance
for
residues
of
bifenthrin
in
or
on
sweet
potato.
This
action
was
in
response
to
EPA's
granting
of
an
emergency
exemption
under
section
18
of
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
authorizing
use
of
the
pesticide
on
sweet
potato.
The
amendment
to
establish
the
tolerance
for
bifenthrin
inadvertently
added
the
tolerance
for
``
sweet
potato''
to
40
CFR
180.442(
a).
However,
40
CFR
180.442(
a)
is
not
designated
for
section
18
emergency
exemptions;
consequently,
the
entry
for
sweet
potato
could
not
be
added
to
§
180.442(
a)
by
the
Office
of
the
Federal
Register.
This
technical
amendment
is
being
issued
to
correctly
add
the
tolerance
for
sweet
potato
to
the
table
in
§
180.442(
b),
which
is
designated
for
time­
limited
tolerances
associated
with
section
18
emergency
exemptions.
In
addition
to
correctly
adding
the
tolerance
to
paragraph
(
b)
of
§
180.442,
based
on
a
final
rule
issued
by
EPA
in
the
Federal
Register
of
July
1,
2003
(
68
FR
39427)(
FRL
 
7308
 
9),
EPA
is
also
changing
the
commodity
term
``
sweet
potato''
to
read
``
sweet
potato,
roots.''

III.
Why
is
this
Technical
Amendment
Issued
as
a
Final
Rule?
Section
553
of
the
Administrative
Procedure
Act
(
APA),
5
U.
S.
C.
553(
b)(
B),
provides
that,
when
an
Agency
for
good
cause
finds
that
notice
and
public
procedure
are
impracticable,
unnecessary
or
contrary
to
the
public
interest,
the
agency
may
issue
a
final
rule
without
providing
notice
and
an
opportunity
for
public
comment.
EPA
has
determined
that
there
is
good
cause
for
making
today's
technical
amendment
final
without
prior
proposal
and
opportunity
for
comment,
because
EPA
is
merely
correcting
the
placement
of
a
tolerance
already
issued
and
previously
published
as
a
final
rule,
and
the
commodity
term.
EPA
finds
that
this
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