[Federal Register: September 3, 2003 (Volume 68, Number 170)]
[Rules and Regulations]
[Page 52343-52353]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03se03-9]
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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; e-mail 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:
[sbull] Crop Production (NAICS 111)
[sbull] Animal Production (NAICS 112)
[sbull] Food Manufacturing (NAICS 311)
[sbull] 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
[[Page 52344]]
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-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 NOAEL: 12.4/14.6
toxicity in rats 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 NOAEL: 106.1/129.4
toxicity in mice 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 NOAEL: 13/14 mg/kg/
toxicity in dogs day (M/F)
LOAEL: 32 mg/kg/
day (reduced BW
gain in both
sexes).
------------------------------------------------------------------------
870.3200 21-Day dermal NOAEL: 1,000 mg/kg/
toxicity in day (HDT)
rabbits LOAEL: >1,000 mg/
kg/day
------------------------------------------------------------------------
870.3700 Developmental Maternal NOAEL: 16
toxicity in rats 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 Maternal NOAEL: 15
toxicity in mg/kg/day
rabbits Maternal LOAEL:
30mg/kg/day (BW
loss and
decreased food
consumption).
Developmental
NOAEL: 30 mg/kg/
day (HDT)
Developmental
LOAEL: 30 mg/kg/day
------------------------------------------------------------------------
[[Page 52345]]
870.3800 2-Generation Parental systemic
reproduction in NOAEL: 17.9/21.7
rats 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 NOAEL: 20/21 mg/kg/
dogs day (M/F)
LOAEL: 55/61 mg/kg/
day (M/F: initial
BW loss and
overall reduction
in BW gain).
------------------------------------------------------------------------
870.4200 Carcinogenicity in NOAEL: 20.3/75.9
mice 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 NOAEL: 7.1/8.8 mg/
rats 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 Not mutagenic
typhimurium/E. under the
coli Reverse gene conditions of the
mutation assay study.
------------------------------------------------------------------------
870.5300 Mammalian cells in Not mutagenic
culture Forward under the
gene mutation conditions of the
assay - CHO cells study.
------------------------------------------------------------------------
870.5375 In vitro mammalian Acetamiprid is a
chromosomal clastogen under
aberrations - CHO the conditions of
cells the study.
------------------------------------------------------------------------
870.5385 In vivo mammalian Acetamiprid did
chromosome not induce a
aberrations - rat significant
bone marrow increase in
chromosome
aberrations in
bone marrow cells
when compared to
the vehicle
control group.
------------------------------------------------------------------------
870.5395 In vivo mammalian Acetamiprid is not
cytogenetics - a clastogen in
micronucleus the mouse bone
assay in mice marrow
micronucleus
test.
------------------------------------------------------------------------
870.5550 UDS assay in Acetamiprid tested
primary rat negatively for
hepatocytes/ UDS in mammalian
mammalian cell hepatocytes in
culture vivo.
------------------------------------------------------------------------
870.6200 Acute NOAEL: 10 mg/kg
neurotoxicity in LOAEL: 30 mg/kg
rats (reduction in
locomotor
activity).
------------------------------------------------------------------------
870.6200 Subchronic NOAEL: 14.8/16.3
neurotoxicity in mg/kg/day (M/F)
rats 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 NOAEL: 16.7/19.1
dogs mg/kg/day (M/F)
LOAEL: 28.0/35.8
mg/kg/day
(reduced BW
gain).
------------------------------------------------------------------------
[[Page 52346]]
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 Male mice, rats or
mice, rats, and rabbits were
rabbits (Special administered
study) 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
[[Page 52347]]
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
----------------------------------------------------------------------------------------------------------------
FQPA SF* and Level of
Exposure Scenario Dose Used in Risk Concern for Risk Study and Toxicological
Assessment, UF Assessment Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (general population NOAEL = 10 mg/kg/day FQPA SF = 1X Acute neurotoxicity
including infants and children) UF = 100............... aPAD = acute RfD/FQPA study
Acute RfD = 0.10 mg/kg/ SF. LOAEL = 30 mg/kg/day
day. = 0.10 mg/kg/day....... based on decrease in
locomotor activity in
males.
-----------------------------------------------------------------------------------------
Chronic dietary (all populations) NOAEL= 7.1 mg/kg/day FQPA SF = 1X Chronic feeding/
UF = 100............... cPAD =................. oncology study in
Chronic RfD = 0.07 mg/ chronic RfD/FQPA SF = rats.
kg/day. 0.07 mg/kg/day. 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 NOAEL= 15 mg/kg/day LOC for MOE = 100 13-Week feeding study
intermediate-term (1 to 6 months) (Residential) in rats; subchronic
Incidental Oral 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 Oral NOAEL = 17.9 mg/kg/ LOC for MOE = 100 2-Generation
intermediate-erm (1 to 6 months) day (Residential) reproduction study.
dermal (dermal absorption LOC for MOE = 100 LOAEL = 51 mg/kg/day
factor = 30%). (Occupational). 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 LOC for MOE = 100 Chronic feeding/
(dermal absorption (Residential) oncology study in
factor = 30%). LOC for MOE = 100 rats.
(Occupational). 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 Oral NOAEL = 17.9 mg/kg/ LOC for MOE = 100 2-Generation
intermediate-term (1 to 6 months) day (Residential) reproduction study.
Inhalation (inhalation absorption LOC for MOE = 100 LOAEL = 51 mg/kg/day
factor = 100%). (Occupational). 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/ LOC for MOE = 100 Chronic feeding/
day (Residential) oncology study in
(inhalation absorption LOC for MOE = 100 rats.
factor = 100%). (Occupational). 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 food-use 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
[[Page 52348]]
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 non-occupational, 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 non-dietary 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
.
[[Page 52349]]
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
[[Page 52350]]
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
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup aPAD (mg/ % aPAD Water EEC Water EEC Acute DWLOC
kg) (Food) (ppb) (ppb) (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
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup cPAD mg/kg/ %cPAD Water EEC Water EEC Chronic
day (Food) (ppb) (ppb) 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 intermediate-term 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:
[[Page 52351]]
Table 5.--Aggregate Risk Assessment for Short- and Intermediate-Term Exposure to Acetamiprid
----------------------------------------------------------------------------------------------------------------
Aggregate Short-/
Aggregate Level of Surface Ground Intermediate-
Population Subgroup MOE (Food + Concern Water EEC Water EEC Term DWLOC
Residential) (LOC) (ppb) (ppb) (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
[[Page 52352]]
copy of your request via e-mail to: opp-docket@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.
0
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346(a) and 371.
0
2. Section 180.578 is amended by alphabetically adding commodities to
the table in paragraph (a)(1) to read as follows:
Sec. 180.578 Acetamiprid; tolerances for residues.
(a) * * *
(1) * * *
[[Page 52353]]
----------------------------------------------------------------------------------------------------------------
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