[Federal Register Volume 68, Number 170 (Wednesday, September 3, 2003)]
[Rules and Regulations]
[Pages 52343-52353]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-22313]


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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: 
[email protected].

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: 
[email protected].

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 [email protected], 
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: [email protected]. 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