[Federal Register Volume 67, Number 59 (Wednesday, March 27, 2002)]
[Rules and Regulations]
[Pages 14649-14660]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-7098]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301225; FRL-6829-3]
RIN 2070-AB78


Acetamiprid; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues 
ofacetamiprid N1-[(6-chloro-3-pyridyl)methyl]-N2-cyano-N1-
methylacetamidine in or on citrus dried pulp, citrus fruit group, 
cotton gin byproducts, cotton undelinted seed, grape, fruiting 
vegetable group, leafy brassica vegetable group, leafy vegetable 
(except brassica) group, pome fruit group, and tomato paste; and 
tolerances for the combined residues of acetamiprid and IM-2-1 N1-[(6-
chloro-3-pyridyl) methyl]-N2-cyano-acetamidine in or on fat, meat, and 
meat byproducts of cattle, hog, horse, goat, and sheep; milk; poultry 
eggs,fat, liver, and meat. Aventis CropScience requested these 
tolerances under the Federal Food, Drug, and Cosmetic Act, as amended 
by the Food Quality Protection Act of 1996.

DATES: This regulation is effective March 27, 2002. Objections and 
requests for hearings, identified by docket control number OPP-301225, 
must be received on or before May 28, 2002.

ADDRESSES: Written objections and hearing requests may besubmitted by 
mail, in person, or by courier. Please follow the detailed instructions 
for each method as provided in Unit VI of the SUPPLEMENTARY 
INFORMATION. To ensure proper receipt by EPA, your objections and 
hearing requests must identify docket control number OPP-301225 in the 
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Akiva Abramovitch, 
Registration Division (7505C), Office of Pesticide Programs, 
EnvironmentalProtection Agency, 1200 Pennsylvania Ave., NW.,Washington, 
DC 20460; 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 affected by this action if you are an agricultural 
producer, food manufacturer, or pesticide manufacturer. Potentially 
affected categories and entities may include, but are not limited to:

------------------------------------------------------------------------
                                                          Examples of
           Categories                 NAICS codes         potentially
                                                       affected entities
------------------------------------------------------------------------
Industry                          111                 Crop production
                                  112...............  Animal production
                                  311...............  Food manufacturing
                                  32532.............  Pesticide
                                                       manufacturing
------------------------------------------------------------------------

    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in the table could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether or not this action might apply to certain entities. If you have 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

[[Page 14650]]

B. How Can I Get Additional Information, Including Copies of this 
Document and Other Related Documents?

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov. 
To access this document, on the Home Page select ``Laws and 
Regulations'', ``Regulations and Proposed Rules,'' and then look up the 
entry for this document under the ``Federal Register--Environmental 
Documents.'' You can also go directly to 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.
    2. In person. The Agency has established an official record for 
this action under docket control number OPP-301225. The official record 
consists of the documents specifically referenced in this action, and 
other information related to this action, including any information 
claimed as Confidential Business Information (CBI). This official 
record includes the documents that are physically located in the 
docket, as well as the documents that are referenced in those 
documents. The public version of the official record does not include 
any information claimed as CBI. The public version of the official 
record, which includes printed, paper versions of any electronic 
comments submitted during an applicable comment period is available for 
inspection in the Public Information and Records Integrity Branch 
(PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., 
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

II. Background and Statutory Findings

    In the Federal Register of May 30, 2001 (66 FR 29213)(FRL-6782-9), 
EPA issued a notice pursuant to section 408 of the Federal Food, Drug, 
and Cosmetic Act (FFDCA), 21 U.S.C. 346a, as amended by the Food 
Quality Protection Act of 1996 (FQPA) (Public Law 104-170), announcing 
the filing of a pesticide petition (PP 0F06082) by Aventis CropScience 
(formerly Rhone-Poulenc Ag Company), P.O. Box 12014, #2 T.W. Alexander 
Drive, Research Triangle Park, NC 207709. This notice included a 
summary of the petition prepared by Aventis CropScience, the 
registrant. There were no comments received in response to the notice 
of filing.
    The petition requested that 40 CFR part 180 be amended by 
establishing tolerances for residues of the insecticide acetamiprid N1-
[(6-chloro-3-pyridyl)methyl]-N2-cyano-N1-methylacetamidine, in or on 
brassica (cole crops) at 1.2 parts per million (ppm), canola seed and 
mustard seed at 0.01 ppm, citrus at 0.5 ppm, cottonseed at 0.06 ppm, 
fruiting vegetables at 0.2 ppm, grapes at 0.2 ppm, leafy vegetables at 
3.0 ppm, and pome fruits at 0.70 ppm. The Agency will not address the 
canola seed and mustard seed tolerances at this time.
    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) 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) 
requires EPA to give special consideration to exposure of infants and 
children to the pesticide chemical residue in establishing a tolerance 
and to ``ensure that there is a reasonable certainty that no harm will 
result to infants and children from aggregate exposure to the pesticide 
chemical residue....''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 and a complete description of 
the risk assessment process, see the final rule on Bifenthrin Pesticide 
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D), EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure, consistent with section 
408(b)(2), for tolerances for residues of the insecticide acetamiprid 
N1-[(6-chloro-3-pyridyl)methyl]- N2-cyano-N1-methylacetamidine in or on 
citrus fruit group at 0.50 ppm, citrus dried pulp and leafy brassica 
vegetable group at 1.20 ppm each, cotton gin byproducts at 20.0 ppm, 
cotton undelinted seed at 0.60 ppm, leafy vegetable group (except 
brassica) at 3.0 ppm, fruiting vegetable group and grape at 0.20 ppm 
each, pome fruit group at 1.0 ppm, and tomato paste at 0.40 ppm; and 
tolerances for the combined residues of acetamiprid and IM-2-1 N1-[(6-
chloro-3-pyridyl) methyl]-N2-cyano-acetamidine in or on meat and fat of 
cattle, hog, horse, goat, and sheep at 0.10 ppm each; meat byproducts 
of cattle, hog, horse, goat, and sheep at 0.20 ppm each; milk at 0.10 
ppm; poultry eggs, meat and fat at 0.010 ppm each; and poultry liver at 
0.050 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 the following Table 1 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
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             Guideline No.                       Study Type                            Results
----------------------------------------------------------------------------------------------------------------
870.3100                                 13-Week Feeding - Rat       NOAEL: 12.4/14.6 mg/kg/day - Male/Female (M/
                                                                      F)
                                                                     LOAEL: 50.8/56.0 mg/kg/day (M/F) based on
                                                                      decreased Body Weight (BW), BW gain and
                                                                      food consumption.
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[[Page 14651]]

 
870.3100                                 13-Week Feeding - Mouse     NOAEL: 106.1/129.4 mg/kg/day (M/F)
                                                                     LOAEL: 211.1/249.1 mg/kg/day (M/F) based on
                                                                      reduced BW and BW gain, decreased glucose
                                                                      and cholesterol levels, reduced absolute
                                                                      organ weights.
----------------------------------------------------------------------------------------------------------------
870.3150                                 90-Day oral toxicity in     NOAEL: 13/14 mg/kg/day (M/F)
                                          nonrodents                 LOAEL: 32 mg/kg/day based on reduced BW
                                                                      gain in both sexes.
----------------------------------------------------------------------------------------------------------------
870.3200                                 21-Day dermal toxicity -    NOAEL: 1,000 mg/kg/day - Highest Dose
                                          rabbit                      Tested (HDT)
                                                                     LOAEL: >1,000 mg/kg/day
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870.3700                                 Prenatal developmental in   Maternal NOAEL: 16 mg/kg/day
                                          rodents                    Maternal LOAEL: 50 mg/kg/day based on
                                                                      reduced BW and BW gain and
                                                                      foodconsumption, increased liver weights.
                                                                     Developmental NOAEL: 16 mg/kg/day
                                                                     Developmental LOAEL: 50 mg/kg/day based on
                                                                      increased incidence of shortening of the
                                                                      13th rib.
----------------------------------------------------------------------------------------------------------------
870.3700                                 Prenatal developmental in   Maternal NOAEL: 15 mg/kg/day
                                          nonrodents                 Maternal LOAEL: 30mg/kg/day based on BW
                                                                      loss and decreased food consumption.
                                                                     Developmental NOAEL: 30 mg/kg/day (HDT)
                                                                     Developmental LOAEL: > 30 mg/kg/day
----------------------------------------------------------------------------------------------------------------
870.3800                                 Reproduction and fertility  Parental systemic NOAEL: 17.9/21.7 mg/kg/
                                          effects                     day (M/F)
                                                                     Parental systemic LOAEL: 51.0/60.1 mg/kg/
                                                                      day (M/F) based on decreased BW, BW 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) based on 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) based on reductions in litter weights
                                                                      and individual pup weights on day of
                                                                      delivery.
----------------------------------------------------------------------------------------------------------------
870.4100                                 Chronic toxicity dogs       NOAEL: 20/21 mg/kg/day (M/F)
                                                                     LOAEL: 55/61 mg/kg/day (M/F) based on
                                                                      initial BW loss and overall reduction in
                                                                      BW gain.
----------------------------------------------------------------------------------------------------------------
870.4100/870.4200                        Chronic toxicity/           NOAEL: 7.1/8.8 mg/kg/day (M/F)
                                          Carcinogenicity - rats     LOAEL: 17.5/22.6 mg/kg/day (M/F) based on
                                                                      decreases in mean BW and BW gain (F) and
                                                                      hepatocellular vacuolation (M)
                                                                     Evidence of treatment-related increase in
                                                                      mammary tumors.
----------------------------------------------------------------------------------------------------------------
870.4300                                 Carcinogenicity mice        NOAEL: 20.3/75.9 mg/kg/day (M/F)
                                                                     LOAEL: 65.6/214.6 mg/kg/day (M/F) based on
                                                                      decreased BW and BW gain andamyloidosis in
                                                                      numerous organs (M) and decreased BW and
                                                                      BW gain (F). Not oncogenic under
                                                                      conditions of study.
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870.5100                                 Reverse gene mutation       Salmonella typhimurium/E. coli - Not
                                          assay                       mutagenic under the conditions of the
                                                                      study.
----------------------------------------------------------------------------------------------------------------
870.5300                                 Mammalian cells in          Not mutagenic under the conditions of the
                                          cultureForward gene         study.
                                          mutation assay - CHO
                                          cells
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870.5375                                 In vitro mammalian          Acetamiprid is a clastogen under the
                                          chromosomal aberrations -   conditions of the study.
                                          CHO cells
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870.5385                                 In vivo mammalian           Acetamiprid did not induce a significant
                                          chromosome aberrations -    increase in chromosome aberrations in bone
                                          rat bone marrow             marrow cells when compared to the vehicle
                                                                      control group.
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870.5395                                 In vivo mammalian           Acetamiprid is not a clastogen in the mouse
                                          cytogenetics -              bone marrow micronucleus test.
                                          micronucleus assay in
                                          mice
----------------------------------------------------------------------------------------------------------------
870.5550                                 UDS assay in primary rat    Acetamiprid tested negatively for UDS in
                                          hepatocytes/ mammalian      mammalian hepatocytes in vivo.
                                          cell culture

[[Page 14652]]

 
----------------------------------------------------------------------------------------------------------------
870.6200                                 Acute neurotoxicity - rat   NOAEL: 10 mg/kg
                                                                     LOAEL: 30 mg/kg based on reduction in
                                                                      locomotor activity.
----------------------------------------------------------------------------------------------------------------
870.6200                                 Subchronic neurotoxicity -  NOAEL: 14.8/16.3 mg/kg/day (M/F)
                                          rat                        LOAEL: 59.7/67.6 mg/kg/day (M/F) based on
                                                                      reductions in BW, BW gain, foodconsumption
                                                                      and food efficiency.
----------------------------------------------------------------------------------------------------------------
N/A                                      28-day feeding - dog        NOAEL: 16.7/19.1 mg/kg/day (M/F)
                                                                     LOAEL: 28.0/35.8 mg/kg/day based on reduced
                                                                      BW gain.
----------------------------------------------------------------------------------------------------------------
870.7485                                 Metabolism - mouse, rat,    Male mice, rats or rabbits were
                                          rabbit Special Study        administered single doses of acetamiprid
                                                                      by gavage, intraperitoneal injection
                                                                      (i.p.) or intravenous injection (i.v.) up
                                                                      to 60 mg/kg. The animals were assessed for
                                                                      a variety of neurobehavioral parameters.
                                                                      In vitro experiments were also done using
                                                                      isolated ileum sections from guinea pigs
                                                                      to assess contractile responses in the
                                                                      absence and presence of agonists
                                                                      (acetylcholine, histamine diphosphate,
                                                                      barium chloride and nicotine tartrate).
                                                                      Acetamiprid was also assessed via i.v. in
                                                                      rabbits for effects on respiratory rate,
                                                                      heart rate and blood pressure; via gavage
                                                                      in mice for effects on gastrointestinal
                                                                      motility; and via i.p. in rats for effects
                                                                      on water and electrolyte balance in urine,
                                                                      and blood coagulation, hemolytic potential
                                                                      and plasma cholinesterase activity. Based
                                                                      on a number of neuromuscular, behavioral
                                                                      and physiological effects of acetamiprid
                                                                      in male mice, under the conditions of this
                                                                      study, a overall NOAEL of 10 mg/kg
                                                                      (threshold) and LOAEL of 20 mg/kg could be
                                                                      estimated for a single dose by various
                                                                      exposure routes.
----------------------------------------------------------------------------------------------------------------
870.7485                                 Metabolism and              Extensively and rapidly metabolized.
                                          pharmacokinetics - rat      Metabolites 79-86% of administered dose.
                                                                      Profiles similar for males and females for
                                                                      both oral and intravenous dosing. Thirty-
                                                                      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-chloronicotinicacid most
                                                                      prevalent metabolite. Phase II metabolism
                                                                      shown by increase in glycine conjugate.
----------------------------------------------------------------------------------------------------------------
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 expure. 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 
thetoxicology study identified as appropriate for use in risk 
assessment is used to estimate the toxicological level of concern 
(LOC). However, the lowest dose at which adverse effects of concern are 
identified (the LOAEL) is sometimes used for risk assessment if no 
NOAEL was achieved in the toxicology study selected. An uncertainty 
factor (UF) is applied to reflect uncertainties inherent in the 
extrapolation from laboratory animal data to humans and in the 
variations in sensitivity among members of the human population as well 
as other unknowns. An UF of 100 is routinely used, 10X to account for 
interspecies differences and 10X for intra species differences.
    For dietary risk assessment (other than cancer) the Agency uses the 
UF to calculate an acute or chronic reference dose (acute RfD or 
chronic RfD) where the RfD is equal to the NOAEL divided by the 
appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is 
retained due to concerns unique to the FQPA, this additional factor is 
applied to the RfD by dividing the RfD by such additional factor. The 
acute or chronic Population Adjusted Dose (aPAD or cPAD) is a 
modification of the RfD to accommodate this type of FQPA Safety Factor.
    For non-dietary risk assessments (other than cancer) the UF is used 
to determine the LOC. For example, when 100 is the appropriate UF (10X 
to account for interspecies differences and 10X for intraspecies 
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to 
exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and 
compared to the LOC.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify carcinogenic risk. The Q* 
approach assumes that any amount of exposure will lead to some degree 
of cancer risk. A Q* is calculated and used to estimate risk which 
represents a probability of occurrence of additional cancer cases 
(e.g., risk is expressed as 1 x 10-\6\ or one in a million). 
Under certain specific circumstances, MOE calculations will be used for 
the carcinogenic risk assessment. In this non-linear approach, a 
``point of departure'' is identified below which carcinogenic effects 
are not expected. The point of departure is typically a NOAEL based on 
an endpoint related to cancer effects though it may be a different 
value derived from the dose response curve. To estimate risk, a ratio 
of the point of departure to exposure (MOEcancer = point of 
departure/exposures) is calculated. A summary of the toxicological 
endpoints for acetamiprid used for human risk

[[Page 14653]]

assessment is shown in the following Table 2:

     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 Dietarygeneral population        NOAEL = 10 mg/kg         FQPA SF = 1              Acute mammalian
 including infants and children        UF = 100...............  aPAD = 0.10 mg/kg/day..   neurotoxicity study in
                                       Acute RfD = 0.10 mg/kg/                            the rat
                                        day.                                             LOAEL = 30 mg/kg based
                                                                                          on reduction in
                                                                                          locomotor activity in
                                                                                          males.
----------------------------------------------------------------------------------------------------------------
Chronic Dietary all populations        NOAEL= 7.1 mg/kg/day     FQPA SF = 3              Chronic/carcinogenicity
                                       UF = 100...............  cPAD = 0.023 mg/kg/day.   study in the rat
                                       Chronic RfD = 0.07 mg/                            LOAEL = 17.5 mg/kg/day
                                        kg/day.                                           based on reduced BW
                                                                                          and BW gain (females)
                                                                                          and hepatocellular
                                                                                          vacuolation (males).
----------------------------------------------------------------------------------------------------------------
Short- and Intermediate-Term           NOAEL= 15 mg/kg/day      LOC for MOE = 300        Co-critical studies:
 Incidental Oral (1 to 30 days and 1                             (Residential)            subchronic oral (rat);
 month to 6 months) (Residential)                                                         subchronic
                                                                                          neurotoxicity (rat)
                                                                                          developmental toxicity
                                                                                          (rat);
                                                                                         LOAEL = 50 mg/kg/day
                                                                                          based on reductions in
                                                                                          BW, BW gain and food
                                                                                          consumption.
----------------------------------------------------------------------------------------------------------------
Short- and Intermediate-TermDermal (1  oral study NOAEL= 17.9   LOC for MOE = 100        2-generation
 to 30 days; and 1 month to 6 months)   mg/kg/day (dermal        (Occupational), 300      reproduction study
 (Residential)                          absorption rate = 30%    (Residential)            (rat)
                                                                                         LOAEL = 51.0 mg/kg/day
                                                                                          based on reductions in
                                                                                          pup weights in both
                                                                                          generations,
                                                                                          reductions in litter
                                                                                          size and viability and
                                                                                          weaning indices among
                                                                                          F2 offspring,
                                                                                          significant delays in
                                                                                          age to attain vaginal
                                                                                          opening and preputial
                                                                                          separation.
----------------------------------------------------------------------------------------------------------------
Long-Term Dermal (6 months to          oral study NOAEL= 7.1    LOC for MOE = 100        Chronic/carcinogenicity
 lifetime) (Residential)                mg/kg/day (dermal        (Occupational), 300      study in the rat
                                        absorption rate = 30%)   (Residential)           LOAEL = 17.5 mg/kg/day
                                                                                          based on reduced BW
                                                                                          and BWgain (females)
                                                                                          and hepatocellular
                                                                                          vacuolation (males).
----------------------------------------------------------------------------------------------------------------
Short- and Intermediate-Term           oral study NOAEL= 17.9   LOC for MOE = 100        2-generation
 Inhalation (1 to 30 days and 1 month   mg/kg/day (inhalation    (Occupational), 300      reproduction study
 to 6 months)(Residential)              absorption rate =        (Residential)            (rat)
                                        100%)                                            LOAEL = 51.0 mg/kg/day
                                                                                          based on reductions in
                                                                                          pup weights in both
                                                                                          generations,
                                                                                          reductions in litter
                                                                                          size and viability and
                                                                                          weaning indices among
                                                                                          F2 offspring,
                                                                                          significant delays in
                                                                                          age to attain vaginal
                                                                                          opening and preputial
                                                                                          separation.
----------------------------------------------------------------------------------------------------------------
Long-Term Inhalation (6 months to      oral study NOAEL= 7.1    LOC for MOE = 100        Chronic/carcinogenicity
 lifetime) (Residential)                mg/kg/day (inhalation    (Occupational), 300      study in the rat
                                        absorption rate =        (Residential)           LOAEL = 17.5 mg/kg/day
                                        100%)                                             based on reduced BW
                                                                                          and BWgain (females)
                                                                                          and hepatocellular
                                                                                          vacuolation (males).
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation) -      .....................    .....................  .......................
 not likely to be carcinogenic.
----------------------------------------------------------------------------------------------------------------
*The reference to the FQPA Safety Factor refers to any additional safety factor that is retained due to concerns
  unique to the FQPA. The PAD (Population-adjusted Dose) incorporates the FQPA Safety Factor into the dose for
  use in risk assessment: PAD = RfD/FQPA SF.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. No tolerances have 
been established for the residues of acetamiprid, in or on raw 
agricultural commodities and no tolerances have been established for 
the combined residues of acetamiprid and IM-2-1 N1-[(6-chloro-3-
pyridyl) methyl]-N2-cyano-acetamidine in or on meat, milk, poultry and 
egg 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 
(DEEM) 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 crops listed on the proposed label were treated and that crops 
listed on the label and livestock had residues of concern at the 
tolerance level. For processed commodities without a proposed 
tolerance, the analysis used the default processing factors provided 
with the model. A Tier 1 analysis results in highly conservative 
estimates of exposure and risk. Consideration of processing factors, 
anticipated residues in foods at the time of consumption, and percent 
of crop treated would result in

[[Page 14654]]

lower exposure and risk estimates than those presented here. Even 
without such refinement, the acute dietary risk estimates are below the 
Agency's level of concern [i.e., <100% of the population-adjusted dose 
(PAD)] for all population subgroups. Dietary (food only) exposure 
estimates were greatest for the population subgroup composed of 
children ages 1-6 years old. Acute exposure is estimated to be 0.039606 
mg/kg (95th percentile of exposure), which is equal to 40% 
of the acute population-adjusted dose (aPAD). The results are 
summarized in the accute dietary exposureportion of Table 3.
    ii. Chronic exposure. In conducting this chronic dietary risk 
assessment the Dietary Exposure Evaluation Model (DEEM) 
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 chronic 
exposure assessments: The assessment assumed that 100% of the crops 
listed on the proposed label were treated and that crops listed on the 
label and livestock had residues of concern at the tolerance level. For 
processed commodities without a proposed tolerance, the analysis used 
the default processing factors provided with the model. A Tier 1 
analysis results in highly conservative estimates of exposure and risk. 
Consideration of processing factors, anticipated residues in foods at 
the time of consumption, and percent of crop treated would result in 
lower exposure and risk estimates than those presented here. Even 
without such refinement the chronic dietary risk estimates are below 
the Agency's level of concern [i.e., <100% of the population-adjusted 
dose (PAD)] for all population subgroups. Chronic exposure is estimated 
to be 0.014687 mg/kg/day, which is equal to 64% of the cPAD. Although 
there is the potential for incidental ingestion of pesticide residues 
and soil from treated vegetables and foliage in home gardens via hand-
to-mouth transfer, incidental oral exposure was not quantitatively 
assessed. 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, the Agency does not believe 
that incidental oral exposure from the requested homeowner uses will 
result in significant incidental oral exposures to children. The 
results are summarized in the chronic exposure portion of Table 3.

                Table 3.--Aggregate Risk Assessment for Acute and Chronic Exposure to Acetamiprid
----------------------------------------------------------------------------------------------------------------
                                                                           Acute                  Chronic
                                                                 -----------------------------------------------
                                                                      95th
                       Population Subgroup                         percentile             Exposure mg/
                                                                  Exposure mg/  %aPAD\1\     kg/day     %cPAD\1\
                                                                       kg
----------------------------------------------------------------------------------------------------------------
U.S. Population (total)                                              0.016921         17     0.005395         24
----------------------------------------------------------------------------------------------------------------
All Infants (<1 year old)                                            0.038317         38     0.010261         45
----------------------------------------------------------------------------------------------------------------
Children 1-6 years old                                               0.039606         40     0.014687         64
----------------------------------------------------------------------------------------------------------------
Children 7-12 years old                                              0.022084         22     0.008072         35
----------------------------------------------------------------------------------------------------------------
Females 13-50                                                        0.011451         11     0.003970         17
----------------------------------------------------------------------------------------------------------------
Males 13-19                                                          0.011627         12     0.004460         19
----------------------------------------------------------------------------------------------------------------
Males 20+ years                                                      0.009624         10     0.003673         16
----------------------------------------------------------------------------------------------------------------
Seniors 55+                                                          0.010242         10     0.004005         17
----------------------------------------------------------------------------------------------------------------
\1\ %aPAD and %cPAD are exposures presented as percentages ofthe acute and chronic population-adjusted doses,
  respectively. For acetamiprid, the aPAD = 0.1 mg/kg; the cPAD = 0.023 mg/kg/day.

    iii. Cancer. The Agency classified acetamiprid into the category 
not likely to be carcinogenic to humans based on the absence of a dose-
response and a lack of a statistically significant increase in the 
mammary adenocarcinoma incidence by pair-wise 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.
    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 concentration in groundwater (SCI-GROW) model is used to 
predict pesticide concentrations in shallow groundwater. 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

[[Page 14655]]

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 below.
    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 4.0 ppb for surface water and 0.0008 ppb 
for ground water.
    3. From non-dietary exposure. The term ``residentialexposure'' 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 
proposed with this notice to be registered for use on the following 
residential non-dietary sites: ornamentals, flowers, vegetable gardens, 
and fruit trees. The risk assessment showed the following: for 
residential applicators, total MOEs for short- and intermediate-term 
residential dermal and inhalation exposures range from 1.2  x  
105 to 6  x  105. For post-application 
activities, short- and intermediate-term MOEs range from 1.8  x  
104 to 1.8 105 for adults and from 2.3  x  
104 to 2.2  x  105 for youth ages 10-12 years. 
The residential uses for acetamiprid are not expected to result in 
long-term exposures.
    4. Cumulative exposure to substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) requires that, when considering 
whether to establish, modify, or revoke a tolerance, the Agency 
consider ``available information'' concerning the cumulative effects of 
a particular pesticide's residues and ``other substances that have a 
common mechanism of toxicity.''
    EPA does not have, at this time, available data to determine 
whether acetamiprid has a common mechanism of toxicity with other 
substances or how to include this pesticide in a cumulative risk 
assessment. Unlike other pesticides for which EPA has followed a 
cumulative risk approach based on a common mechanism of toxicity, 
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 final rule 
for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).

D. Safety Factor for Infants and Children

    1. In general. FFDCA section 408 provides that EPA shall apply an 
additional tenfold margin of safety for infants and children in the 
case of threshold effects to account for 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 margin of exposure 
(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. There is noquantitative or 
qualitative evidence of increased susceptibility of rat or rabbit 
fetuses to in utero exposure in the developmental studies. In the rat, 
an increase in the incidence of shortening of the 13th rib 
was observed in fetuses at the same LOAEL as the dams, which exhibited 
reduced mean body weight, body weight gain and food consumption and 
increased liver weights. No developmental toxicity was observed in the 
rabbit at dose levels that induced effects in the does: body weight 
loss and decreased food consumption. In the multi-generation 
reproduction study, qualitative evidence of increased susceptibility of 
rat pups is observed. The parental and offspring systemic NOAELs are 
17.9/21.7 (M/F) mg/kg/day and the offspring/parental systemic LOAELs 
are 51.0/60.1 mg/kg/day based on a decrease in mean body weight, body 
weight gain and food consumption in the parents and 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 offspring. The offspring effects are 
considered to be more severe than the parental effects.
    3. Conclusion. There is a complete toxicity data base for 
acetamiprid and exposure data are complete or are estimated based on 
data that reasonably accounts for potential exposures. The Agency FQPA 
Safety Factor Committee recommended that the FQPA safety factor be 
reduced to 3x in assessing the risk posed by this chemical. The 
Committee determined that the safety factor is necessary when assessing 
the risk posed by acetamiprid because there is qualitative evidence of 
increased susceptibility following prenatal/postnatal exposure to 
acetamiprid in the 2-generation reproduction study in rats. However, 
the Committee concluded that the safety factor could be reduced to 3x 
for acetamidprid because the toxicology database is complete; there is 
no quantitative or qualitative evidence of increased susceptibility 
following in utero exposure of rat and rabbit fetuses; the dietary 
(food and water) and residential exposure assessments will not 
underestimate the potential exposures for infants, children, and/or 
women of childbearing age; and the requirement of a developmental 
neurotoxicity study is not based on criteria reflecting special concern 
for the developing fetuses or young which are generally used for 
requiring a DNT study and a safety factor. The Committee recommended 
that the safety factor be required for all population subgroups when 
assessing chronic dietary exposures as well as when assessing 
residential short-, intermediate-, and long-term exposure durations to 
address the concern for the effects seen following prenatal/postnatal 
exposure to acetamiprid in the 2-generation reproduction study in rats; 
the FQPA Safety Factor can be removed (i.e., reduced to 1x) when 
assessing acute dietary exposure.

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 drinking 
water level of concerns (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 from food and residential uses. In calculating a DWLOC, the 
Agency determines how much of the acceptable exposure (i.e., the 
population adjusted dose (PAD)) is available for

[[Page 14656]]

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: 2L/70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg 
(child). Default body weights and drinking water consumption values 
vary on an individual basis. This variation will be taken into account 
in more refined screening-level and quantitative drinking water 
exposure assessments. Different populations will have different DWLOCs. 
Generally, a DWLOC is calculated for each type of aggregate risk 
assessment scenario: acute, short-term, intermediate-term, chronic, and 
cancer.
    When EECs for surface water and groundwater are less than the 
calculated DWLOCs, the Office of Pesticide Programs (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 all 
infants (<1 year old) and 40% of the aPAD for children ages 1-6 years. 
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 4:

                      Table 4.--Aggregate Risk Assessment for Acute Exposure to Acetamiprid
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                aPAD (mg/kg/    % aPAD     Water EEC    Water EEC   Acute DWLOC
                                                     day)        (Food)       (ppb)        (ppb)       (ppd)\a\
----------------------------------------------------------------------------------------------------------------
U.S. Population                                         0.10           17       0.0008           17        2,900
----------------------------------------------------------------------------------------------------------------
All Infants (<1 year old)                               0.10           38       0.0008           17          620
----------------------------------------------------------------------------------------------------------------
Children 1-6 years                                      0.10           40       0.0008           17          600
----------------------------------------------------------------------------------------------------------------
Children 7-12 years                                     0.10           22       0.0008           17          780
----------------------------------------------------------------------------------------------------------------
Females 13-50 years                                     0.10           11       0.0008           17        2,700
----------------------------------------------------------------------------------------------------------------
Males 13-19 years                                       0.10           12       0.0008           17        3,100
----------------------------------------------------------------------------------------------------------------
Males 20+ years                                         0.10           10       0.0008           17        3,200
----------------------------------------------------------------------------------------------------------------
Seniors (55+ years)                                     0.10           10       0.0008           17        3,100
----------------------------------------------------------------------------------------------------------------
\a\ Drinking Water Level of Comparison = aPAD-Acute DietaryExposure (mg/kg/day)  x  body weight (kg)  x  1,000
  g/mg  water consumption (L/day). Body weight = 70 kg (males and general pop.), 60 kg
  (females), or 10 kg (infants and children). Consumption = 2 L/day for adults or 1 L/day for infants and
  children. Values have been rounded to 2 significant figures.

    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 24% of the cPAD for the U.S. 
population, 45% of the cPAD for all infants (< 1 year old) and 64% of 
the cPAD for children ages 1-6 years. Based on 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 5:

              Table 5.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Acetamiprid
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground      Chronic
              Population Subgroup                cPAD mg/kg/     % cPAD     Water EEC    Water EEC      DWLOC
                                                     day         (Food)       (ppb)        (ppb)       (ppd)\a\
----------------------------------------------------------------------------------------------------------------
U.S. Population                                        0.023           24       0.0008            4          620
----------------------------------------------------------------------------------------------------------------
All Infants (<1 year old)                              0.023           45       0.0008            4          130
----------------------------------------------------------------------------------------------------------------
Children 1-6 years old                                 0.023           64       0.0008            4           80
----------------------------------------------------------------------------------------------------------------
Children 7-12 years old                                0.023           35       0.0008            4          150
----------------------------------------------------------------------------------------------------------------
Females 13-50 years old                                0.023           17       0.0008            4          670
----------------------------------------------------------------------------------------------------------------

[[Page 14657]]

 
Males 13-19 years old                                  0.023           19       0.0008            4          650
----------------------------------------------------------------------------------------------------------------
Males 20+ years old                                    0.023           16       0.0008            4          680
----------------------------------------------------------------------------------------------------------------
Seniors (55+ years old)                                0.023           17       0.0008            4          670
----------------------------------------------------------------------------------------------------------------
\a\ Chronic Drinking Water Level of Comparison = cPAD-Chronic Dietary Exposure (mg/kg/day)  x  body weight (kg)
  x  1,000 g/mg  water consumption (L/day). Body weight = 70 kg (males and general pop.), 60 kg
  (females), or 10 kg (infants and children). Consumption = 2 L/day for adults or 1 L/day for infants and
  children. Values have been rounded to 2 significant figures.

    3. Short-term risk and intermediate-term risk. Short-term 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 proposed for uses 
that could result in short-term and intermediate residential exposure 
and the Agency has determined that it is appropriate to aggregate 
chronic food and water and short-term and intermediate exposures for 
acetamiprid. Using the exposure assumptions described in this unit for 
short- and intermediate-term exposures, EPA has concluded that 
aggregated food and residential exposures aggregated result in 
aggregate MOEs of 18,000 for adults, and 23,000 for youth (ages 10-12 
years) for the non-oral routes of exposure (i.e., combined dermal and/
or inhalation pathways). These aggregate MOEs do not exceed the 
Agency's level of concern for aggregate exposure to food and 
residential uses. In addition, short-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-term aggregate 
exposure to exceed the Agency's level of concern, as shown in the 
following Table 6:

        Table 6.--Aggregate Risk Assessment for Short-Term and Intermediate-Term Exposure to Acetamiprid
----------------------------------------------------------------------------------------------------------------
                                                                       Surface       Ground      Short-Term and
           Population Subgroup                 MOE       Total Non-   Water EEC    Water EEC   Intermediate-Term
                                            (Food)\a\   Oral MOE\b\     (ppb)        (ppb)      DWLOC (ppd)\c,d\
----------------------------------------------------------------------------------------------------------------
U.S. Population                                  2,780       18,000            4       0.0008              1,500
----------------------------------------------------------------------------------------------------------------
All Infants (<1 year old)                        1,462       N/A\e\            4       0.0008                400
----------------------------------------------------------------------------------------------------------------
Children 1-6 years old                           1,021          N/A            4       0.0008                400
----------------------------------------------------------------------------------------------------------------
Children 7-12 years old                          1,858       23,000            4       0.0008                400
----------------------------------------------------------------------------------------------------------------
Females 13-50 years old                          3,778       18,000            4       0.0008              1,400
----------------------------------------------------------------------------------------------------------------
Males 13-19 years old                            3,363       18,000            4       0.0008              1,600
----------------------------------------------------------------------------------------------------------------
Males 20+ years old                              4,084       18,000            4       0.0008              1,600
----------------------------------------------------------------------------------------------------------------
Seniors (55+ years old)                          3,745       18,000            4       0.0008              1,600
----------------------------------------------------------------------------------------------------------------
\a\ Food MOE = Short-term NOAEL (15 mg/kg/day) Chronic Dietary Exposure (food only)
\b\ Total non-oral MOEs are from the Occupational and Residential Risk Assessment. Note that given the currently
  requested use patterns, incidental oral exposure is an insignificant pathway of exposure and has not been
  factored into the DWLOCs.
\c\ Maximum Water Exposure = Short/Intermediate-term NOAEL (15 mg/kg/day)  x  (1  Target MOE) - (1
   Food MOE + 1  Oral MOE + 1  Non-Oral MOE)
\d\ Short- and Intermediate-term Drinking Water Level of Concern = Maximum Water Exposure (mg/kg/day)  x  body
  weight (kg)  x  1,000 g/mg  water consumption (L/day). Body weight = 70 kg (males and general
  pop.), 60 kg (females), or 10 kg (infants and children). Consumption = 2 L/day for adults or 1 L/day for
  infants and children. Values have been rounded to 2 significant figures.
\e\ N/A = Not Applicable

    4. Aggregate cancer risk for U.S. population. The Agency classified 
acetamiprid into the category not likely to be carcinogenic to humans 
based on the absence of a dose-response and a lack of a statistically 
significant increase in the mammary adenocarcinoma incidence by pair-
wise comparison of the mid- and high-dose groups with the controls. 
Although the incidence exceeded the laboratories historical control 
data from the same lab: the increase was within the range of values 
from the supplier.
    5. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, and to infants and children from aggregate 
exposure to acetamiprid residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Enforcement methods are available for vegetable and non-citrus 
crops, citrus crops, and livestock commodities. Citrus and livestock 
methods consist of solvent extraction, followed by solid-phase cleanup, 
and high performance liquid chromatography/ultraviolet determination of 
residues. The vegetable and non-citrus crop method differs in that it 
employs gas chromatography/

[[Page 14658]]

electron capture detection determination of residues. The livestock 
method analyzes acetamiprid and IM-2-1 simultaneously. Limits of 
quantitation are 0.01 ppm for vegetable and non-citrus fruits, meat, 
milk, fat, and eggs; and 0.05 ppm for citrus and meat byproducts. 
Adequate radiovalidation and independent laboratory validation (ILV) 
data have been received and the method was forwarded to the Analytical 
Chemistry Laboratory (ACL) for petition method validation (PMV). The 
petitioner will be required to make any modifications or revision to 
the proposed enforcement method resulting from PMV. When the PMV is 
finalized, the method may be requested from: Calvin Furlow, PRRIB, IRSD 
(7502C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW, Washington, DC 20460; telephone number: 
(703) 305-5229; e-mail address: [email protected].

B. International Residue Limits

    There are no CODEX, Canadian, or Mexican Maximum Residue Limits for 
acetamiprid in or on citrus fruit group, citrus dried pulp, cotton, 
fruiting and leafy, leafy vegetables, tomato paste; and for the 
combined residues of acetamiprid and IM-2-1 N1-[(6-chloro-3-pyridyl) in 
or on fat, meat, and meat byproducts of cattle, goat, hog, horse, and 
sheep; milk; poultry eggs, fat, liver, and meat.

C. Conditions

    The conditions of the acetamiprid registration contained the 
following confirmatory data and label requirements: rotational crop 
storage stability; and radiovalidation data for IM-2-1-amide in 
ruminant muscle. The storage stability data is considered confirmatory 
data since the Agency has examined other storage stability data of 
acetamiprid and found it to be stable upon storage. The Agency decided 
to impose tolerances on meat and poultry products upon review of the 
data although tolerances for IM-2-1 were not considered by the 
registrant in the original submission.

V. Conclusion

    Therefore, tolerances are established for residues of acetamiprid 
N1-[(6-chloro-3-pyridyl) methyl]-N2-cyano-N1-methylacetamidine in or on 
citrus fruit group, citrus dried pulp, cotton undelinted seed, cotton 
gin byproducts, fruiting vegetable group, grape, leafy vegetable group 
(except brassica), leafy vegetable brassica group, pome fruit group, 
and tomato paste; and tolerances for the combined residues of 
acetamiprid and IM-2-1 N1-[(6-chloro-3-pyridyl) methyl]-N2-cyano-
acetamidine in or on fat, meat, and meat byproducts of cattle, hog, 
horse, goat, and sheep; milk; eggs; fat, liver and meat of poultry.

VI. Objections and Hearing Requests

    Under section 408(g) of the FFDCA, as amended by the FQPA, any 
person may file an objection to any aspect of this regulation and may 
also request a hearing on those objections. The EPA procedural 
regulations which govern the submission of objections and requests for 
hearings appear in 40 CFR part 178. Although the procedures in those 
regulations require some modification to reflect the amendments made to 
the FFDCA by the FQPA of 1996, EPA will continue to use those 
procedures, with appropriate adjustments, until the necessary 
modifications can be made. The new section 408(g) provides essentially 
the same process for persons to ``object'' to a regulation for an 
exemption from the requirement of a tolerance issued by EPA under new 
section 408(d), as was provided in the old FFDCA sections 408 and 409. 
However, the period for filing objections is now 60 days, rather than 
30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket control number OPP-301225 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 May 28, 
2002.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as CBI. Information so marked will not be disclosed except 
in accordance with procedures set forth in 40 CFR part 2. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460. You may also deliver your request to the Office 
of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW., 
Washington, DC 20460. The Office of the Hearing Clerk is open from 8 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Office of the Hearing Clerk is (202) 260-4865.
    2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
identify the fee submission by labeling it ``Tolerance Petition Fees.''
    EPA is authorized to waive any fee requirement ``when in the 
judgement of the Administrator such a waiver or refund is equitable and 
not contrary to the purpose of this subsection.'' For additional 
information regarding the waiver of these fees, you may contact James 
Tompkins by phone at (703) 305-5697, by e-mail at [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.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460.
    3. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VI.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in Unit I.B.2. Mail your 
copies, identified by docket control number OPP-301225, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. 
In person or by courier, bring a copy to the location of the PIRIB 
described in Unit I.B.2. You may also send an electronic copy of your 
request via e-mail to: [email protected]. Please use an ASCII file 
format and avoid the use of special characters and any form of 
encryption.

[[Page 14659]]

Copies of electronic objections and hearing requests will also be 
accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. Do not 
include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

    A request for a hearing will be granted if the Administrator 
determines that the material submitted shows the following: There is a 
genuine and substantial issue of fact; there is a reasonable 
possibility that available evidence identified by the requestor would, 
if established resolve one or more of such issues in favor of the 
requestor, taking into account uncontested claims or facts to the 
contrary; and resolution of the factual issues(s) in the manner sought 
by the requestor would be adequate to justify the action requested (40 
CFR 178.32).

VII. Regulatory Assessment Requirements

    This final rule establishes a tolerance under FFDCA section 408(d) 
in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, 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 FFDCA section 408(d), such as the tolerance in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply. In addition, the Agency has determined that this 
action will not have a substantial direct effect on States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government, as specified in Executive Order 13132, entitled 
Federalism(64 FR 43255, August 10, 1999). Executive Order 13132 
requires EPA to develop an accountable process to ensure ``meaningful 
and timely input by State and local officials in the development of 
regulatory policies that have federalism implications.'' ``Policies 
that have federalism implications'' is defined in the Executive order 
to include regulations that have ``substantial direct effects on the 
States, on the relationship between the national government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government.'' This final rule directly regulates 
growers, food processors, food handlers and food retailers, not States. 
This action does not alter the relationships or distribution of power 
and responsibilities established by Congress in the preemption 
provisions of FFDCA section 408(n)(4). For these same reasons, the 
Agency has determined that this rule does not have any ``tribal 
implications'' as described in Executive Order 13175, entitled 
Consultation and Coordination with Indian Tribal Governments (65 FR 
67249, November 6, 2000). Executive Order 13175, requires EPA to 
develop an accountable process to ensure ``meaningful and timely input 
by tribal officials in the development of regulatory policies that have 
tribal implications.'' ``Policies that have tribal implications'' is 
defined in the Executive order to include regulations that have 
``substantial direct effects on one or more Indian tribes, on the 
relationship between the Federal Government and the Indian tribes, or 
on the distribution of power and responsibilities between the Federal 
Government and Indian tribes.'' This rule will not have substantial 
direct effects on tribal governments, on the relationship between the 
Federal Government and Indian tribes, or on the distribution of power 
and responsibilities between the Federal Government and Indian tribes, 
as specified in Executive Order 13175. Thus, Executive Order 13175 does 
not apply to this rule.

VIII. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of this final rule in the Federal Register. This final 
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: March 15, 2002.
James Jones,
Acting Director, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180-- [AMENDED]

    1. The authority citation for part 180 continues to read as 
follows:

    Authority: 21 U.S.C. 321(q), 346(a) and 374.

    2. Section 180.578 is added to read as follows:


Sec. 180.578  Acetamiprid; tolerances forresidues.

    (a) General. (1) Tolerances are established for residues of the 
insecticide acetamiprid N1-[(6-chloro-3-pyridyl)methyl]-N2-cyano-N1-
methylacetamidine in or on the following commodities:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Citrus, dried pulp.........................................         1.20
Cotton, gin byproducts.....................................         20.0
Cotton, undelinted seed....................................         0.60
Fruit, citrus group........................................         0.50
Fruit, pome group..........................................          1.0
Grape......................................................         0.20
Tomato, paste..............................................         0.40
Vegetable, brassica, leafy group...........................         1.20

[[Page 14660]]

 
Vegetable, fruiting group..................................         0.20
Vegetable, leafy group, except brassica....................         3.00
------------------------------------------------------------------------

    (2) Tolerances are established for the combined residues of the 
insecticide acetamiprid N1-[(6-chloro-3-pyridyl)methyl]-N2-cyano-N1-
methylacetamidine andN1-[(6-chloro-3-pyridyl)methyl]-N2-cyano-
acetamidine in or on the following commodities:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Cattle, fat................................................         0.10
Cattle, meat...............................................         0.10
Cattle, meat byproducts....................................         0.20
Egg........................................................        0.010
Goat, fat..................................................         0.10
Goat, meat.................................................         0.10
Goat, meat byproducts......................................         0.20
Hog, fat...................................................         0.10
Hog, meat..................................................         0.10
Hog, meat byproducts.......................................         0.20
Horse, fat.................................................         0.10
Horse, meat................................................         0.10
Horse, meat byproducts.....................................         0.20
Milk.......................................................         0.10
Poultry, fat...............................................        0.010
Poultry, liver.............................................        0.050
Poultry, meat..............................................        0.010
Sheep, fat.................................................         0.10
Sheep, meat................................................         0.10
Sheep, meat byproducts.....................................         0.20
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]
[FR Doc. 02-7098 Filed 3-26-02; 8:45 am]
BILLING CODE 6560-50-S