Pesticides; tolerances in food, animal feeds, and raw agricultural commodities: Imidacloprid,

[Federal Register: June 13, 2003 (Volume 68, Number 114)]

[Rules and Regulations]

[Page 35303-35315]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr13jn03-21]

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2003-0103; FRL-7310-8]

Imidacloprid; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes tolerances for combined residues of imidacloprid and its metabolites containing the 6-chloropyridinyl moiety, all expressed as the parent in or on acerola; artichoke, globe; avocado; banana (import); canistel; corn, pop, grain; corn, pop, stover; cranberry; currant; elderberry; feijoa; fruit, stone, group 12; gooseberry; huckleberry; guava; jaboticaba; juneberry; lingonberry; longan; lychee; mango; mustard, seed; okra; papaya; passionfruit; persimmon; pulasan; rambutan; salal; sapodilla; sapote, black; sapote, mamey; Spanish lime; star apple; starfruit; strawberry; vegetable, leaves of root and tuber, group 2; vegetable, legume, group 6, except soybean; vegetable, root and tuber, group 1, except sugar beet; watercress; wax jambu. EPA is also deleting certain imidacloprid tolerances that are no longer needed as result of this action. The Interregional Research Project Number 4 (IR-4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA) , as amended by the Food Quality Protection Act of 1996 (FQPA).

DATES: This regulation is effective June 13, 2003. Objections and requests for hearings, identified by docket ID number OPP-2003-0103, must be received on or before August 12, 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: Shaja R. Brothers, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460- 0001; telephone number: (703) 308-3194; e-mail address: brothers.shaja@epa.gov. SUPPLEMENTARY INFORMATION:

1. General Information

   1. Does this Action Apply to Me?

      You may be potentially affected by this action if you an are agricultural producer, food manufacturer, and 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.

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

      1. Docket. EPA has established an official public docket for this action under docket identification (ID) number OPP-2003-0103. 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.

2. Background and Statutory Findings

   In the Federal Register of February 5, 2003 (68 FR 5880) (FRL-7287- 5) and March 5, 2003 (68 FR 10464) (FRL-7291-1) EPA issued notices pursuant to section 408 of FFDCA, 21 U.S.C. 346a, as amended by FQPA (Public Law 104-170), announcing the filing of pesticide petitions (PP1E6268, 1E6254, 1E6237, 1E6225, 0E6203, 2E6403, 2E6406, 2E6409, 2E6417, 2E6421, 2E6435, 2E6414, 2E6458, and 2E6506) by IR-4, 681 U.S. Highway 1 South, North Brunswick, NJ 08902-3390 and PP 0E6074 Bayer CropScience, 2 T.W. Alexander Drive, P.O. Box 12014, Research Triangle Park, NC 27709. Those notices included summaries of the petitions prepared by Bayer CropScience, the registrant. One comment was received in response to the notice of filing of February 5, 2003, from an individual who requested that information about pesticide tolerances be available in grocery stores next to the food labels.

   The petitions requested that 40 CFR 180.472 be amended by establishing tolerances for residues of the insecticide imidacloprid, 1-[(6-chloro-3-pyridinyl)methyl]-N-nitro-2-imidazolidinimine, and its metabolites containing the 6-chloropyridinyl

   [[Page 35304]]

   moiety, all expressed as imidacloprid in or on the raw agricultural commodities as follows: Bushberry subgroup 13B, lingonberry, juneberry and salal at 3.5 parts per million (ppm) (PP 1E6268), okra at 1.0 ppm (PP 1E6254), watercress at 3.5 ppm (PP 1E6237), artichoke at 2.5 ppm (PP 1E6225), cranberry at 0.05 ppm (PP 0E6203), vegetable, legume, except soybean, group 6 at 4.0 ppm (PP 2E6403), avocado, papaya, star apple, black sapote, mango, sapodilla, canistel, and mamey sapote at 1.0 ppm, and lychee, longan, Spanish lime, rambutan, pulasan and persimmon at 3.0 ppm (PP 2E6406), vegetable, leaves of root and tuber, group 2 at 4.0 ppm (PP 2E6409), strawberry at 0.5 ppm (PP 2E6417), fruit, stone, group 12 at 3.0 ppm (PP 2E6421), guava, feijoa, jaboticaba, wax jambu, starfruit, passionfruit, and acerola at 1.0 ppm (PP 2E6435), corn, pop, grain at 0.05 ppm and corn, pop, stover at 0.2 ppm (PP 2E6414), mustard seed at 0.05 ppm (PP 2E6458), and vegetable, root and tuber, except sugar beet, group 1, except sugar beet, at 0.4 ppm (PP 2E6506); imported banana at 0.01 ppm (0E6074). The petition for imported banana was subsequently amended to propose a tolerance at 0.02 ppm.

   EPA is also deleting several established tolerances in Sec. 180.472(a) and Sec. 180.472(b) that are no longer needed, as a result of this action. The tolerance deletions under Sec. 180.472(b) are time-limited tolerances established under section 18 emergency exemptions that are superceded by the establishment of general tolerances for imidacloprid and its metabolites under Sec. 180.472(a).

   The revisions to Sec. 180.472(a) are as follows:

   1. Delete bean, edible, podded at 1.0 ppm and bean, succulent, shelled at 1.0 ppm. Replaced with vegetable, legume, group 6, except soybean at 4.0 ppm.

   2. Delete dasheen, leaves at 3.5 ppm and turnip greens at 3.5 ppm. Replaced with vegetable, leaves of root and tuber, group 2 at 4.0 ppm.

   3. Delete mango at 0.2 ppm. Replaced with mango at 1.0 ppm.

   4. Delete potato at 0.3 ppm and vegetable, tuberous and corm, subgroup at 0.3 ppm. Replaced with vegetable, root and tuber, group 1, except sugar beet at 0.4 ppm.

      The revisions to Sec. 180.472(b) are as follows:

   1. Delete the time-limited tolerance for fruit, stone at 3.0 ppm. Tolerance for fruit, stone, group 12 at 3.0 ppm is established by this action under 180.472(a).

   2. Delete the time-limited tolerance for strawberry at 0.1 ppm. Tolerance for strawberry at 0.5 ppm is established by this action under 180.472(a).

   3. Delete the time-limited tolerance for turnip, roots at 0.3 ppm. Tolerance for vegetable, root and tuber, group 1, except sugar beet at 0.4 ppm is established by this action under 180.472(a).

   4. Delete the time-limited tolerance for turnip, tops at 3.5 ppm. Tolerance for vegetable, leaves of root and tuber, group 2 at 4.0 ppm is established by this action under 180.472(a).

      EPA has received objections to a time-limited tolerance it established for residues of imidacloprid on blueberries in connection with an emergency exemption for such use under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et seq. published in the Federal Register of January 18, 2002 (67 FR 2580)(FRL-6817-6). The objections were filed by the Natural Resources Defense Council (NRDC) and raised several issues regarding aggregate exposure estimates and the additional safety factor for the protection of infants and children. NRDC's objections raise complex legal, scientific, policy, and factual matters and EPA has initiated a public comment period on them in the Federal Register of June 19, 2002 (67 FR 41628) (FRL-7167- 7), which ended on October 16, 2002. Although that proceeding remains ongoing, prior to acting on this current tolerance action, EPA reviewed the imidacloprid-specific objections raised by NRDC and has addressed them at relevant points throughout this preamble. Since EPA review of the objections to the time-limited tolerance for blueberry is ongoing, EPA is not establishing the proposed tolerance for blueberry at this time. Individual commodity tolerances for the other members of the bushberry subgroup (currant, elderberry, gooseberry and huckleberry) are established by this action.

      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).

3. 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 tolerances for combined residues of imidacloprid on banana (import) at 0.02 ppm; cranberry; mustard, seed; corn, pop, grain at 0.05 ppm; corn, pop, stover at 0.20 ppm; vegetable, root and tuber, group 1, except sugar beet at 0.40 ppm; strawberry at 0.50 ppm; acerola; avocado; canistel; feijoa; guava; jaboticaba; mango; okra; papaya; passionfruit; sapodilla; sapote, black; sapote, mamey; star apple; starfruit; wax jambu at 1.0 ppm; artichoke, globe at 2.5 ppm; fruit, stone, group 12; lychee; longan; Spanish lime; rambutan; pulasan; persimmon at 3.0 ppm; currant; elderberry; gooseberry; huckleberry; juneberry; lingonberry; salal; watercress at 3.5 ppm; vegetable, leaves of root and tuber, group 2; vegetable, legume, group 6, except soybean at 4.0 ppm.

   1. 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 imidacloprid 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.

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      Table 1.--Subchronic, Chronic, and Other Toxicity

      Guideline No.

      Study Type

      Results

      870.3200

      21/28-Day dermal toxicity NOAEL = 1,000 mg/kg/day (highest dose (rabbits)

      tested (HDT)) LOAEL = Not identified

      870.3465

      4 Week inhalation toxicity NOAEL = 0.191 mg/liter/day (HDT) (rat)

      LOAEL = Not identified

      870.3700

      Prenatal developmental Maternal NOAEL = 10 mg/kg/day toxicity (rats)

      LOAEL = 30 mg/kg/day based on decreased body weight gain and decreased corrected body weight gain. Developmental NOAEL = 30 mg/kg/day LOAEL = 100 mg/kg/day based on a slight increase in the incidence of wavy ribs.

      870.3700

      Prenatal developmental Maternal NOAEL = 24 mg/kg/day toxicity (rabbits)

      LOAEL = 72 mg/kg/day based on maternal deaths and decreased maternal absolute body weights, body weight gains, and food consumption. Developmental NOAEL = 24 mg/kg/day LOAEL = 72 mg/kg/day based on abortion, total litter resorptions, increased postimplantation loss due to increased late resorptions, decreased fetal weights, and very low incidences of skeletal alterations.

      870.3800

      Reproduction and fertility Parental/Systemic NOAEL = 16.5 mg/kg/day effects (rats)

      LOAEL = 47.3 mg/kg/day based on decreased premating weight gain by F0 males and females and F1 females and decreased gestational weight gain by F1 females. Reproductive NOAEL = 47.3 mg/kg/day (HDT) LOAEL = not identified Offspring NOAEL = 16.5 mg/kg/day LOAEL = 47.3 mg/kg/day based on decreased pup body weights in both litters of both generations.

      870.4100

      Chronic toxicity (dogs) NOAEL = 72 mg/kg/day (HDT) LOAEL = Not identified

      870.4200

      Carcinogenicity (mice) NOAEL = Males: 208 mg/kg/day; Females: 274 mg/kg/day LOAEL = Males: 414 mg/kg/day; Females: 424 mg/kg/day based on decreased body weights, food consumption and water intake. No evidence of carcinogenicity.

      870.4300

      Combined Chronic/

      NOAEL = Males: 5.7 mg/kg/day; Females: 7.6 Carcinogenicity (rats) mg/kg/day LOAEL = Males: 16.9 mg/kg/day; Females: 24.9 mg/kg/day based on thyroid toxicity (increased incidence of mineralized particles in thyroid colloid) in males. No evidence of carcinogenicity.

      870.5100

      Gene Mutation

      Negative in a battery of test. 870.5300

      870.5375

      Chromosome aberrations Negative in battery of tests, except at cytoxic doses in an in vitro mammalian chromosome aberration test and an in vitro sister chromatid exchange test. 870.5380 870.5385 870.5395 870.5900

      870.5550

      Other genotoxic effects Negative in a battery of tests 870.5575

      870.6200

      Acute neurotoxicity

      NOAEL = not identified. screening battery rat LOAEL = 42 mg/kg based on decreased motor and locomotor activities observed in females.

      870.6200

      Subchronic neurotoxicity NOAEL = 9.3 mg/kg/day. screening battery rat LOAEL = 63.3 mg/kg/day based on decreased body weight gain.

      870.6300

      Developmental

      Maternal NOAEL = 20 mg/kg/day. neurotoxicity (rat)

      LOAEL = 55 mg/kg/day based on decreased food consumption and body weight gain during lactation. Offspring NOAEL = 20 mg/kg/day. LOAEL = 55 mg/kg/day based on decreased body weight and body weight gain, decreased motor activity and decreased caudate/putamen width in females.

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      870.7485

      Metabolism and

      Methylene-labeled imidacloprid was rapidly pharmacokinetics rat

      absorbed. There were no biologically significant differences between sexes, dose levels, or route of administration. Urinary excretion was the major route of elimination, with a lesser amount eliminated in feces. Total tissue burden after 48 hours accounted for only approximately 0.5% of the recovered radioactivity, with major sites of accumulation being the liver, kidney, lung, skin, and plasma and minor sites being the brain and testes. There were two major evident routes of biotransformation. The first included an oxidative cleavage of the parent compound to give 6-CNA and its glycine conjugate. Dechlorination of this metabolite formed the 6- hydroxynicotinic acid and its mercapturic acid derivative. The second included the hydroxylation of imidazolidine followed by elimination of water of the parent compound to give NTN 35884. In a comparison between [Methylene-14C] Imidacloprid and [Imidazolidine-4,5-14C] Imidacloprid, the rates of excretion were similar; however, the renal portion was higher with the imidazolidine-labeled test material. The imidazolidine-labeled test material also demonstrated higher accumulation in the tissues, with the major sites of accumulation being the liver, kidney, lung, and skin, and the minor sites being brain and muscle.

   2. 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 intra species differences.

      For dietary risk assessment (other than cancer) the Agency uses the UF to calculate an acute or chronic reference dose (acute RfD or chronic RfD) where the RfD is equal to the NOAEL divided by the appropriate UF (RfD = NOAEL/UF). Where an additional safety factors (SF) is retained due to concerns unique to the FQPA, this additional factor is applied to the RfD by dividing the RfD by such additional factor. The acute or chronic Population Adjusted Dose (aPAD or cPAD) is a modification of the RfD to accommodate this type of FQPA SF.

      For non-dietary risk assessments (other than cancer) the UF is used to determine the LOC. For example, when 100 is the appropriate UF (10X to account for interspecies differences and 10X for intraspecies differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and compared to the LOC.

      The linear default risk methodology (Q*) is the primary method currently used by the Agency to quantify carcinogenic risk. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk. A Q* is calculated and used to estimate risk which represents a probability of occurrence of additional cancer cases (e.g., risk is expressed as 1 x 10-\6\ or one in a million). Under certain specific circumstances, MOE calculations will be used for the carcinogenic risk assessment. In this non-linear approach, a ``point of departure'' is identified below which carcinogenic effects are not expected. The point of departure is typically a NOAEL based on an endpoint related to cancer effects though it may be a different value derived from the dose response curve. To estimate risk, a ratio of the point of departure to exposure (MOEcancer= point of departure/exposures) is calculated. A summary of the toxicological endpoints for imidacloprid used for human risk assessment is shown in Table 2 of this unit:

      Table 2.--Summary of Toxicological Dose and Endpoints for Imidacloprid for Use in Human Risk Assessment

      * Special FQPA SF and Exposure Scenario

      Dose Used in Risk Level of Concern for Study and Toxicological Assessment, UF

      Risk Assessment

      Effects

      Acute Dietary all populations

      LOAEL = 42 mg/kg/day FQPA SF = 1X

      Acute neurotoxicity - UF = 300............... aPAD = aRfD/ FQPA SF... rat Acute RfD = 0.14 mg/kg. = 0.14 mg/kg........... LOAEL = 42 mg/kg, based upon the decrease in motor and locomotor activities observed in females.

      Chronic Dietary all populations

      NOAEL= 5.7 mg/kg/day FQPA SF = 1X

      Combined chronic tox/ UF = 100............... cPAD = cRfD/FQPA SF.... carcinogenicity - rat Chronic RfD = 0.057 mg/ = 0.057 mg/kg/day...... LOAEL = 16.9 mg/kg/day, kg/day.

      based upon increased incidence of mineralized particles in thyroid colloid in males.

      Short-Term Oral (1-30 days)

      oral study NOAEL= 10 mg/ LOC for MOE = 100

      Developmental toxicity kg/day

      (Residential, includes rat the FQPA SF).

      Maternal LOAEL = 30 mg/ kg/day, based upon decreased body weight gain and corrected body weight gain.

      [[Page 35307]]

      Intermediate-Term Oral (1-6 months) oral study NOAEL= 9.3 LOC for MOE = 100

      Subchronic mg/kg/day

      (Residential, includes neurotoxicity - rat the FQPA SF).

      LOAEL = 63.3 mg/kg/day, based upon decreased body weight gain.

      Short-Term Dermal (1-30 days)

      oral study NOAEL= 10 mg/ LOC for MOE = 100

      Developmental toxicity kg/day

      (Residential, includes rat (dermal absorption rate the FQPA SF).

      Maternal LOAEL = 30 mg/ = 7.2%)2.

      kg/day, based upon decreased body weight gain and corrected body weight gain.

      Intermediate-Term Dermal (1-6 months) oral study NOAEL= 9.3 LOC for MOE = 100

      Subchronic mg/kg/day

      (Residential, includes neurotoxicity - rat (dermal absorption rate the FQPA SF).

      LOAEL = 63.3 mg/kg/day, = 7.2%)2.

      based upon decreased body weight gain.

      Long-Term Dermal (> 6 months)

      oral study NOAEL= 5.7 LOC for MOE = 100

      Combined chronic tox/ mg/kg/day

      (Residential, includes carcinogenicity - rat (dermal absorption rate the FQPA SF)

      LOAEL = 16.9 mg/kg/ = 7.2%)2.

      day, based upon increased incidence of mineralized particles in thyroid colloid in males.

      Short-Term Inhalation (1-30 days) oral study NOAEL= 10 mg/ LOC for MOE = 100

      Developmental toxicity kg/day

      (Residential, includes rat (inhalation absorption the FQPA SF).

      Maternal LOAEL = 30 mg/ rate = 100%).

      kg/day, based upon decreased body weight gain and corrected body weight gain.

      Intermediate-Term Inhalation (1-6 oral study NOAEL= 9.3 LOC for MOE = 100

      Subchronic months)

      mg/kg/day

      (Residential, includes neurotoxicity - rat (inhalation absorption the FQPA SF).

      LOAEL = 63.3 mg/kg/day, rate = 100%).

      based upon decreased body weight gain.

      Long-Term Inhalation (>6 months) oral study NOAEL= 5.7 LOC for MOE = 100

      Combined chronic tox/ mg/kg/day

      (Residential, includes carcinogenicity - rat (inhalation absorption the FQPA SF).

      LOAEL = 16.9 mg/kg/day, rate = 100%).

      based upon increased incidence of mineralized particles in thyroid colloid in males.

      Cancer (oral, dermal, inhalation) no evidence of

      Not applicable

      No evidence of carcinogenicity for

      carcinogenicity in humans

      rats and mice.

      * The reference to the FQPA SF refers to any additional SF retained due to concerns unique to the FQPA.

      In its objections to a separate imidacloprid tolerance action, NRDC claims that EPA erred by regulating on the basis of a LOAEL for acute and chronic toxicity. As can be seen from the above table, NRDC is mistaken with regard to use of a LOAEL for estimating the RfD for chronic risk. The acute toxicity endpoint was based upon a LOAEL of 42 mg/kg/day from an acute neurotoxicity study in rats. This value was adjusted with a safety factor of 3X to approximate the value of a NOAEL. EPA has high confidence that this value of 3x is sufficient for several reasons. The effect seen at the LOAEL in the acute neurotoxicity study (decreased motor activity), occurred only in one sex of the rat (females), was characterized as minimal, and may have been a result of the use of the gavage dosing in the study. The decreased motor activity was not replicated following repeated dietary administration (non-gavage) at lower and higher doses (10, 70 or 200 mg/kg/day) in the subchronic neurotoxicity study in the same species (rats). Further, using a safety factor of 3X produces a regulatory endpoint lower than the acute effect levels in other standard studies for determining an acute endpoint, developmental toxicity studies in two species, and in another study that is on occasion used for such a purpose, the developmental neurotoxicity study in rats.

      Also in these objections, NRDC claims that EPA failed to calculate residential risks for some scenarios, based on low toxicity (no endpoints were chosen). On October 8, 2002, the Health Effects Division (HED), Hazard Identification Assessment Review Committee (HIARC) reviewed the hazard database for imidacloprid and established additional endpoints. Endpoints were chosen for each of the following exposure scenarios: acute dietary, chronic dietary, short-term oral, intermediate-term oral, short-term dermal, intermediate-term dermal, long-term dermal, short-term inhalation, intermediate-term inhalation, and long-term inhalation. In the current risk assessment (Unit E of this document), EPA calculated short-term residential risks (oral, dermal, and inhalation) for both adults and children for a wide-range of representative scenarios, including applications to lawns, ornamental plantings, indoor and outdoor potted plants, and dogs and cats. Based on current residential use patterns for imidacloprid, EPA expects the duration of exposure to be short-term (1-30 days), and would not result in intermediate or long-term exposure. EPA also conducted human health aggregate risk assessments for the following exposure scenarios: acute aggregate (food + drinking water), short-term aggregate exposure (food + drinking water + residential), and chronic aggregate exposure (food + drinking water).

   3. Exposure Assessment

      1. Dietary exposure from food and feed uses. Tolerances have been

         [[Page 35308]]

         established (40 CFR 180.472) for the combined residues of imidacloprid, in or on a variety of raw agricultural commodities. Meat, milk, poultry and egg tolerances have also been established for the combined residues of imidacloprid. In conducting dietary exposure assessments EPA used the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID\T\) which incorporates food consumption data as reported by respondents in the USDA [1994-1996 and 1998] nationwide Continuing Surveys of Food Intake by Individuals (CSFII) and accumulated exposure to the chemical for each commodity. The 1994-96 and 1998 data are based on the reported consumption of more than 20,000 individuals over two non-consecutive survey days. Consumption data are averaged for the entire U.S. population and within population subgroups for chronic exposure assessment, but are retained as individual consumption events for acute exposure assessment. Risk assessments were conducted by EPA to assess dietary exposures from imidacloprid 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\TM\) analysis evaluated the individual food consumption as reported by respondents in the USDA [1994-1996/1998] 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: A Tier 1, deterministic acute dietary exposure assessment was conducted using tolerance-level residues, 100% crop treated (CT) information for registered and proposed commodities; and modified DEEMTM (version 7.76) processing factors for some commodities based on guideline processing studies. EPA estimated exposure based on the 95th percentile value from this deterministic exposure assessment.

         In its objections to a separate imidacloprid tolerance action, NRDC asserts that EPA erred by relying on the exposure value for the 95th percentile of the population in estimating exposure. NRDC claims that this approach leaves 5 percent of the population unprotected. These comments by NRDC represent a misunderstanding of EPA's exposure assessments. Although EPA estimated exposure using the 95th percentile, EPA most definitely was not, however, acting in a manner designed to protect only 95 percent of the population. To the contrary, EPA's exposure estimates were designed to reasonably capture the full range of exposures in each population subgroup.

         As explained in its science policy paper on this subject, EPA, in estimating exposure for population subgroups, generally considers various population percentiles of exposure between 95 and 99.99, depending on the extent of overestimation in the residue data used in the assessment. In each exposure assessment EPA is attempting to reasonably estimate the full range of exposures in a subgroup. Accordingly, as EPA noted in its policy paper, just as when OPP uses the 95th percentile with non-probabilistic exposure assessments OPP is not suggesting that OPP is leaving 5 percent of the population unprotected, OPP is not by choosing the 99.9th percentile for probabilistic exposure assessments concluding that only 99.9 percent of the population deserves protection. Rather, it is OPP's view that, with probabilistic assessments, the use of the 99.9th percentile generally produces a reasonable high-end exposure such that if that exposure does not exceed the safe level, OPP can conclude there is a reasonable certainty of no harm to the general population and all significant population groups. (Office of Pesticide Programs, EPA, Choosing a Percentile of Acute Dietary Exposure as a Threshold of Regulatory Concern 31 (March 22, 2000)). Importantly, EPA generally uses a population percentile of 95 when EPA relies on worst case residue values - i.e., all crops covered by the tolerance contain residues at the tolerance value. Even at the 95th percentile of estimated exposure, actual exposure, when based on this assumption tends to be significantly overstated. For example, EPA has found that when it uses realistic residue information (e.g., data from monitoring of the food supply), that exposure estimates are generally substantially lower even at the 99.99th percentile.

         As noted above, EPA did use the worst case assumption that all food covered by imidacloprid tolerances would bear residues at the tolerance level. Hence, EPA believes its exposure estimate is unlikely to understate exposure; rather, in all likelihood, the estimate probably substantially overstates exposure.

         ii. Chronic exposure. The following assumptions were made for the chronic exposure assessments: The chronic dietary exposure assessment was performed using published and proposed tolerance levels, DEEM default processing factors, and percent crop treated information on some commodities.

         iii. Cancer. A quantitative cancer aggregate risk assessment was not performed because imidacloprid is not carcinogenic.

         Section 408(b)(2)(F) of the FFDCA states that the Agency may use data on the actual percent of food treated for assessing chronic dietary risk only if the Agency can make the following findings: Condition 1, that the data used are reliable and provide a valid basis to show what percentage of the food derived from such crop is likely to contain such pesticide residue; Condition 2, that the exposure estimate does not underestimate exposure for any significant subpopulation group; and Condition 3, if data are available on pesticide use and food consumption in a particular area, the exposure estimate does not understate exposure for the population in such area. In addition, the Agency must provide for periodic evaluation of any estimates used. To provide for the periodic evaluation of the estimate of percent CT as required by section 408(b)(2)(F) of the FFDCA, EPA may require registrants to submit data on percent CT.

         The Agency used CT information as follows:

         For the acute assessment, 100% CT was assumed for all registered and proposed commodities. For the chronic assessment, average weighted percent CT information was used for the following commodities: Apple 34%; brussels sprouts 56%; broccoli 35%; cabbage 14%; cantaloupe 31%; cauliflower 52%; collards 10%; corn, field 1%; cotton 3%; cucumber 2%; eggplant 36%; grapefruit 3%; grape 32%; mustard greens16%; honeydew 26%; kale 30%; lemon 1%; lettuce, head 49%; lime 5%; orange 1%; pear 16%; pepper 62%; pumpkin 7%; spinach 15%; squash 7%; sugarbeet 1%; tangerine 9%; tomato 9%; watermelon 6%; wheat 1%. A default value of 1% was used for all commodities which were reported as having 2, 1921 Jefferson Davis Hwy., Arlington, VA-. The Office of the Hearing Clerk is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Office of the Hearing Clerk is (703) 603-0061.

      2. Tolerance fee payment. If you file an objection or request a hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or request a waiver of that fee pursuant to 40 CFR 180.33(m). You must mail the fee to: EPA Headquarters Accounting Operations Branch, Office of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please identify the fee submission by labeling it ``Tolerance Petition Fees.''

         EPA is authorized to waive any fee requirement ``when in the judgement of the Administrator such a waiver or refund is equitable and not contrary to the purpose of this subsection.'' For additional information regarding the waiver of these fees, you may contact James Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov, or by mailing a request for information to Mr. Tompkins at Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460- 0001.

         If you would like to request a waiver of the tolerance objection fees, you must mail your request for such a waiver to: James Hollins, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.

      3. Copies for the Docket. In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit VI.A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in Unit I.B.1. Mail your copies, identified by docket ID number OPP-2003-0103, to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460- 0001. In person or by courier, bring a copy to the location of the PIRIB described in Unit I.B.1. You may also send an electronic copy of your request via e-mail to: opp-docket@epa.gov. Please use an ASCII file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries.

   2. 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).

7. 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

   [[Page 35314]]

   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.

8. 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: June 2, 2003. Debra Edwards, 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 180.472 is amended:

   i. In paragraph (a), in the table, by removing the commodities, ``bean, edible, podded,'' `` bean, succulent, shelled,'' ``dasheen, leaves,'' ``mango,'' ``potato,'' ``turnip, greens,'' and ``vegetable, tuberous and corm, subgroup;'' and by alphabetically adding the following commodities.

   ii. In paragraph (b), in the table, by removing the commodities, ``fruit, stone,'' ``strawberry,'' ``turnip, roots,'' and ``turnip, tops.''

   The additions read as follows:

   Sec. 180.472 Imidacloprid; tolerances for residues.

   (a) * * *

   Commodity

   Parts per million

   Acerola..............................................

   1.0 * * * * * Artichoke, globe.....................................

   2.5 Avocado..............................................

   1.0 Bananna\1\...........................................

   0.02 * * * * * Canistel.............................................

   1.0 * * * * * Corn, pop, grain.....................................

   0.05 Corn, pop, stover....................................

   0.20 * * * * * Cranberry............................................

   0.05 Currant..............................................

   3.5 * * * * * Elderberry...........................................

   3.5 * * * * * Feijoa...............................................

   1.0 * * * * * Fruit, stone, group 12...............................

   3.0 Gooseberry...........................................

   3.5 * * * * * Guava................................................

   1.0 * * * * * Huckleberry..........................................

   3.5 Jaboticaba...........................................

   1.0 Juneberry............................................

   3.5 * * * * * Lingonberry..........................................

   3.5 Longan...............................................

   3.0 Lychee...............................................

   3.0 Mango................................................

   1.0 * * * * * Mustard, seed........................................

   0.05 Okra................................................

   1.0 Passionfruit.........................................

   1.0 Papaya...............................................

   1.0 * * * * * Persimmon............................................

   3.0 * * * * * Pulasan..............................................

   3.0 Rambutan.............................................

   3.0 Salal................................................

   3.5 Sapodilla............................................

   1.0 Sapote, black........................................

   1.0 Sapote, mamey........................................

   1.0 * * * * * Spanish lime.........................................

   3.0 Star apple...........................................

   1.0 Starfruit............................................

   1.0 Strawberry...........................................

   0.50 * * * * * Vegetable, leaves of root and tuber, group 2.........

   4.0 Vegetable, legume, except soybean, group 6...........

   4.0

   [[Page 35315]]

   Vegetable, root and tuber, group 1, except sugar beet

   0.40 * * * * * Watercress...........................................

   3.5 Wax jambu............................................

   1.0 * * * * *

   \1\ There are no U.S. registration as of June 13, 2003 for use on banana.

   * * * * *

   [FR Doc. 03-14880 Filed 6-12-03; 8:45 am]

   BILLING CODE 6560-50-S