Pesticide Tolerances: Chlorantraniliprole

Federal Register: June 26, 2009 (Volume 74, Number 122)

Rules and Regulations

Page 30470-30475

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

DOCID:fr26jn09-7

ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180

EPA-HQ-OPP-2008-0770; FRL-8413-6

Chlorantraniliprole; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes tolerances for residues of chlorantraniliprole in or on almonds; nut, tree, crop group 14, and pistachios. E.I. Du Pont de Nemours and Company requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). This regulation also establishes time-limited rotational crop tolerances for residues of chlorantraniliprole in or on cowpeas, forage and hay; field peas, vines and hay; forage, fodder and straw of cereal grains, crop group 16; grass forage, fodder and hay, crop group 17; leaves of root and tuber vegetables, crop group 2, leeks, nongrass animal feeds

(forage, fodder, straw and hay), crop group 18; okra; onions, green; onions, Welsh; peanuts, hay; shallots; soybeans, forage and hay; strawberries and sugarcane, sugar. The time-limited tolerances expire on April 25, 2010.

DATES: This regulation is effective June 26, 2009. Objections and requests for hearings must be received on or before August 25, 2009, and must be filed in accordance with the instructions provided in 40

CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket identification (ID) number EPA-HQ-OPP-2008-0770. All documents in the docket are listed in the docket index available at http:// www.regulations.gov. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the

Internet and will be publicly available only in hard copy form.

Publicly available docket materials are available in the electronic docket at http://www.regulations.gov, or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac

Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket

Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Kable Bo Davis, Registration Division

(7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 306-0415; e-mail address: davis.kable@epa.gov.

SUPPLEMENTARY INFORMATION:

1. General Information

   1. Does this Action Apply to Me?

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

      Potentially affected entities may include, but are not limited to those engaged in the following activities:

      Crop production (NAICS code 111).

      Animal production (NAICS code 112).

      Food manufacturing (NAICS code 311).

      Pesticide manufacturing (NAICS code 32532).

      This listing is not intended to be exhaustive, but rather to provide 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 Access Electronic Copies of this Document?

      In addition to accessing electronically available documents at http://www.regulations.gov, you may access this Federal Register document electronically through the EPA Internet under the ``Federal

      Register'' listings at http://www.epa.gov/fedrgstr. You may also access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR cite at http://www.gpoaccess.gov/ecfr.

   3. Can I File an Objection or Hearing Request?

      Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation

      Page 30471

      in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-

      HQ-OPP-2008-0770 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 as required by 40 CFR part 178 on or before August 25, 2009.

      In addition to filing an objection or hearing request with the

      Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit this copy, identified by docket ID number

      EPA-HQ-OPP-2008-0770, by one of the following methods:

      Federal eRulemaking Portal: http://www.regulations.gov.

      Follow the on-line instructions for submitting comments.

      Mail: Office of Pesticide Programs (OPP) Regulatory Public

      Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania

      Ave., NW., Washington, DC 20460-0001.

      Delivery: OPP Regulatory Public Docket (7502P),

      Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South

      Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket Facility's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays).

      Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is (703) 305-5805.

2. Petition for Tolerance and Notice of Proposed Rulemaking

   In the Federal Register of December 3, 2008 (73 FR 73640) (FRL- 8390-4), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21

   U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 8F7409) by E.I. du Pont de Nemours and Company, DuPont Crop Protection, 1090 Elkton Road, Newark, DE 19711. The petition requested that 40 CFR 180.628 be amended by establishing tolerances for residues of the insecticide chlorantraniliprole, 3-bromo-N-[4-chloro-2-methyl-6-

   (methylamino) carbonyl phenyl]-1-(3-chloro-2-pyridinyl)-1 H-pyrazole- 5-carboxamide, in or on almond hulls at 5.0 parts per million (ppm), nut, tree, crop group 14 at 0.07 ppm and pistachios at 0.07 ppm. That notice referenced a summary of the petition prepared by E.I. du Pont de

   Nemours and Company, DuPont Crop Protection, the registrant, which is available to the public in the docket, http://www.regulations.gov.

   There were no comments received in response to the notice of filing.

   Based upon review of the data supporting the petition, EPA has reduced the recommended tolerance of 0.07 ppm for nut, tree, group 14 and pistachios to 0.04 ppm. The reason for these changes are explained in Unit IV.D.

   In the Federal Register of October 1, 2008 (73 FR 57040-57046)

   (FRL-8382-4), EPA issued a proposed rule pursuant to sections 408(e) of the Federal Food, Drug and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d)(3).

   The rule proposed that 40 CFR 180.628 be amended by establishing time- limited tolerances for indirect or inadvertent residues of chlorantraniliprole, 3-bromo-N-[4-chloro-2-methyl-6-[(methylamino) carbonyl]phenyl]-1-(3-chloro-2-pyridinyl)-1 H-pyrazole-5-carboxamide, in or on cowpeas, forage and hay at 0.20 parts per million (ppm); field peas, vines and hay at 0.20 ppm; forage, fodder and straw of cereal grains, crop group 16 at 0.20 ppm, grass forage, fodder and hay, crop group 17 at 0.20 ppm; leaves of root and tuber vegetables, crop group 2 at 0.20 ppm; leeks at 0.20 ppm; nongrass animal feeds (forage, fodder, straw and hay), crop group 18 at 0.20 ppm; okra at 0.70 ppm; onions, green at 0.20 ppm; onions, Welsh at 0.20 ppm; peanuts, hay at 0.20 ppm; shallots at 0.20 ppm; soybeans, forage and hay at 0.20 ppm; strawberries at 1.2 ppm; and sugarcane, sugar at 0.20 ppm. The proposal established a 60-day public comment period. There were no comments received in response to the proposed rule.

   This final rule completes Agency action on both the petition from

   E.I. Du Pont de Nemours and Company, DuPont Crop Protection, and EPA's proposed rulemaking of October 1, 2008.

3. Aggregate Risk Assessment and Determination of Safety

   Section 408(b)(2)(A)(i) of 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 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 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....''

   Consistent with section 408(b)(2)(D) of FFDCA, and the factors specified in section 408(b)(2)(D) of 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 for the petitioned-for tolerances for residues of chlorantraniliprole on almond, hulls at 5.0 ppm, nut, tree, group 14 at 0.04 ppm and pistachio at 0.04 ppm. EPA's assessment of exposures and risks associated with establishing tolerances follows.

   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.

      Chlorantraniliprole is not genotoxic, neurotoxic, immunotoxic, carcinogenic, or teratogenic. Chlorantraniliprole has been found to have low acute toxicity by the oral, dermal, and inhalation routes of exposure and has little to no irritation effect on the eyes or skin.

      Additionally, chlorantraniliprole is not a dermal sensitizer. There was only one toxicity study in the toxicity database that indicated that chlorantraniliprole yielded an adverse effect (18-month oral/mouse).

      This study was used to establish a point of departure based on hepatocellular effects for chronic risk.

      Specific information on the studies received and the nature of the adverse effects caused by chlorantraniliprole as well as the no- observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse- effect-level (LOAEL) from the toxicity studies can be found at http:// www.regulations.gov in document Chlorantraniliprole (DPX-E2Y45). Human

      Health Risk Assessment for Proposed Uses on the Tree Nut Group and

      Pistachios and for Increases in the Established Tolerances for Pome

      Fruits, Stone Fruits, Grapes and Raisins due to the Removal of Adjuvant

      Restrictions from the Label for Pome Fruits, Stone

      Page 30472

      Fruits, and Grapes, page 21 in docket ID number EPA-HQ-OPP-2008-0770.

   2. Toxicological Endpoints

      For hazards that have a threshold below which there is no appreciable risk, a toxicological point of departure (POD) is identified as the basis for derivation of reference values for risk assessment. The POD may be defined as the NOAEL in the toxicology study identified as appropriate for use in risk assessment. However, if a

      NOAEL cannot be determined, the LOAEL or a Benchmark Dose (BMD) approach is sometimes used for risk assessment. Uncertainty/safety factors (UFs) are used in conjunction with the POD to take into account 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. Safety is assessed for acute and chronic dietary risks by comparing aggregate food and water exposure to the pesticide to the acute population adjusted dose (aPAD) and chronic population adjusted dose (cPAD). The aPAD and cPAD are calculated by dividing the POD by all applicable UFs. Aggregate short- term, intermediate-term, and chronic-term risks are evaluated by comparing food, water, and residential exposure to the POD to ensure that the margin of exposure (MOE) called for by the product of all applicable UFs is not exceeded. This latter value is referred to as the

      Level of Concern (LOC).

      For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect greater than that expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http://www.epa.gov/ pesticides/factsheets/riskassess.htm.

      A summary of the toxicological endpoints for chlorantraniliprole used for human risk assessment can be found at http:// www.regulations.gov in document Chlorantraniliprole (DPX-E2Y45). Human

      Health Risk Assessment for Proposed Uses on the Tree Nut Group and

      Pistachios and for Increases in the Established Tolerances for Pome

      Fruits, Stone Fruits, Grapes and Raisins due to the Removal of Adjuvant

      Restrictions from the Label for Pome Fruits, Stone Fruits, and Grapes, page 10 in docket ID number EPA-HQ-OPP-2008-0770.

   3. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to chlorantraniliprole, EPA considered exposure under the petitioned-for tolerances as well as all existing chlorantraniliprole tolerances in 40 CFR 180.628. EPA assessed dietary exposures from chlorantraniliprole in food as follows: i. Acute exposure. Quantitative acute dietary exposure and 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 1-day or single exposure.

      No such effects were identified in the toxicological studies for chlorantraniliprole; therefore, a quantitative acute dietary exposure assessment is unnecessary. ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the United States

      Department of Agriculture (USDA) 1994-1996 and 1998 Continuing Survey of Food Intake by Individuals (CSFII). As to residue levels in food,

      EPA assumed all foods for which there are tolerances were treated and contain tolerance-level residues. iii. Cancer. Chlorantraniliprole was classified as ``Not likely to be Carcinogenic to Humans'' based on evidence showing no treatment- related tumors in the submitted chronic and oncogenicity studies in rats and mice, and subchronic studies in mice, dogs, and rats, and no mutagenic concerns in the genotoxicity studies. Therefore, an exposure assessment to evaluate cancer risk is unnecessary. iv. Anticipated residue and percent crop treated (PCT) information.

      EPA did not use anticipated residue and/or PCT information in the dietary assessment for chlorantraniliprole. Tolerance level residues and/or 100 PCT were assumed for all food commodities. 2. Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for chlorantraniliprole in drinking water. These simulation models take into account data on the physical, chemical, and fate/ transport characteristics of chlorantraniliprole. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/ index.htm.

      Based on the Pesticide Root Zone Model/Exposure Analysis Modeling

      System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-

      GROW) models, the estimated drinking water concentrations (EDWCs) of chlorantraniliprole for acute exposures are estimated to be 26.862 parts per billion (ppb) for surface water and 1.06 ppb for ground water. The estimated drinking water concentrations (EDWCs) of chlorantraniliprole for chronic exposures are 3.650 parts per billion

      (ppb) for surface water and 1.06 ppb for ground water.

      Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model.

      For chronic dietary risk assessment, the water concentration of value 3.650 ppb was used to assess the contribution to drinking water. 3. From non-dietary exposure. The term ``residential exposure'' is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets).

      Chlorantraniliprole is currently registered for the following uses that could result in residential exposures: Turfgrass and ornamental plants. EPA assessed residential exposure using the following assumptions. Although residential exposure could occur, due to the lack of toxicity identified for short- and intermediate-term durations via relevant routes of exposure, no risk is expected from these exposures.

      Additional information on residential exposure assumptions can be found at www.regulations.gov (Docket ID EPA-HQ-OPP-2007-0275, pages 36 through 37). 4. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the

      Agency consider ``available information'' concerning the cumulative effects of a particular pesticide's residues and ``other substances that have a common mechanism of toxicity.''

      EPA has not found chlorantraniliprole to share a common mechanism of toxicity with any other substances, and chlorantraniliprole does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that chlorantraniliprole does not have 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 EPA's website at http:// www.epa.gov/pesticides/cumulative.

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   4. Safety Factor for Infants and Children 1. In general. Section 408(b)(2)(c) of FFDCA provides that EPA shall apply an additional tenfold (10X) 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 database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the FQPA safety factor (SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor. 2. Prenatal and postnatal sensitivity. There were no effects on fetal growth or post-natal development up to the limit dose of 1,000 milligrams/kilogram/day (mg/kg/day) in rats or rabbits in the developmental or 2-generation reproduction studies. Additionally, there were no treatment related effects on the numbers of litters, fetuses

      (live or dead), resorptions, sex ratio, or post-implantation loss and no effects on fetal body weights, skeletal ossification, and external, visceral, or skeletal malformations or variations. 3. Conclusion. EPA has determined that reliable data show the safety of infants and children would be adequately protected if the

      FQPA SF were reduced to 1X. That decision is based on the following findings: i. The toxicity database for chlorantraniliprole is complete. ii. There is no indication that chlorantraniliprole is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity. iii. There is no evidence that chlorantraniliprole results in increased susceptibility in in utero rats or rabbits in the prenatal developmental studies or in young rats in the 2-generation reproduction study. iv. There are no residual uncertainties identified in the exposure databases. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to chlorantraniliprole in drinking water. EPA used similarly conservative assumptions to assess post-application exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by chlorantraniliprole.

   5. Aggregate Risks and Determination of Safety

      EPA determines whether acute and chronic pesticide exposures are safe by comparing aggregate exposure estimates to the aPAD and cPAD.

      The aPAD and cPAD represent the highest safe exposures, taking into account all appropriate SFs. EPA calculates the aPAD and cPAD by dividing the POD by all applicable UFs. For linear cancer risks, EPA calculates the probability of additional cancer cases given the estimated aggregate exposure. Short-term, intermediate-term, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the POD to ensure that the MOE called for by the product of all applicable UFs is not exceeded. 1. Acute risk. An acute aggregate risk assessment takes into account exposure estimates from acute dietary consumption of food and drinking water. No adverse effect resulting from a single-oral exposure was identified and no acute dietary endpoint was selected. Therefore, chlorantraniliprole is not expected to pose an acute risk. 2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to chlorantraniliprole from food and water will utilize