Proposed Time-Limited Pesticide Tolerances: Chlorantraniliprole

Federal Register: October 1, 2008 (Volume 73, Number 191)

Proposed Rules

Page 57040-57046

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

DOCID:fr01oc08-23

ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180

EPA-HQ-OPP-2008-0647; FRL-8382-4

Chlorantraniliprole; Proposed Time-Limited Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

SUMMARY: This document proposes to establish time-limited 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 under the Federal Food, Drug, and

Cosmetic Act (FFDCA). The tolerances expire on April 25, 2010.

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DATES: Comments must be received on or before December 1, 2008.

ADDRESSES: Submit your comments, identified by docket identification

(ID) number EPA-HQ-OPP-2008-0647, 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.

Instructions: Direct your comments to docket ID number EPA-HQ-OPP- 2008-0647. EPA's policy is that all comments received will be included in the docket without change and may be made available on-line at http://www.regulations.gov, including any personal information provided, unless the comment includes information claimed to be

Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through regulations.gov or e- mail. The regulations.gov website is an ``anonymous access'' system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e- mail comment directly to EPA without going through regulations.gov, your e-mail address will be automatically captured and included as part of the comment that is placed in the docket and made available on the

Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses.

Docket: 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., 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 either 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 hours of operation of this Docket Facility are 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:

      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 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. What Should I Consider as I Prepare My Comments for EPA? 1. Submitting CBI. Do not submit this information to EPA through regulations.gov or e-mail. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or

      CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as

      CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as

      CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket.

      Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. 2. Tips for preparing your comments. When submitting comments, remember to: i. Identify the document by docket ID number and other identifying information (subject heading, Federal Register date and page number). ii. Follow directions. The Agency may ask you to respond to specific questions or organize comments by referencing a Code of

      Federal Regulations (CFR) part or section number. iii. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes. iv. Describe any assumptions and provide any technical information and/or data that you used. v. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced. vi. Provide specific examples to illustrate your concerns and suggest alternatives. vii. Explain your views as clearly as possible, avoiding the use of profanity or personal threats. viii. Make sure to submit your comments by the comment period deadline identified.

2. Background and Statutory Findings

   EPA on its own initiative, under section 408(e) of FFDCA, 21 U.S.C. 346a(e), is proposing to establish a tolerances for residues of the insecticide chlorantraniliprole, 3-bromo-N-[4-chloro-2-methyl-6-

   (methylamino)carbonyl phenyl]-1-(3-chloro-2-pyridinyl)-1H-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,

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   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.

   Recently, EPA established tolerances for chlorantraniliprole on apple, wet pomace; brassica, head and stem, subgroup 5A; brassica, leafy greens, subgroup 5B; cotton, gin byproduct; cotton, hulls; cotton undelinted seed; fruit, pome, group 11; fruit, stone, group 12; grape; grape, raisen; potato; vegetable, cucurbit, group 9; vegetable, fruiting, group 8; vegetable, leafy, except brassica, group 4; milk; meat; meat byproduct and fat. At that time EPA determined rotational crop tolerances were required, and that the petitioner needed to conduct extensive field rotational crop trials. The Agency concluded that until the requested data are submitted, a restriction should be imposed on labels prohibiting the rotation to any crop not on the label. In response, the registrant submitted proposals for the establishment of tolerances for inadvertent residues for a number of crops pending submission of the requested data. After considering the registrant's submission, EPA is now proposing time-limited tolerances to address rotated crops.

   EPA has decided to propose time-limited rotational crop tolerances for chlorantraniliprole. Rotational crop trials (2003, 2004, 2005) were conducted in Canada and the United States on leafy vegetables (Swiss chard, lettuce, spinach), root vegetables (radish, beet, turnip), cereal grains (wheat, oat) and soybean. Based on the data on chlorantraniliprole, the Agency believes that the residue data would not underestimate residues on rotated crops. Thus the Agency believes that the 0.20 ppm tolerances on rotational crops are appropriate and protective. EPA also determined that adding these proposed tolerances would not change its prior safety finding for chlorantraniliprole.

   EPA's updated risk assessment can be found at http:// www.regulations.gov in docket ID number EPA-HQ-OPP-2008-0647.

   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. . .

   . ''

   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 http://www.epa.gov/ fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm.

3. Aggregate Risk Assessment and Determination of Safety

   Consistent with 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, consistent with section 408(b)(2) of FFDCA, for a tolerance for residues of chlorantraniliprole, 3-bromo-N-[4-chloro-2-methyl-6-

   (methylamino)carbonyl phenyl]-1-(3-chloro-2-pyridinyl)-1H-pyrazole-5- carboxamide, in or on cowpeas, forage and hay at 0.20 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 1.20 ppm; and sugarcane, sugar at 0.20 ppm. EPA's assessment of exposures and risks associated with establishing the tolerance 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 has no significant acute toxicity via the oral, dermal, and inhalation routes of exposure. This substance is not an eye or skin irritant and does not cause skin sensitization. In short-term studies, the most consistent effects are those associated with non adverse pharmacological response to the xenobiotic, induction of liver enzymes and subsequent increase in liver weights. Chlorantraniliprole is not genotoxic, neurotoxic, immunotoxic, carcinogenic, or teratogenic. Furthermore, it is not uniquely toxic to the conceptus as there were no maternal or fetal effects in studies conducted in rats and rabbits. Based on the results of a 28-day dermal study in rats, as well as the dermal LD50study, chlorantraniliprole has relatively low dermal toxicity.

      Overall, chlorantraniliprole exhibits minimal mammalian toxicity after long-term exposure. The only consistent observation in the mammalian toxicology studies is an increased degree of microvesiculation of the adrenal cortex after dermal or dietary administration of chlorantraniliprole. Based on the lack of adverse effect on the function of the adrenal gland, this observation was considered treatment related, but not ``adverse.''In addition to the adrenal effects, liver effects (e.g., increased liver weight and induction of cytochrome P450 enzymes) were reported in the 90-day oral subchronic studies across species and only at the highest dose tested

      (HDT) >1,000 milligram/kilogram/day (mg/kg/day). While in the subchronic studies, these effects were considered adaptive, the liver effects were more pronounced in the 18-month chronic mouse study at the

      HDT. Increased eosinophilic foci (preneoplastic foci) were noted in male mice at 935 mg/kg/day and liver hypertrophy and weight increase were evident at the next lower dose (158 mg/kg/day), but progression to tumors was not apparent for these effects. Therefore, the eosinophilic foci appear to be an adverse effect only seen in the HDT and was graded minimal in severity.

      Specific information on the studies received and the nature of the toxic 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. The referenced document is available in the docket established by this action, which is described under ADDRESSES, and is identified as EPA-HQ-OPP-2007-0275 in that docket.

   2. Toxicological Endpoints

      For hazards that have a threshold below which there is no appreciable

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      risk, the toxicological level of concern (LOC) is derived from the highest dose at which no adverse effects are observed (the NOAEL) in the toxicology study identified as appropriate for use in risk assessment. However, if a NOAEL cannot be determined, the lowest dose at which adverse effects of concern are identified (the LOAEL) is sometimes used for risk assessment. Uncertainty/safety factors (UFs) are used in conjunction with the LOC 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 risks by comparing aggregate 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 LOC by all applicable UFs. Short-term, intermediate-term, and long-term risks are evaluated by comparing aggregate exposure to the LOC to ensure that the margin of exposure (MOE) called for by the product of all applicable

      UFs is not exceeded.

      For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk and estimates risk in terms of the probability of occurrence of additional adverse cases.

      Generally, cancer risks are considered non-threshold. 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/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.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 pome fruit, stone fruit, leafy vegetables, brassica leafy vegetables, cucurbit vegetables, fruiting vegetables, cotton, grapes, potatoes, rice, turf and ornamentals pages 22-24 in docket ID number EPA-HQ-OPP-2007-0275.

   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 CSFII. As to residue levels in food, EPA assumed all foods for which there are tolerances were treated and contain tolerance-level residues.

      The inclusion of additional livestock feeds such as forage, fodder and straw from cowpea, field pea, soybean, cereal grains, nongrass animal feeds or peanut does not increase the livestock dietary burdens and thus the meat and milk tolerances. While the addition of strawberries, sugarcane, leek, onions, shallot, and okra that are considered human food results in a miniscule increase in exposure, a

      DEEM analysis that incorporates all the new commodities does not change the risk outcome which remains at 1% of the cPAD for the most highly exposed population, children ages 1-2. In addition, the dietary exposure from leeks, onions and shallots is negligible. iii. Cancer. Because chlorantraniliprole has been classified as a

      ``not likely human carcinogen'', a quantitative exposure assessment relative to cancer risk is not necessary. 2. Dietary exposure from drinking water. The Agency lacks sufficient monitoring data to complete a comprehensive dietary exposure analysis and risk assessment for chlorantraniliprole 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 environmental fate 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 environmental concentrations (EECs) 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 EECs for chronic exposures are estimated to be 3.650 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. Because no acute hazard, attributable to a single dose, was identified; acute dietary risk was not assessed. For chronic dietary risk assessment, the water concentration value 3.650 ppb was used to access 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 registered for use on the following residential non-dietary sites: Turfgrass and ornamental plants.

      Although residential exposure could occur, due to the lack of toxicity identified for short-term and intermediate-term durations via the 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.''

      Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to chlorantraniliprole and 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 not assumed that chlorantraniliprole has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements released by EPA's Office of Pesticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances

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      found to have a common mechanism on EPA's website at http:// www.epa.gov/pesticides/cumulative.

   4. Safety Factor for Infants and Children 1. In general. Section 408 of FFDCA provides that EPA shall apply an additional (10X) 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 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. In applying this provision, EPA either retains the default value of 10X when reliable data do not support the choice of a different factor, or, if reliable data are available, EPA uses a different additional FQPA safety factor value based on the use of traditional UFs and/or special

      FQPA safety factors, as appropriate. 2. Prenatal and postnatal sensitivity. There were no effects on fetal growth or postnatal development up to the limit dose of 1,000 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 that it would be safe for infants and children to reduce the FQPA safety factor to 1X. That decision is based on the following findings: i. The toxicology database for chlorantraniliprole is complete for the purposes of this risk assessment and the characterization of potential prenatal and postnatal risks to infants and children. ii. No susceptibility was identified in the toxicological database, and there are no residual uncertainties re: prenatal and/or postnatal exposure. iii. There are no treatment-related neurotoxic findings in the acute and subchronic oral neurotoxicity studies in rats. iv. The exposure assessment is protective: The dietary food exposure assessment utilizes tolerance level residues and 100 percent crop treated (PCT) information for all commodities. The submitted field rotational crop studies do not match those recommended in the guidelines. However, data from confined rotational crop studies and field rotational crop studies show that uptake of chlorantraniliprole is below the quantification level in roots and grains, and range of 0.01 to 0.15 ppm in tops of root vegetables and forage, fodder and straw of cereal grains and soybean. The 0.20 ppm tolerances based on the collective data should be conservative. Also, the tolerances on rotational crops strawberry and okra are conservative since the strawberry tolerance is based on residues in grape from direct application of chlorantraniliprole and the okra tolerance is based on residues resulting from direct treatment on tomato and pepper. An exposure assessment using conservative residue values is expected to be protective.

      The drinking water assessment utilizes values generated by models and associated modeling parameters which are designed to provide conservative, health protective, high-end estimates of water concentrations. By using these screening-level exposure assessments, the chronic dietary (food and drinking water) risk is not underestimated. v. Although residential exposure is expected over the short- and possibly intermediate-term (via the dermal and/or incidental oral route), there is no hazard expected via these routes/durations, and therefore no risk for these scenarios.

   5. Aggregate Risks and Determination of Safety

      Safety is assessed for acute and chronic risks by comparing aggregate exposure to the pesticide to the aPAD and cPAD. The aPAD and cPAD are calculated by dividing the LOC by all applicable UFs. For linear cancer risks, EPA calculates the probability of additional cancer cases given aggregate exposure. Short-term, intermediate-term, and long-term risks are evaluated by comparing aggregate exposure to the LOC to ensure that the MOE called for by the product of all applicable UFs is not exceeded. 1. Acute risk. No acute risk is expected because no acute hazard, attributable to a single dose, was identified. 2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to chlorantraniliprole from food and water will utilize