Pendimethalin; Pesticide Tolerances

Federal Register, Volume 80 Issue 28 (Wednesday, February 11, 2015)

Federal Register Volume 80, Number 28 (Wednesday, February 11, 2015)

Rules and Regulations

Pages 7541-7547

From the Federal Register Online via the Government Printing Office www.gpo.gov

FR Doc No: 2015-02705

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

EPA-HQ-OPP-2013-0768; FRL-9921-89

Pendimethalin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes tolerances for residues of pendimethalin in or on multiple commodities which are identified and discussed later in this document. In addition, this regulation removes existing tolerances on fruit, citrus, group 10; fruit, pome, group 11; fruit, stone, group 12; garlic; leek; onion, bulb; onion, green; onion, welsh; shallot; strawberry; sunflower seed; and vegetable, fruiting, group 8, which are superseded by this action. Interregional Research Project Number 4 (IR-4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective February 11, 2015. Objections and requests for hearings must be received on or before April 13, 2015, 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: The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2013-0768, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OPP Docket is (703) 305-5805. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Susan Lewis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone number: (703) 305-7090; email address: RDFRNotices@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. The following list of North American Industrial Classification System (NAICS) codes is

      Page 7542

      not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:

      Crop production (NAICS code 111).

      Animal production (NAICS code 112).

      Food manufacturing (NAICS code 311).

      Pesticide manufacturing (NAICS code 32532).

   2. How can I get electronic access to other related information?

      You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

   3. How can I file an objection or hearing request?

      Under FFDCA section 408(g), 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 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-2013-0768 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before April 13, 2015. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

      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 (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2013-0768, by one of the following methods:

      Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute.

      Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.

      Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html.

      Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets.

2. Summary of Petitioned-For Tolerance

   In the Federal Register of Friday, February 21, 2014 (79 FR 9870) (FRL-9904-98), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 3E8212) by IR-4, IR-4 Project Headquarters, 500 College Road East, Suite 201 W, Princeton, NJ 08540. The petition requested that 40 CFR 180.361 be amended by establishing tolerances for residues of the herbicide pendimethalin, N-(1-ethylpropyl)-3,4-dimethyl-2,6-

   dinitrobenzenamine, and its metabolite, 4-(1-ethylpropyl)amino-2-

   methyl-3,5-dinitrobenzyl alcohol, calculated as the stoichiometric equivalent of pendimethalin, in or on berry, low growing subgroup 13-

   07G at 0.1 parts per million (ppm); fruit, citrus, group 10-10 at 0.1 ppm; fruit, pome, group 11-10 at 0.1 ppm; fruit, stone, group 12-12 at 0.1 ppm; hops, dried cones at 0.1 ppm; onion, bulb subgroup 3-07A at 0.1 ppm; onion, green subgroup 3-07B at 0.2 ppm; sunflower, subgroup 20B at 0.1 ppm; and vegetable, fruiting, group 8-10 at 0.1 ppm. That document referenced a summary of the petition prepared by BASF Corporation, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing.

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 FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for pendimethalin including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with pendimethalin follows.

   1. Toxicological Profile

      EPA has evaluated the available toxicity database 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.

      Pendimethalin has low acute toxicity by the oral, dermal, or inhalation route of exposure. It is not an eye or skin irritant, and is not a skin sensitizer. The target organ is the thyroid. Thyroid toxicity in chronic and subchronic rat and mouse studies was manifested as alterations in thyroid hormones (decreased total T4, and T3, increased percent of free T4 and T3), increased thyroid weight, and microscopic thyroid lesions (including increased thyroid follicular cell height, follicular cell hyperplasia, as well as follicular cell adenomas). Due to these effects, the Agency required that a developmental thyroid assay be conducted to evaluate the impact of pendimethalin on thyroid hormones, structure, and/or thyroid hormone homeostasis during development. A developmental thyroid study was submitted and demonstrated that there is no potential thyroid toxicity following pre- and/or post-natal exposure to pendimethalin.

      The points of departure (PODs) used for the chronic and short-term risk assessments were based on a 92-day thyroid function study in rats, a 56-day thyroid study in rats, and a 14-day intra thyroid metabolism study in rats. Due to several important quantitative dynamic differences between rats and humans with respect to thyroid function, the interspecies uncertainty factor (UF), which used to account for animal to human differences in toxicokinetics and toxicodynamics, was reduced to 3X for

      Page 7543

      the chronic and short-term risk assessments. A 10X interspecies UF was used in the acute risk assessment because the POD was based on an acute neurotoxicity study, not a thyroid study. Although a subchronic inhalation study was not available in the database, EPA determined that one is not needed at this time based on the following:

      1. All relevant hazard and exposure information, including its low acute inhalation toxicity.

      2. Its physical/chemical properties, including its low volatility.

      3. The use of an oral POD that results in occupational and residential inhalation margin of exposure (MOE) (in the case of pendimethalin MOE = 30 based on thyroid POD).

      There is no evidence that pendimethalin is a developmental, reproductive, neurotoxic, or immunotoxic chemical. There is no evidence of increased qualitative or quantitative susceptibility in the young. EPA classified pendimethalin as a ``Group C'', possible human carcinogen based on a statistically significant increased trend and pair-wise comparison between the high-dose group and controls for thyroid follicular cell adenomas in male and female rats. A non-

      quantitative approach (i.e., non-linear, reference dose (RfD) approach) was used to assess cancer risk since mode-of-action studies are available to demonstrate that the thyroid tumors are due to a thyroid-

      pituitary imbalance, and also since pendimethalin was shown to be non-

      mutagenic in mammalian somatic cells and germ cells.

      Specific information on the studies received and the nature of the adverse effects caused by pendimethalin as well as the no-observed-

      adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-

      level (LOAEL) from the toxicity studies are discussed in the final rule published in the Federal Register of August 29, 2012 (77 FR 52240) (FRL-9360-5) and in ``Pendimethalin: Human Health Risk Assessment to Support New Use on Hops and Crop Subgroup Conversions/Expansions for Low Growing Berry Subgroup 13-07G, Onion, Bulb Subgroup 3-07A, Onion, Green Subgroup 3-07B, and Sunflower Subgroup 20B; Crop Group Expansions for Citrus Fruit, Group 10, Pome Fruit, Group 11, Stone Fruit, Group 12, and Fruiting Vegetable, Group 8,'' in docket ID number EPA-HQ-OPP-

      2013-0768.

   2. Toxicological Points of Departure/Levels of Concern

      Once a pesticide's toxicological profile is determined, EPA identifies toxicological POD and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which the NOAEL and the LOAEL are identified. Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level--generally referred to as a population-adjusted dose (PAD) or a RfD--and a safe MOE. 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 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 pendimethalin used for human risk assessment is discussed in the final rule published in the Federal Register on Wednesday, August 29, 2012 (77 FR 52240) (FRL-9360-

      5) establishing tolerances for residues of pendimethalin and its metabolite in or on various commodities.

   3. Exposure Assessment

      1. Dietary exposure from food and feed uses. In evaluating dietary exposure to pendimethalin, EPA considered exposure under the petitioned-for tolerances as well as all existing pendimethalin tolerances in 40 CFR 180.361. EPA assessed dietary exposures from pendimethalin 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.

         Such effects were identified for pendimethalin. In conducting the acute dietary exposure assessment for pendimethalin, EPA used the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID) Version 3.16. This software uses 2003-2008 food consumption data from the U.S. Department of Agriculture's (USDA's) National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). The deterministic acute analysis is based on tolerance-level residues; 100 percent crop treated (PCT) assumptions for all of the pendimethalin use commodities in this assessment and DEEMTM default processing factors or empirical processing factors where available.

         ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the DEEM-FCID, Version 3.16 software with 2003-2008 food consumption data from the USDA's NHANES/WWEIA. The deterministic unrefined chronic analysis is based on tolerance-level residues; 100 PCT assumptions for all of the pendimethalin use commodities in this assessment and DEEMTM default processing factors or empirical processing factors where available.

         iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that a nonlinear RfD approach is appropriate for assessing cancer risk to pendimethalin. Cancer risk was assessed using the same exposure estimates as discussed in Unit III.C.1.ii., chronic exposure.

         iv. Anticipated residue and PCT information. EPA did not use anticipated residue or PCT information in the dietary assessment for pendimethalin. Tolerance-level residues, default processing factors and 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 pendimethalin in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of pendimethalin. 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--New York grape scenario) and Screening Concentration in Ground Water (SCI-GROW) models the estimated drinking water concentrations (EDWCs) of pendimethalin for acute exposures are estimated to be 77.7 parts per billion (ppb) for surface water and 0.036 ppb for ground water; and for chronic exposures are estimated to be 6.0 ppb for surface water and 0.036 ppb for ground water.

         Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute dietary risk assessment, the water concentration value of 77.7 ppb was used to assess the contribution to

         Page 7544

         drinking water. For chronic dietary risk assessment, the water concentration of value 6.0 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).

         Pendimethalin is currently registered for the following uses that could result in residential exposures: Turf, home gardens, and ornamentals. EPA assessed residential exposure using the following assumptions: For handlers, it is assumed that most residential use will result in short-term (1 to 30 days) duration dermal and inhalation exposures. Residential handlers are assumed to be adults wearing short-

         sleeved shirts, short pants, shoes and socks during application of pendimethalin.

         Residential post-application exposure is also assumed to be short-

         term (1-30 days) in duration, resulting from the following exposure scenarios: Gardening: Adults (dermal) and children 6