Quinclorac; Pesticide Tolerances
Federal Register, Volume 82 Issue 231 (Monday, December 4, 2017)
Federal Register Volume 82, Number 231 (Monday, December 4, 2017)
Rules and Regulations
Pages 57144-57149
From the Federal Register Online via the Government Publishing Office www.gpo.gov
FR Doc No: 2017-26078
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ENVIRONMENTAL PROTECTION AGENCY
EPA-HQ-OPP-2016-0384; FRL-9970-05
Quinclorac; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of quinclorac in or on the bushberry subgroup 13-07B, the caneberry subgroup 13-07A, and asparagus. Interregional Research Project Number 4 (IR-4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective December 4, 2017. Objections and requests for hearings must be received on or before February 2, 2018, 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-2016-0384, 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
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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: Michael Goodis, 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:
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General Information
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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 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).
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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.
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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-2016-0384 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 February 2, 2018. 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-2016-0384, 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.
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Summary of Petitioned-For Tolerance
In the Federal Register of November 30, 2016 (81 FR 86312) (FRL-
9954-06), 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 6E8488) by IR-4 Project Headquarters, Rutgers, The State University of NJ, 500 College Road East, Suite 201 W, Princeton, NJ 08540. The petition requested that 40 CFR part 180 be amended by establishing tolerances for residues of the herbicide quinclorac, 3,7-dichloro-8-
quinolinecarboxylic acid in or on asparagus at 0.06 parts per million (ppm); the bushberry subgroup 13-07B, except lowbush blueberry at 0.6 ppm; and the caneberry subgroup 13-07A at 0.06 ppm. That document referenced a summary of the petition prepared by Albaugh, the registrant, which is available 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 modified the levels at which the tolerances are being established. The reason for these changes is explained in Unit IV.C.
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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 quinclorac including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with quinclorac follows.
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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.
Subchronic toxicity of quinclorac includes decreased body weight gains, increased water intake, increased liver enzymes (SGOT, SGPT) and focal chronic interstitial nephritis (rats). Chronic toxic effects of quinclorac include body weight decrement, increase in kidney and liver weights, and hydropic degeneration of the kidneys (dogs). At high doses, chronic
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toxicity also includes increased incidences of pancreatic acinar cell hyperplasia and adenomas (rats). Neurotoxic effects were not observed in any of the acute, subchronic, and chronic studies with quinclorac.
There was no increased qualitative or quantitative fetal or offspring susceptibility in the prenatal developmental or postnatal reproduction studies. Developmental toxicity in the rabbit consisted of increased resorptions, post-implantation loss, decreased number of live fetuses, and reduced fetal body weight. These effects occurred at much higher doses than the maternal effects of decreased food consumption and increased water consumption and decreased body weight gain. In the rat, no developmental toxicity was observed at the highest dose tested (438 mg/kg/day). In the 2-generation reproduction study, parental toxicity and offspring toxicity occurred at the same dose. Parental toxicity consisted of reduced body weight in both sexes during premating and lactation periods. Offspring toxicity consisted of decreased pup weight, developmental delays and possible marginal effect on pup viability. No reproductive toxicity occurred at the highest dose tested (480 mg/kg/day).
There are no mutagenicity concerns. Quinclorac is not mutagenic in bacterial assays and does not cause unscheduled DNA damage in primary rat hepatocytes. There is also no evidence of a genotoxic response in whole animal test systems (in vivo mouse bone marrow micronucleus assay). Quinclorac was negative in a mammalian cell in vitro cytogenetic chromosomal aberration assay in Chinese hamster ovary cells (CHO). Quinclorac was classified by the Agency as a group D carcinogen--not classifiable as to human carcinogenicity. Quantification of cancer risk is not required because the chronic RfD will adequately account for all chronic effects, including carcinogenicity, that may result from exposure to quinclorac.
Specific information on the studies received and the nature of the adverse effects caused by quinclorac 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 the document titled ``Quinclorac: Human Health Risk Assessment for New Proposed Use on Bushberry Subgroup 13-07B, Caneberry Subgroup 13-07A, and Asparagus'' on pages 41-46 in docket ID number EPA-HQ-OPP-2016-0384.
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Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (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 no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). 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 reference dose (RfD)--and a safe margin of exposure (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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
A summary of the toxicological endpoints for quinclorac used for human risk assessment is discussed in Unit III.B. of the final rule published in the Federal Register of November 29, 2013 (78 FR 71523) (FRL-9902-15).
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Exposure Assessment
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Dietary exposure from food and feed uses. In evaluating dietary exposure to quinclorac, EPA considered exposure under the petitioned-
for tolerances as well as all existing quinclorac tolerances in 40 CFR 180.463. EPA assessed dietary exposures from quinclorac 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.
For the general population including infants and children, no such effects were identified in the toxicological studies for quinclorac; therefore, a quantitative acute dietary exposure assessment for these population groups is unnecessary.
However, for females 13 to 49 years of age, such effects were identified for quinclorac. In estimating acute dietary exposure, EPA used food consumption information from the 2003-2008 United States Department of Agriculture's (USDA) National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). As to residue levels in food, EPA assumed tolerance-level residues and 100 percent crop treated (PCT).
ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the 2003-2008 USDA's NHANES/WWEIA. As to residue levels in food, EPA assumed tolerance-level residues and 100 PCT.
iii. Cancer. Based on the current cancer classification of quinclorac, quantification of cancer risk is not required and the chronic RfD will adequately account for all chronic effects, including carcinogenicity, that may result from exposure to quinclorac.
iv. Anticipated residue and PCT information. EPA did not use anticipated residue or PCT information in the dietary assessment for quinclorac. Tolerance level residues and 100 PCT were assumed for all food commodities.
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Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for quinclorac in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of quinclorac. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
Based on the Tier 1 Rice Model and the Pesticide Water Calculator-
Ground Water exposure model, the estimated drinking water concentrations (EDWCs) of quinclorac for acute exposures are estimated to be 511 parts per billion (ppb) for surface water and 817 ppb for ground water and for chronic exposures are estimated to be 481 ppb for surface water and 543 ppb for ground water.
Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For the acute dietary risk assessment, the water concentration value of 817 ppb was used to assess the contribution to drinking water. For the chronic dietary risk assessment, the water concentration of value 543 ppb was used to assess the contribution to drinking water.
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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).
Quinclorac is currently registered for the following uses that could result in residential exposures: Turf grass and ornamentals. EPA assessed residential exposure using the following assumptions: Short-
term residential handler inhalation exposure is expected from the existing uses. The quantitative exposure/risk assessment developed for residential handlers is based on the following scenarios: Loading/
applying granules for belly grinder; loading/applying granules for push type rotary spreader; loading/applying granules for a spoon; loading/
applying granules for a cup and shaker can; applying granules by hand; mixing/loading/applying liquid and dry flowable formulations via manually-pressurized handwand, a hose-end sprayer, a backpack, and a sprinkler can; and mixing/loading/applying ready-to-use formulation via a trigger sprayer, and a hose-end sprayer.
Post-application short-term dermal and incidental oral exposure is expected from quinclorac treated turf in residential settings (i.e., lawns). Dermal exposures were not quantified due to a lack of a dermal toxicological endpoint. Incidental oral exposure risk estimates were calculated for hand-to-mouth, object-to-mouth, and soil ingestion exposures for 1 to
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