Mesotrione; Pesticide Tolerances
Federal Register, Volume 80 Issue 103 (Friday, May 29, 2015)
Federal Register Volume 80, Number 103 (Friday, May 29, 2015)
Rules and Regulations
Pages 30625-30630
From the Federal Register Online via the Government Publishing Office www.gpo.gov
FR Doc No: 2015-12938
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
EPA-HQ-OPP-2014-0303; FRL-9927-75
Mesotrione; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of mesotrione in or on almond, hulls, fruit, citrus, group 10-10; fruit, pome, group 11-10; fruit, stone, group 12-12; and nut, tree, group 14-
12. Syngenta Crop Protection, LLC requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective May 29, 2015. Objections and requests for hearings must be received on or before July 28, 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-2014-0303, 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:
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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 Publishing 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-2014-0303 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 July 28, 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-2014-0303, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov. Follow the online
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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 September 2, 2014 (79 FR 44729) (FRL-
9911-67), 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 4F8240) by Syngenta Crop Protection, LLC, P.O. Box 18300, Greensboro, NC 27419. The petition requested that 40 CFR part 180.571 be amended by establishing tolerances for residues of the herbicide, mesotrione, in or on citrus fruit, crop group 10-10 at 0.01 parts per million (ppm); pome fruit, crop group 11-10 at 0.01 ppm; stone fruit, crop group 12-12 at 0.01 ppm; tree nuts, crop group 14-12 at 0.01 ppm; and almond hulls at 0.015 ppm. That document referenced a summary of the petition prepared by Syngenta Crop Protection, LLC the registrant, which is available in the docket, http://www.regulations.gov. Comments were received in response to the notice of filing. EPA's response to these comments is discussed in Unit IV.C.
Based upon review of the data supporting the petition, EPA has revised the tolerance for residues of mesotrione in or on fruit, citrus, group 10-10 at 0.01 ppm; fruit, pome, group 11-10 at 0.01 ppm; fruit, stone, group 12-12 at 0.01 ppm; nut, tree, group 14-12 at 0.01 ppm; and almond, hulls at 0.02 ppm. The reason for these changes are explained in Unit IV.D.
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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 mesotrione including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with mesotrione 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.
In subchronic and chronic oral studies in the rat, mouse, and dog, mesotrione produced ocular (ocular discharge and corneal abnormalities and lesions), kidney (increased organ weights), and liver effects (increased organ weights and hepatocyte fat vacuolation), which are consistent with the mammalian toxicity profile for hydroxyphenylpyruvate dioxygenase (HPPD) inhibitors caused by high tyrosine levels in the blood. Body-weight decrements and decreased food consumption were also noted in mice and rats in multiple studies. Even though the rat was found to be the most sensitive species for these effects, the mouse was identified as a more appropriate model for assessing human risk due to similar activity in mice and humans of an enzyme involved in tyrosine catabolism. There was evidence of increased quantitative susceptibility of rats and mice in the developmental and reproduction toxicity studies. Offspring effects in the developmental toxicity studies were evidenced by delayed ossification and ancillary ribs and vertebrae at doses below or in the absence of maternal toxicity in both species. In the reproduction toxicity studies, tyrosinemia and ocular discharge were observed in offspring at doses below those for parental toxicity, which was evidenced by increased organ weights (liver in the rat and kidney in the mouse) and tyrosinemia.
Mesotrione was classified as having low acute toxicity via the oral, dermal, and inhalation routes (Toxicity Categories III or IV). It is classified as a mild eye irritant, but it is not a dermal sensitizer or dermal irritant.
There was no evidence of neurotoxicity, mutagenicity, carcinogenic potential, or immunotoxicity in relevant studies. Specific information on the studies received and the nature of the adverse effects caused by mesotrione 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 titled, ``Mesotrione. Human Health Risk Assessment in Support of the Section 3 Request for Use of Mesotrione on Pome Fruit, Stone Fruit, Citrus, and Tree Nuts'', on page 26-29 in docket ID number EPA-HQ-OPP-2014-0303.
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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
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complete description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
A summary of the toxicological endpoints for mesotrione used for human risk assessment is shown in Table 1 of this unit.
Table 1--Summary of Toxicological Doses and Endpoints for Mesotrione for Use in Human Health Risk Assessment
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Point of departure
Exposure/scenario and uncertainty/ RfD, PAD, LOC for Study and toxicological effects
safety factors risk assessment
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Acute dietary (all populations).. Not applicable...... Not applicable..... No adverse effects attributable to
a single dose were observed. As a
result, no hazard was identified
and an endpoint was not selected.
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Chronic dietary (all populations) LOAEL = 2.1 mg/kg/ Chronic RfD = 0.007 Reproduction study (mouse)
day. mg/kg/day. LOAEL = 2.1/2.4 mg/kg/day (M/F)
UFA = 10x........... cPAD = 0.007 mg/kg/ based on tyrosinemia and ocular
UFH = 10x........... day.. discharge. NOAEL not established.
FQPA SF/UFL = 3x....
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Incidental oral short-term (1 to LOAEL = 2.1 mg/kg/ LOC for MOE = 300.. Reproduction study (mouse)
30 days) and intermediate-term day. LOAEL = 2.1/2.4 mg/kg/day (M/F)
(1 to 6 months). UFA = 10x........... based on tyrosinemia and ocular
UFH = 10x........... discharge. NOAEL not established.
FQPA SF/UFL = 3x....
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Dermal short-term (1 to 30 days), LOAEL = 2.1 mg/kg/ LOC for MOE = 300.. Reproduction study (mouse)
intermediate-term (1 to six day. LOAEL = 2.1/2.4 mg/kg/day (M/F)
months), and long-term (>6 UFA = 10x........... based on tyrosinemia and ocular
months). UFH = 10x........... discharge. NOAEL not established.
FQPA SF/UFL = 3x....
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Inhalation short-term (1 to 30 LOAEL = 2.1 mg/kg/ LOC for MOE = 300.. Reproduction study (mouse)
days), intermediate-term (1 to 6 day. LOAEL = 2.1/2.4 mg/kg/day (M/F)
months), and long-term (>6 UFA = 10x........... based on tyrosinemia and ocular
months). UFH = 10x........... discharge. NOAEL not established.
FQPA SF/UFL = 3x....
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Cancer (oral, dermal, inhalation) Classified as ``not likely to be carcinogenic to humans'' based upon lack of
evidence of carcinogenicity in rats and mice.
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FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
level. PAD = population adjusted dose (a = acute, c = chronic). UFA = extrapolation from animal to human
(interspecies). UFH = potential variation in sensitivity among members of the human population (intraspecies).
UFL = use of a LOAEL to extrapolate a NOAEL.
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Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary exposure to mesotrione, EPA considered exposure under the petitioned-
for tolerances as well as all existing mesotrione tolerances in 40 CFR 180.571. EPA assessed dietary exposures from mesotrione 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 mesotrione; 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 USDA National Health and Nutrition Examination Survey, What We Eat in America 2003-
2008. The chronic analysis assumed 100% crop treated (CT), Dietary Exposure Evaluation Model (DEEM 7.81) default processing factors, and tolerance-level residues for all foods. Drinking water was incorporated directly into the dietary assessment using the groundwater concentration and the PRZM-GW model. The chronic dietary risk assessment shows that the chronic dietary risk estimates are not of concern (i.e.,
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