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Federal Register / Vol. 86, No. 114 / Wednesday, June 16, 2021 / Rules and Regulations Mail: OPP Docket, Environmental Protection Agency Docket Center EPA/
DC, 28221T, 1200 Pennsylvania Ave.
NW, Washington, DC 204600001.
Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at https
www.epa.gov/dockets/where-sendcomments-epa-dockets. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http www.epa.gov/dockets.
II. Summary of Petitioned-For Tolerance In the Federal Register of May 8, 2020
85 FR 27346 FRL1000838, EPA
issued a document pursuant to FFDCA
section 408d3, 21 U.S.C. 346ad3, announcing the filing of a pesticide petition PP 9E8807 by the Interregional Project Number 4 IR4, Rutgers, The State University of New Jersey, 500 College Road East, Suite 201W, Princeton, NJ 08540. The petition requested that 40 CFR 180.675 be amended by establishing a tolerance for residues of the insecticide tolfenpyrad, 4-choro-3-ethyl-1-methyl-N-4-4methylphenoxyphenylmethyl-1Hpyrazole-5-carboxamide, in or on artichoke, globe at 5 parts per million ppm. That document referenced a summary of the petition prepared by IR
4, the petitioner, which is available in the docket for this action, Docket ID
EPAHQOPP20200067, at http
www.regulations.gov. There were no comments received in response to the notice of filing.
III. Aggregate Risk Assessment and Determination of Safety
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A. 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.
The toxicology database is considered complete. A variety of toxic effects were noted in the toxicology database for tolfenpyrad. However, the most consistent findings across species and studies were effects on bodyweight and bodyweight gain. Decreases in bodyweight and/or bodyweight gain were observed in adults of all species rat, mice, rabbit, and dog in the majority of the subchronic oral and dermal toxicity studies, and all chronic
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toxicity studies. Bodyweight decreases in rats were observed at much lower doses than in other species. Chronic exposure resulted in bodyweight and bodyweight gain decreases in mice and dogs at lower doses than the effects that were observed from acute and subchronic exposures. In addition, quantitative susceptibility was observed in the database; in the rat developmental study, decreased fetal weights and number of ossified metacarpals were observed in the absence of adverse maternal toxicity and in the one-generation reproduction study, decreased pup weights were observed at a lower dose than the dose at which parental bodyweight decreases reached biological significance.
Tolfenpyrad is classified as not likely to be carcinogenic to humans.
A complete discussion of the toxicological profile for tolfenpyrad as well as specific information on the studies received and the nature of the adverse effects caused by tolfenpyrad as well as the no-observed-adverse-effectlevel NOAEL and the lowest-observedadverse-effect-level LOAEL from the toxicity studies can be found in the document titled TolfenpyradHuman Health Risk Assessment of the New Use on Globe Artichoke hereinafter Tolfenpyrad Human Health Risk Assessment in docket ID number EPAHQOPP20200067 at https
regulations.gov.
B. Toxicological Points of Departure/
Levels of Concern Once a pesticides toxicological profile is determined, EPA identifies toxicological points of departure PODs 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 levelgenerally referred to as a population-adjusted dose PAD or a reference dose RfDand 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
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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-andassessing-pesticide-risks/assessinghuman-health-risk-pesticides.
A summary of the toxicological endpoints for tolfenpyrad used for human risk assessment can be found in the Tolfenpyrad Human Health Risk Assessment.
C. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to tolfenpyrad, EPA
considered exposure under the petitioned-for tolerances as well as all existing tolfenpyrad tolerances in 40
CFR 180.675. EPA assessed dietary exposures from tolfenpyrad 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 tolfenpyrad. In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agricultures USDAs National Health and Nutrition Examination Survey, What We Eat in America NHANES/WWEIA. As to residue levels in food, the acute assessment assumed tolerance-level residues and 100% crop treated PCT
for all commodities. Refinements include a factor to account for the reduction in residues when wrapper leaves are removed from head lettuce, radicchio, cabbage, Chinese Napa cabbage, and Brussels sprouts.
Empirical processing factors were available for processed commodities of apple, orange, cottonseed, grape, plum, potato and tomato, and were translated to other crop processed commodities where appropriate. Where empirical processing factors were not available or were not translated, the Agencys 2018
default processing factors were used.
Several factors were used to account for metabolite residues in/on bulb onion subgroup 307A commodities and livestock commodities.
ii. Chronic exposure. In conducting the chronic dietary exposure assessment, EPA used the food consumption data from the USDAs 20032008 NHANES/WWEIA. As to residue levels in food, EPA used average residues from field trials. The chronic assessment includes estimates of PCT
for some crops and all the refinements
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