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Federal Register / Vol. 86, No. 147 / Wednesday, August 4, 2021 / Rules and Regulations
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duration of exposure is not demonstrated for the cypermethrins.
The NOAEL in the mouse cancer study is 57 mg/kg/day and tumors were seen at 229 mg/kg/day. The acute point of departure POD of 7.16 mg/kg/day selected for risk assessment is 32-fold lower than the dose that induced lung tumors in mice. Only the mouse study with cypermethrin resulted in tumor formation: No evidence of carcinogenicity was observed in cancer studies in rats with cypermethrin or mice with alpha-cypermethrin.
Specific information on the studies received and the nature of the adverse effects caused by zeta-cypermethrin as well as the no-observed-adverse-effectlevel NOAEL and the lowest-observedadverse-effect-level LOAEL from the toxicity studies can be found at http
www.regulations.gov in the document titled Zeta-Cypermethrin, Human Health Risk Assessment for a Proposed Use on Basil and Various Crop Group Expansions and Conversions hereinafter Zeta-Cypermethrin Human Health Risk Assessment on pages 45
51 in docket ID number EPAHQOPP
20190651.
B. Toxicological Points of Departure/
Levels of Concern Once a pesticides 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 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 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-pesticide.

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A summary of the toxicological endpoints for zeta-cypermethrin used for human risk assessment can be found in the Zeta-Cypermethrin Human Health Risk Assessment.
C. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to zeta-cypermethrin, EPA
considered exposure under the petitioned-for tolerances as well as all existing tolerances for the cypermethrins in 40 CFR 180.418. EPA
assessed dietary exposures from zetacypermethrin 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.
In conducting the acute dietary exposure assessment, EPA used the 20032008 food consumption data from the U.S. Department of Agricultures National Health and Nutrition Examination Survey, What We Eat in America NHANES/WWEIA. The acute dietary exposure assessment is a refined probabilistic assessment based on tolerance level residues for most commodities and Pesticide Data Program PDP monitoring data for the commodities that make the most significant contribution to dietary risk.
Estimates of the maximum percent crop treated were used for the same commodities for which PDP data were used and for one commodity for which the tolerance was used. Additional information on the assumptions used in the acute assessment can be found on pages 3536 in the Zeta-Cypermethrin Human Health Risk Assessment.
ii. Chronic exposure. A chronic dietary risk assessment is not required for zeta-cypermethrin because repeated exposure does not result in a POD lower than that resulting from acute exposure.
Therefore, the acute dietary risk assessment is protective of chronic dietary risk. However, EPA performed a chronic dietary exposure assessment for use in the aggregate assessment, since there are residential exposures for zetacypermethrin that need to be aggregated with background exposure from dietary sources. In the aggregate human health risk assessment, the average or chronic exposure estimates are combined with the appropriate residential exposure estimates and compared to the POD for zeta-cypermethrin.
The chronic dietary exposure assessment is a highly refined assessment based on Pesticide Data Program PDP monitoring data for most
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commodities. Tolerance level residues were used for a small number of commodities including fresh and dried basil; however, these commodities are not highly consumed and, therefore, they make a negligible contribution to the dietary risk. Refining the residue estimates for these commodities would have an insignificant effect on exposure estimates. As with the acute assessment, conservative default processing factors were generally used for the processed commodities for which they were available. The Agency made the conservative assumption that 100% of all commodities would be treated. When monitoring data were used, average residues were calculated by incorporating 12 limit of detection LOD values for all non-detects. No zeros were used to calculate the average residues. The cypermethrins have food handling establishment FHE uses that need to be accounted for in the chronic dietary exposure assessment. For these uses, EPA used a residue value of onehalf the tolerance. BEAD provided an estimate of the probability that a food item a person consumes contains residues as a result of treatment in an FHE at some point with any pesticide.
It is not specific to the cypermethrins.
This estimate is 4.65%. In the chronic assessment, this value was used for the same commodities as the ones with the FHE residue value 0.025 ppm. In cases where the total anticipated residue from the FHE use exceeded the total anticipated residue from the agricultural use, the FHE anticipated residue was used.
iii. Cancer. Cypermethrin is classified as a Group C Possible human carcinogen, based on an increased incidence of benign lung adenomas and adenomas plus carcinomas combined in females in a mouse carcinogenicity study on cypermethrin. The Agency has determined that quantification of risk using a non-linear approach i.e., aPAD
or aRfD will adequately account for all chronic toxicity, including carcinogenicity, that could result from exposure to the cypermethrins.
iv. Anticipated residue and PCT
information. Section 408b2E of FFDCA authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide residues that have been measured in food. If EPA relies on such information, EPA must require pursuant to FFDCA
section 408f1 that data be provided 5
years after the tolerance is established, modified, or left in effect, demonstrating that the levels in food are not above the levels anticipated. For the present action, EPA will issue such data call-ins
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