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Federal Register / Vol. 86, No. 105 / Thursday, June 3, 2021 / Rules and Regulations amended by establishing tolerances for residues of the fungicide difenoconazole, in or on persimmon, Japanese at 0.7 parts per million ppm 9E8793; olive including oil at 2 ppm 9E8814; and pepper, black at 0.1 ppm 0E8834. Those documents referenced summaries of the petitions prepared by Syngenta Crop Protection, LLC, and the American Spice Trade Association, Inc., the petitioners, which are available in the dockets for these actions, EPAHQ
OPP20190626, EPAHQOPP2020
0082, and EPAHQOPP20200345 at http www.regulations.gov. Two comments were received related to the import tolerance on black pepper. EPAs responses to these comments are discussed in Unit IV.B.
FFDCA section 408d4Ai permits the Agency to finalize a tolerance that varies from that sought by the petition.
Based upon review of the data supporting the petition, EPA has corrected the commodity definition of olive including oil to olive and olive, with pit, and the tolerance level set with olive varies from that sought by the petition. The reasons for these changes are explained in Unit IV.C.

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III. Aggregate Risk Assessment and Determination of Safety A. Statutory Background Section 408b2Ai of the 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 408b2Aii 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 it does not include occupational exposure. Section 408b2C 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 408b2D, 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 difenoconazole and to make a determination on aggregate exposure for difenoconazole, including exposure resulting from the tolerances
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established by this action. EPAs assessment of exposures and risks associated with difenoconazole follows.
B. Difenoconazole Aggregate Risk Assessment Information on aggregate risk from difenoconazole is found in the Difenoconazole. Human Health Risk Assessment for the Establishment of Tolerances with No U.S. Registrations in/on Japanese Persimmon, Olive, and Black Pepper in docket ID numbers EPAHQOPP20190626, EPAHQ
OPP20200082, and EPAHQOPP
20200345.
C. 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 liver is the target organ in mice and rats; however, effects occur in mice at lower doses and with higher severity than in rats. Furthermore, difenoconazole is classified as Suggestive Evidence of Carcinogenic Potential based on liver tumors adenomas in male and female mice.
Apart from the liver effects in rodents, chronic exposure in dogs leads to lenticular cataracts.
In dermal studies, no systemic toxicity was detected in rats or male rabbits, while in female rabbits, liver effects occurred at the limit dose. Skin hyperkeratosis was detected in rats at the exposure site after repeated exposure to the limit dose. Slight skin irritation was detected after an acute single dose Toxicity Category IV.
Difenoconazole is not a skin sensitizer.
No quantitative susceptibility in fetus or offspring was seen in the database.
Neurotoxicity was detected in an acute neurotoxicity battery study decreased fore-limb strength in males only, but not in a subchronic neurotoxicity battery study with difenoconazole.
In an immunotoxicity study in mice, decreased mean immunoglobin M levels were detected at dose levels 177 mg/
kg/day. There is no other indication of immunotoxicity in the difenoconazole database.
Specific information on the studies received and the nature of the adverse effects caused by difenoconazole as well as the no-observed-adverse-effect-level NOAEL and the lowest-observedadverse-effect-level LOAEL from the toxicity studies can be found at http

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www.regulations.gov in document Difenoconazole. Human Health Risk Assessment for the Establishment of Tolerances with No U.S. Registrations in/on Japanese Persimmon, Olive, and Black Pepper. at page 20 in docket ID
numbers EPAHQOPP20190626, EPAHQOPP20200082, and EPA
HQOPP20200345.
D. 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
www.epa.gov/pesticides/factsheets/
riskassess.htm. A summary of the toxicological endpoints for difenoconazole used for the human health risk assessment is shown in the risk assessment posted to the dockets.
E. Exposure Assessment EPAs chronic dietary food and drinking water exposure assessments have been updated to include the additional exposure from the import tolerances of difenoconazole on olive;
olive, with pit; pepper, black; and persimmon, Japanese. The exposure assessment used tolerance-level residues and default processing factors for all processed commodities. The percent crop treated numbers used for the chronic dietary assessment vary from what was used in the previous assessment and are available in the human health risk assessment posted to the dockets.

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