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Federal Register / Vol. 86, No. 105 / Thursday, June 3, 2021 / Rules and Regulations
khammond on DSKJM1Z7X2PROD with RULES

Drinking water exposures are not impacted by the import tolerances on olive; olive, with pit; pepper, black; and persimmon, Japanese. The estimated drinking water concentrations EDWCs of total toxic residues TTR of difenoconazole can be found in the human health risk assessment.
Acute dietary food and drinking water risks are below the Agencys level of concern of 100% of the acute population adjusted dose aPAD: They are 53% of the aPAD for all infants less than 1-year old, the population subgroup with the highest exposure estimate. Chronic dietary risks are below the Agencys level of concern of 100% of the chronic population adjusted dose cPAD: They are 38% of the cPAD for all infants less than 1-year old, the population subgroup with the highest exposure estimate.
For the aggregate risk assessment, exposures to difenoconazole in food and drinking water are combined with residential exposures for the relevant exposure duration period. Because acute, intermediate-term, or long-term residential exposures are not expected, aggregate acute and chronic risk is equivalent to the dietary risks, which are below EPAs level of concern.
Moreover, a separate cancer dietary risk assessment was not required since the approach used for chronic dietary exposure assessment was found to be adequately protective of all chronic toxicity, including carcinogenicity, that could result from exposure to difenoconazole. Short-term aggregate risk, which combines chronic dietary exposure with the expected residential handler inhalation exposures from applications to gardens/ornamentals via hose-end sprayer, yields a margin of exposure MOE of 5,000, which is not of concern because it exceeds EPAs level of concern MOEs less than or equal to 100. Previously the residential exposure assessments for difenoconazole included a dermal endpoint; however, that endpoint is no longer relevant because the database does not show systemic effects after exposure via the dermal route at doses that would be relevant to risk assessment.
F. Cumulative Effects From Substances With a Common Mechanism of Toxicity Section 408b2Dv of FFDCA
requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider available information concerning the cumulative effects of a particular pesticides residues and other substances that have a common mechanism of toxicity.

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Unlike other pesticides for which EPA
has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to difenoconazole and any other substances, although EPA has previously concluded that there are no conclusive data that difenoconazole shares a common mechanism of toxicity with other conazole pesticides.
Although the conazole fungicides triazoles produce 1,2,4 triazole and its acid-conjugated metabolites triazolylalanine and triazolylacetic acid, 1,2,4 triazole and its acidconjugated metabolites do not contribute to the toxicity of the parent conazole fungicides triazoles. A
separate aggregate risk assessment was conducted for 1,2,4 triazole and the conjugated triazole metabolites Common Triazole Metabolites:
Updated Aggregate Human Health Risk Assessment to Address the Establishment of a Difenoconazole Tolerances with No U.S. Registration for Imported Olive and Black Pepper and to include updated Estimated Drinking Water Concentrations; DP458929, dated September, 14, 2020 and it can be found at https www.regulations.gov at docket ID numbers EPAHQOPP
20190626, EPAHQOPP20200082, and EPAHQOPP20200345. These new tolerances of difenoconazole considered with existing uses of triazole compounds do not result in a risk of concern for 1,2,4-triazole and the conjugated metabolites. Difenoconazole does not appear to produce any other toxic metabolite produced by other substances. For the purposes of this action, therefore, EPA has not assumed that difenoconazole has a common mechanism of toxicity with other substances. For information regarding EPAs efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPAs website at https
www.epa.gov/pesticide-science-andassessing-pesticide-risks/cumulativeassessment-risk-pesticides.
G. Safety Factor for Infants and Children There were no changes since the last risk assessment regarding prenatal and postnatal sensitivity. The FQPA Safety Factor SF is still reduced to 1X;
however, the safety factor reduction rationale section has been modified to:
i. The toxicity database for difenoconazole is sufficient for a full hazard evaluation and is considered adequate to evaluate risks to infants and children.

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ii. The only study that showed neurotoxicity is used as the point of departure for risk assessment and the effect is well characterized with a clear NOAEL and LOAEL. There are signs of neurotoxicity in the acute neurotoxicity battery study decreased fore-limb strength in males, but not in the subchronic neurotoxicity battery study, nor in any other studies in the database.
This risk assessment is protective of the observed neurotoxicity effects because they are used to establish the point of departure POD for the acute oral assessment.
iii. There is no evidence that difenoconazole results in increased quantitative susceptibility in in utero rats or rabbits in the prenatal developmental studies or in young rats in the 2-generation reproduction study.
No fetal effects were detected in rats.
Fetal effects in rabbits and pup effects in rats occurred at the same doses as maternal effects.
iv. There are no residual uncertainties identified in the exposure databases.
The dietary food exposure assessments were performed based on tolerance-level residues and 100% CT for the acute assessment while the chronic assessment assumed tolerance-level residues, the available empirical or HEDs 2018 Default Processing Factors, and average percent crop treated PCT
information for some commodities.
These assumptions will not underestimate dietary exposure to difenoconazole. EPA made conservative protective assumptions in the ground and surface water modeling used to assess exposure to difenoconazole in drinking water. EPA used similarly conservative assumptions to assess postapplication exposure of children. These assessments will not underestimate the exposure and risks posed by difenoconazole.
H. Determination of Safety Therefore, based on the risk assessments and information described above, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children, from aggregate exposure to difenoconazole residues.
More detailed information about the Agencys analysis can be found in Difenoconazole. Human Health Risk Assessment for the Establishment of Tolerances with No U.S. Registrations in/on Japanese Persimmon, Olive, and Black Pepper. dated March 23, 2021 in docket ID numbers EPAHQOPP
20190626, EPAHQOPP20200082, and EPAHQOPP20200345.

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