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Federal Register / Vol. 86, No. 166 / Tuesday, August 31, 2021 / Rules and Regulations In an effort to streamline its publications in the Federal Register, EPA is not reprinting sections that repeat what has been previously published for tolerance rulemaking of the same pesticide chemical. Where scientific information concerning a particular chemical remains unchanged, the content of those sections would not vary between tolerance rulemaking and republishing the same sections is unnecessary. EPA considers referral back to those sections as sufficient to provide an explanation of the information EPA considered in making its safety determination for the new rulemaking.
EPA has previously published a number of tolerance rulemakings for acequinocyl, in which EPA concluded, based on the available information, that there is a reasonable certainty that no harm would result from aggregate exposure to acequinocyl and established tolerances for residues of that chemical.
EPA is incorporating previously published sections from those rulemakings as described further in this rulemaking, as they remain unchanged.
Toxicological profile. For a discussion of the Toxicological Profile of acequinocyl, see Unit III.A. of the June 7, 2018 rulemaking 83 FR 26369 FRL
997820.
Toxicological Points of Departure/
Levels of Concern. For a summary of the Toxicological Points of Departure/
Levels of Concern for acequinocyl used for human risk assessment, please reference Unit III.B. of the January 18, 2017 rulemaking 82 FR 5409 FRL
995685.
Exposure assessment. Much of the exposure assessment remains the same although updates have occurred to accommodate exposures from the petitioned-for tolerance. These updates are discussed in this section; for a description of the rest of the EPA
approach to and assumptions for the exposure assessment, please reference Unit III.C. of the June 7, 2018
rulemaking.
EPAs dietary exposure assessments have been updated to include the additional exposure from the new use of acequinocyl on the commodities in tropical and subtropical, medium to large fruit, smooth, inedible peel subgroup 24B. The assessment used the same assumptions as the June 7, 2018
final rule concerning tolerance-level residues, default processing factors for all processed commodities and 100
percent crop treated.
Drinking water exposure. EPA has revised the acequinocyl drinking water assessment since the June 7, 2018
rulemaking to reflect the water
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solubility limits of acequinocyl and its hydroxylated degradate acequinocyl-OH
R1 due to uncertainty in the environmental fate study data. The recommended acute estimated drinking water concentration EDWC is 21 parts per billion ppb based on the water solubility limits of acequinocyl and acequinocyl-OH added together. The recommended chronic EDWC is 14 ppb, which is the maximum amount of acequinocyl residues of concern that may be present over a year. This level is based on the solubility of the degradate acequinocyl-OH R1, which persists over the chronic exposure period.
Non-occupational exposure. There are no new residential non-occupational exposures associated with the new proposed use. The assessment of exposures to the currently registered uses on residential sites e.g., ornamentals for landscapes, gardens, and trees has not changed since the June 7, 2018 rulemaking.
Cumulative exposure. 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 acequinocyl and any other substances and acequinocyl does not appear to produce a toxic metabolite produced by other substances. For the purposes of this action, therefore, EPA has not assumed that acequinocyl has a common mechanism of toxicity with other substances.
Safety Factor for Infants and Children. EPA continues to conclude that there are reliable data to support the reduction of the Food Quality Protection Act FQPA safety factor. See Unit III.D. of the June 7, 2018
rulemaking for a discussion of the Agencys rationale for that determination.
Aggregate Risks and Determination of Safety. EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute population adjusted dose aPAD and the chronic population adjusted dose cPAD. Short-, intermediate-, and chronic term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate points of departure to ensure that an adequate margin of exposure MOE exists. For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure.
Acute dietary risks are below the Agencys level of concern of 100% of the aPAD; they are 96% of the aPAD for
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children 1 to 2 years old, the population subgroup with the highest exposure estimate. Chronic dietary risks are below the Agencys level of concern of 100% of the cPAD; they are 90% of the cPAD for children 1 to 2 years old, the population subgroup with the highest exposure estimate.
As explained in the June 7, 2018
rulemaking, the Agency has assumed that there will be no residential handler exposure; therefore, a residential handler assessment was not conducted.
The Agency only anticipates short-term post-application dermal exposures from registered uses of acequinocyl in residential areas. Using the exposure assumptions described for short-term exposures, EPA has concluded the combined short-term food, water, and residential exposures result in aggregate MOEs of 1,800 in adults and 1,400 for children 6 to 11 years old. Because EPAs level of concern for acequinocyl is an MOE of 100 or below, these MOEs are not of concern.
As stated in the June 7, 2018
rulemaking, acequinocyl is not registered for any use patterns that would result in intermediate-term residential exposure. Because there is no intermediate-term residential exposure and chronic dietary exposure has been assessed under the appropriately protective cPAD, EPA
relies on the chronic dietary risk assessment for evaluating intermediateterm risk for acequinocyl.
Based on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, acequinocyl is not expected to pose a cancer risk to humans.
Therefore, based on the risk assessments and information described above, EPA concludes there is reasonable certainty that no harm will result to the general population, or to infants and children, from aggregate exposure to acequinocyl residues. More detailed information can be found at http www.regulations.gov in the document titled Acequinocyl. Human Health Risk Assessment for the Proposed New Use on Tropical and Subtropical, Medium to Large Fruit, Smooth, Inedible Peel Subgroup 24B
in docket ID number EPAHQOPP
20200475.
IV. Other Considerations A. Analytical Enforcement Methodology For a discussion of the available analytical enforcement method, see Unit IV.A. of the June 7, 2018 rulemaking.
B. International Residue Limits In making its tolerance decisions, EPA
seeks to harmonize U.S. tolerances with
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