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Federal Register / Vol. 86, No. 231 / Monday, December 6, 2021 / Rules and Regulations for human risk assessment, see Unit III.B. of the May 8, 2019 rulemaking.
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 May 8, 2019
rulemaking.
EPAs dietary exposure assessments have been updated to include the additional exposure from the new use of cyflumetofen on hops. The assessment used the same assumptions as the May 8, 2019 final rule concerning tolerancelevel residues, default processing factors for all processed commodities, and 100
percent crop treated.
Drinking water exposure. EPA has revised the cyflumetofen drinking water assessment since the May 8, 2019 final rule. Based on the Pesticide in Water Calculators PWC version 1.52, the estimated drinking water concentration EDWC of cyflumetofen in surface water is estimated to be 0.18 ppb for non-cancer chronic exposures. The EDWC of 0.18 ppb was used in the chronic dietary assessment.
Non-occupational exposure. There are no new proposed residential nonoccupational uses for cyflumetofen at this time; however, there are registered uses of cyflumetofen on commercial vegetable gardens and ornamental plants. EPAs residential exposure assessment has changed since the May 8, 2019 final rule based on a revised practice. Because all current cyflumetofen labels require handlers to wear personal protective equipment, EPA assumes that cyflumetofen is applied by professional applicators, not residential homeowner applicators.
Therefore, the current assessment does not consider exposure to residential handlers or exposure from direct homeowner applications to ornamentals or home gardens. EPA assumes that potential dermal exposure from consumers handling ornamentals or vegetable transplants is negligible.
Additionally, there is no toxicity endpoint for dermal exposure, so a quantitative residential post-application dermal risk assessment is not required.
Therefore, the aggregate exposure assessment no longer includes residential handler or residential postapplication exposures.
Cumulative exposures. 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
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toxicity finding as to cyflumetofen and any other substances and cyflumetofen does not appear to produce a toxic metabolite produced by other substances. For the purposes of this action, therefore, EPA has not assumed that cyflumetofen 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 May 8, 2019 final rule for a discussion of the Agencys rationale for that determination.
Aggregate risk 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.
An acute dietary risk was not conducted as toxicological effects attributable to a single dose were not identified. Chronic dietary risks are below the Agencys level of concern of 100% of the cPAD; they are less than 3% for children 12 years old, the population subgroup with the highest exposure estimate.
Because EPA has determined that there are no residential exposures, the chronic dietary risk is the same as the overall aggregate risk for cyflumetofen and is not of concern. As stated in Unit III.A. of the May 8, 2019 final rule, EPA
concluded that the nonlinear approach for assessing potential cancer risk is appropriate. The chronic risk resulting from aggregate exposure to cyflumetofen is below the Agencys level of concern;
therefore, the Agency concludes that there is not a cancer risk of concern from exposure to cyflumetofen.
Therefore, based on the risk assessments and information described above, EPA concludes that there is reasonable certainty that no harm will result in the general population, or to infants and children, from aggregate exposure to cyflumetofen residues.
More detailed information can be found at https www.regulations.gov in the document titled Cyflumetofen. Human Health Risk Assessment for the Section 3 Registration Action for a New Use on
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IV. Other Considerations A. Analytical Enforcement Methodology For a discussion of the available analytical enforcement method, see Unit IV.A. of the July 1, 2020 rulemaking 85
FR 39491 FRL1000925.
B. International Residue Limits In making its tolerance decisions, EPA
seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits MRLs established by the Codex Alimentarius Commission Codex, as required by FFDCA section 408b4.
The Codex has not established MRLs for residues of cyflumetofen in/on hops.
V. Conclusion Therefore, a tolerance is established for residues of cyflumetofen, 2methoxyethyl a-cyano-a-4-1,1dimethylethylphenyl-b-oxo-2trifluoromethylbenzenepropanoate in or on hop, dried cones at 30 ppm.
VI. Statutory and Executive Order Reviews This action establishes a tolerance under FFDCA section 408d in response to a petition submitted to the Agency. The Office of Management and Budget OMB has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review 58 FR 51735, October 4, 1993. Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use 66
FR 28355, May 22, 2001 or Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks 62 FR 19885, April 23, 1997. This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act PRA 44
U.S.C. 3501 et seq., nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations 59 FR 7629, February 16, 1994.
Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408d, such as the tolerance in this final rule, do not
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