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Federal Register / Vol. 86, No. 131 / Tuesday, July 13, 2021 / Rules and Regulations
residue were used for all plant commodities. For livestock commodities anticipated residues accounting for parent and the metabolites of concern M700F008 and/or M700F010 were used. An assumption of 100 PCT was also used for the chronic dietary analysis.
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 as are required by FFDCA section 408b2E and authorized under FFDCA section 408f1. Data will be required to be submitted no later than 5 years from the date of issuance of these tolerances.
Drinking water exposures are not impacted by the new uses, and thus have not changed since the last assessment in the May 5, 2016
rulemaking.
Safety Factor for Infants and Children. EPA continues to conclude that there is reliable data to support the reduction of the Food Quality Protection Act FQPA safety factor. See Unit III.D.
of the May 5, 2016 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 chronic PAD 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 PODs 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 14% of the aPAD for 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 75% of the cPAD for all infants less than 1 year old, the population subgroup with the highest exposure estimate. The short-

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term MOE is greater than the Agencys level of concern of 100: It is 1100 for adults and 400 for children.
Intermediate-term or long-term residential exposures are not expected.
Therefore, based on the risk assessments and information described above, EPA concludes there is a reasonable certainty that no harm will result to the general population, or to infants and children, from aggregate exposure to fluxapyroxad residues.
More detailed information about the Agencys analysis can be found at http www.regulations.gov in the document titled Fluxapyroxad. Human Health Risk Assessment for a Proposed Use of Fluxapyroxad on Pomegranate, Crop Group Expansion for Cottonseed Subgroup 20C and Crop Group Conversions for Vegetable, Fruiting, Group 810 and Fruit, Pome, and Group 1110 in docket ID number EPAHQ
OPP20200228.
IV. Other Considerations A. Analytical Enforcement Methodology An adequate residue analytical method is available for the purpose of tolerance enforcement. Liquid chromatographymass spectrometry LC/
MS/MS BASF Method L0137/01, previously deemed acceptable as an enforcement method for plant matrices, is applicable for the analysis of fluxapyroxad residues.
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.
Codex does not have an MRL for fluxapyroxad in/on pomegranate. For the cottonseed crop subgroup 20C, the 0.5 ppm tolerance is harmonized with the Codex MRL. The Agency is not harmonizing with the Codex pome fruit group 1110 MRL of 0.9 ppm because the petitioner requested that the tolerance remain at 0.8 ppm in order to harmonize with Canada and other key exporting countries. EPA also concludes that harmonization with the Codex fruiting vegetable group 810 MRL of 0.6 ppm is not appropriate as it could result in violative residues despite application consistent with approved label rates. The Codex fruiting vegetable MRL is based on a 7-day pre-harvest interval PHI, not a 0-day PHI as currently registered in the United States.

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C. Revisions to Petitioned-For Tolerances The tolerance for the cottonseed subgroup 20C is being established at 0.5
ppm rather than 0.3 ppm as requested in order to harmonize with Codex.
V. Conclusion Therefore, tolerances are established for residues of fluxapyroxad in or on the Cottonseed subgroup 20C at 0.5 ppm;
Fruit, pome, group 1110 at 0.8 ppm;
Pomegranate at 0.2 ppm; and Vegetable, fruiting, group 810 at 0.7 ppm.
Additionally, the existing tolerances for Cotton, undelinted seed; Fruit, pome, group 11; and Vegetables, fruiting, group 8 are removed since they are superseded by the new tolerances established in todays action.
VI. Statutory and Executive Order Reviews This action establishes tolerances 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 tolerances and modifications in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act RFA 5
U.S.C. 601 et seq., do not apply.
This action directly regulates growers, food processors, food handlers, and food retailers, not States or Tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress
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