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Federal Register / Vol. 86, No. 208 / Monday, November 1, 2021 / Rules and Regulations
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 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, and the factors specified therein, 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 and to make a determination on aggregate exposure for fluensulfone including exposure resulting from the tolerances established by this action.
EPAs assessment of exposures and risks associated with fluensulfone follows.
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 rulemakings 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 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 fluensulfone, in which EPA concluded, based on the available information, that there is a reasonable certainty that no harm would result from aggregate exposure to fluensulfone and established tolerances for residues of that chemical. EPA is incorporating previously published sections from those rulemakings that remain unchanged as described further in this rulemaking.
Toxicological profile. For a discussion of the Toxicological Profile of fluensulfone, see Unit III.A. of the fluensulfone tolerance rulemaking published in the Federal Register of April 13, 2018 83 FR 15971 FRL
997576.
Toxicological points of departure/
Levels of concern. For a summary of the Toxicological Points of Departure/

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Levels of Concern for fluensulfone used for human risk assessment, see Unit III.B. of the fluensulfone tolerance rulemaking published in the Federal Register of June 1, 2016 81 FR 34896
FRL994607.
Exposure assessment. This action converts existing crop group tolerances for Brassica, head and stem, subgroup 5A; Brassica, leafy greens, subgroup 5B;
and Vegetables, leafy, except Brassica, group 4, which were established in the fluensulfone tolerance rulemaking published in the Federal Register of May 24, 2019 84 FR 24042 FRL9992
69, to new tolerances for Brassica, leafy greens, subgroup 416B; Celtuce;
Fennel, Florence, fresh leaves and stalk;
Kohlrabi; Leaf petiole vegetable subgroup 22B; Leafy greens subgroup 416A; and Vegetable, Brassica, head and stem, group 516. Although tolerance levels for some commodities have changed as a result of these crop group conversions, they have not impacted the residue estimates or Estimated Drinking Water Concentrations EDWCs used in the dietary exposure assessment for the May 24, 2019 rulemaking for these commodities. Therefore, the dietary exposure assessment remains the same.
For a description of the rest of the EPA
approach to and assumptions for the exposure assessment, including with respect to dietary exposure, residential exposure, and cumulative effects, see Unit III.C. of the May 24, 2019
rulemaking.
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 24, 2019 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 population adjusted dose cPAD. Short-, intermediate-, and chronic 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 21% of the aPAD for infants <1 year old, the group with the highest estimated exposure. Chronic
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dietary risks are below the Agencys level of concern of 100% of the cPAD;
they are 4.8% of the cPAD for infants <1 year old, the group with the highest estimated exposure. EPA concluded that the combined food, water, and residential exposures result in aggregate MOEs above the level of concern of 100
for all relevant exposure scenarios and are not of concern. As the chronic dietary endpoint and dose are protective of potential cancer effects, fluensulfone is not expected to pose a dietary or aggregate cancer risk of concern.
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 fluensulfone residues. More detailed information on this action can be found in the document entitled, Fluensulfone. Petition for Crop Group Conversions to Brassica Head and Stem Vegetable Group 516, Brassica Leafy Greens Subgroup 416B, Leafy Greens Subgroup 416A, Leaf Petiole Vegetable Subgroup 22B, Kohlrabi, Celtuce, and Florence Fennel by going to the docket established by this action, which is described under ADDRESSES.
IV. Other Considerations A. Analytical Enforcement Methodology For a discussion of the available analytical enforcement method, see Unit IV.A. of the May 24, 2019 rulemaking.
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.
EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408b4 requires that EPA explain the reasons for departing from the Codex level.
The tolerance for crop subgroup 4
16B 20 ppm is harmonized with the Codex MRLs for mizuna and mustard greens; all other Codex MRLs for crops within crop subgroup 416B are lower than 20 ppm. The tolerance for kohlrabi 1.5 ppm is harmonized with the Codex MRL for kohlrabi. The tolerance for crop subgroup 416A 4 ppm is harmonized with the Codex MRL for spinach; all other Codex MRLs for commodities within crop subgroup 416A are lower than 4 ppm. The tolerance for crop
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