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Federal Register / Vol. 86, No. 147 / Wednesday, August 4, 2021 / Rules and Regulations
short-term residential exposure plus chronic exposure to food and water considered to be a background exposure level. Zeta-cypermethrin is registered for uses that could result in short-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term residential exposures to zetacypermethrin.
Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded the combined short-term food, water, and residential exposures result in an aggregate MOE of 140 for children and an ARI of 4.7 for adults. Because EPAs level of concern for zeta-cypermethrin is an MOE of 100 or below, or an ARI of 1 or below, these MOEs/ARIs are not of concern.
4. Intermediate-term risk.
Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water considered to be a background exposure level.
While there is potential intermediateterm residential exposure, because the single dose and repeat dosing cypermethrin studies show that repeat exposures do not result in lower points of departure, the residential assessments are conducted as a series of acute exposures and the same endpoint is used regardless of duration. Therefore, the short-term aggregate assessment is considered protective of any intermediate-term exposures.
5. Aggregate cancer risk for U.S.
population. EPA has classified zetacypermethrin as a possible human carcinogen and determined that a nonlinear approach should be used for cancer assessment. As the acute dietary exposure estimates are not of concern, cancer risk is not of concern.
6. Determination of safety. Based on these risk assessments, 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 zetacypermethrin residues.
IV. Other Considerations
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A. Analytical Enforcement Methodology Adequate tolerance-enforcement methods are available in PAM Volume II for determining residues of zetacypermethrin in plant Method I and livestock Method II commodities. Both methods are gas chromatographic methods with electron-capture detection GC/ECD. These methods are not stereospecific; therefore, no distinction is made between residues of
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cypermethrin all 8 stereoisomers, zetacypermethrin enriched in 4 isomers and alpha-cypermethrin enriched in 2
isomers.
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 Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. 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.
There is no Codex MRL for cypermethrin or the enriched forms, alphaand zeta-cypermethrin, in/on basil. There are, however, Codex MRLs for numerous commodities contained in the crop groups and subgroups for which tolerances are being established in this rulemaking. EPA is harmonizing the tolerances with Codex MRLs for teff, grain; tomato; the commodities in the fruit, stone group 1212, fruit, citrus subgroups 1010A, 1010B, and 10
10C, and the nut, tree, group 1412;
edible podded beans and peas; and dried beans and peas.
EPA is not harmonizing several U.S.
tolerances with corresponding Codex MRLs because the Codex MRLs are lower than the U.S. tolerances. The available residue data indicate that use under registered U.S. pesticide products would exceed the Codex MRLs and thus harmonizing could result in food being adulterated when following approved label instructions. EPA does not consider the lack of harmonization in these instances to provide a trade barrier to imports since commodities that comply with the Codex MRL could be imported into the United States. The U.S. tolerances that are not being harmonized for this reason are onion, bulb, subgroup 307A; onion, green, subgroup 307B; fruit, small, vine climbing, except fuzzy kiwifruit, subgroup 1307F; rapeseed, subgroup 20A; sunflower, subgroup 20B;
cottonseed, subgroup 20C; quinoa, grain; leafy greens subgroup 416A;
Brassica, leafy greens, subgroup 416B;

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vegetable, Brassica, head and stem, group 516; fruit, pome, group 1110;
and kohlrabi.
In addition, EPA is establishing tolerances for the fruiting vegetable crop group 810, which includes tomato, bell pepper, nonbell pepper, eggplant, and okra, at 0.2 ppm because the available representative commodity data support establishing the crop group at 0.2 ppm.
While this action harmonizes with the Codex MRL for tomato, it results in tolerance levels for the other commodities in the crop group being different from the Codex MRLs for other commodities in that group since Codex has established different levels for the different commodities. EPA has determined it is appropriate to maintain the crop group based on the representative commodity data supporting the group tolerance. Finally, EPA is not harmonizing tolerances for succulent shelled beans and peas commodities with the Codex MRLs for such commodities because the magnitude of the difference is too great.
The current tolerance for the subgroup is 0.1 ppm, versus the Codex MRL of 0.7
ppm. In addition, the U.S. tolerance is currently harmonized with the Canadian MRL of 0.1 ppm for succulent shelled peas.
C. Response to Comments One comment was received in response to the Notice of Filing. The comment stated in part that the Agency should deny ir4 rutgers chemical profiteering college from getting a permit. Although the Agency recognizes that some individuals believe that pesticides should be banned on agricultural crops, the existing legal framework provided by section 408 of the FFDCA authorizes EPA to establish tolerances when it determines that the tolerance is safe. Upon consideration of the validity, completeness, and reliability of the available data as well as other factors the FFDCA requires EPA
to consider, EPA has determined that the zeta-cypermethrin tolerances are safe. The commenter has provided no information indicating that a safety determination cannot be supported.
D. Revisions to Petitioned-For Tolerances Commodity definitions have been corrected to be consistent with Agency nomenclature. Also, EPA is not establishing a tolerance for edible podded pea as requested because the commodity is being removed from the proposed crop group 619. Edible podded pea is being removed from proposed crop group 619 because it is not referring to any specific pea.

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