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Federal Register / Vol. 86, No. 35 / Wednesday, February 24, 2021 / Rules and Regulations potential risks to infants and children that would impact its conclusions about threshold effects.
E. 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 PAD aPAD and chronic PAD cPAD. For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE
exists.
No adverse effects were observed in the submitted toxicological studies at doses relevant to human health pesticide risk assessment for tetraniliprole regardless of the route of exposure. Effects observed in the data base e.g., decreased body weight were both marginal, and only seen at doses not expected to occur daily or over an extended period. Based on a lack of toxicity at exposure levels expected from approved application rates and an expectation that aggregate exposures to residues of tetraniliprole will not reach the levels required to cause any adverse effects, 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 tetraniliprole residues.
IV. Other Considerations
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A. Analytical Enforcement Methodology An adequate analytical method 01414 which uses high-performance liquid chromatography with tandem mass spectrometry HPLC/MS/MS to quantitate residues of tetraniliprole in various crops is available for enforcement. An adequate HPLC/MS/
MS method, Method FV002A1601, is proposed as the enforcement method for determination of residues of tetraniliprole in livestock matrices. The methods may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701
Mapes Rd., Ft. Meade, MD 207555350;
telephone number: 410 3052905;
email address: residuemethods@
epa.gov.
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
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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. The Codex has not established any MRLs for tetraniliprole.
C. Response to Comments Five comments were received to the notice of filing. Four of the comments were not related specifically to tetraniliprole or pesticides in general, dealing instead with antienvironmental morons, electric cars, and wind farms and their impact on birds and bats. The fifth comment was submitted on behalf of the Center for Biological Diversity that was primarily concerned about EPAs consideration of the impacts of tetraniliprole on the environment, pollinators, and endangered species. None of these comments are relevant to the Agencys evaluation of safety of the tetraniliprole tolerances under section 408 of the FFDCA, which requires the Agency to evaluate the potential harms to human health, not effects on the environment.
D. Revisions to Petitioned-For Tolerances The Agency is establishing tolerances based on the Organization for Economic Cooperation and Development OECD
rounding class practice and to reflect the preferred commodity definitions currently used by the Agency, which results in some variations between established tolerances and the tolerances the petitioner requested.
For field corn and popcorn, the available data support a tolerance of 0.01 ppm, slightly lower than the petitioned-for tolerance 0.015 ppm.
The petitioner requested tolerances on dried fruit prune and potato wet peel.
The available data indicates that residues on those commodities do not concentrate so the new tolerances on stone fruit group 1212 1.0 ppm and vegetable, tuberous and corm, subgroup 1C 0.015 ppm, respectively, are adequate to cover residues in these commodities.
For citrus fruits subgroups 1010A, 10B, and 10C, the Agency used the
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OECD statistical calculation procedures to determine the appropriate tolerance value based on the available field trial residue data, which resulted in a higher tolerance value for each of these subgroups than what the petitioner requested.
Based on the highest average field trial HAFT 0.767 ppm for lime and using a processing factor of 8.6, the Agency calculated that a tolerance of 7
ppm is necessary to cover residues in citrus oil. Similarly, based on the HAFT
0.136 ppm for soybean seed and using a processing factor of 2.6, the Agency determined that a tolerance of 0.4 ppm is appropriate for soybean hulls.
Although the petitioner did not expressly identify certain tolerances as intended to cover indirect or inadvertent residues in rotational crops, because certain crops are only approved as crops that may be rotated into treated fields on the label, EPA is establishing tolerances for indirect or inadvertent residues for those commodities: alfalfa, forage at 0.015 ppm; alfalfa, hay at 0.06
ppm; cottonseed subgroup 20C at 0.4
ppm; cotton, gin byproducts at 30 ppm;
grain, cereal, forage, fodder, and straw, group 16, except field corn, popcorn, and sweet corn at 0.1 ppm; and vegetable, foliage of legume, except soybean, subgroup 7A.
All the proposed tolerances for livestock commodities were revised based on calculation of the dietary burden.
V. Conclusion Therefore, tolerances are established for residues of tetraniliprole, including its metabolites and degradates.
Compliance with the tolerance levels is to be determined by measuring only tetraniliprole 1-3-chloro-2-pyridinylN-4-cyano-2-methyl-6methylaminocarbonylphenyl-3-5trifluoromethyl-2H-tetrazol-2ylmethyl-1H-pyrazole-5-carboxamide, in or on almond, hulls at 4 ppm; cattle, fat at 0.04 ppm; cattle, meat at 0.02
ppm; cattle, meat byproducts at 0.3
ppm; corn, field, forage at 4 ppm; corn, field, grain at 0.01 ppm; corn, field, stover at 15 ppm; corn, pop, grain at 0.01 ppm; corn, pop, stover at 15 ppm;
corn, sweet, forage at 6 ppm; corn, sweet, kernel plus cob with husks removed at 0.01 ppm; corn, sweet, stover at 20 ppm; fruit, citrus, group 10
10, oil at 7 ppm; fruit, pome, group 11
10 at 0.5 ppm; fruit, small vine climbing, except fuzzy kiwifruit, subgroup 1307F at 1.5 ppm; fruit, stone, group 1212 at 1 ppm; goat, fat at 0.04 ppm; goat, meat at 0.02 ppm;
goat, meat byproducts at 0.3 ppm; grain, aspirated fractions at 50 ppm; grapefruit
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