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Federal Register / Vol. 86, No. 165 / Monday, August 30, 2021 / Rules and Regulations
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residue values from field-trial data, empirical or EPAs 2018 default processing factors, and 100 PCT. The analysis also used Tier 1 drinking water estimates. For these reasons, it can be concluded that the analysis does not underestimate risk from acute or chronic exposure to thiabendazole.
Similarly, EPA does not believe that the non-dietary exposures are underestimated because they are also based on conservative assumptions.
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.
1. Acute risk. An acute aggregate risk assessment takes into account acute exposure estimates from dietary consumption of food and drinking water. Using the exposure assumptions described in this unit for acute exposure, EPA has concluded that acute exposure to thiabendazole from food and water will utilize 50% of the aPAD
for children 1 to 2 years old, the population group receiving the greatest exposure.
2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to thiabendazole from food and water will utilize 64% of the cPAD for children 1 to 2 years old, the population group receiving the greatest exposure.
3. Short-term risk. Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water considered to be a background exposure level. Thiabendazole 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 thiabendazole.
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 ARI of 1.88 for adults and an MOE of 200 for children 1 to 2 years
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old. Because EPAs level of concern for thiabendazole is an ARI of less than or equal to 1 or an MOE of 100 or below, these ARIs/MOEs 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.
An intermediate-term adverse effect was identified; however, thiabendazole is not registered for any use patterns that would result in intermediate-term residential exposure. Intermediate-term risk is assessed based on intermediateterm residential exposure plus chronic dietary exposure. Because there is no intermediate-term residential exposure and chronic dietary exposure has already been assessed under the appropriately protective cPAD which is at least as protective as the POD used to assess intermediate-term risk, no further assessment of intermediate-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating intermediate-term risk for thiabendazole.
5. Aggregate cancer risk for U.S.
population. As the risks estimated based on the chronic reference dose are protective of cancer effects, no separate cancer risk assessment is necessary. The chronic dietary aggregate risk assessment is below the Agencys level of concern; therefore, the Agency concludes that aggregate exposure to thiabendazole is not likely to pose a cancer risk.
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 thiabendazole residues.
IV. Other Considerations A. Analytical Enforcement Methodology Adequate spectrophotofluorometric methods are available in the Pesticide Analytical Manual, Volume II PAM II
for enforcement of thiabendazole tolerances.
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
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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.
Codex has established more restrictive i.e., lower MRLs for residues in/on citrus fruits and pome fruits 7 ppm and 3 ppm respectively, versus the existing U.S. tolerances for the old crop groups, which are 10.0 ppm for citrus and 5.0
ppm for pome fruit. Therefore, harmonization with the Codex MRLs are not possible because U.S. growers would be at risk of violative residues of thiabendazole despite legal use according to the label. Instead, EPA is harmonizing the tolerance for fruit, pome, group 1110 with the Canadian MRL of 10 ppm in/on apples and pears.
Additionally, Codex has established an MRL for residues in/on potato at 15
ppm, which is higher than the revised U.S. tolerance of 10 ppm. Per the registrants request, the Agency is not harmonizing with the established Codex MRL for residues in/on potato. Instead, the U.S. tolerance is harmonized with the Canadian MRL for potatoes at 10
ppm because Canada is a major trading partner with the United States for potatoes.
C. Revisions to Petitioned-For Tolerances As mentioned in Unit II., the petitioner requested that the timelimited tolerance in 180.242b at 10
ppm for residues of thiabendazole in/on sweet potato be removed upon the establishment of a permanent tolerance for residues of thiabendazole in/on sweet potato in 180.242a. EPA is not removing the time-limited tolerance on sweet potato in 180.242b due to a difference between the section 18 use pattern and the proposed use pattern for the section 3 registration. There is a potential that use under the current section 18 could result in exceedances if this tolerance was revoked.
D. International Trade Considerations In this rule, EPA is establishing tolerances for thiabendazole residues in or on the Animal feed, nongrass, group 18; Vegetable, Brassica, head and stem, group 516; and the Vegetable, root, except sugar beet, subgroup 1B all at 0.01 ppm that are lower than the current tolerances of Alfalfa forage, Alfalfa hay, Brassica head and stem
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