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Federal Register / Vol. 86, No. 44 / Tuesday, March 9, 2021 / Rules and Regulations
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effects in dogs, is protective of potential thyroid-related effects observed in developing rats or offspring.
iv. There are no residual uncertainties identified in the exposure databases.
The dietary risk assessments are based on high-end assumptions such as 100
PCT assumptions, HAFT and field trial mean residue values, empirical and default processing factors, anticipated livestock residues based on calculated livestock dietary burden and tissue transfer rates from the livestock feeding studies and modeled, high-end estimates of residues in drinking water.
All of the exposure estimates are based on high-end assumptions and are not likely to underestimate risk. EPA made conservative protective assumptions in the ground and surface water modeling used to assess exposure to fluindapyr in drinking water. EPA used similarly conservative assumptions to assess postapplication exposure of children.
These assessments will not underestimate the exposure and risks posed by fluindapyr.
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. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to fluindapyr will occupy 8.9% of the aPAD for all infants <1 year 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 fluindapyr from food and water will utilize 33% of the cPAD for infants <1 year old, the population group receiving the greatest exposure. Based on the explanation in Unit III.C.3., regarding residential use patterns, chronic residential exposure to residues of fluindapyr is not expected.
3. Short-term and intermediate-term risk. Short-term and intermediate-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water considered to be a background
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exposure level. Short-term and intermediate-term endpoints and residential exposure estimates are identical, and so short-term aggregate exposure is considered protective of intermediate-term aggregate exposures.
The three population subgroups assessed for residential post-application exposures are: Adults, youth 11 to <16
years old, and children 6 to <11 years old. Of the three population subgroups, the children 6 to <11 years old represent the highest dermal exposure from postapplication exposures and the highest background dietary exposure. Therefore, this population subgroup is considered protective of the other two population subgroups.
For adults, intermediate-term exposure is not expected for the residential exposure pathway.
Therefore, the intermediate-term aggregate risk would be equivalent to the chronic dietary exposure estimate.
For children, all intermediate-term aggregate risks are equivalent to shortterm aggregate risks.
Using the exposure assumptions described in this unit for short-term and intermediate-term exposures, EPA has concluded the combined shortand intermediate term food, water, and residential exposures result in aggregate MOEs of 720 for youth 6 to <11 yrs.
old with dermal exposure from postapplication exposure to residue from treated golf course. Because EPAs level of concern for fluindapyr is a MOE of 100 or below, these MOEs are not of concern.
4. Aggregate cancer risk for U.S.
population. Based on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, fluindapyr is not expected to pose a cancer risk to humans.
5. 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 fluindapyr residues.
IV. Other Considerations A. Analytical Enforcement Methodology The petitioner has proposed a liquid chromatography with tandem mass spectrometer LC/MS/MS for determination of fluindapyr and metabolites 3OHF9990, F9990DMglucoside, 1OH-Me-F9990, 1OH-MeDMF9990, and 1COOHF9990 in plant commodities. For livestock commodities, adequate enforcement methodology using LC/MS/MS is available for determination of residues of fluindapyr and its metabolites.

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The method 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 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 an MRL for fluindapyr.
C. Response to Comments One comment was received in response to the notice of filing that argued against the use fluindapyr on several commodities and the overall toxicity of pesticides. In addition, the commenter raised three additional concerns: The lack of tests involving the combination of fluindapyr and other chemicals; fluindapyr a potential cancer-causing agent; and fluindapyr is a fluoride compound. 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 Federal Food, Drug, and Cosmetic Act FFDCA
authorized 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 these fluindapyr tolerances are safe. The commenter has provided no information supporting a contrary conclusion.
In its assessment of safety under the FFDCA, EPA considers combinations of pesticides by evaluating the cumulative effects of pesticides that have a common mechanism of toxicity. At this time, EPA has not identified a common
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