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Federal Register / Vol. 86, No. 194 / Tuesday, October 12, 2021 / Rules and Regulations
20200511, by one of the following methods:
Federal eRulemaking Portal: http
www.regulations.gov. Follow the online instructions for submitting comments.
Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute.
Mail: OPP Docket, Environmental Protection Agency Docket Center EPA/
DC, 28221T, 1200 Pennsylvania Ave.
NW, Washington, DC 20460.
Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http
www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http
www.epa.gov/dockets.
II. Summary of Petitioned-For Tolerance In the Federal Register of October 27, 2020 85 FR 68030 FRL1001586, EPA issued a document pursuant to FFDCA section 408d3, 21 U.S.C.
346ad3, announcing the filing of a pesticide petition PP 0F8869 by McLaughlin Gormley King Company D/
B/A MGK, 7325 Aspen Lane N, Minneapolis, MN 55428. The petition requested that 40 CFR 180.586a1 be amended by establishing tolerances for residues of the insecticide clothianidin, E-N-2-Chloro-5-thiazolylmethyl-Nmethyl-N-nitroguanidine, in or on all food items in food handling establishments where food and food products are held, processed, prepared, and/or served at 0.01 parts per million ppm. That document referenced a summary of the petition prepared by McLaughlin Gormley King Company D/
B/A MGK, the registrant, which is available in the docket, http
www.regulations.gov. There was one, non-substantive comment received on November 8, 2020, in response to the notice of filing.
Based upon review of the data supporting the petition and in accordance with its authority under FFDCA section 408d4Ai, EPA is establishing tolerances that vary from what the petitioners sought. The reasons for these changes are explained in detail in Unit IV.C.
III. Aggregate Risk Assessment and Determination of Safety Section 408b2Ai of the FFDCA
allows EPA to establish a tolerance the legal limit for a pesticide chemical residue in or on a food only if EPA
determines that the tolerance is safe.

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Section 408b2Aii of the FFDCA
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 the 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 clothianidin in or on food and feed commodities other than those covered by a higher tolerance.
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 rulemakings and republishing the same sections is unnecessary; 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 recently published a tolerance rulemaking for clothianidin, in which EPA concluded, based on the available information, that there is a reasonable certainty that no harm would result from aggregate exposure to clothianidin and established tolerances for residues of that chemical. EPA is incorporating previously published sections from those rulemakings as described further in this rulemaking, as they remain unchanged.
Toxicological Profile. For a discussion of the Toxicological Profile of clothianidin, see Unit III.A. of the November 25, 2019 rulemaking 84 FR
64772 FRL1000064.
Toxicological Points of Departure/
Levels of Concern. A summary of the toxicological effects of clothianidin, including the specific information on
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the studies received, the nature of the adverse effects caused by clothianidin, the no observed adverse effects level NOAEL and the lowest-observedadverse-effect-level LOAEL from the toxicity studies can be found at http
www.regulations.gov in the document entitled Clothianidin: Draft Human Health Risk Assessment in Support of Registration Review, dated September 7, 2017. This document can be found in docket ID number EPAHQOPP2011
0865.
Exposure Assessment. EPA has updated the exposure assessments of clothianidin to include the petitionedfor tolerances in addition to exposures associated with existing tolerances for clothianidin in 40 CFR 180.586. The acute and chronic dietary exposure assessments for clothianidin were conducted using the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database DEEMFCIDTM, Version 3.16, which incorporates consumption data from USDAs National Health and Nutrition Examination Survey, What We Eat in America, NHANES/WWEIA. This dietary survey was conducted from 2003
to 2008.
The acute dietary exposure assessment is based on tolerance-level residues for all commodities since EPA
typically does not include FHE uses in acute dietary assessments. In addition, the acute dietary exposure assessment assumes 100% crop treated PCT and incorporates the modeled EDWCs.
Therefore, the resulting exposure and risk estimates are conservative.
The partially refined chronic dietary exposure assessment is based on average field trial residues and assumes 100
PCT. Average residues from representative commodities were extrapolated to similar commodities.
Because thiamethoxam, which also breaks down into clothianidin residues, is also registered for FHE use, EPA
accounts for clothianidin residues from both thiamethoxam and clothianidin FHE uses in the chronic assessment. For these analyses, a residue input value for FHE use was entered for all other commodities in DEEMFCIDTM not registered for direct use. Default processing factors were used, except where empirical factors derived from processing studies were available.
Section 408b2E of FFDCA
authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide residues that have been measured in food. If EPA
relies on such information, EPA must require pursuant to FFDCA section 408f1 that data be provided 5 years
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