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Federal Register / Vol. 86, No. 194 / Tuesday, October 12, 2021 / Rules and Regulations after the tolerance is established, modified, or left in effect, demonstrating that the levels in food are not above the levels anticipated. For the present action, EPA will issue such data call-ins as are required by FFDCA section 408b2E and authorized under FFDCA section 408f1. Data will be required to be submitted no later than 5 years from the date of issuance of these tolerances.
EPA also used the same estimates for potential drinking water exposures as reflected in the November 25, 2019, rulemaking. Since the proposed use is for indoor applications, a new drinking water assessment was not needed.
Clothianidin is registered for uses that may result in residential nonoccupational exposures. EPA has assessed the potential for short-term post-application exposure; other exposures are not expected. No residential risks of concern were identified. For aggregate risk assessment, EPA used the risk estimates from the combined dermal and inhalation exposures for adults from indoor aerosol can usage and from the combined dermal, inhalation, and incidental oral exposures for children 1
to less than 2 years old from treated indoor surfaces.
Safety Factor for Infants and Children. Section 408b2C of the FFDCA provides that EPA shall apply an additional tenfold 10x margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the FQPA Safety Factor SF. In applying this provision, EPA either retains the default value of 10 times, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor.
EPA determined reliable data show the safety of infants and children would be adequately protected if the FQPA SF
were reduced to 1x because: 1 The toxicology data base is complete and includes developmental neurotoxicity DNT, adult immunotoxicity and developmental immunotoxicity studies;
2 EPA characterized the degree of concern for the quantitative susceptibility observed in the clothianidin 2-generation reproduction and DNT studies as low based on the clear NOAELs for the offspring effects and the selection of regulatory doses that are protective of those effects; 3
the rat is the most sensitive species
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tested, and the NOAEL and LOAEL
selected from the two-generation reproduction study in rats are protective of effects observed in the toxicology database, including the DNT and developmental immunotoxicity studies;
4 there are no residual uncertainties for preand/or post-natal toxicity; 5
EPA is regulating the use of clothianidin based upon the most sensitive offspring effects observed in the reproduction toxicity study, and therefore the risk assessment is protective of these and other effects that occurred at higher doses; 6 the exposure databases e.g., dietary food, drinking water, and residential are complete; and 7 the risk assessment for each potential exposure scenario does not underestimate potential exposure and risk for infants or children.
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 population adjusted dose aPAD and chronic PAD cPAD. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate points of departure PODs to ensure that an adequate margin of exposure MOE exists. For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure.
The acute dietary risk estimates for clothianidin are 9.5% of the aPAD for the U.S. general population, and 29% of the aPAD for children 1 to 2 years old the most highly exposed population subgroup. The chronic dietary risk estimates are 3.9% of the cPAD for the U.S. general population, and 9.4% of the cPAD for infants less than 1-year old the most highly exposed population subgroup. Because both are below the 100% of the relevant PAD, these risk estimates are not of concern.
The short-term aggregate risk assessments resulted in MOEs of 150 to 490. For clothianidin, the LOC for shortterm risk is an MOE of 100. As the resulting aggregate MOEs exceed the LOC of 100, short-term aggregate risk estimates are not of concern.
Intermediate-term and long-term residential exposures are not expected.
Clothianidin is classified as Not Likely to be Carcinogenic to Humans;
therefore, cancer risk is not a concern and cancer risks are not quantified.
Based on the risk assessments and information described above, EPA
concludes there is a reasonable certainty that no harm will result to the U.S.
general population, or to infants and
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children, from aggregate exposure to clothianidin residues. More detailed information on the subject action to establish a tolerance in or on food and feed commodities other than those covered by a higher tolerance can be found at http www.regulations.gov in the document entitled Clothianidin.
Petition for the Establishment of Permanent Tolerances and Registration for Use in Food Handling Establishment, dated July 15, 2021.
This document can be found in docket ID number EPAHQOPP20200511.
IV. Other Considerations A. Analytical Enforcement Methodology Adequate Liquid Chromatograph/
Mass Spectrometer/Mass Spectrometer LC/MS/MS methods are available for enforcing tolerances of clothianidin residues in/on crop Morse Method Meth-164modified, RM39C1, or Bayer Method 00552 and livestock Bayer Method 00624 matrices.
These methods may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Road, Ft. Meade, MD 20755
5350; telephone number: 410 305
2905; 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.
Codex is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standardssetting organization in trade agreements to which the United States is a party.
Although EPA may establish a tolerance that is different from a Codex MRL, FFDCA section 408b4 requires that EPA explain the reasons for departing from the Codex level.
Codex has not established MRLs for food commodities based on the petitioned-for use in food handling establishments.
C. Revisions to Petitioned-For Tolerances The petition described the use of clothianidin in or on all food items in food handling establishments where food and food products are held, processed, prepared and/or served.

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