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Federal Register / Vol. 86, No. 43 / Monday, March 8, 2021 / Rules and Regulations
water exposures and residential nonoccupational exposures are not impacted by the new uses, and thus have not changed since the last assessment. EPAs conclusions concerning cumulative risk remain unchanged from the February 23, 2018
rulemaking.
Safety Factor for Infants and Children. EPA continues to conclude that there is reliable data to support the reduction of the Food Quality Protection Act FQPA safety factor. See Unit III.D.
of the February 23, 2018 rulemaking for a discussion of the Agencys rationale for that determination.
Aggregate Risks and Determination of Safety. EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing dietary exposure estimates to the acute population adjusted dose aPAD and the chronic population adjusted dose 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 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.
An acute dietary exposure assessment was not conducted as toxicological effects attributable to a single dose were not identified. Chronic dietary risks are below the Agencys level of concern of 100% of the cPAD: They are 92% of the cPAD for all infants less than 1-year old, the population subgroup with the highest exposure estimate. Quizalofopethyl is classified as a Category D
chemical, i.e. Not Classifiable as to Human Carcinogenicity; therefore, quantification of chronic risks using a non-linear approach will adequately account for all chronic toxicity, including any potential carcinogenicity that would result from exposure. There are no registered or new uses of quizalofop ethyl that would result in residential exposure, therefore the aggregate risk estimates are equivalent to the chronic dietary food and water risk estimates and are not of concern.
Therefore, based on the risk assessments and information described above, EPA concludes there is a reasonable certainty that no harm will result to the general population, or to infants and children, from aggregate exposure to quizalofop ethyl residues.
More detailed information about the Agencys analysis can be found at http www.regulations.gov in the documents titled Quizalofop-P-ethyl.
Human-Health Risk Assessment in Support of the Proposed New Uses on
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Carinata, Pennycress, Pome Fruit Group 1110, Stone Fruit Group 12
12, and Small Vine-climbing Fruit, Except Fuzzy Kiwifruit Subgroup 13
07F; and Use Expansions for Sunflower and Cottonseed Subgroups 20B and 20C in docket ID number EPAHQ
OPP20190665.
IV. Other Considerations A. Analytical Enforcement Methodology For a discussion of the available analytical enforcement method, see Unit IV.A. of the February 23, 2018
rulemaking.
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 has not established MRLs for quizalofop ethyl.
C. Response to Comments Although two comments were submitted to the docket in response to the May 8, 2020 Notice of Filing, only one specifically related to this tolerance action. The commenter requested that EPA deny IR4s request for tolerances for quizalofop ethyl on cotton sunflower seeds out of a concern for the general health impacts of pesticides.
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 FFDCA authorizes 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 the quizalofop ethyl tolerances are safe. The commenter has provided no information indicating that a safety determination cannot be supported.
D. Revisions to Petitioned-For Tolerances The commodity definition for carinata has been revised to brassica carinata, seed; and brassica carinata, meal. The tolerance for brassica carinata, seed will be established at 1.5 ppm; and the tolerance for brassica carinata, meal will be established at 2 ppm. EPA is not establishing a tolerance for pennycress, meal as requested by the petitioner because the glucosinolates in
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pennycress meal restrict its use to a livestock feedstuff, not a human food.
EPAs current practice is to set tolerances for livestock feedstuffs only if they are significant, which is not the case for pennycress meal.
V. Conclusion Therefore, tolerances are established for residues of quizalofop ethyl convertible to 2-methoxy-6chloroquinoxaline, expressed as quizalofop ethyl, in or on brassica carinata, meal at 2 ppm; brassica carinata, seed at 1.5 ppm; cottonseed subgroup 20C at 0.1 ppm; fruit, pome, group 1110 at 0.1 ppm; fruit, small, vine climbing, except fuzzy kiwifruit, subgroup 1307F at 0.1 ppm; fruit, stone, group 1212 at 0.1 ppm;
pennycress, seed at 1.5 ppm; and sunflower subgroup 20B at 3 ppm. Upon establishment of the above tolerances, the established tolerances for cotton, undelinted seed at 0.1 ppm; and sunflower, seed at 1.9 ppm will be removed as they are superseded by the new tolerances on subgroups 20C and 20B, respectively.
VI. Statutory and Executive Order Reviews This action establishes tolerances under FFDCA section 408d in response to petitions submitted to the Agency. The Office of Management and Budget OMB has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review 58 FR 51735, October 4, 1993. Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use 66
FR 28355, May 22, 2001 or Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks 62 FR 19885, April 23, 1997, nor is it considered a regulatory action under Executive Order 13771, entitled Reducing Regulations and Controlling Regulatory Costs 82
FR 9339, February 3, 2017. This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act PRA 44 U.S.C. 3501 et seq., nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations 59 FR 7629, February 16, 1994.
Since tolerances and exemptions that are established on the basis of a petition
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