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Federal Register / Vol. 86, No. 25 / Tuesday, February 9, 2021 / Rules and Regulations
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.
Acute dietary risks are below the Agencys level of concern of 100% of the aPAD: They are 44% of the aPAD for children 1 to 2 years old, the population subgroup with the highest exposure estimate. Chronic dietary risks are below the Agencys level of concern of 100% of the cPAD: They are 19% of the cPAD for children 1 to 2 years old, the population subgroup with the highest exposure estimate. Because the chronic dietary risks are below EPAs level of concern, EPA also concludes that benzovindiflupyr will not pose a cancer risk. The short-term aggregate MOE
food, water, and residential is 500 for children 1 to 2 years old. This MOE
exceeds the target level of concern of 100, so it is not of concern. There are no intermediate or long-term residential exposures.
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 benzovindiflupyr residues.
More detailed information about the Agencys analysis can be found at http www.regulations.gov in the documents titled Benzovindiflupyr.
Human Health Risk Assessment for the Proposed New Food Use on Lowbush Blueberries and Ginseng and New NonFood Uses. in docket ID number EPA
HQOPP20200066 and Benzovindiflupyr. Human Health Risk Assessment for the Proposed New Use on Sugar Beets in docket ID number EPAHQOPP20190586.
IV. Other Considerations A. Analytical Enforcement Methodology For a discussion of the available analytical enforcement method, see Unit IV.A. of the June 22, 2018 rulemaking.

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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.

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There are no benzovindiflupyr Codex MRLs established for blueberries, ginseng, or sugar beets.
C. Response to Comments Although three comments were submitted to the docket in response to the February 4, 2020 Notice of Filing, only one specifically related to this tolerance action. The commenter requested that EPA deny Syngentas request for tolerances for benzovindiflupyr on sugar beets 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 benzovindiflupyr tolerances are safe.
The commenter has provided no information indicating that a safety determination cannot be supported.
D. Revisions to Petitioned-For Tolerances Based on available residue data and using the Organization for Economic Cooperation and Development OECD
calculator, EPA has determined that it is appropriate to set the tolerance level for beet, sugar, dried pulp at 0.6 ppm rather than as proposed at 0.15 ppm. Also, the tolerance is being established on Beet, sugar, leaves rather than Beet, sugar, tops to be consistent with Agency nomenclature; this tolerance is being established at 0.07 ppm rather than 0.06
ppm.
V. Conclusion Therefore, tolerances are established for residues of benzovindiflupyr in or on beet, sugar, dried pulp at 0.6 ppm;
beet sugar, leaves at 0.07 ppm; beet, sugar, roots at 0.08 ppm; blueberry, lowbush at 2 ppm; and ginseng at 0.3
ppm.
VI. Statutory and Executive Order Reviews This action establishes tolerances under FFDCA section 408d in response to a petition 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
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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 under FFDCA section 408d, such as the tolerances and modifications in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act RFA 5
U.S.C. 601 et seq., do not apply.
This action directly regulates growers, food processors, food handlers, and food retailers, not States or Tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA
section 408n4. As such, the Agency has determined that this action will not have a substantial direct effect on States or Tribal Governments, on the relationship between the National Government and the States or Tribal Governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian Tribes. Thus, the Agency has determined that Executive Order 13132, entitled Federalism 64 FR 43255, August 10, 1999 and Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments 65 FR 67249, November 9, 2000 do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act UMRA 2 U.S.C. 1501 et seq..
This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12d of the National Technology
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