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Federal Register / Vol. 86, No. 30 / Wednesday, February 17, 2021 / Rules and Regulations 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 May 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 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 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.
No acute effects were identified in the toxicological studies for clopyralid;
therefore, acute risk is not expected.
Chronic dietary risks are below the Agencys level of concern of 100% of the cPAD: They are 30% of the cPAD for children 1 to 2 years old, the population subgroup with the highest exposure estimate. The short-term MOE is greater than the Agencys level of concern of 100: It is 1,400 for children 1 to less than 2 years old, the population group of concern. Intermediate-term or longterm residential exposures are not expected.
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 clopyralid residues. More detailed information about the Agencys analysis can be found at http
www.regulations.gov in the document titled Clopyralid. Human Health Risk Assessment for a Proposed Use on Bulb Onion Subgroup 307B, Caneberry Subgroup 1307A, Wheatgrass, and a Label Amendment for Strawberry in docket ID number EPAHQOPP2019
0641.
IV. Other Considerations
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A. Analytical Enforcement Methodology The Pesticide Analytical Manual Volume II PAM II lists a method utilizing gas chromatography with electron capture detection GC/ECD for determination of clopyralid residues in plant commodities Method I or Method ACR 75.6.

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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.
No Codex MRLs have been established for clopyralid.
V. Conclusion Therefore, tolerances are established for residues of clopyralid in or on the Caneberry subgroup 1307A at 0.1 ppm;
Onion, bulb, subgroup 307A at 0.4
ppm; Wheatgrass, intermediate, bran at 12 ppm; Wheatgrass, intermediate, forage at 9 ppm; Wheatgrass, intermediate, germ at 12 ppm;
Wheatgrass, intermediate, grain at 3
ppm; Wheatgrass, intermediate, middling at 12 ppm; Wheatgrass, intermediate, shorts at 12 ppm; and Wheatgrass, intermediate, straw at 9
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 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.

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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 Transfer and Advancement Act NTTAA 15 U.S.C. 272 note.
VII. Congressional Review Act Pursuant to the Congressional Review Act 5 U.S.C. 801 et seq., EPA will submit a report containing this rule and other required information to the U.S.
Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This action is not a major rule as defined by 5 U.S.C. 8042.
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.

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