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Federal Register / Vol. 86, No. 164 / Friday, August 27, 2021 / Rules and Regulations additional tenfold 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 data base unless EPA concludes that a different margin of safety will be safe for infants and children. Due to the expected low toxicity of oxirane, 2-methyl-, polymer with oxirane, mono-9Z-9octadecanoate, methyl ether, EPA has not used a safety factor analysis to assess the risk. For the same reasons the additional tenfold safety factor is unnecessary.
VII. Determination of Safety Based on the conformance to the criteria used to identify a low-risk polymer, EPA concludes that there is a reasonable certainty of no harm to the U.S. population, including infants and children, from aggregate exposure to residues of oxirane, 2-methyl-, polymer with oxirane, mono-9Z-9octadecanoate, methyl ether.
VIII. Analytical Enforcement Methodology An analytical method is not required for enforcement purposes since the Agency is establishing an exemption from the requirement of a tolerance without any numerical limitation.
IX. Conclusion Accordingly, EPA finds that exempting residues of oxirane, 2methyl-, polymer with oxirane, mono9Z-9-octadecanoate, methyl ether from the requirement of a tolerance will be safe.
X. Statutory and Executive Order Reviews This action establishes a tolerance 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. 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 tolerance 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.
XI. 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.
Dated: August 20, 2021.
Catherine Aubee, Acting Director, Registration Division, Office of Pesticide Programs.

Therefore, for the reasons stated in the preamble, EPA is amending 40 CFR
chapter I as follows:
PART 180TOLERANCES AND
EXEMPTIONS FOR PESTICIDE
CHEMICAL RESIDUES IN FOOD
1. The authority citation for part 180
continues to read as follows:

Authority: 21 U.S.C. 321q, 346a and 371.

2. In 180.960, amend the table by adding in alphabetical order the polymer Oxirane, 2-methyl-, polymer with oxirane, mono-9Z-9octadecanoate, methyl ether, minimum number average molecular weight in amu, 1,200 to read as follows:

180.960 Polymers; exemptions from the requirement of a tolerance.

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Polymer
CAS No.

Oxirane, 2-methyl-, polymer with oxirane, mono-9Z-9-octadecanoate, methyl ether, minimum number average molecular weight in amu, 1,200

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