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Federal Register / Vol. 86, No. 157 / Wednesday, August 18, 2021 / Rules and Regulations
exposure. EPA has concluded the combined short-term food, water, and residential exposures result in aggregate margins of exposure above the level of concern of 100 for all scenarios assessed and are not of concern. EPA has determined that quantification of cancer risk using a non-linear approach i.e., reference dose will adequately account for all chronic toxicity, including carcinogenicity, that could result from exposure to fluensulfone; the chronic aggregate assessment did not result in risk estimates of concern.
Determination of safety. 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 fluensulfone residues. More detailed information on this action to establish a tolerance on soybean can be found in the document entitled, Fluensulfone. Human Health Risk Assessment for a new use on Soybean by going to the docket established by this action, which is described under ADDRESSES.
IV. Other Considerations A. Analytical Enforcement Methodology There are adequate residue analytical methods for enforcing tolerances for fluensulfone residues of concern in/on the registered plant and livestock commodities. These methods include two high-performance liquid chromatography methods with tandem mass-spectroscopy detection HPLC/
MS/MS for determining residues in/on plant and livestock matrices.
The method may be requested from:
Chief, Analytical Chemistry Branch, Environmental Science Center, 701
Mapes Rd., Ft. Meade, MD 207555350;
telephone number: 410 3052905;
email address: residuemethods@
epa.gov.

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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.
EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408b4 requires that EPA explain the reasons for departing from the Codex level.
The Codex has not established a MRL
for fluensulfone on soybean.

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C. Response to Comments EPA received two comments from anonymous sources. One comment cited concern regarding fluoride; this comment is not relevant to the Agencys evaluation of a tolerance for the proposed new use of fluensulfone on soybean. The other comment expresses concern about pesticides in general, and requests that the Agency deny use of fluensulfone without specifically mentioning the new use on soybean.
While the agency recognizes that some people do not like pesticides, the Agency has evaluated the aggregate risk of fluensulfone and has determined that there is a reasonable certainty that no harm will result to the general population, or to infants and children, from aggregate exposure to fluensulfone residues.
D. Revisions to Petitioned-For Tolerances The agency has determined that tolerances are not needed for soybean, forage and soybean, hay, as the label contains a feeding restriction for those commodities, and the commodities will not be in the channels of trade. Further, the agency has recommended amending the proposed tolerance for soybean, seed from 0.1 ppm to 0.07 ppm based upon the OECD MRL/Tolerance Calculation Procedures.
V. Conclusion Therefore, a tolerance is established for residues of fluensulfone on soybean, seed at 0.07 ppm.
VI. 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
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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.
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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