Federal Register - November 2, 2021
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Source: Federal Register
Federal Register / Vol. 86, No. 209 / Tuesday, November 2, 2021 / Rules and Regulations unnecessary. Chronic dietary risks are below the Agencys level of concern of 100% of the cPAD for both benzobicyclon and metabolite B. It is less than 1% of the cPAD for benzobicyclon for all population subgroups and 5.8% of the cPAD for metabolite B for all infants less than 1year old, the population subgroup with the highest exposure estimate for both benzobicyclon and metabolite B.
As noted earlier, there are no residential uses associated with benzobicyclon. Because there is no shortor intermediate-term residential exposure and chronic dietary exposure has been assessed under the appropriately protective cPAD, EPA
relies on the chronic dietary risk assessment for evaluating shortand intermediate-term risk for benzobicyclon and metabolite B.
Based on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, benzobicyclon is not expected to pose a cancer risk to humans. For metabolite B, potential carcinogenicity is not a concern for the HPPD inhibitors and the chronic dietary endpoint and POD for metabolite B is considered protective of any potential carcinogenicity.
Therefore, based on the risk assessments and information described above, EPA concludes there is reasonable certainty that no harm will result to the general population, or to infants and children, from aggregate exposure to benzobicyclon or metabolite B residues. More detailed information can be found at http
www.regulations.gov in the Benzobicyclon Human Health Risk Assessment in docket ID number EPA
HQOPP20200391.
IV. Other Considerations A. Analytical Enforcement Methodology For a discussion of the available analytical enforcement method, see Unit IV.A. of the April 25, 2017 rulemaking 82 FR 18995 FRL996102.
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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.
The Codex has not established an MRL for residues of benzobicyclon in or on rice grain.
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V. Conclusion Therefore, the tolerance for residues of benzobicyclon on rice, grain is increased from 0.01 ppm to 0.15 ppm and is no longer a tolerance with regional restrictions.
VI. Statutory and Executive Order Reviews This action increases 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 to 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,
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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.
Dated: October 27, 2021.
Marietta Echeverria, Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, for the reasons stated in the preamble, EPA is amending 40 CFR
chapter 1 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. Revise 180.693 to read as follows:
180.693 Benzobicyclon; tolerances for residues.
a General. Tolerances are established for residues of the herbicide benzobicyclon, including its metabolites and degradates, in or on the commodity in the table below. Compliance with the tolerance level specified below is to be determined by measuring only benzobicyclon, 3-2-chloro-4methylsulfonylbenzoyl-4phenylthiobicyclo-3.2.1oct-3-en-2one, in or on the following raw agricultural commodity:
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