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Federal Register / Vol. 86, No. 183 / Friday, September 24, 2021 / Rules and Regulations
IV. Other Considerations A. Analytical Enforcement Methodology There are adequate residue analytical methods for enforcing tolerances for metalaxyl residues of concern in/on the registered plant and livestock commodities. These several methods include gas chromatography equipped with an alkali flame ionization detector GC/AFID, gas chromatography equipped with a nitrogen/phosphorus detector GC/NPD, the multiresidue method in PAM, Vol. I section 302
Protocol D in the nitrogen-specific mode, and gas-liquid chromatography/
mass spectrometry in the chemical ionization mode with selected ion monitoring SIM of the M+1 ion at m/
z 268 for determining residues in/on black pepper and livestock.
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.
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 Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. 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 metalaxyl in or on black pepper.
C. Response to Comments Two comments were received in response to the notice of filing. One of the comments was not germane to the petition for metalaxyl tolerances.
The second comment argued against the use metalaxyl on black pepper and expressed concern about the overall toxicity of pesticides. Although the Agency recognizes that some individuals believe that pesticides should be banned on agricultural crops, the existing legal framework provided
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by FFDCA section 408 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 these metalaxyl tolerances are safe. The commenter has provided no information supporting a contrary conclusion.
D. Revisions to Petitioned-For Tolerances EPA is establishing the tolerance at 0.3 ppm rather than at the petitioned-for tolerance level of 1.0 ppm. EPAs analysis of the monitoring data that was submitted to support the tolerance level concludes that 0.3 ppm is sufficient to cover residues in imported black pepper.
V. Conclusion Therefore, tolerances are established for residues of metalaxyl, methyl N-2,6dimethylphenyl-N-methoxyacetyl-DLalaninate, in or on pepper, black at 0.3
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 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
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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 CRA
Pursuant to the CRA 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: September 3, 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 I as follows:

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