Federal Register - August 30, 2021
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Source: Federal Register
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Federal Register / Vol. 86, No. 165 / Monday, August 30, 2021 / Rules and Regulations
IX. Procedural Matters A. When do these actions become effective?
The revocations of the tolerances for all commodities will become effective on February 28, 2022. The Agency has set the expiration date for these tolerances to satisfy its international trade obligations described in Unit X.
Any commodities listed in this rule treated with the pesticide subject to this rule, and in the channels of trade following the tolerance revocations, shall be subject to FFDCA section 408l5. Under this section, any residues of these pesticides in or on such food shall not render the food adulterated so long as it is shown to the satisfaction of the Food and Drug Administration that:
1. The residue is present as the result of an application or use of the pesticide at a time and in a manner that was lawful under FIFRA, and 2. The residue does not exceed the level that was authorized at the time of the application or use to be present on the food under a tolerance or exemption from tolerance that was in effect at the time of the application. Evidence to show that food was lawfully treated may include records that verify the dates when the pesticide was applied to such food.
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B. Response to Comments Todays action responds to the Ninth Circuits order to issue a final rule in response to the 2007 Petition. As such this rule is not finalizing the proposal published in the Federal Register issue of November 6, 2015, nor is it implementing or resolving any registration review activity. Thus, this document is not responding to comments received on the 2015
proposal or the most recent registration review documents. Those activities are separate and apart from the procedural posture of this final rule action.
Moreover, as the registration review process is ongoing, including a separate review of the comments submitted, the Agency intends to respond to the most recent comments in as part of that process, rather than in this rule.
C. Are the Agencys actions consistent with international obligations?
The tolerance revocations in this final rule are not discriminatory and are designed to ensure that both domestically produced and imported foods meet the food safety standard established by the FFDCA. The same food safety standards apply to domestically produced and imported foods.
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EPA considers Codex Maximum Residue Limits MRLs in setting U.S.
tolerances and in reassessing them.
Codex MRLs are established by the Codex Committee on Pesticide Residues, a committee within the Codex Alimentarius Commission, an international organization formed to promote the coordination of international food standards. The FFDCA requires EPA to take Codex MRLs into consideration when establishing new tolerances, and it is EPAs policy to harmonize U.S.
tolerances with Codex MRLs to the extent possible, provided that the MRLs achieve the level of protection required under FFDCA. In the current instance, EPA has determined that the current U.S. tolerances for chlorpyrifos are not safe and must be revoked. EPA has developed guidance concerning submissions for import tolerance support 65 FR 35069, June 1, 2000
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Under the World Trade Organization Agreement on the Application of Sanitary and Phytosanitary Measures SPS Agreement, to which the United States is a party, Members are required to, except in urgent circumstances, allow a reasonable interval between the publication of a sanitary or phytosanitary regulation and its entry into force in order to allow time for producers in exporting Members, and particularly in developing country Members, to adapt their products and methods of production to the requirements of the importing Member.
Ref. 33. The WTO has interpreted the phrase reasonable interval to mean normally a period of not less than six months. Ref. 34. In accordance with its obligations, EPA intends to notify the WTO of this regulation and is providing a reasonable interval by establishing an expiration date for the existing tolerances to allow those tolerances to remain in effect for a period of six months after the effective date of this final rule. After the six-month period expires, the tolerances for residues chlorpyrifos in or on food will no longer be in effect.
X. Statutory and Executive Order Reviews Additional information about these statutes and Executive Orders can be found at https www.epa.gov/lawsregulations-and-executive-orders.
A. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulations and Regulatory Review The Office of Management and Budget OMB has exempted tolerance
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regulations 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 final rule is not subject to Executive Order 13563 76 FR 3821, January 21, 2011.
B. Paperwork Reduction Act PRA
This final rule does not contain any information collection activities subject to OMB review and approval under the PRA, 44 U.S.C. 3501 et seq. An agency may not conduct or sponsor, and a person is not required to respond to a collection of information that requires OMB approval under PRA, unless it has been approved by OMB and displays a currently valid OMB control number.
The OMB control numbers for EPAs regulations in title 40 of the CFR, after appearing in the Federal Register, are listed in 40 CFR part 9, and included on the related collection instrument or form, if applicable.
C. Regulatory Flexibility Act RFA
The RFA, 5 U.S.C. 601 et seq., generally requires an agency to prepare a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements under the Administrative Procedures Act or any other statute. Since this rule, which is issued under FFDCA section 408d4Ai 21 U.S.C.
346ad4Ai directly in response to a petition under FFDCA section 408d, does not require the issuance of a proposed rule, the RFA requirements do not apply.
D. Unfunded Mandates Reform Act UMRA
EPA has determined that this action does not impose any enforceable duty, contain any unfunded mandate, or otherwise have any effect on small governments subject to the requirements of UMRA sections 202, 203, 204, or 205
2 U.S.C. 1501 et seq..
E. Executive Order 13132: Federalism This action will not have federalism implications because it is not expected to have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 64 FR 43255, August 10, 1999. This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established
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