Revocation of Methods of Analysis Regulation

The American Frozen Food Institute (AFFI) appreciates the opportunity to provide comments on the U.S. Food and Drug Administration (FDA or agency) proposed rule, Revocation of Methods of Analysis Regulation, revoking the methods of analysis regulation, § 2.19 (21 CFR 2.19), which describes an FDA policy to use certain methods of analysis to support FDA enforcement, as needed, and when the method of analysis is not prescribed in a regulation. AFFI is the non-profit trade association that represents the frozen food and beverage processors and supporting entities in the broader frozen food supply chain. Our members include fruit and vegetable growers, makers of prepared meals, suppliers and distributors that employ over 670,000 jobs in the United States. In advancing the interests of the frozen food industry, AFFI is dedicated to best food safety manufacturing practices and takes pride in its efforts to advocate for policies that are grounded in science. It is in this scientific vein that AFFI provides these comments on the agency's proposed regulation. AFFI respectively disagrees with the proposed rule to revoke current policy to use certain methods of analysis for FDA enforcement programs when the method of analysis is not prescribed in a regulation. Specifically, the rule aims to revoke §2.19, which states that - it is the FDA policy to use the methods of analysis of the Association of Analytical Chemists (AOAC) International as published in the latest edition of their publication "Official Methods of Analysis of the Association of Analytical Chemists," and the supplements thereto, which are incorporated by reference, when available and applicable. AFFI recommends that FDA retain the methods of analysis regulation at 21 CFR §2.19 to assure robust transparency and certainty for relevant stakeholders, which include other regulatory agencies and bodies, standards-setting organizations, private and public laboratories, and industry. Under the current regulation, where a method of analysis is not prescribed in a regulation, FDA in its enforcement programs will utilize the methods of analysis published in the 13th Ed., 1980 of the AOAC INTERNATIONAL (AOAC) publication "Official Methods of Analysis of the Association of Official Analytical Chemists" and any "supplements thereto." Although the 1980 edition of this compendia is outdated, the regulation, as written, is flexible to keep pace with advances in analytical instrumentation and technology and emerging issues, given there is an annual update with supplements to this official compendium and as evidenced by the fact that FDA's enforcement actions include the use of AOAC methods from the modern era. See attached file for detailed comments.