OFW’s Food & Agriculture team regularly monitors announcements and policy issuances from FDA, USDA, and other agencies to keep our clients apprised of regulatory developments that may impact their business. Here are a few of the developments from February that should be highlighted. If you have any questions or would like more information, please do not hesitate to reach out to us.
U.S. Food and Drug Administration (FDA)
- On February 2, 2024, FDA’s Center for Veterinary Medicine (CVM) published a Letter to Industry announcing the agency’s intent to withdraw its September 19, 1998, Policy and Procedures Manual (PPM) Guide 1240.3605, “Regulating Animal Foods With Drug Claims” (Guide 1240.3605).
- On February 9, 2024, FDA published a draft guidance for the industry, “Recommendations for Collecting Representative Samples for Food Testing Used as Evidence for Release of Certain Fish and Fishery Products Subject to Detention Without Physical Examination (DWPE) and Removal of a Foreign Manufacturer’s Goods From Detention.” The guidance is intended to:
- Provide recommendations for collecting a representative sample for testing when fish and fishery products are subject to DWPE due to the appearance of adulteration caused by pathogens, unlawful animal drugs, scombrotoxin (histamine), and/or decomposition.
- Assist foreign manufacturers and other processors of fish and fishery products subject to DWPE under an import alert (IA) to introduce evidence to the FDA to support a request to remove products from DWPE.
- On February 22, 2024, FDA issued a guidance on “Voluntary Premarket Engagement for Foods Derived from Plants Produced Using Genome Editing.” The guidance encourages voluntary premarket engagement with the agency to ensure developers are taking the steps to ensure the safety of foods from new genome-edited plant varieties.
- On February 28, 2024, announced that grease-proofing substances containing Per and Polyfluoroalkyl Substances (PFAS) are no longer being sold by manufacturers for food contact use in the U.S. market. In addition, FDA stated they are working towards a validated analytical method that would generally allow the agency to monitor the market for PFAS in food contact substances in food packaging.
United States Department of Agriculture (USDA)
- On February 15, 2024, USDA’s Food Safety and Inspection Service (FSIS) reissued FSIS Directive 10010.1, “Sampling Verification Activities for Shiga Toxin-Producing Escherichia Coli (STEC) in Raw Beef Products – Revision 6.” The Directive was updated for the first time since 2015 and instructs inspection program personnel (IPP) on how to conduct sampling activities at establishments producing raw beef products.
- On February 16, 2024, USDA-FSIS announced that in the coming weeks, the agency will be soliciting feedback from small and very small establishment owners through a survey. The agency says the purpose of the survey is to understand how FSIS can better serve the needs of small establishments and improve outreach. The survey is tentatively scheduled to run from March 4 to April 12, 2024.
Other
- On February 8, 2024, the Environmental Protection Agency (EPA) issued the proposed rule, “Listing of Specific PFAS as Hazardous Constituents.” Based on the agency’s PFAS Toxicity Studies, the Proposed Rule would amend the agency’s regulation under the Resource Conservation and Recovery Act (RCRA) by adding nine (9) specific per-and polyfluoroalkyl substances (PFAS)1 to its list of hazardous constituents.
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Please contact Kyla Kaplan (kkaplan@ofwlaw.com) if you have any questions or are interested in additional assistance.
