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 significant developments from May. 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 May 2, 2024, FDA published the Final Rule, “Standards for Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating to Agricultural Water.” The Final Rule updates the 2015 Produce Safety Rule by replacing certain pre-harvest agricultural water requirements with a system-based assessment to minimize potential risks associated with pre-harvest agricultural water for covered produce (except sprouts). On May 20, 2024, FDA hosted a webinar to provide an overview of the Final Rule and respond to questions.
- On May 9, 2024, FDA and Stop Foodborne Illness (STOP) hosted their final webinar (total of 11) focused on “Food Safety Culture: The Journey Continues.” The webinar focused on the steps following the webinar series. It was hosted during the 2024 Food Safety Summit. All webinars are recorded and are available here.
- On May 30, 2024, FDA announced that the Department of Health and Human Services (HHS) had approved FDA’s plan for a unified Human Foods Program (HFP). The plan is meant to improve food safety, nutrition, and regulation of innovative products. FDA says that implementation of the unified HFP is currently targeted for October 1, 2024.
- On May 31, 2024, FDA announced that there is sufficient laboratory capacity in the Laboratory Accreditation for Analyses of Foods (LAAF) program for the import-related food testing covered by the LAAF regulation for mycotoxins. Owners, importers of records, and consignees of imported food subject to the LAAF regulation must use an LAAF-accredited laboratory to conduct covered import-related food testing starting on the applicable compliance date, which is 6 months from the date a specific analyte is listed on a public registry.
United States Department of Agriculture (USDA)
- On May 1, 2024, USDA’s Food Safety and Inspection Service (FSIS) issued a Federal Register Notice announcing its Final Determination declaring Salmonella an adulterant in not ready-to-eat (NRTE) breaded stuffed chicken products when it contains at least 1 colony forming unit (CFU) per gram or higher of Salmonella. This Final Determination will be effective on May 1, 2025; FSIS will begin sampling and verification testing commencing on this date.
- On May 17, 2024, USDA-FSIS published an updated Notice on, “Retail Exemptions Adjusted Dollar Limitations.” The Notice details the dollar limitations on the amount of meat and meat products and poultry and poultry products a retail store can sell to hotels, restaurants, and similar institutions without disqualifying itself for exemption from Federal inspection requirements.
- On May 23, 2024, USDA-FSIS published the revised “FSIS Guideline to Assist with Donation of Eligible Meat, Poultry & Egg Products to Non-profit Organizations.” The Guideline is final and provides information to meat, poultry, and egg products establishments interested in donating products to non-profit organizations in compliance with the Federal Meat Inspection Act (FMIA), the Poultry Products Inspection Act (PPIA), and the Egg Products Inspection Act (EPIA).
Other
- On May 8, 2024, the U.S. Environmental Protection Agency (EPA), FDA, and USDA announced a plan, “The Coordinated Framework for Regulation of Biotechnology,” to update, streamline, and clarify the agencies’ regulations and oversight of mechanisms for biotechnology products. The agencies are focused on five major areas of biotechnology product regulation: (1) Modified plants, (2) Modified animals, (3) Modified microorganisms, (4) Human drugs biologics, and medical devices, (5) Cross-cutting issues.
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Please contact Kyla Kaplan (kkaplan@ofwlaw.com) if you have any questions or are interested in additional assistance.
