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 December 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 December 2, 2024, FDA issued the 2024 edition of the Voluntary National Retail Food Regulatory Program Standards, which defines elements of an effective retail food regulatory program for state, local, tribal, and territorial food regulatory agencies.
• On December 18, 2024, FDA shared the agency’s latest testing results for PFAS in clams. This was a follow-up to the agency’s findings in the 2022 PFAS in seafood survey, which included eight of the National Fisheries Institute’s (NFI) top ten most popular types of seafood in the U.S. in 2018 and detected PFOA – a type of PFAS – in samples of canned clams from China intended for human consumption. FDA determined that the estimated exposure to PFOA from the samples was likely a health concern. Between October 2022 and September 2024, FDA collected and analyzed 12 samples of processed clams with China as the country of origin. All 12 samples had detectable levels of at least one type of PFAS, and PFOA was detected in all samples. Three shipments were refused entry into the U.S. Additional information and the next steps are available here.
• On December 19, 2024, FDA released the final rule, Food Labeling: Nutrient Content Claims; Definition of Term ‘Healthy.’
Additionally, FDA issued a News Release and additional resources, including fact sheets and infographics, available here. The rule is effective February 25, 2025, but the compliance date for the Final Rule is February 25, 2028. Food labeled after February 25, 2028, must comply with the Final Rule, however, manufacturers may voluntarily comply with the Final Rule before this compliance date.
United States Department of Agriculture (USDA)
• On December 3, 2024, and December 5, 2024, USDA’s Food Safety and Inspection Service (FSIS) hosted two, three-hour virtual public meetings to discuss the Salmonella Framework for Raw Poultry Products. The purpose of the Public Meetings was to solicit stakeholder views and facilitate dialogue between stakeholders and the agency on the Proposed Determination and Proposed Rule entitled, “Salmonella Framework for Raw Poultry Products.” FSIS is accepting comments on the Proposed Framework until January 17, 2025.
• On December 17, 2024, the USDA-FSIS announced new measures to enhance oversight of ready-to eat (RTE) food processing facilities that handle meat, poultry, and egg products. The agency’s review was prompted by recent Listeria monocytogenes (Lm) outbreaks linked to ready-to-eat meat and poultry, which led to a significant number of recalls. FSIS will continue reviewing its processes and will share further actions after additional analysis and stakeholder input. To date, FSIS has published 3 FSIS Notices to implement some immediate changes to how the agency addresses Lm in RTE establishments (FSIS Notice 48-24, “PHIS Physical Plant Modification Profile Questionnaire and RTE Questionnaire Task,” FSIS Notice 49-24, “FSIS review of RTE Inspection Fundamentals Training,” and FSIS Notice 50-24, “FSIS Testing for Non-Listeria Monocytogenes”). Additionally, FSIS has issued 2 FSIS Directives regarding its stronger measures (FSIS Directive 5000.1 Rev. 6, “Food Safety Assessment Methodology” and FSIS Directive 5720.4, “Talmadge-Aiken Cooperative Inspection” which OFW is addressing in a separate memorandum).
• On December 31, 2024, USDA’s Animal and Plant Health Inspection Service (APHIS) published an Interim Rule and Request for Comments entitled, “Payment of Indemnity and Compensation for Highly Pathogenic Avian Influenza (HPAI).” Under the new regulations, commercial poultry farms previously infected with HPAI must successfully pass a biosecurity audit before restocking if they wish to qualify for future indemnity payments. Additionally, poultry premises located within a designated buffer zone must also undergo a biosecurity audit before receiving poultry if they want to be eligible for indemnity. Furthermore, indemnity will not be provided for flocks moved onto premises in active infected zones if these birds become infected within 14 days after the control area is dissolved.
Other
• On December 4, 2024, USDA-FSIS and FDA published a Request for Information, “Food Date Labeling.” The RFI is seeking public input on food date labeling such as industry practices and preferences, research results on consumer perceptions, and any impact date labeling may have on food waste. Comments will be accepted until February 3, 2025.
• In December 2024, USDA and FDA both announced the “Uniform Compliance Date for Food Labeling Regulation.” Once Finalized, under the Final Action, any new FDA and USDA-regulated product labeling regulations issued between January 1, 2025, and December 31, 2026, will become effective January 1, 2028. Since 2004, agencies have set uniform compliance dates for new labeling regulations in two-year increments and have issued final rules announcing and requesting comments on those dates.
Please contact Kyla Kaplan (kkaplan@ofwlaw.com) if you have any questions or are interested in additional assistance.
