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 January 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 January 8, 2024, FDA released its’ first annual Coordinated Outbreak Response & Evaluation (CORE) Network report. The report summarizes investigations of foodborne outbreaks and adverse events in FDA-regulated human food for the 2022 calendar year.
- On January 25, 2024, FDA released an update to its regulatory agenda timeline noting it intended to meet the HHS/FDA Unified Agenda for Fall 2023, but “several factors may affect the agency’s ability to do so, including emerging public health issues and new Administration priorities.” We highlight the following updates:
- FDA has adjusted the date it intends to publish the final rule re-defining the term “Healthy” in April 2024; and
- FDA is now planning to issue its Front-of-package (FOP) nutrition labeling regulation in June 2024.
- On January 30, 2024, FDA released an updated Draft Guidance for industry on Hazard Analysis and Risk-Based Preventive Controls for Human Food. The Guidance is intended to help industry comply with specific Preventative Controls for Human Food (PCHR) requirements established in subparts C and G of part 117, such as: A written food safety plan (FSP); Hazard analysis; Preventive controls; Monitoring; Corrective actions; Verification; and Associated records.
United States Department of Agriculture (USDA)
- On January 16, 2024, USDA’s Food Safety and Inspection Service (FSIS) published a Directive entitled, “Ongoing Verification of Product Formulation and Labeling Targeting the Nine Most Common A (”Big 9”) Allergens. This Directive provides instructions on performing the “Big 9” Formulation Verification Task. The Directive has been updated to include sesame as a major allergen, clarify that the milk allergen is “cow’s milk,” and provides additional examples of soy products.
Other
- On January 23, 2024, the Environmental Protection Agency (EPA) published a Notice of proposed rulemaking, “Clean Water Act Effluent Limitations Guidelines and Standards for the Meat and Poultry Products Point Source Category.” The Proposed Rule would revise the Clean Water Act’s (CWA) (40 C.F.R. Part 432) effluent limitations guidelines and standards (collectively, ELGs) for the MPP point source category.
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Please contact Kyla Kaplan (kkaplan@ofwlaw.com) if you have any questions or are interested in additional assistance.
