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 July that we took note of. 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 July 12, 2022, FDA posted the warning letters sent to four companies for illegally selling honey-based products found to contain active drug ingredients not listed on the product(s) labels.
- On July 15, 2022, FDA announced the agency’s Total Diet Study (TDS) Report: FY 2018-2020 Elements data and associated data table. The TDS Report is a continuous survey (started in 1961 and modernized in 2013) and one tool FDA uses to monitor the food supply by collecting food from retail outlets and measuring the food’s concentration of various nutrients and contaminants.
- On July 25, 2022, FDA published in the Federal Register an announcement on the availability of draft guidance for the industry, “Conducting Remote Regulatory Assessments – Questions and Answers” (the Draft Guidance). The Draft Guidance provides the agency’s current thinking on common questions related to the use of Remote Regulatory Assessments (RRAs) – both mandatory and voluntary RRAs. RRAs began during the COVID-19 pandemic as a virtual alternative to agency oversight. Now, FDA plans to continue to use RRAs beyond the pandemic.
- FDA recently announced that on August 11, 2022, at 1:00 pm ET, the agency will host a webinar for stakeholders to discuss Food Facility Registration, Biennial Renewal, and obtaining an acceptable Unique Facility Identifier. Interested persons can register for the event here.
- This month, FDA continued to take action on per- and polyfluoroalkyl substances (PFAS) in food contact applications and in food(s) itself (especially seafood). OFW Law would be happy to provide more information on this.
United States Department of Agriculture (USDA)
- On July 18, 2022, the USDA’s National Agriculture Statistics Service (NASS) Agriculture Statistics Board released its 17th Crop Progress report for the growing season. These reports run weekly through the end of November and look at the conditions and progress of various crops on both the national and state level.
- On July 20, 2022, USDA’s Food Safety and Inspection Service (FSIS) updated the individual establishment Salmonella performance standard category information for raw poultry carcasses, raw chicken parts, and comminuted poultry products on the Salmonella Verification Testing Program Monthly Posting page. FSIS also posted the aggregate sampling results showing the number of establishments in categories 1, 2, or 3 for establishments producing young poultry carcasses, raw chicken parts, or not ready-to-eat (NRTE) comminuted poultry products.
- On July 28, 2022, USDA announced they are extending, through September 2022, funding flexibility in the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) program that previously started after the February 2022 formula recall to provide flexibility and address the added cost of non-contract formula to make it more feasible for states to allow WIC participants to purchase alternate sizes, forms, or brands of infant formula
- On June 30, 2022, the United States Supreme Court issued the widely anticipated decision in West Virginia v. Environmental Protection Agency. In a 6-3 decision, the Court held that the Environmental Protection Agency (EPA) exceeded its authority under the Clean Air Act to promulgate a rule governing caps on carbon dioxide emissions at power plants. The reasoning in the Court’s opinion will curtail the ability of federal agencies, including the United States Food and Drug Administration (FDA) and the United States Department of Agriculture (USDA), to rely solely upon a broadly worded statute to issue regulations when those regulations pose significant economic or political consequences.
- On July 22, 2022, the D.C. Circuit Court of Appeals ruled in a 2-1 decision in Humane Society of the United States et. al. v. USDA, that an agency final rule is in fact a “final rule,” such that withdrawing it requires a new round of notice and comment when the Federal Register (FR) makes it available for public inspection (not when it is officially published in the FR). This case could have consequences for a presidential transition of power because it will not be as easy to withdraw the “final rules” once the FR makes them available.