April Food and Agriculture Regulatory Recap

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 April 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)

  • FDA released the Final Rule for added fluoride levels in bottled water. The final rule amends the allowable level for fluoride in domestically packaged and imported bottled water to which fluoride is added to 0.7 milligrams per liter (mg/L). The final rule will be effective June 19, 2022; the compliance date is October 17, 2022.

  • FDA announced in the Federal Register the availability of draft guidance on “Evaluating the Public Health Importance of Food Allergens Other than Major Food Allergens Listed in the Federal Food Drug and Cosmetic Act.” The draft guidance, when finalized, is intended to explain the agency’s current thinking on the general approach FDA should take when evaluating the public health importance of a food allergen, other than a “major food allergen,” i.e., milk, eggs, fish, crustacean shellfish, tree nuts, wheat, peanuts, soybean, and sesame (sesame allergen disclosure is not required until January 1, 2023).  The draft guidance uses the term “non-listed food allergens” to describe food allergens that are not “major food allergens.”

  • FDA issued a final guidance on, “Compounding Animal Drugs from Bulk Drug Substance,” which is intended to help protect animal health by recognizing the need for access to certain compounded animal drugs. Animal drug compounding is the process of combining, mixing or altering ingredients to create a medication tailored to the needs of an individual animal or a small group of animals.

United States Department of Agriculture (USDA)

  • This month, the USDA Food Safety and Inspection Service (FSIS) posted two new after-action review (AAR) reports for foodborne outbreak investigations: (1) AAR for Listeria monocytogenes (Lm) outbreak linked to ready-to-eat chicken and (2) AAR for Salmonella outbreak linked to Italian-style meats. Following outbreak investigations, FSIS conducts AARs to identify, share, and apply lessons learned with public health, industry partners, and consumers to help prevent future illness and improve future outbreak response.

  • This month, in support of Executive Order (EO) 13985, “Advancing Racial Equity and Support to Underserved Communities,” the agency made its Equity Action Plan publicly available. The plan outlines actions USDA plans to take to advance programmatic equity in order to improve access to programs and services under USDA.

  • USDA Economic Research Service (ERS) continues to predict increasing food prices this year and beyond due to the COVID-19 pandemic, the attacks in Ukraine, and other supply chain disruptions.  USDA-ERS predicts that prices will rise 4.5%-5% this year. Specifically, eating out will see the highest increase at 5.5%-6.5%.

Other

  • On April 15, 2022, FDA and USDA released proposed scientific questions for public comment as the first step in the development process of the Dietary Guidelines for Americans, 2025-2030 (Dietary Guidelines). The public comment period closes on May 16, 2022.

  • The National Antimicrobial Resistance Monitoring System (NARMS) published the 2019 integrated report summary. NARMS is a collaboration between state and local public health departments and federal agencies (such as USDA, FDA, and the Centers for Disease Control (CDC)) that tracks the changes in antimicrobial susceptibility of select foodborne enteric bacteria found in ill people (CDC), retail meats (FDA), and food animals (USDA). The 2019 report describes antimicrobial resistance trends in SalmonellaCampylobacter, generic E. coli, and Enterococcus. This surveillance helps the NARMS public health partners identify new types and patterns of resistance and changes over time. NARMS also aids in understanding the impact of interventions designed to limit the spread of resistance.

  • FDA and USDA have been working collaboratively to understand the seasonal effects and other factors that contribute to outbreaks of E.coli O157:H7 linked to bagged romaine lettuce. Leafy greens, including bagged romaine lettuce, have been implicated in outbreaks of foodborne illness caused by Shiga toxin-producing E. coli (STEC), the most common of which is E. coli O157:H7. In a study recently published in the BMC Environmental Microbiome, FDA and USDA scientists presented findings which reveal that season, and lettuce shelf life, can influence the bacterial communities and behavior of E. coli O157:H7 on cut lettuce stored in modified atmosphere packaging.