Lawsuit requires FDA to designate “high risk” foods

The U.S. Food and Drug Administration (FDA) has reached a settlement with the Center for Food Safety (CFS) that will see the former designate “high risk” foods and propose special recordkeeping requirements for facilities that handle them by September 8, 2020.

FDA has also agreed to publish the final rule and post the list of high-risk foods on its website by November 7, 2022.  CFS and the Center for Environmental Health (CEH) sued FDA in October 2018.

The CFS settlement goes further than the traceability requirements under the Food Safety Modernization Act (FSMA), which never included a date to finalize the reporting requirements for high-risk foods.

Under FSMA, FDA was to designate high-risk foods by January 2012 and propose recordkeeping requirements for facilities that handle those foods by January 2013, all designed to speed traceability in the likelihood of an outbreak.

High-risk foods are defined as those that are most commonly recalled or are produced in a way that makes them more likely to harbor harmful bacteria.  The FDA has to date considered “High Risk” as soft cheeses, seafood, custard-filled bakery products, some fruits and vegetables, and baby formula.  Factors to Be Considered Under section 204(d)(2)(A) of FSMA, FDA’s designation of high-risk foods must be based on the following factors:

  • the known safety risks of a particular food, including the history and severity of foodborne illness outbreaks attributed to such food, taking into consideration foodborne illness data collected by the Centers for Disease Control and Prevention (CDC);
  • the likelihood that a particular food has a high potential risk for microbiological or chemical contamination or would support the growth of pathogenic microorganisms due to the nature of the food or the processes used to produce such food;
  • the point in the manufacturing process of the food where contamination is most likely to occur;
  • the likelihood of contamination and steps taken during the manufacturing process to reduce the possibility of contamination;
  • the likelihood that consuming a particular food will result in a foodborne illness due to contamination of the food; and
  • the likely or known severity, including health and economic impacts, of a foodborne illness attributed to a particular food.

Following the settlement, the agency says it’s already drafting a proposed rule and planning public meetings to involve stakeholders and provide feedback.


Start typing and press Enter to search