The Center for Food Safety (CFS) has forced the FDA to complete the high risk food designations and reporting requirements that were part of the 2011 Food Safety Modernization Act (FSMA). CFS filed a lawsuit against the FDA in October 2018 for delaying those requirements.
Now, the FDA must designate “high risk” foods by September 2020 and establish the reporting requirements for those foods by November 2022. The settlement was decided in the United States District Court for the Northern District of California.
Ryan Talbott, CFS staff attorney, said in a statement, “This is a major victory for public health. FDA has sat on its hands for years, neglecting to make these high-risk designations, while outbreaks caused by Salmonella, E. coli, and other pathogens have sicken and killed people. This settlement ensures FDA will finally take these much-needed actions to reduce the threat of foodborne illness.”
FSMA required many preventive measures to help reduce foodborne illness hazards. High risk foods are those that are more susceptible to becoming a source for food poisoning outbreaks. Congress told the FDA to designate high risk foods by January 2012 and to propose record keeping requirements for the facilities that handle and process those foods by January 2013. The FDA delayed those requirements for more than five years.
In the last year, there have been several large food poisoning outbreaks linked to foods that may be added to the FDA high risk designation, including an E. coli outbreak linked to romaine lettuce that killed five people and sickened 210. We don’t know which foods the FDA will choose to put into the “high risk” category, but we do know that the known safety risks of a food, including the history and severity of food poisoning outbreaks linked to that food, will play a part.
Jaydee Hanson, CFS policy director, said in a statement, “FDA needs to designate what these high-risk foods are and how they should be reported so that we can build a safer food system that prevents as many of these foodborne illness outbreaks as possible.”
This isn’t the first case the Center for Food Safety has brought against the FDA. In 2012 through 2014, CFS filed the first ever FSMA lawsuit over the FDA’s failure to issue seven different major food safety rules. In that case, the FDA was forced to enact those core regulations based on deadlines set by the court.
