FDA has signed a consent decree in federal court agreeing to create a list of high-risk foods and publish a proposed rule establishing industry recordkeeping and traceability requirements by September 2020, with a final rule to be issued by November 2022.
The consent decree, signed in the U.S. District Court for Northern California in June, settled a lawsuit brought in October 2018 against FDA and the Department of Health and Human Services by two consumer advocacy groups. In their complaint, the Center for Food Safety (CFS) and the Center for Environmental Health argued that FDA had violated the Food Safety Modernization Act (FSMA) by failing to publish a high-risk foods list by January 2012 and proposed recordkeeping requirements for facilities that manufacture, process, pack, or hold those foods by January 2013.
The settlement was made without admission or denial of the allegations, with both sides agreeing that “resolution of this matter without further litigation is in the best interest of the parties and the public.”
“This is a major victory for public health,” said Ryan Talbott, CFS staff attorney in a statement. “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 sickened and killed people. This settlement ensures FDA will finally take these much-needed actions to reduce the threat of foodborne illness.”
“After years of stalling, FDA can no longer delay enacting the FSMA high-risk food regulations,” added Jaydee Hanson, CFS policy director. “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.”
Earlier, in May 2018, nine major consumer and food safety groups urged FDA “to designate produce, including leafy greens, as a high-risk food category and propose regulations that will enhance product tracing for produce in the event of an outbreak.” Among the groups signing the six-page letter were the Center for Science in the Public Interest, Consumers Union, Food & Water Watch, the Pew Charitable Trusts, and the Consumer Federation of America.
Noting that retailers can trace the origin of certain produce shipments in mere seconds using blockchain and other advanced technologies, “it is no longer acceptable that the FDA has no means to swiftly determine where a bag of lettuce was grown or packaged,” the groups wrote.
Minefield for Food Industry?
Many food safety experts and consumer groups applauded FDA’s decision to finally move forward on designating a high-risk foods list and proposing rules to mitigate their hazards. But others worry that the effort might have unintended consequences.
“Creating a list of high-risk foods may appear to some to be a great idea, but I am not a big fan of this approach,” explains David Acheson, MD, former associate FDA commissioner for foods and founder and CEO of The Acheson Group.
“Be careful what you ask for in terms of putting industry into compliance for high-risk foods,” Dr. Acheson tells Food Quality & Safety. “In some ways, it could be a minefield for the food industry. As we have learned, any food can become high risk if you don’t grow, produce, transport, or sell it with appropriate food safety controls. I worry that industry will spend too much time trying to navigate from the high-risk to the ‘low-risk’ list,” he wrote in a recent blog post.
If that were to happen, it would likely be driven to some extent by the degree of “demonization” of high-risk foods. “I hope that consumer groups and others providing opinions do not lose sight that any food, if not grown/manufactured/transported/sold with appropriate food safety controls, can be high risk,” Dr. Acheson emphasizes.