Taking Foodborne Illness Off the Menu

Just before Thanksgiving last year, the Centers for Disease Control and Prevention (CDC) issued an alert about yet another E. coli outbreak in romaine lettuce. Instead of informing the public that the source of the contamination had been swiftly identified and removed from the food supply, CDC stated:

"At this time, no common grower, supplier, distributor, or brand of romaine lettuce has been identified. CDC is advising that consumers not eat any romaine lettuce, and restaurants and retailers not sell any, until we learn more about this outbreak and the source of the contaminated lettuce."

It took another week for the Food and Drug Administration (FDA) to find the traceback evidence that indicated the contaminated romaine was harvested somewhere in northern or central California. Even nearly a month after the outbreak started, FDA was only able to narrow the source of the contamination down to three California counties: Monterey, San Benito, and Santa Barbara. All too often, this is the government's response to a foodborne illness outbreak: identify that there is an outbreak and take weeks (if not months) to figure out where the source of the contamination is if it's ever identified at all. In this case, the source was never identified.

This E. coli outbreak was just one in an ongoing epidemic of foodborne illness outbreaks in our country. 47.8 million people, or one in six Americans, are sickened annually as a result of foodborne illness every year according to the CDC,. Tragically, nearly 128,000 of those people are hospitalized and 3,000 die every year. Many suffer serious long-term effects such as kidney failure, chronic arthritis, and nerve and brain damage. These illnesses cost the U.S. economy over $93 billion in medical bills and productivity losses every year, even though we have the technology to handle foodborne illness outbreaks efficiently. Blockchain is a tool that allows retailers to identify the origin of certain produce shipments in seconds. We just have to get FDA to implement it.

Now that FDA has agreed to settle a lawsuit brought by Center for Food Safety (CFS) to enforce vital provisions of the Food Safety Modernization Act (FSMA), we're one step closer to doing just that. FDA has agreed to implement FSMA by identifying foods at "high-risk" for foodborne illness as a part of our settlement. Once these "high-risk" foods are identified, FDA must establish special recordkeeping requirements for those who handle such foods.

These requirements will allow FDA to rapidly identify the source of contamination at the beginning of an outbreak so that the agency can swiftly implement a recall process to reduce the potential for illnesses, hospitalizations, and death. Congress required FDA to designate "high-risk" foods no later than January 2012 and to propose recordkeeping requirements for those foods no later than January 2013. But FDA did not do its job, so we at CFS had to sue the agency simply to force it to do what it should have done more than six years ago.

Faced with our strong argument, FDA agreed to settle the case and comply with the law. Under new deadlines set by the Court, FDA must both designate "high-risk" foods and propose recordkeeping requirements for those foods by September 2020. FDA is required to finalize the rulemaking process for the recordkeeping requirements by November 2022.

We're thrilled that our settlement put FDA on a deadline to finalize the rulemaking process for the recordkeeping requirements. Without CFS's lawsuit, FDA could have continued to drag its feet for years! This settlement ensures that FDA will fully implement FSMA's "high-risk" food provisions to reduce the potential of foodborne illness outbreaks. It also requires the agency to create a rapid-response recall protocol so that when an outbreak does occur, fewer people are sickened. Our food system just got a whole lot safer.