When the U.S. Food and Drug Administration earlier this week issued a proposed rule naming certain high-risk foods, it also settled a 2018 lawsuit with the Center for Food Safety that requires FDA to meet deadlines and reporting requirements as mandated by the 2011 Food Safety Modernization Act (FSMA).

FDA’s proposed rule establishing additional traceability record keeping requirements for certain high-risk foods such as leafy greens, freshcut fruits and vegetables, some types of fish, shell eggs, nut butter and others was accepted by CFS as settlement. 

“We are pleased FDA has now released this important rule, as required by the Court order and settlement in our litigation to compel compliance with FSMA,”said Ryan Talbott, CFS staff attorney. “It should not have taken litigation for FDA to publish this proposed rule but now that it is out, we will be analyzing the merits of the proposal closely and continue to ensure the agency follows the law in finalizing the rule.”

CFS originally sued FDA  in 2018 as the second act of three successful cases that the advocacy group brought against the FDA for failing to meet congressional deadlines contained in the FSMA. In the Act, Congress required FDA to name “high-risk” foods.

“As the continued foodborne illness epidemic in our country shows, there is an urgent need to designate high-risk foods and establish their reporting requirements so that our government can rapidly and effectively respond to outbreaks,” Talbott said when he filed the lawsuit in October 2018. 

“Congress required this done years ago, with good reason. As we have in the past, we will continue to hold the FDA accountable to protect public health.”

In 2012-2014, CFS successfully litigated the first-ever FSMA lawsuit, over FDA’s failure to comply with FSMA’s timelines for issuing seven different regulations. That case resulted in the FDA’s enactment of those regulations based on new court-set deadlines.

Congress required the FDA to designate high-risk foods by January 2012 and to propose recordkeeping requirements for facilities that handle those foods by January 2013. Yet, more than five years after these deadlines, and countless numbers of food safety illness episodes later including  E. coli outbreaks linked to romaine lettuce that resulted in five deaths and 210 sickened people in 36 states.

According to the Centers for Disease Control and Prevention, an estimated one in six Americans, (48 million people), becomes ill from foodborne diseases each year. about 128,000 are hospitalized and 3,000 die based on exposure to pathogens present in the food supply. The annual cost to the U.S. economy in medical bills and productivity losses alone is more than $93 billion. 

The FSMA requires a range of preventive measures that would reduce the impact of many illnesses caused by foodborne hazards, including the designation of “high-risk” foods that are more susceptible to being a source for foodborne illness outbreaks and additional requirements for them.