The Center for Food Safety (CFS) and the Food and Drug Administration have settled their lawsuit over testing of food by accredited laboratories. The CFS sued FDA under the Food Safety Modernization Act about the FSMA’s requirement that FDA establish a laboratory accreditation program by January 2013.
After years of delay, CFS sued FDA in August 2019 looking for a court order for FDA to comply with the FSMA requirement. However, the parties have reached a settlement in which FDA has agreed to establish the laboratory accreditation program by February 2022. The accreditation program will help FDA more rapidly detect and respond to foodborne illness outbreaks.
“This is a big win for consumers and public health,” said Ryan Talbott, CFS staff attorney. “Establishing this program will increase the number of labs that are accredited to conduct food safety testing and will better equip FDA to reduce the threat of foodborne illness. This settlement ensures FDA will finally establish this critical program by a hard deadline.”
Congress enacted FSMA in a bipartisan effort because foodborne illness is a serious epidemic in the United States. President Obama signed it into law in January 2011.
An estimated one in six Americans, or 48 million people, become ill from foodborne diseases each year according to the Centers for Disease Control and Prevention. Approximately 128,000 are hospitalized and 3,000 die every year 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.
FSMA requires a range of measures to address the foodborne illness epidemic, including the establishment of a new laboratory accreditation program. This program is critical for FDA to ensure that food testing laboratories meet high-quality standards and that food producers and processors are complying with other FSMA provisions. Congress required the FDA to establish the laboratory accreditation program by January 2013. Yet more than six years after this deadline, and countless numbers of food safety illness episodes later—including a 2018 E. coli outbreak linked to romaine lettuce that resulted in five deaths and 210 sickened people in 36 states — the FDA has failed to designate any high-risk foods.
“After years of delay, FDA must now follow through and establish this much needed laboratory accreditation program,” said Jaydee Hanson, CFS policy director. “Increasing and integrating the number of labs conducting food testing will better ensure compliance with FSMA’s preventive controls and help FDA to rapidly detect and respond to foodborne illness outbreaks when they do occur.”
This is the third successful case that CFS has brought against FDA to enforce FSMA’s requirements. In 2012-2014, CFS successfully litigated the first-ever FSMA lawsuit. It was about FDA’s failure to comply with FSMA’s requirements that FDA promulgate and issue seven different major food safety rules, the basic rules that oversee all areas of the food system covered by FSMA, including food production, transport, and imports. That case resulted in FDA’s enactment of those core regulations based on new Court-set deadlines.
In 2018-2019, CFS successfully litigated its second FSMA lawsuit. It was about FDA’s failure to designate and establish reporting requirements for foods that are at “high-risk” of foodborne illness outbreaks. That case resulted in FDA agreeing to designate “high-risk” foods by September 2020 and establish reporting requirements for those foods by November 2022.
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