Center for Food Safety Lawsuit Requires FDA to Establish Laboratory Accreditation Program by New Deadline

Program intended to help FDA rapidly detect and respond to foodborne illness outbreaks

Washington, D.C.—Pursuant to a Center for Food Safety (CFS) lawsuit and now-final settlement, the United States Food and Drug Administration (FDA) has agreed to establish a new program for the testing of food by accredited laboratories. The Food Safety Modernization Act (FSMA) required FDA to establish the laboratory accreditation program by January 2013. After years of delay, CFS sued FDA in August 2019 for failing to establish the new program for food testing. The settlement requires the agency to establish the laboratory accreditation program by February 2022.

"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. 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 (CDC). 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 over $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 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—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." 

Background

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, over 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 under 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 over 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.