Food and Drug Administration

New FDA Rule Will Bolster Food Safety Testing Accuracy, but Much More Is Needed

Rule will Establish Protocol for Reliable Test Results, but Far Too Limited Application Leaves Holes in Food Safety System

Washington, D.C. — The U.S. Food and Drug Administration (FDA) today finalized a long awaited rule, titled Laboratory Accreditation for Analyses of Foods, which sets standards for laboratories that test food products for pathogens and other contaminants. The rule marks an important, and long awaited, milestone in the implementation of the Food Safety Modernization Act (FSMA). However, the agency has determined to exercise only a fraction of its FSMA authority, requiring laboratory accreditation for test results used in a narrow range of regulatory actions, and reserving the option to expand those applicable actions through later rulemaking.

The final rule closely resembles FDA’s proposed rule, issued in 2020. CFA and other consumer groups voiced support for that proposal, noting in particular its potential to protect consumers from contaminated food imported from abroad. But the groups also urged FDA to require laboratory accreditation for the full range of testing undertaken to comply with regulatory requirements. In particular, they asked that FDA require accreditation where testing serves as a “corrective action,” following an unsatisfactory inspection. In other words, the rule should prevent a food company from using bogus test results as evidence of food safety, after a government inspection of the company’s facilities and records suggests otherwise.

Under the final rule, FDA will continue to allow companies to use unaccredited labs when taking corrective actions. However, the rule keeps the door open for FDA to expand the scope of its accreditation requirements. In the meantime, the rule establishes a common set of standards that food safety advocates hope will be adopted by a wide range of private laboratories, not just those conducting the tests covered by the rule.

“This rule represents a step forward towards safer food for consumers,” said Thomas Gremillion, Director of Food Policy at Consumer Federation of America. “Most importantly, it strengthens the Import Alert system. By requiring importers to use accredited labs, it will help to avoid public health disasters like the multiple Salmonella outbreaks linked to imported Mexican papayas between 2011 and 2019. Nevertheless, the rule falls short of what Congress directed the agency to do in FSMA. FDA will now need to keep close watch of how the industry responds, particularly domestic food companies subject to corrective action and verification testing. If these companies continue to rely on unaccredited labs to satisfy regulatory requirements, the agency should not hesitate to exercise its full authority