FDA Proposes Rule Requiring Testing in Accredited Labs

November 7, 2019

The FDA has issued a proposed rule to establish an accreditation program for laboratories that test food as required by the Food Safety Modernization Act (FSMA).

Laboratories that voluntarily become accredited will be required to follow model standards and subject to appropriate oversight. The rule will ensure that the testing is done following appropriate processes, which will help produce reliable and accurate results.

The rule specifically mentions testing of shell eggs, sprouts, and bottled water when needed to address a suspected food safety problem. The routine environmental sampling in hen houses would not be subject to this rule. However, once a positive for Salmonella enteritidis is identified from a drag swab, the required egg testing would have to be done by a laboratory meeting the requirements of the rule. The test results will be sent directly to the FDA by the accredited laboratory, as specified by FSMA.

Other food and animal feed tests that would be subject to the rule include: testing of imported foods to support the admissibility into commerce; testing done in response to a food testing order by FDA (a new procedure proposed by this rule to address an identified or suspected food safety problem); and testing done under an import alert through successful consecutive testing.

The FDA is proposing that the final rule establishing this laboratory accreditation program be effective 60 days after publication in the Federal Register. Owners and consignees of food that must be tested by an accredited laboratory would not be expected to comply with the requirements sooner than six months after publication of such notice.  Private laboratories, laboratories run and operated by federal agencies, states, localities, and foreign laboratories will be eligible for accreditation.

UEP's staff and Washington team will continue to study the rule and be prepared to submit comments to the agency before the end of the comment period on March 3, 2020.