FDA extends comment period on lab accreditation rule

The US Food and Drug Administration (FDA) has extended the comment period for the proposed rule to establish a laboratory accreditation programme for the testing of human and animal food in certain circumstances by accredited laboratories as required by the FDA Food Safety Modernization Act (FSMA).

Laboratories that become accredited under this program will be required to follow model standards and will be subject to appropriate oversight. Establishing such a programme aims to help FDA ensure the safety of the US food supply and protect US consumers by helping ensure appropriate oversight of certain food testing that is of importance to public health. It will also ensure that the testing is done in accordance with appropriate model standards which will help produce consistently reliable and valid test results. 

If finalised, the rule would:

• Establish the framework and requirements for accreditation bodies (ABs) seeking recognition by the FDA, as well as requirements for laboratories seeking accreditation
• Incorporate by reference existing voluntary consensus standards for accreditation bodies and laboratories that industries are familiar with
• Require food testing by accredited laboratories in the following specific circumstances, consistent with FDA’s FSMA mandate:
  • To provide evidence to support the admissibility of imported food into US commerce
  • Under an import alert through successful consecutive testing
  • To address an identified or suspected food safety problem and presented to FDA as part of evidence for an informal hearing before a mandatory recall order, as part of a corrective action plan submitted after an order suspending the registration of a food facility, or as part of evidence submitted for an appeal of an administrative detention order
  • In response to a food testing order (a new procedure proposed by this rule to address an identified or suspected food safety problem)
  • To comply with specific FDA testing requirements applied to address an identified or suspected food safety problem (including certain tests for shell eggs, bottled water) require results of the food testing conducted under this programme to be sent directly to the FDA, as FSMA specifies
• Establish a pathway for an accredited laboratory with a successful track record in the FDA programme to streamline their submissions
• Enable FDA to monitor programme activities and to revoke an AB’s recognition or revoke a laboratory’s accreditation under certain circumstances, or place either ABs or laboratories on probation
• Establish a publicly available list of recognised ABs and laboratories accredited under this programme.

The FDA is accommodating requests for an extension to provide stakeholders with additional time to fully consider the proposal and submit comments. The FDA is expected to send the final lab accreditation rule to the Federal Register by 4 February 2022.