By David Fairfield, Senior Vice President, Feed
The U.S. Food and Drug Administration (FDA) on Nov. 4 published a proposed rule that would establish a program for the testing of food by accredited laboratories as required by the Food Safety Modernization Act (FSMA).
When finalized, the laboratory accreditation program will require testing of human and animal food in certain circumstances by accredited laboratories. Accredited laboratories would be required to follow model standards and would be subject to oversight by FDA-recognized accreditation bodies to help ensure consistently reliable testing results.
Currently, FDA requires certain food testing, including environmental testing, to be conducted to evaluate safety. The testing primarily is completed by private laboratories that may conform to a variety of standards and be subject to various levels of oversight. Under the new proposed program, only laboratories accredited by an accreditation body recognized by FDA would be able to conduct food testing for the following purposes:
- Testing conducted to comply with specific FDA testing requirements applied to address an identified or suspected food safety problem (including certain tests of shell eggs, bottled water and sprouts).
- Testing conducted to provide evidence to support the admissibility of imported food into U.S. commerce (e.g., testing conducted for a food that has been detained due to an appearance of adulteration).
- Testing conducted to support the removal of a food from an import alert through successful consecutive testing.
- Testing conducted 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.
- Testing conducted in response to a food testing order issued by FDA; a new procedure proposed by the rule to address an identified or suspected food safety problem.
The results of testing conducted under the proposed program would be required to be sent directly to FDA by the accredited laboratories.
Significantly, for facilities covered by the FSMA-related human or animal food preventive controls rules, the proposed rule would not require testing done as a routine prerequisite program and/or verification activity to be performed by an accredited laboratory and reported directly to FDA.
Under the proposed rule, accreditation bodies would be required to meet criteria specified in ISO/IEC 17011:2017 – “Conformity Assessment, Requirements for Accreditation Bodies Accrediting Conformity Assessment Bodies” – to obtain FDA recognition. Accredited laboratories under the proposal would be subject to oversight of an FDA-recognized accreditation body and be required to meet certain aspects of ISO/IEC 17025:2017 – “General Requirements for the Competence of Testing and Calibration Laboratories” – and other requirements.
FDA has provided until March 3 for stakeholders to submit comments on the proposed rule. NGFA’s three feed-related committees will take the lead in reviewing the FDA proposal and submitting comments to the agency.