No-Objection Letters Issued by FSIS for Non-O157 STEC Test Methods
When FSIS implemented new non-O157 Shiga toxin-producing Escherichia coli (STEC) policy in 2012, the agency acknowledged that reagents and reference strains that were critically necessary to validate STEC test methods were in short supply. In an effort to increase public and industry awareness of available new technologies associated with the implementation of this new policy, FSIS reviewed method data submitted by test kit manufacturers and issued No Objection Letters (NOLs) for non-O157 STEC test methods.
The NOLs were intended to provide domestic establishments with supporting documentation regarding the reliability of verification testing results and were not intended to replace validations conducted by third-party independent certification entities (such as AOAC, AFNOR, MicroVal, or NordVal) that are required for test methods used as part of official sampling programs, such as for state or foreign inspection systems.
Since issuance of these NOLs, STEC test reagents and reference strains have become readily available, and there are STEC detection methods commercially available that have been validated and certified through independent certification entities.
As a result of these positive developments, FSIS discontinued its STEC test method review and NOL issuance process. However, the Agency encourages the test kit manufacturers to seek certification for STEC method validations through independent certification entities such as AOAC, AFNOR, MicroVal, or NordVal.
FSIS relies on independent validation by certified entities to ensure that methods used for official sampling programs, such as state or foreign inspection systems, have appropriate specificity, exclusivity, and sensitivity to be able to detect low levels of potentially injured bacteria that may be present in food samples. FSIS will continue to make available a list of test kits that have been validated for the detection of relevant foodborne pathogens on its website: Foodborne Pathogen Test Kits Validated by Independent Organizations. Although FSIS does not approve or recommend specific kits, methods, brands, or preferred vendors to use when choosing a detection method, FSIS does recommend that laboratories use only methods certified through independent certification entities. FSIS will continue to discourage use of methods that have not been independently validated through independent certification entities. Only methods or kits that have been validated through independent certification entities, including those that originally received NOLs and that have now been validated, will be included in the Foodborne Pathogen Test Kits Validated by Independent Organizations. For more information on test methods and their application, contact the test kit manufacturers directly.
For a complete listing of new technologies or for those interested in using a new technology, direct your request through askFSIS or you may contact the Risk, Innovations, and Management Staff directly at:
United States Department of Agriculture
Food Safety and Inspection Service
Risk, Innovations, and Management Staff
Patriots Plaza III
1400 Independence Ave., SW.: STOP 3782
Washington, DC 20250-3700
Tel: (301) 504-0884
Fax: (301) 245-4793