Hygiena Clarifies Approval Process for Inclusion in USDA FSIS’ Microbiology Laboratory Guidebook
On July 6, Hygiena’s BAX® System was re-adopted by the U.S. Department of Agriculture’s Food Safety and Inspection Service (USDA FSIS) to detect harmful pathogens in meat, poultry, and eggs. The re-adoption took place after FSIS issued an award notice for the detection platforms to both Hygiena and to 3M Corporation.
It is not known, however, if and when the award will result in changes to the FSIS Microbiology Laboratory Guidebook (MLG). Hygiena recognizes that many meat, egg, and poultry establishments have used the BAX® System for pathogen detection because of its inclusion in the MLG, and the July award notice has generated a number of questions. In the meantime, Hygiena wanted to clarify facts on inclusion in the FSIS MLG:
- New dual award--USDA FSIS awarded Hygiena and 3M Corporation an indefinite delivery/indefinite quantity contract for pathogen detection instruments and kits for one year, with an option for the agency to continue the contract for up to five years or discontinue any time after the first year.
- Not an endorsement--FSIS states that the agency neither endorses nor specifies the use of kits or methods. Inclusion in the MLG means that USDA scientists are using that method. Inclusion does not mean that the agency is promoting any method. According to FSIS, “The methods described in this guidebook are for use by the FSIS laboratories. FSIS does not specifically endorse any of the mentioned test products and acknowledges that equivalent products may be available for laboratory use. Method validation is necessary to demonstrate the equivalence of alternative tests, as detailed in the document ‘FSIS Guidance for Evaluating Test Kit Performance’ on the FSIS website.”
- FSIS lists are informational only--FSIS lists test kits that have been validated for detection of relevant foodborne pathogens (Salmonella, Campylobacter, E. coli O157:H7, Listeria species including L. monocytogenes, and non-O157 STECs). These lists are informational and do not endorse or approve any particular method. Methods should be validated for testing relevant foods by: a) a recognized independent body (i.e., AOAC, AFNOR, MicroVal, NordVal), b) a U.S. regulatory body (i.e., FSIS MLG or FDA BAM), or an ISO method.
- Any tests should compare to FSIS method--FSIS-regulated establishments rely on pathogen testing programs to comply with regulatory requirements and ensure the production of safe products. The agency expects that any test used be appropriate for its intended use, be comparable to the FSIS method (if applicable), and not introduce modifications that compromise the test’s performance.
“The feedback from our customers has been overwhelmingly positive,” said Glenn Maloney, national sales director at Hygiena. “The BAX System is a tried and true technology. Customers are comfortable standing behind their results and food safety plans, despite the methodology that USDA may employ. Plus, no other provider can match our years of experience and dedicated lab experts committed to supporting their program.”