Preparing Your Laboratory for FDA’s Proposed Rule

These data elements are often considered standard information on laboratory testing reports. Current FSMA final rules uphold the need for this data.

4. Know the Definition of a Pathogen

While this point may seem obvious to laboratory professionals, the FSMA final rules have aligned the definitions of a pathogen into one. The rules consider a pathogen to be a microorganism of public health significance. Those microorganisms incorporate yeast, molds, bacteria, viruses, protozoa, and microscopic parasites and include species that are pathogens.

5. Follow Established Methods and Guidelines

The final rules reference laboratory methods and guidelines. For example, in the produce safety final rule, the FDA concludes that the environment, rather than spent sprout irrigation water, should be monitored for Listeria monocytogenes. Methods and procedures in the USDA Microbiology Laboratory Guidebook, the Bacteriological Analytical Manual, and those used in the FDA’s compliance activities should be followed for testing for this purpose. The agency will allow other scientifically valid methods, at least equivalent in accuracy, sensitivity, and precision, to be used.

Importantly, the agency has noted that the results of testing not conducted “in accordance with methodologies and procedures designed to ensure valid and accurate results” may not be relied upon.

Good to Know

The final rules repeatedly note that the FDA is developing a proposed rule to implement the laboratory accreditation and model laboratory standards provision within FSMA. With references to laboratory testing woven throughout the final FSMA rules issued to date, food laboratories would be well served to address the quality, accuracy, and reliability of their testing now.

Stombler is president of Auburn Health Strategies and director of the Food Laboratory Alliance. Reach her at [email protected].