Preparing Your Laboratory for FDA’s Proposed Rule

Laboratories, are you ready? Five rules implementing the Food Safety Modernization Act (FSMA) are already in effect, and two additional, final regulations are anticipated in the coming months. While the specific rule for laboratory accreditation and model laboratory standards has not yet been promulgated, the rules issued to date foreshadow what laboratories will need to know.

On Jan. 26, 2016, the latest final rules on produce safety, accreditation of third-party certification bodies, and the Foreign Supplier Verification Program (FSVP) went into effect. Each one of these rules addresses laboratory testing in some capacity. A common refrain is that the agency is developing a proposed rule to implement laboratory accreditation and model laboratory standards as outlined in the law. Yet, these three rules take other actions of which laboratories should be aware. Outlined below are five tips for how conscientious laboratories should prepare.

1. Get Accredited

The FDA states, “For a regulatory audit, (when) sampling and analysis is conducted, the accredited third-party certification body must use a laboratory accredited in accordance with ISO/IEC 17025:2005 or another laboratory accreditation standard that provides at least a similar level of assurance in the validity and reliability of sampling methodologies, analytical methodologies, and analytical results.” While waiting for the laboratory rule, the FDA, at its own initiative, has displayed a preference for laboratories accredited to the ISO 17025 standard, or equivalent. According to the International Organization for Standardization, ISO 17025 indicates general quality, administrative, and technical requirements for laboratories to competently perform testing, regardless of the number of personnel they employ or the extent of the scope of testing.

In addition to documenting that a laboratory is accredited, the FDA will require accredited third-party certification bodies to maintain laboratory testing records and results. Laboratory analyses performed in or used by a food facility must be accounted for in a regulatory audit. Within 45 days of completing a regulatory audit, accredited third-party certification bodies must transmit such information in their report to the FDA and to its recognized accreditation body.

In the FSVP final rule, FDA offered that importers may benefit from using accredited laboratories and that laboratories might consider making their certificates of accreditation available. The agency stopped short in mandating these benefits in this regulation in anticipation of a future laboratory rule.

2. Watch for More Transparency

The FDA will post to its website a list of all recognized accreditation bodies and accredited third-party certification bodies. The business names, contact information, and scope of services will be indexed and searchable. Accredited third-party certification bodies are required to maintain on their websites a timely list of entities to which it has issued food or facility certifications.

If accreditation of a certification body is suspended, withdrawn, or reduced in scope, this information too will be posted and maintained on the FDA website and by the recognized accreditation body. While this public posting is not specific to laboratories, it provides a strong sign of what may be required of laboratory accreditation bodies in the future.

3. Laboratory Data is Important

Importers are now required to retain documentation of each sampling and testing of a food. The specifics of this documentation are spelled out in the FSVP final rule. As might be expected, the food tested must be identified, including, if appropriate, the lot number. The number of samples tested must be recorded. The test conducted, analytical method(s) used, and the results of the testing must also be documented. In addition to noting the test report date, written accounts must record the date on which the test was performed. If a hazard was detected, actions taken to correct the problem must be noted. Laboratories should know that information identifying the laboratory conducting the testing and whether the testing was conducted by a qualified individual will also be collected and retained.

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].