Moving Toward Laboratory Standards

The law does not stop at merely registering organizations that meet desired criteria. The HHS Secretary is compelled to work with recognized laboratory accreditation bodies to increase the number of labs qualified to perform testing. In fact, the law provides another deadline—no later than 30 months after the enactment of FSMA—for food testing to be conducted by federal or non-federal labs that have been accredited for the appropriate sampling or analytical testing methodology. While this requirement applies to testing specific to a food safety problem or in support of certain import conditions, it is clear that accreditation is a desired credential.

For a lab to become accredited for a specific sampling or analytical testing methodology, it must meet model laboratory standards. The HHS Secretary may consult existing standards for guidance, but the law specifies what, at a minimum, model standards should include. These standards are to include methods that ensure appropriate sampling, analytical procedures, and commercially available techniques are followed. Reports of analyses are to be certified as true and accurate. Internal quality systems must be established and maintained. From a lab perspective, this means utilizing lab quality controls and participating in proficiency testing. Training and experience qualifications for lab personnel are considered another model element. Procedures to evaluate and respond promptly to complaints round out the list of model standards, but additional criteria may be added by the HHS Secretary.

The details of these model laboratory standards and how they may be incorporated into the accreditation process will be the subject of future rulemaking by the FDA. However, the framework for the future of food laboratory testing is written within the law.

More Coordination

FSMA outlines several instances where lab coordination should occur. The law requires a progress report in implementing a national food emergency response laboratory network. This network would provide “accessible, timely, accurate, and consistent food laboratory services throughout the United States.” It would coordinate the food laboratory capacities of state, local, and tribal food laboratories, and improve national situational awareness by encouraging data sharing with federal agencies.

As part of the governmental coordination process, a methods repository would be created to share resources among federal, state, and local officials. Through an integrated consortium of laboratory networks, there would be an agreement on common lab methods to reduce the time required to detect and respond to foodborne illness outbreaks as well as encourage information sharing. This effort would be managed by the Secretary of Homeland Security, in collaboration with the Secretaries of HHS, Agriculture, Commerce, and the Administrator of the EPA.

From an international perspective, FSMA also outlines elements of a plan for building the capacity of foreign governments and their food industries with respect to food safety. These governments would conceivably export foods to the U.S. One element of a future, comprehensive plan is to provide for the multilateral acceptance of laboratory methods, testing, and detection techniques.

Accountability

Congress, in drafting FSMA, sought accountability for this new comprehensive food safety law. As such, the law requires the HHS Secretary, in coordination with counterparts at the Departments of Agriculture and Homeland Security, to submit a status report—specifically a progress update on lab accreditation.

In May 2013, FDA followed on this deliverable in its report, “Building Domestic Capacity to Implement the FDA Food Safety Modernization Act.” FDA explained how it was working to develop performance standards, oversight and accountability to ensure “adherence to national standards,” sample collection and analysis procedures, and lab control. The report notes that FSMA provides FDA “with important new tools,” including the requirement that certain testing be conducted by accredited laboratories and the FDA “establish a program for laboratory accreditation to ensure that U.S. food testing laboratories meet high-quality standards.”

What Now?

While the laboratory provisions of the law are pending interpretation and regulatory action by the FDA, food producers may use the time to ask about the standards followed by their in-plant and contract laboratories. Food labs too need not wait for a federal mandate to raise the bar on quality. The law demonstrates a desired move toward lab accreditation and standards for testing. Savvy food labs will not wait to consider their options for implementing recognized quality testing processes and credentials.