Moving Toward Laboratory Standards

Already several rules have been proposed by the FDA outlining how the Food Safety Modernization Act (FSMA) may be implemented. These rules address risk-based preventive controls, produce safety, foreign supplier verification, accrediting of third-party auditors, sanitary transport, and intentional adulteration. Yet, one important component still awaits FDA rulemaking, the oversight of the food lab.

Food laboratory testing is considered an integral part of a modern food safety system. In fact, a majority of the proposed rules issued to date reference lab testing, as does the law itself. FDA notably states that it “plays a very important role in ensuring the safety of food.” The agency explains, “an important purpose of testing is to verify that control measures, including those related to suppliers and those verified through environmental monitoring, are controlling the hazard. Testing is used in conjunction with other verification measures in the food safety system, such as audits of suppliers, observations of whether activities are being conducted according to the food safety plan, and reviewing records to determine whether process controls are meeting specified limits for parameters established in the food safety plan.” The Federal Food, Drug and Cosmetic Act states that owners, operators, or agents in charge of a food facility must verify that preventive controls “are effectively and significantly minimizing or preventing the occurrence of identified hazards, including through the use of environmental and product testing programs…”

Despite recognition of its role, there’s currently little known about the state of food labs, and standards for testing are largely voluntary. There is not an exact tally of the number of food laboratories that exist, nor is there an accounting of the skills and training of the food lab workforce, quality control processes employed, or access to technology. This information deficiency and lack of standardization means the country may not have the capacity to respond effectively to biological or chemical foodborne threats. It means that food producers may have difficulty discerning among laboratories with appropriate capabilities. It also makes it more difficult to trace the source of multi-state foodborne outbreaks.

According to the Law…

FSMA calls for the recognition of laboratory accreditation. Section 202 of the law states that a program for the testing of food by accredited labs shall be established by the Secretary of Health and Human Services (HHS). The program would recognize laboratory accreditation bodies that meet criteria established by the HHS Secretary. It would include independent private laboratories and labs run and operated by federal agencies, states, or localities that demonstrate a capability to conduct one or more sampling and analytical testing methodologies for food. Labs that operate outside of the U.S. may become accredited as long as they meet the same accreditation standards applicable to domestic labs. This provision was to be enacted within two years of the passage of the law.

The details on how this program would operate and the criteria on which it would be based are not yet known. However, the law does outline critical elements of the program and provides insight into the intention of the policymakers.

For example, to ensure compliance, accreditation bodies would be re-evaluated periodically, at least once every five years. Auditors from an accreditation body may be accompanied by HHS to ensure they meet criteria. Accreditation bodies not in compliance with requirements may have their recognition revoked.

FSMA also requires the establishment of a publicly available registry of accreditation bodies. Labs accredited by a recognized accreditation body would be included in the registry. This registry would maintain the name, contact info, and other details about the accreditation organizations and laboratories. While the Secretary of HHS would determine, through rulemaking, how to recognize these bodies, the law makes clear the desire to make public the identities of those facilities that meet essential criteria.