Industry Urges FDA to Release FSMA Lab Proposed Rule

Organizations are banning together in response to FDA’s long delay in releasing a rule under the Food Safety Modernization Act (FSMA) that addresses food laboratory accreditation and model laboratory standards.

“FDA has finalized FSMA rules ranging from Good Manufacturing Practices to foreign supplier verification,” says Robin Stombler, director of the Food Laboratory Alliance, Arlington, Va., which is a coalition of organizations devoted to the safety of the nation’s food supply and the quality of food laboratory testing. “Although the law mentions ‘laboratories’ and ‘laboratory test’ nearly 100 times, a proposed rule addressing the quality and accuracy of that testing remains outstanding.”

FSMA became law on Jan. 4, 2011. The provision of the law establishing a publicly available registry of accreditation bodies recognized by the U.S. Secretary of Health and Human Services and of laboratories accredited by those bodies was expected no later than two years after the law was enacted.

Currently employed on a voluntary basis, industry-wide laboratory accreditation will inspire confidence in food testing results. “Other parts of the FSMA give us reason to believe laboratory accreditation will be set to the international standard ISO/IEC 17025,” says Randy Querry, director of government relations, A2LA, Frederick, Md.

Heather Jordan, director of LGC proficiency testing operations, North America, based in Traverse City, Mich., says, “The law calls for model standards that laboratories must meet for accreditation purposes. But surprisingly, existing standards are all voluntary. If we’re going to make critical decisions based on lab test results, we need to ensure their accuracy.”

When asked why her organization joined with the Food Laboratory Alliance, Mitzi Baum, MSc, CEO of STOP Foodborne Illness, based in Chicago, says the Alliance’s mission matches well with her organization’s beliefs. “Ensuring the quality of food laboratory testing to help provide a safe food supply is essential,” she says. “The Alliance is a collegial group that speaks loudly on this point.”

“Some food laboratories follow standards to assure accurate test results,” explains Mary Kay Krogull, vice president of business administration, Food, North America, at Eurofins Scientific, Inc., Madison, Wis., “Unfortunately, not all do. That puts test results and ultimately the public at risk. We felt a responsibility to work with other quality-minded organizations to fix this problem.”

In order to push FDA to release the rule, the Alliance has provided information and guidance to the public and policymakers on the notable gap in FSMA implementation. “Education about the essential role of food laboratory testing is key,” Stombler says. “With 360-degree support from consumers, food laboratories, food manufacturers, public health advocates, and providers of testing products and services, we work to raise awareness about laboratory testing in support of the nation’s food supply.”

When FDA might release the rule remains unknown. “The sooner the better,” says Brad Goskowicz, CEO of Microbiologics, based in St. Cloud, Minn. “We look forward to reviewing the FDA proposed rule and offering public comments.”

Other organizations joining the movement for issuance of the proposed rule include Association of Public Health Laboratories, Consumer Federation of America, The Pew Charitable Trusts, Trust for America’s Health, and others.