FDA To Require Reporting Of Positive Food Product Test Results
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In the coming months, the FDA will likely begin requiring food manufacturers that obtain positive test results from product samples to report such findings to the agency. Although the new rules will likely have a significant impact on industry as adjustments are made to ensure compliance, the rules (once implemented) would likely add an additional layer of safety to our food regulatory system.
In 2007, former President Bush signed into law the Food and Drug Administration Amendments Act (Public Law 110-85). The Act, which amended the Federal Food, Drug and Cosmetic Act by creating a new section 417 (21 U.S.C. 350f), required the Secretary of Health and Human Services, no later than September 27, 2008, to establish a Reportable Food Registry. The stated purpose of the amendment was “to provide a reliable mechanism to track patterns of adulteration in food [which] would support efforts by the FDA to [better] target [its] limited inspection resources.” Implementation of the new law, along with its mandatory reporting requirements, however, has been delayed while the FDA continues to develop an effective electronic reporting system.
In its current form, the new food registry will apply to food manufacturers, and will define “reportable foods” as any article of food (other than infant formula) found to contain harmful pathogens, “for which there is a reasonable probability that the use of, or exposure to, such of food will cause serious adverse health consequences or death to humans or animals.” 21.U.S.C. 350f. If a food sample tests positive for any pathogen considered an adulterant for the particular food at issue, manufacturers would be required, within 24 hours, to submit an electronic report to the agency.
Currently, the FDA anticipates that the registry (and the associated reporting requirements) will likely go into effect sometime later this spring. We, of course, will keep you posted.
