The FDA has announced a new tool it believes will help prevent future cases of food-borne illness – the Reportable Food Registry.
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 to establish a mandatory reporting registry for potentially dangerous foods. The stated purpose of the amendment was to provide FDA with “a reliable mechanism to track patterns of adulteration in food.” Implementation of the new law, however, was delayed while the FDA worked on developing an effective electronic reporting system.
Now that the Reportable Food Registry (“RFR”) is up and running, the mandatory reporting requirements have gone into effect. The new FDA rules apply to any company that is required to submit registration information to the FDA for a food facility “that manufactures, processes, packs, or holds food for human or animal consumption in the United States.” In turn, the rules extend to any food or animal feed regulated by the FDA, except for infant formula and dietary supplements which are covered by other regulatory requirements.
Under the new FDA rules, a food company is now required to alert the FDA – through the RFR Portal – within 24 hours of becoming aware it has sold and shipped a "reportable food." According to the FDA, a reportable food is defined as any food product that has a “reasonable probability” of causing health problems or death in humans or animals.
As explained by the FDA, some examples of reasons a food may be reportable include bacterial contamination, allergen mislabeling or elevated levels of certain chemical components.
In turn, once a food company discovers a problem with a product it has shipped, and submits a report through the RFR, it will be required to cooperate with the FDA to help determine the cause and prevent potential health problems. Companies will also be required to notify relevant suppliers and distributors of any potential safety issues, be ready to submit further data and tests to the FDA, and initiate their own investigation if the problem is thought to have originated internally.
Notably, however, the new reporting requirements apply only to products that have been shipped into commerce. For this reason, a food company is not required to report a problem to the FDA if it discovered the problem before a food product was shipped, and then corrected the problem or destroyed the food.
Although Michael Taylor (senior advisor to the FDA commissioner) stated that industry should be able to easily judge when a food product is “reportable” under the new guidelines, the Grocery Manufacturers Association quickly responded raising concerns over what it called “questions and ambiguities” in the registry. In turn, the GMA urged the FDA to remain flexible, and to help work through potential ambiguities, as the new regulations go into effect.
For additional information on the registry and reporting requirements, please visit www.fda.gov/ReportableFoodRegistry
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