FDA's Reportable Food Registry

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The U.S. Food and Drug Administration has a new way to head off potential cases of foodborne illness – the Reportable Food Registry (RFR), where food industry officials must use to alert the FDA quickly, through an electronic portal when they find their products might sicken or kill people or animals. The requirement, a result of legislation, took effect with the launch of the portal.

Facilities that manufacture, process or hold food for consumption in the United States now must tell the FDA within 24 hours if they find a reasonable probability that an article of food will cause severe health problems or death to a person or an animal. The reporting requirement applies to all foods and animal feed regulated by the FDA, except infant formula and dietary supplements. Some examples of reasons a food may be reportable include bacterial contamination, allergen mislabeling or elevated levels of certain chemical components.

The opening of the RFR electronic portal reflects a fundamental principle of the President’s Food Safety Working Group that “preventing harm to consumers is our first priority. "By fostering real-time submission to the FDA of information on food safety hazards, the registry enhances FDA's ability to act quickly to prevent foodborne illness," said Michael R. Taylor, senior advisor to the commissioner. "Working with the food industry, we can swiftly remove contaminated products from commerce and keep them out of consumers' hands."

The requirements apply to any person who has 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. These people are termed responsible parties.

A responsible party:

  1. Must investigate the cause of the adulteration if the adulteration of food may have originated with the responsible party
  2. Must submit initial information; followed by supplemental reports
  3. Must work with the FDA authorities to follow up as needed

A responsible party is not required to report if it found the problem before the food was shipped, and corrected the problem or destroyed the food.

Read more at the RFR Guidance here

A media teleconference this morning discussed this new initiative. It was explained that companies must report as soon as practical but no later than 24 hours after recognizing they have a reportable food and a problem. Failure is subject to criminal action and enforcement. The FDA will then follow up and regulatory partners at state and federal level to evaluate a course of action as appropriate. Companies must provide notification to the FDA as well as the immediate previous sources of the food product, as well as to any person or company they have shipped the product to.

John Maday, associate editor of Drovers (Bovine Veterinarian's sister publication) asked if large livestock operations that store and mix their own feed rations would be obligated under this new rule to also report problems with the FDA. Unfortunately, I don't believe that the FDA representatives on the call understood the question as they don't understand how a large operation such as a feedlot or dairy may buy and store large quantities of different feedstuffs and ingredients to then mix into rations. They said farms per se are exempt from this rule, but manufacturers holding animal feeds are subject to the rule.

A question if all reports would be publicly available was asked, but the FDA said information from reports will be constrained except for relevant actions such as recalls, etc., which would be publicly availalble, as well as ongoing trends FDA may release on food safety issues.

Geni Wren, Editor

Bovine Veterinarian Magazine 

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