The Food and Drug Administration has introduced its “Reportable Food Registry” electronic portal for the food industry, along with new requirements for reporting food-safety threats.

With the launch of the RFR portal, food and feed companies up and down the production chain are now required to alert FDA within 24 hours of determining any of their products could sicken or kill people or animals. Reporting that has been voluntary now becomes mandatory. Failure to report a known, reportable problem will place a company in violation of the Food Safety Act and subject to enforcement and penalties from the FDA.

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.

Once a company reports a problem, the FDA will determine appropriate actions, including possibly requiring the company to alert suppliers and customers of the food-safety issue. According to FDA officials, this new system will help identify food-safety problems early and remove contaminated food from commerce before it reaches consumers. "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," says 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."

This effort, FDA officials say, reflects a fundamental principle of the President’s Food Safety Working Group that “preventing harm to consumers is our first priority.”

"President Obama has pledged to strengthen food safety,” says Commissioner of Food and Drugs Margaret A. Hamburg, M.D. “The opening of the Reportable Food Registry electronic portal represents a significant step toward that pledge.”

These requirements apply to any person, termed a “responsible party,” 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. Farms are exempt from these registration requirements, but feed-processing facilities are not.

A responsible party:

  • Must investigate the cause of the adulteration if the adulteration of food may have originated with the responsible party .
  • Must submit initial information; followed by supplemental reports.
  • 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.

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.

According to the FDA’s Guidance, “Registered Food Facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States under section 415(a) of the FD&C Act (21 U.S.C. 350d) are required to report when there is a reasonable probability that the use of, or exposure to, an article of food will cause serious adverse health consequences or death to humans or animals.

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 available, as well as ongoing trends FDA may release on food safety issues.

FDA has issued a Guidance on the RFR.

The new mandatory requirements for reporting food-safety problems to the FDA are part of the Obama administration’s push for prevention of food-borne illness. During Tuesday’s news conference, FDA officials stressed that the regulations, coupled with “real-time” electronic reporting will help remove unsafe food from commerce before it reaches consumers, rather than waiting for someone to get sick before initiating recalls. Whether it actually will reduce sickness remains to be seen, but the policies should at least help reassure consumers, whose confidence has been stung by the recent series of food recalls. — John Maday, managing editor