FDA’s Reportable Food Registry (RFR) is now open, and food industry officials must use the portal to alert the agency quickly 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 U.S.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.
The reporting requirement applies to all foods and animal feed regulated by the FDA, except infant formula and dietary supplements, which are covered by other regulatory requirements. Some examples of reasons a food may be reportable include bacterial contamination, allergen mislabeling or elevated levels of certain chemical components.
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 U.S. 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.
The agency issued draft guidance on the RFR in June and sought comment. The FDA also held three public workshops across the country in which FDA representatives explained the RFR requirements and how the portal will work. A Federal Register notice was issued last week announcing the opening of the RFR electronic portal and the availability of final guidance to assist the food industry in complying with the requirements of the RFR.
For more information, go to www.fda.gov/ReportableFoodRegistry
Source: FDA news release