F.D.A.'s Reportable Food Registry opens
September 08, 2009
by FoodBusinessNews.net Staff
WASHINGTON — The U.S. Food and Drug Administration has introduced the Reportable Food Registry (R.F.R.), a new program the agency said will help address the issue of foodborne illness. The F.D.A. said food industry executives identified as "responsible parties" must alert the F.D.A. within 24-hours through an electronic portal that is available on the agency’s web site (www.fda.gov) when "a company believes there is reasonable probability a product will cause adverse consequences in humans or animals," said Michael Taylor, senior adviser to the commissioner of the F.D.A.
The R.F.R took effect with the launch of the portal today.
The reporting requirement applies to all foods and animal feed regulated by the F.D.A., except infant formula and dietary supplements. Examples provided by the F.D.A. of reasons a food may be reportable include bacterial contamination, allergen mislabeling or elevated levels of certain chemical components.
"By fostering real-time submission to the F.D.A. of information on food safety hazards, the registry enhances F.D.A.’s ability to act quickly to prevent foodborne illness," Mr. Taylor said. "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 F.D.A. for a food plant that manufactures, processes, packs, or holds food for human or animal consumption in the United States, according to the F.D.A. As part of the program, a responsible party must:
• Must investigate the cause of the adulteration if the adulteration of food may have originated with the responsible party.
• Must submit initial information that is followed by supplemental reports.
• Must work with the F.D.A. 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The F.D.A. issued draft guidance on the R.F.R. in June and sought comment. A Federal Register notice was issued announcing the opening of the R.F.R. electronic portal and the availability of final guidance to assist the food industry in complying with the requirements of the R.F.R.
Guidance documents issued by the F.D.A. may be viewed by visiting www.fda.gov/reportablefoodregistry.