WASHINGTON -- The produce industry will need to look out for a new guidance the U.S. Food & Drug Administration is planning to release soon that may change the rules for filing on-line reports under the four-month- old Reportable Food Registry.
As of Sept. 8, registered food facilities for the first time were required to file on-line reports to the FDA when a responsible party knows a product is likely to result in serious health consequences. Companies, which have 24 hours to file the mandatory reports, must investigate the cause of the adulteration, maintain records for two years, and are often asked by FDA to supply a complete list of upstream and downstream product handlers.
Companies are exempt from notifying FDA under the registry if all the following conditions apply: the adulteration originated with the same company; it was detected before it was transferred to another person; and it was destroyed or corrected in-house, said Kathy Gombas, who spoke Jan. 26 during a 90-minute webinar sponsored by the Food Institute.
The advantage of the new system is that problems are identified earlier and products are removed from commerce faster, she said.
But the food industry has raised questions about FDA's definition of "transfer to another person," a trigger that may exempt companies from the reporting system. According to the FDA, a product must be moved to a warehouse owned by the company and transported by the company's trucks to qualify as not being transferred by another person.
But companies have peppered the FDA with questions about moving products to third-party warehouses and other arrangements while retaining control of the food products.
"We will address this further in the new guidance," she said.
Another issue on which FDA will comment is that businesses are not required to report to the FDA on-line if the food is produced for export only. In the current guidance, the FDA does not explore that scenario, but the agency will address it in the future, she added.
Little information has been released about the reports filed since the program was launched last year. Ms. Gombas shared some trend data on the types of commodities and contaminants FDA is seeing under the new program.
Seafood topped the list of commodities the FDA has received the most reports about under the new registry, and most of the reports filed last year were due to undeclared allergens, said Ms. Gombas.
She shared the following commodity-specific breakdown on the 469 registry reports received from Sept. 8 to Dec. 31, 2009: 17 percent were attributed to seafood products; 11 percent to animal feed; 10 percent to bakery goods; 7 percent to produce; 7 percent to dairy products; 6 percent to confectionary; 5 percent to soups; 4 percent to nuts; 3 percent to spices; 3 percent to flour; and another 32 percent to other commodities.
The top reasons for filing were undeclared allergens (41 percent), Salmonella (20 percent), other agents (17 percent) and Listeria (14 percent), she said. Along with the new guidance document, the FDA plans to launch a new version of the on-line portal system later this year that will be more user- friendly.