Inside the Reportable Food Registry

by Staff
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KANSAS CITY — Like it or not, the Food and Drug Administration's Reportable Food Registry (R.F.R.) is in effect, and stakeholders in the food and feed industries must be prepared to follow R.F.R. mandates. That was the reaction of three trade organizations when asked about how those organizations are helping their members meet the mandates of the news regulations.

"They must be prepared to comply with the requirements of the regulation," said Cliff Pappas, senior advisor — HACCP and Quality, for the American Institute of Baking, Manhattan, Kas.

"To help with this, AIB International is planning a webinar for Nov. 9 to cover what we know and answer participant questions."

The American Feed Industry Association provided an R.F.R. webinar on Sept. 22 for its members, during which some 45 questions arose from participants, according to Richard Sellers, vice-president of Feed Regulation and Nutrition for the A.F.I.A. He added that the association provided members with F.D.A.’s Q&A document with some legal, written compliance guidance.

The Produce Marketing Association provided its members with information on the registry and the F.D.A.’s guidance on the association’s food safety web page, said Kathy Means, vice-president of government relations and public affairs for the P.M.A.

The R.F.R. took effect on Sept. 8. The program requires "responsible parties" to alert the F.D.A. within 24 hours through an electronic portal when a company believes there is a reasonable probability a product will cause adverse consequences in humans or animals. Reporting requirements apply to all foods and animal feed regulated by the F.D.A., except infant formula and dietary supplements.

A responsible party must:

• Investigate the cause of the adulteration if the adulteration of food may have originated with the responsible party.

• Submit initial information that is followed by supplemental reports.

• Work with the F.D.A. authorities to follow up as needed.

The AIB, P.M.A. and A.F.I.A., gave input to the F.D.A. regarding the registry and some changes were made based on those comments.

"We told F.D.A. that issuing the guidance on the same day the electronic portal became active was not good public policy and urged a 60-day phase-in," Mr. Sellers said. "F.D.A. heard us and is allowing a 90-day enforcement discretion, provided firms make a good faith effort to report."

The P.M.A. offered comments on the registry, and worked with others to have a produce industry representative test the system with F.D.A. so they could try to work out kinks before it went live, P.M.A.'s Ms. Means said.

She added that the P.M.A. offered real-world input from the association's chief science officer, Dr. Bob Whitaker. She said the P.M.A. agreed with the F.D.A.'s approach in several areas. However, the association had some concerns about F.D.A.'s guidance document.

"In the guidance document, we do see some flexibility in reporting based on presumptive positives or confirmed positives as we outlined in our comments," she said. "However, some of this may still have a chilling effect on testing as outlined in our comments."

Industry has accepted that it must follow the regulation, but some stakeholders believe some issues have gone unaddressed.

"For instance, if a firm finds an adulterant in a product after it takes possession (the statute refers to this as "holds"), then the product must be reported, as the exemptions allow for products to be exempt if the adulteration originated in the firm's operation," Mr. Sellers said. "In this case, the ingredient product will likely be destroyed, but has to be reported."

The AIB also has an issue with the definition of "transfer."

"The current definition will require plants to report items to the Reportable Food Registry, even when they have complete control of the food item," Mr. Pappas said.

Mr. Sellers said the best part of the R.F.R. — and something A.F.I.A. insisted F.D.A. add — is that "F.D.A. must verify the reports and it may conclude, in fact, the products are not reportable."

Ms. Means reiterated the P.M.A.'s commitment to working with F.D.A. to improve the registry.

"It's not about liking or disliking the registry — it's about following the regulations set out by F.D.A.," she said. "Everyone in the industry is now responsible to do so, regardless of whether they like it or not."

Food industry executives will have an opportunity to learn more about the R.F.R. at the AIB webinar scheduled for Nov. 9 from 10 a.m. to noon Central Standard Time. The fee is $100. For more information about the webinar, contact Doreen Towne or Bill Pursley, vice-president of food safety education and international development at 800-633-5137 or 785-537-4750. FSM

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