The Food and Drug Administration announced earlier this month that the twice-delayed implementation of the Reportable Food Registry will become effective September 8, 2009. At the same time, FDA also released for comment a draft guidance document for industry to help companies comply with the registry's requirements.
Included as a provision in the FDA Amendments Act of 2007, the registry will impose new reporting responsibilities on food industry manufacturers and suppliers, including IDFA members. It is intended to improve FDA's ability to ensure the safety of the domestic food supply.
In the act, reportable foods are defined as any food products that could cause serious adverse health consequences or death to humans or animals. This is essentially the same standard that is incorporated into the Bioterrorism Act of 2002, based on criteria for a Class I recall under FDA's recall regulation. In the case of dairy products, reportable foods would most likely be those found to contain pathogens or unlabeled allergens.
Each report to the registry will be required to include the facility's registration number, the date the food was determined to be reportable; the nature of adulteration; results from any investigation if the adulteration happened at the processing facility; the disposition of the food; and pertinent product information, such as product codes, use-by dates and the names of manufacturers, packers or distributors.
The registry's effective date was pushed back twice since 2007 because the electronic portal for receiving the information wasn't available. FDA now plans to open the Reportable Food portal on September 8 as a part of the agency's new electronic system, the MedWatchPlus Portal. FDA will use this system to collect and process reports and other safety information for all FDA-regulated products.
Under the law, companies are required to maintain records related to each report for two years. These records are subject to the Freedom of Information Act and open to inspection by government agencies.
IDFA is reviewing the draft guidance and may decide to submit comments before the July 29 deadline. For more information, contact Clay Detlefsen, IDFA vice president of regulatory affairs, at firstname.lastname@example.org or (202) 220-3554.