President Bush Signs Act Authorizing New Food Safety Registry
President George Bush last Thursday signed the Food and Drug Administration's (FDA) Amendments Act of 2007, which contains a provision that is intended to improve FDA's ability to ensure the safety of the domestic food supply. IDFA is reviewing the legislation, which will impose new reporting responsibilities on food industry manufacturers and suppliers, including IDFA members.
The act is primarily a reauthorization of the Prescription Drug User Fee Amendments to the Federal Food, Drug and Cosmetic Act. Title X of the new act is devoted to food safety and will require the creation of a Reportable Food Registry by FDA within one year to track patterns of adulteration, or potentially harmful changes, in food. (For FDA's definition of "adulteration," click here.)
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, as 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.
Within nine months of enactment, the Secretary of Health and Human Services will be required to issue guidance to the food industry to explain how companies should submit reports to the registry and notify others in the supply chain for each reportable food.
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 will continue to monitor the legislation's progress and provide appropriate guidance on compliance when necessary. For more information, contact Clay Detlefsen, IDFA vice president of regulatory affairs, at firstname.lastname@example.org or 202-220-3554.
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Posted October 1, 2007