Saturday, June 27, 2009

Public Workshops on the FDA Reportable Food Registry

FDA announced three public workshops on the Reportable Food Registry. The public workshops are to explain the purpose of the Registry, how it will work, and the responsibilities of persons required to submit a report regarding instances of reportable food to FDA through the Reportable Food electronic portal. In addition, the role of federal, state and local public health officials in voluntarily reporting instances of reportable food to FDA will be discussed.

Electronic registration is encouraged. Please go to Reportable Food Registry Public Workshops for more information.

On September 27, 2007, the Food and Drug Administration Amendments Act of 2007 (FDAAA) amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) by creating a new section referred to as 417, Reportable Food Registry. Section 417 requires the Secretary of Health and Human Services to establish within the Food and Drug Administration (FDA) a Reportable Food Registry. The congressionally-identified purpose of the Reportable Food Registry is to provide a "reliable mechanism to track patterns of adulteration in food [which] would support efforts by the Food and Drug Administration to target limited inspection resources to protect the public health" (Pub. L. 110-085, § 1005(a)(4)).

The Secretary has delegated to the Commissioner of FDA the responsibility for administering FD&C Act section 417. To further the development of the Reportable Food Registry, section 417 requires FDA to establish an electronic portal by which instances of reportable food must be submitted to FDA by responsible parties and may be submitted by public health officials. A "reportable food" is an article of food (other than infant formula) for which there is a reasonable probability that the use of, or exposure to, such article of food will cause serious adverse health consequences or death to humans or animals.

(FD&C Act § 417(a)(2)). "Responsible party" is defined as the person who submits the registration information to FDA for a food facility that manufactures, processes, packs, or holds food/feed for human or animal consumption in the U.S.

The Registry is scheduled for implementation on September 8, 2009, and applies to all FDA-regulated categories of foods except dietary supplements and infant formula. FDA has published draft Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007 (June 2009). This guidance contains questions and answers relating to the requirements under section 417 of the FD&C Act, including (1) how, when and where to submit reports to FDA; (2) who is required to submit reports to FDA; (3) what is required to be submitted to FDA; and (4) what may be required when providing notifications to other persons in the supply chain of an article of food.

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