Animal & Veterinary
FDA Seeks Comment on the Reportable Food Registry Draft Guidance
June 16, 2009
The U.S. Food and Drug Administration (FDA) is asking for comment on its Reportable Food Registry (RFR) draft guidance for the food industry. The RFR applies to all FDA-regulated categories of foods, including animal feed. Only infant formula and dietary supplements are exempt from the RFR requirements.
The RFR requires a responsible party to file a report through an FDA internet portal when there is reason to believe that an adulterated food will cause serious adverse health consequences or death to humans or animals. "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 for human or animal consumption in the United States. Federal, state, and local government officials may also use the portal to report information that may come to them about such foods. The RFR and electronic portal are scheduled for implementation on September 8, 2009.
The congressionally-identified purpose of the RFR is to provide a "reliable mechanism to track patterns of adulteration in food [which] would support efforts by the FDA to target limited inspection resources to protect the public health."
The draft guidance explains the following:
- Who must submit RFR reports of adulterated foods to FDA,
- How, when and where RFR reports may be submitted,
- What information the RFR reports must include, and
- What steps must be taken to notify others in the supply chain of the adulterated food.
Interested persons may submit written comments on or before July 27, 2009, to the Division of Dockets Management (HFA-305), FDA, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Electronic comments may be submitted to http://www.regulations.gov. Identify all submissions to the docket with the following docket number: FDA-2009-D-0260. Single copies of the draft guidance are available by written request to the Office of Food Defense, Communication and Emergency Response, CFSAN (HFS-005), FDA, 5100 Paint Branch Pkwy., College Park, MD 20740. Please include two self-addressed adhesive labels to assist that office in processing your request.
For questions regarding this draft document, please contact Mr. Kim Young, Center for Veterinary Medicine (CVM), at 240-276-9207.
SUPERCEDED September 2009 - Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007; Draft Guidance Federal Register Notice of Availability; Draft Guidance: Questions and Answers Regarding the Reportable Food Registry