June 11, 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The U.S. Food and Drug Administration (FDA) is asking for comment on its Reportable Food Registry (RFR) draft guidance for the food industry, developed in response to section 1005 of the Food and Drug Administration Amendments Act of 2007 (Pub. L.110-085). The RFR is scheduled for implementation on September 8, 2009, and applies to all FDA-regulated categories of foods, including dietary supplements. Only infant formula is 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 (other than infant formula) 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 The draft guidance is in a question and answer format and explains:
- 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.
The Congressional intent for the RFR is to provide a reliable mechanism to track patterns of adulteration in food in order to support efforts by FDA to target limited inspection resources to protect the public health. The notice announcing the availability of the draft guidance was published in the Federal Register on June 11, 2009. The draft guidance is available at: Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007 or http://www.regulations.gov
Interested parties have 45 days from the date of publication to submit comments to FDA. Submit written comments on the draft guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments on the draft guidance to http://www.regulations.gov. Address written requests for single copies of the draft guidance to the Office of Food Defense, Communication and Emergency Response, Center for Food Safety and Applied Nutrition (HFS-005), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. Send two self-addressed adhesive labels to assist that office in processing your request.