FDA Issues Draft Industry Guidance on Reportable Food Registry
The Food and Drug Administration (FDA) has issued draft industry guidance in a question-and-answer format that provides information about complying with the reportable food registry requirements of a 2007 law. The purpose of the 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.” The draft guidance is a second edition, updated to provide information about a new federal safety reporting portal. FDA requests public comments by July 26, 2010.
The agency is particularly interested in comments addressing the meaning of the word “transfer” which is used in the context of an exemption from the requirement that “a responsible party submit a reportable food report.” For the exemption to apply, “the adulteration must have originated with the responsible party, the responsible party must have detected the adulteration ‘prior to any transfer to another person’ of the article of food, and the responsible party must have corrected the adulteration or destroyed the food.” FDA proposes that “transfer” be interpreted as “when the responsible person releases the food to another person.” Commenters are invited to address whether the interpretation is appropriate and whether it “should be dependent on ownership of the food, or whether there are other interpretations we should consider, such as a combination of possession and/ or ownership.” See Federal Register, May 25, 2010.
Meanwhile, the safety reporting portal, recently launched by the National Institutes of Health and FDA, will, when fully developed, provide “a mechanism for the reporting of pre- and post-market safety data to the federal government.” The new site apparently provides “greater and easier access to online reporting” of safety problems. Industry can currently use the site to report safety problems involving foods, including animal feed and animal drugs, “as well as adverse events occurring on human gene transfer trials.” Consumers are also able to use the portal “to report problems with pet foods and pet treats.” See FDA Press Release, May 24, 2010.
