Reportable Food Registry Will be Operational in September 2009June 17, 2009
By Riëtte van Laack –
The FDA Amendments Act (“FDAAA”) amended the Food, Drug, and Cosmetic Act (“FDC Act”) to create section 417, which directs FDA to establish a Reportable Food Registry (“Registry”). The purpose of the Registry is to provide a “reliable mechanism to track patterns of adulteration in food [which] would support efforts by [FDA] to target limited inspections resources to protect the public health.” Section 417 includes requirements for a responsible party (defined as “owner, operator or agent in charge of a . . . facility engaged in manufacturing, processing, packaging or holding foor for consumption in the United States”) to submit “instances of reportable food” to FDA. In addition, the responsible party must notify immediate previous sources and subsequent recipients of the reportable food. A “reportable food” is a food “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.”
Pursuant to FDAAA, FDA was to establish the Registry by September 27, 2008. On May 27, 2008, FDA issued a Federal Register notice stating that the Agency would not meet this deadline, but that the Agency expected to have the Registry ready for operation in Spring 2009. On June 11, 2009, FDA issued a second Federal Register notice stating that the Registry is again delayed and will be operational on September 8, 2009. In the same notice, FDA announced the availability of a draft guidance document addressing questions regarding the Reportable Food Registry.
The draft guidance clarifies the duties of a responsible party under FDC Act § 417. Most of the information in the draft guidance could be obtained by a careful reading of section 417 and other sections which are referenced in section 417. However, the draft guidance also clarifies some of the less obvious issues such as the notification duties when more than one responsible party is involved (see question 22); the notification duties when there are multiple immediate previous sources or subsequent recipients (see question 24); and acceptable means of notification (see question 26).
Although not required by law, FDA encourages “responsible parties to contact their FDA district office and state or local public health or regulatory officials as soon as possible if they determine that [a food] is a reportable food.”
The draft guidance also clarifies that FDC Act § 417 does not affect FDA’s position (FDA Compliance Policy Guide 7126.20) regarding salvage of adulterated human or animal food by diverting that food to an acceptable animal food use.
The guidance does not appear to address questions submitted to FDA in response to the Agency’s May 2008 Federal Register notice, such as how FDA will address issues regarding coordination between FDA and the U.S. Department of Agriculture and whether anyone can report to the internet portal required by FDC Act § 417.
To ensure that FDA considers comments to the draft guidance, the Agency asks that comments be submitted by July 27, 2009.