FDA Postpones Implementation of Reportable Food Registry and Portal (Expected in Spring 2009)
The Food and Drug Administration has issued a notice postponing the implementation of the Reportable Food Registry (Registry) and its associated electronic portal, both of which the FDA was required to establish by September 27, 2008, pursuant to the Food and Drug Administration Amendments Act of 2007 (FDAAA).
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The FDA expects to establish the portal to implement the Registry in Spring 2009.
In conjunction with this delay announcement, the FDA is requesting comments by August 11, 2008 on certain aspects of the Registry provisions.
Registry/Portal to be Used to Track Food with Probable Health Consequences
The Registry's purpose is to provide a reliable mechanism to track patterns of adulteration in food. Information on "reportable food" (i.e., an article of food (other than infant formula1) for which there is a reasonable probability that the use of, or exposure to, such article would cause serious adverse health consequences or death to humans or animals) will be required to be submitted by "responsible parties" or public health officials via an electronic portal for that purpose.
Information Required from Foreign and Domestic Facilities
The responsible parties that will be required to submit information on reportable food via the portal are the owners, operators, or agents in charge of a domestic or foreign facility2 engaged in manufacturing, processing, packing, or holding food for consumption in the U.S. who submit the registration required under 21 USC 350d for a food facility.
Reports due within 24 hours. Responsible parties are required to submit a report to FDA through the Reportable Food electronic portal as soon as practicable, but in no case later than 24 hours after the responsible party determines that an article of food is a reportable food.
11 required data elements. Eleven data elements will need to be submitted via the electronic portal in the initial report or subsequent report to FDA, including elements such as: (1) the registration numbers of the responsible party provided under section 415(a)(3) of the Federal Food, Drug, and Cosmetic Act (FFDCA); (2) the date on which the article of food was determined to be a reportable food; and (3) a description of the article of food including the quantity or amount.
Alert/notification may be required. The FDA is required to issue, or cause to be issued, an alert or notification with respect to a reportable food using the information from the Registry as FDA deems necessary to protect the public health.
No Penalties While Portal/Registry Under Development
As the FDA intends to implement the FDAAA requirement to establish the electronic portal for reportable food utilizing the business enterprise system, which it expects will be operational in spring 2009, it acknowledges that the prohibited act provisions relating to the Registry will not apply until such time as FDA establishes the electronic portal to implement the Registry.
(Failure to submit a report or provide a notification as required by section 417(d) of the FFDCA is a prohibited act under 21 USC 331(mm)), and persons who commit such prohibited acts may be enjoined or prosecuted criminally.)
Once the portal is available, FDA expects that responsible parties will comply with the requirements of section 417 of the FFDCA, including the requirement to submit instances of reportable food to the FDA via the Reportable Food electronic portal.
Reporting Encouraged Through Existing Mechanisms for Now
Until such time as the Registry and its associated electronic portal are fully implemented, the FDA strongly encourages persons to continue to report instances of adulterated food through existing mechanisms, such as notifying the relevant FDA District office. The FDA will notify the public via the Federal Register of the date the Registry and its associated electronic portal become available to accept reports.
1See ITT's Online Archives or 03/06/06 news, 06030699 6, for BP summary of a FDA frequently asked questions document about its regulation of infant formula.
2The term "facility" includes any factory, warehouse, or establishment (including a factory, warehouse, or establishment of an importer) that manufactures, processes, packs, or holds food. Such term does not include farms; restaurants; other retail food establishments; etc. (See 21 USC 350d for complete definition, including definitions for foreign and domestic facilities.)
(See ITT's Online Archives or 09/26/07 and 10/02/07 news, 07092610 and 07100205, for BP summaries of Congressional passage of the FDAAA and the President's signing it into law, respectively.)
FDA contact - Faye Feldstein (301) 436-2428
FDA notice (D/N FDA-2008-N-0298, FR Pub 05/27/08) available at http://edocket.access.gpo.gov/2008/pdf/E8-11517.pdf