Reportable Food Registry Compliance Guide Available from AFIA
The Reportable Food Registry was created by Congress in the Food and Drug Administration Amendments Act of 2007. On Sept. 8, 2009, the Food and Drug Administration announced the opening of an electronic portal for reporting “reportable foods,” the term the act uses to describe products that have the reasonable potential of causing or having caused a serious, adverse health consequence or death in humans or animals.
This legal standard that originally appeared in the Bioterrorism Act of 2002 is best described in the FDA’s Class recall found here. By looking at the Class II and Class III recall standards, firms may determine if a product event could be classified as a Class I recall and thereby become a “reportable food.”
With its legal counsel, the American Feed Industry Association created a compliance guide for member-firms to turn to when determining how and when to report a “reportable food.” There still are some issues to be clarified by FDA, and this guide details them. As with previous such guides, FDA is likely to provide updates occasionally, and AFIA will pass the updates along to members as they occur.
The new provision applies to all feed, pet food and feed ingredients, and firms must report to FDA within 24 hours a “reportable food” once the firm determines that a product is a “reportable food.”
For instance, if a customer reports to a firm that there are animal deaths and alleges the firm’s feed is the cause, that claim does not automatically make the firm’s feed a “reportable food.” In the normal course of verifying customer complaints, the firm will take samples, look at its records and may talk to experts about the feed the animals consumed and the customer’s on-farm practices—all of which assist in helping the firm determine if the feed was the cause of the animal deaths.
If the firm decides that, indeed, its feed did cause the animal deaths, then the firm has 24 hours to report that finding to FDA using the electronic portal.
AFIA’s guide describes how the portal works and what is required for reporting. You may access the guide here.
You may access FDA’s Question and Answer Guide with this link.
You may access the electronic portal and begin reporting a “reportable food” using this link.
For more information about the Reportable Food Registry, contact AFIA Vice President Richard Sellers at rsellers@afia.org or (703) 558-3569.