FDA Reportable Food Registry Revised
The Food and Drug Administration has released an updated version of its electronic portal and guidance for mandatory reporting of contaminated foods and ingredients. Effective this week, the Reportable Food Registry portal at rfr.fda.gov has been replaced with the Safety Reporting Portal at www.safetyreporting.hhs.gov.
The new site has several improvements, including the ability to save a draft submission for future edits, and registering a facility for faster reporting. Along with the new portal, FDA released an updated draft guidance on who is required to report and when.
"Any operation that manufactures, processes, packs, or holds food and is required to register with the FDA is still required to comply with the Reportable Food Registry; farms are still exempt," said Dr. David Gombas, senior vice president food safety and technology. "A reportable food is still an ingredient or product that testing or other evidence demonstrates is reasonably likely to cause severe adverse health effects or death to humans or animals. Such a food does not need to be distributed to be reportable."
The draft guidance has some important new clarifications. "We've talked with FDA regarding in-field microbiological testing of fresh produce and whether samples that test positive for a pathogen need to be reported," said Gombas. "Question D10 of the Guidance now clearly states that produce tested in the field and found to be positive does not need to be reported, but produce found to be positive for a pathogen after delivery to a handler must be reported."
The guidance is still "draft" and FDA is actively soliciting comments from the industry on ways to improve it. Individuals wanting to provide comments to FDA should visit www.regulations.gov and enter docket FDA-2009-D-0260.
"This new version of the portal is shorter and much easier to use than the original version", said Gombas, "and that is mostly because of the comments FDA received from the industry. There are still opportunities to improve this mandatory reporting system, and it is in the industry’s best interest to share those thoughts with FDA."
A replay of FDA's teleconference on the new portal and Guidance will be available through June 24 by calling 1-888-562-6807 (1-203-369-3941 for international participants), passcode 8084. Please contact Dr. Gombas at 202-303-3400, ext. 411 with any questions about the Reportable Food Registry or the new Safety Reporting Portal.