Food Safety Magazine, June/July 2011

filed as the required data become available.

While the information fields on the Reportable Food portal differ somewhat between mandatory and voluntary submitters, they are both intuitive and not difficult to follow. The fields are a “ rational questionnaire,” meaning that in many instances, the answer to a question dictates what the next question will be.

for follow-up. Follow-up is undertaken in collaboration with the appropriate regulatory commissioned officials in the state or states involved who are automatically notified of any reportable food reports from facilities in their jurisdictions.

When necessary, an FDA District Of-
fice investigator will contact the firm or
individual submitting the report to ob-
tain additional information. The investi-
gator may follow up with a visit to the
firm. If needed, the District Office will
advise the responsible party to notify the
immediate previous supplier(s) of materi-
als and/or the immediate subsequent re-
cipient(s) of a reportable food and
provide them the initial ICSR.

Technical Assistance

Because the food and feed industries are large, various, and complex, FDA has posted guidance to assist submitters with concerns about how their individual situations relate to the Registry. The Draft Guidance for Industry: Questions and Answers Regarding the RFR as Established by the FDA Amendments Act of 2007 (Edition 2), can be accessed via www.fda.gov/ ReportableFoodRegistry.

In addition, there are two Help Desks, the RFR Center at RFRSupport@fda.hhs.gov for questions about policies, procedures, and interpretations and the SRP Service Desk at support.srp@jbsinternational.com for technical and computer-related questions about both RFR reports and the SRP.

Review by FDA

When a reportable food report is submitted to the SRP, it is sent to FDA’s Risk Control Review (RCR) team for review. The RCR team includes the following FDA organizations: the Center for Food Safety and Applied Nutrition, the Center for Veterinary Medicine, the Office of Emergency Operations, and the Office of Regulatory Affairs, which includes FDA’s 19 District Offices at locations throughout the nation. In addition, the District Office for the area from which the report originated receives a copy and participates in the review. Each report is reviewed to assess whether the subject of the report meets the definition of a reportable food and to identify appropriate follow-up actions. If the RCR team concludes that the submission is a reportable food, the submission is entered into the RFR, and appropriate follow-up measures are specified. All such reports are then referred to the appropriate FDA District Office

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