FDA Improves the Reportable Food Registry by Adding New Data Elements
CFSAN Constituent Update
June 4, 2012
June 4, 2012, FDA brings online a new Reportable Food Registry (RFR) Rational Questionnaire which incorporates additional data elements as part of an effort to improve the RFR’s information gathering capability. The RFR is an electronic portal to which the food industry must, and public health officials may, report when they have information about a reportable food. A reportable food is an article of food/feed 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. By gathering and analyzing the new data, FDA will improve its ability to track patterns of adulteration in human food and animal feed (including pet food) and to target its inspection resources. The additional elements are:
- The reason the food has been determined to be reportable (agent);
- A description of the root cause of the reportable food (if applicable);
- A brief justification of the process used to determine which product(s), lot(s), or batch(es) were affected;
- Whether or not the submitter believes all of the reportable food has been removed from commerce;
- A brief description of the corrective actions taken to avoid repeating the reportable event;
- The commodity type of the reportable food;
- The dates that the product was manufactured;
- Whether or not the reportable food underwent treatment to reduce microorganisms;
- A brief description of the microbial reduction treatment;
- Whether or not a bacterial isolate is available for FDA collection;
- For reportable foods intended for animal consumption, the animal species that the reportable food was intended to be consumed by;
- For reportable foods intended for animal consumption, the life stage of the animal that the reportable food was intended to be consumed by;
- Whether the responsible party has notified all of its immediate previous sources (suppliers) of the reportable food (if applicable); and
- Whether the responsible party has notified all of its immediate subsequent recipients (customers) for the reportable food (if applicable).
Providing information in response to the new data elements is voluntary for the time being; however, later this year responses to these elements will become mandatory.
The electronic portal for the RFR is located at www.SafetyReporting.hhs.gov.
For additional information on the RFR program, please see FDA’s Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007 (Edition 2) guidance document.
The RFR Center can answer questions about Reportable Food Registry policies, procedures and interpretations. E-mail questions to: RFRSupport@fda.hhs.gov.
The Safety Reporting Portal Service Desk is available to answer technical and computer-related questions about the Reportable Food Registry electronic portal. E-mail questions to: firstname.lastname@example.org.