The Food and Drug Administration introduced this week a new questionnaire for the Reportable Food Registry as part of its effort to enhance the registry's capability. By gathering and analyzing additional information, FDA aims to improve its ability to track patterns of adulteration in human food and animal feed, including pet food, and to target its inspection resources. Providing the information requested in the new Reportable Food Registry Rational Questionnaire is voluntary for now, but responses will become mandatory later this year, FDA said, although no date has been set.
The Reportable Food Registry is a portal intended to improve FDA's ability to ensure the safety of the domestic food supply. It requires a company to file a report when there is reason to believe that an adulterated food, other than infant formula, will cause serious adverse health consequences or death to humans or animals.
The additional elements included in the questionnaire are:
- The reason the food is considered reportable;
- 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 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;
- Whether the responsible party has notified all of its immediate previous suppliers of the reportable food, if applicable;
- Whether the responsible party has notified all of its customers for the reportable food, if applicable;
- For reportable foods intended for animal consumption, the animal species that the reportable food was intended to be consumed by; and
- For reportable foods intended for animal consumption, the life stage of the animal that the reportable food was intended to be consumed by.
The electronic portal for the registry is located at www.SafetyReporting.hhs.gov.
For additional information on the Reportable Food Registry program, visit 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.
Members with questions may contact Clay Detlefsen, IDFA vice president of regulatory affairs, at email@example.com.