New Requirements Coming as FDA Updates Reportable Food Registry

06/20/2012 09:34:00 AM
David Mitchell

It has been almost three years since the Food and Drug Administration launched the Reportable Food Registry, a Web-based program mandating that companies in the food supply chain notify the agency within 24 hours of uncovering a reasonable probability that their products will cause severe health problems or death to humans or animals.

The FDA said June 4 that it is updating the registry with a new questionnaire which incorporates additional data elements to improve the system’s information gathering capability.

The new elements include the following:

  • the reason the food has been determined to be reportable;
  • a description of the root cause of the reportable food, if applicable;
  • a brief justification of the process used to determine which products, lots, or batches are affected;
  • whether or not the submitter believes all of the reportable food has been removed from the supply chain;
  • a brief description of corrective actions taken to avoid repeating the reportable event;
  • commodity type;
  • 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 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; and
  • whether the responsible party has notified all of its customers of the reportable food, if applicable.

The FDA said providing information related to the new data elements is voluntary now but will become mandatory later this year.

The electronic portal for the registry is located at www.SafetyReporting.hhs.gov.

Questions about policies, procedures and interpretations of the registry can be e-mailed to RFRSupport@fda.hhs.gov.



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