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FDA's Reportable Food Registry

What is the Reportable Food Registry? • Page 4 of 6

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What is the Reportable Food Registry?

Responsible parties must notify FDA as soon as possible, and no later than within 24 hours of determining that an article of food is a reportable food. A "responsible party" is defined as any entity that is required to be registered with FDA as a food establishment (i.e., any facility that manufactures, processes, packs, or holds food for sale or consumption by humans or animals in the U.S.). An owner, operator, or agent in charge of a facility may authorize an individual to report an instance of reportable food on their behalf through the Reportable Food electronic portal. An individual who is authorized by the responsible party to submit a reportable food report need not be the same individual who is authorized to register a facility. FDA also encourages the individual submitting the reportable food report to provide his or her contact information in the reportable food report. Federal, State and local governments are also considered responsible parties; however, their reporting requirements under the RFR are considered voluntarily rather than mandatory.

Once a responsible party believes there is a possible contamination it is required to do the following:

(1) Investigate the cause of adulteration if the adulteration of the food originated with the responsible party.

(2) Submit the required data elements in an initial report and follow-up with supplemental reports on an as-needed basis. Required data elements include:

  • Food Facility Registration Number
  • Date the article was determined to be a reportable food
  • Description of the food (quantity and amount)
  • Extent and nature of the adulteration
  • Results from investigation of the cause of adulteration
  • Disposition of the article of food
  • Product information typically found on packaging sufficient to identify the article of food

In addition, a responsible party is required to work with FDA on any follow-up that may be deemed necessary.

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