FDA Now Requiring Facilities to Report Potentially Adulterated Food through Electronic Reportable Food Registry

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Recently, the Food and Drug Administration (FDA) published a new rule requiring all facilities that manufacture, process, or hold food for consumption in the U.S. to tell the FDA within 24 hours if they find a reasonable probability that a food article will cause severe health problems or death to a person or an animal, using its new Reportable Food Registry (RFR). The reporting requirement applies to all foods and animal feed regulated by the FDA, except infant formula and dietary supplements, which are covered by other regulatory requirements. Failure to timely submit a required report may lead to civil and criminal penalties.

The requirements apply to any person, worldwide, who has to submit registration information to the FDA for a food facility that manufactures, processes, packs, or holds food for human or animal consumption in the United States as required by the 2002 Bioterrorism Act. These people are termed responsible parties. A responsible party:

1. Must investigate the cause of the adulteration if the adulteration of food may have originated with the responsible party
2. Must submit initial information; followed by supplemental reports
3. Must work with the FDA authorities to follow up as needed

The following data elements must be included in any initial report to the FDA’s electronic registry.

1. The facility registration numbers of the responsible party
2. The date on which the article of food was determined to be a reportable food
3. A description of the article of food, including the quantity or amount
4. The extent and nature of the adulteration
5. The results of any investigation of the cause of the adulteration if it may have originated with the responsible party, when known
6. The disposition of the article of food, when known.
7. The product information typically found on packaging, including product codes, use-by dates, and the names of manufacturers, packers or distributors sufficient to identify the article of food.

A responsible party is not required to report if it found the problem before the food was shipped, and corrected the problem or destroyed the food. Although the rule became effective on September 8, 2009, the FDA has announced that it will refrain from enforcing the rule until December 8, 2009 in circumstances where it determines that the responsible party has made a reasonable effort to comply and has otherwise acted to protect public heath.

The agency issued draft guidance on the RFR in June and sought comment. The FDA also held three public workshops across the country in which FDA representatives explained the RFR requirements and how the portal will work.

To view the RFR Guidance or to submit a report, click here.