FDA's Reportable Food Registry

What are a company's obligations once it has determined that it must report?

The required information must be provided in a standardized format through the electronic portal and should also be provided to the District Recall Coordinator. The following must be provided:

• The responsible party’s Bioterrorism Act registration number;
• The date the food was determined to be reportable;
• Description of the food (quantity affected, product codes, names of manufacturers and distributors, etc.); and
• Extent and nature of the adulteration.
• Responsible parties must also report the results of any investigation into the cause of the adulteration and the disposition of the adulterated item. This latter information may be unknown or incomplete at the time of the first submission but, when completed, must be included in an amended report.
• FDA may impose other requirements after evaluating the report. This could include additional information as needed for FDA to conduct its investigation and notify the immediate previous source and/or immediate subsequent recipient(s) of the adulterated item, who in turn may also have to file reports.
• There are requirements to keep records on all reports for two years.
• The report “may be accompanied by a statement, which shall be part of any report that is released for public disclosure that denies that the report or notification constitutes an admission that the product involved caused or contributed to a death, serious injury or serious illness.”

Reports submitted through the portal will be available to the public in response to a Freedom of Information Act (“FOIA”) request, but the Registry itself will not be accessible to the public. To help protect against unauthorized disclosures, confidential business information submitted to the Registry should be marked as such. Additionally, while Section 417(i) of the FDCA provides that a submission to the Registry is not an admission that the food caused or contributed to a death, serious injury, or serious illness, responsible parties making reports to the Registry also may wish to include a safety report disclaimer per Section 756 of the FDCA, stating that the report is not an admission that the food was adulterated or misbranded or posed a risk of harm.

When must a company report the instance of a reportable food?

The company must report the food through the electronic portal as soon as practicable but no later than 24 hours after determining that an article of food is reportable. If it takes longer than 24 hours after receiving positive test results to determine whether or not the problem originated with the company, then FDA advises that the company should report to the Registry before the 24 hours have passed.

What constitutes a reportable food incident?

The required information must be provided in a standardized format through the electronic portal and should also be provided to the District Recall Coordinator. The following must be provided:

• The responsible party’s Bioterrorism Act registration number;
• The date the food was determined to be reportable;
• Description of the food (quantity affected, product codes, names of manufacturers and distributors, etc.); and
• Extent and nature of the adulteration.
• Responsible parties must also report the results of any investigation into the cause of the adulteration and the disposition of the adulterated item. This latter information may be unknown or incomplete at the time of the first submission but, when completed, must be included in an amended report.
• FDA may impose other requirements after evaluating the report. This could include additional information as needed for FDA to conduct its investigation and notify the immediate previous source and/or immediate subsequent recipient(s) of the adulterated item, who in turn may also have to file reports.
• There are requirements to keep records on all reports for two years.
• The report “may be accompanied by a statement, which shall be part of any report that is released for public disclosure that denies that the report or notification constitutes an admission that the product involved caused or contributed to a death, serious injury or serious illness.”

Reports submitted through the portal will be available to the public in response to a Freedom of Information Act (“FOIA”) request, but the Registry itself will not be accessible to the public. To help protect against unauthorized disclosures, confidential business information submitted to the Registry should be marked as such. Additionally, while Section 417(i) of the FDCA provides that a submission to the Registry is not an admission that the food caused or contributed to a death, serious injury, or serious illness, responsible parties making reports to the Registry also may wish to include a safety report disclaimer per Section 756 of the FDCA, stating that the report is not an admission that the food was adulterated or misbranded or posed a risk of harm.

Who is considered a responsible person that must report an incident?