FDA Reportable Food Registry
The U.S. Food & Drug Administration ("FDA") recently implemented the Reportable Food Registry ("RFR"). The RFR is an electronic reporting system that requires food industry members (a "responsible party") to submit reports to FDA about food articles that might pose a serious health risk. FDA in turn will use the RFR to assess reports about adulterated food articles, track the source and recipients of the reported food article, and issue public alerts or notifications about adulterated food articles as deemed necessary by FDA. Industry members that manufacture, process, pack or hold alcohol beverages must comply with the requirements of the RFR, effective September 8, 2009. FDA intends to exercise enforcement discretion until December 8, 2009, in circumstances where FDA determines that an industry member made a reasonable effort to comply with the requirements of the RFR and otherwise acted to protect the public health. The following information outlines essential compliance information about the RFR.
Who is a responsible party?
A responsible party is defined as a person who submits the registration for a food facility with the FDA under the Bioterrorism Act. Alcohol beverage producers, bottlers and those operating warehouse facilities, both in the United States and in foreign countries, are required to register their facilities under the Bioterrorism Act and, thus, are responsible parties subject to the requirements of the RFR.
What is a reportable food?
Reporting requirements are triggered when a responsible party determines that a food article qualifies as a reportable food because:
- The food article is adulterated; and
- There is a reasonable probability that the use of, or exposure to, the adulterated food article will cause serious adverse health consequences or death to humans or animals (e.g., peanut butter contaminated with Salmonella).
A reportable food then is essentially an adulterated food that would fall within the requirements of a Class I recall under FDA regulations. A reportable food may be an ingredient received by the responsible party from a supplier or a food article produced or handled by the responsible party.
What is a responsible party's obligations under the RFR?
Federal law requires that as soon as practicable but no later than 24 hours after determining that a food article qualifies as a reportable food, the responsible party must submit an initial report electronically through an FDA-designated internet portal and investigate whether the cause of the adulteration may have originated with the responsible party.
Testing is critical in determining whether or not a food article meets the requisite reasonable probability of serious harm. So when testing is necessary, at what point does the 24-hour reporting clock start? In its guidance, FDA states that "for a confirmed positive, a test method would be expected to be sufficiently reliable to trigger the reporting requirement." FDA also recognizes that some test methods may not yield presumptive positive results with sufficient reliability to determine a reasonable probability of risk. FDA therefore recommends that "persons in the supply chain use a validated test method whenever possible; follow up any presumptive positive result with additional testing to obtain a final result; and take appropriate action to protect public health when confirmation of a presumptive positive test result is pending."
FDA requires that all reports on reportable foods be submitted via the electronic portal located at http://rfr.fda.gov/. A responsible party's initial report should include:
- The responsible party's FDA registration number(s).
- The date on which the food article was determined to be a reportable food.
- A description of the reportable food including quantity or amount.
- The extent and nature of the adulteration.
- The results of any investigation into the cause of the adulteration if it may have originated with the responsible party (when known).
- The disposition of the reportable food (when known).
- Information typically found on packaging sufficient to identify the reportable food, including product codes, use-by dates, and names of manufacturers, packers, or distributors.
If the responsible party lacks any of the information listed above or finds any report contains an error, it must submit an amended report with the new or corrected information immediately.
When is a responsible party exempt from filing a report?
A responsible party is not required to submit a report on a reportable food if all of the following factors apply:
- The adulteration originated with the responsible party;
- The responsible party detected the adulteration prior to any "transfer" of the reportable food to another person; and
- The responsible party corrected the adulteration or had the reportable food destroyed.
FDA does not consider an intra-company transfer of a food article in a vertically integrated company where the company maintains continuous possession of the food article to be a "transfer to another person." On the other hand, a responsible party would be required to submit a report if a reportable food is transferred to a warehouse owned by a third party, even while the food article is still subject to the ownership and control of the responsible party.
What happens after a report is filed?
After reviewing an initial report, FDA may require the responsible party to provide additional information and reports or take certain actions, such as identifying the immediate supplier or recipient of the food article and notifying such persons about the instance of reportable food. FDA will specify the amount of time that a responsible party has to submit any amended reports.
FDA also may require a supplier or recipient of a food article that is the subject of a reportable food report to conduct its own investigation, submit a report, and issue notifications within its supply chain.
FDA will assign a unique tracking number to each report submitted by a responsible party about a reportable food. Tracking numbers will be used by the responsible party, its suppliers and recipients, and FDA to link together all reports and communications about a reportable food and to identify the supply chain for that reportable food.
What are the record-keeping requirements?
Responsible parties must maintain records related to each reportable food report that they submit to FDA or receive from another for two years.
What confidential protections apply?
FDA classifies any report or notification about a reportable food as a safety report. In case a report or notification is released to the public, such documents should be accompanied by a statement declaring that the report or notification does not constitute an admission that the product involved caused or contributed to a death, serious injury or serious illness. Reports and other records in the RFR are subject to a request for public disclosure under the Freedom of Information Act, except trade secrets and confidential commercial or financial information contained in such reports are protected from public disclosure.
What are the potential consequences if a reportable food is not reported?
If a responsible party fails to submit a required reportable food report, FDA may pursue enforcement action involving seizure of goods, injunction, and/or civil or criminal penalties, depending on the circumstances.