This week, the Food and Drug Administration (FDA) updated the Reportable Food Registry (RFR) to include a Rational Questionnaire incorporating additional data elements as part of an effort to improve the RFR’s information gathering capability.
The additional elements are the following:
- The reason the food has been determined to be reportable (agent);
- A description of the root cause of the reportable food (if applicable);
- A brief justification of the process used to determine which product(s), lot(s), or batch(es) were affected;
- Whether or not the submitter believes all of the reportable food has been removed from commerce;
- A brief description of the corrective actions taken to avoid repeating the reportable event;
- The commodity type of the reportable food;
- 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 or not a bacterial isolate is available for FDA collection;
- For reportable foods intended for animal consumption, the animal species that the reportable food was intended to be consumed by;
- For reportable foods intended for animal consumption, the life stage of the animal that the reportable food was intended to be consumed by;
- Whether the responsible party has notified all of its immediate previous sources (suppliers) of the reportable food (if applicable); and
- Whether the responsible party has notified all of its immediate subsequent recipients (customers) for the reportable food (if applicable).
The RFR, created by Congress as part of the FDA Amendments Act of 2007, is an electronic portal for industry to report when there is "reasonable probability" that an article of food will cause "serious adverse health consequences." It covers all human and animal food/feed regulated by FDA except infant formula and dietary supplements for which FDA has other mandatory reporting systems.
In addition, the RFR does not accept submissions regarding drugs or other medical products, reports about products under the U.S. Department of Agriculture’s jurisdiction, or reports from consumers. Registered food facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States under section 415(a) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 350(d)) are required to submit an electronic report to the FDA within 24 hours of discovering reportable adulterated food.
When a reportable food report is submitted to the Safety Reporting Portal, it is sent to the FDA Risk Control Review (RCR) team for review. The team includes representatives from the Center for Food Safety and Applied Nutrition (CFSAN), the Center for Veterinary Medicine (CVM), the Office of Emergency Operations (OEO), and the Office of Regulatory Affairs (ORA). In addition, the FDA District Office for the geographic area from which the report originated receives a copy and participates in the review. Each report is then reviewed by the RCR team to assess whether the subject food or feed meets the definition of a reportable food, and to identify appropriate follow-up actions.
For reports that FDA considers to meet the definition of reportable food, an FDA District Office investigator is assigned to contact the firm or individual submitting the report to obtain additional information. The District Office investigator may visit the firm to conduct a follow-up investigation. When necessary, District Offices will advise the firm to alerts its supplier and/or its customers of the reportable food.
It is important to point out that submitting a report to the portal can have serious implications for food companies. As Ken Odza, a former Stoel Rives attorney and continued friend of the firm, wrote in a previous post, “Even if a recall has not yet been issued, an RFR report often has the consequences of a Class I recall. While RFR reports can be amended or withdrawn based on new information, in the world of food products, the bell almost never can be unrung.”
For more information about the RFR and its impact on industry, check out some of our other Food Liability Law blog posts on here.