RFR Reporting: Navigating the Shades of Gray
Since 2009, industry has faced requirements to report certain food contaminations to FDA’s Reportable Food Registry (RFR). Despite the decade of its existence, the requirements of reporting to the RFR, who is responsible for doing so, what constitutes a “reportable food,” and when and how to report an issue – all continue to raise question across the food supply chain.
FDA’s explanation appears to be black and white: “The RFR requires responsible parties to file a report through the RFR electronic portal (http://rfr.fda.gov) when there is a reasonable probability that the use of, or exposure to, an article of food will cause serious adverse health consequences or death to humans or animals.” But there are actually many shades of gray, particularly as to what, exactly, should trigger a report and by whom? Having addressed these – and many other – questions in recent customer webinars, I felt it valuable to provide some of that same information in this article.
Let’s start with some background explanations: At its most basic, the Responsible Party is anyone in the food supply chain who becomes aware of a food adulterant. This does not mean that the “party” (e.g., person or company) is responsible for the adulteration, rather that the awareness of the issue makes them responsible for reporting it.
A look at the RFR’s history provides the reasoning behind this. Prior to the passage of the 2007 RFR statute, there was a fairly regular occurrence of food contamination reaching the market, even when detected somewhere along the food chain. Say, for example, a manufacturer contacts its supplier about an adulterated ingredient. The supplier compensates the manufacturer for the delivery – but does not recall other lots of the same product or inform the receiving customers of the issue, thus allowing contaminated product to reach the market. With the requirements of the RFR, FDA places the accountability on the whole supply chain, so that awareness of an issue becomes a responsibility to report it.
A few quick notes:
- RFR reporting applies to FDA-regulated foods, except infant formula and dietary supplements which have their own reporting system.
- The report must be filed at safetyreporting.hhs.gov within 24 hours of the discovery.
- RFR data is not public and does not constitute any “guilt” of the reporting party, so there is no reason to decline to report an issue.
- On the other hand, failing to report an issue of which you are aware is a prohibited act under the Federal Food, Drug, and Cosmetic Act that could lead to dire consequences.
So, what should trigger an RFR report? Any situation that is identified in which there is a reasonable probability that exposure to or ingestion of the food would lead to a serious adverse health consequence or death. Although there is no definitive regulatory definition of serious adverse health consequence or death, there are some that are obvious, such as Listeria or Salmonella in a ready-to-eat food, allergens, etc. Others are a bit more gray, such as chemical and physical contaminants for which a health hazard evaluation will likely be needed.
That said, anytime an adulterant is detected, it should trigger the question and an assessment of whether a report should be filed. To determine this, you’ll want to consider how serious the issue is, where the food is, and where the problem originated. Say, for example, you’ve determined it could lead to serious adverse health consequence or death:
- If the problem originated outside your control (e.g., you identified a problem on an incoming ingredient), that is a definite RFR trigger. In this case, you are required to submit a report – and conduct a root cause investigation.
- If you identified a problem in a product you manufactured, you need to know where product is now. If it is still under your control and you take care of the problem, you don’t need to submit.
In some cases, it is advisable to report to RFR even if you’ve not yet reached a conclusion as to whether it could lead to serious adverse health consequence or death, as filing does not mean you’re “admitting” it to being serious, nor does it necessarily trigger the need for a recall.
RFR Reporting. To report an issue on the RFR, you will need to include your Food Facility Registration Number, date the article of food was determined to be reportable, description of the food (e.g., product information from the packaging), extent and nature of the adulteration, disposition of the food (when known) and results of the root cause investigation (if applicable), and contact information for the immediate previous sources (suppliers) and/or immediate subsequent recipients (customers) of the article of food (as relevant). You may not have all the information upon the initial submission, but you must update the report as information becomes known and maintain all records for two years.
If you don’t think you need an RFR, ask yourself three questions:
- Did the adulteration originate with you (the responsible party)?
2. Was the adulteration detected prior to any transfer to another person of the article of food?
- Was the adulteration corrected or the food destroyed without transfer to another person?
If you can answer YES to all, you don’t need to file an RFR, no matter how bad situation is. But it is recommended that you document your corrective actions – in case you are subject to inspection later. If you answered NO to any of the questions, you are obligated to file an RFR.
While some situations make RFR reporting an obvious obligation, the many shades of gray of other situations can make it incredibly complex, necessitating a deeper dive into the issue and a Health Hazard Evaluation. If you need assistance – or would like to schedule a webinar for your company, give us a call, we can help.