The Reportable Food Registry: A Year In Review
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The FDA’s Reportable Food Registry (“RFR”) has now been up and running for a full year. So, has the RFR been successful?
As we discussed previously, the RFR is an internet based portal through which food manufacturers must notify the FDA of food products that have a “reasonable probability” of causing health problems or death in humans or animals. The RFR applies to any food product regulated by the FDA, with the exception of infant formula and dietary supplements.
This summer, the FDA issued a report on the RFR’s first seven months of operation, September 2009 through March 2010. Click on the following link to view a copy of the THE 2009 - 2010 FDA RFR REPORT.
During the first seven months, food companies submitted 125 “primary reports” through the RFR. A primary report is an initial report concerning a reportable food from either industry or public health officials, such as federal, state, or local regulators. Of those 125 primary reports, 122 were from industry, and 3 were from regulatory officials.
Also during that initial period, 1,638 “subsequent reports” were submitted as a result of a primary report. A subsequent report is a report submitted by either a supplier (upstream) or a recipient (downstream) of a food/feed (including ingredients) for which a primary report was submitted.
The FDA classified the 125 primary reports into seven food safety hazard categories, as illustrated in the pie graph below:
Percent Distribution of 125 Primary RFR Entries by Food Safety Hazard
Because this initial reporting period was so brief, the FDA wisely cautions that inferences cannot be drawn from this data. Nevertheless, the figures are still interesting.
More meaningful, however, is that of the 125 reports, only one caused a health problem – “an allergic-type reaction” in four family members. The FDA pointed out that all the reports had the potential to bring harm. However you want to interpret the fact that there was only a single health problem, it cannot be lost among the other numbers. Perhaps it highlights how the RFR brings an abundance of caution that will only make our food supply even safer.
And a meaningful statement was made by the FDA’s Deputy Commissioner for Foods, Michael Taylor. When asked how industry reacted to the RFR, Taylor said “The industry is taking it very seriously. They know it is a legal duty.” We are in a period of consumer distrust. I would like to share with consumers that not only does industry take food safety regulation seriously, I have personally experienced food manufacturers setting their safety standards above and beyond their legal obligation. Although recent media may suggest otherwise, our food manufacturers, with the exception of a few, care deeply about safety.
After just one year, it is too soon to determine whether the RFR will meet its goals of tracking patterns of adulteration and targeting the FDA’s limited inspection resources. The FDA has labelled the RFR’s first seven months “a success story.” It was not a perfect first year – the electronic submission process was already overhauled once; and questions still remain – how many of the potentially hazardous situations would have been reported under regulation in place prior to the RFR?
In any event, we will continue, of course, to answer your questions about RFR compliance and monitor new RFR developments.
