Initial Reportable Food Registry Numbers Released

The initial findings of the Reportable Food Registry, presented via teleconference in late July, revealed 125 primary reports regarding incidents affecting food safety. “We’re putting out this report [now] so that the public can know what we’re learning,” said Michael R. Taylor, JD, Deputy Commissioner for Foods at the U.S. Food and Drug Administration (FDA). “Over time, we hope that this will build a body of information that can be useful for tracking trends and understanding the patterns of food safety problems.”

Included in the initial findings were two occurrences identified as “notable” by the FDA; the first resulted in a November 2009 recall of products that contained sulfites but were not labeled as such, and the second culminated in a February 2010 recall of hydrolyzed vegetable protein, an action that prevented 177 contaminated products from reaching store shelves. Taylor credited the registry, which has enabled more rapid sharing of information between industry and government, as being key to the prevention of more serious events impacting the health of consumers.

Figure 1. Percent Distribution of 125 Primary Reportable Food Registry Entries by Food Safety Hazard

Figure 1. Percent Distribution of 125 Primary Reportable Food Registry Entries by Food Safety Hazard

Registry Complements Existing Programs

Mandated by Congress and put into effect in September 2009, the registry requires manufacturers, processors, packers, and distributors of food items intended for human, livestock, or pet consumption to immediately report, via electronic portal, any incident that might impact product safety. The intent of the registry is to complement existing surveillance programs by helping the FDA track patterns of product contamination.

As information accrues, data from the registry may also suggest how the resources for on-site product inspection may be allocated. “We can’t be everywhere all the time,” admitted Taylor. “The registry helps by not having us rely on being at a facility or sampling the product ourselves.”

Although the registry received 125 primary reports in its first seven months, it also accounted for over 1,800 additional communications from secondary parties, those downstream in the product supply chain, as generated by the original incidents. Overall, Salmonella was identified as the hazard in 37% of cases, while undeclared allergens or intolerances accounted for 35% and Listeria monocytogenes was found in a further 13% (see Figure 1, above). The types of foods reported represented 11 different commodity categories, with the most common being animal feed or pet food (14 cases), seafood (12), spices and seasonings (11), and dairy products (10 cases).

No Surprises

The initial findings, though important, did not surprise Taylor. “This is consistent with what our experience has been with past recalls,” he said, while further cautioning anyone about drawing particular conclusions about current trends in food safety based on the registry to date, as there are too few data points to consider. Taylor also suggested that, even within the given time frame, the data set might be incomplete.

“Frankly, we don’t know what we don’t know in terms of incidents that should have been reported and haven’t been.”

Speaking to this last point during the teleconference was Kathy Gombas, Acting Deputy Director, Office of Food Defense, Communication and Emergency Response, who said there was some confusion on the part of industry regarding the registry rollout, prompting changes in the reporting mechanism and the drafting of a new guidance to clarify reporting criteria. “On May 24 of this year, FDA and the National Institutes of Health launched the Safety Reporting Portal (SRP), which is a new website for reporting several types of problems, including the reportable foods.”

The SRP is intended to be more user friendly than registry protocol. “At the same time, we have also issued a draft guidance document with questions and answers regarding the registry,” Gombas added. “A critical issue to be addressed is the meaning of ‘transfer’ as it pertains to what constitutes a reportable transference of a potentially tainted food product along the manufacturing chain.”

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