Like a public relations rep for a forgotten celebrity, I sometimes find myself reminding people about the Reportable Food Registry (RFR). The Food Safety Modernization Act (FSMA) may be the latest shiny new toy in town, grabbing all the press, but the RFR continues to chug along, burdening the food industry with important and strict reporting obligations. The RFR was put in place starting in September 2009, a little over a year before the new food safety law was passed, and plays an important role in preventing food safety problems from causing damage, and that includes problems caused by packaging or labeling mishaps.
Food companies or government officials who discover food in commerce that has a reasonable probability of causing serious adverse health consequences or death have 24 hours in which to report to the FDA through a special RFR Internet portal.
These companies, referred to as “responsible parties,” commit a violation of law if they fail to make the required report. Both animal and human foods are covered by the requirement, but dietary supplements and infant formula are not (they each have separate reporting obligations), and meat and poultry are not.
Because the RFR places reporting obligations on essentially everyone who discovers a potentially dangerous food, it’s common for an initial report to be made by one company, and many subsequent reports to follow from their customer companies or suppliers.
The FDA reported recently on the data from the third full year of the RFR’s operations.
The total number of RFR submissions was up a bit in the third year, from 1,153 to 1,471, though the number of primary or initial submissions was almost the same—225 in the second year, 224 in the third.
What hazards are inspiring the RFR reports? More than a third are undeclared allergens on labels (37.9%), almost another third are Salmonella (28.1%), followed by Listeria monocytogenes (21.4%). Other lesser causes include nutrient imbalance, uneviscerated fish, sulfites undeclared on labels, E. coli, and foreign objects. The food products involved in the reports were quite varied, including products such as produce, animal foods, baked goods, seafood, spices and seasonings, dairy products, and others.
The FSMA is regularly described as designed to prevent food outbreaks before they occur, and most but not all of its provisions target that goal directly, by, for example, requiring HACCP- like risk control programs and foreign supplier certifications. The RFR, by contrast, is designed to limit the damage that problematic foods can cause. Because it requires essentially immediate reports about potentially dangerous foods, the RFR provides “early warning about potential public health risks” and allows industry and government to “remove hazards from the marketplace” more quickly, says Michael R. Taylor, FDA Deputy Commissioner for Foods. And what it requires is immediate and detailed reporting by food companies of sensitive information. The RFR is a very real and present burden that often inspires companies to take remedial actions, whereas some of the FSMA obligations might not apply to every food company, and in any event, are not yet fully phased in.
In fact, the FSMA gave the FDA new powers to order responsible parties to give the FDA consumer-oriented information about reportable food, which the FDA can easily summarize and publish, and sets forth procedures for grocery stores to publish it.
Regulators like multiple arrows in their quivers, and food safety is an important priority, but still, it’s useful to ask whether the RFR’s requirements and the FDA’s enforcement powers end up being a little redundant. The RFR is essentially a loud and widespread alarm about a potentially harmful food, and it puts pressure on companies to recall or take other remedial actions when the food they package or handle is associated with such a report. So, despite all the attention being paid to the FDA’s new powers under the FSMA to order food recalls, detain foods, and suspend facility registrations, the RFR program might have been achieving many of the same goals that are behind provisions of the FSMA. We’ll have to see future annual reports about the program to identify any patterns that differ before and after the implementation of FSMA. Until then, someone get the RFR a new PR firm.
About the author: The author, Principal Attorney of Eric F. Greenberg P.C., has been practicing food and drug law, packaging law, and commercial litigation for 31 years, is author of the pioneering Guide to Packaging Law, has contributed a monthly column for Packaging World magazine since 2006, and has been a prominent columnist and seminar/ conference speaker since 1989.
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