by Justin J. Prochnow
As 2010 dawns, it is more apparent than ever FDA is determined to further expand its enforcement capabilities. Last year’s major recalls—from peanut butter to instant milk—were among the most costly in U.S. history and generated an avalanche of negative publicity that FDA is trying to overcome by bolstering its public image as a “stronger and swifter FDA.” One component of that endeavor is the activation of the Reportable Food Registry (RFR). While the electronic portal went “live” on Sept. 8, 2009, many companies remain largely unaware of their obligations with respect to this mandatory online reporting database for companies that manufacture, process, pack or hold food, excluding dietary supplements, which could potentially cause serious adverse health issues. As FDA’s enforcement discretion “deadline” expired on Dec. 8, 2009, food companies must familiarize themselves with the obligations of the RFR or they could find themselves subject to fines (and even jail time) for violations of federal law.
The authority behind FDA’s creation of the RFR actually stems from legislation that was enacted more than two years ago, namely the Food and Drug Administration Amendments Act of 2007 (FDAAA), which amended the Federal Food, Drug and Cosmetic Act (FDCA) by creating a new section 417 entitled the “Reportable Food Registry.” Pursuant to section 417, a “responsible party” is required to submit a report through the RFR portal within 24 hours of determining a food product is a “reportable food.” Subsection (a) of section 417 provides the definitions for these two key terms, responsible party and reportable food. A “responsible party” is defined as any person or entity required to be registered with FDA as a food establishment, including manufacturers, processors, packers or holders of food for sale in the United States. A “reportable food” is any article of food that has a reasonable probability of causing serious adverse health consequences or death to humans or animals, with two exceptions; dietary supplements and infant formula are specifically excluded from the definitions of reportable food. Animal feed and pet food are subject to the reporting requirements if they meet the definition of “reportable food.”
It is no coincidence that “serious adverse health consequences or death” tracks closely with the definition for a Class I recall set forth in 21 CFR §7.3(m)(1), a point emphasized by FDA in its Guidance for Industry regarding the RFR. There can be no doubt that the multiple attacks on FDA for its failure to respond timely to recent food-borne illnesses during the last several years influenced the enactment of FDAAA and the formation of the RFR. FDA sees the RFR as a vehicle to enhance the agency’s ability to act quickly to prevent food-borne illness and swiftly remove contaminated products from consumers’ hands.
Once a company determines it is a responsible party and there is a reportable food issue, it must submit an initial report through the RFR electronic portal (RFR.fda.gov). The initial report consists of certain data elements that must be entered, including, but not limited to, the food registration number of the responsible party, the date on which the product was determined to be a reportable food, the location of the product and information about the problems with the product. Once the initial report has been submitted, FDA may follow up and require the responsible party to file an amended report to provide additional information. The agency may also require the responsible party to provide notification to the immediate previous sources of the reportable food or the immediate subsequent recipients of the reportable food.
The timing requirement for submitting the report through the RFR is another critical element of this safety program of which companies must be cognizant. Subsection (d) of section 417 requires a report be submitted “as soon as practicable, but in no case later than 24 hours after a responsible party determines an article of food is a reportable food.”
