By Ricardo Carvajal –
Section 204 of the Food Safety Modernization Act ("FSMA") directed FDA to establish pilot projects “to explore and evaluate methods to rapidly and effectively identify recipients of food to prevent or mitigate a foodborne illness outbreak and to address credible threats of serious adverse health consequences or death to humans or animals” that result from adulteration or certain types of misbranding. Upon completion of the pilot projects, FDA is to report the findings to Congress “together with recommendations for improving the tracking and tracing of food.” In addition, section 204 authorized FDA to issue a regulation imposing additional recordkeeping requirements on facilities that manufacture, process, pack, or hold foods that FDA designates as “high risk” (such facilities are already subject to the recordkeeping requirements in section 414 of the FFDCA). Ostensibly, those additional requirements would help FDA more effectively respond to outbreaks and to significant threats to the food supply.
The pilot projects mandated by FSMA section 204 are now complete, and FDA has requested comment on the report that summarizes their results. Prepared under contract for FDA, the report makes numerous recommendations, including that “FDA establish a uniform set of recordkeeping requirements for all FDA-regulated foods, and not permit exemptions to recordkeeping requirements based on risk classification” (emphasis added). As the report itself recognizes, FSMA section 204 authorizes the imposition of additional recordkeeping requirements only with respect to high risk foods. However, the report reasons that today’s low risk foods could turn out to be tomorrow’s high risk foods, as illustrated by recent outbreaks associated with foods not historically perceived to be high risk.
The language of FSMA section 204 is clear. FDA must base a high risk designation on a number of specified factors, including “the known safety risks of a particular food, including the history and severity of foodborne illness outbreaks attributed to such food” (emphasis added). This is in keeping with other statutory provisions directing that resources be directed in a manner that gives consideration to risk (e.g., as with FDA inspections). Imposing requirements based on risk helps to ensure that the benefits of those requirements outweigh their significant costs – a constraint that Congress explicitly included in section 204(d)(1)(D).
Comments on the report are due by July 3.