FDA Publishes Draft Approach for Designating High-Risk Foods

By Ricardo Carvajal –

FDA published a notice announcing the availability of a Draft Approach for Designating High-Risk Foods, and asking for comments and information to help the agency refine that approach.  Designation of a food as a High-Risk Food (HRF) would trigger additional recordkeeping requirements intended to facilitate product tracing (current recordkeeping requirements for purposes of product tracing are limited to identity of immediate previous sources and subsequent recipients of a food). 

As explained in the Draft Approach, FSMA section 204(d)(2)(A) sets forth a number of factors on which HRF designations must be based.  In light of those statutory factors, FDA proposes to rely on the following criteria:

1. Frequency of outbreaks and occurrence of illnesses;
2. Severity of illness, taking into account illness duration, hospitalization and mortality;
3. Likelihood of contamination; 
4. Growth potential/shelf life;
5. Manufacturing process contamination probability/intervention;
6. Consumption; and
7. Economic impact.

Throughout the Draft Approach, links to FDA’s other food safety initiatives and activities are evident.  For example, where data on the likelihood of contamination are not available, FDA proposes to rely on RFR reports, its recall database, and its compliance programs.   As an additional example, scoring of the probability of manufacturing process contamination would take into account lessons learned from implementation of preventive controls (i.e., “available control measures and interventions that have been validated… and can be applied during manufacturing to eliminate, reduce (to acceptable levels), or otherwise control a hazard”).

FDA’s notice emphasizes that the Draft Approach is open to revision based on comments submitted to the agency, and that it likely will be subject to peer review.   The notice also asks for comments a number of specific topics, including how food allergens should be considered in developing a list of HRF.  Comments are due by April 7, 2014.