Grain News

FDA Designation of High-Risk Foods For Additional Traceability Requirements

Date Posted: February 25, 2014

This article is reprinted by permission from the NGFA Newsletter, Volume 66, Number 4, Feb. 21, 2014

The Food and Drug Administration (FDA) recently made available draft methodology that the agency intends to use to designate high-risk foods that would be subject to additional recordkeeping requirements to facilitate the rapid and effective tracking and tracing of such foods during a foodborne illness outbreak or other event.

The Food Safety Modernization Act (FSMA) mandates that FDA make such determinations for high-risk foods for which additional traceability requirements are appropriate and necessary to protect public health.

FDA’s draft methodology represents the first step towards establishing such requirements.

In addition to designating high-risk foods, FDA in the future will issue a proposed rule to specify the additional recordkeeping requirements for such foods. FSMA requires that FDA designate high-risk foods for traceability purposes based on the following factors:

 • The known safety risks of a particular food, including the history and severity of foodborne illness outbreaks attributed to such food, taking into consideration foodborne illness data collected by the Centers for Disease Control and Prevention;

 • The likelihood that a particular food has a high potential risk for microbiological or chemical contamination or would support the growth of pathogenic microorganisms due to the nature of the food or the processes used to produce such food;

 • The point in the manufacturing process of the food where contamination is most likely to occur;

 • The likelihood of contamination and steps taken during the manufacturing process to reduce the possibility of contamination;

 • The likelihood that consuming a particular food will result in a foodborne illness due to contamination of the food; and

• The likely or known severity, including health and economic impacts, of a foodborne illness attributed to a particular food.

Significantly, the term “high-risk” has more than one meaning within FSMA.

For example, the law requires that “high-risk” food/feed facilities be subject to more frequent regulatory inspections.

In this context, the “high-risk” determination is based upon facility-specific issues, such as compliance history.

In contrast, the compliance history of facilities is not relevant in determining “high-risk foods” for traceability purposes, which instead is to be based upon the characteristics of the food.

FDA’s draft approach to identifying high-risk foods would use a multi-criteria riskranking model that would consider seven factors: 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.

NGFA will work with several committees to draft comments on the methodology by the April 7 deadline.

For additional information contact Dave Fairfield.

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