The Food and Drug Administration on Feb. 4, in a notice in the Federal Register, requested comments from the food industry and other stakeholders on how the agency should determine what foods should be designated as “high risk” and subject to additional recordkeeping requirements to assist in the tracing and tracking of food in the event of a foodborne illness outbreak.

The fundamental aim of the Food Safety Modernization Act is to prevent and not just react to foodborne illness outbreaks. Critical to that goal is the identification of foods that are more at risk to contamination and, therefore, more likely than others to be potential sources for foodborne illness. The F.S.M.A. requires the F.D.A. to compile a list of high-risk foods and define what additional recordkeeping should be required of manufacturers of such foods. The F.D.A. issued a draft approach for designating high-risk foods on the same date as the Federal Register notice. The F.D.A. asked for comments to be based on or at least consider the document.

High risk qualifications

Factors to be considered in determining whether a food is high-risk.

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The F.S.M.A. requires the F.D.A. to publish its list of high-risk foods on its web site at the same time it issues final rules establishing the additional recordkeeping requirements. The comment period on the agency’s draft approach on designating high-risk foods closes on April 7.

The F.D.A. said “designation of high-risk foods must be based on the historical public health significance of the food with respect to outbreaks and cases of foodborne disease, as well as a number of food- and processing-related factors.”

The F.D.A. said it was considering a “semi-quantitative risk ranking mode” as the most appropriate way to compile a high-risk food list “because it would be data-driven and comprehensive, using explicit criteria related to public health risk; it would be adaptive to a variety of hazards (microbial and chemical contamination of foods); and it would be flexible to consider different foods or categories of foods.” The F.D.A. added such an approach would provide a means for considering all of the F.S.M.A. criteria and linking those criteria to develop a risk score for each food.

The F.D.A.’s draft approach procedure for designating high-risk foods includes seven steps. Using the statutory factors to be considered, the F.D.A. will define criteria and scoring. To the extent applicable, it will develop a comprehensive list of food-hazard pairs (matching a food with a potential hazard) representative of F.D.A.-regulated food or food categories. It will collect data relevant to the scoring criteria for the food-hazard pairs identified. It will execute the draft risk model to determine risk scores for the food-hazard pairs. It will determine the total risk score for a food or food category in which multiple hazards occur. It will validate risk-ranking results from the draft semi-quantitative risk model by using F.D.A. iRISK (the F.D.A.’s comparative risk assessment tool), where necessary. And using the total risk score for foods or food categories, it will create a preliminary list of high-risk foods.

The F.D.A. is considering basing the classification of foods or categories of food for risk ranking on the Reportable Food Registry commodity definitions. The agency said the R.F.R. commodity definitions would be appropriate for the risk ranking because food characteristics as well as manufacturing processes are considered in the definitions. Representative foods within each of the R.F.R. categories would be selected and used in the model.

The draft approach also includes a description of how the F.D.A. intends to develop a risk ranking score for foods. The ranking would consider the frequency of outbreaks and occurrences of illnesses associated with the food; the severity of illness, taking into account illness duration, hospitalization and mortality; the likelihood of contamination; a food’s shelf life related to its ability to support pathogen growth; manufacturing process contamination probability and intervention; consumption frequency of a food, and economic impacts of an illness outbreak related to a food-hazard pair. The draft approach discusses each of these criteria in detail.

David Acheson, founder and chief executive officer of The Acheson Group, commented with regard to the import of the agency’s mandate, “Primarily, it means that if you manufacture, or use in your product, any of the foods on the high-risk list, you will have to adhere to increased recordkeeping requirements (which are yet to be defined) for these foods to increase tracking and tracing capabilities, to make it easier to rapidly and effectively identify recipients of a food to prevent or mitigate a foodborne illness outbreak.

“This also means that if you manufacture both high-risk and non-high-risk foods, you will need to either maintain two separate sets of records, or simply follow the high-risk recordkeeping rules for all your products in order to avoid confusion.”

Mr. Acheson continued, “For imported foods, the high-risk list will be used to identify those foods subject to third-party certification requirements for entry into the United States. We would expect that the list would also inform the authority that F.D.A. has to establish performance standards. Likely it will impact inspection frequency, but hopefully in conjunction with other inputs such as the track record of a given food facility.”

He said he had real concern about how well breaking all food into just 30 categories, as in the Reportable Food Registry, will work in terms of fairness to the food industry. If the intent is to have 30 food groups or fewer, “there are likely to be a few casualties of food that are not high risk landing in a high-risk group.” At the same time, he said he appreciated the need for the number of categories to be manageable.

“A greater concern is the process whereby foods move on and off the high-risk list,” Mr. Acheson asserted. “Clearly, if you are on the non-high-risk list, you want to stay there. How do you do that? Also, if you are on the high-risk list, what are the options to get off that list? What will be the criteria that would allow that? And how long will the removal process take?”

Mr. Acheson also asked, “If you are deemed to be a high-risk group, will there be exceptions?’ Mr. Acheson said a good example of this conundrum is presented by tree nuts.

“If all tree nuts are put on the high-risk list, but some types of tree nuts have systems in place to control risk across the whole industry — as part of an industry-wide mandate — can one type of tree nut be exempt?” he asked. “Lots of questions, and not a lot of answers, yet.”