The draft approach would use a multi-criteria decision analysis approach, similar to that of Anderson e al., 2011 (Ref. 1), to identify those foods which should be designated as high risk. This approach would use the specific criteria identified in section 204(d) (2) (A) of FSMA and would implement those criteria within a risk model. For each of the food and hazard pairs identified, we would determine a total risk score by the weighted sum of the score for each of the defined criteria. For foods that have multiple risk scores because they appear in the list associated with more than one hazard, we would determine the total score for that food using each of the individual food-hazard pair total risk scores. Inclusion on the high-risk food list would be based on the total risk score for foods or food categories. We describe our draft approach, criteria, and scoring system, and provide examples, in the document entitled ‘‘FDA’s Draft Approach for Designating High-Risk Foods as Required by Section 204 of FSMA’’ (Ref. 2). Although the analysis would encompass food-hazard pairs, we do not anticipate this to be a food-hazard list but rather a food list. This draft approach may be further refined pending stakeholder input in response to this notice.