Section 204(d)(2)(A) of FSMA specifically states that the designation of high-risk foods must be based on the:
(1) Known safety risks of a particular food, including the history and severity of food borne illness outbreaks attributed to such food, taking into consideration food borne illness data collected by the Centers for Disease Control and Prevention; (2) 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; (3) Point in the manufacturing process of the food where contamination is most likely to occur; (4) likelihood of contamination and steps taken during the manufacturing process to reduce the possibility of contamination; (5)Likelihood that consuming a particular food will result in a food borne illness due to contamination of the food; and (6) Likely or known severity, including health and economic impacts, of a foodborne illness attributed to a particular food.