The Preventative Controls requirement for foods require in part that food manufacturers and processors identify potential hazards and implement controls to guard against such hazards. Among the hazards that must be considered are hazards that may be intentionally introduced for purposes of economic gain (‘‘economically motivated hazards’’). USP recognized the value of developing a classification scheme for fraud-related adulterants that could aid in the identification of economically motivated hazards. The USP Food Ingredient Expert Committee (FIEC) convened an Expert Panel to undertake the task.
A member of the FIEC, Hyman, Phelps & McNamara, P.C.’s Diane McColl served on the Expert Panel and participated in the development of a scheme to classify food fraud-related adulterants based on their potential health hazard, and application of the scheme to the adulterants in a database of 2,970 food fraud records. The classification scheme consists of three broad categories: 1) potentially hazardous adulterants, 2) adulterants that are unlikely to be hazardous, and 3) unclassifiable adulterants. Categories 1) and 2) are broken down into seven subcategories to further define the range of hazard potential for the adulterants. When applied to the database of economically motivated food adulterants, 45% of the adulterants were found to be potentially hazardous, 46% of the adulterants were found unlikely to be hazardous and 9% of the adulterants were unclassifiable.
Designed to support food fraud mitigation efforts and hazard identification, the classification scheme is just a first step. Experienced risk assessors recognize that further consideration of the specific circumstances of the potential adulteration should be considered, including whether the adulterant is less than food grade, is unstable in the food matrix, may obscure a hazardous defect in the food or may negatively affect the nutritional profile of the finished food. Additional factors to consider are toxicity, stability and purity of the adulterant as well as dietary exposure to the adulterant. Detailed discussion of the classification scheme together with examples for each subcategory is available here.