Regulatory action criteria for filth and other extraneous materials V. Strategy for evaluating hazardous and nonhazardous filth

The U.S. Food and Drug Administration (FDA) uses regulatory action criteria for filth and extraneous materials to evaluate adulteration of food produc ts. The criteria are organized into three categories: health hazards, indic ators of insanitation, and natural or unavoidable defects. The health hazar d category includes criteria for physical, chemical, and microbiological ha zards associated with filth and extraneous materials. The health hazard cat egory encompasses criteria for HACCP (Hazard Analysis and Critical Control Point) hazards and HACCP contributing factors. The indicators of insanitati on category includes criteria for visibly objectionable contaminants, conta mination from commensal pests, and other types of contamination that are as sociated with insanitary conditions in food processing and storage faciliti es. The natural or unavoidable category includes criteria for harmless, nat urally occurring defects and contaminants. A decision tree is presented for the sequential application of regulatory action criteria for filth and ext raneous materials associated with each category and with each type of filth or extraneous material in the three categories. This final report of a ser ies in the development of a transparent science base for a revised FDA regu latory policy in the area of filth and extraneous materials in food include s a comprehensive list of the references that form the science base for the FDA regulatory policy.