Regulatory action criteria for filth and other extraneous materials I. Review of hard or sharp foreign objects as physical hazards in food

A review of the scientific literature concerning physical hazards in food p roducts is combined with the results of 190 evaluations of foreign objects in food that were conducted by the FDA Health Hazard Evaluation Board over a period of 25 years. Hard or sharp objects 7 mm or longer in size were fou nd to be a potential health hazard from laceration, perforation wound, and possible secondary infection. Objects less than 7 mm in size represent a po ssible hazard, especially if a special-risk group (e.g., infants, elderly) is among the intended consumers of the product. The results proved consiste nt with U.S. Department of Agriculture guidance concerning foreign objects in food. Hazard Analysis Critical Control Point applications for physical h azards in food are discussed.