Foreign Material Control: Food Quality, Safety or Both?
How do food processors treat their foreign material control programs? Are they deemed food safety or food quality programs? Foreign material such as glass, wood, metal, fruit pits, bone or stones have the potential to cause injury, as may be seen in Table 1.[1] Based on a review of injuries from certain foods, the U.S. Food and Drug Administration (FDA) has established guidelines for “hard and sharp objects,” defining what they deem to be a hazard and what is not (see “Regulatory Action Guidance”[2]). The position is rather interesting in that there is both an upper and a lower size limit. The upper limit is set at 25 mm (1 inch). The rationale is that something that large would be detected by the consumer and not be hazardous. This guidance document also indicates that hard and sharp objects less than 7 mm may be a hazard for special groups such as infants.
The bottom line, however, is that foreign materials have no place in foods, and processors need to develop, document, implement and maintain programs to ensure that such materials remain out of their products and processes. Now, someone may be thinking, “Hey, what about defect action levels (DALs)?”[3] DALs are set because FDA has deemed that some materials are “unavoidable contaminants.” Yet, it seems that each year, some overzealous newsperson “discovers” that there is such a thing as DALs and runs an investigative piece, focusing on how FDA “allows” such things in the food supply. What consumers must understand is that simply because there is a DAL does not mean that a food will contain the item in question. Processors are not standing over the mixers sprinkling in rodent hairs or insects. In fact, in my years in the industry, I have seen a steady decrease in levels of foreign material, especially for those products for which DALs exist. An elevated level of one of these materials usually means there has been a breakdown in basic Good Manufacturing Practices and sanitation programs, so there are other issues that need to be addressed (Table 2).
A food shall be deemed to be adulterated—
(A) Poisonous, insanitary, etc., ingredients
(1) If it bears or contains any poisonous or deleterious substance which may render it injurious to health; but in case the substance is not an added substance, such food shall not be considered adulterated under this clause if the quantity of such substance in such food does not ordinarily render it injurious to health; (2)(A) If it bears or contains any added poisonous or added deleterious substance (other than a substance that is a pesticide chemical residue in or on a raw agricultural commodity or processed food, a food additive, a color additive, or a new animal drug) that is unsafe within the meaning of section 346 of this title; or (B) if it bears or contains a pesticide chemical residue that is unsafe within the meaning of section 346a(a) of this title; or (C) if it is or if it bears or contains (i) any food additive that is unsafe within the meaning of section 348 of this title; or (ii) a new animal drug (or conversion product thereof) that is unsafe within the meaning of section 360b of this title; or (3) if it consists in whole or in part of any filthy, putrid, or decomposed substance, or if it is otherwise unfit for food; or (4) if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health; or (5) if it is, in whole or in part, the product of a diseased animal or of an animal which has died otherwise than by slaughter; or (6) if its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or (7) if it has been intentionally subjected to radiation, unless the use of the radiation was in conformity with a regulation or exemption in effect pursuant to section 348 of this title.