Foreign Materials in Foods: Control and Evaluation
If one goes to the website of the U.S. Food and Drug Administration (FDA) and searches for “defect action levels,” one will find the agency’s Defect Action Handbook. This handbook provides interested parties with a complete description of how defect action limits (DALs) are defined and what those limits are in foods. The following italicized paragraphs are cited verbatim from the handbook.[1]
Title 21, Code of Federal Regulations, Part 110.110 allows the Food and Drug Administration (FDA) to establish maximum levels of natural or unavoidable defects in foods for human use that present no health hazard. These “Food Defect Action Levels” listed in this booklet are set on this premise—that they pose no inherent hazard to health.
Poor manufacturing practices may result in enforcement action without regard to the action level. Likewise, the mixing or blending of food with a defect at or above the current defect action level with another lot of the same or another food is not permitted. That practice renders the final food unlawful regardless of the defect level of the finished food.
The FDA set these action levels because it is economically impractical to grow, harvest, or process raw products that are totally free of non-hazardous, naturally occurring, unavoidable defects. Products harmful to consumers are subject to regulatory action whether or not they exceed the action levels.
It is incorrect to assume that because the FDA has an established defect action level for a food commodity, the food manufacturer need only stay just below that level. The defect levels do not represent an average of the defects that occur in any of the products—the averages are actually much lower. The levels represent limits at which FDA will regard the food product “adulterated;” and subject to enforcement action under Section 402(a)(3) of the Food, Drug, and Cosmetics Act.
As technology improves, the FDA may review and change defect action levels on this list. Also, products may be added to the list. The FDA publishes these revisions as Notices in the Federal Register. It is the responsibility of the user of this booklet to stay current with any changes to this list.
FDA clearly states that it is economically impractical to grow, harvest and process certain products that are free from such defects. What I find amusing is that every year or so on what seems to be a slow news day, one of the local television stations will hit us with a statement such as “FDA Allows Rodent Hairs in Food X.” They never seem to bother to look at the DALs and why these were established, but the story is presented as if there were an on-line step where someone is dutifully dropping in rodent hairs, insect parts or some other defects that FDA has identified as being “unavoidable” in certain products. On the other hand, there are foreign materials that are simply deemed to be adulterants (see “FDA: Foods – Adulteration Involving Hard or Sharp Foreign Objects”), so as an industry, we must develop, document and implement programs to keep these materials out of what is being processed. Materials such as glass, metal, wood, plastic, bone, rocks and others are among those that the industry works very hard to keep out of raw materials, ingredients and finished goods.
Controlling Foreign Materials in Production
Unfortunately, problems with foreign materials crop up regularly. For those readers who routinely receive recall notices from FDA, the U.S. Department of Agriculture and/or the Canadian Food Inspection Agency, you will see that foreign materials do end up in foods. Kraft Foods issued a massive recall notice for macaroni and cheese in 2015.[2] The company recalled 242,000 cases of product for possible metal contamination and received a total of eight consumer complaints with no reported injuries.
In an effort to control foreign materials, food processors utilize a variety of different programs, many starting with their suppliers. Companies that buy products like preservatives, sugars and other free-flowing materials often mandate that the ingredients be packaged in cases with bright blue or green plastic liners. The theory being that if the bag tears or rips, the blue or green plastic pieces will be more visible and removed from the product being manufactured.
In addition, most suppliers do one or more interventions to ensure that the materials they produce are free from foreign materials. Materials are sieved or screened prior to packaging or passed through a metal detector. Today, specification sheets reflect these practices and the company commitment to quality and safety.
FDA: Foods – Adulteration Involving Hard or Sharp Foreign Objects
Background:
Hard or sharp foreign objects in food may cause traumatic injury including laceration and perforation of tissues of the mouth, tongue, throat, stomach and intestine, as well as damage to the teeth and gums. From 1972 through 1997, the FDA Health Hazard Evaluation Board evaluated approximately 190 cases of hard or sharp foreign objects in food. These included cases of both injury and noninjury reported to FDA. The board found that foreign objects that are less than 7 mm, maximum dimension, rarely cause trauma or serious injury except in special risk groups such as infants, surgery patients and the elderly. The scientific and clinical literature supports this conclusion.
Hard or sharp natural components of a food (e.g., bones in seafood, shells in nut products) are unlikely to cause injury because of awareness on the part of the consumer that the component is a natural and intrinsic component of a particular product. The exception occurs when the food’s label represents that the hard or sharp component has been removed from the food, for example, pitted olives. The presence of the naturally occurring hard or sharp object in those situations (e.g., pit fragments in pitted olives) is unexpected and may cause injury. FDA has established DALs for many of these types of unavoidable defects in other Compliance Policy Guides, and, therefore, they are not subject to the guidance in this document.
Regulatory Action Guidance:
The following represent the criteria for direct reference seizure to the Division of Compliance Management and Operations (HFC-210) and direct reference import detention to the Districts:
a. The product contains a hard or sharp foreign object that measures 7 mm to 25 mm in length, AND
b. The product is ready-to-eat or, according to instructions or other guidance or requirements, it requires only minimal preparation steps, for example, heating, that would not eliminate, invalidate or neutralize the hazard prior to consumption.
Samples found to contain foreign objects that meet criteria a and b above should be considered adulterated within the meaning of 21 U.S.C. 342(a)(1).
The following represent the criteria for recommending legal action to CFSAN [Center for Food Safety and Applied Nutrition] Office of Compliance, Division of Enforcement (HFS-605):
c. The product contains a hard or sharp foreign object that measures 7 mm to 25 mm in length, and the product requires additional preparation or processing that may have an effect on the presence of the foreign objects in the finished food. For example, additional sifting of a product may or may not remove foreign objects, depending on the measurements of the objects and the mesh aperture of the sifter. In these situations, the preparation or processing of the food must be described in the recommendation submitted by the District, OR
d. The product contains a hard or sharp foreign object less than 7 mm in length and, if a special-risk group, as defined in the background section, is among the intended consumers of the product, OR
e. The product contains a hard or sharp foreign object over 25 mm in length.
A sample found to contain a foreign object that meets criterion c, d or e above should be considered adulterated within the meaning of 21 U.S.C. 342(a)(1) if a health hazard is established by CFSAN review. The CFSAN health hazard review in this case will consider various factors including the intended use of the product, subsequent processing steps, official guidance and requirements concerning unavoidable natural defects and other mitigating factors that could eliminate, invalidate or neutralize the hazard prior to consumption of the food product.
Remarks:
If the CFSAN review finds no health hazard associated with a sample containing a hard or sharp foreign object that meets criterion c or d above, the sample should be considered adulterated within the meaning of 21 U.S.C. 342(a)(3) if the CFSAN review finds the article unfit for food. The CFSAN review in this case will consider various factors including subsequent processing steps, extent of contamination and intended use of the product.
CPG 515.350 addresses imbedded objects in confectionary, which may cause such foods to be adulterated within the meaning of 21 U.S.C. 342(d)(1).