![]() ![]() It is FDA's position that pesticides are not the alternative to preventing food defects. USE OF CHEMICAL SUBSTANCES TO ELIMINATE DEFECT LEVELS Moreover, FDA interprets the findings considering available scientific information (e.g., ecology of animal species represented) and the knowledge of how a product is grown, harvested, and processed. The criteria considered is based on the reported findings (e.g., lengths of hairs, sizes of insect fragments, distribution of filth in the sample, and combinations of filth types found). In this procedure, FDA's technical and regulatory experts in filth and extraneous materials use a variety of criteria, often in combination, in determining the significance and regulatory impact of the findings. If there is no defect action level for a product, or when findings show levels or types of defects that do not appear to fit the action level criteria, FDA evaluates the samples and decides on a case-by-case basis. It is the responsibility of the user of this booklet to stay current with any changes to this list. The FDA publishes these revisions as Notices in the Federal Register. 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.Īs technology improves, the FDA may review and change defect action levels on this list. The defect levels do not represent an average of the defects that occur in any of the products-the averages are actually much lower. 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. Products harmful to consumers are subject to regulatory action whether or not they exceed the action levels. 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. That practice renders the final food unlawful regardless of the defect level of the finished food. Likewise, the mixing of 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. Poor manufacturing practices may result in enforcement action without regard to the action level. These "Food Defect Action Levels" listed in this booklet are set on this premise-that they pose no inherent hazard to health. 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. ![]()
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