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CVM and Animal Food, Feed Ingredients, and Additives
Biotechnology products are a growing proportion of the feed components regulated by the Center for Veterinary Medicine. We anticipate that "new" biotechnology will become an even greater source of products in the future. The spectrum of products being presented to CVM for regulation includes biotechnology products from plants, microbes and animals. For more information about the uses of products produced using this technology, see the CVM Biotechnology in Animals and Animal Feeds page. There are two classes of feed contaminants. The first is a toxic or deleterious substance that is an inherent, naturally occurring constituent of an animal food and is not the result of environmental, agricultural, industrial or other contaminations. Examples of this class include some of the mycotoxins, such as aflatoxin and fumonisin, the glucosinolates, and the heavy metals, like lead and cadmium. The second class is made up of industrial toxic or deleterious substances, which are not naturally occurring and are increased to abnormal levels in the animal food through mishandling or other intervening acts. Examples of this class are the polychlorinated biphenyls (PCBs) and certain pesticides, like DDT (1,1’-(2,2,2-Trichloroethylidene)bis[4-chlorobenzene]). CVM may prohibit any detectable amount of a contaminant or establish a regulatory limit for the contaminant, taking into account the protection of the public health, the extent to which the presence of the contaminant cannot be avoided, and other ways in which the consumer may be affected by the presence of the contaminant.
CVM Feed Sampling Survey Assignments
Additional Information
A feed ingredient is a component part or constituent or any combination/mixture added to and comprising the feed. Feed ingredients might include grains, milling byproducts, added vitamins, minerals, fats/oils, and other nutritional and energy sources. Animal feeds provide a practical outlet for plant and animal byproducts not suitable for human consumption. The Official Publication of the Association of American Feed Control Officials (AAFCO) contains a list of feed ingredients with their definitions. Many of these ingredients are not approved food additives and may not meet the criteria needed to be recognized as GRAS (21 CFR 570.30). Nevertheless, FDA has not objected to the listing of certain ingredients (e.g., those used as sources of nutrients, aroma, or taste) in the AAFCO Official Publication or their marketing in interstate commerce, provided there were no apparent safety concerns about the use or composition of the ingredient. Federal regulations require ingredients be listed on the product label by their common or usual name in descending order of predominance according to weight (21 CFR 501.4). A common or usual name is one that accurately identifies or describes the basic nature of the ingredient (21 CFR 502.5). FDA has recognized the definitions as they appear in the Official Publication of AAFCO as the common or usual name for animal feed ingredients including pet food (Compliance Policy Guide 7126.08). There is only one exception to the requirement to list the common or usual name on the label--when the ingredient is part of a collective name. Regulation 21 CFR 501.110 describes the use of collective names. The following are acceptable collective names: animal protein products, forage products, grain products, plant protein products, processed grain byproducts and roughage products. These collective names may be used in the ingredient list for livestock and poultry feeds, but not pet foods. Association of American Feed Control Officials (AAFCO) AAFCO is composed of state, federal, and international regulatory officials who are responsible for the enforcement of state laws regulating the safe production and labeling of animal feed, including pet food. FDA and AAFCO work together in the area of feed regulation, particularly in the establishment of definitions to describe new feed ingredients. Each year AAFCO publishes its Official Publication which includes a model feed bill for states to adopt in regulating feed products and a list of accepted feed ingredients. Most states have adopted all or part of the model feed bill and allow feed ingredients listed in the publication to be used in their respective territories. For more information about AAFCO, please see its internet site.
Food Additives (Food Additive Petitions) Any substance intentionally added to an animal feed, including pet food, must be used in accordance with a food additive regulation unless it is generally recognized as safe (GRAS) among qualified experts for its intended use. The basis of a food additive regulation is an approved food additive petition. The food additive petition should include an adequate factual basis to establish that the food additive is safe for its intended use, under the conditions of use specified in the petition. If the petitioner meets this burden of proof, the food additive can be approved for use in animal feed. There are several types of food additives based on its composition and intended use. A food additive generally provides one or more of the following, i.e., nutrient, aroma/flavor, taste, soluble or insoluble fiber, stabilizer, emulsifier, sequestrant, chemical preservative, anti-oxidant, anti-caking agent, etc. Section 571 of Part 21 of the Code of Federal Regulations (CFR) prescribes the kinds of data that must be submitted by the petitioner and the format which the food additive petition must follow when sent to FDA. While the actual content may vary from petition to petition, depending primarily on the food additive's composition and intended use, each of the following subject areas must be addressed: human food safety, target animal safety, environmental impact, utility, labeling, proposed regulation, assay methodology, and manufacturing process and controls. Subsequently, when the FDA concludes that the available data for a food additive are sufficient to meet current criteria, the FDA issues a regulation permitting the petitioned use of the additive.
Web Page Updated by mdt - November 20, 2007, 10:06 AM ET
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