This guidance document represents the agency's current thinking on rendered animal feed ingredients. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both.
Rendered animal feed ingredients include the various poultry, meat and marine products which result from the rendering of these animal tissues. Rendering of poultry and other animal tissues has been practiced for over a hundred years as a means of salvaging valuable protein and fat content from otherwise waste material. For many years end products from rendering have been used to feed animals. The rendering industry utilizes packinghouse offal, meat processing waste, restaurant waste and animal tissues from other sources including animals that have died otherwise than by slaughter.
There are two types of processes in use by the rendering industry to process this material. They are dry rendering, used by the largest portion of the industry, and wet rendering. Both rendering processes were designed to ensure that the resultant animal feed ingredients pose no threat of disease transmission to animals which are fed the material or to the health of humans consuming their edible products (meat, milk, and eggs). Prior to the appearance of BSE, CVM had no evidence of human or animal disease associated with the feeding of properly rendered and handled animal feed ingredients despite the use of tissues from diseased animals or animals that have died otherwise than by slaughter. In addition, the Center for Veterinary Medicine does not believe that Congress intended the Act to preclude application of different standards to human and animal foods under Section 402. Different standards have historically existed for human and animal food concerned with aesthetics. The Center has permitted other aesthetic variables in dealing with animal feed, as for instance the use of properly treated insect or rodent contaminated food for animal feed.
On August 4, 1997, 21 CFR 589.2000 became effective. This regulation is designed to prevent the establishment and amplification of Bovine Spongiform Encephalopathy (BSE), sometimes referred to as "Mad Cow Disease," through animal feed. The regulation prohibits the use of certain proteins derived from mammalian tissue in feeding ruminant animals.
The regulation places three requirements on renderers who process or distribute prohibited material. They are to:
- Label all products that contain or may contain prohibited material with the following cautionary statement: "Do not feed to cattle or other ruminants."
- Maintain records sufficient to track the materials throughout their receipt, processing, and distribution, and make them available for inspection and copying by the FDA.
- Maintain the records for a minimum of one year.
In addition, renderers that separate prohibited and nonprohibited material are required to provide for measures to avoid commingling or cross-contamination of prohibited material and nonprohibited material and maintain written procedures that document these measures.
No regulatory action will be considered for animal feed ingredients resulting from the ordinary rendering process of industry, including those using animals which have died otherwise than by slaughter, provided they are not otherwise in violation of the law.
Rendered animal feed ingredients which contain harmful microorganisms, toxins or chemical substances may be considered adulterated under Section 402(a)(1) or (2) of the Act. Where a rendering procedure itself raises a question of disease transmission, the ingredient made may be deemed adulterated under Section 402(a)(4).
Animal proteins that are prohibited from use or intended use in runimant feed by 21 CFR 589.2000, are unapproved food additives as defined in Section 201(s) of the Act. The use or intended use of these proteins in ruminant feed causes the feed to be adulterated under Section 402(a)(2)(C). If some or all of the record-keeping or clean-out /separation provisions are not met, the feed is adulterated under Section 402(a)(4). The feed ingredients and/or feed is misbranded under Section 403(f) if the labeling provisions were not met. A Warning Letter is the initial action of choice to achieve compliance. Egregious or repeated violations may warrant more stringent regulatory action such as seizure, injunction, or prosecution.
Where applicable, rendered animal feed ingredients should conform to the definitions promulgated by the Association of American Feed Control Officials, Inc. (AAFCO), as published in its "Official Publication," for feed control purposes. Compliance Policy Guide 7126.08 recognizes the AAFCO definitions as generally constituting the common or usual names for animal feed ingredients conforming in origin and content to these definitions. Included are such products as poultry by-product meal, meat meal, meat and bone meal and fish meal.