CVM GFI #68 Small Entities Compliance Guide for Protein Blenders, Feed Manufacturers, and Distributors
This document is intended to provide guidance for “Animal Proteins Prohibited from use in Ruminant Feed,” 21 CFR 589.2000.
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. An example is meat and bone meal made from cattle. However, certain products are exempt from the regulation:
The following protein products derived from mammals are exempt:
- Blood and blood products
- Milk products (milk and milk proteins)
- Pure porcine (pork) or pure equine (horse) protein
- Inspected meat products, such as plate waste, which have been cooked and offered for human food and further heat processed for animal feed
The following nonmammalian protein products are exempt:
- Marine (fish)
The following are also exempt because they are not protein or tissue:
- Amino acids
- Dicalcium phosphate
If you receive and process ONLY the above exempted products you are not required to comply with the provisions of this regulation. This material is referred to as “nonprohibited material” throughout this guide.
All other mammalian protein will be referred to as “prohibited material throughout this guide. If you receive and process this material, you must comply with the provisions of this regulation.
Ruminant animals are any animals with a four-chambered stomach including cattle, sheep, goats, buffalo, elk, and deer.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.