This document answers questions about 21 CFR 589.2000 “Animal Proteins Prohibited from Animal Feed.” 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.
This document is intended to supplement the Small Entity Compliance Guides for the regulation, specifically the following FDA Guidance for Industry (GFI) documents:
- GFI #67 – Renderers
- GFI #68 - Protein Blenders, Feed Manufacturers, and Distributors
- GFI #69 - Feeders of Ruminant Animals With On-Farm Feed Mixing Operations
- GFI #70 - Feeders of Ruminant Animals Without On-Farm Feed Mixing Operations
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:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.