Issue Date: July 1, 1998
Issued by: Center for Veterinary Medicine
Topic(s): Bovine Spongiform Encephalopathy (BSE), Current Good Manufacturing Practice (CGMP)
Status: Final
CVM GFI #76 Questions and Answers BSE Feed Regulations
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 #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
Download the Guidance Document
