Animal & Veterinary
Resources for You
- Bovine Spongiform Encephalopathy and human biologics (CBER)
- Bovine Spongiform Encephalopathy and human food and cosmetics (CFSAN)
- Centers for Disease Control and Prevention (CDC) and BSE
- Bovine Spongiform Encephalopathy, Animal and Plant Health Inspection Service (APHIS), USDA
Publicaciones en Español del Centro de Medicina Veterinaria (CVM) All About BSE
Bovine Spongiform Encephalopathy
Bovine Spongiform Encephalopathy (BSE) and Creutzfeldt-Jakob Disease (CJD) belong to the unusual group of progressively degenerative neurological diseases known as transmissible spongiform encephalopathies (TSEs). TSE diseases are characterized by long incubation periods ranging from several months for transmissible mink encephalopathy, to several years for BSE. During the incubation period there is no visible indication of the disease.
FDA has published two rules to protect animals and consumers against BSE by prohibiting the use of most mammalian protein in the manufacture of animals feeds given to ruminant animals and by removing high-risk materials from all animal feed. These rules were published in 1997 and 2008.
In 1997, FDA published a final regulation designed to prevent the spread of BSE through animal feed. The 1997 rule prohibits the use of most mammalian protein in the manufacture of animal feeds given to ruminant animals, such as cows, sheep, and goats. The regulation also requires process and control systems to ensure that feed for ruminants does not contain the prohibited mammalian tissue. The two cases of BSE detected in U.S. cattle were both born before the 1997 feed ban.
In 2008, FDA published a regulation that strengthened the 1997 rule by prohibiting the tissues that have the highest risk for carrying the agent thought to cause BSE in animal feed. These high risk cattle materials are the brains and spinal cords from cattle 30 months of age and older. The 2008 rule also prohibits the use of entire carcass of cattle not inspected and passed for human consumption, unless the cattle are less than 30 months of age, or the brains and spinal cords have been removed.
Please direct questions on CVM’s BSE activities to:
Division of Compliance (HFV-230)
Office of Surveillance and Compliance
Center for Veterinary Medicine
U.S. Food and Drug Administration
MPN IV Bldg., Room 146
7519 Standish Place
Rockville, MD 20855-2773
Telephone: (240) 276-9200
FAX: (240) 276-9241
2008 BSE Final Rule Documents
Laws/Regulations
Restrictions on importation of meat and edible products (USDA)
9 CFR 94.18BSE/Ruminant Feed Regulations
21 CFR Part 589.2000BSE/Substances Prohibited from Use in Animal Food or Feed
21 CFR Part 589.2001
Guidance Documents
7371.009 - BSE/Ruminant Feed Ban Inspections (PDF - 351KB)CVM GFI #67 Small Entities Compliance Guide for Renderers (PDF - 66KB)CVM GFI #68 Small Entities Compliance Guide for Protein Blenders, Feed Manufacturers, and Distributors (PDF - 66KB)CVM GFI #69 Small Entities Compliance Guide for Feeders of Ruminant Animals with On-Farm Feed Mixing Operations (PDF - 62KB)CVM GFI #70 Small Entities Compliance Guide for Feeders of Ruminant Animals Without On-Farm Feed Mixing Operations (PDF - 59KB)CVM GFI #76 Questions and Answers BSE Feed Regulations (PDF - 142KB)CVM GFI #158 Use of Material from Deer and Elk in Animal Feed (PDF - 43KB)CVM GFI #195 Small Entities Compliance Guide For Renderers—Substances Prohibited From Use In Animal Food Or Feed (PDF - 251KB)