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Center for Veterinary Medicine
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Bovine Spongiform Encephalopathy (BSE)

Bovine Spongiform Encephalopathy (BSE, sometimes referred to as "mad cow disease") 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.

2008 BSE Final Rule Documents:

  • Final Rule 
    Docket No. FDA-2002-N-0031 (formerly 2002N-0273), CVM 200646. Substances Prohibited From Use in Animal Food or Feed. Pages 22719-22758 [FR Doc. 08-1180] April 25, 2008 [TXT] [PDF] [PRE-PUB] Effective date April 27, 2009 

    Environmental Assessment 
    Finding of No Significant Impact

  • Feed Ban Enhancement:  Implementation Questions and Answers, July 15, 2008 | html | | pdf |

  • Guidance Documents (to be provided at a later date)

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 

Web Page Updated by hd - July 17, 2008, 2:47 PM ET

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