. /.  WORLD TRADE  
ORGANIZATION  G/TBT/N/USA/73 
13 August 2004 
 (04-3417) 
Committee on Technical Barriers to Trade Original:  English 
  
NOTIFICATION 
 
The following notification is being circ ulated in accordance with Article 10.6. 
 
1. Member to Agreement notifying:   UNITED STATES
 
If applicable, name of local government involved (Articles 3.2 and 7.2):         
2. Agency responsible:   Food and Drug Administration (77)  
Name and address (including telephone and fax numbers, e-mail and web-site addresses, if available) of  agency or authority designated to handle comments 
regarding the notification shall be  indicated if different from above:         
3. Notified under Article 2.9.2 [ X], 2.10.1 [   ], 5.6.2 [   ], 5.7.1 [   ], other:         
4. Products covered (HS or CCCN where applicable, otherwise national tariff heading. 
ICS numbers may be provided in  addition, where applicable):   Cosmetics and Human 
Food ICS numbers may be provided in addition,  where applicable):  (HS Chapters 33 and 
2106) (ICS 67.020 and 71.100)   
5. Title, number of pages and language(s) of the notified document:   Use of Materials 
Derived From Cattle in Human Food and Cosm etics; and Recordkeeping Requirements for 
Human Food and Cosmetics Manufactured From, Processed With, or Otherwise Containing, 
Material From Cattle; Final Rule and Pr oposed Rule (19 pages, in English) 
6. Description of content:   The Food and Drug Administration (FDA) is issuing an interim 
final rule (interim final rule) to prohibit th e use of certain cattle material, to address the 
potential risk of bovine spongiform encepha lopathy (BSE), in human food, including 
dietary supplements, and cosmetics. Prohibite d cattle materials include specified risk 
materials, small intestine of all cattle, material from non-ambulatory disabled cattle, 
material from cattle not inspected and passed for human consumption, and mechanically 
separated (MS)(Beef). Specified risk materials ar e the brain, skull, eyes, trigeminal ganglia, 
spinal cord, vertebral column (excluding the ve rtebrae of the tail, the transverse processes of 
the thoracic and lumbar vertebrae, and the wings of the sacrum), and dorsal root ganglia of cattle 30 months and older; and the tonsils and distal ileum of the small intestine of all 
cattle. Prohibited cattle materials do not in clude tallow that contains no more than 
0.15 percent hexane-insoluble impurities and tallo w derivatives. FDA is taking this action in 
response to the finding of an adult cow, im ported from Canada, that tested positive for BSE 
in the State of Washington. This action is consis tent with the recent interim final rule issued 
by the U.S. Department of Agriculture (USDA)  declaring specified risk materials and the 
carcasses and parts of non-ambulatory disabled ca ttle to be inedible, unfit for human food, 
and prohibiting their use as human food and requiring that the entire small intestine be 
removed and disposed of as inedible. Th is action will minimize human exposure to 
materials that scientific studies have demonstrated are highly likely to contain the BSE agent in cattle infected with the disease. Scie ntists believe that the human disease variant 
Creutzfeldt-Jakob disease (vCJD) is likely caused by the consumption of products 
contaminated with the agent that causes BSE.  G/TBT/N/USA/73 
Page 2  
 
Also in this issue of the Federal Register, FDA is proposing to require that manufacturers 
and processors of human food and cosmetics that  are manufactured from, processed with, or 
otherwise contain material from cattle estab lish and maintain records sufficient to 
demonstrate that the food and cosmetics are in compliance with this interim final rule. 
7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of human health 
8. Relevant documents:   69 Federal Register (FR) 42255 14 July 2004; Title 21 Code of 
Federal Regulations (CFR) Parts 189, and 700.  Will appear in the Federal Register when 
adopted. 
9. Proposed date of adoption:   
Proposed date of entry into force:   }To be determined 
10. Final date for comments:   12 October 2004 
11. Texts available from:  National enquiry point [ X] or address, telephone and fax 
numbers, e-mail and web-site addresses, if available of the other body:   
Available on the Internet at URLs: 
http://a257.g.akamaitech.net/7/257/24 22/06jun20041800/edocket.access.gpo.gov/2004/04-
15881.htm  
http://a257.g.akamaitech.net/7/257/24 22/06jun20041800/edocket.access.gpo.gov/2004/pdf/
04-15881.pdf