. /.  WORLD TRADE  
ORGANIZATION  G/SPS/N/USA/933 
20 July 2004 
 (04-3112) 
Committee on Sanitary a nd Phytosanitary Measures Original:   English 
  
 
NOTIFICATION  
 
1. Member to Agreement notifying:   UNITED STATES
 
If applicable, name of local government involved: 
2. Agency responsible:   US Food and Drug Administration  
3. Products covered (provide tariff item numbe r(s) as specified in national schedules 
deposited with the WTO; ICS numbers should be provided in addition, where 
applicable):  Food for human consumption and cosmetics for use in the United States, except 
for meat, poultry and egg products that are excl usively regulated by th e US Department of 
Agriculture 
4. Regions or countries likely to be affected , to the extent relevant or practicable:  
Trading partners who import human food  or cosmetics into the United States  
5. Title, language and number of pages of the notified document:   Use of Materials Derived 
From Cattle in Human Food and Cosmetics, In terim Final Rule (19 pages, available in 
English) 
6. Description of content:  The Food and Drug Administration (FDA) is issuing an interim 
final rule to prohibit the use of certain cattle material, to address the potential risk of bovine 
spongiform encephalopathy (BSE), in human food, including dietary supplements, and 
cosmetics.  Prohibited cattle materials include sp ecified risk materials, small intestine of all 
cattle, material from nonambulatory disabled ca ttle, material from cattle not inspected and 
passed for human consumption, and mechanica lly separated (MS)(Beef).  Specified risk 
materials are the brain, skull, eyes, trigem inal ganglia, spinal cord, vertebral column 
(excluding the vertebrae 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 include tallow that contains  no more than 0.15 percent hexane-insoluble 
impurities and tallow derivatives.  FDA is taking th is action in response to the finding of an 
adult cow, imported from Canada, that tested positive for BSE in the State of Washington.  
This action is consistent with the recent interi m final rule issued by the US Department of 
Agriculture (USDA) declaring specified risk  materials and the carcasses and parts of 
nonambulatory disabled cattle 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.  This action will minimize human exposure to materials that scientific studies 
have demonstrated contain the BSE agent in cattle infected with the disease. Scientists 
believe that the human disease variant Creutz feldt-Jakob disease (vCJD) is likely caused by 
the consumption of products contaminated with the agent that causes BSE. 
7. Objective and rationale:  [ X ] food safety, [   ] animal health, [   ] plant protection, 
[ X ] protect humans from animal/plant pest or disease, [   ] protect territory from other damage from pests G/SPS/N/USA/933 
Page 2  
 
 8. International standard, guideline or recommendation:  
[   ] Codex Alimentarius Commission, [ X ] World Organization for Animal Health 
(OIE), [   ] International Plant Protection Convention, [   ] None  
If an international standard, guideline or recommendation exists, give the appropriate 
reference and briefly id entify deviations:  Certain provisions are consistent with the BSE 
Chapter of the OIE Terrestr ial Animal Health Code. 
9. Relevant documents and language(s ) in which these are available:  Interim Final Rule in 
the Federal Register (FR), 69 FR 42255-42274 (avail able in English).  It can be found at: 
http://www.fda.gov/OHRMS/DOCKETS/98fr/04-15881.pdf  or 
http://www.fda.gov/OHRMS/DOCKETS/98fr/04-15881.htm 
10. Proposed date of adoption:   14 July 2004 
11. Proposed date of entry into force:   14 July 2004 
12. Final date for comments:  Submit written or electronic  comments by 12 October 2004 
Agency or authority designated to handle comments:  [   ] National notification 
authority, [ X ] National enquiry point, or  address, fax number and E-mail address (if 
available) of other body:    
Submit written comments on the document to the Dockets Management Branch (HFA-
305), Food and Drug Administration, 5630 Fisher s Lane, rm. 1061, Rockville, MD 20852, 
USA. It is possible to submit electronic comments to:   
http://www.fda.gov/dockets/ecomments .  Submit comments by indicating DOCKET 
Number 2004N-0081 and Title "Use of Material s Derived From Cattle in Human Food and 
Cosmetics". 
13. Texts available from:  [   ] National notificati on authority, [ X ] National enquiry point, 
or address, fax number and E-mail address (if available) of other body: 
US Enquiry Point, U.S. Department of Agriculture, Stop 1027, Washington, DC  20250.  
Tel:  (202) 720-0677 or (202) 720-4051;  E-mail:  fstsd@usda.gov .  Complete text can also 
be found on the Internet at http://www.fda.gov/OHRMS/DOCKETS/98fr/04-15881.pdf .