. /.  WORLD TRADE  
ORGANIZATION  G/TBT/N/USA/67/Add.1 
21 July 2004 
 
 (04-3150) 
Committee on Technical Barriers to Trade Original:   English 
  
 
NOTIFICATION  
 
Addendum
 
 
 
 The following communication, dated 16 July 2004, is being circulated at the request of the 
delegation of the United States . 
 
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 Use of Materials Derived From Cattle in Human Food and Cosmetics; and Recordkeeping 
Requirements for Human Food and Cosmetics Manuf actured From, Processed With, or Otherwise 
Containing, Material From Cattle;  Final Rule and Proposed Rule 
  The Food and Drug Administration (FDA) is issuing an interim final rule (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 di etary supplements, and cosmetics.  Prohibited 
cattle materials include specified risk material s, small intestine of all cattle, material from 
non-ambulatory disabled cattle, material from cattle no t inspected and passed for human consumption, 
and mechanically separated (MS)(Beef).  Specified risk  materials are the brain, skull, eyes, trigeminal 
ganglia, spinal cord, vertebral column (excluding th e 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 contai ns no more than 0.15 percent hexane-insoluble 
impurities and tallow derivatives.  FDA is taking this  action in response to the finding of an adult 
cow, imported from Canada, that tested positive for B SE in the State of Washington.  This action is 
consistent with the recent interim final rule issued  by the U.S.  Department of Agriculture (USDA) 
declaring specified risk material s and the carcasses and parts of non-ambulatory disabled cattle to be 
inedible, unfit for human food, and prohibiting th eir use as human food and requiring that the entire 
small intestine be removed and disposed of as ined ible.  This 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. Scientists believe that  the human disease variant Creutzfeldt-Jakob disease 
(vCJD) is likely caused by the consumption of produ cts contaminated with the agent that causes BSE.  
Also in this issue of the Federal Register, F DA 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 establish and maintain re cords sufficient to demonstrate that the food and 
cosmetics are in compliance with this interim final rule. 
  DATES
:  The interim final rule is effective on July 14, 2004.  Submit written or electronic 
comments by October 12, 2004.  The Director of th e Office of the Federal Register approves the 
incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51 of certain 
publications in 21 CFR 189.5 and 700.27 as of July 14, 2004. 
 G/TBT/N/USA/67/Add.1 
Page 2  
 
  ADDRESSES
: You may submit comments, identified by Docket No. 2004N-0081, by any of 
the following methods:   Federal eRulemaking Portal: http://www.regulations.gov
.  
 Follow the instructions for submitti ng comments on the agency Web site. 
 
 E-mail: fdadockets@oc.fda.gov .  
 Include Docket No. 2004N-0081 and or RIN number RIN-0910-AF47 in the subject line of  your e-mail message.  FAX: 301-827-6870. 
 
 Instructions: All submissions received must include the agency name and Docket No. or  Regulatory Information Number (RIN) for this  rulemaking.  All comments received will be 
 posted without change to http://www.fda.gov/dockets/ecomments
, including any personal 
 information provided.  For detailed instru ctions on submitting comments and additional 
 information on the rulemaking process, see section V in the SUPPLEMENTARY 
 INFORMATION section of this document.   Docket:  For access to the docket to read bac kground documents or comments received, go to 
 http://www.fda.gov/dockets/ecomments
 and/or the Division of Dockets Management, 
 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
 
 FOR FURTHER INFORMATION CONTACT :  
  Rebecca Buckner,   Center for Food,  
 Safety and Applied Nutrition (HFS-306),  
 Food and Drug Administration,   5100 Paint Branch Pkwy.,   College Park, MD 20740,   301-436-1486. 
 
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