. /.  WORLD TRADE  
ORGANIZATION  G/SPS/N/USA/933/Add.2 
15 September 2005 
 (05-4057) 
Committee on Sanitary a nd Phytosanitary Measures Original:   English 
  
 
NOTIFICATION  
 
Addendum
 
 
 
 The following communication, dated 12 September 2 005, is being circulated at the request of the 
Delegation of the United States.  
_______________ 
  
 On 7 September 2005, the Food and Drug Admini stration (FDA) issued an amendment to the 
interim final rule on use of materials derived from cattle in human food and cosmetics published in the 
Federal Register of 4 July 2004, 69 FR 42255.  In the 4 July 2004, interim final rule, FDA designated 
certain materials from cattle, including the entire sma ll intestine, as "prohibited cattle materials" and 
banned the use of such materials in human food, incl uding dietary supplements, and in cosmetics.  FDA 
took this action in response to comments received on th e interim final rule. Information was provided in 
comments that persuaded the agency that the distal ileum, one of three portions of the small intestine, 
could be consistently and effectively removed from th e small intestine, such that the remainder of the 
small intestine, formerly a prohibited cattle material, could be used for human food or cosmetics.  FDA is 
also clarifying that milk and milk products, hide and hide-derived products, and tallow derivatives are not 
prohibited cattle materials.  Comments also led the agen cy to reconsider the method cited in the interim 
final rule for determining insoluble impurities in tallow and to cite instead a method that is less costly to 
use and requires less specialized equipment.  The amen dments to the interim final rule are effective on 7 
October 2005, and comments are being accepted on the amendments through 7 November 2005. 
  Comments, identified by Docket No. 2004N-0081,  may be submitted by any of the following 
methods: 
     Federal eRulemaking Portal:  http://frwebgate.access.gpo.gov/cgi-
bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.regulations.gov .  
  Follow the instructions for submitting comments.      Agency Web site: http://frwebgate.access.gpo.gov/cgi-
bin/leaving.cgi?from=leavingFR.html&log=li nklog&to=http://www.fda.gov/dockets/ecomments .   
  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. 
     Mail/Hand delivery/Courier [For paper, disk , or CD-ROM submissions]:  Division of Dockets 
Management, Food and Drug Admini stration (HFA -305), 5630 Fisher s Lane, rm. 1061, Rockville, MD 
20852. 
 G/SPS/N/USA/933/Add.2 
Page 2  
 
  Instructions:  All submissions received must include the agency name and Docket No. or 
Regulatory Information Number (RIN) for this ru lemaking. All comments received will be posted 
without change to http://frwebgate.access.gpo.gov/cgi-
bin/leaving.cgi?from=leavingFR.html&log=linkl og&to=http://www.fda.gov/ohrms/dockets/default.htm,  
including any personal information provided. Fo r detailed instructions on submitting comments and 
additional information on the rulemaking process, see the "Effective Date and Opportunity for Public 
Comment'' heading of the SUPPLEMENTARY INFORMATION in section IV of this document.  
 The amendments to the interim final rule publis hed in the Federal Register on 7 September 2005, 
70 FR 53063, can be found at http://www.fda.gov/OHRMS/DOCKETS/98fr/05-17693.pdf
. 
 
 The July 2004 interim final rule can be found at 
http://www.fda.gov/OHRMS/DOCKETS/98fr/04-15881.pdf . 
 
 For further information contact:  Karen Carson,  Center for Food Safety and Applied Nutrition 
(HFS-265), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740-3835, 301-436-1664.   Ms. Julie Morin, United States SPS Enquiry Poin t Officer, USDA Foreign Agricultural Service, 
Food Safety & Technical Services Division, Stop 10 27, Washington D.C. 20250.  Tel:  202-720-4051;  
Fax:  202-690-0677;  Email:  fstsd@usda.gov
 
 
 
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