. /.  WORLD TRADE  
ORGANIZATION  G/SPS/N/USA/933/Add.1 
20 December 2004 
 
 (04-5580) 
Committee on Sanitary and Phytosanitary Measures Original:   English 
 
  
NOTIFICATION  
 
Addendum
 
 
  The following communication, dated 15 December 2004, is being circulated at the request of 
the Delegation of the United States
. 
 
_______________ 
 
  On 14 July 2004, 69 FR 42255, The Food and Drug Administration (FDA) issued an interim 
final rule titled  Use of Materials Derived From Cattle in Human Food and Cosmetics, Interim Final 
Rule (19 pages, available in English) to prohibit th e use of certain cattle material, to address the 
potential risk of bovine spongiform encephalop athy (BSE), in human food, including dietary 
supplements, and cosmetics.  Prohibited cattle materials include specified risk materials, small intestine of all cattle, material from nonambulatory disabled cattle, material from cattle not 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 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.   
 
 Most products covered under the interim final rule are represented by the following tariff codes from the Harmonized Tariff Schedule  of the United States (2004):  
0504 guts for use as casings, other than hog 0506.10.00 ossein (demineralized bones for gelatin) 0506.90.00 other bones 
0510.00.40 gland/organs used in production of pharmaceuticals (in this case dietary supplements)  
0511 dead animals 
1502.00.00 tallow, edible and inedible 
1516.10.00 animal fats and oils 
1517 margarine and edible mixtures of animal fats and oils 
2104 soups and broths 
2106.10.00 protein concentrates 
2106.90.58 gelatin 3003 medicaments (dietary supplements) not in measured doses or not packaged for retail sale 3004 medicaments (dietary supplements) in measured doses or packaged for retail sale 
3304 beauty or make-up preparations or skincare products 
3305 preparations for use on hair 
3306 preparations for oral or dental hygiene 
3307 pre-shave, shaving or after-shave preparations, personal deodorants, bath preparations, depilatories or cosmetics not elsewhere specified. 
  G/SPS/N/USA/933/Add.1 
Page 2  
 
  The document can be found at: 
http://www.fda.gov/OHRMS/D OCKETS/98fr/04-15881.pdf
 or  
http://www.fda.gov/OHRMS/D OCKETS/98fr/04-15881.htm  
 
 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 Point Officer, USDA Foreign Agricultural 
Service, Food Safety & Technical Services Division, Stop 1027, Washington D.C. 20250.  Tel:  202-
720-4051;  Fax:  202-690-0677;  Email:  fstsd@usda.gov  
 
 
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