. /.   WORLD TRADE  
ORGANIZATION  G/SPS/N/USA/933/Add.3 
23 April 2008  
 (08-1930) 
Committee on Sanitary a nd Phytosanitary Measures Original:   English 
  
 
 
NOTIFICATION  
 
Addendum
 
 
 
The following communication, received on 21 April 2008, is being circulated at the request of 
the Delegation of the United States . 
 
_______________  
 
 Use of Materials Derived From Ca ttle in Human Food and Cosmetics
 
 
In an interim final rule published in the Fe deral Register on 17 April 2008 (73 FR 20785), the 
US Food and Drug Administration (FDA) is amending its regulations on the use of materials derived 
from cattle in human food and cosmetics.  FDA regul ations designate certain materials from cattle as 
"prohibited cattle materials" and ban the use of such materials in human food, including dietary 
supplements, and in cosmetics to protect against possible risk for bovine spongiform encephalopathy 
(BSE).  Prohibited cattle materials include specified risk materials (SRMs), the small intestine of all 
cattle unless the distal ileum is removed, material from nonambulatory disabled cattle, material from 
cattle not inspected and passed for human consumpti on, or mechanically separated (MS) (Beef).  
Specified risk materials include the brain, skull,  eyes, trigeminal ganglia, spinal cord, vertebral 
column (excluding the vertebrae of the tail, th e transverse processes of the thoracic and lumbar 
vertebrae, and the wings of the sacrum), and dorsal r oot ganglia of cattle 30 months of age and older, 
and the tonsils and distal ileum of the small inte stine of all cattle.  These regulations were first 
published as an interim final rule in the Federal Register on 14 July 2004 (69 FR 42256), and were 
then amended in a subsequent interim fina l rule published in the Federal Register on 
7 September 2005 (70 FR 53063).  
In the interim final rule published on 17 Apr il 2008, FDA is amending its regulations so that 
FDA may designate a country as not subject to certa in BSE-related restrictions applicable to FDA 
regulated human food and cosmetics.  A country seeking to be so designated must send a written 
request to the Director of FDA's Centre for Food Safety and Applied Nutrition, including information 
about the country's BSE (bovine spongiform encephalopathy) case history, risk factors, measures to prevent the introduction and transmission of BSE, a nd any other relevant information.  Providing this 
exception will achieve essentially the same protection of public health with fewer restrictions on the 
market for cattle-derived materials.  The amen dments to the interim final rule published on 
17 April 2008 are effective 16 July 2008.  
Submit written or electronic comments on this interim final rule by 16 July 2008.  All 
submissions must include the agency name  (FDA), Docket No. 2004N-0081 and RIN 0910-AF47, 
and submitted by any of the following methods: 
 
 G/SPS/N/USA/933/Add.3 
Page 2  
 
  • Federal eRulemaking Portal:  http://www.regulations.gov
.  Follow the instructions for 
submitting comments. 
• Fax:  301 827 6870 • Mail/Hand delivery/Courier [For paper, disk, or CD-ROM submissions]:  Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852 
 
All comments received may be posted without change to http://www.regulations.gov
, 
including any personal information provided.  For additional information on submitting comments, 
see section IV of the Supplementary Information section of the interim final rule. 
 
The amendment to the interim final rule publis hed on 17 April 2008 in the Federal Register 
(73 FR 20785), can be found at http://www.fda.gov/OHRMS/DOCKETS/98fr/08-1142.pdf . 
 
The interim final rule previously publishe d in the Federal Register on 14 July 2004 
(69 FR 42256) can be found at:  http://www.fda.gov/OHRMS/DOCKETS/98fr/04-15881.pdf . 
 
The amendment to the interim final rule  published 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 . 
 
For further information contact:  Rebecca Buc kner, Centre for Food Safety and Applied 
Nutrition (HFS-316), Food and Drug Administration,  5100 Paint Branch Pkwy., College Park, MD 
20740, 301 436 1486.  
In addition, United States SPS National Notifi cation Authority may be contacted at USDA 
Foreign Agricultural Service, International Regul ations and Standards Division (IRSD), Stop 1027, 
Washington D.C. 20250.  Tel:  +(1 202) 720 1301;   Fax:  +(1 202) 720 0433;  E-mail:  
us.spsenquirypoint@fas.usda.gov.  
__________