G/SPS/N/USA/933/Add.4  
 
8 March 2013  
(13-1286)  Page: 1/2  
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
 NOTIFICATION 
Addendum 
The following communication, received on 6 March 2013, is being circulated at the request 
of the Delegation of the United States of America. 
 
_______________ 
 
 Use of Materials Derived From Cattle in Human Food and Cosmetics; Reopening of the Comment 
Period 
 SUMMARY: The US Food and Drug Administrati on (FDA) is reopening the comment period 
for the interim final rule entitled "Use of Materials Derived From Cattle in Human Food and Cosmetics" that published in the Federal Register  of 14 July 2004 (69 FR 42256). The interim final 
rule prohibited the use of certain cattle material to  address the potential risk of bovine spongiform 
encephalopathy (BSE) in human food, including dietary supplements, and cosmetics. In the Federal Register of 7 September 2005 (70 FR 5306 3), FDA amended the interim final rule to make 
changes, including providing that the small intestine of cattle, formerly prohibited cattle material, 
could be used in human food and cosmetics if the distal ileum was removed by a specified procedure or one that the establishment could demonstrate is equally effective in ensuring complete removal of the distal ileum. Since 2005, peer-reviewed studies have been published 
showing the presence of infectivity in the proximal ileum, jejunum, ileocecal junction, and colon of 
cattle with BSE. Therefore, FDA is reopening the comment period for the interim final rule to give interested parties an opportunity to comment on the new studies concerning infectivity in parts of 
the small intestine other than the distal ileum. 
 Federal Register 78 FR 14012 4 March 2013, " http://www.gpo.gov/fdsys/pkg/FR-2013-03-
04/pdf/2013-04869.pdf " 
This addendum concerns a: 
[X] Modification of final date for comments 
[ ] Notification of adoption, publication or entry into force of regulation 
[ ] Modification of content and/or scope of  previously notified draft regulation 
[ ] Withdrawal of proposed regulation 
[ ] Change in proposed date of adoption, publication or date of entry into force 
[ ] Other:  FDA is reopening the comment period for the interim final rule. 
Comment period:  (If the addendum extends the scope of the previously notified 
measure in terms of products and/or potent ially affected Members, a new deadline for 
receipt of comments should be provided, norm ally of at least 60 calendar days.  Under 
other circumstances, such as extension of or iginally announced final date for comments, 
the comment period provided in the addendum may vary.)  
[ ] Sixty days from the date of circulation of the addendum to the notification and/or 
(dd/mm/yy) :  3 May 2013.  Submit electronic comments to 
http://www.regulations.gov. Submit writte n comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Use Docket number FDA-2004-N-0188 when 
submitting comments. G/SPS/N/USA/933/Add.4 
 
- 2 - 
 
  Agency or authority designated to handle comme nts:  [ ] National Notification Authority, 
[ ] National Enquiry Point.  Address, fax number and e-mail address (if available) of 
other body: 
Johnny Braddy, Center for Food Safetyand A pplied Nutrition (HFS-316), Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, +(1 240) 402 2131.  
Text available from:  [X] National Notification Authority, [ ] National Enquiry Point.  
Address, fax number and e-mail addre ss (if available) of other body: 
United States SPS National Notification Authority, USDA Foreign Agricultural Service, International 
Regulations and Standards Division (IRSD), Stop 1014, Washington D.C. 20250; Tel: +(1 202) 720 1301; Fax: +(1 202) 720 0433; E-mail: us.spsenquirypoint@fas.usda.gov  
 
__________