G/SPS/N/USA/933/Add.5  
 
21 March 2016  
(16-1612)  Page: 1/2  
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
  NOTIFICATION 
Addendum 
The following communication, received on 18 March 2016, is being circulated at the request of the 
Delegation of the United States of America. 
 
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 Use of Materials Derived From Cattle in Human Food and Cosmetics; Final rule; adoption of interim 
final rule as final with amendments 
The US Food and Drug Administration (FDA) is issuing a final rule prohibiting the use of certain cattle material to address the potential risk of bovine spongiform encephalopathy (BSE) in human food, including dietary supplements, and cosmeti cs. FDA has designated the following items as 
prohibited cattle materials: Specified risk materials (SRMs), the small intestine from all cattle 
(unless the distal ileum has been removed), material from nonambulatory disabled cattle, material from cattle not inspected and passed, or mechanical ly separated (MS) (Beef). It is taking this 
action to minimize human exposure to certain cattle material that could potentially contain the BSE 
agent. 
The text is available at Federal Register 81 FR 14718, 18 March 2016 and 
https://www.gpo.gov/fdsys/pkg/F R-2016-03-18/pdf /2016-06123.pdf . 
This addendum concerns a: 
[ ] Modification of final date for comments 
[X] 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:   
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) : Not applicable; Final rule. 
Agency or authority designated to handle co mments: [ ] National Notification Authority, 
[ ] National Enquiry Point. Address, fax nu mber and e-mail address (if available) of 
other body: 
Johnny Braddy, Center for Food Safety and Ap plied Nutrition (HFS-315), Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, +(1) 240 402 1709  G/SPS/N/USA/933/Add.5 
 
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  Text(s) available from: [X] National Notificati on 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 
Text can also be found in the Federal Register, Vol. 81, No. 53, Page 14781 or on the Internet at: 
https://www.gpo.gov/fdsys/pkg/F R-2016-03-18/pdf /2016-06123.pdf . 
 
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