. /.  WORLD TRADE  
ORGANIZATION  G/TBT/N/USA/67 
19 July 2004 
 (04-3076) 
Committee on Technical Barriers to Trade Original:  English 
   
NOTIFICATION 
 
The following notification is being circ ulated in accordance with Article 10.6. 
 
1. Member to Agreement notifying:   UNITED STATES
 
If applicable, name of local government involved (Articles 3.2 and 7.2):         
2. Agency responsible:   Food and Drug Administration  (72)  
Name and address (including telephone and fax numbers, e-mail and web-site 
addresses, if available) of  agency or authority designated to handle comments 
regarding the notification shall be  indicated if different from above:         
3. Notified under Article 2.9.2 [ X], 2.10.1 [   ], 5.6.2 [   ], 5.7.1 [   ], other:         
4. Products covered (HS or CCCN where applicable, otherwise national tariff heading. 
ICS numbers may be provided in  addition, where applicable):   Cosmetics and Human 
Food  (HS Chapters 33 and 2106) (ICS 67.020 and 71.100)   
5. Title, number of pages and language(s) of the notified document:   Recordkeeping 
Requirements for Human Food and Cosmetics Manufactured From, Processed With, or 
Otherwise Containing, Material From  Cattle  (10 pages, in English) 
6. Description of content:   The Food and Drug Administration (FDA) is proposing to require 
that manufacturers and processors of human  food and cosmetics that are manufactured 
from, processed with, or otherwise contain, ma terial from cattle must establish and maintain 
records sufficient to demonstrate the food or cosmetic is not manufactured from, processed 
with, or does not otherwise contain, prohibite d cattle materials.  This is a companion 
rulemaking to FDA's interim final rule entitle d "Use of Materials Derived From Cattle in 
Human Food and Cosmetics,'' published in this  issue of the Federal Register.  FDA is 
proposing recordkeeping requirements becau se records documenting the absence of 
prohibited cattle materials are needed by ma nufacturers and processors of human food and 
cosmetics that contain cattle material to ensu re that these products do not contain prohibited 
cattle materials.  In addition, such records are necessary to help FDA ensure compliance 
with the requirements of the interim final rule. 
7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of human health. 
8. Relevant documents:   69 Federal Register (FR) 42275 14 July 2004; Title 21 Code of 
Federal Regulations (CFR) Parts 189, and 700.  Will appear in the Federal Register when 
adopted. 
9. Proposed date of adoption:   
Proposed date of entry into force:   }To be determined G/TBT/N/USA/67 
Page 2  
 
10. Final date for comments:   13 August 2004 
11. Texts available from:  National enquiry point [ X] or address, telephone and fax 
numbers, e-mail and web-site addresses, if available of the other body:   
Available on the Internet at URLs: 
http://a257.g.akamaitech.net/7/257/24 22/06jun20041800/edocket.access.gpo.gov/2004/04-
15880.htm  
http://a257.g.akamaitech.net/7/257/2422/ 14mar20010800/edocket.access.gpo.gov/2004/pdf/
04-15880.pdf  
 