. /.  WORLD TRADE  
ORGANIZATION  G/SPS/N/USA/934 
20 July 2004 
 (04-3115) 
Committee on Sanitary a nd Phytosanitary Measures Original:   English 
  
 
NOTIFICATION  
 
1. Member to Agreement notifying:   UNITED STATES
 
If applicable, name of local government involved: 
2. Agency responsible:   US Food and Drug Administration 
3. Products covered (provide tariff item numbe r(s) as specified in national schedules 
deposited with the WTO; ICS numbers should be provided in addition, where 
applicable):  Food for human consumption and cosmetics for use in the United States, except 
for meat, poultry and egg products that are excl usively regulated by th e US Department of 
Agriculture 
4. Regions or countries likely to be affected , to the extent relevant or practicable:  
Trading partners who import human food  or cosmetics into the United States  
5. Title, language and number of pages of the notified document:   Recordkeeping 
Requirements for Human Food and Cosmetics Manufactured From, Processed With, or 
Otherwise Containing, Material From Cattle, Proposed Rule (11 pages, available 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,  material from cattle must establish and 
maintain records sufficient to demonstrate th e food or cosmetic is not manufactured from, 
processed with, or does not otherwise contain,  prohibited cattle materials.  This is a 
companion rulemaking to FDA’s interim fina l rule entitled "Use of Materials Derived 
From Cattle in Human Food and Cosmetics" (Federal Register, vol 69, pp. 42255-74; 
14 July 2004).  FDA is proposing recordkeeping requirements because records documenting the absence of prohibited cattle ma terials are needed by manufacturers and 
processors of human food and cosmetics that c ontain cattle material to ensure that these 
products do not contain prohibited cattle material s.  In addition, such  records are necessary 
to help FDA ensure compliance with the requirements of the interim final rule. 
7. Objective and rationale:  [ X ] food safety, [   ] animal health, [   ] plant protection, 
[ X ] protect humans from animal/plant pest or disease, [   ] protect territory from other damage from pests 
8. International standard, guideline or recommendation:  
[   ] Codex Alimentarius Commission, [   ] World Organization for Animal Health 
(OIE), [   ] International Plant Protection Convention, [ X ] None  
If an international standard, guideline or recommendation exists, give the appropriate 
reference and briefly identify deviations:  G/SPS/N/USA/934 
Page 2  
 
 9. Relevant documents and language(s) in which these are available:  Notice of Proposed 
Rulemaking in the Federal Register (FR), 69 FR 42274-42285 (available in  English).  It can 
be found at:  http://www.fda.gov/OHRMS/DOCKETS/98fr/04-15880.pdf
  o r   
http://www.fda.gov/OHRMS/DOCKETS/98fr/04-15880.htm  
10. Proposed date of adoption:   The date on which any rulemaking based on this proposal is 
finalized. 
11. Proposed date of entry into force:   The Food and Drug Administration is proposing that 
any final rule based on this  proposed rule be effective 30 days after issuance of that final rule. 
12. Final date for comments:  Submit written or electronic  comments by 13 August 2004 
Agency or authority designated to handle comments:  [   ] National notification 
authority, [  X] National enquiry point, or address, fax number and E-mail address (if 
available) of other body:    
Submit written comments on the document to the Dockets Management Branch (HFA-
305), Food and Drug Administration, 5630 Fisher s Lane, rm. 1061, Rockville, MD 20852, 
USA.  It is possible to submit electronic comments to:   http://www.fda.gov/dockets/ecomments
.  Submit comments by indicating DOCKET 
Number 2004N-0257 and Title "Recordkeep ing Requirements for Human Food and 
Cosmetics Manufactured From, Processed With, or Otherwise Containing, Material From 
Cattle". 
13. Texts available from:  [   ] National notificati on authority, [ X ] National enquiry point, 
or address, fax number and E-mail add ress (if available) of other body:  US Enquiry 
Point, US Department of Agriculture, Stop 1027, Washington, DC  20250;  Tel:  (202) 720-0677;  E-mail:  fstsd@usda.gov
.  Complete text can also be found on the Internet at 
http://www.fda.gov/OHRMS/DOCKETS/98fr/04-15880.pdf