. /.  WORLD TRADE  
ORGANIZATION  G/SPS/N/USA/905 
21 April 2004 
 (04-1798) 
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:   U.S. Food and Drug Administration (FDA) 
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):  Poultry products and animal feeds 
4. Regions or countries likely to be affected, to the extent relevant or practicable:  Any 
US trade partners. 
5. Title, language and number of pages of the notified document:   Direct Food Additives 
Permitted in Food for Human Consumption, Cetylp yridinium Chloride (available in English, 
2 pages) 
6. Description of content:   U.S. FDA has issued a final rule amending the food additive 
regulations under Title 21, Code of Fede ral Regulations, part 73 for the use of 
cetylpyridinium chloride in food as an antimicr obial  agent to treat the surface of raw poultry 
carcasses.  During processing the additive is applied as a fine mist spray of an ambient 
temperature aqueous solu tion to raw poultry carcasses prior to immersion in a chiller at a 
level not to exceed 0.3 grams cetylridinium chloride per pound of raw poultry carcasses.   
The solution shall also contain propylene glycol at a concentration of 1.5 times that of the 
cetylpidinium chloride.  The additive shall be  used in systems that collect and recycle 
solution that is not carried out of the system with  the treated carcasses.  The captured additive 
will be disposed of in an appropriate manner.   
7. Objective and rationale:  [ X ] food safety, [   ] animal health, [   ] plant protection, 
[ X ] protect humans from anima l/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:    
9. Relevant documents and language(s ) in which these are available:  Final rule published in 
the Federal Register at 69 FR  17297 (available in English).   The notice can be found at: 
http://www.fda.gov/OHRMS/ DOCKETS/98fr/04-7399.pdf  
10. Proposed date of adoption:   This rule is effective 2 April 2004 G/SPS/N/USA/905 
Page 2  
 
 11. Proposed date of entry into force:   This rule is effective 2 April 2004 
12. Final date for comments:  Submit written or electronic objec tions and requests for a hearing 
by 3 May 2004. 
Agency or authority designated to handle comments:  Food And Drug Administration   
[  ] National notification authority, [   ] National enquiry point, or address, fax number 
and E-mail address (if ava ilable) of other body:    
Submit written comments on the document to the Dockets Management Branch (HFA-
305), Food and Drug Administration, 5630 Fish ers Lane, rm. 1061, Rockville, MD 20852, 
U.S.A. It is possible to submit electronic comments to:  http://www.fda.gov/dockets/ecomments
.  Submit comments by indicating Docket Number 
2002F-0181, and Title of document, Secondary  Direct Food Additives Permitted in Food 
for Human Consumption. 
13. Texts available from:  [   ] National notificati on authority, [ X ] National enquiry point, 
or address, fax number and E-mail address (if available) of other body:  
U.S. Enquiry Point, U.S. Department of Agriculture, Stop 1027, Washington, DC  20250.  
Tel (202) 720-0677, fstsd@usda.gov .  Complete text of the document can be also be found 
on the Internet at the following Website:   http://www.fda.gov/OHRMS/DOCKETS/98fr/04-7399.pdf
 
http://www.fda.gov/OHRMS/DOCKETS/98fr/04-7399.htm