. /. WORLD TRADE  
ORGANIZATION   
G/SPS/N/USA/1016 
23 December 2004 
 (04-5650) 
Committee on Sanitary and 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):  Fully cooked shelf stable foods, including fully cooked multiple ingredient 
shelf stable foods  (Chapter 16 of the US Harmonized Tariff Code) 
4. Regions or countries likely to be affected , to the extent relevant or practicable:  
Trading partners.  
5. Title, language and number of pages of the notified document:  Direct Food Additives 
Permitted in Food for Human Consumption, Irradiation in the Pr oduction, Processing and 
Handling of Food (available in English, 1 page). 
6. Description of content:  A food additive petition (FAP 3M4744) has been filed by 
Sterigenics International, P.O. Box 17349, Me mphis, TN 31817-0349.  The petition proposes 
that the food additive regulations in part 179 Irradiation in the Production, Processing and 
Handling of Food (21 CFR 179) be amended to provide for the safe  use of ionizing radiation 
in the production of fully cooked shelf stab le foods, including fully cooked multiple 
ingredient shelf stable foods, where the absorbed dose required to cause a 12-log reduction in Clostridium botulinum has been established. 
7. Objective and rationale:  [ X ] food safety, [   ] animal health, [   ] plant protection, 
[   ] 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:    
9. Relevant documents and language(s) in which these are available:  Notification of filing 
of a food additive petition. The notice may be found at 69 FR 69606: 
http://www.fda.gov/OHRMS/ DOCKETS/98fr/04-26334.pdf  
10. Proposed date of adoption:   To be determined. 
11. Proposed date of entry into force:   To be determined. G/SPS/N/USA/1016 
Page 2  
 
 12. Final date for comments:  Comments will be accepted at anytime after publication of the 
notice of filing; however, if a final rule is promulgated, it w ill address only those comments 
that were received prior to publication of the final rule. 
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 Fi shers Lane, rm. 1061, Rockville, MD 20852, 
United States of America..  It is possible to submit electronic comments to:   http://www.fda.gov/dockets/ecomments . 
Submit comments by indicating DOCKET Nu mber 2004F–0455 and T itle of document: 
Sterigenics International, Inc.; Filing of Food Additive Petition 
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:  
US Enquiry Point, US Department of Agri culture, Stop 1027, Washington, DC  20250.  
Tel:  (202) 720-4051;   Fax:  (202) 6 90-0677;  E-mail:   fstsd@usda.gov .  Complete text can 
be also be found on the Internet: 
http://www.fda.gov/OHRMS/ DOCKETS/98fr/04-26334.pdf .   Comments to Dockets can be 
found at:   http://www.fda.gov/ohrms/dockets /dockets/dockets2004.htm  by looking under 
the DOCKET No. 2004F–0455 .