. /.  WORLD TRADE  
ORGANIZATION  G/SPS/N/USA/1018 
6 January 2005 
 (05-0052) 
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 - 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):  X-rays generated from mach ine sources using tantalum  or gold as the target 
material and using energies not to exceed 7.5 million electron volts (MeV) for the treatment 
of foods as regulated in 21 CFR 179.26. 
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:   Irradiation in the 
Production, Processing and Handling of Food, Fi nal Rule (available in English, 3 pages). 
6. Description of content:  FDA has issued a final rule es tablishing a new maximum permitted 
energy level of x-rays for treating food of 7. 5 MeV provided that the x-rays are generated 
from machine sources that use tantalum or gold as  the target material, with no change in the 
maximum permitted dose levels or uses cu rrently permitted by FDA's food additive 
regulations (21 CFR 179.26). 
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 thes e are available:  Notice of Filing in the 
Federal Register  (68 FR 12087, 3 March 2003) (available in English) 
(http://www.fda.gov/OHRM S/DOCKETS/98fr/03-5955.pdf ), Final Rule in the Federal 
Register  (69 FR 76844) (available in English). 
(http://www.fda.gov/OHRMS/ DOCKETS/98fr/04-28043.htm, 
http://www.fda.gov/OHRMS/ DOCKETS/98fr/04-28043.pdf ) 
10. Proposed date of adoption:   23 December 2004 
11. Proposed date of entry into force:   23 December 2004 G/SPS/N/USA/1018 
Page 2  
 
 12. Final date for comments:  24 January 2005 
Agency or authority designated to handle comments:  [ X ] National notification 
authority, [   ] National enquiry point, or address, fax number and E-mail address (if available) of other body:    
Submit written comments on the document to the Division of Dockets Management  
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, 
MD 20852, United States.  It is possible to submit electronic comments to:   http://www.fda.gov/dockets/ecomments
.  Submit comments by indicating DOCKET 
Number 2003F-0088 and title of document, Irradiation in the Production, Processing and 
Handling of Food  
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 Department of Agriculture, Stop 1027, Washington, DC 20250.  Tel:  (202) 720-4051;  
Fax:  (202) 690-0677;  E-mail:  fstsd@usda.gov .  Complete text can be also be found on 
the Internet:  http://www.accessdata. fda.gov/scripts/oc/ohrms/index.cfm  by looking under 
DOCKET No. 2003F-0088.