. /.   WORLD TRADE  
ORGANIZATION  G/SPS/N/USA/1652 
30 July 2007  
 (07-3234) 
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 numb er(s) as specified in national schedules 
deposited with the WTO; ICS numbers should be provided in addition, where 
applicable):  X-rays generated from machine sources at  energies not greater than 10 million 
electron volts (MeV) for the inspection of food,  providing the food does not receive a dose in 
excess of 0.5 gray (HS Code 9022.11-19) 
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, 4 pages) 
6. Description of content:  In the Federal Register of 19 July 2007 (72 FR 39557), the US Food 
and Drug Administration (FDA) responded to objec tions and denied a request that it received 
for a hearing on the final rule that was published in the Federal Register on 10 April 2001 (66 
FR 18537).  That final rule amended the food additive regulations in 21 CFR 179.21 
authorizing the use of X-rays at energies not  greater than 10 MeV to inspect food, provided 
that the food does not receive a dose in excess of 0.5 gray.  
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:   Final Rule in the 
Federal Register (66 FR 18537) (available in English), can be found on the Internet at: 
http://www.fda.gov/OHRMS/DOCKETS/98fr/041001a.pdf   The response to objections, 72 
FR 39557, can be found at: 
http://a257.g.akamaitech.net/7/257/2422 /01jan20071800/edocket.access.gpo.gov/2007/E7-
13947.htm  G/SPS/N/USA/1652 
Page 2  
 
  10. Proposed date of adoption:  10 April 2001 
11. Proposed date of entry into force:  10 April 2001 
12. Final date for comments:  Not applicable.  The docket for the petition on the use of 10 MeV 
X-rays for inspecting food (Docket Number 1994F- 000 8) closed as a result of the publication 
of the response to objections  and requests for a hearing. 
Agency or authority designated to handle comments:  [   ] National notification 
authority, [   ] National enquiry point, or address, fax number and E-mail address (if available) of other body: 
13. Texts available from:  [   ] National notifica tion authority, [ X ] National enquiry point, 
or address, fax number and E-mail ad dress (if available) of other body: United States SPS 
National Notification Authority, USDA Foreig n Agricultural Service, International 
Regulations and Standards Division, Stop 1027, Washington D.C. 20250.  Tel:  +(1 202) 720-1301;  Fax:  +(1 202) 690-0677;  E-mail :  us.spsenquirypoint@fas.usda.gov    
Complete text can be also be found on the Internet at  
http://www.accessdata.fda.gov/ scripts/oc/ohrms/index.cfm
 and insert Docket No. 94F-0008.   
For access to the docket to read backgr ound documents or comments received, go to 
http://www.fda.gov/ohrms /dockets/default.htm  and insert the Docket No. 94F-0008 into the 
"Search" box and follow the prompts.