. /.  WORLD TRADE  
ORGANIZATION  G/SPS/N/USA/1017 
4 January 2005 
 (05-0012) 
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):  Monoenergetic neutron sources producing ne utrons at energies not less than 1 
million electron volts (MeV) but no greater than 14 MeV for inspection purposes. 
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 F ood (available in English, 4 pages). 
6. Description of content:  FDA has issued a final rule to provide for the safe use of  
monoenergetic neutron sources of fast (1-14 MeV)  neutrons to inspect cargo containers that 
may contain food, provided that the absorb ed dose in food does not exceed 0.01 Gray 
(21 CFR 179.21).  Notice of filing for this  petition published on 18 November 1993, in 
58 FR 60860. 
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 (58 FR 60860) (available in English) (document not available by electronic 
means), Final Rule in the Federal Register  (69 FR 76401) (available in English) (can be 
found at http://www.fda.gov/OHRMS/DOCKETS/98fr/04-27868.htm .)   
10. Proposed date of adoption:   21 December 2004 
11. Proposed date of entry into force:   21 December 2004 G/SPS/N/USA/1017 
Page 2  
 
 12. Final date for comments:  20 January 2005 
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 Division of Dockets Management  
(HFA-305), Food and Drug Administration, 5630 Fishers 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 93F-0357 and title of document. 
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) 720-4051  Fax:  (202) 720-0677,  E-mail:  fstsd@usda.gov .  Complete text can 
be also be found on the Internet:  http://www.fda.gov/OHRMS/DOCKETS/98fr/04-
27868.htm  by looking under DOCKET No. 1993F-0357.