. /.  WORLD TRADE  
ORGANIZATION  G/SPS/N/USA/1105 
23 August 2005 
 (05-3736) 
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  
3. Products covered (provide tariff item number(s) as specified in national schedules 
deposited with the WTO; ICS numbers should be provided in addition, where 
applicable):  Molluscan shellfish  
4. Regions or countries likely to be affected , to the extent relevant or practicable:  
Trading partners  
5. Title, language and number of p ages of the notified document:  Irradiation in the 
Production, Processing, and Handling of Food, Fi nal rule (Available in English, 16 pages)  
6. Description of content:  The Food and Drug Administration (FDA) is amending the food 
additive regulations to provide for the safe use of ionizing radiation for control of Vibrio species and other foodborne pathogens in fresh or frozen molluscan shellfish (e.g., oysters, mussels, clams, etc.).  This action is in res ponse to a petition filed by the National Fisheries 
Institute and the Louisiana Department of Agriculture and Forestry.  
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:   
Notice in the Federal Register (70 FR 48057-48073; available in English)  
http://www.fda.gov/OHRMS/ DOCKETS/98fr/05-16279.pdf  
10. Proposed date of adoption:  16 August 2005  
11. Proposed date of entry into force:  16 August 2005  G/SPS/N/USA/1105 
Page 2  
 
 
12. Final date for comments:  Submit written or electronic objections and requests for a 
hearing by 15 September 2005.  See section VI  of this document for information on the 
filing of objections.  You may submit written or electronic objections and requests for a 
hearing identified by Docket No. 1999F-4372, by any of the following methods: 
     Federal eRulemaking Portal: http://www.regulations.gov
.  
Follow the instructions for submitting comments.      Agency Web site: http://www.fda.gov/dockets/ecomments
.  
Follow the instructions for submitti ng comments on the agency Web site. 
     E-mail: fdadockets@oc.fda.gov . Include Docket No. 1999F-4372 in the subject line of 
your e-mail message. 
     Fax: 301-827-6870      Mail/Hand delivery/Courier [For paper, disk, or CD-ROM submissions]:  Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852 
    Instructions: All submissions received must include the agency name and docket number 
for this rulemaking. All objections recei ved will be posted w ithout change to 
http://www.fda.gov/ohrms/dockets/default.htm
, including any personal information 
provided. For detailed instructions on submitti ng objections, see the ``Objections'' heading 
of the SUPPLEMENTARY INFORMATION section of this document. 
    Docket: For access to the docket to read background documents or comments received, 
go to http://www.fda.gov/ohrms/dockets/default.htm  and insert the docket number, found in 
brackets in the heading of this document, into the ``Search'' box and follow the prompts. 
Agency or authority designated to handle comments:  [    ] National notification 
authority, [  X ] National enquiry point, or add ress, fax number and E-mail address (if 
available) of other body:        
13. Texts available from:  [    ] National notification 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:   202-690-0677, E.mail:  fstsd@usda.gov .    Complete text can 
also be found on the Internet http://www.accessdata.fda.gov/scripts/oc/ohrms/index.cfm  by 
looking under Docket No. 1999-4372.