. /.   WORLD TRADE  
ORGANIZATION  G/SPS/N/USA/1413 
4 September 2006 
 (06-4191) 
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  
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):  Bacteriophage prepara tion on ready-to-eat meat and poultry products  
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:  Food Additives 
Permitted for Direct Addition to Food for Hu man Consumption;  Bact eriophage Preparation 
(Available in English, 4 pages)  
6. Description of content:  The US Food and Drug Administra tion (FDA) issued a final rule 
amending the food additive regula tions under Title 21, Code of Federal Regulations part 172 
for the safe use of a bacteriophage preparation on ready-to-eat meat an d poultry products as an 
antimicrobial agent against Listeria monocytogenes . 
FDA had published the food additive petition on 22 July 2002 in 67 FR 47823.  
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 published 
in the Federal Register at 71 FR 47729 (availa ble in English).  The notice can be found at 
http://a257.g.akamaitech.net/7/257/24 22/01jan20061800/edocket.access.gpo.gov/2006/pdf/
E6-13621.pdf . 
10. Proposed date of adoption:  The rule is effective 18 August 2006.  
11. Proposed date of entry into force:  The rule is effective 18 August 2006.  G/SPS/N/USA/1413 
Page 2  
 
  12. Final date for comments:  18 September 2006  
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 or electronic comments identified by Docket No. 2002F-0316, 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 submitting comments on the agency Web site. 
 
Submit written submissions in the following ways: 
• 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 without change to 
http://www.fda.gov/ohrms/dockets/default.htm . 
13. Texts available from:  [   ] National notification authority, [ X ] National enquiry point, 
or address, fax number and E-mail address (if available) of other body:  Deborah 
Thompson, SPS National Notification Authority, USDA Foreign Agricultural Service, Food Safety & Technical Services Division, St op 1027, Washington D.C. 20250.  Telephone:  
202-720-1301 Fax:  202-690-0677;  Email:  fstsd@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. 2002F-0316.  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 No. 2002F-0316 into the "Search" box and follow the prompts.