. /.   WORLD TRADE  
ORGANIZATION  G/SPS/N/USA/2206 
27 April 2011  
 (11-2165) 
Committee on Sanitary a nd Phytosanitary Measures Original:   English 
  
 
NOTIFICATION 
 
1. Notifying Member:  UNITED STATES
 
If applicable, name of local government involved:    
2. Agency responsible:  US Environmental Protection Agency 
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):  Multiple products 
4. Regions or countries likely to be affected, to the extent relevant or practicable: 
[X] All trading partners   
[ ] Specific regions or countries:    
5. Title of the notified document:  FINAL RULE:   Escherichia coli O157:H7 Specific 
Bacteriophages;  Temporary Exemption from the Requirement of a Tolerance 
Language(s):  English  Number of pages:  5 
6. Description of content:  This final rule establishes a temporary exemption from the 
requirement of a tolerance for residues of lytic bacteriophages that are specific to 
Escherichia coli O157:H7, sequence negative for shiga toxins I and II, and grown on toxigenic host bacteria when applied/used  on food contact surfaces in food processing 
plants in accordance with the terms of E xperimental Use Permit (EUP) No. 74234-EUP-2. 
Intralytix, Inc. submitted a petition to EPA under the Federal Food, Drug, and Cosmetic 
Act (FFDCA), requesting the temporary toleran ce exemption.  This regulation eliminates 
the need to establish a maximum permissible le vel for residues of lytic bacteriophages that 
are specific to Escherichia coli O157:H7, seque nce negative for shiga toxins I and II, and 
grown on atoxigenic host bacteria. The temporary tolerance exemption expires on 1 April 2013. 
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. Is there a relevant international stan dard?  If so, identify the standard:  
[ ] Codex Alimentarius Commission (e.g.  title or serial number of Codex standard 
or related text)   
[ ] World Organization for Animal Health (OIE) (e.g. Terrestrial or Aquatic 
Animal Health Code, chapter number)    
[ ] International Plant Protection Convention (e.g. ISPM number)    G/SPS/N/USA/2206 
Page 2  
 
  [X] None 
Does this proposed regulation conform to the relevant international standard?   
 [ ] Yes   [ ] No 
 If no, describe, whenever possible, how and why it deviates from the 
international standard:    
9. Other relevant documents and language (s) in which these are available:  This 
document has been published in the Federal Regi ster and can be found at: Federal Register:  
13 April 2011 (Volume 76, Number 71) Rules and Regulations Page 20542-20546 
Or online at http://edocket.access.gpo. gov/2011/2011-8712.htm    
10. Proposed date of adoption (dd/mm/yy) :  13 April 2011 
Proposed date of publication (dd/mm/yy) :  13 April 2011 
11. Proposed date of entry into force:  [ ] Six months from date of publication , and/or  
(dd/mm/yy) :  13 April 2011 
[ ] Trade facilitating measure   
12. Final date for comments:  [ ] Sixty days from the date of circulation of the notification 
and/or (dd/mm/yy) :  Not applicable 
Agency or authority designated to handl e comments:  [ ] National Notification 
Authority, [ ] National Enquiry Point.  Address, fax number and e-mail address (if available) of other body:  Tracy Lantz, Antimicrobials Division (7510P), Office of 
Pesticide Programs, Environmental Protec tion Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001;  Tel:  +(703) 308-6415;  E-mail:  lantz.tracy@epa.gov 
Please reference docket EPA-HQ-OPP-2010-0274 
13. Texts available from:  [X] National Notification Authority, [ ] National Enquiry Point.  
Address, fax number and e-mail address (if available) of other body:   United States 
SPS National Notification Authority, USDA Fore ign Agricultural Service, International 
Regulations and Standards Division (IRSD), Stop 1027, Washington D.C. 20250;  Tel:  +(1 202) 720 1301;  Fax:  +(1 202) 720 0433;  E-mail:  us.s psenquirypoint@fas.usda.gov