. /.  WORLD TRADE  
ORGANIZATION   
G/SPS/N/USA/2462 
14 September 2012  
 (12-4921) 
Committee on Sanitary and Phytosanitary Measures Original:   English 
  
 
NOTIFICATION 
 
1. Notifying Member:  UNITED STATES OF AMERICA 
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):  Almonds, cucurbit vegetables, fruiti ng vegetables, ginseng, grapes, 
pistachios, pome fruits, potatoes, and strawberries 
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:  Polyoxin D Zinc Salt;  Amendment to an Exemption 
From the Requirement of a Tolerance  Language(s):  English  Number of pages:  6 
http://www.gpo.gov/fdsys/pkg/FR-2012-09-12/html/2012-22315.htm  
6. Description of content:  This regulation amends the existing exemption from the 
requirement of a tolerance for residues of polyo xin D zinc salt when used as a fungicide on 
almonds, cucurbit vegetables, fruiting vegetables,  ginseng, grapes, pistachios, pome fruits, 
potatoes, and strawberries by expanding th e current exemption to include all food 
commodities.  This regulation establishes an ex emption from the requirement of a tolerance 
for residues of polyoxin D zinc salt in or on all food commodities when applied as a fungicide and used in accordance with good ag ricultural practices.  On behalf of Kaken 
Pharmaceutical Co., Ltd., Conn & Smith, Inc. submitted a petition to EPA under the 
Federal Food, Drug, and Cosmetic Act (FFDCA ), requesting that EPA amend the existing 
exemption from the requirement of a tolerance for polyoxin D zinc salt.  This regulation eliminates the need to establish a maximum pe rmissible level for residues of polyoxin D 
zinc salt under the FFDCA. 
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)   G/SPS/N/USA/2462 
Page 2  
 
  [ ] World Organization for Animal Health (OIE) (e.g. Terrestrial or Aquatic 
Animal Health Code, chapter number)    
[ ] International Plant Protection Convention (e.g. ISPM number)    
[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:  
http://www.gpo.gov/fdsys/pkg/FR-2012-03-14/html/2012-6056.htm  (available in English) 
10. Proposed date of adoption (dd/mm/yy) :  12 September 2012 
Proposed date of publication (dd/mm/yy) :  12 September 2012 
11. Proposed date of entry into force:  [ ] Six months from date of publication , and/or  
(dd/mm/yy) :  12 September 2012 
[ ] Trade facilitating measure   
12. Final date for comments:  [ ] Sixty days from the date of circulation of the notification 
and/or (dd/mm/yy) :  13 November 2012 
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:  Colin G. Walsh, Biopesticides and Pollution Prevention 
Division (7511P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001;  Tel:  +(703) 308 0298;  E-mail:  walsh.colin@epa.gov. 
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 1014, Washington D.C. 20250;  Tel:  +(1 
202) 720 1301;  Fax:  +(1 202) 720 0433;  E-mail:  us.s psenquirypoint@fas.usda.gov