. /.   WORLD TRADE  
ORGANIZATION  G/SPS/N/USA/2122 
15 December 2010  
 (10-6736) 
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):  Animals 
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:   N,N,N',N'',-Tetrakis-(2-Hydroxypropyl) 
Ethylenediamine (NTHE);  Exemption Fr om the Requirement of a Tolerance  Language:  
English  Number of pages:  7   
6. Description of content:  This final rule establishes an ex emption from the requirement of a 
tolerance for residues of N,N,N',N'',-Tetrakis-(2-Hydroxypropyl) Ethylenediamine (NTHE; 
CAS no. 102-60-3) when used as an inert ingred ient stabilizer for formulation for pre- and 
post-harvest uses under 40 CFR 180.910 and app lication to animals under 40 CFR 180.930, 
at a maximum concentration of 20 per cent by we ight in pesticide formulations.  The Joint 
Inerts Task Force (JITF), Cluster Suppor t Team Number 15 (CST 15) EPA Company 
No. 84947 submitted a petition to EPA under th e Federal Food, Drug, and Cosmetic Act 
(FFDCA), requesting establishment of an exemp tion from the requirement of a tolerance.  
This regulation eliminates the need to establish a maximum permissible level for residues of NTHE. 
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/2122 
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 Register and can be  found at:  Federal 
Register:  24 November 2010 (Volume 75, Number 226) Rules and Regulations; Pages 
71550-71556 or online at http://edocket.access.gpo.go v/2010/2010-29647.htm .   
10. Proposed date of adoption (dd/mm/yy) :  Not applicable 
Proposed date of publication (dd/mm/yy) :  24 November 2010 
11. Proposed date of entry into force:  [ ] Six months from date of publication , and/or  
(dd/mm/yy) :  24 November 2010 
[ ] 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:   
Lisa Austin, Registration Division (7505P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001;  Tel:  +(703) 305-7894;  E-mail address:  austin.lisa@epa.gov. 
Please reference docket EPA-HQ-OPP-2009-0130. 
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 Foreign Agricultural Service, 
International Regulations and Standards Di vision (IRSD), Stop 1027, Washington D.C. 
20250;  Tel:  +(1 202) 720 1301;  Fax:  +(1 202) 720 0433;  E-mail:  us.spsenquirypoint@fas.usda.gov