. /.   WORLD TRADE  
ORGANIZATION  G/SPS/N/USA/1548 
8 May 2007 
 (07-1916) 
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:  Environmental Protection Agency (EPA) 
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):   Various 
4. Regions or countries likely to be affected, to the extent relevant or practicable:  Any 
US trade partners 
5. Title, language and number of pages of the notified document:  NOTICE.  Formetanate 
Hydrochloride; Modification and Closure of Interim Reregistration Eligibility Decision; 
Notice (available in English, 2 pages) 
6. Description of content:  This notice announces EPA's intention to modify certain risk 
mitigation measures that were imposed as a r esult of the 2006 Interim Reregistration 
Eligibility Decision (IRED) for the pesticid e formetanate hydrochloride (HCl). EPA 
conducted this reassessment of the formet anate HCl IRED in response to comments 
received regarding endpoints chosen for the assessment. The Agency agreed that the 
toxicity endpoints for human health risk ass essment should be re-evaluated.  Hence, the 
resulting assessment modified the mitigation lis ted in the IRED. Therefore, on formetanate 
HCl labels, there will be no requirement for closed cabs for applicators using air-blast 
sprayers on orchard fruit and the Restricted En try Intervals are modified for alfalfa (from 9 
to 4 days), pome and stone fruit (from 8 to 5 da ys) and citrus fruit (from 10 to 9 days).  The 
Agency has reassessed and consequently modifi ed its original dermal and inhalation points 
of departure of 0.1 mg/kg for inhalation a nd 10 mg/kg for dermal to 0.18 mg/kg for the 
inhalation endpoint and 15 mg/kg for dermal.  Th is change in endpoint selection resulted in 
acceptable Margins of Exposure (MOEs) for orchard air-blast applications when using 
double layer Personal Protective Equipment ( PPE).  The Agency has also updated the 
formetanate HCl IRED including a Respon se to Comments memorandum and an updated 
label table. 
7. Objective and rationale: [ X ] food safety,  [   ] animal health,  [ X ] plant protection, 
[ X ] protect humans from animal/plant pest or disease, [   ] protect territory from other damage from pests   G/SPS/N/USA/1548 
Page 2  
 
  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:   
Federal Register: 25 April 2007 (Volume 72, Number 79) Notices Page 20543-20544; 
http://www.epa.gov/fedrgstr/EPA-PEST/2007/April/Day-25/p7766.htm  
10. Proposed date of adoption:  N/A 
11. Proposed date of entry into force:  This is a notification which may or may not result in 
further regulatory action. 
12. Final date for comments:  Comments must be received by 25 June 2007, and may be 
identified by docket number EPA-HQ-OPP-2004-0032. 
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:  Registration Division, (7505P), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001  
13. Texts available from:  [ X ] National notifi cation authority, [   ] National enquiry 
point, or 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:  202-720-1301;  Fax:  2 02-690-0677;  E-mail:  fstsd@fas.usda.gov