. /.   WORLD TRADE  
ORGANIZATION  G/SPS/N/USA/1223 
3 February 2006 
 (06-0460) 
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):  All Food Commodities.  
4. Regions or countries likely to be affected, to the extent relevant or practicable:  Any 
U.S. trade partners.  
5. Title, language and number of pages of the notified document:  Final rule.  Sorbitol 
Octanoate;  Exemption from the Requirement  of a Tolerance (Available in English, 
7 pages).  
6. Description of content:  This regulation establishes an exemption from the requirement of 
a tolerance for residues of the biochemical sorbitol octanoate on all food commodities when 
applied/used in accordance with label directions .  This regulation eliminates the need to 
establish a maximum permissible level for residu es of sorbitol octanoate.  Sorbitol octanoate 
is a fatty acid ester made from sorbitol and caprylic acid.  Caprylic acid, also known as 
octanoic acid, is a common fatty acid in plants th at is derived from edible oils or fats.  It 
also is produced in small quantities in the hum an body and is marketed as a human dietary 
supplement (Ref. 1).  Sorbitol, a food grade sw eetener occurs naturally in fruits such as 
apples, plums, pears, cherries, dates, peaches, and apricots (Ref. 2).  
Based on the toxicology information/data subm itted and other information available to the 
Agency, there is a reasonable certainty that no harm will result from aggregate exposure to 
residues of sorbitol octanoate to the U.S. po pulation, including infants and children, under 
reasonably foreseeable circumstances, when th e biochemical pesticide is used in accordance 
with product label directions and good agricultura l practices.  This includes all anticipated 
dietary exposures and all other non-occupati onal exposures for which there is reliable 
information.  The Agency has arrived at th is conclusion based on the information/data 
submitted (and publically available) demonstra ting negligible toxicity of the chemically-
similar SOEs and sorbitan esters, and of sorb itol octanoate's constituents (sorbitol and 
octanoic acid).  As a result, EPA is establishing an exemption from the tolerance requirements pursuant to FFDCA section 408(c) for residues of sorbitol octanoate in or on 
all food commodities.  
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/1223 
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: 
27 January 2006 (Volume 71, Number 18), Pages 4512-4518.  
http://www.epa.gov/fedrgstr/EPA-PEST/2006/January/Day-27/p756.htm , Available in 
English. 
10. Proposed date of adoption:   
11. Proposed date of entry into force:  This regulation is effective 27 January 2006.  
12. Final date for comments:   Objections and requests for hearings must be received on or 
before 28 March 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:  Biopesticides and Pollution Prevention Division (7511C), Office 
of Pesticide Programs, Environmental Prot ection 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:   
Ms Lashonda McLeod, United States SPS Nationa l Notification Authority, USDA Foreign 
Agricultural Service, Food Safety & Technical Services Division, Stop 1027, Washington, DC 20250.  Tel:  202-720-5683;  Fa x:  202-690-0677;  Email:  fstsd@fas.usda.gov