. /.  WORLD TRADE  
ORGANIZATION  G/SPS/N/USA/1128 
3 October 2005 
 (05-4389) 
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):  Products using Malathion 
4. Regions or countries likely to be affected, to the extent relevant or practicable:  Any 
US trading partners 
5. Title, language and number of pages of the notified document:  NOTICE.  Malathion; 
Revised Risk Assessments, Notice of Ava ilability, and Solicitation of Risk Reduction 
Options (Available in English, 9 pages)  
6. Description of content:  This notice announces the availability of EPA's revised human 
health risk assessment and as well as the start of a 60-day comment period ecological risk 
assessment for the organophosphate pesticid e malathion.  A revised human health 
assessment on malathion was conducted to inco rporate toxicity data which EPA received 
after 2000. Since no additional ecological data  on malathion has been received after 2000, 
EPA's ecological risk characterization has rema ined unchanged.  This notice also solicits 
information or data from stakehol ders and interested parties to help refine the malathion risk 
assessment, and encourages parties to suggest  risk management ideas or proposals to 
address the potential risks which have been id entified. EPA is developing an Interim 
Reregistration Eligibility Decision (IRED) for malathion through the full, 6-Phase public 
participation process, which in this case incl udes reissuing the revised risk assessment for 
an additional Phase 5 public comment period.  The Agency uses this process to involve the public in developing pesticide reregistration a nd tolerance reassessment decisions. Through 
these programs, EPA is ensuring that all p esticides meet current health and safety. 
Malathion is characterized as a non-systemic , broad spectrum organophosphate pesticide 
with numerous commercial agricultural uses, re sidential uses and, as well as several wide 
area uses. Malathion's wide area applications include use as a public health mosquitocide, 
use to control fruit flies, and use in eradica tion programs such as the US Department of 
Argriculture's Boll Weevil Eradication Program. Malathion is also formulated into a pharmaceutical product (Ovide® Lotion) wh ich is approved by the Food and Drug 
Administration for the control of head lice and their ova. EPA's revised human health risk 
assessment has identified potential risks of con cern from various uses of malathion, some of 
which are derived mainly from potential exposure to malathion's oxygen metabolite, 
malaoxon. Concerns include potential exposur e to malaoxon through drinking water, and 
from drift as a result of wide area applications.  The Agency also has potential risk concerns G/SPS/N/USA/1128 
Page 2  
 
 for adults and children who may be exposed to malathion per se from the home fogger use 
of malathion.  EPA has also included an analys is of the pharmaceutical use of malathion. 
The analysis of the pharmaceutical use presents  the proposed safety findings on malathion 
as a pharmaceutical and a pesticide product from the joint perspective of both the Food and 
Drug Administration and EPA.  
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   
8. International standard, guideline or recommendation: 
[   ] Codex Alimentarius Commission,  [   ] World Organization for Animal Health 
(OIE), [   ] International Plant Protection Convention,  [   ] 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: 
23 September 2005 (Volume 70, Number 184, Pages 55839-55842, 
http://www.epa.gov/fedrgstr/EPA-PEST/ 2005/September/Day-23/p18705.htm  (Available in 
English)  
10. Proposed date of adoption:   
11. Proposed date of entry into force:  Not Applicable– this is a notice of availability and may 
or may not result in a future regulatory action.  A notice invites the public to submit 
additional scientific information and comments to the Agency.  
12. Final date for comments:  Comments must be received on or before 22 November 2005.  
EPA has established a docket for this action under docket identification (ID) number OPP-
2004-0348.  
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:   Special Review and Reregistration Division (7508c), 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:   
Ms. Julie Morin, United States SPS National Notification Authority, USDA Foreign 
Agricultural Service, Food Safety & Technical Services Division, Stop 1027, Washington 
D.C. 20250. Tel:  202-720-4051; Fax:  202-690-0677; E-mail:  fstsd@usda.gov