G/TBT/N/USA/1004  
 
1 July 2015  
(15-3391)  Page: 1/2  
Committee on Technical Barriers to Trade  Original: English  
 
  NOTIFICATION 
The following notification is being circulated in accordance with Article 10.6 
 
1. Notifying Member: UNITED STATES OF AMERICA 
If applicable, name of local government involved (Article 3.2 and 7.2):  
2. Agency responsible: Environmental Protection Agency (EPA) [1022] 
Name and address (including telephon e and fax numbers, email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be indicated if different from above : 
Please submit comments to: USA WTO TBT Enquiry Point 
Email: ncsci@nist.gov  
3. Notified under Article 2.9.2 [ ], 2.10 .1 [ ], 5.6.2 [ ], 5.7.1 [ ], other: Transparency  
4. Products covered (HS or CCCN where applic able, otherwise national tariff heading. 
ICS numbers may be provided in addition, where applicable): Endocrine disruptor 
screening. Environmental protec tion (ICS: 13.020), Products of the chemical industry 
(ICS: 71.100) 
5. Title, number of pages and language(s) of the notified document: Use of High 
Throughput Assays and Computational Tools; Endocrine Disruptor Screening Program; 
Notice of Availability and Opportunity for Comment (6 pages, in English) 
6. Description of content: This document describes how EPA is planning to incorporate an 
alternative scientific approach to screen chem icals for their ability to interact with the 
endocrine system. This will impr ove the Agency's ability to fulfill its statutory mandate to 
screen pesticide chemicals and other substances for their ability to cause adverse effects 
by their interaction with the endocrine system . The approach incorporates validated high 
throughput assays and a computational model and, based on current research, can serve as an alternative for some of the current assays in the Endocrine Disruptor Screening 
Program (EDSP) Tier 1 battery. EPA has part ial screening results for over 1800 chemicals 
that have been evaluated using high throughput assays and a computational model for the estrogen receptor pathway. In the future, EPA anticipates that additional alternative 
methods will be available for EDSP chemical screening based on further advancements of 
high throughput assays and computational models for other endocrine pathways. Use of these alternative methods will accelerate the pace of screening, decrease costs, and 
reduce animal testing. In addition, this approa ch advances the goal of providing sensitive, 
specific, quantitative, and efficient screening using alternative test methods to some assays in the Tier 1 battery to protect human health and the environment.  
7. Objective and rationale, including the nature of urgent problems where applicable: 
Protection of animal or plant life or health; Protection of human health or safety; Protection of the environment G/TBT/N/USA/1004 
 
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  8. Relevant documents: 
 80 Federal Register (FR) 35350, 19 June 2015 
 G/TBT/N/USA/969 – Draft Test Guidelines; Endocrine Disruptor Screening Program 
Test Guidelines (Series 890); Three Tier 2 Non-Mammalian Tests; Notice of 
Availability and Request for Comment: http://www.gpo.gov/fdsys/pkg/FR- 2015-01-30/html/2015-01836.htm  
http://www.gpo.gov/fdsys/pkg/FR- 2015-01-30/pdf/ 2015-01836.pdf  
9. Proposed date of adoption: To be determined 
Proposed date of entry into force: To be determined 
10. Final date for comments: 18 August 2015 
11. Texts available from: National enquiry point [ ] or address, telephone and fax 
numbers and email and website addresses, if available, of other body:  
https://members.wto.org/crnattachm ents/2015/TBT/USA/15_2482_00_e.pdf