  
  
G/TBT/N/USA/1276/Rev.1  
1 November 2023  
(23-7365) Page: 1/2 
Committee on Technical Barriers to Trade  Original:  English  
 
  
NOTIFICATION  
Revision  
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 (Articles 3.2 and 7.2):   
2. Agency responsible:   
Environmental Protection Agency (EPA)  
Name and address (including telephone and fax numbers, email and website 
addresses, if available) of  agency or authority designated to handle comments 
regarding the notification shall be indicated if diff erent from above:   
Please submit comments to: USA WTO TBT Enquiry Point  
Email: usatbtep@nist.gov  
3. Notified under Article 2.9.2 [  ], 2.10.1 [  ], 5.6.2 [  ], 5.7.1 [  ], 3.2 [  ], 7.2 [  ], 
other  [X]: EPA is primarily proposing to amend procedural requirements that apply to its 
activities in carrying out risk evaluations under the Toxic Substances Control Act (TSCA). 
However, the Agency is also proposing certain amendments to the pro cess and 
requirements that manufacturers (including importers) would be required to follow when 
they request an Agency -conducted TSCA risk evaluation on a particular chemical 
substance.  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading.  ICS numbers may be provided in addition, where applicable):  Chemical 
substances; Environment and environmental protection in general (ICS code(s): 
13.020.01); Production in the chemical industry (ICS code(s): 71.020); Products of the 
chemic al industry (ICS code(s): 71.100)  
5. Title, number of pages and language(s) of the notified document:  Procedures for 
Chemical Risk Evaluation Under the Amended Toxic Substances Control Act (35 pages, in 
English).; (35 page(s), in English)  
6. Description of content:  Proposed rule - The Environmental Protection Agency (EPA, "the 
Agency") is proposing to amend the procedural framework rule for conducting risk 
evaluations  under the Toxic Substances Control Act (TSCA) . The purpose o f risk 
evaluations under TSCA is to determine whether a chemical substance presents an 
unreasonable risk of injury to health or the environment, without consideration of costs 
or non -risk factors, including unreasonable risk to potentially exposed or susce ptible 
subpopulations identified as relevant to the risk evaluation by EPA, under the conditions 
of use. EPA has reconsidered the procedural framework rule for conducting such risk 
evaluations and determined that certain aspects of that framework should be  revised to 
better align with applicable court decisions and the statutory text, to reflect the Agency's 
experience implementing the risk evaluation program following enactment of the 2016 G/TBT/N/USA/1276/Rev.1  
 
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  TSCA amendments, and to allow for consideration of future scientifi c advances in the risk 
evaluation process without need to further amend the Agency's procedural rule.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of human health or safety; Protection of animal or plant  life or 
health; Protection of the environment   
8. Relevant documents:  88 Federal Register (FR) 74292, 30 October 2023; Title 40 Code 
of Federal Regulations (CFR) Part 702 : 
https://www.govinfo.gov/content/pkg/FR -2023-10-30/html/2023 -23428.htm  
https://www.govinfo.gov/content/pkg/FR -2023-10-30/pdf/2023 -23428.pdf  
This proposed rule is identified by Docket Number EPA -HQ-OPPT-2023-0496. The Docket 
Folder is available on Regulations.gov  at https://www.regulations.gov/docket/EPA -HQ-
OPPT-2023-0496/document  and provides access to primary and supporting documents as 
well as comments received. Docume nts are also accessible from Regulations.gov by 
searching the Docket Number. WTO Members and their stakeholders are asked to submit 
comments to the USA TBT Enquiry Point . Comments re ceived by the USA TBT Enquiry 
Point from WTO Members and their stakeholders by 4pm Eastern Time  on 14 December 
2023 will be shared with the regulator and will also be submitted to the Docket  on 
Regulations.gov if received within the comment period.  
9. Proposed date of adoption:  To be determined  
Proposed date of entry into force:  14 December 2023  
10. Final date for comments:  14 December 2023  
11. Texts available from:  National enquiry point [ ] or address, telephone or fax 
numbers  and email and website address es, if available , of other body:   
https://members.wto.org/crnattachments/2023/TBT/USA/23_13256_00_e.pdf  
 