G/TBT/N/USA/2008  
19 June 2023  
(23-4158) 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) [2039]  
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 different from above:   
Please submit comments to: USA WTO TBT Enquiry Point, Email: usatbtep@nist.gov  
3. Notified under Article 2.9.2 [X], 2.10.1 [  ], 5.6.2 [X], 5.7.1 [  ], 3.2 [  ], 7.2 [  ], 
other :  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  
Perchloroethylene (PCE); Quality (ICS code(s): 03.120); Environmental protection (ICS 
code(s): 13.020); Occupation al safety. Industrial hygiene (ICS code(s): 13.100); 
Domestic safety (ICS code(s): 13.120); Production in the chemical industry (ICS code(s): 
71.020); Products of the chemical industry (ICS code(s): 71.100)  
5. Title, number of pages and language(s) of the  notified document:  
Perchloroethylene (PCE); Regulation Under the Toxic Substances Control Act (TSCA); (72 
page(s), in English)  
6. Description of content:  Proposed rule - The Environmental Protection Agency (EPA) is 
proposing to address the unreasonable r isk of injury to human health presented by 
perchloroethylene (PCE)  under its conditions of use as documented in EPA's December 
2020 Risk Evaluation for PCE  and December 2022 revised risk determination for PCE  
prepared under the Toxic Substances Control Act (TSCA) . PCE is a widely used solvent in 
a variety of occupational and consumer applications including fluorinated compound 
production, petroleum manufacturing, dry cleaning, and aerosol degreasing. EPA 
determined that PCE presents an unreasonable risk of injury to  health due to the 
significant adverse health effects associated with exposure to PCE, including neurotoxicity 
effects from acute and chronic inhalation exposures and dermal exposures, and cancer 
from chronic inhalation exposures to PCE. TSCA requires that  EPA address by rule any 
unreasonable risk of injury to health or the environment identified in a TSCA risk 
evaluation and apply requirements to the extent necessary so the chemical no longer 
presents unreasonable risk. PCE, also known as perc and tetrachl oroethylene, is a 
neurotoxicant and a likely human carcinogen. Neurotoxicity, in particular impaired visual 
and cognitive function and diminished color discrimination, are the most sensitive adverse 
effects driving the unreasonable risk of PCE, and other a dverse effects associated with 
exposure include central nervous system depression, kidney and liver effects, immune 
system toxicity, developmental toxicity, and cancer. To address the identified 
unreasonable risk, EPA is proposing to prohibit most industri al and commercial uses of G/TBT/N/USA/2008  
 
- 2 - 
 
  PCE; the manufacture (including import), processing, and distribution in commerce of PCE 
for the prohibited industrial and commercial uses; the manufacture (including import), 
processing, and distribution in commerce of PCE for al l consumer use; and, the 
manufacture (including import), processing, distribution in commerce, and use of PCE in 
dry cleaning and related spot cleaning through a 10 -year phaseout. For certain conditions 
of use that would not be subject to a prohibition, EP A is also proposing to require a PCE 
workplace chemical protection program that includes requirements to meet an inhalation 
exposure concentration limit and prevent direct dermal contact. EPA is also proposing to 
require prescriptive workplace controls for  laboratory use, and to establish recordkeeping 
and downstream notification requirements. Additionally, EPA proposes to provide certain 
time-limited exemptions from requirements for certain critical or essential emergency 
uses of PCE for which no technical ly and economically feasible safer alternative is 
available.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of human health or safety; Quality requirements  
8. Relevant documents:   
88 Federal Register (FR) 39652, 16 June 2023; Title 40 Code of Federal Regulations (CFR) 
Part 751:  
https://www.govinfo.gov/content/pkg/FR -2023-06-16/html/2023 -12495.htm  
https://www.govinfo.gov/content/pkg/FR -2023-06-16/pdf/2023 -12495.pdf  
This proposed rule is identified by Docket Number EPA -HQ-OPPT-2020-0720. The Docket 
Folder is availabl e on Regulations.gov at https://www.regulations.gov/docket/EPA -HQ-
OPPT-2020-0720/document  and provides access to primary and supporting documents 
as well as comments received . Documents 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 by or before 4pm Eastern Time  on 15 August 
2023. Comments received by the USA TBT Enquiry Point from WTO Members and their 
stakeholders will be shared with t he regulator and will also be submitted to the Docket  
on Regulations.gov if received within the comment period.  
G/TBT/N/USA/1890 and G/TBT/N/USA/1890/Add.1  identified by Docket Number EPA-HQ-
OPPT-2016-0732. 
9. Proposed date of adoption:  To be determined  
Proposed date of entry into force:  To be determined  
10. Final date for comments:  15 August 2023  
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/crnattachments/2023/TBT/USA/23_10392_00_e.pdf