EPA finds trichloroethylene poses an unreasonable risk to human health

Today, the U.S. Environmental Protection Agency (EPA) finalized a revision to the Toxic Substances Control Act (TSCA) risk determination for trichloroethylene (TCE), finding that TCE, as a whole chemical substance, presents an unreasonable risk of injury to human health when evaluated under its conditions of use. The next step in the process is to develop a risk management rulemaking to identify and require the implementation of measures to manage these risks.

Uses and Risks Associated with TCE

TCE is a volatile organic compound used mostly in industrial and commercial processes. Consumer uses include cleaning and furniture care products, arts and crafts, spray coatings and automotive care products like brake cleaners.  

In the revised risk determination based on the 2020 risk evaluation, EPA found that TCE presents unreasonable risk to the health of workers, occupational non-users (workers nearby but not in direct contact with this chemical), consumers, and bystanders. EPA identified risks for adverse human health effects not related to cancer, including neurotoxicity and liver effects, from acute and chronic inhalation and dermal exposures to TCE. EPA also identified risks for cancer from chronic inhalation and dermal exposures to TCE.

EPA used the whole chemical risk determination approach for TCE in part because there are benchmark exceedances for multiple conditions of use (spanning across most aspects of the chemical life cycle from manufacturing (import), processing, commercial use, consumer use and disposal) for health of workers, occupational non-users, consumers, and bystanders, and because the health effects associated with TCE exposures are severe and potentially irreversible (including developmental toxicity, reproductive toxicity, liver toxicity, kidney toxicity, immunotoxicity, neurotoxicity and cancer).

Overall, EPA determined that 52 of the 54 conditions of use EPA evaluated drive the unreasonable risk determination. Two out of 54 conditions of use do not drive the unreasonable risk: consumer use of TCE in pepper spray and distribution in commerce. The revised risk determination supersedes the condition of use-specific no unreasonable risk determinations that were previously issued by order under section 6(i) of TSCA in the 2020 TCE risk evaluation.

The revised risk determination for TCE does not reflect an assumption that workers always and appropriately wear personal protective equipment (PPE), even though some facilities might be using PPE as one means to reduce workers’ exposure. This decision should not be viewed as an indication that EPA believes there is widespread non-compliance with applicable Occupational Safety and Health Administration (OSHA) standards. In fact, EPA has received public comments from industry respondents about occupational safety practices currently in use at their facilities and will consider these comments, as well as other information on use of PPE, engineering controls and other ways industry protects its workers as potential ways to address unreasonable risk during the risk management process. The consideration of this information will be part of the risk management process.

EPA understands there could be occupational safety protections in place at some workplace locations. However, not assuming use of PPE in its baseline exposure scenarios reflects EPA’s recognition that certain subpopulations of workers exist that may be highly exposed because:

  • They are not covered by OSHA standards (e.g., self-employed individuals and public sector workers who are not covered by a state plan);
  • Their employers are out of compliance with OSHA standards;
  • OSHA’s chemical-specific Permissible Exposure Limits (largely adopted in the 1970’s) are described by OSHA as being “outdated and inadequate for ensuring protection of worker health;” or
  • The OSHA permissible exposure limit alone may be inadequate for ensuring protection of worker health, as is the case for TCE.

As EPA moves forward with a risk management rulemaking for TCE, the agency will strive for consistency with existing OSHA requirements or best industry practices when those measures would address the identified unreasonable risk. EPA will propose occupational safety measures in the risk management process that would meet TSCA’s statutory requirement to eliminate unreasonable risk of injury to health and the environment.

Next Steps for TCE

EPA is now moving forward on risk management to address the unreasonable risk presented by TCE. While the risk evaluation included a description of the more sensitive endpoint (fetal heart malformations), it was not relied on to determine whether there is unreasonable risk from TCE because of direction not to do so that was provided by the previous political leadership. Unreasonable risks were nevertheless identified for most uses of TCE, but the magnitude of the risk from exposures to TCE would have been greater had EPA relied upon the fetal cardiac defect (CHD) endpoint that had been used in previous EPA peer-reviewed assessments. Therefore, EPA developed existing chemical exposure limits based on both the immune endpoint and the CHD endpoint in support of risk management, and the public will have an opportunity to comment on these in the forthcoming proposed regulatory action.

Note that in taking this action, EPA has not conducted a new scientific analysis on this chemical substance and the risk evaluation continues to characterize risks associated with individual conditions of use in the risk evaluation of TCE in order to inform risk management.

In June 2021, EPA announced a path forward for the first 10 chemicals to undergo risk evaluation under TSCA to ensure the public is protected from unreasonable risks from these chemicals in a way that is supported by science and the law. The revised risk determination for TCE was developed in accordance with these policy changes, as well as the Biden-Harris Administration’s Executive Orders and other directives, including those on environmental justice, scientific integrity and regulatory review. EPA’s revisions ensure that the TCE risk determination better aligns with the objectives of protecting health and the environment under amended TSCA.

Separately, EPA is conducting a screening-level approach to assess risks from the air and water pathways for several of the first 10 chemicals, including TCE. The goal of the screening approach is to evaluate the surface water, drinking water, and ambient air pathways for TCE that were excluded from the 2020 risk evaluation, and to determine if there are risks that were unaccounted for in that risk evaluation. EPA expects to describe its findings regarding the chemical-specific application of this screening-level approach in its proposed risk management rule for TCE.

Additionally, EPA expects to focus its risk management action on the conditions of use that drive the unreasonable risk. However, EPA is not limited to regulating the specific activities found to drive unreasonable risk and may select from among a wide range of risk management requirements. As a general example, EPA may regulate upstream activities (e.g., processing, distribution in commerce) to address downstream activities (e.g., consumer uses) driving unreasonable risk, even if the upstream activities do not drive the unreasonable risk.

Read more on EPA’s website.

Source: U.S. EPA

TURI releases guide to safer alternatives for halogenated solvents

TURI’s new Alternatives to Halogenated Solvents Used in Surface Cleaning Guide provides insight into safer options for specific applications, shows how to evaluate those alternatives, and determine information needed from equipment vendors. Links to case studies sprinkled throughout showcase safer alternative chemistries and equipment used, performance testing process, and return on investment.

New chemical safety assessment tools developed to help the electronics sector clean up its supply chains

Read the full story at Environment + Energy Leader.

Last week, green chemical solutions advocate Clean Production Action unveiled GreenScreen Certified for Cleaners & Degreasers in Manufacturing, a tool to assess chemical safety in the industrial sector.

GreenScreen Certified™ for Cleaners & Degreasers in Manufacturing launched

Clean Production Action has released GreenScreen Certified,™ for Cleaners & Degreasers in Manufacturing to promote safer chemical use and innovation in the electronics sector and beyond.

Industrial cleaners and degreasers account for some of the highest use materials in the electronics sector and are under increasing scrutiny from regulators and environmental health and safety organizations. Clean Production Action developed the new certification with Apple, a leader in safer chemistry adoption, to create clear criteria for assessing the safety of cleaners used in the electronics industry and beyond. 

For years, Apple has used GreenScreen® for Safer Chemicals to assess and promote safer chemicals in their supply chain and 100% of their supplier final assembly sites now utilize only approved safer cleaners. Today’s launch of GreenScreen Certified creates a path towards an industry-wide transformation by making information about safer alternatives readily available throughout the electronics industry.   

“These standards represent a new playbook to help companies everywhere use safer chemicals that are better for people’s health and for the planet,” said Kathleen Shaver, Apple’s director of environment and supply chain innovation. “We’re always innovating and glad to work with our partners to help drive the use of safer chemicals across industries.”

GreenScreen Certified™ for Cleaners & Degreasers in Manufacturing joins the family of GreenScreen certifications that are advancing safer chemicals in products. The criteria for GreenScreen certifications are freely and publicly available and build upon the well-established GreenScreen® for Safer Chemicals benchmark scores. Certification requirements include full ingredient disclosure, compliance with a comprehensive list of prohibited substances including per- and polyfluoroalkyl substances (PFAS), and testing to demonstrate the absence of priority restricted chemicals and chemical classes.

“Knowing which products are safer for workers in the electronics sector is a complicated task,” said Shari Franjevic, GreenScreen Program Manager. “GreenScreen Certified for Cleaners & Degreasers in Manufacturing now provides assurance that these products are third party certified and free of thousands of chemicals of high concern. We are very proud to supply another tool in the toolbox for safer chemistry innovation.”

For further information on the certification go to: https://www.greenscreenchemicals.org/certified/cleaners-degreasers-standard

Register for the webinar November 18, 2021 at 3:00 PM EDT: https://www.greenscreenchemicals.org/resources/entry/webinar-safer-cleaners-degreasers-for-electronics


About Clean Production Action

Clean Production Action is an independent, non-profit organization based in the United States. Our mission is to design and deliver strategic solutions for green chemicals, sustainable materials, and environmentally preferable products. Our core programs are: GreenScreen® for Safer Chemicals, BizNGO, Chemical Footprint Project, and Investor Environmental Health Network.

About GreenScreen® for Safer Chemicals

GreenScreen is a globally recognized tool designed to assess and benchmark chemicals based on hazard. Companies, governments, and non-governmental organizations (NGOs) use GreenScreen benchmark scores to identify chemicals of concern to human health and the environment, select safer alternatives, and to track and communicate their progress. GreenScreen criteria and guidance are fully transparent and available for anyone to use.

About GreenScreen Certified™

Built upon GreenScreen® for Safer Chemicals, GreenScreen Certified™ is an independent, non-profit certification that promotes the use of inherently safer chemicals in products and manufacturing.

CD Aero Eliminates Use of nPB, Gains Production Capacity

Download the document.

A leading manufacturer of electronic capacitors globally, CD Aero (formally known as Aerovox)
has been in business for over 100 years. Located in New Bedford, Massachusetts, the company
employs 80 people and manufactures intelligent capacitor solutions for industries such as the
medical, military, health and beauty sectors. CD Aero’s capacitors are supplied to original
equipment manufacturers and end up in products such as defibrillators and laser hair removal
devices.

After a change in ownership, CD Aero worked with the Toxics Use Reduction Institute (TURI) and
the Massachusetts Office of Technical Assistance (OTA) to find a safer alternative cleaning
process to the use of n-propyl bromide (nPB). With a new aqueous cleaning process, the
company is now saving $46,000 per year, protecting health and safety and reducing its
regulatory obligations.

Webinar: Safer alternatives for solvent applications

May 26, 2021, 11:30 am-1:00 pm CDT
Register here.

A range of many different types of solvents are used in diverse ways by thousands of companies in the nation. Find out how you can help those companies adopt pollution prevention (P2) measures by guiding them to safer alternatives. Get ideas on where and how to focus P2 efforts.

The US EPA P2 grant program describes several National Emphasis Areas (NEAs) and solvents are used extensively by companies in these NEA sectors. This webinar, sponsored by the Pacific Northwest Pollution Prevention Resource Center (PPRC), will identify nine major solvent applications used in two or more of the NEAs. They will describe:

  • How the solvents are used in the application
  • The types of solvents used
  • The safer alternatives that can be used in their place

Webinar attendees, including P2 program grantees, will have the opportunity to provide input on which solvent application areas they would like to learn more about. Additional webinars may be scheduled in the future that will cover the applications of interest and their alternatives in greater detail.

During the webinar, Dr. Wolf will answer questions on the solvents, safer alternatives, and implementation strategies.

Who should attend this webinar?

  • P2 program grantees
  • State and local government agency P2 technical assistance providers
  • EPA regional P2 staff
  • Industry representatives

Speakers

  • Jean Waters, Pacific Northwest Pollution Prevention Resource Center (PPRC)
  • Katy Wolf, Ph.D., Consultant

EPA releases final risk evaluations for trichlorethylene (TCE) and carbon tetrachloride

U.S. EPA recently completed final risk evaluations for trichlorethylene (TCE) and carbon tetrachloride under the Toxic Substances Control Act (TSCA).

The next step in the process required by TSCA is risk management. EPA will propose and take public comments on actions to address the unreasonable risks identified in the risk evaluation. According to TSCA, the agency must finalize those actions within two years of completing the final risk evaluation. EPA’s proposed regulations could include requirements on how the chemical is used, or limiting or prohibiting the manufacture, processing, distribution in commerce, use, or disposal of this chemical substance, as applicable.

There will be additional opportunities for public participation. Just like the risk evaluation process, there will be opportunities for public comment as EPA works to propose and finalize risk management actions for TCE. You can stay informed by signing up for EPA’s email alerts or checking the public dockets at http://www.regulations.gov. 

Register for EPA’s December 15 Webinar on TCE

On December 15, 2020, from 1:00 PM to 3:00 PM EST, EPA will host a webinar to educate stakeholders on the risk management process under the Toxic Substances Control Act (TSCA) and the findings in the final risk evaluation for trichloroethylene (TCE). The webinar also provides the opportunity for the public to provide input on considerations the agency should take into account for managing these unreasonable risks.

Register for the webinar. If you would like to provide oral comments during the webinar, you must register by December 11 at 5 PM. Select “attend and make a comment” when registering. You may register as a listen-only attendee at any time up to the end of the meeting. For listen-only attendees, select “listen-only” when registering. Information on how to connect to the webinar will be provided upon registration.

Details on how to access the webinar and slides will be sent to participants after registering via Eventbrite.com. Please ensure that emails from Eventbrite.com will not be blocked by your spam filter. EPA will provide a transcript and recording on EPA’s TCE webpage following the webinar.

Additionally, EPA will begin formal consultations with state and local governments, tribes, environmental justice communities, and small businesses. There will also be an open public comment period on any draft risk management regulation.

EPA Seeks Small Businesses Input on Risk Management Rulemakings for Carbon Tetrachloride and TCE

The U.S. Environmental Protection Agency (EPA) is inviting small businesses, governments, and not-for-profits to participate as Small Entity Representatives (SERs) to provide advice and recommendations to two Small Business Advocacy Review (SBAR) panels. There will be one panel for carbon tetrachloride and one panel for trichloroethylene (TCE). Each will focus on the agency’s development of proposed rules to address unreasonable risks identified in EPA’s recently completed Toxic Substances Control Act (TSCA) risk evaluations for these chemicals.

Under TSCA, EPA is required to evaluate the risks associated with exposure to existing chemicals in commerce using the best available science then take action to address any unreasonable risks identified. The agency issued a final risk evaluation for carbon tetrachloride in November 2020, showing unreasonable risks to workers under certain conditions of use. The agency also issued a final risk evaluation for TCE in November 2020, showing unreasonable risks to workers and consumers under certain conditions of use. EPA is now moving to the risk management step in the TSCA process by working to draft regulations to protect public health from the unreasonable risks identified in the final risk evaluations.

The Regulatory Flexibility Act requires agencies to establish a SBAR panel for rules that may have a significant economic impact on a substantial number of small entities. The SBAR panel will include federal representatives from the Small Business Administration (SBA), the Office of Management and Budget (OMB), and EPA.

SERs will be selected by the SBAR Panels to provide comments on behalf of their company, community, or organization and advise the panels on the potential impacts of the proposed rules on small entities. EPA is seeking self-nominations directly from the small entities that may be subject to the rule requirements. Other representatives, such as trade associations that exclusively or at least primarily represent potentially regulated small entities, may also serve as SERs.

SERs provide advice and recommendations to the panels. The SERs participate in consultations with the SBAR Panels via telephone, webinar, or in person in one or two meetings and are given an opportunity to submit written comments to the Panels. Self-nominations may be submitted through the link below and must be received by December 14, 2020.

In addition to engaging with small businesses, EPA is executing a robust outreach effort on risk management that includes formal consultations with state and local governments, tribes, and environmental justice communities. There will also be an open public comment on any draft risk management regulations.

Nominate yourself as a Small Entity Representative to the Carbon Tetrachloride SBAR Panel: https://www.epa.gov/reg-flex/potential-sbar-panel-carbon-tetrachloride-risk-management-rulemaking-under-toxic-substances 

Nominate yourself as a Small Entity Representative to the TCE SBAR Panel: https://www.epa.gov/reg-flex/potential-sbar-panel-trichloroethylene-tce-risk-management-rulemaking-under-toxic

Assessment of Safer and Effective Alternatives for Coating Removal Products

The Massachusetts Toxics Use Reduction Institute did a project to identify and evaluate safer alternatives to methylene chloride and other chemicals of high concern used in coating removal products. Read the results in the final report, Assessment of Safer and Effective Alternatives for Coating Removal Products.

See also: Assessment of Safer and Effective Alternatives to Methylene Chloride for Paint Stripping Products (2017)