The EPA and TSCA

The U.S. Environmental Protection Agency (EPA) is the federal agency responsible for the protection of human health and the environment. It provides technical assistance for recovery planning of public health and infrastructure, such as water and wastewater treatment plants. It supports this mission by developing and enforcing regulations, providing grants, studying environmental issues and educating the public.
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Toxic Substances Control Act

The Toxic Substances Control Act (TSCA) is a United States law that regulates chemicals not covered by other federal statutes, including existing chemicals in commerce and the introduction of new chemicals. Its main objectives to regulate chemicals that pose an unreasonable risk to health or the environment, and to regulate the distribution and use of these chemicals. TSCA also gives the EPA the authority to regulate the manufacture, import, processing, distribution, use, and disposal of certain chemicals.

Process and Timeline

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Step 1: Initiation, December 14, 2023 

In December of 2023, the EPA announced that it was beginning the process to prioritize five additional toxic chemicals, including vinyl chloride, for risk evaluation. This began the 9-12 month process statutory time frame during which the EPA must designate the chemical substances as either high or low priority.

Screening Review
During this phase of the process, the EPA reviewed: The hazard and exposure potential of the chemical substance; Persistence and bioaccumulation;
Potentially exposed or susceptible subpopulations; Storage near significant sources of drinking water; The conditions of use or significant chances in the conditions of use of the chemical substance; and  the volume or significant changes in the volume of the chemical substance manufactured or processed.
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Step 2: Proposed Designation, July 24, 2024

The EPA proposed to designate five chemicals including vinyl chloride as High-Priority Substances for risk evaluation under TSCA. If EPA finalizes these designations as proposed, the agency would immediately move forward with the risk evaluation process.

 Prioritization is the first step under EPA’s authority to regulate existing chemicals currently on the market and in use. EPA’s proposed designations are not themselves a finding of risk. If EPA finalizes these designations, the agency will initiate risk evaluations for these chemicals to determine whether they present an unreasonable risk to human health or the environment under the TSCA conditions of use (the way the chemical is made and used), which the agency is required to complete within 3-3.5 years. If at the end of the risk evaluation process EPA determines that a chemical presents an unreasonable risk to health or the environment, the agency must begin the risk management process to take action to eliminate these unreasonable risks.

The EPA has conducted a preliminary screening and technical review of large data sets to more efficiently identify relevant information for prioritization and risk evaluation and can easily flag information that may be useful to retrieve later in the risk evaluation process. As a result, EPA now has a head start on risk evaluations.
a person in a white protective suit and gloves holding a test tube

Step 3: Final Designation, December 18 2024

After considering public comments, the EPA designated vinyl chloride as a high-priority substanceunder the Toxic Substances Control Act. This designation acknowledges the significant risks posed by this hazardous chemical, which is widely used in water infrastructure materials. In addition to the proposed designation, the EPA published the information, analysis, and basis used to make the designation. The EPA will take public comment on the proposed designation and supporting materials for 90 days.

Step 4: Risk Evaluation, Several Years

If any of the five chemicals are designated as a high-priority substance, the EPA will begin a Risk Evaluation which takes three to three and a half years to complete. During this process, the EPA will provide  a scope document that provides the public with information on the focus of the risk evaluation;
hazard and exposure assessments and a risk characterization to inform the risk determination; and
A risk determination stating whether a chemical substance presents an unreasonable risk to the health or the environment under its conditions of use.
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Step 5: Risk Management

Risk Management determination happens within one year of the final risk evaluation regarding the chemical substance being published. If at the end of the risk evaluation process the EPA determines that a chemical presents an unreasonable risk to the health or the environment, the chemical must immediately move to risk management. The EPA is required to implement via regulation, regulatory restrictions on the manufacture, processing, distribution, use or disposal of the chemical to eliminate the unreasonable risk. EPA is given a range of risk management options under TSCA, including labeling, record keeping or notice requirements, actions to reduce human exposure or environmental release, and a ban of the chemical or certain uses. Like the prioritization and risk evaluation processes, there is an opportunity for public comment.
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July 2029: Final Determination and Possible Outcomes

Regulatory Action: Based on the findings of the review, the EPA may decide to impose restrictions, such as banning or limiting the use of vinyl chloride or require labeling and other risk management measures to protect human health and the environment.
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Public Notification: The EPA may also decide to inform the public about any potential risks associated with vinyl chloride and provide guidance on safe handling and use. These outcomes are determined based on the EPA's assessment of the potential hazards and risks associated with vinyl chloride.
Voluntary Restrictions: The EPA may work with the manufacturer or industry to implement voluntary restrictions or changes in the use of vinyl chloride to mitigate potential risks.
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Additional Research or Data Collection: If the existing information about vinyl chloride is insufficient to make a conclusive determination, the EPA may request or conduct additional research or data collection to better understand the potential risks associated with vinyl chloride. 
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No Action: The EPA may determine that vinyl chloride does not pose an "unreasonable" risk to human health, or the environment based on the available data and research, and no further action is taken. 

Final Determination and Possible Outcomes

Regulatory Action:
  • Impose restrictions.

  • Banning or limiting the use of vinyl chloride.

  • Risk management measures to protect human health and the environment.

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Public Notification:
  • Inform the public about any potential risks.

  • Provide guidance on safe handling
and use.

a yellow circle with a white exclamation mark
Voluntary Restrictions:
  • Implement voluntary restrictions.

  • Voluntary changes in the use of
vinyl chloride.

Additional Research:
  • The EPA may request or conduct additional research.

  • Additional data collection.

No Action:
  • Determine minimal risk to human health, or the environment.

  • No further action is taken. 

Regulatory Action:
  • Impose restrictions.
  • Banning or limiting the use of vinyl chloride.
  • Risk management measures to protect human health and the environment.
a yellow circle with a white megaphone
Regulatory Action:
  • Inform the public about any potential risks.

  • Provide guidance on safe handling and use.
a yellow circle with a white exclamation mark
Voluntary Restrictions:
  • Implement voluntary restrictions.

  • Voluntary changes in the use of vinyl chloride.
Additional Research:
  • The EPA may request or conduct additional research.

  • Additional data collection.
No Action:
  • Determine minimal risk to human health, or the environment

  • No further action is taken.

Stay Informed

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DIPRA’s regional engineers are here to provide support and resources for making informed decisions and ensuring safe drinking water for your communities.
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