Understanding and Engaging in the TSCA Process

In June 2016, a bipartisan majority in Congress amended the Toxic Substances Control Act (TSCA) to reform the regulation of chemicals in commerce in the United States. The amendments provided the U.S. Environmental Protection Agency (EPA) with expanded authority to:

  1. Subject all new and existing chemicals to an EPA safety review;
  2. Focus on chemicals that are the highest priorities for full risk-based safety assessments;
  3. Require additional health and safety testing of chemicals;
  4. Make an affirmative safety determination on conditions of use associated with a chemical; and
  5. Identify and implement risk management options for any use determined to present an unreasonable risk to human health or the environment.

A cornerstone of the TSCA risk evaluation process is the engagement and involvement of the chemical industry to provide relevant human health data, animal laboratory study data, exposure data, and other information to inform EPA’s risk evaluations. The chemical industry is fully committed to supporting effective and efficient implementation of TSCA. The chemical industry will continue to provide EPA with the most relevant, highest-quality information.

The Chemical Prioritization Process

1,3-butadiene was identified as a high-priority candidate chemical for TSCA risk evaluation. It is important to note that a designation of 1,3-butadiene  as a high-priority chemical “does not constitute a finding of risk” and should not be cause for concern. A high-priority designation simply means the EPA has nominated 1,3-butadiene for further risk evaluation.

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What This Means for Your Business

The TSCA risk evaluation process will focus on the lifecycle of the chemical substance. If EPA’s TSCA risk evaluation identifies conditions of use of 1,3-butadiene that it believes present an unreasonable risk, EPA will be required to evaluate and implement risk management options associated with those applications. This could result in changes in how 1,3-butadiene can be utilized in various applications.

The risk evaluations conducted under EPA’s TSCA program can have significant cost and regulatory implications to manufacturers, importers, and users of a chemical identified as a high priority for risk evaluation. For example, the result of EPA’s risk evaluation may also lead to modifications on permitting, procurement, and regulatory requirements at the federal and state level.

How Much a TSCA Risk Evaluation Costs

Manufacturers and importers of 1,3-butadiene will be required to equally share payment of a $1,350,000 fee for EPA to conduct the risk evaluation.

About the 1,3-Butadiene TSCA Risk Evaluation Consortium

The ACC Olefins Panel (Panel) has a long history of conducting scientific research and communicating critical information to stakeholders including regulatory agencies in the U.S and abroad to better understand the hazards and risks potentially associated with exposures to 1,3-butadiene. The Panel’s efforts have included scientific research evaluating potential associations between 1,3-butadiene and cancers and quantifying thresholds for 1,3-butadiene exposure.

The Panel and the newly formed ACC 1,3-Butadiene TSCA Risk Evaluation Consortium are committed to Responsible Care®. Additionally, the Panel is also currently updating its factual product stewardship manual with important information regarding the uses and handling of 1,3-butadiene (CAS # 106-99-0). More information on the product stewardship manual will be available soon.

Learn More

To learn more about the TSCA risk evaluation process and the formation of the 1,3-Butadiene TSCA Risk Evaluation Consortium, download our one-pager.

For more information, contact:

Neera Erraguntla, Ph.D. DABT | American Chemistry Council
Neeraja_Erraguntla@americanchemistry.com

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