EPA Marks 5th Anniversary of Landmark Improvements to Chemical Safety Regulation

June 22, 2021

WASHINGTON (JUNE 22, 2021) — Today, the U.S. Environmental Protection Agency is marking the 5th anniversary of the Frank R. Lautenberg Chemical Safety for the 21st Century Act amendments to the Toxic Substances Control Act (TSCA), our nation’s primary chemical safety law. These amendments were passed with bipartisan support and represented the first major update to an environmental statute in over 20 years. 

“The 2016 TSCA amendments were born out of a recognition that the nation needed a stronger law to protect communities from dangerous chemicals in our environment and in the products we use,” said Michal Freedhoff, Assistant Administrator for the Office of Chemical Safety and Pollution Prevention. “This single piece of legislation provided a transformational framework to revolutionize and modernize EPA’s entire chemical safety process, providing the agency with needed authority to review chemicals and put protections in place when risks are found.” 

These amendments to TSCA provided much needed improvements to EPA’s ability to protect human health and the environment from chemical risks by: 

• Establishing a mandatory and ongoing duty on EPA to prioritize and evaluate existing chemicals against a risk-based safety standard with clear and enforceable deadlines, and manage unreasonable risks where identified.
• Expanding EPA authority to require the generation of health and safety data for chemicals.
• Requiring EPA to affirmatively determine that new chemicals meet the safety standard before entering the market.
• Increasing the public transparency of chemical information.

In the past five years, EPA has made significant progress towards implementing key parts of the law, including:

• Promulgating rules and setting up processes to evaluate the many thousands of existing chemicals in the marketplace.
• Conducting risk evaluations for the first 10 chemicals identified for risk evaluation under TSCA. 
• Issuing risk management rules for five persistent, bioaccumulative, and toxic (PBT) chemicals intended to provide critical protections for children, workers, and other potentially at-risk groups. 
• Taking the first step in addressing risks from methylene chloride by issuing a ban on the consumer use of this chemical in paint removers.
• Expanding the use of our data gathering authority, including issuing the first section 4 test orders under amended TSCA. 
• For the first time, listing the chemicals that are actively being manufactured, processed, and imported in the United States and those that are not on the TSCA Inventory. 
• Reviewing and making determinations on confidential business information claims to ensure that those claims warrant protection and are appropriately substantiated.
• Issuing the first rule for the agency to collect fees from chemical manufacturers to help fund TSCA implementation.

As we move into year six, EPA is committed to implementing TSCA in accordance with executive orders and other direction from the Biden-Harris Administration to restore trust, ensure scientific integrity, and protect human health and the environment. This includes:

• Reconsidering certain approaches and assumptions used for risk evaluations under the prior Administration, including assumptions on worker use of personal protective equipment, developing a process for ensuring all routes of exposure to a chemical are included in risk evaluations, and making risk evaluations more comprehensive by ensuring potentially exposed or susceptible subpopulations are appropriately included.
• Moving expeditiously to risk management for the first 10 chemicals to undergo risk evaluation, taking into account the reconsideration of some policy decisions made under the previous Administration to ensure the rules are fully protective of both health and the environment.
• Improving the agency’s approach to reviewing and selecting the scientific studies that are used to inform TSCA chemical risk evaluations (known as systematic review) based on feedback received from the National Academies of Science, Engineering, and Medicine. 
• Continuing to take action on PFAS to better protect all communities from pollution. EPA is already implementing a new strategy for reviewing and managing low volume exemption requests for new PFAS before they can enter the market. The agency has also issued a proposed rule to require manufacturers (including importers) of PFAS to report information related to chemical identity, categories of use, volumes manufactured and processed, byproducts, environmental and health effects, worker exposure, and disposal. 
• Re-examining the PBT rules and making any necessary changes to them to ensure the agency is delivering on the promise to take a practical approach while also protecting human health and the environment by reducing exposure to toxic chemicals.
• Continuing to make refinements to the agency’s approach to reviewing new chemicals to ensure they can enter the market safely and within the timeframes required by TSCA. EPA has already made several improvements, including stopping the issuance of “not likely to present an unreasonable risk” determinations based on the existence of proposed significant new use rules and assuring adequate protections for workers through regulatory means.
• Continuing and expanding the use of test order authorities to gather additional information on chemicals in the future as needed. 
• Reexamining the rule covering the agency’s risk evaluation process to ensure that it aligns more closely with the legal and scientific requirements of TSCA.
• Revising the fees rule and ensuring the agency has the resources needed to implement TSCA. EPA is currently undertaking required revisions to the fees rule and will continue to work to find ways to ensure fee amounts accurately reflect actual costs of TSCA activities, fees are distributed equitably, and fee payers are identified via a transparent process. The agency’s FY 2022 budget request also includes an additional $15 million and 87 FTE to build capacity in managing chemical safety under TSCA. 

For more information on the 2016 amendments to TSCA, visit https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/frank-r-lautenberg-chemical-safety-21st-century-act.