Chemicals, Regulatory Developments

TSCA Regulations Likely to Get Tougher

Since the first day of his presidency, President Joe Biden has been directing attention to reviewing EPA actions impacting the chemical industry and commercial chemicals—specifically, agency actions under the Toxic Substances Control Act (TSCA).

Chemical data analysis and research, TSCA

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Under TSCA, Congress charged the EPA with regulating the manufacture and import of both existing and new chemicals. The Act’s scope is broad, as it covers “any ‘person’ who manufactures, imports, processes, distributes in commerce, uses or disposes of a chemical substance, regardless of the industry sector,” according to a JD Supra article by international law firm Kilpatrick, Townsend & Stockton LLP.

In June 2016, the Frank R. Lautenberg Chemical Safety for the 21st Century Act amended TSCA and provided more clout to evaluate and regulate chemicals. Key provisions, according to the EPA, include:

  • “Mandatory requirement for EPA to evaluate existing chemicals with clear and enforceable deadlines;
  • Risk-based chemical assessments;
  • Increased public transparency for chemical information; and
  • Consistent source of funding for EPA to carry out the responsibilities under the new law.”

Current Actions

Risk evaluations

In some of the first actions of the Biden administration, in February 2021, the EPA announced it “is actively reviewing the final risk evaluations in light of statutory obligations and policy objectives related to use of the best available science and protection of human health and the environment, in accordance with the Executive Orders and other direction provided by the Biden-Harris Administration,” according to Kilpatrick Townsend.

This reevaluation is expected to take a dramatically different approach than the previous administration.

“Among other things, TSCA’s ‘framework rule,’ which establishes the process for evaluation of existing chemicals, gives the EPA Administrator ‘discretion’ to exclude certain conditions for evaluation,” Kilpatrick Townsend says. “The Trump administration utilized this discretion arguably to develop a narrow approach to chemical uses and exposure pathways. Now the Biden administration may use this discretion in the other direction to broaden the scope of evaluation. This approach could include expanding the range of potential exposures considered in the risk evaluation. For example, an increased emphasis on the impact upon vulnerable populations and potential routes of exposure, including through the ambient environment, is anticipated.”

Additionally, risks evaluated by other government agencies such as the Occupational Safety and Health Administration (OSHA) are expected to be considered, as well.

Fee Assessment

Up to 25% of TSCA implementation costs are collected from chemical manufacturers and imports. The Trump administration issued proposed revisions on December 21, 2020. “The rule proposes a number of exemptions for importers of articles; chemicals that are manufactured as a byproduct or manufactured/imported as an impurity; chemicals used solely for research and development, and manufacture of a chemical in de minimis amounts,” Kilpatrick Townsend adds. “The rule also establishes a product-volume based fee as well as new chemical fee categories.” The Biden administration EPA extended the comment period on the fee assessment rule and is currently reviewing the comments, with the intention of issuing the final rule later this year.

New Chemicals Program

In March 2021, the EPA issued public notice that it is reevaluating the programs, guidelines, and policies under this rule to determine if the current information “adheres to statutory requirements.” Expected changes include an increased focus on worker protections and the rejection of the current practice of issuing “new chemical determinations of ‘not likely to present an unreasonable risk’ based upon the existence of a proposed SNUR (Significant New Use Rule),” according to Kilpatrick Townsend.

Persistent, Bioaccumulative, and Toxic (PBT) Chemicals

In December 2020, final rules were fast-tracked for five PBT chemicals. In March 2021, the EPA opened a public comment period to receive additional comments on this rule. That announcement stated that the “EPA will review and consider revising the final PBT rules with an eye towards reducing exposure to the extent practicable, environmental justice, scientific integrity, and EPA’s mission of protecting human health and the environment, taking into consideration information received while the rules were under development as well as any new information submitted since the rules were finalized and information received in response to this document.”

Tightened Chemical Oversight

Under the Trump administration, the EPA exercised its discretion in implementing the revised TSCA requirements, often opting for “a narrower scope for risk evaluation and procedures to accelerate the process of review and approval,” notes Kilpatrick Townsend.

The Biden administration, however, appears to be charting a different path with respect to TSCA implementation. The current administration’s actions indicate a broader scope when evaluating chemicals and a reliance on the best-available science to ensure the protection of human health and the environment and to advance environmental justice. But with that, according to Kilpatrick Townsend, “the regulated community should expect increased data submission requirements, longer review and approval processes, and increased enforcement.”