In recent years since the 2020 election, the US EPA has doubled down efforts to revise many policies put forth during the Trump Administration. More specifically, the EPA under the Biden Administration has revised the TSCA risk evaluations for the top 10 priority chemicals identified for review under the Lautenberg Act of 2016, which had previously been published under the Trump Administration. These revisions have taken time and effort, and also introduced new “whole chemical” approaches to risk evaluation and management that have drawn scrutiny from industry stakeholders, and yet have been deemed “still not enough” from other third-party stakeholders. It has also further put EPA behind on timelines set forth in the Lautenberg Act for reviewing the risks associated with priority chemicals and seemingly limited their resources for managing the new chemicals program, whereby the EPA has routinely missed deadlines for reviewing pre-manufacturing notices (PMNs).  

 

Most recently, we saw that Assistant Administrator of the EPA, Dr. Michal Freedhoff, testified in front of Congress, where she was asked pointed questions about EPA’s progress and plans for how to implement TSCA reform under the Lautenberg Act in a more timely manner. The questions were notably focused on EPA’s approach to new chemicals for review (under PMNs) and the risk evaluation and management for high priority chemicals.  

 

Though the number of total risk assessments for PMNs has increased considerably in 2023 from 2022, those in industry are still concerned over the lack of transparency in how decisions over new chemicals are made, since most PMN reviews result in additional testing requests, Significant New Use Rules (SNURs), and other time-intensive actions on the part of those submitting the PMN. Dr. Freedhoff indicated that EPA was committed to continued improvement and throughput of new chemical PMN reviews and risk assessments in 2024. 

 

During questioning, Dr. Freedhoff also indicated that the EPA plans to finalize an additional 7 risk evaluations before the end of 2024, including for:  

  • DIDP 
  • DINP 
  • Formaldehyde 
  • TCEP 
  • 1,1-dichloroethane (1,1-DCA) 
  • Asbestos (previously drafted, but now under revision) 
  • 1,4-dioxane (previously drafted, but now under revision) 

 

Congress also questioned Dr. Freedhoff about the approaches to risk evaluation for workers, and methods by which they are determining proposed existing chemical exposure limits (ECELs), which may not be in line with approaches used by OSHA, who is ultimately responsible for setting workplace exposure limits and guidelines. 

 

In addition, Dr. Freedhoff indicated that EPA plans to finalize risk management rules for 9 substances, including: 

  • Trichloroethylene (TCE) 
  • Methylene chloride 
  • Asbestos (chrysotile) 
  • Perchloroethylene (Perc) 
  • Carbon tetrachloride 
  • N-methylpyrrolidone (NMP) 
  • 1-bromopropane (1-BP) 
  • Cyclic aliphatic bromide cluster (HBCD) 
  • Pigment violet 29 (PV29) 

 

A more complete look into EPA’s 2022-2026 Strategic Plan shows their commitment to chemicals management through TSCA. Notably, under their goals for Chemicals, EPA has listed the following objectives for TSCA: 

  • Complete at least 8 High Priority Substance TSCA risk evaluations annually  
  • Initiate all TSCA risk management actions within 45 days of completion of the final risk evaluation 
  • Review 90% of past risk mitigation requirements for TSCA new chemical substances decisions 

 

Outlook: The Biden Administration EPA has been committed to a more extensive reach for their chemicals policy under TSCA and the Lautenberg Act, and aims to finish what they started in a critical Presidential Election year. The plans outlined above by Dr. Freedhoff and in the Strategic Plan are robust and will have lasting impacts for not only industry, but also human health and the environment, if EPA is able to successfully execute their plans. As for now, it appears EPA is continuing its increasing momentum from 2023 to try to achieve these goals. 

Published: March 8, 2024