As we reported in March, the US Environmental Protection Agency (EPA) continues to ramp up their activities under the new and existing chemicals program. The EPA has seen significant activity under the Toxic Substances Control Act (TSCA) in recent months. These developments aim to strengthen chemical safety regulations, improve the efficiency of review processes, and enhance public health protections. Here’s a breakdown of some key areas of development:

1. Strengthening the Chemical Risk Evaluation Process (Finalized New Rule):

A major step forward came with the EPA finalizing a rule to strengthen its risk evaluation process for chemicals under TSCA. This improved framework ensures a more comprehensive assessment of potential health risks associated with a chemical. EPA previously announced some of these changes in 2021 and had started implementing them into TSCA risk evaluations over the last three years. Now the rule will formally apply to all new risk evaluations. Key improvements include: 

  • More Comprehensive Risk Analysis:

    • The process now considers a wider range of factors, including potential exposure routes for different populations (workers, general public, children) and potential environmental impacts. 
  • Stronger Public Engagement:

    • The public will have increased opportunities to provide input during different stages of the evaluation process. 
  • Improved Transparency:

    • The EPA will provide clearer explanations for its risk conclusions and the reasoning behind any risk management actions taken. 

This strengthened framework is expected to lead to more robust risk evaluations and ultimately better protection for public health and the environment, particularly fenceline communities and those overburdened by pollution.

2. Updates to New Chemicals Regulations (Proposed Rule – Ongoing):

The EPA is proposing amendments to streamline and improve the efficiency of its new chemicals review process. These changes aim to: 

  • Align Regulations with Updated TSCA Provisions:

    • The proposal reflects the 2016 Lautenberg amendments to TSCA’s new chemicals review and ensures consistency with current statutory requirements. 
  • Enhanced Review Efficiency:

    • Streamlining submission requirements and clarifying expectations for new chemical notices will expedite the review process. 
  • Focus on High-Risk Chemicals:

    • The proposal eliminates eligibility exemptions for certain persistent, bioaccumulative, and toxic chemicals (PBTs) from the full safety review, ensuring a more thorough evaluation for these potentially harmful substances, such as per- and polyfluoroalkyl substances (PFAS). 

 Once finalized, the updated regulations will guide the review of all new chemicals submitted after the implementation date.

3. Methylene Chloride Ban (Final Risk Management Rule):

While not a recent development, the ongoing implementation of the methylene chloride ban remains a significant TSCA action. Methylene chloride, a hazardous air pollutant with potential health risks, was subject to a significant new use rule (SNUR) in 2019, effectively banning its use in most spray paint stripper applications for the general public. In April 2024, the EPA’s finalized risk management rule bans on the manufacturing, processing and distribution of methylene chloride for all consumer uses and most industrial and commercial uses of methylene chloride, including paint and coating removers. The finalized rule also creates strict worker protections for all remaining uses, and also requires manufacturers, processors, and distributors to notify companies to whom they ship to about the bans and the requirement to maintain records.

4. TSCA Inventory Updates (Updated February 2024):

The EPA regularly updates the public TSCA Inventory, a list of all chemical substances commercially manufactured or imported in the United States. The latest update in February 2024 reflects ongoing efforts to increase transparency. Nearly 900 chemicals were moved from the confidential to the public portion of the inventory, allowing for greater public access to information about these substances. The next update is expected in late summer 2024.

5. Recent Significant New Use Rule (SNUR) Activity:

The EPA continues to issue SNURs for new chemicals entering the market. These rules establish specific conditions under which a chemical can be used without triggering further EPA review. With a new SNUR proposal on April 8, 2024, EPA signaled it will continue its efforts to manage the potential risks from the use of new chemicals by proposing 30 new SNURs for a group of chemicals that previously underwent premanufacture notices (PMNs). Anyone intending to use these chemicals under certain conditions would need to submit a significant new use notice (SNUN) for EPA review. 

These SNURs ensure that the EPA can assess potential risks associated with new chemicals before they are widely used in commerce. EPA has indicated they will continue to try to keep pace with issuing new batches of SNURs regularly under the new chemicals program. 

Looking Ahead: 

The recent developments in TSCA programs demonstrate the EPA’s commitment to strengthening chemical safety regulations. By improving the risk evaluation process, streamlining new chemicals review, and increasing transparency, the Agency aims to better protect public health and the environment. Continued updates to the TSCA Inventory and ongoing SNUR activity further support these goals. As the EPA finalizes the proposed amendments to new chemicals regulations and considers potential further restrictions on methylene chloride, stakeholders can continue to submit comments. 

If you are in need of support with US TSCA regulations, we are here to help. Please get in touch with our services team in North America at info@h2compliance.com 

Published: May 3, 2024