TSCA Reform: If Congress Stalls, Where Does Industry Go From Here?
As the September expiration of Toxic Substances Control Act (TSCA) fee authority approaches, industry stakeholders are closely watching efforts in Congress to not only extend the fee authorization but to also reform key elements of the law. While several legislative proposals have emerged, the path to passage remains uncertain, particularly given the need for bipartisan support in the Senate.
Against that backdrop, attention is increasingly turning to another possibility: implementing meaningful TSCA improvements through regulatory and administrative action rather than waiting for legislative reform.
During a recent TSCA 30/30 webinar hosted by Keller and Heckman, Partners Herb Estreicher and David Fischer examined the current legislative landscape and outlined a series of initiatives they believe the U.S. Environmental Protection Agency (EPA) could pursue immediately to improve TSCA implementation.
Legislative Reform Efforts Face an Uncertain Future
The immediate catalyst for reform discussions is the impending expiration of TSCA fee authority, which was established under the 2016 Lautenberg amendments. Those fees generate approximately $25 million annually and support EPA activities, including new chemical reviews and risk evaluations. Without reauthorization, the agency could face additional resource constraints and growing backlogs.
In response, both the Senate Environment and Public Works Committee and the House Energy and Commerce Committee developed discussion drafts aimed at extending fee authority while addressing broader implementation challenges.
The Senate proposal focused primarily on Section 5, which governs new chemicals. Key concepts include streamlining review timelines, expanding exemptions for low-risk chemicals, and creating a stewardship pathway. The proposal also sought to clarify important legislative terms, such as "conditions of use" and "unreasonable risk."
The House draft takes a broader approach, proposing reforms to Sections 4, 5, and 6. Notable provisions include revising evidentiary standards for risk determinations, expanding PMN exemptions, UVCB equivalency, and requirements for EPA to consider existing workplace and federal regulatory controls when evaluating chemical risks. The proposal also emphasized risk minimization and feasibility considerations rather than pursuing the complete elimination of unreasonable risk in all circumstances.
A third legislative effort, Senate Bill S.4397, focused largely on Section 5 and includes stronger consideration of existing regulatory controls and cost-benefit factors.
Despite these legislative proposals, enacting TSCA reform in the end will require Democratic support, which to date has been sparse.
A Regulatory Opportunity
Many of the most significant TSCA improvements sought by industry may not require statutory amendments at all. EPA already possesses considerable authority to modify policies, procedures, guidance documents, and regulatory practices that affect TSCA implementation.
With that in mind, Keller and Heckman recently established a TSCA Virtual Roundtable of stakeholders to identify practical reforms that could be pursued directly with EPA during the current administration.
Top Priorities for Administrative Reform
1. Overhauling Section 5 Consent Orders
Companies routinely receive consent orders following PMN submissions, and those orders have become increasingly lengthy and burdensome. Current orders can exceed 90 pages and often limit regulatory flexibilities that companies previously relied upon.
EPA has authority to revise consent order practices without additional legislation. Proposed improvements include creating more streamlined distribution provisions and accelerating issuance of Significant New Use Rules (SNURs), which are often necessary before commercial market access can expand.
2. Greater Reliance on Actual Data
EPA should rely more heavily on actual test data and less on conservative analog-based modeling. EPA frequently bases risk assessments on surrogate substances, sometimes even when submitters have provided chemical-specific studies.
EPA should also avail itself of robust study summaries available through the European Chemicals Agency (ECHA). These data are regularly relied upon by regulators across Europe and could improve the quality of EPA's assessments.
3. Defining "Unreasonable Risk"
Another area identified for action is defining the most critical standard in TSCA – “unreasonable risk of injury to health or the environment.” Currently EPA “defines” the term in practice as essentially no risk, in both new chemical reviews and existing chemical risk evaluations.
4. Restoring Non-Section 5 SNUR Flexibility
EPA should return to broader use of non-consent-order SNURs. EPA's recent interpretation that a consent order is necessary before issuing many SNURs represents a departure from earlier agency practice and may not be legally required under TSCA.
5. Establishing Risk Management Rule Procedures
Creation of regulations governing TSCA risk management rulemaking should be a priority. While procedural regulations exist for risk evaluations, a risk management framework would improve transparency, consistency, and defensibility.
Additional Areas Under Consideration
There are several other areas where administrative reforms could reduce regulatory burden and improve efficiency. These include:
- Implementing a tiered review system for PMNs based on complexity and risk profile
- Expanding eligibility under the polymer exemption
- Revising Section 8(e) guidance to clarify what information truly constitutes evidence of substantial risk
- Creating UVCB equivalency mechanisms for inventory-listed substances
- Streamlining Section 12(b) export notifications through aggregated annual reporting
Looking Ahead
While legislative reform remains the preferrable option, stakeholders have a unique opportunity to pursue practical improvements through direct engagement with EPA. Regardless of whether Congress ultimately advances TSCA reform legislation, significant progress can be achieved by addressing implementation challenges that currently affect both the new and existing chemicals programs.
The remaining 2 years of the current Administration represent a critical window in which to shape EPA policies and regulations that govern chemical reviews, risk evaluations, and risk management.