Is Toxic Substances Control Act Reform in Our Future?

Reform of the Toxic Substances Control Act (TSCA) is a hot topic these days. The release in January of the House Energy and Commerce Subcommittee on Environment’s draft bill titled Discussion Draft of Legislation to Modernize the Toxic Substances Control Act (Discussion Draft) has inspired spirited debate. The Discussion Draft marks a notable milestone in Congress’s increasingly vocal promises to address perceived shortcomings in both the landmark 2016 amendments to TSCA and the U.S. Environmental Protection Agency’s (EPA) nearly 10 years of implementation that followed.

The Discussion Draft would impose sweeping changes across many key sections of TSCA, including definitions, testing authorities, review of new chemicals, review and management of existing chemicals, TSCA Inventory nomenclature, relationships with other federal laws, citizens’ petitions, TSCA fees and more. Here are a few highlights and initial observations.

Definitions

Changes to the statutory phrase “conditions of use” that limit EPA’s discretion to identify reasonably foreseen circumstances to those “more likely than not to be” and, in turn, narrow the scope of risk evaluations.

New Chemical Reviews

• A narrowed scope of new chemical reviews, limiting the assessment to just the conditions of use “identified by the submitter of the notice” — rather than the current requirement that EPA consider known, intended and reasonably foreseen circumstances;
• A qualifier on how EPA can determine a new chemical may present an unreasonable risk, in that it must be “more likely than not that such unreasonable risk will occur”;
• A nondelegable requirement for the EPA administrator to personally issue a statement for each premanufacture notice (PMN) review that EPA fails to review timely;
• A new requirement that EPA make “best efforts” to prioritize review of certain new chemical notices, including those that a submitter identifies as offering specified risk reduction benefits, eligible for Safer Choice program inclusion, or are necessary to “improve the security and resiliency of … domestic critical material supply chains” as identified by the Secretary of Commerce; and
• New authority for EPA to exempt new chemicals from the review process upon a showing that the activity has been approved by another Organization for Economic Co-operation and Development (OECD) member country.

Existing Chemical Risk Evaluations

• New emphasis on the likelihood of exposures/hazards, directing EPA to consider only those that “are more likely than not” to result in unreasonable risk;
• Explicit direction to consider the impact of existing federal regulatory limits, and not to assume noncompliance -- including noncompliance with U.S. Occupational Safety and Health Administration (OSHA) standards; 
• Change to make all final risk evaluations “final agency action” and thus immediately judicially reviewable, rather than the current requirement that limits judicial review of an unreasonable risk determination until after the promulgation of a final TSCA Section 6 risk management rule;
• New compensation process and provisions to address the TSCA fee issue of reliant parties that do not fairly contribute to the risk evaluation fee for the particular chemical;
• Extension of TSCA fee authority for another 10 years from the date bill is signed into law, allowing EPA to continue to collect fees for risk evaluation activities; and
• Further direction to prioritize actual information on the chemical versus analog or modeled data. 

Existing Chemical Risk Management

• Change to the risk management standard, from requiring EPA to eliminate the identified unreasonable risk to a requirement that EPA “minimize, to the extent reasonably feasible” such risk; and 
• Amendments to TSCA Section 9 that prohibit EPA from issuing risk management rules that are “inconsistent” with other existing federal requirements.

Citizens’ Petitions

Removal of authority for citizens to petition EPA for issuance of a TSCA Section 6(a) risk management rule — replaced with new authority for citizens to petition EPA to consider designating a chemical as a high-priority substance for risk evaluation. 

TSCA Fee Collection

A 10-year reauthorization of EPA’s authority to collect fees to help defray the costs of its implementation efforts, currently set to expire at the end of fiscal year 2026.

Discussion

While many of the ideas outlined in the Discussion Draft are interesting and laudable, whether this 37-page rewrite of many of the major compromises in the 2016 TSCA amendments gains traction with divergent constituencies is unclear. The clock continues to tick on EPA’s TSCA fee collection authority, the expiration of which could exacerbate the TSCA program’s ongoing resource and workload challenges. Stay tuned!