Comments on the House TSCA Modernization Discussion Draft

Dear Chairman Guthrie and Chairman Palmer, Ranking Members Pallone and Tonko:

The U.S. Chamber of Commerce appreciates the Committee's continued leadership in examining targeted reforms to modernize the Toxic Substances Control Act (TSCA).

We submit these comments in response to the House Discussion Draft and in support of a chemical regulatory framework that protects health and the environment while strengthening domestic manufacturing, innovation, supply-chain resilience, and economic growth.

Congress modernized TSCA in 2016 with bipartisan intent: to enhance chemical safety while preserving a predictable, science-based, risk-driven regulatory system. Nearly a decade later, implementation challenges-particularly within EPA's New Chemicals Program and certain Section 6 rulemakings-have introduced delays and uncertainty that undermine that balanced framework. These challenges affect not only chemical manufacturers, but also small and medium-sized businesses across the supply chain that rely on timely access to innovative chemistries to remain competitive.

Targeted refinements can restore predictability while maintaining strong health and environmental protections and ensuring that American manufacturers are not placed at a disadvantage relative to foreign competitors operating under more streamlined regulatory systems.

Timely and Predictable New Chemical Reviews

EPA has routinely exceeded the 90-day statutory deadline under Section 5, often relying on repeated suspensions of the statutory review period (commonly referred to as "clock stops"), which reduce predictability and discourage capital investment. Legislative reforms should reinforce firm statutory timelines, allow for conditional approvals where appropriate safeguards can address identified risks, and limit the routine use of Consent Orders and Significant New Use Rules (SNURs) to evidence-based concerns.

Congress should also consider accountability mechanisms where statutory review timelines are not met, such as requiring EPA to issue a decision within a defined backstop period based on the administrative record, or providing for deemed approvals where the Agency fails to act. Any such framework should reinforce completion of timely, science-based reviews and discourage reliance on procedural delays, including repeated suspensions of the review period.

Congress should further clarify that reviews of Pre-Manufacturing Notices (PMNs) and Significant New Use Notices (SNUNs) remain focused on the specific conditions of use under consideration within Section 5. Information requests and risk determinations should be limited to data necessary to characterize reasonably foreseen exposure, release, and risk associated with those discrete uses, and should not expand to evaluate unrelated conditions of use or reopen existing uses more appropriately addressed under Section 6.

Predictable review timelines are particularly important for small and mid-sized manufacturers that lack the regulatory compliance resources of larger firms and for downstream businesses that depend on new materials to develop next-generation products.

Coordination Across Federal Programs and Reliance on Prior Determinations

TSCA Section 9 directs EPA to avoid duplicative regulation and to coordinate with other federal agencies where statutory authorities overlap. Congress should reinforce this principle by clarifying that EPA may rely on substantively comparable determinations issued under other federal programs for the same defined conditions of use.

Where a chemical substance and the same defined conditions of use have undergone review and received an approval, listing, or determination under another EPA-administered statutory program-such as the Significant New Alternatives Policy (SNAP) program under Clean Air Act § 612-EPA should administer Section 5 on an expedited, reliance basis for that same use, with information requests limited to issues unique to TSCA and supported by substantial evidence.

Similarly, where the discussion draft contemplates recognition of approvals issued by competent regulatory authorities in OECD member countries for specific conditions of use, approvals issued by agencies of the United States Government for the same conditions of use should receive at least equivalent weight.

Reducing unnecessary duplication strengthens regulatory efficiency and supports domestic production rather than driving innovation and investment offshore.

Grounded, Risk-Based Evaluations and Risk Management Standards

TSCA is a risk statute. Risk evaluations should focus on reasonably foreseen conditions of use grounded in real-world data and support regulatory measures proportional to identified risks.

Unreasonable risk determinations should be made on individual conditions of use, rather than aggregated across the entire chemical substance. Risk evaluations must reflect real-world conditions, including appropriate use of personal protective equipment (PPE), and should not presume universal non-use absent substantial evidence.

The discussion draft's clarification that EPA should apply requirements necessary to minimize, to the extent reasonably feasible, unreasonable risk provides a workable and appropriately tailored risk management standard consistent with TSCA's structure.

Where a chemical substance satisfies one of the statutory criteria under Section 6(g), Congress should clarify that EPA shall grant the applicable exemption from risk management requirements, ensuring consistent application of Congressional intent.

In conducting risk evaluations, EPA should consider relevant exposure limits or thresholds developed by other federal agencies, as well as scientifically robust determinations from competent regulatory authorities in OECD member countries, where such information is applicable to comparable conditions of use. Leveraging both domestic and international data sources can improve scientific rigor, reduce duplication, and promote alignment with global best practices, consistent with Congressional direction governing the use of scientific assessments in regulatory decision-making.

Congress should consider making interagency review of Section 6 risk evaluation and risk management work products mandatory rather than discretionary. Structured consultation-particularly with the Occupational Safety and Health Administration (OSHA) and other agencies with relevant expertise-would improve technical rigor, promote alignment in exposure limit development (including ECELs and PELs), and reduce duplicative regulatory requirements.

The draft's clarification that EPA should not assume noncompliance with other applicable laws or regulations, including occupational safety and health standards, appropriately reinforces recognition of existing federal worker protections and reduces the risk of duplicative regulatory obligations.

When Congress references programs that identify safer or pollution-prevention alternatives for prioritization, such as Safer Choice, those provisions should explicitly include EPA programs that conduct use-specific alternative assessments, including SNAP.

Interagency Review and Supply Chain Considerations

The inclusion of an interagency review process during risk evaluations-providing federal departments and agencies an opportunity to submit information on critical uses, alternatives, and supply-chain impacts-can improve coordination across the federal government. Such consultation should be structured to support timely completion of evaluations and provide clarity regarding how interagency input will be incorporated.

Clear consideration of supply-chain impacts is essential to avoid unintended consequences for critical manufacturing sectors, including energy, electronics, medical devices, defense, and infrastructure.

Replacement Parts for Complex Durable Goods

Congress included a replacement parts exemption in 2016 to protect long-lifecycle products such as automobiles, aerospace equipment, electronics, and industrial machinery. Legislative clarification is needed to ensure this exemption is applied consistently and is self-executing unless EPA demonstrates that a replacement part contributes significantly to unreasonable risk.

Limited upstream production necessary to manufacture exempt replacement parts should remain permitted, with appropriate transition periods where warranted. Congress should also clarify that articles are excluded from Section 6 risk evaluations and risk management rules, consistent with statutory structure and longstanding practice.

This clarity is particularly important for domestic manufacturers seeking to maintain and repair equipment already in commerce without disrupting operations or imposing unnecessary costs on consumers and small businesses.

Equivalency for UVCB Substances

For complex substances, including UVCBs (substances of Unknown or Variable composition, Complex reaction products, or Biological materials), Congress should provide clear direction that substances falling within the defined variability of an existing TSCA Inventory listing are treated as listed chemical substances-not as new chemicals.

Where a UVCB substance is compositionally consistent with a listed substance, based on objective parameters reflected in the Inventory description (such as process descriptors, carbon-number range, and boiling point range), it should be administered in the same manner as that listed substance. Differences in raw material source or manufacturing inputs that do not materially alter the substance's identity or risk profile should not, standing alone, trigger new chemical review. A clear, self-executing statutory framework for determining equivalency would reduce duplicative reviews, improve supply-chain certainty, and better align TSCA implementation with modern manufacturing practices. Consistent with proposed Senate language, Congress should establish objective parameters in statute under which substances falling within an existing TSCA Inventory listing are treated as listed, without requiring case-by-case EPA notification or approval. This approach would preserve EPA's authority to address substances that present materially different risks while allowing manufacturers to rely on existing Inventory listings as they currently do.

PFAS, Section 5, and PBT Implementation

As Congress continues oversight of TSCA implementation, careful attention should be paid to how Section 5 authorities-including Low Volume Exemptions (LVEs)-and Section 6 authorities addressing persistent, bioaccumulative, and toxic (PBT) substances are applied in practice.

For substances such as certain PFAS, regulatory clarity and discipline are essential to ensure that actions are grounded in risk and exposure, appropriately tailored to specific conditions of use-including critical sectors of the economy and critical uses identified by other federal agencies-and consistent with statutory limits.

Overly broad or uncertain application of authorities can create significant supply-chain disruption, particularly where chemistries are used in critical infrastructure, medical, energy, or advanced manufacturing applications.

Congress may wish to continue dialogue with stakeholders regarding how Section 5 and Section 6 tools are implemented in a manner that protects health and the environment while preserving U.S. technological leadership and economic competitiveness.

Avoid Duplicative Federal Regulation

Section 9 directs EPA to avoid duplicating regulatory requirements administered by other federal agencies. The draft clarifies that EPA may not apply a requirement under Section 6(a) that is inconsistent with another requirement applied with respect to the chemical substance under any federal law not administered by EPA. This clarification reinforces interagency coordination and helps avoid duplicative regulatory obligations.

Administrative processes should also be modernized to align statutory notification requirements with EPA's Central Data Exchange (CDX) system. Export notifications under Section 12 require identification of the TSCA section triggering notice; CDX should automatically populate the relevant section upon entry of a chemical's CAS number to reduce administrative burden and improve data accuracy.

Reporting and Administrative Efficiency

TSCA reporting requirements should be implemented in a manner that promotes transparency while avoiding unnecessary burden or duplicative obligations.

For reporting under Section 8 applicable to manufacturers and importers, Congress should clarify that importer reporting is required only where the chemical substance being imported is not listed on the TSCA Inventory. Retroactive or "look-back" reporting requirements should be limited to manufacturers of products and importers of chemical substances not already on the Inventory. In addition, where a manufacturer is already reporting the quantity of a chemical substance produced and distributed into U.S. commerce, Congress should omit duplicative reporting requirements for the importer of record.

Articles should be excluded from reporting requirements under Sections 8, 12, and 13, consistent with statutory structure and longstanding practice.

Congress should also consider aligning TSCA reporting thresholds with existing hazard communication thresholds under OSHA's Hazard Communication Standard (29 CFR 1910.1200), which governs Safety Data Sheet (SDS) disclosure requirements. While SDS Section 15 provides regulatory inventory status by jurisdiction, alignment could focus on harmonizing concentration-based reporting triggers and hazard thresholds used to determine when substances must be disclosed or reported. Greater consistency across TSCA and OSHA frameworks would reduce compliance complexity, improve data quality, and minimize duplicative reporting obligations across federal programs.

Scientific Integrity and Transparency

TSCA requires decisions based on the best available science and weight of the scientific evidence. Congress should reinforce this standard by enhancing transparency into modeling assumptions, ensuring appropriate peer review for major assessments, and aligning methodologies with TSCA's statutory framework.

Disposal and Lifecycle Considerations

Improper disposal can be a pathway of exposure and should be considered during risk evaluations. However, Congress should avoid creating redundant disposal frameworks where existing Resource Conservation and Recovery Act (RCRA) infrastructure and permitting authority already governs hazardous waste management.

Fee Authority and Accountability

Extending EPA's TSCA fee authority should be paired with measurable performance metrics, public reporting, and accountability mechanisms to ensure resources are aligned with statutory obligations and timely implementation. Predictable and transparent fee administration is particularly important for smaller manufacturers and new market entrants.

A modernized and well-functioning chemical regulatory framework is essential to U.S. competitiveness, domestic job growth, and economic security. Strengthening TSCA implementation through targeted, balanced refinements-including risk-based management standards, improved interagency coordination, disciplined Section 5 review practices, measurable accountability, and streamlined reporting-will protect health and the environment while enabling innovation, supporting small businesses, and reinforcing domestic supply chains in an increasingly competitive global marketplace.

We appreciate the Committee's leadership and stand ready to provide technical assistance as you continue consideration of the Discussion Draft.

Sincerely,

Marty Durbin
Senior Vice President, Policy
President, Global Energy Institute
U.S. Chamber of Commerce