15 U.S.C. § 2601 – Toxic Substances Control Act (TSCA): Regulation of Chemical Substances

Code Details

15 USC 2602: Definitions
Text contains those laws in effect on August 26, 2025
From Title 15-COMMERCE AND TRADE
CHAPTER 53-TOXIC SUBSTANCES CONTROL
SUBCHAPTER I-CONTROL OF TOXIC SUBSTANCES

Exact Statute Text

15 U.S.C. § 2601 Summary

This section of the Toxic Substances Control Act (TSCA) serves as the foundational declaration of Congress’s understanding, goals, and intentions regarding the regulation of chemical substances and mixtures in the United States. It outlines three key components: findings, policy, and intent.

First, the “Findings” section acknowledges that humans and the environment are regularly exposed to numerous chemical substances. It recognizes that some of these chemicals pose an “unreasonable risk of injury to health or the environment” through their manufacture, use, or disposal. It also establishes the necessity of regulating both interstate and intrastate commerce in these chemicals for effective control.

Second, the “Policy” section sets forth the core principles guiding chemical regulation. It states that sufficient information about the health and environmental effects of chemicals should be developed, and crucially, that the responsibility for this information development lies with those who manufacture and process these substances. The policy also asserts the need for adequate authority to regulate chemicals presenting an unreasonable risk or those that are “imminent hazards,” while simultaneously aiming to avoid creating undue economic barriers to technological innovation. This balance ensures that innovation proceeds without compromising health and environmental safety.

Finally, the “Intent of Congress” section directs the Administrator (referring to the Administrator of the Environmental Protection Agency, or EPA) to implement the TSCA in a “reasonable and prudent manner.” It mandates that the Administrator consider the environmental, economic, and social impacts of any regulatory actions taken or proposed under this chapter.

In essence, 15 U.S.C. § 2601 lays the groundwork for federal oversight of chemicals, emphasizing the risks they can pose, the industry’s responsibility to prove their safety, and the government’s role in regulation, all while balancing economic considerations. It applies primarily to the EPA as the regulating body and, by extension, to manufacturers and processors of chemical substances in the U.S.

Purpose of 15 U.S.C. § 2601

The legislative purpose behind the Toxic Substances Control Act (TSCA), as articulated in 15 U.S.C. § 2601, is to protect human health and the environment from the potential dangers of chemical substances and mixtures. This statute exists to address a critical problem: the widespread production and use of chemicals, many of which may have unknown or harmful effects on individuals and ecosystems.

Before TSCA’s enactment, there was no comprehensive federal law requiring the assessment of new chemicals before they entered the market or providing broad authority to regulate existing hazardous ones. This section fills that void by establishing a framework that places the onus on chemical manufacturers and processors to develop data regarding the safety of their products. It empowers the Environmental Protection Agency (EPA) to gather this information, evaluate risks, and impose necessary controls—from requiring specific labeling to outright bans—on substances found to present an “unreasonable risk” or to be “imminent hazards.”

The statute’s purpose is also to foster technological innovation in chemical development without compromising safety. By mandating a “reasonable and prudent” approach to regulation that considers economic and social impacts, Congress sought to strike a balance between safeguarding public welfare and avoiding unnecessary impediments to industrial progress. Ultimately, this foundational section ensures that the commerce in chemical substances progresses in a manner that does not present an unreasonable risk to health or the environment.

Real-World Example of 15 U.S.C. § 2601

Imagine a chemical manufacturing company, “ChemInnovate Inc.,” develops a new substance intended to make waterproof fabrics. Before bringing this new chemical to market, ChemInnovate Inc. must navigate the regulatory landscape informed by TSCA, starting with the principles in 15 U.S.C. § 2601.

Guided by subsection (b)(1)’s policy, which states that information on a chemical’s effects on health and the environment is the responsibility of those who manufacture it, ChemInnovate Inc. conducts extensive testing. They assess the chemical’s toxicity, potential for bioaccumulation, and environmental persistence. If these tests, or any subsequent EPA review, reveal that the new substance poses an “unreasonable risk of injury to health or the environment”—for instance, it’s found to be a potent carcinogen or highly damaging to aquatic life, aligning with subsection (a)(2)’s findings—then the EPA, under the authority described in subsection (b)(2), can take action.

The EPA, acting as directed by Congress’s intent in subsection (c), would evaluate the environmental, economic, and social impacts of regulating or restricting this new chemical. They might require specific handling procedures, mandate warnings on packaging, limit its use to industrial settings, or, in severe cases, prohibit its manufacture entirely. This real-world scenario demonstrates how the foundational principles of 15 U.S.C. § 2601 compel industry responsibility and provide the EPA with the mandate to prevent harmful chemicals from endangering public health and the environment.

Related Statutes

Several other statutes within the Toxic Substances Control Act (TSCA) are directly related to 15 U.S.C. § 2601, building upon its foundational findings, policy, and intent:

• 15 U.S.C. § 2602 – Definitions: This section provides specific definitions for terms used throughout TSCA, such as “chemical substance,” “mixture,” “manufacture,” “process,” and “unreasonable risk.” These definitions are crucial for interpreting the scope and application of the regulatory authority established by the Act, including the core principles outlined in § 2601.
• 15 U.S.C. § 2603 – Testing of chemical substances and mixtures: Directly following the policy in § 2601(b)(1) that adequate information should be developed, § 2603 grants the Administrator the authority to require manufacturers and processors to test chemical substances or mixtures if there is insufficient data to determine their effects on health or the environment, and if they may present an unreasonable risk or significant exposure.
• 15 U.S.C. § 2604 – Manufacturing and processing notices: This section outlines the requirements for manufacturers to submit a Premanufacture Notice (PMN) to the EPA before introducing a new chemical substance into commerce or a significant new use of an existing chemical. This directly implements the policy of developing information and preventing unreasonable risk *before* widespread exposure, as set forth in § 2601.
• 15 U.S.C. § 2605 – Regulation of hazardous chemical substances and mixtures: This critical section empowers the EPA to regulate chemical substances and mixtures that present an “unreasonable risk of injury to health or the environment.” The various regulatory actions, from labeling requirements to bans, are the direct operationalization of the policy and intent described in § 2601(b)(2) to control dangerous chemicals.

Case Law Interpreting 15 U.S.C. § 2601

While 15 U.S.C. § 2601 sets forth the foundational findings, policy, and intent of the Toxic Substances Control Act, direct judicial interpretation of this specific introductory section often occurs in the context of challenges to EPA’s actions taken under TSCA’s operational provisions (like §§ 2603, 2604, or 2605). Courts frequently reference § 2601 to understand the overarching legislative purpose and the “unreasonable risk” standard when evaluating the legality of EPA regulations.

A prominent case that extensively discusses the core principles of TSCA, particularly the “unreasonable risk” standard rooted in § 2601(a)(2) and (b)(2), is:

• Corrosion Proof Fittings v. Environmental Protection Agency, 947 F.2d 1201 (5th Cir. 1991): This landmark case involved a challenge to the EPA’s comprehensive ban on asbestos products under TSCA. The Fifth Circuit Court of Appeals extensively analyzed the EPA’s interpretation and application of the “unreasonable risk” standard, drawing heavily on the legislative intent and policy outlined in TSCA’s introductory sections. The court’s decision significantly influenced how the EPA must demonstrate a chemical poses an “unreasonable risk” and how it must weigh the costs and benefits of any regulatory action, aligning with the balance between innovation and safety described in § 2601(b)(3) and the Administrator’s duty to consider economic impacts in § 2601(c). While primarily interpreting § 2605, the ruling’s underpinnings trace directly back to the principles enshrined in § 2601.

Why 15 U.S.C. § 2601 Matters in Personal Injury Litigation

Although 15 U.S.C. § 2601 does not create a private right of action for individuals to sue, its foundational principles are profoundly relevant in personal injury litigation involving exposure to toxic substances. This section establishes the bedrock upon which claims for injuries caused by chemical substances can be built, particularly in Texas personal injury cases.

First, the “Findings” and “Policy” sections, especially subsection (b)(1), underscore the responsibility of manufacturers and processors to develop adequate information about the health and environmental effects of their chemical substances. In a personal injury case alleging harm from a chemical, this statutory declaration can be crucial. If a plaintiff can demonstrate that a manufacturer failed to adequately test a substance, failed to warn of known or discoverable risks, or misrepresented its safety, the manufacturer may be found negligent or strictly liable for the resulting injuries. The existence of this federal policy supports the argument that a higher duty of care is owed by chemical companies.

Second, the concept of “unreasonable risk of injury to health or the environment,” prominently featured in both the findings and policy of 15 U.S.C. § 2601, is a central tenet in product liability and toxic tort cases. When a plaintiff suffers injury due to a chemical, proving that the substance presented an “unreasonable risk”—and that the defendant knew or should have known about it—is often key. This statute provides the legislative context for what constitutes such a risk from a federal regulatory perspective, informing the standard of care expected from chemical producers.

Third, while TSCA regulations stemming from this foundational section don’t directly establish negligence *per se* in all personal injury cases, a defendant’s violation of these regulations can be powerful evidence of a breach of duty. For example, if a company failed to submit a required Premanufacture Notice (PMN) or disregarded EPA-mandated testing, such non-compliance can be used by plaintiff attorneys to demonstrate a defendant’s disregard for safety and public health, directly linked to the legislative intent to prevent unreasonable risks.

Finally, for both clients and legal professionals, understanding 15 U.S.C. § 2601 helps frame the societal expectation that chemical substances should be safe. It clarifies that the federal government recognized the inherent dangers of chemicals and placed the burden of ensuring safety on the industry. This context is invaluable for expert witnesses, jury education, and developing comprehensive litigation strategies in cases involving chemical exposure, such as those related to asbestos, lead, pesticides, or other hazardous materials causing conditions like cancer, respiratory illness, or neurological damage.