What The 'New TSCA' Has Accomplished—and What Comes Next

This article reviews the successes achieved in the regulation of chemicals under the Toxic Substances Control Act (TSCA), 15 U.S.C. §§ 2601–2697, since Congress amended the Act in 2016. Frank R. Lautenberg Chemical Safety for the 21st Century Act, Pub. L. No. 114-182, 130 Stat. 448 (2016). Despite the fact that further improvements may be necessary—particularly to expedite chemical reviews, encourage timely collection of chemical use and exposure data, and secure more resources—the amended TSCA provides a solid foundation for protecting human health and the environment, and a strong federal program for chemical management across the nation is taking shape. The EPA’s implementation of the 2016 amendments has advanced public health protection through nationwide bans on many uses of chemicals—including hazardous solvents, chrysotile asbestos, and a group of persistent, bioaccumulative, and toxic (PBT) chemicals—and through regulations for the majority of new chemicals. Compared to the past, there is far greater public transparency across TSCA’s programs today and a rigorous program for inspecting confidential business information (CBI) claims.

Old TSCA: Key Challenges

Enacted in 1976, TSCA gave the U.S. Environmental Protection Agency (EPA) authority to identify and control potentially hazardous chemicals in U.S. commerce not covered by other environmental laws. While TSCA established an inventory of existing chemical substances in U.S. commerce and required the EPA to review and regulate new chemicals not on this list, it also limited the EPA’s ability to collect data on chemicals under Section 4 and to regulate existing chemicals under Section 6. 15 U.S.C. §§ 2603, 2605 (1976).

From 1976 to 2016, the EPA spent most of its TSCA efforts reviewing premanufacture notifications (PMNs) for new chemicals under Section 5 prior to their manufacture or import. Id. § 2604. The law permitted commercialization after a 90-day review period if the EPA raised no objections, but it did not require companies to generate new health and safety data before making their submissions. Id. § 2604(a)–(b). Nevertheless, the EPA could require data development as a condition of approving the new chemical. Over time, the EPA developed a comprehensive structure-activity relationship (SAR) database of chemical analogs, which allowed it to evaluate the safety of new chemicals despite the absence of data specific to the new chemical. In addition, TSCA did not require the EPA to document and publish determinations of safety for new chemicals or significant new uses, leaving the outcomes a veritable mystery to outsiders.

From the outset, the EPA could require testing of existing chemicals via rulemaking when information gaps impeded risk assessment. Id. § 2603(a)–(b). Often, these rulemakings took years. The EPA had to justify testing based on a finding that a chemical substance may present an unreasonable risk to the environment or human health—a determination that frequently required the very information the agency sought to collect. Voluntary negotiated testing consent orders temporarily eased the challenges associated with rulemakings, and the EPA routinely used Section 4 to issue enforceable consent agreements (ECAs) to secure health and safety data. Nevertheless, the EPA increasingly relied on “worst case” modeling and determinations of toxicity based on data about chemicals similar in structure.

The EPA’s authority to regulate existing chemicals proved largely ineffective. Over TSCA’s first 40 years, the EPA issued only one final, enforceable Section 6 rule to regulate an existing chemical. The 1978 rulemaking for polychlorinated biphenyls (PCBs) established requirements for their manufacture, processing, distribution, use, and disposal, and PCBs were ultimately banned in 1979. EPA, Final Rule, Polychlorinated Biphenyls (PCBs): Disposal and Marking, 43 Fed. Reg. 7150 (Feb. 17, 1978); 15 U.S.C. § 2605(e). Efforts to regulate other chemicals like asbestos and acrylamide dragged on with little results. In Corrosion Proof Fittings v. EPA, the U.S. Court of Appeals for the Fifth Circuit vacated the EPA’s nationwide ban of asbestos under TSCA Section 6, finding that the agency had not adequately considered less restrictive measures such as labeling or partial bans. 947 F.2d 1201, 1230 (5th Cir. 1991). While acknowledging asbestos’ hazards, the court concluded that the EPA’s record lacked substantial evidence to justify a total ban, sending a strong signal that TSCA’s original framework imposed high evidentiary and procedural hurdles to the EPA’s imposition of restrictions. The EPA’s later attempts to resuscitate existing chemicals regulation were largely unsuccessful, save for the development of the 2014 TSCA Work Plan that identified 90 chemicals for risk evaluation. EPA, Off. of Pollution Prevention & Toxics, TSCA Work Plan for Chemical Assessments: 2014 Update (Oct. 2014).

Modernized TSCA: New Milestones

Efforts to “reform” TSCA gained momentum as state-level chemical management statutes emerged, simultaneously raising concerns about a fragmented system while highlighting widespread dissatisfaction with TSCA’s limited progress in controlling risk from existing chemicals in commerce. By 2012, Senator Frank Lautenberg (D-NJ) had introduced TSCA reform legislation in five consecutive Congresses. When he died in 2013, the torch passed to Senator David Vitter (R-LA) and Senator Tom Udall (D-NM).

The EPA’s authority to regulate existing chemicals proved largely ineffective. Over TSCA’s first 40 years, the EPA issued only one final, enforceable Section 6 rule to regulate an existing chemical.

On June 16, 2016, the Frank R. Lautenberg Chemical Safety for the 21st Century Act was signed into law. Pub. L. No. 114-182, 130 Stat. 448 (2016). Congress’ primary aim was to empower the EPA to regulate existing chemicals. The EPA drew the first 10 chemicals for risk evaluation from the 2014 TSCA Work Plan, including asbestos; methylene chloride; NMP; TCE; PCE; carbon tetrachloride; 1,4-dioxane; HBCD; Pigment Violet 29; and 1-bromopropane. The amended statute tasked the EPA thereafter with prioritizing 20 chemicals for designation as low priority for risk evaluation and 20 others for designation as high priority. 15 U.S.C. § 2605(b). Section 6 now requires a three-phase process of prioritization, risk evaluation, and risk management that the EPA must complete within a seven-year period, and the EPA must have at least 20 existing chemicals undergoing risk evaluation at any given time. At least 50% must be chemicals from the 2014 Work Plan. Chemicals that the EPA designates as high priority enter a risk evaluation process that culminates in a risk management rule. Id. § 2605(b)–(c).

A defining change in the 2016 amendments was to the Act’s safety standard. The EPA must now determine, without consideration of costs or other nonrisk factors, whether a chemical may present an unreasonable risk of injury to health or the environment under the conditions of use, including an unreasonable risk to a potentially exposed or susceptible subpopulation. Id. § 2605(b)(4)(A). The EPA’s findings become ripe for judicial review only after a final risk management rule is in place or after the agency issues an order finding no unreasonable risk. Id. § 2605(i).

Section 6(a) of TSCA provides the EPA with a number of risk management options and instructs the EPA to deploy them to the extent necessary to ensure that the chemical no longer presents an unreasonable risk. Id. § 2605(a). With this language, the 2016 amendments “un-paralyzed” the EPA by removing the mandatory “least burdensome” requirement found in the original version of Section 6(a). Options for regulation now include warning requirements; manufacture, process, distribution, and use limitations; amount and concentration limits; compliance testing; disposal restrictions; customer and public notifications; replacement or repurchase programs; and partial and full bans of the chemical altogether. In deciding whether to prohibit or restrict a condition of use of a chemical substance and setting appropriate transition periods, the EPA must consider, to the extent practicable, whether technically and economically feasible alternatives will be reasonably available. The alternatives should benefit health or the environment compared to the use of the chemical that is being regulated. Id. § 2605(c)(2)(C).

The amended TSCA also has allowed the EPA to more comprehensively assess workplace safety, a consideration traditionally left to the Occupational Safety and Health Act (OSH Act). Pub. L. No. 91-596, 84 Stat. 1590 (codified at 29 U.S.C. §§ 651–678); see 15 U.S.C. §§ 2605(b)(4)(A), 2602(12). Specifically, the EPA has introduced the concept of Workplace Chemical Protection Plans (WCPPs) to address unreasonable risks without resorting to bans and is issuing occupational exposure limits that are more stringent than the Occupational Safety and Health Administration’s (OSHA’s) permissible exposure limits (PELs).

The dual role of TSCA’s requirement that the EPA protect workers from unreasonable risks associated with chemical substances, 15 U.S.C. §§ 2605(b)(4)(A), 2602(12), and the OSH Act’s directive to evaluate and reduce risk to workers, 29 U.S.C § 655(a)–(b), is a reality for regulated industries. Both agencies’ rules are intended to reduce workplace exposures, and the control measures they impose can overlap. To foster coordination, in December 2024, the EPA and OSHA signed a memorandum of understanding (MOU) regarding the agencies’ working relationship with respect to existing chemicals. U.S. EPA & .S. Dep’t of Labor (DOL), Memorandum of Understanding Between the U.S. Env’t Prot. Agency Off. of Chem. Safety & Pollution Prevention, Off. of Enf ’t & Compliance Assurance & the U.S. Dep’t of Lab. Occupational Safety & Health Admin. (2024). The objective of this MOU is to facilitate regular information sharing between the agencies. In addition, the agencies will mutually refer to each other potential violations of either set of workplace standards and share information on inspection focus areas, complaints, and enforcement. A 2021 MOU provides for similar information sharing for TSCA Section 5 new chemicals. U.S. EPA & U.S. DOL, Memorandum of Understanding for Implementation of TSCA Section 5 and Sharing of Confidential Business Information (2021). Most recently, a January 2026 House Appropriations Committee report directed the EPA to clarify how the EPA and OSHA will coordinate. H.R. Rep. No. 119-215, at 64 (2025).

Beyond Section 6 of the Act, the 2016 amendments overhauled the CBI provisions in Section 14 to increase transparency and public access to chemical information that may no longer be considered confidential. 15 U.S.C. § 2613(c)(3), (e). Prior to the amendments, TSCA required substantiation only for limited categories of information such as chemical identity and the EPA did not routinely review CBI claims to determine whether they were still valid. The Lautenberg Amendments identify specific business information that is entitled to protection; requires affirmative, written justifications for other information to maintain confidentiality; and calls for review and renewal of CBI claims every 10 years.

Under TSCA Section 5, the EPA now must affirmatively document its findings and conclusions associated with new chemical reviews. Id. § 2604(g). In addition to having the authority to regulate a new chemical or require testing based on hazard or exposure, the absence of information about the chemical is now a sufficient reason for the EPA to regulate its manufacture, processing, distribution, use, and disposal. Id. § 2604(e).

Changes in Section 26 direct the EPA to use “best available science” for “a decision based on science,” and decisions on chemicals must be based on “the weight of the scientific evidence.” 15 U.S.C. § 2625(h), (i). These technical guideposts promote an objective evaluation of the hazards and exposure information on chemicals by the EPA. TSCA reform in 2016 also expanded the services for which the EPA may impose user fees and allow for higher fees and inflationary adjustments, helping to defray EPA’s costs. Id. § 2625(b).

Congress created new federal preemption provisions in Section 18. Id. § 2617. Once EPA takes regulatory action on a specific chemical under TSCA Section 6(c), by issuing either an order or final risk management rule, states are generally precluded from regulating differently. However, TSCA’s preemption provisions are subject to pause, various exceptions, and potential waivers, creating a complex balance between TSCA and existing state laws.

Other sections of TSCA that Congress left untouched in 2016 have nonetheless been affected by the new regulatory regime. For instance, the obligation to file export notifications under Section 12(b) has remained substantively the same—exporters must notify the EPA when exporting a chemical that is subject to certain TSCA actions, such as test rules or Section 4 orders, Section 5 consent orders or rules, or Section 6 proposed or final risk management rules. The EPA in turn can notify the importing country of the chemical’s U.S. regulatory status to inform their decision-making. The scope of the notification obligation has effectively expanded because there are far more regulatory actions under Sections 5 and 6, each of which triggers this notice requirement.

The 2016 amendments also breathed new life into TSCA’s Section 21 citizens petition provision as it relates to existing chemicals. Section 21 enables any person to petition the EPA to initiate a proceeding for the issuance, amendment, or repeal of a Section 6 rule (as well as other types of rules issued under TSCA). 15 U.S.C. § 2620(a). When the EPA denies a Section 21 petition, upon appeal, the district court may make a de novo finding of unreasonable risk, supplanting the EPA’s authority to conduct its own risk evaluation for the chemical. The district court can then direct the EPA to proceed straight to risk management. Since the 2016 amendments, a range of stakeholders have filed petitions under Section 21 requesting that the EPA initiate Section 6 risk evaluations or promulgate Section 6 risk management rules for existing chemicals such as asbestos, TCE, certain flame retardants, mercury-related activities, the tire additive 6-PPD, and chemicals used in oil refining such as hydrogen fluoride. Most, if not all, of them identify one or a handful of the chemical’s uses for EPA to evaluate. Initially, the EPA took the position that these petitions would need to include all conditions of use of a chemical, creating an exceptionally high bar for advancing petitions to restrict chemicals under Section 6 and resulting in rejections on this basis alone. Not all courts have accepted the EPA’s position that petitioners must identify all “reasonably known and foreseeable conditions of use” of a chemical substance as a condition for granting these petitions. Food & Water Watch, Inc. v. U.S. EPA, 2024 WL 4291497, at *4 (N.D. Cal. Sept. 24, 2024). In addition, the EPA is accepting certain petitions while pointing out the need for additional information. EPA, Final Response to Petition No. 001845: Toxic Substances Control Act Section 21 Petition Regarding N-(1,3-Dimethylbutyl)-N’-phenyl-p-phenylenediamine (CASRN 793-24-8, aka 6PPD) in Tires (Nov. 2, 2023). It is not entirely clear that Congress in 2016 anticipated the extent to which Section 21 would be used to deflect requests for rulemaking by invoking the need for more information or to serve as an end run around comprehensive agency risk determinations.

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