An abbreviated guide to the Frank R. Lautenberg Chemical Safety for the 21st Century Act

Updated March 24, 2026

Summary: The 2016 reforms of the Toxic Substances Control Act (TSCA) gave EPA important new authorities and responsibilities to tackle the problem of toxic chemicals. For the first time, the law established enforceable deadlines and schedules for EPA work on chemicals as well as dedicated funding from fees paid by industry. The pace of change will continue to be slow, and there are some loopholes in the law. State authority was unduly infringed under the law, but enough is preserved that states can continue to take the lead in public health interventions for many, if not most, chemicals.

Highlights of the 2016 Reforms

New Chemical Reviews: The original 1976 law required a manufacturer to submit a “pre-manufacture” notice to EPA before it could begin production of a new chemical. No minimum health and safety data was required. EPA had 90 days to review the chemical. If it took no action, the manufacturer could commence production. However, it had the ability during this period to require testing before a chemical could proceed into commerce or to place a Significant New Use Rule on the chemical as a condition of allowing it on the market. (It could require the manufacturer to report if the production volume or uses of the chemical changed from what the manufacturer submitted.) With this authority EPA routinely blocked or restricted new chemicals every year, but it allowed most to move forward to production. 

The 2016 updates to the TSCA required EPA to make an affirmative finding that the chemical is likely not to present an unreasonable risk before it can commence production. While still not requiring minimum information, the provision has strengthened the oversight over new chemicals.

Safety Standard: Section 6 of TSCA governs the tens of thousands of chemicals that are already on the market. The 2016 reforms addressed the limitations on EPA authority that prevented it from regulating asbestos (and by implication, other chemicals) after a 1991 court decision. The 2016 reforms require the EPA to decide whether to regulate a chemical based solely on health and environmental factors. It must identify populations that are disproportionately at risk either due to greater exposure to the chemical or greater susceptibility to injury from the chemical such as children, workers, heavily impacted communities, or pregnant women. The decision to regulate or not is tied to the risk to these groups and any restrictions must protect these groups. 

Taken together and properly implemented, the 2016 reforms to “existing chemical” oversight should lead to chemical restrictions that are meaningful, not just to the general public, but especially to populations in heavily impacted communities and to pregnant women and children. While slowly implemented, they have led to bans and regulation on trichloroethylene and methylene chloride, for example.

Analytical Burden: The 2016 updates also removed the requirement in the original law that EPA must choose the “least burdensome” way of addressing the risk posed by a chemical. This seemingly innocuous phrase was a major factor in EPA’s inability to regulate asbestos, partly because of the way it was interpreted by the court. The court effectively found that EPA had to prove it had analyzed every conceivable way of restricting asbestos and had chosen the one that was “least burdensome” to industry. 

Under the 2016 update, EPA must conduct both a cost-benefit and a cost-effectiveness analysis of any proposed restrictions and describe their impact on the economy. However, the updated law made clear that those analyses are to guide EPA in choosing among a limited number of regulatory options that each should ensure the chemical is safe for the identified populations. While the analytical burden on the agency is still potentially significant, EPA is still required to apply the needed public health and environmental protections.

Deadlines: The mechanism for EPA to choose a chemical to review is to propose it as a High Priority chemical. Within 12 months of such a proposal, the EPA must finalize the prioritization or change its mind citing new information. Once prioritization is finalized, the EPA must conclude the safety review (called a “risk evaluation”) within three years. If it needs more information or time for analysis, it can extend the deadline an additional year. If the chemical flunks the safety review, the EPA then has two years to finalize a rule specifying the restrictions it will place on the chemical in order to protect public health. It can get an extension of up to one year, if needed, to formulate the restrictions. The public can sue the agency for failure to meet these deadlines, which is what makes them “enforceable.” The deadlines are obviously generous, but they are also deadlines that did not exist prior to the 2016 reforms. With adequate resources and political will EPA could move faster.

Schedule: The 2016 law also established a minimum enforceable schedule. It required EPA to begin safety reviews on 10 chemicals within 180 days of enactment and on another 20 chemicals listed as high priority within three and a half years of enactment. Going forward, each time EPA completes a review, it must designate at least one additional chemical as high-priority until every chemical in commerce has been prioritized as either High or Low. There is a mechanism whereby chemical manufacturers can nominate a chemical for EPA to review, and EPA must oblige, provided the manufacturer pays the cost of review. The number of manufacturer-requested evaluations cannot exceed the number of EPA-initiated evaluations at any given time. As with the deadlines, this schedule is clearly meager, but it is also a minimum. With adequate resources and political will EPA could tackle a greater number of chemicals.

Persistent, Bioaccumulative, and Toxic Chemicals (PBTs): The law expedites action on some of these chemicals, which are widely considered to pose great risks to public health and the environment. By the time the 2016 reforms to TSCA were enacted, the EPA had already identified 30 PBTs through its Workplan program. The law requires the agency to apply a potency and exposure criteria to that group and subject any chemicals that meet the criteria to an expedited process whereby they must be restricted within three years and exposure reduced more aggressively than with other chemicals. However, manufacturers could use some of the allotted manufacturer requests (from the process above) to force EPA to first conduct an evaluation of the PBT if the manufacturer is willing to pay for it. Depending on how broadly EPA interprets the PBT criteria and whether manufacturers use their request chits on these chemicals, the provision could lead to expedited action for a significant group of known toxic chemicals.

State Authority: All state restrictions on chemicals that had been taken as of April 22, 2016 were “grandfathered” or allowed to remain in place regardless of what EPA decides about the same chemical in the future. States are free to initiate new restrictions on a chemical until and unless EPA names the chemical as High Priority and publishes a document outlining the “scope”—the uses, conditions, health concerns, etc.—of the risk evaluation they plan to undertake. States are then prohibited (“preempted”) from establishing new restrictions that address the same scope. If EPA declares the chemical safe for all of those uses and conditions, the preemption becomes permanent. If EPA declares any of the uses and conditions in the scoping document unsafe, the preemption is lifted and states are free to impose new restrictions while EPA takes two to three years to decide on its own restrictions. Once EPA establishes its restrictions, the preemption kicks in again and becomes permanent unless a state obtains a waiver that requires it to meet several criteria.

Certain categories of state chemical regulation are exempt from preemption altogether. These include restrictions pursued under state laws that relate to air, water, or waste or which derive from delegated authority under another federal law (like OSHA). State information collection and reporting requirements are exempt as are any actions taken under a state law passed before 2003. This last provision was designed to protect California’s Proposition 65 but it applies to any other pre-2003 law. The temporary preemption provision did not apply to the first 10 chemicals that EPA named or to industry-requested evaluations of any EPA Workplan chemical. This last provision was included to ensure that several recent and pending state actions on Workplan chemicals could take effect.

As this description shows, the preemption provisions in the bill are complicated and over-reaching. However, because of the exemptions described and the fact that preemption is tied to the schedule of EPA reviews, there remained ample room for continued state leadership.

Testing Authority: Under the original law, EPA had to undertake a formal rulemaking—a significant legal administrative process that required years —in order to require a chemical manufacturer to conduct toxicity testing. As a result, only a fraction of chemicals had significant health and safety information. The 2016 reforms simplified EPA’s ability to require toxicity testing through an administrative order. EPA is required to deploy a “tiered testing” approach—whereby a chemical must first raise a red flag in a screening level test before more extensive tests are required. The 2016 law expressly provided however, that EPA can move straight to more extensive testing if it believes it is necessary. The overwhelming scientific consensus is that whole animal testing (including on zebra fish) is still required to accurately assess whether a chemical causes many of the known “toxicities” of concern. Animal testing provisions in the new law, while appropriately encouraging the use of non-animal methods where available, also go beyond that in ways that, depending on interpretation, could discourage independent research that is needed to identify and intercept chemicals that could harm human and animal populations.

In general, the improvements to testing authority in the bill outweigh the limitations and create the potential for substantial improvements in our understanding of toxic chemicals. Unfortunately, nothing in the 2016 law required EPA to use the new authority, so the extent that it does is driven by external demand for more information about chemicals.

Confidential Business Information: Under the original law, much of the limited information that is available about chemicals was hidden from the public because of overly broad and frequently abused provisions allowing manufacturers to claim information as confidential. Under the 2016 law, EPA can share information with state and local governments, first responders, and health providers as long as the confidentiality is maintained. The updates to the law created new guidelines to provide greater clarity about what information can and cannot be claimed as confidential. Confidentiality claims relating to the very identity of a chemical (its actual, technical name) have been among the most controversial in original law. 

The 2016 reforms required that manufacturers substantiate the basis for claiming chemical identity as confidential and created a deadline for EPA review of CBI claims. At the same time, it allowed manufacturers to shield chemical identity from disclosure when it would otherwise be revealed as part of a health and safety review if the chemical name reveals information about how the chemical is produced.

Imported Products: The original law had a mechanism whereby the EPA can require manufacturers or importers of products (called “articles” in the law) to notify the agency if the product contains a chemical of concern. (The mechanism is called a Significant New Use Rule.) The purpose of the mechanism is to ensure that new uses of a chemical—which may not have been regulated because they were not anticipated—don’t proliferate to such a degree that they cause harm. Several companies successfully lobbied for a provision in the 2016 law that would make it harder for EPA to require this notification in the future. Under the 2016 law, EPA is required to make “an affirmative finding” that the article presents a “reasonable potential for exposure” before it can require notification.