Summary:A look at how the amended TSCA should affect toxic chemical regulation under the EPA.
Congress passed the Toxic Substances Control Act in 1976 in response to growing concerns over the health and environmental effects of manmade chemicals. A burgeoning chemical industry and lack of regulation meant that chemicals were flooding the market with little or no understanding of the risks. Through the TSCA, Congress sought to close the regulatory gap by authorizing the EPA to gather information on chemicals, assess risks, and control production, distribution, and use of toxic chemicals. Section 4 of the TSCA authorized the EPA to require testing under certain circumstances to better understand risks posed by a particular chemical. Section 5 required manufacturers to notify the EPA about any new chemicals they intended to market and further authorized the EPA to prohibit or place other limits on the chemical if it determined the new chemical created unreasonable risks. Under §6, if the EPA found that any chemical, new or existing, created an “unreasonable risk,” it could take one of several actions to address the risk, including a complete ban on the manufacture of the chemical.
These provisions, however, were fraught with problems. The EPA’s ability to require testing constrained by the TSCA’s requirement that the EPA find the chemical “may present an unreasonable risk.” But the TSCA failed to give the EPA the means to obtain data necessary to make this initial finding. Moreover, when the EPA made a positive risk determination, it could only require additional testing after a lengthy and contested rulemaking process. The EPA faced similar struggles with new chemicals under §5, which presumed new chemicals were safe unless the EPA could prove otherwise. Two other aspects of §5 made the EPA’s burden even more difficult. First, manufacturers were not required to test new chemicals or provide information on chemical risks beyond what they knew or what was “reasonably ascertainable.” And second, the EPA had only 90 days to make a risk determination. Manufacturing could begin after that period expired. These constraints made the EPA’s review of new chemicals exceedingly difficult. The EPA’s ability to regulate chemicals under §6 was also problematic. The TSCA placed a substantial burden on EPA to prove there was a “reasonable basis” to conclude a chemical created an “unreasonable risk” through onerous procedures and further limited the EPA’s ability to manage risks to the “least burdensome requirements” after a cost-benefit analysis. Finally, the TSCA did not require the EPA to evaluate any of the approximately 62,000 chemicals in use. The TSCA presumed these chemicals were safe.
On June 22, 2016, President Obama signed the Frank R. Lautenberg Chemical Safety for the 21st Century Act into law. The law attempts to remedy the TSCA’s many flaws. One of the most significant amendments requires the EPA to evaluate chemicals that were originally grandfathered. The amendments establish a framework for the EPA to prioritize its assessment of existing chemicals. If a chemical is designated as high priority, the EPA must engage in a risk evaluation of that chemical. If the risk evaluation shows that a chemical possesses an unreasonable risk, then the EPA must take a final risk management action within two years. New chemicals are no longer presumed safe unless the EPA can prove otherwise. The TSCA now requires the EPA to determine new chemicals are safe before they enter the market. The amendments also give the EPA greater authority to require additional testing to help the EPA’s review of chemical risks. In addition, the EPA can require testing without the need to go through a formal rulemaking process.
Two other features of the amended TSCA should have a significant impact on chemical regulation. First, the amendments prohibit the EPA from considering costs or other “nonrisk factors” when evaluating chemical risks and further no longer require the EPA to choose the “least burdensome alternative” to control risks. Second, when the EPA determines that a chemical is safe or has taken action to prevent any risk, states are preempted from regulating that chemical. States are also preempted from taking action on a chemical for up to three-and-a-half years during the EPA’s evaluation of a chemical. States can apply for waivers regarding either type of preemption, but the EPA does not need to necessarily grant the waiver. By preempting any state action, the EPA is guaranteed that each state is regulating chemicals in accordance with the EPA’s findings, but may also overturn a state’s finding that a chemical is potentially risky if the EPA determines it is not.
2017 will be an important year for the TSCA. The amendments require the EPA to complete two important rulemakings by June 2017. Section 6(b)(1) requires the EPA to establish by rule a risk-based screening process for prioritizing its review of existing chemicals. Section 6(b)(4) requires the EPA to promulgate new rules to determine whether existing chemicals present an unreasonable risk, without regard to cost or nonrisk factors. These rules will significantly affect how the EPA deals with toxic chemical regulation under the amended TSCA. With the incoming administration showing strong contempt for the EPA and environmental regulation, it is unclear whether the EPA will meet its deadlines and, if so, whether these rules will be sufficiently protective. We may see litigation on one or both issues.