In a rare bipartisan effort, Congress overwhelmingly passed a bill significantly reforming the chemical safety provisions of the Toxic Substances Control Act (“TSCA”) for the first time in its forty-year history. The Frank R. Lautenberg Chemical Safety for the 21st Century Act (H.R. 2576) (“Lautenberg Bill”) represents the culmination of a years-long effort supported by environmental groups and the regulated community, and President Obama’s signature is expected in the coming days.
TSCA is the primary federal statutory scheme governing the safety of chemicals in commerce (it also contains provisions governing specific substances like asbestos and PCBs). Under TSCA, EPA screens new chemical substances being introduced into commerce, requiring chemical manufacturers and importers to submit information and potential limitations on use. By contrast, the EPA has had limited authority over existing chemical substances – until now.
Existing Substances: Greatly Expanded EPA Authority
The Lautenberg Bill sets forth a three-step process for EPA to evaluate, and potentially regulate, existing chemical substances:
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Prioritization:
EPA must conduct an initial risk-based screening process to identify substances that have a high priority for further study. EPA must designate a substance as high-priority if it concludes that a particular substance may pose an “unreasonable risk of injury to health or the environment,” including impacts on sensitive populations like children and pregnant women under the “conditions of use,” i.e., the circumstances under which a “chemical substance is intended, known, or reasonably foreseen to be manufactured, processed, distributed in commerce, used, or disposed of.” Substances not found to pose such a risk are to be designated low-priority substances and would not be subject to further evaluation or regulation.
EPA may not consider “costs or other nonrisk factors” in its prioritization process. While the exact prioritization process will be laid out in an EPA rulemaking, by statute the prioritization process must take between 9 and 12 months per substance and must include opportunities for stakeholder participation and public comment.
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Risk Evaluation:
High-priority chemical substances are then subject to risk evaluations to determine whether the chemical substance in fact poses an unreasonable risk to human health or the environment. Again, in conducting the risk evaluation, EPA may not consider costs or other nonrisk factors and must “take into account, where relevant, the likely duration, intensity, frequency, and number of exposures under the conditions of use of the chemical substance…” EPA must clearly state the scope of the risk evaluation, and must complete the risk evaluation within 3 years of initiation.
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Risk Management:
For chemical substances determined to present an unreasonable risk to human health or the environment, EPA must develop a risk management rule. EPA must propose a risk management rule for the chemical substance within 1 year of the risk evaluation’s completion, and promulgate a final rule within 2 years of the risk evaluation’s completion (subject to the possibility of a 2-year extension). Stakeholders will have an opportunity to weigh in on the proposed risk management rule as it is being finalized.
While EPA is not permitted to consider costs in the Prioritization and Risk Evaluation phases, EPA is directed to consider economic and practical factors in developing restrictions on a chemical substance, including “the reasonably ascertainable economic consequences of the rule” and the beneficial uses of the chemical substance. In notable contrast to current TSCA, EPA is no longer required to use the “least burdensome” means of regulating a chemical substance.
The Lautenberg Bill provides timelines for EPA action on existing chemical substances:
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Within the first six months after enactment, EPA must have at least 10 risk evaluations underway, on chemical substances drawn from the 2014 update of the TSCA Work Plan for Chemical Assessments.
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Within the first year after enactment, EPA must develop rules for the prioritization of chemical substances (e., designation as either high or low priority for further evaluation), and for the risk evaluation process.
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Within three years after enactment, risk management rules must be in place for certain high-priority chemical substances.
Other Notable Features of the Lautenberg Bill
While the regulation of existing chemical substances is the highlight, the Lautenberg Bill includes several other changes that manufacturers should be aware of, including:
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The pre-manufacture notice process for initiating review of new chemical substances entering commerce is similar to current TSCA, but EPA will be required to more formally and rigorously evaluate the safety of such new chemical substances.
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EPA will have enhanced authority to order testing of both new and existing chemical substances.
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EPA will catalog the chemical substances presently in active commerce and re-set the inventory.
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State programs in existence as of April 22, 2016 are not preempted, but new state regulation of chemical substances may be preempted depending on EPA’s actions with respect to the substance. Preemption was a major sticking point that had to be overcome to achieve the compromise Lautenberg Bill, and there will likely be further controversy (and perhaps litigation) as the states adapt to the new TSCA regime.
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