In June 2016, Congress did something it had not done in over a quarter century: it enacted comprehensive, bipartisan revisions to a major environmental statute. More specifically, it substantially overhauled the Toxic Substances Control Act, or TSCA, a law that was first passed in 1976 and was widely considered to be in need of an update. The TSCA reform law, also known as the Lautenberg Act, expands EPA’s role in reviewing new chemical substances; gives EPA new authority to require testing of chemicals; and directs EPA to prioritize, evaluate and regulate the risks from existing chemicals. It also imposes strict deadlines on EPA for carrying out its new duties under TSCA.

And EPA has apparently taken these deadlines to heart.

On January 19, the Obama administration proposed “framework” rules setting out the procedure by which EPA will perform “risk evaluations” for existing chemical substances under Section 6 of TSCA. Many of the proposed framework rule’s provisions appear to be driven by EPA’s concern about completing risk evaluations — and promulgating any restrictions on those substances that may be appropriate — within the Lautenberg Act’s strict new deadlines.

EPA’s concern is understandable. Historically, the agency has often struggled to meet mandatory deadlines in environmental statutes like the Clean Air Act. Failure to meet these deadlines can lead to lawsuits and ultimately allow court orders, rather than agency priorities, to define EPA’s regulatory agenda. Coupled with the recent hiring freeze on federal workers and the possibility of significant cuts to the agency’s budget, EPA may find it even more difficult to meet TSCA’s deadlines.

Further, the new TSCA provisions contained in the Lautenberg Act require EPA to do a great deal in a relatively short time. When President Obama signed the bill into law, he started the clock on a series of deadlines requiring EPA to begin evaluating a broad range of existing chemical substances to determine whether they present an unreasonable risk of injury to health or the environment. EPA was required to commence risk evaluations for 10 substances by December 2016, and must ensure evaluations are being conducted for 20 high-risk substances by December 2019. Each risk evaluation must be completed within 3 to 3.5 years of commencement. During that time, EPA must:

  • Define the scope of the risk evaluation, including the chemical’s hazards, exposures, conditions of use and any potentially exposed or susceptible subpopulations that EPA expects to consider;
  • Integrate and assess available information on those hazards and exposures;
  • Identify and consider the likely duration, intensity, frequency and number of exposures;
  • Publish a draft risk evaluation and solicit public comment; and
  • Publish a final risk evaluation and address comments on the draft.

The risk assessment is critical because it dictates whether EPA will subsequently need to establish use restrictions to mitigate unacceptable risk. One of the key elements of the Lautenberg Act was the elimination of cost as a factor that may be considered by EPA in setting such restrictions. Therefore, a finding of unacceptable risk will virtually guarantee that use restrictions on existing substances will be imposed.

The Lautenberg Act also tasked EPA with developing a framework rule by June 2017 establishing the process by which EPA will undertake these risk evaluations. The Obama administration issued a proposed framework rule in its waning days. See Procedures for Chemical Risk Evaluation Under the Amended Toxic Substances Control Act, 82 Fed. Reg. 7562 (Jan. 19, 2017). As noted above, many of the provisions of this framework rule appear to be an effort to streamline risk evaluations as much as possible in order to meet TSCA’s new strict deadlines. EPA stated that it “intends to conduct risk evaluations in a way that is manageable given the statutory deadlines.”

In particular, the proposed framework rule gives a very prominent role to the scoping process. This approach could streamline the risk evaluation process by preventing commenters from identifying previously overlooked hazards or conditions of use for a chemical once the risk evaluation is underway, which could snarl the review by introducing new considerations. In fact, rather than defining the factors EPA expects to consider in the risk evaluation, the proposal seems to suggest that the scoping document will define the only hazards, exposures, uses and subpopulations EPA will consider. EPA states that it will “lock down” the conditions of use to be considered at the time of scoping. The agency reinforces this approach by proposing that any objections to the scope of the evaluation that are not raised in comments during the scoping process will be waived.

Some provisions seem aimed at taking advantage of potential efficiencies in the risk evaluation. EPA proposes to use a “fit for purpose” approach to risk evaluations, in which not all conditions of use for a chemical will require the same degree of scrutiny. Likewise, EPA proposes that it may evaluate entire categories of chemical substances rather than just individual chemicals, thus avoiding duplication on similar substances.

Other provisions seem designed to create bright lines for EPA to follow. As noted above, EPA proposes to “lock down” the conditions of use it will consider after the scope of the risk evaluation is published. Similarly, it appears EPA will also lock down the information it is willing to consider after the scoping period closes as well. The agency proposes that the “reasonably available” information it is required to consider will generally be limited to that which exists when the risk evaluation commences. EPA’s rationale is that it will typically be infeasible to develop and assess new test results for a chemical within its 3.5-year risk evaluation period.

This last proposal may prove problematic. TSCA also requires EPA to employ the “best available science.” If the best available science is reflected in studies that came to light after a chemical’s risk evaluation commenced, the agency may find it hard to justify ignoring that information simply because it might disrupt its planned administrative timeline.

Ultimately, it remains to be seen what framework rules EPA will adopt for risk evaluations, and how the agency will square the aggressive deadlines with its intimidating workload under the new TSCA provisions. The public comment period is open until March 20, and after reviewing these comments the Trump administration may decide to take a different approach. However, the scoping process inevitably will play a critical role in defining the risk evaluation. Companies that manufacture, process or dispose of chemical substances should pay particular attention to the scoping processes for those chemicals, given that a failure to speak up at that stage could mean waiving your comments on the issues altogether.