The Court’s TSCA decision is a much bigger win for public health than first meets the eye

Robert Stockman is a Senior Attorney.  Richard Denison, Ph.D., is a Lead Senior Scientist.

Yesterday the Ninth Circuit Court of Appeals ruled in a landmark case involving a challenge to EPA’s so-called “framework rules” that lay out how it will implement core provisions of the Toxic Substances Control Act (TSCA) as amended in 2016 by the Lautenberg Act.

An array of health, labor and environmental groups, EDF among them, (see full list of petitioners below) had challenged EPA’s Risk Evaluation Rule and Prioritization Rule on the grounds that they deviated in significant ways from amended TSCA’s requirements.

We clearly won on a major issue in the litigation, but a careful reading of the Court’s opinion shows that we effectively won on another key issue even though the court ruled against us.  And several of the court’s other rulings either suggest it agrees with, or outright affirms, our view of TSCA’s core requirements.  On those remaining issues, the Court specifically did not foreclose any of our arguments, making it clear that they could be presented in legal challenges we bring to EPA decisions in risk evaluations and determinations for individual chemicals.

Read on for our analysis. 

The Court ruled that EPA must consider legacy use and associated disposal of chemicals

The Court gave us a clear win by ruling EPA must consider what the agency has termed “legacy” use and “associated” disposal of chemicals when evaluating chemicals’ risks.  In the preamble to its rule, EPA had unequivocally said it could and would ignore known exposures, no matter how significant, from ongoing uses and disposal of chemicals where they are no longer produced for those uses.  The Court invalidated (“vacated”) the parts of the rule that allowed EPA to exclude legacy uses and their associated disposal.  As a practical matter, this ruling means that EPA will have to revise its approach to the ongoing risk evaluations for asbestos and the flame retardant HBCD, because EPA had stated its intent to exclude all legacy uses and associated disposals from its risk evaluations for these chemicals.

While the Court ruled in EPA’s favor that it could ignore the risks from chemical disposals that occurred completely in the past, the Court held that EPA still needs to analyze all disposals of chemicals where the disposal is “in fact ongoing,” adopting a broad interpretation of “‘disposal’ to include ‘spills, leaks, and other uncontrolled discharges’—or even ‘actions related to containing . . . or confining’ substances.”  See p. 57 of the opinion.  The Court’s broad interpretation of disposals that EPA must consider will have significant benefits for over-burdened communities because they are disproportionately impacted by these exposures.

But other aspects of the Court’s decision have even broader implications because they apply to all chemicals EPA will review under TSCA.

The Court ruled that EPA’s rule does not grant it discretion to exclude conditions of use from its risk evaluations

The Court then turned to our argument that EPA’s rule illegally asserts it has authority to pick and choose what conditions of use it includes in and excludes from its risk evaluations.  We contended that TSCA requires that EPA prepare comprehensive risk evaluations, analyzing all conditions of use and their resulting exposures, to accurately assess whether a chemical poses any unreasonable risk to human health or the environment.  EPA argued that it had merely asserted the discretion to exclude conditions of use in the preamble to its rule, and as a result, this assertion of discretion was unreviewable by the court.  Crucially, EPA went further and also argued that it does have discretion under TSCA to exclude conditions of use from its risk evaluations.

The Court sided with EPA in ruling that EPA’s assertion of discretion in the preamble to the rule was unreviewable because it was “not the sort of language that indicates an agency has intended to bind itself.”  “The preamble language does not bind the agency to ever exclude any conditions of use from consideration.  It therefore is not reviewable as final agency action under the Administrative Procedure Act.”  See p. 40 of the opinion.

The Court then turned to the provisions of the rule itself.  It rejected our challenge to EPA’s assertion of discretion to exclude conditions of use – not because it agreed EPA has such discretion, but for quite the opposite reason:  because EPA’s rule “unambiguously do[es] not grant EPA th[at] discretion.”  See p. 43 of the opinion; emphasis added.  Interpreting the rule’s provisions, the Court found that “[t]he phrase ‘the conditions of use within the scope of’ an evaluation simply refers to the conditions of use that are applicable to any particular substance—and that therefore are included in the scope of that substance’s evaluation—without excluding any conditions of use in forming that list.”  See pp. 42‑43 of the opinion.  Thus, the Court’s opinion states that EPA’s rule requires that EPA consider all conditions of use when preparing a risk evaluation, which is exactly the outcome that we were hoping to achieve.

Moreover, while the ruling formally only addressed EPA’s discretion under its rule (which was the issue before the Court), part of the Court’s ruling strongly suggests that TSCA itself does not grant EPA discretion to exclude conditions of use.  Interpreting the rule, the Court found that “the phrase that refers to the conditions of use ‘that the EPA plans to consider’ simply refers to the Agency’s role in determining what the conditions of use are for a particular substance.  Petitioners effectively acknowledge as much in arguing that the similar language of TSCA itself referring to the conditions of use that the Administrator ‘expects to consider’ does not grant EPA discretion to exclude conditions of use. See 15 U.S.C. § 2605(b)(4)(D).  We see no reason why ‘plans to consider’ should be read differently than ‘expects to consider.’”  See p. 43 of the opinion.  Thus, the Court adopted our argument that this language does not grant discretion to exclude conditions of use, and the Court found no difference between the statutory and regulatory language.

Notably, the Court explained that “because the scope provisions are not ambiguous on their face, reference to the preamble discussion would be improper.”  See p. 44 of the opinion.  This ruling renders EPA’s assertion of discretion to exclude conditions of use in the preamble meaningless, which was exactly the goal that we were pursuing in this litigation.

The practical implications of this ruling are huge.  In the 10 risk evaluations that EPA currently is preparing, EPA has sought to exclude conditions of use and exposure pathways from analysis based on this preambular language in nine of the risk evaluations.  But under the Court’s ruling, EPA’s rule does not give EPA discretion to exclude conditions of use on this basis.  Thus, EPA will have to revisit each of these risk evaluations and include the conditions of use and exposure pathways it has tried to exclude; the result is that EPA must analyze the risks of exposure to tens of millions of pounds of chemicals that EPA was choosing to ignore.  If EPA fails to do so, we can challenge individual risk evaluations on the basis that EPA’s approach violates both its rule, as interpreted by the Court, and TSCA itself.

The Court declined to rule on whether EPA must analyze how exposures from multiple conditions of use may combine to present a risk

The Court found that we do not yet have standing to challenge EPA’s assertion that it can conduct use-by-use risk evaluations and determinations rather than consider all uses of and exposures to a chemical collectively in deciding whether it poses an unreasonable risk.  But it is essential to understand why the Court so ruled:  the Court found that EPA’s rule does not preclude the agency from conducting broad risk evaluations that consider uses and exposures collectively and that EPA had not definitively stated in its rule that it would not do so.  The Court ruled that petitioners’ alleged harm was too speculative and that we will have to wait until EPA takes a final agency action on a specific chemical, at which point we can sue the agency if it fails to conduct the broad evaluation we believe TSCA requires.

This outcome is a result of several factors.  First, the Court found EPA’s rule ambiguous with respect to whether EPA would ever conduct a risk evaluation on a use-by-use basis; instead the Court found that the regulations would permit EPA to consider conditions of use and their resulting exposures collectively, as petitioners had argued is mandated by TSCA.  Second, in its briefs to the Court, EPA disingenuously argued that it might or might not choose to conduct use-by-use risk evaluations and determinations, and that it was too early to tell what it would do.  That was disingenuous because of the third factor:  EPA has now issued drafts of its risk evaluations for six chemicals, and for five of them EPA has in fact signaled its intent to conduct the very use-by-use risk evaluations and determinations that we were concerned it would.  Unfortunately those drafts were created too late to become part of the administrative record before the Court.

In other words, the Court said we did not yet have standing to sue because EPA had not yet done what it now has made clear it intends to do, namely to act on its asserted authority to make use-by-use risk evaluations and determinations.  There’s no longer anything speculative about EPA’s intent.  And according to the Court, “[i]f EPA does, in the future, fail to consider all conditions of use together in completing a risk evaluation, and if Petitioners are harmed by that failure, then Petitioners may, under TSCA, seek review of EPA’s ‘no unreasonable risk’ determination.”  See p. 35 of the opinion.  Thus, the Court in no way foreclosed this argument but merely postponed it for a later date.

On our challenges that EPA’s regulations would stop EPA from considering reasonably available information, the Court vacated one, remanded two, and read the final two to require EPA to consider all reasonably available information

On the same day that the Court issued its main opinion in the case, the Court also issued a short, unpublished opinion on claims that petitioners raised challenging the rules as limiting EPA’s ability to consider all reasonably available information.  The Court vacated one provision that EPA had conceded needed to be vacated, which petitioners had argued would chill opportunities for public comment.  The Court remanded two other provisions at EPA’s request; petitioners had argued that these provisions would allow manufacturers to withhold reasonably available information when requesting risk evaluations, and EPA requested that the court give EPA an opportunity to revise these provisions before ruling on them.  Finally, the Court ruled that the last two provisions we challenged did not violate TSCA, but for each of them, the Court adopted an interpretation of the provision that requires EPA to consider all reasonably available information.  Thus, EPA will not be able to use these provisions to exclude reasonably available information, which was our concern.

In sum

Overall, the judicial opinion either requires that EPA prepare comprehensive risk evaluations or leaves the relevant questions to be resolved at a later date.  While not everything we wanted, the opinion sends a clear signal that EPA must prepare the comprehensive risk evaluations necessary to protect public health and the environment that TSCA calls for.


Petitioners in this case are:

Safer Chemicals, Healthy Families; Alaska Community Action on Toxics; Environmental Health Strategy Center; Environmental Working Group; Learning Disabilities Association of America; Sierra Club; Union of Concerned Scientists; United Steel, Paper and Forestry, Rubber, Manufacturing, Energy, Allied Industrial and Service Workers International Union, AFL-CIO/CLC; WE ACT for Environmental Justice; Asbestos Disease Awareness Organization; Vermont Public Interest Research Group; Alliance of Nurses for Healthy Environments; Cape Fear River Watch; Natural Resources Defense Council; and Environmental Defense Fund.

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