EPA Seeks to Pause Suit Over Precedent-Setting EtO Sterilizer Air Rule
The Trump EPA is asking a federal appellate court to pause potentially precedent-setting litigation over the agency’s Biden-era rule tightening air toxics limits for ethylene oxide (EtO) sterilizers as they weigh future policy, a request that will likely end litigation on the key question of whether EPA can update such rules because of changes in perceived risk.
Before the Trump administration took office, EPA in a Jan. 8 brief, filed with the U.S. Court of Appeals for the District of Columbia Circuit in the consolidated suit California Communities Against Toxics v. EPA, defended its April 2024 rule limiting EtO emissions from sterilizers.
But EPA in a Feb. 18 motion now asks the court for a 60-day abeyance so it can review the rule and its legal stance, a move that industry petitioners do not oppose, but that environmental petitioners are objecting to, the filing says.
Although the Trump EPA is unlikely to defend the rule, the case tests whether EPA can update air toxics rules because of new, more-conservative risk values.
In the rule, the Biden administration issued a second risk-and-technology review (RTR) of the sector, updating its risk calculations to take into account a controversial 2016 assessment of EtO’s cancer risks conducted under EPA’s integrated risk information system (IRIS).
The IRIS value found EtO risks to be much higher than previously thought. Industry groups criticized the IRIS assessment as too conservative, and say EPA should have used an alternative assessment by Texas air regulators instead, which found risks from EtO much lower.
In a Feb. 12 brief, the Ethylene Oxide Sterilization Association says EPA “asserts that it must have power to revise risk standards when its assessment of a pollutant’s risks changes. But that argument ignores the standard-setting scheme Congress devised, which gives EPA other tools for revising standards when EPA believes appropriate -- but considering costs and technology.”
Historically, EPA has considered the “residual risk” review requirement of the Clean Air Act to be a one-time occurrence eight years after the agency first issues a national emission standards for hazardous air pollutants (NESHAP) rule. The technology review requirement recurs every eight years, however.
But in the light of updated IRIS value for EtO, EPA conducted a second risk review, resulting in tougher rules. In an October amicus brief in the suit, the U.S. Chamber of Commerce warned of EPA unlawfully claiming “massive, open-ended authority” by conducting such a second risk review.
And the American Petroleum Institute (API) similarly warned in its own amicus brief of “the very real possibility that EPA will undertake similar subsequent risk reviews for other[s] of the dozens of [Clean Air Act] section 112 emissions standards for which EPA has already completed a residual risk review.”
The agency has also taken this approach in its rule tightening EtO, chloroprene and other emissions standards for the synthetic organic chemicals and polymers sectors, where the repeated risk assessment is also at issue.
The synthetic chemicals rule also takes into account a revised IRIS value for chloroprene.
An eventual D.C. Circuit decision on whether EPA may conduct second residual risk reviews would set a significant precedent for the air toxics program as a whole, with implications for any rules based on updated risk assessments or other relevant information.
But if the Trump EPA succeeds in delaying the litigation and scaling back the rule, any litigation over the issue is likely a long way off in the future.
‘Reasonable’ Standards
Industry groups are already pushing back on the Biden-era policy. The “statutory text and scheme require EPA to not just set risk-based standards after technology standards, but after taking into account whether those technology standards were sufficient,” industry groups say in their brief.
“EPA also fails to show that its standards are reasonable. They are based on cherry-picked performance test data that EPA admitted is not representative. EPA fails to justify its refusal to provide an alternative mass-based standard. And EPA provides no good reason for refusing to consider the standards’ impacts on medical providers and patients.”
Meanwhile, environmentalists in a second Feb. 12 brief take issue for EPA’s rule for not being tough enough.
In particular, environmental groups fault EPA’s generous phase-in period for the rule, which allows several years for compliance with extensions possible upon request to the agency that would need to be granted by the White House.
EPA included the long and flexible implementation period to assuage fears among industry and also the Food and Drug Administration over a possible shortage of sterilized medical appliances as a result of the tougher standards.
The rule sets a baseline three-year implementation period, although this can be extended by a year in states with delegated Clean Air Act authority for the air rules in question, and EPA is allowing another six months for companies to actually demonstrate compliance. This therefore appears to allow a de facto implementation period of 4.5 years in many states.
Industry can request a two-year presidential waiver if supplies of sterilized equipment are threatened.
But environmental groups say, “EPA’s brief confirms that the agency unlawfully waived the Clean Air Act’s 90-day compliance deadline for existing sources to implement new residual risk standards under section 112(f). Under the Act, EPA may only waive compliance with this deadline if the agency makes two findings: (1) the extension is needed to install new controls; and (2) steps will be taken during the waiver period to protect the public from imminent endangerment.”
“EPA’s lawyers’ new argument -- that EPA must first find imminent endangerment before it is required to make a finding that steps will be taken to protect the public -- is entirely absent from the record and thus post hoc. Moreover, the lawyers’ new test runs counter to the Clean Air Act’s text, which requires EPA to ensure that facilities will take some action to protect communities from harmful emissions during the waiver period.”
Environmentalists also challenge as arbitrary EPA’s decision not to require Title V air operating permits for smaller “area” sources, after proposing to do so. Normally Title V permits are required for large “major source” facilities.
“Unable to find a record-based defense, EPA’s brief similarly resorts to post hoc arguments to defend the agency’s unexplained decision to reverse course and continue to exempt commercial sterilizers from Title V permitting. In its Proposed Rule, EPA found that the benefits of Title V permitting for area sources outweighed its costs. But in the Final Rule, EPA retreated from that position, stating that it now found that Title V permitting would be unnecessarily burdensome, without additional explanation for that change.”