EPA Resolves Ethylene Oxide Regulation Dispute With OIG

EPA Resolves Ethylene Oxide Regulation Dispute With OIG

August 12, 2022 Off By administrator

The U.S. Environmental Protection Agency’s (EPA) commitment to its controversial Integrated Risk Information System (IRIS) value for Ethylene Oxide (EO) remains unwavering as two recent developments reflect. The first is EPA’s commitment to a process for conducting second risk reviews on air toxics as a way to resolve its longstanding dispute with its Office of the Inspector General (OIG) over the Agency’s regulation of EO. The second is EPA’s identification of the top 23 commercial sterilizers whose EO emissions allegedly contribute to elevated cancer risk in nearby communities, similar to the Agency’s 2018 list of 25 high-priority EO manufacturers and sterilizers.

While that commitment translates into immediate consequences for the sterilizer sector, it has longer-term consequences for industry. EPA’s new second risk review process commits the agency to review other air toxics following the same process it used to develop its IRIS value for EO. Yet, that process lacks any requirement for the Agency to consider input from stakeholders other than those within the Agency itself. Moreover, the process precludes judicial challenge at the time a risk review is undertaken, or the IRIS value is published – stakeholders must wait until EPA has “used” that value in a final agency action. 

But an IRIS value itself has influence and substantial consequences well before the appeal of a final agency action becomes ripe. In the interim, EPA can – and with EO certainly has – move forward with a host of agency actions – like proposed rulemakings, public meetings, lists of high-risk facilities, and enforcement initiatives – which significantly impact industry, including by substantially increasing litigation risk. 

Moreover, the science about the risks of EO is far from settled and new developments continue to unfold. For example, one fundamental flaw in the current EO IRIS value that is becoming clear is that it is orders of magnitude below naturally occurring ambient background levels in non-industrialized areas throughout the US. Setting a risk standard below naturally occurring levels, is, to say the least, strange; but it demonstrates what happens when real-life data does not corroborate a highly conservative model.1  If EPA views its process for reviewing the EO IRIS value as a “model” for other air toxics, industry should be prepared for similar scientific and legal wrangling for other focus constituents. 

Eventually, the IRIS value will be subject to judicial review and EPA will be held to rulemaking standards under the CAA and will perhaps finally be required to defend the reasonability of its standard-setting. Presumably, at that point, EPA’s IRIS value can be finally vetted – but the damage to industry may well have been done, and the fears surrounding EO may be permanently ensconced in the public domain.

What Should I Do? 

  • Industrial manufacturers and users of EO…

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