EPA Forges Ahead on EO Actions without Completing Review of the Controversial IRIS Value or Its Use in Rulemaking

Key Takeaways

  • Ethylene Oxide (EO) remains a high priority for the Biden Environmental Protection Agency (EPA) from both a risk and an environmental justice standpoint. Expect that spotlight to continue next year and beyond.
  • In response to criticism from its Office of Inspector General (OIG), EPA has moved forward with a number of proposed resolutions. These include:
    • Multiple public meetings to inform communities about the alleged risks the Agency argues EO poses. Most of these meetings were held in Texas and Louisiana at EO manufacturing facilities; several meetings were quite contentious.
    • Information requests for EO – and chloroprene – emitting source categories. Over the summer, EPA extended last year’s information request in connection with its review of the Sterilizer MACT. EPA also recently announced plans to issue an information request to EO manufacturers as part of its review of the Hazardous Organics NESHAP (HON).
  • Moreover, EPA continues to defend its controversial Integrated Risk Information System (IRIS) value for EO. Although EPA finally – after years of delay – agreed to review its “use” of the IRIS EO in the Miscellaneous Organic Chemical Manufacturing Residual Risk and Technology Review (MON RTR), the Agency (as well as states and plaintiffs’ attorneys) continues to forge ahead as though the IRIS value were uncontroverted. It is not.
  • Affected companies should take proactive steps now to identify, understand, and manage the risks in connection with increased attention on EO emissions as a result of new regulations, enforcement cases, and toxic tort litigation.

Community Risk Communications

Over the summer and into the fall, EPA conducted multiple facility-specific community outreach meetings, primarily in Region 6, to communicate the Agency’s views on the enhanced risks of EO. The meetings were an outgrowth of the running dispute between EPA and OIG about EPA’s communications to residents near 25 EO-emitting facilities.

The meetings varied in their agenda, level of public participation, contention, and the amount of time allotted to industry representatives. Several highlighted charged community attitudes toward EPA, state agencies, and industry. In most meetings, industry stakeholders had little opportunity to participate. EPA stated it will respond to all questions raised during the meetings on its website, but has not yet done so.

Notwithstanding these efforts, OIG remains dissatisfied with EPA’s proposal to develop procedures for communicating air toxic risks. OIG earlier concluded that Region 5 delayed releasing information about the Sterigenics facility in Willowbrook, Illinois for political reasons. In response, EPA proposed that it would develop operating procedures for communicating risks to its “partners.” In November, OIG insisted that its directive was for the Agency to develop communication procedures for the public, not just EPA’s “partners.”

Residual Risk and Technology Reviews

OIG has also called on EPA to conduct new residual risk and technology reviews (RTRs) for numerous source categories based on EPA’s updated EO and chloroprene IRIS values and “to achieve environmental justice.” Among others, OIG identified the source categories of Group I polymers and resins, the synthetic organics chemical manufacturing industry, polyether polyols, commercial sterilizers, and hospital sterilizers.

In May, EPA announced renewal of last year’s information collection request for the Sterilizer MACT (40 CFR Part 63 Subpart O). 85 Fed. Reg. 35931 (June 12, 2020). Separately, in October, thirteen sterilizer facilities were notified that EPA was considering requiring them to report EO releases under the Emergency Planning and Community Right-to-Know Act.

Most recently, in late November, EPA announced to industry plans to issue information requests to several chemical manufacturers, including EO manufacturers, as part of its review of the HON (40 CFR Part 63, Subparts F, G, H and I). The information request will reportedly require fenceline monitoring of several hazardous air pollutants including EO, stack testing, and control device testing. EPA states that it plans to issue proposed revisions to the HON by the end of 2022 and a final rule by 2024.

EPA Agrees to Review Use of IRIS Value

The basis for all of EPA’s actions remains the controversial EO IRIS value. As we have noted previously, that EO value has come under considerable attack for being scientifically flawed – so much so that the Texas Commission on Environmental Quality (TCEQ) took measures to develop its own Effects Screening Level (ESL) for EO. The TCEQ standard estimates EO risk to be an order of magnitude less than EPA’s.

In June, after years of postponement, EPA finally granted reconsideration of its “use” of the IRIS value in developing the MON RTR. 84 Fed. Reg. 69182 (December 17, 2019)(MON proposal); 85 Fed. Reg. 49084 (August 12, 2020)(MON final rule). EPA has also agreed to reconsider the TCEQ EO ESL. The timing for that review is unclear. Nevertheless, EPA is moving quickly ahead on multiple initiatives that rest on an IRIS value that industry and some states believe is fundamentally flawed.

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The impact of EPA’s IRIS value continues to extend well beyond the EPA. Several states (e.g., Georgia and Illinois) are also moving forward with restrictive EO standards of their own, justified by the IRIS value. Across multiple jurisdictions, toxic tort law suits cite to the IRIS value as a basis for establishing risk and causation. Environmental groups are also sounding alarms on EO, seeking new rules and citing to environmental justice considerations. Indeed, the OIG’s own critiques of EPA derive from its assumptions that the IRIS value is correct.

With all this momentum leading up to it, 2022 is poised to be another dynamic year of legal activity on EO. In the meantime, serious questions about the scientific underpinnings of the EO IRIS value go unaddressed.

Beveridge & Diamond assists clients with strategic regulatory compliance and risk assessment, enforcement and investigation, and litigation matters arising from ethylene oxide production or use. Our multidisciplinary team combines substantive expertise with air and chemical regulatory programs, environmental justice, and a deep bench of trial-tested litigators to help our clients succeed. For more information, please contact the authors.