EPA Moves Forward on EO Shares Without Completing Review of Controversial Value of IRIS or Its Use in Rulemaking


Key points to remember

  • Ethylene Oxide (EO) remains a high priority for the Biden Environmental Protection Agency (EPA) from both a risk perspective and environmental justice. Expect this spotlight to carry on into the next year and beyond.
  • In response to criticism from its Office of the Inspector General (OIG), the EPA has moved forward with a number of proposed resolutions. These include:
    • Several public meetings to inform communities of the alleged risks that the Agency maintains that the OE poses. Most of these meetings took place in Texas and Louisiana at EO’s manufacturing facilities; several meetings were quite controversial.
    • Information requests for the categories of sources of EO – and chloroprene. Over the summer, the EPA extended last year’s request for information as part of its review of the MACT sterilizer. The EPA also recently announced its intention to issue an information request to OE manufacturers as part of its NESHAP (HON) review of hazardous organics.
  • In addition, EPA continues to defend its controversial value of the Integrated Risk Information System (IRIS) for the TO. Although the EPA has finally – after years of delay – agreed to review its “use” of IRIS EO as part of the review of residual hazards and miscellaneous organic chemical manufacturing technology (MON RTR ), the Agency (along with state attorneys and plaintiffs) continues to move forward as if the IRIS value is not in dispute. It’s not.
  • Affected companies must take proactive steps now to identify, understand and manage the risks associated with the increased focus on OE emissions as a result of new regulations, enforcement cases and toxic tort litigation.

Community risk communication

Over the summer and into the fall, the EPA hosted several facility-specific community outreach meetings, primarily in Region 6, to communicate the Agency’s views on the increased risks of l ‘OE. The meetings were a consequence of the ongoing dispute between the EPA and the OIG over EPA communications to residents near 25 OE transmitting facilities.

Meetings varied in their agendas, level of public participation, conflicts and the amount of time allocated to industry representatives. Several highlighted charged community attitudes towards the EPA, state agencies, and industry. In most meetings, industry stakeholders had little opportunity to participate. The EPA said it would answer any questions raised during the meetings on its website, but has yet to do so.

Despite these efforts, the OIG remains dissatisfied with the EPA’s proposal to develop air toxicity risk communication procedures. The OIG had earlier concluded that Region 5 had delayed release of information about the Sterigenics facility in Willowbrook, Ill. For political reasons. In response, EPA offered to develop operational procedures to communicate the risks to its “partners”. In November, the OIG insisted that its directive was for the agency to develop communication procedures for the public, not just for EPA’s “partners”.

Residual risk and technology reviews

The OIG also asked the EPA to conduct new Residual Risk and Technology Reviews (RTR) for many source categories based on the EPA’s updated EPA and IRIS chloroprene values. and “to achieve environmental justice”. Among others, the OIG has identified the source categories of Group I polymers and resins, the synthetic organic chemicals manufacturing industry, polyether polyols, commercial sterilizers and hospital sterilizers.

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

More recently, in late November, the EPA announced to industry its intention to submit information requests to several chemical manufacturers, including OEMs, as part of its review of the HON (40 CFR Part 63, Subparts F, G, H and I). The information request will, it appears, require fence monitoring for several hazardous air pollutants, including EO, stack testing, and control device testing. The EPA says it plans to release proposals to revise 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 EPA action remains the controversial EO IRIS value. As we noted earlier, this EO value has come under considerable attack for being scientifically flawed – so much so that the Texas Commission on Environmental Quality (TCEQ) has taken action. to develop its own EEO Effects Screening Level (ESL). The TCEQ standard estimates that the risk of OE is an order of magnitude lower than that of the EPA.

In June, after years of postponement, the EPA finally granted a review of its “use” of the IRIS value in the development of the MON RTR. 84 Fed. Reg. 69182 (December 17, 2019) (MON proposal); 85 Fed. Reg. 49084 (August 12, 2020) (final rule MON). The EPA has also agreed to reconsider the TCEQ EO ESL. The timing of this review is unclear. Nonetheless, the EPA is rapidly advancing on multiple initiatives that rely on an IRIS value that industry and some states see as fundamentally flawed.

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The impact of the EPA’s IRIS value continues to extend far beyond the EPA. Multiple states (for example, Georgia and Illinois) are also moving forward with their own restrictive OE standards, justified by the IRIS value. In several jurisdictions, toxic tort lawsuits cite the IRIS value as the basis for establishing risk and causation. Environmental groups are also sounding the alarm bells on the OT, seeking new rules and citing considerations of environmental justice. Indeed, the OIG’s own criticisms of the EPA stem from its assumptions that the IRIS value is correct.

With all that momentum that came before it, 2022 is set to be another dynamic year of legal activity on the TO. In the meantime, serious questions about the scientific basis for the IRIS EO value remain unanswered.


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