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Today’s alert looks at the current status of challenges to the IRIS EtO URE and EPA’s related rulemaking proceedings.

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Sterilizers have been one of the most widely publicized sources of EtO, and have taken the brunt of enforcement actions and plaintiffs’ lawsuits based on EtO exposures in the past couple years since publication of the 2014 NATA. But to date, formal regulatory challenges and litigation surrounding the validity of the IRIS EtO URE itself have focused on the chemical manufacturing industry.

The ACC was the first to attempt to formally challenge EPA’s use of the IRIS EtO URE. As soon at the 2014 NATA was published on Sept. 20, 2018, the ACC filed a Request for Correction under the Information Quality Act with EPA, requesting that EPA change its risk assessment for EtO based on subsequent studies, but to date EPA has not disposed of ACC’s request or revisited the IRIS EtO URE.

Unless something changes (as it well might), the operative legal framework for future regulation of EtO sources may be resolved in litigation surrounding the NESHAP for Miscellaneous Organic Chemical Manufacturing (MON). The MON, originally adopted in 2003 and codified at 40 CFR Part 63 Subpart FFFF, regulates HAP emissions from a variety of chemical production facilities. Following litigation alleging that EPA had failed to perform a timely Residual Risk and Technology Review (RTR), in 2017 a federal court ordered EPA to complete an RTR of the MON and propose any necessary revisions in response to that analysis.&nbsp;See California Communities Against Toxics, et al. v. Scott Pruitt, 241 F. Supp. 3d 199 (DDC 2017). On Dec. 17, 2019, EPA proposed revisions to the MON, which notably included use of the IRIS EtO URE to determine risk associated with EtO emissions from sources governed by the MON.&nbsp;See generally&nbsp;84 FR 69182&nbsp;et seq. During the public comment phase of the MON rulemaking proceeding, EPA received numerous comments related to the validity of the IRIS EtO URE, including a comment from Texas requesting EPA to review and account for the TCEQ’s peer-reviewed 2020 study on EtO risks. In the proposed MON RTR, EPA promised that it would address the ACC’s 2018 Information Quality Act request and the 2020 TCEQ study as part of the final MON RTR rulemaking. But when EPA promulgated the final rule version of the MON RTR on Aug. 12, 2020, EPA used the IRIS EtO URE, but failed to address either the ACC or the 2020 TCEQ study.&nbsp;See&nbsp;85 Fed. Reg. 49,084&nbsp;et seq. EPA claimed that it simply did not have time to fully respond to the TCEQ study before the court-mandated deadline for publishing an updated MON RTR, and that EPA would respond to the ACC request for correction and the TCEQ study in a separate rulemaking “in the near future.”&nbsp;See&nbsp;85 Fed. Reg. at 49,098. To date, EPA has not issued any such responsive rulemaking.

On Oct. 13, 2020, the ACC filed a lawsuit in the D.C. Circuit challenging the MON RTR, and in its statement of issues, specifically alleged that it was arbitrary, capricious and unlawful for EPA to rely on the IRIS EtO URE as a basis for the MON RTR. This litigation is currently in abeyance pending EPA review of the underlying MON RTR for conformity with President Biden’s Executive Order 13990 (Jan. 20, 2021), which ordered EPA to review administrative actions issued by the Trump administration for conformity with Biden’s environmental policies and priorities. Motions to govern future proceedings in this case are due on June 11, 2021, so we may soon know more about whether this case will be the first to actually litigate the validity of the IRIS EtO URE or whether it will be sent back to the starting line following more MON revisions from the Biden EPA.

Of potential note, the ACC has also filed two other cases challenging EPA actions that involved the IRIS EtO URE (a Sept. 4, 2020 petition for review of the NESHAP RTR for Ethylene Production (EMACT), issued by EPA on July 6, 2020, and a Sept. 8, 2020 petition for review of the NESHAP RTR for Site Remediation, issued by EPA on July 10, 2020). However, those cases are not as far along in the litigation timeline. Issue statements have not even been filed yet, so how prominently the IRIS could feature remains to be seen. Both of those cases have also been put in abeyance in light of Executive Order 13990.

It is possible that the Biden EPA could withdraw these three Trump-era rules and issue new rules, in which case the ACC’s lawsuits would likely be dismissed as moot without addressing the merits of the IRIS EtO URE. If that happens, the new RTRs would likely still be based on the IRIS EtO URE, but could propose even stricter emission controls. However, the time delay resulting from the process for proposing and adopting the new rules, including the associated public notice and comment, potentially could mean that the IRIS EtO URE might instead first be litigated in the context of a different regulatory proceeding.

There are several other EtO related rulemaking proceedings in the pipeline that are likely to involve the IRIS EtO URE. The next highest priority for EPA is the RTR for NESHAP O, which covers commercial sterilizers and fumigation operations, which EPA expects to finalize in late 2022. EPA has also stated that it anticipates issuing EtO related revisions for Hospital Sterilizers (NESHAP WWWWW) in late 2023, and revisions for Group 1 Polymers and Resins (NESHAP U), Polyether Polyols Production (Subpart PPP), and the Synthetic Organic Chemicals Manufacturing Industry (NESHAPs F, G, H, and I; collectively also known as the Hazardous Organic NESHAP, aka HON) in 2024. For businesses affected by these NESHAPs, the best indication so far for what EPA’s revisions may require is the 2020 MON rulemaking, which required 99.9% control efficiency for all process vents and storage tanks handling EtO and removed the option to use design evaluations to demonstrate compliance with emission limits, and instead required performance testing of all control devices.

Businesses which expect to be affected by any of these rulemaking proceedings EPA has not yet initiated would be wise to track and consider even becoming involved in the litigation surrounding the earlier rulemaking proceedings, such as the MON and/or NESHAP O, because once any court gives its imprimatur to the IRIS EtO URE, it will become nearly impossible to challenge the reasonableness of EPA’s choice to use it in the subsequent rulemaking proceedings, and will also make it easier for private plaintiffs to file lawsuits based on exposures in excess of the IRIS EtO URE.

Emerging Chemical Issues – Ethylene Oxide (Part 3 of 5): Challenges to the IRIS EtO URE