S risk value.With EO regulation and litigation presenting a risk for various companies and industries, our next and final edition will focus on insurance coverage considerations.1 See U.S. ENV’T PROT. AGENCY, What EPA Is Doing to Address Ethylene Oxide and to Learn More About the Chemical (last updated Dec. 22, 2022).2 Glaser, Z.R.: Special Occupational Hazard Review with Control Recommendations for the Use of Ethylene Oxide as a Sterilant in Medical Facilities. U.S. Department of Health, Education and Welfare, Public Health Service, Center for Disease Control, National Institute for Occupational Safety and Health, DHEW (NIOSH) Publication No. 77-200, 58 pp. (1977).3 42 U.S.C. § 7412.4 59 Fed. Reg. 62585 (Dec. 6, 1994); 40 C.F.R. part 63, subpart O.5 U.S. ENV’T PROT. AGENCY, EPA/635/R-16/350FA, EVALUATION OF THE INHALATION CARCINOGENICITY OF ETHYLENE OXIDE (2016).6 84 Fed. Reg. 1570 (Dec. 17, 2019).7 U.S. ENV’T PROT. AGENCY, EPA's Work to Understand Background Levels of Ethylene Oxide (last updated Oct. 8, 2021).8 87 Fed. Reg. 77985 (Dec. 21, 2022).9 See Am. Chem. Council, et al. v. U.S. EPA, Dkt. No. 23-1047 (D.C. Cir.); Huntsman Petrochem. LLC v. U.S. EPA, Dkt. No. 23-1045 (D.C. Cir.).10 87 Fed. Reg. 71633 (Nov. 23, 2022).11 40 C.F.R. part 63, subpart wwwww.12 40 C.F.R. part 63, subpart U.13 40 C.F.R. part 63, subparts F, G, H, I.14 40 C.F.R. part 63, subpart PPP.15 40 C.F.R. part 63, subpart VVVVVV.16 U.S. ENV’T PROT. AGENCY, SLIDE SHOW FOR THE REGION 6 WEBINAR ON ETHYLENE OXIDE 101 (2021).As of May 2021, the EPA estimated its NESHAP timeline as follows: Commercial Sterilizers review to be completed in 2022; Hospital Sterilizers review to be completed in 2023; Group 1 Polymers and Resins review to be completed in 2024; Synthetic Organic Chemicals Manufacturing Industry review to be completed in 2024; Polyether Polyols Production review to be completed in 2024; and Chemical Manufacturing Area Sources review to be completed in 2024.17 See supra, n.1; U.S. ENV’T PROT. AGENCY, EPA’s Work to Understand Background
dards for Hazardous Air Pollutants (NESHAP) (2020 MON final rule). Subsequently, EPA received and granted petitions for reconsideration on two issues, specifically, on the use of the EPA’s Integrated Risk Information System (IRIS) value for ethylene oxide in assessing cancer risk for the source category, and the use of the Texas Commission on Environmental Quality’s (TCEQ) risk value for ethylene oxide as an alternative risk value to the IRIS value for purposes of evaluating risk as part of the Clean Air Act (CAA) residual risk review. On February 4, 2022, EPA proposed the Reconsideration of the 2020 NESHAP: Miscellaneous Organic Chemical Manufacturing Residual RTR to address these two issues and request public comment. On December 21, 2022, EPA published its final decision to use the IRIS value for ethylene oxide in the risk assessment for the 2020 MON final rule and its decision to reject the use of TCEQ’s risk value for ethylene oxide as an alternative risk value to the IRIS value. 87 Fed. Reg. 77985. In the final action, EPA made no changes to the risk assessment or related regulatory text for the miscellaneous organic chemical manufacturing source category. The final action was effective on December 21, 2022.PHMSA Revises HMR For Lithium Cells And Batteries Transported By Aircraft: On December 21, 2022, the Pipeline and Hazardous Materials Safety Administration (PHMSA) issued a final rule revising the Hazardous Materials Regulations (HMR) for lithium cells and batteries transported by aircraft. 87 Fed. Reg. 77995. PHMSA notes that the final rule is consistent with the previously published Interim Final Rule, which responded to Congressional mandates; prohibited the transport of lithium ion cells and batteries as cargo on passenger aircraft; required lithium ion cells and batteries to be shipped at not more than a 30 percent state of charge aboard cargo-only aircraft when not packed with or contained in equipment; and limited the use of alternative provisions for smaller lithium