As previously discussed in our recent reports, the Biden administration and the EPA have been emphasizing environmental justice, which includes a focus on Ethylene Oxide (EtO), an industrial solvent widely used as a sterilizing agent for medical equipment that cannot otherwise be sterilized by heat/steam.  EtO may also be used as a component for producing other chemicals, including glycol and polyglycol ethers, emulsifiers, detergents, and solvents.   Allegations that exposure to EtO may increase the risk of certain cancers will increasingly subject certain companies and industries to governmental regulation and/or private tort actions.   In particular, the chemical and healthcare industries must take notice of the increased attention paid to EtO emissions

Recent EPA Action

On May 31, 2023, the EPA provided notice of a proposed consent decree in California Communities Against Toxics, et al. v. Regan, No. 1:22-cv-03724 (D.D.C.). This proposed consent decree is in response to a complaint filed in the United States District Court for the District of Columbia on December 14, 2022 by a number of plaintiffs, including California Communities Against Toxics, Clean Power Lake County, Rio Grande International Study Center, Sierra Club, and the Union of Concerned Scientists.  The Complaint alleged that the EPA had failed to perform its nondiscretionary duty to “review, and revise as necessary” the National Emission Standards for Hazardous Air Pollutants (NESHAP): Ethylene Oxide Emissions Standards for Sterilization Facilities, at least every eight years. The proposed consent decree would establish a deadline for EPA to sign a final rule for this action. The proposed consent decree is available through https://www.regulations.gov.

The proposed consent decree, if finalized, would require that EPA sign a final rule on its review and “necessary revisions” of the Sterilization Facility NESHAP pursuant to section 112(d)(6) by March 1, 2024.

Executive Summary

This proposed consent decree would update standards with respect to EtO emissions by sterilization facilities.  If the standards are tightened significantly, query whether some facilities would opt to shutter their doors rather than invest in expensive equipment that would reduce EtO emissions.

As we have cautioned before, prudence dictates that companies monitor their EtO emissions, and, to the extent possible, reduce them in order to avoid the wrath of the EPA (or state regulators), as well as to preclude being on the wrong end of private tort litigation.  Our previous postings have detailed a September 2022 $363 million verdict for a plaintiff alleging cancer from EtO emissions from the Willowbrook sterilization plant in Illinois, and we have also noted a more recent proposed settlement of $408 million that would include 870 or so plaintiffs who also allege cancer from EtO emissions from the Willowbrook plant.

CMBG3 Consulting & Litigation Defense

CMBG3 continues to closely monitor scientific developments and related regulations and litigation so as to fully advise its clients on the impact of same on their various business concerns.