We summarized in July the status of ethylene oxide (EtO) federal regulation and litigation risks facing companies using EtO. Since then, two personal injury jury trials claiming damages from EtO exposure have concluded – one with a large plaintiff’s verdict, one for the defense.

Both cases, tried in Cook County (Illinois) Circuit Court, claimed that EtO emissions harmed people who lived near Sterigenics’ now-closed Willowbrook, Illinois, commercial sterilization facility. These cases, among many other that have been filed, began in 2018 after the United States Environmental Protection Agency (U.S. EPA) classified EtO as a probable human carcinogen. The federal Agency for Toxic Substances and Disease Registry (ATSDR) also in 2018 identified EtO emissions as an important cancer risk driver in some areas of the country.

In the first trial,[1] the jury awarded the plaintiff $363 million, mostly in punitive damages. The plaintiff argued that the EtO emissions caused her breast cancer and serious reproductive health effects. She claimed that Sterigenics miscalculated how long the EtO emissions would remain in the environment and how far they would travel, as well as failed to install appropriate emissions controls, all while ignoring the science that showed their harmful effects.

In the second case, the jury rejected the plaintiff’s claims.[2] Although her arguments that EtO was responsible for her leukemia and other harms were similar to the other plantiff’s, the jury in this case found no causal link between her illness and the facility emissions.

Despite these split decisions, the $363 million verdict will surely generate many more claims against industries who use EtO, a trend furthered by law practices specializing in personal injury claims from alleged EtO exposure. Indeed, a third trial will begin next month in Cook County – and it will not be the last because hundreds of plaintiffs have filed claims against the company.

Commercial sterilizers of medical equipment, like Sterigenics, have seen the most regulatory scrutiny and civil litigation risk, but EtO is used as a sterilant in dozens of industries. It is found in many different products, including antifreeze, textiles, detergents, polyurethane foam, solvents, pharmaceuticals and adhesives. If your company uses or emits EtO in its operations, the litigation and regulatory risks are rapidly increasing. (Our earlier post discusses several ways to reduce those risks.)

U.S. EPA May Soon Propose an Overdue Rule to Limit EtO Emissions

The U.S. EPA is supposed to send an overdue proposed rule to tighten EtO emission rules to the White House Office of Management and Budget (OMB) for final review. The U.S. EPA missed an earlier, internal deadline in August to propose the regulations and is now being pushed by a lawsuit filed Dec. 14 by several environmental groups in the U.S. District Court for the District of Columbia. The lawsuit demands that the court force the U.S. EPA to review its emissions standards from commercial sterilizers after the agency repeatedly missed statutory deadlines.

The proposed EtO rule would establish new and more stringent standards for emissions from commercial sterilization operations. Although the specifics are unclear, the U.S. EPA has told industry groups that it is considering a number of compliance mechanisms and control operations to curb emissions.

These mechanisms were also identified in the agency’s 2019 Advanced Notice of Proposed Rulemaking – National Emission Standards for Hazardous Air Pollutants: Ethylene Oxide Commercial Sterilization and Fumigation Operations – and may include controls for fugitive emissions, safety measures for the chamber exhaust vents, process equipment improvements and advances in add-on control technologies for point sources. The agency is also considering revisions to performance testing requirements (i.e., frequency, standards and methodology) and improved recordkeeping and reporting of emissions.

As soon as the proposed rule is published in the Federal Register, we will provide an update and summary of the next steps for those concerned the U.S. EPA’s standards need further revision. The rule will be subject to a 60-day public comment period, which will likely be extended given how closely several industries are watching this issue develop.

The information contained in this blog is general in nature and is not offered and cannot be considered as legal advice for any particular situation. The author has provided the links referenced above for information purposes only and by doing so, does not adopt or incorporate the contents. Any federal tax advice provided in this communication is not intended or written by the author to be used, and cannot be used by the recipient, for the purpose of avoiding penalties which may be imposed on the recipient by the IRS. Please contact the author if you would like to receive written advice in a format which complies with IRS rules and may be relied upon to avoid penalties. Opinions and conclusions in this post are solely those of the author unless otherwise indicated.

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