The Biden administration has not been shy about its emphasis on environmental justice, which is a sharp departure from the priorities of the Trump administration.  Increasingly, the Biden administration is focusing on Ethylene Oxide (EtO), a reactive chemical 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, as the EPA targets ethylene oxide, the chemical and healthcare industries must take notice of the increased attention paid to EtO emissions

EPA Targets Ethylene Oxide

In 2014, the EPA classified EtO as a human carcinogen. The International Agency for Research on Cancer (IARC) also classifies EtO as a group 1 human carcinogen, linking exposure to EtO to lymphoma and breast cancer. Notably, however, not all researchers concur, finding no increased risk of these cancers, and based on their own epidemiological studies take issue with the IARC and USEPA classification of EtO as a known human carcinogen. These critics argue that this classification significantly overstates the risk, in large measure due to the fact that they are based only on animal studies.

The EPA is promulgating increasingly stricter regulations concerning both the manufacture and use of EtO. Presumably, this will also serve to give rise to increased private tort litigation. In April of this year, the EPA announced that it would begin requiring companies to report more releases of chemicals, including EtO. This endeavor is a component of the Biden administration’s modifications to the Toxic Release Inventory (TRI) and is focused on facilities near communities where environmental justice efforts are centered, which largely consist of minority communities.

The EPA has the authority to extend TRI reporting requirements to specific facilities based on a chemical’s toxicity, the facility’s proximity to other facilities that release the chemical or to population centers, any history of chemical releases at the facility, or other factors it deems appropriate.

The EPA has now followed up on its April announcement. Last week, Michael Freedhoff, the assistant administrator for the EPA’s Office of Chemical Safety and Pollution, stated that the agency was “committed to taking action to protect people from exposure to EtO, especially children, workers and residents in underserved and overburdened communities.” It announced that it had notified 31 facilities that conduct sterilization for pharmaceutical industry purposes that they will likely soon have to report certain EtO releases.

According to the EPA, this was a “critical first step” toward broadening its TRI as a component of the Biden administration’s increasing focus on environmental justice. These 31 contract sterilization facilities, geographically spread out over the country, may also need to report emissions of ethylene glycol, produced by use of EtO.

The 31 facilities at issue are ones involving sterilization for pharmaceutical industry purposes. The EPA also looked their proximity to certain population centers. In particular, the EPA looked at facilities in densely populated communities with children and/or are close to other polluting facilities, as well as proximity to schools and to communities who have already expressed environmental justice concerns.

According to the EPA, it selected these 31 facilities after it considered a variety of EtO data, which showed that these particular sterilization facilities use the highest amounts of EtO in the contract sterilization facilities sector. The facilities are likely to exceed the 10,000 pounds per year “otherwise used” TRI reporting threshold for EtO.  The facilities at issue received letters from the EPA putting them on notice that the agency was considering requiring them to report to TRI for EtO under the EPA’s discretionary authority.  These facilities were given 30 days to respond with information to help inform the EPA’s final decision. The EPA will consider the information and then decide whether to issue an order applying TRI reporting requirement for EtO.

What Measures Can Your Company Take To Minimize Risk?

What measures should companies take to minimize the risk of being sued by private parties or by regulatory agencies as the EPA targets ethylene oxide?  For one, retaining an expert to review whether the facility is emitting EtO unknowingly (or in excess of allowable regulatory levels) is recommended.  If a problem is identified, consider purchasing (or upgrading) equipment that will bring the facility into compliance.  Be proactive with respect to potential litigation.  Is your facility in a community that is concerned with environmental justice?  Are you in compliance with all state and federal regulations?  The best litigation strategy is to ensure you avoid litigation in the first place.