Multiple cases regarding the use and resulting health effects of ethylene oxide (EtO), a chemical used in the sterilization of certain medical devices, have raised the possibility of additional litigation in a litany of pending cases. From a $363 million jury verdict to an injunction stopping the development of a $9.4 billion chemical plant, ethylene oxide has become a prominent focus in environmental litigation and will likely hold that focus for years to come.
What is EtO?
- According to the EPA, ethylene oxide or EtO (CAS RN 75-21-8) is a colorless gas used to sterilize 50% of medical devices and dental equipment that cannot be sterilized using steam or radiation. It is also used to sterilize some food products and spices, and as a pesticide.
- EtO is also produced in large volumes for use in the manufacture of other chemicals and products including antifreeze, textiles, plastics, detergents, and adhesives.
- The chemical is associated with increased risk of cancer over the course of a lifetime, according to the Environmental Protection Agency (EPA), which in August 2022 launched a community engagement effort related to the risks associated with EtO. Although the emissions from facilities manufacturing or using EtO often do not exceed short-term health benchmarks, the problem is with exposure to the chemical over a lifetime. Consequently, the surrounding communities, referred to as “fenceline communities,” are exposed to these emissions at levels much higher than residents not living in proximity to the 23 medical sterilizing facilities or these other sterilizing facilities throughout the U.S. using EtO. See additional AgencyIQ analysis on the community engagement effort here: EPA reaches out to communities exposed to ethylene oxide emissions from commercial sterilizers.
How EtO is regulated
- In 1994, the EPA promulgated the National Emissions Standards for Hazardous Air Pollutants (NESHAP) for EtO commercial sterilization and fumigation operations which was last updated in 2006. EtO is listed as a substance used in miscellaneous organic chemical manufacturing (MON) under NESHAP. NESHAP establishes emission standards for both major and area sources that use at least 1 ton of EtO in sterilization or fumigation operations in any 12-month period.
- In 2016, the EPA released its updated Integrated Risk Information System (IRIS) unit risk estimate for EtO, which indicated that cancer risks from EtO were significantly higher than previously understood.
- Subsequently, the EPA released the National Air Toxics Assessment (NATA) in August 2018 (data collected in 2014), identifying EtO emissions from commercial sterilization that contribute to health risks across the U.S.
- In an effort to determine if the EtO emissions should be further restricted, the EPA published an advanced notice of proposed rulemaking (ANPRM) in December 2019 to obtain information from industry and the public to potentially revise the existing standards for sterilization facilities utilizing EtO. The ANPRM sought information including, the calculation, capture, and control of fugitive emissions, and practices to reduce them; existing and new types of control devices and process equipment and improvements to efficiency; and improvements to EtO monitoring technologies. This is referred to as the Risk and Technology Review for MON.
- Two information collection requests were proposed in 2020 and 2021, with the goal of better understanding emission sources, measurement and monitoring techniques, available control technologies and efficiencies. The EPA broadened its data collection efforts to include all facilities subject to EtO emission standards for sterilization facilities (40 CFR part 63, subpart O) that were not involved in a December 2019 questionnaire.
- EPA also issued a final rule on August 12, 2020, finalizing the residual risk and technology review conducted for the MON source category regulated under NESHAP. With this rule, the EPA finalized amendments to the technology review for equipment leaks and heat exchange systems, and to the risk review for EtO emissions from storage tanks, process vents, and equipment leaks. The EPA also added monitoring and operational requirements for flares that control EtO emissions and provisions for electronic reporting of performance test results among other changes.
- The EPA then published a rule on February 4, 2022 proposing to reconsider the August 2020 final rule due to the use of the 2016 IRIS inhalation unit risk estimate for EtO in assessing cancer risk for the source category. The risk review determined that the risks for this source category under the current maximum achievable control technology (MACT) provisions were unacceptable due to EtO emissions. This led to the EPA promulgating the 2020 final amendments to the MON that require control of EtO emissions for process vents, storage tanks, and equipment. The EPA declared the 2020 MON final rule reduced risks to an acceptable level with an ample margin of safety to protect public health.
- Following promulgation of the 2020 final rule, EPA received petitions to reconsider EPA’s cancer risk estimation for EtO. The petitions requested reconsideration on two specific issues: (1) the EPA’s use of IRIS unit risk estimates for cancer risk from EtO and (2) petitioning to use the Texas Commission on Environmental Quality (TCEQ) risk values for ethylene oxide. The TCEQ risk value for EtO, which was finalized after the comment period for the proposed MON rulemaking closed, was proposed to be used instead of the IRIS unit risk estimate. Since the 2020 MON final rule preamble stated that the EPA remains open to new and updated scientific information, such as the TCEQ value, EPA reviewed the TCEQ.
- EPA found the TCEQ estimated risk value for EtO is 2000-fold lower than the IRIS risk value. It does not include women in its assessment, nor does it provide new studies or other information suggesting TCEQ’s unit risk estimate (URE) provides a better estimate of risk exposure from EtO. Consequently, EPA proposed to reaffirm its decision to use the IRIS URE in the 2020 MON final rule.
- The EPA is currently reviewing Clean Air Act regulations for industries that emit EtO. These include the previously-mentioned MON rule for chemical plants that manufacture chemicals and emit EtO, as well as a new air toxics rule for the chemical.
- State regulation of EtO is less widespread, but certain states have begun to restrict use of the chemical. In 2019, Illinois passed two bills addressing sources of EtO, which included prohibiting facilities from operating in Illinois unless the facility capture all fugitive EtO emissions and reduced EtO emissions to .2 parts per million for general emissions. The second bill restricted EtO use for non-sterilization facilities, which are now required to obtain permits from the Illinois Environmental Protection Agency which places specific caps on facility EtO emissions. In 2020, Georgia’s state senate filed a bill to require manufacturers that use EtO to report any releases or spills to the Georgia Environmental Protection Division within 24 hours.
- After discovering multiple violations at a plant that uses EtO, the EPA released an administrative order for compliance on consent for a Verona, Missouri plant which at the time of the EPA inspection had more than 10,000 pounds of EtO in the facility. The compliance order requires the plant to, among other requirements, develop and update the EPA on a list of standard operating procedures that will bring the facility into compliance with EPA regulations.
Significant litigation and a recent decision regarding EtO
- On September 19, 2022, an Illinois jury awarded plaintiff Susan Kamuda $363 million in a lawsuit against Sterigenics corporation. The plaintiff had requested $21 million in compensatory damages, and $325 million in punitive damages; the jury awarded the punitive damages as requested but raised the compensatory damages to $38 million. The $38 million in compensatory damages covered Kamuda’s loss of a normal life, emotional distress from her cancer diagnosis, disfigurement, and a shortened life expectancy due to the diagnosis. Sterigenics bore the brunt of the punitive damages at $220 million, with its parent company, Sotera Health, owing $100 million and former plant owner Griffith Foods owing $5 million.
- The suit stemmed from Kamuda’s breast cancer diagnosis, which her lawyers argued was caused by EtO releases in a Sterigenics plant near Kamuda’s home in Willowbrook, Illinois. The plant released EtO from 1985 until the plant was shut down by state authorities in 2019 after detecting the gas near the plant. Kamuda’s lawyers argued that she was not predisposed to breast cancer and Sterigenics’ lawyers argued that Kamuda had not demonstrated a causal link between her diagnosis and EtO releases by the Willowbrook plant. Kamuda’s lawyers pointed to a 2018 EPA air monitoring study conducted near the Willowbrook plant, which pointed to an elevated cancer risk for residents close to the site. The jury ultimately found in favor of Kamuda, awarding her the largest individual jury verdict in Illinois history.
- The short-term air monitoring conducted by the EPA at the Willowbrook plant in 2018 was conducted to detect EtO and determine the potential health effects from the chemical. The EPA took samples over the course of three days in May 2018 to determine whether EtO was detectable and what levels were present in the outdoor air. The EPA requested that the Agency for Toxic Substances and Disease Registry (ATSDR) evaluate the readings to determine whether the EtO levels detected near the plant indicated an elevated health risk. In July 2018, the ATSDR released a report stating that residents surrounding the Willowbrook plant had an elevated risk of cancer, but that non-cancer health effects from EtO were unlikely.
- This is the first jury verdict in a bevy of cases relating to EtO. Although the case is not a traditional bellwether trial, it will be an important tool for the resolution of current cases. A bellwether trial is often used in multi-district or large-scale mass tort litigation as a single trial to represent a larger group of claims and determine future litigation results. As an example, Bayer, the parent company of Monsanto, recently won several bellwether trials regarding the use of glyphosate (marketed as Roundup), including a September, 1, 2022 jury trial, after losing three multi-million dollar trials. These trial wins (and losses) have shaped how the company will settle with plaintiffs in the future.
- Another EtO lawsuit to note: A suit against the Louisiana Department of Environmental Quality (LDEQ) filed by several plaintiffs appealing LDEQ’s decision to issue permits to a Formosa Plastics Group chemical manufacturing complex was initially successful, as the judge ruled that LDEQ had not followed the Clean Air Act when granting the permits and should have denied Formosa’s application. The case partially focused on EtO use at the site in addition to several other pollutants. LDEQ has appealed the ruling, but the court does not appear to have ruled on the issue yet.
What the future may hold
- The Kamuda/Sterigenics trial result will likely prove essential for plaintiffs’ lawyers seeking positive results for their clients, and defense lawyers will have to find ways to distinguish their clients’ cases from Sterigenics. The case is the first of more than 700 filed cases to go to trial, and the main plaintiff’s firm representing Willowbrook residents recently requested the presiding judge consolidate the cases into groups of about 10 plaintiffs each to expedite the litigation.
- Sterigenics may (and likely will) appeal the case to a higher court. A higher court may confirm, change, or vacate the jury verdict or damages award. Many states have caps on punitive damages, either in whole dollar amounts or in multiples of the amount of compensatory damages, but Illinois does not cap punitive damages, meaning that even if Sterigenics appeals, the verdict and damages award may stand.
- Lawsuits could have important regulatory implications for the Food and Drug Administration. If companies no longer feel comfortable making or using EtO for fear of the legal liabilities they may incur, that could mean that medical device sterilization becomes more difficult as EtO goes into shortage. That, in turn, could create shortages of some essential medical devices, impacting patient care. To date, the FDA has been working on pilot programs to assess alternatives to EtO, but it is not yet clear if any alternatives may be proven viable. Future EPA regulations that further restrict the use of EtO could cause significant headaches for organizations that use EtO for sterilization purposes as well.
- The LDEQ case involves one of the largest planned petrochemical complexes in the U.S., spread over more than 2,400 acres close to St. James Parish in Louisiana and would cost more than $9.4 billion to build. Because of the resources expended into the initial permits and planning for the complex, it will be likely tied up in litigation for years to come as it makes its way through the court system.
Contains previous research by Patricia Iscaro, Esq.
To contact the author of this analysis, please email Walker Livingston ([email protected])