What You Need To Know About Ethylene Oxide: Health Impacts, Lawsuits, and Environmental Regulations

Ethylene oxide (EtO) is a highly versatile chemical that is widely used in many industrial and consumer applications. It is commonly used as a sterilizing agent in the medical industry, as well as in the production of plastics, textiles, and other materials. However, recent studies have linked inhalation exposure to ethylene oxide with a range of health problems, including cancer, respiratory issues, and reproductive disorders. In fact, in 2016, the Environmental Protection Agency (EPA) classified EtO as “carcinogenic to humans” when inhaled.

Recently, there has been an increase in lawsuits related to ethylene oxide exposure, with individuals and communities seeking compensation for the health effects they have suffered from occupational or other environmental exposures. For example, cancers like Lymphoma and leukemia have been reported from occupational exposure to ethylene oxide, and stomach and breast cancers may also be associated with exposure. In this blog, we will explore the risks associated with ethylene oxide exposure, current legal ramifications on the horizon, and present an overview of five measures to address and raise awareness for risk and liability for this growing public health concern.

Occupational ethylene oxide lawsuits typically involve workers who have been exposed to ethylene oxide on the job and have developed health problems as a result. These lawsuits may be filed against employers, manufacturers, or other parties who are responsible for the worker's exposure.

Recent Ethylene Oxide Lawsuits 

In 2020, a group of Illinois residents filed a lawsuit against a medical sterilization company alleging that their ethylene oxide emissions had caused them to develop cancer and other health problems. The lawsuit alleged that the company knew about the potential dangers of ethylene oxide but failed to take appropriate measures to protect the community and its employees. Additionally, the company was accused of not properly disclosing the risks associated with ethylene oxide emissions to the public. The lawsuit was eventually settled for $408 million.

Also in 2020, a group of former employees who worked in Lithia Springs, Georgia at a medical device manufacturer filed a lawsuit against the company, alleging that they had been exposed to unsafe levels of ethylene oxide on the job and had suffered health problems as a result. They allege that the manufacturer stored products that had recently been sterilized with EtO. The lawsuit says these stored products then released EtO into the worker’s environment while the products sat on warehouse shelves. The workers say they were never told they were being exposed to EtO from these shelved products, and they never even knew about the health dangers EtO can pose. The lawsuit is ongoing.

In August 2018, the EPA’s National Air Toxics Assessment (NATA) identified a number of areas (census tracts) in the USA with potentially elevated risk from continuous exposure to EtO in the outdoor air. One of these identified areas includes Grand Rapids, Michigan. There, another manufacturer of medical devices used EtO in its sterilization processes up until 2020. According to a story from the Chicago Tribune, a swath of the Grand Rapids area has a cancer risk of nearly four times the nation's average due to ethylene oxide emissions from this plant.

In 2018, the Michigan Department of Environment, Great Lakes and Energy (EGLE) cited this manufacturer in violation of the permitted emission limit, with several other violation notices also being issued to the company. Eventually, the company signed a consent order to stop sterilizing medical devices using ethylene oxide (EtO) at its plant in Grand Rapids, Mich. by Dec. 31, 2020.

The company also agreed to conduct monthly air sampling through February 2020, and to pay a penalty of $110,000. This consent order stemmed from EGLE’s findings that the manufacturer allowed more than the permitted amount of EtO to be released into the air around its Grand Rapids plant. These lawsuits highlight the growing concern over the health risks associated with ethylene oxide exposure, and the need for stronger regulations and enforcement to protect workers and the broader community.

Changes to EtO Environmental Regulations 

Recently, there have been several changes to environmental regulations regarding ethylene oxide (EtO) emissions. In 2020, the US Environmental Protection Agency (EPA) released an updated risk assessment for EtO, which found that the chemical poses a higher cancer risk than previously thought. As a result, the EPA has been working to strengthen regulations related to EtO emissions.

One notable change has been the EPA's proposal to lower the EtO NESHAP emission limit from 1 part per million (ppm) to 0.2 ppm. This proposal is currently under review and is expected to be finalized in 2023. In addition, the EPA has also proposed to add EtO to its list of hazardous air pollutants under the Clean Air Act, which would trigger additional regulations and oversight.

Several states have also taken action to address EtO emissions. For example, in Illinois, the Department of Public Health has established new regulations for medical sterilization facilities, requiring them to install additional emissions control measures and to reduce emissions to as low as reasonably achievable (ALARA). Similarly, in Georgia, a new law requires the state Environmental Protection Division to conduct regular air monitoring for EtO emissions around sterilization facilities.

These regulatory changes reflect a growing recognition of the health risks associated with EtO exposure and the need for more stringent controls to protect public health and the environment.

How to Minimize Risk 

In conclusion, the widespread use of ethylene oxide (EtO) in various industrial and consumer applications has raised significant concerns about its potential health risks. The surge in ethylene oxide-related lawsuits, both occupational and environmental, highlights the urgency of addressing this growing public health concern. Moreover, changes in environmental regulations and heightened awareness of EtO's health risks are encouraging steps toward safeguarding public health.

To minimize the risk of EtO exposure, facilities that use EtO should stay up to date on these changes and take appropriate measures to minimize emissions and ensure compliance with regulations. Occupational risk assessments conducted by Industrial Hygienists can identify potential exposure sources and develop protective strategies. Environmental justice initiatives can address the financial and ethical responsibilities of industry emitters. Furthermore, air permitting and EPA environmental tools can assist in assessing the environmental risks associated with EtO.

By implementing these strategies, businesses can significantly reduce the risk of ethylene oxide exposure to their workers and create a safer working environment. It is essential to consult with industrial hygiene experts and follow regulatory requirements to ensure the best possible practices for worker safety.

Our team of Industrial Hygienists can help identify and address potential ethylene oxide exposure sources and develop a plan to ensure that everyone is protected from exposure to this chemical and create safer working environments for all.

About Antea Group

Antea®Group is an environment, health, safety, and sustainability consulting firm. By combining strategic thinking with technical expertise, we do more than effectively solve client challenges; we deliver sustainable results for a better future. We work in partnership with and advise many of the world’s most sustainable companies to address ESG-business challenges in a way that fits their pace and unique objectives. Our consultants equip organizations to better understand threats, capture opportunities and find their position of strength. Lastly, we maintain a global perspective on ESG issues through not only our work with multinational clients, but also through our sister organizations in Europe, Asia, and Latin America and as a founding member of the Inogen Alliance. Learn more at us.anteagroup.com.