The United States Environmental Protection Agency (EPA) has recently proposed a series of new restrictions aimed at facilities that utilize the cancer-causing chemical ethylene oxide. This colorless and odorless gas is commonly used for sterilizing medical devices and spices. The proposed regulations, although yet to be finalized, are intended to lower the release of ethylene oxide gas by these facilities by 80%. This reduction is necessary to bring the emissions below the Clean Air Act standard for elevated cancer risk.
Several communities exposed to ethylene oxide gas have urged the EPA to implement stricter controls on plants utilizing this chemical. In 2018, an EPA report indicated that numerous communities across the nation were facing heightened cancer risks due to trace amounts of ethylene oxide being released into the air during the sterilization process.
The EPA issued the report on the new risks without a news release, and some impacted communities only became aware of the danger through a health assessment conducted by the Agency for Toxic Substances and Disease Registry (ATSDR) and media coverage. An EPA Inspector General report revealed that some communities were not informed of their risk by the EPA at all.
The heightened risk became evident after a thorough review of ethylene oxide’s toxicity over a two-decade period by scientists in the EPA’s Integrated Risk Information System (IRIS) program. Although the EPA acknowledged the increased danger associated with ethylene oxide, it continued to use older regulations to govern facilities releasing the chemical, as well as companies involved in its production.
The proposed rules aim to align regulations on both ethylene oxide producers and users with the actual cancer risk posed by the chemical. They follow a previous set of proposed rules that would impose new controls on facilities manufacturing ethylene oxide. Together, these two sets of rules are projected to reduce ethylene oxide emissions by 77 tons annually, marking an 84% reduction compared to 2020 levels, according to EPA Deputy Administrator Janet McCabe.
Environmental watchdog groups welcomed the proposed restrictions but noted that they might not go far enough to protect vulnerable communities, particularly those with lower incomes and disproportionate representation of people of color. These groups urged the EPA to expand the standard to cover a broader range of facilities, including off-site warehouses that store recently sterilized equipment, continuing to release ethylene oxide without being regulated for their air emissions.
The EPA should also mandate the use of fenceline monitors, devices constantly reading the air outside facilities to ensure that toxic gas does not drift into nearby neighborhoods, as suggested by Darya Minovi, a senior researcher scientist at the Union of Concerned Scientists.
Jaime Rukstales, a member of the Illinois grassroots advocacy group Stop EtO in Lake County, which is one of the communities affected by ethylene oxide pollution, called for tougher restrictions on all types of facilities impacting community health, including sterilizers, manufacturers, and warehouses located near homes, schools, and businesses.
In response, chemical manufacturers filed a lawsuit against the EPA over its updated hazard assessment for ethylene oxide, advocating for the use of a less protective standard developed by the Texas Commission on Environmental Quality.
AdvaMed, a group lobbying for medical device manufacturers’ interests, expressed concern that additional regulations could lead to problems for patients. The closure of sterilization facilities due to new EPA regulations might result in treatment delays, especially concerning sterile technology supplies, such as pacemakers and surgical equipment, as per Scott Whitaker, President and CEO of AdvaMed.
Despite this concern, the EPA stated that many sterilization and healthcare facilities have already taken steps outlined in the proposal, leading to significant emissions reductions. However, only 25% to 33% of sterilizers are currently controlling fugitive emissions, ethylene oxide escaping or leaking into the room air, indicating that further action is necessary.
If the proposed rules are implemented, sterilizers would have 18 months to make the required changes, which the EPA considers an accelerated timeframe under the Clean Air Act.
The EPA aims to strike a balance between reducing cancer risks for affected communities and workers handling ethylene oxide while maintaining essential sterilization capabilities. The proposed regulations would apply to 86 commercial sterilization facilities in the United States using ethylene oxide to sterilize spices and medical devices.
The EPA estimates that approximately 20 billion medical devices, mainly single-use disposable items in healthcare, such as catheters, gloves, and surgical gowns, are sterilized using ethylene oxide. While the US Food and Drug Administration (FDA) is exploring alternatives to the gas’s use, some devices still cannot be sterilized in any other way.
According to a new EPA analysis, exposure to ethylene oxide significantly increases cancer risks for workers in sterilization facilities and those applying ethylene oxide in healthcare facilities. The additional lifetime cancer risk for a worker exposed to ethylene oxide for eight hours a day, 240 days a year for 35 years, ranges from 1 in 10 to 1 in 36 for workers in sterilization facilities, and from 1 in 12 to 1 in 25 for workers exposed to ethylene oxide in healthcare facilities.
To mitigate these risks, the proposed rules require greater use of personal protective equipment for workers and new controls to reduce ethylene oxide levels in indoor air. Companies would also need to use real-time monitoring methods to ensure pollution controls are effective, and facilities would be required to lower the amount of ethylene oxide used for each sterilization cycle.
The proposed rules seek to eliminate some niche uses of ethylene oxide where alternatives are available, such as its use in museums, archival settings, beekeeping, certain cosmetics, and musical instruments.
The EPA will allow public comment on the proposed rules for 60 days and will hold a virtual public webinar on May 1 to discuss the proposed rules and the new risk assessment.
The EPA’s proposed restrictions on facilities using ethylene oxide are aimed at reducing cancer risks for both workers and communities affected by the gas. While the proposed regulations have been welcomed by environmental watchdog groups, some stakeholders advocate for even more extensive measures to protect vulnerable communities. The EPA’s proposed rules strike a balance between cancer risk reduction and preserving critical sterilization capabilities in the United States.
Ethylene oxide is a colorless and odorless gas used to sterilize medical devices and spices. Its effectiveness in killing microorganisms is well-known, but it is also a concern due to its cancer-causing properties. To protect workers and communities, the United States Environmental Protection Agency (EPA) is working to reduce ethylene oxide emissions. Understanding its role in sterilization and potential health risks is crucial for proper regulation.