The Environmental Protection Agency has announced more stringent regulations for the use of ethylene oxide, a chemical commonly used to disinfect medical equipment. This decision comes after a study revealed higher rates of cancer among those working in facilities that handle billions of devices, such as catheters and syringes, cleaned with this chemical.

The Environmental Protection Agency announced on Thursday that a regulation passed will lower ethylene oxide emissions by approximately 90%. This will be achieved by addressing nearly 90 commercial sterilization facilities nationwide. In addition, these companies will be required to monitor for the presence of the antimicrobial chemical in the air and ensure that their pollution control measures are effective.

According to EPA Administrator Michael Regan, the recently established regulation aims to protect the health of the general population, especially children who are more susceptible to cancer-causing agents during their early years. This rule is the most robust in history and will not only safeguard communities that are highly impacted by toxic air pollution, but it will also ensure the preservation of essential sterilized medical equipment in the country.

The American Lung Association deemed the regulation a significant move towards safeguarding public health from cancer resulting from the release of ethylene oxide.

According to Harold Wimmer, the president and CEO of the group, research on the health hazards of ethylene oxide has demonstrated that both immediate and extended exposure can pose a serious risk to one’s health.

According to Wimmer, individuals residing in close proximity to commercial sterilization facilities have a higher chance of developing cancer throughout their lives. Wimmer also states that no one should have to endure an increased risk of cancer due to air pollution in their local area.

He stated that individuals with respiratory issues and other medical conditions require access to sterile and sanitary medical materials. The efforts put forth by the EPA in creating a final rule that not only reduces harmful emissions but also maintains access to sterilized medical equipment are greatly valued.

Darya Minovi, a senior analyst for the Union of Concerned Scientists, deemed the EPA’s actions as long-awaited.

Minovi stated that for an extended period of time, various communities throughout the nation, particularly those composed of Black and Brown individuals and non-native English speakers, have been put at risk of being exposed to ethylene oxide, a poisonous substance that can lead to cancer.

She stated that politically influential industries attempted to diminish the rule’s health safeguards, but the positive effects on public health that will result from this action are a testament to the unwavering efforts of community activists and experts in the field of public health.

Regan stated that the stricter precautions are a result of the EPA’s increased knowledge on the dangerous nature of ethylene oxide. This substance is categorized as a pesticide. A person working in a medical facility that uses ethylene oxide for sterilization could potentially experience a significant increase in their risk of developing cancer, with the possibility of one additional case for every 10 people exposed. The EPA’s acceptable level of increased risk for lifetime cancer is typically 1 in 10,000.

Ethylene oxide is a gaseous substance commonly utilized for sterilization of approximately half of medical equipment and for maintaining the safety of specific spices and food items. This gas is also utilized for sanitizing a wide range of medical equipment such as catheters, syringes, pacemakers, and plastic surgical gowns. Although brief exposure is not considered hazardous, prolonged inhalation of ethylene oxide increases the risk of breast cancer and lymphoma, as stated by the EPA.

The Environmental Protection Agency (EPA) revised its evaluation of the toxicity of ethylene oxide in 2016 after studying workers who were exposed to the chemical at sterilization facilities. The updated assessment revealed that the chemical is significantly more hazardous than previously thought. The agency conducted a further analysis two years later and discovered that the risk of cancer was too high in the vicinity of certain medical sterilization plants and other facilities that emit ethylene oxide.

In 2022, the Environmental Protection Agency (EPA) identified the potential danger for individuals living near medical sterilization facilities. In Laredo, Texas, residents and advocates worked to address concerns at a sterilization facility operated by Midwest Sterilization Corp, headquartered in Missouri. This facility was one of 23 identified by the EPA as presenting a risk for nearby individuals.

The sterilization company Sterigenics closed a medical sterilization facility in a suburb of Chicago due to higher than normal emissions in surrounding areas. They later resolved multiple legal disputes.

The EPA announced that while some facilities have significantly decreased their emission of ethylene oxide, those that have not will be required to comply with more stringent regulations.

The final rule from the EPA, created in cooperation with the Department of Health and Human Services and other agencies, prioritizes public health. To allow commercial facilities enough time and flexibility to comply, the rule has been carefully developed. This will safeguard the nearby communities and reduce any potential disruptions to the medical device supply chain, according to officials.

Health and Human Services Secretary, Xavier Becerra, celebrated the regulation as a triumph for employees and nearby communities that continue to face risks due to pollution from ethylene oxide.

According to Scott Whitaker, leader and chief executive officer of the Advanced Medical Technology Association, medical sterilization is essential and some equipment cannot be sterilized using alternative methods.

Whitaker stated on Thursday that the industry group is grateful for the EPA’s recent announcement and plans to carefully review the rule. The industry has stressed the importance of having enough time to implement the rule, as well as the flexibility to use various technologies to reduce emissions. Whitaker also mentioned the need to meet EPA targets in a way that would not require resubmission of medical devices for FDA approval.

He expressed confidence that the rule will not adversely affect the healthcare system or our patients.