The Environmental Protection Agency (EPA) recently announced a final rule aimed at reducing emissions of ethylene oxide (EtO), a known carcinogen used extensively in sterilizing medical equipment. Ethylene oxide, an odorless, colorless gas, has been linked to various types of cancer, including lymphoma and leukemia. EPA Administrator Michael Regan emphasized the importance of safeguarding public health, particularly in communities disproportionately affected by pollution, such as low-income and minority neighborhoods.
The new rule targets nearly 90 sterilization facilities across the country, owned and operated by approximately 50 companies. These facilities will be required to reduce ethylene oxide emissions by more than 90 percent, according to the EPA. Compliance deadlines have been extended in response to concerns raised by the medical technology industry. Larger facilities will have up to two years to comply, while smaller facilities will have up to three years, with the option for a one-year extension. This adjustment aims to mitigate potential disruptions in the supply of important medical equipment.
Ethylene oxide plays a role in sterilizing approximately half of all medical supplies in the United States, including syringes, heart valves, pacemakers, and various tubes. Despite its effectiveness, ethylene oxide poses serious health risks, prompting the EPA to implement stricter emissions standards. The agency estimates that the new limits will reduce ethylene oxide emissions by 21 tons per year and decrease the lifetime cancer risk for individuals living near sterilization facilities.
The EPA’s rule incorporates emissions restrictions for facilities using less than one ton of ethylene oxide per year and introduces standards for building leaks and chamber exhaust vents, previously unregulated. The agency aims to ensure that no individual is exposed to ethylene oxide levels exceeding a lifetime cancer risk of 1 in 10,000 people, considering it an acceptable threshold. By following scientific evidence and community input, the EPA wants to strike a balance between protecting public health and maintaining a consistent supply of sterilized medical equipment.
Concerns remain within the medical device industry regarding potential disruptions and shortages. Medical device lobbying groups have emphasized the need for sufficient time and flexibility in meeting the new emissions limits. Scott Whitaker, CEO of AdvaMed, expressed hope that the changes would not adversely affect the healthcare system or patient care. The EPA acknowledges the concerns raised by industry stakeholders and aims to minimize disruptions while ensuring compliance with the new regulations. The EPA’s final rule on ethylene oxide emissions is a step towards protecting public health and advancing environmental justice. By imposing stricter limits on sterilization facilities and extending compliance deadlines, the agency aim to mitigate health risks while maintaining a stable supply of medical equipment. Collaboration between regulatory agencies, industry stakeholders, and advocacy groups remains necessary for addressing environmental challenges and safeguarding community well-being.
