EPA aims to reduce worker exposure to ethylene oxide

Washington — The Environmental Protection Agency wants to lower emissions of ethylene oxide – a gas that’s used to sterilize medical devices and has been linked to cancer and neurological problems.

Ethylene oxide also has been associated with reproductive problems, fatigue, difficulty breathing, and burning of the eyes and skin. A recent EPA analysis estimates that the additional lifetime cancer risk for exposure to ethylene oxide, or EtO, for eight hours a day, for 240 days a year, over a 35-year period is between 1 in 36 and 1 in 10 for workers in sterilization facilities. For workers in health care facilities, the estimated additional risk is between 1 in 25 and 1 in 12.

The agency says people who live, work or attend school near sterilization facilities that use EtO also may face an elevated cancer risk.

If finalized, the proposals – one aimed at workers and the other focused on the general public – would cut annual EtO emissions at sterilization facilities by 80%, EPA says in a press release.

Additionally, the agency is proposing workplace control measures for the substance, including:

• Prohibiting certain uses of EtO where alternatives exist, including use in museums, archival settings, beekeeping, some cosmetics and musical instruments.
• Reducing the amount of EtO that may be applied for medical device sterilization while meeting applicable standards for sterility assurance.
• Requiring engineering controls, such as automation or emissions capture technology, that reduce worker exposures to EtO.
• Mandating personal protective equipment in sterilization facilities when EtO is detected using state-of-the-art monitoring technology.

Facilities would be required to follow new pollution-control requirements within 18 months. EPA collaborated on the proposals with various agencies, including OSHA and the Centers for Disease Control and Prevention.

In a separate release, Union of Concerned Scientists senior research analyst Darya Minovi says the proposals are “long overdue, by almost a decade,” and calls on EPA to expand coverage to include facilities that house medical equipment that has been recently sterilized but isn’t under regulation for air emissions.

However, Scott Whitaker, president and CEO of the Advanced Medical Technology Association, claims that ethylene-oxide sterilization facilities are at capacity, and potential closings could trigger patient treatment delays. Many devices “cannot be sterilized by another method,” Whitaker contends, and the proposed 18-month compliance window isn’t enough time to ensure safe and viable alternatives.

“The EPA’s characterization of employee risk appears to overstate the risk and disregard the strong employee protections already in practice,” he said. “We hope the EPA will take our comments into account and work with us on final regulations that ensure continued infection control while achieving the EPA’s goals, which we share, of protecting community members and employees.”

The comment period for both proposals concludes June 12. EPA has scheduled a public webinar for 8 p.m. Eastern on May 1 to discuss the proposals and risk assessment.