(HealthDay News) — The US Environmental Protection Agency (EPA) has proposed new health protections to reduce exposure to ethylene oxide, a known carcinogen.
The agency proposed more stringent air emissions standards and additional protections for workers who are exposed to ethylene oxide, which is used to sterilize about half of all medical devices in the United States, according to the EPA. Ethylene oxide is also used as a pesticide and to produce other chemicals.
Long-term exposure to ethylene oxide over the course of a working career or from living or going to school near a sterilizing plant can increase the risk of certain cancers, including leukemia, lymphoma, stomach cancer, and breast cancer.
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The EPA issued a proposed rule that would require 86 commercial sterilizing facilities to comply with stricter pollution controls and report results to the EPA twice a year. The facilities would need to comply with these new requirements within 18 months. If finalized, this proposal would reduce ethylene oxide emissions from these facilities by 80%, according to the EPA.
The EPA also proposed new mitigation measures to protect workers and people living in communities near facilities that use ethylene oxide. The EPA proposed:
- Prohibiting the use of ethylene oxide when alternatives exist, such as in museums
- Reducing the amount of ethylene oxide used for medical device sterilization while still meeting sterility standards
- Requiring engineering controls that reduce worker exposures to ethylene oxide, such as automation or emissions capture technology
- Mandating personal protective equipment in sterilization facilities when ethylene oxide is detected.
“I’m relieved and pleased that the EPA has finally issued proposed standards that are based on their own scientists’ recommendations on an updated, higher cancer risk value,” Darya Minovi, a senior research analyst with the Union of Concerned Scientists, said in a statement. Minovi added that the proposal should have also required monitoring at facility fence lines to reassure neighbors.
Scott Whitaker, president and CEO of the Advanced Medical Technology Association, said in a statement that the EPA risk assessment overstates the threat ethylene oxide poses to employees. Not only that, but many devices “cannot be sterilized by another method,” Whittaker explained, and if some facilities close, medical care may be delayed.
Whitaker also called the 18 months allowed for installing technology to reduce emissions “much too short,” adding that “it could take many months for abatement equipment to arrive” due to supply chain and manufacturing issues.
