After finding elevated cancer rates among workers at plants that sterilize medical devices, the Environmental Protection Agency (EPA) is calling for the companies to reduce emissions of the carcinogenic gas ethylene oxide.
The EPA also said in its Tuesday announcement that people who live or go to school near the plants have an increased cancer risk. The proposal would impact 86 facilities, requiring them to slash ethylene oxide emissions by 80% and to reduce the amount of ethylene oxide applied to medical devices to sterilize them.
The facilities would also need to monitor and report emissions to the EPA twice per year. If implemented, the new requirements would go into effect in 18 months, which the EPA called "an expedited timeline."
The head of an advocacy group originally founded by scientists at the Massachusetts Institute of Technology lauded the EPA's move.
"These regulations are long overdue, by almost a decade," Union of Concerned Scientists senior analyst Darya Minovi, MPH, said in a statement. "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."
Ethylene oxide is a colorless gas used to sterilize equipment and plastic devices that cannot be sterilized by steam.
The head of a medical device trade group said most sterilization facilities are at capacity and the new rules would be difficult to implement without impacting healthcare services.
"As the FDA recognizes, many medical devices simply cannot be sterilized by another method. If new EPA regulations force sterilization facilities to close, patients could face treatment delays as sterile technology supplies, such as pacemakers and surgical equipment, fall short," Scott Whitaker, president and CEO of the Advanced Medical Technology Association, said in a statement.
An EPA analysis found that workers who are exposed to ethylene oxide for 8 hours per workday over the course of 35 years have an increased lifetime cancer risk of up to 1 in 10. The risk is reduced if workers use personal protective equipment and have adequate ventilation, which many facilities already do, the EPA said.
Other new regulations in the proposal would prohibit some uses of ethylene oxide where there are alternative options available, such as in museums and archives, beekeeping, and the cosmetic and musical instrument industries.
The proposal is part of the Biden Administration's "Cancer Moonshot" initiative, which aims to reduce national cancer rates by at least 50% over the next 25 years.
The EPA will host an informational webinar on how the proposed actions will affect commercial sterilization facilities and healthcare facilities on May 1.
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Cite this: EPA Wants Emission Limits for Medical Sterilizers Linked to Cancer - Medscape - Apr 12, 2023.