The US Environmental Protection Agency (EPA) has moved to relax air pollution limits on ethylene oxide (EtO), a highly reactive gas used to sterilise an estimated 50% of all medical devices in the US every year. The agency proposed the changes on 13 March, citing concerns that current EtO emission standards put in place by former President Joe Biden threaten the ability of facilities to sterilise equipment and jeopardise one of the US’ only options for a secure domestic supply chain of essential medical equipment.
Almost two years ago, the EtO Commercial Sterilizer final rule put in place stricter air emission requirements for approximately 90 commercial sterilisers across the US. It required operators to use advanced monitoring systems to confirm pollution controls are working effectively and directed them to regularly report results to the EPA.
If finalised, the revised rule would give facilities the choice of installing new monitoring systems or adjusting ventilation systems to meet new standards.
Biden had put the EtO standards in place after several incidents in recent years involving releases of the chemical, which the EPA has classified as ‘carcinogenic to humans’ through inhalation. For example, the US Chemical Safety Board concluded in a report last month that an explosion at a Dow facility in Louisiana in 2023 began when EtO entered a pipe and triggered a chain reaction that led to more explosions, resulting in more than 14 tonnes of the chemical entering the air in the surrounding area.
The American Chemistry Council – a lobby group that represents chemical companies – has applauded the EPA’s reconsideration of the regulation, calling it ‘an important step towards growing domestic chemical production in a streamlined, efficient, and protective way’.
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