The US Environmental Protection Agency (EPA) has proposed new measures to reduce exposure to ethylene oxide (EtO) – a colourless and flammable gas that is widely used as a disinfectant and pesticide. The EPA’s new plans, announced on 11 April, include more stringent air emissions standards and extra protections for workers at facilities where the gas is used to sterilise medical devices and certain spices.
The agency states that long-term exposure to EtO can increase the risk of certain types of cancer. In Europe, the use of EtO in the food industry is prohibited.
The EPA estimates that its new proposals, which are intended to advance US president Joe Biden’s Cancer Moonshot initiative, would cut EtO emissions from commercial sterilisation facilities by 80% annually.
Currently, the EPA approves the use of pesticides subject to certain controls through a registration decision, including antimicrobial pesticides like EtO. But the agency is now proposing to increase control measures on the use of EtO by prohibiting certain uses of the substance where alternatives exist, reducing the amount that may be applied for medical device sterilisation, and mandating engineering controls such as emissions capture technology and the use of personal protective equipment.
Specifically, the EPA has outlined stricter air emission requirements for 86 commercial sterilisers across the US. In addition, all commercial sterilisers would have to use advanced monitoring methods to confirm that these pollution controls are operating effectively, and they would be required to report results to the EPA twice a year.
However, the American Chemistry Council (ACC), an industry body representing almost 200 chemical companies, called EtO ‘a versatile compound’ and estimated that it is used to sterilise 20 billion medical devices each year, helping to prevent disease and infection. The ACC opposes the proposals and argues that the EPA’s risk assessment of the chemical contains ‘severe science-based flaws’.
‘Overly conservative regulations on ethylene oxide could threaten access to products ranging from electric vehicle batteries to sterilized medical equipment,’ the ACC warned.
The EPA is accepting public comments on the plans for a 60 day period and is also hosting a public webinar on the proposals on 1 May.