The U.S. Environmental Protection Agency (EPA) this week announced it is proposing new health protections to reduce exposure to Ethylene Oxide (EtO), including more stringent air emissions standards and additional protections for workers who are exposed to the gas.
By way of background, Ethylene Oxide is a colorless gas with a slightly sweet odor used to make other chemicals used to produce a range of products, including antifreeze, textiles, plastics, detergents, and adhesives. EtO also is used to sterilize medical equipment and plastic devices that cannot be sterilized by steam.
If finalized, EPA’s proposals are estimated to cut EtO emissions from commercial sterilization facilities by 80% each year “and apply more protective standards to control those emissions under the law.”
For more background on why the EPA decided to issue the proposals, check out this explainer from our senior staff attorney John Baillie for a plain-language explanation.
But back to that EPA press release: EPA officials said the proposals will provide a comprehensive approach to addressing EtO pollution concerns - including cancer risk - that will increase safety in communities and for workers while providing a path to maintain a robust supply chain for sterilized medical equipment.
Why should we care about Eto? Long-term exposure to the gas over the course of a 35-year career or 70-year lifetime can increase the risk of certain types of cancer. People who go to school near places where EtO is used are also potentially at an elevated risk of cancer due to EtO levels in the ambient air.
Actual risks will vary based on a facility’s control measures for workers and community members and the distance and amount of time people live, work, or go to school near it.
The new proposals include controls that many facilities are already using, and that EPA would apply nationwide. EPA said it will continue to provide the public - especially in impacted communities and workplaces - with access to the information they need to make informed, independent judgments about risk and to encourage public involvement in the regulatory process.
What’s Being Proposed
The EPA is issuing a proposed rule outlining new requirements for 86 commercial sterilizers across the country, among them two in Pennsylvania. If finalized, the proposal would reduce EtO emissions from these facilities by 80%, bringing emission levels down so that risk falls below the EPA’s Clean Air Act benchmark for elevated cancer risk.
While many of these facilities have already taken steps to reduce emissions, the proposal will require all 86 facilities and any new facilities to comply with these stricter pollution controls, which have already proven to be effective and achievable. All commercial sterilizers will also be required to use advanced source monitoring methods to confirm that these pollution controls are operating effectively. Facilities would be required to report results to EPA twice per year. Under the proposal, facilities would be required to comply with these new requirements within 18 months. This represents an expedited timeline under EPA authority.
EPA required all commercial sterilizers to submit detailed information about EtO emissions and control technologies as part of a 2021 Information Collection Request.EPA used this data to estimate risk to people who live near these facilities. EPA also conducted extensive pre-proposal outreach in 2022, including community meetings and webinars, which supported state and local efforts to protect communities and generated information that informed and strengthened this proposal.
New Safeguards to Protect Workers, Communities, and Reduce Exposure
In addition to new emissions standards, EPA is proposing a comprehensive set of new mitigation measures that will decrease the risk for workers who use EtO to sterilize products and for other people in communities near sterilization facilities.
EPA is now proposing to increase control measures on the use of EtO such as:
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 that reduce worker exposures to EtO, such as automation or emissions capture technology; and
Mandating Personal Protective Equipment (PPE) in sterilization facilities when EtO is detected using state-of-the-art monitoring technology.
EPA is also proposing real-time monitoring of EtO using technology that can measure EtO within sterilization facilities down to 10 parts per billion (ppb). If levels surpass 10 ppb, workers would be required to wear personal protective equipment.
EPA is also instructing industry to develop technologies and methods to identify lower concentrations of EtO, below 10 parts per billion (ppb), inside contract sterilization facilities.
EPA’s proposal also includes new data collection and reporting requirements that would help identify and improve protective monitoring technologies and assess the effectiveness of the proposed mitigation measures.
Based on this data, EPA intends to initiate the next round of registration review for EtO earlier than the mandated timeframe, including assessing these measures and incorporating additional protections based on advances in technology that occur.
Why EPA Initiated the Changes
EPA is moving to advance these new protections based on the Agency’s latest assessment of cancer risks from EtO exposure in occupational settings, which are more significant than previously understood. EPA noted, though, that it has not found that routine exposure to EtO from these facilities causes short-term or acute health risks.
These risks can be reduced through measures that have already been taken or can be taken immediately by increasing access to personal protective equipment, adequate ventilation, and safety protocols to avoid direct contact with EtO. As stated above, many facilities have already successfully implemented these measures, reducing risks.
Last year, EPA released the latest available information on air emissions of EtO from these facilities and undertook extensive engagement with communities where EPA identified the potential for elevated lifetime cancer risks due to long-term exposure to EtO. The Clean Air Act standards EPA is proposing today would, if finalized, reduce lifetime cancer risks for people who live near all commercial sterilizers.
What Now?
EPA is encouraging stakeholders, including community, industry, and public health leaders to participate in the public comment process. You can do that by visiting EPA’s website. Both dockets will be open for public comment for 60 days after publication in the Federal Register.
EPA will also host a public webinar at 8 p.m. May 1 to discuss proposals and risk assessment. Information for the public to register for the webinar will be available on EPA’s Hazardous Air Pollutants: Ethylene Oxide (EtO) webpage. For those who are unable to attend, EPA will post a recording of the webinar on the Agency’s website.
Additionally, EPA announced a separate action last week to reduce risk from EtO to people who live near facilities that make and use EtO in manufacturing.