The US Environmental Protection Agency (EPA) today is proposing new health protections to reduce exposure to Ethylene Oxide (EtO)*. These include more stringent air emissions standards and additional protections for workers who are exposed to the gas used to sterilize medical devices and some spices. The proposal is part of President Biden’s commitment to ending cancer as we know – the so-called Cancer Moonshot. It also reaffirms the Administration’s desire for environmental justice and protecting public health, including for communities that are most exposed to toxic chemicals.
“EPA’s number one priority is protecting people’s health and safety, and we are committed to taking decisive action that’s informed by the best available science,” said EPA Administrator Michael S. Regan. “These proposals build on EPA’s extensive outreach to communities across the nation and reflect close coordination among key federal partners. Together they would significantly reduce worker and community exposure to harmful levels of ethylene oxide. EPA will continue to use every available tool to safeguard our nation’s communities, including workers, from exposure to toxic chemicals and to deliver important public health protections,” Regan said.
Long-term exposure to EtO over the course of a 35-year working span or 70-year lifetime in or near a commercial sterilizer 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 air. Actual risks will vary based upon 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 a facility, EPA said.
If finalized, EPA’s proposals are estimated to cut EtO emissions to the air from commercial sterilization facilities by 80% per year and apply more protective standards to control those emissions under the law. “Together, these 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, EPA said in a release.
EPA is proposing unprecedented real-time monitoring of EtO using technology that can accurately measure EtO within sterilization facilities down to 10 parts per billion (ppb). If levels surpass 10 ppb, workers would be required to wear PPE, personal protect equipment, typically masks. 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.
Reducing Air Emissions
Under EPA’s Clean Air Act authority, the Agency is issuing a proposed rule outlining new requirements for 86 commercial sterilizers across the country. If finalized, the proposal would reduce EtO emissions bringing emission levels down so that risk falls below the EPA’s Clean Air Act benchmark for elevated cancer risk.
Many of these facilities have already taken steps to reduce emissions, but the proposal requires all 86 facilities and any new facilities to comply with these stricter pollution controls, which EPA said 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 is an expedited timeline under EPA authority.
EPA said its proposal is informed by the latest data, science, and extensive outreach and takes full account of the important function of medical sterilization to provide a safe supply of medical devices for patients and hospitals. 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 the risk to people who live near these facilities. EPA also conducted 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.
“OSHA’s mission is to ensure safe and healthful working conditions for workers,” said Doug Parker, Assistant Secretary of Labor for Occupational Safety and Health, “We will continue our partnership with EPA and other federal agencies to reduce risks for people who work every day to maintain our nation’s vital medical device supply chain.”
In addition to new emissions standards, EPA is proposing a comprehensive set of new mitigation measures that will decrease risk for workers who use EtO to sterilize products and for other people in communities near sterilization facilities.
Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), EPA approves the use of pesticides subject to certain controls through a registration decision, including antimicrobial pesticides such as EtO. EPA is now proposing to increase control measures on the use of EtO in the Proposed Interim Decision:
- 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.
*Ethylene oxide (EtO) is a colorless gas used to make other chemicals that are used in making a range of products, including antifreeze, textiles, plastics, detergents and adhesives. EtO also is used to sterilize equipment and plastic devices that cannot be sterilized by steam, such as medical equipment. EtO use can contribute to increased cancer risk. “EPA is committed to reducing this risk by taking action to protect communities, workers in commercial sterilization, and others who might be at increased risk from EtO when it is used to sterilize things,” says EPA.
EPA Wants More Health Protection for Commercial Sterilization
The US Environmental Protection Agency (EPA) today is proposing new health protections to reduce exposure to Ethylene Oxide (EtO)*. These include more stringent air emissions standards and additional protections for workers who are exposed to the gas used to sterilize medical devices and some spices. The proposal is part of President Biden’s commitment to ending cancer as we know – the so-called Cancer Moonshot. It also reaffirms the Administration’s desire for environmental justice and protecting public health, including for communities that are most exposed to toxic chemicals.
“EPA’s number one priority is protecting people’s health and safety, and we are committed to taking decisive action that’s informed by the best available science,” said EPA Administrator Michael S. Regan. “These proposals build on EPA’s extensive outreach to communities across the nation and reflect close coordination among key federal partners. Together they would significantly reduce worker and community exposure to harmful levels of ethylene oxide. EPA will continue to use every available tool to safeguard our nation’s communities, including workers, from exposure to toxic chemicals and to deliver important public health protections,” Regan said.
Long-term exposure to EtO over the course of a 35-year working span or 70-year lifetime in or near a commercial sterilizer 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 air. Actual risks will vary based upon 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 a facility, EPA said.
If finalized, EPA’s proposals are estimated to cut EtO emissions to the air from commercial sterilization facilities by 80% per year and apply more protective standards to control those emissions under the law. “Together, these 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, EPA said in a release.
EPA is proposing unprecedented real-time monitoring of EtO using technology that can accurately measure EtO within sterilization facilities down to 10 parts per billion (ppb). If levels surpass 10 ppb, workers would be required to wear PPE, personal protect equipment, typically masks. 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.
Reducing Air Emissions
Under EPA’s Clean Air Act authority, the Agency is issuing a proposed rule outlining new requirements for 86 commercial sterilizers across the country. If finalized, the proposal would reduce EtO emissions bringing emission levels down so that risk falls below the EPA’s Clean Air Act benchmark for elevated cancer risk.
Many of these facilities have already taken steps to reduce emissions, but the proposal requires all 86 facilities and any new facilities to comply with these stricter pollution controls, which EPA said 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 is an expedited timeline under EPA authority.
EPA said its proposal is informed by the latest data, science, and extensive outreach and takes full account of the important function of medical sterilization to provide a safe supply of medical devices for patients and hospitals. 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 the risk to people who live near these facilities. EPA also conducted 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.
“OSHA’s mission is to ensure safe and healthful working conditions for workers,” said Doug Parker, Assistant Secretary of Labor for Occupational Safety and Health, “We will continue our partnership with EPA and other federal agencies to reduce risks for people who work every day to maintain our nation’s vital medical device supply chain.”
In addition to new emissions standards, EPA is proposing a comprehensive set of new mitigation measures that will decrease risk for workers who use EtO to sterilize products and for other people in communities near sterilization facilities.
Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), EPA approves the use of pesticides subject to certain controls through a registration decision, including antimicrobial pesticides such as EtO. EPA is now proposing to increase control measures on the use of EtO in the Proposed Interim Decision:
*Ethylene oxide (EtO) is a colorless gas used to make other chemicals that are used in making a range of products, including antifreeze, textiles, plastics, detergents and adhesives. EtO also is used to sterilize equipment and plastic devices that cannot be sterilized by steam, such as medical equipment. EtO use can contribute to increased cancer risk. “EPA is committed to reducing this risk by taking action to protect communities, workers in commercial sterilization, and others who might be at increased risk from EtO when it is used to sterilize things,” says EPA.