The proposals would reduce ethylene oxide emissions by 80% per year, requiring stronger worker protections
Washington – Today, the US Environmental Protection Agency (EPA) is proposing new health protections to reduce exposure to ethylene oxide (EtO), including more stringent air emission standards and additional protections for workers who are exposed to the gas used to sterilize medical devices and certain spices if Finalized, EPA’s proposals are estimated to reduce EtO emissions to air from commercial disinfection facilities by 80% per year and implement more protective standards to control those emissions under the Act. Together, these proposals will provide a comprehensive approach to addressing EtO contamination concerns, including cancer risk, that will provide a path to maintaining a robust supply chain for sterile medical equipment while increasing safety for communities and workers.
The proposal advances President Biden’s commitment to end cancer as we know it as part of the Cancer Moonshot and the administration’s commitment to environmental justice and public health protection, including communities that are most exposed to toxic chemicals.
“EPA’s number one priority is protecting the health and safety of people, and we are committed to taking decisive action informed by the best available science,” EPA Administrator Michael S. Regan said. “These proposals build on EPA’s extensive outreach to communities across the country and reflect close coordination among key federal partners. Together they will significantly reduce worker and community exposure to harmful levels of ethylene oxide. EPA will continue to use all available tools to protect our nation’s communities, including workers, from exposure to toxic chemicals and to provide important public health protection.”
The two new proposals announced today mark significant progress as EPA continues to use the full range of its regulatory authority under the Act to protect public health by reducing the risks posed by EtO. Long-term exposure to EtO over a career of 35 years or a lifetime of commercial disinfectants or close to 70 years may increase the risk of certain types of cancer. People who attend schools near places where EtO is used are also at higher risk of cancer due to EtO levels in the air. The actual risk to workers and community members will vary based on a facility’s control measures and the distance and extent of people living, working, or commuting to school near a facility.
The proposals were informed by collaboration across the federal government to maintain complex decontamination capabilities, including discussions between EPA, the US Food and Drug Administration, the US Centers for Disease Control and Prevention, and the Agency for Toxic Substances and Disease Registry and agencies. Occupational Safety and Health Administration. The proposals include regulations that many facilities already use and that EPA would apply nationwide. The Agency has also undertaken vigorous public involvement in this matter and will continue to provide the public, particularly in affected communities and workplaces, with access to information they need to know, make independent decisions about risk, and encourage public involvement in the regulatory process. .
“OSHA’s mission is to ensure a safe and healthy work environment for workers,” said Doug Parker, Assistant Secretary of Labor for Occupational Safety and Health“We will continue our partnership with the EPA and other federal agencies to reduce risk to those who work every day to maintain our nation’s critical medical device supply chain.”
Reducing air emissions to protect communities
Under the 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 from these facilities by 80%, reducing emission levels to below EPA’s Clean Air Act benchmark for elevated cancer risk.
Although many of these facilities have already taken steps to reduce emissions, the proposal would require all 86 facilities and any new facilities to comply with these stricter pollution controls, which have already been proven to be effective and achievable. All commercial sterilizers are required to use advanced source monitoring procedures to ensure these contamination controls are working effectively. Facilities will be required to report results to EPA twice a year. Under the proposal, facilities would have to comply with these new requirements within 18 months. This represents an accelerated timeline under EPA authority.
EPA’s proposal is informed by the latest data, science, and extensive outreach, and takes full account of the critical function of medical sterilization to provide a safe supply of medical devices for patients and hospitals. EPA requires all commercial sterilizers to submit detailed information on EtO emissions and control technologies as part of the 2021 data collection request. EPA uses this data to estimate the risk to people living 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 the new emission standards, the EPA is proposing a comprehensive set of new mitigation measures that will reduce the risk to workers who use EtO to disinfect products and to other people in the community near the disinfection facility.
Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), EPA authorizes 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 over EtO use in the proposed interim decision, such as:
- Banning some uses of EtO exist where alternatives exist, including use in museums, archival settings, beekeeping, some cosmetics, and musical instruments;
- reducing the amount of EtO used for medical device sterilization while meeting applicable standards for sterility assurance;
- require engineering controls that reduce worker exposure to EtO, such as automation or emission capture technology; And
- Mandating personal protective equipment (PPE) in decontamination facilities when EtO is detected using sophisticated monitoring technology.
Some commercial disinfection facilities have already successfully implemented some of these measures, including reducing the amount of EtO used for disinfection and installing engineering controls that reduce worker and community exposure. EPA’s proposal would now require these measures nationwide to protect EtO commercial disinfection facilities and health care facilities and people in communities near these facilities. The proposal includes different timeframes for the controls depending on their complexity and feasibility. For example, workers can re-engineer control systems much faster than they can using respirators.
EPA is proposing unprecedented real-time monitoring of EtO using technology that can accurately measure EtO in sterilization facilities to 10 parts per billion (ppb). If levels exceed 10 ppb, workers must wear PPE. EPA is directing industry to develop technologies and methods to detect low 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 will help identify and improve protective monitoring technologies and evaluate the effectiveness of proposed mitigation measures. Based on these data, EPA intends to begin the next round of registration reviews for EtO before the mandatory deadline, including evaluating these measures and incorporating additional safeguards based on technology advances.
The EPA proposal is driven by the latest science
EPA is moving urgently 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. Of note, EPA did not find that regular exposure to EtO from these facilities causes short-term or acute health risks. EPA’s new analysis estimates an excess lifetime cancer risk associated with continuous workplace exposure to EtO for workers 8 hours per day, 240 days per year, of 1 in 36 in 35 years and 1 in 10 in an occupational setting. Apply EtO in decontamination facilities and between 1 in 25 and 1 in 12 for workers applying EtO in healthcare facilities. These risks can be reduced by measures that are already 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 noted above, many facilities have already successfully implemented these measures, reducing risk.
In commercial disinfection facilities, EPA also found that continuous, long-term exposure to EtO may result in elevated cancer risks for workers who do not directly handle EtO but work in other areas of these facilities. EPA’s proposed mitigation will reduce the risk to people who may be exposed to EtO in or near these settings, and many facilities are already taking these measures or may take additional measures immediately.
Last year, EPA released the latest available data on air emissions of EtO from these facilities and conducted extensive engagement with communities where EPA identified the potential for high lifetime cancer risk from long-term exposure to EtO. The Clean Air Act standards EPA is proposing today, if finalized, would reduce the lifetime cancer risk for people exposed to all commercial disinfectants..
For more information on EPA’s risk findings, visit EPA’s webpage and/or read EPA’s Draft Risk Assessment Addendum.
Next step
EPA is encouraging stakeholders, including community, industry and public health leaders, to participate in the public comment process on each action released today as the agency seeks to reduce risks from EtO while ensuring the continued availability of sterile medical devices that the American people rely on. EPA’s proposed interim decision, and EPA’s draft risk assessment addendum, are available on EPA’s website and will soon be in docket EPA-HQ-OPP-2013-0244 at www.regulations.gov. EPA’s proposed revisions to air emission standards for commercial disinfection facilities can be found at www.regulations.gov in docket EPA-HQ-OAR-2019-0178. Both dockets will be open for public comment for 60 days after publication Federal Register.
EPA will also host a public webinar on May 1, 2023 at 8:00 PM ET to discuss the proposal and risk assessment. Information for the public to register for the webinar can be found on EPA’s Hazardous Air Pollutant: Ethylene Oxide (EtO) webpage. For those unable to attend, EPA will post a recording of the webinar on the agency’s website.
In addition to the proposed measures announced today, EPA continues to take significant steps to address EtO and advance critical EtO research. These actions include:
In addition, the EPA last week announced a separate action to reduce risks from EtO for people who live near facilities that produce and use EtO in production.
For more information about EtO, please visit EPA’s website.