The Environmental Protection Agency (EPA) proposed two new rules on April 11 to restrict how much ethylene oxide (EtO) medical device sterilizers can use and release into the environment, and how much of it workers are allowed to be exposed to.
 
According to the U.S. Food and Drug Administration (FDA) EtO is today used to treat about half of sterile medical devices—about 20 billion devices annually. For some, EtO is the only safe and effective sterilization method available at this time.
 
Under the first rule, EPA proposed strengthening emission standards under the Clean Air Act for the 86 commercial sterilizers operating across the country, as well as new sterilizers. According to EPA, the measure will reduce the amount of EtO coming from these sterilizers by 80%.
 
The first rule requires sterilization facilities to install new pollution controls, with 18 months to comply once the rule is finalized. If finalized, the facilities must install new technologies as necessary and use source monitoring methods to make sure pollution controls are working effectively. Facilities would be required to report their results to EPA twice a year.
 
“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,” EPA administrator Michael S. Regan said in a press release. “These proposals build on EPA’s extensive outreach to communities across the nation and reflects 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.”
 
The second EPA rule aims to protect workers from dangerous levels of EtO exposure under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) by reducing the amount of EtO that can be applied to medical device sterilization, while still meeting standards for sterility assurance. Engineering controls like automation or emissions capture technology will also be required to keep EtO levels below 10 parts per billion (ppb), as well as personal protective equipment (PPE) for workers in EtO sterilization facilities when EtO inside the facilities exceeds 10 ppb.
 
After the EPA’s announcement, AdvaMed said it’s confident it can work with the agency to make sure the rules’ final versions are refined and finalized so they meet everyone’s interests. The group also noted it has some immediate concerns with the rules as they stand.
 
“Two specific items cause immediate concern,” AdvaMed president and CEO Scott Whitaker told the press. “One, 18 months to implement the NESHAP requirements is much too short. It could take many months for abatement equipment to arrive. Supply chains and manufacturing are still recovering from the pandemic.”
 
“Two, it appears the FIFRA preliminary interim decision fails to account for the most current science as well as the best practices on employee safety medtech employs, a concern long raised by many in the scientific community amid calls for third-party expert review of the EPA’s risk assessment,” Whitaker went on. “The EPA’s characterization of employee risk appears to overstate the risk and disregard the strong employee protections already in practice.
 
The Medical Device Manufacturers Association (MDMA) brought up similar concerns that the rules as proposed may negatively impact access to medical devices that can’t be sterilized with other methods.
 
“While we continue to closely review the EPA’s proposals regarding the use of EtO for the sterilization of medical products, MDMA shares the concerns that hospitals, FDA and other stakeholders have raised about limiting the capacity for EtO sterilization,” MDMA president and CEO Mark Leahey told the press. “According to the FDA, 20 billion medical devices are sterilized via EtO annually with no validated alternatives.  Reducing an already stretched supply chain would be catastrophic for patient care, and our sincere hope is that the EPA and the Administration will listen to hospitals, FDA and others to ensure that nothing is done that would compromise patient access to safe and effective medical technologies.”