EPA finalizes rule to reduce EtO emissions from sterilization facilities

After a year of back and forth with the medtech industry, the US Environmental Protection Agency (EPA) has finally published a much-anticipated rule that further restricts the use of the medical device sterilization agent ethylene oxide (EtO). The agency says the rule would significantly curtail EtO emissions but gives companies ample time and flexibility to comply.

The final rule updates EPA’s policy on residual risk and technology review (RTR) for the Commercial Sterilization Facilities source category, which is regulated under the National Emission Standards for Hazardous Air Pollutants (NESHAP) under the Clean Air Act. (RELATED: Medtech groups warn EPA of ‘devastating’ impact of proposed EtO rules, Regulatory Focus 29 June 2023)

“The final amendments to the air toxics standards for ethylene oxide commercial sterilization facilities put in place the strongest measures in US history to reduce emissions of EtO, one of the most potent cancer-causing chemicals,” said EPA. “Through the installation of proven and achievable air pollution controls, commercial sterilizers will reduce emissions by more than 90%.”

EPA said the rule is expected to affect nearly 90 commercial sterilizer facilities that 50 companies operate nationwide. The agency’s finalized amendments to NESHAP address issues such as setting new emissions standards for building leaks and chamber exhaust vents, and vents in sterilization chambers and aeration rooms. The amendments also require most commercial sterilizers to ensure continuous emissions monitoring, compile quarterly reports, and set emissions standards for when sterilization facilities are started up, shut down, or malfunctioning.

EPA estimates the final amendments in the rule will reduce EtO emissions by approximately 21 tons per year (tpy).

“We have followed the science and listened to communities to fulfill our responsibility to safeguard public health from this pollution – including the health of children, who are particularly vulnerable to carcinogens early in life,” said EPA Administrator Michael Regan in a statement. “We’ve arrived at a historically strong rule that will protect the most exposed communities from toxic air pollution while also ensuring that there will be a process that safeguards our nation’s critical supply of sterilized medical equipment.”

FDA spokesperson Kristina Wieghmink said the agency shares EPA’s goal of reducing EtO exposure to workers and communities neighboring sterilization facilities while also ensuring the integrity of medical device supply chains, which is reflected in the final rule.

“We will be closely monitoring the medical device supply chains to ensure US patients, health care providers, and consumers have access to the medical devices they need,” she told Focus. “Our supply chain work is ongoing, and we continue to work closely with manufacturers, sterilizers, and health care systems to promote device availability.”

The Center for Devices and Radiological Health (CDRH said manufacturers should contact its Office of Supply Chain Resilience (OSCR) if they are concerned the EtO rule may cause a supply chain disruption, and it will take steps to warn the public while also working to mitigate the issue.

EtO sterilization still accounts for about half of all medical devices sterilized in the US. However, in recent years, the FDA has held public meetings to discuss alternative sterilization methods and implemented several programs to help companies use EtO alternatives, including launching Sterilization Master File Pilot programs to allow manufacturers to make sterilization changes more easily. The agency also launched innovation challenges to encourage the development of EtO sterilization alternatives and new sterilization strategies that require less EtO.

Earlier this year, FDA also recategorized vaporized hydrogen peroxide (VHP) as a sterilization agent, signaling to medical device manufacturers that it has confidence in the agent’s ability to sterilize medical devices, which could be an alternative to EtO in some cases. (RELATED: FDA updates sterilization category to encourage vaporized hydrogen peroxide use, Regulatory Focus 8 January 2024)

“We will continue to engage with the EPA, industry, and our government partners to help answer questions related to medical device sterilization and provide insight on potential impacts to the medical device supply chains,” said Wieghmink. “We remain committed to working with these partners to advance our shared public health goals.”

Scott Whitaker, CEO of the industry lobby group AdvaMed, told Focus they are reviewing the rule, but there are three broad areas they have been focusing on during the rule-making process, including allowing companies adequate time to implement the changes, flexibility in technologies to remove EtO emissions, and the ability to achieve the targets set by EPA without the need to resubmit a premarket application with FDA.

“We have made clear that we value much-needed updates to the rule,” said Whitaker. “We have always approached the government agencies with relevant oversight as partners and not as adversaries because this rule has a far-reaching impact on patients and public health.”

“We will be reviewing the rule through that lens and remain hopeful that these changes will not have a negative impact on the healthcare system or the patients we serve," he added.

Similarly, Mark Leahey, CEO of the industry group Medical Device Manufacturer's Association (MDMA), said they are also reviewing the rule and are committed to working with the federal government to ensure the rule does not adversely impact medical device supply chains.

EPA noted that the Clean Air Act has a backstop that allows President Biden authority to implement a two-year compliance exemption for sterilization facilities to prevent unintended consequences and ensure orderly implementation so they have extra time to come into compliance.

“EPA has confirmed that the President is prepared to exercise this authority, if necessary to protect the medical supply chain and a commercial sterilizer is working in good faith to come into compliance with the rule,” said the agency.

EPA is also working on a rule under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) to implement mitigation measures to reduce EtO exposure for workers who work with the sterilizing agent.

EPA statement
Final EtO rule

EPA finalizes rule to reduce EtO emissions from sterilization facilities

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