EPA proposes rules on EtO with implications for medical device sterilization

The US Environmental Protection Agency (EPA) has proposed two much-anticipated rules that would restrict how much ethylene oxide (also referred to as EO or EtO) medical device sterilizers are allowed to use and release into the environment, and how much of it workers can be exposed to. The agency said its aim is to reduce cancer risk for workers and communities adjacent to EtO sterilization plants.

Years in the works, EPA announced the two proposed rules on 11 April, alongside the US Food and Drug Administration’s (FDA) announcement of a pilot project to help manufacturers of class III devices move their sterilization processes away from EtO. EPA also consulted the Occupational Health and Safety Administration (OHSA) when developing the rules.

Last year, EPA published a list of ethylene oxide (EtO) sterilization plants around the country that may be linked to increased cases of cancer in nearby communities. Since then, industry and other stakeholders have been awaiting new regulations based on those findings. (RELATED: EPA lists potentially high-risk EtO plants, plans to finally publish air pollution rule by year’s end, Regulatory Focus 3 August 2022)

“These proposals build on EPA’s extensive outreach to communities across the nation and reflects close coordination among key federal partners,” said EPA Administrator Michael Regan. “Together they would significantly reduce worker and community exposure to harmful levels of ethylene oxide.”

Under the first proposed rule, EPA would require EtO commercial sterilizers to comply with stricter pollution controls under the Clean Air Act (CAA), which would bring their EtO emissions down by 80%. The agency said this rule would affect 86 commercial sterilizers in the US.

“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,” said EPA. “All commercial sterilizers will also be required to use advanced source monitoring methods to confirm that these pollution controls are operating effectively.”

If finalized, sterilizers would need to comply with the rule within 18 months and report EtO data to the environmental agency twice a year.

The second proposed rule is meant to protect workers from significant EtO exposure under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). It gives the agency authority to regulate the use of pesticides including antimicrobial pesticides such as EtO.

Specifically, the rule would require reducing the amount of EtO that can be used to sterilize medical devices, require engineering controls to minimize worker exposure to the chemical and would mandate that workers use personal protective equipment (PPE) if EtO inside the facilities exceeds 10 parts per billion (ppb).

EPA noted that some medical device sterilizers have already adopted many of these measures, but the purpose of the rule is to require the same for all sterilizers.

“EPA’s proposal would now require these measures nationwide to further protect workers at EtO commercial sterilization facilities and healthcare facilities and people in communities near these facilities,” the agency said. “The proposal includes different timelines for controls depending on their complexity and feasibility.”

“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),” it added. “If levels surpass 10 ppb, workers would be required to wear PPE.”

The environmental agency said it 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.”

Following EPA’s announcement, the medtech lobby group AdvaMed said it is confident it can work with the agency to ensure the final versions of the rules are “refined and finalized” so they meet the interests of everyone involved. However, it did note that it has some immediate concerns with the rules as they are.

“Two specific items cause immediate concern. One, 18 months to implement the NESHAP requirements is much too short,” said AdvaMed CEO Scott Whitaker. “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,” he added. “The EPA’s characterization of employee risk appears to overstate the risk and disregard the strong employee protections already in practice.”

AdvaMed noted that EtO has been used by the medtech industry for 80 years to sterilize products, especially those that are sensitive to heat and moisture where other sterilization methods are not viable. The group says EtO is used to sterilize half the medical devices manufactured in the US annually.

Whitaker argued that EPA and medtech companies all want to best serve patients and hopes the agency will work with it to achieve their common goals.

“This issue is critical for patients, and as a result, the stakes are high. Ethylene oxide sterilization facilities are at capacity,” he added. “As the FDA recognizes, many medical devices simply cannot be sterilized by another method. If new EPA regulations force sterilization facilities to close, patients could face treatment delays as sterile technology supplies, such as pacemakers and surgical equipment, fall short.”

The Medical Device Manufacturers Association (MDMA) similarly raised concerns that the rules as they have been proposed could negatively impact access to medical devices that cannot be sterilized using 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,” said MDMA CEO Mark Leahey. “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.”

Alongside the EPA proposed rules, FDA announced a voluntary Radiation Sterilization Master File Pilot Program for manufacturers who sterilize products with gamma radiation or EtO that combined account for at least 90% of sterilized medical devices in the US. The agency said it will accept nine volunteers for the program which is meant to allow manufacturers to submit Master Files when making certain changes to their gamma radiation and EtO sterilization processes such as the sterilization site, methods used to sterilize their product and other procedures.

The pilot program only applies to manufacturers of class III single-use medical devices with a premarket approval (PMA) who have been granted a right of reference by a sterilization provider. It allows them to make significant changes to their sterilization processes and develop potential alternative sterilization solutions by submitting a postapproval master file rather than having to file a PMA supplement.

“By helping industry advance alternatives for gamma radiation and EO sterilization of medical devices, the Radiation Pilot Program seeks to help ensure patient access to safe medical devices and, through evaluation of data from pilot participants, provide insights into future regulatory approaches that may help address potential device shortages related to sterilization site, method, or process shifts and facilitate supply chain resiliency,” FDA said.

The agency noted that companies selected for the pilot program will still need to file annual reports identifying changes to their original PMA.

Stakeholders can comment on the EPA’s rules until June 10 on www.regulations.gov under dockets nos. EPA-HQ-OPP-2013-0244 and EPA-HQ-OAR-2019-0178.

EPA proposes rules on EtO with implications for medical device sterilization

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