Clarification: The 93% reduction of ethylene oxide emissions applies to industrial users of the gas. Facilities that use ethylene oxide to sterilize medical devices are considered commercial users. The EPA is scheduled to issue updated regulations of ethylene oxide emissions for medtech sterilization in 2020.
The EPA has announced plans to greatly reduce industrial emissions of ethylene oxide (EtO), the carcinogenic gas used to sterilize billions of medical devices annually.
The agency proposed cutting EtO emissions from industrial facilities by 93% as part of amendments to the Miscellaneous Organic Chemical Manufacturing National Emission Standards for Hazardous Air Pollutants (NESHAP) to reduce hazardous air pollutants. The agency also said it is working on updating how it characterizes air concentrations of EtO.
In addition, the EPA said it is reviewing the national emissions standards for EtO commercial sterilization operations, including medical device sterilization, in advance of updating its EtO regulations in 2020. The agency said it will seek input on several topics, including possible approaches to calculate and control fugitive emissions; potential improvements to EtO monitoring technologies; and process differences between types of sterilization facilities. The EPA will also seek information from several commercial sterilization companies on facility characteristics, control devices, work practices and costs for emission reductions.
“Our efforts are intended to inform a potential future proposed rule for ethylene oxide commercial sterilizers in the coming months,” the agency said.
The profile of EtO has surged nationally since February 2019, when a Sterigenics EtO plant in Willowbrook, Ill. was shut down by state officials over concerns about emissions. The Willowbrook plant sterilized millions of devices per year. That closure was followed by two more in Georgia and the prospect of a third plant being shut down. One of the plants, owned by Becton Dickinson (NYSE:BDX) in Covington, Ga., reopened today after a temporary shutdown last week. BD said in an email to Medical Design & Outsourcing that it doesn’t expect any device shortages related to that shutdown, which began Oct. 28.
The stakes are high for the medtech industry, healthcare systems and the public. More than 20 billion medical devices are sterilized using EtO annually, according to the trade group AdvaMed. The Sterigenics Willowbrook plant closure sent hospitals scrambling for alternative sources of critical devices. Although no major device shortages have ensued, the FDA and the industry have issued dire warnings about that possibility.
Meanwhile, an FDA advisory panel held a two-day meeting this week to gather information about the impact on the medtech ecosystem of reducing EtO emissions or banning EtO sterilization. It also wants more information on potential alternatives to EtO.
Today, the ECRI Institute issued a statement condemning any ban on EtO sterilization, citing the prospect of medical device shortages.
“Even a partial ban on ethylene oxide could cripple the delivery of healthcare in the United States as critical medical-surgical supplies would suddenly become unavailable,” said Dr. Marcus Schabacker, president and CEO of the patient safety organization in a news release. “While environmental health concerns certainly need to be addressed, legislators and the public should be aware that an ethylene oxide ban could severely impact the safe delivery of healthcare. Without access to medical supplies, many surgeries and procedures would not be possible.”
AdvaMed took a different tack, praising the EPA for reconsidering how it characterizes air concentrations of EtO. Specifically, the agency said it has begun “examine the question of whether ethylene oxide is present more broadly in the air in the U.S., and if so, at what levels” — a step AdvaMed has been advocating for months.
The EPA said it has begun to analyze available air quality samples from a subset of existing, longstanding monitoring stations that are not focused on specific industrial sources of EtO to determine whether the gas was present in the air. The results confirmed the presence of ethylene oxide, with six-month averages ranging from about 0.2 to about 0.4 micrograms per cubic meter.
“We believe that there is no immediate, short-term risk from the levels of ethylene oxide found in these limited air monitoring data,” the agency said. “There is a need to better understand low levels of ethylene oxide over a longer-term period. EPA will continue to collect information from its existing air monitoring networks and share data as it becomes available.”
The agency said it has added ethylene oxide to the list of air toxics that will be routinely monitored at all 34 monitoring sites, which are located in urban and rural areas.
“As part of EPA’s ongoing effort to protect people and the environment, yesterday’s preliminary test results show that EtO is present and safe at background levels,” the AdvaMed statement said. “Those levels are safe whether a sterilization facility is present or not. That’s an important finding, and we appreciate EPA’s commitment to doing further research here.
“EPA’s data shows that ambient air levels of EtO are far higher than the proposed standard that some have used as justification to shutter sterilization facilities,” the trade group added. “This demonstrates that the standard is not a reliable or useful gauge for determining appropriate emission levels of EtO. As we continue to study EtO’s presence in our atmosphere, it’s important to remember that leading toxicologists and epidemiologists confirm that the communities surrounding these facilities are safe. We look forward to working with EPA, FDA and other stakeholders to find a reasonable solution to the issue of EtO use that will allow for the continued safe and responsible sterilization of needed medical devices.”
The EPA is accepting comments on its proposal and will hold public hearings in early December in Washington, D.C. and Houston, Texas. Specifics about those meetings will be announced separately.