EPA Finalizes Limits on Ethylene Oxide Sterilization

In a highly anticipated announcement, the Environmental Protection Agency (EPA) today published its new regulations on ethylene oxide (EtO) use in sterilization. An announcement that environmental groups and the medtech industry have both waited for with bated breath, the final rule comes after a year of back and forth with EPA as it weighed the importance of safety from emission contamination in communities surrounding sterilization facilities and a reliable supply chain of medical sterilization devices for patients and healthcare institutions.

EtO is a flammable, colorless gas used to sterilize medical equipment and other plastics that are sensitive to heat or moisture, among other applications. The chemical’s use in the medtech industry is overarching. FDA estimates it is used to sterilize about half of all medical equipment — roughly 50 million devices a day in the United States — because its properties make it especially good at killing viruses, bacteria, and human cells by reacting with proteins, DNA, and other essential cellular components.

But, EtO is classified as a carcinogen, meaning it is a substance that can cause cancer — namely lymphoma and leukemia, according to the EPA, the National Toxicology Program, and the International Association of Research on Cancer. The chemical is also mutagenic, meaning it can change a cell’s DNA and, because of this, children are especially susceptible to its effects.

With all the controversy surrounding EtO, many may question its continued use in sterilization practices. However, stopping use of the chemical is not such an easy task. The EPA considers EtO critical for sterilizing medical equipment and necessary to protect public health. Additionally, FDA reports that it is the only sterilization method available for many medical devices. Devices not chained to EtO for sterilization because of the risk of damage to components can be sterilized through other methods, including heat, gamma radiation, electron beam radiation, x-ray, and hydrogen peroxide plasma.

Now with the final regulations published, EPA said it has implemented rules that will protect people from EtO pollution while also minimizing disruption to the medical device supply chain.

“This final rule to sharply cut toxic emissions of ethylene oxide responds to the ambition set forth by President Biden’s Cancer Moonshot,” said Michael S. Regan, EPA administrator, in the press release announcing the final rules. “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. 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.”

As amendments to the National Emission Standards for Hazardous Air Pollutants (NESHAP) for EtO, the rules will address emissions at nearly 90 commercial sterilization facilities that are owned and operated by approximately 50 companies. The EPA is strengthening the standards initially written in the proposal from an 80% reduction of EtO emissions to the outdoor air to a 90% reduction from commercial sterilizers nationwide. This, the agency said, will be achieved using “proven and achievable air pollution controls,” and “once implemented, [the] rule will reduce the lifetime cancer risk from EtO exposure for people living near commercial sterilization facilities.”

The continuous emissions monitoring will also include a quarterly report for accountability and transparency, ensuring that EtO emissions are controlled and not entering the outdoor air before being captured and controlled.

Safeguarding the sterilized medical device supply chain

When the rule changes were still in its comment period, the Healthcare Industry Resilience Collaborative (HIRC), along with other companies and industry associations in medtech voiced concerns that EPA’s proposed processes to reduce EtO could lead to delays in the completion or sterilization and turnover of surgical devices.

HIRC said that “supply chain disruptions harm patients.” In the statement, the collaborative urged the EPA to give weighted consideration to ensuring sufficient availability of high-quality medical technology with the understood concern of EtO emissions, including “balancing relative environmental risk against the benefit of availability of critical medical supplies and devices that require the same EtO sterilization.”

Also submitting its comments to the proposals at the time, the Advanced Medical Technology Association (AdvaMed) urged continued cooperation between industry and the agency as regulations move forward, but highlighted the potential for massive interruptions in patient care and access due to the changes in sterilization practices resulting in a reduction of capacity for life-saving devices.

“The medtech industry and EPA must continue working together to improve these proposals because as written, we could see significant shortfalls and a risk to patient access resulting from a device sterilization capacity reduction of 30% to 50% nationwide,” said Scott Whitaker, AdvaMed president and CEO.

More recently, Whitaker, in a statement from AdvaMed on Feb. 27, again highlighted the potential for supply disruptions if the rules were finalized as originally proposed.

“Throughout this process, we’ve been clear that the draft rule, if implemented as written, could cause facility shutdowns and closures leading to widespread delays in patient care,” he said. “The FDA shares this concern. If finalized as written, EPA proposals could cause up to a 50% reduction in EtO sterilization capacity for the medical technologies upon which patients’ health and lives depend. We appreciate the willingness of the EPA, FDA, and other agencies to hear our perspective, and we hope the final rule is more workable because they heard us. We’ll review the regulation to see if that’s the case. As we’ve said many times, the stakes are high.”

EPA, in developing the final rule, said that it was mindful of the concerns from industry and “carefully evaluated the feasibility and cost of compliance and any potential implications for the medical supply chain.”

One change from the proposal to final rule included the time in which companies would have to comply with the new requirements.

In the proposal, EPA wrote that all facilities would have 18 months to comply — a timeline which was heavily criticized by the medtech industry. “… 18 months to implement the NESHAP requirements is much too short,” Whitaker previously said in summer 2023. “It could take many months for abatement equipment to arrive. Supply chains and manufacturing are still recovering from the pandemic.”

But under the final rule, larger facilities will have up to two years, while small facilities will have up to three years, with the option to request a one-year extension. For facilities that use over 60 tons of EtO per year — an estimated 28 facilities — the compliance time will be two years, those that use from one to 60 tons per year — an estimated 39 facilities — the compliance timeframe will be two to three years, and companies that use less than one ton per year — an estimated 21 facilities — will get three years to comply.

While still reviewing the finalized regulations with his staff, Whitaker said today, in an email to MD+DI, “We appreciate EPA releasing this update to the rule on medical device sterilization. We have made clear that we value much needed updates to the rule.  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. There are three broad areas we have emphasized throughout the rulemaking: adequate time to implement, flexibility in technologies to remove emissions, and the ability to achieve EPA targets that would not force resubmission of medical devices for FDA approval. 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."

Federal officials and lawmaker reactions

 While controversial, the new regulations have been lauded by lawmakers and federal officials as key to reducing cancer risk in communities surrounding sterilization facilities.

US representative Brad Scheider (IL-10) applauded the finalized rules. Of note, it was in the Chicago suburb of Willowbrook, IL, that Sterigenics was accused of massive EtO emissions, resulting in high cancer rates near the sterilization plant. After nationwide uproar, the plant was closed in 2019. Sterigenics has since agreed to a multimillion-dollar settlement with over 800 plaintiffs after one of the individual cases pertaining to EtO poisoning resulted in a $363M jury verdict.

“I commend the EPA for finalizing regulations in a way that will reduce EtO emissions by more than 90% at facilities across the country,” Schneider said, in the EPA release. “I appreciate that the EPA followed the science to keep Americans safe while also ensuring safe, reliable supply chains for hospitals, physicians, and patients. I have long fought for sensible regulations to address EtO air emissions and assist impacted communities. Today's regulations will rightly require continuous air monitoring to assure communities that the air they breathe is safe, as well as provide an on-ramp for facilities to comply so that we do not have to choose between safe air and a stable supply of medical products. I will continue to be an outspoken advocate for air monitoring in communities where sterilization facilities are present, and I will always fight to prevent harmful toxins from entering our air.”

Additionally, Xavier Becerra, US secretary of Health and Human Services (HHS), said the two agencies will continue to work together to lower EtO exposure risk. “For years, I have called for environmental justice, urging protections for workers and fenceline communities from the dangers of EtO pollution. We will continue to work together with EPA to achieve our shared goals of lowering EtO exposure while also mitigating potential risks of medical device shortages.”

Chairman of the Senate Environment and Public Works Committee also issued a statement after the announcement, which said, “For too long, far too many communities have been exposed to hazardous chemicals and known carcinogens in the air. Every American should have clean air to breathe — no matter their zip code. That is why I have continuously pushed for greater oversight of ethylene oxide emissions. The EPA’s final [EtO] standards for commercial sterilizers are grounded in science and will save lives. I’m grateful for the Biden Administration’s years of work to develop these strong standards.”