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Medical industry worries EPA proposal could hurt supplies

The regulations affect ethylene oxide, which is used to sterilize half of all medical devices in the country.

WASHINGTON (CN) — New regulations announced for a toxic chemical used in medical sterilization is spurring worry among industry representatives about potential disruptions to hospital and clinical supplies.

The Environmental Protection Agency announced the proposal Tuesday, saying it intends to reduce air pollutants from manufacturers of ethylene oxide and chloroprene, while also imposing tougher regulations on commercial sterilizers that use the chemicals. 

Ethylene oxide is used in the production of perfumes, lubricants and paint thinners, but is also an important chemical for sterilizing medical equipment. While that sterilization accounts for less than half a percent of all commercial ethylene oxide in the United States, it is used in half of all medical devices, more than 20 billion devices, according to AdvaMed, a medical technology association. Those devices include syringes, surgical kits, catheters, and implants like hip and knee replacements.

Warning that long-term exposure to ethylene oxide in or near a commercial sterilization facility increases the risk of cancer, the EPA said its proposal balances the need for risk reduction with “maintaining critical sterilization capabilities.” The agency said the measure implements controls that many facilities already use.

“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 Regan said in a statement. “[The proposal] 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 facilities would be required to use advanced source monitoring methods on emissions and report results to the EPA twice a year. The regulations would prohibit some uses of ethylene oxide if alternatives exist, such as in museums, archival settings, beekeeping, some cosmetics and musical instruments. They would also reduce the amount of time the chemical can be applied to medical devices, require engineering controls to reduce worker exposure and mandate personal protective equipment in sterilization facilities.

Facilities must be compliant within 18 months of the regulation going into effect; an expedited timeline, according to the EPA.

Tuesday’s announcement affects 86 facilities and aims to reduce their emissions by 80%.

“Many of these facilities have already taken steps to reduce emissions,” but the stricter pollution controls still require attention, the EPA said.

Some medical industry representatives feel the proposal doesn’t consider the complexity of the sterilization process. They say ethylene oxide is the only method of sterilization for many items that have electrical components, and that alternative methods such as steam cause warp or other damage.

“Many medical devices simply cannot be sterilized by another method,” Scott Whitaker, AdvaMed president and CEO, said, adding that ethylene oxide is “the only effective, viable sterilization method for heat- or moisture-sensitive materials.”

“This issue is critical for patients, and as a result, the stakes are high,” Whitaker said in a statement. “For 80 years, the medtech industry has used ethylene oxide to sterilize medical equipment. We have done so in a manner that is both safe and effective for patients and for communities and employees. If we have careful coordination with the EPA, we are confident we can deliver for all interests as these regulations are refined and finalized."

Even a slight disruption could cause problems and hurt supply chains, Whitaker predicted, noting that sterilization facilities are already at capacity .

“Medtech companies want to continue serving patients without interruption. The EPA should understand, and its regulations should reflect, that like the EPA, medtech is in the business of protecting public health,” Whitaker said. “We hope the EPA will take our comments into account and work with us on final regulations that ensure continued infection control while achieving the EPA’s goals, which we share, of protecting community members and employees.”


Jane Williams, chair of Sierra Club's National Clean Air Team, supports the proposal and said it “won’t create a problem” for medical supplies.

“The sterilizer industry will just have to make investment in their facilities and reduce their emissions,” she said.

A separate regulation that the EPA announced last week aims to cut emissions at plants making synthetic organic chemicals and polymers, such as neoprene, chloroprene and ethylene oxide.

“For generations, our most vulnerable communities have unjustly borne the burden of breathing unsafe, polluted air,” Regan said Thursday, announcing the regulations in Louisiana. “I’m proud that this proposal would … protect people from toxic air pollution in communities across the country. … Every child in this country deserves clean air to breathe, and EPA will use every available tool to make that vision a reality.”

Chloroprene is used in the production of neoprene, which is a synthetic rubber used in some waterproof clothing, adhesives and weather stripping.

If approved, the EPA says the regulations would reduce 6,053 tons of toxic emissions each year, cutting the number of people with elevated cancer risks by 96% in areas surrounding chemical plants.

The rule also aims to reduce levels of benzene, ethylene dichloride, vinyl chloride and 1,3-butadiene, and to cut down emissions on smog-forming compounds by more than 23,000 tons a year.

Some 200 facilities would be covered by the regulations, according to the Sierra Club, which also touted benefits to areas of the country, particularly in the Gulf Coast and parts of Louisiana and Texas, where the facilities are clustered.

“For too long, Gulf Communities have borne the burden of toxic air pollution from chemical manufacturers,” Pedro Cruz, the Sierra Club’s Healthy Communities Campaign director, said in a press release. “With EPA's proposals today, we are finally seeing a step in the right direction, but there is still much work to be done.”

Bryan Parras, of the Sierra Club’s Healthy Communities Campaign, noted there are several large facilities in the area around Houston’s port, including 30 chemical manufacturers that have received multiple environmental regulation violations and lawsuits.

“Put simply, measures to curtail pollution from chemical manufacturers in Houston and beyond are long overdue, and we eagerly await the protections they can bring to our communities,” Parras said in a press release.

Facilities that produce, store, use or emit the chemicals would be required to monitor levels of the pollutants entering the air at the fenceline of their properties. If levels exceed guidelines, owners would be required to find the source of the emission and make repairs. 

The guideline for ethylene oxide would be 0.2 micrograms per cubic meter of air and 0.3 micrograms per cubic meter of air for chloroprene. 

Monitoring data would be publicly available through the EPA’s website.

The proposal is part of the Biden administration’s goal to make breakthroughs in treating and preventing cancer.

“It’s a disease we often diagnose too late and have too few ways to prevent it in the first place,” President Joe Biden said in September. “We know too little about why treatments work for some patients but … a different patient with the same disease it doesn’t work for.”

The EPA will accept written comments on the manufacturing regulations for 60 days and is holding a training seminar on April 30.

A public webinar on the commercial sterilization proposal is set for May 1. Participants can register on the EPA’s website.

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Categories / Environment, Government, Health, National

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