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Chemical sterilizer regulations spark controversy

Photo illustration of a medical worker sterilizing equipment surrounded by abstract shapes.

Photo illustration: Aïda Amer/Axios. Photo: Taylor Glascock/Bloomberg via Getty Images

Ethylene oxide — a substance used for sterilizing medical devices — is at the center of a dogfight over protecting public health while also preserving a supply chain.

Why it matters: A chemical helping to keep Americans alive may also be making people sick, creating a situation that's sent lawmakers scrambling and positioned federal officials against the industries they regulate.

Driving the news: The EPA in April proposed new commercial standards for ethylene oxide, or EtO, including new emissions restrictions for sterilization facilities and chemical plants.

Between the lines: Stakeholders are facing an uncomfortable truth: this chemical's pretty hard to get rid of right now.

  • EtO has a wide range of applications. Crucially, it is used to sterilize half of all medical devices in the U.S. each year, according to FDA.
  • AdvaMed, a medical device lobbying group, and other industry outfits say EPA's proposals would cause "critical shortages" of medical devices.
  • "We support EPA doing a rule," AdvaMed CEO Scott Whitaker told Axios. "The issue for us is that we just need to make sure that we get the rule right and that there aren't any unintended consequences."

Threat level: Chemicals trade representatives in D.C. have aimed at EPA's science and a chemicals program known as IRIS, as well as broadcasting EtO's myriad uses, including in EV batteries.

  • The American Chemistry Council is involved in an ongoing legal challenge to a 2020 rule to reduce EtO emissions that questions the viability of the 2016 risk assessment's findings.
  • Industry has preferred a separate risk analysis by Texas state environmental regulators — which EPA has rejected — suggesting a lower public EtO risk.

Yes, but: Darya Minovi, a senior analyst at the Union of Concerned Scientists, is optimistic FDA can find alternative sterilization methods.

  • "We should value the health of the people who live near these facilities a little bit more than our system has," Minovi told Jael.
  • An FDA spokesperson, meanwhile, says that "while signs of innovation are promising, other methods of sterilization cannot currently replace the use of EtO for many devices."

The intrigue: The EtO fight has sparked visceral reactions from allies and foes in Congress.

  • The fight against EtO has been led primarily by lawmakers from Illinois, home to a high-profile EtO exposure site.
  • Rep. Brad Schneider created a bipartisan EtO task force in 2019 with former Rep. Jody Hice and recently wrote in support of EPA's proposed regulations with Sens. Tammy Duckworth and Dick Durbin.
  • "This is not a binary choice between making sure we have medical devices, medical products, and clean air. We're able to do both," Schneider told Axios.

Republicans have also sketched their battle lines.

  • House appropriators included language in the Interior-Environment bill that would restrict EPA from using funds to create new standards for EtO emissions until FDA certifies that the action won't cause a medical device shortage.
  • Sen. Bill Cassidy also sent a letter opposing the proposed rules to EPA and President Biden last month, saying he was "alarmed at the reckless lack of coordination by the White House of its Executive Branch agencies and departments."

Constituents also want more answers about the chemicals, as Florida Rep. Byron Donalds discovered this summer.

  • When the EPA disclosed that an EtO facility in Fort Myers potentially presented a risk to people living nearby, Donalds toured the facility after it installed new pollution controls and hosted a town hall.
  • EPA "really stirred a hornets' nest in my district, and it was just not appropriate for EPA to do that," Donalds told Axios in a hallway interview.

Yes, but: Chemicals regulation changes sought by Republicans so far have failed to enter bicameral discussions about environmental permitting, which is the place they'd need to be for any progress this Congress.

What EPA says: Shayla Powell, an agency spokesperson, provided a statement saying EPA's goal is to reduce "cancer causing EtO exposure to workers and community members, while maintaining the integrity of the supply chain."

  • "We are working with FDA and others on potential supply chain issues and will use the input gathered during the public comment process in making any final decision."
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