Close-up of exhaust fan on factory roof

EPA’s Final EtO Rule Finally Finalized

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The Environmental Protection Agency on March 14 announced final amendments to the National Emission Standards for Hazardous Air Pollutants (NESHAP) applicable to 90 large commercial sterilization facilities that use ethylene oxide (EtO), a chemical to which long-term exposure can cause cancer or other serious injury.

The EtO rulemaking process has engendered some criticism – most dramatically in lawsuits filed against the EPA by advocates representing neighbors of EtO facilities who claim the rulemaking process was too little too late (covered by ELM here). But according to a March 14 EPA’s press release, the new final rule uses “proven and achievable” methods of controlling EtO emissions and is projected to reduce them by 92 percent while still managing any potential supply chain impacts (a concern covered by ELM here).

The EtO NESHAP amendments, include:

  • Establish standards for previously unregulated emissions (e.g., emissions that escape via exhaust vents) for the purposes of reducing cancer risks and that reflect technological advances;
  • Strengthen already existing standards for emissions sources such as aeration room vents and sterilization chamber vents;
  • Mandate continuous emissions monitoring and quarterly reporting;
  • Ensure that commercial sterilizers apply emissions standards, regardless of the state of operations – whether in startup, shutdown, or in malfunctioning mode – in order to avoid a lapse in air protection; and
  • Other transparency- and safety-promoting requirements such as electronic reporting and technical updates.

Acknowledging the challenges for the affected commercial sterilizers, some of which have faced or are facing record-setting lawsuits and verdicts (regularly covered by ELM, including here and here), the EPA explained the Clean Air Act enables President Biden to implement a two-year grace period for compliance with NESHAP in certain circumstances – one being to protect our medical supply chain and avoid harming distribution of lifesaving medical equipment and supplies that require sterilization.

This final rule comes after years of efforts by the EPA to study and mitigate the potentially cancerous effects of long-term exposure to EtO while educating affected communities and eliciting public feedback, albeit with a severe delay caused by the COVID pandemic, which required unimpeded use of commercial sterilizers for medical supplies and equipment on a previously unimaginable scale.

It also comes one year after the EPA released its proposed final rule (covered, in detail, by ELM here). This latest development combines the Biden administration’s overarching “Cancer Moonshot” goal of ending cancer, as well as its commitment to environmental justice, which focuses on the protection of already vulnerable communities overburdened by pollution.