EPA Aims to Limit Air Emissions From Carcinogenic Sterilizer

April 11, 2023, 3:00 PM UTC

The Environmental Protection Agency announced a proposal for updated hazardous air pollutant rules on Tuesday, targeting worker and resident protections for commercial sterilizer plants using ethylene oxide, or EtO.

The Clean Air Act proposal would require 86 commercial sterilizers across the US to adopt tighter rules and advanced control technology that would reduce emissions of the carcinogenic chemical by 80%, according to the agency.

This action—and another for chemical manufacturing plants announced last week— comes after a nine-month review of elevated cancer risk in communities that surround EtO facilities.

Facilities would be required to have a combination of emissions monitors and operating condition monitors “that will continuously and rigorously” monitor whether emissions are being routed to control devices effectively, according to Deputy Assistant Administrator for the Office of Air and Radiation Tomas Carbonell.

Elevated Cancer Risk

“Failing to take action to address these risks is simply unacceptable,” EPA Deputy Administrator Janet McCabe said at a press briefing on the proposals.

Extended exposure to EtO is shown to increase the risks for cancers, especially among those who live near or work in facilities that use the chemical. Plants rely on EtO to adequately sterilize medical equipment and certain spices.

“The sterilizers proposal announced today and the proposed rule for chemical plants that EPA announced last week would reduce 77 tons a year of EtO, and that is an 84% reduction compared to 2020 emissions from all sources,” McCabe said.

In addition to the Clean Air Act proposal, the EPA is also floating a new set of mitigation measures under the Federal Insecticide, Fungicide, and Rodenticide Act in what is called a “proposed interim decision.”

These protections include prohibiting use of EtO when alternatives exist, reducing the amount of EtO in medical sterilization while complying with FDA rules, and mandating personal protective equipment in sterilization facilities.

The EPA officials on the press call announcing the proposals on Tuesday insisted that many facilities and industry stakeholders are already making use of many of these mitigation measures. Plants have 18 months after the rule is finalized in 2024 to install pollution controls.

To contact the reporter on this story: Jennifer Hijazi in Washington at jhijazi@bloombergindustry.com

To contact the editor responsible for this story: Zachary Sherwood at zsherwood@bloombergindustry.com

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