EPA proposes new regulations on toxic gas used to sterilize spices and medical equipment

By Brenda Goodman

The US Environmental Protection Agency proposed a set of new restrictions on facilities that use the cancer-causing chemical ethylene oxide, a colorless, odorless gas that is used to sterilize medical devices and spices.

The agency said the new rules, which have not been finalized, would help to reduce ethylene oxide gas that these facilities release by 80%, bringing emissions below a Clean Air Act standard for elevated cancer risk.

Communities exposed to ethylene oxide gas had lobbied the EPA to put tighter controls on plants that use ethylene oxide gas.

In 2018, an EPA report found that dozens of communities across the nation faced elevated cancer risks because of trace of amounts of ethylene oxide released into air as part of the sterilization process.

The EPA issued the report on the new risks without issuing a news release, as it had done for the same report in years past. Some affected communities learned of the risk through health assessments conducted by the Agency for Toxic Substances and Disease Registry, a division of the US Centers for Disease Control and Prevention, and media reports. A report from the EPA’s Office of the Inspector General found that some communities weren’t alerted to their risk by EPA at all.

The elevated risk became apparent after a two-decade long review of the toxicity of ethylene oxide by scientists in EPA’s Integrated Risk Information System (IRIS) program.

While the EPA acknowledged that ethylene oxide was more dangerous that had been previously understood, it continued to use an older set of rules to regulate facilities that released ethylene oxide as well as companies that manufacture it.

The proposed rules aim to better align regulations on the producers and users of ethylene oxide with the cancer risk posed by the chemical.

In issuing the proposed rules, the EPA said it aimed to strike a balance between lowing cancer risks for impacted communities and workers who use ethylene oxide while preserving “critical sterilization capabilities.”

The proposed rules would apply to 86 commercial sterilization facilities in the United States that use ethylene oxide gas to fumigate spices and medical devices.

The EPA says 20 billion medical devices — mostly single-use, disposable items used in health care such as catheters, gloves and surgical gowns — are sterilized using ethylene oxide.

The US Food and Drug Administration is actively exploring alternatives to the use of the gas, the EPA said on Tuesday, but some devices still can’t be sterilized any other way.

In proposing the new rules, EPA said its new analysis found that exposure to ethylene oxide, or EtO, on the job significantly increased cancer risks for workers in sterilization facilities and those who apply ethylene oxide in health care facilities.

“Now, a new EPA analysis shows that there may also be significant risks to workers who handle [ethylene oxide] and people who live, work or go to school near places where EtO is used in sterilization. And failing to take action to address these risks is simply unacceptable,” EPA Administrator Janet McCabe said on a call with reporters.

The additional lifetime cancer risk for a worker exposed to ethylene oxide for eight hours a day, 240 days a year for 35 years was between 1 in 10 and 1 in 36 for workers in sterilization facilities; and between 1 in 12 and 1 in 25 for workers exposed to ethylene oxide in health care facilities.

To help lower those risks, the proposed rules require greater use of personal protective equipment for workers and new controls to decrease the amount of ethylene oxide in indoor air.

They will also be required to use new real-time monitoring methods to confirm that these pollution controls are working inside facilities.

These controls can measure ethylene oxide in indoor air down to 10 parts per billion.

They will also lower the amount of ethylene oxide that can be used for each sterilization cycle.

If the rules go into effect, sterilizers would have 18 months to make the changes, which the EPA said is an accelerated time frame under the Clean Air Act.

The EPA is now taking public comment on the new rules.

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