FDA director urges EPA to regulate ethylene oxide

Less than a month after the FDA claimed jurisdiction in regulating ethylene oxide emissions at medical device sterilization facilities, an FDA director is now urging the U.S. Environmental Protection Agency to issue emissions limits on the chemical, which is used to sterilize most of the country's medical devices. 

The two agencies have struggled for months to address growing concern over ethylene oxide, which some fear can cause cancer and damage the environment. 

The EPA has pushed for regulations to reduce ethylene oxide emissions, but the FDA has warned that regulations could cause some sterilization facilities to close, which could cause shortages of critical medical devices since there isn't an alternative sterilization method.

The EPA released a draft version of proposed rulemaking in January asking medical sterilization facilities to use lower volumes of ethylene oxide. But the FDA claimed jurisdiction over ethylene oxide use in sterilization facilities, and the EPA subsequently removed the request from the proposal. 

Now, Jeff Shuren, MD, director of the FDA's Center for Devices and Radiological Health, is encouraging the EPA to issue emissions limits on ethylene oxide. 

"We recognize the critical role that EPA plays in regulating ethylene oxide to protect human health and the environment. EPA should establish EtO emissions limits based on the levels necessary to protect human health and the environment from EtO toxicity," Dr. Shuren wrote in a letter to the EPA. 

Dr. Shuren added, "If a facility is unable to meet EPA emissions limits and its inability to do so could lead to product availability concerns, FDA will work with the facility and other entities in the supply chain to mitigate these concerns."

Read the full letter here

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