EPA backs down on ethylene oxide queries after FDA marks turf

The Environmental Protection Agency backed down on its request to find out more about how medical sterilization facilities use ethylene oxide, a carcinogenic chemical, after the FDA claimed  jurisdiction in the matter, Bloomberg Environment reported. 

Ethylene oxide is used to sterilize about half of all the medical devices used in the U.S. But its use has prompted dozens of lawsuits from people who live near sterilization facilities, claiming exposure to the chemical caused their cancer. 

Prolonged exposure to high concentrations of ethylene oxide may damage eyes, lungs, the brain and nervous system, and may cause certain types of cancer, Bloomberg reported. 

The EPA has been pushing to regulate ethylene oxide use, and in a draft version of proposed rulemaking on the issue, it asked if it would be possible for medical sterilization facilities to use lower volumes of the chemical to minimize emissions. 

But the FDA claimed it has jurisdiction over regulating ethylene oxide use in sterilization facilities, not the EPA.

"The FDA believes this entire section is not relevant to EPA’s role of setting appropriate emission levels and monitoring emissions," the agency wrote in its comments on the EPA's proposed rules, according to Bloomberg. "FDA requests the deletion of this entire discussion about FDA requirements and matters within FDA jurisdiction."

In response, the EPA removed the section dealing with lowering ethylene oxide volumes from the final version of its advanced notice of proposed rulemaking. Instead, it posed a general question about how much it would cost and how feasible it would be to change sterilization practices to lower emissions. 

Read the full article here

More articles on supply chain:
How Cleveland Clinic manages its medical waste
Stryker warns some defibrillators may not deliver shock
FDA warning letters to devicemakers down nearly 90 percent

© Copyright ASC COMMUNICATIONS 2020. Interested in LINKING to or REPRINTING this content? View our policies by clicking here.

 

Top 40 Articles from the Past 6 Months