ACC Statement On EPA's Proposals To Address Ethylene Oxide In Sterilization And Pesticide Uses

Today, the American Chemistry Council (ACC) issued the following statement in response to the Environmental Protection Agency’s draft proposals related to ethylene oxide in commercial sterilization and pesticide registration applications:

“Ethylene oxide (EO) is a versatile building block compound that’s used to help make countless everyday products. EO plays an important role in the development of batteries for electric vehicles, in natural gas purification, as well as in the creation of derivatives that aid drilling at oil and gas wells.

“Another important use of EO is for the sterilization of medical equipment, including personal protective equipment used by health care professionals and hospitals. It is estimated that EO sterilizes 20 billion medical devices each year, helping to prevent disease and infection.

“According to FDA, ‘For many medical devices, sterilization with ethylene oxide may be the only method that effectively sterilizes and does not damage the device during the sterilization process.’

“We support strong, science-based regulations for EO. However, we oppose the use of EPA’s flawed IRIS value as a benchmark in any rulemaking. ACC and others have detailed the severe science-based flaws with the IRIS value that resulted in an overly conservative value that is below background levels of ethylene oxide. Notably, the Texas Commission on Environmental Quality (TCEQ) identified several flaws underlying EPA’s conclusions, and after conducting its own analysis, TCEQ’s peer-reviewed assessment concluded that the risk of EO is 4,000 times lower than what the IRIS program identified. In fact, the IRIS program’s proposed toxicity value is 19,000 times lower than naturally-occurring levels of ethylene oxide found in the human body.

“To date, EPA has ignored or failed to provide a meaningful response to the core, scientific, and substantive issues ACC and TCEQ have raised with the development of the IRIS value for EO.

“We look forward to continuing to engage on this issue throughout the review process.”