Today’s alert looks at the current status of challenges to the IRIS EtO URE and EPA’s related rulemaking proceedings.
Sterilizers have been one of the most widely publicized sources of EtO, and have taken the brunt of enforcement actions and plaintiffs’ lawsuits based on EtO exposures in the past couple years since publication of the 2014 NATA. But to date, formal regulatory challenges and litigation surrounding the validity of the IRIS EtO URE itself have focused on the chemical manufacturing industry.
The ACC was the first to attempt to formally challenge EPA’s use of the IRIS EtO URE. As soon at the 2014 NATA was published on Sept. 20, 2018, the ACC filed a Request for Correction under the Information Quality Act with EPA, requesting that EPA change its risk assessment for EtO based on subsequent studies, but to date EPA has not disposed of ACC’s request or revisited the IRIS EtO URE. Continue Reading