EPA Sends Ethylene Oxide Standard Final Rule to OMB

On Friday, the OMB’s Office of Information and Regulatory Affairs (OIRA) announced that it had received a final rule from the EPA on “National Emission Standards for Hazardous Air Pollutants: Ethylene Oxide Commercial Sterilization and Fumigation Operations”. The notice of proposed rulemaking for this action was published on April 13^th, 2023.

According to the Fall 2023 Unified Agenda entry for this rulemaking:

“The National Air Toxics Assessment (NATA) released in August 2018 identified ethylene oxide (EtO) emissions as a potential concern in several areas across the country. The latest NATA estimates that EtO significantly contributes to potential elevated cancer risks in some census tracts. These elevated risks are largely driven by an EPA risk value that was updated in December 2016. Further investigation on NATA inputs and results led to the EPA identifying commercial sterilization using EtO as a source category contributing to some of these risks. Over the past two years, the EPA has been gathering additional information to help evaluate opportunities to reduce EtO emissions in this source category through potential NESHAP revisions. In this rule, EPA will address EtO emissions from commercial sterilizers.”

That rulemaking entry suggests that the following industry sectors could be affected by this final rule:

• 311423 Dried and Dehydrated Food Manufacturing,

• 311942 Spice and Extract Manufacturing,

• 325412 Pharmaceutical Preparation Manufacturing,

• 33911 Medical Equipment and Supplies Manufacturing, and

• 561910 Packaging and Labeling Services