EPA Sends EO NESHAP Reconsideration NPRM to OMB

Yesterday the OMB’s Office of Information and Regulatory Affairs (OIRA) announced that it had received a notice of proposed rulemaking from the EPA on “National Emission Standards for Hazardous Air Pollutants: Ethylene Oxide Emissions Standards for Sterilization Facilities Residual Risk and Technology Review, Reconsideration”.

According to the Spring 2025 Unified Agenda entry for this rulemaking:

“On April 5, 2024, the EPA published the risk and technology review (RTR) of the National Emission Standards for Hazardous Air Pollutants (NESHAP) for Commercial Ethylene Oxide (EtO) Sterilization Facilities (See 89 FR 73293). EPA announced on March 12, 2025 that this rule will be a prioritized rule for reconsideration. The EPA will be reconsidering this action in order to address several issues that are administration priorities and consistent with the direction of the Agency”

Actually, the Ethylene Oxide NESHAP rule was published at 89 FR 24090. The above referenced Federal Register publication was a more generalized look at changing major source classification to area source. There was no mention of EO in that final rule.

 

As with the publication of the Biden Administration regulation, I do not expect to cover this rulemaking in any detail. I will, at least, be acknowledging publication in the appropriate Short Takes post.

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

EPA Directs 29 Facilities to Begin TRI Reporting for Ethylene Oxide

Today the EPA published a notice of availability in the Federal Register (86 FR 73764-73766) of the “EPA Administrator Determination Extends TRI Reporting Requirements to Certain Contract Sterilization Facilities.” Under the discretionary authority provided to the EPA under 42 USC 11023(b)(2) the EPA has decided “to extend the [Toxic Release Inventory – TRI] reporting requirements for ethylene oxide releases and other waste management activities to 29 contract sterilization facilities; and to extend the reporting requirements for ethylene glycol to 16 of those facilities.”

The facilities identified in the Notice have all been directly contacted by the EPA about their new reporting requirements, so why the interest here? Well, ethylene oxide is a DHS chemical of interest with a screening quantity threshold of 10,000 lbs. The EPA made mention in their notice that they believe “that these facilities are likely to exceed the 10,000 pounds per year “otherwise used” TRI reporting threshold for ethylene oxide.” Thus, these facilities would also be expected to submit a Top Screen report to CISA’s Office of Chemical Security for evaluation for potential inclusion in the Chemical Facility Anti-Terrorism Standards (CFATS) program.

I would suspect that, because of the cooperation between EPA, OSHA and CISA on all matters related to chemical safety and security (most recently evidenced here), OCS has already been made aware of these facilities and has contacted them if a Top Screen has not already been completed. This does, however, point out another industry that CISA may want to add to their CFATS outreach program. I would not be surprised to see a ‘Sterilization Facility Fact Sheet’ added to the CFATS Resources page.