The EPA recently strengthened its regulatory framework for ethylene oxide (EtO), a chemical commonly used in sterilization processes. Then, a new administration took office with differing policies, leaving facilities increasingly uncertain about how, when, and if to comply with these regulations.
In the last year, there have been a series of regulatory updates designed to encourage sterilization facilities to take more stringent measures to reduce risks associated with EtO usage. Final amendments to the National Emission Standards for Hazardous Air Pollutants (NESHAP) for Ethylene Oxide Commercial Sterilization Facilities (Subpart O), the enhanced monitoring requirements under the Hazardous Organic NESHAP (HON) Rule, and most recently an Interim Decision under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) have been released.
Collectively, these regulations introduce substantial compliance challenges for affected industries.
These policies, while aligned in their objective of minimizing EtO-related risks, address different aspects of exposure and emissions control. The increasing collaboration between OSHA and the EPA reflects a heightened emphasis on worker safety, with coordinated enforcement efforts and data sharing designed to ensure long-term effectiveness.
This collaborative approach improves oversight while also reinforcing the importance of facilities to uphold proactive compliance measures.
The following table summarizes the current regulations designed to strengthen emission controls and monitoring requirements for facilities emitting EtO:
Source: Picarro
| Regulation |
Industry |
Effective Date |
Compliance Date1 |
| NESHAP Subpart O |
Commercial Sterilization Facilities |
April 5, 2024 |
April 5, 20262 |
| HON Rule |
Synthetic Organic Chemical Manufacturing Industry and Group I & II Polymers and Resins Industry |
July 15, 2024 |
July 15, 20263 |
| FIIFRA Interim Decision |
Sterilization Facilities and Hospitals |
January 14, 2025 |
January 1, 20264 |
1 Based on the facility being an existing facility as defined in the regulation.
2 Compliance date varies based on the facility's EtO usage; the date provided assumes the earliest compliance deadline.
3 Compliance date pertains to fenceline monitoring requirements.
4 Compliance date relates to workplace monitoring requirements.
How the Current Administration Could Affect Biden-Era Regulations
Although these policies are designed to enhance public and worker protections, political shifts could influence their future. While users of EtO may be able to apply for a temporary exemption, the Congressional Review Act (CRA) serves as a more powerful tool, allowing Congress to overturn federal regulations issued toward the end of a presidential term.
The CRA lookback period, which has now been confirmed to have begun on August 16th, 2024, allows any regulations finalized on or after this date to be subject to review and possible repeal by the new Congress.
Although these delays do not immediately revoke or repeal the rules, they offer the new administration time to review and potentially reshape future regulatory requirements.
How Will This Impact EtO Regulations?
Although the NESHAP Subpart O and HON Rule were finalized before the CRA lookback period, meaning they are not at immediate risk of repeal, they could still experience enforcement delays. Rolling back these rules is unlikely to be a quick or simple process.
The regulatory process takes years, involving mandatory public comment periods, agency reviews, and procedural obstacles. Courts closely scrutinize rollbacks, particularly when the original regulations are rooted in scientific evaluations and public health data. Moreover, input from industry groups, environmental organizations, and advocacy groups can add additional complexity to the process.
With these challenges in mind, while changes remain possible and compliance deadlines could shift, businesses should continue preparing for compliance in case the rules are upheld or reinstated after legal review.
However, FIFRA’s ID, published on January 14th, 2025, falls within the CRA lookback period and is at significant risk of repeal by the new administration. Although this introduces regulatory uncertainty, it also underscores the need for proactive compliance planning, especially with the January 1st, 2026, implementation deadline still in effect.
Looking Ahead: What This Means for Facilities
In the face of the uncertainty caused by regulatory changes and political shifts, one thing is certain: prioritizing worker safety, minimizing emissions, and compliance best practices are foundational for long-term operational stability and maintaining stakeholder trust.
Despite potential near-term regulatory shifts, EtO's air toxin properties continue to raise concerns among environmental agencies and supply chain stakeholders worldwide. Accordingly, facilities must remain proactive to enhance their processes and minimize overall business risk.
Amidst the complexity of these evolving regulations, Picarro offers the expertise and solutions needed to aid facilities in maintaining compliance with confidence and imrpoving operational efficiency.
This information has been sourced, reviewed and adapted from materials provided by Picarro.
For more information on this source, please visit Picarro.