The EPA recently intensified its regulatory framework for ethylene oxide (EtO), a chemical widely used in sterilization processes. On January 14, 2025, the EPA released an Interim Decision under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), introducing stricter measures to mitigate risks associated with EtO usage. This decision complements a series of regulatory updates over the past year, including the final amendments to the National Emission Standards for Hazardous Air Pollutants (NESHAP) for Ethylene Oxide Commercial Sterilization Facilities (Subpart O) and the enhanced monitoring requirements under the Hazardous Organic NESHAP (HON) Rule.

Together, these policies present significant compliance challenges for affected industries.

While these regulations share a common goal of reducing EtO-related risks, they target different aspects of exposure and emissions control. The growing collaboration between OSHA and the EPA signals a stronger focus on worker safety, with coordinated enforcement efforts and data sharing aimed at ensuring long-term effectiveness. This interagency approach not only enhances oversight but also reinforces the need for facilities to stay proactive in compliance.

Navigating these evolving regulations can be overwhelming, but Picarro provides the expertise and solutions needed to help facilities stay compliant with confidence.

The table below outlines the current regulations aimed at strengthening emission controls and monitoring requirements for facilities emitting EtO:

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

While these regulations aim to strengthen public and worker protections, political shifts may alter their future. The Congressional Review Act (CRA) is a powerful tool that allows Congress to nullify federal regulations issued at the end of a presidential term. The CRA lookback period has now been confirmed to have started on August 16, 2024, meaning any regulations finalized on or after this date are subject to review and potential repeal by the new Congress.

With the new Congress now in session and Republicans controlling both chambers, there is a strong possibility that the CRA will be used to roll back Biden-era regulations.

• Senators began introducing CRA resolutions on January 23, 2025
• House Representatives followed on February 5, 2025

Given that Congress has only 60 days of continuous session to review eligible regulations under the CRA, we can expect them to move swiftly in considering and potentially overturning a range of regulations in the coming months. Additionally, the EPA can leverage Section 112(i)(4) of the Clean Air Act to delay enforcement of regulations that fall outside the CRA lookback period by up to two years. While these delays do not immediately revoke or repeal the rules, they provide the new administration with time to conduct its review and potentially reshape future regulatory requirements. 

How Will This Impact EtO Regulations?

The NESHAP Subpart O and HON Rule were finalized before the CRA lookback period, meaning they are not at immediate risk of being overturned, but could face enforcement delays. Rolling back these rules won’t be immediate or straightforward. The regulatory process takes years due to required public comment periods, agency reviews, and procedural hurdles. Courts closely scrutinize rollbacks, especially when the original regulations are based on scientific assessments and public health data. Additionally, input from industry groups, environmental organizations, and advocacy groups can further complicate the process. Given these challenges, while changes are possible and compliance deadlines could shift, businesses should continue preparing for compliance in case rules are upheld or reinstated after legal review.

However, FIFRA’s ID, published on January 14, 2025, falls within the CRA lookback period and faces a high risk of repeal by the new administration. While this introduces regulatory uncertainty, it also highlights the need for proactive compliance planning, particularly with the January 1, 2026, implementation deadline still in place.

Looking Ahead: What This Means for Facilities

While regulatory changes and political shifts introduce uncertainty, one thing remains clear: prioritizing worker safety, reducing emissions, and compliance best practices are essential for long-term operational stability and stakeholder trust. Regardless of potential near-term regulatory changes, EtO as an air toxic of concern has continued to grow among environmental agencies and supply chain stakeholders worldwide, and facilities must stay prepared to improve their processes and reduce overall business risk.

At Picarro, we help businesses optimize their business processes and navigate complex regulatory landscapes with confidence. Our advanced EtO monitoring solutions, compliance expertise, and trusted data empower you to make operational decisions with confidence and stay ahead of evolving EtO regulations through trusted data. Whether you need guidance on emissions tracking, reporting, sterilization process efficiency improvements, or implementing abatement technologies, our team is here to support you. Reach out today to learn how we can help your facility achieve your goals efficiently and effectively.

Contact our experts for more information.