Ethylene Oxide: Ensuring Compliance with 40 CFR Part 63, Subpart O Amendments

Navigating New Emission Limits and Monitoring Requirements in Commercial Sterilization

Understanding the EPA’s 2023 Proposed Amendments to the Hazardous Organic NESHAP (HON) and Performance Specification (PS-19)

The U.S. Environmental Protection Agency (EPA) is introducing pivotal amendments to the National Emission Standards for Hazardous Air Pollutants (NESHAP) for Ethylene Oxide (EtO)  Commercial Sterilization and Fumigation Operations. Set to transform the industry, these proposed regulations demand more stringent emission limits, operating limits, and advanced continuous monitoring.

The proposed amendments are a significant overhaul of the current standards. Aimed at reducing EtO emissions by 80%, these changes include enhanced pollution controls and a shift to advanced continuous source monitoring. This move reflects the EPA’s committment to safeguard community health by minimizing EtO exposure. Your facility needs to adapt to these updates, which involve overhaulinge existing controls and embracing alternative monitoring technologies. The EPA has a consent decree to issue a final rule by March 29, 2024. When the proposed rule is finalized, the affected, facilities will be required to comply within 18 months of promulgation. Let’s explore what this means for your operations and how we can help you achieve compliance with ease.


What Does This Mean for Your Facility?

Transitioning to these new standards isn’t just a regulatory compliance issue; it’s about redefining your operational efficiency. With these amendments, your facility will need to upgrade to new or add-on controls for air emission sources. The EPA proposes two options for compliance: using an EtO Continuous Emissions Monitoring System (CEMS) including optically enhanced FTIR, or conducting initial and annual performance tests combined with continuous perimeter monitoring. These changes are not just procedural but also technical, requiring a deep understanding of the revised methods and procedures.


Spectrum’s Turnkey Approach

Unlike conventional narrow band focus methods, our full-spectrum scan technology offers a comprehensive view of your emission landscape. This approach allows us to quantify multiple compounds in a single scan. Our optically enhanced WaveRunIR-EXT monitor can continously achieve low-part per billion levels from process and emission source applications. With this data, you can not not only meets the stringent EtO monitoring requirements but also obtain insights into your entire sterilization process for enhanced optimization and safety.

  • Full Process Monitoring: With Spectrum’s customizable devices and solutions, we can quantify your compounds of concern in a single scan. Whether you are targeting Ethylene Oxide, Carbon Dioxide, Aldehyde, or even Propylene Oxide, we can craft customized solutions to get the answers you need. With your data in hand, you can monitor your entire sterilization process to ensure maximum efficiency and compliance.
  • Expert Consulting on Environmental Permitting: We understand the nuances of EPA regulations and are adept at navigating the permitting process. Our expert team can guide your facility in meeting all compliance requirements efficiently.
  • Custom In-House Software Development: Technical glitches? We’ve got it covered. Our in-house software development means swift, tailored solutions and minimal downtime.
  • Proactive Notifications System: Our advanced system detects anomalies, often before they escalate. With our remote notifications system and dashboard, your EHS and leadership teams can gain access to the data they need, even if they are off-site. Coupled with our remote troubleshooting capabilities, we ensure any issues are addressed promptly, keeping your operations smooth and compliant.


Comprehensive EtO Emissions Management Solutions

With years of expertise in complex emissions measurement and monitoring, Spectrum Environmental Solutions stands at the forefront of offering comprehensive EtO emissions management solutions. Our combination of advanced technology, expert consultants, and world-class support ensures your facility not only meets the current regulations but is also prepared to meet future regulatory challenges. Embrace sustainable operations and protect your workforce and community with our tailor-made solutions.


Spectrum Helps Commercial Sterilization Clients Achieve Higher Production Efficiencies, Operate Sustainably, and Achieve Compliance. Get in Touch Today.

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