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Navigating New FIFRA Regulations: Why Continuous Monitoring for Ethylene Oxide is Essential for Sterilization Facilities starting January 1, 2026

As of January 1, 2026, the U.S. Environmental Protection Agency (EPA) is implementing significant updates to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), particularly concerning the regulation of Ethylene Oxide (EtO) in commercial sterilization settings. These changes underscore the urgent need for robust chemical monitoring systems to ensure workplace safety and regulatory compliance.

What’s Changing Under FIFRA

Previously, FIFRA focused primarily on pesticide registration and labeling, and OSHA governed EtO occupational exposure under 29 CFR 1910.1047. However, recent changes have expanded the EPA’s scope to include occupational exposure to EtO under the authority of the Clean Air Act. Put simply, EPA has identified a need for worker exposure limits for EtO that are lower than the current OSHA Permissible Exposure Limit (PEL) of 1 ppm. 

With implementation beginning January 1, 2026, facilities using EtO for sterilization must adhere to the following requirements:

  • Implement real-time, continuous monitoring systems to detect EtO concentrations.
  • Ensure EtO monitoring data is visible to workers.
  • Collect personal breathing zone measurements for individual workers.
  • Log and store EtO monitoring data.
  • Prepare to meet a phased decrease in the permissible exposure limit from 1 ppm to 0.1 ppm over the next 10 years.

Steps to Ensure Compliance

To align with the new FIFRA requirements and safeguard your workforce, consider the following actions:

  1. Invest in a practical, easy-to-use, real-time continuous monitoring system for EtO
  2. Educate staff on the importance of continuous monitoring and train your team on proper response protocols to ensure effective management when concentrations rise above the action level.
  3. Regularly perform internal audits and review monitoring data to ensure adherence to both federal and state regulations.
  4. Discuss how your facility will prepare to achieve the phased decrease in EtO permissible exposure limits over the next decade.

     

Act Before It's Too Late

With January 1, 2026, approaching quickly, now is the time to implement comprehensive continuous monitoring solutions. By taking proactive steps today, you can ensure a safer workplace and a smoother transition into the new regulatory landscape.