The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) is a United States federal law that regulates the registration, distribution, sale, and application of pesticides to safeguard human health and the environment. As of January 14, 2025, FIFRA now regulates the exposure of workers to Ethylene Oxide in commercial sterilizers and other related facilities.
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Under FIFRA, the EPA reviews and approves pesticides to ensure they work effectively and are safe when used as directed. The law also sets rules for labeling, worker safety, and proper storage and disposal. To enforce these regulations, the EPA conducts inspections, issues penalties, and imposes restrictions to prevent misuse. Antimicrobial products such as Ethylene Oxide (EtO) are classified as pesticides, and so are subject to FIFRA.
How Does FIFRA Impact EtO Use in Commercial Sterilization Facilities?
FIFRA will require facilities to continuously monitor EtO and display the concentrations visibly to staff within the facility.
FIFRA also requires facilities to achieve stricter limits on worker exposure, with eventual limits set at 100 ppb over an 8-hour Time-Weighted Average (TWA) in areas where employees are expected to be present without PPE.
Because legacy monitoring technologies used in sterilizer plants often lack the sensitivity to reliably measure below 100 ppb, many facilities will need to upgrade their systems during the 2025 calendar year to ensure compliance with these measurement requirements by January 1, 2026.
Applicability of these regulations:
- Commercial sterilizers utilizing EtO will fall under these requirements.
- EtO manufacturers will be obligated to comply with new labeling and record-keeping standards.
- Warehouses and certain medical facilities may also be affected. Efforts are ongoing to verify the complete scope of impacted stakeholders. Please contact Picarro to stay informed as additional details are confirmed.
When Does This Take Effect?
FIFRA mandates for affected facilities, starting at January 1, 2026, as follows:
- January 1, 2026: Continuous monitoring must be operational, collecting personnel exposure data and displaying EtO concentrations (Pg 63, Table 3). TWA must be <1 ppm.
- January 1, 2028, Facilities must adhere to an 8-hour time-weighted average below 0.5 ppm.
- January 1, 2030: Below 0.25 ppm
- January 1, 2035: Below 0.1 ppm
How Can Commercial Sterilizers Ensure FIFRA Compliance
Many facilities are at a critical point where the reliability of passive monitoring devices fail to meet the need of proactive safety programs, and older sensor technology, such as electrochemical, photoionization detector (PID), Fourier-transform infrared spectroscopy (FTIR), and gas chromatography (GC) do not provide low enough detection limits and exhibit false readings due to interference from water vapor, equipment exhausts, and other non-VOC (volatile organic compound) hydrocarbon fumes. In addition, many incumbent technologies are complicated, expensive to maintain, and require large amounts of downtime due to frequent maintenance.
The Picarro Workplace Monitoring System (WMS) is designed to address FIFRA requirements. Picarro’s Cavity Ring-Down Spectroscopy (CRDS)-based solution makes measuring EtO concentrations throughout a facility in real time easy -- supporting up to 25 positions with detection limits as low as 0.25 ppb. Legacy technologies cannot reliably detect concentrations below 100 ppb, creating significant challenges in monitoring and reporting EtO levels for FIFRA compliance.
This information has been sourced, reviewed and adapted from materials provided by Picarro.
For more information on this source, please visit Picarro.