What is FIFRA?
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) is a U.S. federal law that governs the registration, distribution, sale, and use of pesticides to protect human health and the environment. Under FIFRA, the Environmental Protection Agency (EPA) is responsible for evaluating and approving pesticides based on their efficacy and safety, ensuring they do not pose unreasonable risks when used as directed. The act requires manufacturers to provide scientific data on a pesticide's composition, toxicology, environmental impact, and effectiveness before it can be registered for use. FIFRA also establishes requirements for labeling, worker protection, and proper storage and disposal. Enforcement mechanisms include inspections, penalties, and restrictions to prevent misuse and ensure compliance. Importantly, as of January 14, 2025, FIFRA now regulates the exposure of workers to Ethylene Oxide in commercial sterilizers and other related facilities.
How does FIFRA impact EtO Use?
- FIFRA will require facilities to continuously monitor EtO and display the concentrations visibly to staff at the facility.
- FIFRA also requires that facilities meet more aggressive targets for worker exposure, with eventual limits set at 100 ppb over an 8-hour Time-Weighted Average (TWA) for any areas where employees are expected to be present without PPE. Because legacy technologies used for monitoring in sterilizer plants do not typically have the sensitivity to measure below 100 ppb reliably, many facilities will need to upgrade to systems over the 2025 calendar year to be capable of measuring at these levels by January 1, 2026.
Does this apply to me?
- Commercial sterilizers using EtO will be subject.
- EtO producers will be responsible for new labeling and record keeping.
- Warehouses and some medical facilities may also be impacted. We are working to confirm the full scope of impacted stakeholders. Please reach out to Picarro now to ensure you’re in the loop when we have confirmed all details.
When does this take effect?
FIFRA’s will require impacted facilities as soon as Jan 1, 2026:
- Jan 1, 2026: continuous monitoring must be in place, collecting personnel exposure data and displaying EtO concentrations (Pg 63, Table 3). TWA must be <1 ppm.
- Jan 1, 2028, facilities will have to comply with 8-hr time-weighted averages below 0.5 ppm.
- Jan 1, 2030: below 0.25 ppm
- Jan 1, 2035: Below 0.1 ppm
What do I need to do?
The Picarro Workplace Monitoring System (WMS) was designed with FIFRA in mind. Picarro’s CRDS solution makes it easy to measure concentrations across a facility at up to 25 positions, with detection limits as low as 0.25 ppb. Competitor technologies cannot achieve reliable concentrations below 100 ppb, making it almost impossible to monitor EtO for FIFRA compliance.