Having adopted stringent air emission controls on commercial sterilizers that use ethylene oxide (EtO), the Environmental Protection Agency (EPA) has now adopted further controls on workplace exposure to EtO, including adopting new employee exposure limits, limiting the use of EtO in sterilizing food products and cosmetics, establishing requirements for operating commercial sterilizers that use EtO and new recordkeeping and training requirements. These controls represent the next step in EPA’s campaign to control exposure to what it considers a toxic chemical.
Unlike its prior emission regulations, EPA issued these controls as an Interim Registration Review Decision (ID) under its Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) authority to regulate pesticides. Since its primary purpose is anti-bacterial, EtO has been regulated as a pesticide since 1966 and was registered under FIFRA in 1984. FIFRA gives EPA the authority to review and reregister pesticides and to confirm the allowed uses and warning on their required labels. It also allows EPA to issue interim findings and requirements even though it has not completed its registration process.
EPA began the reregistration process for EtO in 2013 but has yet to complete it. In 2021, however, as EPA began its focus on control of EtO, it began considering an ID to limit exposure. In 2023, it issued a draft ID, inviting comments from the regulated and environmental communities. On January 5 2025, EPA issued its final ID, which is not published in the Federal Register but is on EPA’s website.
In the ID, EPA imposes stringent limits on commercial sterilizers. It limits the applicable uses for EtO by stating that EtO can no longer be used for museum, library and archival materials, cosmetics, or musical instruments. The ID also limits EtO uses for food sterilization stating that it can no longer be used generally on whole or ground spices or seasoning materials, although it can be used for a specified list of such materials and used to treat another list of such materials only if additional treatment is necessary. The ID further imposes concentration limits to be applied by 2035, limiting concentration for medical device sterilization to 600 mg/L unless the device design requires greater concentration levels or has U.S. Food and Drug Administration (“FDA”) approvals for greater levels. Finally, commercial sterilization facilities are required to have separate heating, ventilating and air conditioning systems for offices and control rooms and for EtO processing areas.
The ID adds significant rules regarding employee exposure. It goes beyond the Occupational Safety and Health Administration’s (“OSHA”) Permissible Exposure Limits and applies an eight-hour time weighted average exposure limit that ratchets down over time. Through December 31, 2027, facilities are required to assure that the eight-hour time weighted limit is no greater than 1.0 ppm, but by January 1, 2035, the exposure limit must be reduced to 0.1 ppm. EPA adopts similar reductions for the short term exposure limit and the EPA action levels. Similarly, EPA imposes requirements to workers to use either air/airline respirators or self-contained breather apparatus when engaged in tasks involving direct exposure to EtO such as connecting and disconnecting EtO containers or unloading product from the sterilization chamber or aeration area. Finally, the ID requires continuous monitoring devices in both process and non-processing areas.
The ID also imposes enhanced training and recordkeeping requirements. Training must include a discussion of the health effects of EtO exposure and specific language that EtO is a carcinogen and describe symptoms of acute and chronic exposure. Recordkeeping includes monitoring sterilizer EtO concentrations, worker exposure data, indoor monitoring results, and worker training.
The ID imposes similarly stringent rules for sterilizers in healthcare facilities, including hospitals, veterinary facilities, and dental offices. Such facilities may only use EtO in single chamber sterilization devices that utilize emission capturing systems that limit worker and public exposure. The ID also imposes similar worker exposure requirements and similar rules on respirators. The rule on training and recordkeeping are similar as well.
The ID establishes numerous new requirements for EtO use for both commercial sterilizers and healthcare facility sterilizers and each of these requirements have different start and compliance dates. Since the ID is not subject to publication in the Federal Register, these requirements may not have been subject to the broad attention applied to EPA regulations but are just as dramatic and far reaching. EPA issued the ID in the last days of the Biden administration, and it is not clear if the Trump administration is reviewing the ID, along with other late adopted EPA regulations. What is clear is that users of EtO face significant additional requirements as a result of the ID and need to review and understand them.