EPA announces interim rule on ethylene oxide

The Environmental Protection Agency (EPA) posted the Ethylene Oxide (EtO) Interim Registration Review Decision Case 2275 January 2025 on Jan. 14. The rule details the final registration review decision under the Federal Insecticide, Fungicide, and Rodenticide Act, and identifies mitigations health care facilities should take to reduce the extent of environmental exposure to EtO.

Health care facilities such as hospitals, dental offices and veterinary facilities are expected to use significantly smaller volumes of EtO than commercial sterilization facilities. However, given the cancer risks presented by inhaling EtO even at lower concentrations, the EPA believes additional risk mitigation measures are needed within health care facilities.

The EPA has determined that health care facilities must take action when EtO levels reach 0.1 parts per million based on an 8-hour time weighted average. The agency has set an implementation timeline of one year to comply with the interim rule. The rule also establishes additional exposure limit reductions to be implemented over the next 10 years.

The rule establishes additional mitigation requirements for health care facilities such as: 

Engineering controls. The EPA is requiring that all exhaust from all-in-one EtO health care facility sterilization devices be directed through exterior ventilation exhaust. EtO exhaust must be vented to a dedicated exhaust ventilation system that serves the sterilizer area only and routes EtO directly outside of the building. The exhaust duct is also required to terminate away from areas where people walk or work, to be located at least 25 feet away from the building air intake source and to be engineered according to existing codes. Additionally, health care facilities using 10 pounds or more of EtO per year are required to utilize dedicated abatement devices on their sterilizers.

Safety and awareness training. Health care facilities are required to provide information and training to all workers in the facility at the time of initial assignment and annually thereafter. The safety training must include, at a minimum, the following information:

• The potential health effects of EtO.
• The emergency response plan and how to respond in an emergency.
• The availability of safety data sheets and other materials related to the health hazards of exposure to EtO.

Recordkeeping. Monitoring records are required to be maintained according to the Occupational Safety and Health Administration requirements from the date of monitoring for a time of 30 years.

Additionally, training materials provided to workers upon assignment and annually thereafter and records of the dates individual workers are trained should be maintained as part of the recordkeeping requirement. Training records are required to be maintained for two years from the date of training.

The details of these EPA requirements are posted on the decision webpage and can be found starting on Page 88 of the decision docket.