EPA Releases FIFRA Interim Decision on Ethylene Oxide Imposing New Requirements for Medical Device Sterilization

On January 14, 2025, EPA issued an interim decision under the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”) regarding the pesticidal uses of Ethylene Oxide (“EtO”), a commonly used sterilant for medical devices (the “EtO ID”). The EtO ID evaluates the use, risks, and benefits of EtO, and identifies a variety of risk mitigation measures for various industries, including the medical device sterilization industry. The new required risk mitigation measures for medical device sterilization go into effect with phased compliance deadlines ranging from within 60 days to 10 years.

The EtO ID was issued as a part of EPA’s pesticide registration review process. At least once every 15 years, EPA reviews each FIFRA-registered pesticide to ensure that the pesticide in question can carry out its intended functions without creating unreasonable adverse effects to human health and the environment. As part of this registration review process, the agency can issue an interim decision which considers whether additional risk mitigation measures are appropriate and whether the agency needs additional information to complete its review. The interim decision can also require that updated labels—which impose legally binding restrictions on how the pesticide can be used and any safety precautions that must be taken—be submitted for agency approval. At the conclusion of the registration review process, EPA will ultimately issue a final decision once the agency completes its assessment and necessary consultations and analyses.

EPA notes that there are no viable alternatives to EtO for sterilizing certain medical devices, so prohibiting its use would disrupt the medical device supply chain. However, according to EPA, exposure to EtO creates cancer risks to occupational handlers as well as occupational and non-occupational bystanders. To reduce the risk to these individuals, and to minimize negative impacts on the medical device supply chain, EPA has imposed the following mitigation measures for the medical device industry which include reducing EtO use where possible, and requiring certain personal protective equipment as well as engineering and administrative controls. In several respects, these mitigation measures are less stringent than those in EPA’s proposed Interim Decision.

Reducing Concentration Rate Limits

• Reduce the rate of EtO use per sterilization cycle.
  • Limit at 600 mg/L for medical devices for new cycles only.
  • Compliance deadline: ten years.

Engineering Controls

• Facilities may choose which engineering and process controls to use in order to meet the lowered occupational exposure limits (discussed in greater detail in the following Personal Protective Equipment section).
• Separation of HVAC systems for processing and non-processing areas.
  • Compliance deadline: three years.
• Note that healthcare facilities are subject to additional engineering controls, including the requirement that certain facilities install abatement technology on their exhaust systems that handle EtO, and requiring that such exhaust systems are at least 7.6 meters from the building’s air intake source.

Personal Protective Equipment

• Respirators are required for exceedances of occupational exposure limit of 1 ppm (1,000 ppb) (8-hour time weighted average) and short-term exposure limit (“STEL”) of 5 ppm (5,000 ppb) (15-minute time weighted average) in commercial sterilization facilities and healthcare facilities.
• The occupational exposure limit will be lowered incrementally over the next ten years.
  • 0.5 ppm (500 ppb) (3-year compliance deadline),
  • 0.25 ppm (250 ppb) (5-year compliance deadline), and
  • 0.1 ppm (100 ppb) (10-year compliance deadline).
• STEL of 5 ppm (5,000 ppb) duration to be lowered to 10-minute time weighted average (“TWA”) from the current 15-minute duration (10-year compliance deadline).
• Respirators for connecting and disconnecting EtO containers from sterilization process equipment; unloading processed products from the sterilization chamber; loading and unloading product from the aeration area; removing validation test materials from processed product at any time prior to the completion of aeration; opening process lines or equipment that may contain EtO (e.g., for repairs or routine maintenance tasks).
  • Compliance deadline: one year.

Stationary Indoor Air Monitoring

• Continuous stationary indoor air monitoring at 0.1 ppm (100 ppb) with monitoring results that are to be made visible to workers.
• Compliance deadline: one year.

Training

• Training on the potential health effects from EtO exposure for workers in commercial sterilization facilities and healthcare facilities, including information on acute risks and chronic cancer risks.
• Compliance deadline: Immediate upon approved label amendments, and within 60 days for healthcare facilities.

Recordkeeping

• Recordkeeping that demonstrates adherence to the TWA occupational exposure limit and STEL; readings from stationary continuous monitoring of room air; documents the method of initial treatment for food commodities as well as the need for reconditioning/retreatment with EtO; worker training; and adherence to the 600 mg/L limit on new sterilization cycles.
• Compliance deadline based on associated mitigation.

Data Requirements

• Worker exposure data for commercial sterilizers and warehouses (OSCPP GLN 875.1400 Inhalation Exposure Indoor) in order to understand the impacts of complying with EPA’s Clean Air Act requirements and implementing FIFRA EtO ID mitigation requirements, and to better understand how the occupational exposure limit may be further lowered.
• Additionally, EPA is requiring a special study on fumigated commodities for medical devices to better understand exposure to EtO in warehouses.

EPA states that these proposed mitigation measures were designed to afford the necessary flexibility to meet the demand for sterilized medical devices while also reducing worker exposure. EPA expects the impacts of these measures on the availability of sterile medical devices to be “low.” EPA does not explain the rationale for this conclusion, but notes that it amended some of the mitigation measures in response to concerns voiced in comment letters regarding potential disruptions to the medical devices supply chain.

EPA has indicated that it intends to engage in additional data collection and analysis before issuing a final decision. For example, EPA intends to issue a data call-in, which will require pesticide registrants to provide the agency with information regarding worker exposure to EtO. Based on additional data, EPA plans to reevaluate the final occupational exposure limit (of 0.1 ppm) and any other needed mitigations within eight years.

EPA will also need to make effects determinations and any necessary consultations under the Endangered Species Act. It will also need to make a determination under the Endocrine Disruptor Screening Program.

At some point following its completion of these outstanding work streams, EPA will issue a final registration review decision under FIFRA.

Unless reconsidered or successfully challenged in court, this interim decision is binding, and so companies should take appropriate steps to prepare to come into compliance with it.

If you have any questions concerning the material discussed in this client alert, please contact the members of our Medical Devices and Diagnostics and Environmental practices.