Ethylene Oxide: Where Are We Now and What’s Next?

At a Glance

• EPA’s EtO NESHAP Rule and EtO FIFRA Action are now in review, with both expected to be finalized by spring 2024.
• In addition to the current actions, EPA plans to publish a proposed rule covering hospitals with EtO sterilizers in February 2024 and a final rule in June 2025.
• Offsite warehouses that accept EtO-sterilized product should prepare for the possibility that they will be regulated.

Allegations of environmental concerns related to ethylene oxide (EtO) were initially limited to Sterigenics’ commercial sterilizer in Willowbrook, Illinois, then it expanded to other commercial sterilizers in Illinois and Georgia, and then to all commercial sterilizers in the United States. Now, alleged concerns and oversight are expanding well beyond commercial sterilizers to hospitals and warehouses around the country.

As another stage of EPA’s EtO actions recently concluded, what is next for EPA and what are the potential future EtO requirements in the United States?

What are EPA’s next steps on EtO?

The comment periods for EPA’s EtO National Emission Standards for Hazardous Pollutants (NESHAP) Rule and EtO Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Action closed on June 27, 2023, with approximately 1,000 unique written comments. EPA is now in the process of reviewing all the comments and drafting the final actions with the expectation that the rules will be finalized around March 1, 2024, consistent with a proposed consent decree for the EPA EtO NESHAP Rule.

As part of the final action development process, both EPA actions will go through several internal EPA review processes as well as likely engagement from other agencies such as the U.S. Food and Drug Administration and Department of Justice with a goal of concluding the internal review process by the end of this year. Before finalization, EPA’s EtO NESHAP Rule will undergo a formal White House and interagency review process, while EPA’s FIFRA Action will likely be reviewed informally by the White House as well.

EPA is adding rules for hospitals with EtO sterilizers.

EPA’s draft EtO FIFRA Action included hospitals and health care facilities and stated that the upper bound cancer risk from EtO in hospitals and medical facilities was 1 in 12.

In addition to the current actions, on June 13, 2023, EPA released their 2023 Spring Regulatory Agenda that included EPA’s plans to publish a proposed rule covering hospitals with EtO sterilizers in February 2024 and a final rule in June 2025.

States and EPA are considering regulating offsite (i.e., non-co-located) warehouses.

In 2021, EPA collected information on offsite (i.e., non-co-located) warehouses with commercial medical sterilizers as part of their EtO NESHAP Rule. In EPA’s proposed rule, EPA is only proposing to regulate onsite warehouses and states that they do not intend to regulate offsite warehouses as part of this rulemaking. However, EPA states that they plan “to reevaluate the data received and determine what requirements these facilities should be subject to, if any.”

In addition, multiple commenters encouraged EPA not to wait for another rulemaking and include offsite warehouses in the final rule.

States are not waiting for an EPA rule and have begun taking actions that could impact offsite warehouses, including California’s South Coast Air Quality Management District (SCAQMD). SCAQMD has proposed monitoring (including fenceline monitoring) and reporting requirements for certain offsite warehouses that receive EtO-sterilized products.

Georgia’s Environmental Protection Division (EPD) issued a notice of violation to a company for not having an air permit for an offsite warehouse and subsequently required weekly indoor and outdoor fenceline air monitoring as well as requiring control devices to be installed.

Conclusion

EPA is working to finalize their EtO NESHAP Rule and EtO FIFRA Action by March 1, 2024, and is committed to develop new regulations for hospitals. EPA’s final EtO actions will serve as the baseline for all future federal and state regulatory and enforcement actions for commercial sterilizers, hospitals and medical facilities.

At the same time, states continue regulating EtO and expanding the scope of regulated industries. With continued external pressure on EPA and state environmental regulators, offsite warehouses that accept EtO-sterilized product should prepare for the possibility that they will be regulated.