EPA’s Final EtO Rule Has Landed: What Now?

At a Glance

• EPA’s final EtO NESHAP for Commercial Sterilization Facilities (CSF) has been released with significant changes from the proposal.
• CSFs will now have 2.5 to 3.5 years to comply with EPA’s requirements instead of 18 months.
• Emission control standards are based on how much EtO a facility uses with the ability to use alternative compliance options.
• Title V permitting is not required for area/minor sources, although there are increased monitoring, reporting and recordkeeping requirements for such sources.
• Companies will need to quickly begin (or continue) to determine their compliance options for this regulation and to determine how to acquire and install the new abatement equipment.
• While not included in the final rule, EPA has signaled interest in offsite warehouses — and further rulemaking may be forthcoming.

The U.S. Environmental Protection Agency (EPA) recently released their long-awaited final rule regulating ethylene oxide (EtO) emissions from commercial sterilizers. The final rule comes after five years of development, over 1,000 comments, and with estimated compliance costs for industry of up to $900 million.

The final rule differs significantly from EPA’s initial proposed rule. See initial proposal back in April 2023. The changes result in a still restrictive and costly rule, but with more time and options for compliance. These changes come after significant interagency discussions, including discussions with the U.S. Food and Drug Administration (FDA) about the impact of these rules on the medical devices, about half of which are currently sterilized by EtO. According to EPA, there will be no need for companies to revalidate their medical devices due to this final rule. It seems likely, however, that a facility’s ability to comply with the new regulation ultimately may affect sterility validation, so revalidation concerns should not be completely discounted just yet. 

Some of the key provisions of the final rule are summarized below.

Timeline for Compliance

EPA proposed in April 2023 that companies would be provided 18 months to come into compliance with the final rule once issued. Due to concerns with the available technology, EPA has extended compliance deadlines to the greatest extent possible. Thus, depending on the specific regulatory requirement, companies will have 2.5 to 3.5 years to comply with EPA’s regulations.

Additionally, EPA notes that EPA or a state that administers the NESHAP program can extend a particular compliance deadline up to one year. Finally, and not insignificantly, EPA notes in a historic preamble that the president of the United States also has the authority to extend compliance deadlines for an additional two years if certain requirements are met. 

Emission Control Standards

Emissions from EtO commercial sterilizers essentially come from stacks (or vents) and fugitives (not from a stack). Initially, EPA had proposed emission control standards using both destruction or removal efficiency (DRE) and mass limits (how much EtO is used). In the final rule, EPA has removed any mass limits due to concerns that it could reduce sterilization efficacy and result in requiring revalidation of medical devices.

That is not to say, however, that EPA is no longer concerned with the volume of EtO a given facility uses. Under this final rule, the more EtO used at the facility, the stricter the regulatory requirements on that facility. For example, if a facility uses more than 40 tons per year (tpy) of EtO, the facility will be required to remove 98% of certain fugitive emissions; however, if the facility uses less than 40 tpy of EtO, they would only be required to reduce emissions by 80%. 

Alternative Compliance Options

The final rule defines alternative pathways for compliance with this new regulation based on whether a facility combines their emissions streams before entering a control system or implements a site-wide emissions limitation (SWEL). Each pathway then carries options for how to calculate the applicable emissions reduction standard. Generally speaking, the facility is going to need to identify how it controls emissions and apply the most stringent emissions reductions standard to its process.  

Title V Permitting

The final rule does not require Title V permitting for minor sources, to the relief of many of the proposed rules detractors. EPA initially proposed to require that area/minor sources go through the same Title V permitting process that is required for major sources, which would have added significant administrative burden to facilities. The final rule does not require Title V permitting, but it does include robust monitoring, reporting and recordkeeping requirements for all sources, minor and major. EPA considered these requirements as justification for not extending Title V permitting to minor sources. Good news for minor sources, but the monitoring, reporting and recordkeeping requirements for minor sources under this final rule are no small thing. For example, a minor source that uses more than 100 pounds of EtO per year will be required to have continuous emission monitoring systems and report quarterly to EPA.

Fenceline Monitoring and Offsite Warehouses

The question of whether and how EPA would address fenceline monitoring and offsite warehouses has been a hot topic over the course of the last year, with some states implementing their own regulations and many commentors raising this issue for discussion. To be clear, EPA did not include fenceline monitoring or regulation of offsite warehouses in its proposed rule, and neither of these requirements made it into the final cut. EPA declined to require fenceline monitoring both because all emissions are required to run through emission points or stacks and fenceline monitoring presents significant technical feasibility issues. 

The offsite warehouse issue appears to be more of a deferral than a determination not to regulate, however. EPA stated that offsite warehouses could not be regulated as part of this rule because they are not part of the “source category.” EPA stated that it plans to start collecting information on offsite warehouses to determine whether they should be regulated as soon as possible, including by using EPA’s information collection mechanisms. More information on this is sure to come in the near future.

What’s Next?

If affected facilities have not yet determined what their compliance obligations and options are under this rule, the time is now. Notwithstanding the existence of various compliance alternatives, there may be significant work to be done to acquire and install abatement equipment (and potentially PTE) to meet compliance deadlines for which the clock is now running. EPA has estimated that the typical timeline from permit submission to project completion is about one year, which does not account for designing and planning for the submission. With industry facing an estimated compliance cost between $700 and $900 million dollars, affected facilities need to make plans not just for compliance, but also for protecting the supply chain and financial impacts of these new regulations. Although the final rule is in some respects less demanding that the version that was initially proposed, companies should not underestimate the demands and expense that accompany these new regulations. 

Additional information and documents will become available when the CSF NESHAP rule is published in the Federal Register later this month. 

After the rule is published in the Federal Register, stakeholders will have 60 days to file a petition for review in the United States Court of Appeals for the District of Columbia. Additionally, stakeholders could file a petition for administrative reconsideration with EPA requesting that EPA reconsider the rule.

Later this month, EPA will finalize a rule covering EtO from synthetic organic chemical manufacturing (known as the HON rule).

Later this year, EPA plans to finalize the interim decision for registration of EtO as a pesticide and proposing an EtO NESHAP for hospital sterilizers.