Weekly Policy Blog: EPA Releases Final Rule for EtO Sterilization Facilities 

On March 14, the Environmental Protection Agency (EPA) released its update to the National Emission Standards for Hazardous Air Pollutants (NESHAP) final rule for ethylene oxide (EtO) commercial sterilization facilities. EtO is used to sterilize approximately 20 billion, or 50%, of all medical devices in the U.S. each year. According to the EPA’s fact sheet, the “rule will reduce EtO emissions by over 90 percent, reducing cancer risk in dozens of communities nationwide,” and “will enable cost-effective compliance, mitigating and managing any potential risks to the supply chain.” Commercial sterilizers of medical devices will now have at least two years to meet the new emissions limits. 

Amendments to the NESHAP: The EPA is finalizing the following amendments to the NESHAP: 

  • Establish standards for currently unregulated emissions, such as building leaks (“room air emissions”) and chamber exhaust vents, to reduce risk and account for technological developments.  
  • Strengthen standards that are on the books for sources such as sterilization chamber vents and aeration room vents.  
  • Strengthen compliance by requiring the use of continuous emissions monitoring systems, which will provide much-needed assurance to nearby communities.  
  • Include definitions for affected sources. 
  • Ensure that sterilizers are subject to emission standards during periods of startup, shutdown, and malfunction.  
  • Other clarifying items, including electronic reporting and technical revisions. 

Colorado Impact: The final rule will address emissions at nearly 90 commercial sterilization facilities that are owned and operated by approximately 50 companies. Terumo Blood and Cell Technologies’ Lakewood facility is one of those. According to Terumo, “Terumo BCT meets or exceeds every standard for EtO use. Our advanced emissions control system captures over 99% of the EtO used in our Lakewood sterilization operations. A new, state-of-the-art, $22-million emissions control system project is underway that will even further reduce our already very low emissions.” 

As discussed in a recent Denver Post article:  

“When the EPA announced its review of ethylene oxide emissions in 2022, the agency said Terumo’s plant was not in violation of any current regulatory standards.  

…it was unclear Thursday whether [Terumo’s new emissions control] system would meet the EPA’s new emissions standards once it comes online. 

Officials were reading the new 400-page rule to figure out how it will impact the company, said Christine Romero, a Terumo spokeswoman.” 

AdvaMed’s Response: AdvaMed President and CEO Scott Whitaker released the following statement: 

“We appreciate EPA releasing this update to the rule on medical device sterilization.  We have made clear that we value much needed updates to the rule.  We have always approached the government agencies with relevant oversight as partners and not as adversaries because this rule has a far-reaching impact on patients and public health.   

“There are three broad areas we have emphasized throughout the rulemaking: adequate time to implement, flexibility in technologies to remove emissions, and the ability to achieve EPA targets that would not force resubmission of medical devices for FDA approval.  

We will be reviewing the rule through that lens and remain hopeful that these changes will not have a negative impact on the healthcare system or the patients we serve.”  

CBSA Engagement: Colorado BioScience Association has actively engaged throughout the EPA’s efforts to address EtO exposure. CBSA submitted a comment letter to the NESHAP and Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) dockets during the open comment period for the proposed changes that closed on June 27, 2023. We advocated for a longer comment period as well as alternative solutions to meet the EPA’S new emissions standard goals while allowing facilities to continue their sterilization operations and ensure uninterrupted access for patients to critical, life-saving medical technologies and supplies. CBSA and national partners are continuing to follow this activity very closely and working with the life sciences ecosystem to make sure the information being shared about the safety of EtO is accurate. CBSA will continue advocating for the life sciences ecosystem and patients.  

Categories: CBSA News