Just a few months ago (in the Jan/Feb issue of MPO), my Editor’s Letter focused on what was happening with ethylene oxide (EtO) and developing new solutions to address the industry’s need for terminal sterilization. As most are aware, EtO appeared on the U.S. EPA’s radar several years ago when the output from sterilization facilities was coming into question for possibly being harmful to the surrounding community.

This has resulted in trepidation around the future of the chemical and its use as a terminal sterilization solution for approximately 50% of all medical devices. As was further outlined in that Letter, the industry has responded by exploring and introducing alternatives. 

Recently, the agency announced its final amendments to the air toxics standards for ethylene oxide commercial sterilization facilities. Essentially, EPA will require commercial sterilizers to reduce emissions by more than 90%. While flexibility to give companies time to come into compliance with the rule is baked in, the transition to comply must begin soon.

Also, this announcement only involved the environment outside the facility; regulations concerning workers within an EtO commercial sterilization location have not yet been determined. For many, this makes the current information incomplete and the industry anxiously awaits the additional guidance.

When asked for a comment about the latest EPA announcement, Mark Leahey, president and CEO of MDMA stated, “As MDMA is reviewing the NESHAP [National Emission Standards for Hazardous Air Pollutants] final rule that was issued, we remain committed to working closely with the EPA, FDA, and all federal agencies to help ensure that patient access to safe and effective medical technologies is not adversely impacted.”

Meanwhile, Sterigenics, a commercial sterilizer directly affected by the controversy involving the EPA investigation, issued its own statement on the NESHAP announcement. A part of that statement reads, “Sterigenics remains fully committed to our mission of Safeguarding Global Health. We continue to disagree with the EPA’s assessment of the carcinogenicity of low-level emissions of ethylene oxide (EtO) and we anticipate the updated NESHAP requirements will be very challenging for the sterilization industry to meet. However, upon our initial review of the new regulations, we believe that Sterigenics’ significant investments across our EtO facilities in permanent total enclosure (PTE) technology that meets EPA Method 204 and other state-of-the-art facility enhancements have positioned Sterigenics to be able to comply with the updated requirements within the timeframes specified by the final rule.”

That’s great news for the industry as commercial sterilizers are critical partners to get necessary healthcare products to market. But I was more curious about the portion involving the company’s disagreement with the agency, as they aren’t the only one who does. The American Council on Science and Health shares a view that comes in conflict with the agency’s decision.

In an article titled “Ethylene Oxide Final Rule: Less Than Produced in the Human Body,” Susan Goldhaber, MPH, an environmental toxicologist with over 40 years’ experience working at federal and state agencies as well as in the private sector, stated, “the EPA is moving farther and farther away from producing science-driven outcomes.” She goes on to say, “The EPA used 0.0001 parts per billion (ppb) in the air, corresponding to a one-in-a-million lifetime cancer risk, as the acceptable level of ethylene oxide emissions in calculating the emission levels for each [commercial sterilization] facility. This level is less than the amount of ethylene oxide produced in the human body.” Goldhaber points to the agency’s willingness to ignore best scientific practices in favor of advancing the “cancer moonshot” and environmental justice agendas.

The majority of the article then explains more specifically what is wrong with the science being used for the decision recently announced. It has to do with the assessment of the chemical in the air and the model used. Honestly, it’s much too complex for me to present coherently here, so I encourage you to read the article yourself (https://tinyurl.com/4cwspx65) and determine if you think the EPA is misguided on this decision or if they are doing what’s best for the communities around these facilities.

In the meantime, the final rule is still weeks away from being published in the Federal Register. Around that time, EPA has indicated it is preparing a Small Entity Compliance Guide to help small entities comply with the rule. The agency expects this to be available around the time of the publication of the final rule or as soon as possible thereafter.

Be sure to speak with your commercial sterilizer if you use EtO and find out what their plan is to meet the requirements outlined in the EPA’s rule. 

Sean Fenske, Editor-in-Chief
sfenske@rodmanmedia.com