After a COVID-related dip, ethylene oxide (EtO) cannot seem to stay out of the news these days. Every week there is some EtO-related legal or technological development in the United States. And now the public is being encouraged to shape the oversight of EtO use and manufacture.
Following a long pause in years-long and intense regulatory focus — a direct result of the pandemic, an emergency requiring exponential use of EtO, a highly efficient sterilizing chemical used on billions of medical devices and hospital supplies – the EPA by 2022 had gotten back on track to increasing federal oversight of EtO manufacturing and use.
Beginning in 2021, the EPA resumed its ongoing EtO public outreach campaign and informational sessions for fenceline communities neighboring high-exposure commercial EtO plants throughout the United States. And in mid-April of this year, it then released in a grand culmination of EtO developments, the proposed EtO rules, following years of research and drafting, spurred by the 2016 EPA finding that EtO was more toxic than previously understood and could lead to cancers when breathed in for extended periods.
Accompanying the EPA’s April announcement of the releases of long awaited air toxics rules concerning EtO (covered by ELM here), were scheduled deadlines for the finalization and implementation of those more stringent rules and standards. Despite years of preparation leading up to the April 2023 EtO rules release, the EPA has ever so slightly pumped the brakes no fewer than two times.
- On May 25, 2023, at the request of multiple local, state, and industry groups, the EPA announced a 15-day extension for the American public to submit comments about the EPA’s proposed EtO rules, making the new deadline for submission June 27, 2023; and
- On June 21, 2023, the EPA announced a similar comment-period extension for the proposed standards for Synthetic Organic Chemical Plants (“the HON”) and for Groups I & II Polymers & Resins Plants, making that new deadline for comment submission July 7, 2023.
This additional time will perhaps better enable the American public to equip itself with the information needed to more meaningfully participate during the public comment period concerning the proposed EtO rules. Therefore, it is convenient that the EPA also recently released a recording of its May 1, 2023, informational webinar on the EPA’s proposed actions to reduce risk at commercial sterilization & healthcare facilities.
During the EPA’s aforementioned EtO public outreach and informational campaign, in August 2022, the U.S. Food and Drug Administration (FDA) promised it would take actions and initiatives to support medical device sterilization innovations. It seems like we might be seeing some results of the FDA’s promised EtO innovation support nearly a year later, this summer.
Just last week an industrial air-purifying product developer revealed that it had recently demonstrated the destruction and removal of EtO to levels reaching lower than 10 parts per billion (“ppb”) in typical ambient conditions associated with commercial sterilizer plants. The developer has reported 99-percent EtO destruction & removal efficiency, even when combined with high levels of CO2 and methane. By providing support, including by providing a grant to this company in support of its development of products that would get fugitive EtO emissions to those sub-ten ppb levels in various conditions, including a wide humidity range, the FDA is arguably making good on its promise last year to support EtO innovation.
Could it be that when sterilizer businesses, a government agency, and now the American public are all participants in governance over the course of years, real progress can be made in the EtO realm? Only (a bit more…) time can tell.