Following a study of 100 commercial sterilizer facilities, the U.S. Environmental Protection Agency announced on August 3 it would takes steps to inform communities throughout the country about the risks posed by ethylene oxide (EtO) emissions from 23 of specific sterilizer facilities.
The agency further announced that, using data from the same study as well as ongoing critical EtO research, EPA will propose new regulations intended to protect public health from EtO emissions and protect workers at the facilities themselves, by the end of 2022 — just as predicted by ELM (https://environmentallawmonitor.com/emerging-issues/ethylene-oxide-back-in-the-spotlight-with-150-new-lawsuits/).
EtO is a long-used and well-established sterilizing agent highly efficient at preventing bacteria from growing on, or within, products during manufacturing. It is used to sterilize more than two billion products per year, such as medical devices and hospital supplies. However, although results of the EPA’s EtO analysis support the finding that infrequent or short-term exposure to EtO is not necessarily a concern, they do support the conclusion that communities exposed to EtO long term are significantly more likely to suffer health conditions, including various cancers. The 23 commercial sterilizers on which the study focused — located primarily in the American South, Midwest, and Puerto Rico — presented elevated cancer risks in neighboring “fence-line communities” at, or above, 100 in one million.
The EPA indicated it would take a phased outreach approach to engage communities near these commercial EtO facilities, and inform them about the most recent scientific findings for the purposes of ensuring community members to “have up-to-date information about emissions and health risks from EtO,” and so individuals in these communities “can make informed decisions.” (See EPA’s August 3, 2022 EtO announcement here: https://www.epa.gov/newsreleases/epa-launches-community-engagement-efforts-new-ethylene-oxide-risk-information.)
Just last week, the agency kicked off its informational campaign by hosting an interactive EtO webinar for a national audience. It will continue with targeted outreach in the communities themselves, beginning with those highest at risk.
As for the facilities, the EPA explained it would work with these commercial sterilizers to reduce EtO emissions “in a comprehensive way that ensures facilities can operate safely in communities while also providing sterilized medical supplies.” For its part, the U.S. Food and Drug Administration, which is responsible for overseeing sterilization methods of medical devices and related products, made its own August 3 EtO announcement (found here: https://www.fda.gov/news-events/press-announcements/fda-continues-efforts-support-innovation-medical-device-sterilization), emphasizing its prioritization of the reduction of EtO use, coupled with other actions and initiatives to support medical-device sterilization innovations.
The FDA statement assured Americans that the FDA has been pursuing and will continue to pursue these goals while still proactively working with EtO facilities to help them meet the EPA’s standards concerning EtO emissions levels.
Although it is still uncertain if any alternatives to EtO are even feasible at scale — particularly given how uniquely effective its sterilizing properties are as they relate to medical products that make our lives healthier and safer — it is certain that, going forward, continued use of EtO will be balanced against its long-term effects for U.S. EtO facilities’ neighbors.