Earlier this month, I provided testimony to the Environmental Protection Agency (EPA) at a public hearing on the proposed rule on sterilization facilities that emit ethylene oxide (EtO), a cancer-causing gas. These facilities use EtO to sterilize medical equipment, as well as some dried spices and herbs. About half of all sterile medical equipment in the US is sterilized with EtO. EtO is also used to manufacture other chemicals that are used to make products like antifreeze and plastics.
This proposal, which is nearly a decade overdue, updates emissions standards and requirements for “commercial sterilization” facilities. These new standards rely on the findings of a 2016 risk assessment by EPA’s Integrated Risk Information System (IRIS) program, which determined that long-term exposure to EtO can increase your risk of developing cancer. In fact, the 2016 IRIS risk assessment found that EtO was up to 60 times more toxic than previously understood.
These long-delayed regulations will reduce public health harms that communities near these facilities have been exposed to for decades. Many commercial sterilization facilities are in or near residential areas, and in many cases, people do not know that this colorless, cancer-causing gas is being emitted in their community.
Stronger standards are also a matter of environmental justice. In a report published by UCS earlier this year, we found that commercial sterilization facilities are disproportionately located near people of color, people with low income, and people who do not speak English as a first language (particularly Spanish speaking communities). You can see where these facilities are located and learn more about the impacted communities here.
The rule could go further to protect public health
The proposal will cover at least 86 commercial sterilization facilities across the United States and Puerto Rico. While the rule, if implemented, will reduce ethylene oxide emissions from sterilization facilities (by up to 80 percent, based on EPA’s estimate), there are also major gaps. The proposal does not consider cumulative impacts, does not require facilities to install fenceline monitors—which people from impacted communities have asked for—and the rule does not require off-site warehouses, where newly sterilized equipment is stored and continues to off-gas EtO, to control or monitor emissions.
Communities have been left in the dark about this invisible threat for too long and EPA must swiftly act to adopt the strongest regulations possible to protect public health. While EtO undoubtedly ensures that medical devices are safe, we must ask ourselves: can we sacrifice the health and wellbeing of some for the sake of others? In addition to advocating for the strongest controls practicable, we must also work toward phasing out the use of this cancer-causing gas as much as safely possible.
Make your voice heard
At EPA’s public hearing on this proposal, I testified alongside environmental justice advocates, health care workers, public health practitioners, and affected community members who shared their expertise, and for many, their experiences living and working near these facilities. My colleague, Lisa, also testified, not just as a member of UCS staff, but also as someone who lives near two high risk commercial sterilization facilities in Maryland.
In addition to the hearing, EPA is accepting written comments on the rule through June 27. For tips on writing a public comment of your own, see our comment guide on this rule.
Here’s my full testimony:
Hello, my name is Darya Minovi and I’m a senior analyst at the Union of Concerned Scientists. Thank you for the opportunity to testify today.
This rule update is overdue. An analysis that UCS published earlier this year found that nearly 14 million people in the US and Puerto Rico live within five miles of a commercial sterilizer. There are also more than 10,000 schools and childcare centers in this area. While not everyone who lives within five miles may be exposed to hazardous levels of EtO, our analysis sought to understand the communities that may be impacted. We found that in 12 metro areas across the US, there are [quote] sterilizer hotspots, with two or more sterilizers less than 10 miles apart. We also found that the air toxics cancer risk in the census tracts with sterilizers is three times greater than the U.S. average.
Our analysis also found that there was a higher proportion of people of color, people with low-income, and people who speak English as a second language in the communities within five miles of sterilizers when compared to the U.S. average. Latine communities are particularly impacted. There are five sterilizers in U.S.-Mexico border communities and seven in Puerto Rico. As EPA knows, four of these seven had EtO concentrations that exceeded EPA’s acceptable risk threshold. This is unacceptable.
Furthermore, we observed a significant local level disparity. Nearly sixty percent of commercial sterilizers are in communities with a higher proportion of people of color compared to county averages. The air toxics cancer risks were also greater in census tracts with a higher proportion of people of color. In sum, people of color appear to be disproportionately at risk of exposure to EtO emissions, face elevated cancer risks from air toxics, and are in communities that are more likely to have multiple sterilizers.
With this in mind, we are here to echo our support for the asks made by the people who live, work, and play in these communities, many of whom did not know until recently, or still don’t know, that a facility emitting a cancer-causing gas is in their community.
We are encouraged by the proposals to expand coverage to on-site warehouses and other previously excluded processes, as well as consideration of room air emissions. We also support EPA’s decision to continue relying on the best available science and using the 2016 IRIS risk assessment to set emissions standards. However, we strongly urge EPA to first require fenceline monitoring at all sterilizers. As stated in the proposal, many communities have requested fenceline monitoring, and evidence suggests these data can help protect communities. For example, the South Coast Air Quality Management District in California recently required a Sterigenics facility to cease operations because fenceline monitoring levels exceeded the state’s action level. And this is at a facility that has installed permanent total enclosure. Fenceline monitoring saves lives.
Furthermore, the rule should cover off-site warehouses. Many companies transport sterilized medical equipment to warehouses that are not subject to Clean Air Act regulations. In effect, these warehouses act as secondary aeration chambers where the sterilized equipment continues to off-gas. Commercial sterilizers should be required to report where these off-site warehouses are located and how much equipment is stored in them. There should also be required monitoring to protect workers at these facilities and the community.
Finally, we urge EPA to maintain an expedited timeline of at most 18 months for implementation of the rule, to explicitly consider cumulative impacts of EtO and other air toxics in enforcement of this rule, and to ensure that information regarding this rule and the risks to communities is communicated in appropriate languages, especially Spanish.
While I absolutely recognize the importance of medical supply sterilization, I ask that you consider the cruel irony of harming a community’s health for the health of others. In this conversation regarding stronger emissions standards, we must also consider phasing out the use of EtO where it is safe to do so. Safer alternatives exist. It is not necessary to sterilize spices with EtO, and many medical devices can be safely sterilized with substances like hydrogen peroxide. Thank you for your consideration.