Written by Genna Reed, lead science and policy analyst in the Center for Science and Democracy at the Union of Concerned Scientists. Originally published on the Union of Concerned Scientists blog on May 6, 2020.
Union of Concerned Scientists is a member of Coming Clean and has authorized the re-posting of this blog.
As the U.S. government responds to the COVID-19 crisis, it is imperative that frontline communities and essential workers are not saddled with the cost of hastily made decisions.
On March 25, EPA announced that efforts were underway to increase sterilization capacity for medical equipment at several facilities using the known carcinogen, ethylene oxide (EtO): “While we must take into account the risks from emissions of ethylene oxide, and addressing those risks remains a major regulatory priority for the agency, it’s important to bear in mind those risks are linked to exposure over an entire lifetime—over a 70 year period—however, COVID-19 poses an immediate threat to our nation during this crisis.”
But what Administrator Wheeler conveniently failed to mention is that ethylene oxide is not typically used to sterilize masks for reuse. That’s not stopping medical sterilization company Medline from attempting it.
Soon after EPA’s announcement, Medline announced that it was applying to the US Food and Drug Administration (FDA) for an emergency use authorization (EUA) for ethylene oxide sterilization of N95 masks. This company operates the facility in Waukegan, IL, which just recently restarted operations after pressure from community advocates resulted in their installing new emissions and containment controls to reduce ethylene oxide emissions and now could potentially be ramping up operations to reprocess personal protective equipment (PPE)—up to 100,000 N95 masks a day. But despite saying that the company was close to getting FDA approval for its sterilization method, it has still not been authorized by the agency.
One of the makers of N95 masks, 3M, has warned against using ethylene oxide to sterilize its masks “because ethylene oxide is an inhalation-route carcinogen, and any potential off-gassed ethylene oxide residuals would be directly inhaled by the wearer.” CDC has recommended that “any use of ethylene oxide should be accompanied by studies to ensure no off gassing into the breathing zone of the wearer, as ethylene oxide is a carcinogen in chronic inhalation ethylene oxide has been linked to neurologic dysfunction and may cause other harmful effects to the wearer.” The Occupational Safety and Health Administration (OSHA) guidance released April 24 cautioned against ethylene oxide as an option for reprocessing masks due to worker safety concerns. And an April NIH study validated the effectiveness of different methods to reprocess N95 masks, including vaporized hydrogen peroxide, dry heat, and ultraviolet light. Ethylene oxide was not recommended.
The bottom line: Ethylene oxide should not be used to resterilize used N95 masks. If Medline is permitted to use it this way, healthcare workers could be exposed not just to a potentially deadly virus but to a potentially deadly toxin as they attempt to save lives across the country. And healthcare workers aren’t the only people facing the added burden of higher COVID-19 exposure risk and EtO risk.
During the COVID-19 pandemic, many of us privileged enough to work from home to help flatten the curve take for granted that the air we breathe is safe. That’s not the case for everyone. Many frontline communities—disproportionately Black, Latinx, and poor because of systemic racial and social injustices—live near industrial corridors where facilities are continuing to operate (with even less accountability from the government) and are painfully aware that clean air is not a guarantee. As COVID-19 tears through our country, it is magnifying long-established inequities that have led to increased vulnerabilities in marginalized populations, and as our social and economic systems impact our health, these same communities are experiencing the loss of life and property at a disproportionately higher rate.
Ethylene oxide is just one example of a hazardous air pollutant compromising the health and safety of communities in the COVID-19-era. It is a chemical used both in the manufacture of other industrial chemicals and in the sterilization of medical equipment, including some medical equipment needed by healthcare workers on the frontlines of fighting a pandemic. After finding in 2018 that many communities are exposed to EtO at levels exceeding the safety threshold, EPA is working on regulations to address the emissions problem, and FDA is encouraging innovation in the sterilization industry. But innovation should not come at the expense of the long-term health of frontline communities already living with unhealthy levels of air pollution. This administration should be doing everything it can to get healthcare and other essential workers the equipment they need, but it shouldn’t come at the cost of new methods that use a known carcinogen and haven’t been adequately safety tested.
Our community, whether knowingly or unknowingly, is being asked to sacrifice health and lives to ensure the safety of others.
I spoke to Dylan and Diana Burdette, community advocates based in Waukegan, IL. They called attention to the way in which the pandemic has made underlying inequities in the environmental justice community even more pronounced and have concerns about Medline’s new PPE sterilization endeavor. Dylan told me:
Our community, whether knowingly or unknowingly, is being asked to sacrifice health and lives to ensure the safety of others. Now, the pandemic has only strengthened that contrast. What we’re once again being asked to do is put ourselves at risk so that others can be safe. Our own physicians don’t have PPE. On top of that, as a working-class community, a lot of us don’t have access to healthcare. That hasn’t changed—it has only been exacerbated by the pandemic. On top of that, one of the most common issues with people that breathe EtO are respiratory ailments which compound and increase the fatality rates for COVID-19. [As a working class community,] a lot of people cannot shelter in place. They are essential frontline workers. They are the people that work in the gas stations, grocery stores, drive and deliver. They’re the people who are still working. They are at higher risk because of the respiratory ailments associated with pollution in our air and they’re at higher risk of dying if they do contract this virus. What this pandemic has done has cast into an even starker relief the divides in our society, whether that is along class or race lines.
When asked about how EPA and FDA should be making decisions about sterilizing PPE that our healthcare workers need, Dylan pointed out that:
There are serious questions about the science of using EtO to resterilize PPE. The FDA is still considering this. We don’t actually know if it’s going to be safe because of the off-gassing time that is required for EtO sterilization. As first responders are using this PPE that potentially will be sterilized using EtO, are they also going to be put at a higher risk of cancer? This is something that the FDA needs to answer before they move forward. And EPA needs to figure out if this is going to be worth it. Is it worth it to put the rest of the community at risk for a process that may put healthcare workers at higher risk of long-term health impacts? There are methods that seem to work much better, like vaporized hydrogen peroxide.
These safety concerns are not just felt by community members. During a CDC webinar on PPE use in March, Captain Lisa Delaney from the COVID-19 Worker Health and Safety Team spoke about the need for studies showing the safety of this method for mask wearers. Such studies must be conducted and made public before companies even consider using this method. This is echoed by recent OSHA guidance stating that “additional information is needed about worker exposure to EtO associated with use of particular decontamination systems, including while conducting decontamination operations and while wearing particular FFRs that have been decontaminated using such methods.”
I also asked about how EPA could improve the communication of risks faced by communities, as EPA’s own watchdog recommended. Diana told me,
I believe that communicating the risk of living within a toxic community is essential when individuals are initially moving into these communities and while the movement happens. We have a transient community. If we are aware of the dangers within a specific area then we have the ability to take on the risk or not. it The decision to take on added risk should be made by those moving into these areas. That decision has been taken away from us by lack of transparency.” She continued, “The pandemic harms respiratory function and the toxin is equally harming respiratory and immune function. This pandemic is specifically attacking the two aspects that a toxin within our community is also attacking. If we are going to doubly take on a risk we should be able to make that decision for ourselves.
So far, EPA and Medline have not engaged with Waukegan community members to tell them about decisions being made about reduced enforcement and ramped up sterilization during the pandemic. Diana told me,
The least Medline could do as they’re creating more susceptibility to a respiratory disease by putting respiratory toxins into our community is to help equip the medical professionals and other essential workers here with PPE to keep them protected. I know they can’t prevent the spread of COVID-19, but they can provide safety gear that will help assist this community that is currently one of the biggest hotspots in Illinois.
Enforcement discretion will adversely and disproportionately affect public health and impact communities of color.
As EPA works to develop new health-protective technology standards for EtO-emitting users and manufacturers across the country, it is dropping the ball on enforcing current emissions from manufacturers of ethylene oxide (and other industrial pollutants) due to requests from industry related to COVID-19 relief. And it’s not like they’ve been earning a gold star for enforcement over the past three years. Further, a recent EPA inspector general report revealed EPA’s failure to communicate the risks of ethylene oxide exposure to impacted communities, especially to communities of color and low-income communities in the South.
I spoke to Beto Lugo-Martinez with the grassroots organization, CleanAirNow, about concerns he has with the Harcros chemical facility which is headquartered in Kansas City, and has facilities scattered in environmental justice communities throughout the US. It is a user of ethylene oxide and has a track record of violating environmental laws. He said,
Enforcement discretion will adversely and disproportionately affect public health and impact communities of color. Exposure to respiratory irritants may increase respiratory illness amid COVID-19. It is a critical time to maintain stringent enforcement to protect community health and keep communities safe from chemical toxicants.
He is most concerned that:
The communities that are going to suffer the most from COVID-19 are the frontline communities that already have respiratory illnesses and were already suffering before the pandemic hit. They are more susceptible to getting this virus. These areas continue to be the sacrifice zones. We are sacrificing our people in the frontlines at the expense of these facilities polluting higher than EPA limits.
When asked how EPA should be engaging with communities to communicate risk and explain enforcement activities or lack thereof, Beto said,
I would like to see that they have more information available to the community. It’s important that they know what’s happening. They should hold public meetings and share with them any impacts of local emissions to public health and the environment. Communities should hear about alternatives or technology fixes that could reduce health risks associated with harmful pollutants. Another thing is the violation money is not making its way back to communities. Community and local organizations might not even be aware that EPA is collecting fines from these facilities. That money could go to community-led projects that could mitigate the impacts of environmental pollution.
Beto also pointed out that most EPA communications happens at the federal level, not locally. He suggested that the agency put out “local press releases to tell communities about violations happening in communities, to help people understand risks and connections to health. Instead of giving industries a free pass to pollute, the EPA should be doing its job which is to protect human and environmental health. We don’t see that happening.”
As the federal government works to keep us safe and the economy afloat, it cannot ignore the sacrifice of frontline communities. The government must ensure that solutions to the threats associated with the pandemic do not exacerbate long-standing problems in frontline communities and that polluter profits aren’t being prioritized over public health. Safer alternatives should be considered before needlessly exposing communities to additional cancer-causing ethylene oxide emissions. Furthermore, open communication and transparency about government operations with local communities is key for protecting people’s health and safety. The only way we’re going to get through this crisis is by doing it together and learning from past mistakes. We cannot compromise the health and safety of any community right now or in the future – stronger protections mean better health outcomes for everyone.
Beto Lugo-Martinez and his organization, Clean Air Now, can be found on social media at https://www.facebook.com/pg/cleanairnowkc/ and on twitter @BetolMartinez and @MoKanCAN, a member organization of @The_MFN.