Will the EPA Strengthen Ethylene Oxide Standards Without Outside Interference?

February 21, 2024 | 10:21 am
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Darya Minovi
Senior Analyst

One year ago, UCS published a report on ethylene oxide (EtO), a colorless toxic gas that is emitted by chemical manufacturing and medical device sterilization facilities. We found that medical device sterilization facilities, known as “commercial sterilizers,” are scattered throughout residential communities nationwide, within five miles of nearly 13 million people in the United States and Puerto Rico. There are also more than 10,000 schools and childcare centers in these areas. (Check out our interactive map to see if there’s a commercial sterilizer in your community.) Breathing ethylene oxide in the air over a long period of time is associated with an increased risk of developing cancer, especially white blood cell and breast cancers. Workers at these facilities and children who are exposed are especially at risk.

The US Environmental Protection Agency (EPA) regulates emissions of EtO, yet the agency is years behind on updating standards and control requirements, despite mounting evidence of the harm of long-term EtO exposure. A decade overdue, EPA is finalizing updated regulations for commercial sterilizers now. You can find our joint comments on EPA’s proposed new rule here.

Industry seeks to weaken the proposed rules

We support EPA’s efforts to require sterilizers to better control their emissions, but the medical device and sterilization industries have sought to weaken the proposed standards, claiming that they disrupt the medical supply chain. To be clear: EPA is not proposing that these facilities cease operations or suddenly banning the use of EtO. And these regulations are not a surprise to the industry. Occupational studies dating as far back as the 1970s have linked EtO exposure to cancer. Furthermore, in 2016, EPA’s Integrated Risk Information System (IRIS)—which conducts critical chemical risk assessments through a robust years’ long, peer-reviewed process—determined that ethylene oxide exposure via inhalation is carcinogenic, or cancer-causing; in 2021, EPA’s Office of the Inspector General called on the agency to update risk reviews for ethylene oxide-emitting facilities.

This is also not the first time the sterilization industry has attempted to weaken these regulations. In 2005, the last time EPA updated emissions standards for commercial sterilizers, the agency contemplated banning the use of EtO for sterilization at new facilities, but that proposal was promptly scrapped due to concerns around viable sterilization alternatives. Almost 20 years later, the sterilization industry continues to rely on the same argument to shirk accountability for emissions of this toxic gas.

Food and Drug Administration can help reduce EtO at the source

While EPA is responsible for limiting emissions of EtO from these facilities, the US Food and Drug Administration (FDA) could help limit its use in the first place. Last month, we sent a letter, signed by more than 500 public health experts and scientists, to the US Department of Health and Human Services (HHS) and FDA calling on the agencies to support EPA’s efforts to strengthen these standards. The FDA, which is part of HHS, regulates approved methods for medical device sterilization and initiated a process to identify alternative sterilization methods in 2019. Yet, over the last five years, the agency has offered few updates on this process. While the agency did recently approve the use of hydrogen peroxide as a sterilization alternative—which is less toxic to worker and public health and not a carcinogen— these guidelines are not required.

It is critical that these agencies work together to protect public health from EtO exposure. As stated in our letter:

While the EPA is responsible for limiting pollution emissions from facilities that use toxic substances, FDA has the authority to require the use of safer alternatives that ensure there are no toxic emissions to begin with. The FDA’s obligation to ensure that medical devices are safe to use cannot only extend to the patients who benefit from the direct use of those devices but must also include the safety of those throughout the supply chain, including health care and sterilization facility workers, and people who live, work, and play near these facilities.

Public health at stake

The stakes of inaction, or inadequate action, cannot be overstated. It’s been nearly eight years since EPA published its IRIS risk assessment that determined that EtO was up to 60 times more toxic than previously understood. Until recently, many people had no idea that these facilities have been operating in their neighborhoods for decades. And our research shows that these effects are not equitably distributed. Our analysis found that these facilities are disproportionately located near people of color, people with low income, and people that do not speak English as a first language compared to US averages. As with too many other air pollutants, people of color face a disproportionate impact from sterilizers that pose greater cancer risks, co-located facilities, and those violating the Clean Air Act.

With the final rule expected in the next few weeks, it is critical that EPA and FDA continue to hear from you on why commercial sterilizers need to control their emissions and make the transition to sterilization alternatives while still maintaining a safe medical supply chain. The public comment period is closed, but you can still send any questions or concerns to [email protected].