EPA's New Ethylene Oxide Regulations Aim to Cut Cancer Risks for Workers and Communities

In a significant move to enhance public health and worker safety, the U.S. Environmental Protection Agency (EPA) has unveiled the Interim Decision for Ethylene Oxide (EtO), a chemical widely used in the sterilization of medical devices and the treatment of certain dried herbs and spices. This decision, announced on January 14, 2024, aims to mitigate the cancer risks associated with this potent pesticide, which has been linked to various forms of cancer, including breast cancer and non-Hodgkin lymphoma. EtO is a critical component in the medical supply chain, sterilizing around 50% of all medical devices in the United States. However, its carcinogenic properties have raised alarms, particularly for workers in sterilization facilities and individuals living near these operations. The EPA's interim measures are designed to protect both groups from harmful emissions that have the potential to increase cancer risk over prolonged exposure. The Interim Decision introduces a series of stringent regulations and protective measures to reduce EtO exposure. Notably, it sets a trajectory for decreasing the acceptable concentration of EtO for workers, gradually lowering the threshold from the current Occupational Safety and Health Administration (OSHA) standard of 1 part per million (ppm) to 0.1 ppm over the next decade. This progressive reduction underscores the commitment to ensuring a safer working environment for those who handle this chemical regularly. Furthermore, the EPA will phase out the use of EtO on specific dried herbs and spices, while also requiring manufacturers to pursue and implement safer alternatives wherever feasible. The agency's plan includes a robust review process that will evaluate the effectiveness of these measures, with a reevaluation of the Interim Decision scheduled for eight years, rather than the standard 15-year interval. This expedited review is designed to continually assess and enhance safety protocols based on real-world exposure data. Assistant Administrator Michal Freedhoff emphasized the importance of this decision, stating that the new protections will not only reduce exposure to this dangerous chemical but also ensure that the essential uses of EtO in medical sterilization remain intact. The EPA’s actions align with President Biden’s Cancer Moonshot initiative, which seeks to combat cancer through enhanced regulations and preventative measures, particularly in communities disproportionately affected by toxic substances. The announcement follows a comprehensive public comment period, during which the EPA engaged with over 60 stakeholders, including industry representatives, labor unions, and nonprofit organizations. This collaborative approach ensured that the interim measures reflected a wide array of perspectives and addressed the pressing concerns regarding EtO exposure. As the agency implements these changes, it will also conduct a Data Call-In to gather essential information on worker exposure levels at commercial sterilization facilities. This data will be invaluable in understanding the impacts of the new regulations and will aid in shaping future policies aimed at safeguarding public health. In summary, the EPA's Interim Decision regarding Ethylene Oxide represents a crucial step forward in protecting workers and surrounding communities from the health risks associated with this hazardous chemical. With its comprehensive approach to regulation and commitment to ongoing evaluation, the agency aims to strike a balance between the need for medical sterilization and the imperative of public health safety.