Experts from across the biopharmaceutical industry are collaborating with BioPhorum to submit a response to the proposed changes within the National Emission Standards for Hazardous Air Pollutants: Commercial Ethylene Oxide Sterilization Technology Review, docket ID No. EPA-HQ-OAR-2019-0178. On 23 June, 2023 the Ethylene Oxide (EtO) response team submitted their comments to the EPA in response to these changes. The content of which is detailed in this document.
This group supports the Environmental Protection Agency’s (EPA) efforts to protect public health and the environment through the Residual Risk and Technology Review (RTR) process and recognizes the
need to develop stringent emissions standards to mitigate any potential hazards posed by Ethylene Oxide (EtO) emissions. However, they are also cautious of the impact these changes may have on the availability and timely delivery of biotherapeutics to patients who rely on them. Biotherapeutics, including vaccines, therapeutics, and other life-saving medications, play a crucial role in improving patient health outcomes and saving lives. For the biopharmaceutical industry, EtO sterilization is a critical process used to ensure product safety and efficacy.
Any modifications to current emissions standards must be introduced in a way which allows for an appropriate transition period. The EPA must consider the time required for biomanufacturers to adapt their operations and ensure continued compliance without compromising product quality or patient safety. Therefore, the EtO Response team raised several concerns regarding the potential impact of the proposed rule changes on the biotherapeutics market. This document discusses the concerns.