Ethylene oxide (EtO) is one of the most widely used sterilization methodologies in the biopharmaceutical industry. However, the US Environment Protection Agency (EPA) has issued proposals for a five-year timeline for cycle redesign and compliance to reduce EtO used in existing products to ≤500mg/L and two years for new products to market.
The biopharmaceutical industry understands the rationale for the proposed changes but thinks the implementation timelines are too short to plan a safe, appropriate, and economically viable transition.
We sent a delegation from our EtO Response Team to meet with the EPA in October 2023 to share industry’s position and help educate the Agency on why the current proposals would severely impact the supply chain and patient access to critical biotherapeutics and vaccines.
This is a download of the presentation and the event report.
The team asked for a comprehensive impact assessment on how these changes impact the industry and maximum transition periods to allow component suppliers and biomanufacturers time to adapt their operations to meet the revised standards.
Our follow-up actions included:
- liaising with the Office of Pesticides Programs to ensure the proposed timelines minimize the risk to the supply chain and patient access to medicines
- offering to work with regulatory bodies to develop clear guidance and processes that leverage alternative modalities or bring more sustainable use of EtO to market
- offering the EPA and FDA our subject matter expertise to help in any way possible.
In June 2023, the EtO Response Team submitted its comments on the proposed changes to the EPA; these can be read here.