US EPA Proposals To Cut Ethylene Oxide (EtO) Emissions

March 12, 2024

US Regulations


The US Environmental Protection Agency (EPA) is proposing to introduce stringent emission standards for ethylene oxide (EtO). EtO sterilisation is a critical process used to ensure drug product safety and efficacy. The pharmaceutical industry has not been considered by the EPA and disruptions to the current sterilisation process proposed in this rule change have the potential to impact the availability of these vital medications to patients, even beyond the jurisdiction of the USA.

The EPA proposal is to cut emissions of EtO from sterilisation facilities by 80 percent per year. Implementation of these rules will begin 18 months after the rule becomes effective, giving the serialisation facilities only 18 months to make the appropriate changes.

A team of 25 experts from the global industry organisation Bioforum has published a report that lists the concerns about the proposed EPA EtO emissions changes, which are:

  1. The proposed rule changes need to consider the impact of EtO cycle optimisation; stricter regulations may require adjustments in cycle parameters, potentially affecting the overall sterilization efficiency and product quality.
  2. Any disruption or delay in the current sterilisation processes may put biotherapeutic availability and patient safety at risk due to shortages or delays in the delivery of life-saving medications to patients in need. Ensuring the industry continues to have a stable and uninterrupted supply of biotherapeutics to market is essential to safeguard patient health and safety.
  3. Lack of capacity in alternative methodologies; EtO sterilization is considered extremely effective in the biopharmaceutical industry due to its compatibility with various materials and is therefore widely adopted. Transitioning to alternative sterilization methods is not always possible and it is important to consider the practical feasibility and capacity limitations of these alternatives before implementing stricter regulations.

The report ends by looking forward to collaboration between the Bioform EtO team and the EPA to achieve the desired environmental impact reduction of EtO emissions whilst taking into consideration the needs of the biopharmaceutical industry.