EtO Response Team
The EtO (Ethylene oxide) Response Team are working together to collaborate with governing bodies such as the US EPA and FDA after providing comment to the proposed rule changes for EtO emissions reduction. This team is comprised of biomanufacturers, suppliers and sterilization companies, together they are highlighting the serious impact of these changes on the biomanufacturing industry and are hoping to support the governing bodies in providing best practices and guidelines on how to navigate through these changes
The biopharmaceutical manufacturing industry has not been considered in the drafting of these proposed new regulations.
The agency has a limited understanding of the impact on our industry as a regulated industry or the implications that the proposed changes will have on the availability of biotherapeutics for patients – we needed to develop a one-voice-of-the-industry approach to help explain to the agencies because this was deemed (by them) to be more impactful than individual company submissions to the public consultation process
Work together towards an adequate and realistic transition timeline for the biomanufacturing community
The EtO response team submitted a response to the EPA and made an in-person delegation to present to the agency – this was positively received and our voice was heard. The next step is to meet with the FDA and understand how we can support the CBER, CDER, CDHR committees with rolling out these changes to our industry in a way that is risk adverse and realistic.
EtO Response Team deliverables
More related workstreams
Our workstreams focus on the areas with the greatest impact across the industry. Led by science, our members are problem-solving today’s sustainability issues. By working with the regulatory governance community, they are also creating future-ready outcomes for the industry.
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