This report documents the proceedings of a Homeland Security Operational Analysis Center workshop in which key experts considered a genetic database of "sequences of interest." This effort is intended to further the understanding of the potential user base for such a database and the needs of these stakeholders, as well as potential risks related to safety, security, proprietary rights, and privacy to improve biotechnology research efforts.
Assessing the Need for and Uses of Sequences of Interest Databases
A Report on the Proceedings of a Two-Day Workshop
- What are the primary use cases for an SOI database (or databases), and who are the users?
- Is there utility in a database (or databases) of SOIs for the purpose of screening orders?
- What are the scientific, technical, safety and security, funding/continuity, user/sharing, and maintenance requirements for such databases?
- What are the risks and safety implications surrounding the existence of such a database (or databases)?
- What are the potential funding models for such a database (or databases) that ensure access and continuity?
Over the past decade, the biotechnology economy has experienced remarkable growth, resulting in the rapid expansion of biological knowledge and application. Such advances have lowered the technical and financial barrier to entry for bioexperimentation outside the traditional environments of academia and industry. Together these developments provide exciting new opportunities for scientific growth. However, they create openings for actors with malicious intent to harness readily available tools and techniques to create biological threats or bioweapons. In this report, we present the results of a workshop designed to convene key experts from diverse stakeholder groups to understand how a genetic database of "sequences of interest" (SOIs) can best support stakeholders — government agencies, academic researchers, and commercial groups — to improve the utility, safety, and security of biotechnology research endeavors. The sessions consisted of a mix of presentations, panel discussions, and small and large group discussions. This report should be viewed as an exploratory first step in discussing a very complex topic with broad and often conflicting stakeholder interests.
- There is a need for broad stakeholder engagement, collaboration, and transparency across government agencies, as well as among the various nongovernment actors in industry and in the research community.
- There is no consensus on the attributes or boundary conditions that form an operational or implementable definition of an SOI.
- There is a need for and value in several distinct use cases of SOI databases.
- Gene synthesis companies would like a federally sanctioned database for screening orders; in contrast, representatives from federal agencies are hesitant to provide regulation beyond the select agent list and the voluntary Department of Health and Human Services screening framework guidance.
- Several databases exist for the purposes of screening synthetic biology orders; some combination of their design and capabilities may be optimal as a next step for research and development purposes.
- There is a need to balance access to a database with the associated security risks.
Table of Contents
Key Findings and Recommendations
Agenda and Speakers