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Strategies for Identifying and Addressing Biodefense Vulnerabilities Posed by Synthetic Biology

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Scientific advances over the past several decades have accelerated the ability to engineer existing organisms and to potentially create novel ones not found in nature. This report explores and envisions potential misuses of synthetic biology. It develops a framework to guide an assessment of the security concerns related to advances in synthetic biology, assesses the levels of concern warranted for such advances, and identifies options that could help mitigate those concerns.

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Description

To assist the U.S. Department of Defense’s Chemical and Biological Defense Program (CBDP), The National Academies of Sciences, Engineering, and Medicine will appoint an ad hoc committee to address the changing nature of the biodefense threat in the age of synthetic biology. Specifically, the focus of the study will be the manipulation of biological functions, systems, or microorganisms resulting in the production of disease-causing agents or toxins. The study will be conducted in two primary phases and will be followed by a workshop. Initially, the committee will develop a strategic framework to guide an assessment of the potential security vulnerabilities related to advances in biology and biotechnology, with a particular emphasis on synthetic biology.
The framework will focus on how to address the following three questions: What are the possible security concerns with regard to synthetic biology that are on the horizon? What are the time frames of development of these concerns? What are our options for mitigating these potential concerns? The committee will publish a brief interim, public report outlining the developed framework. This framework will not be a threat assessment, but rather, will focus on ways to identify scientific developments to enable opportunities that have the potential to mitigate threats posed by synthetic biology in the near-, mid-, and long-term, with the specific time frames defined by the committee. The framework will lay out how best to consider the trajectory of scientific advances, identify potential areas of vulnerability and provide ideas for potential mitigation opportunities to consider.
In Phase 2 of the study, the committee will use the outlined strategic framework to generate an assessment of potential vulnerabilities posed by synthetic biology. Inputs to this assessment may include information about the current threat, current program priorities and research and an evaluation of the current landscape of science and technology. Conclusions and recommendations will include a list and description of potential vulnerabilities posed by synthetic biology.
In Phase 3 of the activity, after the study portion is completed and the final report is released, the committee will organize a classified workshop to present its findings to the biodefense community and selected members of the synthetic biology community and contribute to the biodefense community’s discussion of potential vulnerabilities and mitigation options. A brief proceedings will be prepared by a rapporteur to capture the discussion at the workshop. The brief proceedings will not contain any findings or recommendations of the committee.

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Conflict of Interest Disclosure

Disclosure of Conflict of Interest: Patrick Boyle

In accordance with Section 15 of the Federal Advisory Committee Act, the "Academy shall make its best efforts to ensure that no individual appointed to serve on [a] committee has a conflict of interest that is relevant to the functions to be performed, unless such conflict is promptly and publicly disclosed and the Academy determines that the conflict is unavoidable." A conflict of interest refers to an interest, ordinarily financial, of an individual that could be directly affected by the work of the committee. As specified in the Academy's policy and procedures (http://www.nationalacademies.org/coi/index.html), an objective determination is made for each provisionally appointed committee member whether or not a conflict of interest exists given the facts of the individual's financial and other interests and the task being undertaken by the committee. A determination of a conflict of interest for an individual is not an assessment of that individual's actual behavior or character or ability to act objectively despite the conflicting interest.

We have concluded that for this committee to accomplish the tasks for which it was established its membership must include among others, at least one person who is currently and directly engaged in the synthetic biotechnology industry with a focus on the large scale development of organisms using synthetic biology..

To meet the need for this expertise and experience, Dr. Patrick Boyle is proposed for appointment to the committee even though we have concluded that he has a conflict of interest because he is an employee of Ginkgo Bioworks, whose financial interests could be affected by the outcome of the study.

As his biographical summary makes clear, Dr. Boyle is an expert in organism design aspects of synthetic biology. He has current industry experience engineering organisms using synthetic biology tools at a company focused on making and selling organisms, with the scale of organism production not observed in academic laboratories. This experience provides a unique lens on both the ability to engineer organisms and a broad knowledge of the effectiveness of DNA design tools in engineering organisms with particular characteristics. This expertise and experience in the design of large numbers of organisms is critical to the ability of the committee to fulfill its task. We believe that Dr. Boyle can serve effectively as a member of the committee and that the committee can produce an objective report, taking into account the composition of the committee, the work to be performed, and the procedures to be followed in completing the work.

After an extensive search, we have been unable to find another individual with Dr. Boyle’s specialized experience in the large scale production of organisms who does not have a similar conflict of interest. Therefore, we have concluded that this potential conflict is unavoidable.

Committee Membership Roster Comments

Effective March 24, 2017, membership has changed with the resignation of Dr. David R. Walt.

Sponsors

Department of Defense

Staff

Marilee Shelton-Davenport

Lead

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