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Scientific Milestones for the Development of a Gene-Sequence-Based Classification System for Oversight of Select Agents

Completed

Select Agents (SAs) are listed dangerous bacteria, viruses, toxins, and fungi. However, natural variation and intentional genetic modification blur the boundaries of a Select Agent list based on names. Access to new DNA synthesis technologies is making it easier for researchers, industry scientists, and amateurs to create pathogens without access to existing stocks or cultures. This has led to concerns that DNA synthesis might be used to create SAs, introduce small changes to their genetic sequences, or create entirely new pathogens.

Description

NIH has requested the National Research Council to convene an ad hoc committee to identify the scientific advances that would be necessary to permit serious consideration of developing and implementing an oversight system for select agents that is based on predicted features and properties encoded by nucleic acids rather than a relatively static list of specific agents and taxonomic definitions. The committee is asked to address several questions: " What would be the key scientific attributes of a predictive oversight system? " What are the challenges in attempting to predict biological characteristics from sequence? " Does the current state of the science of predicting function from sequence support a predictive oversight system at this time?" If not, what are the scientific milestones that would need to be realized before a predictive oversight system might be feasible? " In qualitative terms, what level of certainty would be needed about the ability to predict biological characteristics from sequence data in order to have confidence in a predictive oversight system? " In what time frame might these milestones be realized? What kinds of studies are needed to achieve these milestones?This project is sponsored by NIH. The approximate start date for the project is Jan 12, 2009.A report will be issued at the end of the project in approximately 15 months .

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Conflict of Interest Disclosure

Disclosure of Conflict of Interest: John Mulligan

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 engaged in DNA synthesis of select agents and has practical experience in industry compliance with select agent regulations.

To meet the need for this expertise and experience, Dr. John Mulligan is proposed for appointment to the committee even though we have concluded that he has a conflict of interest because he is the founder and an officer of Blue Heron Biotechnology, Inc., a DNA synthesis company that is required to abide by select agent regulations.

As his biographical summary makes clear, Dr. Mulligan is a recognized expert within the synthetic biology community on DNA synthesis and biosecurity. His experience and expertise in the DNA synthesis industry spans the time when the select agent regulations took effect. Dr. Mulliganโ€™s practical experience with regard to industry compliance with select agent regulations is critical for the committee in meeting its task. We believe that Dr. Mulligan 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 the equivalent current practical experience and technical expertise as Dr. Mulligan who does not have a similar conflict of interest. Therefore, we have concluded that this potential conflict is unavoidable.

Sponsors

National Institutes of Health

Staff

India Hook-Barnard

Lead

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