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Between 1973 and 2016, the ways to manipulate DNA to endow new characteristics in an organism (that is, biotechnology) have advanced, enabling the development of products that were not previously possible. What will the likely future products of biotechnology be over the next 5–10 years? What scientific capabilities, tools, and/or expertise may be needed by the regulatory agencies to ensure they make efficient and sound evaluations of the likely future products of biotechnology? This report analyzes the future landscape of biotechnology products and seeks to inform forthcoming policy making.
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·2017
Between 1973 and 2016, the ways to manipulate DNA to endow new characteristics in an organism (that is, biotechnology) have advanced, enabling the development of products that were not previously possible. What will the likely future products of biotechnology be over the next 5–10 years? What scient...
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Description
An ad hoc committee of the National Academies of Sciences, Engineering, and Medicine will produce a report designed to answer the questions “What will the likely future products of biotechnology be over the next 5-10 years? What scientific capabilities, tools, and/or expertise may be needed by the regulatory agencies to ensure they make efficient and sound evaluations of the likely future products of biotechnology?”
The committee will:
· Describe the major advances and the potential new types of biotechnology products likely to emerge over the next 5-10 years.
· Describe the existing risk analysis system for biotechnology products including, but perhaps not limited to, risk analyses developed and used by EPA, USDA, and FDA, and describe each agency’s authorities as they pertain to the products of biotechnology.
· Determine whether potential future products could pose different types of risks relative to existing products and organisms. Where appropriate, identify areas in which the risks or lack of risks relating to the products of biotechnology are well understood.
· Indicate what scientific capabilities, tools, and expertise may be useful to the regulatory agencies to support oversight of potential future products of biotechnology.
Human drugs and medical devices will not be included in the purview of the study per a sponsor's request.
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Conflict of Interest Disclosure
Disclosure of Conflict of Interest: Steven L. Evans
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 biotechnology industry with a focus on the research, development, and production of novel agricultural biotechnology products.
To meet the need for this expertise and experience, Dr. Steven Evans 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 Dow AgroSciences, whose financial interests could be affected by the outcome of the study.
As his biographical summary makes clear, Dr. Evans has current industry experience working to identify, develop, and acquire new biotechnology capabilities, and has over 30 years of experience in the agricultural biotechnology industry, including the development and production of novel seeds, plant sciences, product chemistry and biochemistry, and the development of bioherbicides. This experience and expertise in the agricultural biotechnology industry is critical to the ability of the committee to fulfill its task. We believe that Dr. Evans 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 current industry experience and equivalent technical expertise and experience in the biotechnology industry as Dr. Evans who does not have a similar conflict of interest. Therefore, we have concluded that this potential conflict is unavoidable.
Disclosure of Conflict of Interest: Jeffrey D. Wolt
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 has current practical expertise in understanding, analyzing, and assessing the risks associated with possible new industrial products of biotechnology.
To meet the need for this expertise and experience, Dr. Jeffrey Wolt is proposed for appointment to the committee even though we have concluded that he has a conflict of interest because he holds investments in a company whose financial interests could be affected by the outcome of the study.
As his biographical summary makes clear, Dr. Wolt has over 35 years of experience in environmental and ecotoxicological risk assessment; food and feed safety risk assessment; soil and environmental chemistry applied to exposure assessment, efficacy, environmental monitoring, environmental toxicology, and environmental fate of agricultural products. This experience and expertise in risk assessment specific to multiple sectors of the biotechnology industry is critical to the ability of the committee to fulfill its task. We believe that Dr. Wolt 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 combination of current technical expertise in the biotechnology industry and broad experience in risk assessment as Dr. Wolt who does not have a similar conflict of interest. Therefore, we have concluded that this potential conflict is unavoidable.
Committee Membership Roster Comments
08/31/2016 Committee composition has changed due to the resignation of Richard Johnson.
Sponsors
Environmental Protection Agency
Staff
Kara N. Laney
Lead