Study Statement of Task

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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Read the Report Here