Expert Report

Preparing for Future Products of Biotechnology (2017)

Topics: Agriculture

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As the U.S. biotechnology economy grows rapidly, the scale, scope, and complexity of products is increasing. More types of organisms will likely be engineered, and the kinds of traits introduced with biotechnology will also increase. Future biotechnology products will range from familiar applications, such as modifying agricultural crops, to products that are entirely new –plants that can serve as sentinels of environmental contamination, for example, and collections of microorganisms that can produce chemical compounds efficiently.

This report concludes that the current staffing levels, expertise, and resources available at EPA, FDA, USDA and other regulatory agencies may not be sufficient to address the expected scope and scale of future biotechnology products. It is critical that the agencies develop new capabilities, tools, and expertise in such areas as understanding relationships between intended genetic changes and an organism’s observable traits, the unintended effects of genetic changes on target and non-target organisms, predicting and monitoring ecosystem responses, and quantifying the economic and social costs and benefits of biotechnologies.

Overall, the federal government should develop a strategy that scans the horizon for new biotechnology products, identifying and prioritizing those products that are less familiar or that present a need for more complex risk analysis. For products that have less-familiar characteristics or more complex risk pathways, new risk-analysis methods may need to be developed. Because biotechnology products are likely to generate substantial public debate, the U.S. regulatory system will need to achieve a balance among competing interests, risks, and benefits when considering how to manage development and use of new biotech products.