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Will the Biden administration ‘follow the science’ on regulatory reform?

Nature Biotechnology volume 39, pages 1334–1335 (2021)Cite this article

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To the Editor — This year marks the 35th anniversary of the US Coordinated Framework for the Regulation of Biotechnology (https://usbiotechnologyregulation.mrp.usda.gov/biotechnologygov/about/about), a blueprint for federal agencies’ oversight of genetic engineering that was prepared by the White House and published by its Office of Science and Technology Policy (OSTP). Early on, it was recognized that the agencies’ regulatory scope was overly broad, so reforms were added in the 1992 follow-on OSTP ‘Scope Document’ (https://obamawhitehouse.archives.gov/sites/default/files/microsites/ostp/57_fed_reg_6753__1992.pdf) to create more narrowly targeted, risk-based oversight. However, those important changes were never implemented. The OSTP now has a perfect opportunity for President Biden to make good on his repeated promises to “always follow the science,” by directing federal agencies to incorporate the Scope Document’s principles into practice, thereby reducing the costly over-regulation that is stifling many of the important benefits of agricultural biotechnology.

The essence of the Scope Document can be summarized in its following three points:

  • “A risk-based, scientifically sound approach to the oversight of planned introductions of biotechnology products into the environment that focuses on the characteristics of the biotechnology product and the environment into which it is being introduced, not the process by which the product is created”;

  • “Exercise of oversight in the scope of discretion afforded by statute should be based on the risk posed by the introduction and should not turn on the fact that an organism has been modified by a particular process or technique”;

  • And “oversight will be exercised only where the risk posed by the introduction is unreasonable, that is, when the value of the reduction in risk obtained by additional oversight is greater than the cost thereby imposed. The extent and type of oversight measure(s) will thus be commensurate with the gravity and type of risk being addressed, the costs of alternative oversight options, and the effect of additional oversight on existing safety incentives.”

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Authors and Affiliations

  1. Arlington, VA, USA

    John J. Cohrssen

  2. The Pacific Research Institute, San Francisco, CA, USA

    Henry I. Miller

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  1. John J. Cohrssen
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  2. Henry I. Miller
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Correspondence to John J. Cohrssen.

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Competing interests

J.J.C. served in senior positions for White House agencies, including as Counsel to the White House Working Group that prepared the 1986 Coordinated Framework for the Regulation of Biotechnology, and is in private legal practice. H.I.M. was the founding director of the FDA’s Office of Biotechnology and is a senior fellow at the Pacific Research Institute.

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Cohrssen, J.J., Miller, H.I. Will the Biden administration ‘follow the science’ on regulatory reform?. Nat Biotechnol 39, 1334–1335 (2021). https://doi.org/10.1038/s41587-021-01084-2

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