"Managing the Promise and Threat of Evolving Biotechnology." CSIS Commission on Strengthening America's Health Security, Center for Strategic and International Studies, September 13, 2018. Accessed October 01, 2020.

Biotechnology is moving swiftly and holds the potential to revolutionize many fields if properly managed.

Photo Credit: University Of Michigan School Of Natural Resources & Environment/Flickr

University Of Michigan School Of Natural Resources & Environment/Flickr

Key Challenges

Balancing Gains Versus Risks

A central tension animates the debate around biotechnology: how are we to balance advancing innovation and the many gains that may follow versus protecting Americans and others against dangerous outcomes that could present grave security threats?

In the past decade, rapidly accelerating molecular and genetic advances have ushered in an era of synthetic biology—“the design and construction of new biological entities such as enzymes, genetic circuits, and cells or the redesign of existing biological systems.”1 Tools enabling such manipulation include sequencing and synthesizing large quantities of DNA, targeted editing of the genome (genetic code) via CRISPR technology, and new methods of gene delivery. Biotechnology holds the potential to revolutionize the fields of medicine, science, agriculture, materials, ecology and manufacturing through advances in disease models, environmental decontamination, agricultural efficiencies, and many more applications. This promise has given rise to one guiding imperative: ensuring the regulatory and policy environment incentivizes and accelerates beneficial innovation.

Yet at the same time, this new technology poses real pathways to danger. New tools can under certain circumstances enable targeted genetic modification of pathogens that could make them deadlier to humans or render them resistant to existing drugs, vaccines, diagnostics, or detectors. Synthetic biology eases the acquisition of dangerous pathogens heretofore secured in a few laboratories. Gene drives, or introduction of a dominant trait into a population that prevails at the expense of other traits, threaten ecology.

Detecting Misuse

The myriad ways in which biotechnology could be applied to nefarious ends are constantly growing and changing and thus exceedingly difficult to predict. To further complicate matters, there are few reliable warning signs of biotechnology’s deliberate misuse, because the same resources, processes, and facilities used for benevolent research can be repurposed to create dangerous bioweapons (the concept of “dual use”) and illicit activities are easily concealed within or around legitimate ones.2 It is therefore difficult to anticipate threats and identify their sources, further obscuring the biosecurity threat and elevating concern of attacks. Additionally, as technology grows more accessible, the need for large-scale state or institutional facilities to support biotech research and development has steadily declined. By substantially reducing the necessary footprint to support research and development in these areas, dangerous activities have become extremely difficult to detect.

Fortunately, there have not yet been instances of actual misuse of modern biotech for harmful purposes. The very infrequent misuse leads some to argue that the true risks of dual-use are low or that the intent to use these capabilities for nefarious purposes by individuals, organizations or countries is lacking. While the opportunity for misuse remains high, the evidence of the intent to do so remains scant.

Disagreement within the Expert Community

Uncertainty about the risk of misuse contributes to a lack of agreement among experts about the magnitude and nature of the threat posed by bioweapons and biotechnology as well as the costs and benefits associated with regulating high-risk research. Indeed, when science and defense experts were surveyed about the likelihood of a large-scale bioweapons attack in any country in the next 10 years and the most likely actor or agent, their answers were highly divergent.3 While the opportunity for misuse is high, so too is the importance this rapidly evolving and innovative technologies to provide essential capabilities to respond to many of the globe’s health security challenges in the form of vaccines, treatments and countermeasures, and advanced diagnostics. The scientific and policy community remain divided about the need and efficacy of efforts to regulate and manage biotech risks. There is no clear consensus on the path forward and significant disagreement in the scientific community about the appropriate level and form of policing.

Regulatory Challenges

When recombinant DNA emerged forty years ago, leading scientists concerned with its future implications met in Asilomar in northern California to hash out new rules of the road to fit this new technology.4 We no longer live in a 1970s Asilomar world. The world of science and innovation today is globalized, private sector-dominated, and vastly bigger and more complex. Many biotechnological experiments and projects require modest resources, space, and training, making advanced biotechnology widely accessible and enabling individuals and informal groups to perform “do-it-yourself” (DIY) biology. This poses challenges for crafting enforceable regulatory and policy regimes for minimizing potential risks associated with biotechnology. Further, much of biotechnological research’s application is occurring in Asian countries where regulatory regimes are weak.

U.S. Government Policies

In 2004, the National Research Council published “Biotechnology Research in an Age of Terrorism,” otherwise known as “the Fink Report,” which responds to the 9/11 and U.S. anthrax attacks by recommending, among other measures, further education of scientists about dual use potential; self-governance; expanded institutional review of research proposals for dual use risks; and establishment of the National Science Advisory Board for Biosecurity.5

In October 2014, the U.S. government paused federal funding of gain-of-function (GOF) research involving influenza, SARS, and MERS viruses.6 This moratorium came in the wake of 2011 H5N1 avian influenza GOF experiments by two laboratory groups in the United States and Netherlands seeking to make the avian flu more transmissible between mammals in order to better prepare public health officials. While the experiments were benevolently intended to determine whether this transmissibility function could evolve in nature and if so, what genetic markers we might herald that change, the U.S. government deemed the GOF threat too large and therefore worthy of possible regulation. In 2014, the Federal Experts Security Advisory Panel (FESAP) was re-chartered with evaluating U.S. biosafety and biosecurity, and in 2017 the FESAP issued an overview of U.S. regulations, along with best practices and guiding principles.7

Three U.S. oversight policies govern research of dual use concern that is conducted or funded by the U.S. government. The 2012 United States Government Policy for Oversight of Life Sciences Dual Use Research of Concern (DURC) establishes regular review of such research.8 A complementary policy, the 2014 United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern, enumerates policies, practices, and procedures to identify and mitigate risks of DURC.9 The U.S. Department of Health and Human Services Framework for Guiding Funding Decisions about Proposed Research Involving Enhanced Potential Pandemic Pathogens, published in 2017, lifted a three-year U.S. government funding moratorium on certain gain-of-function experiments and provides criteria for guiding funding decisions and oversight of research involving potential pandemic pathogens.10

  1. Huimin Zhao, Synthetic Biology: Tools and Applications, 1st ed. (Amsterdam and Boston: Academic Press, 2013). 

  2. Michael J. Selgelid, “Governance of dual-use research: an ethical dilemma,” Bulletin of the World Health Organization 87 (2009): 720-723, 

  3. Crystal Boddie et al, “Assessing the bioweapons threat,” Science 349, no. 6250 (2015): 792-793, 

  4. Paul Berg, David Baltimore, Sydney Brenner, Richard O. Roblin, and Maxine F. Singer, “Summary Statement of the Asimolar Conference on Recombinant DNA Molecules,” Proceedings of the National Academy of Sciences of the United States of America 72, no. 6 (June 1975): 1981-1984, 

  5. National Research Council, “Biotechnology Research in an Age of Terrorism,” The National Academies Press, 2004, 

  6. Francis S. Collins, “Statement on Funding Pause on Certain Types of Gain-of-Function Research,” National Institutes of Health, October 16, 2014, 

  7. “Federal Experts Security Advisory Panel (FESAP),” U.S. Department of Health and Human Services, last reviewed September 13, 2017, 

  8. “United States Government Policy for Oversight of Life Sciences DURC,” U.S. Department of Health and Human Services, March 29, 2012, 

  9. “USG Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern,” U.S. Department of Health and Human Services, September 24, 2014, 

  10. “Framework for Guiding Funding Decisions about Proposed Research Involving Enhanced Potential Pandemic Pathogens,” U.S. Department of Health and Human Services, 2017, 

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