Synthetic biology has multiple definitions, encompassing genetically engineered organisms to biological circuits that produce various small molecules or chemicals. With an international market of more than $2.7 billion, synthetic biology provides opportunities for amateur, budding, and professional scientists to study and engineer biological systems. Scientists continue to push the envelope on developing and applying new tools to solve persistent health, environmental, and agricultural problems. At the same time, concerns about misapplication of these tools to create biological agents (namely, pathogens) for harmful purposes and accidental or intentional release of genetically modified organisms have led to self-governance and policy action to reduce potential security and safety risks.
In her book Synthetic Biology: Security, Safety, and Promise, Gigi Kwik Gronvall, senior associate at the Johns Hopkins University Center for Health Security, seeks to engage synthetic biologists, concerned members of the public, security and safety experts, and policymakers in a dialogue about the risks and benefits of synthetic biology. Her main goal is to drive well-balanced policy discussion about approaches that can minimize security and safety risks while harnessing the educational, scientific, and commercial benefits of synthetic biology. Toward that goal, Gronvall focuses on four central themes: (1) the scale and breadth of the synthetic biology market in the United States and internationally; (2) the security, safety, and ethical risks of synthetic biology applications; (3) the U.S. investment in synthetic biology and engagement with practitioners; and (4) U.S. leadership in shaping international discussions on governance of synthetic biology. Beyond risks and benefits, the book pushes the policy dialogue further by linking investment and innovation in the field with authority in international discussions on governance.
The book begins with a summary of the various definitions of synthetic biology, distinguishing synthetic biology from genetic engineering, which dates to the early 1970s. Gronvall uses several examples to illustrate the concerns or potential promises of synthetic biology. For example, Gronvall describes high-profile efforts, such as the J. Craig Venter Institute’s work toward creating a “synthetic” organism and minimal cell, to illustrate the technical advances occurring in synthetic biology and the ethical questions these efforts raise. In her introduction, she also highlights concerns about the risk of intentional creation of extinct, new, or dangerous pathogens using synthetic biology approaches (security), environmental release of organisms created using synthetic biology (biosafety), accidental release of new or modified organisms from the laboratory (laboratory biosafety), and creation of life from basic building blocks (ethics). Gronvall describes these concerns in further detail in subsequent chapters.
A second strong theme within the book is the risk of misapplying synthetic biology to develop biological weapons and current instruments toward prevention of such uses. Gronvall points to the re-creation of smallpox and rinderpest viruses using synthetic biology approaches as examples to illustrate potential misapplication. These examples provide a platform for discussion of the existing legal and policy instruments for preventing the misapplication of any science for the creation and development of dangerous biological agents. The instruments described in the book are the Biological and Toxin Weapons Convention, which bans the development, production, and stockpiling of biological weapons; United Nations Security Council Resolution 1540, which is enforceable and makes countries responsible for preventing the development and use of biological weapons by state and nonstate actors within national boarders; and the Dual Use Research of Concern policies, which require research institutions in the United States to review, identify, mitigate, and oversee research with dual use potential. Within the scope of these instruments, which assume that biological agents that could be used as weapons are pathogens or biologically-derived toxins, specific security concerns related to synthetic biology are highlighted, including the re-creation of new and/or more dangerous pathogens and organisms that produce the toxins.
However, as Gronvall describes in her fourth chapter, much of the investment in synthetic biology is not in new approaches for developing pathogens, suggesting a misalignment in the current security instruments and potential risks. According to Gronvall, addressing potential security concerns that fall outside the current governance structure requires engagement with practitioners in the field and strong U.S. leadership and investment in synthetic biology. As a solution, she advocates maintaining U.S. competitiveness in the development and application of synthetic biology approaches to enhance U.S. leadership in developing security (and safety) policies for preventing deliberate (and accidental) harm caused by synthetic biology.
The book focuses much of the biosafety discussion on accidental release of biological agents from professional and community laboratories while simultaneously describing the risk of reduced biodiversity caused by release of engineered organisms. Despite potential overlapping measures, these categories of biosafety are distinct, having different stakeholders, international governing instruments, and national-level efforts. For example, environmental groups focus more on the effects of organisms made by synthetic biology on the environment and biodiversity, whereas security and biorisk experts focus on accidental release of a modified organism outside of a laboratory. In the United States, guidance and guidelines incorporated into contractual agreements are viewed as equivalent to national, state, and local laws. Along these lines, in 2013, the U.S. guidance on recombinant DNA was updated to cover synthetic nucleic acids — a clear step in the direction of increasing oversight of synthetic biology at institutions receiving U.S. government research funds. A discussion of this guidance and how it contributes to identifying and preventing biosafety risks of synthetic biology is missing in the relevant chapter. Therefore, examination of all possible instruments is necessary to fully understand the governance of safety and security risks as they pertain to synthetic biology and other enabling biotechnologies.
Gronvall goes on to discuss the strong ethical concerns associated with use of synthetic biology to genetically modified organisms and create synthetic organisms. She describes how concerns about scientists “playing God” and creating life in a laboratory led to much attention by high-level leaders, among them Pope Benedict XVI and President Barack Obama, which initiated public discourse on the ethical implications of synthetic biology. To illustrate these efforts, Gronvall describes selected efforts toward examination of the policy, governance, and social issues associated with synthetic biology. Within this context, Gronvall highlights the work of the Woodrow Wilson International Center for Scholars and members of the Do-It-Yourself Biology (DIY-Bio) community, who together identified a set of ethical principles governing scientific activities of the amateur biology community. Alongside these activities, Gronvall links the 1972 Asilomar conference on recombinant DNA to recent calls for a “new Asilomar” conference at which scientists, members of the concerned public, policymakers, and other relevant stakeholders would examine synthetic biology and mechanisms for addressing associated risks.
After introducing the reader to the social issues associated with synthetic biology, Gronvall describes the scale and breadth of investment in the field. She explicitly includes a survey of the commercial, educational, and scientific benefits of synthetic biology to ensure that readers, primarily those who focus only on the risks, understand the contributions that this field is making to solve big societal and environmental problems. She highlights programs established by the U.S. government and private industry to promote scientific advancement and application of synthetic biology in energy, agriculture, environmental protection, and medicine. She focuses much of her discussion on the importance of U.S. leadership in advancing the science and promoting policy and governance in the field.
Through this book, Gronvall clearly intends to drive broader engagement and dialogue about the risks and benefits of synthetic biology among key stakeholders, including scientists, interest groups, policymakers, and safety and security experts. By presenting synthetic biology as a continuously evolving field with current and future applications in a variety of sectors, the inherent complexity in identifying, mitigating, and preventing risks to people, the environment, and nations, all while reaping the benefits of the science and promoting education and training in the science is shown. With this bigger picture in mind, this book provides something for various stakeholders, including scientists, concerned citizens, policymakers, the public, ethicists, and security and safety experts. In particular, this book should be read by those who spend much of their time focusing on either the risks or the benefits and to those who grapple with balancing the risks and the benefits of enabling biotechnologies and life science research. Gronvall’s approach of examining synthetic biology as a complex tapestry of social contribution and risk can enable new insights in other life science fields and disciplines, such as gene editing and personalized medicine.
