The Living Regulatory Challenges of Synthetic Biology

Abstract

IntroductionSynthetic biology is one of the fastest developing and most promising emerging technologies.1 It will permit scientists to design living organisms unlike any found in nature and to redesign existing organisms to have enhanced or novel qualities.2 3 4 5 While traditional biotechnology involves the transfer of a small amount of genetic material from one species to another, synthetic biology will permit the purposeful assembly of an entire organism. Synthetically designed organisms, it is hoped, might be put to myriad beneficial uses, including better detection and treatment of disease, the remediation of environmental pollutants, and the production of new sources of energy, medicines, and other valuable products.3 Engineered life forms, however, also might pose risks to human health and the environment. Exactly what those hazards are and how they might be controlled cannot be fully determined in advance of the very research necessary to develop this novel science in the first instance.This Article discusses potential regulatory challenges under the existing U.S. regulatory system concerning the first synthetic biology organisms that are anticipated to be commercialized. Much of the policy and ethical commentary on synthetic biology to date has focused on biosecurity concerns associated with synthetic biology, such as the potential malevolent misuse of the technology for bioterrorism, or the possibility of accidental or intentional release of a harmful engineered organism into the community by it yourself (DIY) synthetic biology users.4 While these implications of synthetic biology are of great importance, our focus here is different. We address regulatory and oversight concerns and challenges, and provide recommended strategies for dealing with the potential risks to human health and the environment from the purposeful, beneficial application of synthetic biology. Private companies, universities, and other entities are fast developing numerous legitimate uses of synthetic biology, in areas such as energy production, chemical synthesis, and bioremediation.5 These anticipated uses do not come without risk, risk that is sometimes referred to as as opposed to bioterror. * * * * 6 7 To date, the capacity of the existing regulatory system to address these bioerror risks has received limited attention and investigation, particularly in the legal literature.Our analysis reveals that although the extant regulatory system is capable of sufficiently handling several aspects of these novel synthetic biology organisms, there are also a number of potentially troubling regulatory gaps. These gaps arise because synthetic biology presents particular challenges for the existing U.S. regulatory regime due to three atypical characteristics of this nascent technology: (1) synthetic biology organisms can evolve;7 (2) the traditional assumed relationship between mass and risk may break down for synthetic biology products;8 * and (3) the conventional regulatory focus of existing statutes on end-product chemicals may be a poor match in certain instances for a technology that produces novel organisms, with their own attendant risks, that, in turn, produce the end-product chemicals.9This Article begins in Part I with an overview of synthetic biology and an examination of the potential benefits and risks of expected early synthetic biology products. The Toxic Substances Control Act (TSCA) is anticipated to be the most significant pre-existing regulatory authority concerning potential human health and environmental impacts of synthetic biology. Part II will examine how well TSCA is suited for this role. Part III discusses a number of other statutes, including laws pertaining to hazardous waste, endangered species, and pesticides, as well as National Institutes of Health guidelines that will also play a role in synthetic biology management.10 Part IV introduces several innovative governance approaches that could shore up some of the gaps in the existing regulatory framework for synthetic biology. …