The National Academies of Sciences, Engineering, and Medicine (NAS) has issued a report on assessing biodefense capabilities in view of new biotechnologies that could be used to reactive, alter, or design dangerous microorganisms or toxins. Specifically, the report scrutinizes synthetic biology (an umbrella term for a wide array of techniques available for the purpose of biological design). The report, Biodefense in the Age of Synthetic Biology, is publicly available here. This is an era where public health authorities must think beyond currently existing microorganisms (viruses, bacteria) and contemplate biological attacks or events resulting from novel biological agents.The U.S. Department of Defense asked the NAS to “develop a strategic framework to guide an assessment of potential security vulnerabilities related to advances in biology and biotechnology, with a particular emphasis on synthetic biology.”
In its endeavor, the study committee developed a framework to identify the relative level of concern that should attach to particular technological scenarios. In the event of an outbreak from a novel organism, or an attack with a novel toxin, how should public health officials determine the level of risk? The report's framework for assessing concern consists of four factors, along with descriptive elements within each factor. The factors are Usability of the Technology, Usability as a Weapon, Requirements of Actors, and Potential for Mitigation. Looking at these factors more simply, they assess the ease of using a technology, how feasible it is to use it as a weapon, the identification of what actors could achieve certain technical goals (having both knowledge and access to resources), and finally, the existence of measures to counteract a new biological threat. With that framework for guidance, the report ranks certain threats as warranting higher concern than others:
Of the potential capabilities assessed, three currently warrant the most concern: recreating known pathogenic viruses, making existing bacteria more dangerous, and making harmful biochemicals via in situ synthesis. The first two capabilities are of high concern due to usability of the technology. The third capability, which involves using microbes or synthetic pathways to produce harmful biochemicals or toxins to be used against humans, is of high concern because its novelty challenges potential mitigation options.
The report is a timely summary of how current genetic technologies recast and expand biosecurity threats. The framework that the NAS has provided for a methodical evaluation of a new biological organism or biochemical capability will allow public health and national security responders to more quickly determine risk and response during unanticipated events.
A scholarly survey of the emerging field of synthetic biology has been published by a team of researchers from the UK and Japan, and published in the open-access journal, PLOS One. This is a timely overview of this field, international in scope. The authors detail the language problems that can attach to new fields, where different practitioners or commenters use disparate terms to describe this work. For example, synthetic biology is a field that combines engineering with biology, but in this respect, it overlaps with the established field of genetic engineering, which has been around now since the 1970’s. So what accounts for the difference? Some of it is in the ambition of the field, where declarations of the goal to create entirely new organisms are routine; in contrast, genetic engineering usually relies on genetic manipulation of existing organisms (microbes, plants) to add useful phenotypes. Synthetic biology is also associated with the imperative to unravel biological mechanisms with the goal of establishing a catalogue of modular “parts” that can be used to design new biological circuits and new organisms (see, e.g., the Biobricks initiative which does just that). For legal purposes, this article locates the field against the backdrop of relevant international instruments which have bearing on this field (the Convention on Biological Diversity, relating to equitable sharing of genetic resources) and the Cartagena Protocol on Biosafety (relating to guidelines for the use and transport of living modified organisms). With respect to the U.S., the most authoritative consideration of the legal issues raised by synthetic biology was undertaken by the Presidential Commission for the Study of Bioethical Issues (PCBSI), which published its 2010 study of synthetic biology and issued recommendations for continuing vigilance (noting serious issues of risk assessment and management that could attend the design and release of novel organisms), but no calls for either a moratorium or specific regulation at that time (in fact, noting categorizing its approach as “regulatory parsimony”). More generally, the PCBSI defined a framework for “five ethical principles relevant to considering the social implications of emerging technologies: (1) public beneficence, (2) responsible stewardship, (3) intellectual freedom and responsibility, (4) democratic deliberation, and (5) justice and fairness.” What’s also interesting is a follow-on effort started this year by the Woodrow Wilson International Center for Scholars to track how the recommendations of the PCBSI are implemented. For example, their Synthetic Biology Project scorecard documents no federal activity pursuant to various recommendations relating to risk assessment, where there was federal activity related to ethics and public education. In sum, this new scholarly work on synthetic biology is a necessary prerequisite to any serious international oversight of the field, in that such an effort must be rooted in empirical knowledge of the scope of the field and its practitioners.
