This year’s annual SynBioBeta SF 2016 conference featured a lively panel discussion on how stakeholders in the synthetic biology industry can go about safeguarding the bioeconomy. Panelists from the FBI, DARPA, academia, and industry all weighed in on this topic that is both fascinating and timely for the field of synthetic biology. The panel stimulated critical avenues of discussion about the future of biosecurity and left attendees to consider many important questions. Here we will continue the conversation that was started two months ago in San Francisco through an extended interview with one of the distinguished panelists: DARPA program manager Renee Wegrzyn.
- Can you define what you mean by “bioerror,” a term that you used during the panel discussion that was unfamiliar to many attendees?
While there is no official definition of “bioerror,” it can be interpreted as an adverse biological event that is the result of an accident, mistake, or insufficient understanding of biosafety and biosecurity. Unlike bioterror, bioerror is unintentional. An incident of bioerror could potentially threaten an environment or population of organisms if it extends beyond an otherwise contained environment.
- How do we go about standardizing and measuring biosafety and biosecurity?
It is difficult to measure the effectiveness of biosafety and biosecurity measures because their success is defined by a lack of incidents. However, we have a responsibility to mitigate any foreseeable potential risks. There are some great examples of how this can be approached. For example, each research institution must comply with the standards and requirements of their local Institutional Biosafety Committee (IBC), or national standards such as the NIH Guidelines for Recombinant and Synthetic Nucleic Acids and other similar documents that provide a comprehensive approach on how to assess and mitigate risk in biological research.
One of the goals of [DARPA’s] Safe Genes program is to advance the scientific basis for ensuring biosafety and biosecurity as synthetic biology continues to evolve. In furtherance of that goal, researchers that are funded under the Safe Genes program are required to define quantitative metrics that will be used to assess the biosafety and biosecurity performance of their systems. For example, some of the notional examples of quantitative metrics that were provided to proposers in the original proposal solicitation include the development of genome editing controllers that result in off-target mutations that do not exceed natural mutation rates (e.g., 1×10-9 mutations per base pair per generation for insects and 2×10-8 for mammalian cells); and genome editing controllers whose performance does not degrade over time (over N number of generations).
With regard to novel countermeasures and inhibitors of genome editing, another quantitative safety performance metric could include the absence of toxicity or immunogenicity to the host (e.g., the edit does not elicit a host immune response).
- How can we go about regulating independent bioengineering outside of an institutional setting?
One of the best ways, which is being championed by Ed You at the FBI, is to engage with these communities. Ed emphasizes the responsibility of all scientists to “safeguard” the science (listen to Ed You discuss the future of biosecurity on the Science Friday podcast here).
Independent bioengineering, DIY-bio, and biohacking provide great avenues for people to explore and learn about biology. However, it is in everyone’s interest to ensure that it is done safely. Therefore, it is important that these communities are informed of the risks of bioengineering, know where to go for relevant guidance on safety, and know who to contact should they need assistance.
- Is there a coordinated program on safety that incorporates all major synthetic biology stakeholders so that we can set the standards for the field?
Most risks posed by synthetic biology are similar to the risks of more traditional genetic engineering. In the laboratory, such risks are mitigated by compliance with the NIH Guidelines for Recombinant and Synthetic Nucleic Acids (and, for clinical studies, by FDA and other regulatory bodies). Biosecurity and dual-use risks are considered through the institutional policy for Dual-Use Research of Concern (DURC) and the Select Agents Regulations. Potential environmental risks are generally captured as a biotechnology product undergoes regulatory assessment and approval. Although these are not officially coordinated into one program, [the different programs] work together to help ensure biosafety and biosecurity of synbio research and products. As mentioned above, it is anticipated that DARPA’s Safe Genes program will strengthen the scientific foundation upon which additional safety standards may someday be developed and adopted.
- What would it take to capture the dark side of the public’s imagination and cause the whole synthetic biology industry to shut down?
Although particular applications may capture the public imagination (in both good and bad ways), it’s highly unlikely that synthetic biology as a whole would rise and fall as one entity. Synthetic biology is a diverse field and is comprised of various technologies that contribute to medicine, energy, the environment, consumer goods, etc. It is inextricably linked to the progress of modern technological development.
- We have been deploying biotech for nearly 35 years. What are the major lessons from the past that we’ve gathered so far?
Traditional biotechnology (e.g., genetically engineered corn and engineered bacteria for pharmaceutical production) has been used for decades and has been shown to have a safety profile similar to non-engineered products. However, as we apply more advanced biotechnology techniques, it becomes increasingly important to incorporate safety early in the design process.
The revolution in information technology in the 20th century may offer some lessons. It spurred tremendous innovation and growth, but advancements in safety, cybersecurity, and data encryption often lagged behind. Progress in biotechnology will have a significant impact on human health, economic growth, and national security. We already see the disruptive effects technologies like CRISPR/Cas9 have had. Therefore, it is important that we comprehensively address how technologies that are being or will be developed incorporate safety features such that future risks are acknowledged and mitigated.0