The 2010 Biosecurity convention concluded with a round table discussion of the dual use risks associated with novel technologies, such as synthetic biology and nanotechnology.
Our complete coverage of the convention here at the FAS Biosecurity blog can be found at:
In the interest of full disclosure, the Biosecurity blog acknowledges the free Tim Horton’s coffee shop, imported by the BIO Canada pavilion on the exhibition floor; this generous caffeinated support has been instrumental in ensuring the quality of our coverage of the convention.
Without further ado, the summary of the final panel follows:
Harvey Rubin, MD – Session Chair
Director, University of Pennsylvania Institute for Strategic Threat Analysis and Response
University of Pennsylvania
Jesse Goodman, MPH
Director, Office of Science, FDA
U.S. Food and Drug Administration
Senior Vice President for Research and Development
Amyris Biotechnologies, Inc
Kevin Jarrell, PhD
Modular Genetics, Inc.
J. Craig Venter Institute
UPMC Biosecurity Center
Dr. Rubin opened the discussion by raising the topic of nanotechnology. He asked the panel how nanotechnology affects medicine, and whether there are safety concerns.
Director Goodman stated that FDA premarket review process would cover nanotechnology with the same criteria and regulatory pathways that cover other potential treatments. However, as an emerging technology with toxicology characteristics are not yet fully understood, he stated that more data is needed to predict how nanoparticles will behave.
Dr. Friedman drew a distinction between biological agents and nanoparticles in that nanoparticles typically are not self-replicating. This matters because the molecular threat is not expected to be amplified if released into the environment.
Do-It-Yourself (DIY) Bio
Dr. Gramwell tied nanotechnology in with synthetic biology and the rising “DIY Bio” movement, noting that the barrier to entry is comparatively low and, as with nanotechnology, regulations have not yet necessarily caught up. Individuals who may not have training, experience, or a community capable of evaluating their work are increasingly in the position to engineer life.
Dr. Jarrell’s experience as a researcher dated back to the early days of recombinant DNA. Based on this experience, he cited a need to balance innovation with safety. His training taught him that modifying DNA is a privilege that should be exercised safely.
Dr. Newman referred to the various manipulation technology as “dual purpose” and called for risks to be weighed against the consequences of inaction. For a disease like Malaria, with millions of potentially preventable deaths, he felt that the risks should be balanced against the potential benefits. To stimulate the field, he recommended that individuals be empowered to participate in the building of the industry. He caveated this suggestion by noting that the key question is whether allowing greater numbers of people to participate in the reprogramming of life is worth the risks.
Dr. Gramwell agreed that the DIY/garage biology movement evokes strong responses. She suggested that these techniques can be put to a variety of beneficial uses, citing student projects that have uncovered incidents where stores and restaurants have served cheaper, low-quality fish while fraudulently claiming that they were offering more expensive options.
In reference to the dual use issue, Dr. Rubin cited the example of the reconstruction of the 1918 Influenza virus, which was published after lengthy deliberations. In general, the community agreed with that decision, though it was not without its critics.
Dr. Friedman drew a distinction between DIY Bio conducted using non-hazardous microbes versus potentially dangerous pathogens. New technology that facilitates DNA synthesis has the potential to lower the accessibility bar to these pathogens, but – for the moment – much of that DNA comes from commercial providers who are beginning to monitor for sequences of concern.
Dr. Gramwell noted that the creation of select agents is illegal, regardless of whether it is done in a DIY context. However, she observed that the limits of these types of regulation extend only as far as our own borders.
Dr. Friedman discussed the purpose of the patent system in spurring innovation for the public good in the context of patenting of living organisms. He conceded that there is no clear consensus on how to address this issue yet.
Dr. Newman argued that the status quo for biotech patents will have to shift to a model that supports the combination of inventions towards a greater end. He feels that attempts to commercialize living organisms can invite public backlash.
Director Goodman observed that socially we often fail to explicitly describe the positive and negative uses of a potential technological advance, and suggested that this exercise might help us weigh the pros and cons of these questions.
Director Goodman raised the question of whether there are types of research that, regardless of the ethics and regulations, are unwise pursuits. Would the people conducting such dual use research know it?
Dr Jarrell’s view of synthetic biology is that the focus of the discussion has been on its use to accomplish bad ends. However, he defended the potential use of the technology to combat pathogens. In one example, his company uses synthetic technology to try to produce renewable alternatives to existing chemicals that require the use of petroleum.
Dr. Friedman suggested that, while it may not be possible to remove all risks, it may be possible to address a large portion of the risks without losing the benefits of most legitimate research.
The current national security strategy ultimately focuses more on biologists becoming terrorists than on terrorists learning biology, and therefore places an emphasis on social institutions to encourage responsible culture within biology. Dr. Rubin suggested the perhaps a code of conduct could potentially be effective in encouraging this responsibilities.
Dr. Gramwall agreed that codes of conduct are useful, but was skeptical of their ability to deter misuse. Moreover, she worried that the techniques that are needed to carry out an attack may be more prevalent than people acknowledge.
Dr. Rubin raised the question of whether limitations on specific knowledge could help mitigate threat. However, these types of measures impede the evaluation and reproducibility of science.
Gerald Epstein of AAAS argued that sequences that exist in nature as public health threats must be made public in order to combat threats that will exist regardless of regulations.
Director Goodman argued that there are topics that do not appear to be immediate risks but that a more determined malicious user could harness in unexpected ways. However, he worries that companies underestimate the dangers and overestimate their own ability to mitigate them. In a large enough aggregate, he fears that a failure somewhere in the system grows increasingly inevitable.
Dr Newman looked to all of the benefits of biotechnology, compared to the very limited number of incidents of misuse, and argued that education can further reduce the already improbable threat.
Larry Kerr from the US Office of the Director of National Intelligence argued that we have seen a significant increase in the education of policymakers to the concept that most biotechnology is potentially dual use. However, this complicates risk assessment because the ambiguity of the threat can be concerning. In Kerr’s view, individuals who are already intent on developing bioweapons capability may be beyond help, but he prefers to believe that junior researchers who are raised in a culture of responsibility can be influenced against harmful use of biology. He notes that the national security community has not required censorship of publications, but observes that publications in these areas have proven responsible in the absence of any requirement.
Asked what industry can do to improve the perception of biotechnology, Dr. Rubin said that BIO has done a good job of communicating the benefits of the science. However, Dr. Friedman argued that the community can help by demonstrating that scientists and companies have fully and thoroughly evaluated all of the potential risks.