Initiating the interface between science, industry and risk assessment authorities: notes from the BioRoboost workshop

The need to be able to perform reliable risk assessments in synthetic biology research and for its applications has been identified as a key obstacle to assuring safety of products and mitigating any risks of synthesized microbes in the case of escape for laboratories. Without these assurances widespread use and acceptance of the products of synthetic biology research will remain in many cases out of reach. A 2015 study from the European Commission’s Scientific Committee on Emerging and Newly Identified Health Risks identified gaps in performing reliable risk assessment in synthetic biology. Work Package 6 of BioRoboost, led by Biofaction, is aimed at addressing many of those gaps. As part of that work, Markus Schmidt and Lei Pei from Biofaction and Michele Garfinkel from EMBO organized the workshop Towards enhanced biosafety and risk assessment standards in synthetic biology, 7-9 October 2019 at the EMBO offices in Heidelberg, Germany. The 17 workshop participants included representatives with expertise in academic and industrial research, standards, and risk assessment. This included biosafety experts, biohackers, publishers, researchers and industrial leaders carrying out and supporting the research itself. Several BioRoboost partners participated.

The main mechanism for eliciting information was structured discussions, in which the participants were asked to work through scenarios of the research on and use of synthetic biology applications, asking at each step, what options can we use to improve risk assessment standards? By comparing the answers, we were able to understand not only how each stakeholder group views the use of standards in risk assessment, but as well where there were commonalities or misperceptions that had not been previously identified.

By focusing on the intersection of standards and biological containment, the group was able to consider also one of the most vexing issues in the communication of the safety of GMOs and any other modified organisms: while there is an enormous amount of work that has been done on improving containment, in the environment horizontal transfer of genetic material is a natural and common process that containment will never be able to reduce to zero. Taking that into account, the most striking finding of the analysis is that it appeared, at least for our group, that the type of containment, whether trophic (metabolic) or semantic (control of genetic information flow) did not influence the analysis of any particular option. This is especially relevant in thinking about public views of the science. In that context, we looked at roles for each stakeholder group to contribute to fulfilling those options.

  • For researchers (both academic and in the wider community) looking for a regulatory approval, case-by-case is in fact a burden, and it would be preferable to identify specific properties for regulators to consider. For example, the ability to use a standardised circuit, instead of needing to characterise a promoter every time, would be a significant benefit. It was also highlighted that taking into consideration real-world community behaviour is critical when setting standards.
  • End users, particularly those from industry, frequently provide a push for new and more diverse products. Would the obligatory use of standards decrease product diversity? Potentially, with respect to ease of approval and potentially public acceptance, this could be a good thing. But also noted were past attempts to make products more standardised and uniform, such as in the crop variety and seed market, that led to a dramatic decrease of biodiversity which entailed an increase in pesticides.
  • For those in the group with expert knowledge of risk assessment, there was agreement that there is simply nothing novel to pull from experiences in synthetic biology risk assessment that is any different from the knowledge garnered over 30 years of working with GMOs. Each case will require a characterization to identify any new gap in knowledge.
  • Regulators had a clear view: any harmonization is beneficial to them. Their view further is that such consistency is helpful as well in justifying decisions to the public, and builds trust.

Standards are a product of the community, not of top-down decision-making, and in principle everyone may contribute to the standardisation process. One of the goals of the workshop was to provide an initial look at the concept of a central (online) repository (a “one-stop shop”) that would collect and make available information about useful biosafety systems, for example, the use of standards to assure safe chassis. The participants were supportive about the value of the concept as a way to assist the community in being more closely involved in the setting and use of standards.

Text by: Michele Garfinkel (EMBO), May 2020

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