Can a new model help governance keep up with synthetic biology?

Synthetic biology is moving at a rapid pace, and regulations will need to keep up to allow useful technologies to hit the market while maintaining a high standard of safety. Since most policymakers are not experts in all of the newest synthetic biology technologies, better analysis tools are needed to understand how to react. So two researchers, Christopher Cummings and Jennifer Kuzma, from North Carolina State University and Nanyang Technological University built a model to determine how to prepare for handling the regulation new synthetic biology products.

Building a model for governing new synbio technology

This model for assessing risks of new synthetic biology technologies is called Societal Risk Evaluation Scheme (SRES) and it tries to make governance more anticipatory than just reactive. This is a tough problem. How do we predict the risks of technologies that don’t exist yet? How do we assess products that seem totally new? The field of synthetic biology is pushing the boundaries of what we can do with and to biology.

To create the model the researchers used a Delphi study, which is a structured way of developing forecasts and assessments using a panel of experts. Their Delphi study used four rounds: 1) Standardized open-ended interview to get qualitative data. 2) Online quantitative survey using questions formed using rounds 1. 3) A face-to-face workshop to discuss an ideal governance. 4) A final online survey to gauge opinions on the factors that would affect governance schemes identified in round 3. Experts had backgrounds in academic research, government, industry and non-governmental organization positions that deal with the technological, policy or legal aspects.

Of ten potential case studies, the four cases presented to the expert panel were “biomining using highly engineered microbes in situ, cyberplasm for environmental detection, de-extinction of the passenger pigeon, and engineered plant microbes to fix nitrogen on non-legumes”.

Assessing the potential risks from synbio

As experts evaluated case studies and developed potential governance structures, they had to determine potential risks of new synthetic biology technologies.

For the SRES, the expert users evaluated information for eight categories:

1. Human health risks;
2. Environmental health risks;
3. Unmanageability;
4. Irreversibility;
5. The likelihood that a technology will enter the marketplace;
6. Lack of human health benefits;
7. Lack of environmental benefits; and
8. Anticipated level of public concern.

This visual representation above makes all eight categories into an octagon on which current assessments of risk can be mapped using numerical scores for each category.

How SRES might be actually be used

The SRES model is foremost a tool and not a formula for exactly what should be done. However, a tool that can start to identify the key problems and potential actions would be extremely useful for evaluating technologies that seem totally new to regulators. In a press release co-author Jennifer Kuzma said, “Governance can take many forms, from public engagement efforts to the development of regulations, but in order to determine what measures may be necessary, groups need to first identify relevant research, dialogue and information needs”.

Hopefully governments and organizations make use of models like SRES to do more anticipatory actions rather than just reactions to a problem. A key aspect could be identifying synthetic biology topics that need more public engagement. There are efforts like Building with Biology to engage the public but there isn’t time or resources to discuss every possible synbio technology. By taking a broad view, tools like SRES can help us identify key areas to work on in policy and outreach.

Read the paper for yourself.

Cummings, Christopher L., and Jennifer Kuzma. “Societal Risk Evaluation Scheme (SRES): Scenario-Based Multi-Criteria Evaluation of Synthetic Biology Applications.” PLoS One 12.1 (2017): e0168564.