The Convention on Biological Diversity (CBD) pioneered the discussion on synthetic biology at the global level, with the vast majority of countries asking for the full application of precaution. Following the decisions taken at the twelfth meeting of the Conference of the Parties (COP 12) to the Convention and the report and recommendations of the Ad Hoc Technical Expert Group (AHTEG) on Synthetic Biology in 2015, the CBD still has a great deal of work to do on the issue. Above all, it must continue to lead in pointing out the risks, i.e., potential harms, and calling for the strict application of the precautionary principle.
Synthetic biology includes a number of modern biotechnology techniques, including many developed from standard genetic engineering. However, it goes beyond them in its use of human-made, computer-generated and often highly novel DNA, RNA and amino acids. Synbio processes are frequently automated enabling the production of thousands of slight variations on one organism with unpredictable consequences.
Synbio also involves the attempt to completely redesign metabolic pathways in ways that may never have existed before. Basically, this means that there is nothing to which the results can be compared, leading in turn to new risks and uncertainties that cannot be predicted. Synbio includes attempts to ‘redesign’ organisms that are critical to Earth systems, such as cyanobacteria, and turn them into production factories for novel fuels. Obviously there are serious risks if these escape into ecosystems.
Another major cause for concern is the rapid development of so called ‘gene drives’, an attempt at population engineering or ‘editing’. The Convention may well consider these an appropriate object of study and concern, because of their potentially profound and irreversible impacts on biodiversity.
It is difficult enough to assess the risks around genetic engineering, but synthetic biology greatly increases the level of complexity and the number of unknowns involved. Furthermore, we have no experience of how to deal with this. There have been no assessments to date; and there is no guidance or methodology for carrying out such assessments adequately.
Yet industry claims that synthetic biology will yield billions of dollars and does not need special regulation. They even want exemption from current biosafety rules. The largest energy, chemical, pharmaceutical and agribusiness corporations are involved, and certain governments have already decided that synthetic biology will be a major area of investment. Proponents often claim that new techniques enable greater precision, but it is important to remember that this does not make the impacts more predictable.
Faced with these challenges, the CBD has a special responsibility to act decisively in the public interest for the protection of biodiversity. Governments, populations and regulators need time to understand and assess the many implications of synthetic biology. For example, synthetic biology could generate novel kinds of invasive alien species on a scale that we have not seen previously. We cannot allow pressure from economic interests to increase risks to biodiversity and its sustainability.
ENSURE PROPER RISK ASSESSMENT
We need to ensure that proper risk assessments will be undertaken that take into account all affected Parties. Thus, if synthetic vanilla were to be produced in one country and consumed there or in another, the impact on vanilla growers and biodiversity where vanilla is produced would also have to be taken into account. Parties have an obligation to protect the socio-economic, cultural and ecological role of peasant farmers and indigenous peoples – such as vanilla growers – in maintaining biodiversity and related livelihoods.
The approach taken throughout the AHTEG on Synthetic Biology to keep in mind all three objectives of the Convention is to be welcomed. So is the opinion expressed by the AHTEG that both living organisms and non-living products and components could adversely affect the achievement of those three objectives. Also welcome is the recognition that indirect effects must be taken into account.
However, the absence of representatives of indigenous peoples and local communities in the AHTEG is a major gap, and their views and perspectives must be sought and incorporated in any CBD decision, through discussions at meetings of 8(j) or other forums that they consider appropriate. It is also essential that they should have the space to reflect and to discuss the issues in a manner and on a timescale defined by them.
While the discussion within the CBD proceeds, it is vital to ensure that existing mechanisms and regulations that apply to Synthetic Biology are not overlooked. Living organisms derived from Synthetic Biology should be defined as LMOs according to the definition of the Cartagena Protocol on Biosafety and thus fall under its scope and obligations. They must also come under the scope of the CBD, especially with regards to socio-economic impacts.
Should they not fall under the definition of the Cartagena Protocol, the use of such organisms should be prohibited until regulation is in place that would ensure that no such organisms would be used or released that could lead to severe negative impacts on biodiversity, livelihoods, food security, also taking into account human health.
Finally, CBD deliberations on this topic should be guided by four central elements: the precautionary principle; the relevance of both living and non-living components and products of synthetic biology; the potential impacts of organisms, components and products on the three objectives of the Convention and the obligations of the Parties to the Convention; and, finally, consideration of indirect as well as direct effects, also taking into account full life cycle analysis.