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18    | December 2010 | Realising European potential in synthetic biology 

EASAC

to enumerate the degree of risk for new developments. 

Inevitably, this would be a crude tool but might be useful 

to distinguish remote risks from more immediate ones.

As noted by the European Group on Ethics (EGE, 

Appendix 2), it is important for the European Commission 

to compile information on current risk assessment 

procedures in the EU as a basis for determining if there 

might be gaps in regulation that need to be addressed in 

preparation for the advent of novel products developed 

using the methods of synthetic biology. Safety of different 

product classes would fall within the relevant legislation 

previously established (see chapter 7), taking account 

of the concomitant need, where it exists, to develop 

international standards and procedures.

6.3 Biosecurity

The procedures for ensuring biosafety will not protect 

against those whose objective is to misuse biosciences. 

Policy-makers in the EU have been less active than in the 

USA in considering the issues for biosecurity. An early 

Central Intelligence Agency (CIA) report (2001) warned 

that synthetic biology could produce engineered agents 

worse than any disease known to man and proposed 

that a qualitatively different working relationship was 

now required between the intelligence and biological 

sciences communities. Some in the scientifi c community 

doubt that this is a real threat, if only because it would 

be much easier to misuse natural pathogens. Because 

a pathogen has numerous characteristic properties 

(pathogenicity, infectiousness, host specifi city), it is usually 

assumed to be unlikely that new pathogens could be 

created synthetically, but rather that existing pathogens 

might be modifi ed (for example, so as to be resistant to 

antimicrobial agents).

The Swiss Academy concluded that ‘The possibility 

of the abusive and criminal application of synthetic 

biology, for example, for bioterrorism, is negligible.’ 

Despite this scepticism, it is sensible to consider what 

steps could be taken to improve biosecurity. From 

the academies’ perspective, the focus on synthetic 

biology can be informed by the previous InterAcademy 

Panel (IAP) statement on biosecurity, which presents 

principles to guide individual scientists and scientifi c 

communities, elaborating a code of conduct to reduce 

the risks that bioscience research could be misused 

(Box 1).

Subsequent to this IAP statement, individual academies 

have catalysed further debate. For example, the Royal 

Netherlands Academy of Arts and Sciences (2009) 

published a proposal for a national code of conduct in 

central to the GM agriculture debate when public/non-

governmental organisation (NGO) concerns prevented 

the widespread application of GM crops in Europe. 

Potentially, some of these concerns could be allayed 

if synthetic organisms were modifi ed such that they 

could only survive on substrates not found in nature. 

However, the potential for horizontal gene transfer and 

for evolution to escape design constraints is diffi cult to 

quantify. Until a synthetic organism is demonstrated 

to be harmless, it should be handled with high safety 

requirements, adapted from those already in place 

for uncharacterised microbes and existing genetically 

modifi ed organisms (GMOs) and subject to the well-

established systems of regulation in place at the EU and 

national level.

As discussed in the German Statement, in cases 

of high complexity and uncertainty, application of 

the precautionary principle necessitates spatial and 

temporal containment of experiments together with 

close monitoring and problem-oriented fl exibility. It is 

reasonable to assume that the current management 

systems can serve as a basis for regulating synthetic 

biology research proportionately to risk. The recent 

updating of the guidelines from the US National Institutes 

of Health (NIH) for research involving recombinant DNA, 

to bring synthetic biology within the present framework 

of procedures for safety, assessment and management

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provides a very timely stimulus for updating EU legislation. 

In the NIH view, replication is the unique risk characteristic 

of synthetic biology so that an exemption can be made 

in the guidelines for non-clinical research using synthetic 

nucleic acids that cannot replicate.

It should also be appreciated, however, that the 

increasingly easy access to DNA sequences will lead to 

the adoption of the techniques of molecular biology by 

other disciplines, such as engineering, where there is 

little experience in dealing with biological agents. It is 

important to ensure consistent standards of scientifi c 

management as well as education for those who join the 

community.

Although risk assessment should not be fundamentally 

different for synthetic biology than for other recombinant 

DNA research, assessment may be challenging for 

some of the products of synthetic biology, given the 

diversity of scientifi c approaches currently used such as 

minimal genomes, DNA-based biocircuits and protocells. 

Unsuspected interactions might produce new properties 

for artifi cial systems. It is desirable to develop the 

framework in advance to assess risk and benefi t together 

although this is a demanding task when both benefi t 

and risk are unquantifi ed and, as at present, intangible in 

some respects. A ‘calculus of risk’ has been proposed

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24  

The NIH guidelines are at http://oba.od.nih.gov/rdna/rdna.html.

25 

G Poste, cited in Ball (2004).

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