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| 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
25
24
The NIH guidelines are at http://oba.od.nih.gov/rdna/rdna.html.
25
G Poste, cited in Ball (2004).