Synthetic Biology | Recommendations
71
(OECD 2014). The measures established by the IGSC seem appropriate to minimise potential risks and should
be mandatory for all companies providing SB material.
Safety and security
Control measures to protect people and the environment from exposure to SB organisms must be specified.
Given the state-of-the-art, the current focus should be on the protection of staff working in SB laboratories
and in measures to ensure confinement of the organisms under investigation. All regulatory measures for
working with genetically modified organisms fully apply to SB organisms.
Establishment of containment strategies
To prevent the unintended release of SB organisms into the environment, and to avoid adverse effects of
deliberate or accidental release of SB organisms, adequate containment strategies, including the proper
disposal of waste, have to be put in place, strictly fulfilling the EU regulatory framework and relevant
national legal requirements. On the international level, if no appropriate measures are yet foreseen, it is
recommended to adhere to the relevant National Institutes of Health NIH Guidelines for Research Involving
Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) for physical containment. Generally,
biological containment strategies are not recommended, as single strategies may be too weak and not
reliable and the use of multiple strategies may lead to failure of the containment due to its complexity.
Worker safety
The baseline governing worker safety is the relevant EU or national standards. However, care should be
taken whether unique risks and challenges posed by SB organisms to human health (e.g., unintended
exposure due to aerolisation) potentially trigger the need to augment existing workplace safety procedures
and standards.
Training needs
An important aspect of risk mitigation is to ensure proper training of staff and fitting to the individual tasks.
The multidisciplinarity of the field brings along that not all persons involved have had biological training.
Therefore, the establishment of appropriate training standards is of pivotal importance. Staff dealing with
SB material has to undergo comprehensive biosafety instruction that should follow the relevant EU and/or
national standards.
Possibility to track SB organisms
Traceability of SB organisms could be ensured by obligatory integration of “watermark” sequences into
synthetic genomes, which can then be targeted by a specific PCR reaction. SB organisms can thus be labelled,
and potential unintentional releases could be tracked by standard molecular detection methods.
Synthetic Biology | References
72
8
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