Public consultation on the Preliminary Opinion on Synthetic Biology II - Risk assessment methodologies and safety aspects

This opinion answers the questions regarding the implications of likely developments in SynBio on human and non-human animal health and the environment and determining whether existing health and environmental risk assessment practices of the European Union for GMOs are adequate for SynBio.

Final Opinion on
Synthetic Biology II
Risk assessment methodologies and safety aspects

This Opinion concentrates on the methodology to determine what, if any, risks synthetic biology (SynBio) may potentially pose to public health. It addresses five questions focused on the implications of likely developments in SynBio on human and animal health and the environment and on determining whether existing health and environmental risk assessment practices of the European Union for Genetically Modified Organisms (GMOs) are also adequate for SynBio. Additionally, the SCs were asked to provide suggestions for revised risk assessment methods and risk mitigation procedures, including safety locks.

Final opinion

A public consultation on this Opinion was opened on the website of the non-food scientific committees between 19 December 2014 and 3 February 2015. Information about the public consultation was broadly communicated to national authorities, international organisations and other stakeholders.

20 organisations and individuals from universities, institutes of public health, industry representatives, NGOs and public authorities, participated in the public consultation providing 72 comments.

Each submission was carefully considered by the Scientific Committees and the scientific Opinion has been revised to take account of relevant comments. The literature has been accordingly updated with relevant publications.

Results of the public consultation

Content of the opinion:

In Opinion II, the three Scientific Committees evaluate risk assessment methodology of contained use activities and activities involving the deliberate release of GMOs that are built on the principles outlined in Directives 2001/18/EC and 2009/41/EC and in the 'Guidance notes' published in Commission Decision 2000/608/EC.

As SynBio shares several methodologies and tools with genetic engineering, the framework for risk assessment of new SynBio developments may be addressed using current methodology used for GMO risk assessment. However, there are specific cases in which new approaches may be necessary, which are detailed in the Opinion.

Though present risk assessment methodologies are appropriate for assessing potential risks of SynBio activities and products, the Scientific Committees suggest several improvements to ensure continued safety protection proportionate to risk, while enabling scientific and technological advances in the field of SynBio.

Currently available safety locks used in genetic engineering are not yet sufficiently reliable for SynBio. Notably, SynBio approaches that provide additional safety levels, such as genetic firewalls may improve containment compared with classical genetic engineering. However, no single technology solves all biosafety risks and many new approaches will be necessary.

The Scientific Committees recommend a clear strategy for the analysis, development, testing and prototyping of applications based on new forms of bio-containment and additional layers of containment using orthogonal systems.