Biodiv Sci ›› 2012, Vol. 20 ›› Issue (2): 138-150.  DOI: 10.3724/SP.J.1003.2012.13205

• Reviews • Previous Articles     Next Articles

Assessment and management of biosafety in synthetic biology

Zhengjun Guan1,2, Lei Pei3, Markus Schmidt3, Wei Wei1,*()   

  1. 1 State Key Laboratory of Vegetation and Environmental Change, Institute of Botany, CAS, Beijing 100093, China
    2 Department of Life Sciences, Yuncheng University, Yuncheng, Shanxi 044000, China
  • Received:2011-11-08 Accepted:2012-02-22 Online:2012-03-20 Published:2012-04-09
  • Contact: Wei Wei
  • Supported by:
    NSFC(30811130544);Fonds zur F?rderung der Wissenschaftliche Forschung;Investigating the Biosafety and Risk Assessment Needs of Synthetic Biology in Austria and China, FWF(I215-B17)


While having developed into one of the most dynamic fields of the life sciences, synthetic biology may pose potential risks to the environment and human health. Based on current national and international risk assessment methods and current regulation of synthetic biology, we reviewed risk assessment in relation to synthetic biology’s research subfields (such as DNA-based biocircuits, minimal genome, protocells and chemical synthetic biology), its relation with biosafety engineering, its effect on ELSI (Ethics, Legal and Social Implications) and recent biosecurity challenges, such as biopunk (or biohackery), garage biology, do-it-yourself biology and bioterrorism. Additionally, we investigated existing strategies for management of synthetic biology research, focusing on self-regulatory or technology-focused methods and using the 5P (the principal investigator, the project, the premises, the provider of genetic material and its purchaser) strategy focusing in five different policy intervention points. Furthermore, we reviewed the current research and development of synthetic biology and its current biosafety regulations in China. Finally, we recommended management strategies to guide future research in synthetic biology with necessary amendments, including the establishment of regulations with a core of safety assessment, synthetic biology-specific good laboratory practice guidelines, and arguments for the reinforcement of internal regulation at the institution level and more active public outreach efforts for biosafety.

Key words: synthetic biology, biosafety, biosecurity, risk assessment, risk management