生物多样性 ›› 2012, Vol. 20 ›› Issue (2): 138-150.DOI: 10.3724/SP.J.1003.2012.13205

• 综述 • 上一篇    下一篇

合成生物学生物安全风险评价与管理

关正君1,2, 裴蕾3, 马库斯·施密特3, 魏伟1,*()   

  1. 1 中国科学院植物所环境与植被变化国家重点实验室, 北京 100093
    2 运城学院生命科学系, 山西运城 044000
  • 收稿日期:2011-11-08 接受日期:2012-02-22 出版日期:2012-03-20 发布日期:2012-04-09
  • 通讯作者: 魏伟
  • 作者简介:* E-mail: weiwei@ibcas.ac.cn
  • 基金资助:
    中国国家自然科学基金(30811130544);奥地利科学基金;“中国-奥地利合成生物学生物安全的合作研究”(I215-B17)

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)

摘要:

合成生物学(synthetic biology)已迅速发展为生命科学最具发展潜力的分支学科之一, 但它同时也会给生态环境和人类健康带来潜在的风险。结合国内外合成生物学发展现状, 本文综述了基因回路(DNA-based biocircuits)、最小基因组(minimal genome)、原型细胞(protocells)、化学合成生物学(chemical synthetic biology)等涉及的风险评价、合成生物学与生物安全工程(biosafety engineering)、合成生物学对社会伦理道德法律的影响以及当前热点议题, 如生物朋(黑)客(biopunk (or biohackery))、家置生物学(garage biology)、DIY生物学(do-it-yourself biology)、生物恐怖主义(bioterrorism)等方面的新进展。分析讨论了世界各国合成生物学以自律监管或技术为主的安全管理原则和基于5个不同政策干预点的5P管理策略的合理性与潜在不足。同时结合我国合成生物学当前研究进展以及现有的安全管理规范, 提出了建立以安全评价为核心的法规体系、生物学生物安全规范以及加强研发单位内部管理和生物安全科普宣传等我国合成生物学安全管理制度与措施等建议。

关键词: 合成生物学, 生物安全, 生物安保, 风险评价, 风险管理

Abstract

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