Gronvall Gigi Kwik
Center for Biosecurity of the University of Pittsburgh Medical Center, 621 East Pratt Street, Baltimore, MD 21202, USA.
Biosecur Bioterror. 2010 Dec;8(4):373-6. doi: 10.1089/bsp.2010.0127.
Synthetic biology has advanced to the point where some pathogens can be manufactured from scratch. This technical leap has beneficent implications for medical research and vaccine design, but it also raises concerns that the technology could be used to produce a deadly pathogen for nefarious use. Addressing these concerns, the Department of Health and Human Services (HHS) released their Screening Framework Guidance for Providers of Synthetic Double-Stranded DNA on October 13, 2010. They took the right approach: The oversight framework for gene synthesis companies included in this guidance is adaptable to new technical developments and changing risks, it can be implemented immediately, it can be readily adopted by other countries, and it will cost little. Though there have been some calls to increase the regulatory controls on synthetic biology, these should be resisted. For now, at least, the oversight is appropriate to the risks.
合成生物学已经发展到可以从零开始制造一些病原体的阶段。这一技术飞跃对医学研究和疫苗设计具有有益的影响，但也引发了人们的担忧，即该技术可能会被用于制造致命病原体以达到邪恶目的。为解决这些担忧，美国卫生与公众服务部（HHS）于2010年10月13日发布了针对合成双链DNA供应商的筛查框架指南。他们采取了正确的方法：本指南中包含的基因合成公司监管框架能够适应新的技术发展和不断变化的风险，可以立即实施，能够被其他国家轻易采用，而且成本很低。尽管有人呼吁加强对合成生物学的监管控制，但应该抵制这些呼声。至少目前，监管与风险是相适应的。
