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HHS Guidance on Synthetic DNA Is the Right Step

Gigi Kwik Gronvall
Date posted:
December 10, 2010
Publication type:

Biosecur Bioterror 2010;8(4):373-376

Mary Ann Liebert, Inc.
Open access
See also:

Article available on publisher’s site: HTML • PDF


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.



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