The Seven Stones

Oversight framework for the DNA-synthesis industry


Last April, the US National Science Advisory Board for Biosecurity issued a draft report on Biosecurity (see post below). One point of criticism expressed with regard to this report was that it did not address explicitly concerns specific to synthetic biology.

In a Commentary published in Nature Biotechnology (Bügl et al, 2007), a panel of scientists, executives from the DNA-synthesis industry and members of the US FBI present now their views and concrete recommendations on measures required for an efficient and practical oversight of DNA-synthesis activities.

Rapid progresses in DNA-synthesis technologies are increasingly challenging the current safety measures and oversight mechanisms that were tailored for recombinant DNA technologies (Berg et al, 1975). Two major sources of concerns are expressed by the authors with regard to the combination of facile DNA-synthesis, very short delivery time and internet-based communication: 1) the processes of design, assembly and use of engineered genetic material can be “decoupled” and performed in a fragmented way across different locations, rendering tractability of the overall process difficult; 2) DNA-synthesis may provide a workaround strategy to circumvent the existing physical barriers and containment strategies that currently regulate access to pathogens.

The goals of the proposed oversight framework are listed as follows in Bügl et al:

First, the framework should promote and later compel responsible behavior on the part of users of DNA-synthesis technology. Second, the framework should be sufficiently simple and robust be adopted as best practice throughout industry. Third, the framework should enable common improvement of needed technologies and promote sharing of operational wisdom throughout industry and government. Fourth, the framework should build on the existing practices that have enabled the safe development and application of recombinant DNA technology over the past three decades. Finally, the framework should foster and support international transparency and cooperation.

To achieve these objectives, the authors suggest an initial scheme on how users, industry and government may interact to implement the proposed framework. At the individual level, customers should identify themselves, provide relevant biosafety information and observe local accountability mechanisms. At the corporate level, companies would implement state-of-the-art screening methods and directly cooperate with governments to identify suspicious DNA orders.

In addition, a group of DNA-synthesis companies have formed an “”“>International Consortium for Polynucleotide Synthesis” (ICPS), of which some authors are member, and is proposed to serve as an interface between government agencies and synthetic biology companies.

see also: NSABB Report “Addressing Biosecurity Concerns Related to the Synthesis of Select Agents” (pdf download)


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