Synthetic biology is a multidisciplinary field involving the design, modification, and creation of biological systems and holding broad promise to continue advancing both basic and applied research, in areas ranging from materials science to molecular medicine. However, synthetic nucleic acids and associated technologies may also pose risks if misused.
To balance the potential of synthetic biology with the risk that individuals or organizations with ill intent may exploit the application of nucleic acid synthesis technology to obtain genetic material derived from or encoding
Select Agents or Toxins and, as applicable, agents on the Export Administration Regulations' (EAR)
Commerce Control List (CCL), the U.S. Government issued the
Screening Framework Guidance for Providers of Synthetic Double-Stranded DNA (Guidance) in 2010, providing a framework for screening synthetic double-stranded DNA (dsDNA) orders.
The Guidance was developed in light of providers’ existing protocols, to be implemented without unnecessary cost and to be globally extensible, both for U.S.-based providers operating abroad and for international providers. Rapid and continued advances in nucleic acid synthesis and synthetic biology applications necessitate periodic review of associated risks and mitigation measures.
To determine how risk mitigation measures should be balanced with the need to support both scientific progress and the success of the U.S. biotechnology enterprise, ASPR will issue a Request for Information for the
Review and Revision of the Screening Framework Guidance for Providers of Synthetic Double-Stranded DNA in the U.S. Federal Register, on August 26, 2020. Over the next 60 days, we invite public comments on whether, and, if so, how the Guidance could be updated to mitigate the risks associated with nucleic acid synthesis technologies. More specifically, we are seeking public input on changes that would either expand or limit the following areas:
- Scope of the Guidance
- Sequence Screening
- Biosecurity Measures
- Customer Screening
- Minimizing Burden of the Guidance
- Technologies Subject to the Guidance
Comments on other related topics will also be considered.
Responses must be submitted through SUBMIT COMMENTS button.
