The Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS) has issued a Request for Information (RFI) pertaining to the agency’s 2010 framework for providers of synthetic double-stranded DNA (dsDNA). This framework aims to mitigate the potential biosecurity risks of certain dsDNA products being exploited for nefarious purposes. HHS is inviting public comments on whether the 2010 guidance, Screening Framework Guidance for Providers of Synthetic Double-Stranded DNA, should be modified to address new and emerging developments in the field of synthetic biology over the past decade, and if so, what specific changes should be made.
The primary goal of the Screening Framework Guidance is to minimize the risks and harms that could result from individuals with malicious intent obtaining access to materials included on the Select Agents and Toxins list maintained by HHS and the U.S. Department of Agriculture (USDA), or agents on the U.S. Department of Commerce’s Commerce Control List. The guidance is directed at commercial providers of dsDNA products and includes recommendations for screening both dsDNA customers and the nucleic acid sequences of the dsDNA products themselves for potential concern. As technologies associated with dsDNA production, manipulation, and expression have advanced significantly since 2010, the Screening Framework Guidance is now being revisited to assess what updates, if any, need to be made. HHS is interested in public input on the following areas, with additional details available in the Federal Register Notice for this RFI:
- Scope of the Guidance
- Sequence Screening
- Biosecurity Measure
- Customer Screening
- Minimizing Burden of the Guidance
- Technologies Subject to the Guidance
Researchers who use synthetic dsDNA in their work may be specifically interested in and well-positioned to answer questions related to Sequence Screening (i.e. what technical approaches or bioinformatics tools could be incorporated into the guidance to improve and strengthen its implementation and efficacy), Minimizing Burden of the Guidance (i.e. what challenges, if any, have researchers as customers faced in obtaining dsDNA for their work because of the Screening Framework Guidance), and Technologies Subject to the Guidance (i.e. do any nucleic acid based materials other than dsDNA or novel technologies pose similar biosecurity risks and merit inclusion in the Screening Framework Guidance).
Responses to this RFI must be submitted no later than 12:00 PM ET on October 25, 2020. Comments should be submitted through a web form on the Screening Framework Guidance site, linked below.
Sources and Additional Information
Full details about this RFI are available in the Federal Register, available at https://www.federalregister.gov/documents/2020/08/26/2020-18444/review-and-revision-of-the-screening-framework-guidance-for-providers-of-synthetic-double-stranded.
The current Screening Framework Guidance for Providers of Synthetic Double-Stranded DNA is available at https://www.phe.gov/Preparedness/legal/guidance/syndna/Documents/syndna-guidance.pdf.
The submission form for responding to this RFI is available on the Screening Framework Guidance for Providers of Synthetic Double-Stranded DNA website at https://www.phe.gov/syndna/update2020.