The Department of Health (HHS) hasissued a guidance document with recommended baseline standards for companies providing synthetic double-stranded DNA (dsDNA) to effectively screen orders so they comply with U.S. regulations and encourage best practices in addressing biosecurity concerns associated with potential misuse of their products.
Titled “Screening Framework Guidance for Providers of Synthetic Double- Stranded DNA,” the document is intended to “reduce the risk that individuals 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’s) Commerce Control List (CCL).”
The screening framework protocols, which became effective October 13, 2010, consist of customer screening, sequence screening and follow-up screening. Customer screening involves customer verification and the identification of any “red flags”; sequence screening, “which identifies whether a requested sequence is a ‘sequence of concern,’ is intended to serve as a trigger for further follow-up screening and does not by itself provide a basis for determining whether an order poses a risk. Providers should screen all orders of dsDNA.” According to HHS, follow-up screening aims to “verify the legitimacy of the customer and principal user, to confirm that the customer and principal user placing an order are acting within their authority, and to verify the legitimacy of the end-use.” See Federal Register, October 13, 2010.