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HHS Screening Framework Guidance for Providers and Users of Synthetic Nucleic Acids

S3: Science Safety Security

The HHS Screening Framework Guidance for Providers and Users of Synthetic Nucleic Acids was drafted to address advances in synthetic biology that have occurred since the HHS Screening Framework Guidance for Providers of Synthetic Double-Stranded DNA was first issued in 2010. This guidance sets forth recommended baseline standards for the gene and genome synthesis industry (providers) and for manufacturers of benchtop nucleic acid synthesis devices. It also details best practices for customers of synthetic nucleic acids (i.e., institutions, principal users, end users, and third-party vendors) regarding screening orders for sequences of concern and for responsibly handling the use and transfer of synthetic nucleic acids containing sequences of concern. In addition, this guidance seeks to encourage best practices to address biosecurity concerns associated with the potential misuse of synthetic nucleic acids to bypass existing regulatory controls.

This guidance has several significant updates from the 2010 guidance that address advances in synthetic biology. The 2010 guidance limited its recommendations to providers of synthetic double-stranded DNA and recommended that they screen orders to detect 200 base pair or longer sequences that are unique to regulated agents (i.e., Biological Select Agent or Toxin or Commerce Control List agents). The revised guidance seeks to minimize risks posed by advances in biotechnology and changes in the commercial landscape for synthetic nucleic acids by expanding the scope of its recommendations to include:

  • A definition of Sequences of Concern (SOCs) that includes all sequences that contribute to pathogenicity or toxicity, whether from regulated or unregulated agents;
  • Best practices for all entities involved in the synthesis, use, and transfer of nucleic acids containing SOCs (i.e., providers and customers);
  • Best practices for manufacturers of benchtop nucleic acid synthesis equipment and institutions where they are used;
  • Recommendations for screening orders over a smaller screening window – 50 nucleotides; and
  • Recommendations for screening orders of all types of synthetic nucleic acid orders (i.e., single- and double-stranded forms of DNA and RNA).

To address concerns associated with advances in synthetic biology that have emerged since 2010, the guidance recommends an expanded definition of SOCs. This definition includes all sequences that contribute to pathogenicity or toxicity, whether from regulated agents (i.e., Biological Select Agent or Toxin or Commerce Control List agents) or unregulated agents – as soon as it is practical to do so. To ensure that synthetic genetic materials containing SOCs are distributed and used responsibly, the guidance also recommends that customers (i.e., principal users and end users) and providers and third-party vendors verify the legitimacy of each recipient of nucleic acids containing SOCs – and that all parties maintain records of SOC transfers. The guidance also recommends that manufacturers of benchtop nucleic acid synthesis equipment identify SOCs in nucleic acids prior to their synthesis and verify the legitimacy of their customers.

This Companion Guide to the HHS Screening Framework includes additional explanations and potential scenarios that are intended to assist customers, providers, and manufacturers in implementing the recommendations in the guidance, and the FAQ answers commonly asked questions.

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