Policy on the Ordering or Provision of Synthetic Nucleic Acids in the IRP

IRP researchers responsible for ordering synthetic nucleic acids as Customers, or Providing synthetic nucleic acids, in the course of their NIH research program, must adhere to this NIH Policy which is based upon the Office of Science and Technology Policy’s (OSTP) "Framework for Nucleic Acid Synthesis and Screening." The Framework states:

"As the building blocks for life, nucleic acids underpin much of research and development in the life sciences, thereby serving as a critical control point allowing industry to ensure beneficial usage and minimize the risk of misuse."

The purpose of this Policy is to ensure that NIH staff are complying with the US Government’s measures to mitigate the biosafety and biosecurity risks of potential misuse of synthetic nucleic acids.

Definitions

For other relevant definitions, please refer to the OSTP “Framework for Nucleic Acid Synthesis Screening”

Customer: The individual or entity (such as NIH) that orders or requests synthetic nucleic acids from a Provider, or that purchases nucleic acid synthesis equipment from a Manufacturer.
Providers: An entity that synthesizes and distributes synthetic nucleic acids. Providers may provide nucleic acids to a customer or third-party vendor. A Provider is understood to be synthesizing and distributing nucleic acids as a transactional service, rather than as a research scientist collaborating with a colleague.
Sequences of Concern (SOC): A nucleotide sequence or its corresponding amino acid sequence that is a Best Match to a sequence of federally regulated agents (i.e., the Biological Select Agents and Toxins List (BSAT), or the Commerce Control List (CCL)), except when the sequence is also found in an unregulated organism or toxin.
Covered Synthetic Nucleic Acids: DNA or RNA, single- or double-stranded, 200 nucleotides (including the corresponding amino acid sequence, if applicable) or longer that has been synthesized de novo and are used for research purposes.
Manufacturer: An entity that produces and distributes benchtop equipment for synthesizing nucleic acids. Manufacturers may provide equipment to a customer or third-party vendor.
Benchtop Nucleic Acid Synthesis Equipment: Benchtop nucleic acid synthesis equipment sold by Manufacturers that is intended to be used to synthesize nucleic acids for use within a research laboratory or within an institution. While this nucleic acid synthesis equipment may not be small enough to be placed on a benchtop (e.g., it sits on the laboratory floor), it is still considered benchtop equipment if it is sold with the intent that it will be used by researchers individually or in a core facility in an institution.

NIH IRP Policy

NIH intramural researchers must comply with the OSTP “Framework for Nucleic Acid Synthesis Screening.”

NIH IRP researchers serving as Customers of Providers or Manufacturers may only order synthetic nucleic acids from a Provider or benchtop nucleic acid synthesizing equipment from a Manufacturer that has attested to adhering to the OSTP Framework.
NIH IRP facilities or laboratories serving as Providers of nucleic acids must:
1. Attest to implementing the Framework by stating so on a public website;
2. Screen orders against an appropriate SOC database;
3. Screen Customers who order SOCs to verify legitimacy;
4. Report potentially illegitimate purchase orders;
5. Retain screening records for 3 years; and,
6. Maintain cybersecurity of screening records.
Effective Date: NIH researchers must comply with this Policy, effective April 26, 2025. This policy will be updated to add additional requirements following [the 2026] updates to the OSTP Framework.

NIH intramural researchers with questions about this Policy may contact AIRIO@od.nih.gov or their DOHS Safety & Health Specialists.

Resources

This page was last updated on Wednesday, October 23, 2024