For Customers
This page provides information for individuals or entities (Customers) that order or request synthetic nucleic acids from providers of synthetic nucleic acids (Providers) or that purchase benchtop nucleic acid synthesis equipment from manufacturers (Manufacturers) to comply with the US Framework for Nucleic Acid Synthesis Screening (Framework). The Framework documents established that federal funding agencies will, as appropriate and consistent with applicable law, require that procurement of synthetic nucleic acids and benchtop nucleic acid synthesis equipment using federal life sciences funding be conducted through Providers and Manufacturers that adhere to the Framework.
Update:
The Framework is the result of Executive Order 14110 (October 30, 2023) (EO 14110), which was rescinded on January 25, 2025. EO 14110 tasked federal funding agencies with setting a funding requirement for federally funded entities that synthetic nucleic acid is purchased only from Providers or Manufacturers who adhere to the Framework. According to the Biden administration, federal funding agencies met that requirement, and at least two public documents from the NIH and DOE confirm that. These documents explicitly reference the Framework, which is still live on the ASPR website as of May 2025.
The Executive Order (EO) signed May 5, 2025, Improving the Safety and Security of Biological Research, calls for a revision or replacement of the Framework within 90 days. The EO still calls for agencies to tie Framework compliance to federal funding. It also calls for actions to expand the Framework to non-federally funded entities and requiring the inclusion of enforcement mechanisms for non-compliance with the Framework. There was no explicit mention of the rescinding of the previous Framework at this time.
For a printable version of the following information, see:
Customers: Actions for Compliance (PDF)
Please note: If you are a biofoundry, cloud lab, core facility/academic core facility, or contract research organization (CRO) that “synthesizes and distributes synthetic nucleic acids as a transactional service,” you are considered a Provider under the Framework. Please see the For Providers & Benchtop Manufacturers instead.
Section IV of the Framework provides definitions for many of the terms below. For more information, visit the FAQs section. This page is for informational purposes only and does not constitute legal advice. Users should not rely on the information provided as a substitute for consultation with qualified counsel.
Who is a Customer?
The Framework defines a Customer as an “individual or entity (such as an institution) that orders or requests synthetic nucleic acids from a Provider, or that purchases nucleic acid synthesis equipment from a Manufacturer.” More details about who qualifies as a Customer may become more clear on or after April 26, 2025, when federal funding agencies implement the funding requirements.
What kinds of life sciences research does the Framework apply to?
The Framework “applies to federally funded life sciences research involving the procurement of all types of synthetic nucleic acids—including but not limited to DNA and RNA, whether single- or double-stranded, as well as whole organism genomes (eg, viruses, bacteria)—containing any synthetic SOC. It also applies to federally funded life sciences research involving the procurement of any benchtop equipment capable of synthesizing nucleic acids.”
Note that this includes research conducted outside of the US if that research is supported by US federal funding agencies.
What am I required to do if I receive federal funds and conduct life sciences research?
Specific clarity around the requirements will be available from federal agencies funding life sciences research on or after April 26, 2025. Federal funding agencies will require Customers to purchase nucleic acids only from Providers or Manufacturers who self-attest to adherence with the Framework. A Customer can ensure that they purchase from a Provider or Manufacturer that adheres to the Framework by either:
- Checking a Provider or Manufacturer’s website for a self-attestation to the Framework; or
- Requesting a self-attestation from a Provider or Manufacturer.
Please see the List of Framework-Attesting Nucleic Acid Synthesis Providers & Benchtop Manufacturers for more information on those who self-attest to the Framework on their websites.
List of Framework-Attesting Providers & Benchtop Manufacturers