Does Biosynthesis adhere to the guidelines outlined by the US Department of Health and Human Resources in the US Framework for Nucleic Acid Synthesis Screening?
Yes, we do!
“In October 2023, President Biden issued a landmark Executive Order on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence (“Executive Order”). In section 4.4(b), the Executive Order directs the federal government to reduce the risks of misuse of synthetic nucleic acids and improve associated biosecurity measures. The Executive Order requires that OSTP develop a framework to encourage providers of synthetic nucleic acid sequences to implement comprehensive, scalable, and verifiable synthetic nucleic acid procurement screening mechanisms. 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.”
Source: 2024/04/Nucleic-Acid_Synthesis_Screening_Framework
To adhere to this framework, Providers and Manufacturers should take the following six actions for such procurement, consistent with the 2023 HHS Guidance and the Executive Order section 4.4(b)(iii):
1) Attest to implementing this screening framework through a statement that either is posted on a public website or provided to the federally funded customer and federal funding agency upon request;
2) Screen purchase orders for synthetic nucleic acids to identify SOCs;
3) Screen customers submitting purchase orders of synthetic nucleic acids with SOCs, and purchase orders of benchtop nucleic acid synthesis equipment, to verify legitimacy;
4) Report potentially illegitimate purchase orders of synthetic nucleic acids involving SOCs or of benchtop nucleic acid synthesis equipment;
5) Retain records relating to purchase orders for synthetic nucleic acids and benchtop nucleic acid synthesis equipment; and
6) Take steps to ensure cybersecurity and information security.
Sample Attestation Form
We at Bio-Synthesis Inc. understand that United States federally funded life sciences entities and funding agencies are relying on this attestation prior to purchasing gene synthesis equipment or gene synthesis products. Bio-Synthesis Inc. self-attests to complying with the US Framework for Nucleic Acid Synthesis Screening (2024/04/Nucleic-Acid_Synthesis_Screening_Framework).
Should this information change, Bio-Synthesis Inc. agrees that it will update this statement.
This form 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.
Our signed attestation form is attached as a pdf document.