The Nucleic Acid Standards for Biosecurity Act proposes to amend the Research and Development, Competition, and Innovation Act to support nucleic acid screening. The amendment aims to develop best practices, guidelines, and technical standards for risk management related to engineering biology and biomanufacturing. It also proposes to improve the accuracy, efficacy, and reliability of screening for nucleic acid synthesis, develop security and access controls, and ensure the effectiveness and security of screening measures. A consortium of stakeholders would be convened to develop priorities and roadmaps for synthetic nucleic acid procurement screening mechanisms. Finally, it recommends an appropriation of $5,000,000 for fiscal years 2027 through 2031 to carry out these activities.
Nucleic Acid Standards for Biosecurity Act
This bill explicitly requires the National Institute of Standards and Technology (NIST) to support the development of best practices and technical standards for nucleic acid synthesis.
Nucleic acids, including deoxyribonucleic acid (DNA) and ribonucleic acid (RNA), carry genetic information within cells. Nucleic acid synthesis is the process of designing and creating custom nucleic acids; it is used in the development of medications and agricultural products. However, this technology also poses a risk of misuse (e.g., the intentional or unintentional creation of dangerous biological agents).
The bill requires NIST to carry out measurement research to support the development and improvement of biosecurity best practices and technical standards related to nucleic acid synthesis. This effort must address specified topics including nucleic acid synthesis screening, operational security, and conformity assessment. (A 2023 executive order titled Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence directed NIST to develop and refine similar specifications and best practices for use by synthetic nucleic acid providers. NIST's work on this topic is ongoing.)
In carrying out this effort, NIST must convene stakeholders to develop and periodically update consensus priorities and best practices for synthetic nucleic acid screening mechanisms. Within a specified period, NIST must submit a summary of the stakeholder group’s findings to Congress.
NIST must also take steps to advance risk management best practices and technical standards for engineering biology and biomanufacturing, including with respect to risks associated with the use of artificial intelligence.