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H.R. 3029 · House bill · 119th Congress
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.
This Act may be cited “Nucleic Acid Standards for Biosecurity Act”.
Section 10221 of the Research and Development, Competition, and Innovation Act (42 U.S.C. 18931; enacted as part of title II of division B of Public Law 117–167) is amended—
(1) in subsection (a)(1)—
(A) in subparagraph (C), by striking “and” after the semicolon;
(B) by redesignating subparagraph (D) as subparagraph (E); and
(C) by inserting after subparagraph (C) the following new subparagraph:
“(D) best practices, guidelines, and technical standards for risk management associated with engineering biology and biomanufacturing, including risks associated with the use of artificial intelligence; and”;
(2) by redesignating subsections (b) and (c) as subsections (c) and (d), respectively; and
(3) by inserting after subsection (a) the following new subsection:
“(b) Nucleic acid synthesis screening tools and standards.—
(1) In general.— The Director, in consultation with heads of Federal agencies the Director considers appropriate, shall carry out measurement research to support the development and improvement of best practices and technical standards for biosecurity measures related to nucleic acid synthesis, including the following:
(A) Testing to improve the accuracy, efficacy, and reliability of screening for nucleic acid synthesis.
(B) Best practices, including security and access controls, for operational security and managing sequence-of-concern databases to support such screening.
(C) Technical implementation guidance to ensure such screening is effective and secure.
(D) Conformity-assessment best practices and technical standards.
(E) Methods to evaluate the impact and effectiveness of the implementation of subparagraphs (A) through (D).
(2) Consortium.— In carrying out this subsection, the Director shall convene a consortium of stakeholders, including industry, institutions of higher education, nonprofit organizations, and customers to carry out the following:
(A) Develop and periodically update consensus priorities and best practices, as appropriate, for synthetic nucleic acid procurement screening mechanisms.
(B) Develop roadmaps to inform the activities carried out under paragraph (1).
(3) Report.— Not later than 18 months after the first meeting of the consortium under paragraph (2), the Director shall submit to the Committee on Commerce, Science, and Transportation of the Senate and the Committee on Science, Space, and Technology of the House of Representatives a report summarizing the findings of the consortium.
(4) Authorization of appropriations.— Of the funds authorized to be appropriated for the National Institute of Standards and Technology pursuant to this section for scientific and technical research and services laboratory activities, there is authorized to be appropriated $5,000,000 for each of fiscal years 2027 through 2031 to carry out this subsection.”.