SenateS. 5557119th Congress

SCALE Biology Act

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[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 5557 Introduced in Senate (IS)]

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119th CONGRESS
  2d Session
                                S. 5557

 To establish in the National Institute of Standards and Technology a 
        program of measurement research, and for other purposes.

_______________________________________________________________________

                   IN THE SENATE OF THE UNITED STATES

                           September 24, 2026

Mr. Budd (for himself and Ms. Blunt Rochester) introduced the following 
 bill; which was read twice and referred to the Committee on Commerce, 
                      Science, and Transportation

_______________________________________________________________________

                                 A BILL

 
 To establish in the National Institute of Standards and Technology a 
        program of measurement research, and for other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Standards and Calibration for 
American Leadership in Engineering Biology Act'' or the ``SCALE Biology 
Act''.

SEC. 2. NIST BIOMETROLOGY LABORATORY PROGRAM.

    (a) Certain Implementation Activities.--Section 2(c) of the 
National Institute of Standards and Technology Act (15 U.S.C. 272(c)) 
is amended--
            (1) in the matter preceding paragraph (1), by inserting a 
        comma after ``Director'';
            (2) by redesignating paragraphs (22) through (32) as 
        paragraphs (23) through (33), respectively; and
            (3) by inserting after paragraph (21) the following:
            ``(22) perform research to facilitate and support the 
        development of a voluntary, consensus-based set of technical 
        standards, guidelines, best practices, methodologies, 
        procedures, and processes for engineering biology, 
        biomanufacturing, biotechnology, and biometrology;''.
    (b) Biometrology Laboratory Program.--The National Institute of 
Standards and Technology Act (15 U.S.C. 271 et seq.) is amended--
            (1) by redesignating section 36 (15 U.S.C. 271 note) as 
        section 37; and
            (2) by inserting after section 35 (15 U.S.C. 278t) the 
        following:

``SEC. 36. BIOMETROLOGY LABORATORY PROGRAM.

    ``(a) In General.--The Secretary, acting through the Director, 
shall establish a program of measurement research for engineering 
biology, biomanufacturing, and biotechnology (in this section referred 
to as the `biometrology laboratory program').
    ``(b) Purposes.--The purposes of the biometrology laboratory 
program are the following:
            ``(1) To support innovation and industrial competitiveness 
        in engineering biology, biomanufacturing, and biotechnology.
            ``(2) To improve the accuracy, interoperability, and 
        reliability of biological data and materials.
            ``(3) To support the safe, secure, and responsible 
        development and application of biological technologies across 
        sectors to support economic and national security.
    ``(c) Activities.--In carrying out the biometrology laboratory 
program, the Director shall carry out the following:
            ``(1) Support basic measurement science and technology 
        research for engineering biology, biomanufacturing, and 
        biotechnology to advance the following:
                    ``(A) Measurement technologies to support 
                foundational understanding of the mechanisms of 
                conversion of DNA information into cellular function.
                    ``(B) Technologies for measurement of biomolecular 
                components and related systems used for engineering 
                biology, biomanufacturing, and biotechnology, including 
                biomolecular components and related systems pertinent 
                to commercial scale and distributed manufacturing of 
                products.
                    ``(C) Tools, technical standards, guidelines, best 
                practices, methodologies, procedures, and processes for 
                biological data.
                    ``(D) Life cycle and sustainability assessments of 
                engineering biology, biomanufacturing, and 
                biotechnology products.
                    ``(E) The development of technical standards, 
                guidelines, best practices, methodologies, procedures, 
                and processes that can inform and address biorisk, 
                biosafety, and biosecurity concerns.
                    ``(F) Other areas of measurement science and 
                technology research determined by the Director to be 
                critical to the development and deployment of 
                biometrology.
            ``(2) Inform and expand the development of measurements 
        infrastructure needed to develop technical standards to 
        establish interoperability and facilitate commercial 
        development of the following:
                    ``(A) Biometrology technology.
                    ``(B) Engineering biology, biomanufacturing, and 
                biotechnology.
            ``(3) Seek to convene representatives of industry, 
        institutions of higher education, nonprofit organizations, 
        Federal laboratories, and other Federal agencies engaged in 
        engineering biology, biomanufacturing, and biotechnology 
        research and development to develop coordinated technical 
        roadmaps for authoritative measurement of the molecular 
        components of the cell.
            ``(4) Provide access to user facilities with advanced or 
        unique equipment, services, materials, and other resources to 
        industry, institutions of higher education, nonprofit 
        organizations, and Federal, State, and Tribal government 
        agencies to perform research and testing.
            ``(5) Establish or expand, as appropriate, collaborative 
        partnerships or consortia with other Federal agencies engaged 
        in engineering biology, biomanufacturing, and biotechnology 
        research and development, institutions of higher education, 
        Federal laboratories, and industry to advance engineering 
        biology, biomanufacturing, and biotechnology applications.
            ``(6) Support graduate and postgraduate research and 
        training in biometrology.
            ``(7) Establish and periodically update, as appropriate, 
        common definitions and terminology pertaining to engineering 
        biology, biomanufacturing, biotechnology, and the bioeconomy, 
        and maintain a publicly available lexicon of such definitions 
        and terminology.
            ``(8) Support extramural research, as appropriate, that 
        helps the Institute in advancing measurement science, 
        standards, and guidelines for biometrology, engineering 
        biology, biomanufacturing, and biotechnology.
            ``(9) In coordination with the heads of relevant Federal 
        agencies, as appropriate, identify where technical standards, 
        standardized assessments, or other governance pathways are 
        needed to manage risks and support the commercialization of 
        novel engineering biology, biomanufacturing, and biotechnology.
    ``(d) Engineering Biology Foundry.--In carrying out the 
biometrology laboratory program, and in partnership with industry, 
institutions of higher education, and nonprofit organizations, the 
Director shall support the development of engineering biology related 
foundries to improve measurement assurance and make the engineering of 
living measurement systems more predicable, scalable, and routine.
    ``(e) Outreach.--
            ``(1) In general.--In carrying out the activities under 
        subsection (c), the Director shall seek input from other 
        Federal agencies, institutions of higher education, nonprofit 
        organizations, industry, and Manufacturing USA institutes with 
        relevant experience, on an ongoing basis, to help inform 
        research and development priorities, including through 
        workshops and other multi-stakeholder activities.
            ``(2) Institutions of higher education.--To promote the 
        broadest participation in biometrology research and ensure 
        training outreach will engage all types of institutions of 
        higher education, input sought under paragraph (1) shall 
        include input from minority-serving institutions, historically 
        Black colleges and universities, Tribal Colleges or 
        Universities, and public institutions of higher education that, 
        according to data published by the National Center for Science 
        and Engineering Statistics, are not, on average, among the top 
        100 institutions in Federal research and development 
        expenditures.
            ``(3) Definitions.--In this subsection:
                    ``(A) Historically black college and university.--
                The term `historically Black college and university' 
                means a part B institution, as defined in section 322 
                of the Higher Education Act of 1965 (20 U.S.C. 1061).
                    ``(B) Minority-serving institution.--The term 
                `minority-serving institution' means an eligible 
                institution under section 371(a) of the Higher 
                Education Act of 1965 (20 U.S.C. 1067q(a)).
                    ``(C) Nonprofit organization.--The term `nonprofit 
                organization' means an organization described in 
                section 501(c)(3) of the Internal Revenue Code of 1986 
                and exempt from taxation under section 501(a) of such 
                code.
                    ``(D) Tribal college or university.--The term 
                `Tribal College or University' has the meaning given 
                that term in section 316 of the Higher Education Act of 
                1965 (20 U.S.C. 1059c).
    ``(f) Coordination.--
            ``(1) Federal departments and agencies.--In carrying out 
        the activities under subsection (c), the Director shall 
        coordinate with the heads of appropriate Federal departments 
        and agencies, including the Executive Office of the President 
        and the National Engineering Biology Research and Development 
        Initiative established pursuant to section 10402 of the 
        Research and Development, Competition, and Innovation Act (42 
        U.S.C. 19132).
            ``(2) Manufacturing usa program.--The Director shall 
        coordinate the activities carried out pursuant to subsection 
        (c) with the Manufacturing USA Program and, to the maximum 
        extent practicable, leverage existing capabilities of 
        Manufacturing USA institutes to support United States 
        leadership in biomanufacturing.
            ``(3) Biomass feedstock utilization.--The Director, as 
        practicable and appropriate, shall support efforts relating to 
        the coordination and development of biomass feedstock 
        utilization with the Secretary of Energy and the Biomass 
        Research and Development Board established pursuant to section 
        9008 of the Farm Security and Rural Investment Act of 2002 (7 
        U.S.C. 8108).
    ``(g) Research Security.--The activities authorized under this 
section shall be carried out in accordance with the provision of 
subtitle D of title VI of the Research and Development, Competition, 
and Innovation Act (42 U.S.C. 19231 et seq.) and section 223 of the 
William M. (Mac) Thornberry National Defense Authorization Act for 
Fiscal Year 2021 (42 U.S.C. 6605).
    ``(h) Report.--Not later than 3 years after the date of the 
enactment of this section, 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, and make publicly available on the website of the 
Institute, a report regarding the implementation by the Institute of 
the biometrology laboratory program.
    ``(i) Implementation Plan.--Not later than 1 year after the date of 
the enactment of this section, the Director shall submit to the 
Committee on Commerce, Science, and Transportation and the Committee on 
Appropriations of the Senate and the Committee on Science, Space, and 
Technology and the Committee on Appropriations of the House of 
Representatives, and make available on a public website of the 
Institute, a plan to carry out the biometrology laboratory program, 
including the following:
            ``(1) A plan for establishing the biometrology laboratory 
        program within the Institute as described in this section, 
        including in relation to existing measurement laboratories.
            ``(2) A plan for how the Institute will carry out the 
        activities of the biometrology laboratory program.
            ``(3) A plan for how to leverage existing infrastructure 
        and expertise of the Institute to drive international 
        cooperation for the advancement of voluntary consensus 
        standards.
    ``(j) Definitions.--In this section:
            ``(1) In general.--The following terms have the meanings 
        given those terms, respectively, in section 10401 of the 
        Research and Development, Competition, and Innovation Act (42 
        U.S.C. 19131):
                    ``(A) Biological data.
                    ``(B) Biomanufacturing.
                    ``(C) Biometrology.
                    ``(D) Biorisk.
                    ``(E) Biosecurity.
                    ``(F) Engineering biology.
            ``(2) Additional terms.--
                    ``(A) Bioeconomy.--The term `bioeconomy' means the 
                economic activity derived from the life sciences, 
                particularly in the areas of biotechnology and 
                biomanufacturing, including industries, products, 
                services, and the workforce.
                    ``(B) Biomass.--The term `biomass' means any 
                material of biological origin that is available on a 
                renewable or recurring basis.
                    ``(C) Biosafety.--The term `biosafety' means the 
                practices, controls, and containment infrastructure 
                that reduce the risk of unintended exposure to, 
                contamination with, release of, or harm from pathogens, 
                toxics, and biological materials.
                    ``(D) Biotechnology.--The term `biotechnology' 
                means technology that applies to or is enabled by life 
                sciences innovation or product development.
                    ``(E) Institution of higher education.--The term 
                `institution of higher education' has the meaning given 
                that term in section 101(a) of the Higher Education Act 
                of 1965 (20 U.S.C. 1001(a)).
                    ``(F) Manufacturing usa institute.--The term 
                `Manufacturing USA institute' has the meaning given 
                that term in section 34(d).
                    ``(G) Nonprofit organization.--The term `nonprofit 
                organization' means an organization described in 
                section 501(c)(3) of the Internal Revenue Code of 1986 
                and exempt from tax under section 501(a) of such code.
                    ``(H) Technical standard.--The term `technical 
                standard' has the meaning given that term in section 
                12(d)(5) of the National Technology Transfer and 
                Advancement Act of 1995 (15 U.S.C. 272 note).''.

SEC. 3. TECHNICAL AND CONFORMING AMENDMENTS.

    (a) Repeal.--Section 10221 of the Research and Development, 
Competition, and Innovation Act (42 U.S.C. 18931) is repealed, and the 
item relating to such section in the table of contents in sections 1 
and 10000 for such Act is struck.
    (b) Definitions.--
            (1) Global definitions.--Section 10002 of the Research and 
        Development, Competition, and Innovation Act (42 U.S.C. 18901) 
        is amended--
                    (A) by striking paragraphs (4) and (6); and
                    (B) by redesignating--
                            (i) paragraph (5) as paragraph (4); and
                            (ii) paragraphs (7) through (30) as 
                        paragraphs (5) through (28), respectively.
            (2) Title definitions.--Section 10401 of the Research and 
        Development, Competition, and Innovation Act (42 U.S.C. 19131) 
        is amended--
                    (A) by redesignating paragraphs (1) and (2) as 
                paragraphs (7) and (8), respectively; and
                    (B) by inserting before paragraph (7), as so 
                redesignated, the following new paragraphs:
            ``(2) Biological data.--The term `biological data' means 
        the information, including associated descriptors, derived from 
        the structure, function, or process of a biological system(s) 
        that is measured, collected, or aggregated for analysis.
            ``(3) Biomanufacturing.--The term `biomanufacturing' means 
        the use of biological systems, including the use of biomass as 
        a feedstock, to produce commercially important goods and 
        services.
            ``(4) Biorisk.--The term `biorisk' means the effect of 
        uncertainty expressed by the combination of the consequences 
        and the associated likelihood of occurrence that a biological 
        event will adversely affect the health of humans, nonhuman 
        animals, or the environment.
            ``(5) Biosecurity.--The term `biosecurity' means the 
        security measures designed to prevent the loss, theft, misuse, 
        diversion, unauthorized possession or material introduction, or 
        intentional release of pathogens, toxics, biological materials, 
        and related information or technology.
            ``(6) Engineering biology.--The term `engineering biology' 
        means the design, construction, or assembly of the components 
        of living systems (such as genetics circuits, enzymes, or 
        metabolic pathways) to achieve an intended function or 
        outcome.''.
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