    [House Report 116-270]
    [From the U.S. Government Publishing Office]

    116th Congress }                                            { Report
                            HOUSE OF REPRESENTATIVES
     1st Session   }                                            { 116-270

    ======================================================================

            ENGINEERING BIOLOGY RESEARCH AND DEVELOPMENT ACT OF 2019

                                    _______

    November 5, 2019.--Committed to the Committee of the Whole House on the
                  State of the Union and ordered to be printed

                                    _______

        Ms. Johnson of Texas, from the Committee on Science, Space, and
                      Technology, submitted the following

                                  R E P O R T

                            [To accompany H.R. 4373]

          [Including cost estimate of the Congressional Budget Office]

        The Committee on Science, Space, and Technology, to whom
    was referred the bill (H.R. 4373) to provide for a coordinated
    Federal research initiative to ensure continued United States
    leadership in engineering biology, having considered the same,
    report favorably thereon with an amendment and recommend that
    the bill as amended do pass.

                                    CONTENTS

                                                                       Page
       I. Amendment.......................................................2
      II. Purpose of the Bill.............................................7
     III. Background and Need for the Legislation.........................7
      IV. Committee Hearings..............................................8
       V. Committee Consideration and Votes...............................8
      VI. Summary of Major Provisions of the Bill.........................8
     VII. Section-By-Section Analysis (By Title and Section)..............9
    VIII. Committee Views................................................10
      IX. Cost Estimate..................................................10
       X. Congressional Budget Office Cost Estimate......................11
      XI. Compliance with Public Law 104-4 (Unfunded Mandates)...........12
     XII. Committee Oversight Findings and Recommendations...............12
    XIII. Statement on General Performance Goals and Objectives..........12
     XIV. Federal Advisory Committee Statement...........................12
      XV. Duplication of Federal Programs................................12
     XVI. Earmark Identification.........................................12
    XVII. Applicability to the Legislative Branch........................12
    XVIII.Statement on Preemption of State, Local, or Tribal Law.........12

     XIX. Changes in Existing Law Made by the Bill, As Reported..........13
      XX. Proceedings of Full Committee Markup...........................13

                                  I. Amendment

        The amendment is as follows:
      Strike all after the enacting clause and insert the
    following:

    SECTION 1. SHORT TITLE.

      This Act may be cited as the ``Engineering Biology Research and
    Development Act of 2019''.

    SEC. 2. FINDINGS.

      The Congress makes the following findings:
              (1) Cellular and molecular processes may be used, mimicked,
            or redesigned to develop new products, processes, and systems
            that improve societal well-being, strengthen national security,
            and contribute to the economy.
              (2) Engineering biology relies on a workforce with a diverse
            and unique set of skills combining the biological, physical,
            chemical, and information sciences and engineering.
              (3) Long-term research and development is necessary to create
            breakthroughs in engineering biology. Such research and
            development requires government investment as many of the
            benefits are too distant or uncertain for industry to support
            alone.
              (4) Research is necessary to inform evidence-based governance
            of engineering biology and to support the growth of the
            engineering biology industry.
              (5) The Federal Government can play an important role by
            facilitating the development of tools and technologies to
            further advance engineering biology, including user facilities,
            by facilitating public-private partnerships, by supporting risk
            research, and by facilitating the commercial application in the
            United States of research funded by the Federal Government.
              (5) The United States led the development of the science and
            engineering techniques that created the field of engineering
            biology, but due to increasing international competition, the
            United States is at risk of losing its competitive advantage if
            does not invest the necessary resources and have a national
            strategy.
              (6) A National Engineering Biology Initiative can serve to
            establish new research directions and technology goals, improve
            interagency coordination and planning processes, drive
            technology transfer to the private sector, and help ensure
            optimal returns on the Federal investment.

    SEC. 3. DEFINITIONS.

      In this Act:
              (1) Biomanufacturing.--The term ``biomanufacturing'' means
            the utilization of biological systems to develop new and
            advance existing products, tools, and processes at commercial
            scale.
              (2) Engineering biology.--The term ``engineering biology''
            means the application of engineering design principles and
            practices to biological systems, including molecular and
            cellular systems, to advance fundamental understanding of
            complex natural systems and to enable novel or optimize
            functions and capabilities.
              (3) Initiative.--The term ``Initiative'' means the National
            Engineering Biology Research and Development Initiative
            established under section 4.
              (4) Omics.--The term ``omics'' refers to the collective
            technologies used to explore the roles, relationships, and
            actions of the various types of molecules that make up the
            cells of an organism.

    SEC. 4. NATIONAL ENGINEERING BIOLOGY RESEARCH AND DEVELOPMENT
                        INITIATIVE.

      (a) In General.--The President, acting through the Office of Science
    and Technology Policy, shall implement a National Engineering Biology
    Research and Development Initiative to advance societal well-being,
    national security, sustainability, and economic productivity and
    competitiveness through--
              (1) advancing areas of research at the intersection of the
            biological, physical, chemical, and information sciences and
            engineering to accelerate scientific understanding and
            technological innovation in engineering biology;
              (2) advancing areas of biomanufacturing research to optimize,
            standardize, scale, and deliver new products and solutions;
              (3) supporting social and behavioral sciences and economics
            research that advances the field of engineering biology and
            contributes to the development and public understanding of new
            products, processes, and technologies;
              (4) supporting risk research, including under subsection (d);
              (5) supporting the development of novel tools and
            technologies to accelerate scientific understanding and
            technological innovation in engineering biology;
              (6) expanding the number of researchers, educators, and
            students with engineering biology training, including from
            traditionally underserved populations;
              (7) accelerating the translation and commercialization of
            engineering biology research and development by the private
            sector; and
              (8) improving the interagency planning and coordination of
            Federal Government activities related to engineering biology.
      (b) Initiative Activities.--The activities of the Initiative shall
    include--
              (1) sustained support for engineering biology research and
            development through--
                      (A) grants to individual investigators and teams of
                    investigators, including interdisciplinary teams;
                      (B) projects funded under joint solicitations by a
                    collaboration of no fewer than two agencies
                    participating in the Initiative; and
                      (C) interdisciplinary research centers that are
                    organized to investigate basic research questions,
                    carry out technology development and demonstration
                    activities, and increase understanding of how to scale
                    up engineering biology processes, including
                    biomanufacturing;
              (2) sustained support for databases and related tools,
            including--
                      (A) support for curated genomics, epigenomics, and
                    all other relevant omics databases, including plant and
                    microbial databases, that are available to researchers
                    to carry out engineering biology research;
                      (B) development of standards for such databases,
                    including for curation, interoperability, and
                    protection of privacy and security; and
                      (C) support for the development of computational
                    tools, including artificial intelligence tools, that
                    can accelerate research and innovation using such
                    databases; and
                      (D) an inventory and assessment of all Federal
                    government omics databases to identify opportunities
                    for consolidation and inform investment in such
                    databases as critical infrastructure for the
                    engineering biology research enterprise;
              (3) sustained support for the development, optimization, and
            validation of novel tools and technologies to enable the
            dynamic study of molecular processes in situ, including through
            grants to investigators at institutions of higher education and
            other nonprofit research institutions, and through the Small
            Business Innovation Research Program and the Small Business
            Technology Transfer Program, as described in section 9 of the
            Small Business Act (15 U.S.C. 638);
              (4) education and training of undergraduate and graduate
            students in engineering biology, in biomanufacturing, in
            bioprocess engineering, and in areas of computational science
            applied to engineering biology;
              (5) activities to develop robust mechanisms for tracking and
            quantifying the outputs and economic benefits of engineering
            biology; and
              (6) activities to accelerate the translation and
            commercialization of new products, processes, and technologies
            by--
                      (A) identifying precompetitive research
                    opportunities;
                      (B) facilitating public-private partnerships in
                    engineering biology research and development;
                      (C) connecting researchers, graduate students, and
                    postdoctoral fellows with entrepreneurship education
                    and training opportunities; and
                      (D) supporting proof of concept activities and the
                    formation of startup companies including through
                    programs such as the Small Business Innovation Research
                    Program and the Small Business Technology Transfer
                    Program.
      (c) Expanding Participation.--The Initiative shall include, to the
    maximum extent practicable, outreach to primarily undergraduate and
    minority-serving institutions about Initiative opportunities, and shall
    encourage the development of research collaborations between research-
    intensive universities and primarily undergraduate and minority-serving
    institutions.
      (d) Ethical, Legal, Environmental, Safety, Security, and Societal
    Issues.--Initiative activities shall take into account ethical, legal,
    environmental, safety, security, and other appropriate societal issues
    by--
              (1) supporting research, including in the social sciences,
            and other activities addressing ethical, legal, environmental,
            and other appropriate societal issues related to engineering
            biology, including integrating research on such topics with the
            research and development in engineering biology, and ensuring
            that the results of such research are widely disseminated,
            including through interdisciplinary engineering biology
            research centers described in subsection (b)(1);
              (2) supporting research and other activities related to the
            safety and security implications of engineering biology,
            including outreach to increase awareness among federally-funded
            researchers at institutions of higher education about potential
            safety and security implications of engineering biology
            research, as appropriate;
              (3) ensuring that input from Federal and non-Federal experts
            on the ethical, legal, environmental, security, and other
            appropriate societal issues related to engineering biology is
            integrated into the Initiative; and
              (4) ensuring, through the agencies and departments that
            participate in the Initiative, that public input and outreach
            are integrated into the Initiative by the convening of regular
            and ongoing public discussions through mechanisms such as
            workshops, consensus conferences, and educational events, as
            appropriate.

    SEC. 5. INITIATIVE COORDINATION.

      (a) Interagency Committee.--The President, acting through the Office
    of Science and Technology Policy, shall designate an interagency
    committee to coordinate engineering biology, which shall be co-chaired
    by the Office of Science and Technology Policy, and include
    representatives from the National Science Foundation, the Department of
    Energy, the National Aeronautics and Space Administration, the National
    Institute of Standards and Technology, the Environmental Protection
    Agency, the Department of Agriculture, the National Institutes of
    Health, the Bureau of Economic Analysis, and any other agency that the
    President considers appropriate (in this section referred to as the
    ``interagency committee''). The Director of the Office of Science and
    Technology Policy shall select an additional co-chairperson from among
    the members of the Interagency Committee. The Interagency Committee
    shall oversee the planning, management, and coordination of the
    Initiative. The Interagency Committee shall--
              (1) provide for interagency coordination of Federal
            engineering biology research, development, and other activities
            undertaken pursuant to the Initiative;
              (2) establish and periodically update goals and priorities
            for the Initiative;
              (3) develop, not later than 12 months after the date of
            enactment of this Act, and update every 3 years, a strategic
            plan that--
                      (A) guides the activities of the Initiative for
                    purposes of meeting the goals and priorities
                    established under (and updated pursuant to) paragraph
                    (2); and
                      (B) describes--
                              (i) the Initiative's support for long-term
                            funding for interdisciplinary engineering
                            biology research and development;
                              (ii) the Initiative's support for education
                            and public outreach activities;
                              (iii) the Initiative's support for research
                            and other activities on ethical, legal,
                            environmental, safety, security, and other
                            appropriate societal issues related to
                            engineering biology;
                              (iv) how the Initiative will move results out
                            of the laboratory and into application for the
                            benefit of society and United States
                            competitiveness; and
                              (v) how the Initiative will measure and track
                            the contributions of engineering biology to
                            United States economic growth and other
                            societal indicators;
              (4) develop a national genomic sequencing strategy to ensure
            engineering biology research fully leverages plant, animal, and
            microbe biodiversity to enhance long-term innovation and
            competitiveness in engineering biology in the United States;
              (5) propose an annually coordinated interagency budget for
            the Initiative that is intended to ensure--
                      (A) the maintenance of a robust engineering biology
                    research and development portfolio; and
                      (B) that the balance of funding across the Initiative
                    is sufficient to meet the goals and priorities
                    established for the Program;
              (6) develop a plan to utilize Federal programs, such as the
            Small Business Innovation Research Program and the Small
            Business Technology Transfer Program as described in section 9
            of the Small Business Act (15 U.S.C. 638), in support of the
            activities described in section 4(b)(3); and
              (7) in carrying out this section, take into consideration the
            recommendations of the advisory committee established under
            section 6, the results of the workshop convened under section
            7, existing reports on related topics, and the views of
            academic, State, industry, and other appropriate groups.
      (b) Annual Report.--Beginning with fiscal year 2020, not later than
    90 days after submission of the President's annual budget request and
    each fiscal year thereafter, the interagency committee shall prepare
    and submit to the Committee on Science, Space, and Technology of the
    House of Representatives and the Committee on Commerce, Science, and
    Transportation of the Senate a report that includes--
              (1) a summarized agency budget in support of the Initiative
            for the fiscal year to which such budget request applies, and
            for the then current fiscal year, including a breakout of
            spending for each agency participating in the Program and for
            the development and acquisition of any research facilities and
            instrumentation; and
              (2) an assessment of how Federal agencies are implementing
            the plan described in subsection (a)(3), and a description of
            the amount and number of awards made under the Small Business
            Innovation Research Program and the Small Business Technology
            Transfer Program (as described in section 9 of the Small
            Business Act (15 U.S.C. 638)) in support of the Initiative.
      (c) Initiative Staffing.--The President shall ensure adequate
    staffing for the Initiative, including full-time staff within the
    Office of Science and Technology Policy, who shall--
              (1) provide technical and administrative support to the
            interagency committee and the advisory committee established
            under section 6;
              (2) serve as the point of contact on Federal engineering
            biology activities for government organizations, academia,
            industry, professional societies, State governments, interested
            citizen groups, and others to exchange technical and
            programmatic information;
              (3) oversee interagency coordination of the Initiative,
            including by encouraging and supporting joint agency
            solicitation and selection of applications for funding of
            activities under the Initiative;
              (4) conduct public outreach, including dissemination of
            findings and recommendations of the advisory committee
            established under section 6, as appropriate; and
              (5) promote access to, and early application of, the
            technologies, innovations, and expertise derived from
            Initiative activities to agency missions and systems across the
            Federal Government, and to United States industry, including
            startup companies.

    SEC. 6. ADVISORY COMMITTEE.

      (a) In General.--The President, acting through the Office of Science
    and Technology Policy, shall designate or establish an advisory
    committee on engineering biology research and development (in this
    section referred to as the ``advisory committee'') to be composed of
    not fewer than 12 members, including representatives of research and
    academic institutions, industry, and nongovernmental entities, who are
    qualified to provide advice on the Initiative.
      (b) Assessment.--The advisory committee shall assess--
              (1) the current state of United States competitiveness in
            engineering biology, including the scope and scale of United
            States investments in engineering biology research and
            development in the international context;
              (2) current market barriers to commercialization of
            engineering biology products, processes, and tools in the
            United States;
              (3) progress made in implementing the Initiative;
              (4) the need to revise the Initiative;
              (5) the balance of activities and funding across the
            Initiative;
              (6) whether the strategic plan developed or updated by the
            interagency committee established under section 5 is helping to
            maintain United States leadership in engineering biology;
              (7) the management, coordination, implementation, and
            activities of the Initiative; and
              (8) whether ethical, legal, environmental, safety, security,
            and other appropriate societal issues are adequately addressed
            by the Initiative.
      (c) Reports.--Beginning not later than 2 years after the date of
    enactment of this Act, and not less frequently than once every 3 years
    thereafter, the advisory committee shall submit to the President, the
    Committee on Science, Space, and Technology of the House of
    Representatives, and the Committee on Commerce, Science, and
    Transportation of the Senate, a report on--
              (1) the findings of the advisory committee's assessment under
            subsection (b); and
              (2) the advisory committee's recommendations for ways to
            improve the Initiative.
      (d) Application of Federal Advisory Committee Act.--Section 14 of the
    Federal Advisory Committee Act (5 U.S.C. App.) shall not apply to the
    Advisory Committee.

    SEC. 7. EXTERNAL REVIEW OF ETHICAL, LEGAL, ENVIRONMENTAL, AND SOCIETAL
                        ISSUES.

      (a) In General.--Not later than 6 months after the date of enactment
    of this Act, the Director of the National Science Foundation shall
    enter into an agreement with the National Academies of Sciences,
    Engineering, and Medicine to conduct a review, and make recommendations
    with respect to, the ethical, legal, environmental, and other
    appropriate societal issues related to engineering biology research and
    development. The review shall include--
              (1) an assessment of the current research on such issues;
              (2) a description of the research gaps relating to such
            issues;
              (3) recommendations on how the Initiative can address the
            research needs identified pursuant to paragraph (2); and
              (4) recommendations on how engineering biology researchers
            can best incorporate considerations of ethical, legal,
            environmental, and other societal issues into the development
            of research proposals and the conduct of research.
      (b) Report to Congress.--The agreement entered into under subsection
    (a) shall require the National Academy of Sciences, Engineering, and
    Medicine to, not later than 2 years after the date of the enactment of
    this Act--
              (1) submit to the Committee on Science, Space, and Technology
            of the House of Representatives and the Committee on Commerce,
            Science, and Transportation of the Senate a report containing
            the findings and recommendations of the review conducted under
            subsection (a); and
              (2) make a copy of such report available on a publicly
            accessible website.

    SEC. 8. AGENCY ACTIVITIES.

      (a) National Science Foundation.--As part of the Initiative, the
    National Science Foundation shall--
              (1) support basic research in engineering biology through
            individual grants and through interdisciplinary research
            centers;
              (2) support research on the environmental, legal, and social
            implications of engineering biology;
              (3) provide support for research instrumentation for
            engineering biology disciplines, including support for
            research, development, optimization and validation of novel
            technologies to enable the dynamic study of molecular processes
            in situ;
              (4) support curriculum development and research experiences
            for secondary, undergraduate, and graduate students in
            engineering biology and biomanufacturing; and
              (5) award grants, on a competitive basis, to enable
            institutions to support graduate students and postdoctoral
            fellows who perform some of their engineering biology research
            in an industry setting.
      (b) Department of Commerce.--As part of the Initiative, the Director
    of the National Institute of Standards and Technology shall--
              (1) establish a bioscience research program to advance the
            development of standard reference materials and measurements
            and to create new data tools, techniques, and processes
            necessary to advance engineering biology and biomanufacturing;
              (2) provide access to user facilities with advanced or unique
            equipment, services, materials, and other resources to
            industry, institutions of higher education, nonprofit
            organizations, and government agencies to perform research and
            testing; and
              (3) provide technical expertise to inform the potential
            development of guidelines or safeguards for new products,
            processes, and systems of engineering biology.
      (c) Department of Energy.--As part of the Initiative, the Secretary
    of Energy shall--
              (1) conduct and support research, development, demonstration,
            and commercial application activities in engineering biology,
            including in the areas of synthetic biology, advanced biofuel
            development, biobased materials, and environmental remediation;
              (2) support the development, optimization and validation of
            novel, scalable tools and technologies to enable the dynamic
            study of molecular processes in situ; and
              (3) provide access to user facilities with advanced or unique
            equipment, services, materials, and other resources, as
            appropriate, to industry, institutions of higher education,
            nonprofit organizations, and government agencies to perform
            research and testing.
      (d) National Aeronautics and Space Administration.--As part of the
    Initiative, the National Aeronautics and Space Administration shall--
              (1) conduct and support basic and applied research in
            engineering biology, including in synthetic biology, and
            related to Earth and space sciences, aeronautics, space
            technology, and space exploration and experimentation,
            consistent with the priorities established in the National
            Academies' decadal surveys; and
              (2) award grants, on a competitive basis, that enable
            institutions to support graduate students and postdoctoral
            fellows who perform some of their engineering biology research
            in an industry setting.
      (e) Environmental Protection Agency.--As part of the Initiative, the
    Environmental Protection Agency shall support research on how products,
    processes, and systems of engineering biology will affect or can
    protect the environment.

                            II. Purpose of the Bill

        The purpose of the bill is to provide for a coordinated
    Federal research initiative to ensure continued United States
    leadership in engineering biology.

                  III. Background and Need for the Legislation

        Engineering biology research applies engineering design
    principles and practices to biological systems such as
    molecular, cellular, and microbial systems, to advance
    fundamental understanding of complex natural systems and enable
    novel functions and capabilities. Engineering biology has the
    potential to address some of the most serious societal
    challenges, including providing food for a growing population,
    reducing our dependency on fossil fuels, protecting our
    environment, and improving human health. It will also drive our
    economy in the 21st century. U.S. revenues from engineered
    biological systems reached at least $388 billion in 2017, or 2
    percent of GDP.
        Other countries are making significant progress in
    engineering biology. China, in particular, has made it a
    priority to be the global leader in engineering biology and is
    investing accordingly. In 2018, a Chinese official publicly
    reported that the bioeconomy in China is growing at 15 percent
    annually and in 2015 generated $700 billion, or approximately 4
    percent of GDP, with a government target to more than double
    this to $1.6 trillion by 2020. The European Union has also
    prioritized engineering biology research.
        While the Administration, at the time of the filing of this
    legislative report, is taking steps toward the creation of a
    national bioeconomy initiative with a focus on Federal
    investments in engineering biology R&D, there is currently no
    formal mechanism for a coordinated federal government approach
    to investments in this field or to partnership with the private
    sector. Furthermore, the legislation ensures full transparency
    to the Congress and the public in the development of a federal
    research agenda and the process by which the agencies seek
    expert input from outside stakeholders. Finally, through its
    emphasis on societal implications, including ethics, safety,
    and security, this legislation ensures that the goal of U.S.
    economic leadership in the bioeconomy does not overtake the
    goal of ensuring responsible leadership that protects the
    public, including our most vulnerable populations, the
    environment, and our national security, and takes into account
    societal values.
        H.R. 4373 creates the foundation for U.S. leadership in the
    bioeconomy while also ensuring that the U.S. is positioned to
    lead global discussions about safety, security, ethics, and
    other governance issues related to engineering biology.

                             IV. Committee Hearings

        On March 12, 2019, the Subcommittee on Research and
    Technology of the Committee on Science, Space, and Technology
    held a hearing to review the opportunities and challenges with
    new and emerging bioscience and biotechnologies with
    application in agriculture, energy, and manufacturing; to
    examine the role of the federal government in research and
    development (R&D) and oversight of such science and
    technologies; and to examine the status of U.S. leadership in
    engineering biology. An additional purpose of this hearing was
    to receive testimony on the Engineering Biology Research and
    Development Act.
        The Subcommittee heard testimony from five witnesses: Dr.
    Rob Carlson, Managing Director of Bioeconomy Capital; Dr. Kevin
    Solomon, Assistant Professor of Agricultural & Biological
    Engineering at Purdue University; Dr. Eric Hegg, Professor of
    Biochemistry and Molecular Biology, Michigan State University
    and Michigan State University Subcontract Lead, Great Lakes
    Bioenergy Research Center; Dr. Sean Simpson, Chief Scientific
    Officer and Co-Founder of LanzaTech; and Dr. Laurie Zoloth,
    Margaret E. Burton Professor of Religion and Ethics, and Senior
    Advisor to the Provost for Programs in Social Ethics at the
    University of Chicago.

                      V. Committee Consideration and Votes

        On September 18, 2019, Chairwoman Eddie Bernice Johnson,
    joined by Ranking Member Frank Lucas, Rep. Zoe Lofgren (D-CA)
    and Rep. James Sensenbrenner (R-WI) introduced H.R. 4373, the
    Engineering Biology Research and Development Act of 2019. The
    bill was referred to the House Committee on Science, Space, and
    Technology.
        On September 25, 2019, the Committee on Science, Space, and
    Technology met to consider H.R. 4373. Ms. Johnson offered an
    amendment to make technical corrections; to add curriculum
    development for secondary education in engineering biology to
    the list of activities to be supported by the National Science
    Foundation; and to updated the required study by the National
    Academies to include recommendations for researchers on how
    best to incorporate consideration of ethical and other societal
    issues into the design and conduct of their research. The
    amendment was agreed to on a voice vote. Ms. Johnson moved that
    the Committee favorably report the bill, H.R. 4373, to the
    House with the recommendation that the bill be approved. The
    motion was agreed to by a voice vote.

                  VI. Summary of Major Provisions of the Bill

        H.R. 4374 would establish a federal engineering biology
    research initiative and require a national strategy for federal
    agency investments and a framework for interagency
    coordination. The legislation would also expand public-private
    partnerships and expand education and training for the next
    generation of engineering biology researchers. Further, it
    provides direction for mission-relevant activities in
    engineering biology for several agencies, including the
    National Science Foundation, the Department of Energy, the
    National Institute of Standards and Technology, the
    Environmental Protection Agency and the National Aeronautics
    and Space Administration. Finally, the legislation ensures that
    the authorized Initiative would address potential ethical,
    legal, environmental, safety and security issues associated
    with engineering biology research.

            VII. Section-by-Section Analysis (By Title and Section)

    Section 1. Short title

        Engineering Biology Research and Development Act of 2019.

    Section 2. Findings

        Highlights the importance of engineering biology to
    societal well-being, national security, and the economy, and
    how the federal government can play an important role in
    maintaining U.S. leadership in engineering biology research and
    development.

    Section 3. Definitions

        Defines terms used in the bill.

    Section 4. National Engineering Biology Research and Development
            Initiative

        Subsection (a) establishes a National Engineering Biology
    Research and Development Initiative to advance engineering
    biology research; support risk research to address ethical,
    safety, security and other societal implications of engineering
    biology; support the development of tools to accelerate
    engineering biology research; expand the number of engineering
    biology researchers; accelerate the translation and
    commercialization of engineering biology research; and improve
    interagency planning and coordination of federal engineering
    biology research initiatives.
        Subsection (b) describes the specific activities of the
    Initiative, including support for research grants, research
    centers, ``omics'' databases, novels tools and technologies to
    accelerate research, education and training of students,
    metrics to understand and assess the bioeconomy, and technology
    transfer activities.
        Subsection (c) requires outreach to minority-serving
    institutions and predominantly undergraduate institutions and
    encourages research collaborations among different types of
    institutions.
        Subsection (d) describes how the Initiative should take
    into account the ethical, legal, environmental, safety,
    security, and other appropriate societal concerns.

    Sec. 5. Initiative coordination

        Requires OSTP to designate an Interagency Committee that
    would oversee the planning, management, and coordination of the
    Initiative, in addition to developing and regularly updating a
    strategic plan for the Initiative, developing a national
    genomic sequencing strategy; and submitting to Congress an
    annual coordinated interagency budget proposal for the
    Initiative.

    Section 6. Advisory Committee

        Designates an Advisory Committee of non-Federal members to
    provide advice on the Initiative (in practice the intent would
    be for PCAST to fill this role); charges the Committee with
    specific duties; and requires the Committee to report on their
    findings and recommendations at least every 3 years.

    Section 7. External review of ethical, environmental, and societal
            concerns

        Requires a National Academy of Sciences workshop to review
    the ethical, environmental, societal, and health concerns
    related to engineering biology research and development.

    Section 8. Agency functions

        Describes specific Initiative activities and
    responsibilities for the National Science Foundation, the
    National Institute of Standards and Technology, the Department
    of Energy, the National Aeronautics and Space Administration,
    and the Environmental Protection Agency.

                             VIII. Committee Views

        It is the intent of the Committee that the Director of the
    Office of Science and Technology Policy collaborate and
    coordinate with security and intelligence agencies as needed to
    address any emerging security concerns with respect to
    engineering biology. This may include appointing
    representatives of such agencies to the interagency committee
    required under Section 5. Similarly, the Committee believes
    that more data and analyses of the bioeconomy will be an
    important tool in informing both the Federal research agenda
    and private sector investments. As such, we encourage the
    Department of Commerce's Bureau of Economic Analysis to
    participate in the Initiative IWG and to develop and publish
    new metrics for the bioeconomy.
        Further, while the Committee accepted OSTP's request not to
    establish a formal coordination office in the Act, it is the
    intent of the Committee that the OSTP Director appoint such
    staff as are necessary to carry out all of the responsibilities
    described in Section 5(c), including through the recruitment of
    additional agency detailees with relevant expertise.
        Section 7 requires a National Academies review of ethical,
    legal, environmental and other societal implications of
    engineering biology research and development. While the
    Committee has great respect for the Academies and its
    established process for appointing study committees, we
    encourage the Academies staff to cast a sufficiently broad net
    in seeking experts from both academia and the private-sector to
    reflect the diversity that exists within engineering biology,
    including the diversity in potential products, economic
    sectors, technology areas, and research directions.

                               IX. Cost Estimate

        Pursuant to clause 3(c)(2) of rule XIII of the Rules of the
    House of Representatives, the Committee adopts as its own the
    estimate of new budget authority, entitlement authority, or tax
    expenditures or revenues contained in the cost estimate
    prepared by the Director of the Congressional Budget Office
    pursuant to section 402 of the Congressional Budget Act of
    1974.

                  X. Congressional Budget Office Cost Estimate

                                         U.S. Congress,
                                   Congressional Budget Office,
                                      Washington, DC, November 1, 2019.
    Hon. Eddie Bernice Johnson,
    Chairwoman, Committee on Science, Space, and Technology,
    House of Representatives, Washington, DC.
        Dear Madam Chairwoman: The Congressional Budget Office has
    prepared the enclosed cost estimate for H.R. 4373, the
    Engineering Biology Research and Development Act of 2019.
        If you wish further details on this estimate, we will be
    pleased to provide them. The CBO staff contact is Janani
    Shankaran.
                Sincerely,
                                             Phillip L. Swagel,
                                                              Director.
        Enclosure.

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        H.R. 4373 would direct the Office of Science and Technology
    Policy (OSTP) to establish a national engineering biology
    research and development initiative. Under that initiative,
    federal agencies would provide research grants in engineering
    biology, develop and validate tools and technologies, support
    the commercialization of engineering biology products, and
    conduct related public outreach. The bill would require OSTP to
    establish an interagency committee--with representation from at
    least eight federal agencies--to coordinate those activities.
    H.R. 4373 also would direct the National Science Foundation
    (NSF) to enter into an agreement with the National Academies to
    review ethical, legal, environmental, and societal issues
    related to engineering biology.
        Using information from the affected agencies, CBO expects
    that many agencies are already conducting activities required
    under the bill. On that basis, and considering the costs of
    similar tasks, CBO estimates that each of the eight agencies
    and OSTP would require one additional employee at an average
    annual cost of $150,000 each to participate in the initiative
    and interagency committee. In addition, using information from
    the NSF, CBO estimates that conducting the required review
    would cost less than $1 million. In total, CBO estimates that
    implementing H.R. 4373 would cost $7 million over the 2020-2024
    period; such spending would be subject to the availability of
    appropriated funds.
        The CBO staff contact for this estimate is Janani
    Shankaran. The estimate was reviewed by H. Samuel Papenfuss,
    Deputy Assistant Director for Budget Analysis.

                         XI. Federal Mandates Statement

        H.R. 4373 contains no unfunded mandates.

             XII. Committee Oversight Findings and Recommendations

        The Committee's oversight findings and recommendations are
    reflected in the body of this report.

                 XIII. Statement on General Performance Goals
                                 and Objectives

        H.R. 4373 should result in a more focused and coordinated
    Federal effort in the conduct of engineering biology research
    and development with the goal of maintaining U.S. leadership in
    this field.

                   XIV. Federal Advisory Committee Statement

        The functions of the advisory committee authorized in H.R.
    4373 are not currently being performed by one or more agencies.
    H.R. 4373 permits the President to carry out this requirement
    by enlarging the mandate of an existing advisory committee.

                      XV. Duplication of Federal Programs

        Pursuant to clause 3(c)(5) of rule XIII of the Rules of the
    House of Representatives, the Committee finds that no provision
    of H.R. 4373 establishes or reauthorizes a program of the
    federal government known to be duplicative of another federal
    program, including any program that was included in a report to
    Congress pursuant to section 21 of Public Law 111-139 or the
    most recent Catalog of Federal Domestic Assistance.

                          XVI. Earmark Identification

        Pursuant to clause 9(e), 9(f), and 9(g) of rule XXI, the
    Committee finds that H.R. 4373 contains no earmarks, limited
    tax benefits, or limited tariff benefits.

                 XVII. Applicability to the Legislative Branch

        The Committee finds that H.R. 4373 does not relate to the
    terms and conditions of employment or access to public services
    or accommodations within the meaning of section 102(b)(3) of
    the Congressional Accountability Act (Public Law 104-1).

                XVIII. Statement on Preemption of State, Local,
                                 or Tribal Law

        This bill is not intended to preempt any state, local, or
    tribal law.

           XIX. Changes in Existing Law Made by the Bill, as Reported

        This legislation does not amend any existing Federal
    statute.

                  XX. Proceedings of the Full Committee Markup

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