[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4373 Referred in Senate (RFS)]

<DOC>
116th CONGRESS
  1st Session
                                H. R. 4373


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                           December 10, 2019

    Received; read twice and referred to the Committee on Commerce, 
                      Science, and Transportation

_______________________________________________________________________

                                 AN ACT


 
  To provide for a coordinated Federal research initiative to ensure 
       continued United States leadership in engineering biology.

    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 ``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.
            (6) 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.
            (7) 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;
                    (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 Office.--
            (1) In general.--The President shall establish an 
        Initiative Coordination Office, with a Director and full-time 
        staff, which shall--
                    (A) provide technical and administrative support to 
                the interagency committee and the advisory committee 
                established under section 6;
                    (B) 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;
                    (C) 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;
                    (D) conduct public outreach, including 
                dissemination of findings and recommendations of the 
                advisory committee established under section 6, as 
                appropriate; and
                    (E) 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.
            (2) Funding.--The Director of the Office of Science and 
        Technology Policy shall develop an estimate of the funds 
        necessary to carry out the activities of the Initiative 
        Coordination Office, including an estimate of how much each 
        participating agency described in subsection (a) will 
        contribute to such funds, and submit such estimate to Congress 
        no later than 90 days after the enactment of this Act.
            (3) Termination.--The Initiative Coordination Office 
        established under this subsection shall terminate on the date 
        that is 10 years after the date of the enactment of this Act, 
        unless a determination is made by the President that such 
        Office is necessary to meet the economic or national security 
        goals of the Program.

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.

            Passed the House of Representatives December 9, 2019.

            Attest:

                                             CHERYL L. JOHNSON,

                                                                 Clerk.