```

[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 3734 Introduced in Senate (IS)]

<DOC>

116th CONGRESS
  2d Session
                                S. 3734

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

_______________________________________________________________________

                   IN THE SENATE OF THE UNITED STATES

                              May 14, 2020

 Mrs. Gillibrand (for herself, Mr. Markey, Mr. Rubio, and Mr. Gardner) 
introduced the following bill; which was read twice and referred to the 
           Committee on Commerce, Science, and Transportation

_______________________________________________________________________

                                 A BILL

 
  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 ``Bioeconomy Research and Development 
Act of 2020''.

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 has an obligation to ensure that 
        ethical, legal, environmental, safety, security, and societal 
        implications of its science and technology research and 
        investment follows policies of responsible innovation and 
        fosters public transparency.
            (6) 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.
            (7) 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.
            (8) 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, data, and computational 
        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) improving the understanding of engineering biology of 
        the scientific and lay public and supporting greater evidence-
        based public discourse about its benefits and risks;
            (5) supporting risk research, including under subsection 
        (d);
            (6) supporting the development of novel tools and 
        technologies to accelerate scientific understanding and 
        technological innovation in engineering biology;
            (7) expanding the number of researchers, educators, and 
        students with engineering biology training, including from 
        traditionally underrepresented and underserved populations;
            (8) accelerating the translation and commercialization of 
        engineering biology research and development by the private 
        sector; and
            (9) 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--
                    (A) research conducted at Federal laboratories;
                    (B) grants to investigators at institutions of 
                higher education and other nonprofit research 
                institutions; and
                    (C) 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 and in the related ethical, 
        legal, environmental, safety, security, and other societal 
        issues;
            (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 Federal 
        researchers and 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, safety, 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 Department of Defense, 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 submitted to the Committee on Science, Space, and 
        Technology of the House of Representatives and the Committee on 
        Commerce, Science, and Transportation of the Senate 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 including--
                                    (I) an applied biorisk management 
                                research plan;
                                    (II) recommendations for 
                                integrating security into biological 
                                data access and international 
                                reciprocity agreements; and
                                    (III) an evaluation of existing 
                                biosecurity governance policies, 
                                guidance, and directives for the 
                                purposes of creating a unified, 
                                adaptable, evidence-based framework to 
                                respond to emerging biosecurity 
                                challenges created by advances in 
                                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), including--
                    (A) 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; and
                    (B) a description of the amount and number of 
                projects funded under joint solicitations by a 
                collaboration of no fewer than 2 agencies participating 
                in 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;
                    (E) serve as the coordinator of ethical, legal, 
                environmental, safety, security, and other appropriate 
                societal input; and
                    (F) 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, SAFETY, 
              SECURITY, 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 seek to 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, 
safety, security, 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, safety, security, 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 Academies 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.
    (c) Alternate Contract Scientific Organization.--
            (1) In general.--If the Director is unable to enter into an 
        agreement described in subsection (a) with the National Academy 
        of Sciences before the date specified in such subsection on 
        terms acceptable to the Director, the Director shall seek to 
        enter into such an agreement with another appropriate 
        scientific organization that--
                    (A) is not part of the Government;
                    (B) operates as a not-for-profit entity; and
                    (C) has expertise and objectivity comparable to 
                that of the National Academy of Sciences.
            (2) Treatment.--If the Director enters into an agreement 
        with another organization as described in paragraph (1), any 
        reference in this subsection to the National Academy of 
        Sciences shall be treated as a reference to the other 
        organization.

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, ethical, 
        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) Department of Defense.--As part of the Initiative, the 
Secretary of Defense shall--
            (1) conduct and support research and development in 
        engineering biology and associated data and information 
        sciences;
            (2) support curriculum development and research experiences 
        in engineering biology and associated data and information 
        sciences across the military education system, to include 
        service academies, professional military education, and 
        military graduate education; and
            (3) assess risks of potential national security and 
        economic security threats relating to engineering biology.
    (e) 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.
    (f) Department of Agriculture.--As part of the Initiative, the 
Secretary of Agriculture shall--
            (1) support research and development in engineering 
        biology, including in synthetic biology and biomaterials;
            (2) award grants through the National Institute of Food and 
        Agriculture; and
            (3) support development conducted by the Agricultural 
        Research Service.
    (g) 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.
    (h) Department of Health and Human Services.--
            (1) National institutes of health.--As part of the 
        Initiative, the Director of the National Institutes of Health 
        shall--
                    (A) support research and development to advance the 
                understanding and application of engineering biology 
                for human health, including in synthetic biology, cell 
                and tissue engineering, computational biology, and 
                artificial intelligence;
                    (B) support and accelerate the application of 
                biomedical research and technologies through cross-
                disciplinary collaboration and training programs;
                    (C) support research on ethical, legal, safety, and 
                societal implications of emerging biotechnologies; and
                    (D) award grants on a competitive basis, that 
                enable institutions to support graduate students and 
                postdoctoral fellows who perform some of their 
                engineering biology research across multiple 
                disciplinary departments.
            (2) Food and drug administration.--As part of the 
        Initiative, the Commissioner of Food and Drugs shall--
                    (A) support research and evaluation of safety, 
                potency, and efficacy of novel biologic products and 
                biomanufacturing technologies; and
                    (B) ensure the timely development of screening 
                methods to evaluate safety and security of new 
                biological products and processes.
                                 <all>
```