[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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