I 

116TH CONGRESS 

1ST SESSION H. R. 4373 

To provide for a coordinated Federal research initiative to ensure continued 

United States leadership in engineering biology. 

IN THE HOUSE OF REPRESENTATIVES 

SEPTEMBER 18, 2019 

Ms. JOHNSON of Texas (for herself, Mr. SENSENBRENNER, Ms. LOFGREN, 

and Mr. LUCAS) introduced the following bill; which was referred to the 

Committee on Science, Space, and Technology 

A BILL 

To provide for a coordinated Federal research initiative to 

ensure continued United States leadership in engineering 

biology. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Engineering Biology 

5 Research and Development Act of 2019’’. 

6 SEC. 2. FINDINGS. 

7 The Congress makes the following findings: 

8 (1) Cellular and molecular processes may be 

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1 ucts, processes, and systems that improve societal 

2 well-being, strengthen national security, and con3 tribute to the economy. 

4 (2) Engineering biology relies on a workforce 

5 with a diverse and unique set of skills combining the 

6 biological, physical, chemical, and information 

7 sciences and engineering. 

8 (3) Long-term research and development is nec9 essary to create breakthroughs in engineering biol10 ogy. Such research and development requires govern11 ment investment as many of the benefits are too dis12 tant or uncertain for industry to support alone. 

13 (4) Research is necessary to inform evidence14 based governance of engineering biology and to sup15 port the growth of the engineering biology industry. 

16 (5) The Federal Government can play an im17 portant role by facilitating the development of tools 

18 and technologies to further advance engineering biol19 ogy, including user facilities, by facilitating public20 private partnerships, by supporting risk research, 

21 and by facilitating the commercial application in the 

22 United States of research funded by the Federal 

23 Government. 

24 (6) The United States led the development of 

25 the science and engineering techniques that created 


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1 the field of engineering biology, but due to increas2 ing international competition, the United States is 

3 at risk of losing its competitive advantage if it does 

4 not invest the necessary resources and have a na5 tional strategy. 

6 (7) A National Engineering Biology Initiative 

7 can serve to establish new research directions and 

8 technology goals, improve interagency coordination 

9 and planning processes, drive technology transfer to 

10 the private sector, and help ensure optimal returns 

11 on the Federal investment. 

12 SEC. 3. DEFINITIONS. 

13 In this Act: 

14 (1) BIOMANUFACTURING.—The term ‘‘bio15 manufacturing’’ means the utilization of biological 

16 systems to develop new and advance existing prod17 ucts, tools, and processes at commercial scale. 

18 (2) ENGINEERING BIOLOGY.—The term ‘‘engi19 neering biology’’ means the application of engineer20 ing design principles and practices to biological sys21 tems, including molecular and cellular systems, to 

22 advance fundamental understanding of complex nat23 ural systems and to enable novel functions and capa24 bilities. 


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1 (3) INITIATIVE.—The term ‘‘Initiative’’ means 

2 the National Engineering Biology Research and De3 velopment Initiative established under section 4. 

4 (4) OMICS.—The term ‘‘omics’’ refers to the 

5 collective technologies used to explore the roles, rela6 tionships, and actions of the various types of mol7 ecules that make up the cells of an organism. 

8 SEC. 4. NATIONAL ENGINEERING BIOLOGY RESEARCH AND 

9 DEVELOPMENT INITIATIVE. 

10 (a) IN GENERAL.—The President, acting through the 

11 Office of Science and Technology Policy, shall implement 

12 a National Engineering Biology Research and Develop13 ment Initiative to advance societal well-being, national se14 curity, sustainability, and economic productivity and com15 petitiveness through— 

16 (1) advancing areas of research at the intersec17 tion of the biological, physical, chemical, and infor18 mation sciences and engineering to accelerate sci19 entific understanding and technological innovation in 

20 engineering biology; 

21 (2) advancing areas of biomanufacturing re22 search to optimize, standardize, scale, and deliver 

23 new products and solutions; 

24 (3) supporting social and behavioral sciences 

25 and economics research that advances the field of 


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1 engineering biology and contributes to the develop2 ment and public understanding of new products, 

3 processes, and technologies; 

4 (4) supporting risk research, including under 

5 subsection (d); 

6 (5) supporting the development of novel tools 

7 and technologies to accelerate scientific under8 standing and technological innovation in engineering 

9 biology; 

10 (6) expanding the number of researchers, edu11 cators, and students with engineering biology train12 ing, including from traditionally underserved popu13 lations; 

14 (7) accelerating the translation and commer15 cialization of engineering biology research and devel16 opment by the private sector; and 

17 (8) improving the interagency planning and co18 ordination of Federal Government activities related 

19 to engineering biology. 

20 (b) INITIATIVE ACTIVITIES.—The activities of the 

21 Initiative shall include— 

22 (1) sustained support for engineering biology 

23 research and development through— 


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1 (A) grants to individual investigators and 

2 teams of investigators, including interdiscipli3 nary teams; 

4 (B) projects funded under joint solicita5 tions by a collaboration of no fewer than two 

6 agencies participating in the Initiative; and 

7 (C) interdisciplinary research centers that 

8 are organized to investigate basic research 

9 questions, carry out technology development 

10 and demonstration activities, and increase un11 derstanding of how to scale up engineering biol12 ogy processes, including biomanufacturing; 

13 (2) sustained support for databases and related 

14 tools, including— 

15 (A) support for curated genomics, 

16 epigenomics, and all other relevant omics data17 bases, including plant and microbial databases, 

18 that are available to researchers to carry out 

19 engineering biology research; 

20 (B) development of standards for such 

21 databases, including for curation, interoper22 ability, and protection of privacy and security; 

23 (C) support for the development of com24 putational tools, including artificial intelligence 


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1 tools, that can accelerate research and innova2 tion using such databases; and 

3 (D) an inventory and assessment of all 

4 Federal government omics databases to identify 

5 opportunities for consolidation and inform in6 vestment in such databases as critical infra7 structure for the engineering biology research 

8 enterprise; 

9 (3) sustained support for the development, opti10 mization, and validation of novel tools and tech11 nologies to enable the dynamic study of molecular 

12 processes in situ, including through grants to inves13 tigators at institutions of higher education and other 

14 nonprofit research institutions, and through the 

15 Small Business Innovation Research Program and 

16 the Small Business Technology Transfer Program, 

17 as described in section 9 of the Small Business Act 

18 (15 U.S.C. 638); 

19 (4) education and training of undergraduate 

20 and graduate students in engineering biology, in bio21 manufacturing, in bioprocess engineering, and in 

22 areas of computational science applied to engineer23 ing biology; 


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1 (5) activities to develop robust mechanisms for 

2 tracking and quantifying the outputs and economic 

3 benefits of engineering biology; and 

4 (6) activities to accelerate the translation and 

5 commercialization of new products, processes, and 

6 technologies by— 

7 (A) identifying precompetitive research op8 portunities; 

9 (B) facilitating public-private partnerships 

10 in engineering biology research and develop11 ment; 

12 (C) connecting researchers, graduate stu13 dents, and postdoctoral fellows with entrepre14 neurship education and training opportunities; 

15 and 

16 (D) supporting proof of concept activities 

17 and the formation of startup companies includ18 ing through programs such as the Small Busi19 ness Innovation Research Program and the 

20 Small Business Technology Transfer Program. 

21 (c) EXPANDING PARTICIPATION.—The Initiative 

22 shall include, to the maximum extent practicable, outreach 

23 to primarily undergraduate and minority-serving institu24 tions about Initiative opportunities, and shall encourage 

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1 search-intensive universities and primarily undergraduate 

2 and minority-serving institutions. 

3 (d) ETHICAL, LEGAL, ENVIRONMENTAL, SAFETY, 

4 SECURITY, AND SOCIETAL ISSUES.—Initiative activities 

5 shall take into account ethical, legal, environmental, safe6 ty, security, and other appropriate societal issues by— 

7 (1) supporting research, including in the social 

8 sciences, and other activities addressing ethical, 

9 legal, environmental, and other appropriate societal 

10 issues related to engineering biology, including inte11 grating research on such topics with the research 

12 and development in engineering biology, and ensur13 ing that the results of such research are widely dis14 seminated, including through interdisciplinary engi15 neering biology research centers described in sub16 section (b)(1); 

17 (2) supporting research and other activities re18 lated to the safety and security implications of engi19 neering biology, including outreach to increase 

20 awareness among federally funded researchers at in21 stitutions of higher education about potential safety 

22 and security implications of engineering biology re23 search, as appropriate; 

24 (3) ensuring that input from Federal and non25 Federal experts on the ethical, legal, environmental, 


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1 security, and other appropriate societal issues re2 lated to engineering biology is integrated into the 

3 Initiative; and 

4 (4) ensuring, through the agencies and depart5 ments that participate in the Initiative, that public 

6 input and outreach are integrated into the Initiative 

7 by the convening of regular and ongoing public dis8 cussions through mechanisms such as workshops, 

9 consensus conferences, and educational events, as 

10 appropriate. 

11 SEC. 5. INITIATIVE COORDINATION. 

12 (a) INTERAGENCY COMMITTEE.—The President, act13 ing through the Office of Science and Technology Policy, 

14 shall designate an interagency committee to coordinate en15 gineering biology, which shall be co-chaired by the Office 

16 of Science and Technology Policy, and include representa17 tives from the National Science Foundation, the Depart18 ment of Energy, the National Aeronautics and Space Ad19 ministration, the National Institute of Standards and 

20 Technology, the Environmental Protection Agency, the 

21 Department of Agriculture, the National Institutes of 

22 Health, the Bureau of Economic Analysis, and any other 

23 agency that the President considers appropriate (in this 

24 section referred to as the ‘‘interagency committee’’). The 

25 Director of the Office of Science and Technology Policy 


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1 shall select an additional co-chairperson from among the 

2 members of the Interagency Committee. The Interagency 

3 Committee shall oversee the planning, management, and 

4 coordination of the Initiative. The Interagency Committee 

5 shall— 

6 (1) provide for interagency coordination of Fed7 eral engineering biology research, development, and 

8 other activities undertaken pursuant to the Initia9 tive; 

10 (2) establish and periodically update goals and 

11 priorities for the Initiative; 

12 (3) develop, not later than 12 months after the 

13 date of enactment of this Act, and update every 3 

14 years, a strategic plan that— 

15 (A) guides the activities of the Initiative 

16 for purposes of meeting the goals and priorities 

17 established under (and updated pursuant to) 

18 paragraph (2); and 

19 (B) describes— 

20 (i) the Initiative’s support for long21 term funding for interdisciplinary engineer22 ing biology research and development; 

23 (ii) the Initiative’s support for edu24 cation and public outreach activities; 


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1 (iii) the Initiative’s support for re2 search and other activities on ethical, legal, 

3 environmental, safety, security, and other 

4 appropriate societal issues related to engi5 neering biology; 

6 (iv) how the Initiative will move re7 sults out of the laboratory and into appli8 cation for the benefit of society and United 

9 States competitiveness; and 

10 (v) how the Initiative will measure 

11 and track the contributions of engineering 

12 biology to United States economic growth 

13 and other societal indicators; 

14 (4) develop a national genomic sequencing 

15 strategy to ensure engineering biology research fully 

16 leverages plant, animal, and microbe biodiversity to 

17 enhance long-term innovation and competitiveness in 

18 engineering biology in the United States; 

19 (5) propose an annually coordinated interagency 

20 budget for the Initiative that is intended to ensure— 

21 (A) the maintenance of a robust engineer22 ing biology research and development portfolio; 

23 and 


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1 (B) that the balance of funding across the 

2 Initiative is sufficient to meet the goals and pri3 orities established for the Program; 

4 (6) develop a plan to utilize Federal programs, 

5 such as the Small Business Innovation Research 

6 Program and the Small Business Technology Trans7 fer Program as described in section 9 of the Small 

8 Business Act (15 U.S.C. 638), in support of the ac9 tivities described in section 4(b)(3); and 

10 (7) in carrying out this section, take into con11 sideration the recommendations of the advisory com12 mittee established under section 6, the results of the 

13 workshop convened under section 7, existing reports 

14 on related topics, and the views of academic, State, 

15 industry, and other appropriate groups. 

16 (b) ANNUAL REPORT.—Beginning with fiscal year 

17 2020, not later than 90 days after submission of the Presi18 dent’s annual budget request and each fiscal year there19 after, the interagency committee shall prepare and submit 

20 to the Committee on Science, Space, and Technology of 

21 the House of Representatives and the Committee on Com22 merce, Science, and Transportation of the Senate a report 

23 that includes— 

24 (1) a summarized agency budget in support of 

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1 et request applies, and for the then current fiscal 

2 year, including a breakout of spending for each 

3 agency participating in the Program and for the de4 velopment and acquisition of any research facilities 

5 and instrumentation; and 

6 (2) an assessment of how Federal agencies are 

7 implementing the plan described in subsection 

8 (a)(3), and a description of the amount and number 

9 of awards made under the Small Business Innova10 tion Research Program and the Small Business 

11 Technology Transfer Program (as described in sec12 tion 9 of the Small Business Act (15 U.S.C. 638)) 

13 in support of the Initiative. 

14 (c) INITIATIVE STAFFING.—The President shall en15 sure adequate staffing for the Initiative, including full16 time staff within the Office of Science and Technology 

17 Policy, who shall— 

18 (1) provide technical and administrative support 

19 to the interagency committee and the advisory com20 mittee established under section 6; 

21 (2) serve as the point of contact on Federal en22 gineering biology activities for government organiza23 tions, academia, industry, professional societies, 

24 State governments, interested citizen groups, and 


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1 others to exchange technical and programmatic in2 formation; 

3 (3) oversee interagency coordination of the Ini4 tiative, including by encouraging and supporting 

5 joint agency solicitation and selection of applications 

6 for funding of activities under the Initiative; 

7 (4) conduct public outreach, including dissemi8 nation of findings and recommendations of the advi9 sory committee established under section 6, as ap10 propriate; and 

11 (5) promote access to, and early application of, 

12 the technologies, innovations, and expertise derived 

13 from Initiative activities to agency missions and sys14 tems across the Federal Government, and to United 

15 States industry, including startup companies. 

16 SEC. 6. ADVISORY COMMITTEE. 

17 (a) IN GENERAL.—The President, acting through the 

18 Office of Science and Technology Policy, shall designate 

19 or establish an advisory committee on engineering biology 

20 research and development (in this section referred to as 

21 the ‘‘advisory committee’’) to be composed of not fewer 

22 than 12 members, including representatives of research 

23 and academic institutions, industry, and nongovernmental 

24 entities, who are qualified to provide advice on the Initia25 tive. 


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1 (b) ASSESSMENT.—The advisory committee shall as2 sess— 

3 (1) the current state of United States competi4 tiveness in engineering biology, including the scope 

5 and scale of United States investments in engineer6 ing biology research and development in the inter7 national context; 

8 (2) current market barriers to commercializa9 tion of engineering biology products, processes, and 

10 tools in the United States; 

11 (3) progress made in implementing the Initia12 tive; 

13 (4) the need to revise the Initiative; 

14 (5) the balance of activities and funding across 

15 the Initiative; 

16 (6) whether the strategic plan developed or up17 dated by the interagency committee established 

18 under section 5 is helping to maintain United States 

19 leadership in engineering biology; 

20 (7) the management, coordination, implementa21 tion, and activities of the Initiative; and 

22 (8) whether ethical, legal, environmental, safety, 

23 security, and other appropriate societal issues are 

24 adequately addressed by the Initiative. 


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1 (c) REPORTS.—Beginning not later than 2 years 

2 after the date of enactment of this Act, and not less fre3 quently than once every 3 years thereafter, the advisory 

4 committee shall submit to the President, the Committee 

5 on Science, Space, and Technology of the House of Rep6 resentatives, and the Committee on Commerce, Science, 

7 and Transportation of the Senate, a report on— 

8 (1) the findings of the advisory committee’s as9 sessment under subsection (b); and 

10 (2) the advisory committee’s recommendations 

11 for ways to improve the Initiative. 

12 (d) APPLICATION OF FEDERAL ADVISORY COM13 MITTEE ACT.—Section 14 of the Federal Advisory Com14 mittee Act (5 U.S.C. App.) shall not apply to the Advisory 

15 Committee. 

16 SEC. 7. EXTERNAL REVIEW OF ETHICAL, LEGAL, ENVIRON17 MENTAL, AND SOCIETAL ISSUES. 

18 (a) IN GENERAL.—Not later than 12 months after 

19 the date of enactment of this Act, the Director of the Na20 tional Science Foundation shall enter into an agreement 

21 with the National Academies to convene a workshop to 

22 review the ethical, legal, environmental, and other appro23 priate societal issues related to engineering biology re24 search and development. The goals of the workshop shall 

25 be to— 


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1 (1) assess the current research on such issues; 

2 (2) evaluate the research gaps relating to such 

3 issues; and 

4 (3) provide recommendations on how the Initia5 tive can address the research needs identified. 

6 (b) REPORT TO CONGRESS.—Not later than 2 years 

7 after the date of enactment of this Act, the Director of 

8 the National Science Foundation shall transmit to the 

9 Committee on Science, Space, and Technology of the 

10 House of Representatives and the Committee on Com11 merce, Science, and Transportation of the Senate a sum12 mary report containing the findings of the workshop con13 vened under this section. 

14 SEC. 8. AGENCY ACTIVITIES. 

15 (a) NATIONAL SCIENCE FOUNDATION.—As part of 

16 the Initiative, the National Science Foundation shall— 

17 (1) support basic research in engineering biol18 ogy through individual grants and through inter19 disciplinary research centers; 

20 (2) support research on the environmental, 

21 legal, and social implications of engineering biology; 

22 (3) provide support for research instrumenta23 tion for engineering biology disciplines, including 

24 support for research, development, optimization and 


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1 validation of novel technologies to enable the dy2 namic study of molecular processes in situ; and 

3 (4) award grants, on a competitive basis, to en4 able institutions to support graduate students and 

5 postdoctoral fellows who perform some of their engi6 neering biology research in an industry setting. 

7 (b) DEPARTMENT OF COMMERCE.—As part of the 

8 Initiative, the Director of the National Institute of Stand9 ards and Technology shall— 

10 (1) establish a bioscience research program to 

11 advance the development of standard reference ma12 terials and measurements and to create new data 

13 tools, techniques, and processes necessary to advance 

14 engineering biology and biomanufacturing; 

15 (2) provide access to user facilities with ad16 vanced or unique equipment, services, materials, and 

17 other resources to industry, institutions of higher 

18 education, nonprofit organizations, and government 

19 agencies to perform research and testing; and 

20 (3) provide technical expertise to inform the po21 tential development of guidelines or safeguards for 

22 new products, processes, and systems of engineering 

23 biology. 

24 (c) DEPARTMENT OF ENERGY.—As part of the Ini25 tiative, the Secretary of Energy shall— 


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1 (1) conduct and support basic research, devel2 opment, demonstration, and commercial application 

3 activities in engineering biology, including in the 

4 areas of synthetic biology, advanced biofuel develop5 ment, biobased materials, and environmental remedi6 ation; 

7 (2) support the development, optimization, and 

8 validation of novel, scalable tools and technologies to 

9 enable the dynamic study of molecular processes in 

10 situ; and 

11 (3) provide access to user facilities with ad12 vanced or unique equipment, services, materials, and 

13 other resources, as appropriate, to industry, institu14 tions of higher education, nonprofit organizations, 

15 and government agencies to perform research and 

16 testing. 

17 (d) NATIONAL AERONAUTICS AND SPACE ADMINIS18 TRATION.—As part of the Initiative, the National Aero19 nautics and Space Administration shall— 

20 (1) conduct and support basic and applied re21 search in engineering biology, including in synthetic 

22 biology, and related to Earth and space sciences, 

23 aeronautics, space technology, and space exploration 

24 and experimentation, consistent with the priorities 


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1 established in the National Academies’ decadal sur2 veys; and 

3 (2) award grants, on a competitive basis, that 

4 enable institutions to support graduate students and 

5 postdoctoral fellows who perform some of their engi6 neering biology research in an industry setting. 

7 (e) ENVIRONMENTAL PROTECTION AGENCY.—As 

8 part of the Initiative, the Environmental Protection Agen9 cy shall support research on how products, processes, and 

10 systems of engineering biology will affect or can protect 

11 the environment. 

Æ 


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