IIB 

116TH CONGRESS 

1ST SESSION H. R. 4373 

IN THE SENATE OF THE UNITED STATES 

DECEMBER 10, 2019 

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

and Transportation 

AN ACT 

To provide for a coordinated Federal research initiative to 

ensure continued United States leadership in engineering 

biology. 

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


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1 SECTION 1. SHORT TITLE. 

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

3 Research and Development Act of 2019’’. 

4 SEC. 2. FINDINGS. 

5 The Congress makes the following findings: 

6 (1) Cellular and molecular processes may be 

7 used, mimicked, or redesigned to develop new prod8 ucts, processes, and systems that improve societal 

9 well-being, strengthen national security, and con10 tribute to the economy. 

11 (2) Engineering biology relies on a workforce 

12 with a diverse and unique set of skills combining the 

13 biological, physical, chemical, and information 

14 sciences and engineering. 

15 (3) Long-term research and development is nec16 essary to create breakthroughs in engineering biol17 ogy. Such research and development requires govern18 ment investment as many of the benefits are too dis19 tant or uncertain for industry to support alone. 

20 (4) Research is necessary to inform evidence21 based governance of engineering biology and to sup22 port the growth of the engineering biology industry. 

23 (5) The Federal Government can play an im24 portant role by facilitating the development of tools 

25 and technologies to further advance engineering biol26 ogy, including user facilities, by facilitating publicVerDate Sep 11 2014 23:40 Dec 10, 2019 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H4373.RFS H4373

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1 private partnerships, by supporting risk research, 

2 and by facilitating the commercial application in the 

3 United States of research funded by the Federal 

4 Government. 

5 (6) The United States led the development of 

6 the science and engineering techniques that created 

7 the field of engineering biology, but due to increas8 ing international competition, the United States is 

9 at risk of losing its competitive advantage if does not 

10 invest the necessary resources and have a national 

11 strategy. 

12 (7) A National Engineering Biology Initiative 

13 can serve to establish new research directions and 

14 technology goals, improve interagency coordination 

15 and planning processes, drive technology transfer to 

16 the private sector, and help ensure optimal returns 

17 on the Federal investment. 

18 SEC. 3. DEFINITIONS. 

19 In this Act: 

20 (1) BIOMANUFACTURING.—The term ‘‘bio21 manufacturing’’ means the utilization of biological 

22 systems to develop new and advance existing prod23 ucts, tools, and processes at commercial scale. 

24 (2) ENGINEERING BIOLOGY.—The term ‘‘engi25 neering biology’’ means the application of engineerVerDate Sep 11 2014 23:40 Dec 10, 2019 Jkt 099200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H4373.RFS H4373

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1 ing design principles and practices to biological sys2 tems, including molecular and cellular systems, to 

3 advance fundamental understanding of complex nat4 ural systems and to enable novel or optimize func5 tions and capabilities. 

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

7 the National Engineering Biology Research and De8 velopment Initiative established under section 4. 

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

10 collective technologies used to explore the roles, rela11 tionships, and actions of the various types of mol12 ecules that make up the cells of an organism. 

13 SEC. 4. NATIONAL ENGINEERING BIOLOGY RESEARCH AND 

14 DEVELOPMENT INITIATIVE. 

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

16 Office of Science and Technology Policy, shall implement 

17 a National Engineering Biology Research and Develop18 ment Initiative to advance societal well-being, national se19 curity, sustainability, and economic productivity and com20 petitiveness through— 

21 (1) advancing areas of research at the intersec22 tion of the biological, physical, chemical, and infor23 mation sciences and engineering to accelerate sci24 entific understanding and technological innovation in 

25 engineering biology; 


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1 (2) advancing areas of biomanufacturing re2 search to optimize, standardize, scale, and deliver 

3 new products and solutions; 

4 (3) supporting social and behavioral sciences 

5 and economics research that advances the field of 

6 engineering biology and contributes to the develop7 ment and public understanding of new products, 

8 processes, and technologies; 

9 (4) supporting risk research, including under 

10 subsection (d); 

11 (5) supporting the development of novel tools 

12 and technologies to accelerate scientific under13 standing and technological innovation in engineering 

14 biology; 

15 (6) expanding the number of researchers, edu16 cators, and students with engineering biology train17 ing, including from traditionally underserved popu18 lations; 

19 (7) accelerating the translation and commer20 cialization of engineering biology research and devel21 opment by the private sector; and 

22 (8) improving the interagency planning and co23 ordination of Federal Government activities related 

24 to engineering biology. 


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

2 Initiative shall include— 

3 (1) sustained support for engineering biology 

4 research and development through— 

5 (A) grants to individual investigators and 

6 teams of investigators, including interdiscipli7 nary teams; 

8 (B) projects funded under joint solicita9 tions by a collaboration of no fewer than two 

10 agencies participating in the Initiative; and 

11 (C) interdisciplinary research centers that 

12 are organized to investigate basic research 

13 questions, carry out technology development 

14 and demonstration activities, and increase un15 derstanding of how to scale up engineering biol16 ogy processes, including biomanufacturing; 

17 (2) sustained support for databases and related 

18 tools, including— 

19 (A) support for curated genomics, 

20 epigenomics, and all other relevant omics data21 bases, including plant and microbial databases, 

22 that are available to researchers to carry out 

23 engineering biology research; 


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1 (B) development of standards for such 

2 databases, including for curation, interoper3 ability, and protection of privacy and security; 

4 (C) support for the development of com5 putational tools, including artificial intelligence 

6 tools, that can accelerate research and innova7 tion using such databases; and 

8 (D) an inventory and assessment of all 

9 Federal government omics databases to identify 

10 opportunities for consolidation and inform in11 vestment in such databases as critical infra12 structure for the engineering biology research 

13 enterprise; 

14 (3) sustained support for the development, opti15 mization, and validation of novel tools and tech16 nologies to enable the dynamic study of molecular 

17 processes in situ, including through grants to inves18 tigators at institutions of higher education and other 

19 nonprofit research institutions, and through the 

20 Small Business Innovation Research Program and 

21 the Small Business Technology Transfer Program, 

22 as described in section 9 of the Small Business Act 

23 (15 U.S.C. 638); 

24 (4) education and training of undergraduate 

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1 manufacturing, in bioprocess engineering, and in 

2 areas of computational science applied to engineer3 ing biology; 

4 (5) activities to develop robust mechanisms for 

5 tracking and quantifying the outputs and economic 

6 benefits of engineering biology; and 

7 (6) activities to accelerate the translation and 

8 commercialization of new products, processes, and 

9 technologies by— 

10 (A) identifying precompetitive research op11 portunities; 

12 (B) facilitating public-private partnerships 

13 in engineering biology research and develop14 ment; 

15 (C) connecting researchers, graduate stu16 dents, and postdoctoral fellows with entrepre17 neurship education and training opportunities; 

18 and 

19 (D) supporting proof of concept activities 

20 and the formation of startup companies includ21 ing through programs such as the Small Busi22 ness Innovation Research Program and the 

23 Small Business Technology Transfer Program. 

24 (c) EXPANDING PARTICIPATION.—The Initiative 

25 shall include, to the maximum extent practicable, outreach 


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1 to primarily undergraduate and minority-serving institu2 tions about Initiative opportunities, and shall encourage 

3 the development of research collaborations between re4 search-intensive universities and primarily undergraduate 

5 and minority-serving institutions. 

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

7 SECURITY, AND SOCIETAL ISSUES.—Initiative activities 

8 shall take into account ethical, legal, environmental, safe9 ty, security, and other appropriate societal issues by— 

10 (1) supporting research, including in the social 

11 sciences, and other activities addressing ethical, 

12 legal, environmental, and other appropriate societal 

13 issues related to engineering biology, including inte14 grating research on such topics with the research 

15 and development in engineering biology, and ensur16 ing that the results of such research are widely dis17 seminated, including through interdisciplinary engi18 neering biology research centers described in sub19 section (b)(1); 

20 (2) supporting research and other activities re21 lated to the safety and security implications of engi22 neering biology, including outreach to increase 

23 awareness among federally-funded researchers at in24 stitutions of higher education about potential safety 


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1 and security implications of engineering biology re2 search, as appropriate; 

3 (3) ensuring that input from Federal and non4 Federal experts on the ethical, legal, environmental, 

5 security, and other appropriate societal issues re6 lated to engineering biology is integrated into the 

7 Initiative; and 

8 (4) ensuring, through the agencies and depart9 ments that participate in the Initiative, that public 

10 input and outreach are integrated into the Initiative 

11 by the convening of regular and ongoing public dis12 cussions through mechanisms such as workshops, 

13 consensus conferences, and educational events, as 

14 appropriate. 

15 SEC. 5. INITIATIVE COORDINATION. 

16 (a) INTERAGENCY COMMITTEE.—The President, act17 ing through the Office of Science and Technology Policy, 

18 shall designate an interagency committee to coordinate en19 gineering biology, which shall be co-chaired by the Office 

20 of Science and Technology Policy, and include representa21 tives from the National Science Foundation, the Depart22 ment of Energy, the National Aeronautics and Space Ad23 ministration, the National Institute of Standards and 

24 Technology, the Environmental Protection Agency, the 

25 Department of Agriculture, the National Institutes of 


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

2 agency that the President considers appropriate (in this 

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

4 Director of the Office of Science and Technology Policy 

5 shall select an additional co-chairperson from among the 

6 members of the Interagency Committee. The Interagency 

7 Committee shall oversee the planning, management, and 

8 coordination of the Initiative. The Interagency Committee 

9 shall— 

10 (1) provide for interagency coordination of Fed11 eral engineering biology research, development, and 

12 other activities undertaken pursuant to the Initia13 tive; 

14 (2) establish and periodically update goals and 

15 priorities for the Initiative; 

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

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

18 years, a strategic plan that— 

19 (A) guides the activities of the Initiative 

20 for purposes of meeting the goals and priorities 

21 established under (and updated pursuant to) 

22 paragraph (2); and 

23 (B) describes— 


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1 (i) the Initiative’s support for long2 term funding for interdisciplinary engineer3 ing biology research and development; 

4 (ii) the Initiative’s support for edu5 cation and public outreach activities; 

6 (iii) the Initiative’s support for re7 search and other activities on ethical, legal, 

8 environmental, safety, security, and other 

9 appropriate societal issues related to engi10 neering biology; 

11 (iv) how the Initiative will move re12 sults out of the laboratory and into appli13 cation for the benefit of society and United 

14 States competitiveness; and 

15 (v) how the Initiative will measure 

16 and track the contributions of engineering 

17 biology to United States economic growth 

18 and other societal indicators; 

19 (4) develop a national genomic sequencing 

20 strategy to ensure engineering biology research fully 

21 leverages plant, animal, and microbe biodiversity to 

22 enhance long-term innovation and competitiveness in 

23 engineering biology in the United States; 

24 (5) propose an annually coordinated interagency 

25 budget for the Initiative that is intended to ensure— 


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1 (A) the maintenance of a robust engineer2 ing biology research and development portfolio; 

3 and 

4 (B) that the balance of funding across the 

5 Initiative is sufficient to meet the goals and pri6 orities established for the Program; 

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

8 such as the Small Business Innovation Research 

9 Program and the Small Business Technology Trans10 fer Program as described in section 9 of the Small 

11 Business Act (15 U.S.C. 638), in support of the ac12 tivities described in section 4(b)(3); and 

13 (7) in carrying out this section, take into con14 sideration the recommendations of the advisory com15 mittee established under section 6, the results of the 

16 workshop convened under section 7, existing reports 

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

18 industry, and other appropriate groups. 

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

20 2020, not later than 90 days after submission of the Presi21 dent’s annual budget request and each fiscal year there22 after, the interagency committee shall prepare and submit 

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

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1 merce, Science, and Transportation of the Senate a report 

2 that includes— 

3 (1) a summarized agency budget in support of 

4 the Initiative for the fiscal year to which such budg5 et request applies, and for the then current fiscal 

6 year, including a breakout of spending for each 

7 agency participating in the Program and for the de8 velopment and acquisition of any research facilities 

9 and instrumentation; and 

10 (2) an assessment of how Federal agencies are 

11 implementing the plan described in subsection 

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

13 of awards made under the Small Business Innova14 tion Research Program and the Small Business 

15 Technology Transfer Program (as described in sec16 tion 9 of the Small Business Act (15 U.S.C. 638)) 

17 in support of the Initiative. 

18 (c) INITIATIVE OFFICE.— 

19 (1) IN GENERAL.—The President shall establish 

20 an Initiative Coordination Office, with a Director 

21 and full-time staff, which shall— 

22 (A) provide technical and administrative 

23 support to the interagency committee and the 

24 advisory committee established under section 6; 


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1 (B) serve as the point of contact on Fed2 eral engineering biology activities for govern3 ment organizations, academia, industry, profes4 sional societies, State governments, interested 

5 citizen groups, and others to exchange technical 

6 and programmatic information; 

7 (C) oversee interagency coordination of the 

8 Initiative, including by encouraging and sup9 porting joint agency solicitation and selection of 

10 applications for funding of activities under the 

11 Initiative; 

12 (D) conduct public outreach, including dis13 semination of findings and recommendations of 

14 the advisory committee established under sec15 tion 6, as appropriate; and 

16 (E) promote access to, and early applica17 tion of, the technologies, innovations, and ex18 pertise derived from Initiative activities to agen19 cy missions and systems across the Federal 

20 Government, and to United States industry, in21 cluding startup companies. 

22 (2) FUNDING.—The Director of the Office of 

23 Science and Technology Policy shall develop an esti24 mate of the funds necessary to carry out the activi25 ties of the Initiative Coordination Office, including 


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1 an estimate of how much each participating agency 

2 described in subsection (a) will contribute to such 

3 funds, and submit such estimate to Congress no 

4 later than 90 days after the enactment of this Act. 

5 (3) TERMINATION.—The Initiative Coordination 

6 Office established under this subsection shall termi7 nate on the date that is 10 years after the date of 

8 the enactment of this Act, unless a determination is 

9 made by the President that such Office is necessary 

10 to meet the economic or national security goals of 

11 the Program. 

12 SEC. 6. ADVISORY COMMITTEE. 

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

14 Office of Science and Technology Policy, shall designate 

15 or establish an advisory committee on engineering biology 

16 research and development (in this section referred to as 

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

18 than 12 members, including representatives of research 

19 and academic institutions, industry, and nongovernmental 

20 entities, who are qualified to provide advice on the Initia21 tive. 

22 (b) ASSESSMENT.—The advisory committee shall as23 sess— 

24 (1) the current state of United States competi25 tiveness in engineering biology, including the scope 


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1 and scale of United States investments in engineer2 ing biology research and development in the inter3 national context; 

4 (2) current market barriers to commercializa5 tion of engineering biology products, processes, and 

6 tools in the United States; 

7 (3) progress made in implementing the Initia8 tive; 

9 (4) the need to revise the Initiative; 

10 (5) the balance of activities and funding across 

11 the Initiative; 

12 (6) whether the strategic plan developed or up13 dated by the interagency committee established 

14 under section 5 is helping to maintain United States 

15 leadership in engineering biology; 

16 (7) the management, coordination, implementa17 tion, and activities of the Initiative; and 

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

19 security, and other appropriate societal issues are 

20 adequately addressed by the Initiative. 

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

22 after the date of enactment of this Act, and not less fre23 quently than once every 3 years thereafter, the advisory 

24 committee shall submit to the President, the Committee 

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1 resentatives, and the Committee on Commerce, Science, 

2 and Transportation of the Senate, a report on— 

3 (1) the findings of the advisory committee’s as4 sessment under subsection (b); and 

5 (2) the advisory committee’s recommendations 

6 for ways to improve the Initiative. 

7 (d) APPLICATION OF FEDERAL ADVISORY COM8 MITTEE ACT.—Section 14 of the Federal Advisory Com9 mittee Act (5 U.S.C. App.) shall not apply to the Advisory 

10 Committee. 

11 SEC. 7. EXTERNAL REVIEW OF ETHICAL, LEGAL, ENVIRON12 MENTAL, AND SOCIETAL ISSUES. 

13 (a) IN GENERAL.—Not later than 6 months after the 

14 date of enactment of this Act, the Director of the National 

15 Science Foundation shall enter into an agreement with the 

16 National Academies of Sciences, Engineering, and Medi17 cine to conduct a review, and make recommendations with 

18 respect to, the ethical, legal, environmental, and other ap19 propriate societal issues related to engineering biology re20 search and development. The review shall include— 

21 (1) an assessment of the current research on 

22 such issues; 

23 (2) a description of the research gaps relating 

24 to such issues; 


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1 (3) recommendations on how the Initiative can 

2 address the research needs identified pursuant to 

3 paragraph (2); and 

4 (4) recommendations on how engineering biol5 ogy researchers can best incorporate considerations 

6 of ethical, legal, environmental, and other societal 

7 issues into the development of research proposals 

8 and the conduct of research. 

9 (b) REPORT TO CONGRESS.—The agreement entered 

10 into under subsection (a) shall require the National Acad11 emy of Sciences, Engineering, and Medicine to, not later 

12 than 2 years after the date of the enactment of this Act— 

13 (1) submit to the Committee on Science, Space, 

14 and Technology of the House of Representatives and 

15 the Committee on Commerce, Science, and Trans16 portation of the Senate a report containing the find17 ings and recommendations of the review conducted 

18 under subsection (a); and 

19 (2) make a copy of such report available on a 

20 publicly accessible website. 

21 SEC. 8. AGENCY ACTIVITIES. 

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

23 the Initiative, the National Science Foundation shall— 


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1 (1) support basic research in engineering biol2 ogy through individual grants and through inter3 disciplinary research centers; 

4 (2) support research on the environmental, 

5 legal, and social implications of engineering biology; 

6 (3) provide support for research instrumenta7 tion for engineering biology disciplines, including 

8 support for research, development, optimization and 

9 validation of novel technologies to enable the dy10 namic study of molecular processes in situ; 

11 (4) support curriculum development and re12 search experiences for secondary, undergraduate, 

13 and graduate students in engineering biology and 

14 biomanufacturing; and 

15 (5) award grants, on a competitive basis, to en16 able institutions to support graduate students and 

17 postdoctoral fellows who perform some of their engi18 neering biology research in an industry setting. 

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

20 Initiative, the Director of the National Institute of Stand21 ards and Technology shall— 

22 (1) establish a bioscience research program to 

23 advance the development of standard reference ma24 terials and measurements and to create new data 


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1 tools, techniques, and processes necessary to advance 

2 engineering biology and biomanufacturing; 

3 (2) provide access to user facilities with ad4 vanced or unique equipment, services, materials, and 

5 other resources to industry, institutions of higher 

6 education, nonprofit organizations, and government 

7 agencies to perform research and testing; and 

8 (3) provide technical expertise to inform the po9 tential development of guidelines or safeguards for 

10 new products, processes, and systems of engineering 

11 biology. 

12 (c) DEPARTMENT OF ENERGY.—As part of the Ini13 tiative, the Secretary of Energy shall— 

14 (1) conduct and support research, development, 

15 demonstration, and commercial application activities 

16 in engineering biology, including in the areas of syn17 thetic biology, advanced biofuel development, 

18 biobased materials, and environmental remediation; 

19 (2) support the development, optimization and 

20 validation of novel, scalable tools and technologies to 

21 enable the dynamic study of molecular processes in 

22 situ; and 

23 (3) provide access to user facilities with ad24 vanced or unique equipment, services, materials, and 

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1 tions of higher education, nonprofit organizations, 

2 and government agencies to perform research and 

3 testing. 

4 (d) NATIONAL AERONAUTICS AND SPACE ADMINIS5 TRATION.—As part of the Initiative, the National Aero6 nautics and Space Administration shall— 

7 (1) conduct and support basic and applied re8 search in engineering biology, including in synthetic 

9 biology, and related to Earth and space sciences, 

10 aeronautics, space technology, and space exploration 

11 and experimentation, consistent with the priorities 

12 established in the National Academies’ decadal sur13 veys; and 

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

15 enable institutions to support graduate students and 

16 postdoctoral fellows who perform some of their engi17 neering biology research in an industry setting. 

18 (e) ENVIRONMENTAL PROTECTION AGENCY.—As 

19 part of the Initiative, the Environmental Protection Agen20 cy shall support research on how products, processes, and 


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1 systems of engineering biology will affect or can protect 

2 the environment. 

Passed the House of Representatives December 9, 

2019. 

Attest: CHERYL L. JOHNSON, 

Clerk. 


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