IB 

Union Calendar No. 215 

116TH CONGRESS 

1ST SESSION H. R. 4373 

[Report No. 116–270] 

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 

NOVEMBER 5, 2019 

Additional sponsors: Ms. HILL of California, Mr. FOSTER, Mr. FITZPATRICK, 

Miss GONZA ́LEZ-COLO ́N of Puerto Rico, Mr. BEYER, Ms. KENDRA S. 

HORN of Oklahoma, and Mr. CASTEN of Illinois 

NOVEMBER 5, 2019 

Reported with an amendment, committed to the Committee of the Whole 

House on the State of the Union, and ordered to be printed 

[Strike out all after the enacting clause and insert the part printed in italic] 

[For text of introduced bill, see copy of bill as introduced on September 18, 2019] 


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A BILL 

To provide for a coordinated Federal research initiative to 

ensure continued United States leadership in engineering 

biology. 


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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 

9 used, mimicked, or redesigned to develop new prod10 ucts, processes, and systems that improve societal 

11 well-being, strengthen national security, and con12 tribute to the economy. 

13 (2) Engineering biology relies on a workforce 

14 with a diverse and unique set of skills combining the 

15 biological, physical, chemical, and information 

16 sciences and engineering. 

17 (3) Long-term research and development is nec18 essary to create breakthroughs in engineering biology. 

19 Such research and development requires government 

20 investment as many of the benefits are too distant or 

21 uncertain for industry to support alone. 

22 (4) Research is necessary to inform evidence23 based governance of engineering biology and to sup24 port the growth of the engineering biology industry. 


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1 (5) The Federal Government can play an impor2 tant role by facilitating the development of tools and 

3 technologies to further advance engineering biology, 

4 including user facilities, by facilitating public-private 

5 partnerships, by supporting risk research, and by fa6 cilitating the commercial application in the United 

7 States of research funded by the Federal Government. 

8 (5) The United States led the development of the 

9 science and engineering techniques that created the 

10 field of engineering biology, but due to increasing 

11 international competition, the United States is at risk 

12 of losing its competitive advantage if does not invest 

13 the necessary resources and have a national strategy. 

14 (6) A National Engineering Biology Initiative 

15 can serve to establish new research directions and 

16 technology goals, improve interagency coordination 

17 and planning processes, drive technology transfer to 

18 the private sector, and help ensure optimal returns on 

19 the Federal investment. 

20 SEC. 3. DEFINITIONS. 

21 In this Act: 

22 (1) BIOMANUFACTURING.—The term ‘‘biomanu23 facturing’’ means the utilization of biological systems 

24 to develop new and advance existing products, tools, 

25 and processes at commercial scale. 


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1 (2) ENGINEERING BIOLOGY.—The term ‘‘engi2 neering biology’’ means the application of engineering 

3 design principles and practices to biological systems, 

4 including molecular and cellular systems, to advance 

5 fundamental understanding of complex natural sys6 tems and to enable novel or optimize functions and 

7 capabilities. 

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

9 the National Engineering Biology Research and De10 velopment Initiative established under section 4. 

11 (4) OMICS.—The term ‘‘omics’’ refers to the col12 lective technologies used to explore the roles, relation13 ships, and actions of the various types of molecules 

14 that make up the cells of an organism. 

15 SEC. 4. NATIONAL ENGINEERING BIOLOGY RESEARCH AND 

16 DEVELOPMENT INITIATIVE. 

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

18 Office of Science and Technology Policy, shall implement 

19 a National Engineering Biology Research and Development 

20 Initiative to advance societal well-being, national security, 

21 sustainability, and economic productivity and competitive22 ness through— 

23 (1) advancing areas of research at the intersec24 tion of the biological, physical, chemical, and infor25 mation sciences and engineering to accelerate sciVerDate Sep 11 2014 22:00 Nov 05, 2019 Jkt 099200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6203 E:\BILLS\H4373.RH H4373

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1 entific understanding and technological innovation in 

2 engineering biology; 

3 (2) advancing areas of biomanufacturing re4 search to optimize, standardize, scale, and deliver new 

5 products and solutions; 

6 (3) supporting social and behavioral sciences 

7 and economics research that advances the field of en8 gineering biology and contributes to the development 

9 and public understanding of new products, processes, 

10 and technologies; 

11 (4) supporting risk research, including under 

12 subsection (d); 

13 (5) supporting the development of novel tools and 

14 technologies to accelerate scientific understanding and 

15 technological innovation in engineering biology; 

16 (6) expanding the number of researchers, edu17 cators, and students with engineering biology train18 ing, including from traditionally underserved popu19 lations; 

20 (7) accelerating the translation and commer21 cialization of engineering biology research and devel22 opment by the private sector; and 

23 (8) improving the interagency planning and co24 ordination of Federal Government activities related to 

25 engineering biology. 


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1 (b) INITIATIVE ACTIVITIES.—The activities of the Ini2 tiative shall include— 

3 (1) sustained support for engineering biology re4 search and development through— 

5 (A) grants to individual investigators and 

6 teams of investigators, including interdiscipli7 nary teams; 

8 (B) projects funded under joint solicitations 

9 by a collaboration of no fewer than two agencies 

10 participating in the Initiative; and 

11 (C) interdisciplinary research centers that 

12 are organized to investigate basic research ques13 tions, carry out technology development and 

14 demonstration activities, and increase under15 standing of how to scale up engineering biology 

16 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 en23 gineering biology research; 


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1 (B) development of standards for such data2 bases, including for curation, interoperability, 

3 and protection of privacy and security; and 

4 (C) support for the development of computa5 tional 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 Fed9 eral government omics databases to identify op10 portunities for consolidation and inform invest11 ment in such databases as critical infrastructure 

12 for the engineering biology research enterprise; 

13 (3) sustained support for the development, opti14 mization, and validation of novel tools and tech15 nologies to enable the dynamic study of molecular 

16 processes in situ, including through grants to inves17 tigators at institutions of higher education and other 

18 nonprofit research institutions, and through the 

19 Small Business Innovation Research Program and 

20 the Small Business Technology Transfer Program, as 

21 described in section 9 of the Small Business Act (15 

22 U.S.C. 638); 

23 (4) education and training of undergraduate 

24 and graduate students in engineering biology, in bio25 manufacturing, in bioprocess engineering, and in 


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1 areas of computational science applied to engineering 

2 biology; 

3 (5) activities to develop robust mechanisms for 

4 tracking and quantifying the outputs and economic 

5 benefits of engineering biology; and 

6 (6) activities to accelerate the translation and 

7 commercialization of new products, processes, and 

8 technologies by— 

9 (A) identifying precompetitive research op10 portunities; 

11 (B) facilitating public-private partnerships 

12 in engineering biology research and development; 

13 (C) connecting researchers, graduate stu14 dents, and postdoctoral fellows with entrepre15 neurship education and training opportunities; 

16 and 

17 (D) supporting proof of concept activities 

18 and the formation of startup companies includ19 ing through programs such as the Small Busi20 ness Innovation Research Program and the 

21 Small Business Technology Transfer Program. 

22 (c) EXPANDING PARTICIPATION.—The Initiative shall 

23 include, to the maximum extent practicable, outreach to 

24 primarily undergraduate and minority-serving institutions 

25 about Initiative opportunities, and shall encourage the deVerDate Sep 11 2014 22:00 Nov 05, 2019 Jkt 099200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6203 E:\BILLS\H4373.RH H4373

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1 velopment of research collaborations between research-inten2 sive universities and primarily undergraduate and minor3 ity-serving institutions. 

4 (d) ETHICAL, LEGAL, ENVIRONMENTAL, SAFETY, SE5 CURITY, AND SOCIETAL ISSUES.—Initiative activities shall 

6 take into account ethical, legal, environmental, safety, secu7 rity, and other appropriate societal issues by— 

8 (1) supporting research, including in the social 

9 sciences, and other activities addressing ethical, legal, 

10 environmental, and other appropriate societal issues 

11 related to engineering biology, including integrating 

12 research on such topics with the research and develop13 ment in engineering biology, and ensuring that the 

14 results of such research are widely disseminated, in15 cluding through interdisciplinary engineering biology 

16 research centers described in subsection (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 aware20 ness among federally-funded researchers at institu21 tions of higher education about potential safety and 

22 security implications of engineering biology research, 

23 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 related 

2 to engineering biology is integrated into the Initia3 tive; 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, con9 sensus conferences, and educational events, as appro10 priate. 

11 SEC. 5. INITIATIVE COORDINATION. 

12 (a) INTERAGENCY COMMITTEE.—The President, acting 

13 through the Office of Science and Technology Policy, shall 

14 designate an interagency committee to coordinate engineer15 ing biology, which shall be co-chaired by the Office of 

16 Science and Technology Policy, and include representatives 

17 from the National Science Foundation, the Department of 

18 Energy, the National Aeronautics and Space Administra19 tion, the National Institute of Standards and Technology, 

20 the Environmental Protection Agency, the Department of 

21 Agriculture, the National Institutes of Health, the Bureau 

22 of Economic Analysis, and any other agency that the Presi23 dent considers appropriate (in this section referred to as 

24 the ‘‘interagency committee’’). The Director of the Office of 

25 Science and Technology Policy shall select an additional 


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1 co-chairperson from among the members of the Interagency 

2 Committee. The Interagency Committee shall oversee the 

3 planning, management, and coordination of the Initiative. 

4 The Interagency Committee shall— 

5 (1) provide for interagency coordination of Fed6 eral engineering biology research, development, and 

7 other activities undertaken pursuant to the Initiative; 

8 (2) establish and periodically update goals and 

9 priorities for the Initiative; 

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

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

12 years, a strategic plan that— 

13 (A) guides the activities of the Initiative for 

14 purposes of meeting the goals and priorities es15 tablished under (and updated pursuant to) para16 graph (2); and 

17 (B) describes— 

18 (i) the Initiative’s support for long19 term funding for interdisciplinary engineer20 ing biology research and development; 

21 (ii) the Initiative’s support for edu22 cation and public outreach activities; 

23 (iii) the Initiative’s support for re24 search and other activities on ethical, legal, 

25 environmental, safety, security, and other 


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1 appropriate societal issues related to engi2 neering biology; 

3 (iv) how the Initiative will move re4 sults out of the laboratory and into applica5 tion for the benefit of society and United 

6 States competitiveness; and 

7 (v) how the Initiative will measure 

8 and track the contributions of engineering 

9 biology to United States economic growth 

10 and other societal indicators; 

11 (4) develop a national genomic sequencing strat12 egy to ensure engineering biology research fully 

13 leverages plant, animal, and microbe biodiversity to 

14 enhance long-term innovation and competitiveness in 

15 engineering biology in the United States; 

16 (5) propose an annually coordinated interagency 

17 budget for the Initiative that is intended to ensure— 

18 (A) the maintenance of a robust engineering 

19 biology research and development portfolio; and 

20 (B) that the balance of funding across the 

21 Initiative is sufficient to meet the goals and pri22 orities established for the Program; 

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

24 such as the Small Business Innovation Research Pro25 gram and the Small Business Technology Transfer 


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1 Program as described in section 9 of the Small Busi2 ness Act (15 U.S.C. 638), in support of the activities 

3 described in section 4(b)(3); and 

4 (7) in carrying out this section, take into consid5 eration the recommendations of the advisory com6 mittee established under section 6, the results of the 

7 workshop convened under section 7, existing reports 

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

9 industry, and other appropriate groups. 

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

11 2020, not later than 90 days after submission of the Presi12 dent’s annual budget request and each fiscal year thereafter, 

13 the interagency committee shall prepare and submit to the 

14 Committee on Science, Space, and Technology of the House 

15 of Representatives and the Committee on Commerce, 

16 Science, and Transportation of the Senate a report that in17 cludes— 

18 (1) a summarized agency budget in support of 

19 the Initiative for the fiscal year to which such budget 

20 request applies, and for the then current fiscal year, 

21 including a breakout of spending for each agency par22 ticipating in the Program and for the development 

23 and acquisition of any research facilities and instru24 mentation; and 


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1 (2) an assessment of how Federal agencies are 

2 implementing the plan described in subsection (a)(3), 

3 and a description of the amount and number of 

4 awards made under the Small Business Innovation 

5 Research Program and the Small Business Tech6 nology Transfer Program (as described in section 9 of 

7 the Small Business Act (15 U.S.C. 638)) in support 

8 of the Initiative. 

9 (c) INITIATIVE STAFFING.—The President shall ensure 

10 adequate staffing for the Initiative, including full-time staff 

11 within the Office of Science and Technology Policy, who 

12 shall— 

13 (1) provide technical and administrative support 

14 to the interagency committee and the advisory com15 mittee established under section 6; 

16 (2) serve as the point of contact on Federal engi17 neering biology activities for government organiza18 tions, academia, industry, professional societies, State 

19 governments, interested citizen groups, and others to 

20 exchange technical and programmatic information; 

21 (3) oversee interagency coordination of the Ini22 tiative, including by encouraging and supporting 

23 joint agency solicitation and selection of applications 

24 for funding of activities under the Initiative; 


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1 (4) conduct public outreach, including dissemi2 nation of findings and recommendations of the advi3 sory committee established under section 6, as appro4 priate; and 

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

6 the technologies, innovations, and expertise derived 

7 from Initiative activities to agency missions and sys8 tems across the Federal Government, and to United 

9 States industry, including startup companies. 

10 SEC. 6. ADVISORY COMMITTEE. 

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

12 Office of Science and Technology Policy, shall designate or 

13 establish an advisory committee on engineering biology re14 search and development (in this section referred to as the 

15 ‘‘advisory committee’’) to be composed of not fewer than 12 

16 members, including representatives of research and aca17 demic institutions, industry, and nongovernmental entities, 

18 who are qualified to provide advice on the Initiative. 

19 (b) ASSESSMENT.—The advisory committee shall as20 sess— 

21 (1) the current state of United States competi22 tiveness in engineering biology, including the scope 

23 and scale of United States investments in engineering 

24 biology research and development in the international 

25 context; 


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1 (2) current market barriers to commercialization 

2 of engineering biology products, processes, and tools 

3 in the United States; 

4 (3) progress made in implementing the Initia5 tive; 

6 (4) the need to revise the Initiative; 

7 (5) the balance of activities and funding across 

8 the Initiative; 

9 (6) whether the strategic plan developed or up10 dated by the interagency committee established under 

11 section 5 is helping to maintain United States leader12 ship in engineering biology; 

13 (7) the management, coordination, implementa14 tion, and activities of the Initiative; and 

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

16 security, and other appropriate societal issues are 

17 adequately addressed by the Initiative. 

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

19 the date of enactment of this Act, and not less frequently 

20 than once every 3 years thereafter, the advisory committee 

21 shall submit to the President, the Committee on Science, 

22 Space, and Technology of the House of Representatives, and 

23 the Committee on Commerce, Science, and Transportation 

24 of the Senate, a report on— 


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1 (1) the findings of the advisory committee’s as2 sessment under subsection (b); and 

3 (2) the advisory committee’s recommendations 

4 for ways to improve the Initiative. 

5 (d) APPLICATION OF FEDERAL ADVISORY COMMITTEE

6 ACT.—Section 14 of the Federal Advisory Committee Act 

7 (5 U.S.C. App.) shall not apply to the Advisory Committee. 

8 SEC. 7. EXTERNAL REVIEW OF ETHICAL, LEGAL, ENVIRON9 MENTAL, AND SOCIETAL ISSUES. 

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

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

12 Science Foundation shall enter into an agreement with the 

13 National Academies of Sciences, Engineering, and Medicine 

14 to conduct a review, and make recommendations with re15 spect to, the ethical, legal, environmental, and other appro16 priate societal issues related to engineering biology research 

17 and development. The review shall include— 

18 (1) an assessment of the current research on such 

19 issues; 

20 (2) a description of the research gaps relating to 

21 such issues; 

22 (3) recommendations on how the Initiative can 

23 address the research needs identified pursuant to 

24 paragraph (2); and 


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1 (4) recommendations on how engineering biology 

2 researchers can best incorporate considerations of eth3 ical, legal, environmental, and other societal issues 

4 into the development of research proposals and the 

5 conduct of research. 

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

7 into under subsection (a) shall require the National Acad8 emy of Sciences, Engineering, and Medicine to, not later 

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

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

11 and Technology of the House of Representatives and 

12 the Committee on Commerce, Science, and Transpor13 tation of the Senate a report containing the findings 

14 and recommendations of the review conducted under 

15 subsection (a); and 

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

17 publicly accessible website. 

18 SEC. 8. AGENCY ACTIVITIES. 

19 (a) NATIONAL SCIENCE FOUNDATION.—As part of the 

20 Initiative, the National Science Foundation shall— 

21 (1) support basic research in engineering biology 

22 through individual grants and through interdiscipli23 nary research centers; 

24 (2) support research on the environmental, legal, 

25 and social implications of engineering biology; 


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1 (3) provide support for research instrumentation 

2 for engineering biology disciplines, including support 

3 for research, development, optimization and valida4 tion of novel technologies to enable the dynamic study 

5 of molecular processes in situ; 

6 (4) support curriculum development and re7 search experiences for secondary, undergraduate, and 

8 graduate students in engineering biology and bio9 manufacturing; and 

10 (5) award grants, on a competitive basis, to en11 able institutions to support graduate students and 

12 postdoctoral fellows who perform some of their engi13 neering biology research in an industry setting. 

14 (b) DEPARTMENT OF COMMERCE.—As part of the Ini15 tiative, the Director of the National Institute of Standards 

16 and Technology shall— 

17 (1) establish a bioscience research program to ad18 vance the development of standard reference materials 

19 and measurements and to create new data tools, tech20 niques, and processes necessary to advance engineer21 ing biology and biomanufacturing; 

22 (2) provide access to user facilities with ad23 vanced or unique equipment, services, materials, and 

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1 cation, nonprofit organizations, and government 

2 agencies to perform research and testing; and 

3 (3) provide technical expertise to inform the po4 tential development of guidelines or safeguards for 

5 new products, processes, and systems of engineering 

6 biology. 

7 (c) DEPARTMENT OF ENERGY.—As part of the Initia8 tive, the Secretary of Energy shall— 

9 (1) conduct and support research, development, 

10 demonstration, and commercial application activities 

11 in engineering biology, including in the areas of syn12 thetic biology, advanced biofuel development, biobased 

13 materials, and environmental remediation; 

14 (2) support the development, optimization and 

15 validation of novel, scalable tools and technologies to 

16 enable the dynamic study of molecular processes in 

17 situ; and 

18 (3) provide access to user facilities with ad19 vanced or unique equipment, services, materials, and 

20 other resources, as appropriate, to industry, institu21 tions of higher education, nonprofit organizations, 

22 and government agencies to perform research and 

23 testing. 


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1 (d) NATIONAL AERONAUTICS AND SPACE ADMINISTRA2 TION.—As part of the Initiative, the National Aeronautics 

3 and Space Administration shall— 

4 (1) conduct and support basic and applied re5 search in engineering biology, including in synthetic 

6 biology, and related to Earth and space sciences, aero7 nautics, space technology, and space exploration and 

8 experimentation, consistent with the priorities estab9 lished in the National Academies’ decadal surveys; 

10 and 

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

12 enable institutions to support graduate students and 

13 postdoctoral fellows who perform some of their engi14 neering biology research in an industry setting. 

15 (e) ENVIRONMENTAL PROTECTION AGENCY.—As part 

16 of the Initiative, the Environmental Protection Agency shall 

17 support research on how products, processes, and systems 

18 of engineering biology will affect or can protect the environ19 ment. 


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Union Calendar No. 215 

116TH CONGRESS 

1ST SESSION H. R. 4373 

[Report No. 116–270] 

A BILL 

To provide for a coordinated Federal research iniship in engineering biology. tiative to ensure continued United States leaderNOVEMBER 5, 2019 

Reported with an amendment, committed to the Comand ordered to be printed mittee of the Whole House on the State of the Union, 


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