Engineering Biology Research and Development Act of 2019

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. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 VerDate Sep 11 2014 23:40 Dec 10, 2019 Jkt 099200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H4373.RFS H4373 kjohnson on DSK79L0C42 with BILLS 2 HR 4373 RFS SECTION 1. SHORT TITLE. 1 This Act may be cited as the ‘‘Engineering Biology 2 Research and Development Act of 2019’’. 3 SEC. 2. FINDINGS. 4 The Congress makes the following findings: 5 (1) Cellular and molecular processes may be 6 used, mimicked, or redesigned to develop new prod- 7 ucts, processes, and systems that improve societal 8 well-being, strengthen national security, and con- 9 tribute to the economy. 10 (2) Engineering biology relies on a workforce 11 with a diverse and unique set of skills combining the 12 biological, physical, chemical, and information 13 sciences and engineering. 14 (3) Long-term research and development is nec- 15 essary to create breakthroughs in engineering biol- 16 ogy. Such research and development requires govern- 17 ment investment as many of the benefits are too dis- 18 tant or uncertain for industry to support alone. 19 (4) Research is necessary to inform evidence- 20 based governance of engineering biology and to sup- 21 port the growth of the engineering biology industry. 22 (5) The Federal Government can play an im- 23 portant role by facilitating the development of tools 24 and technologies to further advance engineering biol- 25 ogy, including user facilities, by facilitating public- 26 VerDate Sep 11 2014 23:40 Dec 10, 2019 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H4373.RFS H4373 kjohnson on DSK79L0C42 with BILLS 3 HR 4373 RFS private partnerships, by supporting risk research, 1 and by facilitating the commercial application in the 2 United States of research funded by the Federal 3 Government. 4 (6) The United States led the development of 5 the science and engineering techniques that created 6 the field of engineering biology, but due to increas- 7 ing international competition, the United States is 8 at risk of losing its competitive advantage if does not 9 invest the necessary resources and have a national 10 strategy. 11 (7) A National Engineering Biology Initiative 12 can serve to establish new research directions and 13 technology goals, improve interagency coordination 14 and planning processes, drive technology transfer to 15 the private sector, and help ensure optimal returns 16 on the Federal investment. 17 SEC. 3. DEFINITIONS. 18 In this Act: 19 (1) BIOMANUFACTURING.—The term ‘‘bio- 20 manufacturing’’ means the utilization of biological 21 systems to develop new and advance existing prod- 22 ucts, tools, and processes at commercial scale. 23 (2) ENGINEERING BIOLOGY.—The term ‘‘engi- 24 neering biology’’ means the application of engineer- 25 VerDate Sep 11 2014 23:40 Dec 10, 2019 Jkt 099200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H4373.RFS H4373 kjohnson on DSK79L0C42 with BILLS 4 HR 4373 RFS ing design principles and practices to biological sys- 1 tems, including molecular and cellular systems, to 2 advance fundamental understanding of complex nat- 3 ural systems and to enable novel or optimize func- 4 tions and capabilities. 5 (3) INITIATIVE.—The term ‘‘Initiative’’ means 6 the National Engineering Biology Research and De- 7 velopment Initiative established under section 4. 8 (4) OMICS.—The term ‘‘omics’’ refers to the 9 collective technologies used to explore the roles, rela- 10 tionships, and actions of the various types of mol- 11 ecules that make up the cells of an organism. 12 SEC. 4. NATIONAL ENGINEERING BIOLOGY RESEARCH AND 13 DEVELOPMENT INITIATIVE. 14 (a) IN GENERAL.—The President, acting through the 15 Office of Science and Technology Policy, shall implement 16 a National Engineering Biology Research and Develop- 17 ment Initiative to advance societal well-being, national se- 18 curity, sustainability, and economic productivity and com- 19 petitiveness through— 20 (1) advancing areas of research at the intersec- 21 tion of the biological, physical, chemical, and infor- 22 mation sciences and engineering to accelerate sci- 23 entific understanding and technological innovation in 24 engineering biology; 25 VerDate Sep 11 2014 23:40 Dec 10, 2019 Jkt 099200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H4373.RFS H4373 kjohnson on DSK79L0C42 with BILLS 5 HR 4373 RFS (2) advancing areas of biomanufacturing re- 1 search to optimize, standardize, scale, and deliver 2 new products and solutions; 3 (3) supporting social and behavioral sciences 4 and economics research that advances the field of 5 engineering biology and contributes to the develop- 6 ment and public understanding of new products, 7 processes, and technologies; 8 (4) supporting risk research, including under 9 subsection (d); 10 (5) supporting the development of novel tools 11 and technologies to accelerate scientific under- 12 standing and technological innovation in engineering 13 biology; 14 (6) expanding the number of researchers, edu- 15 cators, and students with engineering biology train- 16 ing, including from traditionally underserved popu- 17 lations; 18 (7) accelerating the translation and commer- 19 cialization of engineering biology research and devel- 20 opment by the private sector; and 21 (8) improving the interagency planning and co- 22 ordination of Federal Government activities related 23 to engineering biology. 24 VerDate Sep 11 2014 23:40 Dec 10, 2019 Jkt 099200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H4373.RFS H4373 kjohnson on DSK79L0C42 with BILLS 6 HR 4373 RFS (b) INITIATIVE ACTIVITIES.—The activities of the 1 Initiative shall include— 2 (1) sustained support for engineering biology 3 research and development through— 4 (A) grants to individual investigators and 5 teams of investigators, including interdiscipli- 6 nary teams; 7 (B) projects funded under joint solicita- 8 tions by a collaboration of no fewer than two 9 agencies participating in the Initiative; and 10 (C) interdisciplinary research centers that 11 are organized to investigate basic research 12 questions, carry out technology development 13 and demonstration activities, and increase un- 14 derstanding of how to scale up engineering biol- 15 ogy processes, including biomanufacturing; 16 (2) sustained support for databases and related 17 tools, including— 18 (A) support for curated genomics, 19 epigenomics, and all other relevant omics data- 20 bases, including plant and microbial databases, 21 that are available to researchers to carry out 22 engineering biology research; 23 VerDate Sep 11 2014 23:40 Dec 10, 2019 Jkt 099200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H4373.RFS H4373 kjohnson on DSK79L0C42 with BILLS 7 HR 4373 RFS (B) development of standards for such 1 databases, including for curation, interoper- 2 ability, and protection of privacy and security; 3 (C) support for the development of com- 4 putational tools, including artificial intelligence 5 tools, that can accelerate research and innova- 6 tion using such databases; and 7 (D) an inventory and assessment of all 8 Federal government omics databases to identify 9 opportunities for consolidation and inform in- 10 vestment in such databases as critical infra- 11 structure for the engineering biology research 12 enterprise; 13 (3) sustained support for the development, opti- 14 mization, and validation of novel tools and tech- 15 nologies to enable the dynamic study of molecular 16 processes in situ, including through grants to inves- 17 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, 21 as described in section 9 of the Small Business Act 22 (15 U.S.C. 638); 23 (4) education and training of undergraduate 24 and graduate students in engineering biology, in bio- 25 VerDate Sep 11 2014 23:40 Dec 10, 2019 Jkt 099200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H4373.RFS H4373 kjohnson on DSK79L0C42 with BILLS 8 HR 4373 RFS manufacturing, in bioprocess engineering, and in 1 areas of computational science applied to engineer- 2 ing 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 op- 10 portunities; 11 (B) facilitating public-private partnerships 12 in engineering biology research and develop- 13 ment; 14 (C) connecting researchers, graduate stu- 15 dents, and postdoctoral fellows with entrepre- 16 neurship education and training opportunities; 17 and 18 (D) supporting proof of concept activities 19 and the formation of startup companies includ- 20 ing through programs such as the Small Busi- 21 ness Innovation Research Program and the 22 Small Business Technology Transfer Program. 23 (c) EXPANDING PARTICIPATION.—The Initiative 24 shall include, to the maximum extent practicable, outreach 25 VerDate Sep 11 2014 23:40 Dec 10, 2019 Jkt 099200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H4373.RFS H4373 kjohnson on DSK79L0C42 with BILLS 9 HR 4373 RFS to primarily undergraduate and minority-serving institu- 1 tions about Initiative opportunities, and shall encourage 2 the development of research collaborations between re- 3 search-intensive universities and primarily undergraduate 4 and minority-serving institutions. 5 (d) ETHICAL, LEGAL, ENVIRONMENTAL, SAFETY, 6 SECURITY, AND SOCIETAL ISSUES.—Initiative activities 7 shall take into account ethical, legal, environmental, safe- 8 ty, security, and other appropriate societal issues by— 9 (1) supporting research, including in the social 10 sciences, and other activities addressing ethical, 11 legal, environmental, and other appropriate societal 12 issues related to engineering biology, including inte- 13 grating research on such topics with the research 14 and development in engineering biology, and ensur- 15 ing that the results of such research are widely dis- 16 seminated, including through interdisciplinary engi- 17 neering biology research centers described in sub- 18 section (b)(1); 19 (2) supporting research and other activities re- 20 lated to the safety and security implications of engi- 21 neering biology, including outreach to increase 22 awareness among federally-funded researchers at in- 23 stitutions of higher education about potential safety 24 VerDate Sep 11 2014 23:40 Dec 10, 2019 Jkt 099200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H4373.RFS H4373 kjohnson on DSK79L0C42 with BILLS 10 HR 4373 RFS and security implications of engineering biology re- 1 search, as appropriate; 2 (3) ensuring that input from Federal and non- 3 Federal experts on the ethical, legal, environmental, 4 security, and other appropriate societal issues re- 5 lated to engineering biology is integrated into the 6 Initiative; and 7 (4) ensuring, through the agencies and depart- 8 ments that participate in the Initiative, that public 9 input and outreach are integrated into the Initiative 10 by the convening of regular and ongoing public dis- 11 cussions through mechanisms such as workshops, 12 consensus conferences, and educational events, as 13 appropriate. 14 SEC. 5. INITIATIVE COORDINATION. 15 (a) INTERAGENCY COMMITTEE.—The President, act- 16 ing through the Office of Science and Technology Policy, 17 shall designate an interagency committee to coordinate en- 18 gineering biology, which shall be co-chaired by the Office 19 of Science and Technology Policy, and include representa- 20 tives from the National Science Foundation, the Depart- 21 ment of Energy, the National Aeronautics and Space Ad- 22 ministration, the National Institute of Standards and 23 Technology, the Environmental Protection Agency, the 24 Department of Agriculture, the National Institutes of 25 VerDate Sep 11 2014 23:40 Dec 10, 2019 Jkt 099200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\H4373.RFS H4373 kjohnson on DSK79L0C42 with BILLS 11 HR 4373 RFS Health, the Bureau of Economic Analysis, and any other 1 agency that the President considers appropriate (in this 2 section referred to as the ‘‘interagency committee’’). The 3 Director of the Office of Science and Technology Policy 4 shall select an additional co-chairperson from among the 5 members of the Interagency Committee. The Interagency 6 Committee shall oversee the planning, management, and 7 coordination of the Initiative. The Interagency Committee 8 shall— 9 (1) provide for interagency coordination of Fed- 10 eral engineering biology research, development, and 11 other activities undertaken pursuant to the Initia- 12 tive; 13 (2) establish and periodically update goals and 14 priorities for the Initiative; 15 (3) develop, not later than 12 months after the 16 date of enactment of this Act, and update every 3 17 years, a strategic plan that— 18 (A) guides the activities of the Initiative 19 for purposes of meeting the goals and priorities 20 established under (and updated pursuant to) 21 paragraph (2); and 22 (B) describes— 23 VerDate Sep 11 2014 23:40 Dec 10, 2019 Jkt 099200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\H4373.RFS H4373 kjohnson on DSK79L0C42 with BILLS 12 HR 4373 RFS (i) the Initiative’s support for long- 1 term funding for interdisciplinary engineer- 2 ing biology research and development; 3 (ii) the Initiative’s support for edu- 4 cation and public outreach activities; 5 (iii) the Initiative’s support for re- 6 search and other activities on ethical, legal, 7 environmental, safety, security, and other 8 appropriate societal issues related to engi- 9 neering biology; 10 (iv) how the Initiative will move re- 11 sults out of the laboratory and into appli- 12 cation for the benefit of society and United 13 States competitiveness; and 14 (v) how the Initiative will measure 15 and track the contributions of engineering 16 biology to United States economic growth 17 and other societal indicators; 18 (4) develop a national genomic sequencing 19 strategy to ensure engineering biology research fully 20 leverages plant, animal, and microbe biodiversity to 21 enhance long-term innovation and competitiveness in 22 engineering biology in the United States; 23 (5) propose an annually coordinated interagen [Text truncated for display. 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