Bioeconomy Research and Development Act of 2021

II 117TH CONGRESS 1ST SESSION S. 1418 To provide for a coordinated Federal research initiative to ensure continued United States leadership in engineering biology. IN THE SENATE OF THE UNITED STATES APRIL 28, 2021 Mr. MARKEY (for himself, Mrs. GILLIBRAND, Mr. RUBIO, and Mrs. CAPITO) introduced the following bill; which was read twice and referred to the Committee on Commerce, Science, and Transportation A BILL 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 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Bioeconomy Research 4 and Development Act of 2021’’. 5 SEC. 2. FINDINGS. 6 The Congress makes the following findings: 7 (1) Cellular and molecular processes may be 8 used, mimicked, or redesigned to develop new prod- 9 VerDate Sep 11 2014 03:06 May 22, 2021 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S1418.IS S1418 kjohnson on DSK79L0C42PROD with BILLS 2 •S 1418 IS ucts, processes, and systems that improve societal 1 well-being, strengthen national security, and con- 2 tribute to the economy. 3 (2) Engineering biology relies on a workforce 4 with a diverse and unique set of skills combining the 5 biological, physical, chemical, and information 6 sciences and engineering. 7 (3) Long-term research and development is nec- 8 essary to create breakthroughs in engineering biol- 9 ogy. Such research and development requires govern- 10 ment investment as many of the benefits are too dis- 11 tant or uncertain for industry to support alone. 12 (4) Research is necessary to inform evidence- 13 based governance of engineering biology and to sup- 14 port the growth of the engineering biology industry. 15 (5) The Federal Government has an obligation 16 to ensure that ethical, legal, environmental, safety, 17 security, and societal implications of its science and 18 technology research and investment follows policies 19 of responsible innovation and fosters public trans- 20 parency. 21 (6) The Federal Government can play an im- 22 portant role by facilitating the development of tools 23 and technologies to further advance engineering biol- 24 ogy, including user facilities, by facilitating public- 25 VerDate Sep 11 2014 03:06 May 22, 2021 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S1418.IS S1418 kjohnson on DSK79L0C42PROD with BILLS 3 •S 1418 IS 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 (7) 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 it does 9 not strategically invest the necessary resources. 10 (8) A National Engineering Biology Initiative 11 can serve to establish new research directions and 12 technology goals, improve interagency coordination 13 and planning processes, drive technology transfer to 14 the private sector, and help ensure optimal returns 15 on the Federal investment. 16 SEC. 3. DEFINITIONS. 17 In this Act: 18 (1) BIOMANUFACTURING.—The term ‘‘bio- 19 manufacturing’’ means the utilization of biological 20 systems to develop new and advance existing prod- 21 ucts, tools, and processes at commercial scale. 22 (2) ENGINEERING BIOLOGY.—The term ‘‘engi- 23 neering biology’’ means the application of engineer- 24 ing design principles and practices to biological sys- 25 VerDate Sep 11 2014 03:06 May 22, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S1418.IS S1418 kjohnson on DSK79L0C42PROD with BILLS 4 •S 1418 IS tems, including molecular and cellular systems, to 1 advance fundamental understanding of complex nat- 2 ural systems and to enable novel or optimize func- 3 tions and capabilities. 4 (3) INITIATIVE.—The term ‘‘Initiative’’ means 5 the National Engineering Biology Research and De- 6 velopment Initiative established under section 4. 7 (4) OMICS.—The term ‘‘omics’’ refers to the 8 collective technologies used to explore the roles, rela- 9 tionships, and actions of the various types of mol- 10 ecules that make up the cells of an organism. 11 SEC. 4. NATIONAL ENGINEERING BIOLOGY RESEARCH AND 12 DEVELOPMENT INITIATIVE. 13 (a) IN GENERAL.—The President, acting through the 14 Office of Science and Technology Policy, shall implement 15 a National Engineering Biology Research and Develop- 16 ment Initiative to advance societal well-being, national se- 17 curity, sustainability, and economic productivity and com- 18 petitiveness through— 19 (1) advancing areas of research at the intersec- 20 tion of the biological, physical, chemical, data, and 21 computational sciences and engineering to accelerate 22 scientific understanding and technological innovation 23 in engineering biology; 24 VerDate Sep 11 2014 03:06 May 22, 2021 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S1418.IS S1418 kjohnson on DSK79L0C42PROD with BILLS 5 •S 1418 IS (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) improving the understanding of engineering 9 biology of the scientific and lay public and sup- 10 porting greater evidence-based public discourse 11 about its benefits and risks; 12 (5) supporting research relating to the risks 13 and benefits of engineering biology, including under 14 subsection (d); 15 (6) supporting the development of novel tools 16 and technologies to accelerate scientific under- 17 standing and technological innovation in engineering 18 biology; 19 (7) expanding the number of researchers, edu- 20 cators, and students and a retooled workforce with 21 engineering biology training, including from tradi- 22 tionally underrepresented and underserved popu- 23 lations; 24 VerDate Sep 11 2014 03:06 May 22, 2021 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S1418.IS S1418 kjohnson on DSK79L0C42PROD with BILLS 6 •S 1418 IS (8) accelerating the translation and commer- 1 cialization of engineering biology research and devel- 2 opment by the private sector; and 3 (9) improving the interagency planning and co- 4 ordination of Federal Government activities related 5 to engineering biology. 6 (b) INITIATIVE ACTIVITIES.—The activities of the 7 Initiative shall include— 8 (1) sustained support for engineering biology 9 research and development through— 10 (A) grants to fund the work of individual 11 investigators and teams of investigators, includ- 12 ing interdisciplinary teams; 13 (B) projects funded under joint solicita- 14 tions by a collaboration of no fewer than two 15 agencies participating in the Initiative; and 16 (C) interdisciplinary research centers that 17 are organized to investigate basic research 18 questions, carry out technology development 19 and demonstration activities, and increase un- 20 derstanding of how to scale up engineering biol- 21 ogy processes, including biomanufacturing; 22 (2) sustained support for databases and related 23 tools, including— 24 VerDate Sep 11 2014 03:06 May 22, 2021 Jkt 019200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S1418.IS S1418 kjohnson on DSK79L0C42PROD with BILLS 7 •S 1418 IS (A) support for curated genomics, 1 epigenomics, and other relevant omics data- 2 bases, including plant and microbial databases, 3 that are available to researchers to carry out 4 engineering biology research in a manner that 5 does not compromise national security or the 6 privacy or security of information within such 7 databases; 8 (B) development of standards for such 9 databases, including for curation, interoper- 10 ability, and protection of privacy and security; 11 (C) support for the development of com- 12 putational tools, including artificial intelligence 13 tools, that can accelerate research and innova- 14 tion using such databases; and 15 (D) an inventory and assessment of all 16 Federal government omics databases to identify 17 opportunities to improve the utility of such 18 databases, as appropriate and in a manner that 19 does not compromise national security or the 20 privacy and security of information within such 21 databases, and inform investment in such data- 22 bases as critical infrastructure for the engineer- 23 ing biology research enterprise; 24 VerDate Sep 11 2014 03:06 May 22, 2021 Jkt 019200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S1418.IS S1418 kjohnson on DSK79L0C42PROD with BILLS 8 •S 1418 IS (3) sustained support for the development, opti- 1 mization, and validation of novel tools and tech- 2 nologies to enable the dynamic study of molecular 3 processes in situ, including through— 4 (A) research conducted at Federal labora- 5 tories; 6 (B) grants to fund the work of investiga- 7 tors at institutions of higher education and 8 other nonprofit research institutions; 9 (C) incentivized development of retooled in- 10 dustrial sites across the country that foster a 11 pivot to modernized engineering biology initia- 12 tives; and 13 (D) awards under the Small Business In- 14 novation Research Program and the Small 15 Business Technology Transfer Program, as de- 16 scribed in section 9 of the Small Business Act 17 (15 U.S.C. 638); 18 (4) support for education and training of un- 19 dergraduate and graduate students in engineering 20 biology, biomanufacturing, bioprocess engineering, 21 and computational science applied to engineering bi- 22 ology and in the related ethical, legal, environmental, 23 safety, security, and other societal domains; 24 VerDate Sep 11 2014 03:06 May 22, 2021 Jkt 019200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\S1418.IS S1418 kjohnson on DSK79L0C42PROD with BILLS 9 •S 1418 IS (5) activities to develop robust mechanisms for 1 documenting and quantifying the outputs and eco- 2 nomic benefits of engineering biology; and 3 (6) activities to accelerate the translation and 4 commercialization of new products, processes, and 5 technologies by— 6 (A) identifying precompetitive research op- 7 portunities; 8 (B) facilitating public-private partnerships 9 in engineering biology research and develop- 10 ment; 11 (C) connecting researchers, graduate stu- 12 dents, and postdoctoral fellows with entrepre- 13 neurship education and training opportunities; 14 and 15 (D) supporting proof of concept activities 16 and the formation of startup companies includ- 17 ing through programs such as the Small Busi- 18 ness Innovation Research Program and the 19 Small Business Technology Transfer Program. 20 (c) EXPANDING PARTICIPATION.—The Initiative 21 shall include, to the maximum extent practicable, outreach 22 to primarily undergraduate and minority-serving institu- 23 tions about Initiative opportunities, and shall encourage 24 the development of research collaborations between re- 25 VerDate Sep 11 2014 03:06 May 22, 2021 Jkt 019200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\S1418.IS S1418 kjohnson on DSK79L0C42PROD with BILLS 10 •S 1418 IS search-intensive universities and primarily undergraduate 1 and minority-serving institutions. 2 (d) ETHICAL, LEGAL, ENVIRONMENTAL, SAFETY, 3 SECURITY, AND SOCIETAL ISSUES.—Initiative activities 4 shall take into account ethical, legal, environmental, safe- 5 ty, security, and other appropriate societal issues by— 6 (1) supporting research, including in the social 7 sciences, and other activities addressing ethical, 8 legal, environmental, and other appropriate societal 9 issues related to engineering biology, including inte- 10 grating research on such topics with the research 11 and development in engineering biology, and encour- 12 aging the dissemination of the results of such re- 13 search, including through interdisciplinary engineer- 14 ing biology research centers described in subsection 15 (b)(1); 16 (2) supporting research and other activities re- 17 lated to the safety and security implications of engi- 18 neering biology, including outreach to increase 19 awareness among Federal researchers and Federally- 20 funded researchers at institutions of higher edu- 21 cation about potential safety and security implica- 22 tions of engineering biology research, as appropriate; 23 (3) ensuring that input from Federal and non- 24 Federal experts on the ethical, legal, environmental, 25 VerDate Sep 11 2014 03:06 May 22, 2021 Jkt 019200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\S1418.IS S1418 kjohnson on DSK79L0C42PROD with BILLS 11 •S 1418 IS safety, security, and other appropriate societal issues 1 related to engineering biology is integrated into the 2 Initiative; 3 (4) ensuring, through the agencies and depart- 4 ments that participate in the Initiative, that public 5 input and outreach are integrated into the Initiative 6 by the convening of regular and ongoing public dis- 7 cussions through mechanisms such as workshops, 8 consensus conferences, and educational events, as 9 appropriate; and 10 (5) complying with all applicable provisions of 11 Federal law. 12 SEC. 5. INITIATIVE COORDINATION. 13 (a) INTERAGENCY COMMITTEE.—The President, act- 14 ing through the Office of Science and Technology Policy, 15 shall designate an interagency committee to coordinate ac- 16 tivities of the Initiative as appropriate, which shall be co- 17 chaired by the Office of Science and Technology Policy, 18 and include representatives from the National Science 19 Foundation, the Department of Energy, the Department 20 of Defense, the National Aeronautics and Space Adminis- 21 tration, the National Institute of Standards and Tech- 22 nology, the Environmental Protection Agency, the Depart- 23 ment of Agriculture, the Department of Health and 24 Human Services, the Bureau of Economic Analysis, and 25 VerDate Sep 11 2014 03:06 May 22, 2021 Jkt 019200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\S1418.IS S1418 kjohnson on DSK79L0C42PROD with BILLS 12 •S 1418 IS any other agency that the President considers appropriate 1 (in this section referred to as the ‘‘Interagency Com- 2 mittee’’). The Director of the Office of Science and Tech- 3 nology Policy shall select an additional co-chairperson 4 from among the members of the Interagency Committee. 5 The Interagency Committee shall oversee the planning, 6 management, and coordination of the Initiative. The 7 Interagency Committee shall— 8 (1) provide fo [Text truncated for display. Full text available on Congress.gov.]