42 USC 19132 - National Engineering Biology Research and Development Initiative

Collapse to view only § 19132. National Engineering Biology Research and Development Initiative

§ 19131. Definitions
§ 19132. National Engineering Biology Research and Development Initiative
§ 19133. Initiative coordination
§ 19134. Advisory committee on engineering biology research and development
§ 19135. Agency activities
§ 19136. Rule of construction

§ 19131. Definitions

In this subchapter:

(1) Initiative

(2) Omics

(Pub. L. 117–167, div. B, title IV, § 10401, Aug. 9, 2022, 136 Stat. 1599.)

§ 19132. National Engineering Biology Research and Development Initiative

(a) In generalThe President, acting through the Office of Science and Technology Policy, shall implement a National Engineering Biology Research and Development Initiative to advance societal well-being, national security, sustainability, and economic productivity and competitiveness through the following:

(1) Advancing areas of research at the intersection of the biological, physical, chemical, data, and computational and information sciences and engineering to accelerate scientific understanding and technological innovation in engineering biology.

(2) Advancing areas of biomanufacturing research to optimize, standardize, scale, and deliver new products and solutions.

(3) Supporting social and behavioral sciences and economics research that advances the field of engineering biology and contributes to the development and public understanding of new products, processes, and technologies.

(4) Improving the understanding of engineering biology of the scientific and lay public and supporting greater evidence-based public discourse about its benefits and risks.

(5) Supporting research relating to the risks and benefits of engineering biology, including under subsection (d).

(6) Supporting the development of novel tools and technologies to accelerate scientific understanding and technological innovation in engineering biology.

(7) Expanding the number of researchers, educators, and students and a retooled workforce with engineering biology training, including from traditionally underrepresented and underserved populations.

(8) Accelerating the translation and commercialization of engineering biology and biomanufacturing research and development by the private sector.

(9) Improving the interagency planning and coordination of Federal Government activities related to engineering biology.

(b) Initiative activitiesThe activities of the Initiative shall include the following:

(1) Sustained support for engineering biology research and development through the following:

(A) Grants to fund the work of individual investigators and teams of investigators, including interdisciplinary teams.

(B) Projects funded under joint solicitations by a collaboration of not fewer than two agencies participating in the Initiative.

(C) Interdisciplinary research centers that are organized to investigate basic research questions, carry out technology development and demonstration activities, and increase understanding of how to scale up engineering biology processes, including biomanufacturing.

(2) Sustained support for databases and related tools, including the following:

(A) Support for the establishment, curation, and maintenance of curated genomics, epigenomics, and other relevant omics databases, including plant, animal, and microbial databases, that are available to researchers to carry out engineering biology research in a manner that does not compromise national security or the privacy or security of information within such databases.

(B) Development of standards for such databases, including for curation, interoperability, and protection of privacy and security.

(C) Support for the development of computational tools, including artificial intelligence tools, that can accelerate research and innovation using such databases.

(D) An inventory and assessment of all Federal government omics databases to identify opportunities to improve the utility of such databases, as appropriate and in a manner that does not compromise national security or the privacy and security of information within such databases, and inform investment in such databases as critical infrastructure for the engineering biology research enterprise.

(3) Sustained support for the development, optimization, and validation of novel tools and technologies to enable the dynamic study of molecular processes in situ, including through the following:

(A) Research conducted at Federal laboratories.

(B) Grants to fund the work of investigators at institutions of higher education and other nonprofit research institutions.

(C) Incentivized development of retooled industrial sites across the country that foster a pivot to modernized engineering biology initiatives.

(D) Awards under the Small Business Innovation Research Program and the Small Business Technology Transfer Program (as described in section 638 of title 15).

(4) Support for education and training of undergraduate and graduate students in engineering biology, biomanufacturing, bioprocess engineering, and computational science applied to engineering biology and in the related ethical, legal, environmental, safety, security, and other societal domains.

(5) Support for a national network of testbeds based on open standards, interfaces, and processes, including by repurposing existing facilities such as those specified in paragraph (3)(C), that would enable scale up of laboratory engineering biology research.

(6) Activities to develop robust mechanisms for documenting and quantifying the outputs and economic benefits of engineering biology.

(7) Activities to accelerate the translation and commercialization of new products, processes, and technologies by carrying out the following:

(A) Identifying precompetitive research opportunities.

(B) Facilitating public-private partnerships in engineering biology research and development, including to address barriers to scaling up innovations in engineering biology.

(C) Connecting researchers, graduate students, and postdoctoral fellows with entrepreneurship education and training opportunities.

(D) Supporting proof of concept activities and the formation of startup companies including through programs such as the Small Business Innovation Research Program and the Small Business Technology Transfer Program.

(d) Ethical, legal, environmental, safety, security, and societal issuesInitiative activities shall take into account ethical, legal, environmental, safety, security, and other appropriate societal issues by carrying out the following:

(1) Supporting research, including in the social sciences, and other activities addressing ethical, legal, environmental, and other appropriate societal issues related to engineering biology, including integrating research on such topics with the research and development in engineering biology, and encouraging the dissemination of the results of such research, including through interdisciplinary engineering biology research centers described in subsection (b)(1)(C).

(2) Supporting research and other activities related to the safety and security implications of engineering biology, including outreach to increase awareness among Federal researchers and federally-funded researchers at institutions of higher education about potential safety and security implications of engineering biology research, as appropriate.

(3) Ensuring that input from Federal and non-Federal experts on the ethical, legal, environmental, safety, security, and other appropriate societal issues related to engineering biology is integrated into the Initiative.

(4) Ensuring, through the agencies and departments that participate in the Initiative, that public input and outreach are integrated into the Initiative by the convening of regular and ongoing public discussions through mechanisms such as workshops, consensus conferences, and educational events, as appropriate.

(5) Complying with all applicable provisions of Federal law.

(Pub. L. 117–167, div. B, title IV, § 10402, Aug. 9, 2022, 136 Stat. 1599.)

§ 19133. Initiative coordination

(a) Interagency committeeThe President, acting through the Office of Science and Technology Policy, shall designate an interagency committee to coordinate activities of the Initiative as appropriate, which shall be co-chaired by the Office of Science and Technology Policy. The Director of the Office of Science and Technology Policy shall select an additional co-chairperson from among the members of the interagency committee. The interagency committee shall oversee the planning, management, and coordination of the Initiative. The interagency committee shall carry out the following:

(1) Provide for interagency coordination of Federal engineering biology research, development, and other activities undertaken pursuant to the Initiative.

(2) Establish and periodically update goals and priorities for the Initiative.

(3) Develop, not later than 12 months after August 9, 2022, and update every five years thereafter, a strategic plan submitted to the Committee on Science, Space, and Technology, the Committee on Agriculture, and the Committee on Energy and Commerce of the House of Representatives and the Committee on Commerce, Science, and Transportation, the Committee on Agriculture, Nutrition, and Forestry, the Committee on Small Business and Entrepreneurship, and the Committee on Health, Education, Labor, and Pensions of the Senate that—

(A) guides the activities of the Initiative for purposes of meeting the goals and priorities established under (and updated pursuant to) paragraph (2); and

(B) describes—

(i) the Initiative’s support for long-term funding for interdisciplinary engineering biology research and development;

(ii) the Initiative’s support for education and public outreach activities;

(iii) the Initiative’s support for research and other activities on ethical, legal, environmental, safety, security, and other appropriate societal issues related to engineering biology, including—(I) an applied biorisk management research plan;(II) recommendations for integrating security into biological data access and international reciprocity agreements;(III) recommendations for manufacturing restructuring to support engineering biology research, development, and scaling-up initiatives; and(IV) an evaluation of existing biosecurity governance policies, guidance, and directives for the purposes of creating an adaptable, evidence-based framework to respond to emerging biosecurity challenges created by advances in engineering biology;

(iv) how the Initiative will contribute to moving results out of the laboratory and into application for the benefit of society and United States competitiveness; and

(v) how the Initiative will measure and track the contributions of engineering biology to United States economic growth and other societal indicators.

(4) Develop a national genomic sequencing strategy to ensure engineering biology research fully leverages plant, animal, and microbe biodiversity, as appropriate and in a manner that does not compromise economic competitiveness, national security, or the privacy or security of human genetic information, to enhance long-term innovation and competitiveness in engineering biology in the United States.

(5) Develop a plan to utilize Federal programs, such as the Small Business Innovation Research Program and the Small Business Technology Transfer Program (as described in section 638 of title 15), in support of the activities described in section 19132(b)(3) of this title.

(6) In carrying out this section, take into consideration the recommendations of the advisory committee established under section 19134 of this title, the results of the workshop convened under section 19132 of this title, existing reports on related topics, and the views of academic, State, industry, and other appropriate groups.

(b) Quinquennial reportBeginning with fiscal year 2023 and every five years thereafter for ten years, the interagency committee shall prepare and submit to the Committee on Science, Space, and Technology, the Committee on Energy and Commerce, and the Committee on Agriculture of the House of Representatives and the Committee on Commerce, Science, and Transportation, the Committee on Health, Education, Labor, and Pensions, the Committee on Small Business and Entrepreneurship, and the Committee on Agriculture, Nutrition, and Forestry of the Senate a report that includes the following:

(1) A summarized agency budget in support of the Initiative for the current fiscal year, including a breakout of spending for each agency participating in the Program, and for the development and acquisition of any research facilities and instrumentation.

(2) An assessment of how Federal agencies are implementing the plan described in subsection (a)(3), including the following:

(A) A description of the amount and number of awards made under the Small Business Innovation Research Program and the Small Business Technology Transfer Program (as described in section 638 of title 15) in support of the Initiative.

(B) A description of the amount and number of projects funded under joint solicitations by a collaboration of not fewer than two agencies participating in the Initiative.

(1) In generalThe President shall establish an Initiative Coordination Office, with a Director and full-time staff, which shall—

(A) provide technical and administrative support to the interagency committee and the advisory committee established under subsection (a) and section 19134 of this title;

(B) serve as the point of contact on Federal engineering biology activities for government organizations, academia, industry, professional societies, State governments, interested citizen groups, and others to exchange technical and programmatic information;

(C) oversee interagency coordination of the Initiative, including by encouraging and supporting joint agency solicitation and selection of applications for funding of activities under the Initiative, as appropriate;

(D) conduct public outreach, including dissemination of findings and recommendations of the advisory committee, as appropriate;

(E) serve as the coordinator of ethical, legal, environmental, safety, security, and other appropriate societal input; and

(F) promote access to, and early application of, the technologies, innovations, and expertise derived from Initiative activities to agency missions and systems across the Federal Government, and to United States industry, including startup companies.

(2) Funding

(3) Termination

(d) Rule of construction

(Pub. L. 117–167, div. B, title IV, § 10403, Aug. 9, 2022, 136 Stat. 1602.)

§ 19134. Advisory committee on engineering biology research and development

(a) In general

(b) Assessment

The advisory committee shall assess the following:

(1) The current state of United States competitiveness in engineering biology, including the scope and scale of United States investments in engineering biology research and development in the international context.

(2) Current market barriers to commercialization of engineering biology products, processes, and tools in the United States.

(3) Progress made in implementing the Initiative.

(4) The need to revise the Initiative.

(5) The balance of activities and funding across the Initiative.

(6) Whether the strategic plan developed or updated by the interagency committee established under section 19133 of this title is helping to maintain United States leadership in engineering biology.

(7) Whether ethical, legal, environmental, safety, security, and other appropriate societal issues are adequately addressed by the Initiative.

Beginning not later than two years after August 9, 2022, and not less frequently than once every five years thereafter, the advisory committee shall submit to the President, the Committee on Science, Space, and Technology, the Committee on Energy and Commerce, and the Committee on Agriculture of the House of Representatives, and the Committee on Commerce, Science, and Transportation, the Committee on Health, Education, Labor, and Pensions, and the Committee on Agriculture, Nutrition, and Forestry of the Senate, a report on the following:

(1) The findings of the advisory committee’s assessment under subsection (b).

(2) The advisory committee’s recommendations for ways to improve the Initiative.

(d) Application of Federal Advisory Committee Act

(e) Termination

(Pub. L. 117–167, div. B, title IV, § 10404, Aug. 9, 2022, 136 Stat. 1605.)

§ 19135. Agency activities

(a) National Science Foundation

As part of the Initiative, the National Science Foundation shall carry out the following:

(1) Support research in engineering biology and biomanufacturing through individual grants, collaborative grants, and through interdisciplinary research centers.

(2) Support research on the environmental, legal, ethical, and social implications of engineering biology.

(3) Provide support for research instrumentation, equipment, and cyberinfrastructure for engineering biology disciplines, including support for research, development, optimization, and validation of novel technologies to enable the dynamic study of molecular processes in situ.

(4) Support curriculum development and research experiences for secondary, undergraduate, and graduate students in engineering biology and biomanufacturing, including through support for graduate fellowships and traineeships in engineering biology.

(5) Award grants, on a competitive basis, to enable institutions to support graduate students and postdoctoral fellows who perform some of their engineering biology research in an industry setting.

(b) Department of Commerce

(1) National Institute of Standards and Technology

As part of the Initiative, the Director of the National Institute of Standards and Technology shall carry out the following:

(A) Advance the development of standard reference materials and measurements, including to promote interoperability between new component technologies and processes for engineering biology and biomanufacturing discovery, innovation, and production processes.

(B) Establish new data tools, techniques, and processes necessary to advance engineering biology and biomanufacturing.

(C) Provide access to user facilities with advanced or unique equipment, services, materials, and other resources to industry, institutions of higher education, nonprofit organizations, and government agencies to perform research and testing.

(D) Provide technical expertise to inform the potential development of guidelines or safeguards for new products, processes, and systems of engineering biology.

(2)

As part of the initiative, the Administrator of the National Oceanic and Atmospheric Administration shall carry out the following:

(A) Conduct and support research in omics and associated bioinformatic sciences and develop tools and products to improve ecosystem stewardship, monitoring, management, assessments. and forecasts, consistent with the mission of the agency.

(B) Collaborate with other agencies to understand potential environmental threats and safeguards related to engineering biology.

As part of the Initiative, the Secretary of Energy shall carry out the following:

(1) Conduct and support research, development, demonstration, and commercial application activities in engineering biology, including in the areas of synthetic biology, advanced biofuel and bioproduct development, biobased materials, and environmental remediation.

(2) Support the development, optimization and validation of novel, scalable tools and technologies to enable the dynamic study of molecular processes in situ.

(3) Provide access to user facilities with advanced or unique equipment, services, materials, and other resources, including secure access to high-performance computing, as appropriate, to industry, institutions of higher education, nonprofit organizations, and government agencies to perform research and testing;.1

1 So in original. The semicolon preceding the period probably should not appear.

(4) Strengthen collaboration between the Office of Science and the Energy Efficiency and Renewable Energy Office to help transfer fundamental research results to industry and accelerate commercial applications.

(d) Department of Defense

As part of the Initiative, the Secretary of Defense shall carry out the following:

(1) Conduct and support research and development in engineering biology and associated data and information sciences.

(2) Support curriculum development and research experiences in engineering biology and associated data and information sciences across the military education system, including the service academies, professional military education, and military graduate education.

(3) Assess risks of potential national security and economic security threats relating to engineering biology.

(e) National Aeronautics and Space Administration

As part of the Initiative, the National Aeronautics and Space Administration shall carry out the following:

(1) Conduct and support research in engineering biology, including in synthetic biology, and related to Earth and space sciences, aeronautics, space technology, and space exploration and experimentation, consistent with the priorities established in the National Academies’ decadal surveys.

(2) Award grants, on a competitive basis, that enable institutions to support graduate students and postdoctoral fellows who perform some of their engineering biology research in an industry setting.

(f) Department of Agriculture

(g) Environmental Protection Agency

(h) Department of Health and Human Services

As part of the Initiative, the Secretary of Health and Human Services, as appropriate and consistent with activities of the Department of Health and Human Services in effect on the day before August 9, 2022, shall carry out the following:

(1) Support research and development to advance the understanding and application of engineering biology for human health.

(2) Support relevant interdisciplinary research and coordination.

(3) Support activities necessary to facilitate oversight of relevant emerging biotechnologies.

(Pub. L. 117–167, div. B, title IV, § 10406, Aug. 9, 2022, 136 Stat. 1606.)

§ 19136. Rule of construction

Nothing in this subchapter may be construed to require public disclosure of information that is exempt from mandatory disclosure under section 552 of title 5.

(Pub. L. 117–167, div. B, title IV, § 10407, Aug. 9, 2022, 136 Stat. 1609.)