H.R. 4373 — what changed

Cellular and molecular processes may be used, mimicked, or redesigned to develop new products, processes, and systems that improve societal well-being, strengthen national security, and contribute to the economy.

Engineering biology relies on a workforce with a diverse and unique set of skills combining the biological, physical, chemical, and information sciences and engineering.

Long-term research and development is necessary to create breakthroughs in engineering biology. Such research and development requires government investment as many of the benefits are too distant or uncertain for industry to support alone.

Research is necessary to inform evidence-based governance of engineering biology and to support the growth of the engineering biology industry.

The Federal Government can play an important role by facilitating the development of tools and technologies to further advance engineering biology, including user facilities, by facilitating public-private partnerships, by supporting risk research, and by facilitating the commercial application in the United States of research funded by the Federal Government.

A National Engineering Biology Initiative can serve to establish new research directions and technology goals, improve interagency coordination and planning processes, drive technology transfer to the private sector, and help ensure optimal returns on the Federal investment.

Biomanufacturing— The term “biomanufacturing” means the utilization of biological systems to develop new and advance existing products, tools, and processes at commercial scale.

Initiative— The term “Initiative” means the National Engineering Biology Research and Development Initiative established under section 4.

Omics— The term “omics” refers to the collective technologies used to explore the roles, relationships, and actions of the various types of molecules that make up the cells of an organism.

In general— The 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—

advancing areas of research at the intersection of the biological, physical, chemical, and information sciences and engineering to accelerate scientific understanding and technological innovation in engineering biology;

advancing areas of biomanufacturing research to optimize, standardize, scale, and deliver new products and solutions;

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;

supporting risk research, including under subsection (d);

supporting the development of novel tools and technologies to accelerate scientific understanding and technological innovation in engineering biology;

expanding the number of researchers, educators, and students with engineering biology training, including from traditionally underserved populations;

accelerating the translation and commercialization of engineering biology research and development by the private sector; and

improving the interagency planning and coordination of Federal Government activities related to engineering biology.

Initiative activities— The activities of the Initiative shall include—

sustained support for engineering biology research and development through—

grants to individual investigators and teams of investigators, including interdisciplinary teams;

projects funded under joint solicitations by a collaboration of no fewer than two agencies participating in the Initiative; and

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;

sustained support for databases and related tools, including—

support for curated genomics, epigenomics, and all other relevant omics databases, including plant and microbial databases, that are available to researchers to carry out engineering biology research;

support for the development of computational tools, including artificial intelligence tools, that can accelerate research and innovation using such databases; and

an inventory and assessment of all Federal government omics databases to identify opportunities for consolidation and inform investment in such databases as critical infrastructure for the engineering biology research enterprise;

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 grants to investigators at institutions of higher education and other nonprofit research institutions, and through the Small Business Innovation Research Program and the Small Business Technology Transfer Program, as described in section 9 of the Small Business Act (15 U.S.C. 638);

education and training of undergraduate and graduate students in engineering biology, in biomanufacturing, in bioprocess engineering, and in areas of computational science applied to engineering biology;

activities to develop robust mechanisms for tracking and quantifying the outputs and economic benefits of engineering biology; and

activities to accelerate the translation and commercialization of new products, processes, and technologies by—

identifying precompetitive research opportunities;

facilitating public-private partnerships in engineering biology research and development;

connecting researchers, graduate students, and postdoctoral fellows with entrepreneurship education and training opportunities; and

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.

Expanding participation— The Initiative shall include, to the maximum extent practicable, outreach to primarily undergraduate and minority-serving institutions about Initiative opportunities, and shall encourage the development of research collaborations between research-intensive universities and primarily undergraduate and minority-serving institutions.

Ethical, legal, environmental, safety, security, and societal issues— Initiative activities shall take into account ethical, legal, environmental, safety, security, and other appropriate societal issues by—

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 ensuring that the results of such research are widely disseminated, including through interdisciplinary engineering biology research centers described in subsection (b)(1);

ensuring that input from Federal and non-Federal experts on the ethical, legal, environmental, security, and other appropriate societal issues related to engineering biology is integrated into the Initiative; and

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.

National Science Foundation— As part of the Initiative, the National Science Foundation shall—

support basic research in engineering biology through individual grants and through interdisciplinary research centers;

support research on the environmental, legal, and social implications of engineering biology;

Department of Commerce— As part of the Initiative, the Director of the National Institute of Standards and Technology shall—

establish a bioscience research program to advance the development of standard reference materials and measurements and to create new data tools, techniques, and processes necessary to advance engineering biology and biomanufacturing;

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; and

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

Department of Energy— As part of the Initiative, the Secretary of Energy shall—

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

National Aeronautics and Space Administration— As part of the Initiative, the National Aeronautics and Space Administration shall—

conduct and support basic and applied 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; and

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.

Environmental Protection Agency— As part of the Initiative, the Environmental Protection Agency shall support research on how products, processes, and systems of engineering biology will affect or can protect the environment.