Bill Summary
The "Engineering Biology Research and Development Act of 2019" establishes a National Engineering Biology Research and Development Initiative to advance societal well-being, national security, sustainability, and economic productivity and competitiveness. It aims to achieve this through various activities, including research and development, education and training, development of databases and tools, addressing ethical and safety concerns, and expanding participation and collaboration. The Initiative will be overseen by the President and an interagency committee, with input from an advisory committee and external review of ethical and societal issues. Various government agencies will also support research and provide access to facilities and funding opportunities.
Possible Impacts
1. The National Engineering Biology Research and Development Initiative will provide sustained support for research and development, education and training, and the development of databases and tools, which will lead to advancements in societal well-being, national security, sustainability, and economic productivity and competitiveness.
2. The advisory committee established by the legislation will assess the current state of US competitiveness in engineering biology and make recommendations for improving the Initiative, potentially leading to increased collaboration between research institutions and expanded participation in the field.
3. The National Science Foundation, Department of Commerce, Department of Energy, National Aeronautics and Space Administration, and Environmental Protection Agency will all undertake activities as part of the Initiative, such as conducting research, providing access to user facilities, and supporting graduate students and fellows, which will contribute to advancements in engineering biology and its potential benefits for society.
[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4373 Referred in Senate (RFS)]
<DOC>
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 Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Engineering Biology Research and
Development Act of 2019''.
SEC. 2. FINDINGS.
The Congress makes the following findings:
(1) 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.
(2) Engineering biology relies on a workforce with a
diverse and unique set of skills combining the biological,
physical, chemical, and information sciences and engineering.
(3) 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.
(4) Research is necessary to inform evidence-based
governance of engineering biology and to support the growth of
the engineering biology industry.
(5) 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.
(6) The United States led the development of the science
and engineering techniques that created the field of
engineering biology, but due to increasing international
competition, the United States is at risk of losing its
competitive advantage if does not invest the necessary
resources and have a national strategy.
(7) 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.
SEC. 3. DEFINITIONS.
In this Act:
(1) Biomanufacturing.--The term ``biomanufacturing'' means
the utilization of biological systems to develop new and
advance existing products, tools, and processes at commercial
scale.
(2) Engineering biology.--The term ``engineering biology''
means the application of engineering design principles and
practices to biological systems, including molecular and
cellular systems, to advance fundamental understanding of
complex natural systems and to enable novel or optimize
functions and capabilities.
(3) Initiative.--The term ``Initiative'' means the National
Engineering Biology Research and Development Initiative
established under section 4.
(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.
SEC. 4. NATIONAL ENGINEERING BIOLOGY RESEARCH AND DEVELOPMENT
INITIATIVE.
(a) 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--
(1) 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;
(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) supporting risk research, including under subsection
(d);
(5) supporting the development of novel tools and
technologies to accelerate scientific understanding and
technological innovation in engineering biology;
(6) expanding the number of researchers, educators, and
students with engineering biology training, including from
traditionally underserved populations;
(7) accelerating the translation and commercialization of
engineering biology research and development by the private
sector; and
(8) improving the interagency planning and coordination of
Federal Government activities related to engineering biology.
(b) Initiative Activities.--The activities of the Initiative shall
include--
(1) sustained support for engineering biology research and
development through--
(A) grants to individual investigators and teams of
investigators, including interdisciplinary teams;
(B) projects funded under joint solicitations by a
collaboration of no fewer than two agencies
participating in the Initiative; and
(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--
(A) 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;
(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; and
(D) 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;
(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
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);
(4) 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;
(5) activities to develop robust mechanisms for tracking
and quantifying the outputs and economic benefits of
engineering biology; and
(6) activities to accelerate the translation and
commercialization of new products, processes, and technologies
by--
(A) identifying precompetitive research
opportunities;
(B) facilitating public-private partnerships in
engineering biology research and development;
(C) connecting researchers, graduate students, and
postdoctoral fellows with entrepreneurship education
and training opportunities; and
(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.
(c) 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.
(d) 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--
(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 ensuring
that the results of such research are widely disseminated,
including through interdisciplinary engineering biology
research centers described in subsection (b)(1);
(2) supporting research and other activities related to the
safety and security implications of engineering biology,
including outreach to increase awareness among 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, security, and
other appropriate societal issues related to engineering
biology is integrated into the Initiative; and
(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.
SEC. 5. INITIATIVE COORDINATION.
(a) Interagency Committee.--The President, acting through the
Office of Science and Technology Policy, shall designate an interagency
committee to coordinate engineering biology, which shall be co-chaired
by the Office of Science and Technology Policy, and include
representatives from the National Science Foundation, the Department of
Energy, the National Aeronautics and Space Administration, the National
Institute of Standards and Technology, the Environmental Protection
Agency, the Department of Agriculture, the National Institutes of
Health, the Bureau of Economic Analysis, and any other agency that the
President considers appropriate (in this section referred to as the
``interagency committee''). 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--
(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 the date of
enactment of this Act, and update every 3 years, a strategic
plan 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;
(iv) how the Initiative will move 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 to enhance long-term
innovation and competitiveness in engineering biology in the
United States;
(5) propose an annually coordinated interagency budget for
the Initiative that is intended to ensure--
(A) the maintenance of a robust engineering biology
research and development portfolio; and
(B) that the balance of funding across the
Initiative is sufficient to meet the goals and
priorities established for the Program;
(6) 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 9
of the Small Business Act (15 U.S.C. 638), in support of the
activities described in section 4(b)(3); and
(7) in carrying out this section, take into consideration
the recommendations of the advisory committee established under
section 6, the results of the workshop convened under section
7, existing reports on related topics, and the views of
academic, State, industry, and other appropriate groups.
(b) Annual Report.--Beginning with fiscal year 2020, not later than
90 days after submission of the President's annual budget request and
each fiscal year thereafter, the interagency committee shall prepare
and submit to the Committee on Science, Space, and Technology of the
House of Representatives and the Committee on Commerce, Science, and
Transportation of the Senate a report that includes--
(1) a summarized agency budget in support of the Initiative
for the fiscal year to which such budget request applies, and
for the then 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; and
(2) an assessment of how Federal agencies are implementing
the plan described in subsection (a)(3), and 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 9 of the Small
Business Act (15 U.S.C. 638)) in support of the Initiative.
(c) Initiative Office.--
(1) In general.--The 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 section 6;
(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;
(D) conduct public outreach, including
dissemination of findings and recommendations of the
advisory committee established under section 6, as
appropriate; and
(E) 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.--The Director of the Office of Science and
Technology Policy shall develop an estimate of the funds
necessary to carry out the activities of the Initiative
Coordination Office, including an estimate of how much each
participating agency described in subsection (a) will
contribute to such funds, and submit such estimate to Congress
no later than 90 days after the enactment of this Act.
(3) Termination.--The Initiative Coordination Office
established under this subsection shall terminate on the date
that is 10 years after the date of the enactment of this Act,
unless a determination is made by the President that such
Office is necessary to meet the economic or national security
goals of the Program.
SEC. 6. ADVISORY COMMITTEE.
(a) In General.--The President, acting through the Office of
Science and Technology Policy, shall designate or establish an advisory
committee on engineering biology research and development (in this
section referred to as the ``advisory committee'') to be composed of
not fewer than 12 members, including representatives of research and
academic institutions, industry, and nongovernmental entities, who are
qualified to provide advice on the Initiative.
(b) Assessment.--The advisory committee shall assess--
(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 5 is helping to
maintain United States leadership in engineering biology;
(7) the management, coordination, implementation, and
activities of the Initiative; and
(8) whether ethical, legal, environmental, safety,
security, and other appropriate societal issues are adequately
addressed by the Initiative.
(c) Reports.--Beginning not later than 2 years after the date of
enactment of this Act, and not less frequently than once every 3 years
thereafter, the advisory committee shall submit to the President, the
Committee on Science, Space, and Technology of the House of
Representatives, and the Committee on Commerce, Science, and
Transportation of the Senate, a report on--
(1) the findings of the advisory committee's assessment
under subsection (b); and
(2) the advisory committee's recommendations for ways to
improve the Initiative.
(d) Application of Federal Advisory Committee Act.--Section 14 of
the Federal Advisory Committee Act (5 U.S.C. App.) shall not apply to
the Advisory Committee.
SEC. 7. EXTERNAL REVIEW OF ETHICAL, LEGAL, ENVIRONMENTAL, AND SOCIETAL
ISSUES.
(a) In General.--Not later than 6 months after the date of
enactment of this Act, the Director of the National Science Foundation
shall enter into an agreement with the National Academies of Sciences,
Engineering, and Medicine to conduct a review, and make recommendations
with respect to, the ethical, legal, environmental, and other
appropriate societal issues related to engineering biology research and
development. The review shall include--
(1) an assessment of the current research on such issues;
(2) a description of the research gaps relating to such
issues;
(3) recommendations on how the Initiative can address the
research needs identified pursuant to paragraph (2); and
(4) recommendations on how engineering biology researchers
can best incorporate considerations of ethical, legal,
environmental, and other societal issues into the development
of research proposals and the conduct of research.
(b) Report to Congress.--The agreement entered into under
subsection (a) shall require the National Academy of Sciences,
Engineering, and Medicine to, not later than 2 years after the date of
the enactment of this Act--
(1) submit to the Committee on Science, Space, and
Technology of the House of Representatives and the Committee on
Commerce, Science, and Transportation of the Senate a report
containing the findings and recommendations of the review
conducted under subsection (a); and
(2) make a copy of such report available on a publicly
accessible website.
SEC. 8. AGENCY ACTIVITIES.
(a) National Science Foundation.--As part of the Initiative, the
National Science Foundation shall--
(1) support basic research in engineering biology through
individual grants and through interdisciplinary research
centers;
(2) support research on the environmental, legal, and
social implications of engineering biology;
(3) provide support for research instrumentation 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; and
(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.--As part of the Initiative, the
Director of the National Institute of Standards and Technology shall--
(1) 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;
(2) 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
(3) provide technical expertise to inform the potential
development of guidelines or safeguards for new products,
processes, and systems of engineering biology.
(c) Department of Energy.--As part of the Initiative, the Secretary
of Energy shall--
(1) conduct and support research, development,
demonstration, and commercial application activities in
engineering biology, including in the areas of synthetic
biology, advanced biofuel 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; and
(3) 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.
(d) National Aeronautics and Space Administration.--As part of the
Initiative, the National Aeronautics and Space Administration shall--
(1) 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
(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.
(e) 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.
Passed the House of Representatives December 9, 2019.
Attest:
CHERYL L. JOHNSON,
Clerk.