[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4521 Introduced in House (IH)]
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117th CONGRESS
1st Session
H. R. 4521
To provide for a coordinated Federal research initiative to ensure
continued United States leadership in engineering biology.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
July 19, 2021
Ms. Johnson of Texas (for herself and Mr. Lucas) introduced the
following bill; which was referred to the Committee on Science, Space,
and Technology, and in addition to the Committees on Agriculture, and
Energy and Commerce, for a period to be subsequently determined by the
Speaker, in each case for consideration of such provisions as fall
within the jurisdiction of the committee concerned
_______________________________________________________________________
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 Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Bioeconomy Research and Development
Act of 2021''.
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 has an obligation to ensure that
ethical, legal, environmental, safety, security, and societal
implications of its science and technology research and
investment follows policies of responsible innovation and
fosters public transparency.
(6) 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.
(7) 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 it does not strategically invest the
necessary resources.
(8) 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, 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; and
(9) 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 fund the work of 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 the establishment, curation, and
maintenance of curated genomics, epigenomics, and other
relevant omics databases, including plant 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; and
(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--
(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; and
(D) awards 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);
(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) activities to develop robust mechanisms for documenting
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
encouraging the dissemination of the results of such research,
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 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; and
(5) complying with all applicable provisions of Federal
law.
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 activities of the Initiative as appropriate,
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 National Oceanic
and Atmospheric Administration, the Department of Agriculture, the
Department of Health and Human Services, 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 the
enactment of this Act, and update every 3 years thereafter, a
strategic plan submitted to the Committee on Science, Space,
and Technology and the Committee on Energy and Commerce of the
House of Representatives and the Committee on Commerce,
Science, and Transportation 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 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 9
of the Small Business Act (15 U.S.C. 638), in support of the
activities described in section 4(b)(3); and
(6) 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) Triennial Report.--Beginning with fiscal year 2022 and ending
in fiscal year 2028, not later than 90 days after submission of the
President's annual budget request and every third 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, for
the following 2 fiscal years, 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), including--
(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 9 of the
Small Business Act (15 U.S.C. 638)) in support of the
Initiative;
(B) a description of the amount and number of
projects funded under joint solicitations by a
collaboration of no fewer than 2 agencies participating
in the Initiative; and
(C) a description of the effect of the newly funded
projects by 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, as
appropriate;
(D) conduct public outreach, including
dissemination of findings and recommendations of the
advisory committee established under section 6, 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.--The Director of the Office of Science and
Technology Policy, in coordination with each participating
Federal department and agency, as appropriate, shall develop
and annually update an estimate of the funds necessary to carry
out the activities of the Initiative Coordination Office and
submit such estimate with an agreed summary of contributions
from each agency to Congress as part of the President's annual
budget request to Congress.
(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.
(d) Rule of Construction.--Nothing in this section shall be
construed to alter the policies, processes, or practices of individual
Federal agencies in effect on the day before the date of the enactment
of this Act relating to the conduct of biomedical research and advanced
development, including the solicitation and review of extramural
research proposals.
SEC. 6. ADVISORY COMMITTEE.
(a) In General.--The agency co-chair of the interagency committee
established in section 5 shall, in consultation with the Office of
Science and Technology Policy, 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.
(e) Termination.--The advisory committee established under
subsection (a) shall terminate on the date that is 10 years after the
date of the enactment of this Act.
SEC. 7. EXTERNAL REVIEW OF ETHICAL, LEGAL, ENVIRONMENTAL, SAFETY,
SECURITY, 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 seek to 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,
safety, security, 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 researchers engaged in
engineering biology can best incorporate considerations of
ethical, legal, environmental, safety, security, 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 Academies 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 research in engineering biology 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; 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.--
(1) National institute of standards and technology.--As
part of the Initiative, the Director of the National Institute
of Standards and Technology shall--
(A) 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;
(B) 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
(C) provide technical expertise to inform the
potential development of guidelines or safeguards for
new products, processes, and systems of engineering
biology.
(2) National oceanic and atmospheric administration.--As
part of the initiative, the Administrator of the National
Oceanic and Atmospheric Administration shall--
(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; and
(B) collaborate with other agencies to understand
potential environmental threats and safeguards related
to 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 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; and
(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) National Aeronautics and Space Administration.--As part of the
Initiative, the National Aeronautics and Space Administration shall--
(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; 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) Department of Agriculture.--As part of the Initiative, the
Secretary of Agriculture shall--
(1) support research and development in engineering
biology, including in synthetic biology and biomaterials;
(2) award grants through the National Institute of Food and
Agriculture and the Agriculture Advanced Research and
Development Authority; and
(3) support development conducted by the Agricultural
Research Service.
(f) 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.
(g) 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 the date of the enactment of this
Act, shall--
(1) support research and development to advance the
understanding and application of engineering biology for human
health;
(2) support relevant interdisciplinary research and
coordination; and
(3) support activities necessary to facilitate oversight of
relevant emerging biotechnologies.
SEC. 9. RULE OF CONSTRUCTION.
Nothing in this Act shall be construed to require public disclosure
of information that is exempt from mandatory disclosure under section
552 of title 5, United States Code.
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