I 
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 Tech-
nology, and in addition to the Committees on Agriculture, and Energy 
and Commerce, for a period to be subsequently determined by the Speak-
er, in each case for consideration of such provisions as fall within the ju-
risdiction 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 Representa-
tives 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: 
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(1) Cellular and molecular processes may be 
used, mimicked, or redesigned to develop new prod-
ucts, processes, and systems that improve societal 
well-being, strengthen national security, and con-
tribute 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 nec-
essary to create breakthroughs in engineering biol-
ogy. Such research and development requires govern-
ment investment as many of the benefits are too dis-
tant or uncertain for industry to support alone. 
(4) Research is necessary to inform evidence- 
based governance of engineering biology and to sup-
port 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 trans-
parency. 
(6) The Federal Government can play an im-
portant role by facilitating the development of tools 
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and technologies to further advance engineering biol-
ogy, 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 increas-
ing 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 
‘‘bio-
manufacturing’’ means the utilization of biological 
systems to develop new and advance existing prod-
ucts, tools, and processes at commercial scale. 
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tionally underrepresented and underserved popu-
lations; 
(8) accelerating the translation and commer-
cialization of engineering biology and biomanufac-
turing research and development by the private sec-
tor; and 
(9) improving the interagency planning and co-
ordination 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, includ-
ing interdisciplinary teams; 
(B) projects funded under joint solicita-
tions 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 un-
derstanding of how to scale up engineering biol-
ogy processes, including biomanufacturing; 
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(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 data-
bases, 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, interoper-
ability, and protection of privacy and security; 
(C) support for the development of com-
putational tools, including artificial intelligence 
tools, that can accelerate research and innova-
tion 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 data-
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bases as critical infrastructure for the engineer-
ing biology research enterprise; 
(3) sustained support for the development, opti-
mization, and validation of novel tools and tech-
nologies to enable the dynamic study of molecular 
processes in situ, including through— 
(A) research conducted at Federal labora-
tories; 
(B) grants to fund the work of investiga-
tors at institutions of higher education and 
other nonprofit research institutions; 
(C) incentivized development of retooled in-
dustrial sites across the country that foster a 
pivot to modernized engineering biology initia-
tives; and 
(D) awards under the Small Business In-
novation Research Program and the Small 
Business Technology Transfer Program, as de-
scribed in section 9 of the Small Business Act 
(15 U.S.C. 638); 
(4) support for education and training of un-
dergraduate and graduate students in engineering 
biology, biomanufacturing, bioprocess engineering, 
and computational science applied to engineering bi-
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ology 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 eco-
nomic benefits of engineering biology; and 
(6) activities to accelerate the translation and 
commercialization of new products, processes, and 
technologies by— 
(A) identifying precompetitive research op-
portunities; 
(B) facilitating public-private partnerships 
in engineering biology research and develop-
ment; 
(C) connecting researchers, graduate stu-
dents, and postdoctoral fellows with entrepre-
neurship education and training opportunities; 
and 
(D) supporting proof of concept activities 
and the formation of startup companies includ-
ing through programs such as the Small Busi-
ness 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 institu-
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tions about Initiative opportunities, and shall encourage 
the development of research collaborations between re-
search-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, safe-
ty, 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 inte-
grating research on such topics with the research 
and development in engineering biology, and encour-
aging the dissemination of the results of such re-
search, including through interdisciplinary engineer-
ing biology research centers described in subsection 
(b)(1); 
(2) supporting research and other activities re-
lated to the safety and security implications of engi-
neering biology, including outreach to increase 
awareness among Federal researchers and Federally- 
funded researchers at institutions of higher edu-
cation about potential safety and security implica-
tions of engineering biology research, as appropriate; 
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(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 depart-
ments that participate in the Initiative, that public 
input and outreach are integrated into the Initiative 
by the convening of regular and ongoing public dis-
cussions 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, act-
ing through the Office of Science and Technology Policy, 
shall designate an interagency committee to coordinate ac-
tivities 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 Aer-
onautics and Space Administration, the National Institute 
of Standards and Technology, the Environmental Protec-
tion Agency, the National Oceanic and Atmospheric Ad-
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ministration, the Department of Agriculture, the Depart-
ment of Health and Human Services, the Bureau of Eco-
nomic 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 Inter-
agency Committee. The Interagency Committee shall over-
see the planning, management, and coordination of the 
Initiative. The Interagency Committee shall— 
(1) provide for interagency coordination of Fed-
eral engineering biology research, development, and 
other activities undertaken pursuant to the Initia-
tive; 
(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 Pen-
sions of the Senate that— 
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(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 engineer-
ing biology research and development; 
(ii) the Initiative’s support for edu-
cation and public outreach activities; 
(iii) the Initiative’s support for re-
search and other activities on ethical, legal, 
environmental, safety, security, and other 
appropriate societal issues related to engi-
neering biology including— 
(I) an applied biorisk manage-
ment research plan; 
(II) recommendations for inte-
grating security into biological data 
access and international reciprocity 
agreements; 
(III) recommendations for manu-
facturing restructuring to support en-
gineering biology research, develop-
ment, and scaling-up initiatives; and 
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(IV) an evaluation of existing 
biosecurity governance policies, guid-
ance, and directives for the purposes 
of creating an adaptable, evidence- 
based framework to respond to emerg-
ing 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 com-
promise national security or the privacy or security 
of human genetic information, to enhance long-term 
innovation and competitiveness in engineering biol-
ogy in the United States; 
(5) develop a plan to utilize Federal programs, 
such as the Small Business Innovation Research 
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Program and the Small Business Technology Trans-
fer Program as described in section 9 of the Small 
Business Act (15 U.S.C. 638), in support of the ac-
tivities described in section 4(b)(3); and 
(6) in carrying out this section, take into con-
sideration the recommendations of the advisory com-
mittee 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 re-
quest and every third fiscal year thereafter, the Inter-
agency Committee shall prepare and submit to the Com-
mittee 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 budg-
et 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 Pro-
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gram, 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 num-
ber of awards made under the Small Business 
Innovation Research Program and the Small 
Business Technology Transfer Program (as de-
scribed 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 num-
ber 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; 
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(B) serve as the point of contact on Fed-
eral engineering biology activities for govern-
ment organizations, academia, industry, profes-
sional 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 sup-
porting joint agency solicitation and selection of 
applications for funding of activities under the 
Initiative, as appropriate; 
(D) conduct public outreach, including dis-
semination of findings and recommendations of 
the advisory committee established under sec-
tion 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 applica-
tion of, the technologies, innovations, and ex-
pertise derived from Initiative activities to agen-
cy missions and systems across the Federal 
Government, and to United States industry, in-
cluding startup companies. 
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(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 ac-
tivities of the Initiative Coordination Office and sub-
mit such estimate with an agreed summary of con-
tributions 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 termi-
nate on the date that is 10 years after the date of 
the enactment of this Act. 
(d) RULE OF CONSTRUCTION.—Nothing in this sec-
tion 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 devel-
opment, including the solicitation and review of extra-
mural research proposals. 
SEC. 6. ADVISORY COMMITTEE. 
(a) IN GENERAL.—The agency co-chair of the inter-
agency committee established in section 5 shall, in con-
sultation with the Office of Science and Technology Policy, 
designate or establish an advisory committee on engineer-
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ing biology research and development (in this section re-
ferred to as the ‘‘advisory committee’’) to be composed of 
not fewer than 12 members, including representatives of 
research and academic institutions, industry, and non-
governmental entities, who are qualified to provide advice 
on the Initiative. 
(b) ASSESSMENT.—The advisory committee shall as-
sess— 
(1) the current state of United States competi-
tiveness in engineering biology, including the scope 
and scale of United States investments in engineer-
ing biology research and development in the inter-
national context; 
(2) current market barriers to commercializa-
tion of engineering biology products, processes, and 
tools in the United States; 
(3) progress made in implementing the Initia-
tive; 
(4) the need to revise the Initiative; 
(5) the balance of activities and funding across 
the Initiative; 
(6) whether the strategic plan developed or up-
dated by the interagency committee established 
under section 5 is helping to maintain United States 
leadership in engineering biology; 
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(7) the management, coordination, implementa-
tion, 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 fre-
quently 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 Rep-
resentatives, and the Committee on Commerce, Science, 
and Transportation of the Senate, a report on— 
(1) the findings of the advisory committee’s as-
sessment under subsection (b); and 
(2) the advisory committee’s recommendations 
for ways to improve the Initiative. 
(d) APPLICATION
OF FEDERAL ADVISORY COM-
MITTEE ACT.—Section 14 of the Federal Advisory Com-
mittee Act (5 U.S.C. App.) shall not apply to the Advisory 
Committee. 
(e) TERMINATION.—The advisory committee estab-
lished under subsection (a) shall terminate on the date 
that is 10 years after the date of the enactment of this 
Act. 
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SEC. 7. EXTERNAL REVIEW OF ETHICAL, LEGAL, ENVIRON-
MENTAL, 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 recommenda-
tions with respect to, the ethical, legal, environmental, 
safety, security, and other appropriate societal issues re-
lated 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 en-
gaged in engineering biology can best incorporate 
considerations of ethical, legal, environmental, safe-
ty, security, and other societal issues into the devel-
opment of research proposals and the conduct of re-
search. 
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and Human Services, as appropriate and consistent with 
activities of the Department of Health and Human Serv-
ices in effect on the day before the date of the enactment 
of this Act, shall— 
(1) support research and development to ad-
vance the understanding and application of engineer-
ing 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 pub-
lic disclosure of information that is exempt from manda-
tory disclosure under section 552 of title 5, United States 
Code. 
Æ 
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