[Senate Report 116-330]
[From the U.S. Government Publishing Office]
Calendar No. 366
116th Congress } { Report
SENATE
2d Session } { 116-330
_______________________________________________________________________
BIOECONOMY RESEARCH AND DEVELOPMENT ACT OF 2020
__________
R E P O R T
of the
COMMITTEE ON COMMERCE, SCIENCE, AND TRANSPORTATION
on
S. 3734
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
December 15, 2020.--Ordered to be printed
__________
U.S. GOVERNMENT PUBLISHING OFFICE
19-010 WASHINGTON : 2020
SENATE COMMITTEE ON COMMERCE, SCIENCE, AND TRANSPORTATION
one hundred sixteenth congress
second session
ROGER F. WICKER, Mississippi, Chairman
JOHN THUNE, South Dakota MARIA CANTWELL, Washington
ROY BLUNT, Missouri AMY KLOBUCHAR, Minnesota
TED CRUZ, Texas RICHARD BLUMENTHAL, Connecticut
DEB FISCHER, Nebraska BRIAN SCHATZ, Hawaii
JERRY MORAN, Kansas EDWARD J. MARKEY, Massachusetts
DAN SULLIVAN, Alaska TOM UDALL, New Mexico
CORY GARDNER, Colorado GARY C. PETERS, Michigan
MARSHA BLACKBURN, Tennessee TAMMY BALDWIN, Wisconsin
SHELLEY MOORE CAPITO, West Virginia TAMMY DUCKWORTH, Illinois
MIKE LEE, Utah JON TESTER, Montana
RON JOHNSON, Wisconsin KYRSTEN SINEMA, Arizona
TODD C. YOUNG, Indiana JACKY ROSEN, Nevada
RICK SCOTT, Florida
John Keast, Staff Director
David Strickland, Minority Staff Director
Calendar No. 636
116th Congress } { Report
SENATE
2d Session } { 116-330
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BIOECONOMY RESEARCH AND DEVELOPMENT ACT OF 2020
_______
Decemer 15, 2020.--Ordered to be printed
_______
Mr. Wicker, from the Committee on Commerce, Science, and
Transportation, submitted the following
R E P O R T
[To accompany S. 3734]
The Committee on Commerce, Science, and Transportation, to
which was referred the bill (S. 3734) to provide for a
coordinated Federal research initiative to ensure continued
United States leadership in engineering biology, having
considered the same, reports favorably thereon with an
amendment (in the nature of a substitute) and recommends that
the bill (as amended) do pass.
PURPOSE OF THE BILL
The purpose of this bill is to provide for a coordinated
Federal research initiative to ensure continued United States
leadership in engineering biology and continued growth in the
U.S. bioeconomy.
BACKGROUND AND NEEDS
In their recent report entitled ``Safeguarding the
Bioeconomy,'' the National Academy of Sciences defined the U.S.
bioeconomy as the ``economic activity that is driven by
research and innovation in the life sciences and biotechnology,
and that is enabled by technological advances in engineering
and in computing and information sciences.''\1\ Using this
definition, the Academy estimated the bioeconomy contributed
$959.2 billion (5.1 percent of gross domestic product) to the
U.S. economy in 2016.\2\
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\1\National Academies of Sciences, Engineering, and Medicine,
Safeguarding the Bioeconomy (Washington, DC: The National Academies
Press, 2020). Available online (https://www.nap.edu/catalog/25525/
safeguarding-the-bioeconomy) (accessed Sep. 17, 2020).
\2\Ibid.
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Although advances in engineering and computer and
information sciences have helped support the bioeconomy,
advances in biotechnology have been the most transformative.
Biotechnology is the use of living organisms to create
products. One of the simplest examples of biotechnology is the
use of yeast to make bread or brew beer. More advanced
techniques can be used to produce medicine or genetically
modify organisms.\3\ Synthetic biology, sometimes referred to
as ``engineering biology,'' is a subset of biotechnology in
which organisms are modified to create a desired product or
outcome.\4\ For example, bacterial genomes can be modified to
produce medicine, help clean pollutants, and reduce chemical
production costs.
---------------------------------------------------------------------------
\3\Norwegian University of Science and Technology, ``What Is
Biotechnology?'' (https://www.ntnu.edu/ibt/about-us/what-is-
biotechnology) (accessed Sep. 17, 2020).
\4\Engineering Biology Research Consortium, ``What Is Synthetic/
Engineering Biology?'' (https://ebrc.org/what-is-synbio/) (accessed
Sep. 17, 2020); National Academies of Sciences, Engineering, and
Medicine, Biodefense in the Age of Synthetic Biology (Washington, DC:
The National Academies Press, 2018). Available online (https://
www.ncbi.nlm.nih.gov/books/NBK535871/) (accessed Sep. 17, 2020).
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Agriculture, Biomedical, and Bioindustrial Biotechnology
The challenges of feeding a growing global population can,
in part, be reduced by advances in biotechnology. Advanced
selective breeding techniques and gene editing have the
potential to create an increase in agricultural yield similar
to what was seen during what is referred to as the ``Green
Revolution,'' which started in the late 1960s.\5\ During the
Green Revolution, selective breeding and synthetic fertilizer
use more than doubled some crop yields. These increased crop
yields decreased cases of malnutrition globally. However,
challenges remain in meeting global micronutrient requirements
and developing agricultural methods that are less energy
intensive.\6\
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\5\Julia Bailey-Serres et al., ``Genetic Strategies for Improving
Crop Yields,'' Nature, 575(7781):109-118, (Nov. 6, 2019) (doi: 10.1038/
s41586-019-1679-0) (accessed Sep. 17, 2020).
\6\Prabhu L. Pingali, ``Green Revolution: Impacts, Limits, and the
Path Ahead,'' PNAS, 109:12302-12308 (Jul. 31, 2012). Available online
(https://www.pnas.org/content/109/31/12302) (accessed Sep. 17, 2020).
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With synthetic biology, several of the downsides of the
Green Revolution can be mitigated--crops can be developed to
meet micronutrient needs and use fewer resources. For example,
what is referred to as ``golden rice'' was created by adding
the gene that produces vitamin A to conventional rice. The
resulting rice contains enough vitamin A to prevent the host of
diseases that can result from vitamin A deficiency.\7\ The need
for synthetic fertilizers may be reduced by adding nitrogen-
fixing genes to bacteria that live on the roots of corn and
other crops. Much like how the bacteria work that live on a
soybean plant's roots, this would allow the crops to
effectively absorb the much needed nitrogen nutrient without
the need for industrially manufactured nitrogen fertilizer.\8\
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\7\Guangwen Tang et al., ``Golden Rice Is an Effective Source of
Vitamin A,'' The American Journal of Clinical Nutrition, vol. 89:6
(2009). Available online (https://www.ncbi.nlm.nih.gov/pmc/articles/
PMC2682994/) (accessed Sep. 17, 2020).
\8\Min-Hyung Ryu et al., ``Control of Nitrogen Fixation in Bacteria
That Associate With Cereals,'' Nature Microbiology, Dec. 16, 2019 (doi:
10.1038/s41564-019-0631-2) (accessed Sep. 17, 2020).
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Advances in biotechnology are also creating opportunities
to advance medicine and keep people healthy. For example,
penicillin, an antibacterial drug produced by a fungus, was
discovered in 1928, but large-scale production of the drug was
difficult\9\ until the 1940s when scientists developed a
process to ferment the drug in 10,000-gallon tanks,\10\ saving
millions of lives.\11\ Influenza vaccines have historically
been grown in chicken eggs, but this process is relatively slow
and the drug cannot be taken by people with egg allergies.\12\
Cell-based flu vaccines are beginning to allow for more
controlled, larger, and faster growing batches of vaccine,
similar to a technique used for diseases like polio and
retrovirus for many years.\13\ New biotechnologies are allowing
scientists to use cells to produce more effective and
increasingly targeted drugs faster. One tool, clustered
regularly interspaced short palindromic repeats (CRISPR),
enables scientists to edit the genome.\14\ CRISPR has been used
to edit animal genes so that they produce useful drugs, such as
a goat that produces an anticlotting protein in its milk and a
chicken that produces eggs containing a drug that fights
cholesterol diseases.\15\ It also has the potential to edit
human cells and repair genetic mutations that cause deadly
diseases, such as amyotrophic lateral sclerosis (ALS) and
Duchenne muscular dystrophy,\16\ though this application
currently carries a host of safety and ethical issues.\17\
Genetically engineered T-cells can be used to attack cancer
cells, in a therapy which has been approved by the Food and
Drug Administration.\18\ Further advances in biotechnology will
likely help cure diseases and decrease human suffering.
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\9\Milton Wainwright, ``The History of the Therapeutic Use of Crude
Penicillin,'' Medical History, 31:1 (1987). Available online (https://
www.ncbi.nlm.nih.gov/pmc/articles/PMC1139683/pdf/medhist00068-0045.pdf)
(accessed Sep. 17, 2020)
\10\John Patrick Swann, ``The Search for Synthetic Penicillin
During World War II,'' The British Journal for the History of Science,
16:2 (1983).
\11\Dr. David Ho, ``Bacteriologist Alexander Fleming,'' Time,
153:12 (Mar. 29, 1999). Available online by subscription (http://
content.time.com/time/magazine/article/0,9171,990612,00.html) (accessed
Sep. 17, 2020).
\12\Michel Lombard et al., ``A Brief History of Vaccines and
Vaccination,'' Revue Scientifique et Technique-Office International des
Epizooties, 26:1 (May 2007). Available for article download (https://
www.researchgate.net/publication/
6205699_A_brief_history_of_vaccines_and_vaccination) (accessed Sep. 17,
2020).
\13\Andy Extance, ``Cell-based Flu Vaccines Ready for US Prime
Time,'' Nature, 10:246 (Apr. 8, 2011). Available online (https://
www.nature.com/articles/nrd3414) (accessed Sep. 17, 2020).
\14\National Institutes of Health, ``What Are Genome Editing and
CRISPR-Cas9?,'' Feb. 21, 2020 (https://medlineplus.gov/genetics/
understanding/genomicresearch/genomeediting/) (accessed Sep. 17, 2020).
\15\Sara Reardon, ``Welcome to the CRISPR Zoo,'' Nature, 531:7593
(Mar. 9, 2016). Available online (https://www.nature.com/news/welcome-
to-the-crispr-zoo-1.19537) (accessed Sep. 17, 2020).
\16\Chengzu Long et al., ``Genome Editing of Monogenic
Neuromuscular Diseases: A Systematic Review,'' Jama Neurol,
73(11):1349-1355 (Nov. 2016). Available online (doi:10.1001/
jamaneurol.2016.3388) (accessed Sep. 17, 2020).
\17\Hopkins Bloomberg Public Health Magazine, ``Should CRISPR Be
Used to Edit Human Genes to Treat Genetic Diseases?,'' Spring 2019
(https://magazine.jhsph.edu/2019/should-crispr-be-used-edit-human-
genes-treat-genetic-diseases) (accessed Sep. 17, 2020).
\18\Tristen S. Park, Steven A. Rosenberg, and Richard A. Morgan,
``Treating Cancer With Genetically Engineered T-cells,'' Trends in
Biotechnology, 29:11 (Nov. 1, 2011). Available online by subscription
(http://doi.org/10.1016/j.tibtech.2011.04.009) (accessed Sep. 17, 2020)
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Previous Government Actions
The 2012 National Bioeconomy Blueprint identified efforts
supporting the bioeconomy in many departments and agencies.\19\
Though there are necessary sector-specific activities, the
Government Accountability Office found that the Federal
Government could better manage synthetic biology research by
assigning roles and responsibilities.\20\ In October 2019, the
White House hosted the Summit on America's Bioeconomy. The
primary goals highlighted by the summit included improving our
workforce to support the bioeconomy, promoting and safeguarding
critical infrastructure and data, leveraging the U.S.
innovative ecosystem, and identifying and reducing regulatory
challenges.\21\
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\19\The White House, National Bioeconomy Blueprint, Apr. 2012
(https://obamawhitehouse.archives.gov/sites/default/files/microsites/
ostp/national_bioeconomy_blueprint_april_2012.pdf) (accessed Sep. 17,
2020).
\20\U.S. Government Accountability Office, Additional Opportunities
to Reduce Fragmentation, Overlap, and Duplication and Achieve Billions
in Financial Benefits, GAO-19-285SP, May 21, 2019 (https://www.gao.gov/
products/gao-19-285sp?utm_source=blog&utm_medium=social&utm_
campaign=watchblog) (accessed Sep. 17, 2020).
\21\Office of Science and Technology Policy, Summary of the 2019
White House Summit on America's Bioeconomy, Oct. 7, 2019 (https://
www.whitehouse.gov/wp-content/uploads/2019/10/Summary-of-White-House-
Summit-on-Americas-Bioeconomy-October-2019.pdf) (accessed Sep. 17,
2020).
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Currently, there is not a breakdown of Federal funding for
activities that support the bioeconomy, but in fiscal year 2015
the Government spent approximately $30.5 billion on life
sciences. Much of this research directly or indirectly supports
the bioeconomy. The bulk of this Federal funding goes through
the Department of Health and Human Services.\22\
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\22\National Academies of Sciences, Engineering, and Medicine,
Safeguarding the Bioeconomy (Washington, DC: The National Academies
Press, 2020). Available online (https://www.nap.edu/catalog/25525/
safeguarding-the-bioeconomy) (accessed Sep. 17, 2020).
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In addition to direct funding, Federal agencies can provide
tools to support the bioeconomy. One such example is the
National Institute of Standards and Technology's Living
Measurement Systems Foundry. The goal of this program is to
provide testing and measurements of engineered microbes.\23\
Additionally, as engineered microbes become more ubiquitous in
everything from medicine to manufacturing, creating testing
that allows for effective, efficient quality assurance is
critical, as are investments in additional bioeconomy research
infrastructure.\24\
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\23\National Institute of Standards and Technology, ``NIST Living
Measurement Systems Foundry'' (https://www.nist.gov/programs-projects/
nist-living-measurement-systems-foundry) (accessed Sep. 17, 2020).
\24\National Academies of Sciences, Engineering, and Medicine,
Safeguarding the Bioeconomy (Washington, DC: The National Academies
Press, 2020). Available online (https://www.nap.edu/catalog/25525/
safeguarding-the-bioeconomy) (accessed Sep. 17, 2020).
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Competitiveness and Security Concerns
There are two primary security and competitiveness concerns
with respect to the bioeconomy. The first is whether the United
States will continue to lead in both research and
commercialization in the bioeconomy. The second is the
potential for the nefarious use of the techniques for and
products of synthetic biology.
Some indicators suggest that the United States is losing
some of its dominance in the bioeconomy. For example, while the
United States still produces the most publications in the
biological and medical sciences, China has been rapidly
increasing the number of papers it produces, particularly on
key topics such as research on CRISPR, therapeutic antibodies,
and metabolic engineering.\25\ With respect to patents, the
United States is still the global leader, but its dominance has
slipped. For example, in 2001, the United States produced
approximately 40 percent of the international patents in
biotechnology; by 2014, the number had dropped to less than 35
percent. With respect to patents just filed in the United
States or China, China overtook the United States in 2011. It
is, however, unclear as to whether these country-specific
patents will result in robust commercialization on China's
part.\26\ It should also be noted that despite the United
States having the most synthetic biology companies in the
world, some of the most productive firms, based on number of
patents, are in Europe.\27\
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\25\National Academies of Sciences, Engineering, and Medicine,
Safeguarding the Bioeconomy (Washington, DC: The National Academies
Press, 2020). Available online (https://www.nap.edu/catalog/25525/
safeguarding-the-bioeconomy) (accessed Sep. 17, 2020).
\26\Ibid.
\27\Ibid.
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The Department of Defense, Department of State, Department
of Homeland Security, and the Office of the Director of
National Intelligence have all identified synthetic biology as
an emerging threat. For example, synthetic biology could be
used to make novel biological or chemical weapons or enhance
the performance of military personnel.\28\ So called dual use
research of concern (DURC) is research that could be reasonably
used for nefarious purposes. The Federal Government has certain
rules for DURC. The rules do not prohibit research, but do
assign clear roles and responsibilities for the institutes and
researchers. Currently, the rules cover research involving 15
agents and toxins and seven categories of experiments.\29\ The
specificity of the categories simplifies the application of the
rules, but may also miss potentially dangerous research,
particularly in emerging fields.
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\28\Government Accountability Office, ``Long-Range Emerging Threats
Facing the United States As Identified by Federal Agencies,'' Dec. 2018
(https://www.gao.gov/assets/gao-19-204sp.pdf) (accessed Sep. 17, 2020).
\29\National Institutes of Health, ``Dual Use Research of Concern''
(https://osp.od.nih.gov/
biotechnology/dual-use-research-of-concern/) (accessed Sep. 17, 2020).
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There are also concerns about asymmetric sharing of data.
For example, China has a very large genetic database, but does
not make it available to researchers outside the country. When
a country like the United States openly shares genetic data,
China is able to start a database of genetic data from U.S.
sources. While not currently possible, technological advances
could theoretically allow an adversary to use one's genetic
code to gain insight into personality traits. The Chinese have
used their large genetic database to target ethnic minorities,
most notably, Uighurs.\30\
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\30\National Academies of Sciences, Engineering, and Medicine,
Safeguarding the Bioeconomy (Washington, DC: The National Academies
Press, 2020). Available online (https://www.nap.edu/catalog/25525/
safeguarding-the-bioeconomy) (accessed Sep. 17, 2020).
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Ethical and Safety Concerns
The advent of new techniques to manipulate natural systems
or living organisms requires careful consideration of the safe
and ethical use of such technologies. While gene editing
techniques have been around for decades, the development of
new, more precise techniques like CRISPR require researchers
and policymakers to carefully consider when and how they are
used, including how genetic modifications may propagate or
impact the environment.\31\ Bioethicist Dr. Jeffrey Kahn notes
that there are three areas of concern related to gene editing:
(1) modifying genetic material that can be passed down to
offspring (germline modifications); (2) the possibility of
cosmetic or otherwise unnecessary genetic modifications; and
(3) the implications of human interference in natural
processes.\32\ Further research is needed to mitigate these
concerns.\33\
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\31\David Baltimore et al, ``A Prudent Path Forward for Genomic
Engineering and Germline Gene Modification,'' Science, vol. 348:6230,
Apr. 3, 2015, https://science.sciencemag.org/content/348/6230/36.full.
\32\Dr. Jeffrey P. Kahn, ``Testimony to the House Committee on
Science, Space, and Technology,'' June 16, 2015, (https://republicans-
science.house.gov/sites/republicans.science.house.gov/files/documents/
HHRG-114-SY15-WState-JKahn-20150616.pdf) (accessed Sep. 17, 2020).
\33\National Academies of Sciences, Engineering, and Medicine,
Safeguarding the Bioeconomy (Washington, DC: The National Academies
Press, 2020). Available online (https://www.nap.edu/catalog/25525/
safeguarding-the-bioeconomy) (accessed Sep. 17, 2020).
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One area of controversy surrounds the use of gene editing
on germline cells, which would change the genes passed on to
offspring and future generations. There may be some cases in
which germline editing to remove hereditary diseases could be
beneficial, though a consensus study on the topic published by
the NASEM notes the significant and complex social, ethical,
technical, and religious concerns about the appropriateness of
such intervention.\34\ There are also concerns about how such
techniques could be weaponized against vulnerable populations
or used without consent.\35\ In the United States, there is a
moratorium on human germline editing, including editing the DNA
of human embryos.\36\
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\34\``Human Genome Editing: Science, Ethics, and Governance,''
National Academy of Sciences, 2017, (https://www.nap.edu/download/
24623#) (accessed Sep. 17, 2020).
\35\Heidi Howard et al, ``One Small Edit for Humans, One Giant Edit
for Humankind?`` European Journal of Human Genetics, January 26, 2018
(https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5839051/) (accessed Sep.
17, 2020).
\36\Francis S. Collins, ``Statement on NIH Funding of Research
Using Gene-Editing Technologies in Human Embryos,'' National Institutes
of Health, April 28, 2015 (https://www.nih.gov/about-nih/who-we-are/
nih-director/statements/statement-nih-funding-research-using-gene-
editing-technologies-human-embryos) (accessed Sep. 17, 2020).
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SUMMARY OF PROVISIONS
If enacted, S. 3734, the Bioeconomy Research and
Development Act of 2020, would do the following:
Establish a Federal engineering biology research
initiative and require a national strategy for Federal
agency investments and a framework for interagency
coordination.
Support the creation of bioeconomy-relevant
databases and tools.
Expand public-private partnerships and education and
training for the next generation of engineering biology
researchers.
Provide direction for mission-relevant activities in
engineering biology for several Federal agencies.
Mandate an independent review of current policies
and create a presidential advisory committee tasked
with providing assessments and analyses of policy.
Ensure that the authorized initiative would address
potential ethical, legal, environmental, safety and
security issues associated with engineering biology
research.
LEGISLATIVE HISTORY
S. 3734, the Bioeconomy Research and Development Act of
2020, was introduced on May 14, 2020, by Senator Gillibrand
(for herself and Senators Markey, Rubio, and Gardner) and
referred to the Committee on Commerce, Science, and
Transportation of the Senate. On May 20, 2020, the Committee
met in open Executive Session and, by voice vote, ordered S.
3734 reported favorably with an amendment (in the nature of a
substitute).
A related bill, H.R. 4373, the Engineering Biology Research
and Development Act of 2019, was introduced on September 18,
2019, by Representative Eddie Bernice Johnson (for herself and
Representatives James F. Sensenbrenner, Zoe Lofgren, and Frank
D. Lucas) and referred to the Committee on Science, Space, and
Technology of the House of Representatives. On December 9,
2019, H.R. 4373, as amended, passed the House of
Representatives.
Another related bill, S. 3191, the Industries of the Future
Act of 2020, was introduced on January 14, 2020, by Senators
Wicker (for himself and Senators Gardner, Baldwin, and Peters)
and referred to the Committee on Commerce, Science, and
Transportation of the Senate. On March 11, 2020, the Committee
met in open Executive Session and, by voice vote, ordered S.
3191 reported favorably with an amendment. S. 3191 would
increase the capacity of research and development programs of
the Federal Government that focus on industries of the future,
including engineering biology.
Hearing
The Committee's Subcommittee on Science, Oceans, Fisheries,
and Weather held a related hearing entitled ``Securing U.S.
Leadership in the Bioeconomy,'' on March 3, 2020. That hearing
examined the Federal Government's role in the bioeconomy. The
Committee received testimony from Dr. Timothy Donohue, Director
of the Great Lakes Bioenergy Research Center at the University
of Wisconsin-Madison; Mr. Jason Gammack, Chief Commercial
Officer of Inscripta Inc.; Dr. Jason Kelly, Co-Founder and
Chief Executive Officer of Ginkgo Bioworks; and Dr. Megan
Palmer, Senior Research Scholar at the Center for International
Security and Cooperation at Stanford University.
ESTIMATED COSTS
In compliance with subsection (a)(3) of paragraph 11 of
rule XXVI of the Standing Rules of the Senate, the Committee
states that, in its opinion, it is necessary to dispense with
the requirements of paragraphs (1) and (2) of that subsection
in order to expedite the business of the Senate.
REGULATORY IMPACT STATEMENT
In accordance with paragraph 11(b) of rule XXVI of the
Standing Rules of the Senate, the Committee provides the
following evaluation of the regulatory impact of the
legislation, as reported:
Number of Persons Covered
S. 3734, as reported, would not impose any new significant
regulatory requirements, and, therefore, would not subject any
individuals or businesses to new significant regulations.
Economic Impact
Enactment of S. 3734 is not expected to have any
significant adverse impacts on the Nation's economy. S. 3734
would serve to drive technology transfer to the private sector,
ensuring optimal return on Federal investment, and support
research that will lead to continued economic strength.
Privacy
S. 3734, as reported, would not have any adverse impact on
the privacy of individuals.
Paperwork
S. 3734 would not impose a substantial paperwork burden on
individuals or businesses. S. 3734 would require two reports
from the committees that would be created by this bill. The
first report would be from the interagency committee to the
Committee on Science, Space, and Technology of the House of
Representatives and the Committee on Commerce, Science, and
Transportation of the Senate within 90 days after the
President's annual budget request, produced triennially,
summarizing agency budgets in support of the Bioeconomy
Initiative and an assessment of how Federal agencies are
implementing the Initiative. The second report would be from
the advisory committee to the Committee on Science, Space, and
Technology of the House of Representatives and the Committee on
Commerce, Science, and Transportation of the Senate to provide
an assessment of U.S. competitiveness in engineering biology,
progress made on implementing the Initiative, and
recommendations to improve the Initiative. The advisory
committee report would be prepared triennially, and the
reporting requirement would terminate after 10 years. The
National Academies of Sciences, Engineering, and Medicine would
also submit a report to Congress to 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.
CONGRESSIONALLY DIRECTED SPENDING
In compliance with paragraph 4(b) of rule XLIV of the
Standing Rules of the Senate, the Committee provides that no
provisions contained in the bill, as reported, meet the
definition of congressionally directed spending items under the
rule.
SECTION-BY-SECTION ANALYSIS
Section. 1. Short title.
This section would provide that the bill may be cited as
the ``Bioeconomy Research and Development Act of 2020''.
Section 2. Findings.
This section would highlight the importance of engineering
biology to societal well-being, national security, and the
economy, as well as how the Federal Government can play an
important role in maintaining U.S. leadership in engineering
biology research and development.
Section 3. Definitions.
This section define the terms ``biomanufacturing'',
``engineering biology'', ``Initiative'', and ``omics'' as used
in the bill.
Section 4. National Engineering Biology Research and Development
Initiative.
Subsection (a) would establish the National Engineering
Biology Research and Development Initiative to do the
following:
Advance engineering biology research, including
social science, biomanufacturing, and economic research
relating to the field.
Improve public understanding of engineering biology.
Support risk research to address ethical, safety,
security and other societal implications of engineering
biology.
Support the development of tools and technologies to
accelerate engineering biology research.
Expand the engineering biology workforce, to include
traditionally underrepresented and underserved
populations.
Accelerate technology transfer and commercialization
of engineering biology research.
Improve interagency planning and coordination of
Federal engineering biology activities.
Subsection (b) outlines the specific activities of the
Initiative, including support for research grants, research at
Federal and non-Federal laboratories, omics databases and
related tools, novel tools and technologies to accelerate
research, interdisciplinary education and training of
undergraduate and graduate students, development of metrics to
understand and assess the outputs and economic benefits of
engineering biology, and technology transfer activities.
Subsection (c) would require the Initiative to engage in
outreach to undergraduate and minority-serving institutions,
encouraging research collaborations among these institutions
and research-intensive universities.
Subsection (d) would direct the Initiative to take into
account ethical, legal, environmental, safety, security, and
societal issues by: (1) supporting research related to these
concerns associated with engineering biology; (2) integrating
input from Federal and non-Federal experts on these topics; and
(3) engaging in public outreach to incorporate public input
into Initiative activities.
Section 5. Initiative coordination.
This section would require the President, acting through
the Office of Science and Technology Policy, to designate an
interagency committee that would oversee the planning,
management, and coordination of the Initiative. The interagency
committee would do the following:
Develop and regularly update a strategic plan to
meet the goals and priorities of the Initiative, which
would be submitted to Congress no later than 12 months
after the date of enactment and updated triennially
thereafter.
Develop a national genomic sequencing strategy.
Develop a plan to utilize Federal programs, such as
those described in the Small Business Act.
Submit a triennial budget report to Congress
beginning with fiscal year 2022 and ending in fiscal
year 2028 that summarizes spending of participating
Federal agencies and provides an assessment of how
Federal agencies are implementing the plan.
Establish and update goals and priorities for the
interagency committee.
Coordinate Federal activities related to engineering
biology.
This section would also direct the President to establish
an Initiative Coordination Office, with a Director and full-
time staff, to provide support to the interagency committee and
the advisory committee established in section 6. The Office of
Science and Technology Policy is directed to draft a cost
estimate for the Initiative Coordination Office, along with a
plan for how participating agencies should contribute to that
cost estimate for Congress' review. The Office would be
terminated 10 years after enactment.
Section 6. Advisory committee.
This section would authorize the head of the interagency
committee co-chair agency, in consultation with the Office of
Science and Technology Policy, to designate or establish an
advisory committee of qualified non-Federal members to provide
advice on the Initiative. The advisory committee would assess
the following:
the state of U.S. competitiveness in engineering
biology;
current market barriers to commercialization of
engineering biology products, processes, and tools;
progress made by the Initiative;
whether the Initiative requires any revisions;
balance of activities and funds across the
Initiative;
whether the Initiative's strategic plan is
effective;
management, coordination, implementation, and
activities of the Initiative; and
whether ethical, legal, environmental, safety,
security, and other appropriate societal issues are
adequately addressed by the Initiative.
The advisory committee would report their findings and
recommendations to the President and Congress no later than 2
years after the date of enactment of the Act, and at least
every 3 years thereafter. The advisory committee would
terminate after 10 years.
Section 7. External review of ethical, legal, environmental, safety,
security, and societal issues.
This section would direct the National Science Foundation
to, not later than 6 months after the date of enactment of this
Act, seek to engage the National Academies of Sciences,
Engineering, and Medicine to conduct a review of the ethical,
legal, environmental, security, safety, and other societal
concerns related to engineering biology research and
development. This review will note research gaps in these
areas, recommend actions the Initiative can take to address
said gaps, and recommend ways engineering biology researchers
can take the societal concerns identified in this section into
account as they develop proposals and conduct research. The
National Academies of Sciences, Engineering, and Medicine are
directed to submit this report to Congress within 2 years after
the date of enactment of this Act, as well as make the report
publicly available.
Section 8. Agency activities.
This section outlines agency-specific activities and the
responsibilities that agencies would be required to undertake
as part of the Initiative. This list includes activities and
responsibilities at the National Science Foundation, the
National Institute of Standards and Technology, the Department
of Energy, the Department of Defense, the National Aeronautics
and Space Administration, the Department of Agriculture, the
Environmental Protection Agency, the National Institutes of
Health, and the Food and Drug Administration.
CHANGES IN EXISTING LAW
In compliance with paragraph 12 of rule XXVI of the
Standing Rules of the Senate, the Committee states that the
bill as reported would make no change to existing law.
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