[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

======================================================================




            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\
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    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).
---------------------------------------------------------------------------

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\
---------------------------------------------------------------------------
    \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).
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \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).
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \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\
---------------------------------------------------------------------------
    \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).
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \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).
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \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).
---------------------------------------------------------------------------

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\
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \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).
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \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\
---------------------------------------------------------------------------
    \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).
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \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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