Presidential DocumentExecutive Order 140812022-20167
Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy
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Published
September 15, 2022
Signed
September 12, 2022
Issuing agencies
Executive Office of the President
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[Federal Register Volume 87, Number 178 (Thursday, September 15, 2022)]
[Presidential Documents]
[Pages 56849-56860]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-20167]
[[Page 56847]]
Vol. 87
Thursday,
No. 178
September 15, 2022
Part III
The President
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Executive Order 14081--Advancing Biotechnology and Biomanufacturing
Innovation for a Sustainable, Safe, and Secure American Bioeconomy
Presidential Documents
Federal Register / Vol. 87 , No. 178 / Thursday, September 15, 2022 /
Presidential Documents
___________________________________________________________________
Title 3--
The President
[[Page 56849]]
Executive Order 14081 of September 12, 2022
Advancing Biotechnology and Biomanufacturing
Innovation for a Sustainable, Safe, and Secure American
Bioeconomy
By the authority vested in me as President by the
Constitution and the laws of the United States of
America, it is hereby ordered as follows:
Section 1. Policy. It is the policy of my
Administration to coordinate a whole-of-government
approach to advance biotechnology and biomanufacturing
towards innovative solutions in health, climate change,
energy, food security, agriculture, supply chain
resilience, and national and economic security. Central
to this policy and its outcomes are principles of
equity, ethics, safety, and security that enable access
to technologies, processes, and products in a manner
that benefits all Americans and the global community
and that maintains United States technological
leadership and economic competitiveness.
Biotechnology harnesses the power of biology to create
new services and products, which provide opportunities
to grow the United States economy and workforce and
improve the quality of our lives and the environment.
The economic activity derived from biotechnology and
biomanufacturing is referred to as ``the bioeconomy.''
The COVID-19 pandemic has demonstrated the vital role
of biotechnology and biomanufacturing in developing and
producing life-saving diagnostics, therapeutics, and
vaccines that protect Americans and the world. Although
the power of these technologies is most vivid at the
moment in the context of human health, biotechnology
and biomanufacturing can also be used to achieve our
climate and energy goals, improve food security and
sustainability, secure our supply chains, and grow the
economy across all of America.
For biotechnology and biomanufacturing to help us
achieve our societal goals, the United States needs to
invest in foundational scientific capabilities. We need
to develop genetic engineering technologies and
techniques to be able to write circuitry for cells and
predictably program biology in the same way in which we
write software and program computers; unlock the power
of biological data, including through computing tools
and artificial intelligence; and advance the science of
scale-up production while reducing the obstacles for
commercialization so that innovative technologies and
products can reach markets faster.
Simultaneously, we must take concrete steps to reduce
biological risks associated with advances in
biotechnology. We need to invest in and promote
biosafety and biosecurity to ensure that biotechnology
is developed and deployed in ways that align with
United States principles and values and international
best practices, and not in ways that lead to accidental
or deliberate harm to people, animals, or the
environment. In addition, we must safeguard the United
States bioeconomy, as foreign adversaries and strategic
competitors alike use legal and illegal means to
acquire United States technologies and data, including
biological data, and proprietary or precompetitive
information, which threatens United States economic
competitiveness and national security.
We also must ensure that uses of biotechnology and
biomanufacturing are ethical and responsible; are
centered on a foundation of equity and public good,
consistent with Executive Order 13985 of January 20,
2021 (Advancing Racial Equity and Support for
Underserved Communities Through the Federal
Government); and are consistent with respect for human
rights. Resources
[[Page 56850]]
should be invested justly and equitably so that
biotechnology and biomanufacturing technologies benefit
all Americans, especially those in underserved
communities, as well as the broader global community.
To achieve these objectives, it is the policy of my
Administration to:
(a) bolster and coordinate Federal investment in
key research and development (R&D) areas of
biotechnology and biomanufacturing in order to further
societal goals;
(b) foster a biological data ecosystem that
advances biotechnology and biomanufacturing innovation,
while adhering to principles of security, privacy, and
responsible conduct of research;
(c) improve and expand domestic biomanufacturing
production capacity and processes, while also
increasing piloting and prototyping efforts in
biotechnology and biomanufacturing to accelerate the
translation of basic research results into practice;
(d) boost sustainable biomass production and create
climate-smart incentives for American agricultural
producers and forest landowners;
(e) expand market opportunities for bioenergy and
biobased products and services;
(f) train and support a diverse, skilled workforce
and a next generation of leaders from diverse groups to
advance biotechnology and biomanufacturing;
(g) clarify and streamline regulations in service
of a science- and risk-based, predictable, efficient,
and transparent system to support the safe use of
products of biotechnology;
(h) elevate biological risk management as a
cornerstone of the life cycle of biotechnology and
biomanufacturing R&D, including by providing for
research and investment in applied biosafety and
biosecurity innovation;
(i) promote standards, establish metrics, and
develop systems to grow and assess the state of the
bioeconomy; to better inform policy, decision-making,
and investments in the bioeconomy; and to ensure
equitable and ethical development of the bioeconomy;
(j) secure and protect the United States bioeconomy
by adopting a forward-looking, proactive approach to
assessing and anticipating threats, risks, and
potential vulnerabilities (including digital intrusion,
manipulation, and exfiltration efforts by foreign
adversaries), and by partnering with the private sector
and other relevant stakeholders to jointly mitigate
risks to protect technology leadership and economic
competitiveness; and
(k) engage the international community to enhance
biotechnology R&D cooperation in a way that is
consistent with United States principles and values and
that promotes best practices for safe and secure
biotechnology and biomanufacturing research,
innovation, and product development and use.
The efforts undertaken pursuant to this order to
further these policies shall be referred to
collectively as the National Biotechnology and
Biomanufacturing Initiative.
Sec. 2. Coordination. The Assistant to the President
for National Security Affairs (APNSA), in consultation
with the Assistant to the President for Economic Policy
(APEP) and the Director of the Office of Science and
Technology Policy (OSTP), shall coordinate the
executive branch actions necessary to implement this
order through the interagency process described in
National Security Memorandum 2 of February 4, 2021
(Renewing the National Security Council System) (NSM-2
process). In implementing this order, heads of agencies
(as defined in section 13 of this order) shall, as
appropriate and consistent with applicable law, consult
outside stakeholders, such as those in industry;
academia; nongovernmental organizations; communities;
labor unions; and State, local, Tribal, and territorial
governments to advance the policies described in
section 1 of this order.
[[Page 56851]]
Sec. 3. Harnessing Biotechnology and Biomanufacturing
R&D to Further Societal Goals. (a) Within 180 days of
the date of this order, the heads of agencies specified
in subsections (a)(i)-(v) of this section shall submit
the following reports on biotechnology and
biomanufacturing to further societal goals related to
health, climate change and energy, food and
agricultural innovation, resilient supply chains, and
cross-cutting scientific advances. The reports shall be
submitted to the President through the APNSA, in
coordination with the Director of the Office of
Management and Budget (OMB), the APEP, the Assistant to
the President for Domestic Policy (APDP), and the
Director of OSTP.
(i) The Secretary of Health and Human Services (HHS), in consultation with
the heads of appropriate agencies as determined by the Secretary, shall
submit a report assessing how to use biotechnology and biomanufacturing to
achieve medical breakthroughs, reduce the overall burden of disease, and
improve health outcomes.
(ii) The Secretary of Energy, in consultation with the heads of appropriate
agencies as determined by the Secretary, shall submit a report assessing
how to use biotechnology, biomanufacturing, bioenergy, and biobased
products to address the causes and adapt to and mitigate the impacts of
climate change, including by sequestering carbon and reducing greenhouse
gas emissions.
(iii) The Secretary of Agriculture, in consultation with the heads of
appropriate agencies as determined by the Secretary, shall submit a report
assessing how to use biotechnology and biomanufacturing for food and
agriculture innovation, including by improving sustainability and land
conservation; increasing food quality and nutrition; increasing and
protecting agricultural yields; protecting against plant and animal pests
and diseases; and cultivating alternative food sources.
(iv) The Secretary of Commerce, in consultation with the Secretary of
Defense, the Secretary of HHS, and the heads of other appropriate agencies
as determined by the Secretary of Commerce, shall submit a report assessing
how to use biotechnology and biomanufacturing to strengthen the resilience
of United States supply chains.
(v) The Director of the National Science Foundation (NSF), in consultation
with the heads of appropriate agencies as determined by the Director, shall
submit a report identifying high-priority fundamental and use-inspired
basic research goals to advance biotechnology and biomanufacturing and to
address the societal goals identified in this section.
(b) Each report specified in subsection (a) of this
section shall identify high-priority basic research and
technology development needs to achieve the overall
objectives described in subsection (a) of this section,
as well as opportunities for public-private
collaboration. Each of these reports shall also include
recommendations for actions to enhance biosafety and
biosecurity to reduce risk throughout the biotechnology
R&D and biomanufacturing lifecycles.
(c) Within 100 days of receiving the reports
required under subsection (a) of this section, the
Director of OSTP, in coordination with the Director of
OMB, the APNSA, the APEP, the APDP, and the heads of
appropriate agencies as determined through the NSM-2
process, shall develop a plan (implementation plan) to
implement the recommendations in the reports. The
development of this implementation plan shall also
include the solicitation of input from external experts
regarding potential ethical implications or other
societal impacts, including environmental
sustainability and environmental justice, of the
recommendations contained in the reports required under
subsection (a) of this section. The implementation plan
shall include assessments and make recommendations
regarding any such implications or impacts.
(d) Within 90 days of the date of this order, the
Director of OMB, in consultation with the heads of
appropriate agencies as determined through
[[Page 56852]]
the NSM-2 process, shall perform a budget crosscut to
identify existing levels of agency spending on
biotechnology- and biomanufacturing-related activities
to inform the development of the implementation plan
described in subsection (c) of this section.
(e) The APNSA, in coordination with the Director of
OMB, the APEP, the APDP, and the Director of OSTP,
shall review the reports required under subsection (a)
of this section and shall submit the reports to the
President in an unclassified form, but may include a
classified annex.
(f) The APNSA, in coordination with the Director of
OMB, the APEP, the APDP, and the Director of OSTP,
shall include a cover memorandum for the reports
submitted pursuant to subsection (a) of this section,
along with the implementation plan required under
subsection (c) of this section, in which they make any
additional overall recommendations for advancing
biotechnology and biomanufacturing.
(g) Within 2 years of the date of this order,
agencies at which recommendations are directed in the
implementation plan required under subsection (c) of
this section shall report to the Director of OMB, the
APNSA, the APEP, the APDP, and the Director of OSTP on
measures taken and resources allocated to enhance
biotechnology and biomanufacturing, consistent with the
implementation plan described in subsection (c) of this
section.
(h) Within 180 days of the date of this order, the
President's Council of Advisors on Science and
Technology shall submit to the President and make
publicly available a report on the bioeconomy that
provides recommendations on how to maintain United
States competitiveness in the global bioeconomy.
Sec. 4. Data for the Bioeconomy. (a) In order to
facilitate development of the United States bioeconomy,
my Administration shall establish a Data for the
Bioeconomy Initiative (Data Initiative) that will
ensure that high-quality, wide-ranging, easily
accessible, and secure biological data sets can drive
breakthroughs for the United States bioeconomy. To
assist in the development of the Data Initiative, the
Director of OSTP, in coordination with the Director of
OMB and the heads of appropriate agencies as determined
by the Director of OSTP, and in consultation with
external stakeholders, shall issue a report within 240
days of the date of this order that:
(i) identifies the data types and sources, to include genomic and multiomic
information, that are most critical to drive advances in health, climate,
energy, food, agriculture, and biomanufacturing, as well as other
bioeconomy-related R&D, along with any data gaps;
(ii) sets forth a plan to fill any data gaps and make new and existing
public data findable, accessible, interoperable, and reusable in ways that
are equitable, standardized, secure, and transparent, and that are
integrated with platforms that enable the use of advanced computing tools;
(iii) identifies--based on the data types and sources described in
subsection (a)(i) of this section--security, privacy, and other risks (such
as malicious misuses, manipulation, exfiltration, and deletion), and
provides a data-protection plan to mitigate these risks; and
(iv) outlines the Federal resources, legal authorities, and actions needed
to support the Data Initiative and achieve the goals outlined in this
subsection, with a timeline for action.
(b) The Secretary of Homeland Security, in
coordination with the Secretary of Defense, the
Secretary of Agriculture, the Secretary of Commerce
(acting through the Director of the National Institute
of Standards and Technology (NIST)), the Secretary of
HHS, the Secretary of Energy, and the Director of OMB,
shall identify and recommend relevant cybersecurity
best practices for biological data stored on Federal
Government information systems, consistent with
applicable law and Executive Order 14028 of May 12,
2021 (Improving the Nation's Cybersecurity).
[[Page 56853]]
(c) The Secretary of Commerce, acting through the
Director of NIST and in coordination with the Secretary
of HHS, shall consider bio-related software, including
software for laboratory equipment, instrumentation, and
data management, in establishing baseline security
standards for the development of software sold to the
United States Government, consistent with section 4 of
Executive Order 14028.
Sec. 5. Building a Vibrant Domestic Biomanufacturing
Ecosystem. (a) Within 180 days of the date of this
order, the APNSA and the APEP, in coordination with the
Secretary of Defense, the Secretary of Agriculture, the
Secretary of Commerce, the Secretary of HHS, the
Secretary of Energy, the Director of NSF, and the
Administrator of the National Aeronautics and Space
Administration (NASA), shall develop a strategy that
identifies policy recommendations to expand domestic
biomanufacturing capacity for products spanning the
health, energy, agriculture, and industrial sectors,
with a focus on advancing equity, improving
biomanufacturing processes, and connecting relevant
infrastructure. Additionally, this strategy shall
identify actions to mitigate risks posed by foreign
adversary involvement in the biomanufacturing supply
chain and to enhance biosafety, biosecurity, and
cybersecurity in new and existing infrastructure.
(b) Agencies identified in subsections (b)(i)-(iv)
of this section shall direct resources, as appropriate
and consistent with applicable law, towards the
creation or expansion of programs that support a
vibrant domestic biomanufacturing ecosystem, as
informed by the strategy developed pursuant to
subsection (a) of this section:
(i) the NSF shall expand its existing Regional Innovation Engine program to
advance emerging technologies, including biotechnology;
(ii) the Department of Commerce shall address challenges in
biomanufacturing supply chains and related biotechnology development
infrastructure;
(iii) the Department of Defense shall incentivize the expansion of
domestic, flexible industrial biomanufacturing capacity for a wide range of
materials that can be used to make a diversity of products for the defense
supply chain; and
(iv) the Department of Energy shall support research to accelerate
bioenergy and bioproduct science advances, to accelerate biotechnology and
bioinformatics tool development, and to reduce the hurdles to
commercialization, including through incentivizing the engineering scale-up
of promising biotechnologies and the expansion of biomanufacturing
capacity.
(c) Within 1 year of the date of this order, the
Secretary of Agriculture, in consultation with the
heads of appropriate agencies as determined by the
Secretary, shall submit a plan to the President,
through the APNSA and the APEP, to support the
resilience of the United States biomass supply chain
for domestic biomanufacturing and biobased product
manufacturing, while also advancing food security,
environmental sustainability, and the needs of
underserved communities. This plan shall include
programs to encourage climate-smart production and use
of domestic biomass, along with budget estimates,
including accounting for funds appropriated for Fiscal
Year (FY) 2022 and proposed in the President's FY 2023
Budget.
(d) Within 180 days of the date of this order, the
Secretary of Homeland Security, in coordination with
the heads of appropriate agencies as determined by the
Secretary, shall:
(i) provide the APNSA with vulnerability assessments of the critical
infrastructure and national critical functions associated with the
bioeconomy, including cyber, physical, and systemic risks, and
recommendations to secure and make resilient these components of our
infrastructure and economy; and
(ii) enhance coordination with industry on threat information sharing,
vulnerability disclosure, and risk mitigation for cybersecurity and
infrastructure risks to the United States bioeconomy, including risks to
biological data and related physical and digital infrastructure and
devices. This
[[Page 56854]]
coordination shall be informed in part by the assessments described in
subsection (d)(i) of this section.
Sec. 6. Biobased Products Procurement. (a) Consistent
with the requirements of 7 U.S.C. 8102, within 1 year
of the date of this order, procuring agencies as
defined in 7 U.S.C. 8102(a)(1)(A) that have not yet
established a biobased procurement program as described
in 7 U.S.C. 8102(a)(2) shall establish such a program.
(b) Procuring agencies shall require that, within 2
years of the date of this order, all appropriate staff
(including contracting officers, purchase card
managers, and purchase card holders) complete training
on biobased product purchasing. The Office of Federal
Procurement Policy, within OMB, in cooperation with the
Secretary of Agriculture, shall provide training
materials for procuring agencies.
(c) Within 180 days of the date of this order and
annually thereafter, procuring agencies shall report
previous fiscal year spending to the Director of OMB on
the following:
(i) the number and dollar value of contracts entered into during the
previous fiscal year that include the direct procurement of biobased
products;
(ii) the number of service and construction (including renovations)
contracts entered into during the previous fiscal year that include
language on the use of biobased products; and
(iii) the types and dollar values of biobased products actually used by
contractors in carrying out service and construction (including
renovations) contracts during the previous fiscal year.
(d) The requirements in subsection (c) of this
section shall not apply to purchase card transactions
and other ``[a]ctions not reported'' to the Federal
Procurement Data System pursuant to 48 CFR 4.606(c).
(e) Within 1 year of the date of this order and
annually thereafter, the Director of OMB shall publish
information on biobased procurement resulting from the
data collected under subsection (c) of this section and
information reported under 7 U.S.C. 8102, along with
other related information, and shall use scorecards or
similar systems to encourage increased biobased
purchasing.
(f) Within 1 year of the date of this order and
annually thereafter, procuring agencies shall report to
the Secretary of Agriculture specific categories of
biobased products that are unavailable to meet their
procurement needs, along with desired performance
standards for currently unavailable products and other
relevant specifications. The Secretary of Agriculture
shall publish this information annually. When new
categories of biobased products become commercially
available, the Secretary of Agriculture shall designate
new product categories for preferred Federal
procurement, as prescribed by 7 U.S.C. 8102.
(g) Procuring agencies shall strive to increase by
2025 the amount of biobased product obligations or the
number or dollar value of biobased-only contracts, as
reflected in the information described in subsection
(c) of this section, and as appropriate and consistent
with applicable law.
Sec. 7. Biotechnology and Biomanufacturing Workforce.
(a) The United States Government shall expand training
and education opportunities for all Americans in
biotechnology and biomanufacturing. To support this
objective, within 200 days of the date of this order,
the Secretary of Commerce, the Secretary of Labor, the
Secretary of Education, the APDP, the Director of OSTP,
and the Director of NSF shall produce and make publicly
available a plan to coordinate and use relevant Federal
education and training programs, while also
recommending new efforts to promote multi-disciplinary
education programs. This plan shall promote the
implementation of formal and informal education and
training (such as opportunities at technical schools
and certificate programs), career and technical
education, and expanded career pathways into existing
degree programs for biotechnology
[[Page 56855]]
and biomanufacturing. This plan shall also include a
focused discussion of Historically Black Colleges and
Universities, Tribal Colleges and Universities, and
Minority Serving Institutions and the extent to which
agencies can use existing statutory authorities to
promote racial and gender equity and support
underserved communities, consistent with the policy
established in Executive Order 13985. Finally, this
plan shall account for funds appropriated for FY 2022
and proposed in the President's FY 2023 Budget.
(b) Within 2 years of the date of this order,
agencies that support relevant Federal education and
training programs as described in subsection (a) of
this section shall report to the President through the
APNSA, in coordination with the Director of OMB, the
ADPD, and the Director of OSTP, on measures taken and
resources allocated to enhance workforce development
pursuant to the plan described in subsection (a) of
this section.
Sec. 8. Biotechnology Regulation Clarity and
Efficiency. Advances in biotechnology are rapidly
altering the product landscape. The complexity of the
current regulatory system for biotechnology products
can be confusing and create challenges for businesses
to navigate. To improve the clarity and efficiency of
the regulatory process for biotechnology products, and
to enable products that further the societal goals
identified in section 3 of this order, the Secretary of
Agriculture, the Administrator of the Environmental
Protection Agency, and the Commissioner of Food and
Drugs, in coordination with the Director of OMB, the
ADPD, and the Director of OSTP, shall:
(a) within 180 days of the date of this order,
identify areas of ambiguity, gaps, or uncertainties in
the January 2017 Update to the Coordinated Framework
for the Regulation of Biotechnology or in the policy
changes made pursuant to Executive Order 13874 of June
11, 2019 (Modernizing the Regulatory Framework for
Agricultural Biotechnology Products), including by
engaging with developers and external stakeholders, and
through horizon scanning for novel products of
biotechnology;
(b) within 100 days of completing the task in
subsection (a) of this section, provide to the general
public plain-language information regarding the
regulatory roles, responsibilities, and processes of
each agency, including which agency or agencies are
responsible for oversight of different types of
products developed with biotechnology, with case
studies, as appropriate;
(c) within 280 days of the date of this order,
provide a plan to the Director of OMB, the ADPD, and
the Director of OSTP with processes and timelines to
implement regulatory reform, including identification
of the regulations and guidance documents that can be
updated, streamlined, or clarified; and identification
of potential new guidance or regulations, where needed;
(d) within 1 year of the date of this order, build
on the Unified website for Biotechnology Regulation
developed pursuant to Executive Order 13874 by
including on the website the information developed
under subsection (b) of this section, and by enabling
developers of biotechnology products to submit
inquiries about a particular product and promptly
receive a single, coordinated response that provides,
to the extent practicable, information and, when
appropriate, informal guidance regarding the process
that the developers must follow for Federal regulatory
review; and
(e) within 1 year of the date of this order, and
annually thereafter for a period of 3 years, provide an
update regarding progress in implementing this section
to the Director of OMB, the United States Trade
Representative (USTR), the APNSA, the ADPD, and the
Director of OSTP. Each 1-year update shall identify any
gaps in statutory authority that should be addressed to
improve the clarity and efficiency of the regulatory
process for biotechnology products, and shall recommend
additional executive actions and legislative proposals
to achieve such goals.
Sec. 9. Reducing Risk by Advancing Biosafety and
Biosecurity. (a) The United States Government shall
launch a Biosafety and Biosecurity Innovation
Initiative, which shall seek to reduce biological risks
associated with
[[Page 56856]]
advances in biotechnology, biomanufacturing, and the
bioeconomy. Through the Biosafety and Biosecurity
Innovation Initiative--which shall be established by
the Secretary of HHS, in coordination with the heads of
other relevant agencies as determined by the
Secretary--agencies that fund, conduct, or sponsor life
sciences research shall implement the following
actions, as appropriate and consistent with applicable
law:
(i) support, as a priority, investments in applied biosafety research and
innovations in biosecurity to reduce biological risk throughout the
biotechnology R&D and biomanufacturing lifecycles; and
(ii) use Federal investments in biotechnology and biomanufacturing to
incentivize and enhance biosafety and biosecurity practices and best
practices throughout the United States and international research
enterprises.
(b) Within 180 days of the date of this order, the
Secretary of HHS and the Secretary of Homeland
Security, in coordination with agencies that fund,
conduct, or sponsor life sciences research, shall
produce a plan for biosafety and biosecurity for the
bioeconomy, including recommendations to:
(i) enhance applied biosafety research and bolster innovations in
biosecurity to reduce risk throughout the biotechnology R&D and
biomanufacturing lifecycles; and
(ii) use Federal investments in biological sciences, biotechnology, and
biomanufacturing to enhance biosafety and biosecurity best practices
throughout the bioeconomy R&D enterprise.
(c) Within 1 year of the date of this order,
agencies that fund, conduct, or sponsor life sciences
research shall report to the APNSA, through the
Assistant to the President and Homeland Security
Advisor, on efforts to achieve the objectives described
in subsection (a) of this section.
Sec. 10. Measuring the Bioeconomy. (a) Within 90 days
of the date of this order, the Secretary of Commerce,
through the Director of NIST, shall, in consultation
with other agencies as determined by the Director,
industry, and other stakeholders, as appropriate,
create and make publicly available a lexicon for the
bioeconomy, with consideration of relevant domestic and
international definitions and with the goal of
assisting in the development of measurements and
measurement methods for the bioeconomy that support
uses such as economic measurement, risk assessments,
and the application of machine learning and other
artificial intelligence tools.
(b) The Chief Statistician of the United States, in
coordination with the Secretary of Agriculture, the
Secretary of Commerce, the Director of NSF, and the
heads of other appropriate agencies as determined by
the Chief Statistician, shall improve and enhance
Federal statistical data collection designed to
characterize the economic value of the United States
bioeconomy, with a focus on the contribution of
biotechnology to the bioeconomy. This effort shall
include:
(i) within 180 days of the date of this order, assessing, through the
Department of Commerce's Bureau of Economic Analysis, the feasibility,
scope, and costs of developing a national measurement of the economic
contributions of the bioeconomy, and, in particular, the contributions of
biotechnology to the bioeconomy, including recommendations and a plan for
next steps regarding whether development of such a measurement should be
pursued; and
(ii) within 120 days of the date of this order, establishing an Interagency
Technical Working Group (ITWG), chaired by the Chief Statistician of the
United States, which shall include representatives of the Department of
Agriculture, the Department of Commerce, OSTP, the NSF, and other
appropriate agencies as determined by the Chief Statistician of the United
States.
(A) Within 1 year of the date of this order, the ITWG shall recommend
bioeconomy-related revisions to the North American Industry Classification
System (NAICS) and the North American Product Classification System
[[Page 56857]]
(NAPCS) to the Economic Classification Policy Committee. In 2026, the ITWG
shall initiate a review process of the 2023 recommendations and update the
recommendations, as appropriate, to provide input to the 2027 NAICS and
NAPCS revision processes.
(B) Within 18 months of the date of this order, the ITWG shall provide a
report to the Chief Statistician of the United States describing the
Federal statistical collections of information that take advantage of
bioeconomy-related NAICS and NAPCS codes, and shall include recommendations
to implement any bioeconomy-related changes as part of the 2022 revisions
of the NAICS and NAPCS. As part of its work, the ITWG shall consult with
external stakeholders.
Sec. 11. Assessing Threats to the United States
Bioeconomy. (a) The Director of National Intelligence
(DNI) shall lead a comprehensive interagency assessment
of ongoing, emerging, and future threats to United
States national security from foreign adversaries
against the bioeconomy and from foreign adversary
development and application of biotechnology and
biomanufacturing, including acquisition of United
States capabilities, technologies, and biological data.
As part of this effort, the DNI shall work closely with
the Department of Defense to assess technical
applications of biotechnology and biomanufacturing that
could be misused by a foreign adversary for military
purposes or that could otherwise pose a risk to the
United States. In support of these objectives, the DNI
shall identify elements of the bioeconomy of highest
concern and establish processes to support ongoing
threat identification and impact assessments.
(b) Within 240 days of the date of this order, the
DNI shall provide classified assessments to the APNSA
related to:
(i) threats to United States national and economic security posed by
foreign adversary development and application of biomanufacturing; and
(ii) foreign adversary means of, and intended usages related to,
acquisition of United States biotechnologies, biological data, and
proprietary or precompetitive information.
(c) Within 120 days of receiving the DNI's
assessments, the APNSA shall coordinate with the heads
of relevant agencies as determined through the NSM-2
process to develop and finalize a plan to mitigate
risks to the United States bioeconomy, based upon the
threat identification and impact assessments described
in subsection (a) of this section, the vulnerability
assessments described in section 5(d) of this order,
and other relevant assessments or information. The plan
shall identify where executive action, regulatory
action, technology protection, or statutory authorities
are needed to mitigate these risks in order to support
the technology leadership and economic competitiveness
of the United States bioeconomy.
(d) The United States Government contracts with a
variety of providers to support its functioning,
including by contracting for services related to the
bioeconomy. It is important that these contracts are
awarded according to full and open competition, as
consistent with the Competition in Contracting Act of
1984 (Public Law 98-369, 98 Stat. 1175). In accordance
with these objectives, and within 1 year of the date of
this order, the Director of OSTP, in coordination with
the Secretary of Defense, the Attorney General, the
Secretary of HHS, the Secretary of Energy, the
Secretary of Homeland Security, the DNI, the
Administrator of NASA, and the Administrator of General
Services, shall review the national security
implications of existing requirements related to
Federal procurement--including requirements contained
in the Federal Acquisition Regulation (FAR) and the
Defense Federal Acquisition Regulation Supplement--and
shall recommend updates to those requirements to the
FAR Council, the Director of OMB, and the heads of
other appropriate agencies as determined through the
NSM-2 process. The recommendations shall aim to
standardize pre-award data collection to enable due
diligence review of conflict of interest; conflict of
commitment; foreign ownership, control, or influence;
or other potential national security
[[Page 56858]]
concerns. The recommendations shall also include
legislative proposals, as relevant.
(e) The Director of OMB shall issue a management
memorandum to agencies, or take other appropriate
action, to provide generalized guidance based on the
recommendations received pursuant to subsection (d) of
this section.
Sec. 12. International Engagement. (a) The Department
of State and other agencies that engage with
international partners as part of their missions shall
undertake the following actions with foreign partners,
as appropriate and consistent with applicable law--with
a specific focus on developing countries, international
organizations, and nongovernmental entities--to promote
and protect both the United States and global
bioeconomies:
(i) enhance cooperation, including joint research projects and expert
exchanges, on biotechnology R&D, especially in genomics;
(ii) encourage regulatory cooperation and the adoption of best practices to
evaluate and promote innovative products, with an emphasis on those
practices and products that support sustainability and climate objectives;
(iii) develop joint training arrangements and initiatives to support
bioeconomy jobs in the United States;
(iv) work to promote the open sharing of scientific data, including genetic
sequence data, to the greatest extent possible in accordance with
applicable law and policy, while seeking to ensure that any applicable
access and benefit-sharing mechanisms do not hinder the rapid and
sustainable development of innovative products and biotechnologies;
(v) conduct horizon scanning to anticipate threats to the global
bioeconomy, including national security threats from foreign adversaries
acquiring sensitive technologies or data, or disrupting essential bio-
related supply chains, and to identify opportunities to address those
threats;
(vi) engage allies and partners to address shared national security
threats;
(vii) develop, and work to promote and implement, biosafety and biosecurity
best practices, tools, and resources bilaterally and multilaterally to
facilitate appropriate oversight for life sciences, dual-use research of
concern, and research involving potentially pandemic and other high-
consequence pathogens, and to enhance sound risk management of
biotechnology- and biomanufacturing-related R&D globally; and
(viii) explore how to align international classifications of
biomanufactured products, as appropriate, to measure the value of those
products to both the United States and global bioeconomies.
(b) Within 180 days of the date of this order, the
Secretary of State, in coordination with the USTR and
the heads of other agencies as determined by the
Secretary, as appropriate, shall submit to the APNSA a
plan to support the objectives described in subsection
(a) of this section with foreign partners,
international organizations, and nongovernmental
entities.
Sec. 13. Definitions. For purposes of this order:
(a) The term ``agency'' has the meaning given that
term by 44 U.S.C. 3502(1).
(b) The term ``biotechnology'' means technology
that applies to or is enabled by life sciences
innovation or product development.
(c) The term ``biomanufacturing'' means the use of
biological systems to develop products, tools, and
processes at commercial scale.
(d) The term ``bioeconomy'' means economic activity
derived from the life sciences, particularly in the
areas of biotechnology and biomanufacturing, and
includes industries, products, services, and the
workforce.
(e) The term ``biological data'' means the
information, including associated descriptors, derived
from the structure, function, or process of a
biological system(s) that is measured, collected, or
aggregated for analysis.
[[Page 56859]]
(f) The term ``biomass'' means any material of
biological origin that is available on a renewable or
recurring basis. Examples of biomass include plants,
trees, algae, and waste material such as crop residue,
wood waste, animal waste and byproducts, food waste,
and yard waste.
(g) The term ``biobased product'' has the meaning
given that term in 7 U.S.C. 8101(4).
(h) The term ``bioenergy'' means energy derived in
whole or in significant part from biomass.
(i) The term ``multiomic information'' refers to
combined information derived from data, analysis, and
interpretation of multiple omics measurement
technologies to identify or analyze the roles,
relationships, and functions of biomolecules (including
nucleic acids, proteins, and metabolites) that make up
a cell or cellular system. Omics are disciplines in
biology that include genomics, transcriptomics,
proteomics, and metabolomics.
(j) The term ``key R&D areas'' includes fundamental
R&D of emerging biotechnologies, including engineering
biology; predictive engineering of complex biological
systems, including the designing, building, testing,
and modeling of entire living cells, cell components,
or cellular systems; quantitative and theory-driven
multi-disciplinary research to maximize convergence
with other enabling technologies; and regulatory
science, including the development of new information,
criteria, tools, models, and approaches to inform and
assist regulatory decision-making. These R&D priorities
should be coupled with advances in predictive modeling,
data analytics, artificial intelligence,
bioinformatics, high-performance and other advanced
computing systems, metrology and data-driven standards,
and other non-life science enabling technologies.
(k) The terms ``equity'' and ``underserved
communities'' have the meanings given those terms by
sections 2(a) and 2(b) of Executive Order 13985.
(l) The term ``Tribal Colleges and Universities''
has the meaning given that term by section 5(e) of
Executive Order 14049 of October 11, 2021 (White House
Initiative on Advancing Educational Equity, Excellence,
and Economic Opportunity for Native Americans and
Strengthening Tribal Colleges and Universities).
(m) The term ``Historically Black Colleges and
Universities'' has the meaning given that term by
section 4(b) of Executive Order 14041 of September 3,
2021 (White House Initiative on Advancing Educational
Equity, Excellence, and Economic Opportunity Through
Historically Black Colleges and Universities).
(n) The term ``minority serving institution'' has
the meaning given that term by 38 U.S.C. 3698(f)(4).
(o) The term ``foreign adversary'' has the meaning
given that term by section 3(b) of Executive Order
14034 of June 9, 2021 (Protecting Americans' Sensitive
Data From Foreign Adversaries).
(p) The term ``life sciences'' means all sciences
that study or use living organisms, viruses, or their
products, including all disciplines of biology and all
applications of the biological sciences (including
biotechnology, genomics, proteomics, bioinformatics,
and pharmaceutical and biomedical research and
techniques), but excluding scientific studies
associated with radioactive materials or toxic
chemicals that are not of biological origin or
synthetic analogues of toxins.
Sec. 14. General Provisions. (a) Nothing in this order
shall be construed to impair or otherwise affect:
(i) the authority granted by law to an executive department or agency, or
the head thereof; or
(ii) the functions of the Director of OMB relating to budgetary,
administrative, or legislative proposals.
[[Page 56860]]
(b) This order shall be implemented consistent with
applicable law and subject to the availability of
appropriations.
(c) This order is not intended to, and does not,
create any right or benefit, substantive or procedural,
enforceable at law or in equity by any party against
the United States, its departments, agencies, or
entities, its officers, employees, or agents, or any
other person.
<GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT>
(Presidential Sig.)
THE WHITE HOUSE,
September 12, 2022.
[FR Doc. 2022-20167
Filed 9-14-22; 11:15 am]
Billing code 3395-F2-P
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</html>Indexed from Federal Register on September 15, 2022.
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