Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy

[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 [www.gpo.gov]

[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

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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.

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.

h

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

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

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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;

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;

lled 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

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)

tor 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.

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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.

nt 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.

imal 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

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

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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.

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.

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:

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

ng 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).

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(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

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

otechnology;

(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:

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

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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.

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).

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.

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

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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.

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;

nology 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

appropriat

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]]

cutive 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:

(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.

ant 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

essing, 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.

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:

f 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.

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

quirements 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:

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

d 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.

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.

easurement

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.

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).

(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.

fect:

(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.

(Presidential Sig.)

THE WHITE HOUSE,

September 12, 2022.

[FR Doc. 2022-20167

Filed 9-14-22; 11:15 am]

Billing code 3395-F2-P