White House Initiative to Advance the Bioeconomy, E.O. 14081: In Brief
White House Initiative to Advance the
Bioeconomy, E.O. 14081: In Brief
October 5, 2022
Congressional Research Service
https://crsreports.congress.gov
R47274
White House Initiative to Advance the Bioeconomy, E.O. 14081: In Brief
Introduction1
The bioeconomy is the portion of the economy based on products, services, and processes derived
from biological resources (e.g., plants and microorganisms). According to the McKinsey Global
Institute, “as much as 60 percent of the physical inputs to the global economy could, in principle,
be produced biologically.”2
Many experts view growing the bioeconomy as a means to address societal challenges such as
climate change, food security, energy independence, and environmental sustainability. Potential
benefits of growing the bioeconomy include
substituting renewable biomass or bio-based raw materials for fossil fuels in the
production of energy, chemicals, and materials;
increasing crop and livestock production;
increasing efficiency in the use of biomass and reducing waste;
developing new drugs and diagnostics to improve human health;
creating new jobs and industries; and
boosting rural development.
According to the Organization for Economic Cooperation and Development (OECD), however,
these potential benefits “will not become reality without attentive and active support from
governments and the public at large.”3 Potential challenges associated with advancing the
bioeconomy and successfully developing and commercializing bioeconomy-related products and
services include
the need for policy coherence amongst the array of sectors involved;
the rigidity of existing production systems;
land use change and feedstock availability;
equitable access to bioeconomy-related products and services; and
consumer acceptance and demand.
On September 12, 2022, President Biden issued Executive Order 14081, “Advancing
Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American
Bioeconomy.”4 According to the White House, “global industry is on the cusp of an industrial
revolution powered by biotechnology. Other countries are positioning themselves to become the
world’s resource for biotechnology solutions and products.”5
1 For more information on the bioeconomy see, CRS Report R46881, The Bioeconomy: A Primer, by Marcy E. Gallo.
2 Michael Chui, Matthias Evers, and James Manyika, et al., The Bio Revolution: Innovations Transforming Economies,
Societies, and Our Lives, McKinsey Global Institute, May 2020, p. vi.
3 Organization for Economic Cooperation and Development, The Bioeconomy to 2030: Designing a Policy Agenda,
OECD Publishing, Paris, 2009, p. 3.
4 Executive Order 14801, “Advancing Biotechnology and Biomanufacturing Innovation,” vol. 87, no. 178 Federal
Register 56849-56860, September 15, 2022.
5 White House, “FACT SHEET: President Biden to Launch a National Biotechnology and Biomanufacturing
Initiative,” press release, September 12, 2022, https://www.whitehouse.gov/briefing-room/statements-releases/2022/09/
12/fact-sheet-president-biden-to-launch-a-national-biotechnology-and-biomanufacturing-initiative/.
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White House Initiative to Advance the Bioeconomy, E.O. 14081: In Brief
While the United States is currently the leader in biotechnology, U.S. competitiveness and
leadership in the future global bioeconomy is uncertain.6 To address this concern, the National
Academies of Sciences, Engineering, and Medicine (NASEM) recommended that the federal
government develop and regularly update a comprehensive bioeconomy strategy to sustain and
grow the U.S. bioeconomy.7 Congress may consider oversight associated with the
Administration’s bioeconomy efforts, including whether the strategy and other activities called
for by the executive order are sufficient or if there is a need to reorganize federal activities under
a bioeconomy framework. Congress may consider whether to pursue bioeconomy-related policies
through new or existing sector-specific focused efforts, or it may evaluate whether current
policies and activities are sufficient.
This report provides an overview of the executive order, details supporting federal investments
announced by the Administration, and offers some policy considerations for Congress regarding
implementation of the executive order. For a broader discussion of the bioeconomy and synthetic
biology/engineering biology see, CRS Report R46881, The Bioeconomy: A Primer, and CRS
Report R47265, Synthetic/Engineering Biology: Issues for Congress.
Executive Order 14081
Executive Order 14081 prescribes 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.”8
The stated goals and objectives of the executive order are 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;
6 John Dileo, Kunal Rambhia, and Matt Downs, et al., Maintaining U.S. Leadership in Advanced Biotechnology and
Growing the Bioeconomy, MITRE Center for Data-Driven Policy, April 2022, p. 3, https://www.mitre.org/sites/default/
files/2022-05/pr-22-00151-01-maintaining-us-leadership-in-advanced-biotechnology-growing-the-bioeconomy.pdf.
7 National Academies of Sciences, Engineering, and Medicine, Safeguarding the Bioeconomy, The National Academies
Press, Washington, DC, 2020, https://doi.org/10.17226/25525.
8 Executive Order 14801, “Advancing Biotechnology and Biomanufacturing Innovation,” vol. 87, no. 178 Federal
Register 56849-56860, September 15, 2022.
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(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.9
The Assistant to the President for National Security Affairs, in consultation with the Assistant to
the President for Economic Policy and the Director of the Office of Science and Technology
Policy (OSTP), is tasked with coordinating the overall effort, which is referred to as the National
Biotechnology and Biomanufacturing Initiative.
The executive order requires a number of actions over the near and mid-term (see Table 1). Some
of the prescribed actions seem consistent with Title IV of Division B of P.L. 117-167 (commonly
known as the CHIPS and Science Act), which directs the President, through OSTP, to implement
a National Engineering Biology Research and Development Initiative to “advance societal well-
being, national security, sustainability, and economic productivity and competiveness” (Section
10402). The statutory goals of the National Engineering Biology Research and Development
Initiative include advancing research and biomanufacturing in engineering biology, including
through the support of social, behavioral, economic, and risk research; accelerating the translation
and commercialization of such research; and improving interagency planning and coordination of
research programs.
Table 1. E.O. 14081 Deliverables and Deadlines
E.O. Section
Deliverable
Deadline
Sec. 3. Harnessing
Requires each of the Secretaries of Health and Human
March 11, 2023
Biotechnology and
Services (HHS), Energy, Agriculture, and Commerce, and the
Biomanufacturing R&D to
Director of the National Science Foundation (NSF) to submit
Further Societal Goals
a report to the President that identifies high-priority basic
research and technology development needs to advance
biotechnology and biomanufacturing and provides
recommendations for actions to enhance biosafety and
biosecurity to reduce risk throughout the biotechnology R&D
and biomanufacturing lifecycles.
9 E.O. 14801.
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White House Initiative to Advance the Bioeconomy, E.O. 14081: In Brief
E.O. Section
Deliverable
Deadline
Requires the Director of the Office of Science and
June 19, 2023
Technology Policy (OSTP), in coordination with the Director
of the Office of Management and Budget (OMB), the
Assistant to the President for National Security Affairs
(APNSA), the Assistant to the President for Economic Policy
(APEP), the Assistant to the President for Domestic Policy
(APDP), and the heads of appropriate agencies, to develop a
plan that implements the recommendations of the agency
reports described above.
Requires the OMB Director, in consultation with the heads of December 11,
appropriate agencies, to perform a budget crosscut to identify 2022
existing levels of agency spending on biotechnology- and
biomanufacturing-related activities to inform the development
of the implementation plan described above.
Requires agencies included in the implementation plan
September 12,
described above to report to the OMB Director, the APNSA, 2024
the APEP, the APDP, and the OSTP Director on measures
taken and resources allocated to enhance biotechnology and
biomanufacturing, consistent with the plan.
Requires the President’s Council of Advisors on Science and
March 11, 2023
Technology to submit a report to the President that provides
recommendations on how to maintain United States
competitiveness in the global bioeconomy.
Sec. 4. Data for the
Requires the OSTP Director, in coordination with the OMB
May 10, 2023
Bioeconomy
Director and the heads of appropriate agencies, and in
consultation with external stakeholders, to issue a report that
(1) identifies the data types and sources 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; (2) sets forth a plan to fil any
data gaps and make new and existing public data findable,
accessible, interoperable, and reusable in ways that are
equitable, standardized, secure, and transparent; (3) identifies
security, privacy, and other risks and provides a data-
protection plan to mitigate such risks; and (4) outlines federal
resources, legal authorities, and actions needed to support
the Data Initiative required by the E.O.
Sec. 5. Building a Vibrant
Requires the APNSA and the APEP, in coordination with the
March 11, 2023
Biomanufacturing Ecosystem
Secretaries of Defense, Agriculture, Commerce, HHS, and
Energy, and the NSF Director and the Administrator of the
National Aeronautics and Space Administration (NASA), to
develop a strategy that identifies (1) 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; (2) actions to mitigate risks posed by foreign
adversary involvement in the biomanufacturing supply chain;
and (3) actions to enhance biosafety, biosecurity, and
cybersecurity in new and existing infrastructure.
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White House Initiative to Advance the Bioeconomy, E.O. 14081: In Brief
E.O. Section
Deliverable
Deadline
Requires the Secretary of Agriculture, in consultation with
September 12,
the heads of appropriate agencies, to submit a plan to the
2023
President to support the resilience of the United States
biomass supply chain for domestic biomanufacturing and bio-
based product manufacturing, while also advancing food
security, environmental sustainability, and the needs of
underserved communities.
Requires the Secretary of Homeland Security, in coordination
March 11, 2023
with the heads of appropriate agencies, to provide the
APNSA with vulnerability assessments of the critical
infrastructure and national critical functions associated with
the bioeconomy and enhance coordination with industry on
threat information sharing, vulnerability disclosure, and risk
mitigation for cybersecurity and infrastructure risks to the
United States bioeconomy.
Sec. 6. Bio-Based Products
Requires any federal agency that is using federal funds for
September 12,
Procurement
procurement that has not yet established a bio-based
2023
procurement program as required by 7 U.S.C. §8102 to do
so.
Requires all appropriate staff of procuring agencies, including
September 12,
contracting officers, purchase card managers, and purchase
2024
card holders to complete training on bio-based product
purchasing.
Requires procuring agencies to report specified data on the
March 11, 2023
procurement of bio-based products (i.e., number and dol ar
and annually
value of contracts) to the OMB Director.
thereafter
Requires the OMB Director to publish bio-based
September 12,
procurement information and to issue scorecards to
2023 and
encourage increased bio-based purchasing.
annually
thereafter
Requires procuring agencies to report to the Secretary of
September 12,
Agriculture specific categories of bio-based products that are
2023 and
unavailable to meet their procurement needs. Requires the
annually
Secretary of Agriculture to publish such information.
thereafter
Sec. 7. Biotechnology and
Requires the Secretaries of Commerce, Labor, and Education, March 31, 2023
Biomanufacturing Workforce the APDP, the OSTP Director, and the NSF Director to
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.
Requires federal agencies that support relevant federal
September 12,
education and training programs identified in the plan
2024
described above to report to the President on measures
taken and resources allocated pursuant to the plan.
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E.O. Section
Deliverable
Deadline
Sec. 8. Biotechnology
Requires the Secretary of Agriculture, the Administrator of
March 11, 2023
Regulation Clarity and
the Environmental Protection Agency (EPA), and the
Efficiency
Commissioner of Food and Drugs (FDA), in coordination
with the OMB Director, the ADPD, and the OSTP Director,
to identify areas of ambiguity, gaps, or uncertainties in the
January 2017 Update to the Coordinated Framework for the
Regulation of Biotechnologya or in the policy changes made
pursuant to Executive Order 13874,b including by engaging
with developers and external stakeholders, and through
horizon scanning for novel products of biotechnology.
Requires the Secretary of Agriculture, the EPA Administrator, June 19, 2023
and the FDA Commissioner to provide to the general public
plain-language information regarding the regulatory roles,
responsibilities, and processes of each agency.
Requires the Secretary of Agriculture, the EPA Administrator, June 19, 2023
and the FDA Commissioner to provide a plan to the OMB
Director, the ADPD, and the OSTP Director with processes
and timelines to implement regulatory reform.
Requires the Secretary of Agriculture, the EPA Administrator, September 12,
and the FDA Commissioner to build on the Unified Website
2023
for Biotechnology Regulationc developed pursuant to
Executive Order 13874 by including on the website the
required plain-language information described above.
Requires the Secretary of Agriculture, the EPA Administrator, September 12,
and the FDA Commissioner to provide an update regarding
2023 and
progress in implementing this section to the OMB Director
annually
of OMB, the United States Trade Representative (USTR), the
thereafter for a
APNSA, the ADPD, and the OSTP Director.
period of 3
years
Sec. 9. Reducing Risk by
Requires the Secretaries of HHS and Homeland Security, in
March 11, 2023
Advancing Biosafety and
coordination with agencies that fund, conduct, or sponsor life
Biosecurity
sciences research, to produce a plan for biosafety and
biosecurity for the bioeconomy.
Requires agencies that fund, conduct, or sponsor life sciences
September 12,
research to report to the APNSA on efforts to achieve the
2023
objectives of the Biosafety and Biosecurity Innovation
Initiative required by the E.O.
Sec. 10. Measuring the
Requires the Director of the National Institute of Standards
December 11,
Bioeconomy
and Technology, in consultation with other agencies and
2022
stakeholders, to create and make publicly available a lexicon
for the bioeconomy.
Requires the Bureau of Economic Analysis (in the
March 11, 2023
Department of Commerce) to assess the feasibility, scope,
and costs of developing a national measurement of the
economic contributions of the bioeconomy.
Requires the establishment of an interagency technical
January 10, 2023
working group (ITWG) chaired by the Chief Statistician of
the United States to improve and enhance federal statistical
data col ection designed to characterize the economic value
of the United States bioeconomy.
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White House Initiative to Advance the Bioeconomy, E.O. 14081: In Brief
E.O. Section
Deliverable
Deadline
Requires the ITWG to recommend bioeconomy-related
September 12,
revisions to the North American Industry Classification
2023
System (NAICS) and the North American Product
Classification System (NAPCS) to the Economic Classification
Policy Committee.
Requires the ITWG to provide a report to the Chief
March 12, 2024
Statistician of the United States describing the federal
statistical col ections of information that take advantage of
bioeconomy-related NAICS and NAPCS codes, and
recommending the implementation of any bioeconomy-
related changes as part of the 2022 revisions of the NAICS
and NAPCS.
Sec. 11. Assessing Threats to
Requires the Director of National Intelligence (DNI) to
May 10, 2023
the United States
provide the APNSA with classified assessments on the threats
Bioeconomy
to U.S. national and economic security posed by foreign
adversary development and application of biomanufacturing;
and on foreign adversary means of, and intended usages
related to, acquisition of U.S. biotechnologies, biological data,
and proprietary or precompetitive information.
Requires the APNSA, in coordination with heads of relevant
September 7,
agencies, to develop and finalize a plan to mitigate risk to the
2023
U.S. bioeconomy.
Requires the OSTP Director, in coordination with the
September 12,
Secretary of Defense, the Attorney General, the Secretaries
2023
of HHS, Energy, and Homeland Security, the DNI, the NASA
Administrator, and the Administrator of General Services, to
review the national security implications of existing
requirements related to federal procurement and
recommend updates to those requirements. The aim of the
required recommendations is to standardize pre-award data
col ection to enable due diligence review of conflict of
interest; conflict of commitment; foreign ownership, control,
or influence; or other potential national security concerns.
Sec. 12. International
Requires the Secretary of State, in coordination with the
March 11, 2023
Engagement
USTR and the heads of other relevant agencies, to submit a
plan to the APNSA to promote and protect the U.S. and
global bioeconomy.
Source: Executive Order 14801, “Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable,
Safe, and Secure American Bioeconomy,” vol. 87, no. 178 Federal Register 56849-56860, September 15, 2022.
Notes: E.O. 14801 requires a number of actions without a defined deliverable or deadline. For example, the
Secretary of Homeland Security, in coordination with the Secretaries of Defense, Agriculture, Commerce, HHS,
and Energy, and the OMB Director, is required to identify and recommend relevant cybersecurity best practices
for biological data stored on federal government information systems. Actions without deliverables or defined
deadlines are not listed in the table.
a. The 2017 Update to the Coordinated Framework for the Regulation of Biotechnology is available at
https://www.epa.gov/sites/default/files/2017-01/documents/2017_coordinated_framework_update.pdf.
b. Executive Order 13874 is available at https://www.govinfo.gov/content/pkg/DCPD-201900384/pdf/DCPD-
201900384.pdf.
c. The Unified Website for Biotechnology Regulation is available at
https://usbiotechnologyregulation.mrp.usda.gov/biotechnologygov/home/.
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Federal Investments Associated with E.O. 14801
On September 14, 2022, the White House hosted a summit led by the National Security Advisor,
Jake Sullivan; the Director of the National Economic Council, Brian Deese; and the acting OSTP
Director, Alondra Nelson, to announce federal agency investments and actions in support of the
National Biotechnology and Biomanufacturing Initiative created by E.O. 14801. According to the
White House, the more than $2 billion in funding for the Initiative will “lower prices, create good
jobs, strengthen supply chains, improve health outcomes, and reduce carbon emissions.”10 The
federal funding highlighted at the summit included previously announced and future investments
in support of the initiative.11
Previously announced investments include:12
$500 million from the U.S. Department of Agriculture (USDA) to support
independent, innovative, and sustainable American fertilizer production;
$32 million from USDA for wood innovation and community wood grants;
$178 million from the Department of Energy (DOE) to advance innovative
research efforts in biotechnology, bioproducts, and biomaterials;
$68 million from USDA to train the next generation of research and education
professionals; and
$200 million from the U.S. Economic Development Administration’s Build Back
Better Regional Challenge for bioeconomy investments in New Hampshire,
Virginia, North Carolina, Oregon, and Alaska.13
Future investments are planned to include:
$40 million from the Department of Health and Human Services (HHS) to
expand biomanufacturing of active pharmaceutical ingredients, antibiotics, and
key starting materials to produce essential medications;
$270 million from the Department of Defense (DOD) over five years for the Tri-
Service Biotechnology for a Resilient Supply Chain program;
$1 billion from DOD over five years to catalyze the establishment of a domestic
biomanufacturing industrial base;
$200 million from DOD to support biosecurity- and cybersecurity-related efforts
associated with the biomanufacturing industrial base;
Up to $100 million from DOE for R&D on conversion of biomass to fuels and
chemicals;
10 White House, “FACT SHEET: The United States Announces New Investments and Resources to Advance President
Biden’s National Biotechnology and Biomanufacturing Initiative,” press release, September 14, 2022,
https://www.whitehouse.gov/briefing-room/statements-releases/2022/09/14/fact-sheet-the-united-states-announces-
new-investments-and-resources-to-advance-president-bidens-national-biotechnology-and-biomanufacturing-initiative/.
11 The White House Summit highlighted some agency actions and activities without mentioning federal funds
associated with such activities.
12 Only federal activities with an identified dollar amount are included.
13 White House, “FACT SHEET: The United States Announces New Investments and Resources to Advance President
Biden’s National Biotechnology and Biomanufacturing Initiative,” press release, September 14, 2022,
https://www.whitehouse.gov/briefing-room/statements-releases/2022/09/14/fact-sheet-the-united-states-announces-
new-investments-and-resources-to-advance-president-bidens-national-biotechnology-and-biomanufacturing-initiative/.
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$60 million from DOE to de-risk and scale up biotechnology products and
biomanufacturing and support the commercialization of biorefineries;
$10 million from USDA for the Bio-product Pilot Program which seeks to
support scale up activities and studies on the benefits of bio-based products;
$14 million from the National Institute of Standards and Technology for R&D to
develop measurement technologies, standards, and data for the U.S. bioeconomy;
$20 million from DOE’s National Nuclear Security Administration for a
bioassurance program to advance U.S. capabilities to anticipate, assess, detect,
and mitigate biological threats; and
$20 million from the National Science Foundation (NSF) for a biosciences data
center to increase understanding of living systems at small scales.14
The executive order requires federal agencies and offices within the Executive Office of the
President to complete analyses that may, in part, identify current and future investment needs (see
Table 1). For example, the Secretaries of HHS, DOE, USDA, and Commerce, and the NSF
Director are required to submit a report to the President that identifies high-priority basic research
and technology development needs to advance biotechnology and biomanufacturing. Federal
agencies are also required to recommend actions that would enhance biosafety and biosecurity
and reduce risks throughout the biotechnology R&D and biomanufacturing lifecycles. In addition,
the OMB Director, in consultation with the heads of appropriate agencies, is tasked with
performing 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 the executive order.
These and other deliverables set forth in Table 1 may impact future agency budget requests and
appropriations. The totality of future investments associated with E.O. 14081 could be subject to
additional analysis once budget requests are submitted and appropriations are enacted.
Policy Considerations
The crosscutting nature of the bioeconomy poses potential challenges to effective policymaking,
including the harmonization of policies and coherent governance. While the National
Biotechnology and Biomanufacturing Initiative created by E.O. 14081 would appear to respond
to calls for a comprehensive strategy for advancing the U.S. bioeconomy, Congress may consider
several questions regarding implementation of the executive order:
Given the potential benefits of advancing the U.S. bioeconomy, should aspects of
the executive order be codified?
The executive order requires the development of a budget crosscut “to identify
existing levels of agency spending on biotechnology- and biomanufacturing-
related activities to inform the development of the implementation plan.” What is
the appropriate level of funding to support and advance the U.S. bioeconomy?
Does the executive order sufficiently address the R&D coordination and other
activities required by Title IV of Division B of P.L. 117-167, the CHIPS and
Science Act?
14 Ibid.
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How do the activities of the executive order align with existing laws and
policies? Is there a duplication of efforts? Can existing laws and policies be
leveraged in support of the bioeconomy? If so, how?
Many of the stated goals of the executive order (e.g., “developing innovative
solutions in health, climate change, energy”) align with the expertise and
regulatory authority of the Environmental Protection Agency (EPA). EPA is
mentioned in a portion of the executive order focused on clarifying the regulation
of biotechnologies. What role, if any, should EPA’s Office of Research and
Development have in the R&D activities of the executive order, including
biosafety and biosecurity research?
The executive order requires the Secretaries of HHS and Homeland Security, in
coordination with agencies that fund, conduct, or sponsor life sciences research,
to produce a plan for biosafety and biosecurity for the bioeconomy. How will
“biosafety and biosecurity” be defined? How will the scope of the definition
impact which federal agencies are involved in developing the required plan?
What gaps exist in biosafety and biosecurity R&D? To what extent, if any, will
impacts to the environment, including ecosystem services, and their subsequent
impact on human health, be considered? Should outside experts be engaged in
developing the biosafety and biosecurity plan? If so, how?
The executive order requires the USDA Secretary, the EPA Administrator, and the
FDA Commissioner to identify “areas of ambiguity” within the regulatory
framework for biotechnology products and to provide updates over the next four
years on any gaps in statutory authority that should be addressed to improve the
clarity and efficiency of regulating such products. Beyond potential statutory
changes, what, if any, mechanisms should be put in place to streamline and
clarify the regulation of future biotechnology products? Should a regulatory
review and assessment occur periodically beyond the four-year period required
by the executive order? Should outside experts or stakeholders be engaged in
these periodic reviews? If so, how?
According to NASEM, science education is crucial for the future workforce and
the pursuit of living-wage jobs but “is not the national priority it needs to be.”15
The executive order appears to focus its efforts on expanding biotechnology and
biomanufacturing training and education within higher education. What changes,
if any, are needed to improve K-12 science education to prepare students for the
biotechnology and biomanufacturing workforce?
Author Information
Marcy E. Gallo
Todd Kuiken
Analyst in Science and Technology Policy
Analyst in Science and Technology Policy
15 National Academies of Sciences, Engineering, and Medicine, Call to Action for Science Education: Building
Opportunity for the Future, The National Academies Press, Washington, DC, 2021, https://doi.org/10.17226/26152.
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