On September 12, 2022, President Biden issued an Executive
Order (“E.O.”) announcing the National Biotechnology and Biomanufacturing
Initiative (1). The White House subsequently announced that the Initiative
would cost $2 billion (2). The objectives outlined by the order include
investing in and promoting biosafety and biosecurity; reducing biological
risks; and ensuring that uses of biotechnology and biomanufacturing are ethical
and responsible. There are ten key policies enacted by the order:
Harnessing Biotechnology and Biomanufacturing
R&D to Further Societal Goals
Assessments required to be submitted within
180 days, after which a 90 day period will commence where the respective
committees will begin coordinating plans:
From the Secretary of Health and Human Services, an assessment of the use
of biotechnology and biomanufacturing to accomplish medical breakthroughs,
reduce overall burdens of disease, and improve health outcomes.
From the Secretary of Energy, an assessment of the use of biotechnology,
biomanufacturing, bioenergy, and biobased products for addressing the causes
of, and adapting to and mitigating the impacts of, climate change.
From the Secretary of Agriculture, an assessment of the use of
biotechnology and biomanufacturing for innovations in food and agriculture;
increased food quality and nutrition; agricultural yields; protection against
plant and animal pests and diseases; and alternative food source cultivation.
From the Secretary of Commerce, an assessment of the use of biotechnology
and biomanufacturing to strengthen U.S. supply chain resilience.
From the Director of the National Science Foundation, an identification
of high-priority fundamental and basic research goals to advance biotechnology
and biomanufacturing as well as the societal goals identified in the E.O
Data for the Bioeconomy Initiative
The goal is to identify data types and
sources most critical for advances in health, climate, energy, food,
agriculture, biomanufacturing, and other bioeconomy-related R&D, as well as
any existing gaps in such data.
Biobased Product Procurement
Procuring agencies have a year to establish a
program for procurement of biobased products, complete related training, and
report within 180 days and annually thereafter information regarding the number
and dollar value of contracts awarded each year that direct procurement of
biobased products, the number of service contracts containing language
regarding biobased products, and the types and dollar value of biobased
products actually used by contractors to perform services contracts.
Biotechnology and Biomanufacturing Workforce
The Secretary of Commerce is directed to work
with other federal officials to develop a plan for relevant Federal education
and training programs within 200 days. The plan must address HBCUs, Tribal
Colleges and Universities, and Minority Serving Institutions, as well as
statutory authorities for promoting racial and gender equity and underserved
Requires the National Science Foundation,
Department of Commerce, Department of Defense, and Department of Energy to
direct resources toward creating and expanding programs that will support the
domestic biomanufacturing ecosystem, consistent with the strategy developed.
The Secretary of Agriculture will submit a
plan to support domestic biomass supply chain resiliency, including programs
that encourage climate-smart production and use of domestic biomass.
The Secretary of Homeland Security will
prepare risk assessments regarding critical infrastructure and national
critical functions relating to the bioeconomy, and enhance coordination with
industry with respect to threat information sharing, vulnerability disclosure,
and risk mitigation.
Biotechnology Regulation Clarity and Efficiency
Within 180 days the FDA must assess gaps,
ambiguities, and uncertainties in existing biotechnology regulatory
requirements, including January 2017 Update to the Coordinated Framework for
the Regulation of Biotechnology (3) or in Executive Order 13874 (Modernizing
the Regulatory Framework for Agricultural Biotechnology Products).
Within 280 days, provide public and
plain-language information relating to regulatory roles,
responsibilities, and processes for each
agency responsible for overseeing products developed using biotechnology and
submit an implementation plan for regulatory reform.
Update the Unified Website for Biotechnology
Regulation (4) to enable developers of biotechnology products to inquire about
particular products and quickly receive a single, coordinated response
providing information and informal guidance regarding the process the
developers must follow for Federal regulatory review.
Biosafety and Biosecurity Innovation Initiative
Requires agencies funding, conducting, or
sponsoring life sciences research to prioritize investments in applied
biosafety research and innovations in biosecurity to reduce biological risk.
Gives agencies time and impetus to develop
a measurement for success and viability of these kind of products and their
related economies and market shares.
Assessing Threats to the U.S. Bioeconomy
Initiates a comprehensive interagency
assessment of ongoing, emerging, and future
threats to U.S. 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.
Agencies must enhance cooperation regarding
biotechnology R&D, especially in genomics, as well as encourage regulatory
cooperation and the adoption of best practices to evaluate and promote
innovative products. The agencies must pursue further collaboration in the form
of joint training arrangements and initiatives to support U.S. bioeconomy jobs
and promote the open sharing of scientific data without inhibiting the rapid
and sustainable development of innovative products and biotechnologies.
Breakdown by Govt Dept:
Department of Health and Human Services will commit $40 million to expand
biomanufacturing for active pharmaceutical ingredients, antibiotics, and
starting materials for essential medications and pandemic response.
Department of Defense is:
a $270 million Tri-Service Biotechnology for a Resilient Supply Chain
$1 billion over five years in bioindustrial domestic manufacturing
an additional $200 million toward enhancing biosecurity and cybersecurity
postures for commercial and defense facilities within the domestic
bioindustrial supply chain.
Department of Agriculture will:
a $500 million grant program to support American fertilizer production
that makes use of biotechnology and biomanufacturing advances;
$68 million for its previously announced Agriculture and Food Research
Department of Energy will:
to leverage sustainable biomass and waste resources to provide domestic
supply chains fuels, chemicals, and materials that collectively will
lower prices to consumers;
$178 million in new awards for biotechnology, bioproducts, and
up to $100 million for R&D efforts to convert biomass to fuels and
$60 million to support scaling up biotechnology and biomanufacturing for
a new $20 million bioassurance program through the National Nuclear
National Science Foundation will:
the E.O.’s requirements through its recently announced Regional
Innovation Engines competition, $125 million (including partner funds)
wood innovation and community grants;
its recently announced competition for a $20 million biosciences data
U.S. Economic Development Administration announced that it will, as part
of its $1 billion Build Back Better Regional Challenge, invest more than
$200 million to bolster America’s bioeconomy, specifically in New
Hampshire, Virginia, North Carolina, Oregon, and Alaska.
National Institutes of Health will:
the I-Corps program, which includes a biotech entrepreneurship bootcamp;
its Cancer Research Data Ecosystem.
Department of Commerce will invest an additional $14 million for
biotechnology research programs to develop measurement technologies,
standards, and data.