On September 12, 2022, President Biden issued an Executive Order (“E.O.”) announcing the National Biotechnology and Biomanufacturing Initiative

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:

1. 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

2. 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.

3. 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.

4. 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 communities.

5. Biomanufacturing Ecosystem

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.

6. 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.

7. 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.

8. Bioeconomy Measurement

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.

9. 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.

10. International Engagement

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:

The 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.
The Department of Defense is:

Launching a $270 million Tri-Service Biotechnology for a Resilient Supply Chain program;
Investing $1 billion over five years in bioindustrial domestic manufacturing infrastructure;
Investing an additional $200 million toward enhancing biosecurity and cybersecurity postures for commercial and defense facilities within the domestic bioindustrial supply chain.

The Department of Agriculture will:

Establish a $500 million grant program to support American fertilizer production that makes use of biotechnology and biomanufacturing advances;
Provide $68 million for its previously announced Agriculture and Food Research Initiative.

The Department of Energy will:

Work to leverage sustainable biomass and waste resources to provide domestic supply chains fuels, chemicals, and materials that collectively will lower prices to consumers;
Announce $178 million in new awards for biotechnology, bioproducts, and biomaterials;
Provide up to $100 million for R&D efforts to convert biomass to fuels and chemicals;
Invest $60 million to support scaling up biotechnology and biomanufacturing for biorefineries;
Establish a new $20 million bioassurance program through the National Nuclear Security Administration.

The National Science Foundation will:

Support the E.O.’s requirements through its recently announced Regional Innovation Engines competition, $125 million (including partner funds) wood innovation and community grants;
Continue its recently announced competition for a $20 million biosciences data center.

The 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.
The National Institutes of Health will:

Expand the I-Corps program, which includes a biotech entrepreneurship bootcamp;
Expand its Cancer Research Data Ecosystem.

The Department of Commerce will invest an additional $14 million for biotechnology research programs to develop measurement technologies, standards, and data.