On September 12, 2022, President Biden issued an Executive Order (“E.O.”) announcing the National Biotechnology and Biomanufacturing Initiative, a “whole-of-government” effort to further biotechnology and biomanufacturing innovations in health, climate change, energy, food security, agriculture, supply chain resilience, and national and economic security. The White House subsequently announced that the Initiative would cost $2 billion. If successful, the Initiative could have sweeping impacts across the entire biotechnology research and development (“R&D”) lifecycle. A summary of the E.O., its requirements, and key takeaways are set forth below.
The E.O. emphasizes that coordination within the Executive Branch and consultation with outside stakeholders will be necessary to achieve the ambitious policy objectives it outlines. In order to achieve the objectives identified, including investing in and promote biosafety and biosecurity; reducing biological risks; and ensuring that uses of biotechnology and biomanufacturing are ethical and responsible, the E.O. identifies ten key policies. Some notable policies include bolstering and coordinating Federal investment in key R&D areas of biotechnology and biomanufacturing; improving and expanding domestic biomanufacturing production capacity and processes; increasing piloting and prototyping efforts in biotechnology and biomanufacturing to accelerate the translation of basic research results into practice; and expanding market opportunities for bioenergy and biobased products and services. This article provides an overview of some of the identified policies most likely to be relevant to government contractors and financial assistance recipients in the biotechnology and biomanufacturing industries.
1. Harnessing Biotechnology and Biomanufacturing R&D to Further Societal Goals
First, to identify high-priority research and technology development needs, opportunities for public-private collaboration, and recommendations to enhance biosafety and biosecurity, the E.O. requires various agency reports to be submitted within 180 days.
- 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.
Within 100 days after the reports’ submission, the Director of the Office of Science and Technology Policy (“OSTP”) must develop an implementation plan for these recommendations. To assist in this effort, within 90 days of the E.O., the Director of the Office of Management and Budget (“OMB Director”) must examine the budget to identify current expenditures for biotechnology- and biomanufacturing-related activities. Within two years, affected agencies must submit reports outlining measures taken and resources dedicated to enhancing biotechnology and biomanufacturing, consistent with the implementation plan. In addition, the E.O. requires a report, within 180 days, regarding the bioeconomy, including recommendations for maintaining domestic competitiveness in the global bioeconomy.
2. Data for the Bioeconomy Initiative
Second, the E.O establishes a Data for the Bioeconomy Initiative (“Data Initiative”) designed to “ensure that high-quality, wide-ranging, easily accessible, and secure biological data sets can drive breakthroughs” for the U.S. bioeconomy. To develop the Data Initiative, the Director of OSTP and OMB Director, in coordination with other relevant agencies, must issue a report within 240 days that:
- Identifies 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.
- Establishes a plan for filling data gaps and leveraging public data by making it findable, accessible, interoperable, and reusable by equitable, standardized, secure, transparent methods that are integrated with platforms that can utilize advanced computing tools.
- Identifies for each data type and source security, privacy, and other risks, and provides a data protection plan for mitigating such risks.
- Outlines legal authorities, Federal resources, and actions necessary for supporting the Data Initiative and achieving its goals.
In conjunction with the Data Initiative, cybersecurity best practices for biological data residing on Federal information systems will be considered, as will be bio-related software (e.g., software for laboratory equipment and instruments) when establishing baseline security standards for developing software sold to the Federal government.
3. Biobased Product Procurement
Third, the E.O. directs procuring agencies that have not already established a program for procurement of biobased products to do so within one year. Procurement officials will have to 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. Procuring agencies also will be required to report annually to the Secretary of Agriculture information regarding biobased products that are not available to meet their needs, including desired characteristics. Agencies are directed to increase their biobased product-only procurements by 2025.
4. Biotechnology and Biomanufacturing Workforce
Fourth, to expand training and education opportunities in biotechnology and biomanufacturing, the E.O. requires the Secretary of Commerce to work with other federal officials to develop a plan for relevant Federal education and training programs within 200 days. The plan must address Historically Black Colleges and Universities, Tribal Colleges and Universities, and Minority Serving Institutions, statutory authorities for promoting racial and gender equity and underserved communities, and funding through Fiscal Year 2023. An additional report is due within two years from agencies supporting relevant Federal education and training programs, and must provide an assessment of the measures taken and resources allocated to biotechnology and biomanufacturing workforce development.
5. Biomanufacturing Ecosystem
Fifth, the E.O. seeks to expand domestic biomanufacturing capacity for products spanning a diverse array of industries by requiring development of a strategy that includes policy recommendations and appropriate supply chain security risk mitigation efforts for doing so, with a focus on improving biomanufacturing processes, connecting infrastructure, and advancing equity. The E.O 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. Additionally, within one year, the Secretary of Agriculture must submit a plan to support domestic biomass supply chain resiliency, including programs that encourage climate-smart production and use of domestic biomass. Finally, within 180 days, the Secretary of Homeland Security must prepare vulnerability 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
Sixth, recognizing the current regulatory system for biotechnology products can be confusing and challenging for businesses to navigate, the E.O. seeks to provide additional clarity and efficiency of the regulatory process for biotechnology products. Specifically, the E.O. calls for the Secretary of Agriculture, EPA Administrator, and FDA Commissioner to:
- Within 180 days, assess gaps, ambiguities, and uncertainties in existing biotechnology regulatory requirements, including January 2017 Update to the Coordinated Framework for the Regulation of Biotechnology or in Executive Order 13874 (Modernizing the Regulatory Framework for Agricultural Biotechnology Products).
- Within 280 days, (1) provide the public plain-language information relating to regulatory roles, responsibilities, and processes for each agency responsible for overseeing products developed using biotechnology and (2) develop and submit an implementation plan for regulatory reform. Within one year, and annually thereafter, provide implementation updates addressing avenues to improve the clarity and efficiency of the biotechnology products regulatory process.
- Within one year, update the Unified Website for Biotechnology Regulation with the plain-language information noted above and 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
Seventh, the E.O. launches a Biosafety and Biosecurity Innovation Initiative, to be helmed by the Secretary of HHS, that requires agencies funding, conducting, or sponsoring life sciences research to prioritize investments in applied biosafety research and innovations in biosecurity to reduce biological risk during the biotechnology R&D and biomanufacturing lifecycles, as well as incentivize and improve biosafety and biosecurity best practices. The E.O. requires the Secretary to report recommendations for accomplishing these objectives within 180 days, and agencies funding, conducting, or sponsoring this research to report on their efforts to accomplish these objectives within one year.
8. Bioeconomy Measurement
Eighth, the E.O. introduces initiatives geared toward establishing a method for defining and measuring the bioeconomy in a way that supports the use of economic measurement, risk assessments, and the application of machine learning and other artificial intelligence tools. These include developing a lexicon that leverages appropriate domestic and international definitions, developing appropriate measurement methodologies, and improving and enhancing Federal statistical data collection intended to characterize the economic value of the domestic bioeconomy, emphasizing biotechnology contributions to the bioeconomy. This also includes, within 180 days, conducting an assessment of the feasibility, scope, and costs of developing such a measurement, and within 120 days, establishing an Interagency Technical Working Group (“ITWG”) responsible for recommending periodic updates to the North American Industry Classification System (“NAICS”) and North American Product Classification System (“NAPCS”) relating to biotechnology. The ITWG also must, within 18 months, submit a report identifying statistical collections of information pertaining to bioeconomy-related NAICS and NAPCS codes, as well as recommendations for implementing changes.
9. Assessing Threats to the U.S. Bioeconomy
Ninth, the E.O. also directs attention to foreign adversaries. In particular, it requires the Director of National Intelligence (“DNI”) to conduct 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. This includes identifying capabilities most likely to have military application and elements of the bioeconomy of highest concern, and establishing processes to support ongoing threat identification and impact assessments. Classified assessments of foreign adversary capabilities and threats are due within 240 days, with a risk mitigation plan due within 120 days thereafter.
The E.O. also calls for a review of procurement-related requirements for national security implications that should be addressed, to include standardizing pre-award data collection to enable due diligence of conflicts of interest and commitment, foreign ownership, control, or influence, or other potential national security concerns.
10. International Engagement
Finally, the E.O. emphasizes international engagement in addition to its primarily domestic focus. It directs the Department of State and other agencies that engage with international counterparts to both protect and promote the domestic and global bioeconomies. For instance, the 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. Consistent with the national security considerations above, the agencies also must anticipate threats to the global bioeconomy and identify opportunities to address those threats, including through engagement with allies and partners to address shared national security threats. The agencies must further risk management efforts, including biosafety and biosecurity best practices, tools, and resources to facilitate appropriate oversight for life sciences, dual-use research of concern, and research involving potentially pandemic and other high-consequence pathogens.
The E.O is expansive in scope, addressing a wide array of industries and issues involving biotechnology and biomanufacturing. At the same time, because the E.O. is largely focused on study and reporting initiatives that various federal agencies must undertake, offers little in the way of substantive developments that immediately affect industry stakeholders. Further developments, including regulatory changes, will depend on the results of such initiatives.
Nevertheless, the E.O. signals the Biden Administration’s focus on bolstering U.S. strength in the biotechnology sector, while reducing reliance on foreign sources. Indeed, it lays the groundwork for significant expansion and enhancement of capabilities within the domestic life sciences and other industries that use biotechnology. For example, the Data Initiative will provide industry with enhanced access to significant data that will support R&D efforts, particularly where such data sets can be combined with artificial intelligence capabilities. The regulatory streamlining efforts will, in theory, increase transparency surrounding the regulatory approval process and decrease time to market, and the workforce development initiatives could foster the development of a diverse, more capable workforce at all levels. Increased preferences for biobased products represent additional collaboration and procurement opportunities with the federal government.
Notably, the White House’s announcement following the E.O. outlined a number of specific initiatives implicated by the E.O. that agencies already are undertaking, or will commence, in furtherance of the Biden Administration’s objectives, namely:
- 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; and
- 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; and
- 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; and
- 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; and
- 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; and
- 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.
At the same time, the E.O. could result in more stringent regulatory requirements, particularly where necessary to address national security concerns and manufacturing risks. What is clear is that this is an area poised for significant future focus and expansion, and stakeholders across numerous industries, including healthcare, climate, agriculture, food, energy, and others would be well advised to keep abreast of developments and seek to provide input when opportunities to do so arise.