Recommendations

1: Prioritize Biotechnology at the National Level

1.1a: Congress must establish a National Biotechnology Coordination Office (NBCO) in the Executive Office of the President with a director, appointed by the President, who would coordinate interagency actions on biotechnology competition and regulation.

1.2a: Congress should direct each relevant agency to designate a senior official to lead biotechnology policy.

1.3a: Congress should establish the Office of Global Competition Analysis to develop timely data and technology forecasting to inform policymakers’ decisions.

2: Mobilize the Private Sector to Get U.S. Products to Scale

2.1a: Congress must direct federal regulatory agencies to create simple pathways to market and exempt familiar products from unnecessary regulation.

2.1b: Congress should direct federal regulatory agencies to prepare for novel products to come to market.

2.2a: Congress must establish and fund an Independence Investment Fund, led by a non-governmental manager, that would invest in technology startups that strengthen U.S. national and economic security.

2.2b: Congress should direct the Department of Energy and the Department of Health and Human Services to use existing authorities to smooth out unpredictable and inconsistent demand for biotechnology products through advance market commitments (AMCs) and offtake agreements and provide new authorities where necessary.

2.2c: Congress should restore full and immediate expensing of research and development (R&D) expenditures.

2.2d: Congress should improve the effectiveness and reach of the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs to support early-stage innovation.

2.3a: Congress must authorize and fund the Department of Energy and the Department of Commerce to develop a network of manufacturing facilities across the country for precommercial bioindustrial product scale-up.

2.3b: Congress should direct the Department of Commerce to create a public-private biopharmaceutical manufacturing center of excellence focused on developing and scaling new ways to make medicines.

2.4a: Congress must direct the Department of Homeland Security to ensure that biotechnology infrastructure and data are covered under “critical infrastructure.”

2.5a: Congress must require public companies to disclose single points of supply chain vulnerability located in foreign countries of concern.

2.5b: Congress must prohibit companies that work with U.S. national security agencies and the Department of Health and Human Services from using certain Chinese biotechnology suppliers deemed to pose a national security threat.

2.5c: Congress should reform the Committee on Foreign Investment in the United States (CFIUS) to better and more nimbly screen the highest-impact, highest-risk types of investment in critical technology sectors in the United States.

2.5d: Congress should direct the International Trade Commission to investigate Chinese dumping or oversupply of biotechnology products and services.

3: Maximize the Benefits of Biotechnology for Defense

3.1a: Congress must direct the Department of Defense to consult with stakeholders to define principles for ethical use of biotechnology for the U.S. military.

3.2a: Congress must direct the Department of Defense to work with private companies to build commercial facilities across the country to biomanufacture products that are critical for Department of Defense needs.

3.2b: Congress should continue oversight of and support for BioMADE’s efforts to create a network of facilities that precommercial bioindustrial companies across the country can use to meet Department of Defense needs.

3.2c: Congress should require changes to military specifications (MIL-SPECs) to enable biotechnology companies to more easily sell their products to the Department of Defense.

3.2d: Congress should require the Department of Defense to enter into advance market commitments (AMCs) and offtake agreements for biotechnology products that are needed for defense.

3.2e: Congress should require the Department of Defense and other agencies involved in national security to train their workforces to be ready for biotechnology.

3.3a: Congress must require outbound investment rules that ensure U.S. capital does not support Chinese development of certain biotechnologies that could pose a national security risk.

3.3b: Congress should direct the Department of Commerce to consider country-wide export controls blocking the sale of specific, highly sophisticated U.S. biotechnology items to China that would pose a substantial risk to national security if used for military end-uses.

3.3c: Congress should require the Department of Defense to incorporate military-relevant applications of emerging biotechnology into wargaming exercises.

3.3d: Congress should resource the intelligence community to prioritize understanding adversaries’ development of biotechnology and its diverse applications. 

4: Out-innovate Our Strategic Competitors

4.1a: Congress must authorize the Department of Energy to create a Web of Biological Data (WOBD), a single point of entry for researchers to access high-quality data.

4.1b: Congress should authorize the National Institute of Standards and Technology to create standards that researchers must meet to ensure that U.S. biological data is ready for use in AI models.

4.1c: Congress should authorize and fund the Department of Interior to create a Sequencing Public Lands Initiative to collect new data from U.S. public lands that researchers can use to drive innovation.

4.1d: Congress should authorize the National Science Foundation to establish a network of “cloud labs,” giving researchers state-of-the-art tools to make data generation easier.

4.2a: Congress must conduct oversight of existing policies, and add new authorities as warranted, to ensure that China cannot obtain bulk and sensitive biological data from the United States.

4.3a: Congress must establish Centers for Biotechnology within the existing National Laboratory network to support grand research challenges.

4.3b: Congress should initiate a grand research challenge focused on making biotechnology predictably engineerable.

4.3c: Congress should initiate a grand research challenge focused on making biomanufacturing scale-up predictable, rapid, and cost-competitive. 

4.4a: Congress must direct the executive branch to advance safe, secure, and responsible biotechnology research and innovation.

5: Build the Biotechnology Workforce of the Future

5.1a: Congress must direct the Office of Personnel Management to provide workforce training in biotechnology across the interagency.

5.1b: Congress must ensure that federal agencies have the necessary expertise across national security and emerging biotechnology issues.

5.1c: Congress should receive accurate, timely, and nonpartisan scientific and technical counsel.

5.2a: Congress must maximize the impact of biomanufacturing workforce training programs.

5.2b: Congress should expand educational efforts in biotechnology for American students.

5.3a: Congress should authorize new green cards for biotechnology talent, especially from allied and partner countries.

5.3b: Congress should optimize the vetting process for foreign nationals to prevent illicit technology transfer.

6: Mobilize the Collective Strengths of Our Allies and Partners

6.1a: Congress must include biotechnology in the scope of the Department of State’s International Technology Security and Innovation Fund to appropriately fund international biotechnology policy, research and development (R&D), and secure supply chains.

6.1b: Congress should direct the Department of State and other agencies to promote the U.S. biotechnology industry in foreign markets, including through commercial diplomacy.

6.1c: Congress should expand regulatory diplomacy for biotechnology.

6.1d: Congress should require the Department of State to form reciprocal biological data-sharing agreements with other countries.

6.1e: Congress should direct the Department of State and the Department of Defense to encourage North Atlantic Treaty Organization (NATO) countries to aggregate demand and pool purchasing power for biotechnology products.

6.2a: Congress should direct the Department of State, along with the National Institute of Standards and Technology, to support the development of international norms and standards, including defining shared values and interests in biotechnology.

6.2b: Congress should require the Department of State to create a strategy for harmonizing multilateral export controls.