Preface
Recommendations
Preface
Recommendations
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Executive Branch
Executive Office of the President
Congress must establish a National Biotechnology Coordination Office (NBCO) in the Executive Office of the President (EOP) with a Director, appointed by the President, who will coordinate interagency actions on biotechnology competition and regulation.*
Congress should direct each relevant agency (including the Office of the United States Trade Representative) to designate a senior official to lead biotechnology policy.*
Congress should establish the Office of Global Competition Analysis to develop timely data and technology forecasting to inform policymakers’ decisions.
Congress must direct federal regulatory agencies (including through the Executive Office of the President) to create simple pathways to market and exempt familiar products from unnecessary regulation.*
Congress should initiate a grand research challenge focused on making biotechnology predictably engineerable (including through the Executive Office of the President).*
Congress should initiate a grand research challenge focused on making biomanufacturing scale-up predictable, rapid, and cost-competitive.
Congress must ensure that federal agencies have the necessary expertise across national security and emerging biotechnology issues.*
Congress must maximize the impact of domestic biomanufacturing workforce training programs.*
Department of Agriculture
Congress should direct each relevant agency (including the Department of Agriculture) to designate a senior official to lead biotechnology policy.*
Congress must direct federal regulatory agencies (including the Department of Agriculture) to create simple pathways to market and exempt familiar products from unnecessary regulation.*
Congress must ensure that federal agencies (including the Department of Agriculture) have the necessary expertise across national security and emerging biotechnology issues.*
Department of Commerce
Congress should direct each relevant agency (including the Department of Commerce) to designate a senior official to lead biotechnology policy.*
Congress must establish and fund an Independence Investment Fund, led by a non-governmental manager, that would invest in technology start-ups that strengthen U.S. national and economic security.
Congress must authorize and fund the Department of Energy (DOE) and the Department of Commerce (DOC) to develop a network of manufacturing facilities across the country for precommercial bioindustrial product scale-up.*
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.
Congress should direct the Department of Commerce (DOC) 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.
Congress should authorize the National Institute of Standards and Technology (NIST) to create standards that researchers must meet to ensure that U.S. biological data is ready for use in AI models.
Congress must direct the Executive Branch to advance safe, secure, and responsible biotechnology research and innovation.
Congress must maximize the impact of domestic biomanufacturing workforce training programs (including at the Department of Commerce).*
Congress should direct the State Department and other agencies to promote the U.S. biotechnology industry in foreign markets, including through commercial diplomacy.
Congress should direct the State Department (DOS), along with the National Institute of Standards and Technology (NIST), to support the development of international norms and standards, including defining shared values and interests in biotechnology.*
Department of Defense
Congress should direct each relevant agency (including the Department of Defense) to designate a senior official to lead biotechnology policy.*
Congress must prohibit companies that work with U.S. national security agencies (including the Department of Defense) and the Department of Health and Human Services (HHS) from using certain Chinese biotechnology suppliers that are deemed to pose a national security threat.*
Congress must direct the Department of Defense (DOD) to consult with stakeholders to define principles for ethical use of biotechnology for the U.S. military.
Congress must direct the Department of Defense (DOD) to work with private companies to build commercial facilities across the country to biomanufacture products that are critical for DOD needs.
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.
Congress should require changes to military specifications (MIL-SPECs) to enable biotechnology companies to more easily sell their products to the Department of Defense.
Congress should require the Department of Defense (DOD) to enter into advance market commitments (AMCs) and offtake agreements for biotechnology products that are needed for defense.
Congress should require the Department of Defense (DOD) and other agencies involved in national security to train their workforces to be ready for biotechnology.*
Congress should require the Department of Defense (DOD) to incorporate military-relevant applications of emerging biotechnology into wargaming exercises.
Congress must ensure that federal agencies (including the Department of Defense) have the necessary expertise across national security and emerging biotechnology issues.*
Congress should direct the State Department (DOS) and the Department of Defense (DOD) to encourage North Atlantic Treaty Organization (NATO) countries to aggregate demand and pool purchasing power for biotechnology products.
Office of the Director of National Intelligence and the Intelligence Community
Congress should direct each relevant agency (including ODNI) to designate a senior official to lead biotechnology policy.*
Congress must prohibit companies that work with U.S. national security agencies (including ODNI) and the Department of Health and Human Services (HHS) from using certain Chinese biotechnology suppliers that are deemed to pose a national security threat.*
Congress should require the Department of Defense (DOD) and other agencies involved in national security (including ODNI) to train their workforces to be ready for biotechnology.*
Congress should resource the intelligence community (IC) to prioritize understanding of adversaries’ development of biotechnology and its diverse applications.
Congress must ensure that federal agencies (including ODNI) have the necessary expertise across national security and emerging biotechnology issues.*
Department of Education
Congress should expand educational efforts in biotechnology for American students (including through the Department of Education).*
Department of Energy
Congress should direct each relevant agency (including the Department of Energy) to designate a senior official to lead biotechnology policy.*
Congress should direct the Department of Energy (DOE) and the Department of Health and Human Services (HHS) to use existing authorities to smooth unpredictable and inconsistent demand for biotechnology products through advance market commitments and offtake agreements and provide new authorities where necessary.*
Congress must authorize and fund the Department of Energy (DOE) and the Department of Commerce (DOC) to develop a network of manufacturing facilities across the country for precommercial bioindustrial product scale-up.*
Congress must authorize the Department of Energy (DOE) to create a Web of Biological Data (WOBD), a single point of entry for researchers to access high-quality data.
Congress must establish Centers for Biotechnology within the existing National Laboratory network to support grand research challenges.
Congress must ensure that federal agencies (including the Department of Energy) have the necessary expertise across national security and emerging biotechnology issues.*
Department of Health and Human Services
Congress should direct each relevant agency (including the Department of Health and Human Services) to designate a senior official to lead biotechnology policy.*
Congress must direct federal regulatory agencies (including the Food and Drug Administration) to create simple pathways to market and exempt familiar products from unnecessary regulation.*
Congress should direct federal regulatory agencies (including the Food and Drug Administration) to prepare for novel products to come to market.*
Congress should direct the Department of Energy (DOE) and the Department of Health and Human Services (HHS) to use existing authorities to smooth unpredictable and inconsistent demand for biotechnology products through advance market commitments and offtake agreements and provide new authorities where necessary.*
Congress must prohibit companies that work with U.S. national security agencies and the Department of Health and Human Services (HHS) from using certain Chinese biotechnology suppliers that are deemed to pose a national security threat.*
Congress must ensure that federal agencies (including the Department of Health and Human Services) have the necessary expertise across national security and emerging biotechnology issues.*
Department of Homeland Security
Congress should direct each relevant agency (including the Department of Homeland Security) to designate a senior official to lead biotechnology policy.*
Congress must direct the Department of Homeland Security (DHS) to ensure that biotechnology infrastructure and data are covered under “critical infrastructure.”
Congress must prohibit companies that work with U.S. national security agencies (including the Department of Homeland Security) and the Department of Health and Human Services (HHS) from using certain Chinese biotechnology suppliers that are deemed to pose a national security threat.*
Congress should require the Department of Defense (DOD) and other agencies involved in national security (including the Department of Homeland Security) to train their workforces to be ready for biotechnology.*
Congress should authorize new green cards for biotechnology talent, especially from partner and allied countries.
Congress should optimize the vetting process for foreign nationals to prevent illicit technology transfer.
Department of the Interior
Congress should direct each relevant agency (including the Department of the Interior) to designate a senior official to lead biotechnology policy.*
Congress should authorize and fund the Department of Interior (DOI) to create a Sequencing Public Lands Initiative to collect new data from U.S. public lands that researchers can use to drive innovation.
Department of Justice
Congress must conduct oversight on existing policies (including at the Department of Justice), and add new authorities where warranted, to ensure that China cannot obtain bulk and sensitive biological data from the United States.*
Department of Labor
Congress must maximize the impact of domestic biomanufacturing workforce training programs (including through the Department of Labor).*
Department of State
Congress should direct each relevant agency (including the Department of State) to designate a senior official to lead biotechnology policy.*
Congress must ensure that federal agencies (including the Department of State) have the necessary expertise across national security and emerging biotechnology issues.*
Congress must include biotechnology in the scope of Department of State’s (State) International Technology Security and Innovation (ITSI) Fund to appropriately fund international biotechnology policy, R\&D, and secure supply chains.
Congress should direct the State Department and other agencies to promote the U.S. biotechnology industry in foreign markets, including through commercial diplomacy.*
Congress should expand regulatory diplomacy for biotechnology.
Congress should require the State Department (DOS) to form reciprocal biological data-sharing agreements with other countries.
Congress should direct the State Department (DOS) and the Department of Defense (DOD) to encourage North Atlantic Treaty Organization (NATO) countries to aggregate demand and pool purchasing power for biotechnology products.*
Congress should direct the State Department (DOS), along with the National Institute of Standards and Technology (NIST), to support the development of international norms and standards, including defining shared values and interests in biotechnology.*
Congress should require the State Department (DOS) to create a strategy for harmonizing multilateral export controls.
Department of the Treasury
Congress should restore full and immediate expensing of R\&D expenditures.
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.
Congress must require outbound investment rules to ensure that U.S. capital does not support Chinese development of certain biotechnologies that could pose a national security risk.
Department of Veterans Affairs
C.4.1i Recommendation: Congress should support the collection and storage of AI-ready biological data using assets that exist in the United States.
Environmental Protection Agency
Congress should direct each relevant agency (including the Environmental Protection Agency) to designate a senior official to lead biotechnology policy.*
Congress must direct federal regulatory agencies (including the Environmental Protection Agency) to create simple pathways to market and exempt familiar products from unnecessary regulation.*
Congress should direct federal regulatory agencies (including the Environmental Protection Agency) to prepare for novel products to come to market.*
National Aeronautics and Space Administration
Congress should direct each relevant agency (including the National Aeronautics and Space Administration) to designate a senior official to lead biotechnology policy.*
National Science Foundation
Congress must establish a National Biotechnology Coordination Office (NBCO) in the Executive Office of the President (EOP) with a Director, appointed by the President, who will coordinate interagency actions on biotechnology competition and regulation (including through the National Science Foundation).*
Congress should direct each relevant agency (including the National Science Foundation) to designate a senior official to lead biotechnology policy.*
Congress should direct federal regulatory agencies (and the National Science Foundation) to prepare for novel products to come to market.*
Congress should authorize the National Science Foundation (NSF) to establish a network of “cloud labs,” giving researchers state-of-the-art tools to make data generation easier.
Congress should expand educational efforts in biotechnology for American students (including through the National Science Foundation).*
Federal Trade Commission
Congress must conduct oversight on existing policies (including at the Federal Trade Commission), and add new authorities where warranted, to ensure that China cannot obtain bulk and sensitive biological data from the United States.*
International Trade Commission
Congress should direct the International Trade Commission (ITC) to investigate Chinese dumping or oversupply of biotechnology products and services.
Office of Personnel Management
Congress must direct the Office of Personnel Management (OPM) to provide workforce training in biotechnology across the interagency.
Securities and Exchange Commission
Congress must require public companies to disclose single points of supply chain vulnerability located in foreign countries of concern.
Small Business Administration
Congress should improve the effectiveness and reach of the SBIR/STTR program to support early-stage innovation.
Congress
Congress
Congress should receive accurate, timely, and nonpartisan scientific and technical counsel.*
Government Accountability Office
Congress should receive accurate, timely, and nonpartisan scientific and technical counsel (including through the Government Accountability Office).*
House of Representatives
Committee on House Administration
Congress should receive accurate, timely, and nonpartisan scientific and technical counsel.*
Committee on Agriculture
Congress must direct federal regulatory agencies (including the Department of Agriculture) to create simple pathways to market and exempt familiar products from unnecessary regulation.*
Congress must ensure that federal agencies (including the Department of Agriculture) have the necessary expertise across national security and emerging biotechnology issues.*
Committee on Appropriations
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.
Congress should establish the Office of Global Competition Analysis to develop timely data and technology forecasting to inform policymakers’ decisions.
Congress must direct federal regulatory agencies to create simple pathways to market and exempt familiar products from unnecessary regulation.
Congress should direct federal regulatory agencies to prepare for novel products to come to market.
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.
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.
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.
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.
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.
Congress should direct the International Trade Commission to investigate Chinese dumping or oversupply of biotechnology products and services.
Congress must direct the Department of Defense (DOD) to work with private companies to build commercial facilities across the country to biomanufacture products that are critical for DOD needs.
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.
Congress should require the Department of Defense and other agencies involved in national security to train their workforces to be ready for biotechnology.
Congress should require the Department of Defense to incorporate military-relevant applications of emerging biotechnology into wargaming exercises.
Congress should resource the intelligence community to prioritize understanding adversaries’ development of biotechnology and its diverse applications.
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.
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.
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.
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.
Congress must establish Centers for Biotechnology within the existing National Laboratory network to support grand research challenges.
Congress should initiate a grand research challenge focused on making biotechnology predictably engineerable.
Congress should initiate a grand research challenge focused on making biomanufacturing scale-up predictable, rapid, and cost-competitive.
Congress must direct the Executive Branch to advance safe, secure, and responsible biotechnology research and innovation.
Congress must direct the Office of Personnel Management to provide workforce training in biotechnology across the interagency.
Congress must ensure that federal agencies have the necessary expertise across national security and emerging biotechnology issues.
Congress should receive accurate, timely, and nonpartisan scientific and technical counsel.
Congress must maximize the impact of biomanufacturing workforce training programs.
Congress should expand educational efforts in biotechnology for American students.
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, R\&D, and secure supply chains.
Congress should direct the Department of State and other agencies to promote the U.S. biotechnology industry in foreign markets, including through commercial diplomacy.
Congress should require the Department of State to form reciprocal biological data-sharing agreements with other countries.
Congress should direct the Department of State and the Department of Defense to encourage North Atlantic Treaty Organization countries to aggregate demand and pool purchasing power for biotechnology products.
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.
House Armed Services Committee
Congress must prohibit companies that work with U.S. national security agencies (including the Department of Defense) and the Department of Health and Human Services (HHS) from using certain Chinese biotechnology suppliers that are deemed to pose a national security threat.*
Congress must direct the Department of Defense (DOD) to consult with stakeholders to define principles for ethical use of biotechnology for the U.S. military.
Congress must direct the Department of Defense (DOD) to work with private companies to build commercial facilities across the country to biomanufacture products that are critical for DOD needs.
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.
Congress should require changes to military specifications (MIL-SPECs) to enable biotechnology companies to more easily sell their products to the Department of Defense.
Congress should require the Department of Defense (DOD) to enter into advance market commitments (AMCs) and offtake agreements for biotechnology products that are needed for defense.
Congress should require the Department of Defense (DOD) and other agencies involved in national security to train their workforces to be ready for biotechnology.*
Congress should require the Department of Defense (DOD) to incorporate military-relevant applications of emerging biotechnology into wargaming exercises.
Congress should direct the State Department (DOS) and the Department of Defense (DOD) to encourage North Atlantic Treaty Organization (NATO) countries to aggregate demand and pool purchasing power for biotechnology products.
Committee on Education and Workforce
Congress must maximize the impact of domestic biomanufacturing workforce training programs (including at the Department of Education).*
Congress should expand educational efforts in biotechnology for American students (including through the Department of Education).
Committee on Energy and Commerce
Congress must direct federal regulatory agencies (including the Food and Drug Administration) to create simple pathways to market and exempt familiar products from unnecessary regulation.*
(or with Financial Services) 2.2a Recommendation: Congress must establish and fund an Independence Investment Fund, led by a non-governmental manager, that would invest in technology start-ups that strengthen U.S. national and economic security.
Congress should direct the Department of Energy (DOE) and the Department of Health and Human Services (HHS) to use existing authorities to smooth unpredictable and inconsistent demand for biotechnology products through advance market commitments and offtake agreements and provide new authorities where necessary.*
Congress must authorize and fund the Department of Energy (DOE) and the Department of Commerce (DOC) to develop a network of manufacturing facilities across the country for precommercial bioindustrial product scale-up.*
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.
Congress must prohibit companies that work with U.S. national security agencies and the Department of Health and Human Services (HHS) from using certain Chinese biotechnology suppliers that are deemed to pose a national security threat.*
Congress should direct the Department of Commerce (DOC) 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.
Congress must authorize the Department of Energy (DOE) to create a Web of Biological Data (WOBD), a single point of entry for researchers to access high-quality data.
Congress should authorize the National Institute of Standards and Technology (NIST) to create standards that researchers must meet to ensure that U.S. biological data is ready for use in AI models.
Congress must conduct oversight on existing policies (including at the Federal Trade Commission), and add new authorities where warranted, to ensure that China cannot obtain bulk and sensitive biological data from the United States.*
Congress must establish Centers for Biotechnology within the existing National Laboratory network to support grand research challenges.
Congress must direct the Executive Branch to advance safe, secure, and responsible biotechnology research and innovation.
Congress must ensure that federal agencies (including the Department of Commerce) have the necessary expertise across national security and emerging biotechnology issues.*
Congress must maximize the impact of domestic biomanufacturing workforce training programs (including at the Department of Commerce).*
Congress should direct the State Department (DOS), along with the National Institute of Standards and Technology (NIST), to support the development of international norms and standards, including defining shared values and interests in biotechnology.*
Committee on Financial Services
(or with E\&C) 2.2a Recommendation: Congress must establish and fund an Independence Investment Fund, led by a non-governmental manager, that would invest in technology start-ups that strengthen U.S. national and economic security.
Congress must require public companies to disclose single points of supply chain vulnerability located in foreign countries of concern.
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.
Congress should direct the International Trade Commission (ITC) to investigate Chinese dumping or oversupply of biotechnology products and services.
Congress must require outbound investment rules to ensure that U.S. capital does not support Chinese development of certain biotechnologies that could pose a national security risk.
Committee on Foreign Affairs
Congress must ensure that federal agencies (including the Department of State) have the necessary expertise across national security and emerging biotechnology issues.*
Congress must include biotechnology in the scope of Department of State’s (State) International Technology Security and Innovation (ITSI) Fund to appropriately fund international biotechnology policy, R\&D, and secure supply chains.
Congress should direct the State Department and other agencies to promote the U.S. biotechnology industry in foreign markets, including through commercial diplomacy.
Congress should expand regulatory diplomacy for biotechnology.
Congress should require the State Department (DOS) to form reciprocal biological data-sharing agreements with other countries.
Congress should direct the State Department (DOS) and the Department of Defense (DOD) to encourage North Atlantic Treaty Organization (NATO) countries to aggregate demand and pool purchasing power for biotechnology products.*
Congress should direct the State Department (DOS), along with the National Institute of Standards and Technology (NIST), to support the development of international norms and standards, including defining shared values and interests in biotechnology.*
Congress should require the State Department (DOS) to create a strategy for harmonizing multilateral export controls.
Committee on Homeland Security
Congress must direct the Department of Homeland Security (DHS) to ensure that biotechnology infrastructure and data are covered under “critical infrastructure.”
Congress must prohibit companies that work with U.S. national security agencies (including the Department of Homeland Security) and the Department of Health and Human Services (HHS) from using certain Chinese biotechnology suppliers that are deemed to pose a national security threat.*
Congress should require the Department of Defense (DOD) and other agencies involved in national security (including the Department of Homeland Security) to train their workforces to be ready for biotechnology.*
Permanent Select Committee on Intelligence
Congress must prohibit companies that work with U.S. national security agencies (including ODNI) and the Department of Health and Human Services (HHS) from using certain Chinese biotechnology suppliers that are deemed to pose a national security threat.*
Congress should require the Department of Defense (DOD) and other agencies involved in national security (including ODNI) to train their workforces to be ready for biotechnology.*
Congress should resource the intelligence community (IC) to prioritize understanding of adversaries’ development of biotechnology and its diverse applications.
Committee on the Judiciary
Congress must conduct oversight on existing policies (including at the Department of Justice), and add new authorities where warranted, to ensure that China cannot obtain bulk and sensitive biological data from the United States.*
Congress should authorize new green cards for biotechnology talent, especially from partner and allied countries.
Congress should optimize the vetting process for foreign nationals to prevent illicit technology transfer.
Committee on Natural Resources
Congress should authorize and fund the Department of Interior (DOI) to create a Sequencing Public Lands Initiative to collect new data from U.S. public lands that researchers can use to drive innovation.
House Committee on Oversight and Government Reform
Congress must direct the Office of Personnel Management (OPM) to provide workforce training in biotechnology across the interagency.
Congress should receive accurate, timely, and nonpartisan scientific and technical counsel (including through the Government Accountability Office).*
Committee on Science, Space, and Technology
Congress must establish a National Biotechnology Coordination Office (NBCO) in the Executive Office of the President (EOP) with a Director, appointed by the President, who will coordinate interagency actions on biotechnology competition and regulation (including through the National Science Foundation).*
Congress should direct each relevant agency (including the National Science Foundation) to designate a senior official to lead biotechnology policy.*
Congress should establish the Office of Global Competition Analysis to develop timely data and technology forecasting to inform policymakers’ decisions.
Congress should direct federal regulatory agencies (and the National Science Foundation) to prepare for novel products to come to market.*
Congress should authorize the National Science Foundation (NSF) to establish a network of “cloud labs,” giving researchers state-of-the-art tools to make data generation easier.
Congress should initiate a grand research challenge focused on making biotechnology predictably engineerable (including through the National Science Foundation).*
Congress should initiate a grand research challenge focused on making biomanufacturing scale-up predictable, rapid, and cost-competitive (including through the National Science Foundation).*
Congress should expand educational efforts in biotechnology for American students (including through the National Science Foundation).*
Committee on Small Business
Congress should improve the effectiveness and reach of the SBIR/STTR program to support early-stage innovation.
Congress should restore full and immediate expensing of R\&D expenditures.
Multi-jurisdictional
Congress must ensure that federal agencies have the necessary expertise across national security and emerging biotechnology issues.
Congress must maximize the impact of domestic biomanufacturing workforce training programs.
Senate
Committee on Agriculture, Nutrition, and Forestry
Congress must direct federal regulatory agencies (including the Department of Agriculture) to create simple pathways to market and exempt familiar products from unnecessary regulation.*
Congress must ensure that federal agencies (including the Department of Agriculture) have the necessary expertise across national security and emerging biotechnology issues.*
Committee on Appropriations
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.
Congress should establish the Office of Global Competition Analysis to develop timely data and technology forecasting to inform policymakers’ decisions.
Congress must direct federal regulatory agencies to create simple pathways to market and exempt familiar products from unnecessary regulation.
Congress should direct federal regulatory agencies to prepare for novel products to come to market.
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.
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.
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.
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.
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.
Congress should direct the International Trade Commission to investigate Chinese dumping or oversupply of biotechnology products and services.
Congress must direct the Department of Defense (DOD) to work with private companies to build commercial facilities across the country to biomanufacture products that are critical for DOD needs.
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.
Congress should require the Department of Defense and other agencies involved in national security to train their workforces to be ready for biotechnology.
Congress should require the Department of Defense to incorporate military-relevant applications of emerging biotechnology into wargaming exercises.
Congress should resource the intelligence community to prioritize understanding adversaries’ development of biotechnology and its diverse applications.
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.
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.
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.
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.
Congress must establish Centers for Biotechnology within the existing National Laboratory network to support grand research challenges.
Congress should initiate a grand research challenge focused on making biotechnology predictably engineerable.
Congress should initiate a grand research challenge focused on making biomanufacturing scale-up predictable, rapid, and cost-competitive.
Congress must direct the Executive Branch to advance safe, secure, and responsible biotechnology research and innovation.
Congress must direct the Office of Personnel Management to provide workforce training in biotechnology across the interagency.
Congress must ensure that federal agencies have the necessary expertise across national security and emerging biotechnology issues.
Congress should receive accurate, timely, and nonpartisan scientific and technical counsel.
Congress must maximize the impact of biomanufacturing workforce training programs.
Congress should expand educational efforts in biotechnology for American students.
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, R\&D, and secure supply chains.
Congress should direct the Department of State and other agencies to promote the U.S. biotechnology industry in foreign markets, including through commercial diplomacy.
Congress should require the Department of State to form reciprocal biological data-sharing agreements with other countries.
Congress should direct the Department of State and the Department of Defense to encourage North Atlantic Treaty Organization countries to aggregate demand and pool purchasing power for biotechnology products.
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.
Senate Armed Services Committee
Congress must prohibit companies that work with U.S. national security agencies (including the Department of Defense) and the Department of Health and Human Services (HHS) from using certain Chinese biotechnology suppliers that are deemed to pose a national security threat.*
Congress must direct the Department of Defense (DOD) to consult with stakeholders to define principles for ethical use of biotechnology for the U.S. military.
Congress must direct the Department of Defense (DOD) to work with private companies to build commercial facilities across the country to biomanufacture products that are critical for DOD needs.
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.
Congress should require changes to military specifications (MIL-SPECs) to enable biotechnology companies to more easily sell their products to the Department of Defense.
Congress should require the Department of Defense (DOD) to enter into advance market commitments (AMCs) and offtake agreements for biotechnology products that are needed for defense.
Congress should require the Department of Defense (DOD) and other agencies involved in national security to train their workforces to be ready for biotechnology.*
Congress should require the Department of Defense (DOD) to incorporate military-relevant applications of emerging biotechnology into wargaming exercises.
Congress should direct the State Department (DOS) and the Department of Defense (DOD) to encourage North Atlantic Treaty Organization (NATO) countries to aggregate demand and pool purchasing power for biotechnology products.*
Committee on Banking, Housing, and Urban Development
(or with CST) 2.2a Recommendation: Congress must establish and fund an Independence Investment Fund, led by a non-governmental manager, that would invest in technology start-ups that strengthen U.S. national and economic security.
Congress must require public companies to disclose single points of supply chain vulnerability located in foreign countries of concern.
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.
Congress must require outbound investment rules to ensure that U.S. capital does not support Chinese development of certain biotechnologies that could pose a national security risk.
Congress should require the State Department (DOS) to create a strategy for harmonizing multilateral export controls.
Committee on Commerce, Science, and Technology
Congress must establish a National Biotechnology Coordination Office (NBCO) in the Executive Office of the President (EOP) with a Director, appointed by the President, who will coordinate interagency actions on biotechnology competition and regulation (including through the National Science Foundation).*
Congress should direct each relevant agency (including the National Science Foundation) to designate a senior official to lead biotechnology policy.*
Congress should establish the Office of Global Competition Analysis to develop timely data and technology forecasting to inform policymakers’ decisions.
(or with Banking) 2.2a Recommendation: Congress must establish and fund an Independence Investment Fund, led by a non-governmental manager, that would invest in technology start-ups that strengthen U.S. national and economic security.
Congress should direct federal regulatory agencies (including the National Science Foundation) to prepare for novel products to come to market.*
Congress must authorize and fund the Department of Energy (DOE) and the Department of Commerce (DOC) to develop a network of manufacturing facilities across the country for precommercial bioindustrial product scale-up.*
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.
Congress should direct the Department of Commerce (DOC) 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.
Congress should authorize the National Institute of Standards and Technology (NIST) to create standards that researchers must meet to ensure that U.S. biological data is ready for use in AI models.
Congress should authorize the National Science Foundation (NSF) to establish a network of “cloud labs,” giving researchers state-of-the-art tools to make data generation easier.
Congress should initiate a grand research challenge focused on making biotechnology predictably engineerable (including through the National Science Foundation).*
Congress should initiate a grand research challenge focused on making biomanufacturing scale-up predictable, rapid, and cost-competitive (including through the National Science Foundation).*
Congress must direct the Executive Branch to advance safe, secure, and responsible biotechnology research and innovation.
Congress must maximize the impact of domestic biomanufacturing workforce training programs (including at the National Science Foundation).*
Congress should expand educational efforts in biotechnology for American students (including through the National Science Foundation).*
Congress should direct the State Department (DOS), along with the National Institute of Standards and Technology (NIST), to support the development of international norms and standards, including defining shared values and interests in biotechnology.*
Commission on Energy and Natural Resources
Congress must authorize and fund the Department of Energy (DOE) and the Department of Commerce (DOC) to develop a network of manufacturing facilities across the country for precommercial bioindustrial product scale-up.*
Congress must authorize the Department of Energy (DOE) to create a Web of Biological Data (WOBD), a single point of entry for researchers to access high-quality data.
Congress should authorize and fund the Department of Interior (DOI) to create a Sequencing Public Lands Initiative to collect new data from U.S. public lands that researchers can use to drive innovation.
Congress must establish Centers for Biotechnology within the existing National Laboratory network to support grand research challenges.
Congress must ensure that federal agencies (including the Department of Energy and the Department of the Interior) have the necessary expertise across national security and emerging biotechnology issues.*
Congress should direct the Department of Energy (DOE) and the Department of Health and Human Services (HHS) to use existing authorities to smooth unpredictable and inconsistent demand for biotechnology products through advance market commitments and offtake agreements and provide new authorities where necessary.*
Committee on Environment and Public Works
Congress should direct each relevant agency (including the Environmental Protection Agency) to designate a senior official to lead biotechnology policy.*
Congress must direct federal regulatory agencies (including the Environmental Protection Agency) to create simple pathways to market and exempt familiar products from unnecessary regulation.*
Congress should direct federal regulatory agencies (including the Environmental Protection Agency) to prepare for novel products to come to market.*
Committee on Finance
Congress should restore full and immediate expensing of R\&D expenditures.
Congress should direct the International Trade Commission (ITC) to investigate Chinese dumping or oversupply of biotechnology products and services.
Committee on Foreign Relations
Congress should direct each relevant agency (including the Department of State) to designate a senior official to lead biotechnology policy.*
Congress must ensure that federal agencies agency (including the Department of State) have the necessary expertise across national security and emerging biotechnology issues.*
Congress must include biotechnology in the scope of Department of State’s (State) International Technology Security and Innovation (ITSI) Fund to appropriately fund international biotechnology policy, R\&D, and secure supply chains.
Congress should direct the State Department and other agencies to promote the U.S. biotechnology industry in foreign markets, including through commercial diplomacy.
Congress should expand regulatory diplomacy for biotechnology.
Congress should require the State Department (DOS) to form reciprocal biological data-sharing agreements with other countries.
Congress should direct the State Department (DOS) and the Department of Defense (DOD) to encourage North Atlantic Treaty Organization (NATO) countries to aggregate demand and pool purchasing power for biotechnology products.*
Congress should direct the State Department (DOS), along with the National Institute of Standards and Technology (NIST), to support the development of international norms and standards, including defining shared values and interests in biotechnology.*
Congress should require the State Department (DOS) to create a strategy for harmonizing multilateral export controls.
Committee on Health, Education, Labor, and Pensions
Congress must direct federal regulatory agencies (including the Food and Drug Administration) to create simple pathways to market and exempt familiar products from unnecessary regulation.*
Congress must prohibit companies that work with U.S. national security agencies and the Department of Health and Human Services (HHS) from using certain Chinese biotechnology suppliers that are deemed to pose a national security threat.*
Congress must ensure that federal agencies (including the Department of Health and Human Services) have the necessary expertise across national security and emerging biotechnology issues.*
Congress must maximize the impact of domestic biomanufacturing workforce training programs (including through the Department of Labor).*
Congress should direct the Department of Energy (DOE) and the Department of Health and Human Services (HHS) to use existing authorities to smooth unpredictable and inconsistent demand for biotechnology products through advance market commitments and offtake agreements and provide new authorities where necessary.*
Congress should expand educational efforts in biotechnology for American students (including through the Department of Labor).*
Committee on Homeland Security and Governmental Affairs
Congress must direct the Department of Homeland Security (DHS) to ensure that biotechnology infrastructure and data are covered under “critical infrastructure.”
Congress must prohibit companies that work with U.S. national security agencies and the Department of Health and Human Services (HHS) from using certain Chinese biotechnology suppliers that are deemed to pose a national security threat.*
Congress should require the Department of Defense (DOD) and other agencies involved in national security (including the Department of Homeland Security) to train their workforces to be ready for biotechnology.*
Congress should receive accurate, timely, and nonpartisan scientific and technical counsel (including through the Government Accountability Office).*
Select Committee on Intelligence
Congress must prohibit companies that work with U.S. national security agencies (including ODNI) and the Department of Health and Human Services (HHS) from using certain Chinese biotechnology suppliers that are deemed to pose a national security threat.*
Congress should require the Department of Defense (DOD) and other agencies involved in national security (including ODNI) to train their workforces to be ready for biotechnology.*
Congress should resource the intelligence community (IC) to prioritize understanding of adversaries’ development of biotechnology and its diverse applications.
Committee on the Judiciary
Congress must conduct oversight on existing policies (including at the Department of Justice), and add new authorities where warranted, to ensure that China cannot obtain bulk and sensitive biological data from the United States.*
Congress should authorize new green cards for biotechnology talent, especially from partner and allied countries.
Congress should optimize the vetting process for foreign nationals to prevent illicit technology transfer.
Committee on Rules and Administration
Congress should receive accurate, timely, and nonpartisan scientific and technical counsel.*
Committee on Small Business and Entrepreneurship
Congress should improve the effectiveness and reach of the SBIR/STTR program to support early-stage innovation.