Section 1 Short title
This Act may be cited as the “Biological Weapons Policy Act of 2021”.
Biological Weapons Policy Act of 2021
A BILL
To strengthen United States oversight of the Biological Weapons Convention and to advance non-proliferation objectives related to biological weapons, dual-use technologies, and life sciences research, and for other purposes.
Sec. 2 Definitions
In this Act:
Appropriate congressional committees— The term appropriate congressional committees means—
the Committee on Foreign Relations and the Committee on Appropriations of the Senate; and
the Committee on Foreign Affairs and the Committee on Appropriations Armed Services of the House of Representatives.
Biological Weapons Convention— The term Biological Weapons Convention means the Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological and Toxin Weapons and on their Destruction, done at Washington, London, and Moscow, April 10, 1972.
Life sciences research— The term life sciences research—
means research that pertains to living organisms, including microbes, human beings, animals, and plants, and their products, including all disciplines and methodologies of biology such as aerobiology, agricultural science, plant science, animal science, bioinformatics, genomics, proteomics, synthetic biology, environmental science, public health, modeling, engineering of living systems, and all applications of the biological sciences; and
is meant to encompass the diverse approaches for understanding life at the level of ecosystems, organisms, organs, tissues, cells, and molecules.
Sec. 3 Findings
Congress makes the following findings:
According to the Department of State, “promoting global health security is a core tenant of the U.S. biodefense strategy because infectious disease threats, whether naturally occurring, deliberate, or accidental, have the potential to spread globally and affect the American people and interests”.
Several countries around the world have known or suspected chemical and biological weapons capability or are undertaking research that poses concerns about such nations’ compliance with the Biological Weapons Convention, as documented by the United States Department of State and the United Nations.
With respect to the Russian Federation, the Department of State, in its 2021 report on Adherence to and Compliance With Arms Control, Nonproliferation, and Disarmament Agreements and Commitments, assessed that “the Russian Federation (Russia) maintains an offensive BW [biological weapons] program and is in violation of its obligation under Articles I and II of the BWC [Biological Weapons Convention]”.
With respect to the People’s Republic of China, the Department of State, also in its 2021 report on Adherence to and Compliance With Arms Control, Nonproliferation, and Disarmament Agreements and Commitments, assessed that it “engaged in activities with dual-use applications, which raise concerns regarding its compliance with Article I of the BWC. In addition, the United States does not have sufficient information to determine whether China eliminated its assessed historical biological warfare (BW) program, as required under Article II of the Convention.”
The People’s Republic of China’s engagement in biological research that presents dual use concerns, its professed prioritization of biotechnology and synthetic biology in relevant national strategies, and evidence that emerged in the midst of the COVID–19 pandemic of collaboration between ostensibly civilian research laboratories in the People’s Republic of China and the People’s Liberation Army, has highlighted the imperative of the United States to monitor closely and conduct diligent oversight of biological research collaboration with the People’s Republic of China.
Another consideration in the imperative for closer oversight is the People’s Republic of China’s prioritization of military-civil fusion, which systematically harnesses all civil and commercial research and technology for potential weapons use.
A potential bioweapons attack or accidental leak of biological research, especially biological research that could be militarized, would have devastating human health, economic, and geopolitical consequences. While the origins of COVID–19 remain under investigation, the current pandemic serves as a sobering example of vulnerability and could inspire malign actors.
The Department of State, particularly the Under Secretary of State for Arms Control and International Security, is responsible for “developing measures to prevent misuse of advances in the life sciences” (1 FAM 457.3). These challenges require that the Department of State have the lead role in preventing the proliferation of bioweapons and in strengthening relevant oversight mechanisms to mitigate the potential risk of a deliberate or accidental bioweapons event.
Sec. 4 Statement of policy
It shall be the policy of the United States to—
conduct rigorous oversight of public health research and innovation that could be weaponized or serve a dual-use function, and incorporate national security and nonproliferation considerations and country-specific conditions into decisions regarding international biological, bacteriological, virological, and other relevant research collaboration;
ensure that United States Government support for public health research and other actions are not inadvertently contributing to the proliferation of biological weapons and dual use technologies in the search for solutions to pressing global health challenges; and
declassify, to the maximum extent possible, all intelligence relevant to the People’s Republic of China’s (PRC) compliance or lack of compliance with its obligations under the Biological Weapons Convention (BWC), and other national security concerns regarding PRC life sciences research that falls outside the scope of the BWC.
Sec. 5 Amendments to Secretary of State authorities
Research, development, and other studies— Section 301(a) of the Arms Control and Disarmament Act (22 U.S.C. 2571(a)) is amended by inserting “biological, virological,” after “bacteriological”.
Oversight of dual-Use research— Title III of the Arms Control and Disarmament Act (22 U.S.C. 2571 et seq.) is amended by inserting after section 301 (22 U.S.C. 2571) the following new section:
“301A. Authorities with respect to biological dual-use research of concern
“(a) Oversight of dual-Use research
“(1) In general—The Secretary of State, working through Chiefs of Mission in each country listed in paragraph (2), as applicable, shall lead the conduct and completion of a Country Team Assessment to evaluate and determine whether, for each discrete proposed research project or other collaboration funded or otherwise supported by the United States Government that involves life sciences dual-use research of concern, including research related to biological agents, toxins, and pathogens, aligns with the national interests of the United States. The Country Team Assessment shall be submitted to the Secretary of State and the head of the Federal department or agency sponsoring the proposed research or collaboration.
“(2) List of countries specified—The countries for which a Country Team Assessment, as described in paragraph (1), must be completed are as follows:
“(A) The People’s Republic of China.
“(B) The Russian Federation.
“(C) The Islamic Republic of Iran.
“(D) The Democratic People’s Republic of Korea.
“(E) The Syrian Arab Republic.
“(F) Any other country specified in the report assessing compliance with the Biological Weapons Convention, as required by section 403(a) of the Arms Control and Disarmament Act (22 U.S.C. 2593a(a)) in the relevant calendar year.
“(b) Report on approvals of collaboration—Not later than September 30, 2022, and annually thereafter for a period of three years, the Secretary of State, in consultation with the heads of other relevant Federal departments and agencies as appropriate, shall submit to the appropriate committees of Congress a report describing any research or collaboration described in subsection (a) that was approved and the justification for such approval.
“(c) Report on efficacy of country team assessment—Not later than September 30, 2025, the Secretary of State, in coordination with the heads of other relevant Federal departments and agencies, shall submit to the appropriate committees of Congress a report that includes the following elements:
“(1) A summary of the work of the relevant country teams over the previous three years.
“(2) An assessment of whether the country team assessment process described in subsection (a) is effective in advancing relevant national interests of the United States, and any associated recommendations.
“(3) Any other key findings and recommendations, including for conducting oversight of and improving interagency coordination on the review and monitoring of collaboration with other countries on life sciences research.
“(d) Definitions—In this section:
“(1) Appropriate committees of Congress—the term appropriate committees of Congress means—
“(A) the Committee on Foreign Relations and the Committee on Health, Education, Labor, and Pensions of the Senate; and
“(B) the Committee on Foreign Affairs and the Committee on Energy and Commerce of the House of Representatives.
“(2) Life sciences dual-use research of concern defined—The term life sciences dual-use research of concern means life sciences research that can be reasonably anticipated to provide knowledge, information, products, or technologies that could be directly misapplied to pose a significant threat with broad potential consequences to public health and safety, national security, or agricultural crops and other plants, animals, the environment, or materiel.”
Enhancements to the annual compliance report— Section 403(a) of the Arms Control and Disarmament Act (22 U.S.C. 2593a(a)) is amended—
in paragraph (5)—
by inserting “or the conduct of life sciences research of dual-use concern (as defined in section 301A),” before “including—”; and
in subparagraph (C), by striking “; and” and inserting a semicolon;
by redesignating paragraph (6) as paragraph (7); and
by inserting after paragraph (5) the following new paragraph:
“(6) a detailed assessment of the national security and proliferation risk of life science research of dual-use concern conducted by the other nations including—
“(A) a review of major issues the Department of State is prioritizing with respect to the misuse or potential misuse of life sciences research;
“(B) a description of all efforts by the Department of State and other relevant departments and agencies to develop and promote measures to prevent misuse or proliferation of advances in the life sciences;
“(C) an assessment of national level policies, research initiatives, or other relevant efforts focused on increasing the pathogenicity, contagiousness, or transmissibility of viruses or bacteria, including initiatives involving or anticipated to involve enhanced potential pandemic pathogens of other nations, including—
“(i) the People’s Republic of China;
“(ii) the Russian Federation;
“(iii) the Islamic Republic of Iran;
“(iv) the Democratic People’s Republic of Korea;
“(v) the Syrian Arab Republic;
“(vi) any other nation identified in paragraphs (4) and (5); and
“(vii) any terrorist group or malign non-state actor;
“(D) an assessment of whether any of the activities described in subparagraph (C) constitute violations of Biological Weapons Convention or pose related national security concerns;
“(E) a description of collaboration between ostensibly civilian entities, including research laboratories, and military entities on life sciences research;
“(F) a description of the confidence-building measures or other attempts by the countries described in subparagraph (C) to justify, clarify, or explain the activities described in such subparagraph;
“(G) an assessment of risks to United States national security and proliferation risks presented by the initiatives described in subparagraph (C);
“(H) a description of all involvement by the Department of State to review United States Government funding or other support, including subgrants, for life sciences research in other countries that qualifies as dual-use research of concern, including research related to biological agents, toxins, and pathogens; and
“(I) a description of all participation in any other United States Government and international groups on biosecurity and dual-use research;”
in paragraph (7), as redesignated by paragraph (2) of this subsection, by striking the period at the end and inserting “; and”; and
by adding at the end the following new paragraph:
“(8) a description of any obstacles or challenges to the ability of United States Government to address the requirements specified in this section, including a description of gaps in authorities, intelligence collection and analysis, organizational responsibilities, and resources.”
Sec. 6 Report on United States funding for life science research in the People’s Republic of China
In general— Not later than 180 days after the date of the enactment of this Act, the President shall conduct a formal review, and produce a written report, of all United States Government grants or funding awarded in the past ten years for research collaboration with the People’s Republic of China related to life sciences, gain-of-function, synthetic biology, biotechnology, or other research areas that pose potential biological weapons proliferation or dual-use concerns.
Elements— The review required under subsection (a) shall analyze—
all such grants and funding requests that were awarded and a detailed project description, the awardee, the amount awarded, any resulting sub-grants to entities under the jurisdiction of the People’s Republic of China, and the criteria met for granting approval of funding;
the exact procedures used to approve or deny such grants or other funding, including coordination, if any, between agencies responsible for public health preparedness and biomedical research, including the Department of Health and Human Services, and national security agencies, including the Department of State;
an assessment of any gaps in United States Government procedures and safeguards to prevent any such research intended for civilian purposes from being diverted for military research in the People’s Republic of China;
an assessment of how to best address any such gaps in procedures and safeguards, especially regarding greater interagency input from national security agencies, particularly the Department of State;
how the research conducted with the grants and funding requests listed pursuant to paragraph (1) may have contributed to the development of biological weapons in the People’s Republic of China;
how the United States Government’s understanding of the People’s Republic of China’s “military-civil fusion” national strategy informed and impacted funding decisions, and how it will inform future funding decisions in research related to gain-of-function, synthetic biology, biotechnology, or other research areas that pose biological weapons proliferation or dual-use concerns;
whether any United States Government funding, including subgrants, was used to support gain-of-function research in the People’s Republic of China during the United States moratorium on such research from 2014 to 2017;
steps taken the by United States Government, if any, to apply additional scrutiny to United States Government funding, including subgrants, to support gain-of-function research in the People’s Republic of China after the United States Government lifted the moratorium on gain-of-function research in 2017; and
any other relevant matter discovered during the course of the review.
Report submission— Within 15 days of the completion of the report required under subsection (a), the President shall submit the report to—
the Committee on Foreign Relations of the Senate;
the Committee on Health, Education, Labor, and Pensions of the Senate;
the Committee on Armed Services of the Senate;
the Committee on Foreign Affairs of the House of Representatives;
the Committee on Energy and Commerce of the House of Representatives; and
the Committee on Armed Services of the House of Representatives.
Form of report— The report shall be unclassified, but may include a classified annex.
Sec. 7 Government accountability office report on oversight of international life sciences research collaboration
In general— Not later than one year after the date of the enactment of this Act, the Comptroller General of the United States shall submit a report to the appropriate congressional committees on the following matters:
An audit of United States Government authorities, policies, and processes governing cooperation with other nations as relates to life sciences research that could be weaponized or pose dual-use concerns, such as pathogens or toxins, synthetic biology, and related emerging technologies, and the degree to which these authorities, policies, and processes account for national security, proliferation, and country-specific considerations in decisions on whether to pursue such collaboration.
An assessment of the degree of coordination between Federal departments and agencies responsible for public health preparedness and the governance of biomedical research and Federal departments and agencies responsible for national security, especially the United States Department of State, to assess and account for security implications of cooperation with other nations on life sciences research.
Elements— The review required under subsection (a) shall address the following elements:
The Federal department or agencies or other governmental entities that provide funding or other material support for life sciences research, especially biological research, with other nations.
The authorities, policies, and processes that currently exist for reviewing, approving, and monitoring grant funding or other material support for biological research with other nations, including a description of all the steps involved reviewing, approving, and monitoring such funding or other support.
Which Federal departments and agencies, including specific bureaus and offices, are involved in the authorities, policies, and processes described in paragraph (2).
The circumstances under which Federal departments and agencies apply enhanced review, monitoring, and coordination to proposed collaboration, as well as an analysis of the extent to which and how national security, proliferation, or country-specific considerations, such as a nation’s adherence to the Biological Weapons Convention, are among the circumstances that trigger enhanced scrutiny of whether the United States Government should fund a particular research program.
The information required to be included in an application for United States Government funding of life sciences research to address potential national security, proliferation, or country-specific concerns, and whether the information required varies across departments and agencies.
The extent to which Federal departments and agencies with national security responsibilities have visibility into the information described in paragraph (5) prior to an award being made, even if grantees are applying to funding from another Federal department or agency.
The processes and timeline by which funds are issued to the awardee or awardees after a grant or other funding award is made, and to what extent these funds are monitored for national security implications thereafter, including how Federal departments and agencies with national security responsibilities are involved in monitoring such research after funds are awarded.
Report submission— Within 15 days of the completion of the report required under subsection (a), the President shall submit the report to—
the Committee on Foreign Relations, the Committee on Health, Education, Labor, and Pensions, and the Committee on Armed Services of the Senate; and
the Committee on Foreign Affairs, the Committee on Energy and Commerce, and the Committee on Armed Services of the House of Representatives.
Form of report— The report required under subsection (a) shall be submitted in unclassified form, but may include a classified annex.
Sec. 8 Prohibition with respect to certain types of life sciences research
No Federal funds may be obligated or expended for the purpose of conducting research that increases the pathogenicity, contagiousness, or transmissibility of viruses or bacteria, including any research anticipated to involve enhanced potential pandemic pathogens, if such research involves a foreign entity that is subject to the jurisdiction of any of the following countries:
The People’s Republic of China.
The Russian Federation.
The Islamic Republic of Iran.
The Democratic People’s Republic of Korea.
The Syrian Arab Republic.
Any other country specified in the report assessing compliance with the Biological Weapons Convention, as required by section 403(a) of the Arms Control and Disarmament Act (22 U.S.C. 2593a(a)) in the relevant calendar year.
Sec. 9 Biological and Toxin Weapons Review Conference
Statement of policy— In order to promote international peace, and security, it is the policy of the United States to pursue adherence to the Biological Weapons Convention and accountability for violations thereof, including as described in subsections (b) and (c).
Activities in advance of the Ninth Review Conference of the Biological Weapons Convention— Before the Ninth Review Conference of the 1972 Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on their Destruction (in this subsection referred to as “the Conference”), the President shall carry out the following activities:
Demand greater transparency from the Government of the People’s Republic of China regarding the dual-use applications of its life science research, which raise concerns regarding its compliance with Article I of the Biological Weapons Convention.
Engage with other governments, the private sector (including in relevant life sciences and technology fields), and other stakeholders, as appropriate, on United States concerns about the People’s Republic of China’s compliance with the Biological Weapons Convention, and the national security, public health, and non-proliferation implications of these concerns.
Emphasize that the People’s Republic of China’s national strategy of “military-civil fusion” undermines the underlying utility, purposes, and enforceability of the Biological Weapons Convention, which may not adequately capture the full range of dual-use biotechnologies being pursued by the People’s Republic of China.
Security Council complaint— If the questions and concerns raised in subsection (b) are not adequately addressed, the President should consider lodging a complaint to the Security Council pursuant to Article VI of the Convention.
Sec. 10 Annual report by the United States Agency for International Development
In general— Not later than 180 days after the date of enactment of this Act, and annually thereafter for seven years, the Administrator of the United States International Development shall submit to the appropriate congressional committees a report describing all engagements and funding, including subgrants, for life sciences research involving or related to the study of pathogens, viruses, and toxins provided to entities subject to the jurisdiction of countries listed in subsection (b), to include a national security justification for such engagements and funding.
List of countries specified— The countries to be covered by the report required in subsection (a) are as follows:
The People’s Republic of China.
The Russian Federation.
The Islamic Republic of Iran.
The Democratic People’s Republic of Korea.
The Syrian Arab Republic.
Any other country specified in the report assessing compliance with the Biological Weapons Convention, as required by section 403(a) of the Arms Control and Disarmament Act (22 U.S.C. 2593a(a)) in the relevant calendar year.
Form— The report required under subsection (a) shall be submitted in unclassified form, but may include a classified annex.
Sec. 11 United Nations agencies, programs, and funds
Prohibition— The Permanent Representative of the United States to the United Nations, in coordination with the United States Representative to the World Health Assembly, shall use the voice, vote, and influence of the United States at the United Nations to bar representatives from countries listed in subsection (b) from serving in leadership positions within any United Nations specialized agency, program, fund, or treaty organization with a nexus to global health (including animal health), biosecurity, atomic, biological or chemical weapons, or food security and agricultural development.
List of countries specified— The countries to be covered by the report required in subsection (a) are as follows:
The People’s Republic of China.
The Russian Federation.
The Islamic Republic of Iran.
The Democratic People’s Republic of Korea.
The Syrian Arab Republic.
Any other country specified in the report assessing compliance with the Biological Weapons Convention, as required by section 403(a) of the Arms Control and Disarmament Act (22 U.S.C. 2593a(a)) in the relevant calendar year.