Biosecurity Law and Policy
S3: Science Safety Security
There are many Presidential Directives, Executive Orders, and federal laws that have been enacted to protect the nation’s research facilities and ensure that proper biosecurity measures are undertaken. The following brief summaries highlight the laws that prescribe laboratory biosecurity measures and ensure the protection of critical assets from theft, loss, or misuse. The regulations governing the Federal Select Agent Program (FSAP) specifically can be found in detail on the Federal Select Agent Program website.
- Federal Information Security Management Act of 2002: Federal government organizations are directed by the Federal Information Security Management Act (FISMA) of 2002 and other legislative and executive directives to develop, document, and implement programs to protect their information and information systems, and to apply a risk-based policy to achieve cost-effective security. Standards and guidelines developed by the National Institute of Standards and Technology (NIST) help agencies carry out effective information security programs based on the management of risk. The FISMA provides a comprehensive framework for ensuring the effectiveness of information security controls over information resources that support Federal operations and assets.
- Critical Infrastructures Protection Act of 2001 (42 USC § 5195c - Critical Infrastructures Protection): A continuous national effort is required to ensure the reliable provision of cyber and physical infrastructure services critical to maintaining national defense, continuity of government, economic prosperity, and quality of life in the United States. It is the policy of the United States that any physical or virtual disruption of the operation of the critical infrastructures of the United States be rare, brief, geographically limited in effect, manageable, and minimally detrimental to the economy, human and government services, and national security of the United States.
- Homeland Security Presidential Directive 7 (2004): Homeland Security Presidential Directive 7 establishes a national policy for Federal departments and agencies to identify and prioritize critical infrastructure and to protect them from terrorist attacks. While it is not possible to protect or eliminate the vulnerability of all critical infrastructure and key resources throughout the country, strategic improvements in security can make it more difficult for attacks to succeed and can lessen the impact of attacks that may occur. In addition to strategic security enhancements, tactical security improvements can be rapidly implemented to deter, mitigate, or neutralize potential attacks. Research facilities are considered to be assets that are vital to the United States and its national security.
- Executive Order 13486 - Strengthening Laboratory Biosecurity in the United States (2009): This Executive Order requires that facilities that possess biological select agents and toxins (BSAT) have appropriate security and personnel assurance practices to protect against the theft, misuse, or diversion to unlawful activity of BSAT. The EO establishes the Working Group on Strengthening the Biosecurity of the United States, within the Department of Defense, in order to implement this policy and to review and evaluate the efficiency and effectiveness of existing laws, regulations, guidances, and practices with respect to Federal and nonfederal facilities that conduct research on BSAT or manage clinical or environmental laboratory operations that involve the possession, use, or transfer of BSAT.
- Presidential Policy Directive- 2 (PPD-2), National Strategy for Countering Biological Threats (2009): PPD-2 was released to ensure implementation of the National Strategy for Countering Biological Threats. It gave Executive Branch Departments and Agencies 180 days to create an initial implementation plan for the Strategy and submit it to the National Security Staff Executive Secretary. It also gave guidance on submitting budgets for programs in support of the Strategy and established oversight for implementation through the Interagency Policy Committee on Countering Biological Threats. Yearly reports on progress toward implementing the Strategy are required beginning February 1, 2011.
- Executive Order 13546—Optimizing the Security of Biological Select Agents and Toxins in the United States (2010): This Executive Order requires that all BSAT are secured in a manner commensurate with their risk of misuse, theft, loss, or accidental release, and that security measures shall be taken in a coordinated manner that balances their efficacy with the need to minimize the adverse impact on the legitimate use of BSAT. The Federal Select Agent Program (FSAP) exists to provide effective regulatory oversight of the possession, use, and transfer of BSAT and to reduce the risk of their misuse or mishandling. The absence of clearly defined, risk-based security measures in the Select Agent Regulations or the FSAP has raised concerns about the need for optimized security and for risk management. To help ensure that BSAT are secured according to level of risk, the Secretaries of Health and Human Services and Agriculture were required to designate a subset of the Select Agent List (Tier 1) that presents the greatest risk of deliberate misuse with the most significant potential for mass casualties or devastating effects to the economy, critical infrastructure, or public confidence. This order also required that options for graded protection of Tier 1 agents and toxins be explored and the overall number of agents and toxins on the Select Agent List be reconsidered when applicable.
- Executive Order 13636 - Improving Critical Infrastructure Cybersecurity (2013): The cyber threat to critical infrastructure continues to grow and represents one of the most serious national security challenges. The national and economic security of the United States depends on the reliable functioning of the Nation's critical infrastructure in the face of such threats. It is the policy of the United States to enhance the security and resilience of the Nation's critical infrastructure and to maintain a cyber environment that encourages efficiency and innovation. These goals can be achieved through partnerships with the owners and operators of critical infrastructure to improve cybersecurity information sharing and collaboratively develop and implement risk-based standards.
- Presidential Policy Directive 21-- Critical Infrastructure Security and Resilience (2013): It is the policy of the United States to strengthen the security and resilience of its critical infrastructure against both physical and cyber threats. The Federal Government shall work with critical infrastructure owners and operators and State, Local Tribal, and Territorial entities to take proactive steps to manage risk and strengthen the security and resilience of the Nation's critical infrastructure, considering all hazards that could have a debilitating impact on national security, economic stability, public health and safety, or any combination thereof. These efforts shall seek to reduce vulnerabilities, minimize consequences, identify and disrupt threats, and hasten response and recovery efforts related to critical infrastructure.
- Biological and Toxin Weapons Convention (1975): The Convention on the Prohibition of the Development, Production, and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on their Destruction, commonly known as the Biological Weapons Convention (BWC) or Biological and Toxin Weapons Convention (BTWC), opened for signature in 1972 and entered into force in 1975. It was the first multilateral disarmament treaty banning an entire category of weapons. It effectively prohibits the development, production, acquisition, transfer, retention, stockpiling and use of biological and toxin weapons and is a key element in the international community’s efforts to address the proliferation of weapons of mass destruction. For additional information, please see the United Nations disarmament website.
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United Nations
Security Council Resolution 1540 (2004): On 28 April 2004, the United Nations Security
Council unanimously adopted Resolution 1540 under Chapter VII of the United Nations Charter,
which affirms that the proliferation of nuclear, chemical, and biological weapons, and their
means of delivery, constitute a threat to international peace and security. The resolution
obliges States, inter alia, to refrain from supporting by any means non-State actors from
developing, acquiring, manufacturing, possessing, transporting, transferring or using nuclear,
chemical or biological weapons and their delivery systems. Resolution 1540 imposes binding
obligations on all States to adopt legislation to prevent the proliferation of nuclear,
chemical, and biological weapons, and their means of delivery, and establish appropriate
domestic controls over related materials to prevent their illicit trafficking.