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Summaries of Biosecurity Related Policy
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Legislation | Presidential Directives and Executive Orders
Summaries of Legislation
Pandemic and All-Hazards Preparedness Act of 2006
Pub. L. No. 109-417: PAHPA identifies the Secretary of Health and Human Services as the lead federal official for public health emergency preparedness and response and establishes the position of the Assistant Secretary for Preparedness and Response (ASPR). PAHPA also provides new authorities for development of countermeasures, establishes mechanisms and grants to strengthen state and local public health security infrastructure, and addresses surge capacity by placing the National Disaster Medical System (NDMS) and the Emergency System for Advance Registration of Health Professions Volunteers (ESAR-VHP) under the purview of HHS.
Public Readiness and Emergency Preparedness (PREP) Act of 2005
Pub. L. No. 109-148; 42 U.S.C. §§ 247d-6d, 247d-6e: The PREP Act authorizes the Secretary of HHS to issue a declaration (“PREP Act declaration”) that provides immunity from tort liability (except for willful misconduct) for claims of loss caused, arising out of, relating to, or resulting from administration or use of countermeasures to diseases, threats and conditions determined by the Secretary to constitute a present, or credible risk of a future public health emergency to entities and individuals involved in the development, manufacture, testing, distribution, administration, and use of such countermeasures. A PREP Act declaration is specifically for the purpose of providing immunity from tort liability, and is different from, and not dependent on, other emergency declarations.
Project BioShield Act of 2004
Pub. L. No. 108-276; 21 U.S.C. 360bbb-3: Under the Project Bioshield Act, if the Secretary of Health and Human Services has determined that a public health emergency exists, if the Secretary of Homeland Security has declared an actual or significant potential for a domestic emergency, or the Secretary of Defense has declared actual or significant potential for heightened risk to the military, the Secretary of HHS may declare an emergency justifying an Emergency Use Authorization (EUA) for the use of an unlicensed drug, device, or biological product, or for the off-label use of an approved drug, device, or biological product. Once an emergency is declared, the Commissioner of the Food and Drug Administration (FDA) may issue an EUA for a particular product or products, assuming other statutory criteria and conditions are met. The EUA expires when the declaration of emergency terminates or when authorization is revoked. The FDA Commissioner may impose conditions on the use of the drug or device.
Public Health Security and Bioterrorism Preparedness and Response Act of 2002
Pub. L. No. 107-188: This act amends the Public Health Service Act to “improve the ability of the United States to prevent, prepare for, and respond to bioterrorism and other public health emergencies.” The Act requires the Secretary of Health and Human Services to “develop and implement” a coordinated strategy in the form of a National Preparedness Plan. Additionally, several provisions for protection of the food and drug supply are included. The Act also directs the Secretary to establish and maintain the Emergency System for Advance Registration of Health Professions Volunteers (ESAR-VHP).
Homeland Security Act of 2002
Pub. L. No. 107-296, as amended; 6 U.S.C. §§ 311-321m: The Homeland Security Act merges 22 disparate agencies and organizations into the new Department of Homeland Security (DHS), including the Federal Emergency Management Agency (FEMA). The Act charges DHS with securing the nation against terrorist attacks and carrying out the functions of all transferred entities, including acting as a focal point regarding natural and man-made crises and emergency planning. The law establishes the National Homeland Security Council, the Directorate of Border and Transportation Security, and the Office for State and Local Government Coordination, and transfers powers from Immigration and Naturalization Service (abolished under 6 U.S.C. 291(a)).
The Public Health Service Act: This act was made law in 1944. Summarized below are biosecurity specific-sections of the act.
Section 319: Public Health Emergencies
42 U.S.C. § 247d: This section of the Public Health Service Act authorizes the Secretary of Health and Human Services to determine that a public health emergency exists if “1) a disease or disorder presents a public health emergency; or 2) a public health emergency, including significant outbreaks of infectious diseases or bioterrorist attacks, otherwise exists.” From the determination of a public health emergency flows the ability of the Secretary to “take such action as may be appropriate” and to utilize funds from the Public Health Emergency Fund (when appropriated). The public health emergency determination remains effective until the Secretary either declares that the emergency no longer exists, or at the expiration of 90 days, whichever occurs first. If the Secretary determines that the same or additional facts continue to warrant a public health emergency, he/she may renew the declaration for 90-day periods.
Section 319F-2: Strategic National Stockpile and Security
42 U.S.C. § 247d-6b: The Stockpile (including drugs, vaccines, biological products, medical devices, and other supplies) is maintained by the Secretary of Health and Human Services to provide for the emergency health security of the United States. The Secretary may deploy the stockpile to respond to an actual or potential public health emergency or to otherwise protect the public health or safety, or as required by the Secretary of Homeland Security to respond to an actual or potential emergency.
Section 361: Regulations to Control Communicable Diseases
42 U.S.C. § 264: This section of the Public Health Service Act authorizes the Secretary of Health and Human Services to make and enforce regulations “to prevent the introduction, transmission, or spread of communicable diseases” into the states and possessions of the United States from foreign countries or possessions or from one state into another. This section also authorizes the apprehension, detention, examination, and conditional release of individuals with certain communicable diseases that are specified in an executive order of the President (see Executive Order 13296, as amended by Executive Order 13375).
Section 362: Suspension of Entries and Imports from Designated Places to Prevent Spread of Communicable Diseases
42 U.S.C. § 265: This section of the Public Health Service Act authorizes the Secretary of Health and Human Services, if he or she determines that a communicable disease exists in a foreign country and that this disease poses a serious danger of introducing the disease into the United States, to prohibit the “introduction of persons” from those foreign or places for the time necessary to avert the danger, in accordance with approved regulations.
Presidential Directives and Executive Orders
Presidential Policy Directive/PPD-8: National Preparedness
The White House, 2011: Issued in March 2011, this directive aims to strengthen the security and resilience of the United States through systematic preparation for the threats that pose the greatest risk to the security of the nation, including acts of terrorism, cyber attacks, pandemics, and catastrophic natural disasters. While this directive is intended to galvanize action by the federal government, it also aims to facilitate an integrated, all-of-nation, capabilities-based approach to preparedness.
Presidential Policy Directive/PPD-2: Implementation of the National Strategy for Countering Biological Threats
The White House, 2009: Presidential Policy Directive 2 highlights the beneficial nature of advances in the life sciences and their importance in combatting infectious diseases of natural, accidental, and deliberate origin. It also outlines specific actions needed to prevent biological threats.
Executive Order 13527: Establishing Federal Capability for the Timely Provision of Medical Countermeasures Following a Biological Attack
The White House, Executive Office of the President, 2009: The Executive Order calls for the establishment of policies that mitigate illness and prevent death, sustain critical infrastructure, and complement and supplement local dispersal strategies by creating a U.S. Postal Service medical countermeasures dispensing model.
Executive Order 13486: Strengthening Laboratory Biosecurity in the United States
The White House, Executive Office of the President, 2009: This Executive Order creates a working group to assess and enhance current policies, with the goal of strengthening biosecurity. The group’s charge includes developing recommendations for new legislation, regulations, guidance, or practices for security and personnel assurance, as well as options for oversight.
Homeland Security Presidential Directive/HSPD-21: Public Health and Medical Preparedness
The White House, 2007: HSPD-21 calls for public health and medical response that marshals all available national capabilities and capacities in a rapid and coordinated manner and the continual and timely flow of information to meet the medical and public health needs of the American people in the event of a catastrophic health event.
Homeland Security Presidential Directive/HSPD-18: Medical Countermeasures against Weapons of Mass Destruction
The White House, 2007: HSPD-18 addresses the need to prepare for an attack by terrorist forces using a weapon of mass destruction. It acknowledges that having sufficient resources on hand at all times and in all places is not a realistic possibility. The policy set forth in the HSPD is a 2-tiered approach for development and acquisition of medical countermeasures. Tier I is a focused development of Agent-Specific Medical Countermeasures and Tier II concerns the development of a Flexible Capability for New Medical Countermeasures.
Homeland Security Presidential Directive/HSPD-10: Biodefense for the 21st Century
The White House, 2004: HSPD-10 outlines policy for biodefense in the 21st century. The United States has pursued aggressively a broad range of programs and capabilities to confront the biological weapons threat. The results of a comprehensive study of our capabilities provide a blueprint for our future biodefense program that fully integrates the sustained efforts of the national and homeland security, medical, public health, intelligence, diplomatic, and law enforcement communities. The pillars of this national biodefense program are Threat Awareness, Prevention and Protection, Surveillance and Detection, and Response and Recovery. A classified version of this directive contains specific direction to departments and agencies.
Homeland Security Presidential Directive/HSPD-9: Defense of United States Agriculture and Food
The White House, 2004: HSPD-9 establishes a national policy to defend the agriculture and food system against terrorist attacks, major disasters, and other emergencies.
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