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U.S. Laws

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Pandemic and All-Hazards Preparedness Act [PDF]

Public Law No. 109-417
Signed into law: December 19, 2006

The Pandemic and All-Hazards Preparedness Act "reauthorizes the Public Health Security and Bioterrorism Preparedness and Response Act; identifies the Secretary of Health and Human Services (HHS) as the lead federal official responsible for public health and medical response to emergencies including a flu pandemic; establishes standard of preparedness from state-to-state; and, requires individual states to meet performance standards developed by the Secretary of HHS." In addition, the legislation moves management of the Strategic National Stockpile from the Centers for Disease Control and Prevention to the office of the HHS assistant secretary for public health emergency preparedness.

Congressional Research Service Summary | Congressional Research Service Report

USA PATRIOT Improvement and Reauthorization Act of 2005 [PDF]

Public Law 109-177
Signed into Law: March 9, 2006

The Act was intended as a renewal of 16 sunset provisions scheduled to expire December 31, 2005 contained in the Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism (USA PATRIOT ACT) Act of 2001 signed into law October 26, 2001, by President George W. Bush as Public Law 107-56.


Project BioShield Act [PDF]

Public Law 108-276
Signed into Law: July 21, 2004

The Project BioShield Act "amend[s] the Public Health Service Act to provide protections and countermeasures against chemical, radiological, or nuclear agents that may be used in a terrorist attack against the United States by giving the National Institutes of Health contracting flexibility, infrastructure improvements, and expediting the scientific peer review process, and streamlining the Food and Drug Administration approval process of countermeasures." According to the Congressional Research Service Summary, the Secretary of Health and Human Services is authorized to "expedite procurement [of qualified countermeasures] to respond to pressing research and development needs by: (1) using simplified procurement procedures for products and services that cost more than the simplified acquisition threshold; (2) allowing other than full and open competition in certain instances; (3) increasing the micropurchase threshold to allow the Secretary to use those procedures; and (4) limiting review of the Secretary's procurement decisions."

Congressional Research Service Summary | Congressional Research Service Report

Smallpox Emergency Personnel Protection Act [PDF]

Public Law 108-20
Signed into Law: April 30, 2003

The Smallpox Emergency Personnel Protection Act "provide[s] benefits and other compensation for certain individuals with injuries resulting from administration of smallpox countermeasures." According to the Congressional Research Service Summary, the Health and Human Services Secretary is "to create a smallpox vaccine injury table identifying adverse effects that shall be presumed to result from the administration of (or exposure to) a smallpox vaccine and the time period in which the first symptom of each such adverse effect must occur for such presumption to apply."

Congressional Research Service Summary

Public Health Security and Bioterrorism Preparedness and Response Act [PDF]

Public Law 107-188
Signed into Law: June 12, 2002

The Public Health Security and Bioterrorism Preparedness and Response Act "improve[s] the ability of the United States to prevent, prepare for, and respond to bioterrorism and other public health emergencies." It authorizes money for the federal, state, and local governments to evaluate public health emergency preparedness and plan and conduct additional preparations for public health emergencies. The act also addresses provisions concerning the control of biological agents and toxins; safety and security measures concerning food, drug, and water supplies; and development of countermeasures against bioterrorism. A section of this act is known as the Agricultural Bioterrorism Protection Act and "directs the Secretary of Agriculture to establish and maintain a list of each biological agent and each toxin that the Secretary determines has the potential to pose a severe threat to animal or plant health, or to animal or plant products."


USA Patriot Act [PDF]

Public Law 107-56
Signed into Law: October 26, 2001

The Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism Act, or the USA Patriot Act, "deter[s] and punish[es] terrorist acts in the United States and around the world [and] enhance[s] law enforcement investigatory tools." The Act also "prescribes penalties for knowing possession in certain circumstances of biological agents, toxins, or delivery systems, especially by certain restricted persons" according to the Congressional Research Service Summary.

Congressional Research Service Summary

Chemical Weapons Convention Implementation Act [PDF]

Public Law 105-277
Signed into Law: October 21, 1998

The Chemical Weapons Convention Implemention Act is a division of the Omnibus Consolidated and Emergency Supplemental Appropriations Act, 1999 and implements the Chemical Weapons Convention. According to the Congressional Research Service Summary, the Act: requires the Deparment of State, designated the United States National Authority by the President, to act as the liason for the Organization for the Prohibition of Chemical Weapons (OPCW) and the Chemical Weapons Convention; makes developing, acquiring, transferring, stockpiling, possessing, or using chemical weapons illegal; and, requires inspection of chemical plants by the OPCW.

Congressional Research Service Summary

Antiterrorism and Effective Death Penalty Act [PDF]

Public Law 104-132
Signed into Law: April 24, 1996

The Antiterrorism and Effective Death Penalty Act "deter[s] terrorism, provide justice for victims, provide for an effective death penalty, and for other purposes." According to the Congressional Research Service Summary, the law makes threatening, attempting, or conspiring to use a biological weapon a federal crime; broadens the definition of biological weapons to include components of infectious substances, toxic materials, and recombinant molecules; and authorizes the Secretary of Health and Human Services to regulate how biological agents are to be identified as potential threats and how they are to be transferred.

Congressional Research Service Summary | Congressional Research Service Report

Biological Weapons Anti-Terrorism Act

Public Law 101-298
Signed into Law: May 22, 1990

The Biological Weapons Anti-Terrorism Act (BWAT) implements the Biological Weapons Convention (BWC) and protects the United States from biological terrorism by prohibiting certain conduct pertaining to biological weapons, including knowingly developing, producing, stockpiling, transfering, acquiring, retaining, or possessing any biological agent, toxin, or delivery system for use as a weapon, or knowingly assisting a foreign state or any organization.

Congressional Research Service Summary



Executive Orders and Directives

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Public Health and Medical Preparedness [PDF]

Homeland Security Presidential Directive 21 (HSPD-21)
Signed: October 18, 2007
Presidential Directive

 "This directive establishes a National Strategy for Public Health and Medical Preparedness (Strategy), which builds upon principles set forth in Biodefense for the 21st Century (April 2004) and will transform our national approach to protecting the health of the American people against all disasters."


Medical Countermeasures Against Weapons of Mass Destruction [PDF]

Homeland Security Presidential Directive 18 (HSPD-18)
Signed: January 31, 2007
Presidential Directive

 "It is the policy of the United States to draw upon the considerable potential of the scientific community in the public and private sectors to address our medical countermeasure requirements relating to CBRN threats.  Our Nation will use a two‑tiered approach for development and acquisition of medical countermeasures, which will balance the immediate need to provide a capability to mitigate the most catastrophic of the current CBRN threats with long-term requirements to develop more flexible, broader spectrum countermeasures to address future threats.  Our approach also will support regulatory decisions and will permit us to address the broadest range of current and future CBRN threats."


Biodefense for the 21st Century[PDF]

Homeland Security Presidential Directive 10 (HSPD-10)
AKA National Security Presidential Directive 33 (NSPD-33)
Signed: April 28, 2004
Presidential Directive

By evaluating biodefense programs and initiatives, Biodefense for the 21st Century continues those efforts by identifying future priorities and actions and integrating the work of national and homeland security, medical, public health, intelligence, diplomatic, and law enforcement communities. The classified version contains specific directions on how departments and agencies are to implement this biodefense program.


Defense of United States Agriculture and Food

Homeland Security Presidential Directive 9 (HSPD-9)
Signed: January 30, 2004
Presidential Directive

Defense of United States Agriculture and Food "establishes a national policy to defend the agriculture and food system against terrorist attacks, major disasters, and other emergencies." Fulfilling the policy requires recognition of important agriculture and food infrastructure and ensuring their protection; development of mechanisms that provide early warning to threats; reduction of weaknesses during production and processing; enhancement of both product screening procedures; and response and recovery.


Further Amendment to Executive Order 12958, As Amended, Classified National Security Information

Executive Order 13292
Signed: March 25, 2003
Federal Register: 68 FR 15313, March 28, 2003
Executive Order

While Executive Order 12958 established that scientific matters not be considered for classification unless it relates to national security, Executive Order 13292 extended that consideration to include scientific matters relating to defense against transnational terrorism.


Implementation of the Chemical Weapons Convention and the Chemical Weapons Convention Implementation Act [PDF]

Executive Order 13128
Signed: June 25, 1999
Federal Register: 64 FR 34703, June 28, 1999
Executive Order

This executive order designates the Department of State as the United States National Authority (USNA) for the Chemical Weapons Convention and Chemical Weapons Convention Implementation Act. The responsibilites assigned to the USNA include coordinating the implementation of the provisions of the Convention and the Act with other federal agencies. In addition, the Secretary of Commerce is to impose and enforce restrictions on the importation of chemicals into the United States as required by the Chemical Weapons Convention.


National Policy on the Transfer of Scientific, Technical, and Engineering Information

National Security Decision Directive 189 (NSDD-189)
Signed: September 21, 1985
Presidential Directive

National Policy on the Transfer of Scientific, Technical, and Engineering Information "establishes national policy for controlling the flow of science, technology, and engineering information produced in federally-funded fundamental research at colleges, universities, and laboratories." That policy indicates that products of research remain unrestricted to the maximum extent as possible. If national security requires control of that research, then it will be controlled through classification.


Renunciation of Certain Uses in War of Chemical Herbicides and Riot Control Agents

Executive Order 11850
Signed: April 8, 1975
Federal Register: 40 FR 16187, April 10, 1975
Executive Order

Through this executive order, the US renounced first use of herbicides in war except for controlling vegetation around within and around US bases, installations, and their defensive perimeter. The US also renounced first use of riot control agents in war except in defensive military mode to save lives in certain specific situations.


United States Policy on Toxins[PDF]

National Security Decision Memorandum 44 (NSDM-44)
Signed: February 20, 1970
Executive Order (from the National Security Council)

In the memorandum United States Policy on Toxins, the US renounced the offensive production, stockpiling, and use of chemical and biological toxins and confined the military research in toxins to defensive purposes. Document acquired from the National Security Archive at George Washington University.


United States Policy on Chemical Warfare Program and Bacteriological/Biological Research Program[PDF]

National Security Decision Memorandum 35 (NSDM-35)
Signed: November 25, 1969
Executive Order (from the National Security Council)

Through this memorandum, the Chemical and Biological Warfare Program were split into two entities, the Chemical Warfare Program and the Biological Research Program. The objective of the Chemical Warfare Program was to deter other nation's from using their chemical weapons. Regarding the Biological Research Program, the U.S. renounced the use of biological weapons, lethal and otherwise, and focused its reseach towards defensive purposes. Document acquired from the National Security Archive at George Washington University.




Federal Agency Rules, Proposed Rules, and Notices

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Possession, Use, and Transfer of Select Agents and Toxins-Reconstructed Replication Competent Forms of the 1918 Pandemic Influenza Virus Containing Any Portion of the Coding Regions of All Eight Gene Segments [PDF]

Submitting Agency: Centers for Disease Control and Prevention
Federal Register: 70 FR 61047, October 20, 2005
Interim Final Rule

"We [the Centers for Disease Control and Prevention] are adding reconstructed replication competent forms of the 1918 pandemic influenza virus containing any portion of the coding regions of all eight gene segments to the list of HHS select agents and toxins. We are taking this action for several reasons. First the pandemic influenza virus of 1918-19 killed up to 50 million people worldwide, including an estimated 675,000 deaths in the United States. Also, the complete coding sequence for the 1918 pandemic influenza A H1N1 virus was recently identified, which will make it possible for those with knowledge of reverse genetics to reconstruct this virus. In addition, the first published study on a reconstructed 1918 pandemic influenza virus demonstrated the high virulence of this virus in cell culture, embryonated eggs, and in mice relative to other human influenza viruses. Therefore, we have determined that the reconstructed replication competent forms of the 1918 pandemic influenza virus containing any portion of the coding regions of all eight gene segments have the potential to pose a severe threat to public health and safety."


Agricultural Bioterrorism Protection Act of 2002; Possession, Use, and Transfer of Biological Agents and Toxins [PDF]

Submitting Agency: Animal and Plant Health Inspection Service
Federal Register: 70 CFR 13242, March 18, 2005
Final Rule

"We [the Animal and Plant Health Inspection Service] are adopting as a final rule, with changes, an interim rule that established regulations governing the possession, use, and transfer of biological agents and toxins that have been determined to have the potential to pose a severe threat to public health and safety, to animal health, to plant health, or to animal or plant products. This action is necessary to protect animal and plant health, and animal and plant products."


Possession, Use, and Transfer of Select Agents and Toxins [PDF]

Submitting Agency: Centers for Disease Control and Prevention
Federal Register: 70 FR 13293, March 18, 2005
Final Rule

"This document establishes a final rule regarding possession, use, and transfer of select agents and toxins. The final rule implements provisions of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and is designed to protect public health and safety. In a companion document published in this issue of the Federal Register, the United States Department of Agriculture has established corresponding final rules designed to protect animal and plant health and animal and plant products."




International Treaties

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Chemical Weapons Convention [PDF]

Opened for Signature: January 13, 1993
Entered into Force: April 29, 1997
Ratified by the US: April 25, 1997

The State Parties of the Convention on the Prohibition of the Development, Production, Stockpiling and Use of Chemical Weapons and on their Destruction, or the CWC, agree not to develop, produce, acquire, stockpile, retain, transfer, or use chemical weapons. State Parties also are to destroy their chemical weapons and chemical weapons production facilities and not use riot control agents in warfare. More information on the CWC can be found at the website for the Organisation for the Prohibition of Chemical Weapons.


Biological and Toxin Weapons Convention [PDF]

Opened for Signature: April 10, 1972
Entered into Force: March 26, 1975
Ratified by the US: March 26, 1975

The signatories to the Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on Their Destruction, the BWC, or the BTWC, agree not to develop, produce, stockpile, or acquire biological agents outside of peaceful purposes and weapons and equipment designed to use biological agents for hostile reasons. More information on the BWC can be found at the Biological and Toxin Weapons Convention Website.


Geneva Protocol [PDF]

Opened for Signature: June 17, 1925
Entered into Force: February 8, 1928
Ratified by the US: January 22, 1975

The Geneva Protocol is also known as the Protocol for the Prohibition of the Use in War of Asphyxiating, Poisonous or Other Gases, and of Bacteriological Methods of Warfare. It restated the prohibition on use of poisonous gases previously laid down by the Versailles and Washington treaties and added a ban on bacteriological warfare. When they ratified or acceded to the protocol, some nations -- including the United Kingdom, France, and the USSR -- declared that it would cease to be binding on them if their enemies, or the allies of their enemies, failed to respect the prohibitions of the protocol. The American position is that the protocol does not apply to the use in war of riot-control agents and herbicides.