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U.S. Legislation, Executive Orders,
and International Treaties
Proposed US Legislation
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Proposed U.S. Legislation

110th Congress

National Agriculture and Food Defense Act of 2007 (HTML) (PDF)
Congressional Research Service Summary
Senate Bill S. 1804
Introduced to Senate: July 17, 2007
Sponsor: Senator Richard Burr [NC]
Status: Referred to Senate Committee on Homeland Security and Governmental Affairs, July 17, 2007

States that: (1) the Secretary of Homeland Security (Secretary) shall lead federal, state, local, tribal, and private efforts to enhance the protection of critical U.S. infrastructure and key resources, including the agriculture and food system; (2) the Secretary of Agriculture shall lead federal efforts relating to agriculture, meat, poultry, and egg food products; (3) the Secretary of Health and Human Services (HHS) shall lead federal efforts relating to other food products; and (4) the Administrator of the Environmental Protection Agency (EPA) shall lead federal efforts relating to drinking water and waste water.


Public Health Preparedness Workforce Development Act (HTML) (PDF)
Congressional Research Service Summary
Senate Bill S. 1882
Introduced to Senate: July 26, 2007
Sponsor: Senator Charles Hagel [NE]
Status: Introduced and referred to the Committee on Health, Education, Labor, and Pensions, July 26, 2007.

Amends the Public Health Service Act to require the Secretary of Health and Human Services to establish the Public Health Workforce Scholarship Program to assure an adequate supply of public health professionals to eliminate critical public health preparedness workforce shortages in federal, state, local, and tribal public health agencies by offering four-year scholarships in return for employment at such agencies.


Global Pathogen Surveillance Act of 2007 (HTML) (PDF)
Congressional Research Service Summary
Senate Report 110-152 (HTML) (PDF)
Senate Bill S. 1687
Introduced to Senate: June 25, 2007
Sponsor: Senator Joseph Biden [DE]
Status: Placed on Senate Legislative Calendar under General Orders. Calendar No. 350, September 11, 2007.

Prohibits assistance under this Act to an eligible developing country that does not: (1) permit World Health Organization (WHO) and the Centers for Disease Control and Prevention (CDCP) personnel to investigate infectious disease outbreaks within its borders; and (2) provide pathogen surveillance data to appropriate U.S. and international agencies and organizations.

 

109th Congress

Pandemic and All-Hazards Preparedness Act (HTML) (PDF)
Congressional Research Service Summary
Senate Report 109-319 (HTML) (PDF)
Senate Bill S. 3678
Introduced to Senate: July 18, 2006
Sponsor: Senator Richard Burr [NC]
Status: Became Public Law No. 109-417

According to Senator Burr's office, 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.


Biodefense and Pandemic Vaccine and Drug Development Act of 2006 (HTML) (PDF)
Congressional Research Service Summary
House Report 109-686 (HTML) (PDF)
House Bill H.R. 5533
Introduced to House: June 6, 2006
Sponsor: Representative Mike Rogers [MI-8]
Status: Referred to the Committee on Health, Education, Labor, and Pensions on 11/13/2006

The Biodefense and Pandemic Vaccine and Drug Development Act "prepare[s] and strengthen[s] the biodefenses of the United States against deliberate, accidental, and natural outbreaks of illness." The Bill proposes the establishment of the Biomedical Advanced Research and Development Authority (BARDA), which would accelerate advanced research and development of countermeasures and products related to biodefense and emerging infectious diseases by: facilitating collaboration among the federal government, industries, and academia; promoting research and development; facilitating necessary communication between researchers and the Food and Drug Administration; and, promoting innovation to reduce time and cost of research and development. The Bill also calls for the National Biodefense Science Board to advise and guide the Secretary of Health and Human Services on matters of interest relating to chemical, biological, nuclear, and radiological agents.


Biodefense and Pandemic Vaccine and Drug Development Act of 2006 (HTML) (PDF)
Congressional Research Service Summary
Senate Bill S. 2564
Introduced to Senate: April 6, 2006
Sponsor: Senator Richard Burr [NC]
Status: Referred to the Committee on Health, Education, Labor, and Pensions on 4/6/06

The Biodefense and Pandemic Vaccine and Drug Development Act "prepare[s] and strengthen[s] the biodefenses of the United States against deliberate, accidental, and natural outbreaks of illness." The Bill proposes the establishment of the Biomedical Advanced Research and Development Authority (BARDA), which would accelerate advanced research and development of countermeasures and products related to biodefense and emerging infectious diseases by: facilitating collaboration among the federal government, industries, and academia; promoting research and development; facilitating necessary communication between researchers and the Food and Drug Administration; and, promoting innovation to reduce time and cost of research and development. The Bill also calls for the National Biodefense Science Board to advise and guide the Secretary of Health and Human Services on matters of interest relating to chemical, biological, nuclear, and radiological agents.


Project BioShield Material Threats Act (HTML) (PDF)
Congressional Research Service Summary
House Bill H.R. 5028
Introduced to House: March 28, 2006
Sponsor: Representative John Linders [GA-7]
Status: Referred to the Committee on Homeland Security on 3/28/06; Referred to the Subcommittee on Health within the House Committee on Energy and Commerce on 4/19/06

The Project BioShield Material Threats Act "amend[s] the Public Health Service Act to improve and expedite the assessment and determination of chemical, biological, radiological and nuclear material threats by the Secretary of Homeland Security under the Project BioShield program." According to the Congressional Research Service Summary, this bill "amends the Public Health Service Act to require the Secretary of Homeland Security (the Secretary) to utilize existing risk assessments to assess current and emerging threats of chemical, biological, radiological, and nuclear agents and determine which of such agents present a material threat against the U.S. population sufficient to affect national security." The bill also "requires the Secretary to group such assessments to facilitate assessments by the Secretary of Health and Human Services on the availability and appropriateness of specific countermeasures to address more than one such agent or address adverse health consequences that are common to exposure to different agents."


Responsible Public Readiness and Emergency Preparedness Act
(HTML) (PDF)
Congressional Research Service Summary
Senate Bill S. 2291
Introduced to Senate: February 15, 2006
Sponsor: Senator Edward Kennedy [MA]
Status: Referred to the Committee on Health, Education, Labor, and Pensions on 2/15/06

The Responsible Public Readiness and Emergency Preparedness Act "provide[s] for the establishment of a biodefense injury compensation program and to provide indemnification for producers of countermeasures." According to the Congressional Research Service Summary, the Act "repeals the Public Readiness and Emergency Preparedness Act (Division C of the Department of Defense, Emergency Supplemental Appropriations to Address Hurricanes in the Gulf of Mexico, and Pandemic Influenza Act, 2006)" and "amends the Public Health Service Act to establish the Biodefense Injury Compensation Program to provide compensation for death or any injury, illness, disability, or condition that is likely to have been caused by the administration of a covered countermeasure pursuant to a declaration by the Secretary of Health and Human Services that an actual or potential bioterrorist incident or public health emergency makes such administration to a category of individuals advisable."


Biodefense and Pandemic Vaccine and Drug Development Act of 2005
(HTML) (PDF)
Congressional Research Service Summary
Senate Bill S. 1873
Introduced to Senate: October 17, 2005
Sponsor: Senator Richard Burr [NC]
Status: Placed on Senate Legislative Calendar on 10/24/05

The Biodefense and Pandemic Vaccine and Drug Development Act "prepare[s] and strengthen[s] the biodefenses of the United States against deliberate, accidental, and natural outbreaks of illness." According to the Congressional Research Service Summary, the Bill proposes amending "the Public Health Service Act to establish the Biomedical Advanced Research and Development Agency (BARDA) within the Department of Health and Human Services (HHS) to coordinate and oversee activities that support and accelerate advanced research and development of qualified countermeasures to exposure to hazardous agents or infectious diseases or qualified pandemic or epidemic products." It also "establishes the National Biodefense Advisory Board to provide expert advice and guidance to the Secretary on the threats, challenges, and opportunities presented by advances in biological and life sciences and the threat from natural infectious diseases and chemical, biological, radiological, and nuclear agents."


National Biodefense and Pandemic Preparedness Act (HTML) (PDF)
Congressional Research Service Summary
Senate Bill S. 1880
Introduced to Senate: October 17, 2005
Sponsor: Senator Edward Kennedy [MA]
Status: Referred to the Committee on Health, Education, Labor, and Pensions on 10/17/05

The National Biodefense and Pandemic Preparedness Act "amend[s] the Public Health Service Act to enhance biodefense and pandemic preparedness activities." According to the Congressional Research Service Summary, the Act, among other matters, "establishes the National BioVenture Trust as a federal government corporation to administer the BioShield Act and support the development of countermeasures and requires the Trust to establish a Vulnerable Populations Working Group; amends the Public Health Service Act to provide for adequate countermeasure domestic manufacturing capacity and construction of additional facilities; expands the definition of 'security countermeasure' to include vaccines or microbicides used to treat or prevent certain diseases or viruses that may contribute to a pandemic; provides incentives for development and production of countermeasures; [and,] requires the Secretary to establish a Select Agent Advisory Committee to advise on matters related to security checks for individuals handling biological agents or toxins."


Project BioShield II Act (HTML) (PDF)
Congressional Research Service Summary
Senate Bill S. 975
Introduced to Senate: April 28, 2005
Sponsor: Senator Joseph Lieberman [CT]
Status: Placed on Senate Legislative Calendar on 5/9/05; Hearings and roundtable discussion held in the Committee on Health, Education, Labor, and Pensions on 7/21/05

The Project BioShield II Act "provide[s] incentives to increase research by private sector entities to develop medical countermeasures to prevent, detect, identify, contain, and treat illnesses, including those associated with biological, chemical, nuclear, or radiological weapons attack or an infectious disease outbreak." According to the Congressional Research Service Summary, the Act, among other matters, "creates incentives for the development of countermeasures, including: (1) payments to manufacturers; (2) accelerated approval of countermeasures; (3) patent term restoration and extension; (4) exclusive marketing; (5) federal tax incentives; (6) reimbursements for production costs; (7) expedited processing of visa applications; (8) grants and contracts for the construction and management of biosafety level 3-4 facilities; and (9) grants and scholarships for personnel to conduct biodefense and infectious disease research."


To amend the Public Health Service Act to provide for an increase in the number of political subdivisions directly receiving awards under the program for improving State and local preparedness for bioterrorism and other public health emergencies (HTML) (PDF)
Congressional Research Service Summary
House Bill H.R. 1987
Introduced to House: April 28, 2005
Sponsor: Representative Gene Green [TX-29]
Status: Referred to the Subcommittee on Health within the House Committee on Energy and Commerce on 5/23/05

According to the Congressional Research Service Summary, this legislation "amends the Public Health Service Act to allow the Secretary of Health and Human Services to increase, relative to FY 2005, the number of political subdivisions or consortia that receive grants under a program to enhance the security of the United States with respect to bioterrorism and other public health emergencies, with priority given to political subdivisions that have a substantial number of residents and face a high degree of risk from bioterrorist attacks or other public health emergencies."


Homeland Security Food and Agriculture Act (HTML) (PDF)
Congressional Research Service Summary
Senate Report 109-209 (HTML) (PDF)
Senate Bill S. 572
Introduced to Senate: March 9, 2005
Sponsor: Senator Daniel Akaka [HI]
Status: Placed on Senate Legislative Calendar on 9/27/05

The Homeland Security Food and Agriculture Act is "a bill to amend the Homeland Security Act of 2002 to give additional biosecurity responsibilities to the Department of Homeland Security." According to the Congressional Research Service Summary, the Act "direct[s] the Secretary of Homeland Security to carry out a program to protect the U.S. agriculture and food supply from agroterrorist acts" and "states that such program shall provide for: (1) advising and coordinating with federal, state, local, regional, and tribal homeland security officials regarding prevention and preparedness for, and the response to, an agroterrorist act; and (2) executing the Secretary's agriculture security responsibilities described in specified Homeland Security Presidential Directives."


Protecting America in the War on Terror Act (HTML) (PDF)
Congressional Research Service Summary
Senate Bill S. 3
Introduced to Senate: January 24, 2005
Sponsor: Senator Judd Gregg [NH]
Status: Referred to Committee on Finance on 1/24/05

Part of the Protecting America in the War on Terror Act is the Biopreparedness Act. Some of the provisions include: "(1) extending the patent terms for certain countermeasure products; (2) exempting meetings between the Secretary of Health and Human Services and parties developing priority countermeasures from antitrust laws; (3) establishing the Commission on Countermeasure and Vaccine Regulation; (4) prohibiting a State from establishing requirements different from certain Federal food and drug laws; (5) allowing tax credits for vaccine and countermeasures manufacturing and research; and (6) requiring procedures for inspecting imported live animals." Also included in the War on Terror Act is the Homeland Security Technology Improvement Act which would allow state and local law enforcement to acquire certain counterterrorism technologies, equipment, and information and prohibit deliberate transport of biological agents and chemical weapons aboard vessels.




U.S. LawsTop

Pandemic and All-Hazards Preparedness Act (HTML) (PDF)
Congressional Research Service Summary
Congressional Research Service Report
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.


USA PATRIOT Improvement and Reauthorization Act of 2005 (HTML) (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 (HTML) (PDF)
Congressional Research Service Summary
Congressional Research Service Report
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."


Smallpox Emergency Personnel Protection Act (HTML) (PDF)
Congressional Research Service Summary
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."


Public Health Security and Bioterrorism Preparedness and Response Act (HTML) (PDF)
Congressional Research Service Summary
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 (HTML) (PDF)
Congressional Research Service Summary
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.


Chemical Weapons Convention Implementation Act (HTML) (PDF)
Congressional Research Service Summary
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.


Antiterrorism and Effective Death Penalty Act (HTML) (PDF)
Congressional Research Service Summary
Congressional Research Service Report
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.


Biological Weapons Anti-Terrorism Act
Congressional Research Service Summary
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.




Executive Orders and DirectivesTop

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 twotiered 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 Top

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 (HTML) (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 (HTML) (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 (HTML) (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 TreatiesTop

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 (HTML) (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 (HTML) (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.


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