A bill to prevent the proliferation of weapons of mass destruction, to prepare for attacks using weapons of mass destruction, and for other purposes.

A bill to reauthorize the Select Agent Program by amending the Public Health Service Act and the Agricultural Bioterrorism Protection Act of 2002 and to improve oversight of high containment laboratories.

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.

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.

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.

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.

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.

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.

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."

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."

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."

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."

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."

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."

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."

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. Laws

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.

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.

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."

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."

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."

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.

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.

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.

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 Directives

 "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."

 "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."

By evaluating biodefense programs and initiatives, Biodefense for the 21^st 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 "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.

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.

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 "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.

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.

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.

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

"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."

"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."

"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

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.

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.

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.