Reports 

Nuclear, Biological, and Chemical Weapons and Missiles: Status and Trends
Congressional Research Service Report
Published: February 2008

"The United States has long recognized the dangers inherent in the spread of nuclear, biological, and chemical (NBC) weapons, and missiles. This report, which analyzes NBC weapons programs potential threat patterns around the globe, is updated as needed."

Ready or Not? Protecting The Public's Health From Diseases, Disasters, And Bioterrorism
Trust for America's Health
Published: December 2007

"This report finds that on some measures, significant progress has been made in the nation's preparedness. There are important areas, however, where continued, concerted action is needed. From assuring an adequate stockpile of pandemic influenza countermeasures to having a public health workforce large enough and trained enough to respond to an emergency, federal and state policies still fall short of their stated goals."

Pandemic and All-Hazards Preparedness Act (Public Law 109-417) Progress Report
Assistant Secretary for Preparedness and Response
Department of Health and Human Services
Published: November 2007

"In December 2006 Congress passed and the President signed the Pandemic and All-Hazards Preparedness Act (PAHPA), Public Law No. 109-417, which has broad implications for HHS's preparedness and response activities. The Act established within the Department a new Assistant Secretary for Preparedness and Response (ASPR); provided new authorities for a number of programs, including the advanced development and acquisition of medical countermeasures; and called for the establishment of a quadrennial National Health Security Strategy. This Progress Report highlights some of the major activities that the Department has undertaken since the enactment of PAHPA. It also includes a preview of the Way Forward - activities the Department plans as it moves ahead to continue implementing the legislation. The Report is divided into eight sections, each of which addresses a major program area under PAHPA."

Technical Input on the National Institutes of Health's Draft Supplementary Risk Assessments and Site Suitability Analyses for the National Emerging Infectious Diseases Laboratory, Boston University
National Research Council
Published: November 2007

"The National Research Council (NRC) established an expert Committee to provide technical input on the document Draft Supplementary Risk Assessments and Site Suitability Analyses for the National Emerging Infectious Diseases Laboratory, Boston University (hereafter referred to as the Draft Supplemental Environmental Report, or DSER) to the Executive Office of Energy and Environmental Affairs of the Commonwealth of Massachusetts. The DSER stated that it was prepared by the National Institutes of Health (NIH) in response to concerns raised in a federal court proceeding to address aspects of the construction of a proposed National Biocontainment Laboratory containing a Biosafety Level 4 (BSL-4) facility in the South End of the City of Boston, Massachusetts (the National Emerging Infectious Diseases Laboratory, or NEIDL)."

Towards a New Implementation Mechanism for the BTWC
Graham S. Pearson and Nicholas A. Sims
University of Bradford
Published: November 2007

"At the Meeting of Experts on 20 to 24 August 2007 it was notable that a number of the States Parties who made statements in the opening plenary session made reference to the importance of an implementation mechanism for the Biological and Toxin Weapons Convention (BTWC). The case for making progress in this respect was argued in the chapter on Article V: Consultation and Cooperation in the Bradford Briefing Book Key Points for the Sixth Review Conference that was circulated to the States Parties to the BTWC in September 2006. This Review Conference Paper has been written to consider how best the States Parties can move forward to a new implementation mechanism as it was evident that some of the statements made at the Meeting of Experts in August 2007 were not reflecting the reality of the situation and appeared to suggest that the States Parties might just resume consideration of the draft 'rolling text' of the legally binding instrument as it was when last considered in 2001."

Science and Security in a Post 9/11 World
National Research Council
Published: October 2007

"Recognizing that a robust national science and engineering research enterprise is critical to our Nation's overall economic well-being and security, the National Academies also took a close look at how the events of September 11th might affect our research universities and institutions and organized a two-day symposium in Washington, D.C., in December 2001. During those deliberations, it became clear that over time there would be a need to assess the effects of new and proposed legislation and regulations-as well as the enforcement of existing requirements-on the conduct of research and the training of scientists at U.S. academic institutions. Subsequently, the House Committee on Science and Technology, under the leadership of Representatives Boehlert and Gordon, asked the National Academies to organize regional meetings on university campuses to gain a better understanding of whether concerns about our country's need to protect itself from terrorist threats had resulted in policy changes that were altering our ability to attract the best and brightest scientists and engineers and to undertake and conduct leading-edge research. Those meetings formed the basis of this report and the recommendations of this committee."

High-Containment Biosafety Laboratories: Preliminary Observations on the Oversight of the Proliferation of BSL-3 and BSL-4 Laboratories in the United States
Government Accountability Office
Published: October 2007

"In response to the global spread of emerging infectious diseases and the threat of bioterrorism, high-containment biosafety laboratories (BSL)--specifically biosafety level (BSL)-3 and BSL-4--have been proliferating in the United States. These labs-classified by the type of agents used and the risk posed to personnel, the environment, and the community-often contain the most dangerous infectious disease agents, such as Ebola, smallpox, and avian influenza. This testimony addresses (1) the extent to which there has been a proliferation of BSL-3 and BSL-4 labs, (2) federal agencies' responsibility for tracking this proliferation and determining the associated risks, and (3) the lessons that can be learned from recent incidents at three high-containment biosafety labs."

Beijing on Biohazards:
Chinese Experts on Bioweapons Nonproliferation Issues
The James Martin Center for Nonproliferation Studies, Amy E. Smithson, Editor
Published: September 2007

"China's attitudes towards arms control in general and biological weapons nonproliferation in particular have evolved over the last few decades. Beijing on Biohazards provides an informative and intriguing snapshot of current Chinese views on a variety of interlocking topics that fall under the umbrella of biological weapons nonproliferation."

NIAID Strategic Plan for Biodefense Research
National Institute of Allergy and Infectious Disease
Published: September 2007

"This updated Strategic Plan for Biodefense Research builds upon the successes and investments of the first plan and accompanying research agendas; it is consistent with the HHS Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Strategy for Chemical, Biological, Radiological and Nuclear Threats, the HHS PHEMCE Implementation Plan, and the Homeland Security Presidential Directive (HSPD)-18, which outline strategies for identifying medical countermeasure requirements and establishing priorities for their research, development, and acquisition. These successes and investments include advances in understanding the biology of specific pathogens and the host's immune response; construction of new biocontainment laboratory facilities; professional training in biosafety and biocontainment; and establishment of critical research resources and infrastructure that support applied science and advanced product development."

A Code of Conduct for Biosecurity
Biosecurity Working Group of the InterAcademy Panel
Published: August 2007

"The Dutch Ministry of Education, Culture and Science asked the Royal Netherlands Academy of Arts and Sciences (knaw) to provide it with advice and input for a national Biosecurity Code of Conduct for scientists, as required by the Biological and Toxin Weapons Convention (btwc), which was ratified in 1972. The request arose in part from the knaw's active contribution to the Statement on Biosecurity issued by the InterAcademy Panel (iap) in 2005. The knaw is the iap's 'lead academy' for activities relating to biosecurity. The knaw agreed to the ministry's request and carried out a study into the possibilities and conditions for a code of conduct on Biosecurity."

Green Paper On Bio-Preparedness
Commission Of The European Communities
Published: July 2007

"This Green Paper intends to stimulate a debate and launch a process of consultation at European level on how to reduce biological risks, and to enhance preparedness and response ("bio-preparedness")". This consultation may lead to concrete actions within the ambit of the Community's and Union's competence, in the field of bio-preparedness in 2008. Concrete actions may have to be presented and developed separately in specific strands of work following the applicable decision-making procedures and, where appropriate, impact assessment."

Federal Funding for Biological Weapons Prevention and Defense,
Fiscal Years 2001 to 2008
Center for Arms Control and Non-Proliferation
Published: June 2007

"Since the 2001 terrorist attacks on the United States, the U.S. government has spent or allocated over $40 billion among 11 federal departments and agencies to address the threat of biological weapons. For Fiscal Year 2008 (FY2008), the Bush Administration is proposing an additional $6.77 billion in bioweapons-related spending, approximately $550 million (9%) more than the amount that Congress appropriated for FY2007. U.S. funding for bioweapons-related activities focuses primarily on research, development, and acquisition of medical countermeasures and protective equipment, enhancing medical surveillance and environmental detection of biological weapons agents, and improving state, local, and hospital preparedness. The Department of Defense proposes to double the amount of money that it spends on efforts to prevent the development, acquisition and use of biological weapons by states and terrorists and other non-state actors in FY2008. However, activities aimed at prevention still account for less than 2% of all federal bioweapons-related funding since FY2001. Further strengthening of prevention efforts, including a commitment to broad cooperative international action, are essential for improving our nation's security."

Proposed Framework for the Oversight of Dual Use Life Sciences Research: Strategies for Minimizing the Potential Misuse of Research Information
National Science Advisory Board for Biosecurity
Published: June 2007

"In this report, the NSABB identifies principles that should underpin the oversight of dual use life sciences research, lists key features of such oversight (e.g., federal guidelines, awareness and education, evaluation and review of research for dual use potential, assessment and management of risk, compliance, and periodic evaluation at the local (e.g., research institution) and federal levels of the impact and effectiveness of oversight procedures) and proposes roles and responsibilities for researchers, institutions, the institutional review entity, and the NSABB and other federal government entities. The report also describes the major steps in local oversight of dual use life sciences research, including evaluation of life sciences research for its dual use potential, review of research identified as being potentially dual use of concern, conduct of dual use research of concern in accordance with risk management strategies, and responsible communication of research with dual use potential."

Report on Activities and Programs for Countering Proliferation and NBC Terrorism, Executive Summary
Counterproliferation Program Review Committee
Published: May 2007

"This Report on Activities and Programs for Countering Proliferation and NBC Terrorism is submitted to the United States Congress as required by the National Defense Authorization Act for Fiscal Year 1994 (as amended). The report provides the findings of the interagency Counterproliferation Program Review Committee (CPRC). The CPRC was chartered by Congress in 1994 to report on the activities and programs of the Department of Defense (DoD), Department of Energy (DOE), and the intelligence community (IC) that address improvements in the U.S. Government's efforts to combat weapons of mass destruction (WMD) and their means of delivery. In 1997, Congress broadened the CPRC's responsibilities to review those research and development (R&D) activities and programs related to countering terrorist nuclear, biological, and chemical threats."

Transformational Medical Technologies Initiative (TMTI)
Fiscal Year 2007 (FY 2007) Congressional Report
Department of Defense
Published: 2007

"The mission of TMTI is to protect the warfighter from conventional or genetically engineered biological threats, known or emerging, by accelerating the seamless discovery and development of broad-spectrum medical countermeasures through the use of novel technology platforms and innovative management approaches. The TMTI program implements one of the key decisions in the Quadrennial Defense Review (QDR) 2006: develop broad-spectrum medical countermeasures against advanced bio-terror threats, including genetically engineered, intracellular bacterial pathogens and hemorrhagic fevers."

The Pandemic and All-Hazards Preparedness Act: Provisions and Changes to Preexisting Law
Congressional Research Service
Published: March 2007

"The 109th Congress passed P.L. 109-417, the Pandemic and All-Hazards Preparedness Act. The act reauthorized a number of expiring preparedness and response programs in the Public Health Service Act, and established some new authorities, including the creation of a Biomedical Advanced Research and Development Authority (BARDA), a new office in HHS to support, coordinate, and provide oversight of advanced development of vaccines and biodefense countermeasures. The act's provisions reflected the concerns of Members of the 109th Congress and others regarding the flawed response to Hurricane Katrina in 2005, and the threat of a possible influenza pandemic."

Project BioShield: Appropriations, Acquisitions, and Policy Implementation Issues for Congress
Congressional Research Service
Published: March 2007

"This report discusses actions taken by Congress and the Administration that have affected this program, describes the decision-making process for choosing countermeasures, describes the countermeasures for which the Department of Health and Human Services (HHS) has contracted, and discusses accounting discrepancies present in budget documents describing Project BioShield."

Anthrax Detection: DHS Cannot Ensure That Sampling Activities Will Be Validated
Government Accountability Office
Published: March 2007

"In September and October 2001, contaminated letters laced with Bacillus anthracis were sent through the mail to two U.S. senators and members of the media. Postal facilities in New Jersey, Washington, D.C., and elsewhere became heavily contaminated. The anthrax incidents highlighted major gaps in civilian preparedness to detect anthrax contamination in buildings. GAO was asked to describe and assess federal agencies' activities to detect anthrax in postal facilities, assess the results of agencies' testing, and assess whether agencies' detection activities were validated."

Biological Research Laboratories: Issues Associated with the Expansion of Laboratories Funded by the National Institute of Allergy and Infectious Diseases
Government Accountability Office
Published: February 2007

"In response to the Strategic Plan, NIAID established the National Biocontainment Laboratory (NBL) and Regional Biocontainment Laboratory (RBL) construction programs. The overall objective of the NBL construction program is to provide funding to design and construct state-of-the-art biosafety level (BSL) 4, 3, and 2 laboratories, including associated research and administrative support space, and the objective of the RBL construction program is to provide similar facilities containing BSL-3 and -2 laboratories...In fiscal year 2003, NIAID awarded funding to two universities to construct NBLs and to nine universities to construct RBLs, and in fiscal year 2005, NIAID awarded funding to four more universities to construct RBLs. As of January 2007, the NBLs and RBLs are at various stages of design and construction and are not yet operational. Because the deliberate or accidental release of biological pathogens from a biocontainment laboratory could have disastrous consequences, concerns exist about the oversight of these laboratories. This report responds to your November 30, 2005, request that we provide information associated with the construction of NBLs and RBLs funded by NIAID in fiscal years 2003 and 2005."

NIAID Biodefense Research Agenda for CDC Category A Agents
National Institutes of Health
National Institute of Allergy and Infectious Diseases
Overview of 2006 Progress Report

"It has been three years since the National Institute of Allergy and Infectious Diseases (NIAID) released its first research progress report on Category A agents. Since that time, extraordinary progress has been made to increase scientific knowledge of these potentially deadly pathogens and to advance medical countermeasures along the research and development pathway."

NIAID Biodefense Research Agenda for CDC Category A Agents
National Institutes of Health
National Institute of Allergy and Infectious Diseases
2006 Progress Report

"In 2002, the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), convened a Blue Ribbon Panel on Bioterrorism and Its Implications for Biomedical Research. This panel of experts came together to provide guidance on the Institute's biodefense research agenda, which was published soon afterward. In 2003, NIAID released its first progress report on accomplishments toward the goals outlined in the Research Agenda. To demonstrate the enormity of the research efforts conducted over the last several years, the 2006 progress report details many examples of scientific accomplishments organized according to the areas of emphasis specified in the Research Agenda: biology of the microbe, host response, vaccines, diagnostics, and therapeutics. The achievements made meet all of the immediate goals outlined in the Research Agenda."

"DNA synthesis technology, in combination with other rapidly-evolving capabilities in the life sciences, such as directed molecular evolution and viral reverse genetics, has galvanized segments of the scientific community. It also has captured the attention of the general public and policymakers, and prompted far-reaching questions about the potential uses of these techniques-including the synthesis of novel forms of life. These techniques promise to accelerate scientific discovery and provide access to previously-unexplored biological and molecular diversity. This technology also is employed in the field of Synthetic Genomics to create sophisticated live vaccines and to discover new therapeutics for infectious diseases. However, this same technology can be misused to generate dangerous pathogens de novo that are subject to oversight, thus circumventing the extant regulatory framework for controlling the possession and use of such organisms. This dichotomy illustrates the dual use nature of synthetic genomics and underscores the need to develop strategies to address the possibility that knowledge and technologies emanating from vitally important biological research will be misused to threaten public health or national security."

"This workshop, held on 4 - 6 September 2006, brought together 84 leading international scientific and policy experts from 23 countries to discuss scientific and technological developments most relevant to the operation of the Biological and Toxin Weapons Convention (BTWC). The meeting aimed to inform the delegates at the Sixth Review Conference being held in Geneva in November 2006. Developments addressed included synthetic biology, post genomic technologies, immunological research, drug discovery and delivery, agricultural and environmental biotechnology, and diagnosis and surveillance of infectious diseases. These advances will undoubtedly bring positive benefits to humankind. The challenge facing the international scientific and political communities is to identify what measures can be taken to reduce the chance of misusing these developments without jeopardising the enormous potential benefits, that is to manage what is often called the 'dual use' risk."

"The threat of bio-terrorism is real. It is becoming increasingly possible for terrorists to be able to produce and deploy bio-weapons, as the volume and sophistication of the necessary information becomes ever more accessible through publications, the internet, and other sources. Given the magnitude of the harm that could be caused by a bioterrorist attack -- an untold number of deaths is possible -- it is clear to Interpol that we must take this threat seriously. This Bio-terrorism Incident Pre-Planning and Response Guide provides important tools to use in prevention and response efforts. Other tools are also provided by Interpol, including web resources and training opportunities available through the Bio-terrorism Unit working in conjunction with National Central Bureaus."

"The federal government's plan for responding to the twin threats of natural pandemics and biological terrorism bears a striking resemblance to the plan that was to guide the federal response to Hurricane Katrina: both assume that state and local entities have the resources and capabilities to take over primary responsibility for managing the crisis. Unfortunately, the reality is that they do not...Since 9/11, the United States has undertaken a series of worthy efforts to strengthen biosecurity, but they do not add up to an effective biosecurity system for all Americans. The primary reason is a failure to correlate plans on paper with the capabilities needed to implement them. The report offers more than three dozen recommendations in the interrelated and mutually reinforcing areas of global nonproliferation, domestic and international public health, and scientific research and development."

"In the years since the 2001 terrorist attacks on the United States, the U.S. government has spent or allocated over $36 billion among 11 federal departments and agencies to address the threat of biological weapons. For Fiscal Year 2007 (FY2007), the Bush Administration is proposing an additional $8 billion in bioweapons-related spending, approximately $120 million (or 1.5%) more than the amount that Congress appropriated for FY2006. This funding has and continues to focus primarily on research, development, and acquisition of medical countermeasures and protective equipment, enhancing medical surveillance and environmental detection of biological weapons agents, and improving state, local, and hospital preparedness. Only 2% of all federal bioweapons-related funding has been devoted to efforts to prevent the development, acquisition, and use of biological weapons by states and terrorists and other non-state actors."

"There are very few transparency enhancement mechanisms in the area of biological arms control and the most important thus far, are the Confidence Building Measures (CBMs). Since their inception, CBMs have suffered from weak participation and mixed quality. Almost half of the States Parties have never submitted a CBM report. In terms of quality, submissions have been plagued with inaccuracies and omissions. While on the one hand, any CBM submission can be seen as a commitment to the Biological Weapons Convention (BWC), in order for there to be an increasing degree of transparency and ultimately confidence in compliance, CBMs need to be accurate, complete, submitted regularly and they must address the relevant topics. This paper analyses information provided in CBM Form F and assesses its accuracy and completeness. CBM Form F requests information on past offensive and defensive biological research and development programmes."

This report examines information regarding Iraq's alleged mobile biological production capacity and speculates what was done to determine if that capability was possible.

"This report argues for the aim of outlawing all weapons of mass destruction. It concentrates on what could and should be short- and medium-term steps in this direction. The Commission takes the view that, while many unilateral, bilateral and regional steps and measures are needed and helpful, the abhorrence of the peoples of all nations of weapons of mass destruction requires an approach that builds on the cooperation and support of the entire world community. Regimes that invite and encourage the adherence of all states must be established and managed on a global scale. Treaties and international organizations, notably the United Nations, are indispensable tools and forums."

"In April 2005, RANSAC [Russian American Nuclear Security Advisory Council] and LNCV [Landau Network-Centro Volta] held a meeting titled Advancing International Cooperation on Bio-Initiatives in Russia and the CIS in Rome, Italy. The participants included government officials and academic experts from key Western countries, and biological scientists and biosecurity experts from Russia, Kazakhstan, and Uzbekistan. The event was the second in a series of meetings on how to further cooperation between these governments and non-governmental organizations (NGOs) to prevent biological terrorism by promoting biosecurity, biosafety, and the involvement of commercial entities in key biological institutes. The event provided for the discussion of a broad range of topics from a spectrum of specialists. The following is a digest of the findings from the RANSAC and LNCV organizers of the meeting and the conference proceedings."

"GAO has done many studies over the past 7 years on anthrax vaccine safety and anthrax detection methods. GAO has reported the lack of validated methods for detecting anthrax contamination and has recommended a coordinated approach to improving the overall process for detecting anthrax that included a probability-based sampling strategy. GAO also reported that the vaccine has not been adequately tested on humans; no studies have been done to determine the optimum number of doses; the long-term safety has not been studied and data on short-term reactions are limited; however, women report higher rates of reactions than do men. Given these problems, GAO recommended the development, of a better, alternative vaccine. The Secretary of Homeland Security needs to develop a formal strategic plan, including a roadmap, outlining how individual agency efforts would lead to the validation of the overall sampling process."

"An integral part of the development of new vaccines and therapeutics is obtaining the necessary approvals from the U.S. Food and Drug Administration both for their initial use in people and their eventual licensure for general use. The present accelerated pace of development, however, has led to several additional needs: standardization of methods for the generation and characterization of aerosols of bioterrorism agents for use in animal studies (necessary for licensure of vaccines and therapeutics), characterization of the threat to the population, and expansion of the number of laboratories conducting the research. The Committee on Animal Models for Testing Interventions Against Aerosolized Bioterrorism Agents was convened by the National Research Council to address these issues. It was tasked by its sponsor, the National Institute of Allergy and Infectious Disease, to prepare a short consensus report that articulates the difficulties of testing countermeasures to aerosolized bioterrorism agents and considers whether there are opportunities for improving current approaches to animal testing of countermeasures against aerosols by applying knowledge from other fields of science."

"The possibility that an adversary may use chemical or biological weapons against U.S. forces makes it important for a weapon system to be able to survive such attacks. In the National Defense Authorization Act for Fiscal Year 2005, Congress mandated that the Department of Defense submit a plan to address weapon system chemical and biological survivability by February 28, 2005. This plan was to include developing a centralized database with information about the effects of chemical and biological agents on materials used in weapon systems. DOD did not submit its plan as mandated. GAO was asked to evaluate (1) the extent to which DOD addresses weapon system chemical and biological survivability during the acquisition process, and (2) DOD's internal controls for maintaining a comprehensive database that includes chemical and biological survivability research and test data for weapon system design and development."

"This Instruction: implements security policy and assigns responsibilities under [DoD Directive 5210.88, 'Safeguarding Biological Select Agents and Toxins']; establishes minimum standards for securing and safeguarding biological select agents and toxins (BSAT) in the custody or possession of the Department of Defense; establishes the criteria for personnel regarding BSAT, including requirements for the Biological Personnel Reliability Program (BPRP); permits BSAT to be used for bona fide research and other peaceful purposes and ensures the security of BSAT from attack, theft, wrongful use, and inappropriate transfer to unauthorized personnel, organizations, and/or laboratories; directs responsible personnel and agencies to ensure secure access and control of applicable BSAT and to establish minimum physical security measures; establishes requirements for initial and periodic security reviews, threat and vulnerability assessments, and inspections."

"This directive establishes the Air Force Biological Security Program and outlines policy to ensure the Air Force safeguards biological select agents and toxins in the manner prescribed by higher Department of Defense (DoD) guidance and the Code of Federal Regulations (CFR). This directive applies to all facilities under Air Force command (to include Air National Guard and Air Force Reserve Command facilities) using, possessing, transferring, or receiving biological select agents or toxins, as well as Air Force contracted facilities furnished DoD-supplied biological select agents or toxins. Compliance with this directive is mandatory for all applicable Air Force military, civilian, and contractor personnel."

"The present report contains recommendations for a global counter-terrorism strategy, with an emphasis on specific proposals for strengthening the capacity of the United Nations to combat terrorism. In formulating these recommendations, [Kofi Annan has] been assisted by the Counter-Terrorism Implementation Task Force, which [Annan] created in 2005 to bring together key actors in the United Nations system and its partners dealing with counter-terrorism issues." According to the report, "the most important under-addressed threat relating to terrorism, and one which acutely requires new thinking on the part of the international community, is that of terrorists using a biological weapon."

"To provide an opportunity for focused discussion of ideas and strategy, the Geneva Forum organised an informal residential seminar on 9-10 March 2006 entitled, Meeting the Challenges of Reviewing the Biological and Toxin Weapons Convention. The seminar brought together 35 high-level representatives of governments, international organizations and non-governmental organizations from around the world...The range of ideas and proposals put forward by participants at the Glion meeting demonstrate that States have been giving serious consideration to how to make the most of the sixth BTWC Review Conference. In presenting some of these ideas and proposals, this report hopes to enrich debate and discussion in the run-up to the Review Conference and to contribute to its successful outcome."

"Some of the same scientific and technological advances that provide great benefits to society can also be used maliciously. For example, biological research on the origins of virulence, the development of vaccines, and the genetic manipulation of biological agents are simultaneously relevant to public health and to biological weapons. Some policymakers are concerned that publishing such dual-use research results in the open literature could aid or further the goals of adversaries of the United States. The National Science Advisory Board for Biosecurity (NSABB) was established to facilitate understanding and oversight of such potentially contentious research. Issues of potential congressional interest include the mechanism and appropriateness of NSABB review of scientific research; the scope of NSABB recommendations with respect to publication of scientific research; the domestic and international adoption of practices or codes developed by the NSABB; the implementation of NSABB guidelines at the local level; and applicability of NSABB recommendations to federal agencies other than HHS."

"This report traces the evolution of SBU [sensitive but unclassified]-related controls; summarizes actions taken to protect certain types of scientific and technical information; describes critiques of some control policies; and summarizes proposals and actions, including congressional, executive and other initiatives, to clarify these issues and develop policies that serve various stakeholders. It also raises issues that may warrant further attention."

"This report indicates the sweep of science and technology in many public policy issues, although it cannot provide a comprehensive examination of every science or technology issue which may be of interest to Congress. In some areas, such as global climate change and stem cell research, the importance of science and technology is explicit and in the forefront of the policy debate. In others, such as patent protection and telecommunications reform, science and technology may not be as explicit, but are important drivers affecting how policy makers may make decisions. This report also addresses key issues that directly affect, or are affected by, science and technology. Other mechanisms which may indirectly impact science and technology - such as tax, antitrust, and trade policies - are outside the scope of this report."

"Over 300 Asian life scientists were surveyed to provide insight into work with infectious agents. This report provides the reader with a more complete understanding of the current practices employed to study infectious agents by laboratories located in Asian countries-segmented by level of biotechnology sophistication. The respondents have a variety of research objectives and study over 60 different pathogens and toxins. Many of the respondents indicated that their work was hampered by lack of adequate resources and the difficulty of accessing critical resources. The survey results also demonstrate that there appears to be better awareness of laboratory biosafety issues compared to laboratory biosecurity. Perhaps not surprisingly, many of these researchers work with pathogens and toxins under less stringent laboratory biosafety and biosecurity conditions than would be typical for laboratories in the West."

"Rather than a formal risk assessment the Committee has proposed, instead, a conceptual framework for how to think about the nature of the future threat landscape. Indeed, as the world becomes more competent and sophisticated in the biological sciences, it is vitally important that the national security, public health and biomedical science communities have the necessary knowledge and tools to address the present and future applications of advances in the life sciences."

"The livestock industry, which contributes over $100 billion annually to the national economy, is vulnerable to foreign animal diseases that, if introduced in the United States, could cause severe economic losses. To protect against such losses, critical research and diagnostic activities are conducted at the Plum Island Animal Disease Center in New York. The Department of Agriculture (USDA) was responsible for Plum Island until June 2003, when provisions of the Homeland Security Act of 2002 transferred the facility to the Department of Homeland Security (DHS). Under an interagency agreement, USDA continues to work on foreign animal diseases at the island. GAO examined (1) DHS and USDA coordination of research and diagnostic activities, (2) changes in research and diagnostic priorities since the transfer, and (3) long-term objectives of joint activities at Plum Island."

"This report offers a listing and brief description of legal provisions that require or authorize the imposition of some form of economic sanction against countries, companies, or persons who violate U.S. nonproliferation norms. For each provision, information is included on what triggers the imposition of sanctions, their duration, what authority the President has to delay or abstain from imposing sanctions, and what authority the President has to waive the imposition of sanctions. This report also includes a list of legislation pending before the 109th Congress that, if enacted, would be relevant in the use of economic sanctions as a part of U.S. nonproliferation policy."

"This study examined the content of hospital terrorism preparedness emergency response plans; whether those plans had been updated since September 11, 2001; collaboration of hospitals with outside organizations; clinician training in the management of biological, chemical, explosive, and nuclear exposures; drills on the response plans; and equipment and bed capacity." This examination was done through a Bioterrorism and Mass Casualty Supplement included in the 2003 National Hospital Ambulatory Medical Care Survey (NHAMCS), - an annual survey of a probability sample of approximately 500 non-Federal general and short-stay hospitals in the United States."

"This year marks the 80th anniversary of the 1925 Geneva Protocol and the 30th anniversary of the entry into force in 1975 of the 1972 Biological and Toxin Weapons Convention. These instruments are relatively widely accepted: 133 states are party to the protocol and 155 to the convention. It was thus felt opportune to draft the following model legislation, not only in light of the anniversaries but also in view of the fact that domestic implementation of the Convention has been relatively weak, and in response to a growing number of requests to the International Committee of the Red Cross (ICRC) by States Parties for assistance in fulfilling their obligations."

"The report offered a number of recommendations that could help restore Russia's ability to join with the United States and the broader international community in leading an expanded global effort to control infectious diseases. A proposed bilateral intergovernmental commission could play a pivotal role toward that end as cooperation moves from assistance to partnership. The report proposed the establishment of two model State Sanitary Epidemiological Surveillance Centers in Russia, more focused support of competitively selected Russian research groups as centers of excellence, the promotion of investments in biotechnology niches that are well suited for Russian companies, and expanded opportunities for young scientists to achieve scientific leadership positions in Russia. Also, the report highlighted the importance of U.S. programs that support the integration of former Soviet defense scientists with civilian researchers who had not been involved in military-related activities."

"The public, scientific community, and policy makers must understand that the threat of an influenza pandemic is real and imminent. To this end, we have republished a section of the Microbial Threats report entitled: -Influenza: A Case in Point- in an effort to educate readers about the ecology of influenza and facilitate an informed response. In addition, we have included the executive summary of the report that has key information about the factors that lead to the emergence of microbial threats and the recommendations of the committee for implementing an effective and appropriate response."

Project BioShield (PDF)
Congressional Research Service Report
Resources, Science, and Technology Division
Frank Gottron, Analyst in Science and Technology Policy
Code RS21507
Published: June 2005

"Many potential biological terrorism agents lack available countermeasures. President Bush proposed Project BioShield to address this need. The 108th Congress considered this proposal in S. 15 (Gregg), S. 1504 (Gregg), and H.R. 2122 (Tauzin). President Bush signed S. 15 into law on July 21, 2004 (The Project BioShield Act of 2004, P.L. 108-276). The main provisions of this law include (1) relaxing procedures for bioterrorism-related procurement, hiring, and awarding research grants; (2) guaranteeing a federal government market for new biomedical countermeasures; and (3) permitting emergency use of unapproved countermeasures. Project BioShield countermeasure procurement is funded by the Department of Homeland Security Appropriations Act, 2004 (P.L. 108-90) which advance-appropriated $5.593 billion for FY2004-FY2013. Additional measures to encourage the development of countermeasures are being considered by the 109th Congress in S. 3 (Gregg) and S. 975 (Lieberman)."

"In 2004, the NIAID recognized a need to further refine information about current BSL-3 laboratory capacity in the US. In partnership with American Society of Microbiologist (ASM), NIAID conducted a survey of academic, biotechnology, and pharmaceutical facilities in the US to help better identify the location, capacity and status of existing and operating US laboratory facilities that incorporate Biosafety Level 3 (BSL-3) containment. BSL-3 containment is applicable to clinical, diagnostic, teaching, research or production facilities in which work is done with indigenous or exotic agents that may cause serious or potentially lethal disease as a result of exposure by the inhalation route."

"As part of its study, the committee held a workshop at the Instituto Nacional de Salud Publica (National Institute of Public Health) in Cuernavaca, Mexico, in September 2004. The purpose of the workshop was to sample global perspectives on the current advancing technology landscape. Experts from different fields and from around the world presented their diverse outlooks on: advancing technologies and forces that drive technological progress; local and regional capabilities for life sciences research, development, and application (both beneficial and malevolent); national perceptions and awareness of the risks associated with advancing technologies; and measures that have been taken, or could or should be taken, to reduce the potential for misapplication of technology(ies) or malevolent purposes. This report summarizes the formal and informal discussions held at the workshop."

"Patents appear to be important in the promotion of innovation, particularly in the pharmaceutical sector. This report explores the role of patents in encouraging the development and commercialization of new inventions and discusses the relationships between patent ownership and the generation of biomedical products. However, the grant of a patent on a pharmaceutical does not permit marketing of the product without the approval of the Food and Drug Administration (FDA). Thus, this report also examines policies concerning the use of FDA marketing exclusivity as an additional incentive to industry research and development (R&D) in this arena. Current law and suggested legislative changes are discussed to provide a context for further exploration of the related issues.

"Oversight of federal research and development in biodefense is an area of international interest, as only defensive research activities are allowed under the Biological and Toxin Weapons Convention. Congressional oversight of programs, especially those performed in federal facilities for homeland security purposes, is considered key to maintaining transparency in biodefense. The Department of Homeland Security (DHS) and the Department of Health and Human Services (HHS) play leading roles protecting civilians against biological weapons. The Department of Homeland Security has requested and received appropriated funding for the construction of the National Biodefense Analysis and Countermeasures Center (NBACC), a biodefense facility dedicated to homeland security activities. This facility, the first DHS laboratory focused on biodefense, has drawn the attention of Congress, arms control experts, and others. This report will outline the organizational structure of NBACC, describe its mission, and report the funding DHS has received for construction of its facility. It will then discuss policy issues such as funding for NBACC facility construction, oversight of NBACC research, and the potential for duplication of federal effort between NBACC and other agencies."

"In September and October 2001, letters laced with Bacillus anthracis (anthrax) spores were sent through the mail to two U.S. senators and to members of the media. These letters led to the first U.S. cases of anthrax disease related to bioterrorism. In all, 22 individuals, in four states and Washington, D.C., contracted anthrax disease; 5 died. These cases prompted the Subcommittee [on National Security, Emerging Threats, and International Relations in the House of Representatives] to ask GAO to describe and assess federal agencies' activities to detect anthrax in postal facilities, assess the results of agencies' testing, and assess whether agencies' detection methods were validated."

"This report presents the results of an Office of the Inspector General (OIG) inspection of the Security Risk Assessment (SRA) program that the Federal Bureau of Investigation (FBI) established under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act), Pub. Law No. 107-188. The OIG initiated the inspection in response to concerns about a backlog at the FBI of pending SRA applications submitted by researchers seeking access to dangerous biological agents and toxins controlled under the Bioterrorism Act. The objectives of our inspection were to: determine whether the FBI had a backlog of pending SRA applications and, if so, why; and identify any program vulnerabilities that needed to be corrected. We initiated our review on September 20, 2004, and analyzed productivity data through January 10, 2005."

"Since 1992, the Congress has provided more than $7 billion for threat reduction and nonproliferation programs in the former Soviet Union (FSU). These programs have played a key role in addressing the threats of weapons of mass destruction and are currently expanding beyond the FSU. The National Defense Authorization Act for Fiscal Year 2004 mandated that GAO assess (1) Department of Defense (DOD) and Department of Energy (DOE) strategies guiding their threat reduction and nonproliferation programs and (2) efforts to coordinate DOD, DOE, and Department of State threat reduction and nonproliferation programs that share similar missions."

"Within the last 30 years, the genomes of thousands of organisms, from viruses, to bacteria, to humans, have been sequenced or partially sequenced and deposited in databases freely accessible to scientists around the world. This information is accelerating scientists' ability to fight disease and make other medical advances, but policymakers must consider the possibility that the information could also be used for destructive purposes in acts of bioterrorism or war. Based in part on views from working biological scientists, the report concludes that current policies that allow scientists and the public unrestricted access to genome data on microbial pathogens should not be changed. Because access improves our ability to fight both bioterrorism and naturally occurring infectious diseases, security against bioterrorism is better served by policies that facilitate, not limit, the free flow of this information."

"Of increasing importance are [threats] from chemical and biological warfare (CW and BW). To help review its current state of preparedness, the Chief of Naval Operations asked the National Research Council (NRC) to assess the U.S. Navy's defense capabilities against CW and BW threats. In particular to what extent are they being developed to enable naval forces to sense and analyze quickly the presence of chemical and biological agents, withstand or avoid exposure to such agents, deal with contamination under a broad spectrum of operational conditions, and over what period will these capabilities be realized. This report presents the results of that assessment. It provides an overview of the potential threats, and an evaluation of the Navy's operations, non-medical programs, and medical countermeasures designed to confront those threats. The report also presents a series of general and specific findings and recommendations based on these assessments."

"Significant progress also has been made since the January 2003 release of the NIAID Biodefense Research Agenda for Category B and C Priority Pathogens; these scientific advances and programmatic activities are described in this new progress report. Specific topics include: progress made towards meeting general recommendations in the areas of research, product development, and research resources, which are crucial for building a robust biodefense infrastructure; and scientific advances and research activities related to the immediate goals in the research agenda. In keeping with these goals, this progress report focuses on basic and applied research aimed at developing pathogen-specific diagnostics, therapeutics, and vaccines, as well as progress in understanding the biology of Category B and C microbes and the host response to them. The report also summarizes scientific progress in the area of immune-based strategies for biodefense."

"Immediately following the 2001 terrorist attacks and the subsequent anthrax release, the Office of Inspector General (OIG) initiated a program to review select agent1 security at laboratories operated by the Department of Health and Human Services (HHS) and universities. In early 2002, we began reviews of 11 universities that received National Institutes of Health (NIH) funding for research involving select agents. Of these, 10 had select agents on the premises, and 1 planned to obtain such agents. We used the following laws, regulations, and guidance as criteria for evaluating the adequacy of security measures at the universities we reviewed: Biosafety in Microbiological and Biomedical Laboratories (BMBL), 4th Edition, Appendix F; the select agent transfer regulation (42 CFR - 72.6); the Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism Act of 2001 (USA PATRIOT Act); and Office of Management and Budget Circular A-130, Appendix III, 'Security of Federal Automated Information Resources.' The purpose of this report is to summarize our findings and discuss the universities' responses, regulatory changes affecting select agents, and actions taken by the Centers for Disease Control and Prevention (CDC) and NIH to address the issues raised by our reviews."

"In recent years much has happened to justify an examination of biological research in light of national security concerns. The destructive application of biotechnology research includes activities such as spreading common pathogens or transforming them into even more lethal forms. Policymakers and the scientific community at large must put forth a vigorous and immediate response to this challenge. This new book by the National Research Council recommends that the government expand existing regulations and rely on self-governance by scientists rather than adopt intrusive new policies. One key recommendation of the report is that the government should not attempt to regulate scientific publishing but should trust scientists and journals to screen their papers for security risks, a task some journals have already taken up. With biological information and tools widely distributed, regulating only U.S. researchers would have little effect. A new International Forum on Biosecurity should encourage the adoption of similar measures around the world. Seven types of risky studies would require approval by the Institutional Biosafety Committees that already oversee recombinant DNA research at some 400 U.S. institutions. These experiments of concern include making an infectious agent more lethal and rendering vaccines powerless."

"Pursuant to [the Directive-Type Memorandum "Safeguarding Biological Select Agents"], this Directive establishes security policy and assigns responsibilities for safeguarding biological select agents and toxins."

"According to a new congressionally mandated report from the Institute of Medicine and National Research Council of the National Academies, to successfully develop these drugs, vaccines, and other medical interventions against biowarfare agents, Congress should authorize the creation of a new agency within the Office of the Secretary of the U.S. Department of Defense. The committee recommended that Congress should improve liability protections for those who develop and manufacture these products, to stimulate willingness to invest in new research and development for biowarfare protection. Giving Full Measure to Countermeasures also identifies other challenges such as the need for appropriate animal models and laboratories equipped with high-level biosafety protections that will require attention if DoD efforts to develop new medical countermeasures are to be successful."

"In addition to increasing the breadth and depth of biodefense research, NIAID has made significant progress in meeting the specific goals and recommendations of the [2002] Blue Ribbon Panel [on Bioterrorism and Its Implications for Biomedical Research]. This progress report describes the progress that has been made toward addressing the immediate goals outlined in the research agenda. The first section of this report reviews progress on meeting the general recommendations made by the panel that apply to all areas of NIAID biodefense research. Research goals specific to each of the Category A pathogens are covered in individual chapters. Finally, the progress made thus far on immunology as it relates to biodefense is described in a separate chapter." This report updates the recommendations and assesses progress in research and development since the February 2002 NIAID Biodefense Research Agenda for CDC Category A Agents.

"The Panel's recommendations focus on protecting citizen health through the creation of a comprehensive national readiness strategy, helping first responders, helping businesses protect our nation and improving the technology of personal identification. Importantly, the actions proposed emphasize helping citizens help themselves. We also offer suggestions on cyberterrorism and other matters involving threat detection, assessment and response. In each instance we attempt to acknowledge the activities that already exist in the private sector (citizen and corporate), and to suggest the appropriate governmental tools that could be applied to achieve the desired objectives in the particular situation addressed. As already noted, in a number of instances the Panel's recommendations are intended to confirm, augment or refocus efforts that are currently under way or under consideration."

Project BioShield (PDF)
Congressional Research Service Report
Resources, Science, and Technology Division
Frank Gottron, Analyst in Science and Technology Policy
Code RS21507
Published: July 2003

"Many potential biological terrorism agents lack available countermeasures. President Bush proposed Project BioShield to encourage companies to develop new bioterror countermeasures. The main provisions of that proposal include: (1) relaxing procedures for bioterrorism-related procurement and peer review; (2) guaranteeing a market through contract authority granted to the Secretary of Health and Human Services (HHS) to buy countermeasures following Presidential approval, funded by a perma