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In 2004, Congress passed the Project BioShield Act (P.L. 108-276) to encourage the private sector to develop medical countermeasures to chemical, biological, radiological, and nuclear (CBRN) terrorism agents and to provide a novel mechanism for federal acquisition of those newly developed countermeasures. Although some countermeasures have been acquired through this law, Congress continues to address several Project BioShield-related policy issues. These include whether to continue diverting Project BioShield acquisition funding to other purposes; whether to change the countermeasure development and acquisition process; how to replace stockpiled countermeasures as they expire; and whether to alter federal efforts to encourage the development of broad-spectrum countermeasures. This law has three main provisions: (1) relaxing regulatory requirements for some CBRN terrorism-related spending, including hiring personnel and awarding research grants; (2) guaranteeing a federal market for new CBRN medical countermeasures; and (3) permitting emergency use of unapproved countermeasures. The Department of Health and Human Services (HHS) has used each of these authorities. The HHS used expedited review authorities to approve contracts and grants related to CBRN countermeasure research and development. The HHS used the authority to guarantee a government market to obligate approximately $2 billion to acquire countermeasures against anthrax, botulism, radiation, and smallpox. The HHS has also employed the emergency use authority several times, including to allow young children with H1N1 "swine" influenza to receive specific antiviral drugs., CRS Report for Congress.

On December 20, 2010, CBS News reported that the Department of Homeland Security had uncovered a credible threat of attacks using poisons, such as ricin, in salad bars and buffets. Ricin, a deadly toxin derived from castor beans, has been identified as a potential bioweapon. Ricin is extremely toxic by ingestion, inhalation, and injection. No treatment or prophylaxis currently exists, though research into new therapies and vaccines against ricin exposure continues. Additionally, research to improve ricin detection is ongoing. Although ricin's potential use as a military weapon was investigated, its predominant use has been in small quantities against specific individuals. Most experts believe that ricin would be difficult to use as a weapon of mass destruction, but do not discount its potential as a weapon of terror. Ricin is on the Select Agent list, and its possession, transfer, or use is regulated under domestic and international law. This report will not be updated., CRS Report for Congress

Recent reports by congressional commissions, the inclusion of bioterrorism issues in President Obama's State of the Union address, and issuance of executive orders have increased congressional attention to the threat of bioterrorism. Federal efforts to combat the threat of bioterrorism predate the anthrax attacks of 2001, but they have significantly increased since then. The U.S. Government has developed these efforts as part of and in parallel with other defenses against conventional terrorism. Several strategy and planning documents direct the Federal Government's biodefense efforts, and many different agencies have a role. These agencies have implemented numerous disparate actions and programs in their statutory areas to address the threat. But despite these efforts, many experts, including congressional commissions, nongovernmental organizations, and industry representatives, have highlighted weaknesses in the Federal Government's biodefense activities. Recent reports by congressional commissions have stated that the Federal Government could significantly improve its efforts to address the bioterrorism threat. Several key questions face congressional policy makers: How sufficiently do the efforts already underway address the threat of bioterrorism?; Have the federal investments to date met the expectations of Congress or other stakeholders?; Should Congress alter, augment, or terminate these existing programs in the current environment of fiscal challenge?; and What is the appropriate federal role in response to the threat of bioterrorism, and what mechanisms are most appropriate for involving other stakeholders, including state and local jurisdictions, industry, and others? This report focuses on four areas under congressional consideration deemed critical to the success of the biodefense enterprise: strategic planning; risk assessment; surveillance; and the development, procurement, and distribution of medical countermeasures., CRS Report for Congress.

Many potential chemical, biological, radiological, and nuclear (CBRN) terrorism agents lack available medical countermeasures. In 2003, President Bush proposed Project BioShield to address this need. The Project BioShield Act became law in July 2004 (P.L. 108-276). This law has three main provisions: (1) relaxing regulatory requirements for some CBRN terrorism-related spending, including hiring personnel and awarding research grants; (2) guaranteeing a federal government market for new CBRN medical countermeasures; and (3) permitting emergency use of unapproved countermeasures. The Department of Health and Human Services (HHS) has used each of these authorities. The HHS used expedited review authorities to approve contracts and grants related to CBRN countermeasure research and development. The HHS used the authority to guarantee a government market to obligate approximately $2 billion to acquire countermeasures against anthrax, botulism, radiation, and smallpox. The HHS has also employed the emergency use authority several times, including allowing young children with H1N1 "swine" influenza to receive specific antiviral drugs., CRS Report for Congress

The following table provides access to names and contact information for CRS experts on policy concerns relating to research and development (R&D) to enhance homeland security. Policy areas identified include: * Mission: scope, magnitude, relationship to other federal homeland security goals; * Conducting and coordinating homeland security R&D; * Catastrophic threats-science and technology; *Countermeasures-science and technology; and * Encouraging private development of countermeasures., CRS Report for Congress

The Federal Government invests in research and development (R&D) to improve the government's ability to prevent, respond to, and recover from terrorist attacks. Given the diverse nature of current and future terrorist threats, homeland security R&D involves nearly every scientific and technical discipline. In addition to conducting and sponsoring much of this R&D, the government is leveraging its investment by encouraging the private sector to similarly invest. Congress continues to face difficult decisions regarding funding, prioritizing, coordinating, and executing the Federal Government homeland security R&D agenda. The Homeland Security Act of 2002 (P.L. 107-296) gave the Directorate of Science and Technology within the Department of Homeland Security (DHS) responsibility for most DHS R&D-related activities. This Directorate has been reorganized multiple times since its inception and has received intense congressional scrutiny. How DHS prioritizes, coordinates, and executes its R&D agenda remains an oversight issue for Congress., CRS Report for Congress.

To safeguard the United States against the introduction of non-native animal disease, Congress has appropriated funds to the U.S. Department of Agriculture (USDA). Some of this work is performed at the Plum Island Animal Disease Center (PIADC), located off the coast of New York. Congress created the Department of Homeland Security (DHS) in 2003 and transferred ownership and operation of PIADC from USDA to DHS. The USDA and DHS cooperate to conduct foreign animal disease research at PIADC, but they have identified PIADC as outdated and too limited to continue as the primary facility for this research. Homeland Security Presidential Directive 9, issued by President G.W. Bush, tasks the Secretaries of Agriculture and Homeland Security to develop a plan to provide safe, secure, and state-of-the-art agriculture biocontainment laboratories for research and development of diagnostic capabilities and medical countermeasures for foreign animal and zoonotic diseases. To partially meet these obligations, DHS has requested Congress appropriate funds to construct a new facility, the National Bio- and Agro-Defense Facility (NBAF). This facility would house high-biocontainment laboratories able to hold the pathogens currently under investigation at PIADC, as well as other pathogens of interest. The DHS has selected Manhattan, Kansas, as the NBAF site and plans to open the facility in 2015. The DHS estimates the final, total facility construction cost as $725 million, significantly exceeding earlier projections. Additional expenses, such as equipping the new facility, relocating existing personnel and programs, and preparing the PIADC facility for disposition, are expected to add $190 million. The DHS plans regarding the NBAF raise several policy issues. Concerns about safety and security, previously expressed about PIADC and other laboratories being built to study dangerous pathogens, are also being voiced about NBAF. Coordination between DHS and USDA, as well as prioritization an, CRS Report for Congress.

Many potential chemical, biological, radiological, and nuclear (CBRN) terrorism agents lack available countermeasures. In 2003, President Bush proposed Project BioShield to address this need. The Project BioShield Act became law in July 2004 (P.L. 108-276). This law has three main provisions: (1) relaxing procedures for some CBRN terrorism-related spending, including hiring and awarding research grants; (2) guaranteeing a federal government market for new CBRN medical countermeasures; and (3) permitting emergency use of unapproved countermeasures. The Department of Health and Human Services (HHS) has used each of these authorities. The HHS used expedited review authorities to approve grants relating to developing treatments for radiation exposure and used the authority to guarantee a government market to obligate approximately $2.3 billion to acquire countermeasures against anthrax, botulism, radiation, and smallpox. The HHS has also employed the emergency use authority several times including all" wing young children with H1N1 "swine flu? to receive specific antiviral drugs., CRS Report for Congress.

The federal government responded to the September 11, 2001, terrorist attacks and the subsequent anthrax attacks with increased focus on and funding for biodefense. A key consideration in this response was addressing shortages in diagnostic, clinical, and research laboratory capacity. Several departments and agencies have increased or are in the process of increasing their laboratory capacity. High-containment laboratories play a critical role in the biodefense effort, offering the hope of better responses to an attack and a better understanding of the threat posed by bioterrorism. However, they also could increase the risk of a biological attack by serving as a potential source of materials or training. Indeed, the Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism recommends tightening government oversight of high-containment laboratories. Policymakers have become increasingly interested in the oversight of these facilities following reports of accidents, regulatory noncompliance, and community resistance. The increase in highcontainment laboratory capacity has raised new policy questions and emphasized existing ones. How much laboratory capacity is enough? What is the necessary federal investment? Should laboratories be consolidated or dispersed? What plans exist to coordinate multiple agency efforts to expand high-containment laboratory capacity? Does increasing laboratory capacity increase the risk of accidents and the opportunity for purposeful misuse? What is an acceptable balance between the benefits these laboratories provide and the risks they pose? Interested Members of Congress might take action to address some or all of these concerns. Alternatively, they might defer action until efforts currently under way assess and make recommendations regarding the existing regulatory structure.

The agricultural and food infrastructure of the United States is potentially susceptible to terrorist attack using biological pathogens. In addition to the impacts of such an attack on the economy, some animal diseases could potentially be transmitted to humans. (These diseases are known as zoonotic diseases.) Scientific and medical research on plant and animal diseases may lead to the discovery and development of new diagnostics and countermeasures, reducing the risk and impact of a successful terrorist attack. To safeguard the United States against animal disease, Congress has appropriated funds to the U.S. Department of Agriculture (USDA) to engage in research at the Plum Island Animal Disease Center (PIADC), off the coast of New York, on animal diseases not native to the United States. When creating the Department of Homeland Security (DHS) in 2003, Congress transferred the PIADC facility from USDA to DHS. Both USDA and DHS, in cooperation with USDA, conduct foreign animal disease research at PIADC, but PIADC has been identified as outdated and too limited to continue as the primary facility for this research. Homeland Security Presidential Directive 9 tasks the Secretaries of Agriculture and Homeland Security to develop a plan to provide safe, secure, and state-of-the-art agriculture biocontainment laboratories for research and development of diagnostic capabilities and medical countermeasures for foreign animal and zoonotic diseases. To partially meet these obligations, DHS has requested Congress to appropriate funds to construct a new facility, the National Bio- and Agro-Defense Facility (NBAF). This facility would house high-containment laboratories able to handle the pathogens currently under investigation at PIADC, as well as other pathogens of interest. Six candidate sites have been identified, one of which is Plum Island. The DHS plans to select the site in 2008 and open NBAF in 2014., CRS Report for Congress

The agricultural and food infrastructure of the United States is potentially susceptible to terrorist attack using biological pathogens. In addition to the impacts of such an attack on the economy, some animal diseases could potentially be transmitted to humans. (These diseases are known as zoonotic diseases.) Scientific and medical research on plant and animal diseases may lead to the discovery and development of new diagnostics and countermeasures, reducing the risk and impact of a successful terrorist attack. To safeguard the United States against animal disease, Congress has appropriated funds to the U.S. Department of Agriculture (USDA) to engage in research at the Plum Island Animal Disease Center (PIADC), off the coast of New York, on animal diseases not native to the United States. When creating the Department of Homeland Security (DHS) in 2003, Congress transferred the PIADC facility from USDA to DHS, though USDA continues its own research programs at the facility. However, the DHS, in cooperation with USDA, has established a foreign animal disease research program at PIADC. The DHS has identified PIADC as outdated and too limited to continue as the primary research facility. Homeland Security Presidential Directive 9 tasks the Secretaries of Agriculture and Homeland Security to develop a plan to provide safe, secure, and state-of-the-art agriculture biocontainment laboratories for research and development of diagnostic capabilities and medical countermeasures for foreign animal and zoonotic diseases. To partially meet these obligations, DHS has requested appropriations to construct a new facility, the National Bio- and Agro-Defense Facility (NBAF). This facility would house high-containment laboratories able to handle the pathogens currently under investigation at PIADC, as well as other pathogens of interest. The DHS plans to select the site in 2008 and open NBAF in 2014., CRS Report for Congress

The Project BioShield Act of 2004 (P.L. 108-276) established a 10-year program to acquire civilian medical countermeasures to chemical, biological, radiological and nuclear (CBRN) agents for the Strategic National Stockpile. Provisions of this act were designed to encourage private companies to develop these countermeasures by guaranteeing a government market for successfully developed countermeasures. Both the Department of Homeland Security (DHS) and the Department of Health and Human Services (HHS) have responsibilities in this program. Funds for this program are appropriated to DHS, while contracts are executed through HHS. The interagency process responsible for deciding which countermeasures to procure has changed multiple times since this program's inception. The Homeland Security Appropriations Act, 2004 (P.L. 108-90) provided an advance appropriation of $5.6 billion to acquire CBRN countermeasures over a 10-year period (FY2004 FY2013). This act also limited the amount that could be obligated during specified time periods. The Project BioShield Act of 2004 (P.L. 108-276) assigned the $5.6 billion advance appropriation to Project BioShield countermeasure acquisitions. The Consolidated Appropriations Act, 2004 (P.L. 108-199) and the Consolidated Appropriations Act, 2005 (P.L. 108-447) reduced the total amount available for Project BioShield by a total of $25 million. Congress retains the power to make additional appropriations and rescissions to this account. HHS has awarded Project BioShield contracts for a countermeasure against botulinum toxin, two types of anthrax vaccine, two types of anthrax treatments, and three kinds of countermeasures against radiological or nuclear agents. HHS reports that it has obligated approximately $1.831 billion from the Project BioShield account. However, the largest contract, $878 million for an anthrax vaccine, was cancelled in December 2006, for failure to meet a contract milestone., The original document contains color images.

Science and technology have a pervasive influence over a wide range of issues confronting the nation. Decisions on how much federal funding to invest in research and development (R&D), and determining what programs have the highest priority, for example, may have implications for homeland security, new high technology industries, government/private sector cooperation in R&D, and myriad other areas., CRS Report Congress.

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 the following; (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). This report will be updated in response to legislative developments., CRS Report for Congress.

This report, which will be updated as necessary, presents a means of assessing the relative threat from terrorist-use of individual chemical, biological, and toxin agents. It focuses on small-scale, targeted chemical and biological attacks, rather than mass-casualty attacks. The framework considers the elements of access, public health impact, medical treatment, prophylaxis, and dissemination. Other factors that may affect potential use by terrorists include the range of lethality, covert employment of an agent, and the availability of dual-use technologies. The results of this framework maybe useful in addressing the threat these agents pose, for example by indicating priorities for countermeasure funding. Other uses include weighing the potential effectiveness of policy options, assessing threat reduction approaches to specific agents, and serving as a resource for developing other specialized frameworks. Defense against chemical and biological agents is high on the list of the nation 5 priorities. No clear consensus exists with respect to which agents pose the greatest threat. Previous analyses of the chemical and biological threat have largely revolved around historical and comparative treatments or been based in a military framework. Examination of the chemical and biological threat to civilians is more complicated. Agents whose characteristics make them poor military weapons may still be powerful if deployed as weapons of terror. Chemical and biological weapons used in the past have not always been chosen for the highest potential fatalities, but rather for other reasons. Some chemical and biological agents are closely regulated, both domestically and internationally. Expansion or further refinement of policies controlling these agents may lower the threat posed by terrorist use of them.

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 permanent, indefinite appropriation; and (3) allowing the Secretary of HHS to permit the emergency use of countermeasures that have not been approved. S. 15, introduced by Senator Gregg incorporates these proposals. Some of these provisions are controversial. Some critics suggest that biotechnology and pharmaceutical companies will require even more incentives than contained in Project BioShield. Additional incentives being considered by the 108th Congress include protection from litigation because of adverse reactions to the countermeasures, and tax and intellectual property incentives (S. 666, Lieberman). Other options include directly funding development or increasing the scope of existing federal programs designed to encourage technology commercialization. This report will be updated in response to legislative developments., CRS Report for Congress