The Department of Defense (DoD) has had a unique mission in biological defense research over the past 4 decades. Throughout this history, the military biological disease threats were relatively straightforward, there was little urgency linked to successful product fielding, there was no mechanism by which to gain Food and Drug Administration (FDA) product licensure, and there was little competition for mission or funds. In the post-September 11, 2001 (9/11) environment, however, the scope of potential threats has increased immeasurably, relative funding for the DoD has decreased, urgency to field solutions has skyrocketed, the FDA has provided a way forward to product licensure, and active non-DoD players in this arena have grown exponentially, aligning with newly designated, congressionally mandated funding sources. The old paradigms that governed the DoD research program structure and mission are no longer viable in this changing environment. This monograph examines the current organization of the DoD biodefense research program in light of the changing national biodefense landscape and industry best practices, and argues that all aspects of the DoD biodefense program should be consolidated with all other federal biodefense resources, including those within the National Institutes of Health, to create a single, focused, and productive program. This new agency, subordinate to the Department of Health and Human Services, will be positioned and equipped to provide medical solutions to the warfighter on the battlefield, as well as to U.S. citizens.

In recent years, substantial efforts have been initiated to develop new drugs, vaccines, and other medical interventions against biological agents that could be used in bioterrorist attacks against civilian populations. 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 challengesâ€"such as the need for appropriate animal models and laboratories equipped with high-level biosafety protectionsâ€"that will require attention if DoD efforts to develop new medical countermeasures are to be successful.

In recent years, substantial efforts have been initiated to develop new drugs, vaccines, and other medical interventions against biological agents that could be used in bioterrorist attacks against civilian populations. 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 challengesâ€"such as the need for appropriate animal models and laboratories equipped with high-level biosafety protectionsâ€"that will require attention if DoD efforts to develop new medical countermeasures are to be successful.

Biological weapons have threatened U.S. national security since at least World War II. Historically, however, the U.S. military has neglected research, development, acquisition, and doctrine for biodefense. Following September 11 and the anthrax letters of 2001, the United States started spending billions of dollars per year on medical countermeasures and biological detection systems. But most of this funding now comes from the Department of Health and Human Services rather than the Department of Defense. Why has the U.S. military neglected biodefense and allowed civilian organizations to take the lead in defending the country against biological attacks? In American Biodefense, Frank L. Smith III addresses this puzzling and largely untold story about science, technology, and national security.Smith argues that organizational frames and stereotypes have caused both military neglect and the rise of civilian biodefense. In the armed services, influential ideas about kinetic warfare have undermined defense against biological warfare. The influence of these ideas on science and technology challenges the conventional wisdom that national security policy is driven by threats or bureaucratic interests. Given the ideas at work inside the U.S. military, Smith explains how the lessons learned from biodefense can help solve other important problems that range from radiation weapons to cyber attacks.

Since renouncing the development, production, stockpiling, and use of biological weapons in 1969, the Department of Defense (DoD) has invested in militarily relevant biological defense. Also in 1969, the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) was created to develop medical defensive countermeasures. Medical biological defensive research has focused mainly on the development of vaccines, drugs, and diagnostics as defensive countermeasures. DoD maintains a network of laboratories and centers dedicated to developing defensive capabilities to protect against biological select agents and toxins (BSATs). Most of these facilities evolved from small specialized laboratories that focused on a particular area of today's modern research and development-performing work that ranges from basic science and technology to supporting systems in biological defense. All laboratories participating in DoD research, development, test, and evaluation (RDT&E) are required to comply with the code of federal regulations and DoD directives, policies, and regulations. These sets of regulations specify safety and security policy, responsibilities, and procedures for service and contract laboratories conducting research and development in support of the DoD biological defense program. In general, biosafety encompasses risk assessment, safe practices, and containment equipment to protect researchers from exposure to infectious agents and facility barrier systems that prevent the release of an agent into the environment to ensure protection of the public health. Biosecurity includes physical security, select agent accountability, and personnel reliability in an effort to prevent unauthorized access to biological select agents and toxins. There is obvious overlap between the two terms. The DoD labs employ an in-depth approach to securing BSATs during operations that require manipulation, storage, or transport of these hazardous materials. Layers of security include physical security of facilities, secured storage equipment, secured transportation of BSATs, surveillance systems, and personnel security processes that assure only the most reliable and skilled personnel have access to the materials necessary to conduct research appropriate to the mission. There are numerous directives and regulations, established by different government agencies that govern biological safety and security (see list of References and Regulations at the end of this report).

This Congressionally-mandated report identifies areas for further cooperation with Russia and other states of the former Soviet Union under the Cooperative Threat Reduction (CTR) program of the Department of Defense in the specific area of prevention of proliferation of biological weapons. The report reviews relevant U.S. government programs, and particularly the CTR program, and identifies approaches for overcoming obstacles to cooperation and for increasing the long-term impact of the program. It recommends strong support for continuation of the CTR program.