The United States biological defense program—in recent years also called the National Biodefense Strategy—refers to the collective effort by all levels of government, along with private enterprise and other stakeholders, in the United States to carry out biodefense activities.
Biodefense is a system of planned actions to counter and reduce the risk of biological threats and to prepare, respond to, and recover from them if they happen. The National Defense Authorization Act (NDAA) of 2016 required high-level officials across the federal government to create a national biodefense strategy together. As a result, in 2018 the National Biodefense Strategy was released by President Donald Trump. In essence, the strategy comprises the U.S. biological defense program in that it is the official framework that provides a "single coordinated effort" to coordinate all biodefense activities across the federal government. To execute the strategy, the White House issued a Presidential Memorandum on the Support for National Biodefense, which puts the specific directives and rules in place for carrying out the plans written in the strategy. The National Biodefense Strategy elevated natural outbreaks as a vital component of the U.S. biological defense program for the first time, mostly because of the significant risk that natural outbreaks pose to civilian, animal and agricultural populations across the country.
The U.S. Biological Defense Program began as a small defensive effort that parallels the country's offensive biological weapons development and production program, active since 1943. Organizationally, the medical defense research effort was pursued first (1956–1969) by the U.S. Army Medical Unit (USAMU) and later, after publicly known discontinuation of the offensive program, by the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID). Both of these units were located at Fort Detrick, Maryland, where the U.S. Army Biological Warfare Laboratories were headquartered. The current mission is multi-agency, not exclusively military, and is purely to develop defensive measures against bio-agents, as opposed to the former bio-weapons development program.
In 1951, due to biological warfare concerns arising from the Korean War, the US Centers for Disease Control and Prevention (CDC) created the Epidemic Intelligence Service (EIS), a hands-on two-year postgraduate training program in epidemiology, with a focus on field work.
Since the 2001 anthrax attacks, and the consequent expansion of federal bio-defense expenditures, USAMRIID has been joined at Fort Detrick by sister bio-defense agencies of the U.S. Department of Health and Human Services (NIAID's Integrated Research Facility) and the U.S. Department of Homeland Security (the National Biodefense Analysis and Countermeasures Center and the National Bioforensic Analysis Center). These—along with the much older Foreign Disease Weed Science Research Unit of the U.S. Department of Agriculture—now constitute the National Interagency Confederation for Biological Research (NICBR).
Broadly defined, the "United States Biological Defense Program" now also encompasses all federal-level programs and efforts to monitor, prevent, and contain naturally occurring infectious disease outbreaks of widespread public health concern. These include efforts to forestall large-scale disastersMordini E. (2016) The Biodefense Field. Bioethics, Volume 30, Issue 6, pages 382–383 such as flu pandemics and other "emerging infections" such as novel pathogens or those imported from other countries.
Overview Biological agents have been used in warfare for centuries to produce death or disease in humans, animals, or plants. The United States officially began its biological warfare offensive program in 1941. During the next 28 years, the U.S. initiative evolved into an effective, military-driven research and acquisition program, shrouded in secrecy and, later, controversy. Most research and development was done at Fort Detrick, Maryland, while production and testing of bio-weapons occurred at Pine Bluff, Arkansas, and Dugway Proving Ground (DPG), Utah. Field testing was done secretly and successfully with simulants and actual agents disseminated over wide areas. A small defensive effort always paralleled the weapons development and production program. With the presidential decision in 1969 to halt offensive biological weapons production—and the agreement in 1972 at the international BWC never to develop, produce, stockpile, or retain biological agents or toxins—the program became entirely defensive, with medical and non-medical components. The U.S. biological defense research program exists today, conducting research to develop physical and medical countermeasures to protect service members and civilians from the threat of modern biological warfare.Franz, David R., Cheryl D. Parrott, and Ernest T. Takafuji (1997), Chapter 19: "The U.S. Biological Warfare and Biological Defense Programs", In: Frederick R. Sidell, Ernest T. Takafuji, David R. Franz (editors), Medical Aspects of Chemical and Biological Warfare (1997); Published by the Office of The Surgeon General at TMM Publications, The Borden Institute.
Both the U.S. bio-weapons ban and the BWC restricted any work in the area of biological warfare to defensive in nature. In reality, this gives BWC member-states wide latitude to conduct biological weapons research because the BWC contains no provisions for monitoring of enforcement.Joseph Cirincione, et al. Deadly Arsenals, p. 35. The treaty, essentially, is a gentlemen's agreement amongst members backed by the long-prevailing thought that biological warfare should not be used in battle.Littlewood, Jez. The Biological Weapons Convention: A Failed Revolution, (Google Books), Ashgate Publishing, Ltd., 2005, p. 9, ().
In recent years certain critics have claimed the U.S. stance on biological warfare and the use of biological agents has differed from historical interpretations of the BWC."Introduction to Biological Weapons", Federation of American Scientists, official site. Retrieved January 9, 2009. For example, it is said that the U.S. now maintains that the Article I of the BWC (which explicitly bans bio-weapons), does not apply to "non-lethal" biological agents. Previous interpretation was stated to be in line with a definition laid out in Public Law 101–298, the Biological Weapons Anti-Terrorism Act of 1989."Original U.S. Interpretation of the BWC", (PDF),Federation of American Scientists, official site. Retrieved January 9, 2009. That law defined a biological agent as:
any micro-organism, virus, infectious substance, or biological product that may be engineered as a result of biotechnology, or any naturally occurring or bio-engineered component of any such microorganism, virus, infectious substance, or biological product, capable of causing death, disease, or other biological malfunction in a human, an animal, a plant, or another living organism; deterioration of food, water, equipment, supplies, or material of any kind ...
According to the Federation of American Scientists, U.S. work on non-lethal agents exceeds limitations in the BWC.
History
1950s After World War II, and with the onset of Cold War tensions, the US continued its clandestine wartime bio-weapons program. The Korean War (1950–1953) added justification for continuing the program, when the possible entry of the Soviet Union into the war was feared. Concerns over the Soviet Union were perceived as justified, for the Soviet Union would pronounce in 1956 that they would use chemical and biological weapons for mass destruction in future wars.Geissler E, ed. Biological and Toxin Weapons Today (Stockholm International Peace Research Institute). Oxford, England: Oxford University Press; 1986. In October 1950, the US Secretary of Defense approved continuation of the program, based largely on the Soviet threat and a belief that the North Korean and Chinese governments would use biological weapons.Harris R, Paxman J. A Higher Form of Killing: The Secret of Chemical and Biological Warfare. New York, NY: Hill and Wang; 1982. With expansion of the biological warfare retaliatory program, the scope of the defensive program was nearly doubled. Data were obtained on personnel protection, decontamination, and immunization. Early detection research produced prototype alarms for use on the battlefield, but progress was slow, apparently limited by technology.Franz, Op. cit.
The U.S. Army Medical Unit, under the direction of The U.S. Army Surgeon General, began formal operations in 1956. One of the Unit's first missions was to manage all aspects of Project CD-22, the exposure of volunteers to aerosols containing a pathogenic strain of Coxiella burnetii, the etiologic agent of Q fever. The volunteers were closely monitored and antibiotic therapy was administered when appropriate. All volunteers recovered from Q fever with no adverse aftereffects. One year later, the Unit submitted to the U.S. Food and Drug Administration an Investigational New Drug application for a Q fever vaccine.
1960s In the following decade, the US accumulated significant data on personnel protection, decontamination, and immunization; and, in the offensive program, on the potential for mosquitoes to be used as biological vectors. A new Department of Defense (DoD) Biological and Chemical Defense Planning Board was created in 1960 to establish program priorities and objectives. Preventive approaches toward infections of all kinds were funded under the auspices of biological warfare. As concern increased over the biological warfare threat during the Cold War, so did the budget for the program: to $38 million by fiscal year 1966.
The U.S. Army Chemical Corps was given the responsibility to conduct biological warfare research for all of the services.Department of the Army. Special Report to Congress. US Army Activity in the US Biological Warfare Programs,1942–1977. Vols 1 and 2. Washington, DC: DA. 24 Feb 1977. Unclassified. In 1962, the responsibility for the testing of promising biological warfare agents was given to a separate U.S. Army Test and Evaluation Command (USATECOM). Depending on the particular program, different test centers were used, such as the Deseret Test Center at Fort Douglas, Utah, the headquarters for the new biological and chemical warfare testing organization. In response to increasing concerns over public safety and the environment, the USATECOM implemented a complex system of approval of its research programs that included the U.S. Army Chief of Staff, the Joint Chiefs of Staff, the Secretary of Defense, and the President of the United States.
During the last 10 years of the offensive research and development program (1959–69), many scientific advances were made that proved that biological warfare was clearly feasible, although dependent on careful planning, especially with regard to meteorological conditions. Large-scale fermentation, purification, concentration, stabilization, drying, and weaponization of pathogenic microorganisms could be done safely. Furthermore, modern principles of biosafety and containment were established at the Fort Detrick laboratories which have greatly facilitated biomedical research in general; still today, these are followed throughout the world. Arnold G. Wedum, M.D., Ph.D., a civilian scientist who was Director of Industrial Health and Safety at Fort Detrick, was the leader in the development of containment facilities.