United States Biological Defense Program
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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 The United States of America (USA), also known as the United States (U.S.) or America, is a country primarily located in North America. It is a federal republic of 50 U.S. state, states and a federal capital district, Washington, D.C. The 48 ...
to carry out biodefense activities.
Biodefense Biodefense refers to measures to counter biological agent, biological threats, reduce biological risks, and prepare for, respond to, and recover from bioincidents, whether naturally occurring, accidental, or deliberate in origin and whether impa ...
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 In the United States, the National Biodefense Strategy is a White House-issued policy document laying out the federal government's approach to biodefense and biosecurity. The document's most recent version was published in October 2022 by the Pres ...
was released by President Donald J. 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 The White House is the official residence and workplace of the president of the United States. Located at 1600 Pennsylvania Avenue Northwest (Washington, D.C.), NW in Washington, D.C., it has served as the residence of every U.S. president ...
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 Maryland ( ) is a U.S. state, state in the Mid-Atlantic (United States), Mid-Atlantic region of the United States. It borders the states of Virginia to its south, West Virginia to its west, Pennsylvania to its north, and Delaware to its east ...
, 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 Korean War (25 June 1950 – 27 July 1953) was an armed conflict on the Korean Peninsula fought between North Korea (Democratic People's Republic of Korea; DPRK) and South Korea (Republic of Korea; ROK) and their allies. North Korea was s ...
, the US
Centers for Disease Control and Prevention The Centers for Disease Control and Prevention (CDC) is the National public health institutes, national public health agency of the United States. It is a Federal agencies of the United States, United States federal agency under the United S ...
(CDC) created the Epidemic Intelligence Service (EIS), a hands-on two-year postgraduate training program in
epidemiology Epidemiology is the study and analysis of the distribution (who, when, and where), patterns and Risk factor (epidemiology), determinants of health and disease conditions in a defined population, and application of this knowledge to prevent dise ...
, with a focus on field work. Since the
2001 anthrax attacks The 2001 anthrax attacks, also known as Amerithrax (a portmanteau of "United States, America" and "anthrax", from its FBI case name), occurred in the United States over the course of several weeks beginning on September 18, 2001, one week after th ...
, 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 disasters such as flu pandemics and other " emerging infections" such as novel pathogens or those imported from other countries.


Overview

Biological agent Biological agents, also known as biological weapons or bioweapons, are pathogens used as weapons. In addition to these living or replicating pathogens, toxins and Toxin#Biotoxins, biotoxins are also included among the bio-agents. More than 1,2 ...
s 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 Biological warfare, also known as germ warfare, is the use of biological toxins or Pathogen, infectious agents such as bacteria, viruses, insects, and Fungus, fungi with the intent to kill, harm or incapacitate humans, animals or plants as an ...
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 Maryland ( ) is a U.S. state, state in the Mid-Atlantic (United States), Mid-Atlantic region of the United States. It borders the states of Virginia to its south, West Virginia to its west, Pennsylvania to its north, and Delaware to its east ...
, while production and testing of bio-weapons occurred at
Pine Bluff, Arkansas Pine Bluff, officially the City of Pine Bluff, is the List of municipalities in Arkansas, tenth-most populous city in the U.S. state of Arkansas and the county seat of Jefferson County, Arkansas, Jefferson County. The population of the city wa ...
, and
Dugway Proving Ground Dugway Proving Ground (DPG) is a United States Army facility established in 1942 to test biological and chemical weapons, located about southwest of Salt Lake City, Utah and south of the Utah Test and Training Range. Location Dugway Provin ...
(DPG),
Utah Utah is a landlocked state in the Mountain states, Mountain West subregion of the Western United States. It is one of the Four Corners states, sharing a border with Arizona, Colorado, and New Mexico. It also borders Wyoming to the northea ...
. 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. 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.
, '' 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 The Biological Weapons Anti-Terrorism Act of 1989 (BWATA), ) was a piece of U.S. legislation that was passed into law in 1990. It provided for the implementation of the Biological Weapons Convention as well as criminal penalties for violation of i ...
.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 World War II or the Second World War (1 September 1939 – 2 September 1945) was a World war, global conflict between two coalitions: the Allies of World War II, Allies and the Axis powers. World War II by country, Nearly all of the wo ...
, and with the onset of
Cold War The Cold War was a period of global Geopolitics, geopolitical rivalry between the United States (US) and the Soviet Union (USSR) and their respective allies, the capitalist Western Bloc and communist Eastern Bloc, which lasted from 1947 unt ...
tensions, the US continued its clandestine wartime bio-weapons program. The
Korean War The Korean War (25 June 1950 – 27 July 1953) was an armed conflict on the Korean Peninsula fought between North Korea (Democratic People's Republic of Korea; DPRK) and South Korea (Republic of Korea; ROK) and their allies. North Korea was s ...
(1950–1953) added justification for continuing the program, when the possible entry of the
Soviet Union The Union of Soviet Socialist Republics. (USSR), commonly known as the Soviet Union, was a List of former transcontinental countries#Since 1700, transcontinental country that spanned much of Eurasia from 1922 until Dissolution of the Soviet ...
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. 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. With expansion of the biological warfare retaliatory program, the scope of the defensive program was nearly doubled. Data were obtained on personnel protection,
decontamination Decontamination (sometimes abbreviated as decon, dcon, or decontam) is the process of removing contaminants on an object or area, including chemicals, micro-organisms, and/or radioactive substances. This may be achieved by chemical reaction, dis ...
, and
immunization Immunization, or immunisation, is the process by which an individual's immune system becomes fortified against an infectious agent (known as the antigen, immunogen). When this system is exposed to molecules that are foreign to the body, called ' ...
. 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 ''Coxiella burnetii'' is an obligate intracellular bacterial pathogen, and is the causative agent of Q fever. The genus ''Coxiella'' is morphologically similar to '' Rickettsia'', but with a variety of physiological differences genetically cla ...
'', 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 The United States Food and Drug Administration's Investigational New Drug (IND) program is the means by which a pharmaceutical industry, pharmaceutical company obtains permission to start human clinical trials and to ship an experimental drug inte ...
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 Mosquitoes, the Culicidae, are a family of small flies consisting of 3,600 species. The word ''mosquito'' (formed by '' mosca'' and diminutive ''-ito'') is Spanish and Portuguese for ''little fly''. Mosquitoes have a slender segmented body, ...
to be used as biological vectors. A new
Department of Defense The United States Department of Defense (DoD, USDOD, or DOD) is an executive department of the U.S. federal government charged with coordinating and supervising the six U.S. armed services: the Army, Navy, Marines, Air Force, Space Force, ...
(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. In 1962, the responsibility for the testing of promising biological warfare agents was given to a separate Testing and Evaluation Command (TEC). 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 TEC 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 Joint Chiefs of Staff (JCS) is the body of the most senior uniformed leaders within the United States Department of Defense, which advises the president of the United States, the secretary of defense, the Homeland Security Council and ...
, 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. During the 1960s, the US program underwent a philosophical change, and attention was now directed more towards biological agents that could incapacitate, but not kill. In 1964, research programs involved staphylococcal enterotoxins capable of causing
food poisoning Foodborne illness (also known as foodborne disease and food poisoning) is any illness resulting from the contamination of food by pathogenic bacteria, viruses, or parasites, as well as prions (the agents of mad cow disease), and toxins such ...
. Research initiatives also included new therapy and prophylaxis. Pathogens studied included the agents causing
anthrax Anthrax is an infection caused by the bacterium '' Bacillus anthracis'' or ''Bacillus cereus'' biovar ''anthracis''. Infection typically occurs by contact with the skin, inhalation, or intestinal absorption. Symptom onset occurs between one ...
, glanders,
brucellosis Brucellosis is a zoonosis spread primarily via ingestion of raw milk, unpasteurized milk from infected animals. It is also known as undulant fever, Malta fever, and Mediterranean fever. The bacteria causing this disease, ''Brucella'', are small ...
, melioidosis, plague, psittacosis, Venezuelan equine encephalitis, Q fever,
coccidioidomycosis Coccidioidomycosis (, ) is a mammalian mycosis, fungal disease caused by ''Coccidioides immitis'' or ''Coccidioides posadasii''. It is commonly known as cocci, Valley fever, California fever, desert rheumatism, or San Joaquin Valley fever. Cocci ...
, and a variety of plant and animal pathogensHarris, ''Op. cit.'' Particular attention was directed at chemical and biological detectors during the 1960s. The first devices were primitive field alarms to detect chemicals. Although the development of sensitive biological warfare agent detectors was at a standstill, two systems were, nonetheless, investigated. The first was a monitor that detected increases in the number of particles sized 1 to 5 μm in diameter, based on the assumption that a biological agent attack would include airborne particles of this size. The second system involved the selective staining of particles collected from the air. Both systems lacked enough specificity and sensitivity to be of any practical use. But in 1966, a research effort directed at detecting the presence of
adenosine triphosphate Adenosine triphosphate (ATP) is a nucleoside triphosphate that provides energy to drive and support many processes in living cell (biology), cells, such as muscle contraction, nerve impulse propagation, and chemical synthesis. Found in all known ...
(a chemical found only in living organisms) was begun. By using a fluorescent material found in fireflies, preliminary studies indicated that it was possible to detect the presence of a biological agent in the atmosphere. The important effort to find a satisfactory detection system continues today, for timely detection of a biological attack would allow the attacked force to use its
protective masks A mask is an object normally worn on the face, typically for protection, disguise, performance, or entertainment, and often employed for rituals and rites. Masks have been used since antiquity for both ceremonial and practical purposes, as ...
effectively, and identification of the agent would allow any pre-treatment regimens to be instituted. The US Army also experimented with and developed highly effective barrier protective measures against both chemical and biological agents. Special impervious tents and
personal protective equipment Personal protective equipment (PPE) is protective clothing, helmets, goggles, or other garments or equipment designed to protect the wearer's body from injury or infection. The hazards addressed by protective equipment include physical, elect ...
were developed, including individual
gas masks A gas mask is a piece of personal protective equipment used to protect the wearer from inhaling airborne pollutants and toxic gases. The mask forms a sealed cover over the nose and mouth, but may also cover the eyes and other vulnerable soft ...
even for military dogs. During the late 1960s, funding for the biological warfare program decreased temporarily, to accommodate the accelerating costs of the
Vietnam War The Vietnam War (1 November 1955 – 30 April 1975) was an armed conflict in Vietnam, Laos, and Cambodia fought between North Vietnam (Democratic Republic of Vietnam) and South Vietnam (Republic of Vietnam) and their allies. North Vietnam w ...
. The budget for fiscal year 1969 was $31 million, decreasing to $11.8 million by fiscal year 1973. Although the offensive program had been stopped in 1969, both offensive and defensive programs continued to be defended. John S. Foster, Jr, Director of Defense Research and Engineering, responded to a query by Congressman Richard D. McCarthy:
It is the policy of the U.S. to develop and maintain a defensive chemical-biological (CB) capability so that our military forces could operate for some period of time in a toxic environment, if necessary; to develop and maintain a limited offensive capability in order to deter all use of CB weapons by the threat of retaliation in kind; and to continue a program of research and development in this area to minimize the possibility of technological surprise.
On 25 November 1969, President
Richard Nixon Richard Milhous Nixon (January 9, 1913April 22, 1994) was the 37th president of the United States, serving from 1969 until Resignation of Richard Nixon, his resignation in 1974. A member of the Republican Party (United States), Republican ...
visited Fort Detrick to announce a new policy on biological warfare. In two National Security Memoranda, the U.S. government renounced all development, production, and stockpiling of biological weapons and declared its intent to maintain only small research quantities of biological agents, such as are necessary for the development of vaccines, drugs, and diagnostics. Ground was broken in 1967 for the construction of a new, modern laboratory building at Fort Detrick. The building would open in phases during 1971 and 1972. With the disestablishment of the biological warfare laboratories, the name of the U.S. Army Medical Unit, which was to have been housed in the new laboratories, was formally changed to U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) in 1969. The institute's new mission was stated in General Order 137, 10 November 1971 (since superseded):
Conducts studies related to medical defensive aspects of biological agents of military importance and develops appropriate biological protective measures, diagnostic procedures and therapeutic methods.
The emphasis now shifted away from offensive weapons to the development of vaccines, diagnostic systems, personal protection, chemoprophylaxis, and rapid detection systems.


1970s

After Nixon declared an end to the U.S. bio-weapons program, debate in the Army centered around whether or not toxin weapons were included in the president's declaration. Following Nixon's November 1969 order, scientists at Fort Detrick worked on one toxin, ''Staphylococcus'' enterotoxin type B (SEB), for several more months. Nixon ended the debate when he added toxins to the bio-weapons ban in February 1970 In response to Nixon's 1969 decision, all antipersonnel biological warfare stocks were destroyed between 10 May 1971 and 1 May 1972. The laboratory at Pine Bluff Arsenal, Arkansas, was converted to a toxicological research laboratory, and was no longer under the direction or control of the DoD. Biological anticrop agents were destroyed by February 1973. Biological warfare demilitarization continued through the 1970s, with input provided by the U.S. Department of Health, Education and Welfare; U.S. Department of the Interior; U.S. Department of Agriculture; and the Environmental Protection Agency. Fort Detrick and other installations involved in the biological warfare program took on new identities, and their missions were changed to biological defense and the development of medical countermeasures. The necessary containment capability, Biosafety Levels 3 and 4 (BSL-3 and BSL-4) continued to be maintained at USAMRIID.


1980s

In 1984, the DoD requested funds for the construction of another biological aerosol test facility in Utah. The proposal submitted by the army called for BSL-4 containment, although maintaining that the BSL-4 inclusion was based on a possible need in the future and not on a current research effort. The proposal was not well received in Utah, where many citizens and government officials still recalled the secretive projects of the military: the areas on DPG still contaminated with anthrax spores, and the well-publicized accidental chemical poisoning of a flock of sheep in Skull Valley, Utah, in March 1968. Questions arose over the safety of the employees and the surrounding communities, and a suggestion was even made to shift all biological defense research to a civilian agency, such as the
National Institutes of Health The National Institutes of Health (NIH) is the primary agency of the United States government responsible for biomedical and public health research. It was founded in 1887 and is part of the United States Department of Health and Human Service ...
. The plan for a new facility was revised to utilize a BSL-3 facility, but not before the
US Congress The United States Congress is the legislature, legislative branch of the federal government of the United States. It is a Bicameralism, bicameral legislature, including a Lower house, lower body, the United States House of Representatives, ...
had instituted more surveillance, reporting, and control measures on the army to ensure compliance with the BWC.


1990s

In the 1990s, the US medical biological defense research effort (part of the U.S. Army's Biological Defense Research Program DRP was concentrated at USAMRIID at Fort Detrick. The army maintained state-of-the-art containment laboratory facilities there, with more than 10,000 ft2 of BSL-4 and 50,000 ft2 of BSL-3 laboratory space. BSL-4, the highest containment level, included laboratory suites that are isolated by internal walls and protected by rigorous entry restrictions, air-locks, negative-pressure air-handling systems, and filtration of all out-flow air through high-efficiency particulate air (HEPA) filters. Workers in BSL-4 laboratories also wore filtered positive-pressure total body suits, which isolated the workers from the internal air of the laboratory. BSL-3 laboratories had a similar design, but do not require that personnel wear positive-pressure suits. Workers in BSL-3 suites were protected immunologically by vaccines. U.S. governmental standards provided guidance as to which organisms might be handled under various containment levels in laboratories such as USAMRIID. The unique facilities available at USAMRIID also included a 16-bed clinical research ward capable of BSL-3 containment, and a 2-bed patient care isolation suite—the Medical Containment Suite (MCS), known as "The Slammer"—where ICU-level care could be provided under BSL-4 containment. Here, healthcare personnel wore the same positive-pressure suits as are worn in BSL-4 research laboratories. The level of patient isolation required depended on the infecting organism and the risk to healthcare providers. Patient care can be provided at BSL-4. There were no patient-care category analogous to BSL-3; humans who are ill as a result of exposure to BSL-3 agents were to be cared for in an ordinary hospital room with barrier nursing procedures. USAMRIID guidelines were prepared to determine which level of containment would be employed for individual patients who required BSL-4 isolation or barrier nursing care. Staff augmentation for BSL-4 critical care expertise came from the
Walter Reed Army Medical Center The Walter Reed Army Medical Center (WRAMC), officially known as Walter Reed General Hospital (WRGH) until 1951, was the United States Army, U.S. Army's flagship medical center from 1909 to 2011. Located on in Washington, D.C., it served more ...
(WRAMC), Washington, D.C., in accordance with a memorandum of agreement between the two institutions. Patients could be brought directly into the BSL-4 suite from the outside through specialized ports with unique patient-isolation equipment. (The MCS was decommissioned and discontinued in December 2010.) Additionally, starting in the 1970s USAMRIID maintained a unique evacuation capability known as the Aeromedical Isolation Team (AIT). Led by a physician and a registered nurse, each of the two teams consisted of eight volunteers who trained intensively to provide an evacuation capability for casualties suspected of being infected with highly transmissible, life-threatening BSL-4 infectious diseases (e.g., hemorrhagic fever viruses). The unit used special adult-sized Vickers isolation units (Vickers Medical Containment Stretcher Transit Isolator). These units were aircraft transportable and isolated a patient placed inside from the external environment. The AIT could transport two patients simultaneously; obviously, this was not designed for a mass casualty situation. During the 1995 outbreak of Ebola fever in Zaire, the AIT remained on alert to evacuate any US citizens who might have become ill while working to control the disease in that country. During this period, some biological defense research also continued at the U.S. Army Medical Research Institute of Chemical Defense, Edgewood Arsenal, Maryland, and the Walter Reed Army Institute of Research (WRAIR), Washington, D.C. USAMRIID and these sister laboratories conducted basic research in support of the medical component of the US biological defense research program, which developed strategies, products, information, procedures, and training for medical defense against biological warfare agents. The products included diagnostic reagents and procedures, drugs, vaccines, toxoids, and antitoxins. Emphasis is placed on protecting personnel before any potential exposure to the biological agent occurs. In 1997,
United States law The law of the United States comprises many levels of Codification (law), codified and uncodified forms of law, of which the supreme law is the nation's Constitution of the United States, Constitution, which prescribes the foundation of the ...
formally defined weaponizable bio-agents as "Biological Select Agents or Toxins" (BSATs) — or simply Select Agents for short — which fall under the oversight of either the U.S. Department of Health and Human Services or the U.S. Department of Agriculture (or both) and which have the "potential to pose a severe threat to public health and safety". In 1998, several DoD organizations consolidated to create the Defense Threat Reduction Agency (DTRA), headquartered in
Fort Belvoir, Virginia A fortification (also called a fort, fortress, fastness, or stronghold) is a military construction designed for the defense of territories in warfare, and is used to establish rule in a region during peacetime. The term is derived from Lati ...
. This agency is DOD's official Combat Support Agency for countering
weapons of mass destruction A weapon of mass destruction (WMD) is a Biological agent, biological, chemical weapon, chemical, Radiological weapon, radiological, nuclear weapon, nuclear, or any other weapon that can kill or significantly harm many people or cause great dam ...
, including bio-agents. DTRA's main functions are threat reduction, threat control, combat support, and technology development. In the US national interest, DTRA supports projects at more than 14 locations around the world, including Russia, Kazakhstan, Azerbaijan, Uzbekistan, Georgia, and Ukraine. In 1999, a "National Pharmaceutical Stockpile" — renamed Strategic National Stockpile in 2002 — was created under the oversight of DHHS. In the same year, the Laboratory Response Network — a collaborative effort within the US federal government involving the Association of Public Health Laboratories and the
Centers for Disease Control and Prevention The Centers for Disease Control and Prevention (CDC) is the National public health institutes, national public health agency of the United States. It is a Federal agencies of the United States, United States federal agency under the United S ...
— was established to facilitate the confirmatory diagnosis and typing of possible bio-agents. Also in 1999, President
Bill Clinton William Jefferson Clinton (né Blythe III; born August 19, 1946) is an American politician and lawyer who was the 42nd president of the United States from 1993 to 2001. A member of the Democratic Party (United States), Democratic Party, ...
issued Executive Order 13139, which provided for experimental anti-WMD drugs to be given to service members at the discretion of the Secretary of Defense only under
informed consent Informed consent is an applied ethics principle that a person must have sufficient information and understanding before making decisions about accepting risk. Pertinent information may include risks and benefits of treatments, alternative treatme ...
; only the President may waive the necessity for informed consent.


2000s

Three secret DoD projects involving countermeasures against anthrax – code named Project Bacchus, Project Clear Vision and Project Jefferson – were publicly disclosed by ''
The New York Times ''The New York Times'' (''NYT'') is an American daily newspaper based in New York City. ''The New York Times'' covers domestic, national, and international news, and publishes opinion pieces, investigative reports, and reviews. As one of ...
'' in 2001. (The projects were undertaken between 1997 and 2000 and focused on the concern that the old Soviet BW program was secretly continuing and had developed a genetically modified anthrax weapon.) Since the
September 11 attacks The September 11 attacks, also known as 9/11, were four coordinated Islamist terrorist suicide attacks by al-Qaeda against the United States in 2001. Nineteen terrorists hijacked four commercial airliners, crashing the first two into ...
and the
2001 anthrax attacks The 2001 anthrax attacks, also known as Amerithrax (a portmanteau of "United States, America" and "anthrax", from its FBI case name), occurred in the United States over the course of several weeks beginning on September 18, 2001, one week after th ...
, the US government has allocated nearly $50 billion to address the threat of biological weapons. Funding for bioweapons-related activities focuses primarily on research for and acquisition of medicines for defense. Biodefense funding also goes toward stockpiling protective equipment, increased surveillance and detection of bio-agents, and improving state and hospital preparedness. Significant funding goes to BARDA (
Biomedical Advanced Research and Development Authority The Biomedical Advanced Research and Development Authority (BARDA) is a center within the Administration for Strategic Preparedness and Response (ASPR) located within the U.S. Department of Health and Human Services (HHS) responsible for the p ...
), part of DHHS. Funding for activities aimed at prevention has more than doubled since 2007 and is distributed among 11 federal agencies. Efforts toward cooperative international action are part of the project. A "Select Agent Program" (SAP) was established to satisfy requirements of the USA PATRIOT Act of 2001 and the
Public Health Security and Bioterrorism Preparedness and Response Act of 2002 Signed into effect on 12 June 2002, the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (PHSBPRA) was signed by the President, the Department of Health and Human Services ( DHHS) and the U.S. Department of Agriculture ...
. The
Centers for Disease Control and Prevention The Centers for Disease Control and Prevention (CDC) is the National public health institutes, national public health agency of the United States. It is a Federal agencies of the United States, United States federal agency under the United S ...
administers the SAP, which regulates the laboratories that may possess, use, or transfer Select Agents within the United States. The Project Bioshield Act was passed by Congress in
2004 2004 was designated as an International Year of Rice by the United Nations, and the International Year to Commemorate the Struggle Against Slavery and Its Abolition (by UNESCO). Events January * January 3 – Flash Airlines Flight 60 ...
calling for $5 billion for purchasing vaccines that would be used in the event of a bioterrorist attack. According to President
George W. Bush George Walker Bush (born July 6, 1946) is an American politician and businessman who was the 43rd president of the United States from 2001 to 2009. A member of the Bush family and the Republican Party (United States), Republican Party, he i ...
:
Project BioShield will transform our ability to defend the nation in three essential ways. First, Project BioShield authorizes $5.6 billion over 10 years for the government to purchase and stockpile vaccines and drugs to fight anthrax, smallpox and other potential agents of bioterror. The DHHS has already taken steps to purchase 75 million doses of an improved anthrax vaccine for the Strategic National Stockpile. Under Project BioShield, HHS is moving forward with plans to acquire a safer, second generation smallpox vaccine, an antidote to botulinum toxin, and better treatments for exposure to chemical and radiological weapons.
This was a ten-year program to acquire medical countermeasures to biological, chemical, radiological and nuclear agents for civilian use. A key element of the Act was to allow stockpiling and distribution of vaccines that had not been tested for safety or efficacy in humans, due to ethical concerns. Efficacy of these agents cannot be directly tested in humans without also exposing humans to the chemical, biological, or radioactive threat being treated. In these cases efficacy testing follows the US
Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respo ...
Animal Rule for pivotal animal efficacy. Since 2007, 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 (NBACC) 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). The expansion of U.S. biodefense programs in the 2000s, particularly through NBACC, raised concerns among some arms control experts regarding compliance with the
Biological Weapons Convention The Biological Weapons Convention (BWC), or Biological and Toxin Weapons Convention (BTWC), is a disarmament treaty that effectively bans Biological weapons, biological and toxin weapons by prohibiting their development, production, acquisition, ...
. A 2003 commentary in '' Politics and the Life Sciences'' by Milton Leitenberg, James F. Leonard, and Richard Spertzel argued that some NBACC activities—including genetic engineering of pathogens, pathogen dispersal modeling, and “Red Teaming” (simulating biothreat scenarios)—could be perceived as offensive biological weapons research rather than purely defensive work. The authors warned that research into pathogen stabilization, packaging, and dispersal resembled previous U.S. offensive biological weapons programs before the BWC came into effect. A 2004 report in '' The Journal of Clinical Investigation'' raised similar concerns, citing a presentation by Lieutenant Colonel George W. Korch Jr., which outlined NBACC research objectives such as acquiring, growing, modifying, storing, stabilizing, packaging, and dispersing biological agents. Experts noted that several of these tasks were categorized by the
National Academy of Sciences The National Academy of Sciences (NAS) is a United States nonprofit, NGO, non-governmental organization. NAS is part of the National Academies of Sciences, Engineering, and Medicine, along with the National Academy of Engineering (NAE) and the ...
as "experiments of concern", particularly those that might increase pathogen virulence, transmissibility, or resistance to countermeasures. Leitenberg warned that high-fidelity modeling and feasibility studies of biological threats might have already "crossed the line" into offensive research. He also suggested that U.S. biodefense activities could provoke other nations to expand their own biological weapons research, increasing global security risks.
Anthony Fauci Anthony Stephen Fauci ( ; born December 24, 1940) is an American physician-scientist and immunologist who served as the director of the National Institute of Allergy and Infectious Diseases (NIAID) from 1984 to 2022, and the chief medical ...
, then Director of the U.S.
National Institute of Allergy and Infectious Diseases The National Institute of Allergy and Infectious Diseases (NIAID, ) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services. NIAID's mis ...
, stated that NBACC’s work focused on developing diagnostics, therapeutics, and vaccines, dismissing comparisons to past offensive bioweapons programs. Gerald Parker, then Director of the U.S. Department of Homeland Security Office of Science-Based Threat Analysis, also denied any intent to enhance pathogen virulence but acknowledged that if intelligence suggested adversaries were modifying pathogens, NBACC "may have to evaluate the technical feasibility" of such modifications. Peter Gilligan of the
University of North Carolina The University of North Carolina is the Public university, public university system for the state of North Carolina. Overseeing the state's 16 public universities and the North Carolina School of Science and Mathematics, it is commonly referre ...
Medical School criticized efforts to enhance virulence or antibiotic resistance in pathogens, citing risks of accidental release, proliferation, and misuse. Gilligan pointed to the 1979 Sverdlovsk anthrax leak as an example of how even defensive biological research can lead to deadly accidents. He also questioned the financial and ethical costs of the biodefense expansion, arguing that billions of dollars were being spent on speculative countermeasures while other pressing global health needs, like countering the spread of HIV in developing countries, remained underfunded.


2010s

In July 2012, the
White House The White House is the official residence and workplace of the president of the United States. Located at 1600 Pennsylvania Avenue Northwest (Washington, D.C.), NW in Washington, D.C., it has served as the residence of every U.S. president ...
issued its guiding document on the '' National Biosurveillance Strategy''.


2020s

In December 2019, Congress moved forward with a spending package that provided increases for several key U.S. biological defense programs, including the Strategic National Stockpile. The Centers for Disease Control and Prevention was slated to receive $8 billion, a $636 million increase over 2019, with a mandate written in the bill for CDC "to maintain a strong and central role in the medical countermeasures enterprise." Within the CDC budget, the Public Health and Social Services Emergency Fund, which prepares for "all public health emergencies" including bioterrorism and federal efforts against infectious diseases, was funded at $2.74 billion. Another change was a specific item in the budget for the Strategic National Stockpile, which directed $535 million for vaccines, medicines and diagnostic tools to fight Ebola, which has become an emerging threat.


Current status

In August 2019, the U.S.
Government Accountability Office The United States Government Accountability Office (GAO) is an independent, nonpartisan government agency within the legislative branch that provides auditing, evaluative, and investigative services for the United States Congress. It is the s ...
(GAO) issued a report that identified specific challenges that the United States faces in protecting the nation against biological events. The report focused on four specific vulnerabilities: assessment of "enterprise-wide threats", situational awareness and data integration, biodetection technologies, and lab safety and security. Products currently being produced or under development through military research include: * Vaccines to prevent
tularemia Tularemia, also known as rabbit fever, is an infectious disease caused by the bacterium '' Francisella tularensis''. Symptoms may include fever, skin ulcers, and enlarged lymph nodes. Occasionally, a form that results in pneumonia or a throat ...
, Q fever, Rift Valley fever, Venezuelan equine encephalitis, Eastern and Western equine encephalitis, chikungunya fever,
Argentine hemorrhagic fever Argentine hemorrhagic fever (AHF) or O'Higgins disease, also known in Argentina as mal de los rastrojos (stubble disease) is a hemorrhagic fever and zoonotic infectious disease occurring in Argentina. It is caused by the Junín virus (an arenavi ...
, the botulinum toxicoses, and anthrax; * Antitoxins for diseases such as
botulism Botulism is a rare and potentially fatal illness caused by botulinum toxin, which is produced by the bacterium ''Clostridium botulinum''. The disease begins with weakness, blurred vision, Fatigue (medical), feeling tired, and trouble speaking. ...
; * Human immune globulin preparations (passive antibody protection) against various bacteria and viruses; and * Antiviral drugs against multiple viral agents. Some vaccines also have applicability for diseases of domestic animals (e.g., Rift Valley fever and Venezuelan equine encephalitis). In addition, vaccines are provided to persons who may be occupationally exposed to such agents (e.g., laboratory workers, entomologists, and veterinary personnel) throughout government, industry, and academe. USAMRIID also provides diagnostic and epidemiological support to federal, state, and local agencies and foreign governments. Examples of assistance rendered to civilian health efforts by the U.S. Army Medical Research and Materiel Command (USAMRMC) include: * The massive immunization program instituted during the Venezuelan equine encephalitis outbreak in the Americas in 1971; * The laboratory support provided to the U.S. Public Health Service during the outbreak of Legionnaire's disease in Philadelphia, Pennsylvania, in 1976; * The management of patients suspected of having African viral hemorrhagic fever in Sweden during the 1980s; * International support during the outbreak of Rift Valley fever in Mauritania in 1989; * Assistance with the outbreak of Ebola infections among monkeys imported to Reston (Virginia) in 1990 (→ Reston virus); and * Epidemiological and diagnostic support to the
World Health Organization The World Health Organization (WHO) is a list of specialized agencies of the United Nations, specialized agency of the United Nations which coordinates responses to international public health issues and emergencies. It is headquartered in Gen ...
–Centers for Disease Control and Prevention field team that studied the Ebola outbreak in Zaire in 1995 (→
Zaire ebolavirus ''Orthoebolavirus zairense'' or Zaire ebolavirus, more commonly known as Ebola virus (; EBOV), is one of six known species within the genus ''Ebolavirus''. Four of the six known ebolaviruses, including EBOV, cause a severe and often fatal hem ...
). The current research effort combines new technological advances, such as
genetic engineering Genetic engineering, also called genetic modification or genetic manipulation, is the modification and manipulation of an organism's genes using technology. It is a set of Genetic engineering techniques, technologies used to change the genet ...
and molecular modeling, applying them toward development of prevention and treatment of diseases of military significance. The program is conducted in compliance with requirements set forth by the U.S.
Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respo ...
(FDA), U.S. Public Health Service,
Nuclear Regulatory Commission The United States Nuclear Regulatory Commission (NRC) is an independent agency of the United States government tasked with protecting public health and safety related to nuclear energy. Established by the Energy Reorganization Act of 1974, the ...
, U.S. Department of Agriculture,
Occupational Safety and Health Administration The Occupational Safety and Health Administration (OSHA; ) is a regulatory agency of the United States Department of Labor that originally had federal visitorial powers to inspect and examine workplaces. The United States Congress established ...
, and
Biological Weapons Convention The Biological Weapons Convention (BWC), or Biological and Toxin Weapons Convention (BTWC), is a disarmament treaty that effectively bans Biological weapons, biological and toxin weapons by prohibiting their development, production, acquisition, ...
.Huxsoll, ''Op. cit.''


References

*''This article contains information that originally came from US Government publications and websites and is in the public domain.'' {{DEFAULTSORT:United States biological defense program Biological warfare
biological weapons Biological agents, also known as biological weapons or bioweapons, are pathogens used as weapons. In addition to these living or replicating pathogens, toxins and biotoxins are also included among the bio-agents. More than 1,200 different kin ...
Military projects of the United States Disaster preparedness in the United States United States biological weapons program Military defense