The NBACC was created as a federal response to the anthrax letter attacks in 2001 as the first national laboratory operating under the Department of Homeland Security.[1] The Department of Homeland Security said the mission of the NBACC is "to provide the scientific basis for the characterization of biological threats and bioforensic analysis to support attribution of their planned or actual use."[2] Part of the NBACC's mission is to conduct realistic tests of the pathogens and tactics that might be used in a bioterrorism attack. It seeks to quantitatively answer questions pertaining to what might happen in a biological attack. This work is carried out by about 180 researchers and support staff and has become more advanced since the NBACC became certified to work with biological select agents and toxins in September 2011.[citation needed]
Its work is necessary in the preparation and response to biological threats, which can be handled as they emerge through the NBACC national security biocontainment laboratory.[1] The NBACC is equipped to develop and investigate genetically engineered viruses and bacteria. The NBACC evaluates new and emerging technologies,[1] along with delivery devices that U.S. adversaries might use to disseminate the pathogens.[citation needed]
The NBACC coordinates closely with the many departments and agencies in the U.S. government, including the U.S. intelligence community which has assigned advisers to the Center. The NBACC is involved in a partnership with the National Interagency Confederation for Biological Research at Fort Detrick and initiated the "Work for Others" program, which expands the NBACC's capacity to share information with a variety of related federal agencies.[3]
Significance of operation
In June 2017, Daniel M. Gerstein, senior policy researcher at the RAND Corporation and former acting Under Secretary and Deputy Under Secretary of the DHS's Science and Technology Directorate, said, "In the last 40 to 60 years, hundreds of new diseases have cropped up across the world ... The country and the world have not proven ready to handle a true public health crisis."[1] Describing the NBACC's value to science, Gerstein said, "Back in 2001, we did not have this facility, and it literally took months in order to do the forensics analysis of samples ... they had to outsource ... to 12 different facilities to get everything analyzed back then. Today, the NBACC can do those forensic analyses in a couple days."[1]
The risk of a bioterrorism attack continues to grow. International terrorist organizations, such as ISIS, have shown growing desire to access and use biological weapons. A 19-page document providing instructions on the creation of biological weapons was discovered on a laptop obtained from ISIS in 2014. Kenyan authorities stopped an ISIS-affiliated anthrax plot in late 2016. In early 2017, South Korea speculated that North Korea was developing biological weapons that could be dispersed through drones. The NBACC and affiliated groups play an important role in protecting the public from these mounting threats.[4]
NBACC has already proven capable of responding to these types of threats, as an important actor in the United States response to the Ebola Outbreak of 2014. During the crisis, NBACC scientists carried out experiments to test the duration of the virus' activity when placed on different surfaces, and best practices for sanitation after completing tests.[1]
Threats to continued work
Under President Trump's budget proposal for fiscal year 2018, the NBACC stands to lose funding that allows it to continue scientific studies. The NBACC is faced with the threat of complete shutdown of its facilities by September 2018. Daniel M. Gerstein said the result of the closure of the NBACC would be a "potentially devastating public health concern."[1]
The cost of replacing the services provided by the NBACC will be more expensive than continuing its operations simply due to the nature of changing the role of the NBACC's facilities, according to Homeland Preparedness News.[1]
Congressman John Delaney (D-MD), who represents the Maryland congressional district in which the NBACC resides, said in a statement from May 2017:[5]
I am 100 percent opposed to the closing of the National Biodefense Analysis and Countermeasures Center in Frederick and will fight this deeply misguided move by the Trump Administration ... The National Biodefense Analysis and Countermeasures Center is a unique facility that is crucial to our homeland security, intelligence, and anti-terrorism endeavors. This is the lab that protects us against anthrax attacks, ricin attacks and other bioterrorism threats.
In May 2017, several faculty at the Johns Hopkins Center for Health Security, said the loss of the NBACC would make the impact of a bioterror attack "far more dire." They said, "In the first moments after the attack is identified, we'd want to know the identity of the pathogen used in the attack, whether it could spread from person to person and what drugs and vaccines would work to treat and protect people. But with ... complete elimination [of the NBACC] ... the delay before these and other facts are known would increase, costing many lives."[4]
In September 2015, the Battelle National Biodefense Institute (which operates the NBACC) was awarded a 10-year contract for operations and management. At the time, Battelle said the contract would be worth $480 million if fully executed. The proposed Trump budget for 2018, though, would see this award retracted, leading to the end of all scientific operations by March 2018.[6]
Facilities
NBACC laboratories operate at the biosafety levels of 2, 3, and 4, providing the optimal level of safety and operational capacity. In particular, the NBACC's biosafety level of 4 allows its facilities to research pathogens that have no existing vaccines or treatment. This makes it one of only seven locations in the United States where this occurs.[citation needed]
In June 2006, construction began on a new $128 million, 160,000sqft (15,000m2) facility inside the Ft. Detrick installation. Space inside the 8-story, glass-and-brick structure opened in 2008 and is divided between NBACC's two centers:
The National Biological Threat Characterization Center (NBTCC), which seeks to identify and prioritize biological threats and our vulnerabilities to those threats through its laboratory threat assessments. It includes biocontainment suites, including air-handling equipment, security controls, and other supporting features. It is classified as a SCIF, or Sensitive Compartmented Information Facility,[3] meaning that while the majority of research that occurs at the lab is unclassified, some research results must remain classified for security purposes.[7]
The National Bioforensic Analysis Center (NBFAC), a forensic testing center equipped to identify and characterize the possible culprit pathogens after an attack has already occurred.
Notable accomplishments
The NBACC achieved a "Superior" Defense Security Service (DSS) rating in 2012 and 2013 and was recognized for staff volunteerism.[2] It has played a role in over 100 federal law enforcement cases.[3]
The NBTCC has unique national biosafety level 3 and 4 aerobiology capabilities, which are necessary to collect crucial data that is used to develop biodefense plans and responses. In 2013, it provided necessary data, which addressed 10 specific biological agent knowledge gaps, to improve hazard, risk, and threat assessments. The data allowed for significant growth in the credibility of hazard and risk assessment modeling of bioterrorism scenarios for a variety of toxin threat agents, including both bacteria and viruses.[citation needed]
The NBFAC played a role in more than 45 federal law enforcement investigations of biological crimes in 2013 alone. Also in 2013, it activated unique bioforensic laboratories at biosafety level 3 with accreditation for casework operations. Its processes maintain operational capability to study more than 60 high-priority human, animal, and plant pathogens and toxins. Its sequencing methods are imperative to enable new kinds of studies. It played a central role in developing capabilities to investigate genetically modified and de novo synthetic agents (new complex molecules formed from simple molecules).[2]
In January 2018, the Intelligence Advanced Research Projects Activity selected Battelle to create a software platform able to fight the development of synthetic biological threats. Battelle said it would develop the threat assessment platform with collaboration from Ginkgo Bioworks, One Codex and Twist Bioscience. The intended final result is a program that can "merge computational approaches into a software tool that can be applied in real-world scenarios."[8]
Controversy and response
Questions have been raised by some arms-control and international law experts as to the necessity and advisability of the very high level of security surrounding the NBACC and as to whether it does (or will) place the United States in violation of the 1972 Biological and Toxin Weapons Convention (BWC). (The BWC outlawed developing, stockpiling, acquiring or retaining pathogens "of types and in quantities that have no justification" for peaceful purposes.)[9]
NBACC's opponents contended that the facility would operate in a "legal gray zone" and skirt the edges of the BWC, which outlaws production of even small amounts of biological weapons. They contend that a high degree of transparency is needed to reassure Americans (and the rest of the world) of the U.S. government's good intentions. In their view, the U.S. government may find it hard in the future to object to other countries testing genetically engineered pathogens and novel delivery systems when they invoke their own national biodefense requirements.[10]
The Bush administration contended that the NBACC is purely defensive and thus its operations are fully legal and in accord with the BWC. A principle is that assessing the technical threat of biological pathogens is essential to inform and help develop biodefense policy. Administration officials say that making small amounts of biowarfare pathogens for study is permitted under a broad interpretation of the treaty.[11]
Faculty at the NBACC provided their own responses to help answer questions raised by critics.
In May 2008, director Patrick Fitch said that research at the laboratory is not conducted to "create threats in order to study them."[7] Maureen McCarthy, former Homeland Security director of research and development, said, "All the programs we do are defensive in nature. Our job is to ensure that the civilian population of the country is protected, and that we know what the threats are." Bernard Courtney, the NBACC's former scientific director, described oversight, mentioning that frequent independent reviews over particular experiments occur. These reviews are operated by a group of up to four scientists on a case-by-case scenario.[12]
Additionally, research at the labs is overseen by the Institutional Biosafety Committee. The CDC also conducts inspections to assure labs comply with Select Agents rules.[13] The Final Environmental Impact Statement, or FEIS, for NBACC facilities states that all research is performed for defense purposes and is conducted in a legal manner, including under the BWC.[14]
Biological warfare, also known as germ warfare, is the use of biological toxins or infectious agents such as bacteria, viruses, insects, and fungi with the intent to kill, harm or incapacitate humans, animals or plants as an act of war. Biological weapons are living organisms or replicating entities. Entomological (insect) warfare is a subtype of biological warfare.
Bioterrorism is terrorism involving the intentional release or dissemination of biological agents. These agents include bacteria, viruses, insects, fungi, and/or toxins, and may be in a naturally occurring or a human-modified form, in much the same way as in biological warfare. Further, modern agribusiness is vulnerable to anti-agricultural attacks by terrorists, and such attacks can seriously damage economy as well as consumer confidence. The latter destructive activity is called agrobioterrorism and is a subtype of agro-terrorism.
Biosecurity refers to measures aimed at preventing the introduction and/or spread of harmful organisms to animals and plants in order to minimize the risk of transmission of infectious disease. In agriculture, these measures are aimed at protecting food crops and livestock from pests, invasive species, and other organisms not conducive to the welfare of the human population. The term includes biological threats to people, including those from pandemic diseases and bioterrorism. The definition has sometimes been broadened to embrace other concepts, and it is used for different purposes in different contexts.
Biodefense refers to measures to restore biosecurity to a group of organisms who are, or may be, subject to biological threats or infectious diseases. Biodefense is frequently discussed in the context of biowar or bioterrorism, and is generally considered a military or emergency response term.
A biosafety level (BSL), or pathogen/protection level, is a set of biocontainment precautions required to isolate dangerous biological agents in an enclosed laboratory facility. The levels of containment range from the lowest biosafety level 1 (BSL-1) to the highest at level 4 (BSL-4). In the United States, the Centers for Disease Control and Prevention (CDC) have specified these levels in a publication referred to as BMBL. In the European Union, the same biosafety levels are defined in a directive. In Canada the four levels are known as Containment Levels. Facilities with these designations are also sometimes given as P1 through P4, as in the term P3 laboratory.
Fort Detrick is a United States Army Futures Command installation located in Frederick, Maryland. Fort Detrick was the center of the U.S. biological weapons program from 1943 to 1969. Since the discontinuation of that program, it has hosted most elements of the United States biological defense program.
Plum Island Animal Disease Center (PIADC) is a United States federal research facility dedicated to the study of foreign animal diseases of livestock. It is a national laboratory of the Department of Homeland Security (DHS) Directorate for Science and Technology (S&T), and operates as a partnership with the U.S. Department of Agriculture (USDA). The facility's director is Dr. Larry Barrett.
The United States Army Medical Research Institute of Infectious Diseases is the U.S Army's main institution and facility for defensive research into countermeasures against biological warfare. It is located on Fort Detrick, Maryland, near Washington, D.C., and is a subordinate lab of the United States Army Medical Research and Development Command (USAMRDC), headquartered on the same installation.
The Science and Technology Directorate (S&T) is a component within the United States Department of Homeland Security. DHS-S&T serves as the research and development arm of the Department as it fulfills its national security mission.
The National Bio and Agro-Defense Facility (NBAF) is a biosafety level 4 research laboratory in Manhattan, Kansas, operated by the United States Department of Agriculture. Slated to open in Summer 2022, the facility is designed to combat biological threats involving human, zoonotic, and foreign animal diseases. The NBAF will be replacing the aging Plum Island Animal Disease Center (PIADC) on Plum Island, New York. The primary research tenants of the facility will be the Agriculture Research Service (USDA-ARS) and Animal Plant Health Inspection Service, Veterinary Services (USDA-APHIS-VS). Construction on the 574,000-square-foot (53,300 m2) facility officially began in May 2015, and was scheduled to be completed by May 2021. The ongoing COVID-19 pandemic, however, has delayed scheduled commissioning to October 2021, followed by further delays to Spring, and, subsequently, Summer 2022. Operations will be fully transferred from the Plum Island facility by 2023. When fully operational, the facility will employ between 250 and 350 people. The facility is a constituent member of the Biosafety Level 4 Zoonotic Laboratory Network, and is currently led by Alfonso Clavijo.
The Project Bioshield Act was an act passed by the United States Congress in 2004 calling for $5 billion for purchasing vaccines that would be used in the event of a bioterrorist attack. 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 which had not been tested for safety or efficacy in humans, due to ethical concerns. Efficacy of such agents cannot be directly tested in humans without also exposing humans to the chemical, biological, or radioactive threat being treated, so testing follows the FDA Animal Rule for pivotal animal efficacy.
The Chemical and Biological Defense Division (CBD) is a division of the Science and Technology Directorate of the United States Department of Homeland Security. Within the Homeland Security Advanced Research Projects Agency, CBD develops technologies to increase the United States's preparedness and protect key national infrastructure against chemical, biological, and agricultural threats and disasters through improved threat awareness and advanced surveillance, detection, and protective countermeasures.
National Urban Security Technology Laboratory is a United States government-owned, government-operated laboratory, part of the Department of Homeland Security (DHS) Science & Technology Directorate. It is located in the Federal Office Building at 201 Varick Street in the Hudson Square neighborhood, Manhattan, New York.
Biosecurity in the United States is governed by the Bureau of Western Hemisphere Affairs, which is part of the US Department of State. It obtains guidance and advice on specific matters relating to biosecurity from various other government agencies.
Texas Energy Engineers, Inc., dba ccrd partners, is a professional engineering firm headquartered in Houston, TX (USA).
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.
The Bipartisan Commission on Biodefense, formerly known as the Blue Ribbon Study Panel on Biodefense, is an organization of former high-ranking government officials that analyzes US capabilities and capacity to defend against biological threats. According to the Commission's mission statement, the organization was formed to "provide for a comprehensive assessment of the state of U.S. biodefense efforts, and to issue recommendations that will foster change."
The National Biodefense Strategy Act of 2016 is a bill introduced in the United States Senate by U.S. Senator Ron Johnson (R-Wisconsin). The bill would amend the Homeland Security Act of 2002 by requiring the government to change its current policy and programs to coordinate and improve biodefense preparedness. Johnson is the current chairman of the Senate Committee on Homeland Security and Governmental Affairs.
The Alliance for Biosecurity is a consortium of companies that develop products to respond to national security threats, including bioterrorism pathogens and emerging infectious diseases. It is headquartered in Washington DC.
The National Interagency Biodefense Campus is a facility in Frederick, MD at Fort Detrick. It hosts members of a scientific collaboration, the National Interagency Confederation for Biological Research.
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