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This is my final paper on Bioterrorism Legislation for my Macaulay Honors Seminar on Science in the City.

Bioterrorism Legislation in the US

The field of bioterrorism in the United States came to the forefront after the anthrax attacks in the months following September 11th 2001. Bioterrorism is a unique threat that combines the fields of public health and national security. Tracking the issue through specific legislation and policy on a federal level shows how difficult sustaining this combination of power is after the initial fear of attack has dissipated.
The major US bioterrorist scare occurred in the fall of 2001, shortly after September 11th, when letters laced with anthrax were mailed throughout the country. These letters infected twenty-two people and caused five deaths, thereby becoming “the worst biological attack in U.S. history.”
After the attacks the Bush Administration made bioterrorism preparedness one of their top security priorities and increased the U.S. Government Civilian Biodefense Funding from $414 million in 2001 to $3.65 billion in 2002. This number is measured by analyzing the budgets and allocations for biodefense at the Department of Health and Human Services (HHS), the Department of Homeland Security (DHS), the Department of Defense (DoD), the Department of Agriculture (USDA), the Environmental Protection Agency (EPA), the National Science Foundation (NSF), and the Department of State (DOS).
However, biodefense is by no means a new field. The act of biological warfare has been traced as far back as the Assyrians. The use of biological weapons in the twentieth century began during World War I when Germans attempted to infect livestock going to France. The United States began its bioweapons program in 1943 and officially discontinued it in 1969. In order to address the threat of bioweapons internationally, the Biological and Toxin Weapons Convention (BTWC) was signed in Washington, London, and Moscow in 1972 and entered into force in 1975. The BTWC is particularly significant and unique for being “the first multilateral disarmament treaty banning the production and use of an entire category of weapons.”
The Convention prohibits any state from developing and owning any forms of “microbial or other biological forms of agents or toxins, in types and in quantities that have no justification for…peaceful purposes.” This convention was supposed to stop any development of bioweapons through international institutions. However, since the treaty was signed, the Soviet Union continued developing both offensive and defense bioweapons programs.
The BWTC was aimed at bioweapons in the hands of states. Bioterrorism as a field is directed at the use of bioweapons in the hands of non-state actors. The first case of bioterrorism in the United States occurred in 1984 when members of a religious sect in Oregon contaminated food with salmonella in order to influence the outcome of a local election. Around 751 people were affected and no one died. Another famous case of bioterrorism is the 1995 Sarin Attack in Tokyo. Members of an apocalyptic religious sect, Aum Shinrikyo, released the nerve agent, sarin, onto crowded train cars. The attack killed twelve and injured around six thousand people.
The shift from state created bioweapons to dangerous toxins in the hands on non-state actors reflects a larger dynamic shift in the post-cold war political environment. In recent history terrorism has replaced Communism as a top US security concern. So what exactly is bioterrorism? It is is defined by the Centers for Disease Control and Prevention (CDC) as “the deliberate release of viruses, bacteria, or other germs (agents) used to cause illness or death in people, animals, or plants.” The White House adds another sentence to this definition, “the act is intended to create fear and/or intimidate governments or societies in the pursuit of political, religious, or ideological goals.” These two definitions represent the challenges faced by officials creating biosecurity legislation and counterterrorist policies. The CDC focuses on the physical and medical damage while the White House focuses on the intention to commit an act of terrorism.
Scholars agree that determining intent and identifying the perpetrators are two of the biggest challenges that biodefense poses. Intent is what separates a natural outbreak of disease and a planned attack. The 1984 Oregon salmonella attack was only discovered to be intentional a year later. In addition, the two of the anthrax letters contained the following message: “09-11-01. THIS IS NEXT. TAKE PENACILIN NOW. DEATH TO AMERICA. DEATH TO ISRAEL. ALLAH IS GREAT” , yet the man believed to be responsible, Dr. Bruce Ivins, was merely posing as a Muslim extremist. Even today there is still a debate over whether or not Dr. Ivins was truly responsible for the attacks. Properly identifying and tracking bioterrorist threats can only come from a combination of public health, foreign policy, and national security.
The first major piece of bioterrorism legislation, the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, addressed issues unique to bioterrorism, like intent, and created a larger national plan for biodefense. Also known as the Bioterrorism Act, it was created to form a comprehensive plan to prepare the country for a bioterrorist attack through research, education, and production of countermeasures.
The bill focused on smaller governmental offices that would help deal with the unique challenges posed by bioterrorism, like determining intentionality and identifying the responsible terrorists. One smaller program within the CDC that gained specific attention in the bill was the Epidemic Intelligence Service (EIS). The EIS is credited with solving the problem and preventing the spread of anthrax. It is a two-year postgraduate training program and it consists of microbiologists, academic epidemiologists, sociologists, doctors, and individuals from many other disciplines. Epidemiologists can determine which diseases are deliberately disseminated based on a number of clues including rareness of the illness, mode of transmission, and the number of people suffering from unexplained illness. This is how scientists can help combat the issue of intent and identification.
The bill also focused on preparation for a bioterrorist attack through building up the public health systems on a national level. As a result, the bill called on the Secretary of the HHS to strengthen the capacity of the CDC on both the federal and state/local levels in addition to the focus it put on offices within the CDC, like the EIS. In order to support these changes, the bill calls for an increased budget for the CDC. This attention made it a focal point of the biodefense research and education.
The Bioterrorism Act of 2002 also called for the National Institutes of Health (NIH) to begin extensive research dedicated to bioterrorism. The bill also demands the Secretary of the HHS to “give high priority to making necessary improvements to the information management systems of the Food and Drug Administration” in order to track food and related agents. Like the CDC these agencies, including the Office of the Secretary, were awarded with much larger budgets to fulfill these goals. The total budget for the Department of Health and Human Service increased from 271 million dollars in 2001 to 2.94 billion in 2002.
One of the primary focuses of the Bioterrorism Act was to take away some of the overwhelming ambiguity surrounding bioterrorism by ensuring that the HHS worked on educating the public on how to identify and rank possible biological threats. For example, the CDC currently has a comprehensive list of potential bioterrorist agents arranged in order of priority on its website, as do many other Federal agency websites. Each agent is ranked based on a number of factors including level of danger to humans, type of preparedness required, and likelihood to cause widespread panic. This method of classification is a clear case of collaboration between the public health and the national security sectors because each agent is assessed by the medical harm it can inflict and its ability to be used as a method of causing fear.
The bill demanded that the Secretary of the HHS establish the position of Assistant Secretary for Public Health Emergency Preparedness (ASPR – PHE) who would be responsible for coordinating “interagency interfaces” between the HHS and “other departments, agencies, offices of the United States.” The “interagency interfaces” was translated into an interdepartmental group that would focus specifically on bioterrorism preparedness. The bill outlined specific ways for the HHS to partner with the Department of Defense (DoD), the Federal Emergency Management Agency (FEMA), the Environmental Protection Agency (EPA), and the Department of Veteran Affairs (VA).
On the whole, the Bioterrorism Act of 2002 reflects the reaction to the real threat of biological warfare. The bill put the HHS, specifically the NIH and CDC, at the forefront of biodefense and set the stage for future biosecurity and biodefense programs on a Federal level. The bill also established the policy of creating strategic national stockpiles of vaccines, specifically smallpox vaccines, in addition to research and production of medical countermeasures.
The next major piece of bioterrorism legislation, The Project BioShield Act of 2004, focused primarily on medical countermeasures and vaccination stockpiles. It also expanded the interdepartmental biodefense group established in 2002 to include the Department of Homeland Security (DHS), which was created in 2003. The DHS became the forefront of counterterrorist research and defense.
The Project BioShield Act was part of a larger federal program called Project BioShield. This bill was created to tackle the difficult field of vaccinations. According to a recent article by Wil S. Hylton in The New York Times Magazine, “smallpox is regarded by biodefense experts as the most threatening biological weapon”. Smallpox is also significant because it is the only human infectious disease that has been eradicated by science. After the funding and attention that followed the Bioterrorism Act, there was an extremely successful effort to expand the US stockpile of the smallpox vaccine.
Like smallpox, there is a vaccination for anthrax. However, the anthrax vaccination proved more problematic. There was a lot of controversy surrounding the vaccination, including rumors that it caused gulf war syndrome and other serious side effects. Instead of stockpiling the current vaccination there was an effort to create a new alternative vaccination for the disease.
Project BioShield was created as a special project to help fund a new vaccination for anthrax and assist the general countermeasure program. George W. Bush introduced the program in his 2003 State of the Union address. In his addressed he proposed “almost $6 billion to quickly make available effective vaccines and treatments against agents like anthrax, botulinum toxin, ebola, and plague.” The BioShield Act focused on speed and consolidation of power in order to help reach this goal.
Just like the Bioterrorism Act of 2002 outlined a larger role and budget for the CDC and its offices, the Project BioShield Act of 2004 expanded the capabilities of the Directors of the NIH and the National Institute for Allergy and Infectious Diseases (NIAID). Specifically, the bill amended procedures and allowed the Director of NIAID “to provide grants for the modernization and construction of biomedical and behavioral research facilities.” It also “increase[d] the Federal share of such NIAID-funded projects.” In this way the billed hoped to increase efficiency in the process of creating new vaccines and medical countermeasures.
However, this was not simply an HHS project. The Department of Homeland Security also played a major role in Project BioShield. In fact, it was the Project BioShield Act that added the Secretary of the DHS to the working group on biodefense and preparedness. The bill gave the NIH and the DHS collaborative control of Project BioShield. According to The Department of Homeland Security Appropriations Act of 2004, the Department of Homeland Security (DHS) was granted the budget of $5.593 billion dollars from September 2004 to September 2013 for medical countermeasures.
The DHS was also working on its own bioterrorism detection and surveillance program known as Project BioWatch. President Bush referenced the program in the same State of the Union address in 2003 that introduced Project BioShield. He announced it as “the nation’s first early warning network of sensors to detect [a] biological attack.” The Science and Technology (S&T) Directorate of the DHS spearheaded this program. The Department of Homeland Security Appropriations Act of 2004 allotted $118 million for this project.
Bringing these sectors together proved difficult in the long run. According to Hylton, in 2010 “two separate review boards evaluated the state of the country’s biodefense program, and each report came back scathing.” The Commission on the Prevention of WMD Proliferation and Terrorism, sponsored by Congress, gave the US government administration a grade of “F” in biodefense for “for its inability to respond quickly to and prevent mass casualties from a biological attack.” The National Biodefense Science Board (NBSB), a task force created in 2006, wrote a report entitled “Where are the Countermeasures?” in March 2010. As the report puts it, “If achieving national goals for developing MCMs is likened to climbing a mountain, then most of the mountain remains to be climbed.” The basic flaws in the program can be traced back to Project BioShield and the pieces of legislation that followed.
One major issue was the anthrax vaccine. There was difficulty with the pharmaceutical development of a new vaccine. No major pharmaceutical companies were willing to take on the project even with the major funding promised by Project BioShield. There were many problems posed by the project at large and the small pharmaceutical company, VaxGen, which had taken on the anthrax vaccine. VaxGen breached their government contracts and “by 2006, the third year of the contract, not one other major project was in development under BioShield.” This referred to the lack of progress in the creation of any vaccines for the other biological toxins most likely to be used as weapons like the ones mentioned in President Bush’s State of the Union Address. Project BioShield was hitting a dead end.
The Pandemic and All-Hazards Preparedness Act of 2006 created the Biomedical Advanced Research and Development Authority (Barda) within the HHS in order to take charge of the flailing project. This bill also established a new Assistant Secretary for Preparedness and Response (ASPR) under the Secretary of the HHS in order to bolster the response and preparedness infrastructure.
The NBSB also described the current biodefense program as “lacking in centralized leadership” and having “poor synchronization of the agencies within the Department of Health and Human Services (HHS).” The creation of Barda and the ASPR should have combated this issue and provided new authorities. Instead, the bill did not grant these agencies enough authority or responsibility to oversee the entire campaign. Instead they just added to the already fragmented and motley alliance of all the other agencies designated to tackle biodefense.
Related to the lack of centralization is the direction of funding used by different groups. According to Hylton, the Director of NIAID, Anthony Fauci, has used over 70% of his biodefense budget for research of naturally occurring diseases like AIDS, malaria and SARS. This liberal interpretation of biodefense reveals a lack of agreement within the field on priorities and a lack of agency accountability to higher authorities. Fauci’s decision also reflects a dissenting opinion on the importance of defense against a bioterrorist attack.
Biodefense as a field needs to be understood in its political and historical context. After September 11th the nation was consumed by fear. The anthrax attacks raised awareness about the possibility of bioterrorism. In addition, Iraq was purported to have biological weapons as a part of their Weapons of Mass Destruction (WMD) stockpiles.
Christopher Chyba, an international security scholar who served on the staff of the National Security Council in the Clinton administration, linked the outbreak of West Nile virus in New York in the summer of 1999 in New York to Saddam Hussein. He writes, “it is remarkable that in April 1999, only a few months before the outbreak, an Iraqi defector had claimed that Saddam Hussein planned to weaponize the virus.” In February of 2011, the aforementioned Iraqi defector admitted that he lied about the bioweapons in order to help take down Hussein’s regime. This difference shows how much can and has changed over ten years.
Bioterrorism and terrorism in general have undergone tremendous changes since 2001. The global context has changed, Osama bin Ladin is dead, the WMDs were not found, our troops will soon be withdrawn from Iraq, and the President is now a Democrat. The threat posed by the natural outbreak of diseases like the SARS virus and the lack of bioterrorist plots contextualize the Director of NIAID’s decision to divert biodefense funding to other projects. Perhaps it’s this changed environment that has resulted in the failure of the biodefense program.
Bioterrorism is a new adaptation on the old practices of bioweapons and terrorism. Therefore it required new legislation to carve out response and defense practices. These new practices include the creation of new agencies like the DHS and the ASPR, the bolstering of old agencies, like the CDC and NIH, and significant collaborative effort. If this is going to work, the field needs to adapt once again to current political climate. Bioterrorism needs be reassessed as a threat. If it is still a major national security threat, there needs to be a serious effort for sustained collaboration under a centralized authority.

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