Bioterrorism Blowback

One of the main national security priorities of the Obama administration is to decrease the threat of a biological terrorism attack against the United States or its allies. The administration’s concerns were catalysed by the US Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism. That bipartisan study group issued a report after last November’s US presidential elections, warning that biological (rather than nuclear) terrorism represents the greatest near-term Weapons of Mass Destruction threat.

Ironically, the Commission also warned that US homeland defence policies since the 2001 anthrax letters incident may actually have made the United States more vulnerable to another biological terrorist incident. Its report cautions that the post-9/11 surge to expand US biological warfare research for defensive purposes may actually be counterproductive since it has increased the number of experts potentially able to make and employ biological weapons and multiplied the number of facilities storing the substances they could use to do so. Many of these new hires have not been comprehensively assessed, either individually or as a group, for their potential security risks, while inspectors have found dangerous safety problems at some of the hastily built biological containment facilities.

The alarm provoked by the recent swine flu outbreak has imparted additional momentum to the already rapidly developing biological defence programmes in the United States. The rush to create new vaccines, anti-viral drugs and other tools to counter natural and man-made biological threats, as well as the increasing number of scientists and institutions involved in researching countermeasures, may inadvertently make it easier for malicious governments, groups or individuals to acquire the knowledge and materials needed to conduct biological warfare attacks. As a result, while biological defences are becoming stronger, so are the potential threats they meant to counter.

The American Surge

In the autumn of 2001, the mailing of letters containing anthrax within the US – the most serious biological terrorism incident on American soil to date – led Congress to tighten regulations governing dangerous biological weapons in the US. A major element of these regulations is the Select Agent Program. Started by Congress in the Antiterrorism and Effective Death Penalty Act of 1996, this programme establishes special regulations for a list of ‘select agents’ that could be used to make biological weapons. The law requires laboratories within the United States that transfer or receive any of these biological agents to register with the Centers for Disease Control and Prevention (CDC), a unit of the Department of Health and Human Services (HHS); or the Animal and Plant Health Inspection Service (APHIS), which belongs to the Department of Agriculture (USDA), and adopt physical access controls.

Congress’s immediate response to the anthrax attacks was to establish certain categories of ‘restricted persons’ who cannot access the controlled agents. In 2002, Congress increased the number of controlled agents to more than seventy types of bacteria, viruses and toxins under the Public Health Security and Bioterrorism Preparedness and Response Act. This legislation also mandates that scientists, technicians, managers and other laboratory personnel pass a FBI security examination before receiving access to the listed pathogens and toxins.

Federal legislation and congressional regulations require that employees at US Army laboratories working with biological weapons for defensive purposes must undergo a more comprehensive background investigation and receive a security clearance. It is also a criminal offence, punishable by heavy fines and possible imprisonment, to possess any select agents in the United States outside the permissible uses and conditions. Nonetheless, the August 2008 revelations that the FBI had identified Bruce E Ivins, a researcher at one of these army labs, as the likely perpetrator of the 2001 anthrax letter attacks underscored that these measures alone cannot prevent a well-trained biologist from becoming a terrorist.

Who is in Charge?

One reason for these continuing problems is that, although Congress added agents to the list in 2002, there has been no comprehensive review since then of whether the listed pathogens and toxins, or the programme’s procedures and reporting mechanisms, need to be changed. Another problem is the gaps and conflicts created by the overlapping political and agency oversight that afflicts US biological defence activities. At present, the CDC regulates some select agents exclusively, others fall under the sole purvue of APHIS/USDA, while others still (such as anthrax) can be regulated by either agency since they can infect both people and animals.

The need for a comprehensive reassessment, and possible restructuring, of existing regulatory structures grows each year. Due to the surge of federal expenditures for bioterrorism, almost 15,000 individuals presently have received approval to access the listed agents. Under current plans, moreover, the number of maximum-containment Level 4 (BSL-4) laboratories (the only US facilities that can legally handle agents for which no cure or vaccine exists) will increase from five in 2001 to fifteen in 2012. The number of high-containment BSL-3 laboratories, operated by private companies and academic institutions in the United States as well as government agencies, is also growing, and now exceeds a thousand.

Another problem is that many other research facilities in the United States store and transfer less strictly controlled, but still dangerous, pathogens (for example, the SARS virus) with little or no regulation as these substances do not appear on the select agent list. The Government Accountability Office (GAO) has repeatedly complained about security lapses at various biodefence laboratories, including a few BSL-4 labs. The CDC ordered the BSL-4 laboratory at Texas A&M University to suspend operations in 2007-08 after detecting several safety and security problems.

GAO investigators also have cited flaws in federal oversight of US-based biological defence research, which involves about a dozen government agencies with overlapping roles, missions, and responsibilities as well as gaps in their coverage. For example, a GAO survey found that no single federal government body knows how many biological containment labs are being built or the location of these facilities. Only laboratories receiving US government funds or handling select agents are subject to federal oversight.

American homeland security and public health managers confront a very complex system of public supervisory bodies, with many overlapping jurisdictions and several unwelcome bureaucratic fissures. For example, the pre-eminence of state public health officials in managing local biological incidents could detrimentally delay intervention by the typically more capable federally run Centers for Disease Control and Prevention. At the federal level, moreover, there is considerable overlap in the public health emergency preparedness roles and responsibilities of the HSS and the Department of Homeland Security. In one respect, the United States finds it more difficult than many other countries to promote biosafety and biosecurity. In many countries, one set of government agencies is responsible for biosafety issues, while another group promotes biosecurity. But in federal systems such as the United States, an additional co-ordination problem arises because various central and regional authorities often exercise independent roles in the regulation of biological facilities in their jurisdictions.

Placing a single federal agency in charge of regulating all high-containment biological facilities (both BSL-4 and BSL-3, regardless of whether they contain select agents) in the United States would help enhance and rationalise external oversight in this area. This lead agency should determine the requirements for all biodefence laboratories, approve the construction of all new facilities, manage a central database of all laboratories, vet their personnel and procedures, and establish and enforce a common set of safety and security regulations at all these facilities (supporting additional training, if necessary).

Toward A Biological Security Culture

Some scientists have expressed concern that overly rigid regulations could impede important biological research on possible disease countermeasures, such as by limiting contacts and specimen exchanges among lab workers, and delay the response to any biological emergency, for instance by preventing experts who lack clearance from contributing to the response. They note that many of the listed agents are either available naturally or readily obtainable through DNA synthesis or from foreign sources. In addition, many newly created agents, exhibiting similar properties to the select agencies, are not on the list.

Although the US regulatory system for dangerous biological pathogens has problems, the biological security practices appear much weaker at the hundreds of international culture collections. These institutions sell the listed agents as well as other dangerous pathogens and toxins on world markets for declared research and industrial purposes. The World Federation for Culture Collections reports that more than 500 culture collections exist in sixty-six countries.

Promoting a stronger ‘security culture’ provides a middle way: reducing the risk that American biological defence efforts will increase the threat of future biological attacks without unduly impeding biologists’ activities through excessive constraints. Information campaigns by government agencies, professional associations, academic institutions and non-governmental organisations can raise the awareness of biological workers of the need to safeguard against the misuse of biological substances and technologies for nefarious purposes. The adoption of formal codes of conduct by life scientists can help ensure that this awareness manifests itself in improved biological safety and security practices. Making greater use of these conscious-raising and voluntary activities would complement the Select Agent Program and other more narrowly targeted efforts to enhance the physical security of dangerous substances and facilities.