Biological Threat Assessment: Is the Cure Worse Than the Disease?

In the three years since the September 11 terrorist attacks and the subsequent mailings of anthrax bacterial spores, federal spending to protect the U.S. civilian population against biological terrorism has soared more than 18-fold. For the 2005 fiscal year, the Bush administration has requested about $7.6 billion for civilian biodefense, up from $414 million at the time of the 2001 attacks.[1] Several federal agencies are involved in biodefense research and development (R&D),[2] and the huge increase in funding from the National Institutes of Health for work on “select agents,” or pathogens and toxins of bioterrorism concern, has attracted thousands of academic scientists.[3]

Of growing concern to U.S. biodefense officials is the possibility that rapid advances in genetic engineering and the study of pathogenesis (the molecular mechanisms by which microbes cause disease) could enable hostile states or terrorists to create “improved” biowarfare agents with greater lethality, environmental stability, difficulty of detection, and resistance to existing drugs and vaccines.[4] (See ACT, July/August 2004.) It is known, for example, that the Soviet biological weapons program did extensive exploratory work on genetically engineered pathogens.[5] The Bush administration’s response to this concern has been to place a greater emphasis on “science-based threat assessment,” which involves the laboratory development and study of offensive biological weapons agents in order to guide the development of countermeasures. This approach is highly problematic, however, because it could undermine the ban on offensive development enshrined in the Biological Weapons Convention (BWC) and end up worsening the very dangers that the U.S. government seeks to reduce.

Biological Threat Assessment—Weighing the Risks
The Bush administration contends that science-based threat assessment is needed to shorten the time between the discovery of new bioterrorist threats, such as pathogens engineered to be resistant to multiple antibiotics, and the development of medical countermeasures, such as vaccines and therapeutic drugs. This rationale is flawed, however, for three reasons.

First, the administration’s biodefense research agenda credits terrorists with having cutting-edge technological capabilities that they do not currently possess nor are likely to acquire anytime soon. Information in the public domain suggests that although some al Qaeda terrorists are pursuing biological weapons, these efforts are technically rudimentary and limited to standard agents such as the anthrax bacterium and ricin, a widely available plant toxin. Assistance from a country with an advanced biological weapons program may be theoretically possible, but no state has ever transferred weaponized agents to terrorists, and the risks of retaliation and loss of control make this scenario unlikely. Although more sophisticated bioterrorist threats may emerge someday from the application of modern biotechnology, they are unlikely to materialize for several years.

Second, prospective threat-assessment studies involving the creation of hypothetical pathogens are of limited value because of the difficulty of correctly predicting technological innovations by states or terrorist organizations. Distortions such as “mirror-imaging”—the belief that an adversary would approach a technical problem in the same way as the person doing the analysis—make such efforts a deeply flawed basis for the development of effective countermeasures.

Third, by blurring the already hazy line between offensive and defensive biological R&D, science-based threat assessment raises suspicions about U.S. compliance with the BWC and fosters a “biological security dilemma” that could lead to a new biological arms race. At the same time, the novel pathogens and related know-how generated by threat-assessment work could be stolen or diverted for malicious purposes, exacerbating the threat of bioterrorism.

Current Threat Assessment Activities
Although biological threat-assessment studies have been under way for several years, they have received a major boost under the Bush administration. On April 21, after a 10-month policy review of national biodefense programs, President George W. Bush signed Homeland Security Presidential Directive 10 (HSPD-10). In addition to allocating roles and responsibilities among various federal agencies, this directive requires the Department of Homeland Security (DHS) to conduct a national risk assessment of new biological threats every two years and a “net assessment” of biodefense effectiveness and vulnerabilities every four years. Under HSPD-10, significant resources will be devoted to projecting future threats, not just addressing current ones. According to an unclassified summary of the directive, the U.S. government is “continuing to develop more forward-looking analyses, to include Red Teaming efforts, to understand new scientific trends that may be exploited by our adversaries to develop biological weapons and to help position intelligence collectors ahead of the problem.”[6]

The expression “Red Teaming” dates back to the Cold War, when “red” symbolized the Soviet Union and its Warsaw Pact allies; the term now refers to any simulation involving the actions of a hostile country or subnational group. In the biodefense context, Red Teaming covers a variety of activities including scenario writing and paper studies, computer modeling of hypothetical biological attacks, and the development and testing of novel pathogens and weaponization techniques in the laboratory in order to guide the preparation of defenses.

To expand U.S. government capabilities in the field of biological threat assessment, DHS recently established a new multi-agency organization called the National Biodefense Analysis and Countermeasures Center (NBACC), headquartered at Fort Detrick, Maryland.[7] NBACC comprises four specialized centers, including a Biothreat Characterization Center whose mission is to “conduct science-based comprehensive risk assessments to anticipate, prevent, and respond to and recover from an attack.”[8] The biothreat characterization program at NBACC will explore how bioterrorists might use genetic engineering and other advanced technologies to make viruses or bacteria more deadly or contagious.[9] During a White House online discussion forum on April 28, 2004, DHS Assistant Secretary for Science and Technology Penrose “Parney” Albright stated, “We are very concerned about genetically modified pathogens that might be, for example, vaccine-resistant or an attempt to elude our detection abilities. We have efforts underway within [DHS, the Department of Health and Human Services (HHS)], and the Department of Defense [to] think through carefully the kinds of genetic modifications and genetic engineering that might be done so we can get ahead of the emerging threat.”[10]

In another published interview, Colonel Gerald W. Parker, director of the Science-Based Threat Analysis and Response Program Office at DHS, explained that the laboratory component of threat characterization “will be focused on addressing high-priority information gaps in either understanding the threat or our vulnerabilities.” When asked if NBACC would conduct exploratory research on genetically engineered pathogens, Parker replied, “We will not be intentionally enhancing pathogenicity of organisms to do ‘what-if’ type studies.... [But] if there is information either in the classified or open literature, and it is validated information, that indicates that somebody may have [enhanced pathogenicity], and that we believe indicates that we might have a vulnerability in our defensive posture, we may have to, in fact, evaluate the technical feasibility and the vulnerability of our countermeasures.”[11]

The Biological Security Dilemma
Even if, as Parker asserts, threat-assessment studies at NBACC involving the creation of genetically modified pathogens will be carried out only in response to “validated” intelligence that a state or terrorist organization has already done so, other countries may perceive such efforts as a cover for illicit, offensively oriented activities. The reason is that the distinction between defensive and offensive biological R&D is largely a matter of intent, giving rise to a “security dilemma” in which efforts by some states to enhance their biological security inadvertently undermine the security of others.[12] Because intent is so hard to judge reliably, states tend to err on the side of caution by reacting to the capabilities, rather than the stated intentions, of potential adversaries. As a result, threat-assessment activities that a country pursues for defensive purposes may be perceived as offensive, particularly if those studies involve the genetic modification of pathogens to enhance their harmful properties.

Although the Bush administration has expressed concern about alleged biological weapons development activities in North Korea, Syria, Iran, and Cuba, it appears to have a blind spot with regard to how its own biological threat-assessment efforts are perceived abroad. Rival nations, fearing that the U.S. exploration of emerging biological weapons threats could generate scientific breakthroughs that would put them at a strategic disadvantage, may decide to pursue or expand similar activities. Even if these programs are initially defensive in orientation, they could acquire a momentum of their own that eventually pushes them over the line into the offensive realm.

The biological security dilemma has been inadvertently deepened by policies that the United States adopted after the September 11 attacks to tighten physical security and access controls at laboratories that possess, store, or transfer select agents.[13] Although these new regulations aim to prevent the theft or diversion of dangerous pathogens and toxins for malicious purposes, they have had the undesirable side effect of reducing the transparency of biodefense R&D at a time when greater openness is needed to reassure outsiders of the benign intent behind such activities.[14] Moreover, since the mid-1990s, the U.S. government has conducted an unknown number of classified threat-assessment studies, three of which were reported by The New York Times in September 2001 (see sidebar). The stated rationale for classification is to prevent terrorists from learning about and exploiting U.S. vulnerabilities to biological attack, but secrecy has the pernicious effect of increasing suspicions about U.S. intentions and worsening the security dilemma.

The most serious risk associated with science-based threat assessment is that the novel pathogens and information it generates could leak out to rogue states and terrorists. To prevent such proliferation, the United States will have to impose even more stringent security measures. Yet history suggests that the greatest risk of leakage does not come from terrorists breaking into a secure laboratory from the outside, but rather from trusted insiders within the biodefense community who decide, for various motives, to divert sensitive materials or information for sale or malicious use.

The expanded pool of researchers currently engaged in biological threat-assessment studies could well include a few spies, terrorist sympathizers, or sociopaths. Moreover, because a pathogen culture can be smuggled out of a laboratory in a small, easily concealable plastic vial, the odds of getting caught are fairly low. Security background checks on scientists working with select agents can reduce the threat of diversion but not eliminate it, as suggested by the cases of CIA or FBI insiders who became spies, such as Aldridge Ames and Robert Hanssen. Indeed, although the perpetrator of the mailings of anthrax bacterial spores in the fall of 2001 remains unknown, the technical expertise needed to prepare the highly refined material points to someone with experience inside the biodefense research complex.

Thus, rather than enhancing U.S. national security, science-based threat-assessment projects involving the development of novel pathogens are likely to create a vicious circle that ends up worsening the problems of biological warfare and bioterrorism. Prospective threat assessment entails two simultaneous risks: (1) developing dangerous new technologies that will leak out to proliferators and terrorists and create a self-fulfilling prophecy, and (2) undermining the norms in the BWC and provoking a biological arms race at the state level, even if the countries involved merely seek to anticipate and counter offensive developments by potential adversaries.

Breaking Out of the Vicious Circle
In order to break out of the vicious circle created by the biological security dilemma, the United States should reduce its current emphasis on science-based threat assessment and pursue a number of strategies to build confidence in the strictly peaceful nature of its biodefense program.

Enhanced Transparency. The U.S. government should promote greater international transparency in biodefense R&D by including in its annual confidence-building measure (CBM) declarations under the BWC a comprehensive list of all of its biodefense activities, including classified projects, while omitting sensitive technical details that could assist proliferators or terrorists. (The fact that the United States had not declared the three secret threat-assessment studies uncovered by The New York Times suggested to some that it wished to avoid international scrutiny of legally dubious biodefense work.) In those rare cases where the risk of proliferation warrants classification, U.S. officials should explain why the experiments were done and provide a clear rationale for the limits on transparency. As a rule, however, openness should be considered the default condition, and any U.S. government agency seeking to classify specific biodefense projects or activities should be required to justify the need for secrecy.

International Collaboration. A second approach to building confidence would be for the United States to conduct biological threat-assessment studies jointly with other countries. NATO allies such as Canada, France, Germany, and the United Kingdom (as well as non-NATO countries such as Sweden) have advanced biodefense programs. Although the U.S. government conducts some joint R&D with allies, these efforts are currently pursued on an ad hoc basis. Integrating Canada, the European Union, and the United States into a formal system of collaborative biodefense R&D that includes effective oversight would give the international community greater confidence that Washington is not pursuing a unilateral path in this highly sensitive area and that its biodefense R&D program is fully compliant with the BWC.

Russia is also a potential U.S. partner in the biodefense field because of the large number of former bioweapons scientists and facilities remaining from the Soviet biowarfare program and the existence of several areas in which the two countries have complementary expertise and pathogen strain collections. To date, however, U.S.-Russian biodefense collaboration has been undermined by Moscow’s refusal to share a genetically modified strain of the anthrax bacterium and the fact that biodefense facilities under the control of the Russian Ministry of Defense remain off-limits to Western scientists.[15] These issues will have to be resolved before joint U.S.-Russian R&D can become a source of greater international confidence in the BWC compliance of both countries.

Domestic Oversight. A third approach to breaking out of the vicious circle is to improve the domestic oversight of biological threat assessment. In October 2003, the National Research Council of the U.S. National Academy of Sciences released the report of an expert panel chaired by Dr. Gerald R. Fink on preventing the malicious application of “dual-use” research in the life sciences.[16] This report identified seven types of experiments that could result in information with a potential for misuse, including the genetic modification of pathogens to explore the mechanisms by which microbes cause disease. The Fink committee recommended the creation of a voluntary system for reviewing the security implications of federally funded biological research at the proposal stage. Such oversight would be performed at the local level by Institutional Biosafety Committees and at the national level by a new oversight board made up of scientists and security experts.

On March 4, 2004, the Bush administration responded to the Fink committee report by announcing the planned establishment of a National Science Advisory Board for Biosecurity (NSABB) under the auspices of the National Institute of Health. This new entity will establish guidelines for the security review of sensitive biological research projects in academia and, on a voluntary basis, in private industry.[17] Although the administration announced this initiative with much fanfare, the creation of the NSABB has proceeded at a snail’s pace, and its first meeting has not yet been scheduled. Moreover, the advisory board will have no binding regulatory authority, and its mandate explicitly excludes the review of classified biodefense research initiated by the U.S. government and conducted at federal facilities with federal money. According to the NSABB web site, “Government-sponsored research that is classified at its inception...will be outside of the purview of the NSABB. This research is subject to other institutional and federal oversight, and is not the target of this biosecurity initiative.”[18]

In fact, “other” federal oversight of classified biodefense R&D is extremely limited. Each U.S. government agency involved in such research is responsible for policing its own compliance with the BWC. The Defense Department, for example, has a Compliance Review Group that subjects the department’s biodefense programs to internal legal review for consistency with the treaty.[19] Yet this committee is not accountable to the National Security Council or to other federal agencies such as the Department of State, which has the lead on the negotiation and legal interpretation of arms control treaties.

As a matter of principle, U.S. departments and agencies should not be responsible for reviewing the BWC compliance of their own biodefense programs because of the clear potential for conflict of interest. For example, lawyers employed by agencies with an institutional and budgetary stake in biological threat assessment may come under pressure to find loopholes so that legally questionable projects can go forward. For this reason, an interagency review process is needed to create internal checks and balances and build international confidence in the U.S. biodefense program.

Given the tenacity with which federal agencies defend their autonomy and turf, presidential leadership will be required to ensure adequate oversight and accountability for biological threat-assessment studies. Improved oversight mechanisms should be introduced by the executive and the legislative branches. For example, the Homeland Security Advisory Council in the White House might establish an interagency oversight board for biodefense consisting of representatives of the Defense and State Departments, CIA, DHS, HHS, and the intelligence community. This board would review the treaty compliance of all federal threat-assessment programs, including special-access (“black”) projects whose existence is not acknowledged publicly. Congress should also pass legislation requiring all federal agencies involved in biodefense work to submit detailed reports on any classified threat-assessment activities to the House and Senate Select Committees on Intelligence, whose members and staff hold high-level clearances. These committees might also conduct closed hearings to review “black” biodefense projects on an annual basis.

Internal government oversight is not a panacea, however, because it can be corrupted by interagency collusion or a lack of good faith on the part of senior administration officials, particularly in an atmosphere of extreme secrecy. Prior to the Abu Ghraib prison-abuse scandal in Iraq, for example, the Department of Justice’s Office of Legal Counsel prepared a memorandum arguing that the president’s authority as commander in chief enabled him to disregard domestic laws and international treaties banning torture during interrogations of enemy combatants, thereby nullifying the existing checks and balances.[20]

Unilateral Restraint. Perhaps the most effective way for the United States to build international confidence in the peaceful nature of its biodefense program would be for the president to make a public statement renouncing the prospective development of genetically modified microorganisms with increased pathogenicity for threat-assessment purposes and urging all other countries to follow suit. As noted above, because the utility of prospective studies of genetically modified pathogens is severely limited by mirror-imaging and other sources of error, abandoning such studies would entail little risk to U.S. national security. On rare occasions, it may be necessary to test the efficacy of standard drugs or vaccines against genetically engineered pathogens that have already been developed by other countries. In these cases, the study should require a special authorization from the president following a careful interagency review to ensure that the proposed work complies with the letter as well as the spirit of the BWC.

To enforce the proposed unilateral ban on the prospective development of new pathogens with increased pathogenicity, the president should encourage scientists within the biodefense community to “blow the whistle” if they become aware of unauthorized studies that violate this policy, regardless of whether the work is being conducted in an academic setting or in a top-secret government laboratory. Confidential reporting channels and legal protections should also be established to shield scientists who expose illicit activities. To bolster the norm of professional responsibility further, scientists working in federal biodefense programs should be required to sign a code of conduct, similar to the Hippocratic oath, that precludes them from deliberately developing agents with enhanced pathogenicity or other harmful properties and requires them to report any deviations from this norm.

At the same time that the United States renounces the prospective development of pathogens for threat-assessment purposes, it should pursue less provocative ways of getting a jump on defending against new bioterrorist threats, such as bacteria that have been genetically modified to make them resistant to multiple antibiotics. One approach would be for researchers to focus on developing broad-spectrum therapeutic and preventive measures that are not agent-specific. A second strategy would be for the U.S. government to invest in building an R&D and industrial infrastructure that can assess novel biological threat agents as soon as they are detected and then develop, test, and manufacture safe and effective countermeasures. With these systems in place, it should become possible to move “from bug to drug” in a matter of weeks or months, rather than years.[21] (The recent identification of the SARS virus and the rapid development of a diagnostic test and a candidate vaccine is a case in point.) Because the two alternative strategies would be unequivocally defensive, they would build confidence that the U.S. biodefense program is fully consistent with the BWC.

These practical steps are needed to prevent the Bush administration’s growing emphasis on science-based threat assessment from increasing biological weapons proliferation risks, exacerbating the security dilemma, weakening the BWC, and drawing the United States into a dangerous biological arms race. It is time to break the vicious circle before it starts.

ENDNOTES

1. Ari Schuler, “Billions for Biodefense: Federal Agency Biodefense Funding, FY2001-FY2005,” Biosecurity and Bioterrorism, 2004, pp. 86-96.

2. Federal agencies active in biodefense research include the Department of Homeland Security; the National Institutes of Health and Centers for Disease Control and Prevention under the Department of Health and Human Services; the National Laboratories operated by the Department of Energy; the U.S. Army Medical Research Institute of Infectious Diseases, Dugway Proving Ground, and the Naval Medical Research Center under the Department of Defense; the U.S. Department of Agriculture; and the U.S. intelligence community.

3. As of June 2004, more than 300 facilities and 11,000 individuals nationwide had been granted permission to work with “select agents.” See Scott Shane, “Bioterror Fight May Spawn New Risks,” Baltimore Sun, June 27, 2004.

4. Mark Wheelis, “Will the ‘New Biology’ Lead to New Weapons?” Arms Control Today, July/August 2004, pp. 6-13; Jennifer Couzin, “Active Poliovirus Baked From Scratch,” Science, 2002, pp. 174-175.

5. See Ken Alibek with Stephen Handelman, Biohazard (New York: Random House, 1999).

6. Homeland Security Council, The White House, Biodefense for the 21st Century, April 2004, p. 4.

7. NBACC is currently being housed in temporary quarters until new buildings are constructed on a seven-acre plot within a new National Interagency BioDefense Campus at Fort Detrick. When completed, the facility will include high- and maximum-containment laboratories (Biosafety Levels 3 and 4) capable of handling the most dangerous and incurable pathogens.

8. DHS Science and Technology Directorate, “Notice of Intent to Prepare and Environmental Impact Statement for the National Biosecurity Analysis and Countermeasures Center Facility at Fort Detrick, Maryland,” Federal Register 69, June 7, 2004, pp. 31830-31831.

9. In a February 2004 briefing titled “The Leading Edge of Biodefense,” Lieutenant Colonel George W. Korch Jr., NBACC deputy director, stated that the Biothreat Characterization Center will conduct studies in 16 subject areas, including genetic engineering of pathogens, susceptibility to current therapeutics, environmental stability, aerosol dynamics, novel delivery systems, and bioregulators and immunoregulators. The center will also study biothreat-agent use and the effectiveness of countermeasures “across the spectrum of potential attack scenarios” through “high-fidelity modeling and simulation.” Milton Leitenberg, James Leonard, and Richard Spertzel, “Biodefense Crossing the Line,” Politics and the Life Sciences 22, 2004.

10. Dr. Penrose “Parney” Albright, “Ask the White House,” April 28, 2004, available at http://www.whitehouse.gov/ask/20040428.html (online interactive forum).

11. Laurie Goodman, “Biodefense Cost and Consequence,” Journal of Clinical Investigation 114, July 1, 2004, pp. 2-3.

12. The security dilemma with regard to biodefense R&D is discussed in Gregory Koblentz, “Pathogens as Weapons: The International Security Implications of Biological Warfare,” International Security 28, Winter 2003/04, p. 118. The concept of the security dilemma is presented in Robert Jervis, Perception and Misperception in International Politics (Princeton, NJ: Princeton University Press, 1976), pp. 169-170.

13. These regulations were mandated by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. For background, see Jonathan B. Tucker, “Preventing the Misuse of Pathogens: The Need for Global Biosecurity Standards,” Arms Control Today, June 2003, pp. 3-10.

14. Gerald L. Epstein, “Controlling Biological Warfare Threats: Resolving Potential Tensions Among the Research Community, Industry, and the National Security Community,” Critical Reviews in Microbiology 27, 2001, p. 346.

15. Kenneth N. Luongo et al., “Building a Forward Line of Defense: Securing Former Soviet Biological Weapons,” Arms Control Today, July/August 2004, pp. 18-23.

16. National Research Council, Committee on Research Standards and Practices to Prevent the Destructive Application of Biotechnology, Biotechnology Research in an Age of Terrorism (Washington, DC: National Academies Press, 2004).

17. HHS Press Office, “HHS Will Lead Government-Wide Effort to Enhance Biosecurity in ‘Dual Use’ Research,” HHS News, March 4, 2004.

18. National Science Advisory Board for Biosecurity, “FAQ,” March 4, 2004, available at http://www.biosecurityboard.gov/faq.htm.

19. Department of Defense, “Directive No. 2060.1,” January 9, 2001. (Implementation of, and Compliance With, Arms Control Agreements).

20. Adam Liptak, “Legal Scholars Criticize Memos on Torture,” The New York Times, June 25, 2004, p. A14.

21. Representative Jim Turner, Beyond Anthrax: Confronting the Future Biological Weapons Threat (May 2004), pp. 10-14.

Jonathan B. Tucker is a senior researcher at the Center for Nonproliferation Studies at the Monterey Institute of International Studies. Some of the ideas presented here were developed during a 2003-2004 seminar series on biodefense organized by the Program on Science and Global Security at Princeton University.