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The Conduct of Laboratory Research to Characterize Biological Threat Agents

Summary of CBW Breakfast Seminar
May 4, 2006

W. Seth Carus, Ph.D., Deputy Director, Center for the Study of WMD, National Defense University

Commentary by Milton Leitenberg, Senior Research Scholar, Center for International and Security Studies at the University of Maryland

Dr. Carus stated that the U.S. government conducts laboratory research on certain biological agents to address scientific and technical gaps in our understanding of the threats of biological warfare (BW) and bioterrorism. This research, which has occurred in some form since at least the early 1980s, supports the needs of the intelligence community, the developers of biodefense countermeasures, and officials responsible for the mitigation of risks. The requirement for laboratory threat characterization studies derives from the inadequacies of U.S. intelligence on foreign BW capabilities, the rapid pace of innovation in the sciences and technologies relevant to biological weapons development, and the uneven understanding of those advances. Much threat research overlaps with research to support medical countermeasures development (such as identifying the infectious and lethal doses of biological agents) or law enforcement investigations (such as understanding methods of small-scale agent production).

The conduct of such research requires careful management and oversight. In addition to ensuring compliance with the provisions of the 1972 Biological and Toxin Weapons Convention (BWC), to which the United States is a party, the research must be compliant with U.S. laws. Ideally, laboratory threat characterization research should be justified by a need to validate or understand intelligence information or to address specific issues of importance to senior officials responsible for biodefense risk-mitigation efforts. For example, the U.S. Department of Defense replicated a Russian experiment to produce a genetically modified strain of the anthrax bacterium in order to understand whether an adversary could evade the protective effects of the anthrax vaccine.

Oversight is complicated by the likely security classification of at least some threat characterization research. While every effort should be made to conduct as much of this research in the open as possible, some degree of secrecy is inevitable. When intelligence information is involved, it may even prove necessary to classify the very existence of a research program to prevent the compromise of sources and methods. Similarly, some research supporting criminal investigations must be kept secret, as the FBI has done in the case of the 2001 anthrax letters. The rationale is that it would pose a danger to society for the FBI to release information that could assist others who are motivated to send letters tainted with anthrax spores through the U.S. mail.

Robust oversight processes will need to ensure scientific quality and compliance with U.S. treaty obligations and laws. The central requirement, however, is building confidence in the appropriateness and legality of the research. Suitable confidence-building measures could include interagency, international, and non-governmental processes. For example, including State Department officials responsible for biological arms control negotiations in the review process would allow those officials to communicate authoritatively to other governments the appropriateness of U.S. biodefense activities. Similarly, the United States could reassure close allies, such as the United Kingdom, by giving them access to classified research. Those allies would then be in a position to reassure other countries that U.S. activities are treaty-compliant. Finally, creating a review board composed of scientists and non-scientists from outside government is crucial to provide an independent evaluation of biological threat characterization activities.

In his comments on Dr. Carus's presentation, Milton Leitenberg made three main points:

First, national BW threat assessments should be based on the realities of state and non-state actor capabilities, and not on hypothetical projections of the technological state of the art.

Second, Mr. Leitenberg examined the planned work program for the National Biodefense Analysis and Countermeasures Center (NBACC) at Fort Detrick, Maryland, and raised questions about whether this research goes beyond what is permitted by Article 1 of the BWC.

Third, Mr. Leitenberg argued for effective national oversight of the U.S. biodefense program. In particular,

• Internal review panels with members selected from in-house laboratories and federal contractors are unlikely to provide critical reviews. Instead, interagency oversight is required, with coordination by the National Security Council.
• Authority to review the BWC compliance of all programs carried out by NBACC should be extended to the Committee on Biodefense Analysis and Countermeasures of the National Research Council.
• The mandate of the National Science Advisory Board for Biosecurity (NSABB), which the Bush administration established to review "dual-use" research in the life sciences that could affect public health or national security, should be expanded to cover classified U.S. government biodefense research.

For a full presentation of these points, see Milton Leitenberg, Assessing the Biological Weapons and Bioterrorism Threat, U.S. Army War College Strategic Studies Institute, 2005, http://www.strategicstudiesinstitute.army.mil/pubs/display.cfm?PubID=639.

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