PerspectivesAre you interested in submitting a Perspective Article? Be sure to read The Science Advisory Board's Editorial Guides for Perspective Articles. Click here. Some Thoughts on Biodefense Research by Jan van Aken and Edward Hammond Research to develop defensive measures against biological weapons got a boost in the wake of the anthrax attacks in the USA. While this may eventually increase a country's ability to deal with a biological attack, it may at the same time pose a threat to international security, as any biological weapons research is beset with the dual-use problem. Only a very thin line separates offensive and defensive bioweapons research. In the course of many biodefense projects, an offensive capability is generated. To test detection systems for biological weapons, the infectious agents are often produced and dispersed. A vaccine against anthrax or plague is not only a defensive tool, it can also support the development of an offensive capability as an aggressor using bioweapons would need a vaccine to protect its own researchers and troops. The dual-use problem makes it very difficult to draw a clear line between legitimate and illicit research, as it is often only a matter of intent whether a given experiment is offensive or defensive. There is no point in arguing generally against any kind of biodefense research. Any development in the biomedical sciencesæbe it the development of a new drug, a new operation technique or genome sequencing tools may eventually be applied to fight off a biological attack and may thus be considered biodefense research. There are obviously big differences, however, between the development of a new drug and the production of lethal anthrax spores, which both have been subsumed under biodefense in popular and government terminology. The difficult task is to distinguish between justifiable and prudent biomedical research and counterproductive projects that endanger international security. The Biological and Toxin Weapons Convention (BTWC) provides only limited guidance in this respect. The Convention's prohibition of biological weapons is based on the "general purpose criterion", which prohibits research undertaken with a hostile purpose, rather than specific items or research projects. Article I reads: "Each State Party to this Convention undertakes never in any circumstances to develop, produce, stockpile or otherwise acquire or retain: (1) Microbial or other biological agents, or toxins whatever their origin or method of production, of types and in quantities that have no justification for prophylactic, protective or other peaceful purposes." (emphasis added) The beauty of the general purpose criterion is that any development and production for hostile purposes is prohibited, regardless of the types, quantities and methods of production. The article also covers as yet unknown future technologies, as it relies on purpose, rather than the identification of specific items. More problematic is the ambiguity created by the article's exemption not only for "peaceful", but also for "protective" purposes, which usually relate to biodefense research. Because no clear definition of the term "protective" is articulated, this leaves abundant space for interpretation, and countries have abused the biodefense "protective" exemption to justify research of an offensive nature. What is needed are better defined criteria to limit legitimate biodefense programmes and to outlaw those projects that increase a country's offensive capabilities to an extent that international security is at risk. In the following, we will use some recent examples of biodefense research to highlight two ideas where to draw lines to distinguish legitimate from illicit research. Means of delivery The US government has been especially creative in interpreting the biodefense exemption of the BTWC. In September last year, US biodefense projects became public which stretch the limits of the Bioweapons Convention andæin some casesæeven violate it. Some of these projects are related to means of delivery of pathogenic agents. To put this specific area into perspective, it is necessary to take another close look at Article I of the BTWC, where means of delivery are specifically addressed in paragraph 2: "Each State Party to this Convention undertakes never in any circumstances to develop, produce, stockpile or otherwise acquire or retain: (1) ... (2) Weapons, equipment or means of delivery designed to use such agents or toxins for hostile purposes or in armed conflict." Again, this language contains an exemption for peaceful purposes, but it is important to note that it does not contain an exemption for "protective" purposes, as it is the case in paragraph 1. Hence, spraying devices to deliver drugs for medical uses are exempted because they were not designed for hostile purposes, while military methods like explosive aerosol delivery, warheads or germ bombs are clearly prohibited. However, this interpretation is obviously not shared by the US government, considering that: In a program code-named Clear Vision, in 1997 the Central Intelligence Agency started to build and test a model of a Soviet-designed germ bomb. According to a New York Times article of Sept. 4 2001, a model was constructed and the agency conducted two test runs with non-pathogenic agents to determine dissemination characteristics of the device. This work was contracted out to the Battelle Institute in Ohio. While this project caused political concern in the Clinton administration, it was finally concluded by US legal analysts that the nature of the programme was defensive and thus not in violation of the Bioweapons Convention. Another project involves the production of aerosols by using explosive devices. According to the annual report of the US Department of Energy, explosive aerosol delivery is studied at different locations to examine various attack modes and study their effectiveness in causing disease. While aerosols are nowadays used widely in pharmacological research and development, the use of explosive devices to generate aerosols has no civilian or medical applications. The US Army also developed hardened warheads for biological agents, according to the 1999 declaration of the USA under the "Confidence Building Measures" (CBM) scheme of the BTWC. In the framework of the Ballistic Missile Defense Organisation, warheads carrying biological agents were designed and produced to examine "potential ways to harden the threat missiles against attack by defensive interceptors". There is no doubt that these means of delivery are "designed to use (...) agents or toxins for hostile purposes or in armed conflict". Hence they are in clear violation of Article 1, paragraph 2 of the BTWC. As already pointed out above, it does not matter if the US government claims defensive purposes here, as this article does not provide for a biodefense exemption. But apart from the legal argument it is difficult to understand what defensive purpose is served by testing the different dispersal mechanisms for pathogenic agents. To protect a population against a biological attack, knowledge on the nature of a particular agent may prove useful, but hardly its method of delivery. To summarize, a clear line to distinguish legitimate from offensive work is already provided for in Article 1, paragraph 2 of the Convention. No country should ever engage in research involving the construction and production of warheads and bombs to deliver microbes, or in explosive aerosol generation with biological agents. Genetic engineering in bioweapons research Genetic engineering is by now a standard technique in almost any medical research laboratory and is consequently part of some biodefense projects. While some experiments involving new genetic techniques may serve peaceful or defensive purposes, it is also obvious that genetic engineering could easily be abused to construct more effective biological weapons. Some concrete examples highlight the dangerous potential of genetically engineered bioweapons: "Invisible anthrax": In a well documented case, a Russian research group in the 1990s succeeded in altering anthrax’s immunological properties, making existing vaccines and detection methods ineffective against the new genetically engineered types.[1] The Russian group also succeeded in developing a new vaccine that is effective against the artificial strain. According to the New York Times, the US Defense Intelligence Agency is now planning to repeat the Russian experiment and build the genetically engineered anthrax in its own labs to test whether the microbe could defeat the American vaccine. Antibiotic resistant tularaemia: Sunshine Project research revealed that the German Army's Institute for Microbiology in Munich works with tularaemia bacteria that were genetically altered to withstand antibiotic treatment. Tularaemia is one of the top candidates for biological warfare and has been weaponized in several offensive programmes. According to the German Ministry of Defense, this project aims at basic research to better understand tularaemia biology. The bacteria were equipped with the gene for a fluorescent protein to follow the infection pathway of the bacteria. As a so called marker gene, a second gene was introduced that codes for a resistance against the antibiotics tetracyclin and chloramphenicol. The rationale behind this experiment might have been defensive, but at the same time the pathogens were conferred a better offensive potential as they could not be treated with these antibiotics any longer. Material degrading microbes: In addition to increasing the effectiveness of existing biological weapon agents like anthrax or tularaemia, genetic engineering may also enable military researchers to construct new types of weapons that have hitherto been impossible. At the US Naval Research Laboratory, researchers are working with microorganisms to degrade a variety of materials. They have patented one genetically engineered microbe that produces an enzyme that digests polyurethane, a type of plastic. Possible military applications have been described by the principal investigator at the Naval Research Lab, among them: "It is quite possible that microbial derived or based esterases might be used to strip signature-control coatings from aircraft, thus facilitating detection and destruction of the aircraft."[2] The US Navy work is purportedly defensive in nature as they seek also to develop coatings to protect against microbial attack. All three projects have three specific features in common: They were performed at military laboratories, they increased the offensive capability of a microbial agent, and they used genetic engineering. Considering the enormous potential of genetic engineering to create extremely powerful biological weapons, we argue that any project involving this combination of features should be banned completely, i.e. any genetic engineering work in military laboratories where "military traits"[3] are transferred to other organisms should be prohibited. There should be no biodefense exemption for this kind of experiments. It is unclear if the States Parties to the BTWC will ever agree on such a measure. Various biodefense laboratories in several countries are probably performing similar experiments or have an interest in it. Those governments that are genuinely interested in strengthening the global ban on biological weapons should start unilaterally to impose these restrictions on their own military research. The German government has an opportunity to set a precedent in this regard by stopping its work with antibiotic resistant tularaemia at its military lab in Munich, and informing others that it has done so. Such a ban, even if it eventually materialises, would not entirely solve the problem. Many biodefense projects are contracted out to civilian laboratories and/or may not be under control of the military. In the USA, for example, large parts of the military research are performed at the National Laboratories that belong to the Department of Energy. The planned US experiment to repeat the Russian work on invisible anthrax will be performed by a non-profit contractor (Battelle), and it was initiated by the CIA. Some countries may easily circumvent the proposed ban by transferring the critical projects to apparently innocuous entities. On the other hand, an extension of a complete ban to every laboratory could be counterproductive. The use of antibiotic resistance marker genes is now a widely used method in molecular biology. Likewise, many other legitimate civilian biomedical research projects involve transfer of genes that may be considered as conferring "military traits". It will be difficult to find feasible ways out of this dilemma, to stop illicit research for military purposes without hampering legitimate experiments. As a minimum measure, international transparency and oversight mechanisms for work involving "military traits" must be developed in the near future which should be embedded in a verification mechanism to make them legally binding, comprehensive and subject to penalties. Production capabilities In contrast to the first two examples, this is an area were it will be difficult to establish clear limits. In the course of many biodefense projects, lethal agents must be produced for testing or other purposes. Usually this requires only minimum quantities, and in many cases inactivated agents or non-pathogenic simulants may be used. As the development of detection methods, for example, can be considered a legitimate goal, a limited production capability may also be legitimate. The following examples highlight the difficulties of establishing well defined limits in this regard: Botulinum toxin: In the early 1990s, the Battelle Institute in Frankfurt, Germany developed a vaccine against botulinum toxin for the German Army. The production process involves two steps. First is production of the toxin itself. Then, the toxin is inactivated through radiation in a second step which yields the vaccine. Thus, large scale production of the vaccine would require the large scale production of the lethal toxin. The pilot production was performed using 20 litre fermenters, yielding 15-20mg of purified toxin per batch. It must be emphasized that the legitimacy of a particular production capability is not directly linked to the quantity of lethal agent that is or may be produced. Some legitimate projects may require rather large amounts of agents, while in other cases even minute quantities are not justified. Measuring the quantity produced against the stated purpose of the research is one way of approaching the issue. In the case of the German botulinum vaccine, the risk of abuse is high as very large quantities of Botulinum toxin would be produced if large vaccine quantities were required. The key questions are whether botulinum vaccination is a valid biodefense strategy, and whether alternative vaccine production methods may provide the same result without generating the same risks. Building a production site: According to the New York Times, the Pentagon assembled a small production plant for biological weapons in the Nevada desert. For about US$ 1million, a 50 litre pilot plant was constructed using commercially available components bought from hardware stores and other suppliers. In two test runs in 1999 and 2000, non-pathogenic simulants have been produced. The stated purpose of the project was the identification of telltale signatures of such a project in order to increase the chances to detect secret bioweapons production sites. According to US officials, the project was also intended to assess how hard it would be for a terrorist or another nation to assemble a germ factory. Weapons grade, dried anthrax: On December 12, 2001, the Baltimore Sun revealed that the US Army's Dugway Proving Ground in Utah has produced batches of several grams of powdered, dried spores of pathogenic anthrax strains since the late 1990s. This production remains unexplained by the US government. Dugway Proving Ground officials argued that the dried spores were needed for testing detection devices and decontamination methods, but this explanation is very questionable. Most experiments can be done with simulants, inactivated spores, non-pathogenic anthrax strains or wet aerosol formulations and with much less than several grams of a particular agent. Again, to assess the legitimacy of this production, we need to balance the nature and quantity of the produced agent with its purpose - which is still a matter of speculation. It is the burden of the US government to publish the purpose of this production and to justify the programme in detail. Absent a convincing justification, the presumption of a non-defensive purpose is reasonable. Secrecy and transparency While in some areas of biodefense research clear borders may eventually be defined, in many others - such as the production capability - this is presently not feasible. It will remain a question of balancing risk and purpose. Considering these ambiguities and the pace of biotechnology breakthroughs, an open information policy - outwards, to other countries, but also inwards - is paramount. It is worth noticing that the US kept a thick layer of secrecy around some of the projects mentioned above and even violated its treaty obligations by omitting them from the annual declarations (CBMs) to the States Parties of the BTWC. A biodefense programme may be perceived by other countries as serving offensive purposes and could thus trigger a biological arms race. This is underlined by the World War II experience, when allied intelligence believed that Nazi Germany had launched an offensive bioweapons programme. This was one of the key reasons why the US and the UK started their own offensive programmes, in order to develop the ability to retaliate in kind if Germany used biological agents. In fact, it was later understood that Nazi Germany did not have a coordinated effort to develop biological weapons. But the biological arms race was on, and some of the offensive programmes went on for decades in the context of the Cold War. The lesson to be learned from this experience is that transparency matters. Mandatory open exchange between states about their civilian and military biomedical research projects, supported by inspection mechanisms, may avoid misconceptions about another country's defensive programme. The secrecy around military biomedical research worldwide is counterproductive and can be destabilizing. Conclusions An "anything goes" mentality on biodefense severely weakens the Bioweapons Convention and runs the risk of triggering a new biological arms race. Currently, the US is especially guilty of stretching the definition of legitimate biodefense to justify very questionable research projects. US arguments have been and could be used by it and other countries to justify the production of weapons-grade and genetically engineered pathogens as well as sophisticated delivery devices with a blunt "defensive" label. A further destructive manipulation of the BTWC's provisions on protective purposes must be prevented. What is permissible for a protective purpose under the BTWC cannot be defined unilaterally by the US or any single State Party to the convention. Governments should consult to define limits for justified protective purposes and to establish a multilateral process that can weight purpose against risk, thereby reducing ambiguity and increasing the political cost of dubious research. We discussed some examples of critical biodefense research and tried to identify some limits for defensive work on dangerous microbes. Steps discussed in this article include: A ban on any work involving military means of delivery of biological agents, as it is already provided for in Article 1, paragraph 2 of the Bioweapons Convention. A ban on genetic engineering work in military laboratories involving the transfer of military traits. An international transparency and oversight mechanism for genetic engineering work in other laboratories that involve military traits. Because biodefense and civilian biomedical research cannot always be completely distinguished, perfectly proscriptive limits cannot be established in all cases. This points to the importance of political processes to discuss them, and the critical importance of international transparency that enables government and public debate about its risks and benefits. References 1. Pomerantsev AP, Staritsin NA, Mockov YV, Marinin Li, Expression of cereolysine ab genes in Bacillus anthracis vaccine strain ensures protection against experimental hemolytic anthrax infection. Vaccine 15, 1997, p. 1846-1850. 2. Defense against biodegradation of military materiel, Presentation of J.R. Campbell of the US Naval Research Laboratory at the 3rd Non-lethal Defense Sympsium at the Johns Hopkins Applied Physics Laboratory in February 1998, http://www.dtic.mil/ndia/NLD3/camp.pdf. 3. The definition of "military traits" may be discussed along the following lines: any insertion or modification of nucleic acid sequences or parts thereof into any organism, which creates or results in change of antigenicity or immunogenicity, increased drug resistance, stability, host specificity, detectability, toxic or disease-causing properties, or ease of production. ### Jan van Aken and Edward Hammond work for the Sunshine Project, a new international organization working to bring facts about biological weapons to light. Contact: Sunshine Project, Jan van Aken, Gross Flottbeker Strasse 44, D-22607 Hamburg, Germany, tel. +49-40-431 88 001. Reprinted with permission. Originally published in the International Network of Engineers and Scientists Against Proliferation, Bulletin 19: Bioterror and Bioweapons Control. To read a summary of The Science Advisory Board's study, Opportunities in Biodefense Research, please visit our December Study Snapshots Newsletter. ### << Previous Next >> [ View All Perspectives ] |
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