NPR 9.1: in the Shadow of Anthrax
JONATHAN B. TUCKER
Viewpoint
In the Shadow of Anthrax: Strengthening the Biological Disarmament Regime
JONATHAN B. TUCKER
Dr. Jonathan B. Tucker has directed the Chemical and Biological Weapons Nonproliferation Program at the Center for Nonproliferation Studies, Monterey Institute of International Studies, since March 1996. He is the editor of Toxic Terror: Assessing Terrorist Use of Chemical and Biological Weapons (MIT Press, 2000), and the author of Scourge: The Once and Future Threat of Smallpox (Atlantic Monthly Press, 2001).
ne of the reasons that biological weapons (BW) reduced the treaty to little more than a gentleman’s agree- have been employed rarely over military history ment. Ois an innate human revulsion against the use of The objectives of biological disarmament are threefold: disease as a method of warfare. Despite this ethical norm, (1) to reassure law-abiding countries that potential enemies Japan is known to have dropped bombs containing have also renounced BW; (2) to deter states that might plague-infected fleas on Chinese cities during World War consider acquiring BW from doing so; and (3) to contain II, and other alleged incidents of biological warfare have the small number of “rogue” states, which either violate 1 been reported. The lethal anthrax spores sent through the BWC or remain outside the regime, with political, eco- the U.S. mail in the fall of 2001 have also aroused new nomic, or military sanctions. As defense analyst Brad concern over bioterrorism. Roberts has argued, “norms matter in international poli- Existing legal prohibitions on BW are flawed or in- tics—not because they constrain the choices of the most complete. The 1925 Geneva Protocol bans the use of bac- malevolent of men but because they create the basis for teriological agents in warfare but not their possession, consensus about responses to actions inconsistent with and the 1972 Biological and Toxin Weapons Conven- those norms.”2 At present, researchers, supported by U.S. tion (BWC) prohibits the development, possession, government assessments, believe that roughly twelve coun- stockpiling, and transfer of biological and toxin weap- tries have active biological warfare programs, including ons but lacks formal measures to ensure that the 144 parties to the BWC such as Iraq, Iran, Libya, China, Rus- parties to the treaty are complying with their obligations. sia, and North Korea. This level of noncompliance indi- Article VI of the BWC offers only the weak option of cates that the moral and legal restraints enshrined in the petitioning the United Nations (UN) Security Council treaty are not strong enough to prevent some governments to investigate cases of suspected noncompliance, a mea- from acquiring and stockpiling BW. Accordingly, it is es- sure that has been rendered ineffective by political dis- sential to take concrete steps to reinforce the biological agreements. As a result, the BWC’s lack of “teeth” has disarmament regime.
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Because the materials and equipment used to develop Protocol negotiators was to design an on-site inspection and produce BW are “dual-use,” or suitable both for mili- system that was intrusive enough to give member states tary purposes and legitimate commercial activities, veri- a reasonable level of confidence in compliance, while fying compliance with the BWC to a high level of protecting legitimate national security information and confidence is exceedingly difficult. For this reason, at the trade secrets of biotechnology and pharmaceutical the Second BWC Review Conference in 1986, States companies. Problems arose when the Ad Hoc Group ac- Parties sought to strengthen the treaty by adopting a set tually began to negotiate the draft Protocol, or “rolling of confidence-building measures (CBMs) that were po- text,” in July 1997. Major differences among national litically rather than legally binding. These measures in- positions meant that large portions of the text were not cluded the exchange of information on research centers agreed by consensus and hence were set off in brackets. equipped with high-containment systems, and informa- In June 2001, in an effort to move the stalled negotia- tion on unusual outbreaks of infectious disease and simi- tions forward, Ad Hoc Group chairman Tibor Tóth pro- lar occurrences caused by toxins. The Third BWC Review posed a 210-page “composite text” of the BWC Protocol Conference in 1991, recognizing the value of CBMs and that replaced the bracketed sections with compromise also their limitations, adopted additional transparency mea- language designed to resolve the outstanding issues. Al- sures, including the declaration of vaccine production plants though most delegations were prepared to accept the (which are easily diverted to production of BW agents), chairman’s text as a basis for further negotiations, the the description of past activities related to biological war- U.S. delegation declared that the draft Protocol could not fare, and the exchange of information on biodefense pro- be salvaged and withdrew from the talks on July 25, grams. Unfortunately, the level of participation in the 2001.5 Bush administration officials argued that the pro- CBMs has been poor. From 1987 to 1995, only 70 of the posed inspection regime would have been ineffective at then 139 members of the BWC submitted data declara- catching violators, creating a false sense of security, tions, and only 11 took part in all rounds of the informa- while imposing undue burdens on the U.S. pharmaceu- 3 tion exchange. tical industry and potentially compromising government In September 1993, a panel of government scientific biodefense secrets. Other participating countries coun- and technical experts known as VEREX, which had been tered that the draft Protocol, while flawed, offered a rea- established to assess the feasibility of verifying the BWC, sonable balance between conducting on-site inspections issued its final report. The VEREX group concluded that intrusive enough to increase confidence in compliance a combination of declarations and inspections to increase and safeguarding legitimate national security and busi- the transparency of dual-capable biological facilities, ness information. such as biodefense labs and biotechnology plants, could Because of the U.S. withdrawal, the Ad Hoc Group enhance confidence in BWC compliance and deter vio- negotiations were formally suspended on August 3, 2001, 4 lations. Accordingly, States Parties to the BWC estab- bringing six and a half years of work to an abrupt halt. lished an Ad Hoc Group in September 1994 to negotiate Although other countries considered proceeding with the a legally binding Protocol to the treaty that would in- talks without the United States, along the lines of the clude declarations of relevant biodefense and biotech 1997 Ottawa Treaty on landmines, they quickly rejected facilities, routine visits to declared sites, challenge in- this option because of the key role of the United States vestigations of suspect facilities, and field investigations and its biotechnology industry. Instead, it was agreed that of the alleged use of BW or suspicious outbreaks of dis- the mandate of the Ad Hoc Group would be retained so ease. that the negotiations might resume at some point in the The “golden rule” of multilateral arms control is that future. the rights and obligations established by a treaty must The next opportunity for progress came four months apply equally to all of the participating states. For ex- later during the Fifth Review Conference of the BWC, ample, if the U.S. government wishes to inspect which convened in Geneva, Switzerland, from Novem- bioindustrial sites in countries of proliferation concern, ber 19 to December 7, 2001. On the first day of the con- such as Russia and Iran, it must be prepared to accept ference, the U.S. delegation tried to allay widespread anger the same types of monitoring activities at plants on over its rejection of the BWC Protocol by proposing an American soil. Thus, the key challenge facing the BWC “alternatives package” of voluntary national measures to
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strengthen compliance with the Convention. These mea- ethical norm against biological warfare has been seriously sures included national legislation to criminalize the pos- challenged by the anthrax-tainted letter attacks in the session and use of BW, to extradite individuals accused United States. The Bush administration’s “à la carte” ap- of this crime, and to impose tighter restrictions on access proach to strengthening the BWC, which emphasizes the to dangerous pathogens.6 negotiation of voluntary national compliance measures, Only two of the proposals in the U.S. alternatives pack- does not effectively address the problem of noncompli- age dealt specifically with monitoring compliance with ance, which the U.S. delegation used as the justification the BWC and with the 1925 Geneva Protocol, which bans for its decision to reject the draft BWC Protocol. the use of BW in war. One proposed measure would ex- The following sections examine three complementary pand the existing consultation procedures in Article V approaches to reinforcing the biological disarmament re- of the BWC by creating a “voluntary cooperative mecha- gime: (1) measures within the framework of the BWC; nism” for clarifying and resolving compliance concerns (2) national measures to strengthen the regime; and (3) by mutual consent, through exchanges of information, external measures to strengthen the regime. These ap- visits, and other procedures. The other measure would proaches are mutually reinforcing and should be pursued strengthen an existing UN procedure for international in a coordinated manner. investigations of alleged use of BW by requiring states to accept visits by expert teams dispatched at the request MEASURES WITHIN THE FRAMEWORK OF of the UN Secretary-General. In principle, such a mecha- THE BWC nism would make it possible to investigate suspicious outbreaks of infectious disease, such as the 1979 epi- Strengthen the Existing CBM Regime demic of human anthrax in the Soviet city of Sverdlovsk. Several politically binding CBMs have been in effect Although Soviet officials engaged in a systematic cover- since the 1986 and 1991 Review Conferences, includ- up at the time, the cause of the anthrax outbreak was later ing annual exchanges of information of biodefense pro- revealed to have been an accident at a clandestine BW grams, relevant facilities, and unusual outbreaks of disease. production facility.7 Unfortunately, compliance with the reporting requirements Other countries at the Review Conference welcomed has been poor. There are two reasons for this problem: the U.S. alternative proposals but argued that they did (1) the fact that the CBMs are politically but not legally not go far enough, and that some type of legally binding binding; and (2) the lack of a BWC Secretariat to remind agreement among BWC States Parties was necessary. On and pressure States Parties to submit their annual data the last day of the Review Conference, however, the U.S. declarations. In the absence of a secretariat, national dec- delegation unexpectedly put forward a proposal termi- larations are simply collated by UN staff and circulated to nating the mandate of the Ad Hoc Group, the sole forum member states in the original languages. Because of these for negotiating multilateral measures to strengthen the limitations, the two sets of CBMs have failed to achieve treaty. This U.S. “killer” amendment, which had not been their stated goal of significantly enhancing openness and discussed in advance with close European allies, was un- transparency with respect to BWC-related activities. acceptable to most delegations and made it impossible The European Union has proposed making some of the for the Review Conference to reach consensus on a Fi- CBMs legally binding, which would increase the level of nal Declaration. In a desperate move to prevent the col- compliance significantly. In addition, creating a small pro- lapse of the meeting, the chairman adjourned it for one fessional Secretariat to assist countries with preparing their year, so it will resume on November 11-22, 2002.8 Dur- annual data declarations could greatly improve the effec- ing this “time out,” the participating states should attempt tiveness of the existing CBMs. Although the United States to hammer out their differences. is unlikely to support or fund a BWC Secretariat, it might be financed through another mechanism, such as the United Where Do We Go from Here? Nations Foundation, and staffed with officials from the With the suspension of the Ad Hoc Group negotiation UN Department of Disarmament Affairs. and the failure—at least for now—of the Fifth BWC Re- view Conference, many countries and NGOs are won- dering how best to bolster the regime at a time when the
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Strengthen the UN Field Investigation Procedure NATIONAL MEASURES TO STRENGTHEN THE The idea of investigating the alleged use of BW under REGIME the auspices of the UN Secretary-General, as proposed by the United States at the Fifth Review Conference of Criminalize BW Possession and Use the BWC, is not new. In a series of resolutions beginning Although the United States has proposed that countries in 1980, the UN General Assembly requested the Secre- voluntarily pass national legislation criminalizing the pos- tary-General to investigate alleged violations of the 1925 session and use of BW, countries that seek such weapons Geneva Protocol, the BWC, and other provisions of “cus- or that sponsor terrorism are unlikely to comply. Only a tomary international law.” On November 30, 1987, the legally binding, multilateral regime would be effective in General Assembly went a step further by adopting Reso- addressing noncompliance by imposing economic and lution 42/37, which grants the Secretary-General the au- other sanctions on violators and non-parties. To this end, thority to launch investigations of alleged use on his own BWC member countries should negotiate an international authority. treaty branding the possession and use of BW as “crimes To date, the UN has investigated four cases of the al- against humanity” under international law, so that even leged use of chemical or biological weapons: (1) of fun- outlaw states such as Iraq would be bound by it. At the gal toxins (“yellow rain”) by the Soviet Union and its same time, participating states would agree to extradite allies against rebel groups in Southeast Asia and Afghani- individuals implicated in the acquisition and use of BW. stan in 1980-83; (2) of chemical weapons (CW) by Iraq The Harvard Sussex Program on Chemical and Biologi- and Iran during the Iran-Iraq War in 1984-88; (3) of CW cal Weapons (CBW) Armament and Arms Limitation has 9 by RENAMO insurgents in Mozambique in 1992; and developed a draft international treaty to this effect. (4) of CW by Armenian forces in Azerbaijan in 1992. In some cases, cooperation was forthcoming (e.g., from Restrict Access to Dangerous Pathogens both sides during the Iran-Iraq War) but in other cases it Would-be bioterrorists who are skilled in microbiology was not (e.g., during the “yellow rain” investigations in might be able to culture deadly germs from natural sources, Laos, Cambodia, and Afghanistan). The investigations but it would be far easier to obtain them from microbial were successful only when they were carried out with culture collections in academic or industrial laboratories the cooperation of the party on whose territory the al- or commercial biological supply houses. Few of these cul- leged attack had occurred. ture collections are adequately secured and regulated. In At the Fifth BWC Review Conference, the United the United States, facilities that possess cultures of an- States proposed requiring member states to accept UN thrax bacteria are believed to number in the hundreds, in- investigations of alleged use on their territory without cluding universities, private institutes, hospitals, veterinary the right of refusal, but countries are unlikely to do so in clinics, and public health agencies. The precise number is the absence of a formal treaty that imposes legally bind- unknown, however, because the federal government does ing rights and obligations. Moreover, the U.S. proposal not maintain a central registry of dangerous pathogens only authorizes investigations of alleged use of BW and owned by academic and private institutions. Unfortu- fails to address the need to prevent their acquisition in nately, simply banning laboratory stocks of dangerous the first place. Thus, instead of relying on the existing pathogens is not an option. Access to anthrax bacterial ad hoc mechanism, BWC member states should negoti- cultures, for example, is vital for scientists studying the ate a formal treaty that requires the participating states disease, which causes serious outbreaks in livestock in to accept UN field investigations on their territory and many parts of the world. extends the authority of the Secretary-General to inves- Some controls on dangerous germs are already in place, tigate suspect BW development and production facili- but they are far from universal in their coverage. The ties as well as use. United States and 32 other like-minded governments con- trol national exports of certain pathogens to countries sus- pected of pursuing BW through an informal coordinating mechanism known as the Australia Group (AG).10 Nev- ertheless, states pursuing biological arms have employed
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numerous strategies to circumvent these controls, such All governments have a common interest in preventing as transshipment points and shell companies. Some coun- deadly microbes from being used against civilian popula- tries that do not belong to the AG also engage in unregu- tions, and regulating the germ trade would put significant lated trade in dangerous pathogens. New measures are obstacles in the path of would-be bioterrorists. clearly needed to control “germ commerce,” both within countries and among them. EXTERNAL MEASURES TO STRENGTHEN THE In 1996, the U.S. Congress passed legislation tighten- REGIME ing controls on shipments of dangerous pathogens and tox- ins within the United States.11 This move followed Expand the Cooperative Threat Reduction Program revelations that a leading biological-supply house near Until at least 1992, the former Soviet Union and then Washington, D.C. had sold cultures of bubonic plague Russia had the world’s largest and most sophisticated bio- bacteria to an Ohio lab technician with links to the Aryan logical warfare program. It included four military mi- Nations, a violent white-supremacist organization. Un- crobiological institutes run by the Ministry of Defense der U.S. regulations that came into force in 1997, any- and a vast complex of ostensibly civilian pharmaceuti- one intending to ship or receive agents on a list of 36 cal facilities, known as Biopreparat, that was secretly microbial pathogens and toxins must register with the engaged in offensive BW development and production. federal Centers for Disease Control and Prevention and After the breakup of the Soviet Union in 1991, the cul- demonstrate a legitimate medical or scientific use for the ture collections, former production facilities, and spe- material. Violations are punishable by prison terms and cialized know-how associated with former Soviet fines of up to $500,000.12 In the aftermath of the Sep- biowarfare facilities in Russia, Kazakhstan, and tember 11 attacks, Congress has moved to close loop- Uzbekistan began to pose serious proliferation threats. holes in the existing law by extending the rules to cover The U.S. government has addressed this problem to some possession as well as transfer of listed pathogens. extent under the Department of Defense’s Cooperative Even so, tighter U.S. regulations, while desirable, will Threat Reduction program, the Department of Energy’s not significantly reduce the global threat unless such con- Industrial Partnership Program, and the International trols are implemented internationally. Hundreds of labs Science and Technology Center in Moscow. Neverthe- and companies overseas work with dangerous pathogens, less, far more must be done to convert former biowarfare yet restrictions on access vary from country to country. facilities into commercially viable enterprises and to According to the World Federation for Culture Collec- keep former weapons scientists gainfully employed in tions (WFCC), a loose association of 472 repositories peaceful research activities, so that they are not suscep- of living microbial specimens in sixty-one countries, 46 tible to recruitment by proliferators and terrorists. The germ banks—in countries as diverse as Germany, India, United States, Japan, and the European Union should and Iran—have stocks of anthrax bacteria. Although the make a substantial financial commitment to dismantle federation recently urged its members to establish tighter the residual BW production capacity in the former So- rules for who is granted access to dangerous microbes, viet Union, to employ former bioweapons scientists, and it does not have the authority to force compliance. More- to enhance the physical security, control, and account- over, less than a third of the more than 1,500 microbial ing of collections of dangerous pathogens. culture collections worldwide belong to the WFCC.13 Enhance Global Epidemiological Surveillance To “harmonize” the uneven patchwork of national regulations, the United States should advocate the im- BWC member states should fund the creation, under mediate negotiation by the UN General Assembly of an World Health Organization (WHO) auspices, of an im- international agreement imposing common limits on ac- proved international system for rapidly detecting and re- cess to dangerous pathogens and uniform standards of sponding to unusual outbreaks of disease. Such a global biosafety and physical security. Possession of deadly system would not only help to contain natural epidem- biological agents by unauthorized individuals should also ics but could have a deterrent effect on the covert use of be made a crime under international law. Negotiating BW. The greater likelihood that covert biological attacks such an agreement would not be as ambitious as it sounds. would be detected could reduce the military utility of bio-
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logical weapons and deter their use by increasing the risk to develop a culture of professional responsibility with re- of attribution and retaliation. spect to potentially hazardous areas of research. Because the WHO must be insulated from political pres- In the past, the U.S. scientific and medical communi- sures to perform its primary public health mission, the glo- ties have addressed ethical issues related to research in- bal epidemiological surveillance system should not be volving human subjects by establishing the Nuremberg explicitly linked to the BWC compliance regime, although guidelines and Institutional Review Boards. Yet scien- such a system would indirectly support the goals of the tists have been largely silent about the threats of biologi- Convention. As a first step, the United States and like- cal warfare and terrorism. There are two likely reasons minded countries should sponsor an effort to develop a for this lack of action. First, scientists are generally re- comprehensive inventory of all disease-surveillance sys- luctant to contemplate the misuse of their research for tems around the globe. WHO member countries should nefarious purposes. Second, scientists are rarely re- then develop a plan of action for funding and organizing warded by their peers—and, indeed, may be punished— an efficient global network, linked by satellite communi- for speaking out on sensitive public policy issues. It is cations, of disease-monitoring stations, reference labora- critical, however, that scientists become more actively tories, and response teams. involved in reinforcing the ethical and legal norm against biological warfare. Encourage Industry Self-Regulation As a standard element of the graduate curriculum in The international biotechnology industry should create the biological and biomedical sciences, as well as in a global association similar to the World Association of medical and veterinary schools, students should be edu- Nuclear Operators (WANO).14 WANO was established cated about the risks of certain lines of scientific inquiry in May 1989 by the international nuclear power industry as well as the norms of scientific responsibility and per- in response to the accident at the Chernobyl nuclear power sonal integrity with respect to biological research. plant in 1986. This disaster forced nuclear operators to Courses or training modules should provide a basic fa- reassess the issue of safety and made them aware of the miliarity with the threat of biological warfare and the need for international cooperation to prevent future acci- provisions of the BWC. In addition, all students who dents. complete an advanced degree in biology or biomedicine should be required to sign a pledge of scientific respon- WANO facilitates the exchange of operating experience sibility, similar to the Hippocratic Oath, stressing the among nuclear power plant operators, so that its mem- importance of ethical guidelines in the conduct of re- bers can work together to achieve the highest possible search. This step would be particularly important with standards of safety and reliability. By creating a similar respect to the large number of foreign students—includ- global organization, the pharmaceutical and biotech indus- ing some from countries of proliferation concern—who tries could work together to establish guidelines and best study at U.S. universities.16 practices, reducing the risk that dual-use technology and production equipment will be misused for purposes of bio- logical warfare and terrorism. Provide Oversight of Hazardous Research In recent years, dramatic advances in the fields of mo- Foster an Ethic of Scientific Responsibility lecular biology and biotechnology have yielded numer- ous benefits for humanity, including improved health and Because scientists would play a key role in any offen- nutrition. Yet these scientific breakthroughs also have a sive biological warfare program, it is incumbent on the dark side: the potential to create more deadly instruments scientific community to complement diplomatic initiatives of biological warfare and terrorism.17 Accordingly, spe- to strengthen the BWC by taking concrete steps to rein- cialists in the biological, biomedical, veterinary, and force the ethical norm enshrined in the treaty.15 As a first plant sciences should take the difficult but important step step, specialists in the biological, biomedical, veterinary, of monitoring and even limiting research that could have and plant sciences should become more aware of the po- direct applications in offensive biological warfare. Har- tential for misuse of advances in genomics and genetic nessing the powerful knowledge arising from the bio- engineering techniques. They should also be encouraged logical sciences in a manner that benefits humankind, while
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preventing its misuse, will require the scientific commu- genes involved in pathogenicity and virulence, adhesion nity to regulate itself. and colonization of host cells, immune-response evasion In January 2001, an inadvertent discovery highlighted and antibiotic resistance, from which to pick and choose 20 the potential risks associated with the new genetic tech- the most lethal combinations.” nologies. Australian scientists developing a contracep- Revelations about the Soviet/Russian biological warfare tive vaccine for controlling field mouse populations program indicate that the potential exists for the deliber- sought to enhance its effectiveness by inserting the gene ate creation of “designer pathogens.” Until at least 1992, for the immune regulatory protein interleukin-4 (IL-4) military scientists working at the Biopreparat institutes into the mousepox virus, which was being used as a de- employed genetic engineering techniques to develop more livery system for the vaccine. Although IL-4 is a sub- lethal strains of anthrax bacteria, smallpox virus, and other stance that is normally produced in mice, insertion of biological warfare agents. According to Ken Alibek, a se- the IL-4 gene into the mousepox virus unexpectedly nior Biopreparat official who defected to the United States transformed it into a virulent strain that shut down the in 1992, the Soviet germ warfare program included ef- mouse immune system and killed all the animals in the forts to develop “advanced” biological agents by engineer- experiment. In addition to rendering mousepox lethal in ing bacterial pathogens to be resistant to multiple antibiotics mice that were genetically resistant to the disease, the and vaccines. Soviet scientists also created hybrid (“chi- inserted gene made the mousepox vaccine ineffective; meric”) viruses through the transfer of genes for protein the recombinant virus killed even those mice that had toxins and virulence factors, and developed incapacitat- previously been vaccinated.18 The Australian team de- ing and behavior-modifying agents through the manipula- bated for months over the wisdom of publishing their tion of natural brain chemicals.21 disturbing results but finally decided to do so as a means Unclassified reports on some of this research were later of warning the scientific community. published in the Russian scientific literature. In 1997, for The mousepox experiment demonstrated that the novel example, scientists working at the State Research Center gene combinations produced by genetic engineering can, for Microbiology at Obolensk, near Moscow, reported that on rare occasions, accidentally yield a more virulent they had developed a strain of anthrax bacteria contain- pathogen—a possibility first raised in the 1970s by sci- ing an inserted gene for a foreign toxin, rendering the agent entists concerned about the safety of gene-transfer ex- resistant to the existing Russian anthrax vaccine.22 In ad- periments.19 The Australian finding also highlighted the dition, scientists at the State Research Center for Virol- potential of genetic engineering to create new and more ogy and Biotechnology “Vector” in Koltsovo, near lethal instruments of biological warfare. Indeed, since Novosibirsk, did a number of experiments on vaccinia, a human beings possess the interleukin-4 gene, it is pos- virus closely related to the causative agent of smallpox sible that inserting this gene into a poxvirus that infects that serves as a vaccine against the disease. One research humans, such as smallpox or monkeypox, could create group at Vector identified a site in the vaccinia DNA where a highly lethal strain that would be resistant to the exist- they could insert foreign genes without disrupting the ability ing smallpox vaccine. of the virus to infect and replicate.23 A second group at Inadvertent discoveries of this type, as well as delib- Vector spliced into vaccinia a gene from the Ebola virus erate efforts to employ the new genetic technologies for coding for a viral protein called “vp24.” When the recom- nefarious purposes, may become increasingly common binant virus was injected into guinea pigs, the Ebola gene as biological research continues to generate a flood of was successfully expressed as a protein and induced the 24 new information about the structure and function of mi- formation of specific antibodies. According to Alibek, croorganisms at the molecular level and the host response the ultimate goal of the Vector research was to create a to infection. According to a recent commentary in the hybrid of the smallpox and Ebola viruses that would com- scientific journal Nature Genetics by Claire M. Fraser, bine the contagiousness of the former with the lethality of director of The Institute for Genomic Research, and the latter. It appears, however, that gene-transfer experi- Malcolm R. Dando, a policy analyst at the University of ments with the smallpox virus itself were never carried Bradford in England, “The ever-expanding microbial out. genome databases now provide a parts list of all potential
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Scientific Community Oversight example, the same technology used to create fusion tox- The scientific community must address the problem of ins for the purpose of killing cancer cells could be redi- hazardous research, ideally through self-governance. Al- rected to produce novel toxins that target normal cells of 25 though many scientists view any restrictions on scientific almost any tissue. Another area of potential concern inquiry as anathema, the alternative could be far worse. involves the engineering of viruses to evade or manipu- If a novel pathogen were created in the laboratory, the late human immune defenses. Gene therapists have resulting public outrage could compel the U.S. Congress sought to introduce curative genes into patients with in- to impose draconian restrictions on scientific inquiry. In herited diseases by developing as molecular carriers the interest of avoiding this outcome, scientists should act “stealth” viruses that are not detected by the immune proactively to ensure that their research does not assist system. Yet such techniques could also be misused to would-be bioterrorists. convert pathogenic viruses into even more deadly war- fare agents.26 A precedent for self-regulation by the scientific com- munity already exists. In February 1975, some 140 bi- The proposed review and oversight system should be ologists, lawyers, physicians, and journalists met at the capable of identifying hazardous lines of research, with- Asilomar Conference Center near Monterey, California, out being so intrusive as to have a chilling effect on le- to discuss the potential risks associated with recombi- gitimate scientific inquiry or to inspire attempts at nant DNA technology, which had only recently been de- circumvention. Because no universal set of criteria is pos- veloped. This conference resulted in a set of research sible, the judgments of the oversight board would have guidelines administered by the National Institutes of to be scientifically informed and made in the context of Health and overseen by a Recombinant DNA Advisory specific research proposals. Hazardous research that is Committee (RAC). The Asilomar analogy goes only so justified for protecting public health or defending against far, however. Whereas the 1975 conference focused on biological warfare would be restricted to a few high-con- the possible unintended consequences of recombinant tainment laboratories, as is already the case with research DNA research, the current concern is over the potential on the smallpox virus. All such work would be transpar- malicious use of this technology for harming or killing ent and the results reported to the international oversight people and for attacking crops or livestock to cause eco- board on a regular basis. Inadvertent discoveries with nomic damage. dangerous implications, such as the Australian mouse- pox experiment, would also be reported to the oversight In order to prevent the deliberate misuse of scientific board, and advice would be sought on whether or not to knowledge for nefarious purposes, a system for “pruden- publish the findings. tial review” of potentially hazardous research should be established. Because science is an inherently interna- Because genetic engineering has become a burgeon- tional activity, a regime focusing on the U.S. scientific ing commercial business, many senior academic re- community alone would not be effective; hence the over- searchers have extensive ties to the private sector. Thus, sight mechanism should be international in scope. Le- to avoid gaping loopholes in the oversight mechanism, gitimate but high-risk projects would be reviewed by a proprietary industrial information must not be exempt scientific oversight board, which would be similar to the from coverage. To give but one example, a biotechnol- RAC but would operate at the international level. Re- ogy company recently created a novel strain of E. coli search projects with direct offensive military applications bacteria containing an inserted gene for botulinum toxin 27 would be forbidden outright, while others would be sub- and engineered for maximally efficient expression. The ject to close monitoring. goal of this effort was to boost commercial yields of botulinum toxin (trade name “Botox”), which has been Regulated activities would constitute a small subset a licensed drug in the United States for more than a de- of scientific research in the fields of microbiology, in- cade and is used to treat neuromuscular disorders and to fectious disease, veterinary medicine, and plant pathol- smoothe wrinkles for cosmetic purposes. Nevertheless, ogy. Areas of particular concern include the cloning and a genetically modified strain of E. coli capable of mass- transfer of toxin genes and virulence factors, and the de- producing a deadly toxin poses a potential biowarfare velopment of antibiotic- and vaccine-resistant strains of threat, particularly in view of the fact that E. coli is a com- microorganisms and genetically engineered toxins. For mon cause of food poisoning and is easily disseminated.
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Challenges Ahead Fourth, scientific journals should develop “opacity” The process of developing an international mechanism policies for declining to publish articles that contain sci- to regulate hazardous “dual-use” research will be com- entific information of direct value to potential bioterrorists plex and difficult, requiring the active participation of a or for removing certain technical details that could be mis- 30 variety of stakeholders, including scientists, lawyers, and used for nefarious purposes. Such decisions will require politicians from several countries.28 It will be challeng- careful deliberation to avoid hampering legitimate scien- ing to achieve consensus within the scientific commu- tific investigation. Given that the ethos of the scientific nity on a regulatory mechanism, and government community is opposed to censorship of any kind, a strong policymakers will also be reluctant to grant an interna- professional consensus must support a decision not to pub- tional body detailed, binding review authority over lish research data because its dissemination could be harm- biodefense activities. Thus, simply agreeing to notify the ful to society. oversight board that such activities are being conducted, In sum, the international scientific community, work- and describing them in general terms, may be all that ing collaboratively through professional societies and na- can reasonably be accomplished.29 Because several years tional academies of science, should negotiate a set of of negotiations will be required to hammer out a practi- rules and procedures for the oversight of potentially dan- cal oversight system, preparatory work should begin as gerous research. In developing such an oversight mecha- soon as possible. nism, public perceptions will play a key role. Even if In crafting an international regime for regulating sci- the scientific community ultimately decides that controls entific research of potential relevance to biological war- on research are impractical, ill-advised, or do not meet fare, a number of difficult issues will need to be addressed. risk-benefit criteria, it will be necessary to explain and First, how will dangerous “designer pathogens” be identi- justify these arguments to a skeptical public in an open fied in advance? What types of inserted genes or gene and understandable manner. fragments would make a garden-variety microorganism declarable? Conclusions Second, how can one give the international oversight The use of anthrax-tainted letters sent through the mail board the authority and power it requires to enforce the to kill and terrorize U.S. citizens has seriously eroded rules, while preventing it from becoming corrupt and au- the norm against biological warfare and terrorism, mak- tocratic? Because of the potential for abuse, the over- ing it imperative to strengthen the existing disarmament sight board must be structured with checks and balances and nonproliferation regime. As described above, a num- so that it does not unduly constrain scientific freedom ber of complementary measures to strengthen the BWC or exploit its privileged access to sensitive and propri- should be taken at the international and national levels, etary information. Obviously, the members and staff of with the involvement of governments, the biotechnol- the oversight body must meet the highest standards of ogy industry, the scientific community, and NGOs. professional ethics. Yet how can one ensure the reliabil- If nothing is done to strengthen the BWC and the in- ity and integrity of the board members? Would they be ternational regime continues to unravel, the conse- subjected to a periodic vetting or clearance procedure? quences could be grim. Widespread proliferation of the Third, how can one alert the scientific community to specialized know-how needed to develop and deliver potential biological warfare threats from research activi- designer pathogens would make mass destruction capa- ties without creating self-fulfilling prophecies? Scien- bilities accessible to small groups of terrorists and even tists from states with biowarfare programs should not to mentally deranged individuals. To prevent this night- be allowed to serve on the international oversight board, mare from becoming a reality, the international commu- because of the possibility that they could be directly in- nity should take concrete steps to reinforce the ethical volved in clandestine weapons development. Yet making and legal norm against biological warfare and to regulate such distinctions would be politically difficult for national hazardous research. governments and would require the scientific community to adopt a “counterintelligence” mentality alien to its pre- vailing culture of openness.
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1 Ken Alibek, for example, has asserted that the Soviet Union employed tulare- (New York: Oxford University Press, 1991), pp. 71-97. mia bacteria as a weapon against German troops during the Battle of Stalingrad 16 The equivalent of a Hippocratic Oath for scientists was adopted by the in 1942. See Ken Alibek with Stephen Handelman, Biohazard (New York: Ran- General Assembly of the International Association of Microbiological Soci- dom House, 1999), pp. 29-31. eties at its meeting in Mexico City in August 1970, but it was never imple- 2 Brad Roberts, “Implementing the Biological Weapons Convention: Looking mented. See Carl G. Hedén, “A Professional Verdict Over BW,” New Scientist Beyond the Verification Issue,” in Oliver Thraenert, ed., The Verification of 47 (September 10, 1970), pp. 508-512. the Biological Weapons Convention: Problems and Perspectives (Bonn: 17 Andrew Pollack, “With Biotechnology, a Potential to Harm,” New York Friedrich Ebert Stiftung, 1992), p. 104. Times, November 27, 2001. 3 Alexander Kelle, “Developing Control Regimes for Chemical and Biologi- 18 R. J. Jackson et al., “Expression of Mouse Interleukin-4 by a Recombinant cal Weapons,” International Spectator 32 (July-December 1997), p. 141. Ectromelia Virus Suppresses Cytolytic Lymphocyte Responses and Overcomes 4 Ad Hoc Group of Governmental Experts to Identify and Examine Potential Genetic Resistance to Mousepox,” Journal of Virology 75 (2001), Verification Measures from a Scientific and Technical Standpoint, Summary pp. 1205-1210. Report, Doc. BWC/CONF.III/VEREX/9, Geneva, September 24, 1993. 19 Stewart A. Newman, “Australian Mouse Study Confirms CRG Warning,” 5 Stephanie Nebehay, “Germ-Warfare Talks Likely to be Pursued,” Philadel- GeneWatch 14 (2001). phia Inquirer, August 19, 2001. 20 Claire M. Fraser and Malcolm R. Dando, “Genomics and Future Biologi- 6 The White House, Office of the Press Secretary, “Statement by the Presi- cal Weapons: The Need for Preventive Action by the Biomedical Commu- dent: Strengthening the International Regime Against Biological Weapons,” nity,” Nature Genetics 29 (2), 2001, pp. 253-256. November 1, 2001; Dana Milbank, “Bush Would Update Germ Warfare Pact,” 21 Alibek, Biohazard, pp. 153-167. Washington Post, November 2, 2001, pp. A16-17. 22 William J. Broad, “Gene-Engineered Anthrax: Is It a Weapon?” New York 7 U.S. Delegation to the Fifth Review Conference of the BWC, “Concept Times, February 14, 1998; Nicolas Wade, “Tests with Anthrax Raise Fears Paper: New Ways to Strengthen the International Regime Against Biological That American Vaccine Can Be Defeated,” New York Times, March 26, 1998. Weapons,” Geneva, October 19, 2001, pp. 10-12. 23 Oleg Serpinskiy, et al., “Construction of Recombinant Variants of 8 Elizabeth Olson, “Conference on Biological Weapons is Stalled by Deep Orthopoxviruses by Building Foreign Genes into Intergeneic Spacers of the Divisions,” New York Times, December 8, 2001, p. A7. Viral Genome,” Molecularnaya Biologiya (Moscow) 30 (1996), pp. 1055- 9 Harvard Sussex Program on CBW Armament and Arms Limitation, “A 1065, (in Russian). Draft Convention to Prohibit Biological and Chemical Weapons Under Inter- 24 A. A. Chepurnov, et al., “Immunobiological Properties of vp24 Protein of national Criminal Law,” The CBW Conventions Bulletin, No. 42 (December Ebola Virus Expressed by a Recombinant Vaccinia Virus,” Voprosy Virusologii 1998), pp. 1-5. 42 (May-June 1997), pp. 115-120, (in Russian). 10 For information on the Australia Group, see
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