Abstract
Last fall, five letters contafnfng a highly lethal preparation of powdered anthrax spores were sent through the U.S. postal system, killing five people, sickening 18 others, and forcing tens of thousands to take powerful antibiotics. The anthrax mailings provoked worldwide anxiety when post offices and federal buildings were shut down, causing billions of dollars in damage. Today, the perpetrator(s) remain at large–perhaps capable of further attacks.
As bad as it was, the fallout from the anthrax letters only hints at the devastation that could result from a large-scale bioterrorist attack. In light of September 11, such a possibility must be taken seriously. Because bioterrorism poses a clear and present danger to international security, the United States and its allies must take concerted action to stop terrorists from getting hold of deadly pathogens and toxins. To this end, the Bush administration should take an international leadership role: first, by pursuing enhanced national regulations that control and secure these dangerous materials; and second, by launching the negotiation of a new “bio-security convention.”
Although biological agents can be obtained from natural sources, such as soil or diseased animals, the collection of agents demands expertise in microbiology and a fair degree of luck. Effectively weaponizing anthrax is also tricky. Technical hurdles prevented the Japanese doomsday cult Aum Shinrikyo, for example, from perpetrating large-scale bioterrorist attacks in the early 1990s. Aum Shinrikyo scientists unwittingly obtained a natural strain of anthrax bacteria that turned out to be “avirulent”–incapable of causing disease. So although the cult successfully mass-produced and released anthrax spores in central Tokyo on several occasions, the attacks caused no known casualties. It would be far easier, and provide a greater chance of success, for would-be bioterrorists to buy or steal cultures of dangerous pathogens from academic, industrial, or commercial labs.
Whether or not the anthrax mailings were “made in America,” as some now believe, the Federal Bureau of Investigation's difficulty identifying the source of the anthrax spores shows that the U.S. government does not effectively monitor culture collections within its own borders, let alone in other countries. The number of U.S. labs that possess cultures of anthrax bacteria is thought to be in the hundreds and includes universities, private institutes, hospitals, veterinary clinics, and public health agencies. Simply banning laboratory stocks of these microbes is not a practical option; the pathogens must be available for legitimate scientific research and the development of new medical therapies.
Restricting access to legitimate scientists will be impossible until federal agencies develop a comprehensive inventory of the stocks of disease agents and toxins held by U.S. academic and industrial labs, research institutes, and commercial suppliers.
In 1996, following revelations that a leading biological-supply house had sold cultures of bubonic plague bacteria to an Ohio lab technician with links to the Aryan Nations (a violent white-supremacist organization), Congress passed anti-terrorism legislation tightening controls on transfers of dangerous pathogens within the United States. Regulations introduced in 1997 require anyone intending to ship or receive agents on a list of 36 pathogens and toxins to register with the federal Centers for Disease Control and Prevention (CDC) and demonstrate a legitimate medical or scientific use for the material. Violations are punishable by prison terms and fines of up to $500,000.
Congress tightened controls after Larry Wayne Harris (center, in 1998) illegally obtained bubonic plague cultures.
Put it on the fast track
In requesting fast-track authority, the Bush administration would outline its negotiating objectives in consultations with Senate leaders of both parties and with representatives of the U.S. biotechnology and pharmaceutical industries. The administration might also agree to inform and consult with the Senate by submitting quarterly reports on the status of negotiations.
A commitment to fast-track negotiating authority by the Senate's Democratic leadership would demonstrate bipartisan problem-solving and provide reassurance that the U.S. government is working to protect Americans. Although granting fast-track authority would curtail the leadership's prerogative to control committee and floor deliberations, Senate Democrats would gain influence over the negotiating goals and strategies of the Republican administration.
Granting fast-track authority now would shield senators from special-interest pressures later on. Moreover, barring filibusters and requiring a simple up/down floor vote would prevent a single powerful senator from delaying consideration of the treaty, as has occurred in recent years. Fast-track authority would also prevent a repeat of the 1997 Senate debate over ratification of the Chemical Weapons Convention, when treaty opponents attached unilateral waivers and exemptions to the Resolution of Ratification, seriously weakening the accord by creating loopholes that proliferators could exploit.
Finally, granting the White House fast-track authority to negotiate the biosecurity convention would help reshape international expectations about what must be done to combat bioterrorism. Senate approval of fast-track would reflect the urgency of the issue and underscore the need for all countries to put aside “business as usual” when confronting the grave threat that biological weapons pose to international peace and security.
Unfortunately, this law contains a major loophole: Labs that simply hold or work with dangerous cultures, but do not transfer them across state lines, are not required to register with the CDC. In the aftermath of September 11, Congress has moved to close the loophole by extending the law to regulate possession as well as transfers.
Perhaps more troubling is that U.S. efforts to combat bioweapons may have created unaccountable sources of dangerous pathogens. Recent revelations indicate that the U.S. biode-fense program secretly produced weapons-grade anthrax powder for the purpose of testing detection equipment at Dugway Proving Ground in Utah. Given suspicions that the perpetrator of the anthrax mailings could be a biodefense program insider, the need for effective controls and oversight on work with dangerous pathogens has become all the more acute. Otherwise, expanding biodefense work (as the Bush administration wants to do) could have the paradoxical effect of increasing the availability of deadly germs to terrorists.
Aum Shinrikyo attempted both biological and chemical weapons attacks in Japan. Here, Tokyo inspectors check for nerve gas, April 1995.
Even if the United States can put its own house in order, the international scope of the problem still looms large.
Hundreds of companies and labs around the world work with dangerous pathogens, but regulations on access vary widely. According to the World Federation for Culture Collections (WFCC), a loose association of 472 repositories of living micro-bial specimens in 61 countries, there are 46 germ banks–in countries as diverse as Germany, India, and Iran–that stock anthrax cultures. Although the federation recently urged its members to tighten access to dangerous microbes, it lacks the authority to force compliance. Moreover, more than 1,000 germ banks worldwide do not belong to the federation, and few of their culture collections are adequately secured or regulated.
Controls on “germ commerce,” or trade in microbial cultures, are also far from universal. The United States and 32 other like-minded governments belong to an informal forum known as the Australia Group, which serves to coordinate national controls over exports of dangerous pathogens and certain sensitive dual-use biotechnology equipment. Member states pledge not to undercut other suppliers by selling to countries that have already been denied access to sensitive goods. But states that seek bioweapons can evade Australia Group controls by using transshipment points and shell companies or by trading with countries that are not members of the group.
The most accessible source of biowarfare materials and equipment is foreign commercial suppliers. Unauthorized access to dangerous pathogens from these suppliers poses both an international and domestic threat. An international campaign to regulate exports and imports of these materials and to harmonize the uneven patchwork of national regulations would significantly hinder would-be bioterrorists.
October 31, 2001: After a recent anthrax attack, a mail carrier wears a protective mask and gloves.
Over the past year, international efforts to deal with state acquisition and use of biological weapons have come to a standstill. Although the 1972 Biological and Toxin Weapons Convention (BWC) bans the development, production, stockpiling, and transfer of microbial disease agents and natural poisons (toxins) as weapons, it lacks any formal measures to ensure treaty compliance. This lack of teeth has rendered the BWC incapable of dealing with a series of alleged violations.
In early 1995, a group of BWC member states began to negotiate a legally binding protocol to “strengthen the effectiveness and improve the implementation” of the treaty by establishing a system of mandatory declarations and on-site inspections of dual-use facilities like vaccine plants (which can be easily diverted to bioweapons production). These measures would have been backed up with the right to request “challenge” inspections of suspected undeclared facilities and field investigations of alleged bioweapons use or suspicious outbreaks of disease.
In July 2001, the Bush administration rejected the draft protocol to the bioweapons treaty and abruptly withdrew from the negotiations after more than six years of effort. Bush officials argued that the proposed inspection measures were ineffective and would allow a determined proliferator to conceal an offensive biowarfare program with little risk of detection. At the same time, officials said, on-site inspections would jeopardize the trade secrets of American pharmaceutical and biotech companies.
In the wake of the U.S. rejection of the BWC protocol, several governments and non-governmental organizations are looking for a way to enforce treaty compliance. Although President Bush said in November that the United States remains committed to the bioweapons treaty, his administration has done little to prove it. During the Fifth Review Conference of the BWC last November and December, the United States proposed a package of nine alternative measures to strengthen the treaty. Most of the suggestions were based on domestic legislation and other voluntary actions. Some of these ideas have merit, such as urging treaty members to criminalize the possession and use of bioweapons and to facilitate extradition. But others are questionable (such as the proposal for states to accept international inspections of suspicious disease outbreaks and alleged bioweapons use on a politically, not legally, binding basis), or merely in the realm of good intentions (such as devising a code of bioethics for scientists).
Late on the conference's last day, the United States shocked attendees by proposing to do away with the forum that had negotiated the BWC protocol. When other countries objected, the conference came dangerously close to collapse before the chairman suspended the meeting for one year. During this “time out” it will be important for treaty members to find a way out of the current impasse. [See “Bioweapons: U.S. Vetoes Verification,” by Susan Wright, March/April 2002 Bulletin.]
The manifest threat of bioterror-ism dwarfs U.S. efforts to prevent it. In the wake of September 11, the United States and other countries have begun to address domestic bioterrorism problems. But these efforts must be expanded. If the United States were to promote a realistic agenda, a coordinated and multilateral international response to bioterrorism could be developed.
U.S. officials should work with like-minded countries to develop domestic legislation to prevent unauthorized access to pathogens and to regulate germ commerce. Basing these laws on the strengthened U.S. legislation recently adopted by Congress would help to create more uniform regulations over labs that work with or transfer dangerous pathogens.
Parallel to these efforts, the United States should promote an international biosecurity convention, which would be distinct from the bioweapons treaty but would complement it by primarily addressing the threat of bioterrorism. In addition, the biosecurity convention should build on the ongoing implementation of the 1992 Biological Diversity Convention and its 2000 Cartagena Protocol on Biosafety, which includes provisions for the safe handling, transfer, and use of genetically modified organisms. By focusing on the safety and security of dangerous pathogens, the biosecurity convention would depart from the facility-inspection approach that was the basis of the rejected BWC protocol.
In many respects, the biosecurity convention could follow the model of the 1994 Nuclear Safety Convention, which set international benchmarks for the safe operation of civilian nuclear power plants. As an “incentive instrument,” the Nuclear Safety Convention does not enforce compliance through adversarial inspections, but rather through a common interest in better nuclear plant safety. Political pressure and the need for the appearance of responsibility provide additional incentives for countries to participate.
October 19, 2001: Hazardous material workers conduct tests in the Ewing Township, New Jersey, post office where an employee was believed to have been exposed to anthrax spores.
Like the Nuclear Safety Convention, the biosecurity convention should not specify highly detailed rules because standards developed today may be rendered obsolete by technological advances. Instead, countries should agree on a set of basic obligations and guidelines, which would be implemented in detail by each member-state through its national legislative process.
The biosecurity convention should include three basic elements: a legal commitment by the contracting parties; agreed principles for developing progressively higher standards with respect to regulation and licensing of microbial culture collections; and mechanisms for oversight and progressive refinement of standards through periodic conferences.
The convention would:
• Require member countries to identify microbial and toxin agents of potential concern for biowarfare and terrorism and to establish national registers of culture collections containing these agents, as well as genetically modified strains and engineered agents containing virulence factors and toxin genes transferred from the listed microorganisms;
• Establish uniform international standards to account for and secure listed pathogens and toxins, whether they are stored, transferred, imported, or exported;
• Mandate the passage of domestic legislation to establish licensing and import/export controls over listed pathogens and toxins, and the creation of regulatory bodies to implement this system;
• Establish cooperative procedures to assist member-states in implementing the agreed safety and security standards and in establishing regulatory bodies;
• Require member states to comply fully with the convention's safety and security standards within five years of joining;
• Call for regular conferences where member states report on the development and implementation of their domestic regulatory systems and answer other countries' questions regarding their compliance;
• Create a small secretariat staff in the Department of Disarmament Affairs at the United Nations to organize the review conferences and to facilitate implementation; and
• Require member-states to terminate all commerce and scientific exchanges in the field of biotechnology with any state that does not join the convention within five years of its entry into force.
The Hart Senate Office Building was closed for 95 days for anthrax decontamination. It reopened on January 22.
For several years, some members of the Nonaligned Movement (NAM)–including China, India, Pakistan, and Iran–have sought to link compliance with the bioweapons treaty to greater access to dual-use biotechnology equipment and materials for developing countries. These countries have also wanted to disband the Australia Group, which aims to prevent transfers of such technologies to countries suspected of pursuing chemical or biological weapons. During the development of a biosecurity convention, the NAM states might try to link their acceptance of the new treaty to the elimination of export-control arrangements, as they did during BWC protocol negotiations. Such a quid pro quo would be unacceptable to the United States and other Australia Group members.
This problem could be avoided if the Western group of industrialized states negotiated the biosecurity convention, and then opened it to accession by other states. The drawback, of course, is that states like Brazil, China, Indonesia, Iran, Mexico, and Russia have pathogen collections that would not be covered, at least initially, and bioterrorists could simply focus their procurement efforts on those countries.
A second approach would be for the Western industrialized states to agree on a narrow negotiating mandate and then open the negotiation on an ad hoc basis to any state willing to accept it, while resisting efforts to link the biosecurity convention to other sensitive issues. This model would be similar to the negotiation of the 1997 Ottawa Convention on Landmines.
Enhanced domestic and international security through a new biosecurity convention will require U.S. presidential leadership. In the early 1970s, President Richard M. Nixon earned worldwide respect for his decision to terminate the U.S. offensive biological warfare program and to negotiate the BWC. Leading a global campaign to prevent bioterrorism would garner President Bush similar acclaim, to the benefit of the nation and the world.