Any major turn to the use of biotechnology for hostile purposes could have consequences qualitatively different from those that have followed from the exploitation of earlier technologies. Unlike the technologies of conventional or even nuclear weapons, biotechnology has the potential to place mass destruction capability in a multitude of hands. It should be evident that any intensive exploitation of biotechnology for hostile purposes, whether against combatants, innocent civilians, animals, or crops, could take humanity down a terrible path. After the terrorist attacks on September 11, 2001, it is even more apparent that the next decade will test whether biotechnology, like all major predecessor technologies, will come to be intensively exploited for hostile purposes or whether history will take a different course.

The single most important step to avoiding the exploitation of biotechnology for hostile purposes has already been taken: responsible governments worldwide have forsaken all disease-based weapons. In 1969, President Nixon announced that the United States would unilaterally and unconditionally renounce biological weapons. The U.S. biological weapons stockpiles were destroyed and the facilities for developing and producing them were dismantled or converted to peaceful uses. Three years later, the United States, the Soviet Union, the United Kingdom and many other countries signed the Biological Weapons Convention (BWC), which most have subsequently ratified. The BWC establishes a clear international legal norm prohibiting the exploitation by States of biological agents or toxins for hostile purposes. Our common purpose must be to push for universal adherence to this Convention and strict compliance with its terms -- and to improve upon it in effective ways.

The United States is committed to strengthening the BWC as part of a comprehensive and multidisciplinary strategy for combating the proliferation of weapons of mass destruction and international terrorism. As we work with the international community to find new and effective ways to fight against international terrorism, we would like to explore new ideas -- new in terms of both substance and modalities - – for achieving the objective of strengthening the BWC. We would like to share these ideas with our international partners, and to consult about other approaches they might have for achieving our shared goals.

Our intention is to make positive, creative proposals at the November BWC Review Conference for concrete near-term measures that could be agreed in a final statement of the Conference, as well as for a work plan for follow-on negotiations to address more complex issues that require additional time and attention. The United States Government will be seeking the substantive input of friends, allies, industry, and non-governmental experts into our preliminary ideas for these proposals, with the aim of finding a common way forward.

Conventional wisdom has held that the only meaningful way to strengthen the BWC is through verification measures, such as those which accompany treaties controlling other weapon types. But the changing nature of the BW threat and the dual-use and nondescript nature of BW-capable facilities make it impossible to determine a reasonably bounded set of facilities that would be subject to mandatory declaration and inspection. Efforts to inspect large numbers of facilities in countries whose activities are not in question will only place a burden on industry, academia, and biodefense programs without providing meaningful verification gains. In this respect, biological weapons differ from traditional chemical weapons, and the verification model of the Chemical Weapons Convention (CWC) does not appropriately address the threat that the BWC seeks to eliminate.

We believe that there are sound, effective, and negotiable ways to strengthen the BWC. The key to identifying these measures is to broaden our understanding of what kinds of measures are potentially valuable. By defining the problem and threat more broadly, we open up new avenues for strengthening our overall effort against biological weapons – avenues more responsive to the possibility of the terrorist use of biological agents. Many of these ideas will bear little resemblance to the traditional arms control measures of the past. In addition to the long-standing problem of BW acquisition by determined proliferators, we see five emerging, inter-related dimensions of the long-term biological threat to the security and well-being of all nations and their citizens.

1. Disease Outbreaks. Infectious agents have been the deadliest enemy of mankind throughout human history. States Parties to the BWC have undertaken special responsibilities in the international fight against disease. They have renounced weapons that are intended to cause disease, and have also committed themselves to cooperate in the further development and application of scientific discoveries in biology to peaceful purposes, including the prevention, diagnosis, and treatment of disease. Infectious disease is not just an enormous global health problem; disease outbreaks may be mistaken for a BW attack, and vice versa. In this era of global trade and rapid, high-volume international travel, a disease outbreak can spread worldwide in a matter of days or months. The BWC parties could help address this problem by improving international disease control and establishing mechanisms for sending expert response teams to cope with outbreaks, as well as by dealing with suspicious outbreaks or allegations of BW use. These efforts could not only contribute to strengthening global disease-fighting efforts, but may even help to deter attempts to cause disease deliberately, whether through bioterrorism by non-state actors or through biological warfare by states.
   
   
2. Novel BW Agents. Rapid progress in biomedical sciences and industry opens the prospect that the BW threat of the future could extend well beyond the BW threat of today. The range of possible BW agents will expand dramatically, while abuse of these powerful new techniques could lead to even more harmful biological weapons proliferation or bioterrorism. Agreed international standards may slow the rate at which the BW threat evolves by promoting sound national oversight of genetic engineering, appropriate national criminal laws, and a solid normative/ethical framework for bioscientists. There may also be a role for some forms of international technical assistance in the area of biosafety.
   
   
3. Accidental or Inadvertent Release of Pathogens. The rapid development and dissemination of modern techniques for studying, manipulating, and producing microorganisms not only provides important new economic and health benefits, but also presents potentially serious security challenges. Among these potential challenges is the risk that accidents in handling pathogenic organisms may lead to inadvertent outbreaks of disease. The potential consequences are literally global. Members of the BWC are obligated not only to refrain from using microorganisms for biological weapons themselves, but also to promote responsible conduct in the study, use, modification, and shipment of pathogenic organisms. Biosafety regulations could help address this dimension of the threat, as might an ethical code of conduct. There may also be a role for some forms of international technical assistance in the area of biocontainment.
   
   
4. Bioterrorism and Other Crimes Involving Biological Agents. The delayed onset, environmental imperceptibility, lethality, and sheer frightfulness of biological weapons make the possibility of bioterrorism a national security threat of terrifying proportions. Crimes and terrorism involving BW agents are growing more prevalent, and there are increasing indications of interest in biological weapons by established terrorist organizations. National legislation which criminalizes the activities prohibited by the BWC could help address this threat, as could additional national measures such as a requirement to report the possession of particularly dangerous biological agents. The international regime against biological weapons would be strengthened by a commitment by states to enact national legislation to criminalize the activities prohibited by the BWC as well as an expanded extradition requirement. 
   
   
5. Concerns regarding compliance with the BWC. Given the difficulty of distinguishing between legitimate civil activities and prohibited biological weapons activities, concerns and suspicions are likely to arise on occasion. It may be possible to resolve these concerns and suspicions, and we could consider augmenting international procedures for helping to deal with situations of this sort. Flexible procedures for discussing such issues bilaterally and mechanisms for investigating suspicious outbreaks of disease could help to eliminate unwarranted concerns and thereby help to focus international attention and pressure on determined proliferators.

The ideas we propose to discuss would by no means constitute a panacea to the long-term problem of the hostile exploitation of pathogens and biotechnology. Individually and together, however, they could make positive contributions to important public purposes -- not all of which are strictly about national security -- and to strengthening the BWC through a new multilateral instrument. Below are specific candidate concepts for strengthening the BWC in the following general areas:

1. Measures to strengthen Article IV (national implementation)

1. National criminal legislation supplemented by an enhanced extradition regime
2. Security standards for pathogenic microorganisms
3. Genetic engineering oversight
4. Professional code of conduct

2. Measures to strengthen Article V (consultation and cooperation)

1. Mechanism for investigating suspicious outbreaks of disease
2. Procedures for addressing BWC compliance concerns

3. Measures to strengthen Article VII (assistance to victims) and Article X (technical and scientific cooperation)

1. Biosafety standards
2. Infectious disease control
3. International rapid response teams

In developing these proposals, we have sought to identify measures that: (a) could be agreed in a BWC context, and (b) would be valuable even if they are respected and implemented only by responsible states and are violated by irresponsible states. Fortunately, the vast majority of governments are responsible, and among these states are the world’s leaders in biotechnology and biomedical science.

We do not believe that this is a comprehensive list of potentially valuable and negotiable measures. We invite our international partners, as well as private-sector experts and industry, to develop ideas and concepts of their own. We are committed to extensive consultations with other governments and with non-governmental stakeholders for the purpose of developing an ambitious, detailed, and sophisticated plan for moving ahead.

Article IV of the BWC requires each State Party, in accordance with its constitutional processes, to take any necessary measures to prohibit and prevent anyone from carrying out activities prohibited by the Convention on its territory or anywhere under its jurisdiction. In essence, this requires states to ensure that the prohibitions apply not only to the government itself, but also to individuals under its jurisdiction. The requirement in the BWC is stated in very broad terms and has not been interpreted uniformly. Clearer national standards and clearer national requirements to establish criminal penalties would help to strengthen implementation.

1.(a) National criminal legislation supplemented by an enhanced extradition regime

Some states have implemented the requirements of Article IV through national legislation governing the conduct of individuals. Unfortunately, many states have not taken steps to ensure that individuals who conduct biological weapons activities are subject to specific criminal penalties. A clear requirement for states to do so would help strengthen the implementation of the Convention within States Parties.

U.S. legislation, embodied in the Biological Antiterrorism Act of 1989, provides criminal penalties up to life imprisonment, as well as fines, for anyone convicted of knowingly developing, producing, stockpiling, transferring, acquiring, retaining, or possessing any biological agent, toxin, or delivery system for use as a weapon. The penalties also apply to anyone who assists a foreign state or any organization to conduct any of these activities, or who attempts, threatens, conspires, or aids and abets the commission of these activities. The legislation also provides for extraterritorial Federal jurisdiction over an offense committed by or against a national of the United States.

The prosecutions under the Biological Antiterrorism Act of 1989 to date have related to preparations made by individuals or small groups to carry out terrorist attacks. As a result of the events of September 11, the United States is currently working to strengthen its statutory framework relating to biological weapons. In light of the potential for mass casualties, measures under consideration focus on the critical need to deter and prevent acts of bioterrorism. The U.S. Government is considering legislation which more closely tracks the language of the BWC and more explicitly prohibits the possession of biological agents and delivery systems for other than peaceful purposes.

An important element of a commitment to criminalize biological weapons activities would be agreement by states to enhance their ability to extradite biological weapons fugitives to countries that are prepared to assume criminal jurisdiction. This expansion could be done by amending existing bilateral extradition treaties to add biological weapons offences, and, if their domestic law so permits, to extradite for BW offenses even where a bilateral treaty is not in place with the country seeking extradition. These types of extradition provisions would generally parallel the provisions found in Article 11 of the 1988 Convention for the Suppression of Unlawful Acts against the Safety of Maritime Navigation; Article 6 of the 1988 Convention Against Illicit Traffic in Narcotic Drugs and Psychotropic Substances; and Article 9 of the 1997 International Convention for the Suppression of Terrorist Bombings.

In this connection, the United States notes that under its long-standing law and practice, international extradition from the United States is possible only pursuant to bilateral extradition treaties and not pursuant to multilateral treaties with countries with which we do not have a bilateral extradition treaty. As a result, for the United States such a provision would have the immediate effect of adding BW offenses to its extradition "list" treaties. Dual criminality treaties between the United States and other parties (i.e., treaties that do not rely on lists of offenses) would cover biological weapons offenses as between the United States and any other party that has similarly criminalized biological weapons offenses.

The United States proposes that states agree to enact national criminal legislation as part of their implementation of Article IV of the BWC. The legislation should make it a criminal offense, punishable by imprisonment and fines, for anyone to conduct any activity prohibited by the BWC – namely, to develop, produce, stockpile, or otherwise acquire or retain (a) 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 protective purposes, and (b) weapons, equipment or means of delivery designed to use such agents or toxins for hostile purposes or in armed conflict. In this connection, the United States proposes that states commit to enhancing their ability to extradite fugitives for biological weapons offenses by adding biological weapons offenses to currently available extradition provisions between Parties and, where applicable, by creating a new basis for extradition of such fugitives.

In addition, and separately, the U.S. Government proposes that states agree to consider national legislation which requires that those who possess particularly dangerous biological agents to report their possession to a competent governmental authority.

1.(b) Standards for Security of Pathogenic Microorganisms

In light of attempts by individuals and proliferators to obtain pathogenic microorganisms, the physical security and protection of microbial culture collections and laboratory stocks of human, zoonotic, animal, and plant pathogens is an increasing international security concern. Efforts are underway in some countries to review and upgrade security procedures in light of increased concern about the adequacy of existing practices. The United States, for example, is considering a number of steps to prevent unauthorized persons from gaining access to particularly dangerous microorganisms, including possible restrictions on who may possess or acquire such materials.

Safe transfer of highly pathogenic organisms is closely related to the issue of security. Within the United States, the Centers for Disease Control and Prevention (CDC) regulate the transfer of certain human pathogens and toxins, termed "select agents." (Similar regulations established by the U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS) apply to dangerous plant and animal pathogens.) These regulations allow transfer only between registered facilities which are equipped to handle such agents, and which have a legitimate purpose for them. The World Health Organization (WHO) has also developed guidelines for the transfer of infectious human and zoonotic organisms and diagnostic specimens between registered facilities to meet legitimate needs. The Office of International Epizootics (OIE) has done the same for animal pathogens. The guidelines are applicable to national and international transfers. The WHO guidelines are based on recommendations of the United Nations Committee of Experts on the Transport of Dangerous Goods.

The United States proposes that states commit themselves to: (a) adopt and implement strict national regulations for access to particularly dangerous microorganisms, including regulations governing domestic and international transfers; and (b) report internationally any adverse events, such as accidental release of a highly infectious pathogen from containment, that could impact other countries. States should consider possible restrictions on who may possess or acquire specific organisms that are categorized as particularly dangerous and where they may be handled.

1.(c) Genetic Engineering Oversight

Responding to concerns about the potential risk of certain types of experiments involving the cutting and splicing of genetic material (deoxyribonucleic acid, DNA) in living organisms, a number of countries, including the United States, have established guidelines that specify practices for constructing and handling recombinant DNA, as well as organisms and viruses containing recombinant DNA. These guidelines lay out a framework for assessing risk and assigning appropriate containment and handling practices. The guidelines also describe an oversight structure providing increasing scrutiny commensurate with the risk of a proposed experiment. For example, an experiment involving the incorporation into non-pathogens of genes coding for a toxin would be considered high risk.

Existing guidelines are intended primarily to ensure the safety of laboratory workers and the surrounding community and do not cover possible misuse of this recombinant DNA technology for biological weapons purposes. Types of genetic modifications not covered by existing guidelines may have dramatic and unexpected consequences with relevance for biological weapons. For example, in a well-known recent case, scientists working with mousepox virus inadvertently created a much deadlier virus that kills mice by crippling their immune systems. More comprehensive and stringent national review of genetic modification activities would reduce public health risks and might help isolate and stigmatize efforts to use genetic engineering techniques for biological weapons development. The review could include a determination by existing review committees that there are no weapons applications or that any weapons potential is outweighed by intended peaceful applications.

The kinds of experiments that might raise concerns about biological weapons potential include the following examples: (1) the insertion of genes or genetic elements that enhance virulence or pathogenicity (ability to cause disease), such as the insertion of the Interleukin 4 gene into mousepox, which enhanced its lethality for mice even though the investigator was trying to develop a vaccine; (2) the insertion of genes or genetic elements that enhance or change transmissibility -- for example, by putting the Ebola virus glycoprotein gene into the genetic background of a related and more easily transmitted virus such as Respiratory Syncytial virus (RSV), or putting hepatitis c genes into the virus that causes the tropical disease dengue fever; (3) insertion of genes or genetic elements that alter tissue specificity of the infectious agent or perhaps extend the host range, making a virus or bacterium that might normally be a pathogen for an animal suddenly able to infect humans, for example, changing avian influenza viruses so that they are able to replicate in humans, and (4) imparting antibiotic resistance to a pathogenic bacterium. In the United States, all such experimentation falls under the purview of the Recombinant DNA Guidelines.

Steps should be taken to encourage institutions and individual scientists to consider the implications of their work and its potential for exploitation for biological weapons purposes. While the risk that genetic engineering techniques might be misused for weapons purposes has been publicized in very general terms, little dialogue has taken place among scientists, or between scientists and governments, to clarify what types of experiments might pose the highest risks. Such a dialogue should be initiated in a carefully planned way that minimizes the risk that it would assist proliferators.

The United States proposes that BWC States Parties commit to sensitize scientists working in the field of genetic modification to possible biological weapons implications of such work and to explore what type of national oversight might be appropriate. This effort initially could be conducted within individual States Parties with professional societies, national academies of science, and appropriate non-governmental organizations taking the lead. The result could be recommendations to national authorities for general criteria to be used by existing committees that review proposed experiments.

1.(d) Professional Code of Conduct

A code of ethical conduct for those who do laboratory work with pathogenic organisms could underscore that scientists, clinicians, and laboratory workers have personal responsibility to prevent accidental and deliberate releases of such organisms into the environment. Such a code could be an element within a multi-faceted approach to promoting responsible handling and use of pathogenic microorganisms.

A code of conduct would help sensitize individual researchers to the implications of their work and help stigmatize prohibited biological weapons activities. Moreover, it would encourage the vast majority of ethical scientists to question and report on illegal activities thus strengthening the BWC.

The United States proposes that BWC States Parties commit to support development and adoption of a code of conduct for scientists working with pathogenic microorganisms, perhaps under the auspices of national and international professional societies. Such a code could build on existing ethics codes, such as the code of ethics of the American Society for Microbiology and other similar codes. It could include as a guiding principle, inter alia, a statement that scientists will use their knowledge and skills for the advancement of human welfare and will not conduct any activities directed toward use of microorganisms or toxins for hostile purposes or in armed conflict.

Under Article V of the BWC, States Parties undertake to consult one another and to cooperate in solving any problems that may arise. Consultation and cooperation under this article may take a variety of forms, including bilateral diplomacy or procedures of the United Nations. Apart from this very general commitment, however, the BWC does not indicate any specific consultation mechanisms for dealing with situations that may be considered ambiguous or which give rise to concerns about possible non-compliance. Experience with other international agreements suggests that developing some general procedures for raising and clarifying such situations could help to maintain confidence in the Convention by facilitating resolution of problems at an early stage.

2.(a) Mechanism for Investigating Suspicious Outbreaks of Disease

Any disease outbreak, for which there are reasons to suspect a relationship to illicit biological weapons activity or alleged use, is of concern to all States Parties to the BWC. It is, therefore, essential that States Parties agree to cooperate in investigating all such outbreaks. The "Sverdlovsk Anthrax Outbreak" in 1979 stands out as a dramatic historical illustration of the need for such an international mechanism.

An international mechanism already exists to facilitate such cooperation but it should be strengthened. Beginning in 1980, a series of UN General Assembly resolutions gave the Secretary General the authority to investigate any allegations of BW or CW use brought to his attention by a UN member state. Since this mandate required the consent of the state where the investigation would occur, international teams unfortunately have conducted such investigations only when invited by the hosting state. Although Iran, Mozambique, and Azerbaijan have permitted investigations, Iraq and Laos have not.

The UN General Assembly mandate for the Secretary General could be strengthened through the negotiation of a arrangement under which states would commit in advance to cooperate in investigating suspicious outbreaks of disease through consultations and, if requested, through access by international experts to the location of the outbreak.

The United States proposes that States Parties agree on the following mechanism for investigation of outbreaks that appear to be related to illicit BW activities or alleged use of BW.

• Any State Party could request any other State Party to clarify and resolve concerns about an outbreak of disease that is potentially related to illicit BW activities or alleged use of BW.

• Any State Party could request an investigation to resolve a concern regarding a suspicious outbreak of disease (e.g., accidental release of agent by an illicit BW production facility) or alleged BW use in violation of the Biological Weapons Convention or the BW use provisions of the 1925 Geneva Protocol.

• When requested, a State Party would be required to provide access to the site of the outbreak on a timely basis.

• Investigations would be conducted by an international team, drawn as appropriate from a list of national experts nominated by States Parties, and commissioned by the UN Secretary General, in close consultation with the President of the UN Security Council, to conduct the investigation.

• In order to ensure that the investigation would not jeopardize legitimate national security and commercial interests, all access within an area of investigation would be controlled by the State on whose territory the investigation was taking place. States Parties would agree to cooperate with the investigating team in addressing the stated concern and, if requested access is not granted, to make every reasonable effort to clarify the concern that generated the investigation.

• The team would prepare a factual report that would be distributed by the UN Secretary General to all States Parties.

2.(b) Cooperative Mechanism for Addressing ComplianceConcerns

Although it is impossible to verify compliance with the BWC, it would be useful to strengthen existing international mechanisms for clarifying and resolving concerns that a state may raise. In some cases, the concerns could prove to have been mistaken because they are based on fragmentary or vague information. In such instances, cooperative procedures for resolving compliance concerns could help a state demonstrate its adherence to the BWC, thus reducing the suspicions of other states.

Under Article V of the BWC, states undertake to consult and cooperate in solving any problems that may arise with respect to the Convention. It would be useful to spell out in greater detail possible procedures for doing so to aid states in identifying procedures that have been generally accepted and found useful.

In order to make the provisions of Article V more effective, the United States proposes that States Parties endorse the following procedures:

• Any State Party could request any other State Party to clarify and resolve any matter which may cause doubt about compliance with the BWC or gives rise to concerns about a related matter which may be considered ambiguous.

• The State Party receiving the request should respond promptly and fully, explaining how the information provided resolves the matter.

• States Parties may arrange among themselves by mutual consent for exchanges of information, visits or any other procedures to clarify and resolve any matter which may cause doubt about compliance or gives rise to a concern about a related matter which may be considered ambiguous. Such arrangements shall not affect the rights and obligations of any Party under other provisions of the Convention.

Article VII of the BWC contains an undertaking by States Parties to provide or support assistance to any Party that requests it if the Security Council decides that the Party has been exposed to danger as a result of a violation of the Convention. The aim of this provision is to assure states that other Parties would come to their aid if they were attacked with biological weapons or were threatened with attack. This provision is, however, somewhat narrowly focused, as it requires a decision by the Security Council and agreement by the Council that the Convention has been violated. (Of course, there is no restriction on states voluntarily providing assistance outside the BWC framework.) With several states – including the United States – now actively preparing for the possibility of biological weapons attacks through the stockpiling of vaccines and other pharmaceuticals, it is worth considering how the principle of mutual assistance contained within Article VII should be improved upon.

Under Article X of the BWC, States Parties agree, inter alia, to cooperate in contributing to the further development and application of scientific discoveries in the field of biology for prevention of disease. Recognizing that infectious disease is the enemy of all mankind, this provision complements the Convention’s core prohibition against the deliberate use of disease as a weapon with an obligation to cooperate internationally in the fight against the predations of naturally occurring disease. We can and should, therefore, strengthen the basic prohibition of Article I by reinforcing and implementing fully the scientific and epidemiological commitments of Article X.

The United States takes seriously its obligations under Article X. As President Bush stressed last May in announcing the establishment of a new global health trust fund, the devastation across the globe left by AIDS, malaria, and tuberculosis alone is almost beyond comprehension. Many other diseases make this grim situation even more terrible. The fact that the carnage results from naturally occurring outbreaks, rather than deliberately induced ones, does not excuse BWC States Parties from coming to the assistance of the stricken. Parties have a responsibility to take a global approach to dealing with the threat of disease to human security and well-being.

3.(a) Biosafety Standards

Growing recognition of the risk of accidental release of highly pathogenic microorganisms from laboratories has spurred interest in improving the safety of activities involving such materials. Ensuring safety of laboratory workers, the general public, and the environment is critically important in research involving pathogenic microorganisms and particularly for research involving modern genetic modification techniques. BWC States Parties, who have committed themselves not to deliberately spread disease, also need to make sure that their peaceful activities do not accidentally cause disease.

The WHO Communicable Disease Unit has published a Laboratory Biosafety Manual, a detailed practical guide to essential safety precautions and techniques that should be followed in all laboratories handling infective microorganisms. The U.S. National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC) have also published an extensive manual on proper biosafety procedures and standards. Similar Department of Agriculture guidelines exist for handling plant and animal pathogens. Since publication of the CDC-NIH manual, the number of reported biosafety incidents in the United States has dropped significantly. The WHO guidance is very similar to the CDC-NIH document but is suitable for a wide range of countries.

Internationally, biosafety procedures and practices vary enormously from country to country. Once released, of course, microorganisms do not respect borders. Standardized biosafety procedures for human, plant, and animal pathogens will benefit public health and national security for all countries. Technical assistance in establishing biosafety programs might also be considered.

The United States proposes that BWC States Parties commit themselves to adopt and implement strict biosafety procedures, based on: (a) WHO guidelines or equivalent national guidelines for human pathogens; (b) analogous guidelines for handling animal pathogens based on guidelines issued by the Office of International Epizootics or equivalent national guidelines; and (c) national guidelines for handling plant pathogens.

3.(b) Infectious Disease Control

Epidemiological and laboratory surveillance and disease control activities at the local and national levels provide the main defense against the international spread of communicable diseases. Given the wide disparity in the availability of expertise and resources – and the international benefits of improved public health – infectious disease surveillance and control is a high priority for international cooperation.

The WHO gives high priority to surveillance and response to outbreaks of human and zoonotic infectious disease. It has emphasized development of a "network of networks," which links existing local, regional, national, and international networks of laboratories and medical centers into a super surveillance network. The WHO offers a unique global framework, politically neutral and technically competent, under which national and global surveillance and response networks can efficiently operate in a timely and coordinated way. The Office of International Epizootics offers the same international framework for animal diseases.

Current WHO International Health Regulations require notification for only three diseases – yellow fever, cholera, and plague. The World Health Assembly of WHO has directed that the Regulations be revised. The revision is expected, inter alia, to increase the scope to cover all infectious disease incidents of international importance and enhance disease monitoring and control efforts. Addressing possible intentional use of pathogenic microbes is included in the revision efforts.

The Office of International Epizootics has established a list (List A) containing 15 reportable transmissible animal diseases (of which a few are zoonotic) that: (a) have the potential for very serious and rapid spread, irrespective of national borders; (b) are of serious socio-economic or public health consequence; and (c) are of major importance in the international trade of animals and animal products.

Improved disease surveillance, in addition to its obvious public health benefits, will help to identify outbreaks of suspicious origin, whether due to bioterrorism or other use of biological weapons. This in turn will facilitate efforts to identify the cause of the outbreak, to bring help to the victims in a timely manner, to limit economic impact, and to enforce the BWC.

One possibility is a surveillance and reporting system based on sets of symptoms ("syndromes"), rather than on disease or organism. "Syndromic reporting" would be well-suited to detect outbreaks due to novel organisms or agents engineered for novel characteristics or effects. A WHO pilot study has tentatively concluded that syndromic reporting can be valuable within a national system, but problematic as the only approach in an international regulatory framework. Support for international surveillance for plant and animal diseases should also be increased.

The United States suggests that BWC States Parties commit to support the WHO’s efforts to strengthen the global system for disease surveillance and its capabilities to respond in a timely fashion to assist in controlling disease outbreaks. (Support should also be provided to the Office of International Epizootics and the Food and Agricultural Organization (FAO) for improved surveillance of animal and plant diseases, respectively.)

3.(c) International Rapid Response Teams

In the event of a serious disease outbreak, countries with the means to do so should provide rapid emergency medical and investigative assistance, if requested. States should also be expected to request assistance under circumstances where local resources are clearly not sufficient to contain and eliminate a disease outbreak. In fact, one of the main points in current efforts to revise the WHO’s International Health Regulations is to gain the agreement of countries to report problems and to invite a team coordinated by WHO to enter the country and provide assistance.

The international efforts should take into account WHO standards, guidelines, and "best practices" for the types of procedures, equipment, personnel, and supplies needed in relation to a disease outbreak. Countries could commit to provide certain forms of assistance – or make a more general pledge. This commitment would reinforce and extend the pledge made in the BWC to provide assistance to victims of biological weapons attacks, as well as benefit the afflicted state and the entire international community by helping to ensure that serious disease outbreaks, whatever their origin, are dealt with before they can spread.

The United States proposes that BWC States Parties commit themselves to provide appropriate rapid emergency medical and investigative assistance, if requested, in the event of a serious outbreak of infectious disease and to indicate in advance what types of assistance they would be prepared to provide.

In terms of modalities, our strong preference is to accomplish as much as possible through politically binding commitments in the Review Conference Final Document. Alternatively we could consider one or more legally binding agreements, closely linked to the BWC, that set global obligations and standards, but that generally leave implementation and enforcement to national authorities. Such an agreement (or agreements) could address a wide range of potentially harmful activities associated with pathogenic organisms and aim broadly at preventing unauthorized access, diversion and use of such organisms. The agreement(s) might contain provisions which would:

• commit states to ensure responsible use of pathogenic organisms;

• commit states to enact national criminal legislation to prohibit persons on its territory or in any other place under its jurisdiction from undertaking any activity prohibited to a BWC State Party and to extend this legislation to actions anywhere by its nationals;

• require adoption of national measures to prevent unauthorized access to, or diversion of, specified biological agents, such as appropriate levels of physical protection where specified agents are employed and domestic registration of entities handling specified agents and restrictions on possession or acquisition of these agents;

• commit states to share information regarding any adverse effects that could impact on another state;

• provide mechanisms for investigation of suspicious outbreaks or alleged use of biological weapons;

• require national adoption of appropriate biosafety measures for handling specified agents, including domestic shipment; and

• commit states to provide appropriate assistance in dealing with serious outbreaks of disease.

Additionally, such measures as a professional code of conduct, elaboration of procedures for cooperative clarification of compliance concerns, and strengthened global disease surveillance might appropriately take the form of political commitments, such as provisions in the final document of the BWC Review Conference. States might commit themselves, for example, to support specific relevant activities at the WHO. These new initiatives should be crafted carefully, and appropriate additional resources provided, on a voluntary, extra-budgetary basis, so that WHO’s focus on improving health in developing countries is strengthened, rather than diminished. To help ensure follow up, the declaration should be quite specific about a work plan or other definite action to be taken.

It is important to emphasize that these measures should constitute only one aspect of an overall, multi-disciplinary strategy against the threat of weapons of mass destruction, including most importantly biological weapons. Because these proposals for strengthening the BWC are essentially consensual and reciprocal in nature, we should expect their impact on the threat posed by determined BW proliferators to be at best indirect and attenuated. We will need to address the problem of determined BW proliferators through other, non-consensual elements of an overall strategy, such as export controls and biodefense.