Federation of American Scientists Working Group on BW Verification

Declaration Triggers:

Critique of the Rolling Text

September 1998

Subjective vs Objective Triggers

Because of the dual-use problem, compliance or non-compliance with the BWC may often depend on intention, which is difficult or impossible to assess. This is one of the reasons why a compliance regime is needed. In drafting the protocol the concept of intention should be avoided whenever possible. Subjective terminology such as "which would be used to...," "which as their main task are...," "designed for...," "intended for...," etc. can be interpreted in different ways and is likely to cause confusion. Formulation of triggers so that they lend themselves readily to objective corroboration will result in fewer uncertainties about declarations and much greater confidence in compliance.

Transition Period

Appropriate declaration triggers may initially be difficult to implement. Instead of throwing out the triggers that may be prone to transition problems, time should be allowed for adjustment to the new requirements. For example, for the first [4] years after the protocol enters into force, non-challenge visits could be devoted to identifying and solving implementation problems. States Parties and facilities could also request consultations for this purpose. During this grace period, incomplete declarations, when accompanied by a brief explanation of the difficulties, could be followed up with assistance visits or consultations. The BWC organization, the States Parties and the relevant facilities would work together to develop new procedures to make future declarations routine and easy. During the transition period, facilities could inventory agents and equipment, eliminate those that are not wanted, institute better record-keeping practices, and separate BWC-relevant from irrelevant information and activities. Governments could establish procedures for licensing, registering or issuing permits for various kinds of facilities, overseeing the safe handling of pathogens, and managing data for declarations. Planning for managed access could be undertaken. At the end of the transition period, biological activities should be safer and better documented everywhere.

Comments on Individual Triggers

1. BW Defense Programs

To inspire confidence in compliance, all facilities directly participating in a BW defense program should be listed, regardless of the fraction of their activities, time, budget, staff, etc. involved.

All contractors or other facilities indirectly participating in a BW defense program should be listed if they conduct research, development, testing, evaluation, microbial production or production of other biological materials for BW defense purposes. This formulation would exempt contractors for janitorial services, secretarial supplies and so forth. For contractors not captured under another trigger it should be sufficient only to state the general type of work done for the program.

Other criteria for facility declaration under the BW Defense trigger are not needed and should not duplicate other triggers. Questions such as the use of listed agents can be included in the BW Defense declaration form.

2. Vaccine Production Facilities

This trigger should not be adopted unless it captures facilities that would not be captured by any other trigger. There is no need for the protocol to single out certain types of activities, when other types (and some perhaps not yet envisaged) could also be of particular interest. Automated methods for analyzing declarations will make it easy to select facilities of any particular type, regardless of what triggered their declarations.

As this trigger now stands in the Rolling Text, the exclusion of facilities in which "vaccines or toxoids were produced solely in research or development programmes at an earlier stage than phase I or other initial clinical trials" is a loophole that undermines the entire trigger. Furthermore, it is not clear whether such facilities are excluded from declaring under all other triggers, as well.

3. Maximum Biological Containment Facilities

Because BW programs can be carried out without maximum containment, this trigger is useful but not necessarily essential.

Cataloging all the WHO specifications for maximum (BL4) containment as criteria for declaration will eliminate many, perhaps most, facilities working with Risk Group 4 agents. Modifications and adaptations of the basic specifications are widely practiced.

Whether or not containment specifications are adopted as criteria for this trigger, the alternative criteria listed in the Rolling Text, based on the kinds of agents a facility is meant to handle, should also be included in order to preserve the spirit of this trigger--namely, declaration of facilities for handling Risk Group 4 agents.

4. [Work With] Listed Agents

This trigger should be made objective by changing "Work With" to "Possession of" Listed Agents.

Complicated formulations for this trigger are sure to result in misunderstandings and loopholes. All the subcriteria should be questions on the declaration form. Transparency requires declaration of all facilities that simply possess a listed agent; otherwise, stockpiles, even huge ones, would be exempt. The number of facilities with listed agents is not prohibitive. There should be no threshold for agents that can replicate themselves.

Linking the Agent trigger to production is unjustified, because production can readily be carried out at a different site from research, development, weaponization, etc.

Linkage to aerosol studies would limit aerosol declarations to work with listed agents. But aerosol studies are a key choke point in BW development. Declaration of aerosol work with other agents, including simulants, as well as with listed agents will inspire confidence in compliance. There should be a free-standing, unqualified Aerosol trigger.

Instead of linking genetic modification activities to the Agent trigger, genetic modifications and transfers of nucleic acid sequences could be handled more simply and effectively by including them in the List of Agents, as follows: all genetically-modified forms of the listed agents, all microorganisms in which gene[s] from listed agents have been inserted, and all genetic material from listed agents. Because of the usefulness of non-pathogenic strains in BW development (e.g., as simulants), "listed agents" should be defined as including both pathogenic and non-pathogenic strains.

The List of Agents should also include all organisms capable of producing the listed toxins or toxic derivatives thereof. It would not then be necessary to declare small quantities of isolated toxins, since they cannot reproduce themselves. A threshold quantity, below which a facility would be exempt from declaring toxins, should be chosen to exclude most research and medical facilities that work with toxins, but to include declaration of listed toxin stocks sufficient for use in terrorism or warfare. We suggest a threshold of one gram. The threshold value should be revisable.

Culture collections that contain listed pathogens, and all uncharacterized collections, should be declared and their purpose stated, whether or not they are "registered and designated." Not all culture collections are commercial. Culture collections are possible sources for virulent strains.

Facilities that possess active listed agents for testing and evaluation purposes (e.g., food and water testing for contaminants, or testing the efficacy of antimicrobial preparations, vaccines, toxoids or antitoxin immunoglobulin preparations), or for development of diagnostic tests, should be declared. Very few of these facilities have a need for listed agents. These agents are not widespread pathogens and do not have any particular economic interest. Furthermore, active microbial samples are not often needed in testing for contaminants; inactivated samples are usually available and adequate for use as standards.

Exclusions: Exclusively diagnostic or medical treatment facilities should be excluded, provided that listed agents are inactivated immediately after diagnosis and no live samples are retained. The few reference laboratories and other facilities that may require live listed agents should have to submit declarations.

Declaration of the possession of listed agents will result in improved laboratory safety and lower risk of accidental release or acquisition by terrorists. Some countries already require permits for the listed plant and animal agents; human health should be similarly safeguarded.

5. Production Facilities

In general, bio-industry prefers a broad trigger that would not be discriminatory.

Limiting declaration under this trigger to production facilities making specific kinds of products has no value. It is the capability that matters. When needed, expertise for handling BW agents can be brought into a cover facility that normally makes other products but could be converted to produce BW agents if they were wanted for hostile purposes.

Limiting declaration to production facilities with modern containment features is self-defeating. History has shown that elaborate BW programs can be carried out without such features. Modern production facilities, which use self-contained, self-sterilizing equipment for non-pathogens as well as pathogens, should not be singled out because they take extra safety precautions, and facilities that may be willing to risk unsafe practices should not be selectively omitted.

Linking aerosol work or genetic modification to a production trigger is not realistic. These activities are not usually carried out at production sites.

Production threshold: Many experts believe that 50 liters is significant and that a pilot plant would be sufficient for BW production. For pilot plants these days, 100 liters is rather large. The US pharmaceutical industry cites facilities with microbial production capability greater than 100 liters as highly relevant to BWC concerns. We consider 100 liters to be the maximum acceptable threshold, with commensurate thresholds for production in flow bioreactors, eggs and animals. An aggregate capacity of 100 liters should include only vessels of a minimum size or larger (e.g., 10 liters).

A transition period would allow facilities to get rid of unwanted bioreactors and to establish a system for documenting the history of unused reactors being kept in reserve.

Exclusions: The danger in exclusions is illustrated by the exclusion, in the Rolling Text, of the one type of production facility (single-cell protein) that was destroyed by UNSCOM because of its involvement in a BW program! There is a logic to excluding facilities that are in use for producing solely human food or beverages. Facilities for bioremediation or waste treatment, or manufacture of soap, cosmetics, detergents, fertilizers or animal foods (which are listed for exclusion in the Rolling Text), however, would make good covers for illicit activities. An additional problem posed by exclusions is discussed below under the Transfer trigger.

6. Capability for Aerosol Studies

A separate Aerosol trigger is needed. Aerosol studies, both small-scale and in the open air, are critical steps in developing a BW capability. Linking them to the Production trigger is not useful because aerosol work is unlikely to be carried out at production sites. Linkage to the Agent trigger would not cover aerosol work with toxins (below the threshold quantity) or with microbial simulants, which can be used for many purposes. Nor can it be assumed that all relevant aerosol facilities will be captured by the BW Defense Program trigger.

The Aerosol trigger should be based on the presence of an aerosol generator producing droplets in the range 1-5 microns. No capacity limitations are needed; nose cones, aerosol chambers and field release should all be covered. In this droplet range, no exemptions should be allowed. The range would generally exclude agricultural sprayers and nasal drug delivery, which use considerably larger droplets. Testing of industrial products is unlikely to involve lung penetration (which would require droplets in the critical range). Testing of drugs or other substances delivered as aerosols via the lung should be declared.

7. Transfers

The value of Transfer declarations lies in the BWC organization's ability to compare sender and receiver declarations and to track the use of the transferred equipment over time, through future declarations. Equipment types that do not trigger declarations could not be tracked except when sent both from and to facilities declared under triggers unrelated to the equipment. Therefore, broad Agent, Production and Aerosol triggers based on the presence of listed agents, production equipment or aerosol equipment, without further qualification such as linkage to specific activities or products, would be desirable for tracking transfers.

If broad Agent, Production and Aerosol triggers are adopted, the declaration forms for those triggers can request information on transfers of listed agents, production equipment and aerosol equipment and a separate trigger for transfers will not be needed. Any significant exemptions to these three triggers will limit the transfer information available by this route and make a separate Transfer trigger necessary.

8. Outbreaks

Outbreaks of unusual diseases are not readily recognized. They are often confused with endemic diseases. Identifying the syndrome and the causative agent is likely to require expertise that is not widely available. Even when an outbreak is recognized and diagnosed, governments are anxious to avoid the economic risks of reporting. They would have no incentive to report to an organization that could not provide medical help. Thus, the BWC organization is more likely to learn of unusual outbreaks from WHO, which makes all official reports public, than directly from a State Party. Experience under the CBM's supports this prediction.

The BWC organization will also have access to ProMED-mail, the unofficial, publicly available, independent rapid reporting system for outbreaks. ProMED-mail posts responsible reports from all sources, including the media and individuals, unhampered by bureaucratic restrictions. The existence of this global Internet service, which is usually the fastest comprehensive source for outbreak news, makes declaration of outbreaks under the protocol--inevitably a much slower process--unnecessary, redundant and undesirable.

9. Implementation of Article X of the BWC

Annual declaration of measures taken to implement Article X is important as evidence that the State Party takes its Article X obligations seriously.

The BWC organization should be charged with reviewing these declarations annually and making recommendations to each State Party for optimizing its cooperative activities.

10. National Legislation and Regulations

National laws, regulations and other legal measures, standards and recommendations that cover the following subjects should be declared: 1) Safety measures, including containment, immunization and handling practices, for infectious and toxic materials; 2) Quarantine arrangements in case of outbreaks of human, animal or plant disease; 3) Transfers, both national and international, of pathogens and listed equipment; 4) Criminalization of activities that would violate the BWC.

Copies of the relevant documents should be submitted when the measure is declared. The BWC organization should have these, as well as national implementing legislation, on file for every State Party so that they can be consulted on short notice in preparing for a visit or investigation. Knowledge of local standards and requirements will make on-site activities easier for both inspectors and hosts.