Under a BWC Compliance Regime
July 1996, Revised December 1997
Transparency
Most activities relevant to the BWC are dual-use and cannot, per se, be categorized as permitted or prohibited. Therefore, the modus operandi of a compliance regime, within a legally-binding protocol to the BWC, must be transparency. A regime designed to provide transparency in dual-use capabilities will significantly deter non-compliance by imposing a risk of discovery and increasing the costs of clandestine operations. It will facilitate the assessment of compliance, reduce the number of sites that raise questions, and provide a basis for vigilance, precautions and political action in cases where the requirements for openness are not met.
Objective Criteria
In a regime requiring increased transparency, objective criteria for the elements that provide transparency are desirable. Objective criteria can readily be specified for dual-use capabilities, but they are harder to establish for activities, which are transitory and readily changed, and therefore are difficult to verify. The regime will be more effective and less controversial if it is based primarily on capabilities rather than activities.
Facility and Program Declaration Triggers
Criteria
To increase transparency, the triggers for declaration and the data to be provided in the declaration form must elicit information that was not readily accessible before. Triggers must not be chosen to select only ideally-contained, conveniently-scaled operations that have obvious BW capabilities. Although these have frequently been the focus of discussion, unconventional facilities may be of greater concern. As a rule of thumb, triggers should be based on features that would cause concern if covert. They must be appropriate for both industrially developed and less developed regions.
Declaration triggers should be selected, to the extent possible, on the basis of:
capabilities that could raise concerns if concealed objective verifiability acceptable burden on those affected simplicity and clarity selectivity.
Proposed Facility and Program Declaration Triggers
The following triggers would capture vaccine producers and relevant non-defense military activities and civilian activities, including relevant containment facilities. Genetic modification would be useless as a trigger because it is too widespread and there is no identifying equipment. Questions regarding containment, genetic modification, vaccine production, military or government funding, etc.should be included in the Declaration form.
1. Participation in a biodefense program
2. Presence of a listed agent (exemption: exclusively diagnostic and/or therapeutic facilities, provided that isolates of listed agents are destroyed immediately following diagnosis and no live samples are retained)
3. Microbial production capability greater than 50 liters (including fermentation, tissue culture, and culture in eggs, animals, or plants)
4. Specified aerosol capabilities
5. Field release sites for pathogens or simulants (excluding unlisted plant pathogens)
6. Dual-use biological agent delivery systems (including insect and animal vectors)
7. Transfers of listed agents or equipment (senders and recipients)
Categories 4, 5 and 6 will require careful specification and limitation.
Lists and Definitions
The following lists and definitions, among others, will be needed for facility and program declaration triggers:
definition of "facility" list of priority pathogens (microbial or other biological agents or toxins) list of equipment/materials list of disease vectors definitions of "pathogen" and "simulant"
It will also be considered necessary to define some of the other terms used, such as "microbial production capability," "aerosol capability" and "dual-use biological agent delivery system".
Declarations on Request
Consideration should be given to circumstances under which a State Party could request declaration of an undeclared facility, at the next declaration due date, as an unintrusive form of challenge.
National Declaration Triggers
In addition to triggers for facility and program declarations, the following relevant national information should be declared by States Parties. These declarations would not be subject to inspections/visits for validation.
1. National laws, regulations and programs concerning:
BWC and protocol implementation biosafety and biocontainment trade in dual-use equipment/materials and priority pathogens mass civilian immunization programs civilian BW defense programs
2. Outbreaks of human, animal or plant disease or other impairment caused by or
possibly caused by listed pathogens or newly-recognized ones; and unusual outbreaks caused by unknown agents. These declarations should be submitted to WHO and/or other specified international health agencies. The BWC office handling declarations should keep in close touch with the specified agencies. This trigger is further discussed in the FAS Report on "Investigation of Alleged Use or Release of Biological or Toxin Weapons Agents" (April, 1996), where it is proposed that investigations should be undertaken only on the basis of suggestive evidence that an outbreak is the result of prohibited activity.
Inspections/Visits
Logically, all inspections/visits should be carried out under a single set of rules, which should provide for investigation on short notice pursuant to a specific mandate. The nature of the mandate determines the type of inspection/visit. The measures used should be those necessary to fulfill the mandate with only as much intrusion as is necessary. Managed access procedures must be permissible and protection of confidential information must be a primary consideration. Additional measures and greater intrusion should be employed only for demonstrable cause, if questions arise in pursuing the mandate. Experts agree that much evidence can be rapidly eliminated and that biological inspections/visits should be undertaken as rapidly as possible after notification, preferably within 24 hours. Without short notice and without the ability to follow up onsite observations that raise questions, inspections/visits will not increase transparency or provide any confidence or deterrence and will merely be wasteful of BWC resources.
Onsite Protection of Confidential Information
A permanent, neutral, standing Inspectorate is absolutely critical. Inspectors will need to have both industrial and weapons expertise. Industry and others would vehemently oppose inspectors who were not employed as international servants. Borrowing them would raise serious fears of industrial or military espionage.
States Parties should have the right to refuse access to individual inspectors by registering their refusal in advance; inspectors from States Parties hosting or requesting an inspection/visit should be ineligible to participate; and inspection teams should be selected so that their composition cannot be predicted in advance. These measures will help to minimize the danger of losing confidential information.
Triggers for Inspections/Visits
We propose two triggers for inspections/visits:
1. Request by a State party for an inspection/visit to any declared or undeclared site, with a mandate to investigate a specific concern.
2. Random selection of declared sites by weighted lottery, as suggested below. The mandate would be to validate the accuracy and completeness of declarations, with particular attention to recent onsite changes.
1. Inspections/Visits on Request
If adequate transparency is to be achieved in the eyes of all States Parties, each must have the right to request and obtain an inspection/visit at any site, upon presentation of information relating to its specific concern(s). Only in clear cases of abuse of this privilege should an executive body be empowered to negate a request. It would also be useful if the Inspectorate could request an inspection/visit under the same terms.
2. Random Inspections/Visits
Random non-challenge onsite inspections/visits to validate declarations are essential for the following reasons: Encourage full and accurate declarations and provide a real increase in transparency; Minimize the number of sites of concern; Accumulate information on local standards, in order to facilitate interpretation; Maintain the skills of a neutral Inspectorate; and Distribute the burden of inspections/visits equitably.
An excellent discussion of the need for non-challenge inspections/visits is found in a recent paper by Gordon K. Vachon ("Verifying the Biological and Toxin Weapons Convention: The Role of Visits and Inspections," based on a presentation at the Friedrick Ebert Stiftung, 7 May 1996).
3. Facility Weighting
To ensure timely and accurate declarations, there must be a significant probability that they will be verified onsite. If the probability of receiving an inspection/visit is related to the perceived BW potential, a small number of inspections/visits per year, e.g., 100, would suffice to provide grounds for confidence. This could be arranged through a weighted lottery. Declared facilities could be weighted in the lottery according to weights given the trigger(s) to which they respond. Triggers could be weighted on the basis of their perceived risk. We propose the following scheme:
Lowest weight: facilities triggered to declare only by pathogen possession or microbial production capability.
Higher weights: defense or aerosol facilities, field release sites, or multiply- triggered facilities.
Additional weight increment: facilities nominated anonymously by States Parties, with no implication of non-compliance (see below).
Some possible weight values for these categories, and the resulting likelihoods that an individual facility would receive an inspection/visit, are given in Table I.
4. Anonymous Nomination of Facilities by States Parties
In order further to focus random visits on the facilities of greatest concern, each State Party could be given the right to nominate, anonymously, one declared facility per year; in addition, the Inspectorate could be allotted a quota of nominations. Each nomination would add an increment to the weight of the facility nominated. The process could be carried out automatically by computer so that facility nominations and the resulting weights would never be revealed.
5. Undeclared Facilities
Consideration could be given to the possibility of nominating undeclared as well as declared facilities for the lottery. This would have a high deterrent value.
6. Advantages of the Proposed Weighted Lottery
Concentrates on sites of particular interest, while remaining non-confrontational. Responds to concerns of lesser magnitude than allegations of non-compliance. Effective with a low number of inspections/visits, thereby keeping costs down. Permits flexibility (nominations will respond to changing conditions). "Random" inspections/visits for "validation of declarations" are low-key terms acceptable to commercial establishments.
7. Limitations on Random Inspections/Visits
To prevent inequities, limitations should be set on the number of random inspections/visits that any State Party or any single facility could receive in one year. We suggest:
A total of 100 random inspections/visits per year; No more than two inspections/visits per year at a single facility; For each State party, the number of random inspections/visits should not exceed some fixed percentage of the total number of its declared facilities, or two, whichever is larger.
In order to retain a degree of uncertainty even after a random inspection/visit has taken place, the maximum number per year should not be less than two.
Triggers That Would Constitute Export Controls in the Regime
Export controls are security measures and therefore they form an appropriate part of a compliance regime. Some of the triggers proposed here would serve as export controls that would deter the use of transferred dual-use items for prohibited purposes and discourage surreptitious secondary transfers. This could be done without any restrictions on trade among the participants in the compliance regime.
Incorporation of export controls within the compliance regime would make possible an important incentive for the adoption of a compliance regime: the prohibition of external biological dual-use export controls on States Parties in good standing under the compliance regime (except in cases of total trade embargo). Delaying the lifting of external controls for a period of two years after entry of the protocol into force would allow time to establish "good standing." States Parties would retain the option to require licensing of dual-use transfers, provided that all transfers to participants in the compliance regime were permitted on a non-discriminatory basis. Incorporation of export controls in the compliance regime is discussed in more detail elsewhere.
The following elements would constitute an export control mechanism within the compliance regime:
Transfers and acquisitions of listed priority pathogens and equipment/materials as triggers for declaration. The declarations should contain the following information: the source, destination, approximate quantity and intended use of the items transferred, and information on unfilled requests for transfer. Subsequent declarations by recipient facilities should contain documentation on the fate of individual acquisitions, over a period of years, to control reshipment. Considerable information from both suppliers and recipients could be collected and collated by computer, with appropriate design of declaration forms and software.
Weighted random selection of declared facilities for inspections/visits.
Appropriate weighting of facilities declaring acquisitions would increase the likelihood of their onsite validation. This possibility would deter misuse. Over a period of years the mechanism would provide end-use verification.
Prohibition of transfers of listed items to BWC non-parties.
TABLE 1
Examples of Several Facility Weighting Schemes and the Resulting Probabilities of
Hosting a Random Inspection/Visit
| Facility Category | AssignedWeight | Number of
Facilities
in Category (Estimate) |
Total Weight
in the Category (assigned weight x number of facilities) |
Probability
of Selecting the Category at each draw |
Probability
of Selecting an Individual Facility at each draw |
Yearly
Probability
of
Inspection, Assuming 100 Inspections (Individual Facility) |
I. A simple example (all facilities weighted 1 or 10, with no intermediate weights):
| Facilities with
low weight |
1 |
2,000 |
2,000 |
2/7 |
1/7,000 |
1.4 % |
| Facilities with
high weight |
10 |
500 |
5,000 |
5/7 |
1/700 |
13.3 % |
Sum = 7,000
II. Same as I, with nomination of 50 facilities of weight 10, one nomination each:
| Facilities with
low weight |
1 |
2,000 |
2,000 |
2/7.5 |
1/7,500 |
1.3 % |
| Facilities with
high weight |
10 |
450 |
4,500 |
4.5/7.5 |
1/750 |
12.5 % |
| 50 Facilities
(wt 10) each nominated once |
10 +10 |
50 |
1,000 |
1/7.5 |
2/750 |
23 % |
Sum 7,500
III. Same as II, with one facility of weight 10 nominated 5 times:
| Facilities with
low weight |
1 |
2,000 |
2,000 |
2000/7540 |
1/7,540 |
1.3 % |
| Facilities with
high weight |
10 |
450 |
4,500 |
4500/7500 |
10/7540 |
12.5 % |
| 50 Facilities
(wt 10) each nominated2 once |
10 +10 |
49 |
980 |
980/7540 |
20/7540 |
23 % |
| One Facility
(wt 10) nominated Five Times |
10 + 5 x 10 |
1 |
60 |
60/7540 |
60/7540 |
55 % |
Sum 7,540