Federation of American Scientists Working Group on BW Verification

AEROSOL TRIGGER

December 1998

Rationale

A BWC compliance regime should require declaration of dual-use capabilities that could be used for purposes prohibited by the BWC. The capability for certain kinds of aerosol work is one of the most important discriminators for potentially illicit activities because aerosol work is critical to BW development and has relatively few peaceful purposes. Aerosol studies are a "choke point" at which legitimate and illicit activities with microorganisms or toxins often begin to diverge. Declaration of aerosol capabilities, contributing to their transparency, is therefore particularly important for establishing confidence in compliance.

Criteria to trigger an aerosol declaration should include concrete, objective criteria for aerosol capability, i.e., equipment and materials, as well as the actual conduct of aerobiological studies. Both types of criteria are needed, because concrete signatures for aerosol work may not be easily identifiable or may be readily hidden. The possibility that concrete evidence might be discovered, however, would encourage accurate declaration of aerobiological work, which otherwise might be easy to deny.

Linking aerosol declaration to other triggers is not adequate because aerosol work could readily be separated physically from production or BW defense programs and thereby escape declaration. Aerosol work with simulants or new agents as well as listed agents is relevant and should also be declared.

Like all triggers for declarations, the aerosol trigger must capture legitimate, peaceful capabilities that could potentially be misused for prohibited purposes. We suggest the following criteria for aerosol declaration.

Proposed Criteria for Aerosol Declaration

A facility or site must be declared if any of the following three criteria apply:

1. Aerosol work is conducted with any microorganism, toxin or simulant.

This criterion covers work with aerosols of human, animal and plant agents and simulants; It covers this type of work regardless of whether it involves exposure of animals or plants; and It applies not only to facilities but also to field test sites for open-air release of aerosols of any microorganism, toxin or simulant.

Exception: open air use for pest control.

This exception would exclude the actual open-air use of microorganism or toxin aerosols for controlling plant pests, disease vectors and other environmental pests. However, aerosol work involved in research, development or testing of pest control agents would be declarable.

Possible additional exception: exposure of rodents to aerosols of microorganisms, toxins or simulants using nose-only equipment accommodating fewer than [20] rodents.

This exception would exclude the most common use of aerobiology in medical research. The exposure of small numbers of rodents is "dual use," however, and could play a significant role in BW development.

2. Fine milling, spray drying, and/or microencapsulation of any microorganism or toxin is conducted; or finely powdered and/or microencapsulated microorganisms or toxins of any kind are present.

Exception: the presence (but not the preparation) of finely powdered and/or microencapsulated microorganisms when intended for and appropriate for open-air use for pest control.

3. An aerosol chamber having a capacity of one cubic meter or larger, or any explosive aerosol test chamber, or any system or device for nose-only, partial or full aerosol exposure of animals is present.

Exception: devices for use in delivering aerosols of pharmaceuticals to individual humans or animals for medical treatment.

Exception: devices for nose-only aerosol exposure of fewer than [20] rodents.

Summary of Exemptions from Aerosol Declaration

1. The actual use of aerosols of microorganisms or toxins for open-air pest control, and the aerosol generators and agents (even if milled or microencapsulated) appropriate for this use.

2. Equipment for nose-only exposure of fewer than [20] rodents to aerosols of any kind; and, possibly, the use of such equipment with biological aerosols (see discussion under Criterion 1).

3. Devices for use in delivering aerosols of pharmaceuticals to individual humans or animals for medical treatment.

Definitions

â "Microorganism" means any microorganismb, killed or alive.

â "Finely powdered" means in the form of fine particles of which a significant [specified] fraction are smaller than 10 microns in diameter. Such particles can be produced by fine milling or spray drying.

â "Fine milling" means milling to produce a "finely powdered" product.

â "Respirable aerosol" means a fine mist or spray of droplets or particles, a significant fraction of which have a diameter of less than 10 microns.