12/18/96 13:48 To: Joshua Lederberg From:Susan Blanchard 202-797-4866 Page 3/6

BIOLOGICAL DEFENSE PROJECT SUMMARY AND STATEMENT OF PURPOSE

It has long been recognized that the 1972 Biological Weapons Convention needs to be
strengthened in order to be made more reliably effective. The convention formally prohibits the
preparation and actual use of biological agents for offensive purposes but necessarily allows the
development of defensive and therapeutic measures. With regard to research and development
activities, the distinction is inherently difficult to draw, and there are no generally agreed standards for
doing so. Moreover, there is an unresolved legacy of suspicion that is currently compounding the
inherent difficulty. The military establishments that have historically been most intensely involved in
investigating the potential of biological agents as instruments of warfare have been unable to establish
a working presumption of mutual compliance with the BWC. In particular, there is a serious dispute at
the moment between Russia and the United States. Russia firmly maintains that the offensive
development program acknowledged to have been conducted by the Soviet Union has been terminated
and that Russia itself has never violated the convention. The United States does not accept that
assurance. Efforts to arrange a program of mutual inspection of facilities that might help to resolve the
issue have not succeeded, and those who have been involved in that official effort are pessimistic about

the prospects.

In response to this situation the United States National Academy of Sciences is attempting to
develop a collaborative initiative with Russian colleagues that is intended to provide a constructive
basis for resolving the historical problem and for generally strengthening the BWC. The basic idea ts
to design an institutionalized arrangement foxConducting joint research and managerial oversight of
the most dangerous human pathogens. The arrangement would be primarily directed to the public
health problems associated with these pathogens but would also provide the most promising basis for
assuring effective implementation of the BWC.

The specific initiative being undertaken will outline a program of joint research designed to
enhance the protection of human populations against any naturally occurring or deliberately induced
outbreak of the diseases caused by the pathogens in question, and it will conduct a small number of
specific joint projects with Russian colleagues designed to demonstrate the benefits of combining the
established expertise of the two countries. The initiative will also outline the institutional provisions
that would be required to sustain systematic research collaboration, to provide for joi reaction to any
actual outbreak of the diseases of concern, and to establish common regulatory practices for
preventing deliberate misapplication of the critical pathogens.

THE BASIC DESIGN

The idea for this initiative is derived from an appreciation of the special difficulty and special
opportunities that arise in attempting to control the danger of biological weapons.

The special difficulty emerges from the fact that biological agents unlike standard weapons are
generated naturally. In the first instance, their existence does not depend on a design bureau or a
manufacturing organization. Moreover, most of the relevant information about biological agents is
generated by medical science and is inherently and unavoidably available throughout the world. So are
the pathogens themselves. As a result, dangerous development and production activities could in
principle be undertaken in virtually any country with small scale operations that are readily concealed.
These features of the situation preclude reliance on a system of control patterned on those developed,
for example, for fissionable materials or for major items of military hardware. Security classification
of information and the licensing of access to materials are not reliable means of controlling biologigaf
agents.
12/18/96 13:48 To: Joshua Lederberg From: Susan Blanchard 262-757-4006 Page 4/6

There are, however, some advantages. Biological agents are not the weapons of choice for
tactical application by a fundamentally capable military establishment. Whatever questionable
activities might have occurred historically in what is now Russia or in the United States, there is no
reason to believe that either of their military forces ever made such an extensive commitment to the
development of these weapons or ever developed such an important operational reliance on them that
effective eradication of residual offensive capability is the equivalent of radical surgery. In reality both
societies and both military establishments are far more plausibly threatened by small state or terrorist
use of biological agents than they are by each other. They therefore have a common security as well as
public health interest to build upon. Moreover, in the international community as a whole, there is a
general aversion to biological weapons that provides a potentially powerful attitudinal foundation for
the BWC. Since no country or organization can afford to be truly ostracized in the globalizing
economy, operational rules and the incentives to uphold them can be quite effective when they are
based on a broadly accepted moral and legal standard. And finally anyone who works with the most
dangerous pathogens and survives the experience will have to have had some exposure to advanced
training and therefore to the scientific community that conducts the training. As well as conveying
relevant information the scientific community can embody consequential norms.

In advancing an arrangement appropriate for the problem, the NAS initiative proposes to place
primary reliance on a set of rules that would be established among practicing research scientists who
would also be the principal agents of enforcement. The central provision of the BWC -- a categorical
prohibition on offensive application of biological agents -- would be promulgated as a legal and
professional obligation of all scientists and research workers authorized to deal with the designated
pathogens. Anyone so authorized would be obliged to register with an oversight institution and to
declare the basic purposes of their research activities. The same institution would record all known
strains of the designated pathogens -- information that is particularly important for preparing
preventive and therapeutic measures. It would also establish procedures for collaborative reaction to
any actual outbreak of the diseases in question. The oversight institution would be established in the
first instance by Russia and the United States with the intention of ultimately making it a global
arrangement.

Such an arrangement would extend responsibility for compliance with the BWC down to the
individual level and would build up a set of basic standards and transparency procedures designed to
reinforce and protect this fundamental responsibility. It would aspire eventually to encompass all
individuals who handle the designated pathogens and to make any unregistered activity ipso facto
illegitimate. The oversight organization would be responsible for recording information rather than
issuing approval or undertaking direct enforcement, but it would develop guidelines for safe and
responsible practice that the participating governments would act to uphold. The scheme might be
characterized as organized and transparent self-enforcement.

The principal incentives that the oversight institution would have at its disposal would be
positive in character. It would be a principal channel of financing research work on the disease
pathogens and also the basic repository of information on strain variations. Access to financing and
information would depend on compliance with the institution’s basic guidelines. Presumably
provisions would have to be made for the institution to initiate remedial action in instances where there
is evidence that its guidelines are being violated, but negative enforcement actions - changing the
directing personnel of a research institute, for example, or prosecuting individuals -- would remain the
responsibility of the relevant government. In instances where some government appeared to be the
source of violation, the oversight institution’s standards reflecting general public health interests
would provided the basis for the participating governments to organize effective sanctions.

wad wesc fo emtatns’ GAL,

2
12/18/96 13:48 To: Joshua Lederberg From:Susan Blanchard 202-797-4886 Page 5/6

CENTRAL ISSUES

There are a number of demanding issues that would have to be resolved if this basic idea were
actually to be adopted and implemented. In presenting its report on the question, the NAS committee
appointed to undertake the project will attempt to advance reasonable judgments on the following
questions:

1) What pathogens require special handling?

Many thousands of human, animal and plant pathogens have been identified, but only a

relatively small number of these have the potential to be used as casualty Saleh

that do pose this danger share the characteristics that they Sega . eat Ye

hosts, have a high rate of infection, are lethal to a high proportion of those infected, and have a ~ -
relatively rapid progression of disease. The thought is that some 30 to 50 pathogens can be mw Hardt
distinguished by these criteria as requiring the special arrangements supa with chnaae
contingency provisions made for new ones that might be identified. 7

2) Can the public health and national security functions be effectively combined?

In essence a fully developed arrangement would integrate public health and national security
functions for the special disease categories. To be effective the oversight institution would
have to enlist the cooperation of CDC and USAMRIID in the United States and the
corresponding agencies and research institutions in Russia. That in turn would be a significant
organizational innovation in both countries, requiring a different conception of the basic
problem and more extensive coordination than appears to have been practiced up to this point.
The combination of national security and public health functions makes sense if it is accepted
that the primary threat is to civilian populations. The historical assignment of BW defense
functions to the military implicitly assumed that the primary threat was to military forces.

3) What is an appropriate budget for the oversight activity and from what source would it be
provided?

It is presumed at this point that the oversight organization would have a governing board
routinely meeting perhaps at quarterly or six month intervals with an executive director and a
small permanent staff. In the initiating phase the board would be appointed by the Russian and
the United States governments and would in tum appoint the executive director who would
hire the staff. The staff would include both American and Russian nationals. There would

have to be office locations in both countries. Most of the budget would be expended on
research grants carried out by established research institutions in Russia and in the United
States. There would have to be provision in the budget for periodic training of teams prepared
to react to any disease outbreaks, but presumably any major actual exercise of that sort would
have to be financed from the regular operating budgets of the two governments.

In the course of the project the NAS committee expects to develop rough estimates of what an
organization of this sort should cost and the main determinant will be the scope of the research
effort that ought to be sustained. At the moment it is imagined that the appropriate amount
would be on the order of $10 million per year jointly provided by the Russian and United
States governments.
12/18/96 13:48 To:Joshua Lederberg From:Susan Blanchard 202-797-4066 Page 6/6

5) What is the appropriate sequencing and proportionate burden for developing the
organization?

It is important that the oversight organization operate from the start on principles of full
reciprocity and that its costs and benefits be equitably shared. As a practical matter, however,
it seems probable that during an initial phase the United States would have to provide a
disproportionate share of the financing. The final report will suggest a schedule for developing
the institution that balances considerations of equity and practicality.

6) How is assurance of compliance to be achieved?

One of the major dilemmas in developing the suggested arrangement is determining the level
of confidence in BWC compliance that must be established at cach stage in the process. A fully
matured arrangement would provide cumulatively improving assurance that the participating
governments were not harboring illegitimate activities of any serious significance. There is
unlikely to be any feasible means, however, of establishing a very high standard of confidence
instantly. Despite that reality, there is a tendency in the American political system and
potentially in the Russian one as well for elected officials to insist on unimpeachable assurance
as a precondition for systematic collaboration rather than as an eventual result. In particular
legislators appropriating financial support will predictably insist on credible provisions for
preventing research results and registered information from being diverted to offensive
purposes.

The project will attempt to devise appropriate measures of reassurance for this situation and
will attempt to suggest a practical schedule for implementing them. At the moment it is
imagined that these would rely primarily on agreed transparency rules. Presumably there will
have to be some connection between the size and scope of the joint research effort that is
undertaken and the completeness and robustness of the transparency miles. The basic objective
in this regard is to provide enough confidence at the start to be able to initiate the collaborative
process that is expected to provide high confidence over time.