Workshop on BSE and vCJD Risks in North America
Pan American Health Organization Headquarters
Washington D.C., July 10, 2008

The goal of the proposed PrioNet Canada one-day workshop was to share North American risk management expertise of Bovine Spongiform Encephalopathy (BSE), variant Creutzfeldt-Jakob disease (vCJD) and Chronic Wasting Disease (CWD) issues. PrioNet Canada is attempting to advance the use of research, basic science, and social science for policy making. PrioNet’s approach is to improve the understanding of emerging prion disease risk issues and to identify approaches for better risk assessment and management of prion diseases. This meeting will allow policy makers from Canada, the United States and Mexico to discuss management issues related to BSE, CWD and vCJD. The multi-stakeholder participants include international scientific experts, decision makers, industry leaders and public interest groups.

The social, economic and financial impacts of Canada’s BSE episode have been nothing short of catastrophic: Ted Haney of the Canadian Beef Export Federation, commenting on the accumulated financial impact of BSE in Canada, said: “We stopped counting at $20 billion”; he noted that those impacts have not yet ended. There is no existing account of the non-financial human impacts. Adding these types of considerations to the risk management framework was one of the main objectives the project to develop an integrated risk management framework for BSE in Canada.

The project addressed the social and policy aspects for BSE. The lack of any information regarding non-economic impacts or impacts to farm producers is a huge gap for policy makers and regulators. To our knowledge this project funded by PrioNet is the only research that is attempting to comprehensively catalogue impacts to producers, families and communities in a way that the results can be incorporated into future decision-making.

A comprehensive risk management framework is one in which all of the major components of this approach have been analyzed and included – specifically, risk assessment, impact assessment (economic, social, regional, trade), public perception of risk, and risk control or risk reduction options. Although the components must be analyzed separately, the results of the analysis must be carefully integrated in order for the benefits of the approach in policy making to be realized. For example, if the risk frequency is properly characterized, but the full range of potential impacts is not, the analysis is incomplete and the results might not be as useful as they could be or even misleading.

Analysis of past cases indicates that risk management decision-making most often fails because some critical decision inputs are either missing entirely or in part, have been carried out inadequately, or have not been delivered when needed. Therefore, the framework needs to be re-examined with a view to determining whether all of the necessary decision inputs are specified; in addition, the separate inputs must be specified, as clearly as possible, in a form that can be readily integrated with all others. For example, the analysis of psychosocial effects and their impacts must be capable of being “rolled up” and “converted” into an operational form that can be assimilated, along with other factors, within a decision exercise. - 2 -

Decisions for public policies should use an integrated risk management framework that incorporates more than the standard scientific assessments of risk. With this in mind, a new BSE Risk Assessment and Management Framework was developed that includes information at the micro (individual), meso (family and community) and macro (national and international) levels. Cataloguing the results and integrating them into an improved framework will allow resources to be appropriately prioritized to better manage the ongoing risks of prion disease.

The prototype risk management framework was completed and includes (i) analysis of farm family focus groups; (ii) country case studies best practices; (iii) BSE risk assessment and modeling; and (iv) a national survey and its analysis.

Thus, the new framework for BSE management, revised in response to earlier challenges, should be designed according to a set of key requirements derived from the study of the development of risk management models in the period after 1983, in the context of the extensive case-study literature that has grown up in the same period. These are:

1. The model must clearly indicate an agency that has “core responsibility” and accountability for a major risk issue, thus satisfying the need for clear accountability, and also show the relation between other domestic and international agencies;
   
   
2. The model must use a sequential decision-making structure, and also show clearly what key inputs are required, thus satisfying the need for clarity and transparency in the decision process;
   
   
3. The model must respond to the need for timeliness in decision-making, by incorporating a requirement for an initial phase of informal risk estimation that precedes the later, more elaborate exercises;
   
   
4. The model must stipulate the operationalization of all decision inputs, in terms of either qualitative or quantitative measures, or both, thus permitting the integration and “rolling up” of all inputs;
   
   
5. The model must be able to show interactions with external stakeholders that are specific in nature, and are related to the generation of equally specific decision inputs;
   
   
6. The model must show clearly the points where the core agency is responsible for communicating risk assessment results to the public and stakeholders;
   
   
7. The model must be sensitive to the dynamics of the interface of science and policy, and in particular, how the risk assessment may be “protected against inappropriate policy influences” (using the mechanism of independent and external peer review for the key analytical documents).

Workshop Agenda

Workshop summary report

Daniel Krewski, University of Ottawa
The Nature of Prion Disease Risks

Michael G. Tyshenko, University of Ottawa
International Country Case Studies

Louise Lemyre, University of Ottawa
Public Perceptions of Prion Disease Risk

William Leiss, University of Ottawa
Integrated BSE Risk Management Framework and Canadian Perspective

Jorge Enrique Jiménez Rice, Mando de Coordinación de la Comision Mexico USA
A Mexican Perspective

Daniel Krewski, University of Ottawa
Summary and Conclusion