1. Controlling Dangerous Pathogens Elisa D. Harris Center for International and Security Studies at Maryland BWC Meeting of Experts Geneva, 19 August 2003

2. Introduction Today’s presentation will focus on mechanisms “to establish and maintain the security and oversight of pathogenic microorganisms and toxins.” Efforts to enhance security have focused largely on controlling access to materials. Efforts to enhance oversight have focused largely on safety. Little attention has been given to broader implications of actual work with pathogens and toxins. Effective action IS possible.

3. Current Approach to Security: Access US –Registration requirements for facilities –Inspections to ensure safety & security –Background checks on those with access UK –Similar requirements for notification, inspections & personnel vetting for facilities Czech Republic –Licensing of individuals handling specified pathogens and toxins

4. Current Approach to Oversight: Safety US –NIH Guidelines provide basis for non-binding oversight of rDNA research; largely local –New bioterror regulations establish legal requirements for two specific categories of rDNA work EU –Contained Use Directive requires prior notification & approval –Similar requirements for Deliberate Release Directive UK –Contained Use Regulation goes further than EU

5. Limitations of Current Approaches Variation across countries Narrow focus on controlling physical access to pathogens/toxins or ensuring safety of work Virtually no attention to broader implications of high consequence work with pathogens and toxins This is not a future problem

6. CISSM Approach Tiered peer review Principles Bottom-up Global Focused Flexible Secure System design Local, National, Global

7. Local Review Body Responsible for overseeing potentially dangerous activities (i.e. those that increase potential for otherwise benign pathogens to be used as weapons) Similar to GM Safety Committees in UK Majority of activities would fall into this category or not be affected at all

8. National Review Body Responsible for overseeing & approving moderately dangerous activities (i.e. those involving pathogens or toxins identified as public health threats) Similar to NIH RAC in US

9. Global Implementing Body Responsible for overseeing & approving extremely dangerous activities (i.e. those that involve or could result in pathogens more dangerous than currently exist) Closest precedent is oversight exercised by WHO for smallpox work in US and Russia Other responsibilities: defining activities, overseeing implementation, administering database, & assisting national governments

10. Conclusion High consequence work with pathogenic microorganisms and toxins is underway throughout the world. Effective action on the security and oversight of pathogens and toxins requires uniform, harmonized rules and procedures across countries. CISSM approach provides one possible way of achieving this goal.