During July 10-13, 2011, 68 participants from 32 countries gathered in Istanbul, Turkey for a workshop organized by the United States National Research Council on Anticipating Biosecurity Challenges of the Global Expansion of High-containment Biological Laboratories. The United States Department of State's Biosecurity Engagement Program sponsored the workshop, which was held in partnership with the Turkish Academy of Sciences. The international workshop examined biosafety and biosecurity issues related to the design, construction, maintenance, and operation of high-containment biological laboratories- equivalent to United States Centers for Disease Control and Prevention biological safety level 3 or 4 labs. Although these laboratories are needed to characterize highly dangerous human and animal pathogens, assist in disease surveillance, and produce vaccines, they are complex systems with inherent risks.

Biosecurity Challenges of the Global Expansion of High-Containment Biological Laboratories summarizes the workshop discussion, which included the following topics:

• Technological options to meet diagnostic, research, and other goals;
• Laboratory construction and commissioning;
• Operational maintenance to provide sustainable capabilities, safety, and security; and
• Measures for encouraging a culture of responsible conduct.

Workshop attendees described the history and current challenges they face in their individual laboratories. Speakers recounted steps they were taking to improve safety and security, from running training programs to implementing a variety of personnel reliability measures. Many also spoke about physical security, access controls, and monitoring pathogen inventories. Workshop participants also identified tensions in the field and suggested possible areas for action.

Contents

• THE NATIONAL ACADEMIES
• COMMITTEE ON ANTICIPATING BIOSECURITY CHALLENGES OF THE GLOBAL EXPANSION OF HIGH-CONTAINMENT BIOLOGICAL LABORATORIES
• COMMITTEE ON INTERNATIONAL SECURITY AND ARMS CONTROL
• BOARD ON LIFE SCIENCES
• Preface and Acknowledgments
• OVERVIEW
  • DETERMINING AND ADOPTING APPROPIRATE SAFEGUARDS
  • SAMPLE AND STRAIN TRANSPORT
  • NATIONAL REGULATIONS
  • LABORATORY PLANNING
• 1. INTRODUCTION
  • BACKGROUND
  • WORKSHOP STRUCTURE
  • THE FUNCTION AND EVOLUTION OF BIOCONTAINMENT LABS
  • STANDARDIZING BIOSAFETY
  • FUTURE TRENDS
• 2. FRAMING THE ISSUE (PLENARY SESSIONS)
  • OPENING REMARKS
  • PART 1 THE FUNCTION OF HIGH-CONTAINMENT LABS AND FACTORS ENCOURAGING AND CONSTRAINING THE CREATION OF NEW LABS
  • PART 2 THE CURRENT STATUS AND OPPORTUNITIES FOR THE FUTURE
• 3. ASSESSMENTS OF NEEDS, CHALLENGES, AND RESOURCES (PLENARY SESSION)
  • PLENARY PRESENTATIONS
  • DISCUSSION
• 4. AVAILABLE RESOURCES, REGULATIONS, AND GUIDELINES (PLENARY SESSION)
  • PLENARY PRESENTATIONS
  • NATIONAL RESOURCES, REGULATIONS, AND GUIDELINES: SUMMARIES OF COUNTRY OVERVIEWS
  • DISCUSSION
• 5. PATHS FROM ASSESSMENTS TO FUNCTIONAL LABS (BREAKOUT SESSIONS)
  • BREAKOUT SESSION 1: EASTERN ASIA
  • BREAKOUT SESSION 2: AFRICA
  • BREAKOUT SESSION 3: EASTERN EUROPE AND WESTERN ASIA
  • SYNTHESIS OF BREAKOUT GROUP DISCUSSISONS
• 6. PUBLIC HEALTH NEEDS: COSTS, EFFECTIVENESS, AND BIOSAFETY REQUIREMENTS FOR DIAGNOSTIC PROCEDURES (BREAKOUT SESSIONS)
  • BREAKOUT SESSION 1: HUMAN DISEASES PART 1
  • BREAKOUT SESSION 2: HUMAN DISEASES PART 2
  • BREAKOUT SESSION 3: ANIMAL AND LIVESTOCK DISEASES
• 7. IDENTIFYING AREAS FOR POSSIBLE ACTION (BREAKOUT SESSIONS)
  • BREAKOUT SESSION 1: DETERMINING NECESSARY AND APPROPRIATE PRECAUTIONS
  • BREAKOUT SESSION 2: IMPROVING ORGANIZATIONAL CULTURE AND PRACTICES
  • BREAKOUT SESSION 3: DESIGN AND OPERATIONAL OPTIONS FOR IMPROVING SUSTAINABILITY, BIOSAFETY, AND BIOSECURITY
• 8. REQUIREMENTS FOR AND CHALLENGES ASSOCIATED WITH BSL-4 LABS (PLENARY SESSION)
  • PLENARY PRESENTATIONS
  • DISCUSSION
• 9. CONCLUDING PLENARY DISCUSSIONS: MAJOR THEMES AND NEXT STEPS
  • TRANSITIONING FROM BIO SAFETY LEVEL-BASED TO FULLY RISK-BASED PRECAUTIONS
  • IMPORTANCE OF COLLABORATION
  • STRATEGIES TO AFFECT IMPROVEMENTS
• ABBREVIATIONS AND ACRONYMS
• REFERENCES
• APPENDIX A WORKSHOP AGENDA
• APPENDIX B COMMITTEE, PARTICIPANT, AND STAFF LIST
• APPENDIX C COMMITTEE, PARTICIPANT, AND STAFF BIOGRAPHIES
• APPENDIX D DESCRIPTION OF TOUR OF PENDIK VETERINARY CONTROL AND RESEARCH INSTITUTE
• APPENDIX E COUNTRY AND REGION OVERVIEWS

Rapporteurs: Alison K. Hottes, Benjamin Rusek, and Fran Sharples.

This study was supported by Contract/Grant No. STAT-8740 / S-L-MAQM-08-CA-140 and STAT-6253 / S-LMAQM-09-GR-056 between the National Academy of Sciences and the United States Department of State’s Biosecurity Engagement Program. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the authors and do not necessarily reflect the views of the organizations or agencies that provided support for the project.

NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance.