1. 1-0200 Biosafety Program Development Presented by: Lisa Wisser, CIH AIHCE - June 6, 2001

2. 1-0200 Outline  Who Needs a Biosafety Program?  Program Elements  Program Management

3. 1-0200 You Need a Program When...  You use Risk Group 3 or 4 agents  Otherwise: –Are you using Risk Group 2 agents or materials? –…in high concentrations or large quantities? –…in aerosol generating procedures?

4. 1-0200 You Need a Program When...  Regulators insist –OSHA - Bloodborne Pathogens –CDC - Select Agents and Toxins –NIH - Recombinant DNA –USDA APHIS - Plant Pathogens

5. 1-0200 You Need a Program When...  No matter what agents or materials are used: –One of your employees develops a laboratory-acquired infection –Your researchers disregard standard microbiological practices or lack training in microbiology –Your customer requires a program

6. 1-0200 CDC Maximum Containment Laboratory, Atlanta

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8. Biosafety Program Goals  Assist laboratory research and support personnel in working safely with biological agents and materials  Meet regulatory requirements and guidelines  Provide a competitive advantage to the organization

9. 1-0200 Go! Tools Committee Needs assessment Management support Program Development

10. 1-0200 Go! Tools Committee Needs assessment Management support Program Development

11. 1-0200 Program Elements  Management support –Laboratory management n Responsible for safety in the laboratories –Facility management n Facility maintenance and improvement –EHS management n Technical support n Program coordination

12. 1-0200 Program Elements  Needs Assessment –Listen to the research staff –Facility walkthrough n Inspection form n Keep records and follow up follow up n Report to Committee

13. 1-0200 Program Elements  Needs Assessment –Survey n Mail, e-mail, in person, etc. n Who works with what where –Records review n Training - identify needs such as emergency and spill response, waste handling, hazard identification, and exposure control n Medical Surveillance

14. 1-0200 Program Elements  Institutional Biosafety Committee (IBC) –Members n Principal Investigators / Microbiologists n Occupational Physician n Biosafety Specialist n EHS Team / Emergency Response n Other Specialists

15. 1-0200 Program Elements  Institutional Biosafety Committee (IBC) –Procedures –Risk Assessment n Pathogens n rDNA n Select agents n Human blood and tissues n Other hazards

16. 1-0200 Program Elements  Institutional Biosafety Committee (IBC) –Coordinate with other committees n Animal Care and Use n Human Subjects Review n Radiation Safety n Laboratory Safety

17. 1-0200 Program Elements  Tools –Biological Use Authorization Form n Researcher information n Agents/materials used n rDNA information n Work description n Others… –Renewal period - e.g., 2/3 yrs

18. 1-0200 Program Elements  Tools –Database n Track BUAs n Agents/materials n Researchers n Laboratories n Others

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20. Program Elements  Tools –Develop standard procedures, such as: n Standard microbiological practices n Sample receipt and handling and handling n Decontamination n Waste handling n Packaging and shipment shipment

21. 1-0200 Program Elements  Tools –More standard procedures... n Biological safety cabinet use and maintenance n Spill and emergency response n Ventilation requirements n Sharps n PPE

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23. Program Elements  Go! –Beta test –Roll out to all identified on database n Communicate expectations n Train on procedures –Offer extensive help n Resources - person to answer questions, web resources, web site, forms, etc.

24. 1-0200 Program Elements  Go! –More on training n introductory laboratory biosafety n annual BBP and biosafety refresher n IBC procedures n specialized situations - new lab work n emergency response

25. 1-0200 Program Management  Responsibilities –Researchers –IBC –Biosafety Officer  Processes –Medical surveillance –Training –Safety procedures –Spill response –Emergency response –Periodic program review

26. 1-0200 Program Management  Elements –Audits and inspections –Quarterly reports to IBC –Ongoing communication with other committees –Regulatory compliance - BBP, select agents, medical waste, rDNA, BMBL

27. 1-0200 Summary  Evaluate what you need in a “program”  Roll out the program in a logical sequence  Ensure consistent program management

28. 1-0200 Useful Resources  http://www.cdc.gov/od/ohs/default.htm (CDC OHS)  http://www.cdc.gov/od/ohs/biosfty/bmbl4/bmbl4toc. htm (BMBL)  http://www.cdc.gov/od/ohs/lrsat.htm (LR/SAT)  http://www4.od.nih.gov/oba/rdna.htm  http://www.absa.org/  http://www.hhmi.org/  Biological Safety, Principles and Practices. 3rd edition. Ed. by D. O.Fleming and D. L. Hunt. ASM Press.