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Building Blocks of Biosafety Management

Building Blocks of Biosafety Management. CSHEMA Regional Conference November 2007. Building Blocks of Biosafety Management. Presenters Denise Donnelly, University of Colorado, Boulder Therese M. Stinnett, University of Colorado at Denver & Health Sciences Center. Learning Objectives.

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Building Blocks of Biosafety Management

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  1. Building Blocks of Biosafety Management CSHEMA Regional Conference November 2007

  2. Building Blocks of Biosafety Management Presenters • Denise Donnelly, University of Colorado, Boulder • Therese M. Stinnett, University of Colorado at Denver & Health Sciences Center

  3. Learning Objectives • Identify potentially infectious & hazardous biological materials in academic and research settings • Identify applicable regulatory compliance schema • Understand the processes for assessing & managing risks in the laboratory • Identify & locate key biosafety resources.

  4. Definitions • Biological Safety, “Biosafety” • Biohazardous Materials • Risk Groups • Biosafety Levels

  5. Risk Groups 1- 4

  6. Biosafety Levels 1 - 4

  7. Animal Biosafety Levels

  8. Plant Biosafety Levels

  9. Regulatory Compliance • Regulatory Compliance Schema • Risk Assessment Schema • Risk Management Schema

  10. NIH Grants Policy Statement • “Grantees are responsible for meeting Federal, State, and local health and safety standards….the following regulations must be followed when developing and implementing health and safety operating procedures and practices for both personnel and facilities:”

  11. NIH Grants Policy Statement • Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (P.L. 107-188) • 42 CFR 73, Select Agents and Toxins Regulations, CDC • USA PATRIOT Act, (P.L. 107-56)

  12. NIH Grants Policy Statement • 29 CFR 1910.1030, Bloodborne pathogens; • 29 CFR 1910.1450, Occupational exposure to hazardous chemicals in laboratories; • and other applicable occupational health and safety standards issued by OSHA, included in 29 CFR Part 1910, and the General Duty Clause

  13. NIH Grants Policy Statement • Biosafety in Microbiological and Biomedical Laboratories, CDC and NIH, HHS • Considered the consensus best practices document and cornerstone of biosafety practice and policy in the United States

  14. Risk Assessment • Who is responsible for Risk Assessment? • How can it best be accomplished? • How to accurately assess risk from initiating the experiments through the waste disposal process?

  15. Roles & Responsibilities • Institutional Level • Institutional Biosafety Committee or equivalent • Biosafety Officer (not always required) • Principal Investigator • Individual Employee/Student

  16. What to Assess? • Refer back to federal, state and local regulations • And your institutional mission—academic, research, & clinical activities

  17. What to Assess • Human blood & bodily fluids exposures • Other types of infectious materials—including potential exposures to animals carrying zoonotic diseases • Any recombinant DNA/RNA materials, including Synthetic DNA/RNA

  18. Where to Assess? • Academic labs • Field studies • Research labs • Clinical settings

  19. IBC • Roles & Functions • How to Prepare for an NIH-OBA Site Visit

  20. IBC – Roles & Functions • Policy – “it is the responsibility of the institution and those associated with it to adhere to the intent of the NIH Guidelines as well as to their specifics.”

  21. IBC – Roles & Functions • Responsibilities of the Institution • Establish and implement policies for safety and compliance • Establish an IBC

  22. Register a New IBC with OBA • Identify members & submit the following information to NIH-OBA • Roster of the IBC with complete contact information for each person & their role   • Biosketches (e.g., curricula vitae, résumé) for every member on the committee    • Cover letter explaining that you are establishing a new IBC

  23. Responsibilities of the Institution • Appoint a Biological Safety Officer (BSO) if conducting BL-3, BL-4, or large-scale research (>10 Liters)

  24. Responsibilities of the Institution • Appoint at least one individual with expertise in plant, plant pathogen, or plant pest containment principles • Appoint at least one individual with expertise in animal containment principles

  25. Responsibilities of the Institution • Additional requirements for recombinant DNA research involving human subjects (clinical trials) • Assist Principle Investigators with compliance to NIH Guidelines

  26. Responsibilities of the Institution • Ensure appropriate training for IBC members and Principle Investigators • Determine the necessity for health surveillance of personnel and if appropriate, conduct a health surveillance program

  27. Responsibilities of the Institution • File an annual report with the NIH Office of Biotechnology Activities • Establish procedures that the IBC shall follow in its initial and continuing review and approval of applications, proposals, and activities

  28. Responsibilities of the Institution • Make available to the public, upon request, all IBC meeting minutes and any documents submitted to or received from funding agencies that those agencies must make available to the public

  29. How to Prepare for an NIH-OBA Site Visit • A current IBC roster identifying the chair, IBC contact person, BSO, animal, plant, and human gene transfer experts, as appropriate • Copies of the IBC members’ biographical sketches

  30. How to Prepare for an NIH-OBA Site Visit • Copies of the minutes for all IBC meetings held in the past two years. • The minutes provided should be the same version that would be made available to the public, if so requested

  31. How to Prepare for an NIH-OBA Site Visit • Copies of emergency plans for handling accidental spills and personnel contamination • Copies of any forms or registration documents used to register recombinant DNA research with the IBC

  32. How to Prepare for an NIH-OBA Site Visit • A list of all recombinant DNA protocols subject to the NIH Guidelines, currently registered with the IBC indicating which section of the NIH Guidelines each registration falls under and the Biosafety Level for which they have been approved

  33. Additional Documentation for an NIH-OBA Site Visit – If Available • IBC standard operating polices and procedures • IBC charter • MOU between the IBC and other institutional oversight committees • Institutional policy for providing IBC meeting minutes to the public

  34. Additional Documentation for an NIH-OBA Site Visit – If Available • All reports of laboratory accidents involving recombinant DNA or violations of the NIH Guidelines occurring in the last 5 years

  35. Additional Documentation for an NIH-OBA Site Visit – If Available • Recombinant DNA-related training program materials • Copies of laboratory inspection checklists and a sample of an inspection report

  36. Training & Delivery of Training • How to use a biological safety cabinet? • How to handle/dispose of waste? • Sterilization/Disinfection/Decontamination • Shipping Materials/Import Permits & Export Administration • On-Job-Training

  37. How to use a biological safety cabinet? • Don’t use volatile or toxic chemicals • Wear appropriate PPE • Turn on cabinet blowers at least 15 minutes before beginning work • Adjust chair height so face is above the front opening • Wait 1 minute before manipulating materials

  38. How to use a biological safety cabinet? • Move arms in/out of cabinet slowly • Never cover any part of the front work surface grille • Perform all work at least 4 inches from the inside edge of the front grille • Only place materials and equipment required for immediate work inside the BSC

  39. How to use a biological safety cabinet? • Don’t use an open flame in the BSC • Wash hands • Decontaminate when work is complete and at the end of the day

  40. How to handle/dispose of waste? • On-Site • Off-Site

  41. Sterilization / Disinfection / Decontamination • Sterilization – “completely free of all living microorganisms and viruses.”

  42. Sterilization / Disinfection / Decontamination • Disinfection – “eliminates nearly all recognized pathogenic microorganisms but not necessarily all microbial forms (e.g., bacterial spores) on inanimate objects.”

  43. Sterilization / Disinfection / Decontamination • Decontamination – “renders an area, device, item, or material safe to handle, that is, reasonably free from a risk of disease.”

  44. Shipping Materials • Infectious substances, human or animal diagnostic specimens, or other biological substances • DOT, IATA, USPS, Private Carriers • Training and Documentation

  45. Import Permits & Export Administration • Import Permits • Export Administration

  46. On-Job-Training • Who is responsible? • Documentation • SOP’s • Biohazard Control Plan

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