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Meeting Agenda for 11/18/09

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Biosafety Requirements & Resources

IBC Review/Approval & Meetings

Containment categories for commonly used agents

Human Subject Studies that Require IBC Approval

Institutional Biosafety Committee (IBC)

Biosafety Requirements & Resources

• Biosafety Level 1 (restricted access)
• Biosafety Level 2 (restricted access)
• Comparison Chart for Biosafety Level 1 vs. Biosafety Level 2 vs. Biosafety Level 2 plus (restricted access)

 

• Animal Biosafety Level 1 (restricted access)
• Animal Biosafety Level 2 (restricted access)
• Comparison Chart for Animal Biosafety Level 1 vs. Animal Biosafety Level 2 (restricted access)

 

• Biosafety Level 3 - contact Biosafety Officer at X53014
• Animal Biosafety Level 3 - contact Biosafety Officer X53014

ATCC - Searchable catalog of biological materials. Includes risk group assignments for cell lines

CDC/NIH 5th Edition “Biosafety in Microbiological and Biomedical Laboratories"

Health Canada Material Safety Data Sheets for Infectious Agents

National Institutes of Health Guidance for Research Involving Recombinant DNA Molecules  

Risk Group Classifications for Infectious Agents

• Video - Working at Animal Biosafety Level 1
• Video - Working at Animal Biosafety Level 2
• Video - Working at Animal Biosafety Level 3
• Video - Overview of Risk Assessment and Risk Management in Laboratory Animal Biosafety

UR Laboratory-Specific Biosafety Manual Template (Word Version)

Animal Allergies

• UR Guidance for Animal Allergy Prevention
• NIOSH/CDC Alert - Preventing Asthma in Animal Handlers
  

Autoclaves

• Effective Use of Autoclaves

Biohazard Spill Procedures

• UR Emergency Procedures for Biohazard Spills Outside the Biosafety Cabinet

 

Biosafety Cabinets, Laminar Flow Hoods, Tissue Culture Hoods

• UR Requirements for Class II Biosafety Cabinets
• Primary Containment for Biohazards: Selection, Installation and Use of Biological Safety Cabinets

Bloodborne Pathogens

• Susceptibility of Hepatitis B Virus to Disinfectants or Heat
• UR Exposure Control Plan for Bloodborne Pathogens
• UR Fact Sheet for the Hepatitis B Vaccine Series
• OSHA: Bloodborne Pathogens and Needlestick Prevention Guidance
• Hepatitis B Declination Form
  

Flow Cytometry

• UR Biosafety Requirements for Flow Cytometric Activities (restricted access)

IBC Forms

IBC Registration

Laboratory Handling of Monkey Tissue and Fluids

• UR Requirements for Experimental Use of Unfixed Non-Human Primate Tissue and Fluids (restricted access)

Lab Waste

• UR Laboratory Waste Disposal Guidance 
• UR Hazardous Waste Management Unit
• Disinfectants for Biohazardous Materials
  

Other Federal Sites

• Institutional Biosafety Committees
  • What they are, what they do. From NIH-OBA
• NIH guidelines
  • See Appendix B for risk group assignments for Bacteria and Viruses
• Federal Register
  • Searchable database of all federal regulations
• National Science Advisory for Biosecurity (NSABB)
• GeMCRIS
  • Searchable database for Human Gene Transfer studies

Requirements for Handling Live Sheep (or other ungulates)

• UR Requirements for Q Fever Control  (restricted access)
  

Select Agents

• UR Select Agents Program (restricted access)

Shipment, Importation

• U-Florida Site
  • General overview.
• CDC Biosafety Homepage
  • Includes links for shipment of biologicals.
• DOT Guidelines for Shipment of Biohazards
• FAA Website on Hazardous Materials
• USDA/APHIS
  • US government regulatory agency concerned with importation of Biological Materials. Forms online, more
• Suppliers of Dangerous Goods/Infectious Material Shipping Materials and Info
  • IATA - list of manuals and guides
  • Air Sea Atlanta - sells labels, packaging
  • LabelMaster - sells labels
  • SafTpak - sells labels, packaging and a training CD

Shipping and Transportation

• UR Requirements for Transporting Hazardous Samples within Buildings
• Shipping Non-Hazardous Materials (through USPS)
  

State Sites

• New York State Health Rules and Regulations, NYCRR Title 10 Section 61.
  • Search under "recombinant DNA". Note that State and Federal regulations on recombinant DNA are in very nearly complete harmony.

UR Serum Banking Information

UR Sites

• SMH Infection Control
• SMH TB Control
• Resources for Researchers at URMC (Includes links to UCAR, RSRB, ORPA)

 UR Vaccinia Virus Vaccine Information

• Laboratory Acquired Vaccinia Infection
  • Laboratory-Acquired Vaccinia Exposures and Infections - - United States, 2005-2007
  • "The Risks of Vaccinia in Laboratory Workers" by Vincent A. Fulginiti , J. of Investigative Dermatology
  • "Laboratory Acquired Infection with Recombinant Vaccinia Virus Containing an Immunomodulating Construct" by Martin Mempel, G. Isa, N. Klugbauer, H. Meyer, G. Wildi, J. Ring, F. Hofmann and H. Hofmann , J. of Investigative Dermatology
  • "Laboratory-acquired vaccinia infection" by Clifford Wlodaver, G. Palumbo and J. Waner, J. Clinical Virology
  • "Risks associated with vaccinia virus in the laboratory" by Adam MacNeil, M.G. Reynolds and I.K. Damon
  • "Laboratory-acquired vaccinia virus infection - Virginia 2008" in Morbidity and Mortality Weekly Report, CDC

Viral Vectors and Genetically Engineered Viruses Safety Information

• UR Biosafety Assessment and Safety Guidelines for Experimental Use of Replication-Defective Adenoviral Vectors
• UR Biosafety Assessment and Safety Guidelines for Experimental Use of Replication-Defective Feline Immunodeficiency Virus (FIV)
• NIH Biosafety Considerations for Research with Lentiviral Vectors
• Safety Considerations in Recombinant DNA Research with Pathogenic Viruses
• Assessment for Recombinant Amphotropic Retroviral Vectors Containing Oncogenes and Lentiviral Vectors Containing Oncogenes (restricted)
• Assessment for Recombinant, Pseudotyped Lentiviral Vectors (HIV and SIV Vectors) (restricted)
• "A Broad-Spectrum Microbiocide with Virucidal Activity against Sexually Transmitted Viruses" by M.K. Howett, E.B. Neely, N.D. Christensen, B.Wigdahl, F.C. Krebs, D. Malamud, S.D. Patrick, M.D. Pickel, P.A. Welsh, C.A. Reed, M.G. Ward, L.R. Budgeon and J.W. Kreider, Antimicrobioal Agents and Chemotherapy
• "Inactivation of Adenovirus Type 5 by Caustics" by Risat Jannat, D. Hsu and G. Maheshwari, Biotechol. Prog.
• "Virus inactivation by nucleic acid extraction reagents" by Jamie A. Blow, D.J. Dohm, D.L. Negley and C.N. Mores, J. Virological Methods
• "Virus inactivation by protein denaturants used in affinity chromatography" by Peter L. Roberts and D. Lloyd, Biologicals
  

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