104/20061CDC/UNMCGeneral Biosafety TrainingOverviewCDC/UNMCGeneral Biosafety TrainingOverviewModule 1A04/20062General BiosafetyModule 1 Outline• Overview– Module 1A• Biosafety Levels 1 and 2– Module 1B• Safety Equipment– Module 1C• Decontamination and Biohazardous Waste Handling– Module 1D 04/20063General BiosafetyModule 1A Synopsis• Information about this training module–For a comment or to ask a question, you will find a link on the main page of the course.– To enhance the size of this PowerPoint presentation, click on the “screen icon” at the bottom right of this page– Once this section is completed, click on the “X” and the top right of the window to close it and return to the main page to access Module 1B.04/20064General BiosafetyModule 1A Synopsis• This module gives an overview of the federal guidelines concerning biosafety practices and how these practices are applicable to the research laboratory04/20065Who needs this training?Individuals who work with or have access to biohazardous materials.04/20066Definition• Biohazardous materialsMaterials of biological origin that have the capacity to produce deleterious effects on humans or animals.204/20067Examples of Biohazardous Materials• Recombinant DNA molecules• Microorganisms containing recombinant DNA molecules• Microorganisms classified as risk group 2 (RG-2), RG-3, or RG-4 (defined in the next series of slides)• Biological products derived from RG-2, RG-3, or RG-4 organisms• Diagnostic specimens known or reasonably expected to contain RG-2, RG-3, or RG-4 organisms.• Clinical/ medical waste derived from the medical treatment of humans or animals or from biomedical research.04/20068DefinitionBiosafetyThe combined application of laboratory practice and procedure, laboratory facilities, and safety equipment when working with potentially infectiousmicroorganisms.04/20069NIH Guidelines• Federal guidelines that must be followed when performing research using biohazardous agents• The Guidelines’ purpose is to specify practices for constructing and handling rDNA molecules and organisms containing these molecules.• UNMC/ UNO also use these guidelines to include the handling of other biohazardous agents (not associated with rDNA) as a part of the biosafety program.04/200610Institutional Biosafety Committee• Members appointed by the University with the following duties:– Review research for compliance with NIH Guidelines– Notify PI of the results of an IBC review;– Setting containment levels for experiments;– Periodic review of research to ensure adherence to NIH Guidelines;– Adoption of an emergency plan covering accidental spills and personnel contamination; and– Report significant problems with or violations of the NIH Guidelines.(NIH Guidelines, Section IV-B-2b)04/200611Biosafety Officer• Appointed by the Institution with duties to include– Periodic inspections to ensure that laboratory standards are rigorously followed;– Reporting to the IBC any significant problems, violations of the NIH Guidelines, and significant research-related accidents or illnesses;– Developing an emergency plan for handling accidental spills and personnel contamination;– Providing advice on laboratory security; and– Providing technical advice to PIs and the IBC on research safety procedures.(NIH Guidelines, Section IV-B-3)04/200612Principal Investigator’s Responsibility• Make available to all laboratory staff the protocols that describe the potential biohazards and the precautions to be taken;• Instruct and train laboratory staff in the practices and techniques required to ensure safety and the procedures dealing with accidents; • Inform the lab staff of the reasons and provisions for any precautionary medical practices advised or requested;• Supervise the safety performance of the laboratory staff;• Investigate and report any significant problems pertaining to the operation and implementation of containment practices to the IBC;• Correct work errors and conditions that may result in a release of a biohazardous agent; and• Ensure the integrity of the physical and biological containment.(NIH Guidelines, Section IV-B-7-c,d,e)304/200613NIH Committee Overviews•OBA– Office of Biotechnology Activities– Office within the NIH that is responsible for review and coordinating all actions of the NIH Guidelines•RAC– Recombinant DNA Advisory Committee– Public advisory committee that advises the Department of Health and Human Services and NIH Director on recombinant DNA research issues.04/200614Experiments Requiring IBC Approval• Five major categories– IBC and NIH Director approval and RAC Review before initiation– IBC and NIH/OBA approval before initiation– IBC and IRB approval and RAC review before initiation– IBC approval before initiation– IBC notice simultaneous with initiation(NIH Guidelines, Section III)04/200615IBC and NIH Director Approval and RAC Review•Example– Experiments involving the deliberate transfer of a drug resistant trait to microorganisms not known to acquire that trait naturally– NIH Guidelines, Section III-A04/200616IBC and NIH/OBA Approval•Example– Experiments involving the deliberate formation of rDNA containing genes for the biosynthesis of toxin molecules lethal for vertebrates at an LD50 of less than 100 ng/kg body weight– NIH Guidelines, Section III-B04/200617IBC and IRB Approval and RAC Review•Example– Experiments involving the deliberate transfer of rDNA into human research participants– Also called human gene transfer experiments– NIH Guidelines, Section III-C04/200618IBC Approval Before Initiation•Examples– Experiments involving the introduction of rDNA into risk group 2, RG-3, or RG-4 agents– Experiments involving the use of infectious or defective viruses in the presence of helper virus in tissue culture– Experiments involving whole animals in which the animal has been altered by the introduction of DNA or RNA (transgenic animals)– Experiments to genetically engineer plants by rDNA methods– Experiments involving more that 10 liters of culture material– Experiments in which DNA for RG-2, RG-3, or RG-4 agents is cloned into nonpathogenic prokaryotic or lower eukaryotic host vector systems– NIH Guidelines, Section III-D404/200619IBC Approval Simultaneous with Initiation•Example– Experiments in which all components are derived from non-pathogenic prokaryotes and non-pathogenic