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A Review of Biosafety Standards. The Three Regulatory Sets of Biohazards. Potentially infectious materials Infectious agents Recombinant DNA. The Three Regulatory Standards:. For potentially infectious materials – when there could be a biohazard, such as in handling clinical specimens:

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A Review of Biosafety Standards

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A review of biosafety standards l.jpg

A Review of Biosafety Standards


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The Three Regulatory Sets of Biohazards

  • Potentially infectious materials

  • Infectious agents

  • Recombinant DNA


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The Three Regulatory Standards:

  • For potentially infectious materials – when there could be a biohazard, such as in handling clinical specimens:

  • The Bloodborne Pathogens Act of 1994, which mandates

    • Implementation of Universal Precautions for potentially infectious materials

    • An Exposure Control Plan


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The Three Regulatory Standards:

  • For infectious agents – when there is a biohazard, such as in deliberate culture of infectious microorganisms:

  • Biosafety in Microbiological and Biomedical Laboratories (BMBL), which prescribes

    • Classification of microorganisms into Biosafety Levels 1-4

    • Microbiological practices, safety equipment and facilities that constitute Biosafety and Animal Biosafety Levels 1 – 4


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The Three Regulatory Standards:

  • For recombinant DNA – when there is a biohazard created de novo in constructing or synthesizing nucleic acids:

  • NIH Guidelines For Research Involving Recombinant DNA Molecules , which mandates

    • Classification of etiologic agents as Risk Groups 1-4

    • Biological (host-vector) containment and physical (biosafety level) barriers


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In the research laboratory…

The three regulatory standards are virtually equivalent in practice. In general…

  • One does not work under Biosafety Level 2 without carrying out universal precautions.

  • In maintaining universal precautions, it is common, almost unavoidable, that Biosafety Level 2 will be maintained.

  • The risks imposed by research involving recombinant DNA are contained in part by Biosafety Level practices


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But…

  • Biosafety Level 2 is often convenient for practicing Biosafety Level 1.

  • Research involving recombinant DNA often is conveniently carried out at Biosafety Level 2, even though the applicable Risk Group is 1.


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Note bene…

  • It is absolutely incumbent on the researcher to…

    • understand these principles;

    • apply them appropriately; and

    • train her/his research staff and students.


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Potentially Infectious Materials

  • The practices of Universal Precautions, for handling potentially infectious materials, and for compliance with the Bloodborne Pathogens Act are described in…

    • The Exposure Control Plan of Mercer University, at…

    • http://www.mercer.edu/ehso/Attached%20Documents/Exposure%20Control%20Plan.Oct2002.pdf


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Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5th EditionU.S. Department of Health and Human ServicesCenters for Disease Control and PreventionandNational Institutes of HealthFifth Edition, Feb. 2007, rev. Dec. 2009US Government Printing OfficeWashington: 2009http://www.cdc.gov/biosafety/publications/bmbl5/index.htm[most recent as of July 2010]


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WHO Risk Groups as adapted by NIH (and BMBL)

  • Risk Group 1

    • WHO individual / community: low / low

    • NIH: "Agents that are not associated with disease in healthy adult humans."

  • Risk Group 2

    • WHO individual / community: moderate / low

    • NIH: "Agents that are associated with human

    • disease which is rarely serious and for which

    • preventive or therapeutic interventions are

    • often available."


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WHO Risk Groups as adapted by NIH (and BMBL)

  • Risk Group 3

    • WHO individual / community: high / low

    • NIH: "Agents that are associated with serious or lethal human disease for which preventive or therapeutic interventions may be available."

  • Risk Group 4

    • WHO individual / community: high / high

    • NIH: "Agents that are likely to cause serious or lethal human disease for which preventive or therapeutic interventions are not usually available."


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Biosafety Levels (BMBL)

  • agents

  • practices

  • primary barriers / personal protective equipment (PPE)

  • facilities (secondary barriers)


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AN APPROACH TO ASSESS RISKS AND SELECT APPROPRIATE SAFEGUARDS

  • First, identify agent hazards and perform an initial assessment of risk.

  • Second, identify laboratory procedure hazards.

  • Third, make a final determination of the appropriate biosafety level and select additional precautions indicated by the risk assessment.


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AN APPROACH TO ASSESS RISKS AND SELECT APPROPRIATE SAFEGUARDS

  • Fourth, evaluate the proficiencies of staff regarding safe practices and the integrity of safety equipment.

  • Fifth, review the risk assessment with a biosafety professional, subject matter expert, and the IBC.


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NIH GUIDELINES FOR RESEARCHINVOLVING RECOMBINANTDNA MOLECULES(NIH GUIDELINES)April 2002, rev. September 2009http://oba.od.nih.gov/rdna/nih_guidelines_oba.html[most recent as of July 2010]


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An Outline

  • SECTION I.SCOPE OF THE NIH GUIDELINES

    • Section I-A.Purpose

    • Section I-B.Definition of Recombinant DNA Molecules

      • "In the context of the NIH Guidelines, recombinant DNA molecules are defined as either: (i) molecules that are constructed outside living cells by joining natural or synthetic DNA segments to DNA molecules that can replicate in a living cell, or (ii) molecules that result from the replication of those described in (i) above."


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  • Section I-C.General Applicability

  • Section I-D.Compliance with the NIH Guidelines

  • Section I-E.General Definitions


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  • SECTION II.SAFETY CONSIDERATIONS

    • Section II-A.Risk Assessment

      • Section II-A-1.Risk Groups

    • Section II-B.Containment


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  • SECTION III.EXPERIMENTS COVERED BY THE NIH GUIDELINES

    • Note:If an experiment falls into Sections III-A, III-B, or III-C and one of the other sections, the rules pertaining to Sections III-A, III-B, or III-C shall be followed. If an experiment falls into Section III-F and into either Sections III-D or III-E as well, the experiment is considered exempt from the NIH Guidelines.

    • experiments involving recombinant DNA

    • those that require...


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  • Section III-A: Institutional Biosafety Committee (IBC) approval, RAC review, and NIH Director approval before initiation

  • Section III-B: NIH/OBA and Institutional Biosafety Committee approval before initiation

  • Section III-C: Institutional Biosafety Committee and Institutional Review Board approvals and RAC review before research participant enrollment

  • Section III-D: Institutional Biosafety Committee approval before initiation

  • Section III-E: Institutional Biosafety Committee notification simultaneous with initiation

  • Section III-F: [no review and therefore] are exempt from the NIH Guidelines


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  • Section III-A.experiments that require IBC, NIH RAC, and NIH Director approval before initiation

    • the deliberate transfer of a drug resistance trait to microorganisms that are not known to acquire the trait naturally, if such acquisition could compromise the use of the drug to control disease agents


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  • Section III-B.experiments that require NIH/OBA and IBC approval before initiation

    • experiments involving the cloning of toxin molecules with LD50 < 100 ng / kg body wt


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  • Section III-C.experiments that require IBC and IRB approvals and RAC review before research participant enrollment

    • experiments involving the deliberate transfer of recDNA, or DNA or RNA derived from recDNA, into one or more human research participants


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  • Section III-D.experiments that require IBC approval before initiation

    • experiments using Risk Group 2, 3, or 4 or Restricted Agents as host-vector systems

    • experiments in which DNA from Risk Group 2, 3, or 4 or Restricted Agents is cloned into nonpathogenic prokaryotic or lower eukaryotic host-vector systems

    • experiments involving the use of infectious DNA or RNA viruses or defective DNA or RNA viruses in the presence of helper virus in tissue culture systems

    • experiments involving whole animals

    • experiments involving whole plants

    • experiments involving more than 10 L of culture


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  • Section III-E.experiments that require IBC notice simultaneous with initiation

    • experiments involving the formation of recDNA molecules containing no more than two-thirds of the genome of any eukaryotic virus

    • experiments involving whole plants

    • experiments involving transgenic rodents


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  • Section III-F. Exempt Experiments

    • those that are not in organisms or viruses

    • those that consist entirely of DNA segments from a single nonchromosomal or viral DNA source

    • those that consist entirely of DNA from a prokaryotic host... when propagated only in that host (or a closely related strain)... or when transferred to another host by well established physiological means

    • those that consist entirely of DNA from an eukaryotic host... when propagated only in that host (or a closely related strain...).


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  • those that consist entirely of DNA segments from different species that exchange DNA by known physiological processes

  • those that do not present a significant risk to health or the environment... as determined by the NIH Director


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  • APPENDIX C.EXEMPTIONS UNDER SECTION III-F-6

    • Appendix C-I.Recombinant DNA in Tissue Culture

    • Appendix C-II.Escherichia coli K-12 Host-Vector Systems

    • Appendix C-III.Saccharomyces Host-Vector Systems

    • Appendix C-IV.Bacillus subtilis or Bacillus licheniformis Host-Vector Systems

    • Appendix C-V.Extrachromosomal Elements of Gram Positive Organisms

    • Appendix C-VI.The Purchase or Transfer of Transgenic Rodents


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