This section has been reviewed and updated as needed: June 2014

Planning and implementation of control practices for the prevention of laboratory-acquired infections and for the protection of the general environment are to be included in all research programs involving biohazardous agents.
Biohazardous agents are infectious microorganisms, or their toxins, which cause or may cause human disease.
These requirements apply to microorganisms and viruses listed by the CDC/NIH Biosafety in Microbiological and Biomedical Laboratories Manual. These agents are listed in the Biological Safety Manual.
There are no facilities on campus appropriate for working with Biosafety Level 4 pathogens so work involving these agents is prohibited.
Each principal investigator is responsible for ensuring that laboratory personnel are trained in safe practices; reporting exposures and potential exposures to these biohazardous agents to the Environment, Health and Safety Office; and submitting a Laboratory Safety Plan for research under his/her direction to the Environment, Health and Safety Office.
Procedures describing the use of biohazardous agents are to be included in the Laboratory Safety Plan. The Laboratory Safety Plan is to describe the procedures that will be used to insure the safe handling of biohazardous agents, an assessment of the potential risks, the need for medical surveillance, and procedures for handling accidental spills and waste disposal methods.
Proposed research projects involving biohazardous agents should be reviewed with the Environment, Health and Safety Office to ensure that the budget includes consideration of any specialized requirements to insure the safe conduct of the research.
All overt accidental exposures of personnel to biohazardous agents, such as exposure to a concentrated contaminated aerosol from research procedures, accidental spills, or accidental inoculation with a contaminated needle, should be reported to the University Employee Occupational Health Clinic (919-966-9119) and to the Environment, Health and Safety Office. After regular working hours and on weekends, the employee should call the Health Link (919-966-7890) to be instructed on how to seek treatment.
Recommended safety practices and facilities for the use of biohazardous agents are given in the Biological Safety Manual.

NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules

It is the policy of this University that the PI is responsible for complying with the NIH “Guidelines for Research involving Recombinant or Synthetic Nucleic Acid Molecules”, regardless of the source of the funds supporting that research. It is impossible to summarize the whole of those guidelines, but there are three groups of experiments that probably encompass the majority of work being done on campus. If your work does not fall clearly into one of these groups, consult the “Guidelines” and the Institutional Biosafety Committee (IBC).

Section III-D: Experiments that Require IBC Approval Before Initiation

Several categories of protocol fall under this section including:

  • Experiments involving the introduction of recombinant DNA into risk group 2, 3 or 4 agents (mostly BSL2, BSL3, and BSL4 organisms)
  • Experiments in which DNA from risk group 2, 3 or 4 agents (mostly BSL2, BSL3, and BSL4 organisms) is transferred into nonpathogenic prokaryotes or lower eukaryotes
  • 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, including the creation of transgenic organisms other than rodents and the introduction of recombinant DNA or RNA into whole animals
  • Experiments involving whole plants
  • Experiments involving more than 10 liters of culture

Section III-E: Experiments that Require IBC Notice Simultaneous with Initiation

Several categories of protocol fall under this section including:

  • Experiments involving the formation of recombinant or synthetic molecules containing no more than 2/3 of the genome of any eukaryotic virus
  • Experiments involving the creation or mating of some transgenic rodents (see explanation in III-F)
  • Experiments that don’t fall into any other category, such as experiments involving the introduction of risk group 1 DNA/RNA into risk group 1 organisms such as E. coli BL21

Section III-F: Experiments Exempt From NIH Guidelines but Which Require Notification of the OUHSC IBC

  • Experiments that consist entirely of DNA from a prokaryotic host when propagated only in that host or those that consist entirely of DNA from a eukaryotic host when propagated only in that host.
  • Experiments involving recombinant DNA containing less that ½ of any eukaryotic viral genome propagated and maintained in cells in tissue culture.
  • Experiments which use risk group 1 or 2 DNA/RNA inserted into E. coli K-12, Saccharomyces, or Bacillus subtillus or Bacillus lichenformis host-vector systems (E. coli BL21 does not fall into this category), which do not involve the cloning of toxin molecules or large-scale experiments (more than 10 liters of culture)
  • Experiments involving the mating of two transgenic lines to form a third, unique transgenic line that also meets the following criteria:
    1. Both parental rodents can be housed under BL1 containment
    2. neither parental transgenic rodent contains the following genetic modifications:
      1. incorporation of more than one-half of the genome of an exogenous eukaryotic virus from a single family of viruses
      2. incorporation of a transgene that is under the control of a gammaretroviral long terminal repeat (LTR)
    3. the transgenic rodent that results from this breeding is not expected to contain more than one-half of an exogenous viral genome from a single family of viruses.

To obtain more detailed information about how your particular experiments are classified under the Guidelines, call Biosafety at Environment, Health & Safety (919-962-5507).

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