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Health & Safety Manual - Biological Safety

2.11 Hazardous Materials: Registration and Approval

2.11.1 Recombinant DNA
2.11.2 Other Hazardous Materials Requiring Registration and Approval

2.11.1 Recombinant DNA
Recombinant DNA refers to either: (i) molecules constructed outside of living cells by joining natural or synthetic DNA segments to DNA molecule that can replicate in a living cell, or (ii) molecules that result from the replication of those described in (i) above.

The NIH’s Guidelines for Research Involving Recombinant DNA Molecules apply to all rDNA activities at Columbia, regardless of the funding source for a particular project.
The NIH’s risk assessment criteria for most viral vectors give very little weight to ‘replication deficiency’ alone.  This requires applying the same hazard assumptions as if wild type virus were being used, as well as commensurate biological safety procedures.

All uses of  rDNA must be described in a submittal to the University’s Institutional Biosafety Committee. The NIH defines protocols which are ‘exempt’ from submission requirements, but this category is narrower than most people assume and investigators must, at a minimum, submit an initial application for the IBC to make this determination.
To submit your lab’s rDNA work:

  • Go
  • Select ‘Hazardous Materials’ from the menu on the left side of the welcome screen
  • Log in with your CU UNI and password
  • Under Create a New Request, select “Recombinant DNA (Appendix A)”
    • If recombinant DNA will be used as part of an animal care protocol,  check the “Used/Administered as part of a protocol” box at the top of the form.
    • If recombinant DNA will be used only in vitro check the “Invitro/Invertebrates only” box. Complete and save the application
  • The completed application can then be either attached to an IACUC protocol  or submitted directly to EH&S for in vitro-only activities

2.11.2 Other Hazardous Materials Requiring Registration and Approval
The intended use of Infectious Agents (Appendix B), use of human materials (blood, body fluids, tissues, cells, human cell lines (Appendix C), or use of hazardous chemicals or biological toxins (Appendix E) must also be documented by using the same RASCAL-based submittal process as described for recombinant DNA.

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