risk management
Recombinant DNA Classification
The NIH requires that investigators classify their recombinant DNA research along certain criteria. The following are the classification/registration criteria as interpreted by the MUSC Institutional Biosafety Committee. This information is intended to help researchers answer the registration category question (B1) found on the recombinant DNA section (section 4) of the IBC forms.
Research | Classification | Minimum Required Biosafety Level | Example Activity |
Cloning of insert genes from Risk Group 2 agents (including mammals) in to bacteria and yeasts | D2a | 1 | Cloning into Risk Group 1 strains of E. coli (K12, DH5alpha, BL21 and TOP10) or S. cerevisiae. |
| Cloning of insert genes from Risk Group 2 (including mammals), 3 or 4 agents into mammalian or insect cells. | D2a | 2 | Transfecting plasmids into cultured mammalian or insect cells |
| Cloning into viral vectors not requiring a helper virus | D1a and either D2a (in vitro) or D4 (in vivo) | 2 | Cloning into Retroviral or Adenoviral vectors (classified as D1a) and either
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| Cloning into viral vectors requiring a helper virus | D3a and either D2a (in vitro) or D4 (in vivo) | 2 | Cloning into Adeno-Associated Viral vectors (classified as D3a) and either
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| Administering recombinant DNA or cells modified with recombinant DNA into animals | D4 | 2 | Gene transfer into animals using plasmids or viral vectors Transfer of cells or organisms (including viral vectors) modified with recombinant DNA into animals |
Using, creating or purchasing genetically modified animals | D4c | 1 | Includes knockout or transgenic animals. Note: Animals treated with viral vectors must be classified as D4, requiring BSL2 containment. |
| Propagating cultures modified with recombinant DNA with volumes exceeding 10 liters | D6 | 2 | Industrial scale protein expression experiments |
| Administering recombinant DNA in to plants | D5 | 2 | Cloning into plants |
| Administering recombinant DNA in to humans | C1 | 2 | Human gene transfer or gene therapy |
| Cloning of biological toxins | B1 | 2 | cloning of biological toxins into bacteria for protein expression |
| Transferring drug resistance into Risk Group 2, 3 or 4 microorganisms that do not acquire it naturally | A1a | 2 | Providing antibiotic resistance to pathogenic microorganisms that would impair medical intervention in the event of infection (e.g. creation of MRSA or antibiotic resistant tuberculosis or anthrax) |