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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

  • In vitro infection of cell lines ( classified as D2a)
  • In vivo infection of animals (classified as D4)
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

  • In vitro infection of cell lines ( classified as D2a)
  • In vivo infection of animals (classified as D4)
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

2Cloning into plants
Administering recombinant DNA in to humans

C1

2Human gene transfer or gene therapy
Cloning of biological toxins

B1

2cloning 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

2Providing 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)
 
 
 

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