Would the breeding of two different strains of knock-out mice require IBC approval under the NIH Guidelines?
The techniques used initially to create knock-out animals involve the stable introduction of recombinant DNA into the animal’s genome, and thus these animals are considered transgenic. As the breeding of two different strains of knock-out mice will potentially generate a novel strain of transgenic animal, the work is covered under the NIH Guidelines and as such requires IBC review and approval. Sections in the NIH Guidelines that cover work with rodents include III-E-3 for work that requires Biosafety Level (BL) l containment and III-D-4 for work that requires BL2, BL3 and BL4 containment. 4. Is IBC registration and approval needed for the maintenance of a transgenic animal colony? The maintenance of a transgenic rodent colony (i.e. breeding within a particular transgeneic strain) at BL1 is an activity that is exempt from the NIH Guidelines and, as such, does not require IBC registration and approval. The maintenance of a transgenic rodent colony at BL2 or higher falls under Section II
