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TitleFAQs About Transgenic Animals and the Use of ant DNA in Animals (2)
TagsExperiment Recombinant Dna Genetically Modified Organism Transgene National Institutes Of Health
File Size69.8 KB
Total Pages2
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Page 1

Transgenic Animals and the Use
of Recombinant DNA in Animals

FAQs for Research Subject to the
NIH Guidelines

1.� Under which section of the NIH Guidelines does the generation of transgenic rodents fall?

The creation of transgenic rodents falls under one of two portions of the NIH Guidelines depending on the containment level
required to house the rodents. Experiments involving the creation of transgenic rodents that can be housed under Biosafety
Level 1 conditions are covered under Section III-E-3. Experiments involving the generation of transgenic rodents requiring
BL2, BL3 and BL4 containment are covered under Section III-D-4.

2.� Under which section of the NIH Guidelines does the generation of transgenic animals other than rodents
fall?

The creation of all transgenic animals (other than rodents that can be housed under BL1 containment conditions) is covered
under Section III-D-4 of the NIH Guidelines.

3.� 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) 1 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 transgenic strain) at BL1 is an activity that is
exempt from to 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 III-D-4-b and requires IBC approval. The breeding of all other
transgenic animals is subject to the NIH Guidelines under Section III-D-4-a or III-D-4-b depending on the containment level
required.

5.� Is the purchase and transfer of transgenic rodents exempt from the NIH Guidelines?

Under Appendix C-VI of the NIH Guidelines, the purchase or transfer of transgenic rodents may be maintained at BL1
containment are exempt from the NIH Guidelines. The purchase or transfer of transgenic rodents that require BL2 or higher
containment is not exempt from the NIH Guidelines. These animals are covered under Section III-D-4, and purchase and
transfer of such animals requires IBC registration and approval.

It should be noted that the subsequent use of transgenic rodents may not be exempt from the NIH Guidelines. Experiments
using transgenic rodents at BL1 are exempt from the NIH Guidelines if the experiment does not involve the use of
recombinant DNA. If the protocol does involve the use of recombinant DNA or is conducted at BL2 or higher then the work
falls under III-D-4 of the NIH Guidelines and as such requires IBC review and approval prior to initiation.

6.� Is the purchase and transfer of transgenic animals other than rodents exempt from the NIH Guidelines?

No, only the purchase or transfer of transgenic rodents that may be maintained at BL1 containment is exempt from the NIH
Guidelines. The purchase or transfer of any other animal for research purposes at any biosafety level (including BL1) is not
exempt, nor is the purchase and transfer of transgenic rodents that require BL2 or higher containment.

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