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Re-Endorsed: July 25, 2019

Purpose and Scope

The purpose of this policy is to describe Tufts University/Tufts Medical Center’s Institutional Biosafety Committee (IBC) oversight for activities that involve any animal in which the genome has been altered by stable introduction of recombinant or synthetic nucleic acid molecules, or nucleic acids derived there from, into the germ-line (henceforth described as “transgenic”). This policy covers the purchase, transfer, use, breeding, or creation of transgenic animals. Even if the animal is not created at this institution, it may still need to be registered with the IBC.

This policy ensures compliance with the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines).

IBC Review Categories and Processes

There are three categories that transgenic animal use falls under in the NIH Guidelines, depending on the animal model and type of work being performed. It may be exempt from review, or it may fall under III-E, or III-D-4. The latter two categories of use must be approved by the IBC.

  1. EXEMPT FROM IBC REVIEW

The IBC recognizes the 2011 amendment to the NIH Guidelines, Sections III-E-3 and Section III-F-8 Appendices C-VII and C-VIII that exempt the following activities with transgenic rodents:

  • The purchase, use, and/or transfer of rodents, if only Biosafety Level 1 (BSL-1) containment is required.
  • The breeding between rodents of the same strain if only BSL-1 containment is required.
  • The breeding of two different rodent strains with the intent of creating a new strain that requires only BSL-1 containment, if:
    • Both parental rodents can be housed at BSL-1 containment, AND
    • Neither parental transgenic rodent contains the following genetic modifications:
      • Incorporation of more than one half of the genome of an exogenous eukaryotic virus from a single family of viruses, or
      • Incorporation of a transgene that is under the control of a gammaretroviral long terminal repeat (LTR), AND
    • The transgenic rodent that results from this breeding is not expected to contain more than one half of an exogenous viral genome from a single family of viruses.

The Principal Investigator (PI) is asked to confirm the above in the IACUC protocol and amendment forms. To account for new lines and new breeding combinations, the PI will be asked to re-confirm that rodent strains are exempt on a yearly basis via the IACUC Annual Renewal form. If any work involving transgenic animals does not fit into the exempt category above, the PI is required to obtain IBC approval (see below).

B. NOT EXEMPT FROM IBC REVIEW

Any work as described below requires the submission of an IBC Biological Materials Registration form and approval by the IBC. The IBC shall refer to Section III and the Table of Animal Experiments of the Guidelines to determine appropriate containment. NIH Guidelines Section III-D-4 or III-E will apply, depending on the methodology used.

TRANSGENIC RODENTS:

  • The purchase, use, transfer, or breeding that requires Biosafety Level 2 or higher containment (NIH Guidelines Section III-D-4).
  • Any creation of new strains by use of recombinant or synthetic nucleic acid technologies. Methods for this include, but are not limited to: DNA microinjection, retrovirus-mediated gene transfer, and embryonic stem cell mediated gene transfer (NIH Guidelines III-E).
  • Some breeding crosses present a potential risk regarding recombination of viral sequences and therefore require IBC oversight to ensure that a risk assessment is conducted and that the resulting rodents are contained appropriately. Breeding must be approved by the IBC (NIH Guidelines III-E) if either of the following conditions apply:
  1. Breeding experiments that involve transgenic rodents that contain more than 50 percent of the genome of an exogenous eukaryotic virus from a single family, to prevent inadvertent reconstitutions of an exogenous virus in the resultant transgenic rodent; and/or:
  2. Breeding experiments in which the transgenic rodent’s transgene is under the control of a gammaretroviral long terminal repeat (LTR), to address the small risk of recombination with endogenous retroviruses which could potentially result in mobilization of the transgene via a replication-competent mouse retrovirus.

ALL OTHER TRANSGENIC ANIMAL SPECIES:

  • Any purchase, use, transfer, breeding, or creation of transgenic non-rodent animal species by use of recombinant or synthetic nucleic acid technologies requires the submission of a Biological Materials Registration form and Full Committee IBC Approval. The IBC shall refer to Section III-D-4 of the Guidelines to determine appropriate containment.

Biological Containment Levels for Experiments Involving Transgenic Animals

The physical and biological containment levels for experiments involving transgenic animals must conform to the NIH Guidelines unless a different level has been approved by the IBC. The containment levels required for work involving recombinant or synthetic nucleic acid molecules associated with or in animals are based on classification of experiments in the NIH Guidelines. Please refer to Office of Science Policy’s Animal Activities Table. The requirements to meet the assigned containment level are described in either Appendix G or Appendix M of the NIH Guidelines, depending on the animal species.