Policy IBC2A – Oversight of Transgenic Mice Biohazards

Purpose
Applicability
Definitions
Animal Facility Security
Animal Containment
Animal Disposal
Policy
References

This policy is designed to provide assurance that the Institutional rDNA Biosafety Committee conducts sufficient oversight with respect to the biohazards relative to transgenic mice. It ensures that animal facility security, animal containment and animal disposal is being conducted according to the NIH GUIDELINES FOR RESEARCH INVOLVING RECOMBINANT DNA MOLECULES (NIH GUIDELINES).

This policy is applicable to all activities, whether sponsored or unsponsored, conducted under the auspices of the University. The policy applies to all University locations, excluding the College of Medicine at Hershey, which maintains separate assurances regarding the use of biohazardous materials.

Transgenic Mice –
For the purpose of this policy, transgenic mice are animals with a genome that has been altered by the stable introduction of recombinant DNA into the animal's germ-line (transgenic animals) and that are NOT expressing hazardous materials or shedding viable organisms (viral vectors).

Institutional rDNA Biosafety Committee –
This committee is appointed to review proposed uses of genetically modified materials and hazardous agents by the University. Proposed projects are reviewed for compliance to the NIH guidelines.

Institutional Animal Care and Use Committee –
This committee is appointed to review all proposed uses of non-human vertebrate animals by the University. Projects are reviewed for compliance with the regulations governing the care and use of research animals.

NIH Guidelines for Housing Transgenic Animals –

The NIH guidelines require the following provisions be met when generating or utilizing transgenic animals. These requirements are in addition to those listed in the Guide for Care and Use of Laboratory Animals.

• Animal Facility Security

  Animal facilities housing transgenic mice are secured in accordance with NIH guidelines. Containment facilities are locked and access is limited to research personnel and animal caretakers. Animal facilities are monitored on a regular basis by attending veterinarians, caretakers and research personnel.

• Animal Containment

  Animals are confined according to NIH guidelines. Transgenic mice are housed in enclosed structures according to Federal and State regulations. All facilities are maintained to minimize the possibility of theft, escape or accidental release of animals.

• Animal Disposal

  As prescribed by the NIH, dead or euthanized animals are disposed of according to established guidelines. They are maintained frozen at animal facilities and routinely delivered to the Penn State University Diagnostic lab for incineration.

Approval for generating and utilizing transgenic mice must be obtained from the Institutional Animal Care and Use Committee. For the purpose of Institutional Biosafety Committee oversight and since transgenic mice (as defined in the definition section of this policy) are contained according to the NIH guidelines, the committee will recognize such activities to be in compliance with guideline requirements and consider IACUC approval of the animal activities notification and documentation of utilizing transgenic mice in accordance with the NIH guidelines.

This policy is exclusively for the use of policy defined transgenic mice. The use of any other transgenic animals must be submitted to the Institutional rDNA Biosafety Committee for review and approval.

Penn State University Policy RA15 – Care and Use of Vertebrate Animals

National Institutes of Health - NIH Guidelines for research involving recombinant DNA Molecules

Guide for the Care and Use of Laboratory Animals

Policy IBC2A, Last Approved by the IBC on 11/12/2007