Administration of Biological Materials to Animals
All research involving animals at MUSC must receive IACUC approval. IACUC applications involving administration of materials posing potential biological hazards (including cells, biological fluids, recombinant DNA, microbes, biological toxins, etc.) must include a Biological Materials Appendix, which must be approved by the MUSC Biosafety Officer.
Applications can be submitted for IACUC consideration without the Biological Materials Appendix, but final approvals will not be released without submission of an approved Biological Materials Appendix if biological hazards will be administered to live animals.
The Biological Materials Appendix is available below and can also be downloaded from the IACUC website.
Guidance for Answering Questions Listed on the Biological Materials Appendix
Question 3, Animal Housing: Animals receiving recombinant DNA, infectious agents or biological toxins must be housed in Animal Biosafety Level 2 housing (ABSL-2). Such housing guarantees proper containment, personal protective equipment and safety practices are utilized by researchers and animal caretakers who may be exposed to agents while handling animals or manipulating contaminated cages and spent bedding. Click here for a list of locations currently approved to provide Animal Biosafety Level 2 housing.
MUSC's Division of Laboratory Animal Resources (DLAR) can upgrade existing BSL-1 rooms to BSL-2 if additional BSL-2 housing is required and space is available. Such an upgrade in containment level requires DLAR to modify air handling within animal rooms and implement BSL-2 procedures for animal handling and cage changing. A minimum of 2 weeks advance notice should be provided to DLAR to accommodate requests for upgraded containment.
Question 9, Biohazards and the Institutional Biosafety Committee: Use of recombinant DNA, microbes/infectious agents and biological toxins must be registered with the MUSC Institutional Biosafety Committee (IBC). Registrations are submitted online via the ERMA system. Investigators are asked to provide their IBC approval number in question 9A. Approval numbers have 1-3 digits (e.g. 1, 23 or 191) and should not be confused with the four-digit (e.g. 2001) Investigator Number given to each faculty member as a personal identifier.
Question 10, Human Materials: Unfixed human materials may contain blood borne pathogens such as HIV, HBV, HCV, etc. Cell lines and tissues may harbor additional human pathogens. Human materials can be tested to determine if they harbor certain infectious agents.
- Question 10A is intended to determine whether these human materials have been tested and certified to be free of blood borne pathogens.
- Question 10B requires Investigators to agree to follow the MUSC Blood Borne Pathogen Infection Control Plan which requires the use of standard precautions for use of infectious agents.
- Question 10C prompts Investigators to declare if all personnel have complied with the annual OSHA requirement for Blood Borne Pathogen training. Personnel lacking this training can obtain it via CATTS.
Pathogen Testing of Cell Lines and Biological Materials Used in Rodents
This section ensures cell lines administered to animals comply with the MUSC IACUC Cell Line Policy requiring rodent pathogen testing (by PCR, Mouse/Rat Antibody Production MAP/RAP testing) of established cell lines or biologicals derived from human or other mammalian tissues that have been passed in rodents. Biologicals with a clear history that excludes contact with rodent materials are exempt.
Biologicals that require testing prior to in vivo use:
- Cell lines, transplantable tumors, serum, tissues, body fluids, and antibody preparations derived from rodents outside DLAR colonies.
- Non-rodent derived cell lines, transplantable tumors, serum, tissues, body fluids, and antibody preparations that have been passaged through rodents or exposed to rodents outside DLAR colonies.
Question 14-15, Previous exposure of animals in DLAR facilities to the biological material: Materials that have been previously used in animals may have been indirectly tested for pathogens through the DLAR sentinel animal testing program if experimental animals remained in DLAR facilities for atleast three months following exposure and failed to exhibit any obvious signs of disease. Biological materials meeting this criteria are exempt from rodent pathogen testing.
Questions 17-19, Containment and control of laboratory animals during procedures: Laboratory animals should be anesthetized or restrained during experimental procedures if unexpected movement during experimental procedures may increase the lab personnel's risk of exposure to biological hazards. Biological safety cabinets (A.K.A. laminar flow hoods or cell culture hoods) should be utilized whenever experimental procedures may result in splashing or aerosolization of biohazards.
Question 20, Personal Protective Equipment (PPE): Gloves and gowns/lab coats are the minimum required level of PPE for an animal biosafety level 2 facility. Increased face and respiratory protection may be required based on the risks associated with the agents and procedures utilized as part of the experimental design.
Questions 21 and 22, Shedding of biological hazards: Agents transferred to animals may be shed in to bedding via secretions (saliva) or excretions (urine and feces). Viral vectors administered to animals can be reasonably expected to be shed in the animals' bedding and can pose an occupational exposure risk to research personnel manipulating the animals and animal caretakers who change the bedding and clean the contaminated caging.
Question 23, Inactivation of waste and waste disposal: Contaminated surfaces will be decontaminated with a suitable disinfectant (e.g. 70% ethanol, 10% bleach, etc.). Contaminated PPE and other solid waste will be placed in a biohazard waste bag. Sharps will be disposed in sharps boxes immediately after use without recapping.
Question 24, Disposal of animal carcasses: Animal carcasses will be placed in a biohazard waste bag and deposited in a red infectious waste bin.
Additional Resources and Further Assistance
- All personnel will be required to comply with the containment and safety practices dictated by the CDC's guidelines for Biosafety in Microbiological and Biomedical Laboratories, 5th Edition.
- Further training for work with animals at various biosafety levels is available from the American Biosafety Association.
- Medical Center Policy 128 for use of research animals in the Medical Center.
- For further assistance, please contact the MUSC Biosafety Officer.