Safety Procedures for Handling and Care of Animals Exposed to Human
Origin Tissue, Cells or Tumors
Policy No: 105.03
Revision No: New
Effective Date: August 31, 2010
Revision Date: June 30, 2014
Category: Personnel Health and Safety
Purpose:
The purpose of this SOP is to define biosafety procedures for the handling and care of animals exposed
to human origin tissues, body fluids, cells or tumors. This includes research animals that receive human
origin material directly through such routes as injection, surgery or implantation. Of particular interest are
immunocompromized animals such as Severe Combined Immunodeficient (SCID) or athymic nude
rodents, and animals receiving irradiation or other immunosuppressive treatments. These safety
procedures are designed to protect personnel from pathogenic agents that may originate or be carried in
the human material that has been transferred to the research animals.
Procedure:
A. Human tissues, body fluids, cells or tumors must be considered potentially infectious and handled
with appropriate safety precautions. Because blood and body fluid transmissible pathogens pose
a hazard to personnel the general precautions in patient care (Universal Precautions) apply to
the laboratory handling of human origin material as described by the OSHA Blood Borne
Pathogen Standard (29CFR 1910.1030) and the University Guide to Laboratory Safety.
B. All research animals receiving human origin material via injection, surgery, implantation or other
routes of exposure that could potentially result in transmission of human pathogens must be
handled in accordance with NIH/CDC Biosafety Level 2 Procedures. This applies to animals
used in laboratories and the animal research facilities as described in facility biosafety standard
operating procedures.
C. The principal investigator must submit all animal research protocols to the Institutional Animal
Care and Use Committee via the Animal Use Protocol and indicate if tumor cells, tissue, sera, or
other biological materials from human sources are to be used. The supplier and quality control
tests to insure that biological agents are free from infectious agents and results of those tests
must be listed. It is not required that human biological material be tested for human pathogenic
organisms if handled under appropriate biosafety conditions.
D. The principal investigator must submit all animal research protocols involving the study of known
biohazardous agents including human pathogens to the Institutional Biosafety Committee. The
Institutional Biosafety Committee does require the review of animal research protocols involving
human origin tissue. All such studies will be conducted in accordance with NIH/CDC Biosafety
Level 2 Procedures or higher under Laboratory Animal Services standard operating procedures.
E. Husbandry and care of animals, sanitation, and handling of cages or accessory equipment will be
carried out in accordance with specific animal facility biosafety standard operating procedures.
Cages must be appropriately labeled with identification of biohazard.
F. Human Origin material being inoculated into animals for the recovery of known or suspected
pathogens must be done at least at biosafety Level 2; a higher level may be required in some
cases.
References:
1.
CDC. Recommendations for Prevention of HIV Transmission in HealthCare Settings
MMWR 1987, 36: No. 25, 317.
2.
3.
4.
5.
6.
7.
CDC. Update: Universal Precautions For Prevention of Transmission of Human
Immunodeficiency Virus, Hepatitis B Virus, and other Bloodborne Pathogens in Health Care
Settings MMWR 1988, 37: No. 24, 377387.
CDC. Supplement: 1988 Agent Summary Statement for Human Immunodeficiency Virus and
Report on Laboratory Acquired Infection with HIV. MMWR 1988, 37, No. 54, 122.
CDC. Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5 th ed. 2007.
Thomas Jefferson University Hospital Isolation Manual.
Thomas Jefferson University – Guide to Laboratory Animal Safety.
Milman G and D'Souza P. HIV Infections in SCID Mice: Safety Considerations. ASM News 1990,
56; No. 12 639642.
Signatures:
Reviewer:
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Approved by:
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