VCOM Institutional Policy and Procedure Manual

VCOM Policy and Procedure

Policy #R012

2.5. Definitions Biohazardous Material : The categories below represent the areas of primary concern with respect to biosafety. Projects involving material(s) included by any of these categories must be submitted for IEBC approval:

1. Chemical carcinogens used in conjunction with animals. 2. Toxic/infectious agents used in conjunction with animals. 3. Oncogenic viruses used in conjunction with animals.

4. Infectious agents requiring handling conditions above Biosafety Level-1 (biosafety level determinations are based on the recommendations outlined by the CDC-NIH publication Biosafety in Microbiological and Biomedical Laboratories ).

5. Recombinant DNA (unless exempted by National Institutes of Health Guidelines). 6. Human blood and blood products, human body fluids, and/or human tissue.

7. Toxins produced by living organisms (>1 mg of pure toxin, or solutions with concentrations of >1 mg/ml pure toxin). This provision excludes toxins covered by the Select Agent regulations (see number 9 below). 8. Radioactive materials, either used as experimental reagents or in conjunction with animals. 9. Whenever a contractual agreement or grant proposal requires Institutional Biosafety Committee approval for the safe handling of a biological or chemical product. 10. "Select Agents" as defined in 42CFR72.6, Public Law 107-188, Public Health Security and Bioterrorism Response Act. These agents are listed in Appendix B. 11. Restricted animal pathogens/high consequence livestock pathogens/diseases, toxins, and listed plant pathogens, as determined by the United States Department of Agriculture (USDA), are listed in Appendix C. These lists are taken from the CDC/NIH’s Biosafety in Microbiological and Biomedical Laboratories. 12. Any research that requires a permit from USDA Animal and Plant Health Inspection Service (APHIS). The IEBC also serves as an advisory committee for College projects that involve possible biohazards that do not appear to fall into any of the areas above. When it is unclear as to whether a material constitutes a potential biohazard, the Institutional Biosafety Officer should be consulted. VCOM Institutional Environmental and Biosafety Committee (IEBC) : The IEBC is a committee appointed by the Provost, Dean and Executive Vice President to review and approve the use of biohazardous materials in research. The membership of this Committee includes faculty and staff with expertise in relevant areas. Membership of this Committee is consistent with federal regulations on the review of projects involving the use of biohazardous material, toxins, recombinant DNA, etc. 2.6. Requests for Biohazard Review IEBC review and approval must be obtained by completing and forwarding four copies of the Application for Use of Biohazardous Materials to the Institutional Biosafety Officer (IBO). The PI is responsible for providing sufficient information to allow the IBO to determine if this work can be conducted safely and appropriately according to the policies of the institution. If a proposal has been submitted to a funding source, a copy of the grant proposal must accompany the completed application. A separate submittal will be required for each project and must contain all potentially hazardous agents involved. In addition, any pertinent federal forms must also be completed and submitted to the IBO. A written safety protocol will be required for projects that involve biohazardous materials used in conjunction with animals, select agents, projects involving USDA restricted plant pathogens and any project conducted at Biosafety Level 2 or higher. The safety protocol will require signatures from the Institutional Biosafety Officer and the Chief of Operations.

VCOM Policies and Procedures Governing Environmental Health & Safety

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