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Policy: Biosafety 


Date: 06/30/05 Policy ID: SEC-012 Status: Final

Policy Type: University
   
Contact Office: Environmental Health and Safety
   
Oversight Executive: Vice President for Research
   
Applies To:  Academic Division and the Medical Center.
   
Table of Contents: 

Policy Statement
Registration and Approval Mechanics

   
Reason for Policy: 

To protect University faculty, staff, students, visitors and the general public from biological agents used by the University of Virginia.

   
Policy Summary: 
   
Definition of Terms in Statement: 

Biological Agents:

  1. Microorganisms
  2. Human and non-human primate derived materials which may contain human pathogens (e.g. blood, fluids, tissues, organs, primary and established cell lines, etc.).
  3. Biotoxins with an LD50 of less than 100 micrograms per kilogram of body weight in vertebrates.
  4. Recombinant DNA activities as described in the NIH Guidelines for Research Involving Recombinant DNA Molecules.

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Policy Statement: 

The University of Virginia will comply with all applicable federal, state and local regulations which apply to the possession, manipulation and disposal of biological agents. Additionally, consensus biosafety guidelines such as those from the National Institutes of Health, Centers for Disease Control, and other organizations will be applied as appropriate to protect personnel and the environment from potentially adverse exposures to biological agents.

All Principal Investigators or faculty who possess or use biological agents must register the possession and use of biological agents with the University of Virginia Institutional Biosafety Committee (IBC). Investigators and faculty are authorized to proceed with the proposed activities only after obtaining IBC approval. Principal Investigators and faculty are responsible for ensuring that their practices, equipment and facilities do not jeopardize the health and well-being of themselves, their personnel, or the general public. The IBC and Environmental Health and Safety provide consultation and assistance to Principal Investigators and faculty in this regard.
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Registration and Approval Mechanics
All Principal Investigators and faculty who possess or use biological agents are required to complete an IBC registration document. Those investigators or faculty who indicate regulated status will have their submission document reviewed at a convened IBC meeting.

  • New registrants are contacted to schedule a laboratory inspection which includes evaluation of appropriate work practices, containment, signs and labeling, an acceptable biosafety manual, and other factors. Completion of a satisfactory inspection, submission of requested records, forms, or other documentation results in assignment of an approval number and an acceptance letter, at which time the Principal Investigator or faculty member is authorized to proceed with the proposed activities.

  • Once initial IBC approval has been granted, Principal Investigators and faculty must submit registration modifications for review and approval prior to acquiring new biological agents, adding work or storage areas, or engaging in new procedures. The IBC's disposition of proposed registration modifications will depend largely upon the nature of the modification, and may result in: immediate approval, request for additional information or inspection, or disapproval. Principal Investigators and faculty who have not submitted modifications in the previous one year period are required to review the previous online registration submission to confirm its accuracy.

  • Investigators/faculty who possess or use biological agents without appropriate IBC approval are subject to suspension of research funding, and laboratory closure at the discretion of the IBC, Institutional Biosafety Officer, or Responsible Official (per 42 CFR Part 73). The Office of Sponsored Programs will not release external funding for projects involving biological agents without evidence of IBC approval.

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Procedures: 
   
Related Information: 
   
Policy Background: 
   
Major Category: Safety, Security and Environmental Quality
   
Category Cross Reference: 
   
   
Process: 
   
Next Scheduled Review: 06/30/14
   
Approved By, Date: Policy Review Committee, 06/30/05
   
Revision History: Updated 7/21/11.
   
Supersedes (previous policy):  Biosafety XIV.D.1