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Biosafety Manual
Chapter 1: Introduction and Administration

Chapter 1: Introduction and Administration

1. PURPOSE:

The Biosafety Manual shall provide policy and guidance related to biological safety for West Virginia University (WVU). It is the responsibility of all faculty, staff, and students working with biohazards, potentially infectious materials, or recombinant and synthetic nucleic acids to abide by the guidance set forth in this manual.

2. SCOPE:

The Biosafety Manual is for all facilities at WVU working with biohazards, potentially infectious materials, or recombinant and synthetic nucleic acid molecules.

3. DEFINITIONS:

3.1. Biological Safety Levels (BSL): Designations of laboratories in ascending order based on the degree of risk associated with the laboratory work being conducted and the degree of protection provided to personnel, the environment, and the community.

3.2. Biohazards: Any biological agent that has the potential to cause harm to people, animals, plants, or the environment. Also referred to as Infectious Materials.

3.3. Biosafety: The discipline addressing the safe handling and containment of infectious microorganisms and hazardous biological materials through the application of containment principles and risk assessment.

3.4. Blood Borne Pathogen: Microorganisms carried in the blood that can cause disease in humans.

3.5. Infectious Materials: Synonym for Biohazards. See Biohazard for definition.

3.6. Institutional Biosafety Committee (IBC): An institutional committee, required by the NIH Guidelines for Research Involving Recombinant and Synthetic Nucleic Acids, which reviews research being conducted on all campuses involving recombinant and synthetic nucleic acids, pathogens, toxins, wild animals, exotic pests, and human-derived materials.

3.7. Other Potentially Infectious Materials (OPIM): Any human body fluids which can be contaminated by blood including: semen, vaginal secretions, cerebrospinal fluid, synovial fluid, pleural fluid, pericardial fluid, peritoneal fluid, amniotic fluid, or saliva. Unfixed human tissues or organs, other than intact skin, are also considered OPIMs. Lastly, cells/tissue cultures, organ cultures, and culture medium or other solutions containing human immunodeficiency virus (HIV) or hepatitis B virus (HBV) blood, organs, and other tissues from experimental animals infected with HIV or HBV.

4. ROLES:

4.1. West Virginia University Environmental Health & Safety (EHS) Department

The EHS Biosafety Office, under the direction of the Biosafety Officer, is responsible for overseeing all matters related to biological safety on all of WVU’s campuses. The Biosafety Office will maintain the Biosafety Manual and ensure all procedures and guidelines are current. It will also provide training related to matters of biological safety.

4.2 Principal Investigators (PI)

The PIs are responsible for ensuring that all work being performed within their laboratory is performed in compliance with federal and university regulations, policies, and guidelines including the Biosafety Manual. PIs will perform risk assessments for all procedures to be performed within the laboratory. They will secure approval, prior to the initiation of any research, from applicable university committees (e.g. IBC, ACUC, IRB) and ensure lab personnel has completed, and remain up to date, with all training related to biological safety.

4.3. Faculty, Staff, and Students

Faculty, staff, and students will abide by all policies and procedures set forth in the Biosafety Manual and will complete all applicable biological safety training, including refresher training.

4.4. Institutional Biosafety Committee (IBC)

The IBC will meet to review and approve protocols related to all research at WVU that involves the following: recombinant or synthetic nucleic acids, pathogens, toxins, wild animals, or exotic pests.

5. REFERENCES:

West Virginia University adopted and utilized the following regulations and guidelines to create WVU Biosafety Manual:

CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL) provides biosafety guidelines related to working with biohazards.

NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules govern work involving recombinant and synthetic nucleic acids.

OSHA Blood Borne Pathogens Standard (29 CFR 1910.1030) provides regulations related to the use of human-derived materials and other potentially infectious materials (OPIM).

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Continue to Chapter 2: Institutional Biosafety Committee

Version History:

Revision Control Table
Version	Changes	Revised by
1.0	Initial version	Matt Stinoski