I. INTRODUCTION

This Manual is applicable to all laboratory, research, service and support activities that may involve exposure to biohazardous agent or materials and that come under the purview of the Institutional Biosafety Committee (IBC).

Activities which are specifically addressed are those involving:

• Various bacterial, fungal, and parasitic agents
• Live viruses
• Recombinant DNA; exposure to research animals
• Human blood and tissues
• Receipt, handling, and disposal of biological materials

The Manual does not address issues of radiation or chemical safety. These are covered by the University Radiation Safety Committee and the Chemical Hygiene Plan. UND Biological Safety

B. Regulatory Forces and Guidelines

Guidelines developed by the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC) form the basis for the biosafety practices included in this manual. These guidelines must be followed to ensure the continuation of grant funds from federal agencies.

The NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines):

• Mandate the establishment of an Institutional Biosafety Committee (IBC) for the review and oversight of biological research
• Outline roles and responsibilities for biosafety
• Establish the practices, procedures, and conditions under which recombinant DNA work must be conducted.

The companion guidelines from CDC-NIH, Biosafety in Microbiological and Biomedical Laboratories (BMBL) address the appropriate measures and facilities for work with all microbial agents, including bacterial, viral, fungal, parasitic, and rickettsial agents.

For work with human blood and some other body fluids and tissue, the requirements of the Occupational Exposure to Bloodborne Pathogens standard from the Occupational Safety and Health Administration (OSHA) apply. Special training, medical surveillance, procedures, and equipment that must be in place are described in Section IVof the Institutional Biosafety Manual.

The obtaining, possession, use, or transfer of any select biological agent or toxin is strictly regulated by federal code and regulations. It requires federal permits and inspection as well as significant measures of lab security, personnel training, and accurate record keeping regarding the status of possessed materials. Further information on select agents and toxins is found in Section IV of the Manual.

Handling and disposal of bio hazardous waste is regulated and monitored by the North Dakota Department of Health under the Infectious rules found in the North Dakota Administrative C itation 33-20-12. The procedures for biological waste handling outlined in Section IV F of the Manual comply with the requirements of these rules.

The requirements for packaging and shipment of biomedical materials are provided in the Public Health Service regulation 42 CFR Part 72 Interstate Shipment of Etiologic Agents and parts of the Department of Transportation Hazardous Materials regulation 49 CFR, Parts 171-180. A Material Transfer Agreements (MTA) may be required, contact RD&C (777-4278) for more information. Information on shipping procedures that comply with these regulations is found in Section IV ( G and H) of the Manual.

C. The Biological Safety Program at UND

The biological safety program at UND developed from the University’s commitment to address and comply with the NIH Guidelines regarding safe research with Recombinant DNA and associated viral materials. Oversight of UND’s biological safety program is provided by the Institutional Biosafety Committee (IBC). The key components of the program are:

• The Institutional Biosafety Committee (IBC)
• Research Development and Compliance (RD&C)
• The Department Chair
• The Principal Investigator
• The Researcher or User
• Environmental Health and Safety (EHS)
• Employee Health ( Student Health Center)
• Campus Veterinarian

The roles and responsibilities of each are described below:

1. The Institutional Biosafety Committee (IBC):

• Oversees the biological safety program
• Reviews research proposals involving rDNA and other biological agents and materials agents, and approves those that comply with NIH and CDC guidelines and University policy
• Adopts policies supporting the safe use of biological materials and the elimination or reduction of exposure to potentially biohazardous materials or agents
• Addresses biosafety issues related to experimentally-infected laboratory animals

2. Research Development and Compliance (RD&C) – Contact the Administrative Secretary of the IBC and IRB at 777-4279 :

• Initiates the registration of biological research (IBC Application process) by providing departments with the application material
• Accepts all Applications and Annual Reviews for research proposals submitted by Principal Investigators and departments and coordinates their review by the IBC.
• Accepts research proposals involving the use of humans and coordinates their review by the Institutional Review Board (IRB)

3. Department Chairperson

• Receives from RD&C the material for registration of biological research
• Ensures that application forms are completed by each Principal Investigator conducting applicable research

4. Principal Investigator

• Completes a UND Institutional Biosafety Committee Application for all research proposals involving the use of biological materials or agents
• Submits completed applications and annual registration forms to RD&C
• Accepts direct responsibility for the health and safety of those working with biological materials in his/her laboratory
• Ensures proper training and instruction for laboratory personnel in safe practices and protocols, including, at a minimum, training in aseptic techniques and biology of the organism(s) being used
• Ensures that laboratory personnel receive any necessary medical surveillance
• Ensures compliance by laboratory personnel with the relevant regulations, guidelines, and policies
• Ensures biosafety cabinets are certified as needed and personal protective equipment is provided and used.

5. The Researcher or User:

• Participates in appropriate training and instruction
• Becomes familiar with all biological agents being used in the lab and the potential risks associated with exposure
• Follows all laboratory practices and protocols and complies with all applicable guidelines and policies
• Completes any necessary medical surveillance
• Reports all accidents, spills, or contamination incidents to supervisor

6. EHS (Biosafety Officer) – Contact: Associate Vice President for Research (777-4278)

• Consults with researchers on issues of biosafety and the safe use of biological materials in the laboratory
• Develops protocols and procedures to address issues of biosafety
• Provides training in safe use and practices for those involved in work with potentially biohazardous materials and activities
• Advises researchers on proper waste disposal methods based on federal and state regulations and established University practice.
• Provides oversight of the BBP program and conducts initial and annual training for laboratory personnel with such exposure
• Investigates Adverse Events

7. Employee Health – Contact: Medical Director of Student Health (777-3963)

• Advises on need for medical surveillance and/or immunization for those personnel exposed or potentially exposed to biological agents
• Provides medical review and medical surveillance, as appropriate, for live virus workers, those exposed to laboratory animals, and those in the BBP Program
• Altru Occupational Health and the Altru Emergency Room can be utilized for serious injuries or contaminations that will require more than 1 visit to the Student Health Center; or after business hours. If you are unsure contact the Student Health Center for advise at 777-4500.

8. Animal Health – Contact: Director of Center of Biomedical Research (777-4493)

• Advises investigators and animal care personnel on the potential biohazards and risk of physical injury associated with laboratory animals and on the procedures for reducing or eliminating exposure
• Provides training to all animal users in bio methodology and safe animal handling

9. Other Committees (Human Subjects (IRB), Animal Care and Use (IACUC), Radiation Safety)

• Consults and coordinates with the IBC on any proposals under their purview which involves the use of potentially biohazardous materials or activities