The Princeton University Biosafety Manual is intended to be a resource for information, guidelines, policies, and procedures that will enable and encourage those working in the laboratory environment to work safely and reduce or eliminate the potential for exposure to biological hazards. The information presented here also reflects the requirements and guidelines of federal and state regulations. It is intended that the Principal Investigator and supervisory personnel will supplement this information with instruction and guidance regarding specific practices and procedures unique to the work being done by those in their laboratories.

Your comments and suggestions concerning the Manual are welcomed and can be made on-line at the
web site.

I. INTRODUCTION

A. Scope (top)

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

Activities which are those specifically addressed are those involving:

• work with recombinant DNA
  
• various bacterial, fungal, and parasitic agents
  
• Live viruses
  
• experimentally infected 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 in the University Radiation Safety Manual and the Chemical Hygiene Plan and can be accessed here.

B. Regulatory Forces and Guidelines (top)

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 II of the 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 IIC of the Manual.

Handling and disposal of bio hazardous waste is regulated and monitored by the NJ Department of Environmental Protection under the Regulated Medical Waste rules found in the NJ Administrative Code at 7:26-3A. 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. 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 Princeton University (top)

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

• The Institutional Biosafety Committee (IBC)
  
• Office of Research and Project Administration (ORPA)
  
• The Department Chair
  
• The Principal Investigator
  
• The Researcher or User
  
• Environmental Health and Safety (EHS)
  
• Occupational Medicine
  
• Campus Veterinarian

The roles and responsibilities of each are described below:

The Institutional Biosafety Committee (IBC):

The IBC membership includes representative faculty and administrators, the University Biosafety Officer, a University Physician, the Campus Veterinarian, and representatives from Princeton Township and Borough. The committee’s current membership is listed in the current University Register. The IBC:

• Oversees the biological safety program
  
• Reviews research proposals involving rDNA and other biological agents and materials, 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

Office of Research and Project Administration (ORPA) – Contact Joseph Broderick, Secretary of the IBC and IACUC at 258-3976:

• Initiates the registration of biological research (Memorandum of Understanding and Agreement [MUA] process) by providing department chairs with the registration material
  
• Accepts all MUAs and Annual Registrations for research proposals submitted by Principal Investigators and departments and coordinates their review by the IBC
  
• Accepts research proposals involving the use of animals and coordinates their review by the Institutional Animal Care and Use Committee (IACUC)

Department Chairperson

• Receives from ORPA the material for registration of biological research
  
• Ensures that MUA forms are completed by each Principal Investigator conducting applicable research
  
• Submits completed MUAs and annual registration forms to ORPA

Principal Investigator

• Completes a Memorandum of Understanding and Agreement (MUA) for all research proposals involving the use of biological materials or agents
  
• Accepts direct responsibility for the health and safety of those working with biological materials in his/her laboratory
  
• Ensures proper lab orientation, training, and instruction for laboratory personnel in safe practices and protocols, including, instruction in good microbiological techniques and practices needed to work safely with the biological agents and materials involved
  
• 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
• Reports immediately to OPRA any significant violations of the NIH Guidelines, problems with containment and any significant research - related accidents or illinesses

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

Environmental Health and Safety (EHS) – Contact Don Robasser (Biosafety Officer) at 258-6256:

• 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 manages on-line web-based training program for those with potential exposure
• Conducts periodic inspection of labs using biological materials

Employee Health– Contact Peggy Henke (Office Manager), Sara Ingraffia (RN), or Alice Kerwick (RN) at 258-5035:

• 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

Campus Veterinarian – Contact Vicki Eng at 258-1113

• 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

Other Committees (Human Subjects, 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

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