University of Alabama

Application for Approval and Registration of Biohazardous Agents - Class 3

Investigator  ________________________________________________________________

Building(s)  ________________________________         Room(s)  ____________________ 

Dept  ____________________________________           Date  _______________________

Biosafety Level 3 (BSL-3) is applicable to clinical, diagnostic, teaching, research, or production facilities in which work is done with indigenous or exotic agents which may cause serious or potentially lethal disease as a result of exposure by inhalation.  Laboratory personnel have specific training in handling pathogenic and potentially lethal agents, and are supervised by competent scientists who are experienced in working with these agents.  Standard microbiological practices and Universal Precautions apply to all work done with BSL-3 agents.  In addition, all procedures involving the manipulation of infection materials are conducted within biological safety cabinets or other physical containment devices, or by personnel wearing appropriate personal protective clothing and equipment.  The laboratory has special engineering and design features.

A biosafety manual must be prepared and be made readily available to all lab workers.  This biosafety plan must summarize the hazards of the work and describe the safety precautions and emergency procedures to be followed in the event of a spill or release.  The plan should be included in the initial training for new lab workers and should be reviewed with all workers annually. 

WRITTEN SAFETY PLAN

Agent Information:  Please give the following information on the agent/agents in the lab area. 

                Name:

                Epidemiology of diseases caused by or associated with the agent:

                Disease symptoms:

                Hazard Assessment:

                Check all the apply:    Human Hazard _____    Animal Hazard _____    Plant Hazard _____

Usage Information:  Briefly summarize how Class 3 agent(s) are to be used or investigated.  If available, you can attach copies of grants, publications, protocols, etc., that describe intended usage in detail.

Safety Precautions:  List all the safety practices and handling procedures which all laboratory personnel are required to follow.

                General Safety Practices (other than standard practices and universal precautions):

                Required Personal Protective Equipment/Clothing:

                Procedures requiring a Biological Safety Cabinet:

                Decontamination of work surface:

                Decontamination of equipment:

                Disposal of waste:

                Has BSL-3 signage been requested from EHS?    _____ Yes     _____ No  If no, contact EHS at 348-5905.

                Is the work area highly restricted?  _____ Yes  _____ No

                Does a double set of doors separate the lab from other areas?  _____ Yes    _____ No

Medical Surveillance:

                If using a human pathogen, is a vaccine available?    _____ Yes    _____ No    _____ NA

                If yes, have all potentially exposed personnel been offered the vaccine?     _____ Yes    _____ No

                Required immunizations:

      Have all personnel received appropriate immunizations or tests for agents in use?  ____ Yes  ____ No

      Have baseline serum samples been collected for all at-risk personnel?   _____ Yes    _____ No

 **Documentation of tests and immunization must be maintained by the LBSO.              

Security Procedures:  Persons who are at increased risk of acquiring infection or for whom infection might have serious consequences are not allowed in BSL-3 areas.  Please describe how access to the area is restricted and the specific entry requirements for the area (e.g., immunization, training, etc).

Please describe the procedures in place for inventory control. 

**In the event that samples of agent are noticed as missing, contact the LBSO and EHS.

Human Components:  If human blood components, body fluids or tissues are used, additional concerns may arise.  Please list below the specific substances to be used, the source of substances, and how they will be used.

                Have all new personnel had Bloodborne Pathogen Training?  Yes _____    No _____    NA ____  If not, contact EHS at 348-5905 to schedule training.

                Have all existing personnel had annual retraining on Bloodborne Pathogens?  Yes _____   No_____  If not, contact EHS at 348-5905 to schedule retraining.

Disposal Methods:  Please describe the disposal methods to be used for any waste containing infectious agents, biological toxins, or human blood components, fluids or tissues. 

Decontamination Practices:  Please describe the decontamination methods used for work surfaces and equipment.  If using a chemical disinfectant, please state type and concentration of product.

Emergency Procedures:  Describe the procedures to be followed in the event of personnel exposure or spills.

As LBSO, I certify that the above information is correct to the best of my knowledge and that I will follow the procedures outlined in the UA Biological Safety Manual as well as prudent microbiological safety and research practices.  I further certify that I will train all students and lab workers on this plan as well as on the practices and procedures required for their work.

Name of LBSO (printed):

Date:

Signature:

The IBSC has reviewed this application.  There was a majority vote to approve/disapprove the proposed work with BSL-3 agents.

Signature of IBSC Chair:                                                                                        Date: