New Pathogen Approval

Procedure for Manipulating a New Pathogen within the Biosafety Level 3 Facility

The Biosafety Level 3 (BL-3) Facility may only be used for the manipulation of pathogens that have been assigned to or below Risk Group 3 by the National Institutes of Health, Office of Biotechnology Activities.  Pathogens that have been assigned to Risk Group 4 are strictly prohibited from entering the BL-3 Facility.

An investigator wishing to manipulate a pathogen that has not been previously manipulated within the BL-3 Facility must:

1.  Submit a REQUEST FORM  and an ECP for the approval from the BL-3 Advisory Group. The request includes the following information:

a.    The name and description of the pathogen

b.    A description of the organism's pathogenicity in humans

c.    A list of the available diagnostic tests and vaccine specific for the pathogen

d.    A description of the procedures that will be used in the manipulation of the pathogen

e.    A list of equipment needed 

f.    A description of the procedure to be used for the disposal of all waste 

    that is generated by the manipulation of the pathogen

   g.    A list of references relating to the laboratory manipulation of the pathogen

2.  Agree to present an in-service to all of the users of the BL-3 Facility for the purposes of informing them of the new pathogen, the procedures that will be used within the Facility for its manipulation, and for addressing any questions and/or concerns the facility users may have.

The Facility Research Assistant (RA) will acquire supplementary information regarding the manipulation of the pathogen as needed, including relevant guidelines published by the CDC, the National Institutes of Health (NIH), and information from outside experts who are experienced with handling of the pathogen.  The RA must also participate in the in-service that is presented to the users of the Facility.  

When the protocol proposal has been approved by the BL-3 Advisory Group, the BL-3 Facility management will:

1. Formulate and institute a program for the surveillance of facility users for exposure to the pathogen.

2. Amend the current versions of the Guidelines for the Use of the BL-3 Core Facility, and the Blood Borne Pathogens Exposure Control Plan to include the surveillance program, and the approved guideline and protocol for the safe handling of the new pathogen.  The amended documents will be distributed to all users of the Facility.

Manipulation of the pathogen within the BL-3 Facility will not be allowed to proceed before all of the above actions have been successfully completed.