Bio by keralaguest

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									Biological Agent Registration
University of Florida


The following agents require registration & approval BEFORE you begin the research:

      1) Biosafety level 2 (BSL-2) or BSL-3 human, animal, or plant pathogens. Note that BSL-4
         agents may not be used at UF.
      2) Unknown human and animal pathogens - these are considered BSL-2 until identified.
      3) Cell lines or cultures that:
             a. have been immortalized with a virus (such as EBV or a retrovirus), or
             b. are primary human tumor cells
           these are considered BSL-2 (or higher).
      4) Human blood or other tissues that are known to be HIV positive (or positive for any
         human disease-causing virus or other agent), when used in research.



Project submissions are reviewed by Institutional Biosafety Committee (IBC) members; BSL-3
projects or those using select agents will require additional information & are forwarded to the
full IBC for review, comment, and approval.
The IBC Committee is composed of scientists that may not be experts in your particular field of
research. Please tailor your project description accordingly.


We must get enough information from you to be able to make determinations about the
necessary containment level, facilities, procedures, practices, and expertise/training necessary
for the safe conduct of the project, so please be thorough. Insufficient information will delay the
approval process; the form will be returned to you for revision. Please use the fillable form; hand
written forms will be returned.




1/4                                                                  EHS-Bio-Agent-Reg. ver. 06/08
University of Florida                                                        Biological Agent Registration
Environmental Health & Safety
Biological Safety Office                                                     #BA -
bso@ehs.ufl.edu
phone: (352)-392-1591
fax: (352)-392-3647

Principal Investigator:                                        PI’s Title:
Department:                                                    Address/Box:
Phone:                                                         Email:
Project Title:

Sponsor: __                ________________________________________________________________

1. Location of project                               2. Animal Use on THIS project:        Yes    No
Building:              Room(s):                         IACUC(s)#:
                                                        (if not yet approved, write “pending”)
3. R-DNA Use?   Yes            No                       Where will animals be housed?
   IBC/EH&S #: RD-                                      Where will animal procedures be done?

4. Isotope Use?     Yes        No If yes, RSC approval date:


5. List each agent and its biosafety level/risk category (see http://www.absa.org/resriskgroup.html)
 Agent (genus, species, common name if applicable)                     Biosafety level (BSL)/risk category




6. Where will you be obtaining these agents from:

7. Are any of these agents Select Agents http://www.ehs.ufl.edu/Bio/select.htm             Yes    No

8. Project Summary/Abstract (Describe your project clearly & simply. Include background, purpose, objectives, methods, etc.
Use attachment if necessary)




9. Will you transport or ship biological agents/infectious substances/diagnostic specimens?            Yes     No

2/4                                                                                    EHS-Bio-Agent-Reg. ver. 06/08
10. Have your staff taken the Shipping & Transport of Biohazardous Materials class we offer?                Yes        No
      See http://www.ehs.ufl.edu/Bio/default.asp for information on training.


11. Will you work with human body fluids, human tissues, human primary cell cultures?      Yes    No
      Will you work with non-human primate body fluids, tissues, or primary cell cultures?    Yes   No
      Have your staff been registered in the blood borne pathogen program?   Yes      No
      http://www.ehs.ufl.edu/Bio/BBP/default.htm

      If yes, what project personnel?




      See also http://www.ehs.ufl.edu/Bio/tissue.htm, and/or http://www.ehs.ufl.edu/Bio/hiv.htm

12. Will you work with biological agents in any of the following aerosol-producing devices/procedures:

Centrifuges                    Tissue grinders   Blenders     Yes       No   Autopsy/necropsy saws
   Yes      No                   Yes       No                                      Yes        No
                                                 Shakers     Yes       No
Does the rotor have a cover    Sonicators                                    Intranasal/Intratracheal
or do the buckets have lids?     Yes       No    Pressurized vessels         Inoculation of animals
   Yes     No                                                                      Yes        No
                                                 (besides autoclaves)
                               Vortexers            Yes     No
                                 Yes       No

13. Will you work with large volumes ( 10 L) of infectious material?        Yes         No

14. Have staff received immunizations and/or tests for agents in use or potentially present in the lab

      (e.g. hepatitis B or vaccinia vaccines, TB skin testing, serum banking)?      Yes List:                     No

       See http://www.ehs.ufl.edu/Bio/vaccinia.htm, or http://www.ehs.ufl.edu/Bio/BBP/tnv.pdf,
       or http://www.ehs.ufl.edu/Bio/Animal/achand.htm

15. Safety Equipment and Procedures:

        Bio-safety cabinet:  Yes  No
                                                            Autoclave available:          Yes      No
        Note: Laminar flow hoods NOT ACCEPTABLE
                                                            location:
        model:
                                                            Proper function and testing
        location/room:                                      monitored by (name):

        certification date:                                 Test method/frequency:
 Personal protective equipment used (list):
                                                            How do you dispose of biohazardous waste?



                                                            Are Standard Operating Procedures (SOPs)
 Method of inactivation of agent:
                                                            prepared for work with these agents?
                                                                 Yes    No

                                                            Hand washing sink available:            Yes     No


3/4                                                                                      EHS-Bio-Agent-Reg. ver. 06/08
   Disinfection of surfaces procedure:




                                                                                BIOLOGICAL AGENT
                                                                                                             Registration

  This page can be signed then faxed, mailed, or scanned and e-mailed.

  16. The undersigned individual(s) will be involved in the experimentation described above. They are familiar with
     and agree to abide by the current University of Florida guidelines as outlined in the Biological safety manual
     http://www.ehs.ufl.edu/Bio/BioMan.pdf . ALL PARTICIPANT SIGNATURES REQUIRED.

        Name (Please Type or Print)                Signatures                                   Date




  I attest to the fact that these individuals are properly trained in the area of biological agent experimentation.
  I agree to comply with UF requirements pertaining to handling, shipment, transfer, & disposal of biological agents.
  I am familiar with and agree to abide by the provisions of the current biosafety manual and other specific biosafety
  office/IBC instructions pertaining to the proposed project.
  I understand that I must have EH&S or IBC approval before beginning this work.
  I understand that changes to the project described above must be reported to EH&S Biosafety in advance.
  I understand that associated IACUC or IRB approvals may be held pending EH&S or IBC approval of this work.
  The information above is accurate and complete to the best of my knowledge.


                                                       Principal Investigator                     Date


Notes (EH&S/IBC use only):




  E-mail, fax, or mail form to the Biosafety office
  bso@ehs.ufl.edu, fax: (352) 392-3647, mail: PO Box 112190
  4/4                                                                              EHS-Bio-Agent-Reg. ver. 06/08

								
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