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					         University of California, Irvine                               IBC USE ONLY
       Institutional Biosafety Committee                                Biosafety Level Required:
             (IBC) Modification Form                                    Date Received:              IBC Approval #

 This form is to be used to request approval for modification(s)
 of previously approved IBC protocols.

 Modifications include changes in methods or procedures, location of research facilities, personnel, rDNA, or other biological
 materials. Changes must not be implemented until IBC approval is granted. E-mail the complete application to
 ibc@uci.edu. Fax or mail a signed copy of the Investigator’s Acknowledgment of Responsibilities to Fax (949) 824-1325 or
 4600 Health Sciences Rd ZOT 2725

Principal Investigator:                             Phone:                          Fax:            UCI E-mail:

IBC Protocol #                                      Project Title:
          MODIFICATIONS: Check all that apply
          Investigator contact information, Personnel, Location – complete Section A
          rDNA – complete Section B
          Generation of transgenic animals (including cross breeding, knock outs, breeding of two different strains) or
          other genetically animals - complete Section B-1
          Generation of transgenic plants- complete Section B-2
          Infectious Agents – complete Section C
          Whole animals (vertebrates vs invertebrates) – complete Section D
          Human/Primate Materials- complete Section E
          Biological Toxins – complete Section F

 Project Description
 1.        Explain how the requested modification(s) will affect the scope of work:
             a. In lay language, provide a one paragraph summary of your overall research objectives.
             b. Summarize the purpose and goals and anticipated outcomes
             c. Explain why and how specific agents are used.



 2.    Explain what precautions, decontamination, and disposal methods will be employed as a result of the
 modification.



 3.      Why should the new procedure(s) be a modification of the existing project rather than a new protocol
 submission?


 4. Describe how personnel have been (or will be) trained in the handling of the new or changed material.



 Section A:
Contact Information Change only:
New Mailing Address:               Telephone        Fax                    UCI e-mail address            New emergency number




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 Personnel                               Complete the sections below only if you are adding personnel

                                                                  Position            EH&S training completed                                     Occupational
    Action
                  Name: Last,            UCI E-Mail               Title               Bloodborne pathogens (BBP) (required annually)              Health
                  First                  e.g. anteater@uci.edu    e.g. Staff          Laboratory Core and Hazardous Waste required every (3       Requirements
                                                                  researcher          years). Fulfills CalOSHA requirements                       Check all that apply
    Add                                                                                  Select Agents            BBP       Viral Vectors            None         Vaccine
    Delete                                                                               Hazardous Waste          BSL-3     Laboratory Core          Hep B        Respirator
                                                                                         Other:                                                      Other:
    Add                                                                                  Select Agents            BBP       Viral Vectors            None         Vaccine
    Delete                                                                               Hazardous Waste          BSL-3     Laboratory Core          Hep B        Respirator
                                                                                         Other:                                                      Other:
    Add                                                                                  Select Agents            BBP       Viral Vectors            None         Vaccine
    Delete                                                                               Hazardous Waste          BSL-3     Laboratory Core          Hep B        Respirator
                                                                                         Other:                                                      Other:
    Add                                                                                  Select Agents            BBP        Viral Vectors            None        Vaccine
    Delete                                                                               Hazardous Waste          BSL-3      Laboratory Core          Hep B       Respirator
                                                                                         Other:                                                       Other:




 Location of Study
                Building:               Room #        Shared room or       Room functions              Aerosol containment control                      Biosafety Level
                e.g. Hewitt Hall        e.g.103       open bench           Check all that apply        equipment                                        BSL1, BSL2,
   Action                                             space                                            Check all that apply                             BSL2+,
                                                                                                                                                        BSL3, or ABSL1, 2,
                                                                                                                                                        3,
    Add                                                                        Bench work
    Delete                                                                     Agent storage              Fume hood           Cert Date:
                                                        Bench
                                                                               Tissue culture             Biosafety cabinet Cert Date:
                                                        No
                                                                               Animal procedure           Glove box           Cert Date:
                                                        Yes, PI’s name:
                                                                                room                      Sealed centrifuge cups
                                                                               Other:                     Sealed rotors on centrifuge
                                                                               Other:
    Add                                                                        Bench work
    Delete                                                                     Agent storage              Fume hood           Cert Date:
                                                        Bench                  Tissue culture             Biosafety cabinet Cert Date:
                                                        No                     Animal procedure           Glove box           Cert Date:
                                                        Yes, PI’s name:         room                      Sealed centrifuge cups
                                                                               Other:                     Sealed rotors on centrifuge
                                                                               Other:
    Add                                                                        Bench work
    Delete                                                                     Agent storage              Fume hood           Cert Date:
                                                        Bench
                                                                               Tissue culture             Biosafety cabinet Cert Date:
                                                        No
                                                                               Animal procedure           Glove box           Cert Date:
                                                        Yes, PI’s name:
                                                                                room                      Sealed centrifuge cups
                                                                               Other:                     Sealed rotors on centrifuge
                                                                               Other:
    Add                                                                        Bench work
    Delete                                                                     Agent storage              Fume hood           Cert Date:
                                                        Bench
                                                                               Tissue culture             Biosafety cabinet Cert Date:
                                                        No
                                                                               Animal procedure           Glove box           Cert Date:
                                                        Yes, PI’s name:
                                                                                room                      Sealed centrifuge cups
                                                                               Other:                     Sealed rotors on centrifuge
                                                                               Other:


 Section B
rDNA Check one             Addition of a new rDNA host – vector system and/or                Change(s) to an approved rDNA
host-vector system
Identify host (s) to be used: Example E. Identify the vector(s) to be used: Examples: Identify the nature of the DNA sequence,
coli, S. cerevisiae, human/animal cells, whole        Bacterial plasmids, yeast plasmids, cultured cell plasmid    including the species of origin (i.e., specific gene,
animals, humans.                                      vectors, baculoviruses, transforming viruses                 promoter, expressed product and function (if known).




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Will an attempt be made to purify any of the foreign gene product(s)?               Yes      No
If yes, indicate which foreign gene product will be purified and describe the procedures for purification


If replication-incompetent vectors will be used, explain how incompetent vectors will be tested for reversion mutations
(e.g., endpoint dilution analysis, plaque assay).



 Change(s) to the experiments covered by NIH guidelines –
                         SUMMARY OF EXPERIMENTS COVERED BY THE “NIH GUIDELINES”
The NIH Guidelines can be found at http://oba.od.nih.gov/oba/index.html

Mark the appropriate section(s) that describes this project. If experiment does not fall into any of these categories, contact
Biosafety Office for assistance at extension 49888 (check all that apply): Appendix B of this application describes Risk
Groups (RG).
     1. III A....must receive approval from IBC, Recombinant DNA Advisory Committee, and NIH Director before
        initiation of experiments.
    III-A-1-a: The deliberate transfer of a drug resistance trait to microorganisms that are not known to acquire the trait naturally if such
acquisition could compromise the use of the drug to control disease agents in humans, veterinary medicine, or agriculture. (Note that
antibiotic resistance markers used for selecting and propagating plasmids in E. coli are not included.)
     2. III B….must receive approval from NIH/OBA and IBC before initiation of experiments.
    III-B-1: Experiments involving the cloning of toxin molecules with LD50 of <100ng per kg body weight (e.g., microbial toxins such as
botulinum toxin, tetanus toxin).
     3. III C.....must receive approval from IBC, IRB, and RAC review before research participant enrollment.
    III-C-1: Experiments involving the deliberate transfer of rDNA, or DNA or RNA derived from rDNA, into one or more human research
participants.
NOTE: Attach response to Points to Consider under: Appendix M of the NIH Guidelines and submit any
supplemental documents such as investigator brochure, clinical study, correspondence with NIH, etc
     4. III D....must receive approval from IBC before initiation of experiments.
    III-D-1      Experiments using Risk Group 2, Risk Group 3, Risk Group 4, or Restricted Agents as host-vector systems
    III-D-2      Experiments in which DNA or RNA from Risk Group 2, Risk Group 3, Risk Group 4, or Restricted Agents is cloned into
                          nonpathogenic prokaryotic or lower eukaryotic host-vector systems
    III-D-2-a   Experiments in which DNA from RG- 2, RG- 3 agents, or RG-4 agents is transferred into nonpathogenic prokaryotes or
                lower eukaryotes.

   III-D-2-b Containment conditions for experiments in which DNA from restricted agents is transferred into nonpathogenic
prokaryotes or lower eukaryotes shall be determined by NIH/OBA following a case-by-case review (see Section V-L, Footnotes and
References of Sections I-IV). A U.S. Department of Agriculture permit is required for work with plant or animal pathogens (see Section
V-G, Footnotes and References of Sections I-IV)

    III-D-3        Experiments involving the use of infectious DNA or RNA viruses or defective DNA or RNA viruses in the presence of
helper virus in tissue culture systems (Section III-D-3)
    III-D-3-a   Use of infectious or defective RG-2 viruses in the presence of helper virus.
    III-D-3-b   Use of infectious or defective RG-3 viruses in the presence of helper virus may be conducted at BL3 containment.
    III-D-3-d   Use of infectious or defective restricted poxviruses in the presence of helper virus shall be determined on a case-by-
                case basis following NIH/OBA review. A USDA permit is required for work with plant or animal pathogens.
    III-D-3-e   Use of infectious or defective viruses in the presence of helper virus not covered in Sections III-D-3-a through III-D-3-d.


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     5. III D 4         rDNA Involving Whole Animal

   III-D-4-     Experiments involving whole animals in which the animal's genome has been altered by introduction of DNA or RNA into
                the germ line (transgenic animals) and experiments involving viable recombinant DNA-modified microorganisms tested
                on whole animals.
   III-D-4-a    rDNA, or DNA or RNA molecules derived therefrom, from any source except for greater than two-thirds of eukaryotic
                viral genome may be transferred to any non-human vertebrate or any invertebrate organism and propagated under
                conditions of physical containment comparable to BSL1 or BSL1-N and appropriate to the organism under study.
                Animals that contain sequences from viral vectors, which do not lead to transmissible infection either directly or indirectly
                as a result of complementation or recombination in animals, may be propagated under conditions of physical
                containment comparable to BSL1 or BSL1-N and appropriate to the organism under study. Experiments involving the
                introduction of other sequences from eukaryotic viral genomes into animals are covered under Section III-D-4-b.
                Investigator must demonstrate that the fraction of the viral genome being utilized does not lead to productive infection.
   III-D-4-b    Experiments involving rDNA, or DNA or RNA derived therefrom, involving whole animals, including transgenic animals,
                and not covered by Sections III-D-1 or III-D-4-a, may be conducted at the appropriate containment determined by the
                IBC.
   III-D-4-c-1 Experiments involving the generation of transgenic rodents that require BSL1 containment as described under Section
               III-E-3
   III-D-4-c-2 Purchase or transfer of transgenic rodents that are exempt from the “NIH Guidelines” under Section III-F but must be
               registered with the IBC (Section III-D-4-c-2)

   III-D-6      Experiments involving more than 10 liters of culture. (The appropriate containment will be decided by the IBC. Where
                appropriate, Appendix K of the “NIH Guidelines” will be used to determine containment conditions.)


     6. III E – Experiments that require IBC notice prior to initiation

   III-E-1      Experiments involving the formation of R-DNA molecules containing no more than 2/3 of the genome of any eukaryotic
                virus (all viruses from a single Family being considered identical) which may be propagated and maintained in cells in
                tissue culture using BL1 containment? (It must be shown that the cells lack helper virus for the specific Families of
                defective viruses used. The DNA may contain fragments of the genome of viruses from more than one Family but each
                fragment shall be less than two-thirds of a genome.)

   III-E-2-b-5 Experiments with recombinant DNA-modified arthropods or small animals associated with plants, or with arthropods or
               small animals with recombinant DNA-modified microorganisms associated with them if the recombinant DNA-modified
               microorganisms have no recognized potential for serious detrimental impact on managed or natural ecosystems.

   III-E-3      Experiments involving the generation of rodents in which the animal’s genome has been altered by stable introduction of
                recombinant DNA, or DNA derived therefrom, into the germ-line (transgenic rodents)? (Only experiments that require
                BL1 containment are covered under this section; experiments that require BL2, BL3, or BL4 containment are covered
                under Section III-D-4.)

     7. III F – Experiments that are exempt from the NIH Guidelines but require submission prior to initiation

   III-F-1      Recombinant DNA molecules that are not in organisms or viruses

   III-F-2      Recombinant DNA molecules that consist entirely of DNA segments from a single nonchromosomal or viral DNA source,
                though one or more of the segments may be a synthetic equivalent

   III-F-3      Recombinant DNA molecules that consist entirely of DNA from a prokaryotic host including its indigenous plasmids or
                viruses when propagated only in that host (or a closely related strain of the same species) or when transferred to
                another host by well established physiological means.

   III-F-4      Recombinant DNA molecules that consist entirely of DNA from a eukaryotic host including its chloroplasts, mitochondria,
                or plasmids (but excluding viruses) when propagated only in that host (or closely related strain of the same species).

   III-F-5      Those that consist entirely of DNA segments from different species that exchange DNA by known physiological
                processes though one or more of the segments may be a synthetic equivalent.


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              III-F-6         Those that do not present a significant risk to health or the environment as determined by the NIH Director, with the
                              advice of the RAC, and following appropriate notice and opportunity for public comment.

                                                                     ADDENDUM B-1
                                       Use and Creation of Transgenic or Genetically Modified Animals
1.      Yes       No Are you creating a new strain of genetically engineered (e.g transgenic or knock out) animals?
This includes cross breeding two strains of genetically engineered animals.

2. If "Yes", please describe (procedure and technique) how the transgenic animal will be created.


2a. If the animal is created by use of viral vectors, describe the vector and promoter.


3. Provide the gene name and function


4. Provide a description of the possible hazards associated with the alteration


5.     Yes No Has the source animal already been genetically modified?
If yes, describe the genetic modification(s)


6. Yes No Is the transgenic/knockout line created at the UCI Transgenic Core Facility?
If no, provide an alternate facility location.


7.     Yes        No        Does the transgenic animal pose a potential hazard to animal caregivers? If yes, describe the precautions that must be
followed.




                                                                     ADDENDUM B-2
                                        Use and Creation of Transgenic or Genetically Modified Plants.
1. What is the source of the material:
   PI laboratory
   Collaborator at UCI Provide PI name:
   Outside of UCI: Provide name:

2.      Yes No Have you received authorization from the appropriate federal, state, and local regulatory agencies to acquire these
materials?
3. List all applicable authorizing agencies:
4. Describe how the transgenic plant is constructed (check and describe all that apply):
   Yes No Agrobacterium:
   Yes No Rhizobium:
   Yes No Electroporation :
   Yes No Microprojectile bombardment :
   Yes No Viral directed transformation or viral infection :
   Yes No Other :

         SUMMARY OF EXPERIMENTS COVERED BY THE NIH GUIDELINES SECTION VIII FOR RESEARCH INVOLVING
                                     RECOMBINANT DNA (rDNA) IN PLANTS
                              Mark the appropriate section(s) that describes this project.
     III D....must receive approval from IBC before initiation of experiments.
        III-D-5         Experiments involving whole plants



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    III-D-5-a BL3-P (Plants) or BL2-P + biological containment which is recommended for experiments involving most exotic (see Section
V-M, Footnotes and References of Sections I-IV) infectious agents with recognized potential for serious detrimental impact on managed or
natural ecosystems when recombinant DNA techniques are associated with whole plants (Section III-D-5-a)

    III-D-5-b BL3-P or BL2-P + biological containment which is recommended for experiments involving plants containing cloned genomes
of readily transmissible exotic infectious agents with recognized potential for serious detrimental effects on managed or natural ecosystems in
which there exists the possibility of reconstituting the complete and functional genome of the infectious agent by genomic complementation in
planta

    III-D-5-d BL3-P containment is recommended for experiments involving sequences encoding potent vertebrate toxins introduced into
plants or associated organisms (also refer to Section III-B-1)

    III-D-5-e BL3-P or BL2-P + biological containment is recommended for experiments with microbial pathogens of insects or small
animals associated with plants if the rDNA-modified organism has a recognized potential for serious detrimental impact on managed or
natural ecosystems

III E …..Experiments that require IBC notice prior to initiation
    III-E-2     Experiments involving R-DNA-modified whole plants, and/or experiments involving R-DNA-modified organisms associated with
plants, except those that fall under Section III-A, III-B, III-C, III-D, and III-F? (See Section III-E-2 for recommendation of containment levels.)

    III-E-2-a BL1-P which is recommended for all experiments with recombinant DNA-containing plants and plant-associated
microorganisms not covered in Section III-E-2-b or other sections of the NIH Guidelines? Examples of such experiments are those involving
recombinant DNA-modified plants that are not noxious weeds or cannot interbreed with noxious weeds in the immediate geographic area,
and experiments involving whole plants and recombinant DNA-modified non-exotic (see Section V-M, Footnotes and References of Sections
I-IV) microorganisms that have no recognized potential for rapid and widespread dissemination or for serious detrimental impact on managed
or natural ecosystems (e.g., Rhizobium spp. and Agrobacterium spp.)

   III-E-2-b    BL2-P or BL1-P + biological containment is recommended for the following experiments:

   III-E-2-b – (1) Plants modified by rDNA that are noxious weeds or can interbreed with noxious weeds in the immediate geographic area.

   III-E-2-b – (2) Plants in which the introduced DNA represents the complete genome of a non-exotic infectious agent.

   III-E-2-b – (3) Plants associated with rDNA-modified non-exotic microorganisms that have a recognized potential for serious detrimental
impact on managed or natural ecosystems.

   III-E-2-b – (4) Plants associated with rDNA-modified exotic microorganisms that have no recognized potential for serious detrimental
impact on managed or natural ecosystems

     Section C
    Infectious Agents
                                      Risk         Biosafety Level                                   Room
               Agent                                                           Building                                           Room Use
                                      Group        (BSL1-4)                                         Number
            (Adenovirus)                                                       Med Sci C                                  (experiment, storage or both)
                                      RG2          BSL2                                               123




     Section D
    Whole animals (vertebrates vs invertebrates)
    Biological Materials used         Animal      Max           Max dose       Method of          Specify route(s) of       Please explain the measures
    (Infectious agents, vectors, or   species     infectious    per            delivery: e.g      shedding/excretion        your lab will take to prevent
    human cell lines used in live     e.g. Mice   units/dose    animal         Intravenous,       of infectious             accidental exposure to
    animals?)                                     e.g.10^8 ml   e.g. 5         Intranasal,        agents: e.g. Urine,
    e.g. MLV retrovirus                                                        Subcutaneous,      Feces, Saliva, Blood,
                                                                               Intramuscular      Unknown


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  Section E
Human Material
   Material – List each         Type          Source        Origin of materials                                  Known        Building        Room
     material per line          e.g. HEK      e.g. Human    Check all that apply                               Pathogens    e.g. Med Sci     Number
 e.g. Established cell line                                 Clinical specimens                                  e.g. None                    e.g.123
                                                                Commercial vendor    Clinical specimens
                                                                Field  Primate center     None
                                                                Other
                                                                Commercial vendor    Clinical specimens
                                                                Field  Primate center     None
                                                                Other
                                                                Commercial vendor    Clinical specimen
                                                                Field  Primate center     None
                                                                Other


  Section F
Biological ToxinS
Toxin                Building              Room #          Room Used          Amount          Physical stage     Beginning         Final concentration
                                                           (experiment,       Purchased       of agent           concentration     use
                                                           storage, or
                                                           both)




1. Describe the type of work being done with Toxin(s) listed above (1-2 sentences only)


2. Describe the dilution procedures.


3. Describe safe handling and disposal procedures that will be used for this         toxin.



Acknowledgement of Responsibilities
I attest that the information contained in this IBC modification is accurate and complete. I agree to comply with all requirements pertaining to the
use, handling, storage and disposal of biohazardous agents and recombinant DNA molecules as outlined in my approved IBC protocol and this
modification request.


 Typed Name of Principal Investigator                        Signature of Principal Investigator                                 Date
Approval for inclusion of this modification into the referenced protocol has been granted by the IBC


Signature of IBC Chair or designee                                                                         Date


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