Notification of a Notifiable Low Risk Dealing

Document Sample
Notification of a Notifiable Low Risk Dealing Powered By Docstoc
					Notification of a Notifiable Low Risk Dealing (NLRD)

Notifying Organisation Name:        THE UNIVERSITY OF QUEENSLAND

Accreditation Number:               ACCR 030/2002


   Project Supervisor


   NLRD Project Title:


   IBC Project identifier:

   Exempt Identifier (if applicable):




  Is this notification to replace an existing dealing?
   No      Yes  provide IBC or OGTR no. here:



  Is this notification accompanied by an application for a declaration that
  certain information be treated as Confidential Commercial Information (CCI)?
    No      Yes  provide previous CCI no. if relevant




  Will the dealing involve the import of GMOs into Australia?    No    Yes




    Date of Notification to Supervisor/Applicant

    Date of Project Commencement:


    Date of Project Termination (Five years from project
    commencement followed by indefinite storage):




                                            1                             UQ NLRD
General Information
Notification of a notifiable low risk dealing (NLRD)
Regulation 13 of the Gene Technology Regulations 2001 (as amended with effect from 31 March
2007 by the Gene Technology Amendment Regulations 2006) requires that an Institutional
Biosafety Committee (i) confirms that an NLRD is a dealing of a kind mentioned in Part 1 of
Schedule 3 of the Regulations; and (ii) considers that the personnel to be involved in the proposed
dealing have appropriate training and experience.
According to the Act, to “deal with” in relation to a GMO, means any of the following: (a) conduct
experiments with the GMO; (b) make, develop, produce or manufacture the GMO; (c) breed the
GMO; (d) propagate the GMO; (e) use the GMO in the course of manufacture of a thing that is not
a GMO; (f) grow, raise or culture the GMO; (g) import the GMO; and includes the possession,
supply, use transport or disposal of the GMO for the purposes of, or in the course of, a dealing
mentioned in any of (a) to (g).
Accuracy of information
Please answer all questions unless otherwise indicated. Please check that the information
provided in this notification is true and accurate. The Act provides for penalties to a person who
knowingly gives information to the Regulator that is false or misleading.



Part 1:          Project Supervisor

  Project supervisor’s name:
  Position within the
  organisation:
  School/Institute etc
  Relevant qualifications:
  Relevant experience:



Contact details of the Project Supervisor


  Business telephone number:

  Mobile telephone number:

  Facsimile number:

  E-mail address:




                                                2                                        UQ NLRD
  Part 2:      Description of the Dealings and GMO(s)
Briefly describe the purpose of the Dealing (in no more than a few sentences) and
proposed methods to be undertaken in the dealing (as dot points).



  Purpose of the Dealing:



  Proposed methods:

        Exempt dealings relevant to this Application:


         Description of NLRD dealings:

     

     

        This project will include indefinite storage of GMOs and/or GMO products.




                                               3                                     UQ NLRD
      Part 2 Table: is intended to generate a concise, accurate record of all the GMOs to be generated or used and the purpose of the proposed dealings.
     Attachment 1 provides example reference responses to the description of the GMOs. Attachment 2 provides information relating to the completion of the
     column headed ‘NLRD Type’.


       4A                    4B                       4C                    4D                             4E                               4F               4G
COMMON NAME OF      SCIENTIFIC NAME OF    VECTOR(S) & METHOD OF       EXEMPT HOST/    IDENTITY & FUNCTION OF NUCLEIC ACID &         ORGANISMS OR         NLRD
PARENT ORGANISM     PARENT ORGANISM       TRANSFER                    VECTOR          ORGANISM OF ORIGIN                            TISSUES TO BE USED   TYPE
                                                                      SYSTEM ?                                                      WITH THE GMO(S)




                                                                                 4                                                               UQ NLRD
     Part 3: Containment Facilities
    Please provide information for all facilities to be used in connection with this NLRD



     FACILITY NAME                              FACILITY ADDRESS                           CONTAINMENT             OGTR ID            EXPIRY
                                                                                           LEVEL & TYPE                                DATE
  (building and room no.)

eg #64/733                     eg MacGregor building, room 733                             PC2 lab              IBC will enter      IBC will enter




    STORAGE OF GMOs
    GMOs may be stored outside a certified facility provided that:
    1.   transport to storage outside the facility, must be in accordance with any transport guidelines.
    2.   GMOs or organisms containing GMOs may be stored outside the facility in a storage unit (freezer, fridge, controlled temperature room or
         other container). A biohazard symbol must be posted on the storage unit. The storage unit must be locked when not in use, unless access is
         restricted to the room or area where the storage unit is located. Access to the storage unit must be restricted or controlled to prevent
         unintentional release of GMOs into the environment.
    3.   GMOs or organisms containing GMOs being stored outside the facility must be double-contained. The primary container must be sealed
         to prevent the escape or release of the GMOs and must be labelled. The primary container must be stored in an unbreakable secondary
         container. In the case of a small storage unit such as a fridge, freezer or liquid nitrogen container, the secondary container may be the
         storage unit.

     UNCERTIFIED STORAGE FACILITY NAME                                        UNCERTIFIED STORAGE FACILITY ADDRESS

eg #64/736 or Not applicable                                  eg MacGregor building, room 736 or Not applicable


                                                                          5                                                              UQ NLRD
                           Part 4: Declarations
A.           Declaration of the Project Supervisor

I (Project Supervisor Name) DECLARE THAT:

    In addition to PC2 laboratory work practices, all personnel involved in the
     dealings have appropriate training and experience in procedures and equipment
     used. This training has been signed and documented; and
    All personnel involved in the dealings have been notified of the risks associated
     with the material being used and the procedures being undertaken (as indicated
     in the risk assessment).
    Documented procedures are in place to decontaminate any spills involving GMOs
     inside or outside the nominated facilities.


     Signature                                               Date




B.           Declaration of the Organisation submitting this notification
This declaration must be signed by the CEO or another person with the authority to
sign on behalf of the organisation.

I DECLARE THAT:
    I am duly authorised to sign this declaration;
    The Institutional Biosafety Committee detailed in Part 1 of this form has
     confirmed that the dealings listed in this notification are Notifiable Low Risk
     Dealings;
    Persons undertaking these dealings have been notified in writing that the
     dealings are NLRDs; and
    Personnel involved in the dealings have appropriate training and experience.

University of Queensland IBC Representative

       Printed                                   Signature
        name
      Job title                                   Date of
                                                     IBC
                                                 Approval




                                             6
                                                                                    Examples Only
            Attachment 1
            Examples of responses to Part 2 - Description of the GMO(s)
            Note: “Parent Organism” means organism(s) (or tissue derived from organisms) that you propose to genetically modify. “Host” equates to “Parent”.

COMMON NAME             SCIENTIFIC NAME OF                     VECTOR(S) & METHOD OF TRANSFER                             EXEMPT      IDENTITY & MODIFIED TRAIT/ FUNCTION OF GENE(S) &                 ORGANISMS      NLRD
OF PARENT               PARENT ORGANISM                                                                                    HOST/                    ORGANISM OF ORIGIN                                OR TISSUES TO   TYPE
ORGANISM                                                                                                                  VECTOR                                                                      BE USED WITH
                                                                                                                         SYSTEM ?                                                                      THE GMO(S)
Zebrafish                      Danio rerio                                       Plasmid                                    no        Expression of green fluorescent protein (GFP) from Aequorea           -         PC2(a)
                                                                       microinjected into embryos.                                                               victoria

Mouse                        Mus musculus               Bacterial artificial chromosomes (BACs) microinjected into          no                 Growth hormone from various Mus species                      -         PC2(aa)
                                                                                mouse embryos

Thale cress               Arabidopsis thaliana              Non tumorigenic disarmed Ti plasmid via vacuum                  no           Expression of pigment related genes from Arabidopsis               -         PC2(b)
                                                                               infiltration.                                                                   species.

Vibrio                       Vibrio harveyi              Standard non-conjugative plasmid expression vector by              no        Expression of cell surface antigen fragments from V. cholerae         -         PC2(c)
                                                                           electroporation.

Escherichia           Escherichia coli (pathogenic      Standard non-conjugative cloning vector pUC, pBluescript            no            Expression of defective virulence genes from E. coli        Mouse and Rat   PC2(d)
                                strains)                                  by electroporation.

Human cultured       Human cell line (fibroblast cell        Replication defective human adenoviral vector.                 Yes       Expression of wild type and mutant oncogenes isolated from         Mouse        PC2(i)
cells                             line)                                                                                                                      Homo sapiens.

Escherichia               Escherichia coli K12                     Standard non-conjugative plasmids.                    Yes (>10L)          Expression of insulin gene from Homo sapiens                   -         PC2(f)

Salmonella                Salmonella enterica                             Conjugative plasmids.                             no         Complementation of single virulence related genes from S.            -         PC2(g)
                                                                                                                                                    enterica into knock-out host

Escherichia               Escherichia coli K12                Non-conjugative plasmids by electroporation.                  Yes          cDNA library from Clostridium toxin producing species              -         PC2(h)


Human cultured        Human cell line (HEK-293)            Replication defective 3rd generation lentiviral vector           No           Expression of green fluorescent protein from Aequorea              -         PC2(i)
cells                                                                                                                                                            victoria



                                                                                            Examples Only
                                                                                                                     7
Attachment 2
The column NLRD TYPE requires that you select one of the following categories
which best describes the dealing with the GMO(s) – as per Schedule 3 Part 1 of the
Gene Technology Regulations 2001 (as amended by the Gene Technology
Amendment Regulations 2007).

Part 1        Notifiable low risk dealings suitable for physical
              containment (PC) level 1
     PC1 (a) a dealing involving a genetically modified laboratory mouse or a genetically
              modified laboratory rat, unless:
               (i) an advantage is conferred on the animal by the genetic modification; or
              (ii) because of the genetic modification, the animal is capable of secreting
                   or producing an infectious agent;

    PC1 (b) a dealing involving a host/vector system mentioned in Part 2 of Schedule 2,
               if the donor nucleic acid confers an oncogenic modification;

    PC1 (c) a dealing involving a defective viral vector able to transduce human cells in a
              host mentioned in item 4 of Part 2 of Schedule 2 (animal or human cell
              culture), unless:
               (i) the vector is a retroviral vector; or
              (ii) the donor nucleic acid confers an oncogenic modification



Part 2        Notifiable low risk dealings suitable for physical
              containment (PC) level 2

   PC2 (a) a dealing involving whole animals (including non-vertebrates) that:
              (i)    involves genetic modification of the genome of the oocyte or zygote or
                     early embryo by any means to produce a novel whole organism; and
              (ii)   does not involve any of the following:
                       (A) a genetically modified laboratory mouse;
                       (B) a genetically modified laboratory rat;
                       (C) a genetically modified Caenorhabditis elegans;

   PC2 (aa) a dealing involving a genetically modified laboratory mouse or a genetically
                 modified laboratory rat, if:
               (i) the genetic modification confers an advantage on the animal; and
              (ii) the animal is not capable of secreting or producing an infectious agent
                   as a result of the genetic modification;

   PC2 (ab) a dealing involving a genetically modified Caenorhabditis elegans, if:
              (i)    the genetic modification confers an advantage on the animal; and




                                             8
            (ii)   the animal is not capable of secreting or producing an infectious agent
                   as a result of the genetic modification;

PC2 (b)       a dealing involving a genetically modified plant (including a genetically
      modified flowering plant), if the dealing occurs in a facility that is designed to
      prevent the escape from the facility of:
            (i) pollen, seed, spores or other propagules which may be produced in the
                course of the dealing; and
           (ii) invertebrates that are capable of carrying the material mentioned in
                subparagraph (i);

PC2 (ba) a dealing involving a genetically modified flowering plant, if, before
      flowering, all inflorescences are wholly enclosed in bags designed to prevent
      escape of viable pollen and seed;

PC2 (c)        a dealing involving a host and vector that are not mentioned as a
               host/vector system in Part 2 of Schedule 2, if:
             (i) the host has not been implicated in, or had a history of causing, disease
                  in human beings, animals, plants or fungi; and
            (ii) the vector has not been implicated in, or had a history of causing,
                  disease in human beings, animals, plants or fungi;

PC2 (d)        a dealing involving a host and vector that are not mentioned as a
               host/vector system in Part 2 of Schedule 2, if:
             (i) either:
                   (A) the host has been implicated in, or has a history of causing,
                          disease in human beings, animals, plants or fungi; or
                   (B) the vector has been implicated in, or has a history of causing,
                          disease in human beings, animals, plants or fungi; and
            (ii) the donor nucleic acid is characterised and is not known to alter the host
                  range or mode of transmission, or increase the virulence, pathogenicity
                  or transmissibility of the host or vector;

PC2   (e)      a dealing involving a host/vector system mentioned in Part 2 of Schedule
               2, if the donor nucleic acid:
             (i) encodes a pathogenic determinant; or
            (ii) is uncharacterised nucleic acid from an organism that has been
                   implicated in, or has a history of causing, disease in human beings,
                   animals, plants or fungi;

PC2   (f)     a dealing involving a host/vector system mentioned in Part 2 of Schedule 2
              and producing more than 10 litres of GMO culture in each vessel
              containing the resultant culture, if:
            (i) the dealing is undertaken in a facility that is certified by the Regulator:
                  (a) as a large scale facility; and
                  (b) to at least physical containment Level 2; and



                                           9
                (ii)   the donor nucleic acid satisfies the conditions set out in item 4 of Part 1
                       of Schedule 2;

    PC2   (g)    a dealing involving complementation of knocked-out genes, if the
          complementation does not alter the host range or mode of transmission, or
          increase the virulence, pathogenicity, or transmissibility of the host above that of
          the parent organism before the genes were knocked-out;

    PC2   (h)      a dealing involving shot-gun cloning, or the preparation of a cDNA library,
          in a host/vector system mentioned in item 1 of Part 2 of Schedule 2, if the donor
          nucleic acid is derived from either:
                 (i) a pathogen; or
                (ii) a toxin-producing organism;

    PC2   (i)       a dealing involving the introduction of a replication defective viral vector
          able to transduce human cells into a host mentioned in Part 2 of Schedule 2 if:
                 (i) the donor nucleic acid is incapable of correcting a defect in the vector
                     leading to production of replication competent virions; and
                (ii) either:
                       (A) the vector is a retroviral vector; or
                       (B) the donor nucleic acid confers an oncogenic modification.

.




                                                10

				
DOCUMENT INFO
Shared By:
Categories:
Tags:
Stats:
views:2
posted:8/27/2011
language:English
pages:10