IBC reference No. Institutional Biosafety Committee _____________________________ Exempt Dealing Evaluation Report Does your proposed Exempt work fall into one or more of the categories listed below? Please note this also includes possession (storage) of this material. Read each category carefully. If your work with genetically modified organisms (GMOs) is listed in the following descriptions, print this document out, sign and date it (below), and forward it to the IBSC secretary (biosafety@uq.edu.au). At this point you may commence the work. For ANY work being conducted with GMOs that is not described below, or if you are unsure, contact the IBSC secretary for advice on how to proceed further, or consult the Gene Technology Regulations (2011) http://www.ogtr.gov.au/pubform/legislation.htm Any dealing with a genetically modified nematode (Caenorhabditis elegans) unless: (a) an advantage is conferred on the animal; or (b) the animal becomes capable of producing or secreting an infectious agent. NOTE: All transgenic rodent work (knockout, knockdown, transgenic etc) must be done under a Notifiable Low Risk Dealing (NLRD) or Licenced Dealing (contact Biosafety Approvals Adviser for details). A dealing with an animal into which genetically modified somatic cells have been introduced, if: (a) The somatic cells cannot give rise to infectious agents as a result; and (b) The animal is not infected with a virus capable of recombining with the GM nucleic acid of the somatic cells. A dealing with an animal whose somatic cells have been genetically modified in vivo by a replication defective viral vector, if (a) the in vivo modification occurred as part of a previous dealing; and (b) the replication defective viral vector is no longer in the animal; and (c) no germ line cells have been genetically modified; and (d) the somatic cells cannot give rise to infectious agents as a result of the genetic modification; and (e) the animal is not infected with a virus that can recombine with the genetically modified nucleic acid in the somatic cells of the animal. A dealing involving a host/vector system listed on page 2 and producing no more than 25 litres of GMO culture in each vessel, provided that the gene of interest: (a) (b) (c) (d) (e) does not code for a vertebrate toxin with an LD50 of less than 100 g/kg; and does not code for a vertebrate toxin with an LD50 of 100 g/kg or more, if the intention is to express the toxin at high levels; and is not uncharacterised nucleic acid from an organism producing a vertebrate toxin; does not include a viral sequence that can lead to production of replication competent virions in the host cell. must satisfy either of the following requirements: (i) the gene must not be uncharacterised DNA derived from organisms implicated in, or with a history of causing, disease in human beings, animals, plants or fungi; or (ii) if the gene is derived from such disease-causing organisms, then the gene must be characterised and not known to alter the host range or mode of transmission, or increase the virulence, pathogenicity or transmissibility of the host or vector. A dealing involving shotgun cloning or the preparation of a cDNA library, in a host/vector system mentioned in the bacterial class below, if the donor nucleic acid is not derived from either a pathogen or a toxin-producing organism. University of Queensland, 2014 1 Institutional Biosafety Committee Part 2 Schedule 2: Host/vector systems for Exempt dealings Class Bacteria Host Escherichia coli strains K12, B, C, Nissle 1917: any derivative that does not contain: (a) generalised transducing phages; or (b) genes able to complement the conjugation defect in a non-conjugative plasmid Vector 1. Non-conjugative plasmids 2. Bacteriophage (a) lambda (b) lambdoid (c) Fd or F1 (eg M13) 3. None (non-vector systems) Agrobacterium tumefaciens — disarmed strains 1. Non-tumorigenic disarmed Ti plasmid Agrobacterium rhizogenes — disarmed strains vectors, or Ri plasmid vectors Agrobacterium radiobacter 2. None (non-vector systems) Note: Several other specific bacterial species and strains are included in this listing - consult the Biosafety Approvals Advisor or http://www.ogtr.gov.au/pubform/legislation.htm for further information. Fungi Kluveromyces lactis 1. All vectors Neurospora crassa – laboratory strains 2. None (non-vector systems) Pichia pastoris Saccharomyces cerevisiae Schizosaccharomyces pombe Trichoderma reesei Yarrowia lipolycta Slime Dictyostelium species 1. Dictyostelium shuttle vectors moulds 2. None (non-vector systems) Tissue Animal or human cell cultures 1. Non-conjugative plasmids culture (including packaging cell lines) 2. Non-viral vectors, or defective viral vectors unable to transduce human cells 3. Avipox vectors (attenuated vaccine strains) 4. Baculovirus (Autographa californica nuclear polyhedrosis virus), polyhedrin minus 5. None (non-vector systems) Plant cell cultures 1. Non-tumorigenic disarmed Ti plasmid vectors, or Ri plasmid vectors, in Agrobacterium tumefaciens, A. rhizogenes or A. radiobacter 2. Non-pathogenic viral vectors 3. None (non-vector systems) In addition to the above, unfixed material derived from genetically modified organisms is deemed as being in the Exempt category so long as the there is no virus or micro-organism capable of replication in the samples, and the donor DNA meets the above criteria. Any work using nanoparticle as a delivery system is also deemed as being in the Exempt category, so long as the host is listed above AND the DNA meets the above criteria. I declare that: 1) My research group conducts Exempt dealings with GMOs, including possession, that are described in one or more of the categories listed on this form. I will submit applications for dealings with GMOs not listed on this form (eg NLRD, DNIR) to the IBC for approval. 2) If my work changes to include dealings not described here, or if I am unsure about the category of work, I will contact the Biosafety Approvals Advisor for advice. 3) The work will be done in accordance with the OGTR “Guidelines for the Containment of Exempt Dealings” and the “Guidelines for the Transport of GMOs (Exempt Dealings)”. Project supervisor Name: School/phone/email: Signature: Date / / After signing and returning this form, you may conduct any of the kinds of dealings described on this form until such time as the Gene Technology Regulations are altered and/or your receive other advice from the IBC. University of Queensland, 2014 2