GENE TECHNOLOGY REGULATIONS 2001 2001 NO. 106 - SCHEDULE 4 Prescribed information

Commonwealth Numbered Regulations

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GENE TECHNOLOGY REGULATIONS 2001 2001 NO. 106 - SCHEDULE 4

Prescribed information - application for a licence

Part 1 Dealings not involving an intentional release of a GMO into the environment (Division 3 of Part 5 of the Act)
1.1 Information to be given by all applicants
For an application to which Division 3 of Part 5 of the Act applies (a Division 3 application ), the following information is required:
1.1.1 General information

(a): name, address, telephone number and other contact details, of applicant;
(b): name, position within the organisation and contact details, of applicant's project supervisor in relation to the proposed dealing, or dealings, with the GMO or GMOs involved;
(c): title of the project involving the proposed dealing or dealings;

(d) description of the GMO or GMOs involved, including:

(i): the common name of the parent organism; and
(ii): the scientific name of the parent organism; and
(iii): the modified trait; and
(iv): the identity of the gene responsible for the modified trait;

(e): description of the proposed dealing or dealings;
(f): description of the purposes and aims of the dealing or dealings;
(g): address of the premises where the dealing is, or dealings are, proposed to be undertaken;
(h): proposed date of commencement, and proposed date of completion, of the dealing or dealings.

1.1.2 Genetics of the GMO
(a) details of the biological system intended to be used, including:

(i): the biological source of the donor DNA; and
(ii): the intended host organism, or tissue; and
(iii): the vector or vectors, or the method, intended to be used for the transfer of DNA; and
(iv): whether the intended host/vector system is a system mentioned in Part 2 of Schedule 2.

1.1.3 Risk assessment information

(a): details of all risks that could arise from the genetic modification, including occupational health and safety risks for persons involved;

(b) details of all risks that could arise from an unintentional release of the GMO or GMOs into the environment, including:

(i): risks to the health and safety of people; and
(ii): risks to the environment;

(c) details of all previous applications (whether successful or unsuccessful) made under the Act, or to the Genetic Manipulation Advisory Committee, in relation to a proposed dealing with the GMO or GMOs, setting out in relation to each:

(i): any reference number given to the application by the Regulator or the Genetic Manipulation Advisory Committee; and
(ii): the date of the application; and
(iii): the name of the applicant's project supervisor, or intended supervisor.

1.1.4 Risk management information

(a): details of the facility in which the dealing or dealings are to be undertaken, and of its physical containment level (as certified under Division 2 of Part 7 of the Act);

(b) in relation to certification of the facility:

(i): the date of certification; and
(ii): the certification number allocated to the facility by the Regulator; and
(iii): the date of the most recent inspection of the facility by the Regulator or the facility's Institutional Biosafety Committee;

(c): if the GMO is, or GMOs are, intended to be transported or moved outside the facility, details of the arrangements for that transport or movement;
(d): details of any arrangements for disposal of the GMO or GMOs;
(e): details of action proposed to be taken in the case of an unintentional release of the GMO, or GMOs, from containment;
(f): details of other actions and precautions proposed to be taken by the applicant to minimise any risks posed by the proposed dealing or dealings;
(g): details of the qualifications and experience of the project supervisor for the proponent organisation.

1.1.5 Suitability of the applicant

(a): a copy of the applicant's statutory annual report, or other information about the financial viability of the applicant;
(b): for section 58 of the Act, details of any relevant convictions (within the meaning of that section) of the applicant or the project supervisor;
(c): for section 58 of the Act, details of any failure to comply with:

(i): a provision of the Act or the Regulations; or
(ii): a condition of a licence or permit (within the meaning of paragraph 58 (1) (b) or 58 (2) (c) of the Act), particularly if resulting in a revocation or suspension;

(d): details of any failure to comply with an advice to proceed issued by the Genetic Manipulation Advisory Committee;
(e): details of applicant's capacity to manage any risks posed by the proposed dealing or dealings.

1.2 Additional information if volume of GMO culture exceeds 10 litres
If a GMO will be produced as a culture of cells exceeding 10 litres in volume, the following additional information is required for a Division 3 application:

(a): details of the size of the proposed project, in terms of the volume of GMO culture to be produced and the area of the facility affected;
(b): details of the main product, or products, of the intended dealing, or dealings, by-products (if any, including effluents) and the concentrations of those products and by-products at different stages of the production process;
(c): details of precautions proposed to be taken to prevent any unintended dispersal of the GMO;
(e): details of the plan, procedures and data collection program to be used to ensure the purity of the main product or products;

(f) details of the facility to be used for the proposed project, including:

(i): the physical arrangements for each working unit involved; and
(ii): the operational procedures of each unit; and
(iii): how the intended level of physical confinement of GMOs is to be achieved;

(g) details of arrangements for personnel management, including:

(i): supervision; and
(ii): training; and
(iii): health surveillance; and
(iv): emergency care;

(h): details of the justification for the containment level proposed;
(i): details of the project designs dealing with the risks mentioned in paragraphs (a) and (b) of item 1.1.3;
(j): a statement on whether the site, within the host genome, of integration of the resultant transgene is known, and, if so, details of any secondary effects that could result from the integration, or further integration, at the site.

1.3 Additional information — GMO that is a whole plant, or is to be used in conjunction with a whole plant
If a Division 3 application relates to a GMO that will be a whole plant, or is to be used in conjunction with a whole plant, the following additional information is required for the application:

(a): a statement on whether the parent organism is a weed or closely related to plants that are weeds and, if so, identification of the weeds that are closely related;
(b): details of the stage of development that plants used in the proposed dealing, or dealings, will be allowed to reach;
(c): details of the method that will be used to dispose of plants used in the proposed dealing or dealings;
(d): a statement on whether soil, or soil substitute, will be used as the growing medium for the plants, and, if so, details of how that medium will be subsequently sterilised or disposed of.

1.4 Additional information — GMO that is an animal, or is to be used in connection with an animal
If a Division 3 application relates to a GMO that will be an animal, or that is to be used in connection with an animal, the following additional information is required for the application:
(a) details of the number of:

(i): GM animals to be involved in the proposed dealing or dealings; and
(ii): other animals to be involved;

(b) details of proposed arrangements:

(i): for breeding the animals; or
(ii): for ensuring that the animals do not breed;

(c): details of how the animals will be able to be readily identified (for example, the use of labels on cages or, for larger animals, branding or tattooing).

1.5 Additional information — GMO that is for use in clinical trials with human beings
If a Division 3 application relates to a GMO that will be used in a clinical trial with a human being (as a vaccine or, in a gene therapy trial, as a vector), the following additional information is required for the application:
1.5.1 Information about the purpose of the trial

(a): details of the disease to be treated, or prevented, by use of the GMO;
(b): details of the host range of the parent organism from which the vaccine or vector is constructed.

1.5.2 Information about the vaccine or vector

(a): details of the potential for the genetic material of the vaccine organism or gene therapy construct to become incorporated in whole, or in part, into the genome of any cells of a treated person;
(b): details of the factors that prevent multiplication or spread of the vaccine organism or the vector in a treated person;
(c): details of the period over which the GMO will be detectable in a person, or his or her excretions;
(d): if the GMO is a defective virus, details of its potential for acquiring the capacity for viral replication by complementation or recombination with intracellular viruses;
(e): details of any deleterious effects the GMO may have on a pregnant person;
(f): a statement on whether the GMO has a teratogenic effect on a foetus at any stage of gestation and, if so, details of the effect;
(g): a statement on whether the use of the GMO is likely to preclude its use for vaccination against other diseases subsequently;
(h): a statement on whether the GMO produces spores;
(i): a statement on whether the viability of the GMO is compromised by desiccation;
(j): a list of sterilising and anti-microbial agents (if any) that are active against the GMO;
(k): a statement on whether the GMO is susceptible to ultraviolet or ionising radiation.

1.5.3 Information about the effect of the GMO on the environment

(a): details of:

(i): the potential for the GMO to spread from persons to whom the GMO has been administered to other persons or to other species; and
(ii): if the potential exists, the likely mechanism and frequency of such spread;

(b): a statement on whether a person who undergoes the treatment could be more susceptible to an adverse outcome because of:

(i): the state of health of the person at the time of treatment (for example, the person presents with immunosuppression or superimposition of disease); or
(ii): other treatments, such as drugs;

(c): details of the potential for the GMO to be disseminated into the environment through human waste during or after the trial;
(d): details of proposed methods for disposing of waste containing the GMO;

(e) a statement on whether, at the end of the trial, live GMOs will be carried by a person to whom the GMO has been administered and, if so, details of:

(i): the potential for their dissemination through family contact, or to the general population; and
(ii): measures intended to be taken to minimise the potential for dissemination; and
(iii): the potential for the organisms to cross the placenta of a pregnant person or animal.

Note
For persons relying on National Health and Medical Research Council funding, additional requirements may apply (through the Gene and Related Therapies Research Advisory Panel) to dealings of the kind to which this item applies.

1.6 Supporting information to be given by IBC
Information required for a Division 3 application includes the following information to be given by an Institutional Biosafety Committee ( IBC ):

(a): confirmation that the information given to the Regulator by the applicant has been checked by the IBC and found to be complete;
(b): confirmation that the IBC considers that personnel intended to be involved in dealing with the GMO or GMOs have adequate training and experience for the task;

(i): the date of the evaluation;
(ii): the full name of the IBC;
(iii): the name and contact details of the chairperson and of the secretary of the IBC;

(d): a copy of the evaluation report, prepared in accordance with any guidelines issued by the Regulator;
(e): a statement that the IBC is established in accordance with the Regulator's guidelines under section 98 of the Act.

Note
If the applicant is an accredited organisation, the IBC giving the information could be an IBC established by that organisation.

Part 2 Dealings involving an intentional release of a GMO into the environment (Division 4 of Part 5 of the Act)
2.1 Information to be given by all applicants
For an application to which Division 4 of Part 5 of the Act applies (a Division 4 application ), the following information is required:
2.1.1 General information

(a): details of the name, address, telephone number and other contact details, of applicant;
(b): details of the name, position within the organisation and contact details, of applicant's project supervisor for the proposed dealing, or dealings, with a GMO, or GMOs;
(c): title of the project involving the proposed dealing or dealings;
(d): description of the GMO or GMOs;
(e): description of the proposed dealing, or dealings, in terms of paragraph 40 (4) (a), (b) or (c) of the Act, as applicable;
(f): description of the aims and purposes of the proposed dealing, or dealings;
(g): identification of the person, persons or class of persons, intended to be authorised to undertake the dealing, or dealings;
(h): the proposed date of commencement, and proposed date of completion, of the dealing or dealings.

2.1.2 Risk assessment information - the parent organism

(a): details of the species to be released including, if relevant, information about the strain, cultivar etc;
(b): an assessment of whether the parent organism is capable of causing disease or other ill-health in people, plants or animals and, if so, details of the possible effects;
(c): details of the natural habitat of the parent organism, and its range;
(d): details of the location where the parent organism was originally isolated for the purpose of the proposed dealing or dealings;
(e): details of the distribution of the parent organism, and closely related organisms, in Australia;
(f): a statement on whether the parent organism, or a closely related organism, is present at or near the site of the proposed release and, if so, details of the population or populations;
(g): a statement on whether the parent organism is exotic in Australia;
(h): details of any known predators, or parasites, of the parent organism in Australia.

2.1.3 Risk assessment information - the GMO

(a): details of the origin of the DNA to be inserted;
(b): if the inserted DNA will come from an organism that causes disease or other ill-health in humans, animals, plants or fungi, details of the effects;
(c): details of the genetic modification that will be made, including details of the steps to be undertaken in its construction;
(d): details of the stability of the genotype of the GMO or GMOs, including a statement on whether it has a potentially unstable genotype;
(e): details of the extent to which the genetic modification has been characterised (that is, the DNA sequenced, and the potential gene products understood);
(f): details of the intended location of the inserted DNA in the final construct, and the number of copies that will be present;
(g): details of the markers or sequences that will enable the GMO or GMOs to be identified in the laboratory and under field conditions;
(h): details of the type of vector to be used in the transfer (including a description of the vector), showing the position of the inserted DNA and any other control sequences or markers in the vector;
(i): details of whether the vector has the ability to transfer to other hosts and, if so, details of the host range;
(j): details of whether the recombinant vector will be present in the final construct and if not, how it will be removed;
(k): if no vector will be involved, details of how the DNA will be introduced and how many copies of the gene will be inserted;
(l): details of how the modification will change the phenotype of the organism to be released, including information to demonstrate the effect of the modification;
(m): details of secondary genetic effects that may be anticipated;
(n): a statement on whether the site, within the host genome, of integration of the resultant transgene is known;
(o): details of the intrinsic genetic features, if any, of the GMO or GMOs that will regulate survival in the environment, including a statement on how stable those features are;
(p): details of the genetic changes, if any, that will be included in the GMO or GMOs to limit or eliminate any capacity to reproduce or transfer genes to other organisms.

2.1.4 Risk assessment information - proposed dealing with the GMO

(a): a description of the proposed dealing, or dealings, with the GMO or GMOs, including a description of the proposed intentional release into the environment;
(b): a statement of:

(i): the proposed date or dates for the intentional release into the environment; or
(ii): if release is to occur over a number of days, the proposed commencement and completion dates;

(c): a statement of the number of GMOs to be released;
(d): a statement of the number of releases of the GMO that are proposed;

(e) details of:

(i): the number of sites for proposed release; and
(ii): the area of land to be used; and
(iii): the location of the proposed release or releases, including identification of the local government area in which any release will take place and the geographical location, grid references and GPS coordinates of the site or sites;

(f): details of the reasons for the choice of location or locations for the releases or releases;
(g): details of how the GMO or GMOs will be released;
(h): details of the methods to be used to test for batch to batch consistency, if large scale production is required to produce GMOs for release;
(i): details of the measures that have been taken, or will be taken, in the production process to ensure quality and purity of GMOs intended to be released;
(j): details of the arrangements for conducting any other dealings in association with the proposed release, such as importation of a GMO and transportation of a GMO to or from a release site;
(k): details of proposed uses of the GMO or GMOs, or of things derived or produced from the GMO or GMOs, following release into the environment;

Examples
1.
Collecting field trial material for laboratory analysis.
2.
Giving GM product to animals as stockfeed.
(l) details of all previous applications (whether successful or unsuccessful) made under the Act, or to the Genetic Manipulation Advisory Committee, in relation to a proposed dealing with the GMO or GMOs, setting out in relation to each:

(i): any reference number given to the application by the Regulator or the Genetic Manipulation Advisory Committee; and
(ii): the date of the application; and
(iii): the name of the applicant's project supervisor, or intended supervisor.

2.1.5 Risk assessment information - interaction between GMO and the environment

(a): a statement on whether release of a proposed GMO could prejudice any beneficial function of the parent organism in the environment;

(b) on the basis of contained experiments, details of:

(i): the survival times of the GMO in habitats relevant to the release; and
(ii): the growth rate (or generation time) of the parent organism and GMO in the ranges of environmental conditions characteristic for the place and date of release; and
(iii): the frequency of reversion or loss of the genetic change;

(c): details of the capability of the GMO to disperse from the release area or areas, and, if any, the dispersal mechanism;
(d): a statement on whether the GMO is likely to be able to establish in the environment outside the release site or sites;
(e): a statement on whether the GMO will be able to form long-term survival structures, such as seeds or spores;

(f) a statement on whether the inserted genetic trait will be able to be transferred to other organisms found at the release site and surrounding environment and, if so, details of:

(i): the organisms the trait can be transferred to and the frequencies at which it can be transferred, including information about the species that have been tested for transfer and the rationale for selecting the test species; and
(ii): the transfer mechanisms involved; and
(iii): the techniques that have been used to demonstrate transfer; and

(iv) any possible adverse effects of the transfer, including:

(A) any advantage that affected organisms are likely to have over members of the species that do not contain the transgene; and
(B) environmental risks posed by such an advantage;

(g) a statement on whether interactions between pathogens and the transgene are possible (for example, gene silencing) and, if so, details of:

(i): the incidence and distribution of relevant pathogens; and
(ii): possible effects of interaction;

(h): a statement on whether the GMO is likely to show any competitive advantages over its unmodified parent in mixed populations under the conditions at the release site or sites, and, if so, details of the nature of the advantages;
(i): a statement on whether the modified trait will confer a selective advantage on the GMO under certain conditions and, if so, details of the conditions, including data on growth rates with and without selection pressure;
(j): details of features of the physical environment of the release site or sites, particularly features that may minimise or exacerbate any undesirable effects of the GMO;
(k): details of the proximity of the release site, or sites, to population centres, centres of agricultural activity, or the habitat of biota that might affect, or be affected by, the proposed release;
(l): a statement on whether the GMO is expected to remain in the environment after release and, if so, details of:

(i): the period of time; and
(ii): any environmental risks posed by the GMO during that period;

(m): details of any other environmental risks that may be posed by the GMO.

2.1.6 Risk assessment information - risks GMO may pose to the health and safety of people

(a): details of any allergens or toxins that may be expressed by the proposed GMO that are not found in the parent organism;
(b): details of any pathogenic properties in the GMO that are not found in the parent organism;
(c): details of any occupational health and safety risks to personnel dealing with the GMO and safety risks to the wider community.

2.1.7 Risk management information

(a): details of proposed measures for monitoring any risks posed by the proposed GMO, including monitoring for:

(i): the survival or presence of the GMO, or transferred genetic material, beyond the proposed release site or sites, including specificity, sensitivity and reliability of detection methods; and
(ii): impacts on the characteristics, or abundance, of other species; and
(iii): transfer of the introduced gene to other species; and
(iv): any other hazards or deleterious effects;

(b): details of proposed measures for limiting the dissemination or persistence of the GMO, or its genetic material, in the environment;
(c): details of the methods that will be used to minimise the effects of any transfer of the modified genetic trait to other organisms;
(d): details of the specific experimental methods proposed for detecting the presence of the GMO, or transferred genetic material, in the recipient organism;
(e): details of proposed measures for disposing of:

(i): the GMO when the release is complete; and
(ii): any waste deriving from the GMO;

(f): details of proposed release-site supervision procedures and any safety procedures to be undertaken by staff, including a description of procedures for on-site supervision of the release if the release site is located at some distance from the location of the IBC;

(g) details of proposed measures for:

(i): informing persons covered by the licence of any licence conditions; and
(ii): informing the public about the proposed dealing or dealings;

(h): details of proposed procedures for auditing, monitoring and reporting on compliance with any conditions imposed by the Regulator;
(i): details of any contingency measures that will be in place to rectify any unintended consequence if a hazard becomes evident during the course of the release;
(j): details of ongoing monitoring to be undertaken after the release is completed.

2.1.8 Information about previous assessments or approvals

(a): details of results of any applications made for approval of the GMO, or any derived GM products, by any other regulator in Australia or overseas, including information about conditions (if any) attaching to the approval;
(b): details of any previous licence under the Act for dealing with the GMO, or of a notification of a dealing under the Act, from which the work in the present application has developed;
(c): if the GMO has been previously released in Australia or overseas, details of any adverse consequences of the release, including identifying references and reports of assessments;
(d): a list of Commonwealth and State government authorities that have been consulted about the proposed dealings with the GMO (including names of contact officers);
(e): for an imported GMO — the date of importation or intended importation, including, if possible, a copy of documentation of clearance or assessment from the Australian Quarantine and Inspection Service (AQIS).

2.1.9 Suitability of the applicant

(a): details of qualifications, experience and proposed role of each person to be involved in the dealing or dealings;
(b): a copy of the applicant's statutory annual report, or other information about the financial viability of the applicant;
(c): for section 58 of the Act, details of any relevant convictions (within the meaning of that section) of the applicant or the project supervisor;
(d): for section 58 of the Act, details of any failure to comply with:

(i): a provision of the Act or the Regulations; or
(ii): a condition of a licence or permit (within the meaning of paragraph 58 (1) (b) or 58 (2) (c) of the Act), particularly if resulting in a revocation or suspension;

(e): details of any failure to comply with an advice to proceed issued by the Genetic Manipulation Advisory Committee;
(f): details of applicant's capacity to manage any risks posed by the proposed dealing or dealings.

2.2 Additional information — GMO that is a plant
If a Division 4 application relates to a proposed GMO that is a plant, the following additional information is required for the application:
2.2.1 Information about the use of the parent plant

(a): statement about whether the parent plant has an extended history of cultivation and safe use.

2.2.2 Information about any unintended pleiotropic effects

(a): details of undesirable effects on the parent plant that may result from expression of the transgene, or an associated insertion-related mutation, in the GMO (for example, reduced fertility, increased disease prevalence, production loss, grain shedding), including the likelihood of any such events.

2.2.3 Information about pollen and cross-pollination

(a): details of the mechanism of pollen spread (by insect vectors or by other means) in the plant population;
(b): details of pollen viability for the parent plant and the GMO;
(c): details of any potential pollinators for the parent plant and the GMO, and their range and distribution in Australia;
(d): quantitative data on successful cross-pollination between the parent plant, the GMO and its wild relatives;
(e): if sexually compatible plants live near a site of the proposed release, details of the quantity and the chances for cross-pollination with the GMO;
(f): if cross-pollination with the GMO were to occur, details of the likely resulting plants and an assessment of whether they would survive and compete well with unaffected plants.

2.2.4 Information about weeds

(a): details of members of the family of unmodified parent plants that are known to be weeds in any environment;
(b): details of cross-pollination between the species to which the GMO belongs and relatives known to be weeds, including a copy of any peer-reviewed reports that support the information.

2.2.5 Information about the possible result of the imparted characteristics being integrated into other species

(a): a statement on whether the novel characteristics of the GMO could be integrated into other species and, if so, details of its potential to affect:

(i): the distribution and abundance of populations of the affected species; and
(ii): factors that normally control populations of the affected species in the environment (for example, pathogens, herbivory and physiological stress);

(b): details of any other possible adverse consequences;
(c): details of proposed measures to minimise the risk (for example, by imparting male sterility or other means of reproductive isolation).

2.2.6 Information about the seeds of the GMO

(a): a statement on whether the GMO proposed to be released will be allowed to set seed and, if not, whether setting seed is planned for a later release;
(b): if the GMO is to be allowed to set seed — a statement on whether mature seed is expected to be shed (from, for example, an ear, capsule or pod), and, if so, an indication of the proportion of seed likely to remain in the environment following harvest;
(c): a statement on whether the seed has the potential to be dispersed by natural mechanisms and, if so, details of the mechanisms;
(d): details of the length of time the seeds will be capable of being dormant.

2.2.7 Information about whether the GMO can be dispersed by vegetative propagation

(a): a statement on whether the GMO proposed to be released can be dispersed by vegetative propagation and, if so, the possible mechanisms.

2.2.8 Information about whether the capacity of the GMO to add substances to, or subtract substances from, soil will change

(a): a statement on whether the novel characteristic of the proposed GMO will change the capacity of the plant to add substances to, or subtract substances from, soil (for example, nitrogen or toxic compounds) and, if so, details of all such change.

2.2.9 Information about toxicity

(a): an assessment of whether there is any likelihood that the introduced trait could cause the proposed GMO to have greater toxicity (for animals, including human beings) than would an unmodified plant and, if so, details of that likely effect;
(b): an assessment of whether any products of the GMO could concentrate in the natural or human food chain to levels which become toxic, and available data (if any) on that subject;
(c): an assessment of whether the biodegradability of the GMO will be different to that of the parent organism and, if so, details of the differences.

2.2.10 Information about any secondary ecological effects that might result from the release

(a): an assessment of possible effects of the proposed release on:

(i): native species; and
(ii): resistance of insect populations to an insecticide; and
(iii): abundance of prey or parasites.

2.2.11 Information about resistance of the GMO to a chemical agent (other than selective agents, such as antibiotics, used in strain construction)

(a): for a GMO that, as a result of the modification, will have resistance to a chemical agent (for example, a herbicide, but not a selective agent, such as an antibiotic, used in strain construction) — details of any environmental risks related specifically to that resistance.

2.2.12 Information about resistance of GMO to a biological agent

(a): for a GMO that, as a result of the modification, will have resistance to a biological agent (for example, an insect or a fungal disease) — details of any environmental risks related specifically to that resistance.

2.3 Additional information — GMO that is a micro-organism (not living in or on animals and not a live vaccine)

If a Division 4 application is in relation to a proposed GMO that is a micro-organism:

(a): including a micro-organism associated with plants, and a micro-organism that might be applied to modify the physical or chemical environment (for example, to modify soil properties); but
(b): not including a micro-organism living in or on animals, or a micro-organism that is a live vaccine;

the following additional information is required for the application:
2.3.1 Information about GM micro-organisms associated with plants

(a): details of any partner species of plant, including information about the specificity of the interaction and the range of plant species with which the proposed GMO can interact;
(b): an assessment of the effect of the proposed GMO on the partner plant species, and details of how it will be monitored;
(c): an assessment of any secondary effects that the proposed GMO might have on the partner plant species;
(d): an assessment of whether the modification is likely to cause any change to the range of host plant species susceptible to infection by the organism;
(e): an assessment of the effect, if any, of the proposed GMO on the distribution and abundance of host plant species or other species with which the proposed GMO can interact;
(f): an assessment of the effect the proposed GMO might have on insects, birds, animals or humans that may eat the plant.

2.3.2 Information if the parent organism has an extended history of use in agriculture

(a): if the parent organism has an extended history of use in agriculture, a description of the use.

2.3.3 Information if the GM micro-organism is associated with plant species that are food crops

(a): if the GM micro-organism is associated with plant species that are food crops, an assessment of whether the proposed GMO could affect the suitability of the resultant produce for consumption by animals or human beings and, if so, details of the effect.

2.3.4 Information about the impact of the GMO on soil and water

(a): details of the expected effects of the proposed GMO on local soil chemistry (for example, pH, mineral leaching and nutrient levels);
(b): details of the possible effects of the proposed GMO on local water quality;
(c): details of the effects the proposed GMO might have on soil organisms that are known to be beneficial to plants (for example, Rhizobium , Azospirillum , Frankia and mycorrhizal fungi) and that are likely to be in a release site.

2.3.5 Information about any interactions between the GMO and closely related micro-organisms

(a): details of any known interaction between the proposed GMO and closely related micro-organisms in any partner plant (if applicable) and in the environment of the release site.

2.3.6 Information about known genetic exchange between parent organism and plant pathogens

(a): details of any known exchange of genetic material between the parent organism and plant pathogens.

2.3.7 Other information

(a): information about the expected survival and dispersal of the proposed GMO, including dispersal in natural waters, soil and on other natural surfaces;
(b): a statement about whether the proposed GMO will produce spores;
(c): a statement about whether the proposed GMO will be resistant to desiccation;
(d): a list of sterilising and anti-microbial agents (if any) that are expected to be active against the proposed GMO;
(e): a statement about whether the proposed GMO will be susceptible to ultraviolet or ionising radiation.

2.4 Additional information — GMO that is a micro-organism that lives in or on animals
If a Division 4 application is in relation to a proposed GMO that is a micro-organism living in or on animals (including an organism such as gut biota living in larger hosts, and a micro-organism applied externally to an animal (for example, bacteria to prevent fleece rot)), the following additional information is required for the application:
2.4.1 Information about the impact of the GMO on the host

(a): identification of the animal host species;
(b): a statement about whether the parent organism has an extended history of use in agriculture and, if so, details of the use;
(c): an assessment of any new capacity the proposed GMO will provide for the host species (for example, ability to degrade plant or pasture toxins);
(d): an assessment of whether the competitive advantage, ecological fitness, biology or distribution, of the host will be altered, and relevant data (if any) on the subject;
(e): details of any secondary effects expected to result from the introduction of the proposed GMO into or onto the host (for example, information about any possibility of the genetic insert being transferred to other organisms in the host, or to host cells).

2.4.2 Information about the impact of the GMO on the environment (particularly the impact on other animals, plants, soil and water)

(a): any evidence that the proposed GMO might be capable of establishing in, or on, other animals, including feral animals;
(b): any evidence of other likely effects (including secondary effects) on other plants or animals in the agricultural and natural environments;
(c): if the proposed GMO will establish in an animal, information about whether the GMO will be excreted or otherwise leave the animal and, if so, the time period that it is expected the GMO can survive outside the animal;
(d): an assessment of the possible effects of the GMO on local water quality.

2.4.3 Other information

(a): a statement about whether the proposed GMO will produce spores;
(b): a statement about whether the proposed GMO will be resistant to desiccation;
(c): a list of sterilising and anti-microbial agents (if any) that are expected to be active against the proposed GMO;
(d): a statement about whether the proposed GMO will be susceptible to ultraviolet or ionising radiation.

2.5 Additional information — GMO that is a live vaccine for use in animals
If a Division 4 application is in relation to a GMO that is a live vaccine for use in animals, the following additional information is required for the application:
2.5.1 Information about the purpose of the vaccine

(a): identification of the disease to be treated, or prevented, by use of the vaccine;
(b): identification of the host species on which the vaccine is to be used;
(c): details of the host range of the parent organism from which the vaccine is constructed;
(d): details of the level, and duration, of immunity produced in the host species after administration of the vaccine.

2.5.2 Information about the vaccine

(a): an assessment of the potential for the genetic material of the vaccine organism to become incorporated in whole, or in part, into the genome of any cells of the vaccinated host;
(b): an assessment of the period over which the vaccine GMO will be detectable in a test animal, or its excretions;
(c): if the GMO is a viral vaccine, information about the potential for the nucleic acid of the virus in the vaccine to be rescued, or to be restored to wild type, by recombination or complementation with intracellular viruses;
(d): details of any deleterious effects the vaccine GMO may have on a pregnant animal;
(e): a statement on whether the vaccine GMO has a teratogenic effect on a foetus at any stage of gestation;
(f): a statement on whether the use of the vaccine GMO is likely to:

(i): preclude its use for vaccination against other diseases subsequently; or
(ii): affect its usefulness for other vaccinations;

(g): a statement on whether the vaccine GMO produces spores;
(h): a statement on whether the vaccine GMO is resistant to desiccation;
(i): a list of sterilising and anti-microbial agents (if any) that are active against the GMO;
(j): a statement on whether the GMO is susceptible to ultraviolet or ionising radiation.

2.5.3 Information about the effect of the GMO on the environment

(a): details of:

(i): the potential for the vaccine GMO to spread from vaccinated to unvaccinated animals or to other species (including human beings); and
(ii): if the potential exists, the likely mechanism and frequency of such spread;

(b): an assessment of whether the susceptibility of the host to the vaccine organism could be affected by:

(i): the state of the host at the time of vaccination (for example, immunosuppression, or superimposition of other disease); or
(ii): other treatments, such as drugs;

(c): details of proposed methods for disposing of waste containing vaccine GMO;
(d): details of the intended fate of vaccinated animals at the end of the trial;

(e) information about whether live vaccine organisms will be carried by an animal at the end of the trial and, if so:

(i): the potential for dissemination of the live vaccine organisms through the animal's family contact, or to the general population of the species; and
(ii): measures intended to be taken to minimise the potential for dissemination; and
(iii): the potential for the organisms to cross the placenta of a pregnant animal.

2.6 Additional information — GMO that is a vertebrate animal
If a Division 4 application is in relation to a GMO that is a vertebrate animal (other than aquatic organisms), the following additional information is required for the application:
2.6.1 Information about the effects of the GMO on the environment

(a): information about the likelihood of any unintended effect on an animal resulting from the release;
(b): information about any intended gains that are directly linked to changes in other characteristics of the subject species.

2.6.2 Information about any effects the expression of the modified trait might have on the animal

(a): information about expected effects on the physiology, behaviour and reproduction of the animal or animals.

2.6.3 Information about future dealings with the GMO

(a): a statement on whether an animal in the experiment is intended to be allowed to breed and, if not, whether breeding is planned in the future;
(b): a statement on whether the proposed arrangements for handling any offspring are the same as those for the experimental animal or animals, and, if not, the proposed different arrangements.

2.6.4 Information about feral populations of subject species, if any, that exist in Australia or that may be established

(a): details of any agricultural, environmental or disease-control problems caused by feral populations of the subject species;
(b): details of any experimental work that has been done on expression of the novel genetic material in feral animals (such as cross-breeding of GMOs with captive feral animals), and the results of such work;
(c): an assessment of the likelihood of the novel genetic material entering the feral gene pool (for example, by interbreeding with modified farm animals);
(d): an assessment of the effect that the entry of the novel genetic material into a feral gene pool might have:

(i): on the distribution and abundance of the feral population; or
(ii): on the ability of the feral population to cause agricultural or environmental problems; or
(iii): in contributing to the spread of infectious disease;

(e): if no feral population exists in Australia, information about:

(i): the likelihood of the imparted characteristic enhancing the ability of the species to establish feral populations; and
(ii): if there is a likelihood, the arrangements in place to prevent this from occurring.

2.6.5 Information about the capacity of the GMO to interbreed

(a): details of the capacity of the GMO to interbreed with any species native to, or currently present in, Australia.

2.6.6 Information about requirements for optimal expression of the introduced trait

(a): details of the management procedures and environmental factors, if any, that would be required for optimal expression of the introduced trait or traits.

Note
All work involving animals should be conducted according to the NHMRC Australian Code of Practice for the Care and Use of Animals for Scientific Purposes , under which it requires review by an Institutional Animal Ethics Committee and by the relevant authority administering State animal welfare legislation.

2.7 Additional information — GMO that is an aquatic organism
If a Division 4 application is in relation to a GMO that is an aquatic organism (for example, fish, crustaceans and molluscs), the following additional information must be included:
2.7.1 Information about effects of the GMO on the environment

(a): a statement on whether the GMO could produce any novel metabolites, or toxins, that are likely to have deleterious effects on parasites or predators and, if so, the likely effect;
(b): details of any unintended effects that may result from the release;
(c): a statement on whether the expression of the modified gene is expected to be directly linked to undesirable changes in other characteristics of the subject organisms (for example, a decrease in nutritional value);
(d): information about:

(i): whether the modified genetic material can be transmitted to any other species; and
(ii): if so, the expected mechanism of transfer, the likely affected species and any likely consequences.

2.7.2 Information about any impact on natural populations

(a): information about whether natural populations of the parental organism, or a closely related species, exist in Australia (including in rivers, lakes, dams or coastal waters) and, if so, details about any problems the natural populations cause with other organisms;
(b): if no natural populations of the organism to be modified exist in Australia, information about the potential for the modified traits to enhance the ability of the species to establish populations in aquatic habitats;
(c): information about the results of any experimental work that has been done on phenotypic expression of the modified genetic material in naturally occurring organisms (such as cross-breeding of GMOs with wild or farmed stocks);
(d): an assessment of the likelihood of the modified genetic material entering the gene pool of natural populations;
(e): information about any impact the entry of the modified genetic material into the gene pool of a natural organism could have on:

(i): the distribution and abundance of the organism; or
(ii): associated aquatic farms; or
(iii): the environment; or
(iv): public health;

(f): information about mechanisms intended to be used to prevent dispersal of the GMO into other ecosystems.

2.7.3 Information about future dealings with the GMO

(a): a statement about whether an organism in the experiment is intended to be allowed to breed and, if not, whether breeding is planned in the future;
(b): a statement about whether the proposed arrangements for handling any offspring are the same as those for the experimental organisms and, if not, the proposed different arrangements.

2.8 Additional information — GMO that is an invertebrate animal
If a Division 4 application is in relation to a GMO that is an invertebrate animal, the following additional information must be included:

(a): information about the effect the GMO might have on the food chain;
(b): information about the potential for the GMO to produce any novel metabolites, or toxins, that are likely to have deleterious effects on parasites or predators;
(c): information about other unintended effects that may result from the release;
(d): a statement on whether the GMO will be fertile and, if not, whether it is intended to use fertile organisms in later releases;
(e): information about whether populations of the parental organism, or a closely related species, exist in Australia and, if so, any environmental or public health problems, or benefits, caused by the populations;
(f): information about:

(i): whether the modified, genetic material can be transmitted by means other than by reproduction normal for the species; and
(ii): if so, the likelihood of that genetic material entering gene pools of natural populations;

(g): information about:

(i): whether the modified, genetic material can be transmitted to any other species; and
(ii): if so, the expected mechanism of transfer, and the likely affected species;

(h): information about any experimental work that has been done on the phenotypic expression of the novel genetic material in other genetic backgrounds (such as cross-breeding of modified strains with wild or caught stock);
(i): information about the effect, on the distribution and abundance of the natural populations of the organism, of the entry of the novel genetic material into the gene pool of those populations;
(j): details of the mechanisms proposed to be used to prevent dispersal of the GMO into other ecosystems.

2.9 Additional information — GMO that is to be used for biological control
If a Division 4 application is in relation to a GMO that is to be used for biological control, the following additional information must be included:
2.9.1 Information about the expected interaction between the GMO and the species targeted for biological control

(a): the name of the species targeted for biological control;
(b): details of any direct effects the parent organism has on the target species;
(c): details of any direct effects the GMO is expected to have on the target species;
(d): details of how the GMO is intended to be transferred from one target organism to another, and what factors affect the transferability;
(e): details of the genetic response that may be invoked in populations of the target organism as a result of the use of the GMO (for example, increased resistance to the modified organism), and the expected evidence for the response.

2.9.2 Information on the possible effects of the GMO on non-target organisms

(a): details of the host range of the GMO, and details of any difference between that host range and the host range of the parent organism;
(b): a list of the non-target organisms that have been tested for susceptibility to the GMO, and the rationale for the choice of species tested;
(c): if the modified traits can be transmitted to other organisms that are likely to be in the environment, details of any effects those other organisms are likely to have on non-target species.

2.9.3 Information on other possible effects of the GMO on the environment

(a): a statement about the secondary effects that can be envisaged on competitors, predators, prey or parasites of the target species;
(b): an assessment of the consequence of the removal, or reduction, of the target species on the management of agriculturally significant plants or farm animals;
(c): details of any predicted change in the ecosystem resulting from a reduction in the population of the target organism;
(d): information about:

(i): whether the GMO produces metabolites that may have deleterious effects on other organisms, including human beings:

(A) directly; or
(B) indirectly, through concentration in the food chain; and

(ii): if so, the likely effect.

2.10 Additional information — GMO that is to be used for bioremediation
If a Division 4 application is in relation to a GMO that is to be used for bioremediation, the following additional information must be included:
2.10.1 Information about the expected interaction between the GMO and the target substrate for bioremediation

(a): identification of the target substrate for bioremediation;
(b): details of the effect the parent organism has on the target substrate;
(c): details of the effect the GMO is expected to have on the target substrate;
(d): a list of the substances other than the target substrate that can be metabolised by the GMO and that cannot be metabolised by the parent organism.

2.10.2 Information about the GMO and its impact on the environment

(a): a statement about whether the GMO will be self-sufficient if added to the contaminated site or whether additional measures may be required (for example, provision of supplementary nutrients and growth factors, or other environmental modifications);
(b): a list of any metabolites produced by the GMO that may have deleterious effects on other organisms:

(i): directly; or
(ii): indirectly, through concentration in the food chain;

(c): details of effects the GMO might have on water, air or soil quality;
(d): details of effects the GMO might have on organisms that ingest it;
(e): a statement on whether the GMO will be dispersed from the site of application and, if so, the proposed mechanisms involved and the likely consequences.

2.11 Additional information — GMO intended to be used as food for human or vertebrate animal consumption
If a Division 4 application is in relation to a GMO that is intended to be developed for use as a food for consumption by human beings or animals, the following additional information must be included:

(a): details of:

(i): whether the parent organism or the donor organism is of a kind already in use as a food for consumption by human beings or animals, or used in the production of such a food; and
(ii): whether any processing is needed, or is commonly applied, before consumption;

(b): details of any metabolites produced by the GMO that may have adverse effects on the consumer (human or animal), including available data on toxicology, allergenicity and other possible adverse effects;
(c): details of any products of the GMO that are expected to concentrate in the food chain to levels which may become toxic;
(d): details of any expected changes to the nutritional quality of such food as a result of the genetic modification;
(e): a statement on whether the GMO is a major component of such food as consumed, or a minor component (for example, yeast cells in beer).

Note
For a food for human consumption that contains GMOs or GM products, see also the assessment requirements under the Australia New Zealand Food Authority Act 1991 .

2.12 Supporting information to be given by IBC
Information required for a Division 4 application includes the following information to be given by an Institutional Biosafety Committee ( IBC ):

(a): confirmation that the information given to the Regulator by the applicant has been checked by the IBC and found to be complete;
(b): confirmation that the IBC considers that personnel intended to be involved in dealing with the GMO or GMOs have adequate training and experience for the task;

(i): the date of the evaluation;
(ii): the full name of the IBC;
(iii): the name and contact details of the chairperson and of the secretary of the IBC;

(d): a copy of the evaluation report, prepared in accordance with any guidelines issued by the Regulator;
(e): a statement that the IBC is established in accordance with the Regulator's guidelines under section 98 of the Act.

Note
If the applicant is an accredited organisation, the IBC giving the information could be an IBC established by that organisation.

1. Notified in the Commonwealth of Australia Gazette on 31 May 2001.

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