7 September 2011

Application for licence for Intentional Release of GMOs into the environment: Application No. DIR 111

Summary Information


Project Title: Limited and controlled release of wheat and barley genetically modified for altered grain composition, nutrient utilisation efficiency, disease resistance or stress tolerance 1
Applicant: Commonwealth Scientific and Industrial Research Organisation (CSIRO)
Common name of the parent organism: Wheat and Barley
Scientific name of the parent organism: Triticum aestivum L. and Hordeum vulgare L.
Modified trait(s):
  • Altered grain composition
  • Improved growth, grain weight, yield and biomass in heat and drought prone environments through enhanced stem water soluble carbohydrates, nutrient use efficiency, carbon assimilation, water use efficiency and photosynthesis
  • Enhanced rust resistance
  • Selectable marker gene expression
Identity of the gene(s) responsible for the modified trait(s):
  • Four partial genes from wheat (T. aestivum) and two genes from barley (H. vulgare) for altered grain composition
  • 28 genes from either wheat or barley for improved growth, grain weight, yield, biomass and rust resistance
  • hpt gene from the bacterium Escherichia coli (antibiotic resistance selectable marker)
  • nptII from the bacterium E. coli (antibiotic resistance selectable marker)
  • bar from the bacterium Streptomyces hygroscopicus (herbicide resistance selectable marker)
Proposed Location(s): One site in the Australian Capital Territory (ACT)
Proposed Release Size: Up to 2.3 hectares (ha)
Proposed Release Dates: May 2012 – June 2017


Introduction

The Gene Technology Act 2000 (the Act) in conjunction with the Gene Technology Regulations 2001, an inter-governmental agreement and corresponding legislation that is being enacted in each State and Territory, comprise Australia’s nationally consistent regulatory system for gene technology. Its objective is to protect the health and safety of people, and the environment, by identifying risks posed by or as a result of gene technology, and managing those risks by regulating certain dealings with genetically modified organisms (GMOs).

The Act establishes a statutory officer, the Gene Technology Regulator (the Regulator), to administer and make decisions under the legislation. The Regulator is supported by the Office of the Gene Technology Regulator (OGTR), an Australian Government regulatory agency located within the Health and Ageing portfolio.

The legislation sets out requirements for considering applications for licences for dealings with GMOs, including matters that the Regulator must take into account before deciding whether or not to issue a licence. The Regulator’s Risk Analysis Framework2 outlines the assessment process that will be followed.

The application and the proposed dealings

The Regulator has received an application from CSIRO for a licence for dealings involving the intentional release of genetically modified (GM) wheat and barley into the Australian environment on a limited scale under controlled conditions.

CSIRO proposes to release up to 232 GM wheat and 41 barley lines3 containing genes to alter grain composition, enhance fungal disease resistance and improve agronomic characteristics under different abiotic stress conditions.

The purpose of the trial is to:
    • evaluate the agronomic performance of the GMOs in rain-fed, drought/heat-prone and fungal disease-prone environments
    • analyse any changes in grain composition, nutritional characteristics, dough making properties and end product quality
    • collect GM material and seeds for subsequent trials.

Flour derived from the grain of a few GM wheat and barley lines with altered grain composition is proposed to be used for a range of carefully controlled, small scale animal and human nutritional feeding trials under the oversight of CSIRO Human Nutrition Animal Ethics Committee and CSIRO Human Nutrition Research Ethics Committee, respectively.

The applicant proposes to limit the release to one site at a CSIRO research facility in the ACT on a maximum area of 2.3 ha per year between May 2012 and June 2017. Access to the site would be limited to authorised CSIRO staff only.

The applicant has proposed a number of control measures to restrict the spread and persistence of the GMOs and their introduced genetic material, which will be considered in the assessment of this application, including:
    • locating the trial site at least 1 km from natural waterways
    • separating the trial site from other wheat and barley plantings by an isolation zone of at least 200 m
    • restricting animal access by surrounding the trial site with a livestock proof fence and covering with a bird net
    • surrounding the GMOs with a 2 m wide buffer zone (that will remain as bare fallow for rodent control) and a 10 m monitoring zone where growth of related species will be controlled
    • destroying all plant materials not required for testing or future trials
    • cleaning of any equipment used prior to removal from the site
    • monitoring of the trial site post-harvest for a period of 24 months and destroying any volunteer GMOs before they flower
    • transporting and storing all GM material outside the trial site according to the Regulator’s Guidelines for the Transport of GMOs
    • not allowing GM plant material to enter the commercial human food or animal feed supply.

Confidential Commercial Information

Some details, including the identity, source and modified expression of two genes, and the associated phenotypes are the subject of an application for declaration as Confidential Commercial Information (CCI) under section 185 of the Act, which is still under consideration. Details of some of the other genes and some data related to GMO characterisation have already been declared CCI under section 185 of the Act. The confidential information will be made available to the prescribed experts and agencies that will be consulted on the Risk Assessment and Risk Management Plan (RARMP) for this application.

Parent organism

The parent organisms are wheat (cultivars Bobwhite 26, Frame, Gladius and NB1) and barley (cultivar Golden Promise), which are exotic to Australia. Commercial wheat and barley cultivation occurs in the wheat belt from south eastern Queensland through New South Wales, Victoria, southern South Australia and southern Western Australia. A small amount of barley is also grown in Tasmania.
Bobwhite 26, NB1 and Golden Promise are not currently grown commercially in Australia but are commonly used for their relative amenability to genetic modification. Frame and Gladius are commercial wheat varieties.

The genetic modifications and their effect

The applicant proposes to release a maximum of 232 GM wheat and 41 GM barley lines. Based on similarities in the modified traits, the GMOs can be broadly classified into two categories:
    • Category 1 consists of 50 wheat lines and one barley line genetically modified for altered grain composition using four partial genes derived from wheat and two genes from barley
    • Category 2 consists of 182 wheat lines and 40 barley lines genetically modified for improved agronomic characteristics under different biotic and abiotic stress conditions using a total of 28 genes derived from wheat or barley. Among them, 27 genes are responsible for improved growth, grain weight, yield and biomass in heat and drought prone environments through enhanced nutrient use efficiency, carbon assimilation, water use efficiency and photosynthesis, and one gene is responsible for enhanced rust resistance.

The GM wheat and barley lines may also contain one of the three selectable marker genes: bar, hpt and nptII. The herbicide resistance gene bar, derived from the bacterium Streptomyces hygroscopicus, encodes the enzyme phosphinothricin acetyl transferase which provides resistance to herbicides containing glufosinate ammonium. The antibiotic resistance selectable marker genes hpt and nptII, derived from the common gut bacterium E. coli, encode the enzymes hygromycin phosphotransferase and neomycin phosphotransferase type II, respectively; the former confers resistance to hygromycin and the latter to kanamycin and neomycin. These genes were used in the laboratory to select transformed GM plants during early stages of development.

Short regulatory sequences derived variously from plants (including wheat, barley, maize and rice), a soil bacterium (Agrobacterium tumefaciens) and a plant virus (cauliflower mosaic virus) which control expression of the introduced genes are also be present in the GM wheat and barley lines.

Method of genetic modification

The GM wheat lines were generated using either biolistic (also known as particle bombardment) or Agrobacterium-mediated transformation methods. The GM barley lines were generated using Agrobacterium-mediated transformation only.

The biolistic technique involves coating very small gold particles with the gene constructs and ‘shooting’ these into immature wheat embryos.

In the Agrobacterium-mediated transformation method, genes were introduced into wheat and barley using plasmid vectors carried by A. tumefaciens. Both the biolistic and Agrobacterium-mediated transformation methods have been widely used in Australia and overseas for introducing genes into plants.

Previous releases of the same or similar GMOs

Some of the GM wheat and barley lines included in this licence application have been previously approved for release on a limited scale under controlled conditions under CSIRO’s licences DIR 054/2004 (field trial completed), 092, 093, 094 and 099 (current trials). Some GM wheat lines included in this application were previously approved by the Regulator under CSIRO’s licence DIR 100, but have not yet been trialled in the field.

Previously, the Regulator also authorised field trials of wheat genetically modified for salt tolerance (Grain Biotech: licence DIR 053/2004) and drought tolerance (DPI Victoria: licences DIR 71/2006 and DIR 080/2007), and wheat and barley genetically modified for abiotic stress tolerance (University of Adelaide: licences DIR 077/2007 and DIR 102). These trials have all been completed except for DIR 102, which is current.

There have been no reports of adverse effects on human health and safety or the environment resulting from any of these releases.

Suitability of Applicant

Section 43(2)(f) of the Act requires the Regulator to be satisfied regarding the suitability of the applicant to hold a licence as a pre-requisite for considering DIR applications. The matters to be considered are outlined in section 58 of the Act and include capacity to meet the conditions of a licence, relevant convictions and revocation of a licence or permit held under law relating to the health and safety of people or the environment.

The Regulator has determined that CSIRO currently meets the suitability requirements and will verify this continues to be the case prior to making any decision regarding the issuing of a licence.

Consultation process for this DIR application

The Regulator has decided that the application qualifies as a limited and controlled release, under section 50A of the Act. The principal purpose of the application is to enable the conduct of experiments, and the applicant has proposed limits on the size and duration of the release and controls to restrict the spread and persistence of both the GMOs and their genetic material in the environment.

This means that the Regulator is not required to consult on the assessment of this application until after a RARMP has been prepared in accordance with section 51 of the Act. In the interim, copies of the application are available on request from the OGTR. Please quote application number DIR 111.

The Regulator will seek comment on the consultation RARMP from the public as well as a wide range of experts, agencies and authorities including the Gene Technology Technical Advisory Committee, State and Territory Governments, Australian Government agencies and the Minister for the Environment. The RARMP will then be finalised, taking into account matters raised relating to risks to human health and safety and the environment, and form the basis of his decision whether or not to issue a licence.

At this stage, the RARMP is expected to be released for comment in December 2011. The public will be invited to provide submissions on the RARMP via advertisements in the media and direct mail to anyone registered on the OGTR mailing list. The RARMP and other related documents will be available on the OGTR website, or in hard copy from the OGTR.

If you have any questions about the application or the assessment process, or wish to register on the mailing list, please contact the OGTR at: The Office of the Gene Technology Regulator, MDP 54 GPO Box 9848 Canberra ACT 2601 Telephone: 1800 181 030 Facsimile: 02 6271 4202 E-mail

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1The title of the licence application submitted by CSIRO is ‘Limited and controlled release of genetically modified wheat and barley with altered grain composition, nutrient utilisation efficiency or stress tolerance’

2The Risk Analysis Framework and further information on the assessment of licence applications is available from the Office of the Gene Technology Regulator (OGTR). Free call 1800 181 030

3The term ‘line’ is used to denote plants derived from a single plant containing a specific genetic modification resulting from a single transformation event.