Download Summary of risk management plan and specific licence conditions

Office of the Gene Technology Regulator
RISK ASSESSMENT AND RISK MANAGEMENT PLAN
AND LICENCE FOR INTENTIONAL RELEASE OF GMOs
INTO THE ENVIRONMENT:
Application No. DIR 010/2001
SUMMARY INFORMATION
Project Title:
Small and large scale trialing of InVigor® canola (Brassica
napus) for development for the Australian cropping system
Applicant:
Aventis CropScience Pty Ltd
391-393 Tooronga Rd
East Hawthorn VIC 3123
Common name of the parent
organism:
Canola
Scientific name of the parent
organism:
Brassica napus
Modified traits:
Hybrid breeding system based on male sterile and fertility
restorer lines; and
Herbicide tolerance (glufosinate ammonium)
Identity of the genes responsible
for the modified traits:
Locations:

barnase gene from the bacterium Bacillus
amyloliquefaciens (male sterility)

barstar gene also derived from B. amyloliquefaciens
(fertility restorer)

bar gene from the bacterium Streptomyces
hygroscopicus (herbicide tolerance)
Winter trial locations selected from the Shires of:
Ararat, Glenelg, Hindmarsh, Horsham, Moyne, Northern
Grampians, Southern Grampians, Yarriambiack (Victoria);
Grant, Naracoorte/Lucindale, Wattle Range (South Australia);
Coolamon, Culcairn, Lockhart, Junee, Narrandera, Wagga
Wagga (New South Wales); and
Beverly, Brookton, Goomalling, Quairading, Victoria Plains,
Wongan Ballidu (Western Australia).
Summer trial locations selected from the Shires of:
Grant, Naracoorte/Lucindale, Wattle Range,
(South Australia); and Glenelg (Victoria).
NB: The licence holder will notify the Regulator of the precise
location details prior to planting in each season. These details will
be included in the Record of GMO and GM Product Dealings.
Date of Releases:
Winter and Summer 2002, 2003, 2004
Trial Sizes:
A maximum of 318 hectares at 90 sites over 3 years,
comprising 106 hectares at 30 sites in each year including 61
hectares at 13 sites in each Winter season and 45 hectares
at 17 sites in each Summer season.
The maximum area for any individual site will be 9 hectares.
Maximum area
Maximum No. of sites
Winter
61 ha
13
Summer
45 ha
17
Per year
106 ha
30
Total over 3 years
318 ha
90
Introduction
The Gene Technology Regulator (the Regulator) has made a decision to issue a licence in
respect of the application (DIR 010/2001) of Aventis CropScience Pty Ltd (Aventis). Aventis
applied for a licence to undertake a limited and controlled release of genetically modified
(GM) canola (InVigor® canola) into the environment.
The decision was made after extensive consultation on the risk assessment and risk
management plan for this application with the public, State and Territory governments,
Commonwealth agencies, the Gene Technology Technical Advisory Committee, the
Federal Environment Minister and relevant local councils, as required by the
Gene Technology Act 2000 (the Act).
The purpose of the release is to conduct plant breeding trials to develop lines suitable for
use under Australian conditions and produce seed for potential commercial lines for future
releases in Australia and overseas. Future releases in Australia, including commercial
release, would be subject to further licence applications.
InVigor® canola plants have been genetically modified to introduce a hybrid breeding system
based on male sterile (MS) and fertility restorer (RF) lines to emulate the natural
phenomenon of hybrid vigour, and enable the production of high purity, hybrid seed.
Traditional plant breeding selects for plants with agronomically valuable characteristics but
can also produce highly in-bred plants. This causes ‘inbreeding depression’, usually
defined as a lowered fitness or vigour of inbred individuals compared with their non-inbred
counterparts. The converse of inbreeding depression is hybrid vigour, which results when
offspring of crosses of genetically distinct parents outperform the parental lines. Hybrid
vigour is greatest in the first generation and declines in subsequent generations. Plant
breeders have often used male sterile plants to accomplish hybrid seed production.
The male sterile line of InVigor® canola contains the barnase gene from the soil bacterium
Bacillus amyloliquefaciens. The barnase gene encodes the enzyme Barnase, a ribonuclease
(RNase), which results in the death of the plant cells in which it is expressed. The barnase
gene is controlled by an anther-specific promoter. (A promoter is a small piece of DNA that
controls the level of expression of genes, acting like a switch). This means that the barnase
gene is only active in the plant cells responsible for development of the anthers (the male,
pollen-bearing parts of the flower). Anther-specific expression of the barnase gene results
in male sterility because the flowers cannot develop anthers.
The fertility restorer line of InVigor® canola contains the barstar gene, also derived from
B. amyloliquefaciens. Expression of the barstar gene in InVigor® canola is also restricted to
the anthers by an anther-specific promoter. The barstar gene encodes a ribonuclease
inhibitor protein, Barstar, which binds specifically to the Barnase protein, suppressing the
ribonuclease activity.
In hybrid InVigor® canola plants derived from conventional crosses of male sterile and fertility
restorer lines, both the barstar and barnase genes will be expressed during anther
development. These hybrids are fully fertile because the Barstar protein blocks the action
of the Barnase protein on the anther producing cells, ensuring anther development and
pollen production.
Both the male sterile and fertility restorer lines of InVigor® canola have been also genetically
modified to be tolerant to the herbicide glufosinate ammonium (the active ingredient in
Liberty® and Basta®). This was achieved by the introduction of the bar gene from the soil
bacterium Streptomyces hygroscopicus. The bar gene encodes the enzyme
phosphinothricin acetyltransferase (PAT) that detoxifies glufosinate ammonium. The
herbicide tolerance trait is used as a selection tool for the breeding system and also enables
the application of glufosinate ammonium to control weeds in the canola crop.
Aventis requested approval to carry out a limited and controlled release on a maximum of
318 hectares at 90 sites over 3 years, comprising winter plantings of 61 hectares at 13 sites
and summer plantings 45 hectares at 17 sites in each year. The maximum area permitted
to be sown to the GM canola at any site is 9 hectares. Sites would be selected from 23
local government areas, with Winter plantings in Victoria, South Australia, New South Wales
and Western Australia and summer plantings in Victoria and South Australia only. The
licence imposes conditions that prohibit any releases of the GM canola beyond these limits.
Aventis has indicated that a reduction in the number of sites for the winter 2002 season is
likely because of the lateness of planting.
Aventis has previously conducted similar releases of InVigor® canola. Winter releases were
conducted in New South Wales, Victoria, Queensland, South Australia, Western Australia
and Tasmania. Summer releases were conducted in South Australia and Tasmania.
There have been no reports of adverse effects on human health or the environment resulting
from these releases.
Summary information about the genetically modified organisms (GMOs), the application and
the regulatory system established by the Act is available in the document, Summary
information on application number DIR 010/2001. More detailed information is available in
the risk assessment and risk management plan that has been prepared in accordance with
the requirements of the Act. Further background information is available in the document
The biology and ecology of canola. All three documents are available from the Office of the
Gene Technology Regulator (OGTR) website or from the OGTR (see contact details below).
This document summarises the conclusions of the risk assessment process and the risk
management plan, including the specific licence conditions, developed to manage the risks
to human health and safety and the environment identified by the risk assessment. The
Regulator considers that these conditions are sufficient to manage any risks posed by the
current release (see below, Summary of risk management plan).
Summary of risk assessment
A number of possible hazards that could arise as a direct result of the genetic modification of
InVigor® canola were identified. They include:



the potential for the genetically modified canola to be harmful to other organisms,
including humans, because it is toxic or allergenic;
the potential for the genetically modified canola to be harmful to the environment
because of inherent weediness or increased potential for weediness; and
the potential for the new genes introduced into the canola to transfer to other organisms
with adverse consequences.
Risk of toxicity or allergenicity
It is considered that the likelihood of adverse impacts on humans or other species, as a
result of toxicity or allergenicity of InVigor® canola, is very low. No plants or plant
byproducts from the trial will be used for human food or animal feed.
There is no evidence that InVigor® canola will be more toxic or allergenic to humans or other
organisms than conventional canola varieties. The proteins produced by the introduced
genes are not considered to be toxic or allergenic. Oil derived from InVigor® canola has been
approved by Food Standards Australia New Zealand (FSANZ, formerly the Australia New
Zealand Food Authority (ANZFA), for details refer to ANZFA Final Assessment Report,
Application A372, 2001, available from the FSANZ website www.foodstandards.gov.au).
Risk of weediness
Canola is not a problematic weed in habitats outside agricultural areas and the introduced
genes are not likely to increase weediness. The risk of InVigor® canola spreading into the
environment and causing environmental harm is low and unlikely to be greater than that for
conventional canola. Tolerance to glufosinate ammonium would not confer a survival
advantage on the plants in the absence of this herbicide.
The use of glufosinate ammonium in Australia is currently restricted to horticultural situations
and is not used as a herbicide for weed control in broad acre cropping or in the natural
environment. The release will use the glufosinate ammonium tolerance trait in selection of
hybrids. In addition, glufosinate ammonium may be used at some of the winter sites for
weed control for demonstration purposes, or if conventional weed control strategies are
ineffective. Glufosinate ammonium is not currently registered for use on canola, and its use
during the release will require a permit from the National Registration Authority for
Agricultural and Veterinary Chemicals (NRA). The Regulator has imposed conditions to
manage any potential weediness risk (see below, Summary of risk management plan).
Risk of gene transfer
There is a potential for transfer of the introduced genes to non-GM canola crops but the level
of outcrossing will be very low, and, given the relatively small scale of the proposed release,
management measures can be imposed that will further reduce the likelihood of gene
transfer occurring. The risk of gene transfer to closely related Brassica species (B. rapa
and B. juncea) is even lower. The risk of gene transfer to other Brassica plants, including
Brassicaceous weeds is extremely low. The risk of gene transfer to other unrelated plant
species or to animals or microorganisms is negligible.
The Regulator has imposed conditions on the licence issued to Aventis to manage these
risks (see below, Summary of risk management plan). The conclusions with respect to
each transferred gene sequence are as follows:
Herbicide tolerance gene
There is a low risk of transfer of the bar gene from the genetically modified canola to
commercially grown non-GM canola, an even lower risk of gene transfer to other B. rapa or
B. juncea, and a negligible risk of gene transfer to other Brassicaceous weeds or other
organisms. There would be no adverse consequences in the natural environment if
outcrossing to canola or related species occurred, as tolerance to glufosinate ammonium
would not confer a survival advantage on the plants in the absence of a selection pressure
from this herbicide. Canola (B. napus) is not regarded as a weed in Australia and
glufosinate ammonium is not used in broad acre cropping or for control of canola in the
natural environment. If gene transfer to animals or microorganisms occurred, there would
be no adverse effects because herbicides are only used to control plants.
Male sterility gene
As with the bar gene, there is a low risk of transfer of the barnase gene to non-GM canola,
an even lower risk of gene transfer to other B. rapa or B. juncea, and a negligible risk of
gene transfer to other Brassicaceous weeds or other organisms. There would be no
adverse consequences from transfer of the male sterility gene even if outcrossing occurred,
as this is not likely to be toxic or allergenic to other organisms. Nor would it increase the
weediness of the recipient plants, as a high proportion of the progeny of a plant receiving the
barnase gene would be male sterile and could not reproduce and persist in the environment
unless pollinated by another plant. The proportion of male sterile GM plants would
decrease in subsequent generations.
Fertility restorer gene
There would be no adverse consequences from transfer of the barstar gene in the unlikely
event that outcrossing occurred, as this is not likely to be toxic or allergenic to other
organisms, or to increase the weediness of the recipient plants. The fertility restorer gene
would have no impact on a plant’s phenotype apart from restoring fertility to a proportion of
the progeny resulting from crosses with a male sterile InVigor® canola plant.
Regulatory sequences
InVigor® canola contains some regulatory sequences derived from a plant pathogen, the
common soil bacterium Agrobacterium tumefaciens. These sequences only represent a
very small proportion of the pathogen genome and are not, in themselves, infectious or
pathogenic. A. tumefaciens and the regulatory sequences used in the genetically modified
canola are already present in the environment and in the human diet.
Horizontal gene transfer from plants to microorganisms, including viruses, or to animals and
humans is extremely unlikely.
Summary of risk management plan and specific licence conditions
To give effect to the risk management plan, specific conditions have been included in the
licence relating to risk management. Details of these conditions are provided in the full risk
assessment and risk management plan, which can be obtained from the OGTR (see below).
Risk of toxicity or allergenicity
On the basis of the risk assessment, the risks of toxicity or allergenicity of InVigor ® canola
are considered to be extremely low, and the scale of the release is relatively small, thereby
limiting any environmental exposure to the GM canola. It is not considered necessary to
include any management strategies in the risk management plan in relation to the potential
toxicity or allergenicity of the GM canola.
Nevertheless, the licence includes specific conditions that will minimise any risks of toxicity
and allergenicity:

prohibiting the use of the canola plants from the trials or their by-products in human
food or animal feed;

limiting the scale and location of the release; and

limiting the spread and persistence of the GM canola (see below).
Risks of weediness or gene transfer
It has been concluded that the risks relating to weediness or gene transfer are low and can
be managed to an acceptable level by implementing various measures to minimise the
spread and persistence of InVigor® canola, or the modified genetic material, in the
environment.
The licence imposes specific conditions to implement the management strategies, detailed
below, and these are considered adequate to manage the risks of weediness and gene
transfer:
Measures during the trial


Isolation zone
The GM canola must be isolated from other canola, B. rapa and B. juncea crops by
an isolation zone:

1 km if no other measures to minimise pollen flow are used;

400 metres if used in conjunction with other measures to minimise pollen flow:
- all of the GM canola at the site is male sterile;
- all the flowers are bagged;
- the GM canola is covered by an insect-proof tent; or
- the GM canola is surrounded by a 15-metre pollen trap of non-GM or male
sterile GM canola.
Monitoring zone
Destruction of sexually compatible Brassica plants and Brassicaceous weeds in the
trial site and within a monitoring zone extending 50 metres from the edge of the GM
canola (or pollen trap) both prior to and during flowering of the GM canola
Measures after the trial

After harvest of the GM canola, destroy all viable material from the trial except for
seed retained for analysis or future use, or for export;

Lightly till the trial site twice within twelve months after harvest to promote the
germination of any remaining canola seed and deplete the seedbank; and

Monitor and destroy canola volunteers that grow on the trial site, pollen trap and
monitoring zone for three years and until the site is free of volunteer plants for 12
months.
Other measures – notification, reporting and research

In order to assist the independent monitoring conducted by the Regulator (see
Monitoring and enforcement of compliance by the OGTR below), the licence imposes
conditions requiring the licence holder to notify the Regulator of forecasted and
actual dates of planting, flowering and harvest of the GM canola. These stages of
the trial represent the times of highest likely risk of dissemination or persistence of
the GM canola in the environment.

The licence holder must report regularly to the Regulator on the progress of the trial
and post-harvest monitoring.

The licence also imposes an obligation on the licence holder to develop a program of
research agreed with the OGTR to obtain data on the effectiveness of pollen traps
and isolation zones and on the rate of outcrossing from canola at short distances
(0-10 metres) under Australian conditions.
Monitoring and enforcement of compliance by the OGTR
It should be noted that, as well as imposing licence conditions, the Regulator has additional
options for risk management. The Regulator has the legislative capacity to enforce
compliance with licence conditions and, indeed, to direct a licence holder to take any steps
the Regulator deems necessary to protect the health and safety of people or the
environment. The OGTR also independently monitors authorised trials. At least 20% of all
trial sites will be monitored each year, to determine whether the licence holder is complying
with the licence conditions, or whether there are any unforseen problems.
In identifying when to undertake routine monitoring visits, sites are selected on the basis of a
risk profile. In assembling a risk profile of a site, a number of factors are taken into account,
including the type of GMO(s) and its biology, and seasonal/geographical/ecological risk
factors for both current and post-harvest field trial sites.
For example, the critical periods for monitoring to occur in respect of GM field trials are when
the trial is at its ‘higher risk’ points (ie. when there is an inherently higher risk to the health
and safety of people and the environment). The licence requires the removal of related
Brassicaceous plants within 50 m of the GM crop (or pollen trap if used) prior to flowering.
Therefore, one crucial period for monitoring would be immediately before flowering occurred
to ascertain whether sexually compatible plants had been removed from the trial site.
Contact details
Copies of the risk assessment and risk management plan, as well as this summary
information, can be obtained from the OGTR at the address below or from the Office’s
website. Copies of the licence application are also available from the Office. Please quote
application Number DIR 010/2001.
Office of the Gene Technology Regulator
MDP 54, PO Box 100
WODEN ACT 2600
Telephone: 1800 181 030
Facsimile: 02 6271 4202
Website: http://www.ogtr.gov.au
Email: [email protected]