Download Summary of risk management plan and licence conditions

Office of the Gene Technology Regulator
RISK ASSESSMENT AND RISK MANAGEMENT PLAN AND LICENCE FOR INTENTIONAL RELEASE OF A
GMO INTO THE ENVIRONMENT:
Application No. DIR 008/2001
SUMMARY INFORMATION
Project Title:
Integrated Pest Management Systems for INGARD® Cotton
in the Kimberley, WA
Applicant:
Western Australian Department of Agriculture
Locked Bag 4
Bentley Delivery Centre WA 6983
Common name of the parent organism:
Cotton
Scientific name of the parent organism:
Gossypium hirsutum
Modified trait(s):
Insecticidal action, antibiotic resistance
Identity of the gene(s) responsible for the
modified trait(s):

cry1Ac from the bacterium Bacillus thuringiensis
(insecticidal gene)

nptII and aad genes from bacterial Tn5 and Tn7
transposons, respectively, (antibiotic resistance
genes)
Location
Shire of Wyndham-East Kimberley (Western Australia)
Trial Size:
A maximum of 148 hectares on 12 sites
Introduction
The Gene Technology Regulator (the Regulator) has made a decision to issue a licence in respect of the
application (DIR 008/2001) by the Western Australian (WA) Department of Agriculture. The
application is for a licence to undertake a controlled and limited release of genetically modified (GM)
cotton into the environment in Western Australia.
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 WA Department of Agriculture applied for a licence for a limited and controlled release (field trial)
of GM insecticidal cotton which is registered under the trade name INGARD® cotton. INGARD®
cotton is resistant to the major caterpillar pests that attack cotton. It contains an insecticidal gene from
a common soil bacterium that produces a protein that is toxic to specific insects.
There have been several previous limited and controlled releases of INGARD® cotton in Australia,
including in northern Australia, under the previous voluntary system overseen by the Genetic
Manipulation Advisory Committee (GMAC).
INGARD® cotton was approved for commercial release in Australia in 1996, by the National
Registration Authority for Agricultural and Veterinary Chemicals. The release was restricted to south
of latitude 22 South because of concerns about the potential for increased weediness of cotton in
tropical regions and the possibility of outcrossing to related native cotton species present in northern
Australia. These issues have also been considered in the context of this application.
The WA Department of Agriculture has requested approval to carry out a limited release on 12 sites
over a total area of 148 hectares in the Shire of Wyndham-East Kimberley (WA). This is a reduction
from the original application which proposed 30 sites over a total area of 500 hectares. The purpose of
this release is: to evaluate strategies for the integrated management of INGARD® cotton pests; to
evaluate the agronomic performance of new varieties of INGARD® cotton; to assess the effects of
releasing INGARD® cotton on key pests and beneficial insects; and to assess the potential development
of pests resistant to the insecticidal action of the cotton.
None of the GM cotton plants produced in the trial, or their by-products, will be incorporated in human
food or animal feed in Australia. As noted above, INGARD® cotton has been approved for commercial
release, and seed from the release will be exported, observing appropriate transport conditions within
northern Australia.
Summary information about the original application, the genetically modified organisms (GMOs)
proposed for release and the regulatory system established by the Act are in the accompanying
document: ‘Summary information on application number DIR 008/2001’. Detailed information is
available in the full risk assessment and risk management plan. You can obtain these documents
on-line or from the Office of the Gene Technology Regulator (see below).
This document summarises the conclusions of the risk assessment process and the risk management
plan and describes the licence conditions which have been imposed to ensure that the risks identified by
the risk assessment are managed effectively.
Summary of risk assessment
A number of possible hazards that could arise as a direct result of the genetic modification of
INGARD® cotton were identified. They include:




the potential for the GM cotton to be harmful to other organisms, including humans, because it is
toxic or allergenic;
the potential for the GM cotton to be harmful to the environment because of inherent weediness or
increased potential for weediness;
the potential for the new genes introduced into the cotton to transfer to other organisms with
adverse consequences; and
the potential for resistance to the insecticidal protein produced by the introduced Cry1Ac gene to
develop in target insects in the long term.
Risk of toxicity or allergenicity
It is considered that the likelihood of adverse impacts on humans or other species (other than
lepidopteran insects), as a result of toxicity or allergenicity of INGARD® cotton, is very low.
There is no evidence that INGARD® cotton will be more toxic or allergenic to humans or other
organisms (other than lepidopteran insects) than conventional cotton. As noted above, none of the
GM cotton plants produced in the trial, or their by-products, will be incorporated in human food or
animal feed in Australia. Agriculturally, the scale of the proposed release is relatively small and any
environmental impacts due to non-target toxicity are likely to be localised to the specific release sites
and, therefore, will be manageable.
Risk of weediness
It is concluded that INGARD® cotton is highly unlikely to become weedy, and that the risk of the
GM cotton spreading into the environment and causing environmental harm is low and unlikely to be
greater than that for conventional cotton. In summary, the reasons for these conclusions are that cotton
itself is not a problematic weed and the introduced genes are not likely to increase the weedy potential
of the plants.
As noted above, commercial release of INGARD® cotton was restricted to south of latitude 22 South
because the potential for weediness may be greater in northern Australia compared to other cotton
growing regions. This could occur if the tropical climate favours increased growth of cotton, or if
there is increased insect pressure in this region. Because of its insecticidal action, the GM cotton
might have a survival advantage in regions where insect predation limits plant growth and regulates
plant population density.
However, the distribution of cotton and its native relatives appears to be determined more so by soil
type and climatic conditions, than by insect pressure. Further data relating to these issues would be
required before any more widespread, less restricted release of INGARD® cotton could be considered in
northern Australia. Nevertheless, the licence conditions that have been imposed are considered
sufficient to manage any potential risks posed by the current release (see below, Summary of risk
management plan and licence conditions, Risks of weediness or gene transfer).
Risk of gene transfer
The likelihood of gene transfer from the GM cotton to commercially grown cotton or wild cotton is
very low, and is negligible for transfer to other plant species, including native cottons present in
northern Australia, or to animals or microorganisms. Moreover, the licence conditions that have been
imposed are considered sufficient to manage this risk (see below, Summary of risk management plan
and licence conditions, Risks of weediness or gene transfer). The conclusions with respect to each
transferred gene sequence are as follows:
Insecticidal genes
It is possible that if these genes were transferred to wild, native, or cultivated cotton, the plants might
have a survival advantage in regions where insect predation limits their growth and regulates their
population density.
Antibiotic resistance genes
Transfer of these genes to organisms other than bacteria would not present a hazard, since the
antibiotics in question are only used to treat or prevent bacterial infections. Horizontal transfer from
the GM cotton to bacteria is also extremely unlikely and is considered to pose negligible risks to human
health and the environment. The incidence of naturally occurring bacterial strains resistant to the
antibiotics in question is already very high. Even if the resistance genes were transferred to a
bacterium, this would be unlikely to have any detectable impact on the existing level of resistance in
microbial populations. In any case, the antibiotics in question are not of major clinical or veterinary
significance.
Viral regulatory sequences
Horizontal gene transfer from plants to microorganisms, including viruses, or to animals and humans is
extremely unlikely. It has been suggested that there are risks posed through recombination of viral
sequences inserted into plant genomes with the other viruses infecting the plants, to create new viruses,
or of integration of the viral sequences into the genes of other species causing mutations, cancer or
reactivation of dormant viruses. However, these claims have been refuted in the scientific literature.
The viruses in question and the regulatory sequences used in the GM cotton are already present in the
environment and in the human diet.
Risk of insecticide resistance
The likelihood of selecting resistant insects in the current trial is negligible. Licence conditions have
been imposed to ensure that the WA Department of Agriculture grow refuge crops to delay the
development of insects resistant to the insecticidal action of the cotton (see below, Summary of risk
management conditions, Risk of insecticide resistance). The likelihood of development of insects
resistant to the Cry1Ac protein will be further limited by the scope of the proposed release, both in scale
and time.
Summary of risk management plan and licence conditions
Risk of toxicity or allergenicity
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 cotton. The risks are very low, and the scale of
the release is relatively small, thereby limiting any environmental exposure to the GMO. Products
from INGARD® cotton grown in the release will not be incorporated in human food or animal feed in
Australia, and conditions have been included in the licence to restrict the use of GM material produced
during the trial. It is also noted that any future application proposing unrestricted release on a
commercial scale would have to include further data to confirm that INGARD® cotton, or its
by-products, is not toxic or allergenic to non-target organisms.
Risks of weediness or gene transfer
The release is above latitude 22 South, out side the area approved for general release of INGARD®
cotton, and the risks relating to weediness or gene transfer are potentially greater than in other regions
of Australia. Nevertheless, it was considered that these risks are low and can be managed by
implementing various measures to minimise the spread and persistence of INGARD® cotton, or the
modified genetic material, in the environment. The licence includes a number of specific conditions
relating to these strategies (see below, Risk management conditions).
Risks of insecticide resistance
The likelihood of selecting resistant insects in the current trial is low because of the limited scope of the
proposed release. Nevertheless, licence conditions require the WA Department of Agriculture to grow
refuge crops as part of their insecticide resistance management strategy (see below, Risk management
conditions).
Risk management conditions
To give effect to the risk management plan, a number of specific conditions have been included in the
licence relating to risk management. These conditions include: requirements to isolate the GM cotton
crop from other cotton by at least 50 m or to surround the release plots with 20 m buffer rows of
conventional cotton; to grow specified refuge crops for insecticide resistance management; to develop a
program to evaluate the effectiveness of these measures and the potential environmental impacts of the
GM cotton; to develop a program to monitor the potential for allergic reactions in workers handling the
GM cotton; after harvest, to destroy any viable material not exported or required for subsequent trials
(which would require separate licences); and to monitor the trial site after harvest and remove any
cotton plants (volunteers) that germinate or regrow after the trial for a period of 12 months.
Details of the licence conditions are provided in the full risk assessment and risk management plan
which can be obtained on-line, or from the Office of the Gene Technology Regulator (see below).
Monitoring and enforcement of compliance by the OGTR
The OGTR will independently monitor trials it has authorised. At least 20% of all trial sites will be
monitored each year, at times when any problems would be most apparent, to determine whether the
licence holder is complying with the licence conditions, and to confirm that there are no unforseen
problems. It should be noted that, as well as imposing licence conditions, the Regulator has additional
options for risk management should this be necessary. 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 Office of the Gene Technology Regulator
PO Box 100
Woden ACT 2600
Website: www.ogtr.gov.au
E-mail: [email protected]
Phone: 1800 181 030
Fax: (02) 6271 4202