Download Application No. DIR 115 - Office of the Gene Technology Regulator

21 May 2012
TECHNICAL SUMMARY OF THE RISK ASSESSMENT AND RISK
MANAGEMENT PLAN (CONSULTATION VERSION)
FOR
APPLICATION NO. DIR 115
FROM
THE COMMONWEALTH SCIENTIFIC AND INDUSTRIAL RESEARCH
ORGANISATION (CSIRO)
Introduction
A licence application (DIR 115) has been received from Commonwealth Scientific and Industrial
Research Organisation (CSIRO) for a limited and controlled release of genetically modified (GM)
cotton.
The Gene Technology Act 2000 (the Act), the Gene Technology Regulations 2001 and
corresponding state and territory law govern the comprehensive and highly consultative process
undertaken by the Gene Technology Regulator (the Regulator) before making a decision whether or
not to issue a licence to deal with a genetically modified organism (GMO).
In accordance with the gene technology legislation, a detailed Risk Assessment and Risk
Management Plan (RARMP) for the dealings proposed by the applicant has been prepared for
consultation. The Regulator now invites submissions in order to finalise the document, which will
then form the basis of his decision whether or not to issue a licence.
The application
CSIRO has applied for a licence for dealings involving the intentional release of eight types of GM
cotton into the environment on a limited scale and under controlled conditions. The GM cotton
plants have been genetically modified for enhanced fibre yield. The applicant proposes to conduct
the trial between August 2012 and August 2015 at one site per growing season at the local
government area of Narrabri, New South Wales. The maximum area of a site would be 0.5 ha.
The purpose of the trial is to evaluate the potential for increasing fibre yield by increasing
expression of one or more of the three cotton genes that are all involved in regulation of fibre
development. The trial will establish whether these regulatory genes are valid targets for genetic
modification for enhancing fibre yield and will also generate information on genetic regulation of
fibre development. The GM cotton would not be permitted to enter the human or animal food
supply chains.
The applicant proposes to release eight types of GM cotton plants modified to over-express one or
more of the GhMYb25, GhMYB25-like and GhHD1 genes either constitutively or in a seed specific
manner. All the three genes are from cultivated cotton Gossypium hirsutum and encode gene
transcription factors (proteins that regulate expression of their target genes). The GM cotton plants
intended for release are expected to have higher fibre yield as compared to the parent cultivar. All
Office of the Gene Technology Regulator
the GM cotton plants also contain an antibiotic resistance marker gene, nptII, which was used to
select the GM plants during development of the plants in the laboratory.
The GM cotton plants also contain short regulatory sequences that control expression of the
introduced genes. Regulatory sequences were derived from plants (Petunia hybrida, Flavaria
bidentis) or plant viruses (Subterranean Clover Stunt Virus).
Six of the eight types of GM cotton plants proposed for release contain a single genetic
modification or ‘transformation’ event (primary lines1). The remaining two types of the GM cotton
will contain two or more transformation events combined or ‘stacked’ (stacked lines) by
conventional cross-breeding between the primary lines. None of the GM cotton plants has been
previously approved by the Regulator for limited and controlled release in Australia or by
regulatory authorities in other countries.
CSIRO proposes a number of controls to restrict the spread and persistence of the GM cotton plants
and their genetic material into the environment. These controls have been considered during the
evaluation of the application.
Risk assessment
The risk assessment takes into account information in the application (including proposed
containment measures), relevant previous approvals and current scientific/technical knowledge.
A reference document, The Biology of Gossypium hirsutum L. and Gossypium barbadense L.
(cotton), was produced to inform the risk assessment process for licence applications involving GM
cotton plants. The document is available from the OGTR or from the website
<http://www.ogtr.gov.au>.
Initially, potential pathways that might lead to harm to people or the environment as a result of gene
technology are postulated (risk scenarios), and those that warrant detailed characterisation are
determined. This process is described as risk identification.
Four risk scenarios were postulated, including consideration of whether or not expression of the
introduced genes could result in products that are toxic or allergenic to people or other organisms or
alter characteristics that may impact on the spread and persistence of the GM cotton The
opportunity for gene flow to other organisms, and its effects if it were to occur, was also assessed.
A risk is only identified for further assessment when a risk scenario is considered to have some
chance of causing harm. Pathways that do not lead to an adverse outcome, or could not reasonably
occur, do not advance in the risk assessment process.
The characterisation of the four risk scenarios in relation to both the seriousness and likelihood of
harm, in the context of the control measures proposed by the applicant and considering both the
short and the long term, did not give rise to any identified risks that required further assessment.
The principal reasons for this include:
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widespread presence of the same or similar proteins encoded by the introduced genes in the
environment and lack of known toxicity or evidence of harm from them.
plant characteristics and abiotic factors limiting the ability of GM or non-GM cotton plants
to establish and persist in non-cultivated environments
limited ability and opportunity for the GM cotton plants to transfer the introduced genes to
commercial cotton crops or other cotton plants
The term ‘line’ is used to denote plants derived from a single plant containing a specific genetic modification resulting
from a single transformation event.
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Office of the Gene Technology Regulator
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limits on the size, location and duration of the release proposed by CSIRO
the controls proposed by CSIRO to restrict the spread and persistence of the GM cotton
plants and their genetic material
none of the GM plant materials or products will be permitted to enter commercial human or
animal food supply chains.
Risks to the health and safety of people, or the environment, from the proposed release of the GM
cotton into the environment are assessed to be negligible. Hence, the Regulator considers that the
dealings involved in this limited and controlled release do not pose a significant risk to either people
or the environment2.
Risk management plan
Risk management is used to protect the health and safety of people and to protect the environment
by controlling or mitigating risk. The risk management plan evaluates and treats identified risks,
evaluates controls and limits proposed by the applicant, and considers general risk management
measures. The risk management plan is given effect through proposed licence conditions.
As none of the four risk scenarios characterised in the risk assessment give rise to an identified risk
that requires further assessment, the level of risk from the proposed dealings is assessed to be
negligible. The Regulator's Risk Analysis Framework defines negligible risks as insubstantial, with
no present need to invoke actions for their mitigation in the risk management plan. However, a
range of conditions are proposed to restrict the spread and persistence of the GMOs and their
genetic material in the environment and to limit the release to the size, locations and duration
proposed in the application, as these were important considerations in establishing the context for
assessing the risks.
Proposed licence conditions
The Regulator has proposed a number of licence conditions, including requirements to:
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limit the release to 0.5 ha per growing season in the LGA of Narrabri, NSW between August
2012 and August 2015
restrict gene flow via pollen from the field trial site by surrounding the trial site with a 20 m
pollen trap of non-GM cotton
harvest and gin any GM cotton plant material required for analysis or future planting
separately from other cotton crops
clean all equipment used in connection with the cotton plant material
destroy any excess plant material not required for analysis or future planting
after cleaning of sites, apply measures to promote germination of any cotton seeds that may
be present in the soil
after cleaning of sites, monitor for and destroy any GM cotton that may grow for at least 12
months, and until no volunteers are observed for a continuous 6 month period
transport and store the GM plant material in accordance with the Regulator’s guidelines or
other specific conditions
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If the Regulator considers that none of the proposed dealings pose a significant risk to people or the environment,
section 52(2)(d)(ii) of the Act mandates a minimum period of 30 days for consultation on a RARMP. However, the
Regulator has allowed up to 6 weeks for the receipt of submissions from prescribed experts, agencies and authorities
and the public.
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Office of the Gene Technology Regulator
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not allow GM plant material or products to be used for human food or animal feed.
Other regulatory considerations
Australia's gene technology regulatory system operates as part of an integrated legislative
framework that avoids duplication and enhances coordinated decision making. The Regulator is
responsible for assessing risks to the health and safety of people and the environment associated
with the use of gene technology. However, dealings conducted under a licence issued by the
Regulator may also be subject to regulation by other Australian government agencies that regulate
GMOs or GM products, including Food Standards Australia New Zealand (FSANZ), Australian
Pesticides and Veterinary Medicines Authority, Therapeutic Goods Administration, National
Industrial Chemicals Notification and Assessment Scheme and Department of Agriculture,
Fisheries and Forestry (DAFF) Biosecurity3.
FSANZ is responsible for human food safety assessment and food labelling, including GM food.
The applicant does not intend to use materials generated from the GM cotton plants in the proposed
release in human food or in animal feed.
In addition, dealings authorised by the Regulator may be subject to the operation of State legislation
declaring areas to be GM, GM free, or both, for marketing purposes. In addition, dealings
authorised by the Regulator may be subject to the operation of State legislation declaring areas to be
GM, GM free, or both, for marketing purposes.
Identification of issues to be addressed for future releases
Additional information has been identified that may be required to assess an application for a large
scale or commercial release of these GM cotton plants, or to justify a reduction in containment
conditions. This includes:
 additional phenotypic characterisation of the GM cotton plants, in particular of traits which
may contribute to weediness
 additional molecular and biochemical characterisation of the GM cotton plants including
potential for increased toxicity.
Conclusions of the consultation RARMP
The risk assessment concludes that this limited and controlled release of eight types GM cotton
planted at one site per growing season with a maximum area of 0.5 ha over three years in Narrabri,
New South Wales poses negligible risks to the health and safety of people or the environment as a
result of gene technology.
The risk management plan concludes that these negligible risks do not require specific risk
treatment measures. If a licence were to be issued, conditions are proposed to limit the release in
size, locations and duration, and to require controls in line with those proposed by the applicant as
these were important considerations in establishing the context for assessing the risks.
More information on Australia’s integrated regulatory framework for gene technology is contained in the Risk
Analysis Framework available from the Office of the Gene Technology Regulator (OGTR). Free call 1800 181 030 or at
<http://www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/riskassessments-1>.
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