How CSIRO takes precautions when undertaking gene technology experiments
CSIRO operates within strict guidelines when conducting gene technology research. This approach ensures the safety of the community and the environment, and also ensures that rigorous scientific practices are followed.
All CSIRO research involving gene technology is performed according to Australian legislation for gene technology, including regulations set out by the Office of the Gene Technology Regulator (OGTR).
CSIRO sites undertaking gene technology research have Institutional Biosafety Committees (IBCs), whose role is to ensure all procedures are in accordance with OGTR regulations.
CSIRO has ten IBCs operating to ensure consistency and best practices are followed across the Organisation and to monitor and improve internal safety procedures. The activities of all ten IBCs are coordinated centrally to ensure they all maintain the same standards of regulatory oversight.
In particular, the regulations require the safe conduct of gene technology research within laboratories. The OGTR also requires any release of genetically modified organisms into the environment be licensed and comply with biosafety conditions that minimise risks.
The majority of CSIRO's gene technology research on plants is carried out in CSIRO Plant Industry; that on animals in CSIRO Livestock Industries.
Their safety procedures are described in more detail in the following pages. Other parts of CSIRO also conduct gene technology research involving plants, animals, insects and microorganisms, and follow similar procedures.
How CSIRO takes precautions when undertaking gene technology experiments: plants
CSIRO Plant Industry is rigorous in following the OGTR regulations and has in place additional mechanisms to ensure the safe conduct of its research, the safety of its staff, the community and environment. The procedures followed by CSIRO Plant Industry are similar to those in other CSIRO Divisions.
Plant Industry has four Institutional Biosafety Committees (IBCs) and representation on one other. These IBCs monitor seven sites conducting gene technology research.
The IBCs have experts and scientists in various fields of study that are relevant to the research under way. For example, experiments involving plants have experts on weeds, agronomy (farming), ecology and insects to name a few.
But it's not just scientists on these committees – people from non-scientific backgrounds and the community are also members and contribute their advice and concerns.
The IBCs have regular meetings to review the conduct of gene technology research, and to ensure compliance with OGTR regulations.
Gene technology experiments at CSIRO Plant Industry are predominantly conducted under laboratory and glasshouse conditions – under the gene technology legislation, these projects are classified as exempt dealings, notifiable low risk dealings (NLDRs) or licensed dealings not involving intentional release (DNIRs).
All projects involving gene technology, apart from certain dealings the OGTR has exempted, are registered with the OGTR, and are undertaken only with the approval of the Chief of Plant Industry.
The labs and glass houses are certified by the OGTR as PC2 (Physical Containment Level 2) facilities. In some cases, higher levels of containment (PC3 or PC4) may be used.
The containment level used depends on the type of research being done. Most gene technology labs and glasshouses are rated at the lowest level, PC2. The design, operation and structure of glasshouses registered as PC2 minimises any unintentional movement of plant materials (including seeds) and soil from them.
Containment facilities are regularly inspected by IBCs to make sure they are in accordance with safety practices as specified by the regulators.
The scientists in these labs and glasshouses work according to the regulations specified by the OGTR. Supervisors make sure everyone follows correct procedures.
When experiments are finished, waste materials from laboratories are disposed of by autoclaving. Autoclaving is a very high temperature, high-pressure process that destroys all living biological materials.
Field trials are an important part of gene technology research. Plant Industry carries out field trials to test experimental crops that are developed from laboratory studies.
It is CSIRO policy that any genetically modified organism CSIRO may intend to release into field trials must be assessed and monitored carefully to minimise any potential adverse environmental effects. Field trials do not proceed if there is any unacceptable risk to the environment or the community.
Field trials of GM crops can proceed only with the issue of a licence for intentional release (DIR) from the OGTR. Approval from the OGTR is provided after researchers have satisfied all safety testing requirements for the GMO in the laboratory and secure glass house.
Strict rules are applied to the conduct of field trials ('intentional releases'). Non-compliance can attract severe penalties. The rules include:
- Institutional Biosafety Committees (IBCs) assess proposals and advise of necessary changes.
- Following IBC endorsement, the proposal is sent to CSIRO's Executive in charge of gene technology policy who, after assessment and approval on behalf of the Chief Executive, forwards the proposal to the OGTR.
- OGTR assesses the proposed trial, develops a risk analysis and management plan (RAMP) and, subject to its assessment, issues licence conditions under which the trial can be done. Any changes to the proposed field trial must be notified to the OGTR.
The IBCs ensure scientists follow all set licence conditions. The particular gene and crop plant being investigated determines what conditions of field trials must be in place.
Typical conditions may include:
- the inclusion of buffer crops (to act as pollen traps) and specified separation zones from other crops
- animal and bird proofing and/or minimisation of insects
- special pruning and/or harvesting procedures
- set periods of isolation for monitoring of any potential volunteer plants.
For example, as cotton pollen and seed have a low tendency to disperse, small zones of buffer crops are needed. But bigger buffer zones are needed for crops where pollen may be dispersed by wind.
Pollen from such crops may also be contained by placing bags over flowers before maturity. In addition, crop management practices like pruning are used to minimise flower formation.
Usually the buffer plants are destroyed after the trial. But sometimes they are first examined by researchers to determine the extent of 'gene flow', if any, from the trial plants to the buffer plants.
Where flowering and seed formation is not required, plants may be harvested and destroyed before flowering, so seed and pollen are not produced.
Once the field trial is complete, seeds are generally harvested by hand or by machines specifically operated by CSIRO, so as to avoid any possible dispersal of GM seeds.
Harvesting machines are also cleaned carefully after use. Vegetative plant material like leaves and stems are ploughed back into the ground unless otherwise specified by the OGTR. Some plant materials may be kept for further laboratory analysis. Some seed may be retained in secure conditions for further research or future development of the crop.
The land where field trials are conducted is typically monitored for 1–5 years after completion of a trial to ensure that the plant does not persist in the environment. Any plants that may grow are removed, may be analysed and are then destroyed as described above, and/or herbicide may be applied, depending on licence conditions.
All outcomes of field trials are reported to the OGTR. The OGTR also conducts regular inspections of field trial sites, both during the plant growth period and in post-harvest monitoring, to ensure that licence conditions are met. The OGTR has the power to issue severe penalties in cases of non-compliance.
How CSIRO takes precautions when undertaking gene technology experiments: animals
CSIRO Livestock Industries complies with gene technology and associated legislation regulations and has additional mechanisms in place to ensure the safe conduct of its research, including the safety of its staff, the community and environment.
The procedures followed by CSIRO Livestock Industries are similar to those of other CSIRO Divisions.
Livestock Industries has Institutional Biosafety Committees (IBCs) in place to monitor work conducted in gene technology research.
The IBCs have experts and scientists in various fields of study that are relevant to the research undertaken. For example, experiments involving animals have experts on animal health and welfare, parasites, reproduction, genetics and microbiology to name a few. But it's not just scientists on these committees - people from non-scientific backgrounds and the general community are active participants.
In addition to the requirements under the Gene Technology Act, all animal experiments must be endorsed by Animal Ethics Committees (AEC). These committees are composed of internal experts, external experts not engaged in animal experimentation and lay people (concerned non-scientists and people from animal welfare organisations).
They ensure that welfare concerns are balanced against the benefit of the knowledge gained.
All projects involving gene technology, apart from projects that are exempt from the gene technology legislation, must be registered with the OGTR, and may be undertaken only with the approval of the Chief of Livestock Industries.
The labs, animal houses and secure enclosures are certified by the OGTR and are regularly inspected by IBCs to ensure they comply with the necessary standards as specified in the legislation.
Most gene technology facilities are rated at a level of containment, PC2 (Physical Containment Level 2). In some cases, higher levels of containment (PC3 or PC4) may be used. The containment level used depends on the type of research being done.
Outdoor enclosures that are certified for use with GM animals and all animals are individually identified with prominent permanent tags, and are monitored regularly.
The scientists in these labs and other facilities work according to the regulations specified by the gene technology legislation.
Field trials are an important part of gene technology research. For GM animals, a field trial might involve keeping the animals in an ordinary paddock rather than a secure outdoor enclosure that has been certified by the OGTR.
It is CSIRO policy that any GMO that CSIRO may intend to release into field trials must be assessed and monitored carefully to minimise any potential adverse effects to health or the environment. Field trials will not proceed if there is any unacceptable risk to animal welfare, the environment or the community.
Field trials of GM animals or other organisms can proceed only with approval from the OGTR. This is only provided after researchers have satisfied all safety testing requirements for the GMO in the laboratory and secure facility.
To date, all animal research has been experimental and CSIRO has not undertaken any field trials of genetically modified animals under commercial conditions.
If field trials were to be considered, it would only be after extensive laboratory work and consultation with community groups and other stakeholders, and would follow all appropriate guidelines required by the OGTR. The rules that would be followed include:
- Institutional Biosafety Committees (IBCs) assess proposals and advise of necessary changes.
- Following IBC endorsement, the proposal is sent to CSIRO's Executive in charge of biotechnology who, after assessment and approval on behalf of the Chief Executive, forwards the proposal to the OGTR.
- OGTR assesses the proposed trial, conducts a risk analysis and management plan (RAMP) and, subject to its assessment, issues licence conditions under which the trial can be done. Any changes to the proposed trial must be notified to the OGTR.
- The IBCs ensure scientists follow all set conditions and conduct routine inspections.