Commercial release of canola genetically modified for herbicide tolerance and a hybrid breeding system

Expression of the introduced genes in other sexually compatible plants

335. 
     Transfer and expression of the introduced genes for herbicide tolerance and a hybrid breeding system in other sexually compatible plants could increase the weediness potential, or alter the potential allergenicity and/or toxicity of the resulting plants. As discussed in Risk scenario 1, the introduced genes do not encode proteins that are considered toxic or allergenic. Therefore, even if the introduced genes were to be transferred to, and expressed in, sexually compatible species, the recipient species would likely be no more toxic or allergenic than their unmodified precursors.
     
336. 
     Under natural conditions, canola can cross with cultivated Brassica species (B. napus, B. juncea, B. rapa and B. oleracea) and, at very low frequencies, with three weed species important in Australia (R. raphanistrum, H. incana and S. arvensis) (Salisbury 2002b).
     
337. 
     The risks associated with transfer of the introduced genes from the parental GM canola lines was previously assessed as very low to negligible, as summarised in Chapter 1, Section 5.6.2. The GM canolas proposed for release were produced by conventional breeding, and the potential for gene flow from them to compatible species, and the fitness of the resulting hybrids, is expected to be as low as for the parental GM canola lines.
     
338. 
     The only difference in the consequence of gene flow from the GM canola proposed for release and the parental GM canola lines is the potential for the transfer of genes conferring tolerance to two herbicides in a single cross pollination event. This may confer a selective advantage in cultivated areas and non-cropped disturbed habitats where the corresponding herbicides are applied. However, these plants could be controlled using the range of alternative herbicides and non-chemical management techniques currently used in integrated weed management to control brassicaceous weeds.
     
339. 
     Conclusion: The potential for allergenicity in people, toxicity in people and other organisms or increased weediness due to the expression of the introduced genes in other sexually compatible plant species as a result of gene transfer is not identified as a risk that could be greater than negligible. Therefore, it does not warrant further detailed assessment.
     
340. 
     Horizontal transfer of genes or genetic elements to sexually incompatible organisms
     
341. 
     Horizontal gene transfer (HGT) is the stable transfer of genetic material from one organism to another without reproduction (Keese 2008). Data are accumulating to show that HGT is more widespread than previously believed and has been a significant force in the evolution of eukaryotic genomes (Bock 2010). In general, HGT between multicellular eukaryotes appears to be rare, occurring only on an evolutionary timescale, but has occurred between plants as well as between plants and less complex organisms (Bock 2010). All genes within an organism, including those introduced by gene technology, are capable of being transferred to another organism by HGT. HGT itself is not considered an adverse effect, but could be part of a scenario potentially leading to harm. A gene transferred through HGT could confer a novel trait to the recipient organism, through expression of the gene itself or by altering the expression of endogenous genes. The novel trait may result in negative, neutral or positive effects.
     
342. 
     Risks that might arise from horizontal gene transfer have been reviewed (Keese 2008) and considered in previous RARMPs (eg DIR 057/2004, DIR 085/2008 and DIR 091) which are available from the OGTR website or by contacting the Office. From the current scientific evidence, HGT from GM plants to other organisms presents negligible risks to human health and safety or the environment. This is due to the rarity of such events, relative to those HGT events that occur in nature, and the limited chance of providing a selective advantage to the recipient organism that would promote the spread and persistence of the transferred material.
     
343. 
     Baseline information on the presence of the introduced or similar genetic elements is provided in Chapter 1, Section 7.2.3. All of the introduced genetic elements are derived from naturally occurring organisms that are already present in the wider Australian environment.
     

5. Presence of the introduced genetic material in other organisms as a result of horizontal gene transfer

344. 
     Possible risks arising from HGT of the introduced genetic material to other organisms involves consideration of the potential recipient organisms and the nature of the introduced genetic material.
     
345. 
     HGT could result in the presence of the introduced genes for herbicide tolerance, a ribonuclease and a corresponding ribonuclease inhibitor in bacteria, plants, animals or other eukaryotes. However, the introduced genes were isolated from common bacteria that are widespread in the environment (See Chapter 1, Section 7.2.3). It is far more likely that horizontal gene transfer will occur from naturally occurring B. amyloliquefaciens, S. hygroscopicus, S. viridochromogenes, O. anthropi or A. tumefaciens bacteria than from the GM canola plants.
     
346. 
     In addition, the introduced genes are present in the parental GM canola lines already approved for commercial release. The bar, pat, and cp4 epsps genes are also present in GM cotton approved for commercial release (for example see DIR 062/2005, DIR 066/2006 and DIR 091). Therefore, the introduced genes are already available for HGT from the source organisms or commercially approved GM plants.
     
347. 
     The likelihood of gene transfer was recently found to be negligible in studies on HGT of the cp4 epsps gene from GM canola to microorganisms during digestion in ruminants and during in vitro incubations (Sharma et al. 2004; Alexander et al. 2006; Reuter et al. 2007; EFSA 2009c).
     
348. 
     Furthermore, the introduced bar, pat, cp4 epsps and goxv24 genes in the GM canola plants have been modified for plant codon usage, so in the unlikely event that gene transfer were to occur, only relatively low levels of gene expression in bacteria would be expected. The gene sequences expressed from the introduced genetic material are not expected to assist the process of HGT by facilitating gene movement across cell membranes or recombination with a host genome. Therefore, any rare occurrence of HGT of introduced genetic material to other organisms is not expected to persist and/or result in an adverse effect.
     
349. 
     A key consideration in the risk assessment process should be the safety of the protein product resulting from the expression of the introduced gene rather than horizontal gene transfer per se (Thomson 2000). If the introduced genes, the encoded proteins or their end products are not associated with any risk then even in the unlikely event of HGT occurring, they should not pose any risk to humans, animals or the environment. Conclusions reached for Risk Scenarios 1 - 4 associated with the expression of the introduced genes did not represent an identified risk.
     
350. 
     Conclusion: The potential for an adverse outcome as a result of horizontal gene transfer is not identified as a risk that could be greater than negligible. Therefore, it does not warrant further detailed assessment.
     
351. 
     Risk estimate process
     
352. 
     The risk assessment begins with postulation of credible pathways that might lead to harm to the health and safety of people or the environment during the proposed release of GMOs due to gene technology, and how it could happen, in comparison to the parent organism and within the context of the receiving environment.
     
353. 
     Five risk scenarios were identified whereby the proposed dealings might give rise to harm to people or the environment. This included consideration of whether 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 plants. The opportunity for gene flow to other organisms and its effects if it occurred were also assessed. These risk scenarios were considered over both the short and long term.
     
354. 
     A risk is only identified when a risk scenario is considered to have some chance of causing harm. Risk scenarios that do not lead to harm, or could not reasonably occur, do not represent an identified risk and do not advance any further in the risk assessment process.
     
355. 
     The characterisation of the five risk scenarios in relation to both the seriousness and likelihood of harm did not give rise to any identified risks that required further assessment. The principal reasons for this include:
     

• 
  the GM canola has been produced by conventional breeding of GM canola lines that have previously been assessed and authorised for commercial release in Australia
  
• 
  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
  
• 
  limited capacity of the GM canola to spread and persist in undisturbed natural habitats.
  

356. 
     Therefore, any risks to the health and safety of people, or the environment, from the proposed release of the GM canola plants into the environment is considered to be negligible. Hence, the Regulator considers that the dealings involved in this proposed release do not pose a significant risk to either people or the environment^®.
     
357. 
     Uncertainty
     
358. 
     Uncertainty is an intrinsic property of risk and is present in all aspects of risk analysis, including risk assessment, risk management and risk communication. Both dimensions of risk (ie consequence and likelihood) are always uncertain to some degree.
     
359. 
     Uncertainty in risk assessments can arise from incomplete knowledge or inherent biological variability¹¹. For commercial/general releases, where there may not be limits and controls to restrict the spread and persistence of the GMOs and their genetic material in the environment, uncertainty may be addressed through post release review (see Chapter 3, 388.
     
360. 
     InVigor® x Roundup Ready® canola has been approved by the Regulator for limited and controlled release (field trials) under licences DIR 069/2006 and DIR 104. These licences also authorised the release of several other lines of GM canola as well as lines of GM Indian mustard (Brassica juncea). In the DIR 069/2006 and DIR 104 RARMPs, information was identified as requiring possible consideration if Bayer were to submit an application for a larger scale release of the GMOs. The information identified that is relevant to the GM canola lines can be categorised as follows:
     

• 
  additional molecular and biochemical characterisation of the GM canola and Indian mustard lines (eg genotypic stability, and expression levels of the introduced genes)
  
• 
  data on the potential toxicity of plant material from the GM canola and Indian mustard lines including levels of known endogenous toxins
  
• 
  phenotypic characterisation of the GM canola and Indian mustard lines, particularly with respect to traits that may contribute to biotic or abiotic stress tolerance, weediness (eg germination and reproductive capacity) or persistence (eg seed dormancy)
  
• 
  the level of pollen mediated gene flow between both canola and Indian mustard and related species in Australia
  

361. 
     Bayer has submitted five reports characterising the InVigor® x Roundup Ready® canola proposed for commercialisation in Australia in relation to the first three points listed above. These have been discussed in Chapter 1.
     
362. 
     No new data on the level of pollen mediated gene flow between canola and related plants in Australia was provided by the applicant. However, the uncertainty noted in the RARMP for DIR 104 was associated with the potential for pollen-mediated gene flow from GM Indian mustard plants, rather than from the GM canola. Information on gene flow from canola is available in published literature, and the potential for gene flow between canola and sexually related plants is discussed in Risk Scenario 4.
     
363. 
     For all commercial or long-term releases uncertainty exists in relation to changes in the context surrounding the release. The risk assessment has been prepared in the context of current agricultural practices, climate and weather patterns, and the conclusions are appropriate in this context, however, over time if these were to change then the appropriateness of these conclusions is less certain.
     
364. 
     The level of uncertainty about InVigor® x Roundup Ready® canola is considered to be low given the now several years of growing the parental GM canola lines in Australia and overseas, eg in Canada and the USA.
     
365. 
     Risk management
     

4. 
   Background
   

366. 
     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 informs the Regulator’s decision-making process and is given effect through proposed licence conditions.
     
367. 
     Under section 56 of the Act, the Regulator must not issue a licence unless satisfied that any risks posed by the dealings proposed to be authorised by the licence are able to be managed in a way that protects the health and safety of people and the environment.
     
368. 
     All licences are subject to three conditions prescribed in the Act. Section 63 of the Act requires that each licence holder inform relevant people of their obligations under the licence. The other statutory conditions allow the Regulator to maintain oversight of licensed dealings: section 64 requires the licence holder to provide access to premises to OGTR inspectors and section 65 requires the licence holder to report any information about risks or unintended effects of the dealing to the Regulator on becoming aware of them. Matters related to the ongoing suitability of the licence holder are also required to be reported to the Regulator.
     
369. 
     The licence is also subject to any conditions imposed by the Regulator. Examples of the matters to which conditions may relate are listed in section 62 of the Act. Licence conditions can be imposed to limit and control the scope of the dealings. In addition, the Regulator has extensive powers to monitor compliance with licence conditions under section 152 of the Act.
     
370. 
     Risk treatment measures for identified risks
     
371. 
     The risk assessment of risk scenarios listed in Chapter 2 concluded that there are negligible risks to people and the environment from the proposed release of GM canola. These risk scenarios were considered in the context of the large scale of the proposed release and the receiving environment. The Risk Analysis Framework (OGTR 2009), which guides the risk assessment and risk management process, defines negligible risks as insubstantial with no present need to invoke actions for their mitigation. Therefore, no conditions are imposed to treat these negligible risks.
     
372. 
     General risk management
     
373. 
     All DIR licences issued by the Regulator contain a number of general conditions that relate to general risk management. These include conditions relating to:
     

• 
  applicant suitability
  
• 
  identification of the persons or classes of persons covered by the licence
  
• 
  reporting structures
  
• 
  a requirement that the applicant allows access to specified sites for purpose of monitoring or auditing.
  
• 
  Applicant suitability
  

374. 
     In making a decision whether or not to issue a licence, the Regulator must have regard to the suitability of the applicant to hold a licence. Under section 58 of the Act, matters that the Regulator must take into account include:
     

• 
  any relevant convictions of the applicant (both individuals and the body corporate)
  
• 
  any revocation or suspension of a relevant licence or permit held by the applicant under a law of the Commonwealth, a State or a foreign country
  
• 
  the applicant's history of compliance with previous approved dealings
  
• 
  the capacity of the applicant to meet the conditions of the licence.
  

375. 
     If a licence were issued, the conditions would include a requirement for the licence holder to inform the Regulator of any circumstances that would affect their suitability.
     
376. 
     In addition, any applicant organisation must have access to a properly constituted Institutional Biosafety Committee and be an accredited organisation under the Act.
     
377. 
     Testing methodology
     
378. 
     If a licence were issued, Bayer would be required to provide a method to the Regulator for the reliable detection of the presence of the GMOs and the introduced genetic materials in a recipient organism. This instrument would be required within 30 days of the issue date of the licence.
     
379. 
     Identification of the persons or classes of persons covered by the licence
     
380. 
     If a licence were issued, any person, including the licence holder, could conduct any permitted dealing with the GMOs.
     
381. 
     Reporting requirements
     
382. 
     If issued, the licence would oblige the licence holder to immediately report any of the following to the Regulator:
     

• 
  any additional information regarding risks to the health and safety of people or the environment associated with the dealings
  
• 
  any contraventions of the licence by persons covered by the licence
  
• 
  any unintended effects of the release.
  

383. 
     The licence holder would also be obliged to submit an Annual Report containing any information required by the licence.
     
384. 
     There are also provisions that enable the Regulator to obtain information from the licence holder relating to the progress of the commercial release (see Section 4, below).
     
385. 
     Monitoring for Compliance
     
386. 
     The Act stipulates, as a condition of every licence, that a person who is authorised by the licence to deal with a GMO, and who is required to comply with a condition of the licence, must allow inspectors and other persons authorised by the Regulator to enter premises where a dealing is being undertaken for the purpose of monitoring or auditing the dealing.
     
387. 
     In cases of non-compliance with licence conditions, the Regulator may instigate an investigation to determine the nature and extent of non-compliance. The Act provides for criminal sanctions of large fines and/or imprisonment for failing to abide by the legislation, conditions of the licence or directions from the Regulator, especially where significant damage to health and safety of people or the environment could result.
     
388. 
     Post release review
     
389. 
     Regulation 10 requires the Regulator to consider the short and the long term when assessing risks. The Regulator does not fix durations, but takes account of the likelihood and impact of an adverse outcome over the foreseeable future, and does not disregard a risk on the basis that an adverse outcome might only occur in the longer term. However, as with any predictive process, accuracy is often greater in the shorter rather than longer term.
     
390. 
     For the current application for a DIR licence, the Regulator is proposing to incorporate a requirement in the licence for ongoing oversight to provide feedback on the findings of the RARMP and ensure the outcomes remain valid for future findings or changes in circumstances. If a licence was issued, this ongoing oversight would be achieved through post release review (PRR) activities. The three components of PRR are:
     

• 
  adverse effects reporting system (Section 4.1)
  
• 
  requirement to monitor specific indicators of harm (Section 4.2)
  
• 
  review of the RARMP (Section 4.3).
  

391. 
     The outcomes of these PRR activities may result in no change to the licence or could result in the variation, cancellation or suspension of the licence.
     
392. 
     Adverse effects reporting system
     
393. 
     Any member of the public can report adverse experiences/effects resulting from an intentional release to the OGTR through the Free-call number (1800 181 030), fax [phone]), mail (MDP 54 – GPO Box 9848, Canberra ACT 2601) or via email to the OGTR inbox ([e-mail]). Reports can be made at any time on any DIR licence. Credible information would form the basis of further investigation and may be used to inform a review of a RARMP (see 4.3 below) as well as the risk assessment of future applications involving similar GMO(s).
     
394. 
     Requirement to monitor specific indicators of harm
     
395. 
     Additional specific information on the proposed release provides a mechanism for ‘closing the loop’ in the risk analysis process and for verifying findings of the RARMP, by monitoring the specific indicators of harm that have been identified in the risk assessment. Specific indicators of harm may also be identified during later stages, eg following the consideration of comments received on the consultation version of the RARMP, or if a licence were issued, through either of the other components of PRR.
     
396. 
     The term ‘specific indicators of harm’ does not mean that it is expected that harm would necessarily occur if a licence was issued. Instead, it refers to measurement endpoints which are expected to change should the authorised dealings result in harm. Should a licence be issued, the licence holder would be required to monitor these specific indicators of harm as mandated by the licence.
     
397. 
     The triggers for this component of PRR may include risk estimates greater than negligible or uncertainty in the risk assessment.
     
398. 
     The characterisation of the risk scenarios discussed in Chapter 2 did not identify any risks that could be greater than negligible. Therefore, they did not warrant further detailed assessment. No specific indicators of harm have been identified in this RARMP for application DIR 108.
     
399. 
     Review of the RARMP
     
400. 
     The third component of PRR is the review of RARMPs after a commercial/general release licence is issued. Such a review would be desktop-based and take into account any relevant new information, including any changes in the context of the release, to determine if the findings of the RARMP remained current. The timing of the review would be determined on a case-by-case basis and may be triggered by findings from either of the other components of PRR or be undertaken after the authorised dealings have been conducted for some time. If the review findings justified either an increase or decrease in the initial risk estimate(s), or identified new risks to people or to the environment that needed managing, this could lead to review of the risk management plan and changes to the licence conditions.
     
401. 
     Conclusions of the RARMP
     
402. 
     The risk assessment concludes that this commercial release of GM canola poses negligible risks to the health and safety of people or the environment as a result of gene technology.
     
403. 
     The risk management plan concludes that these negligible risks do not require specific risk treatment measures. If a licence were to be issued, general conditions are proposed to ensure that there is ongoing oversight of the release.
     

Proposed licence conditions

5. 
   Interpretations and Definitions
   

1. 
   In this licence:
   

1. 
   unless defined otherwise in this licence, words and phrases used in this licence have the same meaning as they do in the Act and the Regulations;
   
2. 
   words importing a gender include any other gender;
   
3. 
   words in the singular include the plural and words in the plural include the singular;
   
4. 
   words importing persons include a partnership and a body whether corporate or otherwise;
   
5. 
   references to any statute or other legislation (whether primary or subordinate) are a reference to a statute or other legislation of the Commonwealth of Australia as amended or replaced from time to time and equivalent provisions, if any, in corresponding State law, unless the contrary intention appears;
   
6. 
   where any word or phrase is given a defined meaning, any other part of speech or other grammatical form in respect of that word has a corresponding meaning;
   
7. 
   specific conditions prevail over standard conditions to the extent of any inconsistency.
   

404. 
     In this licence:
     

‘Act’ means the Gene Technology Act 2000 (Cth) or the corresponding State legislation under which this licence is issued.

‘Annual Report’ means a written report provided to the Regulator within 90 days of each anniversary of the date of issue of this licence containing all the information required by this licence to be provided in the Annual Report.

‘Canola’ means plants of the species Brassica napus L.

‘GM’ means genetically modified.

‘GMOs’ means the genetically modified organisms that are the subject of the dealings authorised by this licence.

‘OGTR’ means the Office of the Gene Technology Regulator.

‘Personal Information’ means information or an opinion (including information forming part of a database), whether true or not, and whether recorded in a material form or not, about an individual whose identity is apparent, or can reasonably be ascertained, from the information or opinion.

Licence conditions

1.