Summary of issues raised in submissions received from the public on the consultation RARMP for DIR 113
The Regulator received two submissions from the public on the consultation RARMP. These submissions are summarised in the table below. Issues raised relating to human health and safety and the environment were considered in the context of currently available scientific evidence in finalising the RARMP that formed the basis of the Regulator’s decision to issue the licence.
View (general tone): n = neutral; x = do not support; y = support
Issues raised: AR: Antibiotic resistance genes; AS: Applicant suitability; E: Environment; F: GM food; HS: human safety; PC: Public consultation; RA: Risk analysis; U: Uncertainty; W: Weediness
Other abbreviations: Act: Gene Technology Act 2000; CCI: Confidential Commercial Information; DIR: Dealings involving Intentional Release; GM: Genetically Modified; GMO: Genetically Modified Organism; OGTR: Office of the Gene Technology Regulator; RARMP: Risk Assessment and Risk Management Plan.
Type: IB: Industry body; NGO: Non-government organisation.
|Sub. No:||Type||View||Issue||Summary of issues raised||Comment|
|1||IB||y||RA||Supports the RARMP for DIR 113 and believes that the proposed trial poses negligible risk to human health and safety or the environment.||Noted.|
|HS||Asserts that GM insect resistant and herbicide tolerant crops have improved occupational health of agricultural workers by reducing exposure to insecticide sprays during hand hoeing.||Benefits of gene technology are outside the matters to which the Regulator may have regard when deciding whether or not to issue a licence.|
|E||Commercial GM cottons have reduced environmental insecticide and herbicide residues due to the reduction in the use of insecticides by 80-90% and residual herbicides by over 30%. The commercial GM cottons also have reduced tillage requirements leading to improved soil conservation practices.||Benefits of gene technology are outside the matters to which the Regulator may have regard when deciding whether or not to issue a licence.|
|RA, PC||Appreciates the rigorous scientific assessment and public consultation process.||Noted.|
|2||NGO||x||AS||Asserts that the applicant is unsuitable to hold GM licences, due to convictions for offences against laws of foreign countries, and failure to report these offences to the OGTR as required by the Act.|
Contends that Bayer CropScience Pty Ltd in Australia is a business under the control of a parent company, Bayer CropScience AG, on the grounds that:
the Bayer CropScience AG website states that Germany is the location of “Global Bayer CropScience Headquarters”, and
In order to demonstrate financial suitability to hold a GM licence, Bayer CropScience Pty Ltd submitted a financial report for the global Bayer Group as part of its licence application.
Provides a list of criminal fines and civil damages levied against Bayer Group companies in the USA and Switzerland.
|The applicant for licence DIR 113 is Bayer CropScience Pty Ltd, an Australian proprietary company limited by shares. The Regulator has assessed the suitability of Bayer CropScience Pty Ltd to hold a DIR licence as required by the Act. The company is considered suitable as the Regulator is satisfied that no relevant convictions have been recorded, no licences or permits have been cancelled or suspended under laws relating to the health and safety of people or the environment, and the organisation has the capacity to meet the conditions of the licence. Bayer CropScience Pty Ltd has submitted a financial report pertaining to its own operations.|
|PC||Asserts that the applicant’s CCI claims are unjustified. The application concerns approved plant varieties that have been conventionally crossed and stacked with others, and there is no case for hiding such details. In particular, information about approvals by regulatory agencies and published references must be in the public domain. Failure to disclose which selectable markers are used prevents members of the public to fairly and fully exercise their right to comment on the application.|
Recommends that the OGTR review its CCI approval and exercise its discretion in favour of the public’s right to know.
|The CCI application received from Bayer CropScience Pty Ltd was considered in accordance with the requirements of the Act. Information that could reveal CCI has not been included in the publicly released RARMP. CCI is available to the OGTR, prescribed experts and Commonwealth and State government agencies for the purposes of risk assessment.|
|RA||Asserts that Bayer’s application fails to satisfy the OGTR’s Risk Analysis Framework requirements due to inadequate data provided in the application form. The application is also based on old and outdated evidence.|
Points out that the RARMP does not cite the recent study:
Aris et al., 2011, Maternal and fetal exposure to pesticides associated to genetically modified foods in Eastern Townships of Quebec, Canada
|The RARMP for this release considered both information provided by the applicant and the currently available scientific information (including many recent as well as relevant older publications and reports). During the risk assessment process additional information was requested from and provided by the applicant. In the context of the limits and controls imposed by the licence, the RARMP concluded that risks to human health and the environment are negligible.|
The Aris et al. paper relates to food safety which is the regulatory responsibility of FSANZ. FSANZ have responded to this paper via a fact sheet published on the FSANZ website. GM cotton material from the current release will not be permitted to enter human food or animal feed.
|AR||Points out that technologies exist for removal of antibiotic resistance marker genes to generate marker-free plants. Recommends that the OGTR require that antibiotic resistance marker genes be completely removed from all potential commercial GM food crops, in the interests of human and animal health.||The antibiotic resistance marker gene present in some of the GM cotton varieties has been considered in detail by the OGTR, by other Australian regulatory agencies, by regulatory agencies in other countries and by international bodies, and has not been found to pose a risk to people or the environment. No adverse effects from its use in field trials or commercial release of GMOs have been recorded in Australia or elsewhere.|
Nonetheless, GM cotton material from the current small-scale trial will not be permitted to enter human food or animal feed.
|RA, W, U||Recommends that the OGTR require trials to be designed so that robust data will be available towards the precautionary assessment of any subsequent applications. In particular, recommends that the applicant be required to manage these trials so as to gather data about potential weediness.||Section 4 of Chapter 3 of the RARMP lists additional information that may be required to assess a large scale or commercial release of the GM cotton varieties. The list includes additional phenotypic characterisation of the GM cotton varieties, in particular of traits which may contribute to weediness. OGTR has advised the licence holder that they should consider how this data could be collected. If insufficient data is presented in a future application, the application may not be accepted, more data may be required from the applicant, risk treatment measures imposed or a licence refused.|
|F||Notes that Bayer’s application states ‘Highly processed edible oils contain virtually no protein, indicating a minimal allergenic potential of cottonseed oil for human consumption’, which contradicts FSANZ’s view that processed vegetable oils contain no DNA or protein. Recommends that the OGTR initiates a review on the regulatory assumptions that are not supported by the evidence. Suggests that all GM foods that contain any novel DNA or protein should be labelled as such.||No GM cotton materials or products from the current trial will be permitted to enter human food or animal feed.|
Bayer’s application cites clinical trials demonstrating the absence of both water-soluble allergens and clinical allergy observations.
Food safety and food labelling are the responsibility of FSANZ.
|RA, F||Asserts that the RARMP is selective in its citations of evidence and considers only likely scenarios and never worst case scenarios.|
Asserts that the OGTR’s dominant assumption is that ingested DNA and protein do not survive digestion, based on research using simulated gastric juices.
Points out that the OGTR does not cite the study:
Netherwood et al., 2004, “Assessing the survival of transgenic plant DNA in the human gastrointestinal tract”.
|RARMPs are prepared using the risk analysis model and terminology as described in the Regulator’s Risk Analysis Framework (RAF), which is based on the internationally recognised Australia-New Zealand Standard on Risk Management (AS/NZS ISO 31000:2009).|
Risks are assessed within the risk assessment context, and a risk is only identified for further assessment when a risk scenario is considered to have some reasonable chance of causing harm. Pathways that do not lead to harm, or could not plausibly occur, do not advance in the risk assessment process.
The assessment of potential toxicity in the RARMP (Risk Scenario 1, Chapter 2) for DIR 113 is based primarily on direct toxicity tests in animals and humans.
The fact that all introduced genes and proteins in the GM cotton varieties are also widely present in the environment in non-GM organisms which are likely to form part of the human diet and cause no known toxicity, along with testing demonstrating that the introduced DNA and proteins are largely digested in the gastrointestinal tract (supported by the Netherwood et al paper, among many others) are used as supplementary evidence for the risk assessment.
Risk Scenario 1 of the RARMP concludes that the potential for toxicity in people as a result of exposure to the GM cotton, in the context of the limits and controls imposed by the licence, poses negligible risk.
|U||Recommends that trait stability determination, the number and position of all transgenic inserts, and complete molecular and phenotypic characterisation of all GMOs proposed for release be required prior to licencing.
Recommends that GMOs with stacked traits should be the subject of separate applications to the OGTR due to the lack of characterisation.
Asserts that application deficiencies were ignored and that the application should be rejected.
|Uncertainty is an intrinsic property of risk assessments. In the context of the limited scale of the release and the proposed control measures, and acknowledging knowledge gaps, the dealings proposed were assessed to pose negligible risk to people or the environment.|