An article today in the Western Mail contains the following piece of pro-GM spin:
"Tony Combes is director of corporate affairs with GM company Monsanto UK Ltd. He said... the CSIRO decision to halt research and destroy the GM pea that inflamed lung tissue in laboratory mice showed how the regulatory system was working exactly as intended."
In fact, as revealed below, the regulators never had any involvement in this study by CSIRO or in the decision to halt the research.
Parliamentary question reveals OGTR not involved in decision to withdraw GM peas
- FSANZ and the OGTR are regulatory agencies. In common with other such agencies, they do not undertake or conduct research, they evaluate applications.
- The various animal models that are available are not considered to be sufficiently well developed or validated to use at the present time in this context.
- CSIRO's decision to end the research reflects a cautious approach and the ANU test data were never submitted to regulatory authorities.
Network note: The pro-GM spin on the GM pea issue was that the regulatory process is working when the data was never submitted to the regulatory authorities.
QUESTIONS WITHOUT NOTICE: ADDITIONAL ANSWERS
Genetically Modified Food
Senator PATTERSON (Victoria””Minister for Family and Community Services and Minister Assisting the Prime Minister for Women’s Issues) (3.01 p.m.)””Yesterday I was asked a question about allergic reactions in mice to a genetically engineered field pea developed by the CSIRO. I have a very long answer here. I am happy to read it but, to assist the progress of the Senate, I will seek leave to incorporate the answer in Hansard.
The answer read as follows””
SENATOR SIEWERT””My question is directed to Senator Patterson, representing the Minister for Health and Ageing.
Is the Minister aware of the recently published research by the Australian National University that showed an allergic reaction in mice to a genetically engineered field pea developed by the CSIRO? Can the Minister outline what similar independent published scientific research is undertaken by the Office of the Gene Technology Regulator and Food Standards Australia New Zealand to assess the health risks to the general public posed by the existing commercialised genetically engineered foods on sale in Australia today?
Is the Minister aware of the announcement yesterday by the WA Minister of Agriculture that WA will fund independent scientific research into the health risks of existing GE foods on the market? Will the Minister commit the Commonwealth through the OGTR, the FSANZ and other independent bodies to conduct similar research in an expedient manner to ensure the safety of the Australian public?
SENATOR PATTERSON””The Minister for Health and Ageing has provided the following answer to the honourable Senator's question:
FSANZ and the OGTR are regulatory agencies. In common with other such agencies, they do not undertake or conduct research, they evaluate applications. The data required to support applications are extensive and include studies like those referred to by the Senator. The evaluation process is intensive and includes a critical assessment of the supporting data in the context of the relevant international literature.
All genetically modified, or GM, foods included in the Food Standards Code have undergone a rigorous pre-market safety assessment conducted by FSANZ in accordance with internationally accepted standards. Inclusion in the Food Standards Code is approved by the Food Standards Ministerial Council, which consists of the Commonwealth and State Governments and New Zealand.
All genetically modified organisms, or GMOs, licensed for environmental release by the Gene Technology Regulator have undergone a thorough evaluation, involving the preparation of a comprehensive Risk Assessment and Risk Management Plan and extensive consultation with a range of expert authorities and key stakeholders, including State Governments and the public.
Neither FSANZ nor the Gene Technology Regulator would issue approvals if they were not satisfied that sufficient, scientifically credible data were available to support the decision.
Approvals of GM foods for human consumption by FSANZ are based on comprehensive, rigorous and science-based safety assessments that follow international best practice and guidelines developed by the Food and Agricultural Organisation of the United Nations (FAO), World Health Organisation (WHO), Organisation for Economic Co-operation and Development (OECD) and Codex Alimentarius Commission. These international guidelines have been adopted by food regulators worldwide, including in the US, Canada, Japan, Europe and many other countries.
Assessments of GMOs for release into the environment by the Gene Technology Regulator are equally rigorous and science-based and follow a Risk Analysis Framework using the Australia-New Zealand Standard on Risk Management that is recognised as best practice internationally.
In relation to the study in mice published by the ANU, at present there is no single test that can be used to determine if a new protein is likely to be allergenic to humans. The internationally accepted approach, which has been elaborated by the Codex Alimentarius Commission, FAO and WHO and followed by FSANZ, is to use a variety of data and information, which when considered together can be used to reach a conclusion about potential allergenicity of a new protein in food. The OGTR adopts a similar approach in evaluating non-food human health risks, as well as potential adverse impacts for other organisms in its environmental assessments.
The various animal models that are available are not considered to be sufficiently well developed or validated to use at the present time in this context. This also applies to the mouse model used in the ANU study. While the study in mice appears to have been very carefully planned, conducted and reported, the animal model used has not been validated to predict human immune or allergic responses to food. CSIRO has also emphasised this point that no conclusions could be drawn about whether actual harm to humans would occur if the GM peas were consumed by people. CSIRO's decision to end the research reflects a cautious approach and the ANU test data were never submitted to regulatory authorities.
Nevertheless, the research was conducted in anticipation of applying for regulatory approvals. The findings demonstrate the importance of case-by-case evaluation of GMOs and GM products, and the effective role science-based decision-making can play in ensuring the safe introduction of GM foods to the food supply or release of GM crops into the environment.
The research announced by the WA Minister for Agriculture appears to comprise long term animal feeding experiments with GM food. This type of study is not considered to be as useful as other currently accepted methodologies as there are significant problems in interpreting the results from a scientific perspective. For example, effects unrelated to introduced GM proteins are known to arise where the food being tested is not part of the normal diet of the animals. Such effects can be compounded by the animals being required to consume large amounts of the food because the level of GM protein expression is usually extremely low.
FSANZ and OGTR continue to monitor new scientific information and testing methodologies as they become available. Where appropriate, they will take this into account and modify data requirements for the conduct of safety assessments to ensure the continued safety of the Australian community and environment.