Response to article by Dr Judy Carman [Canberra Times, 28 July]

Dr Paul Brent is Chief Scientist of Food Standards Australia New Zealand

In her article ‘Too many unknowns in the manufacture and use of GM foods’ [CT, 28 July], Dr Judy Carman raises concerns about the safety of genetically modified foods and the way this safety is evaluated by Food Standards Australia New Zealand (FSANZ).

GM foods approved for sale in Australia are safe to eat.   GM crops and foods must overcome significant regulatory hurdles before they are allowed into the Australian and New Zealand food supply or the environment. These assessments are rigorous, thorough and independent.

Approval of a GM food is contingent upon an independent pre-market safety assessment which is undertaken by the scientists of Food Standards Australia New Zealand (FSANZ). These assessments are published in full on the foodstandards web site ( www.foodstandards.gov.au ) and are open for comment by anyone who wishes to do so, before each application is approved. In evaluating the suitability of any new GM food, FSANZ uses a process that is based on principles developed internationally, with Australian participation, and which is followed by Canada, Europe, Japan, and the US.

The recent article ignores a number of key facts about the safety assessment of GM foods. Conventional plant breeding methods often unintentionally introduce undesirable characteristics into crops in an uncontrolled way, and further breeding must be done to remove these. In contrast, genetic modification introduces one or two genes of known function into a plant. Selection of a suitable plant line then occurs in much the same manner in both cases.  

The claim that companies decide what information is needed for GM food assessments is entirely wrong. Companies must comply with strict data requirements from the time of development in the laboratory through to the extensive field trials in which plants are tested under commercial agricultural conditions. These data must be further supported by biochemical and animal toxicity studies, generated in independently certified laboratories, on any new protein arising as a result of the introduced genetic change. To complete all of the studies necessary for the regulatory assessment generally takes between five and ten years and costs many millions of dollars. All data from these studies must be provided in extensive detail such that every individual measurement and reading is provided, not just summaries or averages as is the case for published material.   The strength of this system is that regulatory scientists around the world can independently assess the information and critically evaluate the results. Like other regulators, FSANZ does not hesitate to demand more safety studies where necessary.  

Those who raise concerns about the assessments of GM foods often confuse traditional toxicity studies using a chemical substance, with animal feeding studies using whole GM foods. The important scientific differences between these types of studies and how they are used to assess safety fails to be acknowledged. Traditional animal toxicity studies, which examine organ health, are of limited value for GM proteins that have clearly been shown to be broken down by normal digestive processes. Also ignored is the fact that the new protein in many approved GM foods is already in the diet, or is currently applied in the same manner as conventional plant protection products, and generally has a long history of safe human consumption. One such plant protection protein, the Bt protein, has been widely used in organic farming in Australia for more than a decade.

Feeding studies, on the other hand, are designed specifically to answer general questions on the nutritional value of the GM food and its ability to support typical growth and wellbeing. Young, rapidly-growing animals with high dietary requirements are suitable for these experiments, where the objective is simply to compare the performance of a diet containing the GM food with a similar control diet. Measured outcomes vary according to the animal species and the nature of the GM food being tested.

The small group of studies often cited as showing harmful effects due to GM foods have, without exception, been discredited by the weight of mainstream scientific evidence and opinion, including that of the UK Royal Society, and by regulatory agencies around the world. Comprehensive assessment of the studies shows that they failed to conform to accepted methods and protocols, failed to properly identify the material being tested, or failed to reach conclusions based on rigorous and logically consistent interpretation of the results. Those who criticise the internationally agreed testing regimes for GM foods are conspicuously quiet when asked to elaborate in open forum on their proposed alternative methods for testing GM foods, and to submit their proposals to scrutiny by the broader scientific community.

Environmental assessment of GM organisms, including GM crops, is the responsibility of the Gene Technology Regulator. The scientific risk assessment for each GM crop is rigorous and transparent. The Regulator will not approve cultivation of a GM crop unless satisfied that human health and the environment are protected. Together, FSANZ and the Gene Technology Regulator represent a combined system of regulation that is serving Australians well. To imply a connection between the consumption of GM foods and ill-health in people is both misleading and unsupported by any credible evidence.