New studies show decision to deregulate gene editing was flawed

Last year, the Federal Government decided not to regulate a range of new genetic modification (GM) techniques referred to as Site Directed Nucleases 1 (SDN-1) in animals, plants and microbes. This means these organisms can be released into our environment with no requirement for any safety assessment. The Office of the Gene Technology Regulator (OGTR) argued that organisms produced using these techniques “present no different risk than organisms carrying naturally occurring genetic variations and cannot be distinguished from conventionally bred animals or plants.” Two new peer-reviewed studies now reveal both claims to be false.

This week, an open source test was released for detecting the first commercial gene edited crop – a herbicide tolerant canola variety produced by the biotechnology company Cibus. The genetic change was extremely small – just a single base pair edit – meaning similar tests could easily be produced for other gene editing techniques – including the ones the Federal Government has deregulated. This directly contradicts the OGTR’s claim to states and territories, that it would be “unfeasible to ensure compliance via a testing or monitoring regime if SDN-1 organisms were to be regulated as GMOs.”

Another study published last month found that all gene editing techniques pose risks that are fundamentally different to natural breeding or mutagenesis. These include the accidental insertion of bacterial plasmids and DNA – which are often not detected by developers. Gene editing techniques can also be used to create genetic changes that could never be produced using natural breeding or mutagenesis. These include nutritional changes that could have important implications for the environment and food safety.

The study concludes “it is not possible to make a general presumption that genome-edited organisms created by SDN-1 and SDN-2 applications do not pose additional risks compared to conventional breeding processes based on the fact that no novel genes remain (or were not inserted) in the genome. Genomic irregularities, caused by the genome editing process, have potential implications for food, feed and environmental safety.”

Louise Sales from Friends of the Earth’s Emerging Tech Project said “the release of an open source test for detecting the first commercial gene edited crop is a game changer. It refutes the claims of the biotechnology industry and the OGTR that gene edited organisms are “indistinguishable” from non-GM organisms, and so cannot be regulated.”

“These studies show that the reasons the OGTR gave for deregulating these techniques are scientifically indefensible. To make matters worse, the OGTR relied on advice from scientists with clear commercial conflicts of interest in making its decision.”

“Unlike New Zealand – which is regulating these techniques – our government is conducting a giant uncontrolled experiment with our health and environment. Minister Colbeck should never have allowed this to happen and needs to urgently intervene to protect public health and our environment.”
“The development of the open source test also raises serious implications for Australia’s export markets, now that a number of gene editing techniques have been deregulated here. Farmers and food companies will now need to make commercial decisions on the assumption that gene edited crops will be detected and visible to consumers.”

Market sensitivity to GMOs is clearly demonstrated by the rapidly rising volumes of food products being certified as Non-GM. In North America, US$26 billion in products are certified by the Non-GMO Project, while the German Retailer Association for Non-GM food products (VLOG) certified 9 billion euros of products last year. Both have said they will require the new test to be used for product certification.

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