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Safety of novel food and genetically altered crops - What would science-based regulation look like?

Seminar by Andrew Bartholomaeus, Ph.D.

13 October 2015


On 13 October 2015, a seminar by Dr Andrew Bartholomaeus, the former General Manager of the risk assessment branch of the Food Standards Australia New Zealand (FSANZ), entitled “Safety of novel food and genetically altered crops - What would science-based regulation look like?” was held at headquarters of the Food and Agriculture Organization of the United Nations (FAO). Dr Bartholomaeus discussed general principles of food safety regulations emphasizing the fact that the “natural” plant genome is highly plastic and “natural” crops are genetically unstable, thus sound regulatory frameworks should take this fact in considerations. The scientific consensus around the safety of new and established biotechnology-based breeding is stronger than any other scientific issues around food regulations. With our current knowledge, wide spread insertions, deletions or Single Nucleotide Polymorphisms (SNPs) in a non-toxic crop have never produced a de novo toxin, but somehow these are strictly regulated with rigorous safety assessment requirements. On the other hand, known toxins already present in a “natural” crop that can stress related to pest pressure, climate, environment and agronomic practices are not in the usual scope for the safety assessment requirements. This leads to disproportionate regulatory imposts when considering the reality based impacts on public health and food security. Dr Bartholomaeus suggested FAO to consider organizing expert consultations to discuss the needs in risk-based regulatory framework in the context of biotechnology within the spectrum of comprehensive plant genome plasticity. Video of the seminar is also available on YouTube at

Final report



Adjunct Professor Dr Andrew Bartholomaeus is a toxicologist with a background covering a broad spectrum of regulatory toxicology including human and animal pharmaceuticals, nanotechnology, agricultural chemicals and food safety. Prior to his retirement from the Food Standard Australia New Zealand (FSANZ) , he was the General Manager of the risk assessment Branch of the Agency. He currently spends majority of time providing training and development to food regulators in the East and South East Asian area across the broad range of food safety issues including the regulation of novel food and biotechnology.