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Response to Heinemann et al on the regulation of GM crops and foods developed using gene silencing

(May 2013)

Key points

  • A recent scientific article (Heinemann et al, 2013) claims that small double-stranded RNAs (dsRNAs) generated in GM plants as a result of using gene silencing techniques can create biosafety risks that are not being adequately assessed by regulators such as Food Standards Australia New Zealand (FSANZ). They suggest changes to the safety assessment process to address their concerns.
  • FSANZ has carefully examined the arguments put forward in the article, and has thoroughly researched the scientific literature on gene silencing. The weight of scientific evidence published to date does not support the view that small dsRNAs in foods are likely to have adverse consequences for humans.
  • In formulating their hypothesis, the authors have not taken into account the fact that small dsRNAs are ubiquitous in the environment and in the diverse range of organisms we consume as food, including plants and animals. This establishes a long history of safe human consumption which pre-dates the use of such techniques in GM plants.
  • The authors failed to adequately acknowledge that developing oral therapies based on small dsRNAs targeted against human viruses and other diseases such as cancer has so far been unsuccessful because of the barriers that exist to their uptake, distribution and targeting within the body.
  • The authors have also underestimated the strengths of the GM food safety assessment to detect possible unintended effects, including those that could arise from the use of gene silencing.
  • There is no scientific basis for suggesting that small dsRNAs present in some GM foods have different properties or pose a greater risk than those already naturally abundant in conventional foods.
  • The current case-by-case approach to GM food safety assessment is sufficiently broad and flexible to addresses the safety of GM foods developed using gene silencing techniques. This approach enables additional studies to be requested should that be necessary to further inform the safety assessment of a particular GM food.
  • FSANZ will continue to monitor the scientific literature for any new developments which may be relevant to GM food safety assessment.

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