FDA findings undermine Royal Society on GE Deregulation

14/08/2019 FDA findings undermine Royal Society Call for GE Deregulation

Trust in the Royal Society will be undermined, after the FDA scientists found gene editing errors were being overlooked. The latest was in gene edited (GE) “hornless” cattle where the gene editing accidentally caused antibiotic resistance. [1]

Te Apārangi / The Royal Society has released four reports calling for the reduction or removal of regulation for gene editing. [2] These reports amount to an effort to lobby Government to relax the Hazardous Substances and New Organisms legislation to allow gene editing of plants.

In response there are renewed calls for strict liability on biotechnology companies, as highlighted by Local Government NZ; for the restoration of the Bioethics Council or a referendum on whether gene editing should be regulated under the HSNO Act.

Professor Dearden, Royal Society of New Zealand, interviewed on TVNZ’s Q&A programme spoke about the precision of gene editing as the reason that regulation should be changed to free up use of GE.

The Royal Society reports provide examples that would alter plant traits through “precision” gene editing like “drought tolerance, disease resistance, fruit ripening, grain number and size, and animal traits (e.g. angora coat length, increased meat yield, lack of horns and disease resistance)”. [3]

Precision engineering to alter gene traits invokes the same promises made in the 1990s when GM laboratory techniques were first introduced. Those promises have been broken, as independent scientists confirm there are unacceptable risks posed by those techniques.

Overseas, GMO’s were released prematurely — before the long-term effects were researched — and countries that grow them now have problems with weed and insect resistance to pesticides, increasing overuse of pesticides, and contamination of conventional seed. The GE plants also produced lower yields, and farmers are moving to non-GM crops as US and European consumers seek non-GMO products. Traditional seed breeding has outperformed GMO’s in terms of outcomes. [4]

“There is evidence that gene editing can have unexpected effects that must be subject to regulation," said Jon Carapiet, spokesperson for GE-Free NZ.

“Genetic Engineering has been used overseas for more than twenty years. Despite backers initial claims, GMOs have not reduced climate change or global hunger, and it is naïve to believe there is no need for regulation when unintended effects are being identified.”

The US FDA evaluation of GE cattle which have been gene edited to be hornless (polled) has found unexpected and unintended “off target effects”. Findings show there was an integration of the complete DNA sequences (plasmid and a second copy) conferring antibiotic resistance. [5]

"This highlights the inaccuracy of screening techniques and the probability of unforeseen and overlooked risks that the Royal Society denies need to be regulated by independent authorities," said Jon Carapiet.

The Royal Society’s examples of gene editing techniques using enzymes attached to RNA like CRISPR as “scissors” to cut out genes, explain how the process works but fail to mention the research identifying multiple mutations, unexpected changes and other problems. [6]

“This is not an acceptable argument for deregulation of gene editing. The dangers of unknown adverse effects, the lack of accurate screening tools, and overlooking longer term risks create issues that will be left to the next generation to deal with” said Jon Carapiet.

"The Royal Society's lobbying is driving new calls for users of gene edited products to be strictly liable and for a citizens' referendum on whether the public want gene editing regulated."

References:

[1] Genetically engineered hornless cattle: flaws in the genome overlooked https://www.testbiotech.org/en/news/genetically-engineered-hornless-cattle-flaws-genome-overlooked

[2] Call for overhaul of gene editing technologies.https://royalsociety.org.nz/news/calls-for-overhaul-of-gene-technology-regulations-and-wide-public-discussion/

[3] Gene Editing Scenarios Primary Industries https://royalsociety.org.nz/assets/Uploads/Gene-Editing-Scenarios-Primary-industries-DIGITAL.pdf

[4] Failure to Yield https://www.ucsusa.org/food_and_agriculture/our-failing-food-system/genetic-engineering/failure-to-yield.html

[5] https://www.biorxiv.org/content/10.1101/715482v1.full

[6] Advanced Gene Editing Technologies GMO 2.0 https://www.gefree.org.nz/documents/advanced-gene-editing-technologies-gmo-2-0/

ENDS

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