In 1932, a legal issue which started with a tenacious Scottish single-parent shop-assistant, who took exception to being served up a decomposing snail in her ice-cream float and pursued her complaint all the way to the House of Lords, ended with the creation of a consumer rights law which became established throughout the world.
The significance of this case is that manufacturers of "articles of common household use" have a legal duty of care to ensure the safety of their products for anyone likely to use them.
From a GM food perspective, novel foods have never been comprehensively tested to ensure their safe, life-long, consumption by any likely consumers.
GM sceptics might suggest that the failure to carry out human trials or use up-to-date analytical techniques on GM foods is to make sure the manufacturer doesn't know about any potential problems.
What better way to avoid that pesky duty of care to ensure safety?
Gene-edited foods, which are being waved through by regulators all over the world on the grounds that they contain no foreign DNA, may have some nasty surprises inside them.
The first gene-edited wonder-food we've been told to expect, probably by 2023, is mushrooms which age without turning brown.
These have been altered using a bacterium-generated DNA sequence which codes for the 'CRISPR' editing device [1]. This sequence is installed in the DNA of the target cell where it creates the device, edits the cell, and apparently disappears.
Some years ago, Korean scientists pointed out that, although it disappears from the target gene edit site, their research has revealed small fragments of the bacterial DNA from the editing device actually end up scattered throughout the target cell genome. Investigations of the outcome of gene-editing in animal cells (much more extensively studied than plant cells) have found scattered off-target DNA changes in 35 to 95 percent of all the edited cells depending on the editing method used.
Molecular geneticist, Michael Antoniou, comments that the failure to regulate gene-edited products is "not in tune with the latest concepts of molecular genetics. Even small changes in the genome can have wide-ranging implications for genome network functioning." Developers of 'precision breeding' check the edited DNA in the cell to make sure it's ended up 'precisely' changed as intended, but off-target wreckage and debris in the plant genome, plus the damage to genome network functioning, is assumed to be impossible and is neither tested nor considered.
The Korean team stress the need for whole-genome DNA sequence analysis to make sure foreign DNA is not present. Antoniou agrees with this need and adds the advice to carry out profiles of the cell's proteins, biochemistry and DNA expression to ensure no unintended and potentially harmful functional and compositional changes have taken place. If they have, it's a strong indication that the plant's biochemistry has been altered in unexpected ways. These could include the production of toxins or allergens, higher levels of existing toxins and allergens, or altered nutritional value.
Antoniou, who uses the suggested tests in his work in the medical field adds that they are widely available and not expensive to carry out: "Many labs have the capability to perform, them. So there is no excuse for failing to do so."
The only excuse is that the manufacturers of gene-edited foods don't want to know.
Such tests are also essential to validate the developer's position that gene-edits could happen in nature [2] and therefore can't harm the health of the plant itself or its consumers. Indeed, we seem to be entering a Wild West of GM foods, where developers can declare absence of foreign DNA and 'naturalness' without ever carrying out the science to support their claims.
The obvious conclusion is that industry knows it can't validate the claim, so it makes sure the science isn't done.
This lax, complacent attitude to regulation is applied not only to industry but to government-backed research where tax-payers' money is being spent with no accountability whatsoever.
Note that there are alternative non-DNA devices for carrying out CRISPR gene-editing, but they are expensive and time-consuming. Industry clearly doesn't want to be bound to this inconvenience or to carry the costs.
No matter what gene-editing procedure is used, the risk of harmful physical and functional disruption to the genome of our food plants, and the attendant risk to ourselves, is ever-present.
It strikes us that, since the non-browning gene-edited mushrooms are designed to lie around in fridges for a long time before being eaten, the need for safety testing over the full newly-extended life-span of the mushroom is needed besides ensuring they're safe for the full range of people likely to consume them.
What if someone decides to check out the stay-white mushrooms, or any other gene-edited offering, for the presence of foreign DNA or, possibly, the odd decomposing snail?
We may need another tenacious, Scottish, single-parent shop-assistant to take both the biotech industry and regulators to task for their failure to ensure the safety, not only of gene-edited mushrooms, but of all other novel foods.
Any volunteers?
Background
[1] CRISPR/Cas9 GENE EDITING - March 2016
[2] 'NATURAL' GENE EDITING JUST DOESN'T HAPPEN - July 2022
SOURCES:
The first gene-edited wonder-food we've been told to expect, probably by 2023, is mushrooms which age without turning brown.
These have been altered using a bacterium-generated DNA sequence which codes for the 'CRISPR' editing device [1]. This sequence is installed in the DNA of the target cell where it creates the device, edits the cell, and apparently disappears.
Some years ago, Korean scientists pointed out that, although it disappears from the target gene edit site, their research has revealed small fragments of the bacterial DNA from the editing device actually end up scattered throughout the target cell genome. Investigations of the outcome of gene-editing in animal cells (much more extensively studied than plant cells) have found scattered off-target DNA changes in 35 to 95 percent of all the edited cells depending on the editing method used.
Molecular geneticist, Michael Antoniou, comments that the failure to regulate gene-edited products is "not in tune with the latest concepts of molecular genetics. Even small changes in the genome can have wide-ranging implications for genome network functioning." Developers of 'precision breeding' check the edited DNA in the cell to make sure it's ended up 'precisely' changed as intended, but off-target wreckage and debris in the plant genome, plus the damage to genome network functioning, is assumed to be impossible and is neither tested nor considered.
The Korean team stress the need for whole-genome DNA sequence analysis to make sure foreign DNA is not present. Antoniou agrees with this need and adds the advice to carry out profiles of the cell's proteins, biochemistry and DNA expression to ensure no unintended and potentially harmful functional and compositional changes have taken place. If they have, it's a strong indication that the plant's biochemistry has been altered in unexpected ways. These could include the production of toxins or allergens, higher levels of existing toxins and allergens, or altered nutritional value.
Antoniou, who uses the suggested tests in his work in the medical field adds that they are widely available and not expensive to carry out: "Many labs have the capability to perform, them. So there is no excuse for failing to do so."
The only excuse is that the manufacturers of gene-edited foods don't want to know.
Such tests are also essential to validate the developer's position that gene-edits could happen in nature [2] and therefore can't harm the health of the plant itself or its consumers. Indeed, we seem to be entering a Wild West of GM foods, where developers can declare absence of foreign DNA and 'naturalness' without ever carrying out the science to support their claims.
The obvious conclusion is that industry knows it can't validate the claim, so it makes sure the science isn't done.
This lax, complacent attitude to regulation is applied not only to industry but to government-backed research where tax-payers' money is being spent with no accountability whatsoever.
Note that there are alternative non-DNA devices for carrying out CRISPR gene-editing, but they are expensive and time-consuming. Industry clearly doesn't want to be bound to this inconvenience or to carry the costs.
No matter what gene-editing procedure is used, the risk of harmful physical and functional disruption to the genome of our food plants, and the attendant risk to ourselves, is ever-present.
OUR COMMENT
It strikes us that, since the non-browning gene-edited mushrooms are designed to lie around in fridges for a long time before being eaten, the need for safety testing over the full newly-extended life-span of the mushroom is needed besides ensuring they're safe for the full range of people likely to consume them.
What if someone decides to check out the stay-white mushrooms, or any other gene-edited offering, for the presence of foreign DNA or, possibly, the odd decomposing snail?
We may need another tenacious, Scottish, single-parent shop-assistant to take both the biotech industry and regulators to task for their failure to ensure the safety, not only of gene-edited mushrooms, but of all other novel foods.
Any volunteers?
Background
[1] CRISPR/Cas9 GENE EDITING - March 2016
[2] 'NATURAL' GENE EDITING JUST DOESN'T HAPPEN - July 2022
SOURCES:
·
Jungeun Kim and Jin-Soo Kim, 2016, Bypassing
GMO regulations with CRISPR gene editing, Correspondence, Nature
Biotechnology 34:10
·
Brett M. Sansbury, et al., 2019, Understanding
the diversity of genetic outcomes from CRISPR-Cas generated homology-directed
repair, Communications Biology 2
·
"Transgene-free" GMOs may be
exempted from GMO regulations under false pretences, GM Watch, 9.04.22
·
UK: Guidance on GMOs that "could have
arisen through natural processes" is vague, unscientific, and
irresponsible, GM Watch 06.05.22
·
'Paisley snail' case sets the pace at Scots
law meeting, Metro, 25.05.22
· Joshua King, Donoghue v Stevenson: 90 years since a snail in ginger beer and a woman in Paisley changed the legal world, The Scotsman, 22.05.22
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