Are GMO foods really substantially equivalent

[Will Wiley]

We have had many discussions here about GMO foods and one of the main arguments presented by the anti-science boneheads is that GMO's are substantially equivalent, and therefore safe.
It is also a crucial argument made by the American FDA.

This has been called into question.

An integrated multi-omics analysis of the NK603 Roundup-tolerant GM maize reveals metabolism disturbances caused by the transformation process

Glyphosate tolerant genetically modified (GM) maize NK603 was assessed as ‘substantially equivalent’ to its isogenic counterpart by a nutrient composition analysis in order to be granted market approval. We have applied contemporary in depth molecular profiling methods of NK603 maize kernels (sprayed or unsprayed with Roundup) and the isogenic corn to reassess its substantial equivalence status. Proteome profiles of the maize kernels revealed alterations in the levels of enzymes of glycolysis and TCA cycle pathways, which were reflective of an imbalance in energy metabolism. Changes in proteins and metabolites of glutathione metabolism were indicative of increased oxidative stress. The most pronounced metabolome differences between NK603 and its isogenic counterpart consisted of an increase in polyamines including N-acetyl-cadaverine (2.9-fold), N-acetylputrescine (1.8-fold), putrescine (2.7-fold) and cadaverine (28-fold), which depending on context can be either protective or a cause of toxicity. Our molecular profiling results show that NK603 and its isogenic control are not substantially equivalent.

 

[bigfield]

anti-science boneheads

Ironic.

We have had many discussions here about GMO foods and one of the main arguments presented by the anti-science boneheads is that GMO's are substantially equivalent, and therefore safe.

That argument has never been made on TFT, and the concept of substantial equivalence has probably never even been mentioned before on TFT.

An integrated multi-omics analysis of the NK603 Roundup-tolerant GM maize reveals metabolism disturbances caused by the transformation process

Glyphosate tolerant genetically modified (GM) maize NK603 was assessed as ‘substantially equivalent’ to its isogenic counterpart by a nutrient composition analysis in order to be granted market approval. We have applied contemporary in depth molecular profiling methods of NK603 maize kernels (sprayed or unsprayed with Roundup) and the isogenic corn to reassess its substantial equivalence status. Proteome profiles of the maize kernels revealed alterations in the levels of enzymes of glycolysis and TCA cycle pathways, which were reflective of an imbalance in energy metabolism. Changes in proteins and metabolites of glutathione metabolism were indicative of increased oxidative stress. The most pronounced metabolome differences between NK603 and its isogenic counterpart consisted of an increase in polyamines including N-acetyl-cadaverine (2.9-fold), N-acetylputrescine (1.8-fold), putrescine (2.7-fold) and cadaverine (28-fold), which depending on context can be either protective or a cause of toxicity. Our molecular profiling results show that NK603 and its isogenic control are not substantially equivalent.

The anti-GMO cranks cream themselves every time the Séralini group and friends put out a new article.

After browsing some criticisms of the study, I've found there are several reasons why the results are not meaningful and why one can to expect that a replication study would not reproduce Mesnage et al's results:

1. The study doesn't mention anywhere how they determined that the crops were isogenic, other than the fact that the selected 'isogenic' strain is the closest relative to the GMO that they could get from a catalogue. Close enough to be consider isogenic? Mesnage et al doesn't do the analysis, therefore they don't know.
2. They only used a single field/plot for each crop type, failing to allow to differences in soil content, elevation, water retention, and pathogen exposure. To control for this they clearly needed to divide the three crop groups into several smaller plots that alternate with each other, to average out differences in the farmland.
3. The study analyses isogenic maize, transgenic maize, and transgenic maize sprayed with Roundup, but not isogenic maize sprayed with Roundup. The inclusion of the Roundup group makes no sense, and the reasons given by the study make no sense. One would be surprised if a pesticide didn't produce a response from a crop.
4. Mesnage et al make up their own standard for substantial equivalence. They make no effort to show that their standard is the same as that used by the OECD.
5. The study fails to mention the effects of a pathogen on the maize, and presents the effects of the pathogen as if it were due to genetics.

It is also hypocritical that cranks find it perfectly acceptable to cite a study funded by an anti-GMO lobbying group (the Sustainable Food Alliance) and conducted by anti-GMO activists. It is a blatant conflict of interest.

 

[scombrid]

[*]They only used a single field/plot for each crop type, failing to allow to differences in soil content, elevation, water retention, and pathogen exposure. To control for this they clearly needed to divide the three crop groups into several smaller plots that alternate with each other, to average out differences in the farmland.

This one is kind of critical to me.

Also, who funds the "Sustainable Food Alliance"? There's always hand-wringing among the alternative medicine/anti-vax/anti-gm crowd about industry funding in studies. How about we know who funds some of these other lobbies?

I always feel like these anti-GMO studies are shared in social media by the same people that take Russia's side in Ukraine and Syria, that supported Trump... It almost seems like it is coming from entities with a specific interest in damaging the American agriculture brand as opposed to promoting food safety.

 

[Will Wiley]

Ironic.

We have had many discussions here about GMO foods and one of the main arguments presented by the anti-science boneheads is that GMO's are substantially equivalent, and therefore safe.

That argument has never been made on TFT,

Yes it has. Do you think it is possible you just didn't see it? Or don't remember seeing it?

As to your other points, they might be fair points, but you missed my point. I said that is being called into question.
From the paper.

Glyphosate tolerant genetically modified (GM) maize NK603 was assessed as ‘substantially equivalent’ to its isogenic counterpart by a nutrient composition analysis in order to be granted market approval.

What is being called into question is whether GMO's can be said to be "substantially equivalent"merely on the basis of nutrition studies.

Again from the paper.

We have applied contemporary in depth molecular profiling methods

If someone wants to claim that two things are substantially equivalent, then there is a valid question as to whether we should use contemporary molecular profiling to answer that question.
You yourself only found problems with the design of the study etc. You did not say that a better designed study would not be useful to decide whether the two products were "substantially equivalent.

It is also hypocritical that cranks find it perfectly acceptable to cite a study funded by an anti-GMO lobbying group (the Sustainable Food Alliance) and conducted by anti-GMO activists. It is a blatant conflict of interest.

Sure..it would be good if someone independent did these studies, but that is very unlikely to happen. And it is extremely unlikely that Monsanto would do such a study.

As it is extremely unlikely that no one else will such a study, would you prefer that no one at all did such studies, or raised the question?

 

[Will Wiley]

I always feel like these anti-GMO studies are shared in social media by the same people that take Russia's side in Ukraine and Syria, that supported Trump... It almost seems like it is coming from entities with a specific interest in damaging the American agriculture brand as opposed to promoting food safety.

If the American FDA is interested in food safety, then why would they allow the companies profiting from the sale of GMO's to do their own "safety" studies?
Why aren't they asking that more than just the nutritional value be looked at when assessing "substantial equivalence"?


Without quantitative criteria, then the claim of substantial equivalence can't really be called science.

Potential Health Effects of Foods Derived from Genetically Modified (GM)
plants – What are the issues?

In the European Union, the acceptance and regulation of GM crops/foods is based on the safety
data which the biotech companies provide for EFSA (European Food Safety Authority) and not
on the results of the EFSA’s own investigations. The situation is worse in the USA where there is
effectively no regulation and the commercialization of GM crops/foods is based on the flawed
concept of ‘substantial equivalence’. This, without stringent quantitative criteria can only serve at
best, as an indication of comparability, but at worst, it can be misleading. It is therefore
imperative that each GM crop is subjected to, as a minimum, the following:

 

[bigfield]

That argument has never been made on TFT,

Yes it has. Do you think it is possible you just didn't see it? Or don't remember seeing it?

Yes, which is why I checked your claim using the forum's search function rather than relying on my memory.

As to your other points, they might be fair points, but you missed my point. I said that is being called into question.
From the paper.

Glyphosate tolerant genetically modified (GM) maize NK603 was assessed as ‘substantially equivalent’ to its isogenic counterpart by a nutrient composition analysis in order to be granted market approval.

What is being called into question is whether GMO's can be said to be "substantially equivalent"merely on the basis of nutrition studies.

Again from the paper.

We have applied contemporary in depth molecular profiling methods

If someone wants to claim that two things are substantially equivalent, then there is a valid question as to whether we should use contemporary molecular profiling to answer that question.

Using proteomics and metabolomics to establish substantial equivalence would improve the detail with which substantial equivalence is measured. The 'substantial equivalence' standard used by the OECD doesn't (yet) include standards for these methods.

Like Texan sharpshooters, Mesnage et al chose to invent their own standard for what qualifies as substantial equivalence. They did their analysis, found a discrepancy between their crop groups at the peptide level, and declared it evidence that the crops were not substantially equivalent.

You yourself only found problems with the design of the study etc. You did not say that a better designed study would not be useful to decide whether the two products were "substantially equivalent.

In order for the study to be useful, it would need to have better controls and it would need to test against a meaningful definition of 'substantial equivalence' as applicable to proteomics and metabolomics, otherwise the study says nothing about the standards used by the OECD.

It is also hypocritical that cranks find it perfectly acceptable to cite a study funded by an anti-GMO lobbying group (the Sustainable Food Alliance) and conducted by anti-GMO activists. It is a blatant conflict of interest.

Sure..it would be good if someone independent did these studies, but that is very unlikely to happen. And it is extremely unlikely that Monsanto would do such a study.

As it is extremely unlikely that no one else will such a study, would you prefer that no one at all did such studies, or raised the question?

No information is better than misinformation funded and published by anti-GMO activists.

If the American FDA is interested in food safety, then why would they allow the companies profiting from the sale of GMO's to do their own "safety" studies? Why aren't they asking that more than just the nutritional value be looked at when assessing "substantial equivalence"?

Existing standards already require that 'more than just the nutritional value' to be looked at:

Food safety evaluation issues of foods derived from GMcrops comprise:

• Molecular characterization of the introduced geneticfragment and resulting new proteins or metabolites (inaddition, an increasing number of European memberstates routinely ask for characterization of the insertionpoint of the transgenic fragment);
• Analysis of the composition of the relevant plant partswith respect to key nutrients and anti-nutrients,including natural toxins and potential allergens;
• Potential for gene transfer of specific genes from the GMfood to – particularly – microorganisms in the humanand animal gastro-intestinal tract;
• Potential allergenicity of the new gene products, oralteration of the intrinsic allergenicity of the GM foodorganism;
• Estimated intake levels of the newly introduced proteinsas well as of the final product, including any alteredconstituent;
• A toxicological and nutritional evaluation of the resultingdata; and
• Additional toxicity testing (of the whole food) wherenecessary.

https://www.researchgate.net/publication/9078528_Comparative_safety_assessment_for_biotech_crops

Substantial equivalence just serves as a starting point for determining GM food safety.

 

[Will Wiley]

https://www.researchgate.net/publication/9078528_Comparative_safety_assessment_for_biotech_crops

Substantial equivalence just serves as a starting point for determining GM food safety.

The subject is regulatory requirements for GMO's.
Why are you posting a proposal that has nothing to do with that?

From the abstract, again.

Glyphosate tolerant genetically modified (GM) maize NK603 was assessed as ‘substantially equivalent’ to its isogenic counterpart by a nutrient composition analysis in order to be granted market approval

.

Nothing you posted mentions the regulators.

 

[bigfield]

The subject is regulatory requirements for GMO's.
Why are you posting a proposal that has nothing to do with that?

Because it explains what OECD regulations cover:

If the American FDA is interested in food safety, then why would they allow the companies profiting from the sale of GMO's to do their own "safety" studies? Why aren't they asking that more than just the nutritional value be looked at when assessing "substantial equivalence"?

Existing standards already require that 'more than just the nutritional value' to be looked at:

Food safety evaluation issues of foods derived from GMcrops comprise:

• Molecular characterization of the introduced genetic fragment and resulting new proteins or metabolites (inaddition, an increasing number of European member states routinely ask for characterization of the insertion point of the transgenic fragment);
• Analysis of the composition of the relevant plant parts with respect to key nutrients and anti-nutrients,including natural toxins and potential allergens;
• Potential for gene transfer of specific genes from the GM food to – particularly – microorganisms in the human and animal gastro-intestinal tract;
• Potential allergenicity of the new gene products, oral teration of the intrinsic allergenicity of the GM food organism;
• Estimated intake levels of the newly introduced proteins as well as of the final product, including any altered constituent;
• A toxicological and nutritional evaluation of the resultingdata; and
• Additional toxicity testing (of the whole food) wherenecessary.

https://www.researchgate.net/publication/9078528_Comparative_safety_assessment_for_biotech_crops

Substantial equivalence just serves as a starting point for determining GM food safety.

 

[bigfield]

If the American FDA is interested in food safety, then why would they allow the companies profiting from the sale of GMO's to do their own "safety" studies?

Because that's how everything is regulated.

Do you expect the taxpayer to pay the costs of compliance?

 

[Learner]

Substantially equivalent ... I doubt it.

GMO's = patented ownership .

 

[blastula]

I only eat cloned food, raised by my clone army of farmers.

 

[LordKiran]

We have had many discussions here about GMO foods and one of the main arguments presented by the anti-science boneheads is that GMO's are substantially equivalent, and therefore safe.
It is also a crucial argument made by the American FDA.

This has been called into question.

An integrated multi-omics analysis of the NK603 Roundup-tolerant GM maize reveals metabolism disturbances caused by the transformation process

Glyphosate tolerant genetically modified (GM) maize NK603 was assessed as ‘substantially equivalent’ to its isogenic counterpart by a nutrient composition analysis in order to be granted market approval. We have applied contemporary in depth molecular profiling methods of NK603 maize kernels (sprayed or unsprayed with Roundup) and the isogenic corn to reassess its substantial equivalence status. Proteome profiles of the maize kernels revealed alterations in the levels of enzymes of glycolysis and TCA cycle pathways, which were reflective of an imbalance in energy metabolism. Changes in proteins and metabolites of glutathione metabolism were indicative of increased oxidative stress. The most pronounced metabolome differences between NK603 and its isogenic counterpart consisted of an increase in polyamines including N-acetyl-cadaverine (2.9-fold), N-acetylputrescine (1.8-fold), putrescine (2.7-fold) and cadaverine (28-fold), which depending on context can be either protective or a cause of toxicity. Our molecular profiling results show that NK603 and its isogenic control are not substantially equivalent.

Here's some free language advice:

The word "Equivalent" does not need any qualifier. Something is either equivalent or it isn't.

"Substantially equivalent" is something someone says who is trying to sound smarter than he might otherwise. In reality, it just makes you sound like a ponce.

 

[bigfield]

"Substantially equivalent" is something someone says who is trying to sound smarter than he might otherwise. In reality, it just makes you sound like a ponce.

https://en.wikipedia.org/wiki/Substantial_equivalence

 

[Juma]

We have had many discussions here about GMO foods and one of the main arguments presented by the anti-science boneheads is that GMO's are substantially equivalent, and therefore safe.
It is also a crucial argument made by the American FDA.

This has been called into question.

An integrated multi-omics analysis of the NK603 Roundup-tolerant GM maize reveals metabolism disturbances caused by the transformation process

Here's some free language advice:

The word "Equivalent" does not need any qualifier. Something is either equivalent or it isn't.

"Substantially equivalent" is something someone says who is trying to sound smarter than he might otherwise. In reality, it just makes you sound like a ponce.

on the contrary. equivalence always needs a qualifier. it just that for most cases that qualifier is implied. in some ways a priest is equivalent toa a big sack of potatoes, in others it isnt.

 

[LordKiran]

Here's some free language advice:

The word "Equivalent" does not need any qualifier. Something is either equivalent or it isn't.

"Substantially equivalent" is something someone says who is trying to sound smarter than he might otherwise. In reality, it just makes you sound like a ponce.

on the contrary. equivalence always needs a qualifier. it just that for most cases that qualifier is implied. in some ways a priest is equivalent toa a big sack of potatoes, in others it isnt.

You know what I mean though as it relates to his post and title. It doesn't help to elaborate the degree of equivalency at all so its wasted words.

 

[bigfield]

Why the obsession with Roundup and Roundup Ready corn, anyway?

Anti-GMO cranks show no interest in other GMOs and the companies who produce them. They focus entirely on Monsanto.

This thread is titled 'Are GMO foods really substantially equivalent', but like most anti-GMO threads it focuses entirely on Roundup Ready corn and cites low-quality research from the Seralini team.

 

[Will Wiley]

on the contrary. equivalence always needs a qualifier. it just that for most cases that qualifier is implied. in some ways a priest is equivalent toa a big sack of potatoes, in others it isnt.

You know what I mean though as it relates to his post and title. It would be like saying "Kinda pure." It doesn't work that way.

Substantial Equivalence:
The Review Process for Regular Reports

Can you at least learn a little about the topic before foolishly weighing in?

- - - Updated - - -

Why the obsession with Roundup and Roundup Ready corn, anyway?

Anti-GMO cranks show no interest in other GMOs and the companies who produce them. They focus entirely on Monsanto.

This thread is titled 'Are GMO foods really substantially equivalent', but like most anti-GMO threads it focuses entirely on Roundup Ready corn and cites low-quality research from the Seralini team.

I'm happy to look at studies that test Roundup rather than just glyphosate. Can you show us any?

 

[bigfield]

on the contrary. equivalence always needs a qualifier. it just that for most cases that qualifier is implied. in some ways a priest is equivalent toa a big sack of potatoes, in others it isnt.

You know what I mean though as it relates to his post and title. It doesn't help to elaborate the degree of equivalency at all so its wasted words.

He didn't make up the term. Substantial equivalence is a principle that the OECD has been used for over 20 years, while the term itself dates back to the 70s.

 

[LordKiran]

You know what I mean though as it relates to his post and title. It would be like saying "Kinda pure." It doesn't work that way.

Substantial Equivalence:
The Review Process for Regular Reports

Can you at least learn a little about the topic before foolishly weighing in?

- - - Updated - - -

Why the obsession with Roundup and Roundup Ready corn, anyway?

Anti-GMO cranks show no interest in other GMOs and the companies who produce them. They focus entirely on Monsanto.

This thread is titled 'Are GMO foods really substantially equivalent', but like most anti-GMO threads it focuses entirely on Roundup Ready corn and cites low-quality research from the Seralini team.

I'm happy to look at studies that test Roundup rather than just glyphosate. Can you show us any?

Mm fair enough. Though does this concept of Substantial Equivalence have anything to do with GMO foods? I see it linked to tobacco products.

Also in retrospect I wasn't technically weighing in on the conversation. I was nitpicking your word choice.

 

[Will Wiley]

Differential Effects of Glyphosate and Roundup on Human Placental Cells and Aromatase

Roundup is a glyphosate-based herbicide used worldwide, including on most genetically modified plants that have been designed to tolerate it. Its residues may thus enter the food chain, and glyphosate is found as a contaminant in rivers. Some agricultural workers using glyphosate have pregnancy problems, but its mechanism of action in mammals is questioned. Here we show that glyphosate is toxic to human placental JEG3 cells within 18 hr with concentrations lower than those found with agricultural use, and this effect increases with concentration and time or in the presence of Roundup adjuvants. Surprisingly, Roundup is always more toxic than its active ingredient. We tested the effects of glyphosate and Roundup at lower nontoxic concentrations on aromatase, the enzyme responsible for estrogen synthesis. The glyphosate-based herbicide disrupts aromatase activity and mRNA levels and interacts with the active site of the purified enzyme, but the effects of glyphosate are facilitated by the Roundup formulation in microsomes or in cell culture. We conclude that endocrine and toxic effects of Roundup, not just glyphosate, can be observed in mammals. We suggest that the presence of Roundup adjuvants enhances glyphosate bioavailability and/or bioaccumulation.

Cardiotoxic Electrophysiological Effects of the Herbicide Roundup(®) in Rat and Rabbit Ventricular Myocardium In Vitro.

Roundup (R), a glyphosate (G)-based herbicide (GBH), containing unknown adjuvants is widely dispersed around the world. Used principally by farmers, intoxications have increasingly been reported. We have studied R effects (containing 36 % of G) on right ventricular tissues (male Sprague-Dawley rats, up to 20,000 ppm and female New Zealand rabbits, at 25 and 50 ppm), to investigate R cardiac electrophysiological actions in vitro. We tested the reduced Ca(++) intracellular uptake mechanism as one potential cause of the electrical abnormalities after GBH superfusion, using the Na(+)/K(+)-ATPase inhibitor ouabain or the 1,4-dihydropyridine L-type calcium channel agonist BAY K 8644 which increases I Ca. R concentrations were selected based on human blood ranges found after acute intoxication. The study showed dose-dependent V max, APD50 and APD90 variations during 45 min of R superfusion. At the highest concentrations tested, there was a high incidence of conduction blocks, and 30-min washout with normal Tyrode solution did not restore excitability. We also observed an increased incidence of arrhythmias at different doses of R. Ouabain and BAY K 8644 prevented V max decrease, APD90 increase and the cardiac inexcitability induced by R 50 ppm. Glyphosate alone (18 and 180 ppm) had no significant electrophysiological effects. Thus, the action potential prolonging effect of R pointing to I Ca interference might explain both conduction blocks and proarrhythmia in vitro. These mechanisms may well be causative of QT prolongation, atrioventricular conduction blocks and arrhythmias in man after GBH acute intoxications as reported in retrospective hospital records.

Bigfield do you have any relevant studies at all?

I would live to see them if you can find any. Thanks