Rigging the regulations (and the science)

March 2019

New GMO blockbusters are predicted to include animals, algae and gene drives. These will be controversial, and the biotech industry knows it.

Before these new GM products can be moved forward, the priority is "a pacified regulatory environment" (Latham). And, what better way to achieve this than to take over GM regulation from the inside.

Populating GM assessment bodies with biotech industry employees and close collaborators is successfully hijacking the process from the start.

Back in 2007, the conference of GMO regulators, organised by the International Society for Biosafety Research, aspired to scientific independence from agribusiness. Four years later, it had become a platform for industry to dictate the talking points and to present regulatory initiatives as if they had the blessings of science. By 2017, companies were on the conference's organising committee, paying most of the conference costs, and conferring travel scholarships to participants.

Now, the talking points and regulatory initiatives being pushed forward include the 'sound', 'logic' of using a 'tiered' risk assessment. In this, animal tests are carried out in the laboratory: if no harm is observed, the GMO is deemed safe. If, however, a problem emerges in these closely controlled conditions, the experiment is repeated on a larger, presumptively more realistic, scale: if no harm is observed, the GMO is deemed safe. If harm is shown, a field test under much more complex, much less controlled, conditions is conducted.

Put another way, tiered risk assessment has no provision for rejecting the GMO. It just keeps on testing under increasingly variable background conditions until the visibility of the problem is under control. Approvals are, thus, guaranteed.

COMMENT This is an interesting extension of the unscientific inclusion of historical controls to convert an observed problem into a normal variation by widening the goal posts.

'Modernisation' of the risk assessment is also high on the biotech industry agenda. This means blank out the DNA-altering process (along with all its inherent disruption and side-effects), and adopt a 'trait-based' approach to GMO regulation. Thus, for example, if a GM crop generates a pesticide, the toxic substance will be tested in isolation only. If the GMO produces a flavour or enhanced nutrients, it will be assumed safe without testing.

In any other context, 'risk assessment' is all about identifying whether a product is doing something it's not supposed to do. 'Modernised' biotech industry risk assessment procedure asks only what the crop is supposed to do, and so by-passes the potential harm (the risks!) and all regulation.

To shore up its novel form of risk assessment, the biotech industry is also pushing for 'data transportability'. This means that a one-size-fits-all set of 'safety' data is passed around the world for every regulator to accept, whether the experimental conditions are relevant to the local context or not. This means minimal cost and time for the applicant, and a vanishingly small risk of their GMO failing approval, especially when combined with a tiered risk assessment.

Part of data transportability seems to be one-size-fits-all experimental conditions. To this end, biotech scientists are developing special "artificial diet systems" with the stated purpose of standardising the testing of Bt insecticides generated by many GM crops.

A recent study noted that, in feeding experiments to test the effects of Bt toxins on non-target insects, the artificial diets used contained surprisingly large amounts of antibiotics in different combinations, ostensibly to prevent spoilage of the test feed.

The problem with this is that antibiotics in the diet are known to slow down, or even eliminate the toxic effect of Bt: biotech wisdom has it that specific Bt toxins bind to the gut of specific insects where they create a hole in the gut wall. As the digestive fluids leak into the insect's body, the pest dies. However, this by itself isn't a certain process. Bt-induced insect death, as needed by the farmer to save his crop, is caused by the leakage of the vast natural microbial population from the gut into the pest's body. So, if you feed the pest antibiotics and kill off its gut microbes, the insect won't die from eating Bt.

This has lots of implications for what happens in the environment.

First, by reducing the lethal reaction to Bt with antibiotics, the level of toxin needed to control the target pests in the field may be over-estimated, and the GM plants may then be engineered to produce far higher levels of Bt than needed. This could, in turn, mean more environmental harm from the excess levels of Bt in plant debris, pollen, soil and water, and possible increased risk to livestock and human consumers.

Second, by reducing the lethal reaction to Bt with antibiotics in experiments on non-target insects, experiments will mistakenly 'prove' that the toxin has no effect on them, and that it is specific to the target pest only. Indeed, tests conducted with the new artificial diets have already been used by biotech-friendly scientists to cast doubt on previous findings of ecological harm.


Since antibiotics in the diet will alter the gut microbial composition and affect health, they obviously can't be used in any feeding study designed to assess safety.

GM foods look set to arrive with 'safe' written all over them courtesy of a rigged, selectively deaf, regulatory process, using a rigged risk assessment with approval baked in, and science rigged to prove whatever the industry wants to prove.

"We are part of the natural world, and if we destroy our 'mother earth', we destroy ourselves as well" (Soil Association CE, 2017)
Demand independent, validated, modern (not blinkered or regulation-oriented) science on the safety of GM foods for people and for the environment on which we depend.

  • Helen Browning, 70 Years On, Mother Earth, Summer 2017
  • Jonathan Latham, The Biotech Industry Is Taking Over the Regulation of GMOs from the Inside,, 19.07.17
  • Jonathan Latham, Rigging the Science of GMO Ecotoxicity,, 29.01.19
  • Angelika Hilbeck, et al., 2018, Impact of Antibiotics on Efficacy of Cry Toxins Produced in Two Different Genetically Modified Bt Maize varieties in Two Lepidopteran Herbivore Species, Ostrinia nubilalis and Spodoptera littoralis, Toxins 10
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