GMO Regulations undermined

The UK House of Commons Select Committee on Science and Technology’s report hyping GM crops is an attempt to dismantle and undermine Europe’s GMO regulations, explains Claire Robinson in the second of a two-part series

The UK House of Commons Select Committee on Science and Technology’s report on GM crops is dangerous in a way that has been widely missed, no doubt because the argument is couched in coded language that won’t mean much to most people. The report repeats the GMO lobby’s current mantra of demanding trait-based GMO regulation instead of Europe’s existing process-based regulation.

This dull terminology obscures a massive change in regulatory approach that has long been pushed for by a number of pro-GMO British and European organizations, such as the Biotechnology and Biological Sciences Research Council (BBSRC) and the European Academies Science Advisory Council (EASAC). The report makes clear that the lobbying will be scaled up. That’s why it’s vital that the public knows what’s going on and opposes it at every turn.

What is trait-based and process-based regulation?

Trait-based (or product-based) regulation assumes that all organisms, whether derived from genetic modification or from conventional breeding, carry similar safety considerations. The fact that a food or crop is genetically modified is not thought to pose any special risks that require specific regulation. Proponents of this regulatory system, such as Prof Michael Bevan of the John Innes Centre in the UK in his evidence to the Select Committee, claim that GM technology is “neutral” and that regulators only need consider the final trait.

Process-based regulation, in contrast, emphasizes the GM technology itself, requiring detailed case-by-case health and environmental risk assessments of all GMOs before they are released into the environment and the food system.[1]

Who has which kind of GMO regulation?

Canada has trait-based GMO regulation. GMOs are regulated as “plants with a novel trait” – a category that is not restricted to GMOs but can include plants developed through conventional breeding and mutagenesis (bombarding the plant with chemicals or radiation to cause mutations), as well as foods that contain a novel trait due to processing methods. It is the novel trait that triggers the regulation, not the genetic modification.

The Select Committee report presents the Canadian system as the model system for regulating GMOs.

Europe has process-based GMO regulation. Whatever the intended trait, the fact that the plant has been developed through the process of genetic modification is enough to trigger GMO-specific risk assessment. But the regulatory system also (albeit inadequately) considers the intended trait of the GMO, such as herbicide tolerance or the insecticidal protein in GM Bt crops.

Europe’s process-based regulations theoretically accept that unintended changes could occur in the plant due to the inherent imprecision of the GM technique. For example, in the case of a new GM crop, Europe currently requires a 90-day animal feeding trial with the whole crop, a requirement that would almost certainly be dispensed with under a trait-based system unless the crop was deliberately engineered to be toxic.

Shortcomings of the Canadian system

Canada’s trait-based-only regulatory system for GMOs assumes that the only change in the plant will be the one intended by the genetic engineer. It is based on the notion that – contrary to the findings of a large body of scientific evidence – the genetic engineer can cut-and-paste the desired trait into the plant in a precise and targeted way without causing any other effects in the genome and without any effect on the plant’s metabolism.

In this way, the focus is removed from any unintended changes that can and do happen as a result of the crude and imprecise genetic engineering process. Regulation is only triggered if the intended trait introduced into the plant is thought to merit it, and the type of regulation triggered depends on what that deliberately inserted trait is intended to do.

While the Canadian trait-based regulatory system pays lip service to the potential for unintended effects caused by the genetic engineering process, regulators do not act on it – for example, by demanding animal feeding trials. And it seems likely that many GMOs might escape any regulation at all, depending on the intended trait.

The faulty assumptions underlying trait-based-only systems have been proven wrong again and again by:
•    Compositional studies, which show that genetic engineering can result in altered nutritional value in a crop,[2] and
•    Animal feeding studies, which show that unintended changes in GM crops can result in their being more toxic or allergenic than non-GM crops.[3]

Shortcomings of the European system

Europe does not have a trait-based regulatory system outside of the GMO regulations. So while in Canada, a herbicide-tolerant crop developed by mutagenesis would trigger a risk assessment, in Europe it would not.

This is a serious omission. Herbicide-tolerant crops, whether GM or not, absorb large amounts of herbicides, which are eaten along with the crop by the human or animal consumer. This may pose risks to health. In addition, the cultivation of herbicide-tolerant crops was found in the UK government’s farm-scale trials to cause more harm to the environment than non-GM, non-herbicide-tolerant crops grown under standard chemical-intensive management. And the cultivation of Roundup Ready GM crops in the US has wiped out 90% of monarch butterflies. As Prof Ottoline Leyser of the UK Royal Society told the Select Committee, this is a problem of the trait and is not GM-specific.

This is why we need process- and trait-based regulations for some traits, such as herbicide tolerance, whether or not the plant is GM.

Why do some GMO lobbyists want to change the system?

The lobbyists want to blur the line between GM and non-GM crops, potentially enabling GM foods to escape GMO regulation and labeling and so gain acceptance in the marketplace.

The Select Committee report cites new GM techniques such as genome editing and gene silencing (RNAi or RNA interference) as supposedly being more precise and, by implication, less risky than the first generation of genetic engineering methods.

Examples of products developed through gene silencing include the Arctic non-browning apple and the Innate non-browning potato.

These GM foods slipped through the US regulatory system apparently without challenge from the regulators – and without any animal testing that we know of. But Europe’s process-based based legislation defines and regulates these new crops as GMOs – and requires that they carry a GMO label. That means consumers and the food industry would shun them.

The Select Committee is using the new GM techniques to create confusion around the definition of GMOs. That’s in line with the report’s Orwellian recommendation to avoid using the term “GM” altogether and only use the phrase “genetic modification” with reference to the old-style GM techniques.

But the Committee doesn’t just want to exempt new-style GMOs from GMO regulation. It wants to exempt all GMOs.

A vision of how this might work can be found in the testimony Prof Rosie Hails, chair of the Advisory Committee on Releases to the Environment, to the Select Committee. Hails said: “At the moment, if you were considering a crop that was very well known – maize, for example – and were inserting into it a trait, the behaviour of which you understood very well, and that had a long history of safe use, but that was produced by recombinant DNA technology [GM], in the EU it would need to go through the regulatory system. If there were a trait-based system and you were looking at a history of safe use, it would not necessarily need to do so. We would advocate using novelty of the trait as the trigger for regulation.”

We have become used to GMO lobbyists arguing that herbicide-tolerant and Bt insecticidal GMOs have a long history of safe use. So by logical extension, Hails’ argument may imply that even these old-style GM crops could escape regulation and labelling under a trait-based system.
It seems clear that introducing a solely trait-based regulatory system is a recipe for gutting GMO oversight and abolishing labeling – for GMOs engineered using new or old methods alike.

Problem: No evidence that new GM techniques are precise or safe

In reality, genome editing and gene silencing are not the revolution in precision and safety that is claimed by the Select Committee report and others. Plants in the approvals pipeline with gene-silencing based-traits still involve laboratory manipulation of genes and their insertion by what have always been regulated GM techniques. And there is no evidence that the products of genome editing and gene silencing technologies are any safer than old-style GM products. The necessary in-depth research has not been done, but some existing studies already show that genome editing and gene silencing techniques can cause off-target effects.[4,5] And GMOs produced through gene-silencing technology carry additional risks that have been underestimated by regulators, according to both the US EPA and scientists who have researched the topic.[6] 

A trait-based regulatory system could allow future organisms developed through gene-silencing techniques to escape regulation and GMO labelling – for example, if no new DNA is present. That would be risky, as simple exposure to gene-silencing RNA molecules could cause an adverse effect, even in the absence of new DNA.[7]

And critically, depending on the wording of the legislation, trait-based regulation may assume that the only environmental effect will be from the whole GM plant. This assumption would be wrong in the case of, for example, a gene-silencing RNA molecule intended as a plant-incorporated protectant (pesticide). The RNA molecule that is generated is not intended to alter the characteristics (traits) of the plant, but to transfer to a pest, where it is amplified and altered. In effect, the ability of the plant-produced molecule to further replicate and change in the pest is the intended trait. To only observe the RNA molecule in the plant would be to turn a blind eye to other environmental or human exposures to the novel pesticide once it moves beyond the plant.

Any form of regulation must find a way of covering these downstream effects. Meanwhile, it is irresponsible and scientifically unjustifiable for GMO lobbyists – and the Select Committee report – to promote gene-silencing technologies as more precise, predictable, or safe than the first-generation GMOs engineered to produce a novel protein. Their effects could be far-reaching and catastrophic.

It’s clear that the products of genome editing and gene silencing should be regulated and labelled as GMOs. The same goes for so-called cisgenic GMOs, in which genes are transferred between organisms of the same species or closely related organisms that could be conventionally bred. In cisgenesis, the GM gene cassette will still contain DNA from unrelated organisms like bacteria and viruses, and cisgenesis is just as likely to cause mutations as any other kind of genetic engineering. Cisgenic GMOs carry many of the risks associated with old-style transgenic GMOs, and must be regulated and labelled in the same process-based way.

New Zealand High Court agrees genome editing is genetic engineering

In a landmark ruling, the New Zealand High Court decided that genome-editing techniques are a form of regulated genetic engineering under New Zealand law. The judge based her decision on the testimony of two expert witnesses, respectively selected by the Sustainability Council of New Zealand and the New Zealand Environmental Protection Agency. The Sustainability Council argued that genome editing was a form of regulated genetic engineering, whereas the EPA argued it was not.

In her ruling, the judge quoted the testimony of Prof Jack Heinemann for the Sustainability Council, to the effect that when determining if an organism is genetically modified or the product of natural processes, using the outcome (as in trait-based regulation) rather than the processes (as in process-based regulation) as the point of distinction assumes there is equal information and experience with the processes creating these outcomes and therefore the risks when that is not the case.[8]

In simple terms, the judge said we don’t know as much about the risks of genome editing as natural breeding and therefore process-based regulation of genome-edited products is needed.

Even if the products of new GM techniques were safer than old-style GMOs – and there’s no evidence that they are – the vast majority of the GMOs currently commercialized and in the regulatory pipeline are old-style, engineered using the gene gun method or infection with a soil bacterium.

Science Media Centre rams home Select Committee’s lobbying point

The UK Science Media Centre was evidently keen that the world’s press did not miss the lobbying purpose of the Select Committee report – to replace Europe’s process-based regulation with trait-based. It quoted Prof Jonathan Jones, plant scientist at the Sainsbury Laboratory, Norwich and founder of the patent-owning biotech company Mendel Biotechnology, as saying, “There is nothing intrinsically risky about the GM method, EU regulation of the method is not fit for purpose, we should regulate traits and not the method by which they are delivered, and do so at the EU nation state level. It is now time for EU and UK policymakers to act on these recommendations with alacrity.”

In order to make the claim that there is nothing “intrinsically risky” about GM technology, Jones ignored a wealth of scientific data showing that GMOs are different from non-GM crops in unintended and sometimes harmful ways. Some of this evidence can be found in GMO Myths and Truths and in the US lawyer Steven Druker’s book, Altered Genes, Twisted Truth.[9]

Select Committee’s model regulatory system is a failed one

Canada’s trait-based regulatory system for GMOs came under severe criticism from an expert panel convened by the Royal Society of Canada (RSC). Their RSC panel’s hard-hitting report, published in 2001, concluded with 53 recommendations to address regulatory weaknesses, and called for a fundamental re-evaluation of the concept of “substantial equivalence” on which the regulations are based.

In a peer-reviewed paper in 2006, the political scientist Peter Andrée, PhD, then at Trent University, Ontario, asked whether the regulatory approach had changed since the RSC expert panel’s report. Andrée concluded that it had not: “While some efforts have indeed been made, the Government of Canada continues to fall far short of meeting the RSC Panel’s expectations in key areas, including food safety, environmental assessment, peer review, transparency, and monitoring and surveillance.” He added, “There appears to be a culture within the Canadian regulatory system for GMOs that simply does not recognize the value of the more precautionary approach proposed by the RSC Panel.”[10]

“Be careful what you wish for”: Pro-GMO scientist

Do those lobbying for trait-based regulation really want it? The answer appears to be: Only if it means no GMO regulation at all. They do not want to see the scrutiny that is currently applied to GMOs being applied to all plants with novel traits. Rather they want the minimum or zero scrutiny that is currently applied to non-GM plants developed through conventional breeding techniques rolled out to encompass GMOs. They do not want the system levelled up to the highest standards, but levelled down to the lowest, so that GM crops get a free regulatory pass.

The danger for the pro-trait-based lobby is that their strategy may backfire and result in Europe introducing trait-based regulation for non-GMO herbicide-tolerant plants on top of its existing process-based GMO regulation. Guy Poppy, advisor to the UK Food Standards Agency, spelled out the risk in his evidence to the Select Committee: “The one cautious note I would sound in my negotiations with the Commission and others is that, if we move towards a more trait-based approach, many of the issues that are considered in GM but not in other systems should not be moved across. I know that some people are concerned that it would complicate regulation for everything, rather than just overcomplicate it for GM. Be careful what you wish for.” Poppy’s caution was echoed by Lord de Mauley, Parliamentary Under-Secretary at the farming ministry DEFRA.

Changing EU legislation “not a trivial issue”

A second problem for the trait-based lobbyists is that, as Julian Little, chair of the GMO industry association, the Agricultural Biotechnology Council, warned the Select Committee, changing European GMO legislation is “not a trivial issue”. Lord de Mauley, Parliamentary Under-Secretary at the farming ministry DEFRA, agreed, adding that there is “no realistic prospect of the EU departing from an EU-specific regulatory regime in the foreseeable future… Our immediate focus is on trying to improve the existing GM regime.”

De Mauley’s words imply that GMO lobbyists will continue their attacks on Europe’s current GMO regulations. Even if they do not succeed in overturning or weakening specific laws, they can still do damage. For example, they can drive a wedge into GMO regulations by trying to get new-type GMOs exempted from them. Or they can encourage lawmakers to apply existing regulations lightly to certain types of GMOs, using the “position papers” of bodies like the Select Committee as props. The letter of the law is one thing, implementation is another – and there can be a yawning gap between the two.

There is a worrying precedent. The progressive EU pesticides regulation of 2009 insisted for the first time that studies from the independent peer-reviewed literature, as distinct from industry’s commercially secret safety data alone, must be considered in pesticide risk assessments. But this requirement was gutted by the European Food Safety Authority (EFSA), which issued a guidance document providing a loophole enabling industry to exclude almost any independent study from the risk assessment on the grounds of its alleged lack of reliability.[11] To this day, independent studies with far more sensitive and up-to-date designs than the industry studies continue to be dismissed from pesticide risk assessments.

TTIP will push for trait-based GMO regulation

The Select Committee has a powerful ally in its drive to dismantle Europe’s GMO regulation: The TTIP trade deal between the EU and the US. Geoff Mackey of BASF said in his evidence to the Committee that the aim of TTIP is “to align the regulatory environments”. In practice, that means that by hook or by crook, our regulatory standards will be lowered to fit the US and Canadian regimes. TTIP could also give corporations the right to sue governments in secret courts for upholding laws designed to protect health and the environment.

It’s time to call out career genetic engineers and GMO promoters on their lobbying for changes in EU legislation that will benefit only GMO companies and research institutions looking to be part of a GM product pipeline. To allow these people and organizations to dictate policy is as reasonable as allowing the pharma lobby to dismantle the regulatory regime for medicines in order to enable maximum profitability. It does a disservice to science and the public.


1. Andrée P (2006). An analysis of efforts to improve genetically modified food regulation in Canada. Science and Public Policy 33(5): 377-389.
2. See GMO Myths and Truths,  “The sham of substantial equivalence”
3. See GMO Myths and Truths, Chapter 3.1
4. See “Is GM technology becoming more precise?” in GMO Myths and Truths
5. See “Worldwide: Lack of regulation of a new type of GMO based on gene-silencing technology” in GMO Myths and Truths
6. See “Worldwide: Lack of regulation of a new type of GMO based on gene-silencing technology”, in GMO Myths and Truths
7. See “Worldwide: Lack of regulation of a new type of GMO based on gene-silencing technology”, in GMO Myths and Truths
8. Mallon J (2014). The Sustainability Council of New Zealand Trust vs The Environmental Protection Authority. High Court of New Zealand, CIV 2013-485-877 [2014] NZHC 1067. 20 May 2014.
9. Available on Amazon:
10. Andrée P (2006). An analysis of efforts to improve genetically modified food regulation in Canada. Science and Public Policy 33(5): 377-389.
11. Robinson et al (2013). Conflicts of interest at the European Food Safety Authority erode public confidence. J Epidemiol Community Health 67: 717–720.

Note: Where references are given to the Earth Open Source report GMO Myths and Truths, this is shorthand for referencing the peer-reviewed studies and other soundly evidenced data collected in the relevant sections of the report. This is pointed out in anticipation of the usual objection to GMO Myths and Truths that it is not peer-reviewed.