The Scottish Parliament and Scottish Parliament Infor mation C entre l ogos .

SPICe Briefing

Food for Thought: Scotland & Genetically Modified Organisms (GMOs)

16 December 2015

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Joe Ryan-Hume

This briefing examines genetically modified organisms (GMOs), focussing principally on GM crops. It provides introductory information on GMOs and outlines the EU Regulatory framework, including the recent EU Directive on GM cultivation. It describes the Scottish and UK Government positions on GM crops, and those in other EU Member States. It includes information on public opinion and consumer acceptability of GM products, both within the UK and more widely; and it examines the potential benefits and risks of GMOs.

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CONTENTS

EXECUTIVE SUMMARY .............................................................................................................................................. 3

PART 1 – GENETICALLY MODIFIED ORGANISMS (GMO) ..................................................................................... 5

WHAT IS A GMO?.................................................................................................................................................... 5 GM Crops ............................................................................................................................................................. 6 Box 1: GM Beyond Crops .................................................................................................................................... 6 Recent GM Developments in Science ................................................................................................................. 7

THE BENEFITS AND RISKS OF GM TECHNOLOGY ............................................................................................ 7 Possible Benefits .................................................................................................................................................. 7 Possible Risks ...................................................................................................................................................... 9 ADAS Report: Environmental risk assessment of GM Crops in Scotland ......................................................... 10

WHERE ARE GMOS GROWN? ............................................................................................................................ 11 GM Crops Grown Around the World .................................................................................................................. 11 GM Crops in Europe .......................................................................................................................................... 13 GM Crops in the UK ........................................................................................................................................... 15 Box 2: GM Research in the UK .......................................................................................................................... 15

PART 2 – REGULATION OF GMOS ......................................................................................................................... 16

EU REGULATORY FRAMEWORK ON GMOS ..................................................................................................... 16 Authorisation procedure ..................................................................................................................................... 18 Box 3: Genetically Modified Microorganisms (GMM): ........................................................................................ 20 New EU GMO Cultivation Directive ................................................................................................................... 20 Concerns expressed with the New Directive ..................................................................................................... 22 GM Food and Feed in Europe ........................................................................................................................... 22 New EU Food and Feed Proposal ..................................................................................................................... 22 GMOs and TTIP ................................................................................................................................................. 25 Box 4: Labelling Regulations ............................................................................................................................. 25

PART 3 – POLICY POSITIONS ACROSS EUROPE ................................................................................................ 27

Policy on GMOs in Scotland .............................................................................................................................. 27 Debate following the Scottish Government Announcement .............................................................................. 27 The Political Context in the rest of the UK ......................................................................................................... 30 Decisions of Other EU Member States .............................................................................................................. 30

PART 4 – PUBLIC OPINION & CONSUMER CHOICE............................................................................................. 31

Public Opinion .................................................................................................................................................... 31 Consumer Choice .............................................................................................................................................. 32

ANNEX ....................................................................................................................................................................... 35

Comprehensive List of GM Regulations: ........................................................................................................... 35

SOURCES .................................................................................................................................................................. 36

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EXECUTIVE SUMMARY

A Genetically Modified Organism (GMO) is an organism (i.e. plant, animal or microorganism) in which the genetic material (DNA) has been altered in a way that does not occur naturally by mating and/or natural recombination. A hotly debated subject, GM is regarded by some as the answer to increasing food output in a growingly resource-strained world. Likewise, utilising GM technology to both increase nutrient supply per hectare and output per hectare in a climate-constrained world is seen by some as a crucial way to guarantee future food security. However, from the moment scientists developed the ability to genetically modify organisms in the late 20th Century, the issue of altering or changing the genetic makeup of a plant, animal, or microbe has become deeply controversial, with opponents arguing that GM could potentially have a number of damaging environmental and epidemiological (study of how often diseases occur in different groups of people and why) consequences. For example, according to some environmental groups, GM crops negatively affect the environment by seriously threatening the biodiversity of an area. On the other hand, GM for medical purposes (e.g. in vaccines, etc.,) has been implemented globally with almost minimal opposition. Since the introduction of the first commercially cultivated GM crop in 1994, GM crops have come to dominate the market for certain crops, particularly in North and South America. Currently, four crops – soya, maize, cotton, and oilseed rape – account for 99% of the area of GM crops worldwide -- an area of 181 million hectares. Just ten countries account for almost all – 98% – of the area of GM crops grown around the world. The top three countries that cultivate GM crops – the US, Argentina and Brazil – account for over three quarters of global GM hectares. Out of the 181 million hectares of GM crops in 2014, the US accounted for 73.1 million hectares (40.39%), Brazil 42.2 (23.31%), Argentina 24.3 (13.43%), India and Canada 11.6 (6.41%) respectively, and China 3.9 (2.5%), (with 7.9% divided amongst the rest). In Europe, there is only one GM crop currently commercially cultivated: Monsanto’s GM maize MON 810. Authorised in 1998, this product's genetic modification aims to protect the crop against a harmful pest – the European corn borer. In fact, almost all varieties of GM crops on the world market are genetically engineered with either one or both of just two types of GM traits: herbicide tolerance and insect resistance. In 2014, MON 810 was planted in the EU on approximately 143,015 hectares across five countries: Slovakia (411ha), Romania (711ha), Czech Republic (1,754 ha), Portugal (8,542 ha), and Spain (131,537ha). Controlled through an EU Regulatory Framework based on the precautionary principle, thereby ensuring a high level of protection through preventative decision-taking in the case of risk and a strong scientific basis, GMOs in Europe are monitored both at EU and national level (a detailed examination of the regulatory framework is provided in Part 2 of this briefing). A recent EU Directive gives Member States more flexibility to ‘opt-out’ of GM cultivation at two distinct points – by placing an amendment to the geographic scope option, which they can request while a GM crop is going through the approval process, or by invoking a variety of factors after EU approval, such as socioeconomic grounds and/or impacts on local or regional environments. By October 2015, over half of the EU’s Member States, as well as four regionally devolved administrations, were seeking geographical exclusion from a number of GM products authorised or awaiting approval in the EU. Described by some as a ‘green-wave’ of anti-GMO sentiment

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sweeping across Europe, around two-thirds of the EU’s population – and of its arable land – can be considered GM-free based on this new opt-out Directive (19 Member States have made use of this opt out provision - 17 Member States have utilised full geographic exclusion while 4 devolved regions within Member States have opted out of cultivation). Incidentally, 3 of the devolved regions are in the UK, while the UK Government chose not to include England in the scope of ‘opt-out’ decisions. In August 2015, Scotland was the first country to announce that it was utilising this ‘opt-out’ provision. The Scottish Government indicated that the opt-out decision was taken to protect the ‘clean, green environment’ that supports Scotland’s food and drink sector – a sector with an annual turnover of £13.9 billion in 2014, and a target of £16.5 billion by 2017. When announcing the decision, the Cabinet Secretary said that ‘Scotland is known around the world for our beautiful natural environment - and banning growing genetically modified crops will protect and further enhance our clean, green status’ (Scottish Government, 2015). Yet opponents criticised what they saw as the lack of scientific consultation in the decision-making process, and asked for a ‘rational debate’ regarding GM (RSE, 2015). The Scottish Government had previously commissioned a risk assessment report by ADAS (2010) to scrutinize peer-reviewed publications and examine the potential impact of GM crops on the environment in a Scottish context. The report found a number of environmental risks from GM technologies, including from the introduction of GM herbicide tolerant oilseed rape where it found ‘a high risk of gene flow’ between GM and non-GM plants (discussed on page14). From the recent announcements, it is clear that some EU nations take the view that GM poses a potential threat to public health and biodiversity, and could affect the reputation and integrity of their local agricultural produce. On the other hand, some welcome the technology as not only an extension of evolving scientific and agricultural practices, but also a tool with the potential to feed a growing world population. Likewise, from public opinion polls and consumer choice surveys, it is clear that GM continues to divide opinions on the ground as well. The most recent Eurobarometer poll (2010) for example, found that, on average, 61% of EU citizens opposed the development of GM foods across the EU. Yet a more recent Ipsos Mori poll (2014) on Public Attitudes to Science found that more people in the UK believed that the benefits of GM crops were greater than the risks – though this was closely divided at 36% to 28%. Clearly, GM continues to split opinions. Indeed, as the public opinion section demonstrates, one of the key drivers of this divide is the perceived monopolisation of the market by a select few GM companies, particularly regarding the practice of patenting GM seeds. This has raised a number of ethical objections, especially as GM seeds are acquired through the payment of a licence fee for the intellectual property, and farmers are required to pay for seeds each year. Instead of traditionally saving seed for the next harvest, because GM crops are modified so that the seeds they produce are infertile, farmers cannot save their own seed. This leads to a belief that GM allows corporate control of the food chain by multinational conglomerates. Finally, several new technologies are revolutionising the way that plant characteristics can be altered, potentially blurring the boundaries between GM and non-GM. With some gene transfer techniques for example, the end product is seemingly indistinguishable from its non-GM counterpart. The relationship between GM and conventionally bred methods of crop cultivation is also clouding the debate. According to an EU report into the risks of GMOs in 2010, titled ‘A Decade of EU-funded GMO research, 2001-2010,’ biotechnology, and in particular GMOs, ‘are not per se more risky than e.g. conventional plant breeding technologies’ (EU Report, 2010). What remains clear is that GMOs will continue to be a contentious issue, both within Scotland and elsewhere.

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PART 1 – GENETICALLY MODIFIED ORGANISMS (GMO)

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WHAT IS A GMO?

For thousands of years, humans have been adapting ways to cultivate land and breed animals in order to develop more sustainable and profitable produce. Yet with recent advances in science, it has become possible to modify the genetic make-up of living cells and organisms using techniques of modern biotechnology. A genetically modified organism (GMO) is the result. The World Health Organisation (WHO) defines GMOs as organisms (i.e. plants, animals or microorganisms, such as bacteria, parasites and fungi.) ‘in which the genetic material (DNA) has been altered in a way that does not occur naturally by mating and/or natural recombination.’ Article 2(1) of EU Directive 2001/18/EC defines an ‘organism’ as ‘any biological entity capable of replication or of transferring genetic material.’ Through intervention at molecular level, this introduction of new traits – by inserting DNA pieces, whole genes, long stretches of DNA segments from many different organisms (transgenics), or transferred genes from the same species (cisgenics) – changes the organism, often to develop a hybrid resistant to some form of inherent fault or environmental characteristic. For example, in trials GM technology has been successfully implemented in potatoes to protect them from blights and/or diseases, while a number of crops, including the only cultivated GM crop in the EU – MON810 – have been designed to resist harmful pests and/or weeds. The technology is also often called “modern biotechnology” or “gene technology”, sometimes “recombinant DNA technology” or “genetic engineering.”’

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GM Crops

GM in crops seeks to develop certain key characteristics:

Improving their ability to survive in particularly harsh environments;

Providing greater resistance to pests and diseases;

Improving nutritional qualities; and/or;

Creating tolerance to certain herbicides.

Since introduction of the first commercially cultivated GM crop in 1994, GM crops have come to dominate the market for certain crops, particularly in North and South America (as Map 1 indicates). Four crops: soya; maize; cotton, and oilseed rape account for 99% of the area of GM crops worldwide (CBAN, 2015b). Insects, plant pathogens, diseases, and weed pests reduce potential food production by 40% each year, according to a College of Agriculture and Life Sciences report (Pimentel, 2009). Almost all varieties of GM crops on the market are genetically engineered with either one or both of just two types of GM traits: herbicide tolerance and insect resistance.

Insect-resistant crops are engineered with a gene from the bacteria Bacillus thuringiensis (Bt.), which is toxic to a number of insects. GM Bt. plants are engineered to synthesize a toxin (Bt. Endotoxin) in their cells, making the entire plant toxic to some above and/or below ground insects such as butterflies and beetles, or in the context of Europe, the European corn borer, which Monsanto’s maize crop MON 810 was developed to resist.

Herbicide-tolerant (Ht.) crops are engineered to survive applications of particular herbicides. These are typically nonspecific herbicides that kill all plants. This means that the herbicide can be applied on an entire field, killing the weeds but leaving the GM crop standing. Monsanto’s GM ‘Roundup Ready’ crops, which are genetically engineered to tolerate applications of the company’s glyphosate-based herbicide, ‘Roundup’, are the most common Ht. crops found today.

Box 1: GM Beyond Crops

Whilst this briefing will principally consider GM in crops, it is important to highlight that GM is also utilised in other ways. Food and feed which contain or consist of GMOs, or are produced from GMOs, are called GM food or feed, and currently, there is substantial use of GM crops in animal feed in the EU (see page 22). Likewise, Genetically Modified Microorganisms (GMM), such as bacteria, parasites and fungi, which grow rapidly and in most cases are easy to cultivate, are particularly found in drug development (e.g. vaccines, medicines with improved treatment potential, or increased safety). In stark contrast to GM crops, GM for medical purposes has been implemented globally with almost minimal opposition.

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Recent GM Developments in Science

Several new technologies are revolutionising the way that plant characteristics can be altered. The objective of plant breeding in general is to generate genetic variation and to select variants with desirable characteristics. Consequently, plant breeding produces a vast number of off-types that have to be discarded during the process of producing a new variety. New technologies are being developed that aid precision and thereby efficacy, thus reducing the number of off-types to be discarded, both in GM and non-GM plant breeding. As a recent UK Parliamentary Office of Science and Technology (POST, 2014) note demonstrates, these include:

Genome editing - precise gene transfer into targeted sites of the genome to reduce the risk of unintended consequences. According to the UK’s Council for Science and Technology (CST) report (2014), ‘the end result of a gene targeted modification might be indistinguishable from a non-GM variety created by chemical or radiation mutagenesis’;

Site-directed mutagenesis - induces single mutations at specific target sites in genes. The end-product is seemingly indistinguishable from its non-GM counterpart, potentially blurring the boundaries between GM and non-GM.

Metabolic engineering - inserting genes that alter (amplify or silence) plant metabolism;

Epigenetic modification - amplifying or silencing gene expression by manipulating the small molecules that regulate genes;

MutationMap - identifies small genetic differences associated with specific traits (such as salt tolerance in rice) to accelerate conventional selective plant breeding.

Progressive innovations in technology have allowed many of these techniques to develop. Likewise, the CST (2014) reports that many GM methods and traits are ‘in the pipeline’, pointing to recent laboratory science that has identified genes with effects in experimental situations that could benefit crop plants including: photosynthetic efficiency, nitrogen use efficiency, aluminium tolerance, salinity tolerance and other abiotic stresses, pest and disease resistance, and phosphate use efficiency. According to the report, ‘…in the longer term, nitrogen fixation in GM crops is likely, and once synthetic biology has been developed, there is the potential for developing more complex novel traits in plants, including the production of novel compounds for biofuels or industrial biotechnology.’

THE BENEFITS AND RISKS OF GM TECHNOLOGY

Possible Benefits

Proponents view GM production as merely an extension of evolving scientific and agricultural practices. According to the CST (2013), GM promises a range of strategic economic, environmental and international development benefits for the UK through:

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Helping farmers of all kinds manage their land, or reduce costs by growing crops that resist insect attack, or are tolerant of specific weed killers, or extreme weather conditions, such as drought;

Enhancing the nutritional value of foods for humans and animals, including maize and soya with increased levels of amino acids or improved oil composition, reducing the need for dietary supplements;

Providing a production base for renewable industrial compounds (e.g. biodegradable plastics) and pharmaceutical products (e.g. vaccines).

GM practices also reportedly lead to more efficient farming, meaning less time spent tilling the land, as well as improved environmental conditions through fewer CO2 emissions from farm equipment. According to the CST (2014), GM crops make it easier for farmers to control weeds or insects, by reducing not only the amount of chemical pesticides applied, but also the amount of diesel used for tractors to apply the pesticides. This can generate increased income for farmers. The CST report (2014) points out that cumulatively, since 1996, GM insect resistant varieties have ‘added an estimated $25.8 billion to the income of global maize farmers, and 11.6% to the global value of the cotton crop.’ Incidentally, as the ‘consumer choice’ section demonstrates, this a contested subject, with a recent Canadian Biotechnology Action Network (CBAN, 2015a) report showing that ‘patented GM seed is significantly more expensive than non-GM seed and these costs are chipping away at farmers’ incomes.’ According to another report, by the Agriculture and Horticulture Development Board (AHDB, 2015a), the adoption of GM cereals and oilseed crops could benefit farmers, consumers and the animal feed supply chain, while protecting the environment and supporting UK competitiveness in the global marketplace.1 The AHDB commissioned an independent report (AHDB, 2015b) by researchers at the University of Reading in 2015 that found the benefits of GM implementation included increased gross crop margins and better soil conditions through less need for pesticide and/or herbicide application. Accordingly, better soil conditions could be reached by utilising herbicide tolerant crops to promote the use of the so-called ‘no-till’ systems of agriculture. According to greenbiotech (2012), this type of agriculture:

‘…leaves the crop residues on the field after the harvest and does not plough them under in winter. These crop residues offer benefits such as decreased soil run-off and less erosion, better retention of moisture, a much better carbon sequestration, decreased use of machinery and fuel, and increased

1 Researchers at the University of Reading used the report to predict the impact on UK farming from

growing Insecticide Resistant maize and Herbicide Tolerant oilseed rape. Pulling together data from

more than 170 publications, reports, and studies to explore possible scenarios for the UK, according

to HGCA’s Dr Vicky Foster, ‘it was important to develop an independent evidence-base, free from

distortion and speculation, to better prepare the industry for the implications of GM crop production,

should the technology become available in the UK. We recognise that GM is an emotive subject but

this report is specifically focused on the science, rather than consumer acceptability of GM products.

However, we live in a market economy and farmers and processors are reliant on consumer demand

for their products. Although this study demonstrates there would be tangible benefits to farmers and

the environment in certain GM crop production scenarios, ultimately the decision rests in the hands of

the consumer.’

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humus content of the soil, which is positive for soil fertility and sustainable productivity.’

Indeed, GM companies often market themselves as important actors in protecting biodiversity and ensuring environmental sustainability. Monsanto for example, releases an annual ‘sustainability report’, with the most recent one (2014a) illustrating how the company works with farmers to ‘conserve the earth’s resources and preserve the natural ecosystem.’ By pledging to reduce greenhouse gases and develop agronomic practices to help use fewer resources, as well as working with environmental groups to protect natural species and habitats, Monsanto has sought to engage in a dialogue about sustainable agriculture. Additionally, by using the example of MON810, a GM crop developed and approved for cultivation in the EU to stymie the impact of a harmful pest (the European corn borer), studies have demonstrated the efficiency of the insect resistant trait (Bt) to maize yields.2 The AHDB report (2015b) shows that on the farm, Bt maize has achieved higher yields (ranging from 0.4t/ha in Canada to 2.1t/ha in the Czech Republic), with an average gross margin increase in Spain (the largest adopter of the product in the EU) of $266/ha (£178/ha) in 2010, for example. The AHDB report (2015b) also demonstrated that adoption of GM maize in Spain included: lower costs of production, largely from reduced expenditure on pesticides, and higher profits, resulting from reduced production and management costs. Finally, the AHDB report (2015b) argues that ‘unless British farmers are allowed to grow GM crops in the future, the competitiveness of farming in the UK may decline relative to overseas competitors.’

Possible Risks

Opponents view GM as an unsound science, with the potential to have a variety of damaging environmental and epidemiological consequences. For example, according to some environmental groups, GM crops have the potential to negatively affect the environment by threatening biodiversity and creating a monoculture that could cause soil depletion and be problematic in the event of a plague (Vecchione et al, 2015). Cross contamination through unanticipated gene transfer from GM crops to non-GM crops also has the potential to affect the biodiversity of a region. The EU recognises that there is a consequent need for significant coordination and strong coexistence measures to attempt to manage the potential for admixture between regions as best as possible, but some environmental groups have pointed out that the distance requirements are often too short. Evidence also suggests that non-GM farming in Europe has actually outperformed GM farming in the US, thus diminishing the argument that adoption of GM results in higher output (Heinemann et al., 2014). Several studies have demonstrated that repeated and widespread use of glyphosate, an active substance in many herbicides (weedkillers), on GM crops is resulting in glyphosate resistant weeds. In the US for example, according to one study (Brown, 2013), 21 different weed species have been identified that show resistance to glyphosate herbicides, with almost half of farms affected. Another study (Heap, 2015) by the International Survey of Herbicide Resistant Weeds (ISHRW) lists 32 2 One report (Kocourek et al., 2012) found that ‘the efficacy of Bt maize on the reduction of the

number of tunnels caused by ECB per 100 maize plants before harvest was always 100%’

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different weeds worldwide that are now resistant to glyphosate. Due to the fact that glyphosate resistant weeds have evolved in a number of countries as a result of repeated use and over-reliance, the ISHRW (2015) recently released a guideline for minimising the risk of occurrence in the UK. Thus, the argument goes that as weeds and insects become resistant to the controlling chemicals, additional and potentially more toxic pesticides will be needed to combat them in the future. The EU published a report into the risks of GMOs in 2010, titled ‘A Decade of EU-funded GMO research, 2001-2010.’ Drawn from the efforts of more than 130 research projects, and involving more than 500 independent research groups, the report concluded that biotechnology, and in particular GMOs, ‘are not per se more risky than e.g. conventional plant breeding technologies’ (EU Report, 2010). Likewise, an EFSA panel on GMOs concluded its own study (2012) into GM and conventionally bred plants, finding similar hazards associated with them both, and pointing out that the risks to human and animal health and the environment depended more on exposure factors, such as the extent to which the plant is cultivated and consumed, than on the technology itself. The CST (2014) report went one point further, bemoaning the current regulatory framework in the EU (discussed in Part 2) for discouraging the development and investigation of GM technology in the field:

‘As there is no evidence for intrinsic environmental or toxicity risks associated with GM crops, it is not appropriate to have a regulatory framework that is based on the premise that GM crops are more hazardous than crop varieties produced by conventional plant breeding… a future regulatory framework should be product- rather than process- based so that it is consistent and applies to the novelty of the characteristics of new plant varieties.’3

ADAS Report: Environmental risk assessment of GM Crops in Scotland

The Scottish Government commissioned a risk assessment report by ADAS (2010) to scrutinize peer-reviewed publications and examine the potential impact of GM crops on the environment in a Scottish context. With some caveats, including environmental issues and co-existence measures, meaning the ways in which different agricultural systems are managed to co-exist side by side in a sustainable manner, ADAS concluded in 2010 that there are several GM crops that could be grown in Scotland in the next 5-10 years, should they be approved at the EU level and have sufficient market acceptance: ‘The crops include herbicide tolerant (HT) oilseed rape, maize and cereals, blight resistant potatoes and potato cyst nematode (PCN) resistant potatoes.’ With a select criteria that examined:

A crop species already grown in Scotland;

A trait which addresses a problem currently experienced in Scotland;

A product that could be commercially available within the next 10 years.

3 The CST report writes that ‘this issue has become more prominent in recent years, as many new

plant breeding techniques that have been developed since the GMO legislation was adopted in 1990

were not foreseen, and it is not clear whether the definition of a GMO applies to the plants produced

by them. This uncertainty will increasingly inhibit innovation in biotechnology.’

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The ADAS report also discussed the potential risks, particularly the environmental risks, of a number of GM technologies. With the introduction of GM herbicide tolerant oilseed rape in Scotland for example, ADAS found that:

‘In the absence of co-existence measures there is a high risk of gene flow between crop genotypes either in the same year or from volunteers in following crops [volunteers being plants that grows on their own, rather than being deliberately planted – often from seeds that float in on the wind, are dropped by birds, or are inadvertently mixed into compost]. The risk from volunteers is higher as they cannot be mitigated by separation distances, and their control may be more difficult particularly in field margins.’

Finally, the report pointed to the uncertainties and unanswered questions associated with GM:

‘The main uncertainties are in crops where commercialisation is still some way off. The evidence base on environmental risk of HT cereals is particularly limited and significant new research will be required to establish the extent of these risks. There has been sufficient work on potatoes with respect to geneflow and invasiveness, however there are some uncertainties on the management and development of virulence against the GM traits in blight and PCN populations.’

WHERE ARE GMOS GROWN?

GM Crops Grown Around the World

In 2014, 57% of the world’s GM crops were engineered to be herbicide-tolerant, 15% were engineered to be toxic to pests (Bt.), and 28% were ‘stacked’ with both herbicide tolerance and insect resistance (CBAN, 2015b).

Figure 1 – Proportion of GM Crops with specific traits

Proportion of GM crops with Ht., Bt, & 'Stacked' Traits

Herbicide-Tolerant

Insect-Resistant

Stacked' with Both

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Just ten countries account for almost all – 98% – of the area of GM crops grown around the world. The top three countries that cultivate GM crops – the US, Argentina and Brazil – account for over three quarters of global GM hectares. Out of the 181 million hectares of GM crops in 2014, the US accounted for 73.1 million hectares (40.39%), Brazil 42.2 (23.31%), Argentina 24.3 (13.43%), India and Canada 11.6 (6.41%) respectively, and China 3.9 (2.5%), (with 7.9% divided amongst the rest) (ISAAA, 2014). Figure 2 – Breakdown of GM Crops in the World

In terms of area cultivated, soybean is far more successful than any other GM crop. In 2009, more than three-quarters (77%) of the 90 million hectares of soybean grown globally were GM, while for cotton, almost half (49%) of the 33 million hectares were GM. Over a quarter (26%) of the 158 million hectares of globally grown maize and 21% of oilseed rape (with a total area of 31 million hectares) were GM (Kaphengst et al., 2010).

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Percentage of GM Crops by Country

Percentage of GM CropHectarage in the World

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Map 1 – GM Crop Cultivation figures by Country

GM Crops in Europe

There is only one GM crop which is currently commercially cultivated in the EU: Monsanto’s maize MON810. Authorised in 1998, this product's genetic modification aims to protect the crop against a harmful pest – the European corn borer. In 2014, MON810 was planted in the EU on approximately 143,015 hectares across five

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countries: Slovakia (411ha), Romania (711ha), Czech Republic (1,754 ha), Portugal (8,542 ha), and Spain (131,537ha) (Monsanto, 2014b). One other GM product cleared for cultivation, the ‘Amflora’ GM potato, was later withdrawn when the authorisation decision was annulled by the EU General Court in 2013 because the Commission failed to fulfil its procedural obligations. Following the failure of EU government ministers and officials to approve or reject the proposal to allow cultivation of the potato, the Commission exercised its power to grant approval unilaterally in 2010. But in its judgment, the General Court said that following the publication of an updated scientific opinion by the European Food Safety Authority (EFSA) in 2009, the Commission should have submitted new proposals for approval by EU governments rather than simply adopting its 2007 version. According to the court, the Commission (2013) ‘infringed the procedural rules of the systems for authorising GMOs in the European Union.’ Map 2 – EU Member States on MON810 Cultivation (IHS Quarterly, 2015) The IHS map displays the position of a number of EU Member States on GM cultivation of MON810 (Member States in blue currently cultivate MON810, while those in orange have utilised safeguard action – discussed in Part 2 – to ban MON810; this is separate from the recent opt-out Directive that allows Member States more freedom to determine internal GM policies – also discussed in Part 2).

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GM Crops in the UK

There are currently no GM crops cultivated in Scotland, nor in the UK (though as Box 2 indicates, GM research is currently being carried out in the UK, both within a contained setting and in open field trials [not in Scotland]).

Box 2: GM Research in the UK

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While GM crops are currently not commercially cultivated in the UK, GM research is taking place in a number of places in the UK, both within laboratories in a contained setting and in open field trials – though a significantly higher proportion of GM research is carried out in a contained setting than in an open field trial setting. In open field trials for example, researchers have examined GM potatoes resistant to potato cyst eelworm or potato cyst nematode (PCN) and GM Wheat developed to repel aphid pests.

Currently, research is being carried out by a number of organisations, including Rothamsted, a UK research institute of agricultural science in Hertfordshire, in open field trials. At the moment, Rothamsted is carrying out field trials on GM variations of Camelina and Wheat:

The GM wheat field trial, a 5 year research project, recently came to an end and had its results – described as ‘disappointing’ by Rothamsted - published in the scientific journal Scientific Reports.

Field trials of GM false flax (Camelina sativaa) are ongoing, with researchers investigating whether the crop can accumulate high levels of Omega 3 oils in its seeds, so that it could be used as feed in fish farming or as a health supplement.

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Scientists at the John Innes Centre (JIC) in Norwich, UK have started to look beyond the UK to develop some of their GM research, including current research on GM ‘purple tomatoes’ harvested in Ontario, Canada. The colour of the tomatoes is derived from high levels of anthocyanins, compounds normally found in blueberries, blackberries and other deeply coloured berries. According to the JIC, the purple tomatoes have been shown to have anti-inflammatory effects compared to regular ones and to slow the progression of soft-tissue carcinoma in cancer-prone mice. Research like this is part of a wider exploration of GM crops designed to appeal to consumers - the first types were aimed specifically at farmers as new tools in agriculture.

Opting to outsource the research and development of the technology was largely due to the ‘rigid’ regulatory process in the EU, according to one of the lead researchers on the project.4 A report by the CST (2014) points to the ‘stringent’ regulatory process in the EU as the reason for ‘a significant reduction in experimental field trials in the UK, with only one in 2012, compared with 37 in 1995.’5 For more information on GM research in the UK – including a list of sites with active consents for GMOs – see the UK Government GM webpage.

PART 2 – REGULATION OF GMOS

EU REGULATORY FRAMEWORK ON GMOS

GMOs are primarily regulated through European Union (EU) legislation, with secondary UK-wide and Scotland-specific legislation supporting and implementing the EU measures (see the regulation list in the Annexe). Made up of several different regulations and directives, the framework is complex and requirements differ depending on whether the GM product is being grown or kept in closed or open conditions (lab or field trial); whether it is capable of being propagated and cultivated; and whether it is intended for food or feed use or for processing and/or other non-food use. At EU level, two main legal instruments regulate various aspects of GMOs, from authorisation requirements to procedural issues. The first of these legal instruments is Directive 2001/18/EC on the release of GMOs into the environment. This came into force in March 2001 and covers two main types of GMO activities:

The experimental release of GMOs into the environment (for example the cultivation of GMOs in connection with experimental field tests), which is regulated by Part B of the Directive.

The placing on the market of GMOs (for example the commercial cultivation of GM seeds in the EU, the importation and transformation of GM material in the EU), which is regulated by Part C of the Directive.

4 Professor Cathie Martin of JIC told the BBC (2014) that changing regulations would help scientists

make progress with GM varieties: ‘It takes 10 years to get European regulators to approve a new GM

trial, and costs in the order of $150m. How can any small company do that?’ 5 For comparison, in 2013 there were 601 trials in the US, with herbicide tolerant corn representing

the largest category. CST report (2014), p. 11

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Part B of this directive deals with research releases - these are small scale releases carried out under tight control. Research releases can involve trials of GM crops in field plots but also includes medical trials of GM pharmaceuticals such as vaccines administered under controlled conditions in hospitals and clinics. A GMO will only be released into the environment when a competent authority is satisfied that the release will be safe for human health and the environment. With regards to GM crops for research purposes for example, consent would only be provided after a detailed risk assessment has been submitted to the Crop Policy Branch of the Rural and Environment Directorate, who are Scotland’s Competent Authority for the regulation of the deliberate release of GMO’s under the Directive, and has been fully considered by ACRE (Advisory Committee on Releases to the Environment). Following this procedure, authorisation is granted on a case by case basis by Scottish Ministers. See Box 2 earlier for a discussion of GMO research in the UK. In Scotland there are currently no field trials of GM crops. GM research in Scotland is carried out either in contained conditions in labs or glasshouses or in medical trial in hospitals and clinics. Part C of the directive relates to commercial releases – this means deliberate releases to the environment authorised under the directive, or under the Genetically Modified Food and Feed Regulation (EC) No 1829/2003 (discussed next). This type of authorisation covers import and use of a GMO for food or feed and non-food use and it can allow EU-wide commercial scale growing of a GM crop. In order to gain authorisation, applications under Regulation 1829/2003 must comply with the requirements set out in Commission Implementing Regulation (EU) 503/2013, including:

I. Purpose and scope; II. All relevant data, studies and analysis of the results;

III. Monitoring plan; IV. Labelling proposal; V. Detection method;

VI. An indication of confidential information.

Following this, commercial releases are only authorised at European level after an EFSA risk assessment and consideration by a Committee with representatives from the competent authorities of all Member States (more details provided under ‘authorisation procedure’ heading). The Food Standards Agency and Food Standards Scotland is then responsible for food safety issues whilst the Department for Environment, Food and Rural Affairs (Defra) and the devolved agriculture departments are responsible for monitoring risks to the environment. Science and Advice for Scottish Agriculture (SASA), which is a division of the Agriculture, Food and Rural Communities Directorate (AFRC), has taken responsibility for the inspection and enforcement of the deliberate release and marketing of GMOs (principally crops/plants) in Scotland since May 2000. No GM crops have ever been grown commercially in Scotland. Typically, SASA’s Inspectorate role has come into play when there has been an accidental or unintended GM release, such as in 2014 when a pet shop was selling/distributing unauthorised GM tropical fish (see Scottish Government GM Notices for more details).

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The second main legal instrument, Regulation (EC) No 1829/2003, amended the 2001 Directive to revise the procedures for evaluation and authorisation of GM in food and feed. The Regulation came into force in April 2004 and covers food and feed consisting of, containing, or produced from GMO – e.g. food such as GM sweetcorn, as well as processed foods containing GM (GMO Compass, 2006). This regulation applies to food and feed and addresses health, safety, and labelling requirements (discussed in more detail under ‘labelling’ heading). Complementing these two ‘building blocks’ of GM legislation – is Regulation (EC) No 1830/2003 on traceability and labelling of GMOs, which came into force in November 2003 to harmonise measures across Member States, and Regulation (EC) 1946/2003, which regulates trans-boundary movements of GMOs within the EU to protect biodiversity and human health and transposes the UN’s Cartagena Protocol on Biosafety (CPB) into EU law.6

Authorisation procedure

As many GM applications to the EU are multi-purpose i.e. they cover food/feed use as well as cultivation, the EU system employs a ‘one door–one key’ procedure, integrating processes to allow for one scientific assessment and authorisation decision relating to GMOs and derived foods and feeds. Thus, one single risk assessment is conducted, and one single authorisation is granted for a GMO and its derived products based on that assessment. Under this ‘one door–one key’ principle, applications for release of GMOs into the environment can be made under, Directive 2001/18/EC and Regulation (EC) No 1829/2003. But where applications are made for the release of GM crops under the latter, the applicant must also comply with the requirements of the Directive – the EU has the authority to approve the marketing of GM products (Part C), while national/regional governments control the authority to approve the release of GMOs for research and development purposes (Part B). After applications are submitted under either 2001/18 or 1829/2003, they are assessed by EFSA.7 Indeed, all GMOs, regardless of intended use, are subject to an extensive, case-by-case, science-based evaluation by EFSA, in cooperation with the scientific bodies of the Member States. This risk assessment needs to demonstrate that, under its intended conditions of use, the GMO product is safe for human and animal health and the environment. Responsibility for the scientific risk assessment covering both the environmental risk and human and animal health safety assessment was designed to create a uniform EU procedure for all marketing applications, whether they concern the GMO itself or resultant food and feed products. Once complete, Member States’ Competent Authorities are invited to comment on EFSA’s risk assessment. The European Commission then drafts a proposal for

6 The objective of the CPB is to ensure an adequate level of protection, safe handling, and use of

‘living modified organisms resulting from modern biotechnology’ that may have adverse effects on

conservation, biodiversity, and human health in trans-boundary movement. There are 162 countries

party to the protocol; (CBD, 2000) 7 Member states can also comment on applications (e.g. in UK ACRE will often look at EU GM

dossiers and provide a view).

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granting or refusing authorisation. Representatives of Member States approve the Commission’s proposal by qualified majority in:

The Standing Committee on the Food Chain and Animal Health (SCoFAH) if the application was submitted under Regulation 1829/2003;

The Regulatory Committee under Directive 2001/18/EC if the application was submitted under Directive 2001/18.

If the proposal is neither accepted nor rejected by a qualified majority, it is referred to an Appeal Committee that also consists of Member States’ Representatives. If this committee takes no decision within three months, or does not reach a qualified majority indicating that it accepts or opposes the proposal, the European Commission can adopt its own decision. Yet, as the European Parliamentary Research Service (2015a) reports, ‘due to Member States' divisions over GMO cultivation, approvals tend to be blocked in Council, with a qualified majority neither for nor against approval.’ With the precautionary principle as the central tenet of all regulation, thereby placing crucial emphasis on scientific consensus, EU legislation is designed to ensure a high level of protection of human life and health, whilst safeguarding the free movement of human food and animal feed. The legislation also imposes a post-market monitoring of the environment for each authorised GMO allowing the Commission and Member States to take appropriate measures in case a non-anticipated adverse effect is identified. The European Commission outlined the EU’s current approach to GMOs as the following:

‘The approach chosen in the EU as regards GMOs is a precautionary approach imposing a pre-market authorisation for any GMO to be placed on the market and a post-market environmental monitoring for any authorised GMO. This approach ensures a high level of protection of human and animal health and the environment. The GMO legislation lays down specific procedures for assessing and authorising GMOs that are time-limited and transparent. The risk assessment is performed on the basis of harmonised criteria which are recognised as being amongst the most stringent in the world’ (EC Press Release, 2015a).

Thus, the EU legal framework on GMOs provides that no GMO or genetically modified food and/or feed can be placed on the market before it has been granted an authorisation in accordance with that legal framework. Authorisations are valid for 10 years and are renewable.

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Box 3: Genetically Modified Microorganisms (GMM):

Separate from the above pieces of legislation, though still within the EU regulatory framework of GMOs, Directive 2009/41/EC on the contained use of genetically modified micro-organisms lays down common measures for the contained use of GMMs, aimed at protecting human health and the environment. Contained use means GM research experiments carried out within a contained environment, for example a laboratory or glasshouse, under the terms of Directive 2009/41/EC (previously 90/219/EEC). In Scotland, the Health and Safety Executive (HSE) and the Scottish Government act as a joint competent authority and both organisations are responsible for signing any contained use consent. The HSE considers the risk to the operator and the Scottish Government considers the risk to the environment or ecosystem from any release. For more information, see the HSE website.

New EU GMO Cultivation Directive

In July 2010, the European Commission proposed a change to the existing European GMO-legislative framework in response to a long standing request from several Member States. After a protracted period of debate, in March 2015 the Council and the Parliament agreed on an amendment to allow Member States to restrict or prohibit the cultivation of authorised GMOs (Directive 2015/412/EU). This newly adopted Directive allows EU member states wishing to ban the cultivation of GM crops to do so even though EFSA has issued a positive opinion (in other words given the GM crop the all clear in terms of safety). The new directive allows Member States to decide on GM cultivation at two distinct points in time (EC Press Release, 2015a):

During the authorisation procedure at EU level: a Member State can ask to amend the geographical scope of the application to ensure that part or all of its territory will not be covered by the EU authorisation (without the need to provide grounds);

After a GMO has been authorised by the EU: a Member State may prohibit or restrict the cultivation of the crop based on grounds related, amongst others, to environmental or agricultural policy objectives, town and country-planning, land use, socio-economic impacts, co-existence, and/or public policy.

Before the adoption of this Directive, Member States could provisionally prohibit or restrict the use of a GMO on their territory only if they had new scientific evidence that the organism concerned constituted a risk to human health or the environment (or in the case of an emergency where it became evident that an authorised product constituted a ‘serious risk to human health, animal health, or the environment’ - Article 34 in Regulation 1829/2003). Temporary restriction could be used by applying emergency measures or using the so-called safeguard clause (Article 23 of Directive 2001/18/EC) – using scientific evidence to show that the environmental risk of growing a particular GM crop is higher in their region than elsewhere in Europe. Eight Member States (Austria, Bulgaria, Germany, Greece, Hungary, Italy, Luxembourg and Poland) have adopted safeguard measures prohibiting the cultivation of MON810 on their territories. France

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also had a cultivation ban in place until August 2013, when it was annulled by the Conseil d'Etat (the highest administrative court in France), following a 2011 ruling of the EU’s Court of Justice (Court of Justice, 2011). Yet no Member State which has adopted the ‘safeguard clause’ has so far been in a position to put forward new evidence to fulfil the key requirement for a safeguard action – production of scientific evidence using a robust methodology to support a claim. Under the new Directive, however, Member States are allowed to restrict or prohibit the growth of GMOs not only on environmental grounds (grounds not assessed previously by EFSA) but also on a number of other grounds outlined above, such as socio-economic and agricultural policy objectives. Under the new Directive, countries had until 3 October 2015, to inform the Commission that they wished to opt out of new EU GMO cultivation approvals and many chose to do so. In fact, as the map below indicates, 19 Member States have made use of this opt out provision –17 Member States have utilised full geographic exclusion while 4 devolved regions within Member States have opted out of a number of GM products authorised or awaiting approval in the EU (2015). Finally, the Directive requires Member States to strengthen national laws on co-existence and liability to protect GM-free farming and limit cross-border contamination. Map 3 – GM Cultivation Opt-Out decisions in the EU8

8 Attained through personal communication with the NFUS

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Concerns expressed with the New Directive

Conversely however, in what campaigners have termed a ‘double-edged sword’, many believe that the new Directive is built on legally weak foundations. Greenpeace’s EU agriculture policy director Marco Contiero said:

‘Environment ministers say they want to give countries the right to ban GM crop cultivation on their territory, but the text they have agreed does not give governments a legally solid right. It ties their hands by not allowing to use [sic] evidence of environmental harm to ban GM cultivation. This leaves those countries that want to say ‘no’ to GM crops exposed to legal attacks by the Biotech firms argue [sic] that the opt-outs could undermine ESFA’s credibility, the integrity of the internal market and science based decision making’ (Greenpeace, 2014).

GM Food and Feed in Europe There are 67 genetically modified products authorised in the EU (covering maize, cotton, soybean, oilseed rape, sugar beet, and microorganisms), with 43 applications currently pending (EPRS, 2015b). Most recently, in April 2015 the Commission (EC Press Release, 2015b) adopted 10 new GMO authorisations for food/feed use, 7 renewals of existing authorisations, and the authorisation for the importation of 2 GMO cut flowers (not for food or feed). There is substantial use of GM crops in animal feed in the EU. The European Feed Manufacturers' Association estimates that the EU feed industry annually imports more than 70% of its maize, soya and rapeseed requirements. Brazil, Argentina, Paraguay and the US are major producers of soya beans and soya bean meal, almost all of which is now GM (FSA, 2013). In 2013, the EU imported 18.5 million tonnes of soymeal and 13.5 million tonnes of soybean, representing more than 60% of the EU’s needs in vegetable proteins. Indeed, the EU’s livestock sector is highly dependent on third countries' production for its vegetable proteins - the EU produces merely 1.4 million tonnes of soybean annually (which is de facto non-GM as no GM soya is authorised for cultivation in the EU). This has a lot to do with the fact that soybeans cannot be grown easily in the EU for climatic and agronomic reasons (EC Press Release, 2015c). The European Commission sees the large presence of GM feed on the EU market as evidence of the functionality of the regulatory framework. The absence of GM on the food market, in the view of the Commission, is not caused by the framework but by market forces (van der Meulen & Yusuf, 2015). Consumer acceptability (discussed later) plays a heavy role in the differing situations between the GM food and feed market in the EU.

New EU Food and Feed Proposal

The recent amendment to the EU regulatory framework (discussed earlier) only covers the cultivation of GM crops. A proposal to ‘mirror and complement’ this was introduced by the European Commission in April 2015 to allow Member States to tighten the use of GMOs within their territory further. This proposal would devolve

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decision making power regarding the use of EU-authorised GMOs for animal (feed) or human (food) consumption to the Member States by amending EU Regulation 1829/2003. EU Health and Food Safety Commissioner Vytenis Andriukaitis said of the measure:

‘I am pleased to deliver on one of the important commitments taken by this Commission, reviewing the legislation on the decision-making process on GMOs. The Commission has listened to the concerns of many European citizens, reflected in the positions expressed by their national governments. Once adopted, today's proposal will, fully in line with the principle of subsidiarity, grant Member States a greater say as regards the use of EU- authorised GMOs in food and feed on their respective territories’ (EC Press Release, 2015d).

Yet the proposal, condemned as unworkable and a threat to the EU single market, was rejected by the EU Parliament on 28 October 2015. Commenting on the proposal, rapporteur Giovanni La Via (EPP, Italy), whose recommendation to reject the proposal was approved by 577 votes to 75, with 38 abstentions, said:

‘I believe that this proposal could have negative consequences for agriculture in the EU, which is heavily dependent on protein supplies from GMO sources. It could also have indirect negative effects on imports. Finally, there are concerns over whether this proposal could even be implemented, because there are no border controls in the EU’ (EP Press Release, 2015)

Whereas cultivation necessarily takes place on a Member State’s territory, GMO trade crosses borders, which means that a national ‘sales and use’ ban could be difficult or impossible to enforce without reintroducing border checks on imports. Opponents also feared that if implemented, segregation of GM products in the feed chain based on this proposal could become a costly issue as new structures would have to be created to trace, inspect, and coordinate the measure. Nevertheless, Andriukaitis has said that the European Commission will not withdraw the legislative proposal, meaning it will still be discussed by EU Ministers. Clearly, any legislative agreement on the issue is some time away. In the meantime, a number of supermarkets around the EU, including Edeka in Germany, have opted for voluntary labelling of some products where GM is involved.

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Figure 3 – Theoretical outline of how the new GM food and feed proposal would fit within the EU Regulatory framework (EC Press Release, 2015e)

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GMOs and TTIP

This issue is further complicated by the geopolitical ramifications of Transatlantic Trade and Investment Agreement (TTIP), a proposed free trade agreement between the EU and US. In the name of TTIP’s ‘regulatory harmonization’ and free trade expectations, pressure is being placed on the EU to allow GM products from the US into EU markets, despite the EU’s current regulatory framework (The Guardian, 2014). As part of TTIP negotiations, the US Department of Agriculture and Foreign Agricultural Service (2014) has explicitly identified ‘the EU’s non-tariff barriers to US agricultural products’, specifying in particular ‘long delays in reviews of biotech products [that] create barriers to US exports of grain and oil seed products.’ With TTIP negotiations ongoing, it remains unclear how recent GM regulatory actions will impact it. As a reaction to TTIP and the recent GM developments in the EU, various NGOs, scientists, members from 64 regional governments, and the business association ‘Danube Soya’ jointly organized a conference titled ‘GMO-FREE EUROPE: Future Opportunities and Challenges’ (2015). Here they adopted the so-called ‘Berlin Declaration’, where they set out a strategy to rid the continent of GM feed, calling on Member States to uphold the ‘precautionary principle’ regardless of TTIP pressure and celebrating the new opt-out provision. They also called on Member States to strengthen current labelling regulations to ensure consumer choice and transparency.

Box 4: Labelling Regulations

An important part of the EU’s approach to GMOs concerns labelling. In order to provide consumers with information and freedom of choice, traceability and labelling obligations were imposed for any authorised GMO in the EU in 2003.

In summary:

GMOs, including food and feed products derived from GMOs, placed on the market must comply with labelling and traceability rules;

If a food or feed contains or consists of GMOs, or contains ingredients produced from GMOs, this must be indicated on the label;

However, products produced with GM technology, for example cheese produced with GM enzymes and products such as meat, milk and eggs from animals fed on GM animal feed, do not need to be labelled.

Yet some foods that contain GM are exempt from the requirement:

Foods in small packages, less than 10 square centimetres;

Foods packaged in clear bottles which are intended to be reused.

As part of the EU regulatory framework, traceability and labelling rules, (1830/2003/EC), include a threshold of 0.9%, above which the adventitious (accidental) presence of material from an EU authorised GMO in a non-GM product triggers traceability and labelling of the product. As SASA outlines, ‘enforcement of these regulations – (1829/2003 and 1830/2003) – in Scotland is the responsibility of Local Authority Environmental Health (food) or Trading Standards (feed) Departments’ (SASA, 2015). Likewise, the GM Inspectorate at SASA is responsible

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for ensuring compliance with the regulations governing the deliberate release into the environment of GMOs in Scotland. The GM Inspectorate is also required to audit seed producers/importers to ensure appropriate steps (due diligence) have been taken and that appropriate documentation is available to establish whether any form of GM is present – thus, ensuring labelling protocols are adhered to. Yet a GMO that has not been approved in the EU is not allowed at any level (zero tolerance) in food and feed for sale in the EU.

This approach differs dramatically from the US (among other countries). A hotly contested subject in the US, in 2007 President Obama promised on the campaign trail to label GMOs (Politico, 2014). Despite this, the Safe and Accurate Food Labeling Act of 2015, termed the DARK Act (Deny Americans the Right to Know Act) by its detractors, has recently passed the House of Representatives and looks set to pass the Senate in this session (Congress, 2015). This Act would pre-empt states from requiring labelling on GM products and eliminate the federal government’s ability to craft a national labelling system. ‘Just Label it’, a campaign with more than 600 participating organisations, cites several studies that show a large majority of Americans support a mandatory labelling system, in some cases by as much as 90%. Yet despite this, the US may well decide to ban a labelling requirement and continue a lightly regulated system of GMO oversight. This is in contrast to the European model which requires labelling of all GM products.

Figure 4 – The U.S. & EU Regulatory Processes (Lau, 2015)

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PART 3 – POLICY POSITIONS ACROSS EUROPE

GMO cultivation in the EU is limited partly because of concerns expressed by stakeholders about adverse effects on the environment, farmlands, and biodiversity. In a recent article on GM policy in Europe, Stuart Smyth and Peter Phillips (2014) argue that:

‘The EU has moved from science-based regulation as the underpinning of international trade to the use of socio-economic considerations in decision-making, by increasingly incorporating the principles of the CPB into regulatory frameworks and especially into the product approval process. EFSA’s science-based risk assessments of GM crop variety applications have been increasingly rejected by the politics within the European Commission.’

Political considerations and divergent interpretations of scientific studies drive the EU’s GM debate and largely inform Member States’ stances on the issue.

Policy on GMOs in Scotland

The Scottish Government has devolved competence over GMO policy in Scotland but is required to act in accordance with European legislation. Thus, Scotland recently announced (Scottish Government, 2015) that it would ‘opt-out’ of GM cultivation, citing that: ‘The amendment to Directive 2001/18/EC… allows Member States and Devolved Administrations to restrict or ban the cultivation of genetically modified organisms (GMOs) within their territory.’ In the new Directive (Directive 2015/412/EU), Article 26b permits Member States to request notifiers to apply geographical restrictions to any (re-)authorisation notification, i.e. to exclude all or part of that Member State’s territory from the scope of the notification. Therefore, whilst any requests or opt-outs may relate to regions or localities within a Member State, rather than the entirety of the State, the provision leaves the decision in the hands of the Member State rather than individual regions (even where they hold legislative competence nationally). Scotland (as the devolved power) requires the UK (as the EU Member State) to make the request. The ‘Concordat on the Implementation of Directive 2001/18/EC and Regulation 1946/2003/EC’ (‘The Concordat’), an agreement reached between the UK Government and devolved powers in 1999 with regards to GMOs, sets out the broad understanding of the principles and practices that underlie relations between the UK Government and the devolved administrations, and ensured that Scotland’s recent announcement was relayed to the EU by the 3 October 2015 deadline.

Debate following the Scottish Government Announcement

The Scottish Government decision sparked debate in both civic society and in Parliament. An open letter opposing the decision was sent to the Cabinet Secretary for Rural Affairs, Food and the Environment, Richard Lochhead MSP on 17 August 2015, signed on behalf of 28 universities, institutes, learned societies, and a number of other institutions. Sent by the organisation ‘Sense about Science’, the letter (2015) claims that the proposal ‘to ban cultivation of all genetically modified crops, regardless of current or future scientific evidence about the benefits of particular

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applications, risks constraining Scotland's contribution to research and leaving Scotland without access to agricultural innovations which are making farming more sustainable elsewhere in the world.’ In response, the Cabinet Secretary (14 Sept. 2015) addressed the Government’s position in an opinion sent to The Herald (2015):

‘The Scottish Government has always been clear about the reasons behind our GM policy. Recent changes in the European Union broke the link between scientific assessment of the safety of a GM crop – which is undertaken on behalf of EU countries by the EFSA – and the decision whether or not a GM crop may be grown in a certain area or region. Our decision was not one based on scientific considerations but, rather, one which took into account the wider ramifications that GM crops might have for Scotland… The announcement last week that turnover for our booming food and drink sector has hit a record high of £14.3 billion validates the Scottish Government’s position. Scotland’s global reputation for fresh, tasty and naturally high quality premium produce is key to this phenomenal success and it would be foolish to put that at risk.’

In another open letter to the Cabinet Secretary (GM Watch, 2015), a group of 30 scientists and experts from universities and research institutes across the world, sought to ‘congratulate’ the Scottish Government on its drive to ‘GM-free status.’ Moreover, when openly criticised for the GM decision in the chamber, First Minister Nicola Sturgeon MSP emphasised that the decision would not affect research in Scotland:

‘The types of GM science that are undertaken in many of our universities and research institutes are unaffected by the decision, which relates only to the potential cultivation of EU-authorised GM crops in the open environment. We have taken that decision because we value the clean, green environment that supports our food and drink sector. That is the Scottish Government’s position’ (Scottish Parliament Official Report, 2015a)

The Cabinet Secretary reinforced this viewpoint in a written reply to a parliamentary question from Drew Smith MSP (PQ, 2015). In the reply, the Cabinet Secretary stated that GM crops could ‘threaten the brand that underpins Scotland's reputation for producing high quality and natural foods and damage Scotland's image as a land of food and drink.’ Maintaining this image is a key facet of the Scottish Government’s GM decision. Alongside the £14.3 billion figure quoted by the Cabinet Sectary above, Scotland Food and Drink, a non-profit organisation supported by the Scottish Government, have set an industry target of £16.5 billion by 2017 (Scotland Food & Drink Report, 2015a). Moreover, in partnership with the Scottish Government, VisitScotland, EventScotland and Think Local, 2015 has been labelled as the ‘Year of Food and Drink.’ According to Scotland Food & Drink (2015b), the aim of the Year is to ‘mark, highlight and promote Scotland’s abundant, quality produce to our people and visitors, demonstrating that we are a destination for delicious food and drink and its key role in our economic growth and cultural development.’ Despite this, however, Scotland Food & Drink chief executive James Withers recently told The Sunday Herald (2015) newspaper that the decision to ban GM was made without any prior consultation with

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the food industry. More generally, the reaction of stakeholders to this announcement has been very mixed. The announcement of the Scottish Government position has been backed by a number of stakeholders, including the Scottish Crofting Federation, who, together with other civil society organisations, wrote an open letter of support to the Scottish Government:

‘We underline the precautionary principle that the Scottish Government upholds - that the potential risks from GMOs to public health and our environment outweigh any potential benefits of the technology. As stakeholders in Scotland's food system, we recognise the importance of protecting and enhancing Scotland's reputation for good, clean food. We are aware that many of our major export customers have concerns about GM’ (The Ecologist, 2015).9

Alison Johnstone MSP, the Scottish Greens’ food spokesperson, also welcomed the announcement, stating that: ‘Opting out of growing genetically-modified crops is the right move for Scotland. Cultivation of GM crops would harm our environment and our reputation for high quality food and drink’ (Scottish Greens, 2015). Yet the National Farmers Union of Scotland (NFUS, 2015) opposes the move, pointing out that to them ‘rhetoric rather than science’ drives the GM debate. Scott Walker, chief executive of NFUS, said: ‘Other countries are embracing biotechnology where appropriate and we should be open to doing the same here in Scotland. Decisions should be taken on the individual merits of each variety, based on science and determined by whether the variety will deliver overall benefit’ (The Guardian, 2015a). Moreover, the Scottish Government’s former chief scientific advisor, Professor Muffy Calder, warned that the decision could have ‘apocalyptic’ consequences, while some Members of the Scottish Parliament also voiced their dismay (The Scotsman, 2015). Scottish Conservative rural affairs spokesman Alex Fergusson MSP said:

‘Plant and animal breeding and cross breeding has been going on since time immemorial, and GM technology is simply an extension of that science. It has the potential to provide an exciting new future for agriculture – of which the principle purpose must always be to feed an ever-increasing world population… The Scottish Government must realise by making this ill-thought out decision, it is slamming the door on potential scientific advances that could revolutionise the industry’ (Scottish Conservatives, 2015).

The Royal Society of Edinburgh (RSE), one of the signatories of the ‘Sense about Science’ letter, recently released a report (RSE, 2015) looking at the opportunities for GM in Scotland and calling for a ‘rational debate’ on the issue. The RSE’s report voices the organisation’s ‘disappointment’ that the Scottish Government’s announcement was ‘presumptive’ in ‘assuming hostile public opinion’ and bemoans

9 As well as the Scottish Crofting Federation, signatories on the letter include Nourish Scotland,

Friends of the Earth Scotland, Global Justice Now, Unite, Common Good Food, CommonWeal,

Compassion in World Farming, and Scotland's Allotments and Gardens Society.

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the fact that no scientific consultation was taken during the decision making process. This elicited an exchange at First Ministers Questions on GM crops in the Scottish Parliament chamber on 24 September 2015 as Ruth Davidson MSP and the First Minister contested the merits of the announcement (Scottish Parliament Official Report, 2015b).

The Political Context in the rest of the UK

Recently joining Scotland in taking advantage of the ‘opt-out’ provision, Northern Ireland's Environment Minister, Mark H Durkan, announced on September 21 (Northern Ireland Executive, 2015), that he was prohibiting the cultivation of GM crops in Northern Ireland. In reaching a similar conclusion to Scotland, the Minister explained the rationale behind the decision: ‘…we are rightly proud of our natural environment and rich biodiversity. We are perceived internationally to have a clean and green image. I am concerned that the growing of GM crops, which I acknowledge is controversial, could potentially damage that image.’ Likewise, Wales has also requested a geographical exclusion order under EU regulations for GM cultivation. A policy that enjoys cross-party support, Wales’ stance is ‘to maintain a restrictive and precautionary approach to GM crop cultivation’ (Welsh Government, 2015). Wales’ deputy Minister for Food and Farming, Rebecca Evans, expanded: ‘These new rules proposed by the European Commission provide Wales with the necessary tools to maintain our cautionary approach by allowing us to control the future cultivation of GM crops in Wales. It will allow us to protect the significant investment we have made in our organic sector and safeguard the agricultural land in Wales that is managed under voluntary agri-environment schemes’ (Farmers Weekly, 2015). On the other hand, the UK Government is open to GM products if scientific evidence indicates that people and the environment will not be harmed. The most recent policy statement (UK Government, 2015) acknowledges that while maintaining an ‘independent’ and ‘robust’ evaluation system that assesses the safety of GM products on a case-by-case basis, the UK government supports ‘farmers having access to developments in new technology and being able to choose whether or not to adopt them.’ ‘If and when GM crops are grown in England commercially, we [the UK Government] will ensure pragmatic and proportionate measures to segregate these from conventional and organic crops, so that choice can be exercised.’ UK government policy goes on to state that, provided it is used safely, GM foods could be a tool with which to address global food security and climate change, and help with sustainable agricultural protection.10 While notifying the EU of the geographical exclusions for Scotland, Wales, and Northern Ireland, the UK Government did not include England in the scope of ‘opt-out’ decisions.

Decisions of Other EU Member States

A number of Members States have since followed Scotland’s lead as the first country to announce a ban on GM cultivation, based on the recent EU directive. Germany, Greece, Latvia, and France (which happens to be Europe’s largest grain grower and exporter), are among those ‘opting-out’ of GM cultivation and seeking geographical

10

Section also informed by personal communication with Defra

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exclusion from any approved GM crop across the EU (see Map 3). All told, the Guardian (2015b) pointed out that ‘around two-thirds of the EU’s population – and of its arable land – will be GM-free.’ Described by some as a ‘green-wave’ of anti-GMO sentiment sweeping across Europe, Germany, Europe’s largest nation, was one of the first countries to announce its ban after Scotland, citing, according to the Agriculture Ministry, that ‘The German government is clear in that it seeks a nationwide cultivation ban… There’s resistance from all sides, from the public to the farmers’ (Bloomberg, 2015). These opt-outs apply not only to Monsanto's MON810, but also to seven varieties of GM maize currently awaiting approval by the European Commission.11 Yet, this is not to say that Europe is in blanket agreement on GM. The UK Government is not alone in its relatively open stance to GM. As demonstrated earlier, countries such as Spain and Portugal already cultivate GM crops, while a number of others chose not to take a stand on the opt-out directive (again, see Map 3). It is clear that Europe is still divided on GM.

PART 4 – PUBLIC OPINION & CONSUMER CHOICE

Public Opinion

Public concern over the use of GM technologies is found at numerous points, though in stark contrast to the use of GM technology in drug development, which has been implemented globally with almost minimal opposition. Indeed, where medicines are concerned, many consumers more readily accept biotechnology as beneficial for their health (e.g. vaccines, medicines with improved treatment potential, or increased safety). The perceived monopolisation of the market by a select few GM companies has raised ethical objections, particularly regarding the practice of patenting GM seeds. For example, ‘saved seed’ (collecting seed from crops to replant the next year) is a tradition stretching back centuries and is an important resource for farming sustainability. But GM seeds are acquired through the payment of a licence fee for the intellectual property, and farmers are required to pay for seeds each year – instead of saving them for the next harvest, because GM crops are modified so that seeds they produce are infertile, meaning farmers cannot save their own seed. This leads to a belief that GM allows corporate control of the food chain by multinational conglomerates. There is also scepticism about the impartiality of many of the industry’s most vocal supporters/critics. Professionals with a career or financial interest in GMOs are much more likely to endorse it than those who have no such interest. The New York Times (2015) recently published an article revealing the extent to which the biotech industry has ‘colluded’ with academics to promote the ‘health and safety of their product.’ Alongside industry funding for research, a major point of contention focuses on the ‘revolving door’ aspect of the GM industry and government regulatory jobs.

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Syngenta has since withdrawn its 2 GM applications so we are left with 5 applications pending.

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Consumer Choice In order to assay consumer tendencies towards GMOs, polls have been conducted to gauge the public’s receptiveness of GM. The most recent Eurobarometer poll (2010) for example, found that, on average, 61% of EU citizens opposed the development of GM foods across the EU. Such data led BASF, a German chemical company, to announce on January 16, 2012, that it no longer made business sense to operate in the EU market. Moving its headquarters from Germany to the US, BASF described the ‘lack of acceptance for [GM] technology in many parts of Europe from the majority of consumers, farmers and politicians,’ as influencing its decision (Politico, 2012). In demonstrating just how close the debate on GM actually is, a recent Ipsos Mori poll (2014) on Public Attitudes to Science found that while more people in the UK believed that the benefits of GM crops were greater than the risks, they were divided only 36% to 28%. Though, in compiling the data of an array of studies, Costa-Font, Gil, & Traill (2008) were able to deduce in their study that in most European countries,

‘…and specifically in Nordic countries, Britain, and Germany, consumers find benefits associated to GM food as insufficient to overcome their associated (perceived) risk. On the other hand, in the US and also in some European countries, such as Spain and Italy, consumers mainly reveal perceptions of risks and benefits associated with GM food, where benefits can potentially outweigh risks.’

Opinions of farmers and consumers towards GM are different. In a survey where UK farmers were asked whether they might consider growing GM crops if licensed by the Government for example, 50% of those currently growing maize said they would consider it, as did 62% of those growing oilseed rape and 63% of those growing sugar beet (Jones & Tranter, 2014). Conversely, the Institute of Grocery Distribution (IGD), who regularly tracks shoppers’ attitudes towards GM food in the UK, found in 2014 that while a majority remained neutral/don’t know, more shoppers opposed GM than supported it (IGD, 2014). That said, the survey results reveal a growing acceptance of GM by some consumers (the proportion slightly or strongly supporting has increased from 14% in 2003 to 20% in 2014):

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Figure 5 – Shopper Attitudes to GM Foods in the UK (IGD, 2014)

The fact that so many chose the neutral/don’t know option is an important point in itself. It is clear that many consumers have yet to form an ultimate opinion on the topic, often citing a lack of information when pushed for a stance. Yet when the survey moved onto safety aspects, the ‘don’t know’ section shrunk, with 57% of shoppers concerned about the safety of GM food. Figure 6 – Shopper Attitudes to Safety of GM Foods in the UK (IGD, 2014)

As well as poll data, the actual behaviour of consumers while shopping is another indicator of public attitudes to GM technology. Some studies (Vecchione et al, 2015) have demonstrated a positive correlation between consumer attitudes towards foods not containing GMOs and purchasing behaviour. A study funded by the European Commission (Costa-Font et al., 2008) found evidence that consumers were generally willing to pay a premium for non-GM food.12 Socio-demographic factors, gender, and

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Conversely, another study funded by the European Commission (KCL, 2008) addressed the question of whether consumers in the EU would buy GM-foods and found that most shoppers do not actively avoid GM-labelled-products. According to the report, ‘responses given by consumers when

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household income all influence the purchasing behaviour of consumers but attitudes towards, and knowledge of GM is generally the most significant predictor of behavioural intention. Indeed, in the US activists often point to the GM industry’s fear that shoppers would choose non-GM products over GM products if mandatory labelling were introduced. Clearly, GM splits opinions, with many arguing that more epidemiological and environmental studies are needed to provide appropriate regulatory comparators to ascertain the impact and/or unintended effects of GMOs. All told, crops should be assessed thoroughly with regard to the technical, ecological, and economic, as well as the social risks posed in different contexts. And with recent advancements in science blurring the lines between GM and non-GM, it is clear that the debate will continue to rage on for some time.

prompted by questionnaires about GM-foods are not a reliable guide to what they do when shopping in grocery stores.’

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ANNEX

Comprehensive List of GM Regulations:

EU Regulations

Directive 2001/18/EC (Deliberate Release)

Directive (EU) 2015/412 (Deliberate Release-possibility to restrict cultivation of GMOs in Member State's territory)

Directive 2009/41/EC (Contained Use)

Regulation 1829/2003 (Food and Feed)

Regulation 1830/2003 (Traceability and Labelling)

Regulation 1946/2003 (Transboundary Movements)

Scottish/UK regulations

The Genetically Modified Organisms (Contained Use) Regulations 2014

The Genetically Modified Organisms (Deliberate Release) (Scotland) Regulations 2002

Environmental Protection Act 1990

Genetically Modified Food (Scotland) Regulations 2004

Genetically Modified Organisms (Traceability and Labelling) (Scotland) Regulations 2004

Genetically Modified Organisms (Transboundary Movements) (Scotland) Regulations 2005

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