March 1996 NOVEL FOODS, OLD TRICKS GRAIN After years of research and investment, the agrobiotech industry has started to bring its genetically modified products to market, and many more are waiting in the wings for regulatory approval. To smooth their path, industry is concentrating its lobbying efforts in two main areas: deregulating the use and release of genetically manipulated organisms (GMOs) and minimising the labelling of its products. Relaxation of such legislation has serious implications for consumers and the environment. Tomatoes have been making the news recently. Not just any old tomatoes, but tomatoes that have been refashioned by scientists to express characteristics that nature never could. In 1994, Calgenes rot-resistant Flavr Savr tomato was the first genetically engineered crop to reach the supermarket shelves. Since then, Zeneca's tomato paste (made from genetically engineered processing-friendly, squishy tomatoes) and Monsanto's genetically engineered slow ripening tomatoes have been approved in the UK and the US respectively. Many other products have been also been approved for commercial use in at least one country: Ciba-Geigy's Bt-corn, Plant Genetic Systems' rapeseed resistant to a Hoechsts chemical herbicide, and Monsanto's soybeans resistant to the companys herbicide, Roundup. In the accompanying table we list genetically engineered crops that are ready to hit the marketplace. The agrobiotech industry anticipates that its years of research and development requiring heavy investments and negative balance sheets will soon be over. Biotech companies and their supporting multinational seed and agrochemical corporations are ready to harvest the fruits of their labours. Their public relations departments are busy generating public acceptance and a perceived need for their products. Reports and editorials are paving the way. The promises of the biotech revolution (environmentally-friendly agriculture, pesticide- and pest-free crops, higher nutritious content, high-yielding and stress-resistant plants that will help to eradicate hunger in the world) are repeated once again. The negative impacts are often ignored, dismissed or exaggerated beyond credibility, while industry loudly reassures the public that biosafety legislation will contain any risks that may exist. Meanwhile, behind the scenes, industry is doing its best to dismantle that very legislation, which it perceives as one of the main obstacles to the steady expansion of their products and profits. The other major obstacle is consumer concerns about the health and environmental impacts of genetically modified food. The first obstacle is systematically being dismantled by industrys successful lobbying efforts, which are steadily weakening existing regulations concerning the handling and release of GMOs. With respect to the second, pressure is being directed towards preventing people from knowing when they are consuming foods which are the products of genetic engineering. Lowering biosafety regulatory thresholds The US regulatory authorities have been very receptive to industrys attempts at deregulation. In August 1995, the US Department of Agriculture (USDA) issued a proposal to deregulate the field testing of genetically engineered crops. If adopted, this will mean that 99% of all such field tests in the US will be exempt from risk assessments, according to the USDA itself. The Union of Concerned Scientists (UCS) warns that the USDA will no longer evaluate the risks of gene flow from crops to wild relatives, nor those of most viral genes added to crops for virus resistance. Companies will no longer be required to submit reports on completed field trials, and the public will be left without access to data to assess the safety of field testing. The proposal would also expedite the approval of crop varieties that are closely related to previously commercialised varieties, which, according to UCS, "potentially opens a huge loophole that may allow companies to avoid assessments of risky crops". Meanwhile, the USDA calculates that these changes will save companies some 95% of their administrative costs for field testing. The proposal was open for comments until October 1995, and the final decision has yet to be taken. Influenced by the US example and under pressure from industry, deregulation is also moving fast in the European Union (EU). JÃ¼rgen Drews, president of international R&D of Hoffmann-La Roche and chairman of SAGB, the pan-European biotech industry lobby organisation, recently wrote a letter to the President of the European Commission (EC), expressing concern that current safety legislation concerning the handling of GMOs is compromising the competitiveness of the European biotech industry against its American and Japanese counterparts. GENETICALLY ENGINEERED CROPS REACHING THE MARKET COMPANY PRODUCT TRADE BRAND NEW TRAIT NEW GENES FROM AGRITOPE Tomato Altered ripening ? ASGROW Squash Freedom II Resistance to viruses Viruses BEJO ZADEN Chicory Resistance to herbicide ? CALGENE Oilseed rape Laurical High lauric acid California bay, turnip rape, bacteria, virus CALGENE Tomato Flavr Savr Delayed ripening Tomato, bacteria, virus CIBA-GEIGY Corn Maximiser Resistance to European Corn Borer Bacillus thuringiensis DELKAB Corn Resistance to herbicide glufosinate Bacteria, virus DNA PLANT TECHNOLOGY Tomato Endless Summer Delayed ripening Tomato, bacteria, virus DU PONT Cotton Resistant to herbicide sulfonylurca Tobacco, bacteria HOECHST/AGREVO Corn Liberty link Resistance to herbicide glufosinate Bacteria, virus MONSANTO Corn Resistant to corn borer Bacillus thuringiensis MONSANTO Cotton Bollgard Resistant to boll-worms and budworm Bacillus thuringiensis MONSANTO Potato NewLeafe Resistance to Colorado potato beetle Bacillus thuringiensis MONSANTO Soybean Roundup Ready Resistant to herbicide glyphosphate Petunia, soybean, bacteria, viruses MONSANTO Tomato Thicker skin, slow ripening Tomato, bacteria, viruses MYCOGEN Corn NaturGard Resistance to corn borer Bacillus thuringiensis PLANT GENETIC SYSTEMS Oilseed rape Resistance to herbicide glufosinate Not available ZENECA/PETOSEED Tomato Thicker skin, altered pectin Tomato, bacteria, virus SOURCES: Union of Concerned Scientists and Gene Exchange Industrial lobbyists are making their mark in the European Commission. The 1990 directive on the contained use of genetically modified micro-organisms was dramatically weakened in December 1995, as result of an outrageous political move on the part of the Commissioners of Industry and Research, who completely by-passed the amended proposal put forward by the Environment Commissioner and imposed a much weaker one. The same Commission is expected to deliver a proposal for the amendment of the directive on the deliberate release of GMOs in late March or April 1996, which is likely to be subjected to a similar fate. Drews argues that the procedures for commercial approval should be "constantly simplified", as is happening in the US. He also says that "in the light of experience" industry considers that there is no inherent danger in releasing "new" genes into the environment. But, as the Greens in the European Parliament (EP) argue, how can deregulation be possible across the EU when few countries have experience in GMO field testing or adequate regulatory systems in place? Industrys experience of field testing is extremely limited. Its trials involve small areas, short time frames, few transgenes per plant, and the destruction of seeds and other reproductive organs (to limit the spread of genes). These tests do not provide an accurate model of the conditions characterising the commercial use of these crops, and do not address crucial ecological and evolutionary questions (see box). Nevertheless, it is experiments such as these that have provided the "evidence" of the lack of significant biosafety problems which have led to a relaxation of US and European legislation on GMO releases. Meanwhile, a growing body of evidence from fields trials indicates that the impact of the introduction of GMOs may be more significant than was previously thought. For example, in a recent experiment in Scotland with genetically engineered oilseed rape, which used much larger fields than have been used in most trials, pollen escaped and fertilised plants up to 8 km away. ECOLOGICAL RISKS INVOLVED IN MASSIVE RELEASE OF TRANSGENIC CROPS ELEMENT OF RISK LIKELY DIRECT EFFECTS LIKELY AND POSSIBLE INDIRECT EFFECTS Hybridisation with free living populations of the same or related species. Wild populations both the crop and related species are "ecologically released". The hybridised plants become weedy both in fields and in non agricultural areas, including protected areas. Increased genetic erosion of wild crops and relatives because of competitive exclusion. Increased genetic erosion of unrelated rare species because of competitive exclusion. Resistance to herbicides Transgenic resistance of wild populations of the same or related species. Increased selection of herbicide-resistant weeds. More frequent crop rotations on soil polluted with hazardous herbicides will be possible. Transgenic crops themselves become weeds. Resistance to insects Generation of resistance in target insect populations. Impact on non-target invertebrate species (i.e. earthworms) and insects: predators, pollinators and parasitoids. Impact on rare insect taxa. Impact on vertebrate predators (i.e. birds). Co-ocurring Insect species become new pests. Resistance to viruses Creation of new viral types by transencapsidation and recombination. Uncertain SOURCE: GRAIN, from "Ecological Risks of Cultivating Transgenic Plants" and other sources These "hidden" aspects of the agricultural biotechnological promise, along with concerns about the impact of genetically modified food on human health, have already generated public resistance to the use of genetic engineering in food production. To counter this, industry has developed a second front to its lobbying efforts: preventing the public from knowing the truth about their products. Novel foods: keeping the public in the dark? The new biotechnologies are creating a whole range of new foods. These novel foods include foods produced by the chemical or physical modification of existing foods, foods modified by genetically engineered micro-organisms, and genetically engineered plants, animals and micro-organisms which are themselves foods. Novel foods that have already reached the supermarket shelves or are about to do it include cheddar cheese containing a genetically engineered form of the enzyme chymosin, beer with a high alcohol content conferred by a genetically modified yeast, oil derived from herbicide-resistant genetically modified oilseed rape and soybean, pest-resistant corn, and a genetically engineered tomato which ripens more slowly than normal ones. Although genetically modified crops are only just beginning to reach the market, other novel foods made with the assistance of genetically engineered enzymes, hormones and other chemicals have already established a market niche. The public is often unaware of the methods used to create these products. The emergence of these novel foods has required new legislation to regulate their use. In theory this offers an opportunity to create a framework to make the activities of the biotechnology industry more transparent and accountable to the public. But it may do the opposite. Industry is working hard to ensure that the legislation creates a tool for it to conceal the real nature of its products. Among the most controversial aspects of novel foods regulation is the issue of labelling. Consumer organisations world-wide (including the European Consumers' Organisation and Consumers International) have been demanding the compulsory labelling of all products of genetic engineering. However, the EU Industry Commissioner reflected industrys position when he stated that "information that is not useful to the consumer should not be included on the label", and that "informing consumers that a product was genetically modified makes no sense if the composition, nutritional value or flavour of the end product is no different from a traditional food". The US policy is founded on these principles. Although no formal legislation has been passed on the labelling of novel foods, in practice the US Food and Drug Administration (FDA) considers it "inappropriate" to label plants that have been modified in a way that does not significantly change their composition. This "significant change" is analysed only in terms of nutritional content and organoleptic characteristics (properties that can be apprehended by the senses such as taste, smell and appearance). This excludes from labelling any plants genetically engineered for agronomic purposes, such as making them resistant to stress, herbicides or/and pests, which include many with the highest potential to cause environmental disruption. It is taking the European Union many years to agree on Novel Foods legislation. In March the Parliament approved a proposal which was largely based on a "Common Position" developed by the European Commission and the Council of Ministers. This text was heavily biased toward industry interests (see box), and the Parliament adopted a number of amendments to it. For example, the original text excluded from labelling requirements food from crops genetically engineered solely for its agricultural characteristics, and the parliament wants these also labelled. It remains to be seen what will happen to the few amendments that survived the Parliamentary discussions. The Commission and the Council are not obligated to accept the Parliament's amendments, and can opt for another discussion round to further weaken the text. It can also decide to withdraw the regulation. NOVEL FOODS PING-PONG June 1994: After many coming and goings between the European Commission and Council of Ministers to the European Parliament, a 13th draft is on the table for discussion. October 1995: The European Commission and the Council of Ministers reach a "Common Position" Text on the Directive, which is strongly biased towards industry positions. February 1996: The Environmental Committee of the European Parliament ammends the Common Position Text turning it into a comprehensive piece of legislation. March 1996: The Plenary of the European Parliament votes in favour of the Common Position Text and largely ignores the amendments proposed by its Environmental Committee, accepting only 7 of them. Next? The Council can either adopt EP's remaining amendments, and thus the regulation would be adopted, or refuse them. In this case, a third compromise would have to be reached both within the Council and the European Parliament; otherwise, the regulation would be withdrawn. If the EPs amendments are disregarded, of all the novel foods described above, only Calgenes slow-ripening tomato would have to be labelled. Such an outcome would be completely unacceptable to consumer associations which have repeatedly called for compulsory labelling of all novel foods and food ingredients, so that consumers are given the liberty to choose for themselves. However, a decision in favour of industry and against consumers will come as no surprise, in the light of the recent behaviour of European policy makers over the issuance of permits for commercialisation. The case of Plant Genetic Systems (PGS) herbicide-resistant oilseed rape has been, at the very least, didactic. HOLES IN EU NOVEL FOOD The "Common Position" text, as presented to the European Parliament by the European Commission and the Council of Ministers, is full of holes and shortcoming. Below we highlight four areas Scope: Additives and extraction solvents are excluded even though there is no specific environmental or health risk assessment procedure in the separate legislation which theoretically regulates such items. Processing agents, including enzymes will also be excluded. In practice, this would exclude of the scope of the regulation most of existing or projected gene foods. Procedures: There is no requirement for a new safety assessment related to the commercial scale of a product release and many products will be simply notified to the competent authorities , rather than being scrutinised prior to consent. Transparency: There is no requirement for public information on what products have been notified or approved. There will therefore no publicly accessible register of new gene foods. Labelling: With the exception of life GMOs in foodstuffs, the majority of genetically modified products will simply not require labelling. Changes to agronomic characteristics are excluded, as are other modifications if they do not lead to any substantial change in the apparent composition of the end product. (This last point has been challenged by an amendment of the Parliament) SOURCE: European NGO- Network on Genetic Engineering (GENET) Oilseed rape: industry jams its foot in the door... In 1994, PGS applied in the UK to commercialise as breeding material its oilseed rape (Brassica napus), which is genetically modified to be resistant to Hoechsts chemical herbicide, Basta. The EU directive on the deliberate release of GMOs requires approval from the Council of Ministers. If the majority of member vote for approval, then all EU countries must allow the commercialisation of the GMO. Since this was the first application for the large-scale marketing of a transgenic plants, and would set a precedent for other applications, the PGS claim was a battle field for all interested parties. Linda Bullard from the Greens in the European Parliament reported that Member States which approved the rapeseed did so on condition that the seed bags were clearly labelled as genetically engineered. But, by the time authorisation reached the Commission, this requirement had mysteriously disappeared. An attempt by the Environment Commissioner Ritt Bjerregaard to reinstate the word "modified" in the labelling failed. In February 1995, the EC authorised the use of PGS oil seed rape. The conditions attached were that it be used only for breeding purposes, and that it be clearly labelled accordingly, along with an indicator of its resistance to a specific class of herbicides. Labelling of its genetically modified nature itself, was not required. The consequences of this decision are immense. In the first place, the decision for the rapeseeds commercial release was taken in a legal vacuum, requiring no environmental risk assessment of the increased herbicide use that would result from the planting of a herbicide-resistant crop. This move sets a precedent for other approvals without risk assessments. In this particular case, the EU is really playing with fire, given that Mediterranean Europe is the centre of origin of oilseed rape, as it is for the whole of the Brassica family. Many of its wild relatives are known to be "weedy", which means that they grow vigorously and enthusiastically in many environments and often present serious threats to cultivated crops. This means that there is a high risk of the novel genes in PGS oilseed rape spreading widely, both through the propagation of the genetically engineered plant itself and transfer of the novel genes to its wild relatives. As the novel characteristic is tolerance to a herbicide, one could expect that soon a lot of weeds which the herbicide is meant to kill will also become tolerant. In fact, scientific field experiments in Denmark already provided strong evidence that this is exactly what occurs. It would have been difficult for the European Commission to find a worse plant family (and a worse characteristic) to start experimenting with the commercialisation of genetically engineered plants. In any case, the European Commission did not wait for a decision on the Novel Foods Regulation before approving PGS oilseed rape. The Commission is in favour to drop labelling requirement for "only" agronomic features, such as herbicide tolerance. However, this position is highly questionable as in France a second commercialisation permit has already been applied for PGS oilseed rape to be used as feed and food. ... In order to open it for soybeans In 1995, the US requested permission to export to Europe Monsanto's Roundup-Ready Soybean (RRS), which is genetically engineered to resist the companys own herbicide Roundup. The application was for all kind of uses as a product, but not for planting. Its approval was delayed because Denmark, Sweden and Austria insisted on labelling the soybeans as "genetically modified". This prompted a very strong reaction from US trade representatives, who argued that before long it would be impossible to distinguish RRS from ordinary soybeans, as they would end up in the same bags or containers. Since they expect RRS soon to be approved in other countries such as Argentina, by which time "all soybean shipments, from the US or anywhere else, can be assumed to include RRS". The US representatives note that there is much more at stake than just the $1.6 billion market for soybeans exported to the EU. The entire agricultural trade to the EC could be affected in the long run. The US could threaten with trade sanctions if the EU would oppose the entry of Monsanto's soybean. Even attaching a statement to the shipments saying that the beans may include RRS "is not acceptable to US trade". The Commission's decision on PGS' oilseed rape compromised its ability to insist on the labelling of Monsanto's soybean. It could have delayed the decision on the RRS case until the Regulation of Novel Foods came into force, but instead it cleared the way for Monsanto's soybean on March 15th. Choosing to make the decision before the Novel Foods Regulation was approved demonstrates the Commissions lack of respect for the EPs wishes to extend labelling to the products of plants genetically engineered for agronomic purposes. First engineered rapeseed only for breeding purposes, now soybean for food and feed....the European Commission is ignoring its own procedures and laws under development to give in to the pressures of an industry interested in a wide opened European door to the large-scale introduction and commercialisation of genetically modified crops. Codex alimentarius: the immediate battle Whilst the EU is allowing for a precedent for their international trade on unlabelled GMOs, the USA are busy on their diplomatic efforts to ensure a global framework that will ensure that genetically engineered foods go unnoticed by the public. Their main objective now is the Codex Alimentarius meeting the 15 of May in Ottawa, Canada. The Codex Alimentarius is a joint committee between the FAO and the World Health Organisation (WHO) of little significance until it became the World Trade Organisation's (WTO) chosen authority for world standards on all food issues. This means that any standard that a given country may implement which is not in line with the maximum standards approved by the code may be accused of putting up technical barriers to trade. One and a half year ago, the US submitted a paper where it recurred to the industry's arguments not only to avoid the compulsory labelling of genetically modified foods, but also for preventing the use of the expression "genetically engineered" under any circumstance. The proposal, if adopted, would prevent governments from labelling genetically engineered foods. This would mean that once a GMO had obtained permission for commercialisation within a given country, or for international trade, in many cases it would not be possible anymore to distinguish among normal and genetically modified products. This would undermine any other country's biosafety efforts as the GMOs would enter the country unnoticed through the normal trade channels. In this regard, the Norwegian Food Control Authority has written a letter to the Codex Commission expressing "... reservations to some of the statements and conclusions in the US document as regards the consequences of recombinant DNA techniques in food production" and that "... all food products and food ingredients containing GMOs in any form, or produced by genetic technology, shall be labelled as such, whether or not the product has different properties or characteristics compared to conventional food". Why wait for a biosafety protocol? In its confrontation with the European Union, and specifically with Denmark in the soybean case, the US has made clear its position on the trade of genetically engineered plants. It assumes that if a product has successfully satisfied domestic environmental, health and agronomic standards, there is no scientific ground for its lack of approval in other countries, and any measure that these countries take that go beyond US requirements (such as demanding the labelling of GMOs) constitutes a trade barrier. By taking this hardline approach, the US trade representatives and the industry they so enthusiastically represent ignore the deep concerns about the environmental, social, economic, and ethical implications of genetic engineering expressed in Art.19 (3) of the Convention on Biological Diversity. These concerns resulted in the decision of COP II last November in Jakarta to establish an open-ended working group to commence work "as a matter of urgency" to develop "a negotiation process to develop in the field of safe transfer, handling and use of living modified organisms, a protocol on biosafety, specifically focusing on transboundary transfer" of GMOs. This decision was a major victory for developing countries over the US and the EU, which had strongly opposed any internationally binding regulatory framework for the transfer, handling and use of GMOs since the Convention was signed in 1992. The path the US seems to have chosen to undermine such a protocol is to make it redundant through a policy of "fait accompli" and taking advantage of the current legal vacuum to expand international trade for genetically engineered organisms using existing commercial mechanisms. If the US gains export approval for the genetically modified crops it has authorised for commercial use at home, and if it succeeds in blocking labelling requirements, there is no way anyone in the world can tell which agricultural products, crops or seeds in agricultural trade are genetically engineered and which one are not. By the time the biosafety protocol is agreed to, it might be impossible to figure out how to implement it as the GMOs -- "subject matter" of the protocol -- are effectively mixed up with, and hidden amongst, their more natural brothers and sisters in international trade. References: * Mike Ward, "Another push to revise Eurobiotech directives", Bio/Technology, Vol. 14, February 1996, pag. 133. * The Union of Concerned Scientists, "A Public Voice on Biotechnology and Agriculture", Gene Exchange, Vol 6, N 2&3, December 1995. * Debora MacKenzie, "Trouble in the wind over altered soybeans", New Scientist, 2 December 1995, pag. 12 * The Splice of Life , Monthly Bulletin of The Genetics Forum, several issues. * A. A. Snow and P. Moran-Palma, Ecological risks of cultivating transgenic plants, Ohio State University, 1995. * P. Kareiva, Parker I, Environmental Risks of Genetically Engineered Organisms and Key Regulatory Issues, Greenpeace International, 1994. * Biosafety Scientific Findings and the Need for a Protocol. An Independent Expert Report prepared for the Biodiversity Convention, November 1995.