Access to Research - The Seeds of Thought, the Wisdom of Tradition

Access to patented seed for research and development has been very much in the news of late. Of course, it is not the patent necessarily rendering a product inaccessible for research, but the agreements licensing the seed.

27 representatives of the research community and industry met in Ames, Iowa, 30 June 2009, to consider the issues surrounding access to research in the seed industry. The meeting generated discussion on a set of principles to support public sector research on commercial, patented seed products. The final version of these principles will be presented to the major industry bodies for approval in September (going to the Biotechnology Industry Organization (BIO) 10 September, and to the American Seed Trade Association (ASTA) Executive Committee of the Board of Directors, 17 September). Their implementation by the industry will be of interest.

Although agricultural biotechnology is a significant commercial and innovative bonus to the seed industry, its promise for food security in the developing world is less certain and more socio-political. Wilhelmina Quaye argues that agricultural biotechnology is a socio-cultural issue. Writing in Business Daily, Quaye says in order to improve the use of biotechnology for food security and advancement in developing countries, the communities themselves must be involved in its implementation and development: "it must improve their capacity rather than create ties of dependency." Quaye also notes in Africa in particular the fear over losing traditional ways of farming: "The bottom line is that anyone developing biotechnologies must respond effectively to the intended users' needs and aspirations ... To do this, biotech agendas must consider the socio-cultural realities in Africa."

In the United States, the real significance of traditional agricultural knowledge and practices is starting to be recognised. The US Department of Agriculture (USDA) recently released the 2007 Agricultural Census, which is the first to count all individual Native American farmers on reservations across the country. Native Americans in Arizona, for instance, have been found to operate more than half that State's farms and ranches. And the numbers are expected to be even higher. Despite efforts to publicise the Census widely, including meeting with tribal leaders to discuss the process, individuals were inevitably missed. Farms are generally smaller than the national average, but nearly the entirety of the Dine reservation is under cultivation or grazing. One Hopi farmer, Richard Kuwunvana (pictured at right), says, "Our family has farmed this land forever. We're part of the corn, and it's part of us."

Going to Seed - More Corporate Drama in the Fields

Following on from the story in "Seeded Players" (18 August 2009), Monsanto is again in the news over alleged anti-competitive behaviour. The New York Times reports today that DuPont and Monsanto are locked in a battle, with DuPont accusing Monsanto of anti-competitive practices, while Monsanto has retaliated saying DuPont has committed a "serious breach of business ethics."

In a letter obtained by Reuters, Monsanto chief executive, Hugh Grant (pictured at right), requests DuPont chairman, Charles O. Holliday Jr. (pictured below left), to establish a special committee of DuPont's independent directors to investigate the matter. Meanwhile, Monsanto has released a statement in response to the increased negative press. The claims of corporate misconduct include allegations that DuPont provided financial support to critics of Monsanto and forged documents. But DuPont has stood fast saying that Monsanto has conducted itself anti-competitively to the detriment of farmers and others.

And in May this year, Monsanto sued DuPont for patent infringement; in June DuPont retaliated with a countersuit in antitrust: "This case involves a scheme by Monsanto to monopolize agricultural biotech traits in corn and soybeans, and emerging combinations of such traits." Trait-stacking is where more than one trait (such as herbicide and insect resistance) is transferred to a crop, and so more than one gene. Cross-breeding of GM plants can achieve this as well as genetic engineering. The litigation follows a breakdown in a licensing arrangement between the two companies. DuPont claims it was entitled to combine the traits from Optimum GAT (DuPont) and Roundup Ready (Monsanto) under the terms of its licence. However, Monsanto argues that this is infringement of its patent and that "DuPont’s unauthorized use of our technology and patents is simply unacceptable."

However, the US Department of Justice Antitrust Division appears to have a different position. Indeed, investigations into several recent mergers in the industry have required significant divestitures, including that required of Monsanto and Delta & Pine Land, where a significant seed company and other assets had to be divested before the companies could proceed with their merger. The companies were also required to amend licensing agreements to respond to concerns with trait-stacking. Philip J Weiser, the Deputy Assistant Attorney-General, explains, "because DPL had had a license allowing it to "stack" a rival's trait with a Monsanto trait, Monsanto was also required to amend certain terms in its current trait license agreements with other cottonseed companies to allow them, without penalty, to stack non-Monsanto traits with Monsanto traits. As a result, producers of genetically modified traits gained greater ability to work with these seed companies."

Notably, the US Department of Agriculture and the US Department of Justice has announced that they will investigate antitrust concerns in the seed industry through a series of public workshops in 2010. In an address to the Organization for Competitive Markets two weeks ago, Weiser said, "Over the last twenty years, changes in technology and the marketplace have revolutionized agriculture markets, producing some substantial efficiencies as well as concerns about concentration. Notably, farmers today increasingly turn to patented biotechnology ... At the same time, this technological revolution and accompanying market developments have facilitated the emergence of large firms that produce these products, along with challenges for new firms to enter the market."

A lawyer for DuPont, Donald L Flexner, spoke to Reuters, "This is not just a DuPont problem. This is a competition problem. They've gained illegal monopoly power."

Seeded Players - Corporate Control in Agricultural Research

Genetic modification is not infrequently referred to as the future for food security and agricultural sustainability in developing countries. This alone is perhaps a controversial statement and many would take issue - for instance, questions of environmental security and loss of agricultural biodiversity are just some of the major questions raised.

But rather crucially, apart from debates over the nature of the technology, there must be access to that technology, not only for its immediate application but also for its ongoing development and improvement. This is a major issue raised in a recent editorial in Scientific American. Agritech companies like Monsanto and Syngenta are regularly requiring those purchasing their seed to contract out of any research or experimental use exemption that might be provided in patent law and other areas of intellectual property law. Such an exemption (often referred to as the experimental-use defence) allows for research on a patented invention in order to continue to the cycle of innovation. In other words, research conducted upon a patented invention is exempted from infringement. Indeed, this is perhaps one of the fundamental and historical premises of patent law - that is, to disclose an invention in order to acquire a monopoly. It may be argued by some that this is a legitimate exploitation of the monopoly, however such contractual restrictions may persist well beyond the life of a patent, thus compromising the supposed calculation of time needed to balance the costs of research and development and the public benefit of access to innovation. Thus, if such an agreement can override exceptions for research and become a genuine and explicit obstacle to independent research, then the notion of "user rights" sometimes applied to exceptions in patent law and other areas of intellectual property becomes somewhat problematic, if not specious. But what of the rights of purchasers of seed?

Thus, it is not an issue with patent law per se, but an issue of contract law. If the exception is not to be compromised, the relevant legislation must preclude a contractual condition having effect. But this is an issue that is not necessarily addressed in the applicable legislation, not only in the US but also in the UK and elsewhere in Europe. Similarly, many developing countries have introduced patent regimes that neglect this protection. Nevertheless, in Europe the rights of the user with respect to research conducted upon seeds may indeed be less ambiguous. For instance, in relation to plant variety rights, Switzerland has implemented recently a separate defence to prevent the practice of contracting out of the research exception (Article 8), restricted of course to plant variety aspects. Many have recommended that this sort of protection should be harmonised throughout Europe (and indeed internationally).

According to Scientific American, the agreements deployed by Monsanto and others "have explicitly forbidden the use of the seeds for any independent research. Under the threat of litigation, scientists cannot test a seed to explore the different conditions under which it thrives or fails ... And perhaps most important, they cannot examine whether the genetically modified crops lead to unintended environmental side effects." As the article explains, research is still published, but only that research approved by the company itself, completely disabling the intellectual freedom of scientific research and perhaps also the objectivity upon which scientific knowledge bases its import.

Monsanto strikes back - Company takes action against the ban of its transgenic maize by the German government

After last week´s sowing ban of MON 180, a genetically modified maize strain by the German Federal Minister of Agriculture, Ilse Aigner ("Patenting lives" reported), the patent holder Monsanto launched a legal action against this decision yesterday. A representative of Monsanto stated that the ban was contradictory and not in accordance with EU-rules. Hence, along with filing an action at the administrative court of Braunschweig, Monsanto is also seeking injunctive relief by the court. The haste in which these steps are taken is grounded on the fact that maize would need to be sown in May. According to Monasanto´s speaker the company is expecting a decision by the court by mid May.

MON 180 is genetically modified strain of maize which includes a gene from the bacillus thuringiensis and produces a poison which repels the parasitic larvae of the European Corn borer, a butterfly. By declaring the sowing ban, Ms Aigner applied the Safeguard Clause by which the competent authority may suspend the permission to dispose genetically altered organisms if new or additional information becomes available which may lead to a new risk assessment. The Minister based her decision on new studies which apparently have provided reasonable evidence that the genetically modified strain of maize would present a hazard to the environment - specifically for butterflies, lady birds and creature od the water.

Meanwhile, evidence is given that the German Federal Government has not yet reached a common consensus on its position on green genetical engineering. The Federal Minister of Education and Research, Annette Schavan, is critizising her colleague´s decision to mandate a sowing ban on MON 180. Ms. Schavan refers to green genetic engineering as one of the technologies of the future. Additionally she announced that fundings for such technologies will be expanded.

The Minister has announced that she is scheduling a roundtable in Berlin for the 20th of May on genetical engineering. Hereby all stakeholders would be invited. This would include associations, companies, scientists, non-governmental organisations as well as churches.

The outcome of this roundtable might shed some light on what direction green genetical engineering might be heading to in Germany. This will most certainly have an impact on the wider, namely the European scale.

"Pig patent" and ban of genetically modified crops - The week on biotech patents in Germany

Last week has been a noteworthy one in Germany for biotechnological patents for agricultural applications and has received wide interest, nationally as well as internationally.

Hundreds of farmers, environmentalists and others gathered outside of Munich´s Erhardtstrasse 27, the principal seat of the European Patent Office (EPO) last Wednesday to protest against the so-called „Pig patent“ EP 1651777 B1 (above; 30 pigs "accompanied" the protests). The protesters used this opportunity to file a notice of opposition backed by more than 5000 individuals and more than 50 associations against the patent at the EPO which was granted on the 16th of July 2008 to Newsham Choice Genetics.

The protesters criticized the practice of patenting biological processes since “they have nothing to do with inventions”, as Hubert Weiger, the head of the “Bund Naturschutz Bayern”, an environmental group in Bavaria, stated. The farmers were specifically concerned that the continuing patenting of life stock would seriously aggravate their work by being threatened to pay excessive royalty fees to patentees which usually are multinational corporations in this area.

Initially the patent application contained 30 claims, from which some were related to animals as such, DNA sequences and the test kit. However the examination of the EPO has limited the claims to the screening method, whereas the claims to animals (pigs), the gene sequences and the test kit were rejected. The patent now solely relates to a “breeding method whereby a genetic analysis is carried out to screen for a variation (polymorphism) occurring naturally in some pigs, with a view to identifying those animals suitable for improving pork production and to selection appropriate breeding pairs” (see the press release of the EPO).

The main motto of the protest however was: “Stoppt das Patent auf die arme Sau” which stands for “No patents on the poor pig” and hereby – deliberately or negligently - wishes to render the patent as granted to a patent on pigs as such and hence being misleading. This may be excused due to the fact that this slogan is in its German meaning quite catchy and therefore serves the purpose of the protests. The press release of the EPO however clearly highlights that no patent on animals or gene sequences has been granted. The claims as they were initially filed may have lead to the realisation of such fears as expressed by the protesters but the examiners at the EPO did their job well in applying the rules of the European Patent Convention (EPC).

However, the protests and the hereby created public interest actually do highlight a major deficiency in the IP system and its public perception. It has not been achieved to thoroughly inform society as a whole what IP, and specifically patents is all about, how it operates and where its limitations are. IP has lately had a bad press whereas its benefits are often overseen. This needs to be addressed, bearing in mind its possible negative effects as well as to further explore how these may be overcome.

The press release by the EPO has highlighted in its last paragraph another rather more legal deficiency, which remains a hot topic and warrants determined action by policy makers. The EPO ceases to have jurisdiction totally 9 months after grant and the patent then falls within the jurisdiction of the nominated Member States. Post grant “quality control” by litigation on what should be patented is therefore seriously being hampered. In case of the “pig patent” (18 of the 35 Member States of the European Patent Organisation have been nominated for patent protection) this could mean multiple - and therefore expensive - litigation in all nominated jurisdictions.

Earlier this week the German Federal Minister of Agriculture, Ilse Aigner, has proclaimed a ban on the use of the genetically modified maize strain MON 810, which has been patented by Monsanto. The Minister was not hesitant to state that the decision was not a political one but was solely based on the facts of the case. Therefore, the decision should not be regarded as a fundamental verdict on the use of genetically modified crops in Germany, as Ms. Aigner affirmed. However, the political pressure is constantly growing. The Minister of Environment of the Federal State of Bavaria, Marcus Söder, has expressed the wish to make Germany a „genecrop-free zone“ and has reaffirmed this goal in a speech at Wednesdays´ protests against the “pig patent”. He joins the Ministry of Environment of the Federal State of Hessen, which is about to launch a legislative initiative in the „Bundesrat“, the 2nd chamber of parliament in Germany which consists of representatives from the 16 federal governments, to ban the patenting of newly bred animals and plants. By doing this, the Ministry wishes to call upon the German Federal Government to lobby the European Council and the European Commission to tighten Directive 98/44/EC on the legal protection of biotechnological inventions.

It now remains to be seen what impact the incidents of last week in Germany will have on the patenting of biotechnology. Mon 810 is currently banned in 6 countries of the European Union, including Germany. And it appears that the European Commission is willing to reconsider certain issues on patenting biotechnology.

GM Wars

Last week's announcement that UK Minister for the Environment, Jeff Rooker, was leaving government and Hilary Benn was appointed Secretary of State for Environment, Food and Rural Affairs led many to consider this a strong shift in the politics of GM food in the UK.

At a fringe meeting of the Labour Party Conference in Manchester, the then Minister (pictured at right) was credited with describing opponents of GM as being "... on a messianic mission. It is almost a religion where there isn’t any science base to it." However, a Jay Rayner writing in Sunday's Observer disagrees: "Benn has hardly been a friend of those who have been calling for an end to all GM experiments."

As the April report of the International Assessment of Agricultural Knowledge, Science and Technology for Development (IAASTD) explains there are new liability concerns for farmers with the advent of GM: "Farmers face new liabilities: GM farmers may become liable for adventitious presence if it causes loss of market certification and income to neighboring organic farmers, and conventional farmers may become liable to GM seed producers if transgenes are detected in their crops." In other words, the revolutionary changes in farming include not only influences upon traditional methods but also a revolution in the way in which farmers interact with their resources as patented materials.

As Rayner's article explains, the debate over GM is a debate not only in science, but also in politics and indeed commercial law. As a consumer issue, it is also a competition issue when intellectual property rights might interfere with access not only for consumers but for the farmers themselves. Noting Monsanto's practices of conscientious pursuit of litigation and the creation of seed "technology packages," the article raises the links between competition and intellectual property. Such packages (or bundling) as discussed earlier in Patenting Lives, are considered by the article to "force farms into a dependence on the company." It is this constraint upon ordinary farming practice that is credited with a breakdown in trust, not only for the technology but also for the commercial re-structuring of traditional farming practices.

The Prince and GM: A Potential Bundle of Problems

Except when inundated with repeated stories about medal hauls, it would have been difficult to miss Prince Charles's comments on the GM agriculture debate in the news today.

In an interview with the Daily Telegraph, Prince Charles criticised the terms of the debate: "What we should be talking about is food security, not food production - that is what matters and that is what people will not understand."

Although branded a Luddite by Des Turner, Labour MP and member of the Commons science committee, can this statement really be dismissed out-of-hand? Des Turner stated in the same article: "In some developing countries, where for instance there is a problem with drought or salinity, if you can develop salt or drought-resistant crops there are great benefits." But is it really clear that the transfer of GM technology to this part of the world has really been this efficient or philanthropic? Or is this just the query of a troubled misanthrope?

Far be it from me, an Australian, to unpick a statement of the UK's leading republicanism campaign group, but Republic is reported by the BBC as saying "Prince Charles is quickly making his position as heir to the throne untenable with his meddling in politics." So it's accepted that GM is a political debate, not just one over the grocery trolley?

Perhaps providing greater insight into the issues of the UK debate are the farmers themselves. In an interview broadcast by the BBC today, Michael Hart of the Small and Family Farmers' Alliance set out the real terms of the problem. He explained that when purchasing GM seed, farmers must agree to purchase the "related" products as well, including pesticides, fertiliser and so on. And of course, contrary to 1000s of years in farming traditions around the world, farmers cannot ordinarily save seed from their crops because to do so would usually infringe any patent or plant variety right on the seed they have purchased (because it amounts to keeping a protected product outside the terms of the licence).

Apart from the obvious concern with the obstacles presented by intellectual property rights to traditional farming methods, what should also be considered are the competition concerns with what sounds like licences that are "bundling" products. Bundling is where a company, which is found to be in a dominant position in the market, sells two or more products together as a bundle, charging more for the bundle than for the component parts. Assuming that the seed is not incompatible with every other fertiliser and pesticide on the market, then if a seed company is shown to be dominant within the market, it may well be acting anti-competitively because it causes customers to purchase seeds and related products as a "bundle" from that company only. As Michael Hart put it, it's the "package deal" that is the problem.

The Luddites rioted against the changes of industrialisation when machines threatened their employment and owners could replace artisans with unskilled labour. Today, loss of traditional skills and diversity of knowledge in trades is being lamented. This is not to say that industrialisation was a negative and undesirable process, but the debate is far more complex than a mere comedy in technophobia. The technology perhaps requires some diversity and innovation from all participants and potential beneficiaries in the way in which it is introduced and managed.

In principle, were the Luddites really far wrong?

Poland to Commence Public Consultations on GM Foods

Poland has remained one of the strongest opponents to the introduction of GM foods since the WTO Panel Decision on the approval and marketing of biotech products in the EU. The panel was assembled in response to complaints from the US, Canada and Argentina regarding the de facto moratorium on GM foods.

Nevertheless, opposition to GM persists throughout Europe and Poland in particular has continued to block approvals. In January this year, in the face of the deadline to comply with the Panel Decision, the Commission was expected to take legal action in the ECJ. In April this year, the Commission brought an action against Poland (C165/08) seeking a declaration that Poland was failing to comply with its obligations under Directive 2001/18/EC (on the deliberate release into the environment of genetically modified organisms) by introducing a ban on the movement of genetically-modified seed.

The case is yet to be heard, but meanwhile the Polish government will launch public consultations this week on the draft of new Polish Act on Genetically Modified Organisms, prepared by the Ministry of Environment. Among other things, the new Act introduces criminal penalties for unauthorised introductions and will give authorities the power to establish GMO-free areas, without necessarily imposing a blanket ban. Therefore, the new Act is proposed to take account of European obligations towards the introduction of GMO while at the same time inviting public consultations to take account of the widespread opposition in Poland to the introduction of GMO.

The consultation comes after an earlier survey, conducted for Gazeta Wyborcza by the PBS DGA market research company.

Poland is just one of several European countries opposed to GM, including the United Kingdom. The Environmental News Network reported this week that British opposition to genetically modified crops has increased with nearly all 54 trials over the last 8 years being attacked.

Monsanto's Blooms and Booms

In the current climate of recessions and dwindling sales figures, agricultural companies are enjoying a bumper crop.

According to yesterday's Financial Times, Monsanto is the top seller of corn seeds in US and Brazil, where there is huge demand for Roundup-Ready soybean in particular. The corollary of this is that there was a 25% increase in the volume of herbicide in Brazil last quarter. According to the FT, "High food prices are inspiring some farmers to plant extra acreage and drench valuable plants in even more Roundup than usual to avoid crop losses.

Concerns, from both farmers and from consumers, over the risks of contamination are well-known. Indeed, these risks are part of the background to Europe's stance on GM, the subject of a complaint to the WTO by the US, Canada and Argentina.

One problem for farmers is that classical patent protection of GM seeds can lead to costly infringement proceedings, either through drift or through the usual practices of saving and re-using seed. In other words, the business models of patented seed industries are contrary to established farming practices, as the recent case of Homan McFarling v Monsanto Co shows. On the question of saving seed, McFarling's lawyers argued that patent law does not allow Monsanto to control the natural products (future seeds) from the seeds legitimately purchased and planted by McFarling. But the Supreme Court denied the petition for writ of certiorari and let stand the lower court ruling that second-generation seeds were copies, the saving of which amounted to unlicensed use of the patented invention.

The intrusion of multinational corporations upon local farming practices and communities was the subject of a 25th anniversary Pesticide Action Network (PAN) meeting in Penang, Malaysia in December. At the meeting, food security campaigners raised concerns over the concentration of sales within a small number of MNCs, including Monsanto.

Anil Netto reports that vertical integration, where the corporatisation and propertisation of agriculture dominates all stages in the food production cycle: "from the development of proprietary strains of DN and the sales of seeds to farmers right down to the distribution and retail sales of food products in supermarkets and hypermarkets." Monsanto recently purchased Agroeste Sementes, a Brazilian corn seed company.

Javier Souza Casadinho, Centre for Studies on Appropriate Technologies in Argentina, has been raised concerns that such activity leads to a concentration of market control in those MNCs: "The transnational corporations are buying up companies that have the potential to create added value ... [and] entering into contracts with food producers that will determine what is produced, how it is produced, for whom it is produced and at what price and quality."

In the same article, Antonio A Tujan Jr, International Director of the Ibon Foundation Inc, describes vertical integration as turning the market into a sellers' market, compromising the choice for consumers. This is very similar to the concerns raised in the GM debate in Europe, where the risk of contamination is conceptualised as a serious risk to the conditions for consumer choice of organic, conventional or GM products.

What is at stake is not only the limits of the product but also the limits of the markets that preserve consumer choice. And in technologies in living organisms, those limits are sometimes difficult to define.

GM and Europe

Last Friday the deadline by which the European Communities were to comply with the WTO Panel Decision on the approval and marketing of biotech products, including an end to national bans on GM products otherwise approved by the EU as a whole, came and went.

The de facto moratorium ended in 2004 and so this was not ultimately an issue in the final panel decision. However, with ongoing national bans, the original complainants (United States, Canada and Argentina) may request WTO sanctions for noncompliance.



France is one country in the European Communities that is considering a long term ban following the temporary measure put in place by President Sarkozy last October, which is due to expire next month. French activist and one of the 12 candidates for the French Presidency 2007, Jose Bove (pictured at left), was joined by 15 people on a hunger strike last year to campaign for the year long ban.



Other countries, including Germany, advocate a temporary halt to all authorisations until an effective mechanism is in place for such approvals. Minister of Agriculture, Horst Seehofer, has described the procedure as "questionable" for its failure to take adequate account of public opinion and concerns.

And the European Commission's environment minister, Stavros Dimas (pictured at right at the Climate Change Conference, Bali, December 2007), in plans to reject applications from Syngenta and Pioneer Hi-Bred International to grow GM maize, demonstrates the emphasis in Europe on the ability to exercise the fundamental precautionary principle, presuming the environmental will be damaged without adequate evidence to the contrary (rather than placing the burden on the decision not to introduce). Dimas's stance has attracted criticism as a political rather than a scientific decision. However, perhaps it is better science to demand the evidence that the environment will not be harmed (that is, that markets can be protected through containment), rather than trying to delimit a perhaps less well-defined risk that the environment will be harmed (where markets and consumer choice are perhaps more vulnerable). Or is it simply misunderstanding the consumer stakes to expect the possibility of the separation of science and politics?

Arguably such criticism should take account of not only the market in GM, but also the market in organic foods and the potential costs to organic farmers if contamination should occur. The question is whether certain standards in handling and the mechanisms and procedures for approval, are sufficient to protect these markets such that they may co-exist in a genuine way both for consumers and for farmers.

US Rice Industry Adopts Plan to Save 2007 Crop

The US rice industry has adopted a plan to eliminate the illegal Liberal Link strains from the 2007 crop.

Discovery of the two contaminating strains in US imports, LLRICE601 and LLRICE62, have led the EU to decide upon mandatory testing of all US rice coming into Europe, with significant implications for the US rice industry. Farmers in the US are taking Bayer, the proprietor of the strains, to court for damage to their markets (a full list of Patenting Lives posts on this issue is available here).

The USA Rice Federation sought legal counsel following the August announcement of the contamination, and engaged King & Spalding in assessing its position. A USA Rice paper setting out the legal position of USA Rice suggests that the Federation does not have legal standing for a class action. However, it also indicates that "aggressive legal action" by individual and similarly situated members is not ruled out.

Earlier this month, the USA Rice Federation issued a press release in which Al Montna, Chairman of the USA Rice Federation and California rice producer, described the decision on mandatory testing as "an unfortunate overreaction."

The USA Rice Federation Daily, 1 Nov 2006, reports that representatives at the two-day USA Rice Federation Conference on GE Elimination adopted a plan to begin immediate work on ridding the 2007 crop of the contaminating strains. Strategies include plans to certify negative test results, suspending planting of the 2007 Cheniere variety, and a decision by mills to purchase rice grown only from negative seed (or farm-saved seed that has tested negative).

The draft plan will be submitted to the USA Rice Executive Committee to be adopted this week.

GM "Round-Up" - Rice, Romania, Rampura, and Regionalism

Over the past few months there has been extensive press, including here at Patenting Lives (click here for all stories on GM rice), on the controversial GM contamination of US rice imports to Europe, first announced in August.

In September the UK Food Standards Agency (FSA) published a statement declaring there to be no health risk associated with the contamination. Now the FSA is preparing to face a legal challenge over its response to the contamination Friends of the Earth UK (FOE) has filed in the High Court an application for judicial review. In a press release last week, FOE stated that the FSA "failed to take necessary action to prevent UK consumers being exposed to illegal GM rice in their food." Back in September, the BBC reported that FOE first wrote to the FSA in an attempt to avoid legal action. In that same report, the FSA response was, "We haven't told retailers not to test, but haven't required them to test."

The application follows the decision of the Standing Committee on the Food Chain and Animal Health (SCFCAH) to back the Commission Decision on strict counter testing of all US rice imports. Speaking in a report by Andrew Bounds, in the Financial Times, Philip Tod, spokesperson for Markos Kyprianou (EU Commissioner for Health and Consumer Protection and pictured at right), said, "We can only be responsible for our own testing and controls ... It is incumbent on other countries to enforce theirs."

The US and Europe have yet to agree on a common testing regime. Floyd Gaibler, US Deputy Undersecretary for Farm and Foreign Agricultural Services, has been reported in Farm Futures as stating that the burden of mandatory testing will effectively end its rice trade with Europe: "it would just have the effect of not allowing trade to resume." European environment ministers are calling for international rules to improve the detection of contamination. This has been supported by EuropaBio, the European association for bioindustries. Simon Barber of EuropaBio told the FT, "Because we have a global trading system there is always the possiblity that minute trace levels of GMOs will turn up where they do not have legal approval. This is going to happen again and again." According to the Andrew Bounds, US GM proprietors "appear to have lost control of their technology."

Such "lost control" has prompted Greenpeace to demand immediate suspension of all US imports, asking for Bayer to be "held accountable for its negligence" by banning the company from conducting further trials. Greenpeace described Bayer as "clearly incapable of controlling contamination of rice with its genetically engineered varieties," after the discovery of a second illegal strain from Bayer in as many months. Meanwhile, US farmers are suing Bayer because of the commercial threat of contamination, closing markets and driving away consumers.

But a report in Thailand's The Nation describes the "burden" for the US as a "windfall" for Thai farmers. The report notes that the Thai government has remained committed to its non-GM policy. Open field trials were banned in 2001, but papaya farmers have had the ban lifted. But in light of the "windfall," Greenpeace has petitioned the Administrative Court to end open-field trials, as reported in the Bangkok Post. Greenpeace also filed a petition against the Department of Agriculture and its Director, Adisak Sreesunpagit, for negligence in preventing a leak of GM papaya seeds during a controlled field trial by Khon Kaen Horticultural Research Station in 2004. According to Patwajee Srisuwan of Greenpeace, contamination continues despite the Department's decision to elminate all GM papaya at Khon Kaen. Earlier this week, the Bangkok Post Business reported that Thai authorities have re-assured importers that Thai rice is GM-free.

The EU mandatory testing has also led India's top rice exporters and farmers unions to warn against further field trials for GM rice. A report by the BBC states that farmers insist that any doubt in the GM-free status of their rice will threaten their trade. And the newspaper, The Hindu, reports that leading rice exporters are concerned that restrictions now imposed on the US could be extended to other countries, including India, if contamination is not prevented . Reuters has reported that farmers and importers are concerned that contamination during storage or transportation will undermine not only consumer confidence but also India's reputation. According to the director of Tilda Riceland, RS Seshardri, "Indian rice is GM-free and we want to keep it that way."

And farmers are certainly taking action to keep it that way. The Bharatiya Kisan Union (BKU), a farmers union in India, recently destroyed a GM rice trial in Haryana. According to a report in the India Express, around 400 farmers, many from the Rampura village in the Karnal district of Haryana, met at the site of the trial, calling for its destruction for fear of GM contamination. The group then torched the trial in what the Indian Express described as a "serious setback" for GM field trials.

One of the protestors, Paramjit Singh, was in fact the farmer on whose land Mahyco-Monsanto was conducting the trial. A report in the Business Standard says that Mr Singh had not been informed that the trial was a GM trial. But nevertheless, the burning was described as "unwarranted" by the Department of Biotechnology (DBT) Review Committee on Genetic Manipulation (RCGM). Member Secretary of the RCGM, Dr TV Ramanaiah, appeared to dismiss the obligation to inform was apparently dismissed by Member Secretary, saying to the Business Standard, "Mahyco which grew the crop for contained field trial had our approval. So it was a legal activity. As for informing farmers, how do you expect every farmer to be told about the various experiments that are being done." How indeed. The Business Standard report states "Activists of BKU pointed out that neither the farmer nor the panchayat president were told of the trials, as is required under the regulations." The farmer had leased the land for contract farming at Rs 15 000.

Meanwhile, Mahyco has come under other "fire" recently, after the publication of the findings of an investigation by the Centre for Sustainable Agriculture (CSA) into Bt Okra trials in the Gulbarga district of Karnataka. The report notes also that the DBT Guidelines are not always being followed, leading to similar problems with information. The state government of Karnataka was unable to respond adequately to applications for information, admitting that it had no information on where GM trials were being undertaken in the region.

The Supreme Court of India banned new field trials of GM crops earlier this year, following a public interest petition filed in May 2005. The petition claimed inadequate biosafety protocols, including allowing field childs to commence prior to biosafety testing, were a serious threat to both public health and the environment. The Supreme Court ban is to allow for an examination of these approval mechanisms.

And recently, Iran's Department of Environment (DoE) has decided against issuing an official approval to commence cultivation of GM rice. According to reports, the DoE did not receive sufficient documentation to be convinced that the benefits outweighed the potential risks.

Back in Europe, resistance to GM among consumers remains high. A recent AFP report says that very little GM food ends up on the plates of European consumers. And the preferences of EU citizens have relevant and significant effects on the markets for EU member states, particularly those for organic products. Efforts to achieve meaningful co-existence measures for traditional, organic, and GM crops, are repeatedly undermined by contaminations.

The UK Department for Environment, Food and Rural Affairs (DEFRA) has recently received strong criticism for its coexistence proposals. According to a report in Farmers Weekly, a joint response by FOE, the Soil Association, and GM Freeze, to the government's coexistence consultation claimed that some of the proposals breached European law. In an FoE press release, Pete Riley, Director of GM Freeze, and Peter Melchett, Policy Director of the Soil Association, both condemn the proposals as removing the rights of consumers and farmers to choose. Clare Oxborrow, of FoE, said that "The proposals are a thinly veiled attempt to introduce GM crops through the back door." She said further, "Allowing routine, unlabelled, GM contamination of conventional and organic crops is not only unacceptable to the public, it is legally flawed too." The consultation closed Friday, 20 October.

Elsewhere in Europe, contamination continues to undermine arguments that coexistence can been meaningfully achieved. Planet Ark recently reported that organic farmers in Spain have been forced to abandon maize crops after detecting traces of GM strains. And farmers in Greece are taking action against Syngenta, Pioneer, and the Greek Government for GM maize contamination in 2004. The General Confederation of Greek Agrarian Association (GESASE).

Meanwhile, GM crops threaten to defeat Romania's ability to meet the deadline for banning GM "Roundup Ready" soybean crops. The deadline, an effort to meet EU environmental rules, is set at 1 January 2007, the same day Romania is to join the EU. Unlike many citizens in the EU, however, Romanians are reported as being less concerned about the regulation of GM. The Balkan Insight reports that "A poor level of compliance reflects the lack of interest in the subject felt by Romanian consumers." Whether this also reflects levels of awareness, information, or engagement in the debate is unclear.

And the push towards bilateral negotiations adds to these concerns. A report, Bilateral Biosafety Bullies, by GRAIN and the African Centre for Biosafety identifies a relationship between bilateral trade channels and an associated weakening in biotech regulations, in favour of opening markets for GM crops. This kind of regionalism threatens to undermine genuine multilateral negotiation. "The push to regulate - or rather, prevent the regulation of - GM food through bilateral instruments is not happening in isolation. It is part of a much larger trend in international relations."

But European consumers will continue to work to buck the trend.

GM Rice in Europe - New Strains and New Tests

Today, the European Commission tabled a Decision imposing mandatory testing for US long grain rice.

The Decision (2006/601/EC) was tabled at today's meeting of the Standing Committee on the Food Chain and Animal Health (SCFCAH), section for genetically modified food and feed and environmental risk. A press release last week stated that discussions between the US and European Commission had not been able to achieve a consensus on a protocol for sampling and testing. Further, it was confirmed that certification requirements will continue to be imposed, in keeping with those announced in August and reported in Patenting Lives. The draft Decision is to introduce sampling and testing for all consignments of US long-grain rice at the point of entry to the EU, with costs to be incurred by the operators.

The Decision follows the controversial contamination of US imports of long grain rice by the unauthorised variety LLRICE601, back in August this year. Subsequently, Chinese rice imports were also found to be contaminated with unauthorised GM strains, prompting Friends of the Earth Europe (FOEE) to call for an immediate ban.

In September, Bayer released a subsequent statement declaring that the variety was safe according to the US Department of Agriculture (USDA) and the Food and Drug Administration (FDA), as well as authorities elsewhere in the world, including the UK's Food Standard Agency (FSA) as well as the European Food Safety Authority (EFSA).

Since then, a second variety of Bayer GM rice has been detected according to Philip Tod, the Commission's spokesperson for health and consumer issues, speaking to Dow Jones Newswires Friday (courtesy of Indymedia). The second strain, LLRICE62 was found in France by authorities and was notified under the European rapid alert system for food and feed (RASFF). The strain is authorised for marketing in the US but to date has not been commercialised there, as confirmed by Anette Josten, speaking on behalf of Bayer and quoted in the Dow Jones Newswire piece. The recent finding of the unauthorised LLRICE62 was noted in the press release announcing the tabling of the Decision, with counter tests confirmed as able to detect this strain as well as the original contaminating strain, LLRICE601.

Consumers in Europe remain concerned about GM technology in food products, despite confidence in other areas of technology. Today, Planet Ark reported on research showing that 75% of Italians continue to view GM food as a health risk. Civil society and environmental organisations have maintained strong support for robust testing and certification procedures, with Greenpeace last week calling for strategies to prevent further contamination by other GMOs, and FOEE welcoming proposals for testing. Last week, FOEE released a list of episodes of GM rice contamination in Europe, noted a "growing number of cases." Adrian Bebb, of FOEE, said, "This is absolutely necessary since there have now been almost eighty cases of contamination across Europe in the past six weeks."

According to EurActiv, officials at the US mission to the EU declined to comment.

Rice Patents - An Obstacle to Research

At the 2nd International Rice Congress 2006, held in Delhi last week, delegates considered whether patent protection presents a major obstacle to research and innovation.

The international event attracted scientists from around the world concerned with research and development contributing to food security, alleviating poverty, and enhancing economic and social development.

Areas of interest included genetic enhancement and development of seeds compatible with environmental conditions in developing countries, as well as technologies in production and storage and sustainability. In addition, the Congress also addressed related commercial and research industry concerns, including creating markets for rice, use of information and communication technologies (ICT), and public-private partnerships.

At the recent meeting, farm ministers from China, India, Indonesia, Laos, Nepal, Pakistan, the Philippines, Sri Lanka, and Vietnam, signed an accord for multilateral cooperation on these issues.

However, patent monopolies remain on the agenda as a significant obstacle to research and to the achievement these aims. Reporting on the Congress, Ashok Sharma notes in the Indian newspaper, the Financial Express, "rice scientists are likely to face major hurdles in moving towards their goal." The report notes the monopoly control of Syngenta in this area of agricultural production, and criticises the company's action in "seeking global patent rights over thousands of gene sequences." The article suggests that this is comparable to ownership of "the world's most important staple crop." Although strictly speaking, such patentability is tied to the identification of the gene sequence's function, this nevertheless raises the issue of classical interpretation leading to the consequences of a gene sequence in effect being subject to a monopoly. And indeed, this is what Sharma is suggesting, in arguing that Syngenta is attempting to extend monopolies over all uses on the basis of one use - thus, in effect, achieving a monopoly.

Also speaking at the Congress was Robert S Zeigler (pictured at right), of the International Rice Research Institute (IRRI) as well as a member of the International Advisory Board of Biotec. Biotec is one fo the centres of the National Science and Technology Agency (NSTDA), Thailand. Zeigler argued against the patenting of germplasm, maintaining that, while final products could be patentable, basic research tools should not be. Although Sharma expresses concern that this might not be possible, if a purpose-bound approach is pursued, the potential for relevant patent protection in gene technologies is available.

On this issue, the European Commission recently adopted a second report to the European Parliament on the Biotechnology Directive. The report is concerned with the implications of patent law in biotechnology and genetic engineering, including patents relating to gene sequences and stem cells. In particular, the report considers the "scope of protection" and the need or otherwise for a more limited "purpose-bound" approach to protection. Although not taking a position in the report, the issue nevertheless remains relevant to the Commission not only in a legal context, but also in an economic one, in that Member States have taken varying approaches to the interpretation of so-called gene patents. France and Germany both rely on purpose to limit the interpretation of patents in some technologies this area.

Also considered at the Congress was the impact of GM on international markets and the complexity of trade, as reported in another article in the Financial Express. Issues relating to food safety and certification were significant to the discussions, particularly in the light of the recent US GM rice contamination (see recent Patenting Lives posts, US Farmers to Sue Bayer, European Standing Committee Considers Rice Contamination, More Trouble for US Rice Industry, Japan Lifts Rice Ban, and Russia Suspends US Rice). And the fall-out from this contamination continues. In a press release from GE Free NZ, activists are urging the Ombudsman to become involved in New Zealand, in response to a rejection by the New Zealand authorities of calls to test for the contaminating strain, LLRICE601.

The International Food Policy Research Institute (IFPRI) will be hosting a Policy Seminar, "Distributional Effects of WTO Agricultural Reforms in Rich and Poor Countries," which will be considering some of these issues in food security and market concerns. The seminar will be held at the offices of IFPRI, Washington DC, 2 November.

Pew Workshop Report on Co-Existence

The Pew Initiative on Food and Biotechnology (Pew) has published a report on co-existence in agriculture.

The Report, "Peaceful Coexistence Aong Growers Of: Genetically Engineered, Conventional and Organic Crops," is the output of a Workshop held in March this year. The workshop was the second of three sponsored by Pew together with NASDA (National Association of State Departments of Agriculture).

Coexistence remains a critical issue in Europe, with consumers continuing to be concerned about the introduction of GM crops in Europe. Despite the recent WTO Panel Decision, countries in Europe continue to impose a ban on GM crops, including Italy, where the organic market remains one of the strongest in Europe.

Meanwhile, the controversy over the GM rice contamination of US exports (with bans in the European Union, Japan, and Russia, among others) has raised major concerns about not only the potential environmental risks but also the tangible damage to the commercial assets of organic and traditional farmers, leading to large compensation payments from governments.

In a recent BBC viewpoint, Sue Mayer has described GM crops as looking like "more of a liability than an asset." And in Australia, the Western Australian Agriculture Minister, Kim Chance, has criticised strongly the Australian Federal Government's premature call for all states to lift their moratorium on GM crops. The call, from the Hon Peter McGauran, Federal Minister for Agriculture, Fisheries and Forestry (DAFF), responds to the DAFF report, Creating Our Future: Agriculture and Food Policy for the Next Generation (Corish Report).

While governments and trade disputes remained entrenched in a debate over scientific evidence, the distraction from the real problem of product credibility and consumer confidence is potentially marginalised.

Russia Suspends US Rice

Rosselkhoznadzor, Russia's Federal Agency of Veterinary and Phytosanitary Surveillance, has announced that it has stopped issuing quarantine permits for US rice imports, following the GM rice contamination revealed in August this year.

LLRICE601 has not been passed for human consumption, however, as reported in an earlier post, Bayer CropScience are seeking an extension on the basis that it is not significantly different from deregulated GM varieties.

Meanwhile, Reuters reports that two bargeloads that had previously been certified for import into the EU, have subsequently tested positive for the GM strain.

PUBPAT Challenges Monsanto Patents

"It appears as though Monsanto wants to control all of America's farmland and - unfortunately - the patent system is providing them the perfect means."


The Public Patent Foundation (PUBPAT) has filed formal request with the United States Patent and Trademark Office (USPTO) to revoke four Monsanto patents.

In a press release, Monsanto is described as using the patents "to harass, intimidate, sue - and in many cases bankrupt - American farmers." Executive Director of PUBPAT, Dan Ravicher, says "Monsanto's aggressive assertion of its patents is not only obnoxious and offensive to the core fabric of American life and culture, it is also causing substantial public harm."

The Center for Food Safety (CFS) completed a study on these concerns, and recently released the Monsanto v US Farmers Report, looking into the extent to which US farmers are negatively affected by litigation of patented GM crops.

The filings have included the submission of prior art which PUBPAT says will show that the patents lack novelty, are therefore invalid, and should be revoked.

Japan Lifts Rice Ban

Japan has lifted its ban on US long grain rice.

According to a report in Capital Press, Japan has now lifted its ban on US long grain rice after tests did not reveal any evidence of contamination.

Meanwhile, it is likely that rice farmers' legal action against Bayer will be heard in Arkansas in January. A report in the Economist suggests that the farmers are likely to prevail in their demands for stricter controls. But, as the Economist report says, "once genetically modified foods are out in the environment it is pretty hard to recall them, regardless of what politicians would like."

One of the most critical aspects for the GM industry is perhaps not a monopoly in seeds but the oversight necessary to generate consumer confidence in a market.

WTO Panel Decision on EU Biotech Cases

The WTO Panel has delivered its final report on the European Communities (EC) approval and marketing of biotech products.

In May 2003, the United States, Canada, and Argentina took their complaints to the WTO Dispute Settlement Body on EC approval and marketing of biotech products and, in particular, the moratorium on GM agricultural and food imports (introduced in the context of a need for effective regulation of co-existence of agricultural markets in Europe). The final report was published Friday afternoon, 29 September, and has concluded that the moratorium is inconsistent with obligations under the WTO Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement).

Although the Panel concluded that the moratorium had caused "undue delay" and so the EC had acted inconsistently with obligations under Annex C(1)(a) and thus Article 8 (Control, Inspection and Approval Procedures), the complainants had either failed to establish their position or the EC had not acted inconsistently in respect of the other obligations raised in the complaints.

Consumer groups have criticised the report, suggesting that alternative mechanisms must be available to rule on what are international environmental laws, not trade disputes as such. On this point, consumer groups have objected to the prohibition of public involvement.


Of particular interest, a Friends of the Earth Europe press release, suggested that it makes no difference to the rejection of GM products by European consumers. Earlier posts to Patenting Lives, including GM Food in Europe and Beyond: Consumer Trends, make similar observations.

European Standing Committee Considers GM Rice Contamination

The European Commission released a press release today on the meeting of the Standing Committee on the Food Chain and Animal Health (SCFCAH), reviewing the GM rice contamination.

As discussed in a earlier post, the contamination of US rice exports by the GM strain, LL601, led to immediate bans on imports in Europe and Japan, with the European Commission announcing that it would require certification to prevent further entry of GM rice.

The Federation of European Rice Millers (FERM), representing over 90% of the milling capacity in Europe, was in attendance at the meeting to report on the system of control of rice imports. Last month, FERM released a statement supporting the Commission's decision to introduce a system of testing and certification and at the SCFCAH meeting a detail report was provided of the controls and validated testing methods currently in place. FERM reported that 33 of the 162 samples tested had returned positive results for LL601. Indications at the SCFCAH meeting were that LL601 could be present on the European markets, but actual tests could not be confirmed for another 2 weeks at least. However, of the Member States already testing, no positive results for LL601 have been returned.

As mentioned in an earlier post, the Commission adopted a decision in August to require all rice to be certified free of LL601. Since then, no consignments without certification have entered the EU market.

A shipment of approximately 20000 tonnes of US rice was detained in Rotterdam, 26 August 2006. After testing the barges, 3 have been positive for LL601 while 20 have been negative and have since proceeded to market. The positive consignments are to be returned to the USA or destroyed. Shortly thereafter, evidence of GM rice in Chinese imports was reported by Greenpeace and Friends of the Earth. The Commission has requested the submission of information and samples to the competent authorities to confirm this and has also written to the Chinese authorities for further information.

The SCFCAH is one of several Regulatory Committees which assist the European Commission in the development of food safety measures at all stages of the food chain. Referred to as the “from the farm to the fork” approach, the Committee deals with food & feed safety, animal health, animal welfare and plant health.