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October 18, 2010


How to Debate? Life-Saving Field Trials; Golden Opportunity, Red Tape; Regulatory Bottleneck; No Meeting of The Minds


* How to Debate Genetic Engineering in Agriculture?
* Field trials of life-saving drought-tolerant transgenic maize
* Golden Rice May Be A Golden Opportunity
* Golden Opportunity, Red Tape
* The Regulatory Bottleneck for Biotech Specialty Crops
* In China, No Meeting of The Minds on GM Crops

How to Debate Genetic Engineering in Agriculture?
- African Technology Development Forum, October 15, 2010

How can Europeans be empowered to talk in a morally meaningful way about genetic engineering in agriculture in the absence of any concrete experience with the new technology? GM food is practically unavailable in retails stores, GM crops are hardly grown anywhere and governments largley failed to introduce biotech toolkits in schools. No wonder that general knowlege about the technology is low and moral judgment tends of be of heteronomous nature. The heteronomy of moral judgment is reflected in the fact that Europeans have to rely on what they are told by their teachers - while the teachers, again, tend to rely on mass media coverage that tends to portray the stakeholders that oppose GMOs as defenders of the public interest.
Another problem is that Europe is slowly losing its competence on biosafety because conducting field trials costs millions of dollars - just to protect such trials from human beings who want to destroy it. The costs imposed by such opponents as well as the uncertain and time-consuming process of regulatory approval are probably the most important reason why industry concentration is increasing in agribusiness in Europe. After all small companies cannot cope with this regulatory uncertainty and its resulting costs.
In view of hostile public opinion, governments are also increasingly reluctant to fund biosafety risk assessment in the field. How can Europe remain credible on issues related to biosafety and ensure moral authority in the debate on the role of technology in sustainable development in such a tense and negative social and political environment? There is an urgent need for more practical and concrete experience with the technology and for tools that allow people to become more familiar with perspectives that are not featured or even censored in the popular media.


Scientists prepare for confined field trials of life-saving drought-tolerant transgenic maize

- African Agricultural Technology Foundation, Oct 14, 2010

If successful, water-efficient maize for Africa would be available royalty-free to the region where over 300 million people depend on a crop routinely crippled by droughts

DES MOINES, IOWA - Crop specialists in Kenya and Uganda have laid the groundwork for confined field trials to commence later this year for new varieties of maize genetically modified to survive recurrent droughts that threaten over 300 million Africans for whom maize is life, according to a speech given today by the head of the African Agricultural Technology Foundation (AATF) at the World Food Prize Symposium.

Scientists working with AATF believe it's important to explore the potential of biotechnology to maintain and increase food production in Africa, given the large number of families dependent on maize, and warnings that maize yields could drop dramatically as climate change increases drought frequency and severity across the continent.

There is preliminary evidence that the Water Efficient Maize for Africa (WEMA) varieties, which were developed through a public-private partnership, could provide yields 24-35 percent higher than what farmers are now growing.

The process for testing the WEMA varieties has been informed by a series of "mock trials" conducted in 2009 in Kenya and Tanzania. The mock trials carefully simulated field conditions, procedures, and regulatory oversight that will occur in the actual trials.

"The mock trials have provided an opportunity for researchers working on the WEMA project to fine-tune the procedures of carrying out the actual transgenic trial in 2010," according to Daniel Mataruka, executive director of AATF.

The mock trials were supervised by national biosafety committees in both countries and adhered to all requirements that will apply to transgenic plants.

"Everything we have seen in the simulated trials shows that we can safely test transgenic maize varieties in carefully controlled and confined field trials in Africa and evaluate their potential to produce high yields in drought conditions," said Dr. James Gethi, the WEMA-Kenya country coordinator.

Drought is the most important constraint to African agricultural production, and its effects are particularly severe on maize, which is the most widely-grown staple on the continent. For millions of small-scale farmers who rely on rainfall to water their crops, risk of crop failure from drought is a major barrier to the adoption of improved farming practices.

A more reliable harvest could give farmers the confidence to invest in improved techniques that could further boost their yields and incomes.

The push to develop drought-tolerant varieties has been given added urgency by threats likely to come from climate change. A study by scientists at the Consultative Group on International Agricultural Research (CGIAR) warns that by 2050, climate change could make droughts more frequent and intense, potentially causing maize yields to drop by 20 percent or more in parts of East Africa, including northern Uganda and southern Sudan, and semi-arid areas of Kenya and Tanzania. The Food and Agriculture Organization of the United Nations (FAO) has acknowledged biotechnology as a powerful tool in the effort to develop drought-tolerant crops.

The drought-tolerant WEMA varieties are being developed under a partnership involving AATF, the International Maize and Wheat Improvement Center (CIMMYT), Monsanto, and the national agriculture research systems in Kenya, Tanzania, Mozambique, South Africa and Uganda. CIMMYT has provided high-yield maize varieties adapted to African conditions, while Monsanto has provided proprietary genetic resources (germplasm), advanced breeding tools and expertise, and drought-tolerant transgenes developed in collaboration with BASF.

According to AATF, experience has shown that the gains possible through advanced breeding and biotechnology are greater and faster than those that can be achieved through breeding alone.

"There have already been positive gains made in drought tolerance using traditional breeding methods by our partners," said Mataruka. "WEMA is working to further increase those gains in drought tolerance in hybrids adapted to eastern and southern Africa through both advanced breeding techniques and biotechnology."

If the transgenic corn is found to be safe and successful, the new varieties will be made available to smallholder farmers royalty-free. Under its agreement with its partners, any approved varieties would be licensed to AATF, which would then distribute to farmers through local seed supplies at a price competitive with other types of maize seed. The project partners expect that pricing will not be influenced by the requirement to pay royalties, as none of the partners will receive any royalty payment from seed companies for the drought tolerant lines/transgenic trait incorporating their intellectual property protected technology.

Pending regulatory approval, at least 12 WEMA varieties will be tested in confined field trials (CFTs) in Kenya, Uganda, Tanzania, South Africa and Mozambique. After the trials, the transgenic corn produced in the CFTs will be destroyed in compliance with the regulations in the respective countries.

The African Agricultural Technology Foundation (AATF) is a not-for-profit organisation that facilitates and promotes public/private partnerships for the access and delivery of appropriate proprietary agricultural technologies for use by resource-poor smallholder farmers in Sub-Saharan Africa (www.aatf-africa.org).


Golden Rice May Be A Golden Opportunity

- Peter Nowak, CBC News October 15, 2010

Genetically engineered crop may soon save millions of lives

Golden Rice, right, provides more Vitamin A than typical white rice. Vitamin A deficiency causes an estimated one to two million deaths a year. (Courtesy Golden Rice Project)

Saturday is the United Nations' World Food Day, an annual event intended to bring attention to hunger problems around the globe.

Increasingly, technology is taking centre stage during such events as continuing population growth and shrinkage of arable farmland ratchet up the pressure on world food supplies.

One key technology to fighting shortages, food scientists say, is bio-engineered crops óalso known as genetically modified organisms.

The first commercially available GMO, the Flavr Savr tomato ó engineered to ripen more slowly so that it would retain its firmness and colour longer ó hit the U.S. market in 1994. Since then, GMO crops have spread to become the norm in many countries, with pesticide- and insect-resistant corn, cotton and canola among those being grown.

The crops have been hugely controversial, though, with organizations such as Greenpeace raising questions about their environmental and health impacts, as well as the motives of the people behind them. Critics have said that companies such as Monsanto and DuPont are only in the GMO business to make money and don't really care about humanitarian possibilities.

One crop, however, was created strictly with humanitarian purposes in mind. Golden Rice, a strain engineered by German academics Ingo Potrykus and Peter Beyer to have a higher Vitamin A content, is close to finally being rolled out.

First formulated 10 years ago, Golden Rice produces beta-carotene, which the human body processes into Vitamin A. Deficiency of the vitamin is a major cause of blindness and death in developing countries, causing an estimated one to two million deaths a year.

Controversy around GMOs, especially in Europe, means the yellow-coloured rice has spent years running regulatory hurdles around the world. It is currently in tests in a number of countries and the Golden Rice Project, a group of scientists shepherding its development, are hopeful that it will soon pass muster.

Dr. Adrian Dubock, a former sheep farmer from the U.K. and food scientist at Swiss agri-giant Syngenta, discussed Golden Rice's past and future with CBC News.

CBC: Early on, Golden Rice was criticized for not containing much Vitamin A. How much of that claim was correct and how much has it actually improved?

Dubock: In calculating how much you need to make a difference, you have to multiply together a number of factors and each of those factors has a range. [Greenpeace] took the least favourable of those numbers and multiplied them together and came up with [the statement] that you'd need a large amount. We actually didn't know then how much was needed to make a difference because there were a number of things we couldn't know at that stage. For example, how many units of beta-carotene are converted into Vitamin A in the human body? We didn't know that, we've only known for the past couple of years. We didn't know how much of the daily recommended allowance we'd have to supply in order to make a difference in mortality and morbidity.

Greenpeace created a stunt and you couldn't argue with it in a way because we could see how they arrived at it, at least conceptually, but it was misleading and wrong. Just recently, we've run the calculations with the things that we know about ó the bio-conversion ratio and so on ó and even with the original amount, about a hundred grams a day would have supplied something like 40 or 50 per cent of the estimated daily requirement, which is probably enough to lift people out of death and morbidity.

The situation now is that 100 grams, which is about half a teacup, will be enough to prevent death and, previous to that, blindness from Vitamin A deficiency, which is tremendous. We got there by doing some nutritional work with humans, which we were criticized for, but how can you get to know how it works with humans without using humans? We're on track to roll the technology out, finally, probably in 2012 or 2013.

CBC: It seemed like controversy slowed Golden Rice's rollout, but it also sounds like there was quite a bit of work to do on it. Was it a combination or would it have happened a lot sooner if there hadn't been the criticism?

Dubock: It's hard to quantify the effect of that criticism, but it does create suspicion and suspicion has a political effect. The political effect is that countries and organizations become cautious and that leads to delays. In the old days, when they wanted to try different varieties of wheat from one country to another, they'd just say, 'Send me some seeds.'

The Cartegena Protocol, a treaty right at the beginning of genetic modification [in 2000] put an international framework for regulation in place that obligated countries that signed on. Then an organization, the UN's environmental program, went off training countries in risk assessment so that they could in theory set up programs to carry out scientifically based assessment of risk. The guy who set that up came and talked here in Switzerland a few years ago and I had a meeting with him afterwards and I said, 'It's great that you've trained them all in risk assessment, but where's the assessment of benefit?' And he said, 'That's somebody else's job, that's not our job.' To me, risk is a relative thing ó what's the benefit to the risk?

So where this is functioning, it's got a lot of people looking at all sorts of incredible detail often asking about areas that for other crops are not even known about. It creates suspicion and people think, 'Well if there's all this regulation, there must be something really, seriously of concern about this technology. Why would all this be there if there were no problems?' The advocacy groups that are against the technology then leverage that suspicion in one way or another and that just causes political delay.

For example, before the licensing structure was signed in India, there were something like 30 questions in the Indian Parliament about Golden Rice. It wasn't just off-the-top-of-their-head things, they were very carefully thought-through, devious questions. Once we got the licence signed, the Indian breeders said, 'OK, now we'd like to have the materials.' Between them asking for the materials and getting them, it took a whole year because of the paperwork that had to be filled in. So here's a really good example of questions in Parliament that have been sensitized by advocacy groups, and on top of that there's a whole bureaucratic process taking time to do everything. I've seen this reflected in the attitudes of grant-giving agencies, companies, research institutions. It makes all institutions nervous and that's one of the big reasons for delay.

CBC: Is it safe to assume that when Golden Rice finally does get approved, it'll happen in Asia first?

Dubock: Definitely, and it's because Asia is predominantly where rice provides the staple carbohydrate and it's where there are a lot of marginalized people. Vitamin A deficiency comes about as a result of people having too narrow a diet and white rice only basically contains carbohydrates. If you don't have some fish or vegetables or fruit in your diet and you only eat carbohydrates, you can easily end up with Vitamin A deficiency. Half the world, three billion people a day, eat rice and of those many populations are getting about 80 per cent of their calorific value from rice, so that's where the problem is.

CBC: Are you hopeful that the long path taken by Golden Rice will make it easier for other humanitarian GMOs to make it through the process?

Dubock: That's our assessment. It's a slightly uncomfortable burden to have but clearly there is a lot riding on the success of this project. It's about more than just Vitamin A deficiency alleviation to rice-consuming populations because this project happens to counteract most if not all of the earlier arguments against GMOs. Originally, it was environmental risk ó well that's largely gone away, people don't really think that any more. Then it was all these untold health risks that may be occurring ó nobody is taking that so seriously anymore. Then there's questions of, 'How can you know what the genome effect is inserting another gene?' But as knowledge arises about similarity of gene effects, with similar genes in different organisms having a unity of purpose ó when you start to understand that, and the world will ultimately understand it, then you can see from a scientific perspective that all this over-regulation is really over-regulation.

When you really dig down to opponents, often they get down to feeling that GMOs are some way that the private sector will take charge of the food chain and that it's only for the benefit of industrialized farmers. [Smaller] farmers will lose choice and become dependent and monopolization will force up prices. But with Golden Rice, you have a project now that is demonstrably public sector where the [genetic] trait will be provided free of charge, there's no licence fee, it's for poor farmers, it's for health.

If Golden Rice is successful, it will help the appreciation of the utility of the technology for wider society. That's the big sin of this controversy against GMOs ó that this technology is extremely scaleable and it can help poor people in developing countries much more than a lot of other technologies in agriculture because, basically, it doesn't cost anything. It doesn't require rocket-science skills to do it either. It is very, very pertinent to developing countries.

CBC: The inventors of Golden Rice were initially angry when companies claimed they had violated their patents in creating it, but they eventually changed their tune. What happened?

Dubock: Ingo and Peter felt they had made this great scientific breakthrough and they would have it in farmers' hands in three years. When they published (in the journal Science in 2000), they were told there was an analysis that had been done which suggested they had real intellectual property problems. I can't remember the exact detail of the analysis but it was something like 72 patents from 32 organizations had been infringed. They were hit by this sledgehammer between the eyes and thought, 'Oh god, how do we deal with that? We're a couple of academics.' That was what drove them to start talking to the private sector.

That's when I came along and we did the deal and we said, 'We'll help you with this problem.' The analysis was stupid. There were two major problems with it. One was it analyzed the American patent scene, where patents are national in character, they're time limited and if they're applied for doesn't mean they'll be granted, and even if they're granted doesn't mean they're valid. The other problem with the analysis, which was done by a unit at Cornell University, is they included patented technologies that had been legitimately used as a result of commercial arrangements. Including those is like including Boeing using a patented screwdriver to fix wings together on their planes, and then the screwdriver owner coming along and saying, 'We need a share of all the passenger receipts.' It's nuts.

When I got our patent people at Zeneca to take a look, they concluded that maybe a maximum of half a dozen patents had been infringed. I then went to the owners of those patents and persuaded them to contribute that technology, if it had been infringed ó and we're not saying it was ó for the humanitarian purpose, and they all did that. I went and talked to them to fix it, and it didn't take long.

CBC: In other areas of technology, especially computing, there's the law of accelerating returns, which sees advances stack on each other, leading to rapid advancement. Is that happening with GM crops?

Dubock: That's a very interesting question and not one I've answered before. I think it has the potential to do that, but it's constrained by the controversy and politics that I've explained. Clearly, the understanding is growing but understanding would grow more if more applications could be achieved. The applications being achieved, especially in the public sector, are extremely constrained by this suspicion and bureaucratic, unscientific regulatory aspect. In the private sector, the know-how grows but there's nervousness from the controversy and there's a tendency to keep things a trade secret unless they're patentable.

But the early traits and tools of biotechnology are already off-patent or coming off-patent, and that actually means they're available for anybody to use. Sometimes you need this plus that plus that, but increasingly, they're going to be off-patent. The companies that are principally the drivers of novelty will keep trying to stay ahead of the curve in terms of the benefits they can deliver so they can keep their commercial edge, but the other stuff that's coming out at the other end of the patent pipeline, that's available for anyone to use. From that perspective, yes there's a capability to be picked up but the problem, repeatedly, is regulation. The danger is the regulation and the sensitivity created by it will kill the technology before it gets anywhere close to delivering what it can deliver.

CBC: How much are you paying attention to the debate regarding genetically modified animals ó such as salmon ó going on in the U.S.? Do you see those companies as allies?

Dubock: Within the Golden Rice Project per se, we're completely neutral about that. My personal view is coloured by my experience in the public sector as well as working in the public sector. To formulate a view about how good or bad that technology is needs a better understanding than I have about whether the genetic trait is containable or not, and so on. On the other hand, you have to think about the food protein demands of the world. It's pretty clear that the [fish] resources in the sea are reducing hugely and it's also pretty clear that farmed salmon and chickens, at the moment, provide cheaper protein than just about anything else. You could say that if you could extend that trend, it should be good. People want protein and they want cheap and plentiful food. Unless we get on top of birth control, and if we keep combating old age and other diseases, there's going to be nine billion people to feed instead of six billion. They can't all eat beef.

There appears to be even more sensitivity in the public's eye about genetic modification used for animals than there is for plants. It's a strange world because most new pharmaceutical drugs that are coming out of the pipeline actually arise from biotechnology. A lot of genetic modification is used and has been used for many years in items that many people consider to be normal, like cheese and beer and things like that. Public reaction is not very scientific at all and it can easily be manipulated. In broad terms, we have to embrace all the technology we can to provide wholesome food and of course, it should be questioned whether the technology is safe or not, but you also have to look at the benefits that arise or the costs of not doing anything. You need a holistic view of these things. It's what governments are for, to take all these views and not be bamboozled by them.

CBC: It's been said that opposition to GMOs is a luxury that only people in relatively wealthy developed countries can afford. Do you agree?

Dubock: Yes, and it's borne out by two facts that I'm aware of. There's a guy named Kim Anderson, who's an economist out of Adelaide University and a consultant to the World Bank, and he did some estimates on the value of having GMO crop foods in Europe. The benefit to the population, about five years ago, worked out to about the price of a cup of coffee for each individual. So you could say, 'Do they want to take the risk?' The answer is [obviously not]. The same economist did a study on the economic benefit of adopting Golden Rice to Asia and he estimated, conservatively, it would add $18 billion annually to the GDP of Asia.


Read more: http://www.cbc.ca/technology/story/2010/10/15/golden-rice-food-technology.html#ixzz12iEFYKZ8

Golden Opportunity, Red Tape

- Henry I. Miller, Daily Caller, October 14, 2010 http://dailycaller.com/

Former leader of the Soviet Union Joseph Stalin famously said that a single death is a tragedy but a million deaths is just a statistic.  His observation seems to have borne out yet again by the media feeding frenzy over the successful rescue operation in Chile for 33 copper miners trapped underground for two months.

The human interest in the situation was undeniable, to be sure, but the coverage and the hyperventilating of journalists were out of all proportion to the actual event.  What could be more important than the very survival of 33 hardworking men?  How about the ongoing catastrophe of malnutrition, illness and premature death of millions of children in developing countries from a single preventable cause: vitamin A deficiency.

In developing countries, 200-300 million children of preschool age are at risk of vitamin A deficiency, which increases susceptibility to common childhood [ http://dailycaller.com/2010/10/14/golden-opportunity-red-tape/print/# ]infections such as measles and diarrheal diseases and is the single most important cause of childhood blindness in developing countries.  Every year, about 500,000 children become blind as a result of vitamin A deficiency, and 70% die within a year of losing their sight. These wholly preventable deaths have been met with total indifference and deafening silence from the media.

What could be done to prevent the ravages of vitamin A deficiency?  One approach would be simply to supplement children’s diets with vitamin A in capsules or add it to some staple foodstuff, the way that we add iodine to table salt to prevent hypothyroidism and goiter.  That’s a good idea in theory, except that neither the resources — hundreds of millions of dollars annually — nor the infrastructure for distribution are available.

Plant genetic engineering offers a better, cheaper, more feasible solution: “Golden Rice,” a collection of new rice varieties biofortified, or enriched, by the introduction of genes that express beta-carotene, the precursor of vitamin A. (It is converted in the body, as needed, to the active form.)  The concept is simple: Although rice plants do not normally synthesize beta-carotene in the seeds because of the absence of two necessary enzymes of the biosynthetic pathway, they do make it in the green portions of the plant. By using genetic engineering techniques to introduce the two genes that express these enzymes, the pathway is restored and the rice grains accumulate therapeutic amounts of beta-carotene.

These new varieties are critical because in many developing countries, vitamin A deficiency is epidemic among the poor, whose diet is heavily dominated by rice (which contains neither beta-carotene nor vitamin A) or other [ http://dailycaller.com/2010/10/14/golden-opportunity-red-tape/print/# ]carbohydrate-rich, vitamin-poor sources of calories.  Golden Rice offers the potential to make contributions to human health and welfare as monumental as any in history. With wide use, it could save hundreds of thousands of lives a year and enhance the quality of life for millions more.

But one aspect of this shining story is tarnished.  Intransigent opposition by anti-science, anti-technology activists — Greenpeace, Friends of the Earth and a few other groups — has spurred already risk-averse regulators to adopt an overly precautionary approach that has stalled approvals. There is absolutely nothing about Golden Rice that should require endless case-by-case reviews, bureaucratic dithering and delays. As the scientific journal Nature editorialized in 1992, a broad scientific consensus holds that “the same physical and biological laws govern the response of organisms modified by modern molecular and cellular methods and those produced by classical methods. … [Therefore] no conceptual distinction exists between genetic modification of plants and microorganisms by classical methods or by molecular techniques that modify DNA and transfer genes.”

Putting it another way, government regulation of field research with plants should focus on the traits that may be related to risk — invasiveness, weediness, toxicity, and so forth — rather than on which genetic manipulation technique was used.

In spite of its vast potential to benefit humanity — and negligible likelihood of harm to human health or the environment — Golden Rice remains hung up in regulatory red tape with no end in sight.  In a July commentary in the journal Nature, Potrykus pointed out that Golden Rice has been “stalled at the development stages for more than ten years by the working conditions and requirements demanded by regulations.”

By contrast, plants constructed with less precise techniques such as hybridization or mutagenesis — which, with the exception of wild berries, wild game, wild mushrooms and fish and shellfish comprise virtually everything in European and American diets — are subject to no government scrutiny or requirements (or opposition from activists) at all.  And that applies even to the numerous new plant varieties that during the past half century have resulted from “wide crosses,” hybridizations that move from one species or genus to another across what used to be thought of as natural breeding boundaries.

Pulling no punches, Potrykus holds gratuitous regulation “responsible for the death and blindness of thousands of children and young mothers.”  At the very least, the politicians, activists and regulators who have insisted on, implemented and maintained those regulations are guilty of what the legal system calls “reckless disregard for life.”

The hundreds of journalists and pundits rhapsodizing about the rescue of the Chilean miners might want to give some thought to the preventable, ongoing disaster of vitamin A deficiency that is making millions of lives so miserable — and short.  Once they stop hyperventilating, that is.
Henry I. Miller, a physician and molecular biologist, is a fellow at Stanford University’s Hoover Institution.  He was the founding director of the FDA’s Office of Biotechnology.  His most recent book is “The Frankenfood Myth.”


The Regulatory Bottleneck for Biotech Specialty Crops

- Jamie K Miller & Kent J Bradford, Nature Biotechnology, volume 28, number 10, October 2010

Specialty crops, which include fruits, vegetables, nuts, turf and ornamental crops, are important components of human diets and provide environmental amenities1. In 2007, such crops represented ~40% of the $140 billion in total agricultural receipts, despite being cultivated on just 4% of the total cropped area2. Although tomato was the first genetically modified (GM) food crop to be commercialized in 1994, the only GM specialty crop traits currently marketed are virus-resistant papaya and squash, insect-resistant sweet corn and violet carnations. All of these received initial regulatory approval over 10 years ago.

As a group, GM specialty crops have garnered limited market share (the exception is GM papaya resistant to papaya ringspot virus1, which now produces 90% of Hawaii’s crop). In contrast, GM field crops, such as soybean, maize, cotton and canola, have come to dominate the markets in countries where they have been released3. What is responsible for this disparity in the commercialization of GM field crops versus specialty crops?

One possibility is that the dearth of GM specialty crops indicates a lack of current research or of beneficial traits for crop improvement through genetic engineering. Alternatively, research may have continued but progression through the regulatory process to the marketplace may have failed. Anticipated lack of market acceptance could have stopped either research or regulatory submissions. To find out why specialty crops with GM traits have fared so poorly, we have analyzed the research, regulatory and market pipeline to determine which steps in the process may be responsible for the limited range of commercially available products.

To assess the recent research and development pipeline for GM specialty crops, an extensive search was conducted on a global scale for scientific journal articles, describing work in specialty crops using recombinant DNA (transgenic) methods, published between January 2003 and October 2008 (Supplementary Table 1). In most cases, these reports demonstrate proof of concept of the effectiveness of the transgene in producing the phenotypic trait in the species studied. Among 313 published articles on specialty crops, 46 species were represented, of which tobacco, potato and tomato accounted for 59% of the total reports, in part due to their use as easily transformed model plants in research laboratories (Fig. 1a). Although the United States is the leader in the number of articles published, many reports originate from the European Union (EU; Brussels), India, Japan and China (Fig. 1b). Other plant biotech surveys also indicate that a number of GM specialty crops are being developed in China4,5.

Following laboratory studies and proof of concept, development of GM crops generally proceeds to field trials. Because countries began establishing their independent regulatory processes specifically for GM organisms beginning in the early 1990s, thousands of field trial permits have been granted worldwide. The Organization for Economic Co-operation and Development (OECD; Paris) developed the UNU-MERIT field trial database, which collates GM trials that are ongoing in 24 developed countries, although data for China and India are not included (A. Arundel, OECD, personal communication). During this six-year period (2003–2008), the United States accounted for ~70% of all field trials, with 15% of the total field trials being conducted on specialty crops (Fig. 2a). The United States and Canada were responsible for
88% of the 1,231 permitted field trials on specialty crops, with the majority of the Canadian trials focused on mustard crops. The Information Systems for Biotechnology database (http://gophisb.biochem.vt.edu) was also queried to identify all approved field test permit applications in the United States between 1992 and October 2008. Field trials of specialty crops averaged 39% of the number in commodity crops from 1992 to 2002, but only 18% since 2003
(Fig. 2b). Qualitative data on GM crops under development internationally confirm that although laboratory and field trials
have been conducted on GM specialty crops in many countries, none has progressed to commercial production outside the United States, except perhaps virus-resistant tomato and pepper in China, the commercial status of which is currently uncertain6,7.

To further evaluate the scope of research that has been conducted on GM specialty crops, we categorized the traits from scientific reports and field trials into two categories: output traits, which would directly benefit consumers; and input traits, which primarily benefit producers and only indirectly benefit consumers through reduced agricultural inputs, higher productivity, lower cost or reduced environmental impacts. This compilation identified 77 specialty crops (listed in Supplementary Table 2) and 260 unique traits (Supplementary Data and Supplementary Table 1). The output traits included modifications in oil, sugar and starch content, protein quality and amino acid composition, vitamin content and nutritional quality, flavor and postharvest quality as well as reduced allergenicity. Input traits included tolerance to abiotic and biotic stresses, insect and nematode resistance, herbicide tolerance, nitrogen acquisition and yield.

These data demonstrate that there is a broad global research pipeline for GM specialty crops using traits that would be beneficial to both producers and consumers.

Governmental approval is required before GM crops can be marketed. Since 1992, 24 governmental bodies have approved or deregulated a total of 84 unique plant and trait combinations (http://www.cera. gmc.org/). Regulatory approvals of GM specialty crops averaged 48% of the number in commodity crops from 1992 to 2002, but only 5% since 2003 (Fig. 2c). Although nature biotechnology volume 28 number 10 oCTober 2010

21 approvals have been granted by all governmental bodies for nine specialty crops, only two have occurred since 2000. These two transgenic events are reduced nicotine content in tobacco and virus resistance in plum. The tobacco product was marketed briefly in the United States as an aid to smoking cessation, and the GM plum variety still awaits final approval from the US Environmental Protection Agency before it can be grown commercially.

The distribution of all regulatory approvals exhibits two distinct phases (Fig. 2c). Approvals initially peaked in 1995, followed by a decline to only one approval each in 2000 and 2001. The number of approvals then increased, albeit slowly, but only for commodity crops. A recent analysis shows that innovations in agbiotech were on an exponentially increasing trend during the 1990s, which then abruptly leveled off around 1998, with a decline in subsequent years8. Furthermore, new innovations entering the pipeline after 1998 were less likely to move toward commercialization. These patterns were attributed to a global change in regulatory and market policies toward GM crops, notably the moratorium on new approvals and therefore marketing in the EU beginning in 1998. Our results indicate that in contrast to the pre-1998 era, only commodity crop developers were able to participate successfully in this new regulatory and market environment.

There are a number of possible reasons why GM specialty crops are not progressing past the research phase, and exploring these deserves further research. Previous analyses have documented that the $1–15 million in additional costs per insertion event associated with receiving regulatory approval9,10 (which is not required for varieties developed using other breeding methods) are out of proportion to the potential additional market value that can be recovered on the limited areas devoted to these crops11. Similarly, a review on ornamental specialty crops concluded that although there is considerable technology available and valuable traits to be exploited, GM varieties are still unattractive from an economic perspective, primarily due to regulatory costs9.

Lack of demand or market rejection of GM specialty crops could also be the reason for their absence. This is undoubtedly the case in some countries and markets that unconditionally ban GM products, but the hypothesis is difficult to test, as until they receive regulatory approval, GM products are not available for consumers to accept or reject. For example, although Indian Minister for the Environment Jairam Ramesh cited a lack of public confidence when he recently blocked regulatory approval of insect-resistant GM brinjal (eggplant)12, his action precluded consumers from having the opportunity to demonstrate their preferences in the marketplace.

Given the limited number of GM specialty crops that have received regulatory approval, consumer acceptance remains largely untested in the market. Our interviews with specialty crop seed companies and nurseries provide extensive anecdotal evidence that many potentially marketable GM products have been created and tested in the private sector, but the cost and uncertainty of the regulatory process has made further development uneconomical and prevented them from testing actual market acceptance.

The justification for requiring costly regulatory testing of GM plants is to ensure that potential risks are fully assessed before commercial release. Thus, it can be argued, if specialty crops cannot meet this standard economically, that is the price to be paid to eliminate risk. However, even virtually identical traits do not require such approval if developed using non-GM methods and no actual risks unique to the recombinant DNA process per se have been experienced with the GM crops currently marketed. On the other hand, the constriction in commercialization of GM traits has resulted in lost societal benefits due to foregone innovations that are estimated to be in the billions of dollars10,13.

When GM crops could reduce environmental impacts or improve health and nutrition relative to current varieties (Supplementary Data), failure to use them also constitutes risks that generally are not considered in regulatory evaluations14. Although research on GM specialty crops continues to explore a wide range of input and output applications, their commercialization may depend upon a reexamination of the balance between potential risks versus foregone societal benefits and consequent adjustments in regulatory requirements.


In China, No Meeting of The Minds on GM Crops

- Li Jiao, Science, Oct 15, 2010
- http://news.sciencemag.org/
WUHAN, CHINA-If anyone is under the impression that the Chinese public is ready to embrace genetically modified (GM) crops, they are mistaken. At a hastily arranged session at a symposium here earlier this week, members of the general public berated and quizzed scientists on concerns ranging from the legitimate to the bizarre.

The Chinese government is pushing hard on GM. Last year, China launched a $3.5 billion R&D effort on GM crops, and in 2008 Premier Wen Jiabao declared, "To solve the food problem, we have to rely on big science and technology measures, rely on biotechnology, rely on GM." Buoyed by high-level support, the agriculture ministry last November issued safety certificates to two rice varieties bearing a protein from Bacillus thuringiensis that's toxic to insect pests.

But the Chinese public is pushing back. A group of protestors descended on the "Communication and Dialogue of Agribiotech Symposium" at Huazhong Agricultural University on 11 October, prompting organizers to set up a side session that afternoon between members of the general public and scientists.

It soon became evident that scientists face an enormous task in communicating accurate information about GM crops. "If I eat GM rice, wings will grow in my body, correct?" asked an elementary school student. An adult then posed an only slightly less farfetched question, expressing his fear-fed by sensational articles in Chinese newspapers-that GM rice will suppress sperm levels and lead to "subjugation and genocide" in China. "We only want to live healthily, why must you harm us?" he asked.

Experts sought to reassure the audience that consumption of GM crops has been linked neither to growth of human wings nor to suppressed sperm levels. But they also acknowledged that there are legitimate questions about the long-term safety of GM foods, both to human health and the environment, that are the subject of ongoing research. "I cannot say that GM food is totally safe," says Zhu Zhen of the Institute of Genetics and Developmental Biology of the Chinese Academy of Sciences (CAS).

Although the encounter yielded little consensus, scientists appreciated the chance to try to set the record straight. The onus is now on science communicators to provide accurate information and "play a role as a bridge" between scientists and the public, says symposium organizer Jia Hepeng, chief editor of CAS's Science News biweekly magazine. But with sentiments in China running strong against GM crops, and GM rice in particular, Huazhong's Zhang Qifa, a leading rice researcher, says that he can't predict how long it will take for GM rice to win approval for commercial planting. "I have tried my best for research, but I can't control others," he says.