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February 24, 2009


A Golden Opportunity, Squandered; Modified Food's Moment; France's Frankenban


* A Golden Opportunity, Squandered
* Modified Food's Moment?
* Kenya Approves GM After Years of Delays
* France's Frankenban
* Super Cassava' to Enter Field Trials

A Golden Opportunity, Squandered

- Henry I. Miller, Trends in Biotechnology, Vo. 27, Issue 3, March 2009, Pages 129-130 http://dx.doi.org/10.1016/j.tibtech.2008.11.004

Even when used to make products of negligible risk and that contribute significantly to public health, recombinant DNA technology (a.k.a. 'genetic modification', or GM) applied to agriculture has a tough row to hoe. 'Golden Rice', which has been enriched by the addition of genes that allow rice to synthesize beta-carotene (the precursor of vitamin A) in its edible endosperm, has endured resistance from activists and a decade of imposing and gratuitous obstacles to regulatory approval. This is an ominous precedent for other 'biofortified' foods made with recombinant DNA technology.

The announcement in November 2008 by a group of multi-national European scientists that they had produced an extraordinary new, recombinant DNA-modified tomato variety garnered a great deal of media attention worldwide. This variety, which contains two snapdragon transcription factors, boasts deep purple skin and flesh and contains levels of antioxidants threefold greater than its unmodified parent. Most important, when fed to highly cancer-susceptible mice, the tomatoes significantly extended the life span of the animals [1].

These tomatoes are a so-called functional food, one fortified or enhanced with something that confers health benefits. This is not a new idea: for more than 80 years, iodine has been added to table salt to prevent hypothyroidism and goiter (see http://www.iccidd.org/pages/protecting-children/fortifying-salt/history-of-salt-iodization.php). Newer functional foods, including eggs with enhanced levels of omega-3 fatty acids to reduce the incidence of heart disease and probiotic yogurt with extra bacteria to aid digestion, are becoming more common.

The announcement of the enhanced-antioxidant tomato received wide attention from the press and scientific community, but an equally momentous achievement of plant genetic modification that is almost a decade old has been largely ignored. That innovation is 'Golden Rice', a collection of new rice varieties biofortified, or enriched, by the introduction of genes that enable the edible endosperm of rice to produce beta-carotene, the precursor of vitamin A (see http://www.goldenrice.org). (It is converted in the human body, as needed, to the active form.)

Why are these new varieties so important? After all, most physicians in North America and Europe never see a single case of vitamin A deficiency in their professional lifetimes. The situation is very different in many developing countries, however. Vitamin A deficiency is epidemic among poor people whose diet is comprised largely of rice (which contains neither beta-carotene nor vitamin A) or other carbohydrate-rich, vitamin-poor sources of calories.

In developing countries, 200-300 million children of preschool age are at risk of vitamin A deficiency, which can be devastating and even fatal. It increases susceptibility to common childhood infections such as measles and diarrheal diseases and is the single most important cause of childhood blindness in developing countries. Every year, not, vert, similar500 000 children become blind as a result of vitamin A deficiency and 70% die within a year of losing their sight (see http://www.cdc.gov/nccdphp/dnpa/immpact/micronutrient_facts.htm).

Why not simply 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? It's a good idea in theory, except that neither the resources - hundreds of millions of dollars annually - nor the infrastructure for distribution are available.

Recombinant DNA technology offers a cheaper and more feasible solution: Golden Rice, which, after the insertion of two genes coding for phytoene synthase (psy) and phytoene desaturase (crt I), is able to accumulate beta-carotene in the endosperm, the edible portion of the genetically altered rice grains (see http://www.goldenrice.org/Content2-How/how1_sci.html). The concept is simple: although rice plants do not normally synthesize beta-carotene in the endosperm 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 recombinant DNA techniques to insert the two genes that express these enzymes, the pathway becomes functional and the rice grains accumulate therapeutic amounts of beta-carotene. Golden Rice and the enhanced-antioxidant tomatoes are examples of what has been called the 'second generation' of plants developed with recombinant DNA technology - those that provide consumer-directed benefits, as opposed to plants that offer only improvements in agronomic properties.

Golden Rice offers the potential to make contributions to human health and welfare as historic as those made by the discovery and distribution of the Salk polio vaccine. 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 radical groups - has provided already risk-averse regulators political 'cover' 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 and bureaucratic dithering. As the 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.' [2]

Putting it another way, government regulation of field research with plants should focus on the traits inherent in the host plant and in the introduced genes that might be related to risk-invasiveness, weediness, toxicity and so forth - rather than on whether one or another technique of genetic manipulation was used.

In spite of its vast potential to benefit humanity - and negligible likelihood of harm to human health or the environment - a decade after its creation Golden Rice remains hung up in regulatory red tape with no end in sight (see http://www.goldenrice.org/Content2-How/how4_regul.html). Lactoferrin and lysozyme produced in recombinant DNA-modified rice by 'biopharming' (which is often cited as the 'third generation' of recombinant DNA-modified plants) and used to treat children with diarrhea has endured similar regulatory delays (see http://www.washingtontimes.com/news/2004/jul/05/20040705-095035-5659r/).

If Golden Rice had been created with conventional techniques of genetic improvement (which is not possible for technical reasons), it would have required 2-3 years to breed relevant local varieties and to produce seed for distribution. Because all plants produce high amounts of carotenoids, their presence in rice will not introduce any new substances into the environment or provide any additional selective advantage in the field. beta-carotene is already present in the food supply and is, in (U.S.) regulatory terms, 'Generally Recognized As Safe', or GRAS (see http://www.cfsan.fda.gov/not, vert, similardms/gras-ov.html); as such, it would not require a pre-market governmental review. Cancer-preventing tomatoes, take notice.

In contrast to plants modified with recombinant DNA technology, those constructed with less precise techniques, such as hybridization or mutagenesis, generally are subject to no government scrutiny or requirements (or opposition from activists) at all. That absence of scrutiny applies even to the numerous new plant varieties that have resulted from 'wide crosses', hybridizations that move genes from one species or genus to another across what used to be thought of as natural breeding boundaries. (One arguable exception is Canada, where regulations are, in theory, triggered by whether a trait in a given species is 'novel', but the reality is that recombinant DNA-modified organisms there are subjected to a far higher standard than those crafted with conventional technologies.)

It should be noted that the commonly cultivated and consumed varieties of rice - all of which have been developed with conventional techniques - are the product of wide crosses [3] and, therefore, are 'transgenic' by any reasonable scientific definition. However, these constructions are less precisely crafted, less well characterized and less predictable than recombinant DNA constructions. Thus, we have a situation in which for more than two decades the degree of regulatory scrutiny (and therefore, the time and expense required for the development of new varieties) has been inversely proportional to the perceived degree of risk. This is absurd.

Regulators and activists are not the only villains of the piece. The media - and even scientific journals (see Ref. [4]) - have been undiscriminating and overly tolerant of the misrepresentations and distortions of anti-biotechnology activists, and politicians have opposed recombinant DNA technology for reasons of trade protectionism.

Judith Rodin, the President of the Rockefeller Foundation, announced in October 2008 that her organization will provide funding to the International Rice Research Institute to shepherd Golden Rice through national regulatory approval processes in Bangladesh, India, Indonesia and the Philippines (see http://www.rockfound.org/about_us/speeches/101708food_prize.shtml).

Although this is presumptive good news, what is really needed is a multi-faceted, aggressive effort to reform regulation so that new genetic constructions will be able to succeed even if they do not enjoy the patronage of a powerful benefactor. Employing a laboratory metaphor, the regulatory travails of Golden Rice are analogous to a positive control in the laboratory that doesn't work: in other words, if we cannot move this product expeditiously through the regulatory labyrinths and into the rice-cookers of the developing world, then the application of recombinant DNA technology to biofortified foods is truly 'cooked'.

In an April 2008 editorial in the journal Science, Nina Fedoroff, an eminent plant geneticist at Pennsylvania State University who is currently serving as senior scientific advisor to the U.S. Secretary of State, wrote: 'A new Green Revolution demands a global commitment to creating a modern agricultural infrastructure everywhere, adequate investment in training and modern laboratory facilities, and progress toward simplified regulatory approaches that are responsive to accumulating evidence of safety. Do we have the will and the wisdom to make it happen?' [5]

The Golden Rice story makes it clear that the answer is, not yet.

1 E. Butelli et al., Enrichment of tomato fruit with health-promoting anthocyanins by expression of select transcription factors, Nat. Biotechnol. 26 (2008), pp. 1301-1308. Full Text via CrossRef | View Record in Scopus | Cited By in Scopus (0)

2 Anonymous, U.S. biotechnology policy, Nature 356 (1992), pp. 1-2.

3 R.M. Goodman et al., Gene transfer in crop improvement, Science 236 (1987), pp. 48-54. View Record in Scopus | Cited By in Scopus (27)

4 H.I. Miller et al., Is biotechnology a victim of anti-science bias in scientific journals?, Trends Biotechnol. 26 (2008), pp. 122-125. Article | PDF (109 K) | View Record in Scopus | Cited By in Scopus (0)

5 N. Fedoro f, Seeds of a perfect storm, Science 320 (2008), p. 425. Full Text via CrossRef | View Record in Scopus | Cited By in Scopus (1)

Author is at Hoover Institution, Stanford University, Stanford, CA 94305-6010, USA


Modified Food's Moment?

- Toni Johnson, Council on Foreign Relations, Feb. 18, 2009

More than 40 million people joined the ranks of the undernourished in 2008, increasing the number of very hungry to nearly one billion. Feeding them has become harder in the midst of a global financial crisis, with economic bailouts dominating the agenda of the rich donor nations. Easing commodity prices have provided some relief, but the financial slump is making it harder for farmers to get loans. A $30 billion per year investment in agriculture "could eradicate the root causes of global hunger by 2025," suggests a Christian Science Monitor editorial.
Advocates and producers of genetically modified (GM) food contend they have part of the answer to the crisis.

They say their products can improve crop yields in adverse conditions such as droughts, reduce the use of fertilizers and pesticides, and offer extra nutrition. British bioethicist Albert Weale argues in Cosmos Magazine that despite potential concerns over modified foods, there is "an ethical obligation to explore whether GM crops could reduce poverty, and improve food security and profitable agriculture in developing countries." But some critics see no place for modified foods at the table. "The food crisis should not be an opportunity to make more money through the sale of fertilizers, agrochemicals and genetically modified seeds," says one sustainable agriculture advocacy group based in Spain.

According to the World Watch Institute, a U.S.-based environmental think-tank, modified agriculture represented about 9 percent of global crop production in 2007 in twenty-three countries, and that number could double in the next decade. To date there is no international consensus on the merits or drawbacks of genetically modified organisms (GMOs). The UN Food and Agriculture Organization has acknowledged the potential benefits of genetically modified agriculture for the world's neediest people but has joined the World Health Organization in studying potential safety issues. In many countries, GM foods remain either banned or strictly controlled over safety and biodiversity concerns. Such regulation has in some cases caused trade friction with the largest producer of GM foods--the United States.

Engineered seeds can be two to four times as expensive as normal seeds. GMO makers argue that they price seeds higher because they will provide farmers more profits through bigger yields. But critics say engineered seeds may not offer all the benefits advertised (Grist). An intergovernmental assessment of agriculture knowledge notes in a 2008 report that GMO licensing practices, such as prohibiting seed saving (PDF), could damage "local practices that enhance food security" in developing countries. Some humanitarian groups point to the suicides of thousands of indebted Indian farmers after their modified cotton crops failed (The National) as evidence of the risk of using GM seeds. Yet modified seeds have raised the net income of many Indian farmers, according to an October 2008 study by the International Food Policy Research Institute. Though purchasing modified seeds contributed to Indian farmer indebtedness (PDF), other factors "played an indispensable role," the study asserts.

Advocates of organic farming say their methods offer a better solution for developing-nation farmers because they require less energy and fertilizer use. Meanwhile, many humanitarian activists attribute the food security problem in developing countries to poorly crafted food aid policies that benefit developed-country agriculture. In a recent paper on development aid, CFR Senior Fellow Laurie Garrett says "Buy American" mandates for U.S. food aid undermine "regional markets for agricultural products, driving local farmers into deeper poverty" (PDF).

Funding agriculture instead of donating food, however, could expand the markets of GM producers in developing countries. In June 2008, biotech-giant Monsanto offered to provide modified seeds to African nations (BusinessWeek) royalty-free. Monsanto Chief Executive Hugh Grant said rather than it being a feel-good gesture, "[satisfying] the demand curve is a great business opportunity."


India's GM Cotton Plantation Seen Rising

- Reuters, Feb 18, 2009

NEW DELHI - Indian farmers will grow genetically modified cotton on 90 percent of the area under cotton cultivation in two years, a group that advocates the use of such crops said on Wednesday. "Indian farmers have overwhelmingly adopted genetically modified cotton as better yields pushed output substantially and drastically cut pesticide use," said Clive James, chairman of the International Service for the Acquisition of Agri-biotech Applications.

The organisation advocates large-scale use and application of genetically modified crops. "It is noteworthy that for the seven year period 2002-2008, there was a 150 fold increase in Bt cotton in India," he said.

Indian farmers grow cotton on about 9 million hectares (22 million acres). He said India planted genetically altered fibre on 7.6 million hectares in 2008, up from 6.2 million hectares a year earlier.

Cotton output in India, the world's second-biggest producer, is expected fall to 29 million bales (1 bale=170 kg) in the crop year to September 2009 from 31.5 million bales a year ago as late sowing would cut output, according to official estimates.

India allowed commercial cultivation of bacillus thuringiensis or Bt cotton in 2002, sparking protests from activists who say genetically altered crops are a health hazard, spoil soil texture and harm the environment.

Increasing cotton output has encouraged government officials to support the technology which is seen as a viable step to feed the country's more than one billion population when farmland is shrinking rapidly due to industrialisation and urban spread.

A committee of experts under the federal environment ministry has already allowed large-scale field trials of popular brinjal vegetable, the first genetically altered food crop to be tested. An official at Monsanto, the world's biggest seed company, told Reuters on Tuesday that the company had started field trials for genetically modified corn in India but a commercial launch was a few years away.


Kenya Approves GM After Years of Delays

- David Njagi, Scidev.net, Feb. 18, 2009

Kenya has become the fourth African country to allow the production and use of genetically modified (GM) crops after president Mwai Kibaki signed off on parliament's approval of new biosafety legislation last week (13 February).

The Biosafety Bill 2008 sees the East African nation join Burkina Faso, Egypt and South Africa as African nations which permit genetically modified farming, following years of fine-tuning to the proposed regulations and mechanisms to monitor and regulate GM technology, and protect farmers and consumers (see Kenya prepares to approve biosafety legislation).

A National Biosafety Authority will now be created, under the National Council for Science and Technology, to implement the legislation and to follow priorities as stated in the National Biotechnology Development Policy passed in 2006 (see Kenya approves a national policy on biotechnology), Margaret Karembu, director of the Kenya-based African centre of the International Service for the Acquisition of Agri-biotech Applications (ISAAA), told SciDev.Net.

She adds that the new legislation will fast-track the Water Efficient Maize for Africa (WEMA) project to develop drought-resistant maize, which had stalled due to the lack of a legislative framework.

Charles Watoro, director of Kenya Agricultural Research Institute (KARI) says a lot of agricultural research has been delayed due to several postponements in passing the legislation. The new law will allow open field trials in several locations, removing previous restrictions and speeding up agricultural improvements, he says.

"But we need implementation of this law very fast," he adds. Watoro says KARI researchers are working on cotton, maize, cassava, sweet potatoes and sorghum genetically modified to resist common pests.

Meanwhile, an international survey of 13 years of genetically modified agriculture up until 2008, released in Nairobi in the same week (11 February) by ISAAA, says there is substantial evidence that crops genetically modified to withstand drought, salt, insects and diseases are safe for human consumption.

ISAAA founder Clive James said at a press conference in Nairobi (12 February) that biotechnology delivers food that is as safe as those produced through conventional agriculture. "This technology is regulated more heavily than any other,'' said James.

James applauded the ratification of the Biosafety Bill by the Kenyan president, saying the process indicated mature leadership responding to the food crisis, which has been declared a national disaster. He added that ISAAA is interested in helping developing countries like Kenya with the decision-making process but that ultimately it is up to the individual countries to make decisions on biotechnology.


France's Frankenban

- The Wall Street Journal Europe, Feb. 16, 2009

Science isn't a concern when greens try to block biotech crops and goods. French food-safety authorities have finally owned up to the fact that a form of genetically modified corn isn't dangerous. Now it's up to the rest of the EU to make sure Paris doesn't keep using junk science to ban the crop.

Reversing an earlier decision, the food agency known by its French initials AFSSA concluded recently that Monsanto's MON 810 corn poses no health risks. The change of heart corrected not only an error of science but one of intellectual honesty: Twelve of the 15 scientists who wrote the original report protested that politicians had misused their work. Yet AFSSA didn't deign to make its latest findings public until Le Figaro published a story about them.

Predictably, Prime Minister Francois Fillon promised to maintain the government ban on GM crops as a "precaution." The European Commission has criticized France's unscientific stance, and today an EU panel of experts will consider a proposal to force France and Greece to overturn their bans on MON 810. The issue could be punted to a March 2 meeting of environment ministers, who in the past have been loath to force national capitals to accept biotech seeds and products.

Hiding behind the "precautionary principle"-which holds that we should avoid any activity that might, in the future, somewhere, have some sort of not-so-perfect effect on, well, something-is not only bad science. It's also contrary to what farmers want. Despite fear mongering about "frankenfoods," biotech planting in Europe rose by 21% last year from 2007, according to CropLife International, an industry lobbying group. Even so, the Old Continent is quickly being left behind when it comes to GM crops, which are gaining in popularity from Egypt to Uruguay to China.

Many of the same groups that oppose genetically modified goods in spite of the science support CO2 restrictions because of the supposedly settled science of global warming. We guess science is king only when the greens say it is.


Super Cassava' to Enter Field Trials

- Aisling Irwin, Scidev.net, Feb. 19, 2009

An ambitious attempt to bioengineer cassava into a "complete meal" took a step forward last week with the approval of field trials for the plant by Nigeria's National Biosafety Committee.

The genetically modified cassava contains 30 times as much beta-carotene, a precursor of vitamin A, as its normal counterpart. Ultimately it is hoped the cassava will contain increased levels of iron, protein, zinc and vitamin E that will meet the minimum daily allowance in a 500 gram meal.

"This is one of the most ambitious projects ever attempted in a major crop plant," said Richard Sayre of the Donald Danforth Plant Science Center in St Louis, Missouri, who spoke at the annual meeting of the American Association for the Advancement of Science, held in Chicago, the United States last week (13 February).

Sayre directs the BioCassava Plus programme, which began in 2005 under the Grand Challenges for Global Health Programme. The challenge is to provide complete nutrition in a single staple crop.

Some 250 million people in Sub-Saharan Africa - and 800 million people globally - rely on cassava as their main source of energy. But it is low in nutrients, vulnerable to plant viruses, and it lasts only two days without processing.

As well as adding extra nutrients, the team has successfully produced varieties with increased virus resistance, decreased amounts of poisonous cyanides - which can remain in cassava if the crop is poorly processed - and a longer shelf life.

"We're transforming it into a staple that will provide complete nutrition," Sayre told SciDev.Net. Laboratory and greenhouse tests have been successful - for example, iron levels were increased ninefold, zinc fourfold and protein fourfold. The next stage is confined field trials - small-scale field trials to evaluate the performance of the crop under stringent conditions.

If those succeed, there will be nutrition trials, first in animals and then in humans. Nigeria's approval is the first it has granted for a GM confined field trial, said Sayre - though the document awaits the signature of the country's environment minister. The Nigerian National Root Crops Research Initiative will oversee the trials.

So far the traits have been introduced individually into plants. The first product with multiple traits is likely to contain just elevated vitamin A, iron and protein as well as virus resistance.

"To add the other four is going to be technologically more challenging," said Sayre. The team also hopes to begin confined field trials in Kenya, to be overseen by the Kenya Agricultural Research Institute, before the end of 2009.

"We are now in the process of training African scientists in our labs. They are going to learn the technology to make a transgenic cassava plant. They will return and make the final products themselves," said Sayre.