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Drugs in Crops - The Unpalatable Truth

Nature Biotechnology Editorial
February 2004 Volume 22 Number 2 p 133

In the United States, genetically modified (GM) wheat (containing predictably a gene for resistance to a proprietary herbicide) is on the verge of approval. In Europe, having come unscathed through the UK farm-scale trials, GM maize has received the go-ahead from both ACRE, the UK government advisory group on GM crops, and from English Nature, the UK government's advisor on the environment. And yet, despite the progress with these crops, biotech companies seem determined to embark on another suicidal tussle with the anti-biotech lobby, in the process exposing their businesses not only to accusations of high-handedness and negligence but to unnecessary commercial risks. It seems that an industry in which the PhD is the intellectual norm is either incapable of learning a simple lesson from the past or cannot bring itself to act appropriately, despite what it has learned previously.

This time around, the tussle concerns the production of pharmaceuticals in GM food crops. Many companies, among them Diversa, Dow, Epicyte, Samyang Genex, Meristem Therapeutics, Maxygen and ProdiGene are exploring the expression of biopharmaceuticals in corn (maize)—130 acres of which were grown in the United States in 2002 (of a total transgenic acreage of 31.1 million). Other organizations are looking at other major crops: rice, potatoes, alfalfa. One might expect—and some in the industry obviously - that drug production in plants could be good for the image of GM crops. After all, new/cheaper medicines are the sort of thing that consumers want.

The problem is - as anti-GM lobbyists have argued already - that the production of drugs or drug intermediates in food or feed crop species bears the potential danger that pharmaceutical substances could find their way into the food chain through grain admixture, or pollen-borne gene flow (in maize, at least) or some other accidental mix-up because of the excusably human inability to distinguish between crops for food and crops for drugs. The 'contamination' of soybeans and non-GM corn in 2002 with a corn engineered by Prodigene to produce an experimental pig vaccine shows just how plausible this is (Nat. Biotechnol. 21, 3, 2003). This position is not anti-GM (something industry should appreciate) - we should be concerned about the presence of a potentially toxic substance in food plants. After all, is this really so different from a conventional pharmaceutical or biopharmaceutical manufacturer packaging its pills in candy wrappers or flour bags or storing its compounds or production batches untended outside the perimeter fence?

The difficulty is that, when it comes to pharming, the biotech industry and some of its supporters seem to be taking a stand that is principled and libertarian, rather than sensible. They argue there is an unalienable right for every corporate entity to develop whichever technology it wants and to undertake that development wherever it wants (as long as it is safe to do so, of course). The specific right in question is the right to grow drug-containing corn crops in the US Corn Belt. After a shift in position at the beginning of 2003, the US Biotechnology Industry Organization (BIO) is now firmly in this libertarian camp.

But if an industry association has a role - and BIO certainly does - then it should be to represent the longer-term interests of its broad membership. It should be trying to ensure that in the not-too-distant future, the commercial prospects for pharma plants are unhindered by predictable and avoidable political and social concerns. BIO's role ought to be to steer its membership past the obstacles, rather than plotting a course for a head-on collision.

The predictable obstacles are: that regulatory oversight will become more stringent and exhaustive because of the juxtaposition of drug crop and food crop; that protest lobbies will obstruct the drugs-in-food-crops companies directly through the legal system; that they will also obstruct them indirectly by applying pressure on corn producers generally; that producers and farmers' interest groups will run away very quickly from the fight as soon as any of their markets are threatened; that European corn producers will decry the potential commingling of food-corn and drug-corn; that a consignment of drug-corn will find its way into bird-feed mix and, by an amazing coincidence, be picked up by random tests conducted by Friends of the Earth; that 'Pigeon Fanciers [Twitchers] Against GM' will mobilize celebrity ornithologists against drug-corn; that politicians in technologically lagging nations will introduce trade barriers, such as traceability, that have little technical merit but much populist appeal. In short, the whole farce of GM food could play out again, only this time with much greater justification.

It is possible to preempt such a mess. The key is to put in place some form of foolproof segregation between food crops and drug crops. And that does not mean increased fallow zones, special cleaning routines for farm machinery, increased frequency of inspections or any other of the measures introduced last year by the US Department of Agriculture.

Instead, there are two rather obvious and nontechnical levels at which that segregation could work effectively. The first is geographical. If drugs must be produced in food crops, then those crops should be grown away from non-drug food crops. Drug crops are not commodities; it shouldn't be necessary to use the highest yielding strains of corn under the climatic conditions for which that strain has been designed (a back-of-the-envelope calculation suggests that even with present low yields, only 0.19% of total US corn production would be required to supply every insulin-dependent diabetic on the planet). So don't grow your drug-corn in the Corn Belt - grow it in California or New England. Better still, if you want to segregate geographically, grow the crop on an island where that crop is not grown for food or feed. There is already a company, for instance, that is planning to develop pharmaceutical barley and grow it in Iceland, a country that can grow the crop, but doesn't. [we're told Iceland does grow barley!!!]

The second and possibly more effective form of segregation would be culture. Simply don't use food plants for producing drugs. Why not? Precisely because they are food plants. This is not a biological distinction, it is a cultural one, but it is the source of most of the anxiety that the public is likely to feel and which the lobby groups are likely to mobilize. In essence, the only reasons that the major food crops are attractive as pharming hosts are we know how to grow/harvest them efficiently and we know how to manipulate these species genetically. Let's grow pharma plants, but let those plants be Arabidopsis, or flax, or duckweed.


Washington Lawyer Says Ban On GMO Seeds Could Pass Legal Challenge

By David Mace
Vermont Press Bureau
February 12, 2004

MONTPELIER - An attorney for the nonpartisan research arm of Congress has told Rep. Bernard Sanders, I-Vt., that a ban on genetically engineered crops in Vermont could survive a constitutional challenge.

The memo from the Congressional Research Service's Stephen Vina undercuts one of the key arguments that opponents of banning GE seeds in Vermont have raised against the plan.

"... It appears a state law that places a moratorium on the planting of GE seeds would likely survive the posed constitutional challenges," Vina wrote in a response to requests from Sanders' staff, noting that states can legally act to protect the health and safety of citizens.

Jeff Weaver, Sanders' chief of staff, said the congressman had made the request on behalf of a constituent, and that while it wasn't definitive it was an important development in the debate over whether the state could regulate GE crops.

"At a minimum I think this document shows that it's an open question, and given the amount of research CRS has done they certainly feel that it is constitutional, that the state of Vermont could prohibit the planning of genetically modified crops."

The seeds - also known as genetically modified organisms, or GMOs - have been the subject of legislative efforts for several years.

Organic farmers have argued that GE crops like corn could contaminate their crops through pollen drift, and environmentalists claim the potential impact of the plants cross-pollinating with native species are unknown.

Opponents also say that while federal agencies have determined the products are safe, most of the research backing up those claims has been funded by the producers of GE seeds.

The Democratically controlled Vermont Senate passed a bill last year that would require the labeling and registration of genetically modified seeds, but House Republicans blocked the measure and the Douglas administration has opposed it.

Agriculture Commissioner Stephen Kerr has said that conventional farmers need to be able to use GE crops, and been working with an ad hoc panel to come up with "co-existence" rules to protect organic farmers from contamination, a compromise that organic farmers have largely rejected.

Kerr has also made it clear that advice from the Vermont Attorney General's Office has been that attempts to regulate GE crops would likely run afoul of federal law, namely the U.S. Constitution's interstate commerce clause preventing states from unduly burdening such trade.

On Tuesday, he reiterated that position, but said he couldn't comment on the Congressional Research Service memo until he'd consulted with attorneys.

But Kerr rejected the arguments of those who liken the issue to mercury regulation, where Vermont's first-in-the nation law requiring the labeling of products containing mercury was upheld.

Instead, he said the case was closer to the state's law trying to require the labeling of milk products from cows treated with the synthetic hormone rBST, where a federal judge determined that there was no compelling public safety issue at issue and therefore Vermont's law was unconstitutional.

"There's no scientific dispute that mercury is a toxin," Kerr said. "The preponderance of scientific evidence says there's no health risk from GE traits. They're miles apart."

Asked to elaborate on the memo, CRS officials said that the public health and safety standard could be interpreted to include threats to the environment, but that a compelling factual case would have to be made before a judge.

Supporters of efforts to require labeling or a moratorium hailed the ruling.

"(GE supporters) been saying the main reason they can't do this, put in a moratorium, is it's unconstitutional, and no credible source has said it would stand up to that challenge," said Amy Shollenberger, policy director for farm advocacy group Rural Vermont. "There's no more credible source than the Congressional Research Center."

Rep. David Zuckerman, P-Burlington, an organic farmer who has spearheaded legislative efforts to regulate or ban the use of GE crops in Vermont, echoed Shollenberger's comments.

"I do think a two or three year time out to evaluate the consequences should remain on the table considering the potential impact of GMOs," he said.

Efforts to reach officials at CropLife America, a Washington DC-based industry trade group, for comment were unsuccessful.

Weaver said the matter may ultimately have to be settled by a judge.

"A legislature tries not to do things that are obviously illegal or unconstitutional," he said. "... Congressman Sanders has been active on this issue, and it's our opinion that the constitutional question should not stand in the way of the Vermont Legislature working its will on this issue."

Contact David Mace at


EU Races To Thwart Influx Of GM Food From East

By Paul Brown, environment correspondent
The Guardian
February 14, 2004

Biotech giants accused of using new member states as 'trojan horse'

The EU is racing against time to stop genetically modified foodstuffs entering western Europe from the east after the community's enlargement on May 1, the Guardian has learned. Some of the 10 new member states have been growing GM crops for some time, but recent checks have shown that the testing facilities to monitor their spread to neighbouring crops are either flawed or non-existent.

The biggest agricultural country in eastern Europe, Poland, which has been growing GM crops for several years, has had no testing facilities at all.

Environmental groups accuse biotech companies such as Monsanto and Pioneer of using the former eastern bloc as a "trojan horse" to get GM products into the EU. However, these companies have been legitimately marketing their seed varieties there since 1996.

The problem is not lack of legal regulation. The EU has ensured that all the new members have rules on GM similar to those in the rest of the community. The difficulty is enforcement. Some of the newcomers have no idea whether their crops contain GM organisms since their testing regimes are inadequate. Where tests have been carried out by green groups some samples have been clear but others found to contain GMOs well above the EU legal limit for labelling.

The EU has recognised this as a problem and has been helping those countries without facilities to set up laboratories that can detect genetic modification in crops and foodstuffs.

Iza Kruszewska, a researcher for the Northern Alliance for Sustainability, an environment and development group, believes that by asking countries such as the Czech Republic and Poland to permit the commercialisation of GM maize before May "the biotech industry is trying to use the enlargement process to introduce GM by the back door of EU accession".

Beate Gminder, a spokeswoman for the health and consumer protection directorate of the European commission, disagrees. She says she is sure the problem of detection will be solved by May 1.

Each country will be responsible for certifying its own products.

"According to the law, all products containing GM will have to be labelled," said Ms Gminder. "If countries did not have the testing facilities or expertise to check their products they could contract the work to countries and laboratories that could do the work. I am sure everyone understands that."

She said the rules were clear. Some GM crops had been approved in the EU. If a food product contained more than 0.9% of an approved GM crop then it would have to be clearly labelled. Products containing more than 0.5% of crops - such as GM potatoes - that were not approved in the EU would have to be labelled as containing GM ingredients.

This second provision is an added hurdle for some of the 10 new member states because they have been growing crops not yet approved in the EU. Some of these may never be approved because they have been superseded by other varieties and have fallen out of fashion.

Geert Ritsema, the Friends of the Earth GM campaigner for Europe, said: "These regulations are all about the consumer's right to choose whether to eat GM or not. Poland has allowed growing of GM soya but without any regulations being implemented. People can buy and sell these things and plant contaminated seed with out fear of prosecution or detection because there is no method of doing so.

"After May 1 all edible oils will have to be labelled if they contain GM. Soya and maize oil would require a GM-free certificate. But in an unregulated country who knows whether the certificate means anything? If supermarkets want to be sure what they're selling to consumers they'll have to test the products themselves."

Besides the internal EU rules, he said the bio-safety protocol, which EU countries had ratified, made it illegal to export and import GM seeds without prior informed consent. Because of the history of growing GM in an unregulated fashion seed from eastern Europe needed to be tested to make sure it did not contain some contamination.

A second problem for Europe concerns some of the countries farther east, such as Ukraine, which have been growing GM potatoes since 1997, and candidate countries like Romania and Bulgaria, which wish to join the union in 2007. Romania, anxious to please the US, has grown GM crops on a large scale. Neighbouring Serbia accuses Romania of contaminating its supposedly GM-free crops as a result of grain smuggling across the border.

This is a particularly sensitive issue for countries such as Hungary, which has taken a strong GM-free stance to protect its seed-growing industry. EU states have been increasingly turning to Hungary as a source of GM-free seed. Remaining uncontaminated is a key to this continuing export trade. Hungary, along with the Czech Republic, is fully equipped with laboratories that can certify seed and food as GM-free. Most other new member states, while believing that their grain is GM-free, have no way of being sure.

Tony Combes, director of corporate affairs for Monsanto UK, rejected accusations of using eastern Europe as a trojan horse. He said: "Each accession country must comply with all aspects of EU rules and regulations to be full members - this includes the enforcement of product labelling in every industry. Equally, existing EU-approved GM crops may be marketed in accession countries once they have joined."

He added: "It is more a case of the EU being used as the standard to which the accession countries have to comply."


GloFish Sales Halted By Feds: Genetically Modified Species Raises Health Fears

By Leanne Dohy and Hanneke Brooymans
Calgary Herald (Alberta, Canada)
February 15, 2004

The zebra danio's stripes could be taken as stereotypical prison garb since Environment Canada slapped a "seized and detained" order on pet store stocks of the fluorescent red fish.

Government authorities swooped down on stores in Calgary and Edmonton recently with orders preventing the sale of the world's first genetically modified pet.

"They didn't take the fish because they'd have nowhere to put them all, but we can't sell them," said Wayne Woo, co-owner of Riverfront Aquariums in downtown Calgary.

"It would have been nice if they'd told us about this before we brought them in. It could be three or four months before we know if we're able to sell them."

The formerly dowdy zebra danio, a freshwater aquarium fish, now boasts a rosy red glow thanks to scientists who injected the fluorescent gene of a sea anemone into the eggs of regular danios.

Originally developed to help detect pollution, the fish were promptly marketed as a novelty pet by an American company under the name GloFish.

But Yorktown Technologies did not know the Canadian government requires living products of biotechnology to go through a risk assessment, said Kim Hibbeln, head of Environment Canada's biotechnology section.

The federal department wants to make sure the fish won't harm human health or the environment.

Genetically modified plants and animals have raised concerns that they may harm the environment if they accidentally escape.

Critics also worry tinkering with pet genes could lead to the ethically controversial practice of human genetic engineering.

Yorktown Technologies sold hundreds of the fish to Canadian suppliers before they realized they needed the assessment done, said Hibbeln.

About 400 were seized in Alberta, the department estimates.

Woo said his store still has 50 to 60 of zebra danios on display, and had sold about as many before the detention order came down.

Ron Thompson, manager of Edmonton's Aquarium Illusions Inc., said it appears some suppliers have not been told they must stop selling the transgenic pets.

"I could have bought more today from my supplier," he said.

A large aquarium in the store's back room has a piece of paper taped to it that reads "Seized and detained" in large letters.

The store is responsible for keeping all the fish, dead or alive, on its premises until Environment Canada decides whether they can be sold in Canada.

Thompson said a conservation officer visited the store a week ago, posted the sign and counted the number of fish: 23.

He told Thompson it could take 120 to 180 days before Yorktown Technologies wades through the assessment process.

The fish cannot be sold in that time. The maximum penalty for breaking this law is a $300,000 fine and up to six months in jail.

Other fish species are dyed or injected to make them brighter, Thompson said. He does not think GloFish are much different. Nor are they dangerous, he added.

"People take their poodles and have them dyed pink to match their clothing. Yeah, it's frivolous, but it's fun."

But Dave Tomlinson, another customer, said he thinks the fish are neat.

"I'm all for genetics. Without science, where would we be? So knock yourself out."

Yorktown Technologies president Alan Blake could not be reached for comment.


Bio-pharm crops: Proceed With Caution

By Patrick Byrne
BioScience News and Advocate - Guest editorial
February 17, 2004

In my home state of Colorado, the ongoing battles over agricultural biotechnology seemed to be calming down about a year ago. Attempts to require labeling of genetically modified (GM) food had lost steam, and a policy adopted by Boulder County promoted the co-existence of GM and organic crops. One could begin to look forward to an era of continuing compromise and mutual respect between the opposing camps.

The relative peace was shattered in spring of 2003 by a request from Meristem Therapeutics, a French company, to grow a plot of corn that produces lipase, an enzyme used in the treatment of cystic fibrosis patients. This was the first field trial proposed for Colorado involving a "bio-pharm" or "plant-made pharmaceutical" (PMP) crop. Immediately after the Meristem application became public knowledge, the protests began: demonstrations at the state capitol, op-ed pieces in newspapers, and worried letters to state officials.

What was notable in this round of the biotech battles was that it was not just the usual suspects (Friends of the Earth, the organic foods lobby, etc.) who were voicing concern. This time family farmers, nutritionists, the grocery industry, and the "person in the street" expressed apprehension, if not downright alarm, at the prospect of medicines in their cornflakes.

Meristem's application to grow the trial was tentatively approved by the U.S. Department of Agriculture and was forwarded to the state Department of Agriculture for concurrence. The state had a mere 30 days to evaluate the application and respond to USDA.

To make a long story short, the state convened a technical advisory panel, which raised a series of concerns and questions of Meristem and the contracted farmers. After the concerns were deemed to be adequately addressed, the state issued its concurrence with USDA, and the company was issued its permit. However, by the time the permit was granted, optimal planting dates for corn had passed, and Meristem decided not to plant the crop.

The attention on bio-pharm crops, however, has not abated. State government, university think tanks, entrepreneurs, farmers' groups, and environmental organizations are all studying the issue and discussing their next moves. At the national level, USDA has announced its intentions to review the way it regulates field release of GM organisms. About the same time, the National Research Council released a report questioning the adequacy of any single gene containment strategy, instead calling for redundant levels of containment.

All this ferment adds up to a clear message, at least in the Colorado context: Now is not the time to forge ahead with PMP field trials. There is too much public anxiety about producing pharmaceuticals in food crops, too many policy reviews underway, too many questions about gene containment. A misstep now (a la Starlink) could derail the infant industry for years.

In the interests of long-term benefit to medical patients and rural economies, it's time to slow down, carefully analyze risks and benefits, explain bio-pharming to the public, and consider alternative PMP strategies in non-food crops like algae or tobacco. Proceeding with caution now will pay ample dividends in the future.


Bad For the Poor and Bad For Science

by Colin Tudge
February 20, 2004

As revealed in this week's leaked minutes, the government's commitment to GM crops is unswerving. Revealed once more, too, is its arrogance; for it acknowledges public resistance but hopes that "opposition might eventually be worn down by solid, authoritative scientific argument". Most worrying of all, though, is the truly astonishing ignorance of people in high places.

The arguments for genetically modified organisms (GMOs) that have been dinned into us for 15 years are based on an almost sublime misreading of the world's food problems. Indeed, GMOs are part of a political and economic trend that is threatening all humanity.

The crucial claim for GM crops is that they are necessary. They can out-yield traditional varieties, and can be made especially rich in protein and vitamins. The world's population is rising fast and without GM, the story has it, famine and increasing deficiency are inevitable. To oppose their development is to be effete to the point of wickedness.

But this is not the whole picture. The world population stands at 6 billion, and the UN says it will reach 10 billion by 2050 - but then should level out. Present productivity could be doubled by improving traditional breeding and husbandry, so whatever the virtues of GMOs, necessity is not among them.

Present-day deficiencies are almost never caused by an inability to produce enough. Angola is a good example: it is always bordering on disaster, yet it has two-and-a-half times the area of France and every kind of climate, and only 12.5 million people. Its farmers are highly accomplished. Famines result not from inability but from the civil war that raged for 30 years.

Behind the claim that GMOs are necessary lies a deep - and racist - failure to appreciate traditional farming. It's assumed that farmers of the developing world, with their small farms, cannot cope. But all who have looked closely know that traditional farmers are remarkably adept. Their greatest need is for financial security: especially small loans with regulated rates of interest. Technological innovation becomes pertinent only when the traditional ways have been given half a chance, and shown to be lacking.

But, say the enthusiasts, GMOs are part of the transition from peasant-based, low-output subsistence to industrialized production based on biotech, modern chemistry and machines. This is "progress". It "liberates" the peasants, enabling them to migrate to the cities, to work for proper wages. We see the transition in India, home (with China) to the world's fastest-growing IT industry. Even more to the point, modern farming is profitable, as traditional farming is not. The profits contribute to GDP, and everyone benefits.

But extra productivity can be harmful, while profit is achieved primarily by cutting labor, which is the most expensive input. In Britain and the US, only about 1% of the labor force works on the land. In India, as in the third world as a whole, it's 60%. If India farmed as the British do, 594 million people would be out of work. India's IT industry, flaunted as the hope for the future, employs 60,000 - which falls short of what would be required by 10,000 to one. To replace the status quo with hi-tech, low-labour, industrialized agriculture would create social problems on a scale that mercifully has not yet been seen. For the foreseeable future the world's economy has to be primarily agrarian.

Ironically, one victim of the GM madness is science itself, for in principle GMOs could be of real use. I saw an example in Brazil: GM papaya, designed to resist local diseases. This is hi-tech as it should be: designed by the people for the people. Contrast this with GM "golden rice", widely presented as an unequivocal triumph. It is is fitted with a gene that produces carotene, which in effect is vitamin A - lack of which causes blindness in tens of millions of children.

But carotene is one of the commonest organic compounds in nature. People who practice horticulture have no fear of vitamin A deficiency; and traditionally, horticulture was universal. Modern, corporate farming - monocultural rice, or maize grown for export as cattle feed - is a prime cause of the deficiency that leads to blindness. It's all good for the GDP but not for people.

The prime task for people seriously interested in humanity's food problems is to help the world's small farmers. Technical up-grading is desirable, and could include GM. But wholesale transition of the kind now in process, in which GM has become a key player, is a disaster. GMOs have drawn attention to the disaster, and for this perhaps we should be grateful. They are also drawing attention to the shortcomings of government and of experts in general. That needs urgent attention, too.

Colin Tudge is the author of 'The Impact of the Gene' and 'So Shall We Reap', an analysis of world food production.

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