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August 2006 Updates

Federal Court Rules Biopharm Permits Issued Illegally in Hawai'i

Paul Achitoff, Earthjustice, (808) 599-2436 x12
Bill Freese, Center for Food Safety, (202) 547-9359 x14
August 14 2006

Ruling first ever on controversial drug-producing GE crops manufactured by Monsanto and others

Honolulu, HI -- Citing possible harm to Hawai'i's 329 endangered and threatened species, a federal district judge has ruled that the U.S. Department of Agriculture (USDA) violated the Endangered Species Act (ESA) in permitting the cultivation of drug-producing, genetically engineered crops throughout Hawai'i. The court found that USDA acted in "utter disregard" of the ESA, and also violated the National Environmental Policy Act (NEPA), by failing to conduct even preliminary investigations prior to its approval of the plantings.

The August 10 decision represents the first federal court ruling ever on "biopharming," the controversial practice of genetically altering food crops to produce experimental drugs and industrial compounds. Biopharming has provoked the ire of the food industry, public interest groups, and farmers concerned about contamination of foods and the environment with potent drugs, and potential economic losses from adulterated food. The four USDA-issued permits primarily at issue in the case authorized Monsanto, ProdiGene, Garst Seed Company, and the Hawai'i Agriculture Research Center to plant over 800 acres (1.25 square miles) of drug-producing corn and sugarcane at various sites in Kaua'i, O'ahu, Moloka'i, and Maui from 2001 to 2003.

The plaintiffs in the case -- Center for Food Safety, Friends of the Earth, Pesticide Action Network North America, and KAHEA (the Hawaiian-Environmental Alliance) -- sued the USDA in November 2003. Plaintiffs were represented by Earthjustice and Center for Food Safety.

"This decision shows that regulatory oversight of this out-of-control industry has been woefully inadequate. The agency entrusted with protecting human health and the environment from the impacts of genetic engineering experiments has been asleep at the wheel," said Paul Achitoff, attorney with Earthjustice.

"The ruling is a clear victory for Hawai'i's environment," said Joseph Mendelson, Legal Director of the Center for Food Safety. "It will help protect the islands from the illegal field-testing of genetically engineered, drug-producing crops."

Plaintiffs point to a scathing critique of USDA's regulation of biopharm and other genetically altered crops issued by the agency's Inspector General in December 2005 as evidence that USDA continues to neglect its regulatory duties. That report documented numerous violations, including USDA's failure to record locations of field trial sites and conduct required inspections. In two instances, USDA regulators were unaware that a total of more than two tons of harvested biopharm crop material was stored at uninspected facilities for over a year.

Hawai'i is the nation's leading state for plantings of experimental, genetically engineered crops, having hosted more than 5,000 such tests from 1987 through 2004, including several dozen biopharm crop trials. Biopharm crops produce substances such as experimental vaccines, growth hormones, blood-clotting and -thinning agents, antibodies, and industrial enzymes. Two high-profile contamination incidents in 2002, in which biopharm corn produced by ProdiGene contaminated soybeans and corn in Nebraska and Iowa, provoked widespread criticism of the practice, which nevertheless continues.

Plaintiffs have also challenged USDA's practice of concealing the locations of trials from the public, and in most cases not disclosing the substances being grown in the plants.

Judge J. Michael Seabright ordered the parties to appear in court on August 22, 2006, to discuss remedies for the government's violations.

"We will not rest until the federal government prohibits the irresponsible and hazardous field-testing of drug-producing, genetically engineered crops," said Andrew Kimbrell, executive director of Center for Food Safety.

Read a copy of the court's ruling (pdf file)


Law to Label GM Foods Gazetted in Sri Lanka

Centre for Environmental Justice
August 03, 2006

Colombo - As requested by the Centre for Environmental Justice in its case filed on 4th May 2005, the Government of Sri Lanka finally gazetted GM food labeling legislation earlier this month making it mandatory for importers and local manufacturers of GM foods to label their produce in the future.

The law which will come into effect from January 1, 2007 requires all GM food items to carry a prominent sticker informing that the product contains GM materials, giving the consumer the freedom of choice. Defaulters of this Law will have to face a six-month jail term or a Rs. 10,000 fine or both under the Food Act, No. 26 of 1980. All GM food importers will be required to apply for a permit from the Food Advisory Committee chaired by the Health Services Director General to import GM products in future.

The permit will be given after verifying that the products are safe for human consumption and with the condition that it will be prominently labelled.

Read the regulation in Gazette Ex. Ordinary. 1456/22 , 3rd August 2006


Escaped Golf-Course Grass Frees Gene Genie in the US

By Andy Coghlan
New Scientist, issue 2564, page 9
August 09, 2006

A nondescript grass discovered in the Oregon countryside is hardly an alien invasion. Yet the plant - a genetically modified form of a grass commonly grown on golf courses - is worrying the US Department of Agriculture (USDA) enough that it is running its first full environmental impact assessment of a GM plant.

It is the first time a GM plant has escaped into the wild in the US, and it has managed it before securing USDA approval. The plant, creeping bentgrass (Agrostis stolonifera, carries a bacterial gene that makes it immune to the potent herbicide glyphosate, better known as Roundup. The manufacturer, The Scotts Company, Marysville, Ohio, is hoping the grass will provide a turf that makes it easier for golf course owners to manage their fairways and greens by letting them kill competing weedy grasses with glyphosate. "It could prove extremely popular with the thousands of golf course managers in the US, making it easy for it to spread"

Jay Reichman and colleagues at the US Environmental Protection Agency's labs in Corvallis, Oregon, identified nine escapees out of 20,400 plants of various grass varieties sampled within a 4.8-kilometre radius of the site where the bentgrass is being cultivated, the most distant 3.8 kilometres away. The team showed that the GM grass has spread both by pollinating non-GM plants to form hybrids, and by seed movement.

Bentgrass is a perennial, so once out there it regrows year after year, whereas most GM crops - mainly soybeans, maize and canola (oilseed rape) - are annuals, unable to reproduce, harvested each year and replaced with an entirely new crop the next. Another worry is that unlike the other GM crops, bentgrass has many relatives in the US with which it can cross-breed or hybridise, potentially passing on the glyphosate-resistance gene to other species - with unpredictable results.

"It's a cautionary tale of what could happen with other GM plants that could be of greater concern," says Reichman. "I suspect that more examples of this will show up." His report will appear in the October issue of Molecular Ecology.

If bentgrass is approved by the USDA, it could prove a hit with the thousands of golf course managers throughout the US, making it easy for the crop to spread far and wide. If it reaches environmentally sensitive wildernesses or establishes itself by waterways, removing it could require weedkillers far more harmful than the relatively benign glyphosate.

"It's definitely a new set of variables we've not had to deal with in previous GM crops," says Eric Baack of Indiana University in Bloomington, who comments on Reichman's findings in Current Biology (vol 16, p R1). Still, it isn't clear whether the gene would have much impact in the wild. "You wouldn't expect the weedkiller-resistance gene to be a particular advantage in the wild," says Baack. Also, the USDA doesn't class conventional bentgrass as a "noxious" weed.

There is however the possibility of litigation if the GM grass contaminates other elite grass strains under cultivation. Some 70 per cent of the US's commercial grass seed is grown in Oregon, so there is the potential for accidental adulteration.

The USDA is not taking any chances. "This is a perennial, and has wild and weedy relatives, and it's something we think we need to know the environmental impact of before it's deregulated," says a spokeswoman for the USDA's Biotechnology Regulatory Services in Riverdale, Maryland. "There's no current set date for when [the environmental impact assessment] will be finished," she says.

Whether the US public takes any notice of the furore is another question entirely. "I don't think people will worry about lawns and golf courses if they've not shown any worries already about GM food," says Baack.


Grass Created in Lab Is Found in the Wild

By Andrew Pollack
New York Times
August 16, 2006

An unapproved type of genetically engineered grass has been found growing in the wild in what scientists say could be the first instance in the United States in which a biotechnology plant has established itself outside a farm.

Ecologists at the Environmental Protection Agency said they had found a small number of the grass plants growing in central Oregon near the site of field tests that took place a few years ago.

The E.P.A. scientists and others said the grass would probably not pose an ecological threat. Still, it could provide fodder for critics who say that agricultural biotechnology cannot be adequately controlled.

"It is a cautionary tale that you have to think about the possibility of plants escaping into populations where there are wild relatives present," said Jay Reichman, an agency ecologist who is the lead author of a study to be published in the journal Molecular Ecology.

The genetically engineered grass, called creeping bentgrass, is being developed by the Scotts Miracle-Gro Company and Monsanto for use on golf courses. It contains a bacterial gene that makes the grass resistant to the herbicide Roundup, known generically as glyphosate.

The goal is to create a product to allow groundskeepers to spray the herbicide on greens and fairways to kill weeds without hurting the grass.

The Department of Agriculture is evaluating whether to approve the grass. A department spokeswoman said that no timetable had been set for making a decision, but that the new information would be assessed.

One concern often raised by critics of agricultural biotechnology is that genes that make crops resistant to herbicides or pests may escape to wild relatives, creating "superweeds" that would be harder to eradicate.

That is hardly a risk for the main types of genetically engineered crops grown in the United States - soybeans, corn and cotton - because they generally do not have wild, weedy relatives in this country.

But it has been a concern with the genetically engineered grass, which has wild relatives. And, unlike corn or soybeans, grass does not have to be replanted every year.

Some scientists have expressed concern that if the gene escapes, weedy grasses could be harder to control with glyphosate, a widely used herbicide.

Because of those concerns, the Agriculture Department is doing a full environmental impact assessment before making a decision. It will be its first involving a genetically engineered crop.

Two years ago, scientists at the E.P.A. laboratory in Corvallis, Ore., published a paper showing that pollen from a test plot of the grass had spread as far as 13 miles downwind, much farther than many had expected. That made it likely that genetically engineered grass would be found in the wild, though the scientists did not look for that.

In the new study, scientists sampled 20,400 plants up to three miles from the edge of an 11,000-acre zone surrounding the test plots. They found 9, or 0.04 percent, that were genetically engineered, the farthest being 2.4 miles from the control zone border.

The scientists said some of the plants had been created by seeds that had blown off the test plot and others by hybridization of wild grass with pollen from the genetically engineered grass. All were of the same species of grass being developed by Scotts and Monsanto.

A spokesman for Monsanto said that creeping bentgrass lacked the characteristics needed to become a weed and that other herbicides could control Roundup-resistant bentgrass if need be.

Jim King, a spokesman for Scotts, said the company had already admitted that some grass was growing outside the test plots and that the company was working to eradicate it. In field tests, Mr. King said, a windstorm arose when the grass had been cut and was drying in the field, dispersing seeds.

Scotts argues that grass on golf courses, which is kept short, does not pose the same threat of seed dispersal or pollen flow as grass grown to produce seeds.

The company says the nonengineered bentgrass now used on golf courses has not become a weed, and people outside of golf courses do not try to control it by spraying Roundup.

But Norman C. Ellstrand, a professor of genetics at the University of California, Riverside, said that in some parts of the country bentgrass was considered a problem and was controlled. Dr. Ellstrand, an expert on gene flow in plants, said that foreign genes put into crops had escaped into the wild in other cases abroad.

Scientists in Canada have reported an instance in which herbicide resistance appears to have spread by pollination from genetically engineered canola, which is widely grown there, to a wild relative.

In Japan, transgenic canola was found growing near some ports and roadsides. Since the crop is not grown commercially in Japan, scientists hypothesized that imported seeds had escaped during transportation to oil-processing facilities.


Frankenstein Fuels

By Mark Lynas
New Statesman
August 7, 2006

Pioneered by bearded hippies running clapped-out vans on recycled chip fat, biofuels now mean big business, sold to us as a solution to global warming. We must not be fooled, argues Mark Lynas

Late every summer, large areas of central Borneo become invisible. There's no magic involved - most of the densely forested island simply gets covered with a pall of thick smoke. Huge areas of forest burn, while beneath the ground peat many metres thick smoulders on for months. These trees are burning in a good cause, however. They are burning to help save the world from global warming.

Here is how the logic goes. As the natural forest is cleared, land opens up for lucrative palm-oil plantations. Palm oil is a feedstock for biodiesel, the "carbon-neutral" fuel that the European Union is trying to encourage by converting its vehicle fleet. By reducing use of fossil fuels for its cars and trucks, the EU believes it can reduce its carbon emissions and thereby help mitigate global warming. Everyone is happy. (Except the orang-utan. It gets to go extinct.)

It's a con, of course. In 1997, the single worst year of Indonesian forest- and peat-burning, 2.67 billion tonnes of carbon dioxide were released by the fires, equivalent to 40 per cent of the year's entire emissions from burning fossil fuels. That was a particularly bad year: most summers, the emissions are only a billion or so tonnes, or about 15 per cent of total human emissions. The biggest Indonesian fires, in 1997 and 1998, took place on plantation company land, while in neighbouring Malaysia 87 per cent of recent deforestation has occurred to make way for palm-oil plantations. It is stretching credulity to argue that biofuels produced through this destructive process are helping combat climate change.

The EU is undaunted (though it has undertaken a public consultation), and persists with a target that 5.75 per cent of its vehicle fuels should be "renewable" by the year 2010. Not all of this will come from tropical sources such as palm oil - but nor can their importation be restricted on environmental grounds. The campaigning journalist George Monbiot has discovered that world trade rules would prevent the EU taking any measures to restrict imports of palm oil produced on deforested lands. Free trade comes first.

Some of this "deforestation diesel" will be processed and refined in the UK. A company called Biofuels Corporation has just finished building a biodiesel plant at Seal Sands, near Middlesbrough, and supplies fuel throughout the UK. With an annual production capacity of 284 million litres of biodiesel, it is strategically located next to a deep-water port to ease its access to imports of palm and other vegetable oils. A spokesman confirmed that imported palm oil from Malaysia is being used as feedstock, and that the source cannot at present be guaranteed as "rainforest-free". A second company, Greenergy Biofuels, is putting up a GBP13.5m plant at Immingham on Humberside, and plans another. Palm oil is again expected to be one of the main feedstocks imported.

As the promise of profits increases, the big players are beginning to get involved. The two largest external stakes in Greenergy Biofuels are held by Tesco and Cargill. Tesco will shift the product on its petrol forecourts, while Cargill - one of two giants that dominate the world food market - will supply the feedstock. Gone are the days when biofuels meant bearded hippies running their clapped-out vans on recycled chip fat.

Even the oil majors are sniffing around this new market. BP has teamed up with DuPont to develop a liquid fuel called biobutanol, derived from sugar cane or corn starch, which they aim to launch in the UK next year as an additive to petrol. In the meantime, the oil giant is ploughing half a billion dollars into biofuels research at a new academic laboratory called the Energy Biosciences Institute. Indeed, "biosciences" are what it's all about. Speak to anyone in the corporate energy or agricultural sectors and they will probably go dewy-eyed about the technological "convergence" of energy, food, genetics - in fact, just about everything. In the biotechnology industry the atmosphere is reminiscent of the heady days of genetic modification, before the companies realised that consumers didn't want to eat "Frankenstein foods". Frankenstein fuels, however, might prove an easier sell.

The GM industry now plans to reinvent itself, following the example of the nuclear industry, on the back of climate change. "Producing genetically modified crops for non-food purposes, as a renewable source of alternative fuels, may provide the basis for a more rational and balanced consideration of the technology and its potential benefits, away from the disproportionate hysteria which has so often accompanied the debate over GM foods," suggests the Agricultural Biotechnology Council, an umbrella organisation for the biggest biotech companies.

The Swiss corporation Syngenta is already marketing a variety of GM corn - one not approved for human consumption or animal feed - specifically intended for ethanol biofuels. It has just applied, with support from the UK, for an EU import licence - even though it admits it "cannot exclude" the possibility that some of this corn will find its way into the normal supply chain. The European biotech association EuropaBio is delighted with the EU's biofuels initiative. "Biotechnology will help to meet Europe's carbon-dioxide emission reduction targets, reduce our dependence on oil imports and provide another useful income stream for our farmers," enthuses its secretary general, Johan Vanhemelrijck.

In the United States, biofuels are welcomed as a way to help wean the country off its dependence on oil produced by shady, Allah-obsessed Arabs. "Every gallon of renewable, domestically produced fuel we use is a gallon we don't have to get from other countries," beams Congressman Kenny Hulshof, a Republican sponsor of the Renewable Fuels and Energy Independence Promotion Act being considered by Congress. Not surprisingly, the American Soybean Association is also a supporter. "ASA is urging all soybean growers to contact their members of Congress and ask them to co-sponsor this legislation," says its president, Bob Metz, in a press release. "The toll-free number for the Congress operator is 1-888-355-3588."

In America, biofuels combine patriotism with economic self-interest in a seamless match. Farmers love it because biodiesel and ethanol are brewed from agricultural commodities, helping drive up farm-gate prices. Red-state senators love it because federal tax subsidies keep Republican-voting farmers happy. Even George W Bush loves it: "I like the idea of a policy that combines agriculture and modern science with the energy needs of the American people," the president told the Renewable Fuels Association in April.

Democrats and Republicans are united in touting ethanol. "All incumbents and challengers in Midwestern farm country are by definition ethanolics," the agricultural policy adviser Ken Cook told the New York Times. There are 40 ethanol plants under construction, and the US is poised to overtake Brazil (which uses sugar cane on a large scale to make the fuel) as the world's largest producer within a year. Cargill's CEO compares the transformation to "a gold rush".

But not everybody loves biofuels. David Pimentel, professor of insect ecology and agriculture at Cornell University, hates them. "There is just no energy benefit to using plant biomass for liquid fuel," he complains. Pimentel's own studies have concluded that making ethanol from corn uses 30 per cent more energy than the finished fuel produces, because fossil fuels are used at every stage in the production process, from cultivation (in fertilisers) to transportation. "Abusing our precious croplands to grow corn for an energy-inefficient process that yields low-grade automobile fuel amounts to unsustainable, subsidised food burning," he fumes.

Pimentel is not alone in thinking that burning food in cars while global harvests decline is not necessarily a good idea. China, with its enormous population, is already having second thoughts about going down the biofuels path. "Basically this country has such a large population that the top priority for land use is food crops," says Dr Sergio Trindade, an expert on biofuels. The same problem will doubtless hamper the biofuels revolution in Europe. According to one study, meeting the EU's 5.75 per cent target for its vehicles will require about a quarter of Europe's agricultural land. For the even more car-dependent US, it would take 1.8 billion acres of farmland - four times the country's total arable area - to produce enough soya biodiesel to cover annual petrol consumption.

So which gets priority: cars or people? A very simple answer to this land/fuel conundrum would be for people to use their cars less, and to cycle and walk more. But discouraging car use is not at the top of any politician's agenda, either in Europe or the US. Meanwhile, our leaders must be seen to be doing something about the rising greenhouse-gas emissions from road tran sport, so biofuels are the perfect technofix.

The dilemma might bring to mind Douglas Adams's Hitchhiker's Guide to the Galaxy, where the alien Ford Prefect took the name of a car because - looking down from above at all the busy roads and motorways - he had mistaken them for the dominant life form. If cars chug happily around between massed ranks of starving people in our biofuelled future, then perhaps Ford Prefect won't have got it so wrong after all.


Gene-Altered Crops Denounced

By Rick Weiss
Washington Post Staff Writer
August 16, 2006

Environmental Groups Seek Moratorium on Open-Air Tests

Environmental groups yesterday called for a moratorium on open-air tests of crops genetically engineered to produce medicines and vaccines, citing a federal court's conclusion last week that the Agriculture Department repeatedly broke the law by allowing companies to plant such crops on hundred of acres in Hawaii.

In a toughly worded 52-page decision released without fanfare late last week, a U.S. District judge in Hawaii concluded that USDA's Animal and Plant Health Inspection Service (APHIS), which grants permits for the planting of genetically engineered crops, should have first investigated whether the plants posed a threat to any of that state's hundreds of endangered species.

The corn and sugar cane plants, already harvested because the experiments involving them were completed before the case was decided, had been modified to produce human hormones, drugs and ingredients for vaccines against AIDS and hepatitis B.

"APHIS's utter disregard for this simple investigation requirement, especially given the extraordinary number of endangered and threatened plants and animals in Hawaii, constitutes an unequivocal violation of a clear congressional mandate," wrote Judge J. Michael Seabright in his Aug. 10 decision.

The ruling is the first by a federal court on the controversial practice of "bio-pharming," in which crops are engineered to produce potentially therapeutic human proteins. But it is not the first damning federal critique of APHIS's oversight. A December 2005 audit by the Agriculture Department's Office of Inspector General found multiple failings in the agency's enforcement of research rules for gene-altered plants.

APHIS spokeswoman Rachel Iadicicco said yesterday that the agency had already corrected the major problems cited in the 2005 report and had recently made policy changes to satisfy the court's concerns, as well. In addition, she said, APHIS is crafting a sweeping "programmatic" environmental impact statement addressing larger, long-standing concerns about its oversight of biotech crops.

But opponents said they have heard such assurances before.

"We are asking the judge to enjoin the issuance of any biopharma permits anywhere in the country unless and until APHIS completes a programmatic analysis of their regulatory program," said Paul H. Achitoff, managing attorney for Earthjustice in Honolulu, which litigated the case with the Washington-based Center for Food Safety.

The judge has scheduled a hearing for Tuesday to decide what remedies to impose.

The court ruling is the latest in a decade-long struggle that has pitted biotech companies against an uneasy coalition of environmentalists and conventional food producers and distributors.

Advocates believe that some drugs and vaccines may be produced more economically in crops than in the laboratory cultures that are commonly used today. Some even envision "edible vaccines," such as bananas laden with proteins that would boost blood levels of protective antibodies -- an attractive strategy for developing countries, where the refrigeration needed for many conventional vaccines is often not available.

But opponents fear that ordinary crops may become contaminated with drug-spiked versions grown in open fields, and that unwanted drug exposures from foods could trigger allergic reactions or other problems in people or animals.

Fears of admixture gained credence in 2002 when a Texas company was found to have broken rules in its cultivation of corn plants engineered to make a pig diarrhea vaccine. The error necessitated the destruction of 500,000 bushels of potentially contaminated soybeans, and left the now defunct company, ProdiGene, stuck with millions of dollars in cleanup costs.

"The use of food crops to produce materials not intended to be in the food supply must only proceed under systems proven to prevent any contamination or adulteration of the food supply," said Jeffrey Barach of the Food Products Association in Washington. "To date, effective control programs have not been demonstrated to our satisfaction."

The federal court decision responds to a 2003 lawsuit filed by several public interest groups. Taking a novel tack, the groups charged that APHIS failed to consider the potential impacts on endangered species when it approved four Hawaii field studies in the previous three years. The plants were produced by ProdiGene, Monsanto, the Hawaii Agriculture Research Center and Garst Seed of Slater, Iowa.

The plaintiffs -- including Friends of the Earth, Pesticide Action Network North America and Kahea, a Hawaiian environmental alliance -- noted that Hawaii is home to 329 endangered or threatened species, more than any other state, including many birds with easy access to test plots.

Seabright agreed with the groups that, although proof of harm is lacking, APHIS's issuance of the permits for 800 acres on four Hawaiian islands without consideration of those potential impacts was "arbitrary and capricious."

"This is probably the strongest message yet to USDA that they need to do a much better job at regulating all genetically engineered crop field trials," said Bill Freese of the Center for Food Safety, noting that about a dozen pharma permits are approved in a typical year. "They've been rubber-stamping for too long, and they need to get serious about these crops."

But the judge rejected the groups' broader claim that APHIS had broken its promise to improve its overall system of oversight.

"Although the Plaintiffs are understandably upset by the fact that this process has taken over three years, the court accepts APHIS's representations" that the delay is justified and progress is under way.

Stephanie A. Whalen, president of the Hawaii Agriculture Research Center, which ran the studies involving sugar cane engineered to make a human blood protein, said the ruling "looks backward" at problems already corrected.

"The idea that this has got the potential for harm has been all blown out of proportion," she said. "We're really proud of the work we do, and we know how important it is to safeguard the environment."

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