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November 2010 Updates

Congress Fights FDA Approval of GE Salmon

By Natalia Real
Fish Information and Services
November 23, 2010

US Senator Mark Begich last week introduced legislation to stop the approval of genetically engineered (GE) fish by the Food and Drug Administration (FDA). His bill follows hearings by the FDA on the "Frankenfish," a product created by AquaBounty Technologies and now being reviewed by the FDA for human consumption.

If the FDA approves the GE fish, a second piece of legislation would require that the product be labeled as such.

These bills accompany two bills sponsored by Representative Don Young; Begich's new bill is co-sponsored by Senator Lisa Murkowski and Senator Patty Murray. The labeling bill is co-sponsored by Senators Murkowski and Murray plus Senator Ron Wyden.

"Our main objective is to stop the FDA from ever approving this science project that will potentially harm wild Alaska salmon, while posing human and other environmental health risks," Begich declared.

"But, at the very least, any type of genetically engineered fish has to have a label. If the FDA decides this is safe for human consumption, it should be clear to the public what's in and not in the package," he continued.

Begich has been a leader in the opposition to GE salmon, a development of AquaBounty Technologies that involves a hybrid Atlantic salmon altered with a Chinook salmon growth gene and an antifreeze gene from an eel that let it grow larger and faster than wild salmon.

Last September, Begich and 10 other senators wrote to the FDA with doubts regarding the review process and the safety of a GE animal for human consumption; the FDA has not replied.

"The FDA seems to be on its own timeline and hasn't even responded to a letter signed by several lawmakers. We will move ahead without the agency, taking steps to ban Frankenfish and keep humans and our wild salmon safe," Begich asserted.

The letter received the support of 52 consumer and environmental groups, commercial and recreational fisheries associations and food businesses and retailers, including the Alaska Marine Conservation Council, Bristol Bay Regional Seafood Development, the Yukon River Drainage Fisheries Association and consumer rights group Food and Water Watch (FWW).

Analysis by a Duke University-led team that was published in this week's Science determined that the review process used by the FDA to assess the safety of GE salmon does not consider the full effects of the fish's extensive production, reports EP Magazine.

Begich rebuked the editors of Time magazine for its current edition listing GE salmon as one of the 50 best inventions of 2010.

"Despite the supposed advantage of growing twice as fast as wild salmon, serious concerns remain about the environmental and human health impacts of these gene-spliced fish," Begich wrote to the editor.

"Want more salmon? Here's a better idea: protect its natural habitat, maintain water quality and manage wild stocks for sustainability. That's what Alaska has done for over 50 years and now returns of wild salmon are at historically high levels. And wild salmon taste a lot better than anything you'll cook up in a laboratory," he went on.

"Let's leave "Frankenfish" on the operating table and not the dinner table," Begich concluded.


Agencies Refused to Publicize Spread of Biotech Bentgrass

By Mitch Lies
Capital Press
November 18, 2010

CORVALLIS, Ore. -- The Oregon Department of Agriculture and the USDA refused to alert the public that genetically modified bentgrass had spread from a test plot in Western Idaho to irrigation ditches in Eastern Oregon.

Carol Mallory-Smith, an Oregon State University weed scientist, made the discovery last month after she received samples from farmers in Malheur County. The Roundup-resistant creeping bentgrass, under development by The Scotts Co., isn't approved for unrestricted commercial production.

She asked ODA and USDA's Animal and Plant Health Inspection Service, the agency responsible for regulating the crop, to make the discovery public. Both declined.

Mallory-Smith believed it was important for farmers to be on the watch for the genetically modified bentgrass.

And she believed the information was potentially relevant to a lawsuit being waged in U.S. District Court in San Francisco. In the suit, federal Judge Jeffrey White is deciding whether to allow restricted production of genetically engineered sugar beet stecklings.

White earlier this year halted production of Roundup Ready beets, pending a new environmental study.

"The issue for me was, I thought it should be disclosed to both sides of the sugar beet lawsuit," Mallory-Smith said. "It may not have any legal implications, but in fairness to both sides, I thought it should be disclosed."

Mallory-Smith decided to act on her own.

"I notified Scotts, I notified the Oregon Department of Agriculture, and I notified the people involved in the sugar beet lawsuit," she said.

On Nov. 4, an Earthjustice attorney introduced the information in testimony in the steckling case, making the information public.

ODA Director Katy Coba said the department didn't feel it was its place to publicize the discovery.

"It's not an Oregon Department of Agriculture issue," Coba said. "Our role has been trying to find alternative pesticides for folks to use in irrigation ditches. This is strictly a federal issue, and it is an APHIS issue."

In an e-mail response to Capital Press questions, APHIS said the incident is still under investigation: "When the investigation is complete, we will notify the public of our findings," the agency said.

The agency said it has inspectors and compliance specialists on the ground investigating the incident.

On Oct. 14, Mallory-Smith received a package containing samples of bentgrass plants that Malheur County residents shipped to the OSU weed lab. The residents were unfamiliar with bentgrass, having never seen the plant in the area before, Mallory-Smith said. They found they couldn't kill the plants with Roundup.

"It was in the irrigation ditches," Mallory-Smith said. "They didn't know what it was, and it wasn't dying."

Mallory-Smith was familiar with the Roundup-resistant gene from working with The Scotts Co.'s bentgrass plants in Central Oregon in the early and mid-2000s. She found the gene in the samples. The next day she hopped a plane to Ontario and surveyed irrigation canals between Ontario and Nyssa.

"I surveyed nine miles north-to-south and two-to-three miles east-to-west, and saw it throughout the area," she said.

"My guess is some of those plants have been there for three or four years," Mallory-Smith said. "They are well established. It has gone to seed. It has been spreading for a while."

Mallory-Smith said she subsequently learned that Scotts was finding escapes on an annual basis outside the two Canyon County, Idaho, trial sites since removing the fields in 2006. Scotts planted the fields in 2005.

The information was not particularly surprising: Mallory-Smith found escapes when working with the Roundup-resistant bentgrass in Central Oregon. But it was alarming, she said.

"It would have been nice to have a heads-up that they are still finding plants over in Parma (Idaho) close to the field, so that you could be monitoring for it (in Oregon)," Mallory-Smith said.

As the crow flies, the test fields are within four miles of the irrigation canals in Eastern Oregon, which is within the range of escapes that Mallory-Smith found in Central Oregon.

"Maybe three years ago, we could've said to these irrigation districts that you ought to be on the lookout," she said.

Back in Corvallis, Mallory-Smith started working with state and federal scientists on removing the bentgrass.

The big hurdle, she said, is finding an efficacious herbicide registered for irrigation ditches.

Only two herbicides are registered for irrigation ditches in Oregon, according to Rose Kachadoorian with the Oregon Department of Agriculture. One is Rodeo, an aquatic version of Roundup. The other is Roundup, which is approved for dry ditches. Both, of course, are ineffective on the bentgrass.

"Part of the problem is the EPA considers irrigation canals an aquatic site -- even if you are not directly applying the pesticide to water -- and they require aquatic pesticide data," Kachadoorian said. "And registrants haven't generated those data."

The department is working with EPA and OSU to try to find one or more herbicides with sufficient efficacy to take out the bentgrass with a toxic profile safe to aquatic species, Kachadoorian said.

The department hopes to find and register the herbicide under an emergency use permit in a short time frame -- hopefully in time to control the plants this year before temperatures dip to levels that render herbicides ineffective.

Whether the discovery ultimately affects the sugar beet suit is unclear. Mallory-Smith believes the tiny seeds involved in the bentgrass escape are far more given to spreading outside field borders than sugar beet stecklings. But plaintiffs in the suit are using the escapes as a cautionary example that the herbicide-resistant gene can escape beyond field borders.

In the e-mail response to whether the escape could play a role in the lawsuit, R. Andre Bell, an APHIS public affairs specialist, said: "That remains to be seen."

The escape also could play a role in The Scotts Co.'s efforts to get the Roundup-resistant bentgrass deregulated.

Jim King, a spokesman for The Scotts Co., said he doesn't think it will.

"Assuming it is deregulated, you likely are going to have situations where you have seed spills here, pollen flows there," he said. "Once you identify it is there, it is a very controllable plant. It's just that there is one herbicide that doesn't work on it."

The company is moving forward on efforts to deregulate the crop, he said.

"We continue to have conversation with folks at APHIS and folks at USDA and hope to have it deregulated sooner rather than later," King said.

APHIS slapped Scotts Miracle-Gro with a $500,000 civil penalty in 2007 after Mallory-Smith and other scientists found nine genetically modified bentgrass plants within a three-mile radius of a seed-production field near Madras, Ore.

The field was planted to transgenic bentgrass in 2002 and plowed out in 2003.

Mallory-Smith said she found biotech bentgrass plants that originated from seed 4.5 miles from the field. EPA scientists found the biotech bentgrass gene in plants 12 miles from the field.

Under the Plant Protection Act, APHIS has authority to impose fines up to $1 million for willful violations, Bell said in the e-mail response.

"APHIS inspectors and compliance specialists are investigating," he said.


Canada's Transgenic Enviropig Is Stuck in a Genetic Modification Poke

By Jessica Leeder and Wency Leung
Globe and Mail
November 25, 2010

Under development for more than a decade, the University of Guelph's 20 Enviropigs are close behind a Canadian-made supersized salmon in a race to become the first genetically modified animals allowed into the food system.

Starting with the discovery that an E.coli gene could produce a digestive enzyme that regular pigs lack, the Guelph scientists realized they could introduce genetic material from that bacterium into pigs to minimize the environmental impact of the animals' waste, reducing a major pollutant from large-scale production - and allowing pork producers to cut operation costs.

The market may soon need Enviropig. To feed the projected world population of nine billion in 2050, food production will have to increase by 70 per cent, according to the Food and Agriculture Organization of the United Nations. Genetically engineered organisms will have to be part of the equation, according to the globe-spanning community of experts concerned with meeting those looming targets.

"You cannot feed the world at affordable prices without using the modern arsenal of inputs," said Marco Ferroni, head of the Syngenta Foundation, a Swiss-based non-profit established by its namesake seed company to pursue sustainable improvements in farm yields.

Among those "inputs" are controversial genetic modification techniques that enable faster and more environmentally friendly production of food, including intensive aquaculture and livestock, which are blamed for a significant amount of global greenhouse gas emissions. Critics say that genetic modification is a backward solution, one that papers over the problems of industrial food production.

But with mounting pressure to meet the world's food needs, the developers of the salmon and the Enviropig - both Canadian innovations - are taking their technology to countries where demand, commercial opportunities and the chances of regulatory approval are greatest. Although research in this country is responsible for both animals, the first country to commercialize them isn't likely to be Canada.

Scientists created the first Enviropig in 1999 by combining genetic material from E. coli bacteria and a snippet of mouse DNA. The gene alteration allows the pig to produce phytase, an enzyme regular pigs lack, which helps it digest naturally occurring plant phosphorous in its feed more efficiently. Pigs need phosphorous to grow. So as researchers see it, the benefits of Enviropig are twofold: Farmers would no longer need to supplement pigs' diets with mineral phosphate or commercially produced phytase, thus reducing feed costs, and they would decrease the amount of the nutrient that winds up in pigs' waste - making it less polluting.

The proverbial guinea pig to the Enviropig is the AquAdvantage salmon, owned by Massachusetts-based biotech firm AquaBounty and pioneered in Prince Edward Island. The genetically altered fish grows twice as fast as non-genetically modified salmon, and therefore requires fewer production inputs.

In September, the salmon was deemed safe to eat in a preliminary analysis conducted by the United States Food and Drug Administration. A committee of the agency is still considering whether more research is needed before the salmon can enter the final steps to market.

So far, the salmon has shouldered the brunt of public concern and regulators' scrutiny. AquaBounty's application to have the fish approved for human consumption has hopped more regulatory hurdles than the corresponding Canadian application for Enviropig.

"The FDA may not publicly state it, but it seems quite obvious to many people that they want to be the first to approve the latest and upcoming trends in technology," said David Hobson, manager of technology transfer at the University of Guelph.

The "FDA has a lot of resources at hand, as well as a government and an economy that promotes technology, believes in technology and is much more interested in having the best technology in the world," Mr. Hobson said. "Canada's maybe not as aggressive when it comes to technology."

He said Chinese regulators are also quickly catching up.

Garth Fletcher, one of the researchers from Memorial University in Newfoundland who did the original research for the genetically altered salmon, feels some affinity with other overlooked Canadian inventors - including those who came up with a light bulb before Thomas Edison. "Very few people know that it wasn't Edison but a Canadian scientist who invented the light bulb," he said, predicting that the Canadian roots of AquaBounty's salmon might also be forgotten.

It made commercial sense for AquaBounty to seek approval in the United States first because the potential market there is so much bigger, Dr. Fletcher said.

Still, genetically altering animals for human consumption remains uncharted territory, and regulators in the United States and Canada are still grappling with how such food technology should be handled. U.S. regulators have decided to treat genetically modified animals as veterinary drugs; in Canada, at least three federal agencies are involved in the application process (no animal or fish has ever been approved for human consumption in either country).

Mr. Hobson at the University of Guelph said that if the AquAdvantage salmon is approved, applications for other technologies from other companies will quickly follow. "But nobody really wants to go first, because it's probably five times as hard to go first as it is to follow."

Fewer government resources in Canada means the application for approval of Enviropig - which has cost more than $5-million to research - has been slow. The University of Guelph submitted applications to Health Canada, the Canadian Food Inspection Agency and Environment Canada last year, as well as to the FDA.

Although Enviropig is about halfway through the FDA's seven-step approval process, the university does not know where it stands with Health Canada and the CFIA. (In February, Environment Canada approved Enviropig for commercial production because it was legally required to respond within 120 days. But without approval from the other agencies, any commercially bred Enviropigs at this point would merely be expensive pets.)

Even if Enviropig got the go-ahead in Canada, it would still require U.S. approval before it was brought to market locally, said Cecil Forsberg, one of the creators of the Enviropig. Since the United States buys so much Canadian pork, the entire domestic industry would be undermined if Enviropig were to slip into that food system unapproved, he said.

Dr. Forsberg said he has no hesitations about the safety of eating Enviropig meat. "I would almost be prepared to do it illegally, except I'd run into problems here on campus."

Lucy Sharratt, co-ordinator of the Canadian Biotechnology Action Network, however, isn't convinced the market wants or even needs DNA-altered animals. "Genetically engineered animals are so far from what consumers want, so far from the trend looking toward a sustainable local food system, it doesn't make any sense that governments would waste taxpayers' money assessing the safety," said Ms. Sharratt, whose Ottawa-based group promotes sustainable local agricultural production.

She said dispersing hog production and reducing the size of farms - steps that would essentially reverse the trend of global food production - would ease the environmental burden of pig excrement without Enviropig.

Dr. Forsberg noted that the industry has indicated it wants Enviropig. If, and when, regulators approve it, the biggest hurdle will be winning over consumers.

"If consumers will accept it, they will produce it," he said. "So that's where the issue lies."


Federal Court Orders First-Ever Destruction of a GMO Crop

By Earthjustice, Center for Food Safety
Press Release
November 30, 2010

Orders Removal of Genetically Engineered Sugar Beet Seed Crop
Finds Government and Monsanto rushed to illegally plant herbicide resistant crop

San Francisco, CA - Today Federal District Judge Jeffrey S. White issued a preliminary injunction ordering the immediate destruction of hundreds of acres of genetically engineered (GE) sugar beet seedlings planted in September after finding the seedlings had been planted in violation of federal law. The ruling comes in a lawsuit filed by Earthjustice and Center for Food Safety on behalf of a coalition of farmers, consumers, and conservation groups. The lawsuit was filed on September 9, shortly after the U.S. Department of Agriculture (USDA) revealed it had allowed the seedlings to be planted.

The court outlined the many ways in which GE sugar beets could harm the environment and consumers, noting that containment efforts were insufficient and past contamination incidents were "too numerous" to allow the illegal crop to remain in the ground. In his court order, Judge White noted, "farmers and consumers would likely suffer harm from cross-contamination" between GE sugar beets and non-GE crops. He continued, "the legality of Defendants' conduct does not even appear to be a close question," noting that the government and Monsanto tried to circumvent his prior ruling, which made GE sugar beets illegal.

Paul Achitoff of Earthjustice, lead counsel for the plaintiffs, said, "USDA thumbed its nose at the judicial system and the public by allowing this crop to be grown without any environmental review. Herbicide resistant crops just like this have been shown to result in more toxic chemicals in our soil and water. USDA has shown no regard for the environmental laws, and we're pleased that Judge White ordered the appropriate response."

Plaintiff Center for Food Safety's Senior Staff Attorney George Kimbrell said, "Today's decision is a seminal victory for farmers and the environment and a vindication of the rule of law. The public interest has prevailed over USDA's repeated efforts to implement the unlawful demands of the biotech industry."

The plaintiffs - The Center for Food Safety, Organic Seed Alliance, High Mowing Organic Seeds, and the Sierra Club - had immediately sought a court order to halt the planting. On September 28 Judge White ruled that USDA's Animal and Plant Health Inspection Service (APHIS) had violated the National Environmental Policy Act (NEPA) by allowing the plantings without analyzing the potential environmental, health, and socioeconomic impacts of growing GE sugar beets. Judge White heard testimony from the parties during a three-day hearing in November before issuing today's ruling.

Monsanto created "Roundup Ready" crops to withstand its Roundup herbicide (with the active ingredient glyphosate), which it then sells to farmers together with its patented seed, for which it charges farmers a substantial "technology fee." Earlier this year, the Department of Justice announced it had opened a formal investigation into possible anticompetitive practices in Monsanto's use of such patented crops. Growing previous Roundup Ready crops such as soy, cotton, and corn have led to greater use of herbicides. It also has led to the spread of herbicide resistant weeds on millions of acres throughout the United States and other countries where such crops are grown, and contamination of conventional and organic crops, which has been costly to U.S. farmers. There is also evidence that such herbicide-resistant crops may be more susceptible to serious plant diseases.

In an earlier case the court ruled that USDA had violated NEPA by allowing the crop to be commercialized without first preparing an Environmental Impact Statement (EIS). In August the court made any future planting and sale unlawful until USDA complies with federal law. (USDA has said it expects to complete an EIS in spring 2012.) But almost immediately after the ruling, USDA issued permits allowing companies to plant seedlings to produce seed for future Roundup Ready sugar beet crops, even though the crops are still illegal to grow, and no EIS has been prepared. The seed growers rushed to plant the seed crop in Oregon and Arizona, apparently hoping to outrun the legal action to stop it. In this latest case, USDA argued that the seedlings were separate from the rest of the sugar beet crop cycle and had no impact by themselves, but Judge White rejected this. He found that the law requires USDA to analyze the impacts of not only the seedlings, but the rest of the Roundup Ready sugar beet production process as well, before any part of that process can begin.

Courts have twice rescinded USDA's approval of biotech crops. The first such crop, Roundup Ready alfalfa, is also illegal to plant, based on the vacating of its deregulation in 2007 pending preparation of an EIS. Although Monsanto appealed that case all the way to the Supreme Court and the High Court set aside part of the relief granted, the full prohibition on its planting - based on the same initial remedy granted here, the vacatur - remains in place.

This case is Center for Food Safety v. Vilsack, No. C10-04038 JSW (N.D. Cal. 2010).

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