USDA Proposes First-Ever Industrial GE Crop

Press Release
Center for Food Safety
January 4, 2009

USDA is poised to deregulate the world's first genetically engineered (GE) industrial crop. Similar to GE pharma crops that use corn for producing drugs, Syngenta's "Event 3272" is genetically engineered to use corn for energy (ethanol) production and not for food. This unprecedented, industrial application of a GE technology poses a variety of environmental, health, and economic risks that must be carefully evaluated to determine whether the widespread use of this GE industrial corn crop should be allowed on farms across our nation.

In a "business as usual" move, USDA has fast-tracked the commercialization of this GE industrial corn and has forgone conducting a full Environmental Impact Study (EIS), as required by law. Instead, USDA is basing its decision to approve the industrial GE corn upon a shorter assessment that falls woefully short of the thorough review the law requires before a new GE crop is approved. Moreover, USDA has failed to acknowledge that this GE technology requires even greater scrutiny since it transforms a ubiquitous food crop - corn - into an industrial crop - ethanol - making it no longer fit for human consumption. The Obama Administration's USDA must complete a full EIS to address these concerns. The agency is accepting public comments only until January 20, 2009.

Event 3272 corn contains an exotic enzyme derived from "thermophilic" (heat-loving) microorganisms living near deep sea hydrothermal vents. The enzyme - alpha-amylase - breaks down starches into complex sugars. Syngenta's alpha amylase is generated at extremely high levels in the corn kernels themselves for the purpose of eliminating one step in ethanol production and save a little money. The trouble is that this enzyme might be capable of causing food allergies in people who inadvertently consume this corn. Humans have never been exposed to this form of alpha amylase before. But, we know some versions of this enzyme (from fungi) cause respiratory allergies, which are closely related to food allergies. Syngenta's corn-embedded enzyme has two characteristic properties of food allergens: it's extremely resistant to breakdown by heat, and it tolerates somewhat acidic conditions. Thus it will likely survive food processing and may withstand gastric juices intact, which means a higher likelihood of triggering allergic reactions.

Despite the fact that this GE corn is meant strictly for industrial use, USDA admits that if Event 3272 corn is intentionally or accidentally diverted into the food supply, it could negatively impact food quality. And there's no doubt Event 3272 will enter the food supply. Corn cross-pollinates at great distances, and there are absolutely no requirements to plant this industrial corn away from food-grade corn. Instead of reviewing the foreseeable negative impacts of biological contamination on organic and conventional corn from Event 3272 corn, USDA has merely relied on Syngenta, the creator of the GE corn, to protect non-industrial corn from contamination.

If we have learned anything from the StarLink episode, it is that voluntary, industry-led agreements to curtail contamination do not work in the real world. StarLink was a GE corn variety only approved for animal feed, not the human food supply, because leading allergists said it might cause food allergies. Despite grower agreements and voluntary stewardship measures, it massively contaminated the food supply, costing farmers, food companies, and taxpayers millions of dollars in recalls and lost sales. This experience, along with other contamination episodes, showed us that weather, pollen flow, and basic human error are simply unavoidable once GE crops are released in the open environment. To approve another non-food corn crop based solely on Syngenta's word that they will police themselves is irresponsible and ignores the realities of farming, food production, human error, and basic ecology. Thus far, none of our major corn export markets have cleared Event 3272 for import and, therefore, any corn shipments contaminated with Event 3272 are likely to be rejected by Japan, Korea and other GE-sensitive markets.

So why is USDA even considering going down this road again? In the draft approval document APHIS claims that Event 3272 corn is needed "to help the U.S. meet its goals for ethanol production." Yet Congress's targets for ethanol production in the Energy Policy Act of 2005 and the Energy Independence and Security Act of 2007 have already surpassed the 2012 target (7.5 billion gallons) in 2007 (8.2 billion gallons)! And with 10 billion gallons of ethanol produced in 2008, we're well on the way to achieving the mandate for 2022 without the introduction of Event 3272 corn.

The dramatic worldwide surge in food prices last year - which unfortunately has already pushed 100 million more of the world's poor into hunger and poverty - has caused a radical and necessary rethinking of biofuels. Food experts from academia to the World Bank have decried the massive diversion of corn from food to fuel, blaming it for at least part of the steep price increases in food staples like corn, wheat and rice., Unbelievable as it may seem, U.S. farmers devoted a full 23% of the 13 billion bushel corn harvest to ethanol production in 2007 and in 2008, that percentage rose to 30%.

Event 3272 poses unacceptable risks to human health, the environment, and the economic well-being of farmers, and is not needed to meet U.S. biofuels production targets. And even if it were, the food crisis makes painfully clear what should have been obvious all along: that diverting stupendous quantities of staple food crops (i.e. 30% of U.S. corn) to feed automobiles has dramatically increased the price not only of corn, but also of all primary staple crops driving hunger throughout the world.

Leading Catholic Hospital System Takes Action for Sustainable Food Production

Press Release
Catholic Healthcare West
January 6, 2009

SAN FRANCISCO, CA, Jan 06, 2009 (MARKET WIRE via COMTEX) -- Catholic Healthcare West (CHW) announced today that its food purchasing dollars will be focused on promoting sustainable food production practices, in part by seeking alternatives to foods produced with genetically engineered sugar, as well as meat and dairy produced with animal clones. The CHW position was developed in recognition of the serious health and environmental concerns these technologies raise and the threat they pose to healthier and more sustainable food production options. Among the concerns CHW is raising about genetically engineered and cloned foods are genetic contamination, increased pesticide use, animal cruelty, and the deep ethical and moral issues associated with these untested new technologies.

CHW recently asked eight of its largest food suppliers for their policies on genetically engineered sugar beets, which are being planted for commercial use for the first time this year. Results from the survey found that its suppliers would prefer non-genetically engineered sugar beets. Only Diamond Crystal indicated their intent to avoid buying genetically engineered sugar and that they will seek out suppliers that do not use genetically engineered foods through a validation process. CHW intends next to survey its meat and dairy suppliers on their potential use of animal cloning since the U.S. FDA recently decided to allow marketing of food from animal clones.

"We are working with our purchasing organization, Premier, and developing relationships with allied healthcare partners in looking for food companies that will provide us with meat and dairy products that are not from animal cloning, and foods that are made without genetically engineered sugar beets," stated Pat Burdullis, CHW's administrator of non-clinical supply chain contracts. "If these same food companies can provide foods that are natural and non-genetically engineered for their European customers, we believe they should provide us with the same level of service."

Genetic engineering and animal cloning are controversial in food production, since the technologies have not been subject to long-term safety testing and could create irreversible environmental damage. Genetically engineered crops can contaminate natural foods and have promoted the use of herbicides that may be harmful to human health and natural systems. Scientists say that animal clones are often abnormal and suffer from a host of often painful defects. A New England Journal of Medicine article stated that, "[It] may be exceedingly difficult, if not impossible, to generate healthy cloned animals."

"Genetic engineering and animal cloning are in direct conflict with our sustainable food service vision and corporate sustainability goals," stated Sr. Mary Ellen Leciejewski, CHW's ecology program coordinator. "We have numerous unanswered concerns about the imminent introduction of genetically engineered sugar beets and marketing of food from animal clones. Previous genetically engineered crops have increased pesticide use, and animal cloning is a cruel and unnecessary technology in meat and dairy production. Our aim is to promote alternative approaches that produce foods that are safer and healthier for our patients, staff, and visitors and that can sustain the farmers and food producers in our communities."

CHW has successfully advocated with its suppliers for safer, more environmentally friendly products, most recently with regard to its PVC/DEHP-free IV products now being provided by B.Braun.

With respect to food production, CHW is advocating for public policies that meet the following safeguards:

Drug from Genetically Engineered Goats a First

By Associated Press
International Herald Tribune
January 7, 2009

WASHINGTON: You've heard of making cheese from goats' milk, but prescription drugs?

In what would be a scientific first, an anti-clotting drug made from the milk of genetically engineered goats moved closer to government approval Wednesday after experts at the Food and Drug Administration reported that the medication works and its safety is acceptable.

Called ATryn, the drug is intended to help people with a rare hereditary disorder that makes them vulnerable to life-threatening blood clots.

Its approval would be a major step toward new kinds of medications made not from chemicals, but from living organisms genetically manipulated by scientists. Similar drugs could be available in the next few years for a range of human ailments, including hemophilia.

ATryn was developed by a Massachusetts biotechnology company, GTC Biotherapeutics, by altering the genes of goats so they would produce milk rich in antithrombin, a protein that in humans acts as a natural blood thinner.

About 1 in 5,000 people don't produce enough of the protein, putting them at risk of developing blood clots in their veins. Such clots can be extremely painful. If they break loose and travel through the bloodstream to the lungs or the brain, the consequences can be catastrophic. Pregnant women with the disorder are at high risk of miscarriage or stillbirth, because of blood clots in the placenta.

In their everyday lives, patients with antithrombin deficiency are managed with conventional blood thinners. That would not change. ATryn is for use only when patients are undergoing surgery or having a baby, times when the risk of dangerous clots is particularly high. Those patients would receive the drug by intravenous infusion for a limited time before and after their procedures.

Karen Janes of Santa Fe, N.M., whose teenage daughter Mary Karen died of a brain clot linked to the disorder, said the issue is whether the drug works, not how it is made.

"I think this goat thing is just wonderful," said Janes. "I do want this drug to go through all the rigors of testing by the FDA. But if it can work, and it can save other families from what we went through, I think that's marvelous." Her daughter died in 1998.

Scientific advisers to the FDA will weigh the risks and benefits of ATryn at a meeting Friday, and make a recommendation on approval. The FDA will make the final decision.

"It's the first time we've held an advisory committee meeting on any product from a genetically engineered animal," said FDA spokeswoman Siobhan DeLancey. If the drug is approved, the FDA may require follow-up monitoring to make sure that patients' immune systems don't start making antibodies in reaction to the medication.

"I think this is an important tipping point," said Geoffrey Cox, chairman of GTC, the drug maker. "The real dramatic thing that is happening here is that we've been able to reduce some very clever science to the practical level of producing a drug that's safe and efficacious. Those things aren't trivial."

To make the drug, scientists at GTC put DNA for the human antithrombin protein into single cell embryos of goats. Goat embryos with the gene were then inserted into the wombs of surrogate mothers who gave birth to baby goats carrying the new trait.

The first of these goats were called the "founders." Their offspring also carry the gene. The females produce high levels of antithrombin in their milk, from which the protein is collected and purified.

GTC's production comes from a herd of about 200 goats on a farm in central Massachusetts, milked twice a day.They look no different from any other goats.

Up to now, antithrombin has been produced from blood products collected from human donors. Making the protein from goats may be better for humans, said Dr. Stephan Moll, a hematologist at the University of North Carolina, Chapel Hill, who consults for the company. It would ensure a steady supply and reduce concerns about infection.

"It's a new mechanism by which drugs could be produced in pretty large volume in the future," said Moll, who is also a top medical adviser to the National Alliance for Thrombosis and Thrombofilia, a group that represents patients with the blood disorder.

ATryn has already been approved in Europe.

Bye Bye rBST?

By Steve Taylor, N.H. Correspondent
Lancaster Farming
January 23, 2009

CABOT, Vt. - For all intents and purposes, the New England dairy industry will be "rbST-free" by the end of summer 2009.

Facing the threat of losing markets for its highly successful Cabot brand of cheeses, cooperative owner Agri-Mark has told its member farmers that if they want to continue using bovine somatotropin to boost production their milk will have to go to a cheese plant in northern New York State at a cost to them of up to $2 per hundredweight to cover the trucking.

"Cabot sales were at risk, and we were going to lose markets if we continued to accept milk from rbST-treated cows at our Middlebury and Cabot (Vt.) cheese plants and our West Springfield (Mass.) butter and powder plant," says Bob Wellington, senior vice president of Agri-Mark, the largest producer cooperative in New England.

Milk going into Class I, or fluid, sales had been essentially rbST-free in New England for at least the past two years. Promotion of "no artificial hormones" milk was a key to rapid growth for Portland, Maine-based Oakhurst Dairy starting a decade ago, and the rest of the fluid processors doing business in the six-state area eventually followed suit and committed to accepting only supplies from non-rbST herds.

The two primary marketers of farm milk in New England, Agri-Mark and Dairy Marketing Services/Dairy Farmers of America, have wrestled with assembling and marketing two separate streams of farm milk, one from farms using rbST and one from farms that shun the technology.

Agri-Mark's board of directors has set Aug. 1 as the cutoff for any rbST milk coming into its system, a decision which essentially is the deadline for both its member farms and all the rest of the New England and eastern New York farms shipping into the New England market.

That's because Agri-Mark operates the only major manufacturing plants that serve to balance the region's milk supply, Cabot, Middlebury and West Springfield. Milk beyond the needs of fluid processors, ice cream plants and a handful of small cheese enterprises has to find a home somewhere, and Agri-Mark is the only entity that can economically handle it.

"West Springfield is the big one, as it serves to balance the New England market, and much of New York State, too," Wellington says. Closures of cheese plants, particularly a large facility in Hinesburg, Vt., last fall, have made the job of clearing the region's milk market challenging over the past year.

Customers for rbST farm milk in New York have decreased sharply, with only a couple of Class I handlers and a handful of manufacturing plants left willing to receive product from producers employing the artificial hormone.

Wellington says the vast majority of producers who have continued to use rbST even as markets for their milk have withered now seem to be accepting the reality that they'll have to abandon the practice within a few months.

"I'd say most have seen it coming for quite a while, and feel if it impacts everybody the same way they can accept it. Some will wait right up to the very end, because they believe it makes them money," Wellington says.

He adds that Agri-Mark waited as long as it could to close the door on rbST, but the pressures coming back from consumers and retailers forced the cooperative to protect its Cabot brand.

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