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Pharming Underground

By Joshua Tompkins
Popular Science
July 2005

Can subterranean laboratories ease safety woes over crops that sprout medicine?

Don't tell anyone, but Doug Ausenbaugh has built an underground drug farm - in bucolic southern Indiana, no less. It's cleverly cached in an old limestone mine near the hamlet of Marengo. There, carefully cultivated stalks flourish under the glare of artificial lights and the rainlike spatter of drip irrigation.

The facility, run by Ausenbaugh's biotech startup firm, Controlled Pharming Ventures, in cooperation with researchers from Purdue University, is intended for growing pharmaceutical crops - corn, tomatoes, tobacco and other plants whose DNA has been altered to produce a vaccine or medicinal compound. Drug companies have hailed this new field, known as biopharming, as a low-cost alternative to traditional manufacturing. But environmentalists, food-industry officials and other critics have decried pharma crops - which aren't meant to be eaten and in some cases are toxic to humans - because of the danger of contaminating food supplies.

The fears aren't based on mere conjecture. In 2000, evidence of a genetically modified corn intended only for animal consumption showed up in Taco Bell taco shells. Aventis CropScience, the corn's grower, quickly abandoned the product and was forced to pay $2.4 million to people who said they had suffered allergic reactions to it. Two years later, federal officials fined the biotech company ProdiGene $3 million for allowing pharma corn carrying an experimental pig vaccine to contaminate soybeans in Iowa and Nebraska. Regulations have since been tightened, and the young industry suffered a huge blow when biotech behemoth Monsanto abandoned its biopharming research in 2003. Although several plant-produced biopharmaceuticals are still under clinical evaluation, none have reached the market yet.

Going underground, Ausenbaugh says, will resolve many of the sector's problems. The 60-acre mine in Indiana provides a formidable barrier between the grow room and the rest of the world, easing the burden of containment in several ways. It makes pesticides unnecessary (the space is free of bugs), and it reduces the threat of vandalism (the entrance is policed by armed guards). What's more, the constant 51°F air temperature in the cavern serves as a natural cooling system for the hot grow lights. And there's no danger of a Midwestern storm unhinging Ausenbaugh's creation and strewing hazardous materials for miles. (A tornado flattened Marengo just last spring.)

All things considered, a properly run underground facility "would probably be an order of magnitude safer" than a surface operation for a typical crop such as corn, says geneticist Norman Ellstrand of the University of California at Riverside. As a result, it would let growers sidestep some of the regulatory rigmarole to which biopharming is usually subjected by the U.S. Department of Agriculture - one of at least three federal agencies that scrutinize the various aspects of production, along with the Environmental Protection Agency and the Food and Drug Administration. "We probably wouldn't have regulatory authority inside a contained facility such as a mine," says John Turner, director of policy coordination in the USDA's Biotechnology Regulatory Services branch.

Best of all, the underground yield can be surprisingly bountiful. Scientists at the Marengo facility recently harvested their first test crop (a modified but edible variety of corn, not an actual pharma product), and the output was prodigious - the equivalent of 337 bushels per acre, more than twice the typical amount for field corn. Each plant was grown separately from a container full of a claylike artificial soil designed for the underground conditions and irrigated with fertilized water. A computer maintains the room's environmental conditions, including temperature, humidity and carbon dioxide level.

Considering the vast number of unused mines and other cavernous spaces in many parts of the country, Ausenbaugh sees potential for more facilities like his. He's built a second grow room and will spend the next few months working with tomatoes, tobacco and other pharma crop candidates to see whether they fare as well as the corn. If the crops flourish, drugmakers could very well find themselves venturing into the stygian depths. Although no deals have been struck, Ausenbaugh is hopeful that his idea will help put the biopharming industry back on track, while keeping the meds out of your cornflakes.


Ballot Fight Targets Biotech Crops

By Jim Wasserman
Sacramento Bee
July 3, 2005

As sides square off in Sonoma, others want to outlaw bans by counties

Saying their livelihoods are threatened, powerful forces that drive California's $27 billion agricultural economy are mobilizing to defeat a November ballot initiative to ban biotech crops in Sonoma County, and possibly even prohibit such county bans with new legislation in coming days.

Farm interests in Sonoma County say they've already raised $200,000 to fight a local ballot measure promoting a 10-year moratorium on growing genetically modified crops. Statewide, the California Farm Bureau Federation, California Cattlemen's Association and others have launched a political organizing effort, campaign Web site and fundraising operation to confront anti-biotech groups at the polls Nov. 8 and into next year when more counties consider such bans.

"The whole world is watching what is going on here," said Sonoma County Farm Bureau Executive Director Lex McCorvey. "This will put our farmers and ranchers at a competitive disadvantage," he said, noting that some already grow biotech corn for cattle feed.

If passed, the major wine-grape growing and dairy county would become California's fourth to ban genetically engineered seeds. In 2004, Mendocino, Marin and Trinity counties became the nation's first to ban the growing of such seeds, despite having few, if any, biotech crops. Voters in Butte, San Luis Obispo and Humboldt counties rejected their proposed bans. The Humboldt County town of Arcata and tiny Point Arena in Mendocino County have also banned growing of biotech crops inside their city limits, while elected officials in nine counties have passed resolutions supporting biotech.

Opponents of genetically modified agricultural crops, which were first commercialized in 1996, say their long-term effects on the food supply, public health and the environment haven't been adequately studied, and frequently link them to an industrial-style agriculture system they say produces food with harmful environmental practices. According to the Washington-based Council for Biotechnology Information, biotech seeds were planted last year on 200 million acres in 17 nations.

"Once it's out there you can't recall it," said Daniel Solnit, campaign coordinator for GE-Free Sonoma County, the group that qualified the ballot measure with 45,000 voter signatures this year. "This is not like a defective product you take back. It's not like chemical contamination. This is biological contamination that lasts forever."

Genetically modified crops represent one of the biggest advances in the 10,000-year history of agriculture, biotech supporters say, with potential to greatly increase yields and defend plants from pests and diseases. Scientists create the seeds by splicing new materials into their genetic codes, a now routine laboratory practice that some fear may eventually lead to unintended environmental consequences.

"The insertion of foreign genes into a species is when the problems arise," said Renata Brillinger, director of Sonoma County-based Californians for GE-Free Agriculture.

California has an estimated 600,000 acres of biotech crops, mostly cotton and corn and largely in the Central Valley.

While many farmers say such crops cut their fuel and chemical costs, and require fewer tractor trips across their fields every year, biotech opponents are preparing to initiate battles to restrict the crops beyond Sonoma County to at least a dozen other counties next year, including Sacramento, Yolo, Placer and Nevada.

Already, prospects of such county bans spreading beyond California have prompted a dozen state legislatures to outlaw them, and California will soon become the 13th, if state Sen. Dean Florez, a Shafter Democrat, gets his way.

"We think that debate belongs in the state," Florez said. The senator, who represents parts of Kern, Tulare and Fresno counties, is seeking a special Assembly Agriculture Committee hearing this week on legislation he said could stop Sonoma County's vote.

With time short, Florez is planning a controversial, but common parliamentary procedure known inside the Capitol as a "gut and amend," stripping one of his air pollution bills of its language and inserting new language outlawing county bans on biotech seeds.

That's prompted a massive rallying effort by anti-biotech forces, who call the senator's move a last-minute "dark room" deal to subvert local democracy in California.

"I agree in principle that regulating at the state level is more consistent," Solnit said. "But guess what? They aren't doing it. They've had 12 years. They aren't on the ball, and they're showing no sign of doing it."

Solnit and other biotech foes say lack of sufficient federal and state oversight of genetic engineering has forced them to make it a local issue.

But Yolo County rice farmer Tim Miramontes, who planted his first biotech crop this year, 15 acres of herbicide-resistant canola for a European seed company, said his positive experience proved to him that county bans are shortsighted.

A biotech crop "helps the farming community by keeping our costs down," he said. "It saves more on pesticides and herbicides, which people don't want us to spray anyway."

In the meantime, battle lines are already hardening in Sonoma County, where the pro-biotech coalition recently ran a half-page advertisement in the Santa Rosa Press Democrat. In the ad, a letter from Bill Pauli, a Mendocino County vineyard and winery owner, and president of the Sacramento-based California Farm Bureau Federation, urged voters to be wary of "scare tactics" and an outsider-financed "campaign of fear and misinformation."

Responded Ryan Zinn, a San Francisco campaign coordinator with the Minnesota-based Organic Consumers Association, which contributed to previous county biotech campaigns: "It's really disingenuous to say this is outsiders causing problems. In all these counties we have more members than the Farm Bureau does."


Grain of Doubt

By David Rice
Journal Raleigh
July 10, 2005

Genetically modified rice in Eastern North Carolina is setting off a whirlwind of criticism and concern

PLYMOUTH - North Carolina farmers haven't grown rice in many years, so they welcome the green sprigs now poking out of a flooded field near an agricultural-research station here.

But this is not your Uncle Ben's rice.

Last month, with approval of two permits from the U.S. Department of Agriculture, Ventria Bioscience, a biotechnology company in California, planted 75 acres of rice that has been genetically engineered to produce proteins found in human milk, saliva and tears.

The company says that the proteins it will extract from the rice eventually could be used in granola bars, sports drinks or rehydration formula to help infants in the Third World avoid death from diarrhea.

Environmentalists say that the rice poses a significant threat to other crops and to the human food chain.

The planting is on private land near the state-owned Tidewater Research Station in Washington County. On the way to North Carolina, Ventria encountered opposition from rice growers, food vendors and environmentalists in California and Missouri.

When the company tried to grow its rice in Missouri this spring, beer-maker Anheuser-Busch threatened not to buy any rice grown in Missouri. The two companies eventually reached a truce in which Ventria agreed not to grow genetically modified rice within 120 miles of commercial rice crops.

Environmentalists and others say that the recent planting of Ventria's rice crop near Plymouth brings the international debate over genetically modified foods to North Carolina.

It also tests the state's considerable efforts to throw out a welcome mat for the biotech industry.

"If it wasn't a food crop, I think it would be a lot less controversial. But they've chosen to introduce a genetically modified, pharmaceutical-producing food crop in North Carolina," said Hope Shand, the research director at the Action Group on Erosion, Technology and Concentration in Carrboro.

"They were run out of California, run out of Missouri, and then welcomed with open arms in Eastern North Carolina," Shand said. "I just can't see this as a viable rural-development strategy for North Carolina.

"Many scientists have concluded that it's virtually impossible to contain these pharmaceutical crops," Shand said. "It's not just a bunch of wild-eyed environmentalists who are concerned about this. We have the Grocery Manufacturers Association, the Food Products Association who are concerned about this experiment."

Researchers also use a nursery at the research station, less than a mile from Ventria's test site, to grow seed stock for new rice varieties. Scientists involved in those tests say that Plymouth was chosen for the tests because it is 650 miles east of any commercial rice crop.

At least two scientists wrote to the USDA to say that there is a remote possibility that pollen or disease from Ventria's rice could contaminate rice grown at the nearby nursery and be distributed to rice growers nationwide.

"It's not smart to introduce this pharmaceutical rice so close to germplasm rice," said Jane Rissler, a senior scientist with the Union of Concerned Scientists in Washington.

"That's the fundamental mistake - pharmaceuticals should not be grown in food crops," Rissler said. "With human error, with the vagaries of weather, it's going to be practically impossible to keep this out of the food supply."

Company officials say that the risks are overstated, and that they take every precaution to isolate Ventria's rice.

They point out that, unlike corn, rice is self-pollinating. The plant's male and female organs are contained within the same flower, so its pollen rarely travels farther than a few feet.

"There is a .001 percent chance of cross-pollination within 10 or 15 feet," said Somen Nandi, the director of molecular breeding for Ventria, who is evaluating which of the company's rice varieties grow best in North Carolina.

At the test site, an 18-inch dike borders the rice plots to keep water in the field. A dedicated ditch provides water only to the rice field, and water is screened before it leaves the field to keep rice from traveling.

Company officials say they will use equipment that is used only to grow and harvest Ventria's rice. After harvest, they will drain the field and burn the remnants to destroy plant matter.

And they say that adequate buffers are in place to protect other crops from any crop migration. Nandi pointed to a field of cotton 200 feet away, across a dirt road and a ditch.

"Not a single plant of rice will grow there. Not a single plant," he said. "It (the rice plot) is a completely unique ecological niche."

Like much of the cotton grown in Eastern North Carolina, the cotton across the road has been genetically modified for resistance to the herbicide Roundup so that farmers can overspray young plants and make fewer applications overall.

"This (cotton) is 100 percent GMO," Nandi said. "What's the problem with rice?"

Scott Deeter, Ventria's president, says that human proteins for use in rehydration formulas such as Pedialyte could help prevent the deaths of 1.9 million children that the World Health Organization estimates are killed by diarrhea each year.

"Breast-fed babies are healthier than babies who are fed with infant formula. These two proteins are part of the reason for that," Deeter said.

"It's a significant human-health problem," he said. "The challenge, of course, is we've got to have a cost-effective, affordable therapy. That's the advantage of using the rice."

Once harvested, Ventria's rice would not enter the food supply as grain, he said. It would be pulverized into a powder. "We're not directly feeding the rice. We're using the rice sort of as a factory, and we're extracting the proteins," he said. Though it won USDA approval to grow its rice here, Ventria is still waiting for the U.S. Food and Drug Administration to approve its two human proteins - lactoferrin and lysozyme - for use in foods. The proteins are being tested in Peru for use in treating acute diarrhea, Deeter said.

"Putting proteins that are in saliva in a plant - every time we swallow, we're swallowing these proteins," Deeter said. "The only difference here that I can see is that it's new."

If Ventria wins FDA approval of its products, he said, the company will try to expand production, depending on demand.

"At peak, 20,000 to 30,000 acres is a possibility if we're very successful. How much of that is in North America, and ultimately in North Carolina, is an open question," he said.

Researchers at N.C. State University who are monitoring the project say they are investigating many of the claims from environmentalists and the food industry that Ventria's rice crop could migrate, cross-pollinate with other plants and contaminate the human food supply.

"Our interest is in monitoring these very sorts of issues," said Ron Heiniger, an associate professor of crop science who works at the Plymouth research station.

"That's what we're concerned about - do we get rice where we didn't get rice before?" he said. "I'd like the opportunity to know scientifically what the risks are."

Because no rice is grown commercially in North Carolina, researchers will know exactly where it came from if it shows up outside the test plots, Heiniger said.

"We'd have the environment to isolate the crop ... and prevent the crop movement," he said. "If it is a worst-case scenario, if we get a lot of movement of rice, then what better place to know that?"

Washington County lies along a major bird-migratory route. Bald eagles soar over the research station and the rice field in summer, occasionally plucking catfish from ponds at the research station. Rather than pollen migration, Heiniger said, the possibility of movement of the rice crop through waterfowl and other birds that feed on rice seed is researchers' biggest concern.

They also want to study how to keep rice seed from washing away during major floods like those caused by Hurricane Floyd in 1999.

"It'd be a miracle, frankly, to get the pollen to cross-pollinate," he said. "There are unknowns, as with anything.... You expect the unexpected - such as birds."

Deeter and Nandi, though, point to studies that found that once birds eat rice seeds, they digest them completely.

"Once they're digested, they're not viable," Deeter said. "It seems plausible, but it's not really supported by the science.... You've got to use the science, because if you don't use the science, you're just using emotion."

And despite his own questions about birds, Heiniger sees enormous potential for farmers who grow Ventria's rice.

"They think they could have a huge impact on the health of children in the Third World," he said. "These proteins right now come out of mammalian tissue.... We're talking hundreds of dollars per ounce. If they can grow them in rice that can be readily harvested, we're talking cents per pound."

Genetically modified crops such as Roundup-ready cotton and soybeans, as well as corn that has been genetically altered for insect resistance, are already common in North Carolina.

So in rural Washington County, residents appear far more worried about the U.S. Navy's plans to build an outlying landing field (OLF) than about genetically modified organisms.

Local farmers who are accustomed to growing genetically modified corn, cotton and soybeans appear to welcome Ventria's overtures as a new opportunity for value-added agriculture.

"Several of them have offered - 'You can use my land,'" Heiniger said.

Joe Landino, the president of the Blackland Farm Managers Association, a group of about 50 large-scale farmers in several eastern counties, says that farmers are excited about growing pharmaceutical rice and think that Ventria's effort will be a tightly controlled experiment.

Organic farmers, in particular, are often wary of genetically modified crops that could creep into their fields. But the closest organic farmer to Ventria's test site says he isn't worried.

"It's a virtual impossibility," said Wade Hubers, who grows organic corn and soybeans in Hyde County, roughly 12 miles from the research station.

Hubers said that the organic corn and soybeans he grows fetch twice the price of conventional crops, more than making up for the lower yield on organic crops.

But the potential benefits from Ventria's rice far outweigh the risks, he said.

"They're going to have a good buffer around it," he said. Though there are some risks, Hubers said, "I look at this rice kind of like a pharmaceutical company growing it in a greenhouse. It's that kind of risk."

When rice growers in Missouri opposed Ventria's plans there, "I think they totally overreacted to it, but that's to North Carolina's benefit," Hubers said.

Landino said that despite environmentalists' worries, economic forces will continue to drive demand for drugs and other products that can be grown in plants.

"There's opposition to this biotechnology worldwide. But it's all in vain, because people are going to be begging for these biotech products," he said. "You don't want to shut down something that can be so productive in the future."

He also noted that although there is no commercial rice grown in North Carolina, there are a few small plantings for ducks and other waterfowl.

"We've grown rice before down here," he said. "We know we can grow rice. This is just a special project that needs a little more intensive management."

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Genetically engineered food is corporate bioterrorism