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Farmers grow a field of dilemma

(Monday, Dec. 23, 2002 -- CropChoice news) -- Justin Gillis, Washington Post: KNIERIM, Iowa -- One spring day, just outside this hamlet in north-central Iowa, two brothers named Joe and Bill Horan tore open a big wooden crate to find a lot of paperwork and some bags of seed corn. They planted the corn and watched it grow tall in the rich black earth of their native state, one of the best places in the world to grow that grain.

The Horan brothers were happy, for this wasn't just any old corn: The plants were genetically altered to produce a drug in their kernels that might prove useful for people with the life-threatening ailment cystic fibrosis.

The crop was the culmination of a half-dozen years of effort by the Horan brothers, who felt they were well on their way to establishing a new industry for the Corn Belt and its sophisticated but hard-pressed community of farmers. Fields of food plants would become living factories capable of churning out as many as 400 new drugs and industrial enzymes. New laboratories and workers would be needed to purify the drugs. The investment could ultimately be worth billions.

"You can see what this starts to look like to a place like rural Iowa," Bill Horan said.

But today the Horan brothers' dream is suddenly up in the air, and the biotechnology industry in the United States is in turmoil. Errors by a small biotech company in College Station, Tex., called ProdiGene Inc. have called into question the whole idea of growing drugs in food crops, seeming to vindicate years of warnings from environmental groups and more recent concerns from big food companies.

ProdiGene's mistakes led to potential grain adulteration in two states. No suspect grain reached the food supply, but the errors have nonetheless set off a behind-the-scenes political struggle in Washington, with farm interests, food companies, biotechnology companies and three government agencies debating what to do next. One question is whether to impose geographic restrictions, moving drug-producing crops away from places like the Corn Belt, where much of America's food is grown, to more remote areas.

New rules to regulate "pharming" have been in the works at the Agriculture Department for a while, but now they are likely to get tougher, and two other agencies -- the Food and Drug Administration and the Environmental Protection Agency -- also appear ready to take a stronger approach. Bills to strengthen regulation are pending in Congress.

Broad public interests are at stake. Plants may be the cheapest way, or in some cases the only way, to produce a slew of proteins that would be useful as drugs, industrial compounds or even renewable sources of fuel. It is a nascent, potentially valuable industry in which the United States is poised to lead the world.

Yet the recent problems raise questions about whether these unusual crops, if planted widely, could be properly confined, or whether they would inevitably make their way into the distribution channels that put corn flakes and baby food into American pantries. That could provoke expensive product recalls and undermine public confidence in the food supply.

The stakes are highest, perhaps, in rural America, where a generation of farm families is fervidly looking for more valuable crops to help them preserve a way of life many feel is under siege. Foreign countries with lower costs are competing with them to supply the world's commodity crops, such as corn, wheat and soybeans.

"Iowans are concerned about the future of family farmers, the value system that is represented by family farms and rural communities," said Thomas J. Vilsack, a small-town lawyer who worked closely with Iowa farmers before he became the state's Democratic governor. "We believe one future option is to turn grain into cures for cancer and other illnesses and diseases."

But if that is going to happen at all, it won't happen easily. Recent events in two adjacent states, Iowa and Nebraska, illustrate why many people are intrigued by the idea of pharming -- and why so many others are alarmed.

The StarLink Experience

The techniques that may allow companies to grow drugs or industrial chemicals in plants are part of a revolution in the life sciences that began three decades ago, when biologists learned to slice and dice the genetic carrier molecule, deoxyribonucleic acid, or DNA, and move it around. Great fear attended that technology at first. But most of its uses have proven benign, to the point that high school students now manipulate genes in biology class. Vast factories crank out drugs such as insulin using bacteria into which human genes have been inserted.

The technology still provokes some controversies, though, and the biggest in recent years has involved genetic manipulation of plants. Monsanto Co. and its competitors in the mid-1990s introduced crop varieties containing foreign genes to help the plants resist worms and weeds. These varieties were a hit with farmers and quickly took over half the nation's acreage of row crops, only to run into fierce opposition overseas, particularly in Europe, where prominent figures such as Prince Charles accused biotech companies of playing God.

The crops have generally proven safe to eat. But containing them on their plots has proven to be the Achilles' heel of the technology -- plant seeds and their genes simply tend to move around a lot, and gene-altered crops are starting to show up in all sorts of unexpected places. The most dramatic example occurred in 2000, when a corn variety called StarLink, approved for use only as animal food, made its way into the food supply and wound up on grocery shelves, causing concern about allergic reactions and prompting expensive recalls of taco shells and other products.

The pace of development slowed, though biotech companies continued to push forward with plant research. These days, the new frontier is "plant-made pharmaceuticals," a catch-all term that includes industrial enzymes. These plants are often food crops, such as corn, but they are not meant for eating. Instead, scientists insert foreign genes to tell the plant how to make some potentially valuable protein, which would typically be refined out and bottled like any other drug.

Well before the recent troubles, environmental groups had grown concerned about the trend, wondering what would happen if, say, tens of thousands of birds or other animals were exposed to human drugs by eating field crops. These groups often favor health-related uses of the technology, but they want these strange plants locked up tight in greenhouses or laboratories -- a restriction the biotech companies contend is impractical.

More recently, scarred by the StarLink experience, food companies and their influential lobbies in Washington have raised alarm bells, contending that federal regulators have failed to put adequate safeguards in place.

"We are the final step to the consumer," said Rhona Applebaum, executive vice president of the National Food Processors Association, at a recent public discussion in Washington. "The food industry is left holding the bag."

The Problem of Human Error

Orvin Bontrager's pickup truck bounced across the furrows of a soybean field outside Aurora, Neb., recently. He wore a pensive look. "To be honest, if anybody wants to point fingers, they ought to be pointed at me," he said, acknowledging partial responsibility for the troubles in Nebraska this autumn. "Yet all I can say is I did what I thought I was told to do to the best of my ability."

He braked the truck and braced himself against a bitter wind as he pointed to the outlines of what was, in 2001, a small plot of experimental corn deep in the soybean field. Bontrager is a consulting agronomist. ProdiGene, a small Texas company in the vanguard of those trying to make pharmaceuticals in plants, used this plot to test the ability of corn to produce a pig vaccine. Bontrager's job, in part, was to make sure the vaccine didn't find its way into the food supply.

At Bontrager's urging, a farmer tending the field in 2002 applied herbicide to make sure no corn plants, sprouting from seed left over the year before, would grow large amidst new crops, since these "volunteer" plants would have risked spreading pollen to commercial corn nearby. Bontrager checked the field every week, filing written reports. He checked a final time on Aug. 29, after the soybeans had formed a dense canopy likely to crowd out any corn. The government now contends Bontrager stopped three weeks too early, but he says he was unaware of the deadline. Two weeks before his last check, a hailstorm damaged the soybean canopy. He now believes the extra sunlight caused some corn plants to sprout, but he says they were too small to see beneath the soybeans on Aug. 29.

Similar problems with volunteer corn plants cropped up at a different ProdiGene test plot, in Iowa. In a routine inspection there in September, the Agriculture Department found corn plants where they shouldn't have been, on a plot in Pocahontas County, apparently after a different ProdiGene consultant let too much time elapse between field checks.

That situation was handled easily enough: The government ordered the company to buy up and burn 155 acres of surrounding corn that might have received pollen from ProdiGene's plants. But it raised enough alarm bells with Cindy Smith, interim head of biotech regulation at the Agriculture Department, that she sent government inspectors to look over all of ProdiGene's operations. It didn't take them long to find the corn plants Bontrager had missed among the soybeans.

His records seemed to rule out cross-pollination with nearby commercial corn -- the volunteers emerged far too late in the season. He attempted to remove the plants, though he allows now he might have missed a couple.

There appears to have been little communication between the company and federal agencies about what to do with the beans. The farmer harvested them over a weekend and took them to a cooperative in Aurora, where they were dumped into a warehouse containing tons of soybeans grown across a broad area.

Only later that week did Smith and her aides start asking urgent questions about the beans, taking note of photographs that suggested small amounts of corn material could have been mixed in. By then it was too late: Whatever was in them, if anything, had also been mixed into 500,000 additional bushels. About 550 tractor-trailer loads of beans would have to be destroyed, the government decided.

ProdiGene has acknowledged errors in both Iowa and Nebraska, agreeing to a $250,000 fine, and it will reimburse the Agriculture Department as much as $3 million to buy and burn the entire warehouse full of beans. The company has vowed to improve its procedures, acknowledging that a crop-growing system that scattered responsibility among consulting agronomists, farmers and far-flung company managers is no longer going to work.

Yet the Nebraska circumstances raise a broader question. Some errors there were of a sort that seem endemic to human nature. Skeptics wonder if this kind of thing can ever be prevented entirely. Can the weird effects of every hailstorm, every vicissitude of nature be safeguarded against?

The Agriculture Department is going to try, in proposed regulations likely to be released in Washington in a matter of weeks. Smith, the biotech regulator, noted that the Nebraska problem was caught in time, which she said was evidence of a system that worked, but she also promised to strengthen it. "We have the ability to protect agriculture, the food supply and the environment," she said.

Skepticism lingers in many quarters. Said Larry Bohlen, who has studied the issue for the environmental group Friends of the Earth: "The USDA is in a fantasyland when they're allowing food crops to be engineered with chemicals and drugs, and hoping there's no such thing as human error."

Growers on the Defensive

Greeting a visitor the other day on his farm amid the rolling hills of north-central Iowa, Bill Horan walked around his shop showing off advanced equipment, including components of a robotic sprayer that guides itself by satellite.

Things have changed down on the farm. A new generation of educated farmers, such as Bill and Joe Horan, is using the latest technology to try to stay ahead of foreign competitors. The Horan brothers inherited a small operation from their father, but today they use big machines to farm close to 4,000 acres, their invested capital runs into the millions, and their dad's old barn has been renovated into a modern office stuffed with computers and leather sofas.

Yet they fear their operation is not nearly big enough. Like many U.S. farmers, they already depend on federal subsidies to make a profit. And as countries like Brazil convert millions of acres of grassland to intensive farming, driving down commodity prices worldwide, matters are likely to get worse. "I stood in a 60,000-acre soybean field" on a visit to Brazil, Bill Horan said. "I thought, 'I've just attended my own funeral.' "

The only choice the Horans see is for American farmers, or at least the best ones, to start easing their way out of commodity crops to grow something more valuable. They've been experimenting for years with crops like high-value soybeans for tofu. But nothing has excited them as much as the idea that their farm could become the first step in a pharmaceutical production chain.

When they began studying the issue, years ago, the Horans realized that containing the crops and keeping them separate from food would be critical. After extensive planning, they flew to France to give one of the leading companies a PowerPoint demonstration of their capabilities. Meristem Therapeutics was impressed, and hired the Horan brothers to grow its gene-altered corn over the past two years. The company has entered human tests of a drug produced in the corn, lipase, that may be helpful for people with cystic fibrosis.

The Horan brothers say they have adopted stringent procedures to keep their pharmaceutical grain separate from food crops. They wrote and follow a fat manual of operating procedures that calls for labor-intensive steps throughout the growing season to keep pollen from drifting. At harvest, they use a separate harvester and other equipment, dedicated solely to the pharmaceutical crop, and store the corn in a separate, locked building that is off-limits to visitors. The Horans say that after the growing season, they keep a constant eye out for volunteer corn plants that need to be destroyed.

Most significant, perhaps, is that the Horans say they take personal responsibility for complying with the letter and spirit of government regulations. They, not Meristem, hold the permit with the Agriculture Department, and they say they realize their reputation is on the line. This tight control appears to be a notable contrast to the ProdiGene system of scattering various duties among growers, consultants and company employees.

The Horans' two-season track record is spotless, and they have pulled together a group of 72 elite Iowa farmers to pursue this new opportunity. The governor of Iowa calls the brothers "the Barry Bondses of agriculture."

Yet the recent events have forced the Horans and their allies on the defensive. One of the obvious ways to manage the risk of pharmaceutical crops tainting food would be to grow them in remote areas, far from where most food is produced. That would rule out Iowa and the rest of the midwestern Corn Belt. The Biotechnology Industry Organization, a Washington trade group, recently imposed such geographical restrictions on its members in a concession to the food companies.

The Horans contend geographic limits won't work. They point out that Iowa and its neighboring states are the ideal place to grow corn -- the nutrient-rich earth, abundant rain and hot summer sun allow the states of the Corn Belt to produce 35 percent of the world's supply of the grain. Moreover, they note that at least some amount of food is produced in every state, so sloppy production anywhere might lead to a problem. One of their allies, Sen. Charles E. Grassley (R-Iowa), has pressed the BIO to back down. The geographic restrictions remain in effect, technically, but the BIO has waffled on how vigorously it will enforce them.

The Washington debate on this particular issue may not matter in the near term: Because of the ProdiGene incidents, other biotech companies now see a huge business risk to growing their crops in the Corn Belt. Meristem, the French biotech company, appears likely to back out of Iowa, and ProdiGene, too, is talking of fleeing. The Iowa farmers are worried that a golden opportunity could be passing them by.

"If I didn't understand our process and somebody told me that in the cornfields of Iowa, some farmer was out there growing pharmaceuticals, I would certainly have concerns," Bill Horan said. "We are not claiming we have all the answers, but we are saying we have a system that is very good and we are continuing to perfect it."

The Search for Middle Ground

Environmental groups want pharmaceutical crops strictly confined to greenhouses or laboratories, and food companies are pushing to have them grown only in plants never used as food. The biotech industry, with two decades and millions of dollars invested in learning to grow them in grains such as corn, opposes both restrictions.

A few groups that influence Washington debate on matters like this have begun searching for middle ground. One of them, the Center for Science in the Public Interest, is a consumer group that supports the technology but wants it more tightly regulated. Gregory Jaffe, director of biotechnology issues at the center, notes that government policy toward these new crops has been driven by a fundamental premise: that any amount of these grains in the food supply is unacceptable. "Zero tolerance" is the operative term.

But Jaffe, like others in the debate, is starting to ask how much sense that makes. After all, the government permits pesticides in food at low levels, even though these chemicals are demonstrably harmful at high levels. Most pharmaceutical proteins would not be harmful even if eaten by the pound, since they are readily broken down in human digestion before they can have any effect. (As drugs, they would typically be refined out of the plant and given by injection.) The biggest risk from the proteins in food is that people might have an allergic reaction to them. More serious effects are theoretically possible, however, so safety cannot be assumed -- it must be proven case by case.

Jaffe is pushing the idea that companies ought to be required to do early human safety assessments, before they begin field trials of a pharmaceutical crop, to rule out harmful effects. Rigorous efforts would still be made to keep the crops out of food, but Jaffe argues that such safety data could give federal agencies cover to avoid ordering huge recalls if some tiny amount of a protein trickled into the food supply.

Environmentalists and some consumer groups, such as Consumers Union, oppose this plan, reasoning that it could lead to pervasive sloppiness in handling the new crops. Food companies are wary of the idea too, since it probably wouldn't alleviate public fears in a contamination incident. And biotech firms have long resisted conducting expensive food-safety tests on proteins that they do not, after all, mean to sell as food.

But with the recent events threatening to derail what many people see as a promising technology, interest in Jaffe's plan has risen. Sen. Richard J. Durbin (D-Ill.) has introduced a bill that would fine-tune federal regulations and require such tests. The idea has found backing from such figures as Vilsack, the Iowa governor, who has been a big booster of pharmaceutical crops. He laments "not having enough information" about any given protein to know whether it poses a threat in food.

"The first order of business should be for state and national governments to develop a process to identify what risks are associated with these products," Vilsack said. "In fact, it's probably likely that hardly any of them have significant risk."