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TITLE:  Farmers Grow a Field of Dilemma
        Drug-Making Crops' Potential Hindered by Fear of Tainted Food
SOURCE: Washington Post, USA, by Justin Gillis
DATE:   Dec 23, 2002

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Farmers Grow a Field of Dilemma
Drug-Making Crops' Potential Hindered by Fear of Tainted Food

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 

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 

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 

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 

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."


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