2-Plants: Farmers Grow a Field of Dilemma
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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
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
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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