Titel: Reaping A Biotech Blunder
Datum: February 19, 2001
Biotech Activists(biotech_activists@iatp.org) Posted: 02/08/2001 By blilliston@iatp.org

Reaping A Biotech Blunder;
Just about everybody ignored the safety rules on a kind of biotech corn
called Starlink. Luckily, no one died from eating it. But what if someone

BY Brian O'Reilly

For anyone in the business of growing corn, one of the biggest frustrations
of the job is a brown inchworm-like creature that spends most of the summer
and fall munching and tunneling through the corn, only to emerge as a moth
that flies off to spawn a lot more inchworms. Like many adolescents, corn
borers can be enormously destructive. Depending on when in the growing
season they arrive, they can damage arteries that carry moisture to the
corn, or even cause the entire ear to fall off before harvest. The borer
costs American farmers and their $20 billion corn crop upwards of $1
billion a year, if you count diminished yields plus the price of pesticides
and other measures needed to keep the borer at bay.

So in 1995, when scientists produced an early variety of genetically
modified corn that poisoned the borer shortly after its first cornstalk
casserole, farmers fairly jumped for joy. But last summer, right in the
middle of the harvest, things got messy. Plant Genetics Systems, a company
now owned by Aventis, a giant European pharmaceuticals firm, had developed
another borer-killing gene that it called Starlink. However, the toxin that
Starlink produced in the corn plant resembled a substance that triggers
violent allergies in some people. When federal regulators threatened to ban
Starlink corn until its safety in humans could be established, the
developers thought they had a better idea. In effect, they promised to sell
Starlink seed only to farmers using it for feed corn; in turn, the farmers
would agree not to sell the seed to anyone who would put it in human food.
Okay, said the feds. But be careful.

Well, guess what? Almost everybody involved screwed up. Even though
Starlink was on the market for just three years--and made up just 0.5% of
the 80 million acres of corn planted in the U.S. last year--it began
showing up in all sorts of places it didn't belong, including tacos, corn
chips, breweries, and muffin mix. The promises made by Starlink's inventors
proved worthless, falling prey to managerial inattention, corporate
mergers, blind faith, misplaced hope, woeful ignorance, political activism,
and probably greedy farmers too, if you can imagine such a thing.

The episode hardly qualifies as a disaster, since no one seems to have
gotten seriously ill from eating Starlink corn. Howard Buffett, son of
Warren and a farmer near Decatur, Ill., even sees a bright side to it; he
says Starlink has revealed the shortcomings of federal oversight and has
pointed up the inability of the grain-handling industry to segregate subtly
different products. Still, Starlink has caused no end of hassles for
farmers, grain-elevator operators, railroads, and food processors. Neil
Harl, an agricultural economist at Iowa State University, calls it "the
biggest assault on American agriculture I have ever witnessed." Altogether,
the fiasco could cost Aventis half a billion dollars.

The long-term consequences may be more severe. So far Americans have been
much more accepting of genetically modified food than the rest of the
world. If Starlink triggers hysteria among Americans, the world's biggest
appetite for that promising technology will shrink, and the whole science
will be retarded for years. If foreign food processors that buy U.S.
agricultural commodities worry that American grain glows in the dark, they
will turn even more to Brazil and other countries for their food, and U.S.
farm prices, already depressed, will fall further.

One of the more surprising revelations of the Starlink mess isn't that
genetically modified food has suddenly appeared in the food supply, but
rather how much such food is already out there. Most of us have heard about
such oddities as strawberries protected from frost damage by a gene
transplanted from an arctic fish. But did you know that genetically
modified soybeans now account for 60% of all soy grown in the U.S.? Called
Roundup Ready, the plants were developed by Monsanto to tolerate Roundup,
one of the company's weed-killers. Says Gary Niery, a farmer in central
Illinois: "Before Roundup, we used to use a quart of herbicide per acre.
Now it's just ounces." Similarly engineered soy plants, including
LibertyLink from Aventis, are sold by other companies.

Close on the heels of Roundup Ready soy came another kind of genetically
altered plant: one that produced its own pesticide. That's where the
Starlink story begins. For nearly 30 years farmers have sprayed crops with
solutions derived from a soil bacterium called Bacillus thuringiensis. This
so-called Bt spray is harmless to humans but quite effective against a
variety of pests, including corn borers. However, it doesn't kill all corn
borers, especially those that often show up in a second wave of infestation
in midsummer. In 1995 seed companies such as Pioneer Hi-Bred and DeKalb won
approval to sell corn genetically altered to produce the pesticide found in
soil bacteria; this seed killed nearly 99% of corn borers. About 18% of
corn planted in the U.S. last year was of the Bt variety.

One bag of seed corn (enough to plant 2 1/2 acres) costs $ 90; Bt corn
costs an additional $ 15 per bag. Corn-borer infestations vary widely from
year to year, depending on wind and rain. If infestations are mild, it's
cheaper to fight the borer with sprays. But in broad swaths of the Cornbelt
where the borer is a chronic problem, the Bt varieties of seed are more
economical. Roughly a quarter of the corn grown last year in Iowa, Kansas,
Nebraska, and Minnesota was of the Bt type; the figure was 35% in South

Pioneer and DeKalb's head start in the Bt- engineered crop business worried
Aventis, a $ 20-billion-a-year French pharmaceuticals and agricultural
sciences company formed last year by the merger of Rhone-Poulenc and
Hoechst. Although most of Aventis' revenues come from drugs such as
Allegra, a prescription antihistamine, the company's crop-sciences division
had sales of $ 4 billion last year, making it one of the biggest
ag-products operations in the world. At least some Aventis officials had
big hopes for genetic engineering. "We were spending $ 450 million a year
on R&D in the agricultural division," says an executive who, like all
Aventis officials interviewed by FORTUNE, declined to be identified. "We
had gone about as far as you could fighting weeds and pests with chemicals
and needed to make a big shift to biotechnology." Even before their
companies merged, executives at Rhone-Poulenc and Hoechst worried that
rivals were grabbing market share in key agricultural technologies that
would be difficult to win back later.

Buried in the welter of corporate subentities created by the
Rhone-Poulenc/Hoechst combination was a small Belgian company called Plant
Genetics, which Hoechst had acquired in 1996. Corporate life cannot have
been easy for the managers and scientists at Plant Genetics, who had been
working for a decade on a Bt variety of corn. Four years before the Aventis
merger, Hoechst had formed a joint venture with Schering, the U.S. drug
company. Plant Genetics was acquired by the joint venture, called Agrevo,
which was later folded again into a division of Aventis. The point here is
less the details than the big picture. There was lots of upheaval at Plant
Genetics--its tiny U.S. headquarters moved through three cities in four
years. It is reasonable to assume, too, that operational details
surrounding a corn gene were hardly the most important concern of senior
Aventis executives trying to manage a $ 20 billion merger. Until it was too

Although scientists at Plant Genetics were a few years behind the
competition, they were excited about what they had created: a variety of
the Bt protein that destroyed a different part of the corn borer's gut.
This was important because an additional vulnerability would make it harder
for the corn borer to develop resistance to Bt pesticides. The Bt variety
created in Starlink corn was called Cry9. (Bt proteins have a crystalline
shape, so different varieties were called Cry1, Cry2, etc.) Aventis
scientists thought Cry9 was a winner that would make them significant
players in the next generation of agricultural products. Federal regulators
in the U.S. were more cautious.

In the early 1980s, when the prospect of bioengineered crops first emerged,
people from numerous U.S. government agencies met to discuss how to
regulate the products. They agreed that the Department of Agriculture would
determine whether a new plant was safe to grow outdoors: Would it run amok,
for example, and harm other plants or animals? If a genetically altered
plant was supposed to produce a pesticide, the Environmental Protection
Agency would decide whether the plant was safe in food. The Food and Drug
Administration would enforce the food safety standards established by the

In 1997, when EPA scientists were evaluating Starlink, they saw something
they hadn't seen in other brands of Bt corn. Starlink's Cry9 protein didn't
dissolve in stomach acid as quickly as proteins in other Bt varieties. Nor
did it break down as rapidly during cooking or processing. This meant that
the Cry9 protein, unlike the others, might stay in the stomach long enough
to be passed intact into the bloodstream, where it could trigger an
allergic reaction. "Other Bt proteins lasted only a few seconds in
simulated gastric juices," says Stephen Johnson, deputy assistant
administrator of the EPA in charge of pesticide regulations. "This broke
down much more slowly." In other tests, however, the Cry9 protein seemed
fine. "We looked at the structure of the molecule and asked if it walked
and talked like other known allergens," says Johnson. "It did not. So we
were faced with two of three studies saying there was something different
about this pesticide. We decided we couldn't allow it in food without more

Starlink's developers, eager to market their product, invoked a
little-known EPA rule that allows some pesticides and herbicides to be used
on feed for animals but not on food destined for humans. This "split
registration" had never been sought for genetically modified products,
Johnson notes. "We looked at each other and said, 'What do we know about
allergens? We know they don't pass through cattle.' We spoke to USDA and
FDA, and they said [Starlink] passes the standard. We didn't feel real
comfortable with it. But the law prevents us from saying, 'We don't like
your product.' So we allowed it but put restrictions on it." For their
caution, Johnson says, "we were denounced as pointy-headed regulators."

The restrictions on Starlink corn were severe. It could be grown only for
animal feed or for nonfood use, such as conversion to ethanol. Because
regulators worried that windblown pollen from Starlink stalks could pass
the Cry9 gene to ordinary corn, farmers had to leave 660-foot buffer strips
around their Starlink fields. Farmers bringing the corn to market had to
notify grain elevators that it could not be used in human food. The EPA
ordered Starlink's developers to require all farmers who bought the seed to
sign a form affirming that they understood the restrictions and would abide
by them. The company also promised to conduct a "statistically valid"
survey of Starlink growers to ensure they were following the rules.
Finally, says Johnson, "the company agreed to accept full liability if
anything went wrong."

Neither Aventis nor its predecessor companies ever produced much Starlink
corn. Instead they inserted the newly spliced genes into small amounts of
corn and sold the resulting sprouts to seed companies. These then planted
Starlink in greenhouses, harvested the corn, and replanted it to create
more seed. Eventually the seed companies contracted with farmers who grow
large volumes of corn for seed under controlled conditions outdoors. Once
that seed was harvested, the companies had enough Starlink seed to begin

Ultimately, about a dozen small seed companies licensed Starlink corn from
Plant Genetics. The Garst Seed Co., which is near Des Moines and has one of
the longest pedigrees in the seed business, produced the vast majority of
Starlink corn, according to Aventis executives. Garst, as is common with
smaller seed companies, relies heavily on "farmer dealers" to sell its
products. These are usually farmers who use the slow winter months to
schmooze relatives and neighbors into buying a few thousand dollars' worth
of seed. In 1998, the first year Starlink was on the market, just 10,000
acres were planted. Last year a mere 350,000 of America's 79.6 million
acres of corn were Starlink. The highest concentration of Starlink in any
state last year was 1.1% in Iowa, Garst's backyard.

Nevertheless, the proliferation of Bt corn was causing growing concern
outside the Farmbelt. In April 1999 an entomology professor at Cornell
University researching corn-borer resistance to Bt reported that he had fed
a diet of corn pollen to monarch butterflies' larvae. Many of the monarchs
that ate Bt pollen died. This caused a furor among environmentalists, who
admire the monarch for its yearly migration from Mexico and back. Many
environmentalists are profoundly worried about all genetically altered
plants and animals, fearful that they contain health hazards that won't
become apparent for years, or that they will somehow reproduce wildly and
overwhelm ordinary species. For environmentalists, the monarch was about to
become the poster butterfly of the anti-Frankenfood movement.

Among the environmentalists who led the charge against Bt corn was Larry
Bohlen, an engineer by training and a senior official in the Washington
office of Friends of the Earth. For years FOE and other greens had been
trying to get the U.S. government to sign international protocols on the
use of genetically modified organisms. "When the Cornell study on monarch
butterflies came out, we had our first tangible example of the kind of
impact genetic crops could have," says Bohlen. He wrote to President
Clinton asking that use of Bt plants be suspended until their effect on
nontarget animals could be determined. And he began writing to
consumer-product companies like Campbell's, Kellogg, and Frito-Lay, urging
them to forswear all genetically modified food. Last July the campaign
began in earnest. Bohlen arranged for popular foods to be tested for
genetically altered ingredients "so we could contact the manufacturers and
tell them to be more careful."

Eventually Bohlen learned about Starlink. "When I asked grain-elevator
operators and farmers how Starlink and other unapproved varieties were
being segregated, I was told that separation was difficult and that very
little segregation was being done." Bingo. Bohlen had his galvanizing
image. "By summer it seemed there was a good chance Starlink had made it
into the food supply." In late July of last year, Bohlen went to the
Safeway near his home in Silver Spring, Md., and filled his grocery cart
"with all the corn products I could find." He sent them to Genetic ID, an
Iowa lab that routinely checks commodity shipments bound for Europe to make
sure they comply with European Union standards. In September the news that
Starlink corn had been found in tacos made by Kraft and sold under the Taco
Bell brand was splashed across the front page of the Washington Post.

David Witherspoon, president of the Garst Seed Co., can't recall where he
was when the news broke. That's surprising, because if anybody should have
been electrified by the development, it was the head of Garst, which sold
nearly all the Starlink produced in the U.S. "We were very concerned,"
Witherspoon now says. Aventis executives say they were flabbergasted and
didn't believe the reports at first. A biotech industry organization
immediately questioned the reliability of Genetic ID. But then Kraft
ordered its own tests of the tacos; it found Starlink and recalled more
than a million boxes. Other taco makers did the same. Kellogg shut down one
of its mills because it feared Starlink contamination. Grain elevators, in
the midst of gathering the fall harvest, scrambled for ways to test
arriving truckloads for Starlink contamination. In many ways it was too
late; most of the Starlink in the nation's food had come from the 1999 corn
crop. And because 1999 had been a bumper year, there were more than a
billion bushels of unsold corn still sitting in silos. No one knew how much
of it was mixed with Starlink.

How did this happen? Every farmer who had bought Starlink signed a form
agreeing to keep it out of the human food supply, right? Well, not exactly.
Many of the 2,500 Starlink farmers appear to have been clueless about it.
Hundreds claimed their seed salesmen never told them they were buying
Starlink, and certainly didn't pass on any precautions about how to plant
it. The head of the agriculture committee of the Iowa House of
Representatives, Ralph Klemme, says he bought Starlink but was never told
it was forbidden for use in food. Thomas Miller, the Iowa Attorney General,
says "the vast majority" of farmers did not sign any forms acknowledging
planting and marketing limits. It was not until a few weeks after the
Starlink news broke that farmers who planted the seed received a letter
asking them to sign and return some forms; the forms appear to have been
backdated to before the spring planting. Aventis executives vigorously deny
having anything to do with the letter. In a telephone interview, Garst CEO
Witherspoon said he would "prefer not to get into that," citing potential

Witherspoon insists that Garst provided information to all its salesmen
about Starlink. Asked whether Garst salesmen were diligent about having
farmers sign the EPA-required forms, Witherspoon was vague. "The dealers
would have started getting the forms and would know we had them. We tried
to get them to dealers. We'd remind them to use them."

It seems unlikely that Garst's farmer salesmen would have knowingly
deceived customers. The seed business relies heavily on the trust that
exists when farmers sell seed to relatives and neighbors. Garst is one of
the oldest companies in the business; it began in 1930 by marketing hybrid
seeds developed by Henry A. Wallace, the founder of Pioneer Hi-Bred.
(Wallace was later Vice President under Franklin Roosevelt.) Garst was so
well known that Soviet Premier Nikita Krushchev visited its founder,
Roswell Garst, on his Iowa farm in 1959. But the company ran into trouble
in the early 1980s, when Pioneer severed its relationship with Garst to
market its own seed. Garst lost the bitter lawsuit that ensued. The family
sold the business to ICI, the British chemical company, in 1985. (Du Pont
bought Pioneer in 1999.) ICI later spun off its U.S. seed business to
Zeneca, a British drug company. Garst is now a part of Advanta, a joint
venture between Zeneca and Royal VanderHave Group in the Netherlands.
Ironically, Advanta made headlines in Europe last year when canola seeds it
had sold there were found to contain small amounts of genetically altered
material forbidden by the EU. The seeds, grown in Canada, may have been
contaminated by windblown pollen from other canola nearby.

Aventis eventually took responsibility for the Starlink mess; the company
is spending millions to locate the rogue corn so that it can be put into
animal feed. Aventis executives say that they thought Garst was spelling
out the restrictions on Starlink to farmers, but hint that they didn't
monitor Garst carefully. Neil Harl, the agricultural economist at Iowa
State, says he doubts Garst was motivated to be very explicit about how
Starlink had to be grown and sold. "What farmer would buy a variety of seed
if he was told he had to plant a 660-foot buffer strip around it, and would
have to go through all sorts of special separation and storage after the
harvest?" Witherspoon disagrees, saying the company sent 15 mailings to
Starlink farmers. As for the "statistically significant" survey of farmer
compliance that Aventis had promised the EPA, the company appears to have
dropped the ball. Garst conducted the survey, says an Aventis executive,
but did it right after the harvest, when most corn was still stored on farms.

Both Garst and Aventis officials implied in interviews that if they failed
to live up to all their agreements with the EPA, it was because they were
convinced Starlink would soon get full approval for use in food and that
the special conditions would be lifted. "Aventis was working very hard on
those approvals," says Witherspoon.

Even after giving Aventis and Garst their share of the blame, there's
plenty more to go around. Johnson, the EPA official, now concedes that a
split registration for Starlink, allowing it in feed but not food, was a
dumb idea. "It was the first and last time we will allow that," he says.
Critics point accusingly at the FDA, which was supposed to enforce food
standards established by the EPA. Larry Bohlen at Friends of the Earth says
the FDA didn't even have a way of testing for Starlink in food and that the
agency moved slowly when news of the contamination first came out. "Kraft
ran circles around the FDA. The day Kraft pulled its tacos off the shelf,
the FDA was faxing me to ask if I would send them some of my taco shells.
Kraft had already tested and confirmed on multiple lots." An FDA
spokeswoman declined to comment on the agency's role in Starlink.

To its belated credit, Aventis has been aggressively trying to locate
Starlink seed. It requested Garst's list of Starlink customers and met with
all of them within days. Aventis is paying farmers up to 25 cents for each
bushel of Starlink seed fed to animals. When grain-elevator owners discover
that a batch of Starlink has contaminated a million-bushel silo, Aventis
negotiates compensation for their added efforts and expense. The company
has also paid for millions of test kits used by farmers, food processors,
and grain handlers to identify traces of Starlink. Just how much is out
there is anybody's guess. Because many farmers failed to plant buffer
strips, pollen sometimes drifted into neighbors' fields, causing that corn
to test positive. Moreover, some Garst seed varieties that weren't supposed
to contain Starlink turn out to have been contaminated, the company now
admits, and that adds to the difficulty of finding it.

Even though Aventis executives don't argue with assertions that the debacle
may cost the company hundreds of millions of dollars, Wall Street appears
unfazed. Aventis ADRs climbed from $ 71 to $ 77 between early September and
late January. Some farmers have fared well too. Even if they planned all
along to feed the Starlink they grew to their cattle, Aventis is paying
them a premium for it.

But the reactions of people like Jerry Rowe are more typical. Rowe manages
the Farmers Grain Cooperative, a four-million-bushel grain elevator in
Dalton City, Ill. He says Starlink has greatly complicated his life. At
peak times he unloads a truck every two minutes. "The Starlink test takes
five minutes per truck, and I can't afford to slow down." And his sampling
probe could miss Starlink lurking in a far corner of a truck. "Maybe I'll
miss it coming in, but the customer finds it when I'm shipping it out,"
says Rowe. Corn that Rowe could sell for $ 2.14 a bushel to Archer Daniels
Midland in nearby Decatur might get rejected, forcing him to spend 20 cents
a bushel to ship it to Cedar Rapids, where the pay is just $ 2.06. Rowe
also worries that if he finds Starlink in his bins a year from now, Aventis
won't compensate him. Aventis claims that it will.

The long-term consequences of Starlink seed are hard to predict. No serious
health problems have emerged so far. About three dozen people complained to
the FDA about bad reactions to corn products in the days after Starlink
first made headlines. Many clearly did not have allergic reactions, and
virtually all the rest had mild problems like itchy eyes or a tight throat.
A pediatric allergist from Duke University told a scientific advisory panel
convened by the EPA that unless someone has an anaphylactic reaction to
Starlink, he or she does not have a food allergy. But the panel decided
that Starlink does indeed walk and talk like a potential allergen, and
advised the EPA to turn down a request by Aventis that small amounts of it
be allowed in the food supply.

Starlink has not triggered widespread hysteria about genetically modified
food in the U.S., to the disappointment, no doubt, of some environmental
groups. But Johnson at the EPA still worries that the episode may slow the
acceptance of genetically modified products. "I am outraged at Aventis," he
says. "This is enormously important technology. We trusted Aventis to
handle it properly, and they didn't."

He is probably right to be concerned. Pierre Deloffre, head of a large
French vegetable-processing company, told a seed trade convention in
Chicago last December that Europeans turned abruptly away from genetically
modified foods during the 1990s. Deloffre blames government regulators and
scientists who failed to respond properly to Chernobyl, AIDS in the blood
supply, and mad cow disease for eroding Europeans' confidence in
technology. "Five years ago the first boatloads of genetically modified
soybeans arrived here without the slightest reaction," says Deloffre. Now
the EU barely touches them.

Although Europe hasn't imported much American corn for years, Japan is a
large customer. The Japanese have been fairly tolerant of bioengineered
food, but they, too, are growing cautious. New rules that take effect in
Japan this spring will require labels on food to state if it contains
genetically modified ingredients. An executive at ADM says orders from
Japan for unmodified corn and soy have already begun to climb in
anticipation of the new labels.

Since it caused no serious illnesses, Starlink will probably be a footnote
in future agronomy textbooks. In reality, though, this was a disturbingly
close brush with disaster. Starlink was probably circulating in the food
supply for a year before it was found. If it had been slow acting but truly
dangerous, like mad cow disease, the damage could have been enormous.
Critical links in the food chain--from Aventis and Garst to thousands of
small farmers--turned out to be either unconcerned about or oblivious to
what they were selling and growing.

If we're lucky, maybe Starlink will also be a wake-up call, reminding us
that tinkering with Mother Nature is risky business--and that it's not just
white-coated lab technicians who must be careful. Solving the problem of
hunger and malnutrition may ultimately depend not so much on science as on
our faith in science and all its stewards. And if you can't trust a farmer,
who can you trust?