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Summary Article on GE from Washington Post. After 5 years EPA still has
not issued detailed guidelines to measure ecological impact of GE foods.
EPA is currently considering approval of corn with a GE (cry9C) protein that survives digestion.

Biotech Food Raises a Crop of Questions
By Rick Weiss
Washington Post Staff Writer
Sunday, August 15, 1999; Page A1

Steve Taylor practically yawned when researchers at Pioneer Hi-Bred, the
giant agricultural seed company, asked him in 1995 to study a new soybean
they had invented. "I didn't think we'd find anything interesting," the
University of Nebraska scientist recently recalled.

Little did Taylor know that his findings would help trigger a wave of
anxiety over the safety of genetically engineered food in Europe, a wave
that, years later, now threatens to engulf the United States as well.

Pioneer had spliced a Brazil nut gene into soybeans, creating a soybean
that boasted a nutritious nut protein. Taylor's task was to find out
whether the new soybean would cause allergies in people allergic to Brazil
nuts, a potential danger because people with allergies to nuts wouldn't
think to avoid soy.

The company had put just one of the Brazil nut's thousands of proteins into
its new soybean, and the odds of that one causing the nut's allergies
were
incredibly low, Taylor said. So he could hardly believe it when first one
test, then another, and finally a third indicated that the transferred
protein was indeed a major cause of Brazil nut allergies.

In trying to build a better soybean, the company had made a potentially
deadly one.

Pioneer immediately halted the soybean project. But Taylor's study lives on
today as a symbol of everything that is both frightening and reassuring
about genetically altered food, which has quietly made its way into nearly
every American kitchen.

Frightening because the study proved that a gene-altered food could cause
an unexpected and potentially fatal reaction.

Reassuring because the problem was detected before the product was marketed.

And symbolic above all because it was, and still is, one of the very few
studies ever to look directly for any harm from an engineered food or crop.

That dearth of studies is the legacy of a U.S. policy that considers
gene-altered plants and food to be fundamentally the same as conventional
ones, a policy some Americans are starting to question.

It is also the legacy of the sheer scientific difficulty of conducting the
kinds of tests that might assure people that engineered crops and food are
safe.

And it is the legacy of broken promises by the Food and Drug Administration
and the Environmental Protection Agency, both of which have said for the
past five years that they intend to write rules to minimize the chances
that gene-altered food will cause allergies or damage the environment.

"Americans are starting to realize that this process is not as all wrapped
up as they thought it was," said Carol Tucker Foreman, a food safety
specialist at the Consumer Federation in Washington.

Genetically engineered food, which is endowed with bacterial, viral and
other genes not native to human food, has been widely, if mostly
unknowingly, consumed in the United States since 1996. As far as scientists
can tell, no one has ever been harmed.

But with evidence accumulating that the crops may be less environmentally
benign than biotech companies had predicted-most recently, gene-altered
corn was found capable of killing monarch butterflies-some Americans are
reconsidering the technology's overall safety.

"I've had more calls about this allergy research in the past three months
than I've had in the three years since we published it," Taylor said.

In Europe, that crisis of confidence already runs deep. Activists regularly
vandalize newly planted plots of gene-altered crops. Major grocery chains
have refused to carry engineered food. And food processors have begun to
hire DNA fingerprinting labs to verify that their products are free of
foreign genes.

The British Medical Association has warned that the technology may lead to
the emergence of new allergies and speed the evolution of microbes
resistant to antibiotics. Other groups worry that gene-altered crops may
lead to the growth of insecticide-resistant bugs, or "superweeds" unfazed
by herbicides.

In this country, gene-altered food is virtually unavoidable. About
one-third of the corn growing in the United States is genetically
engineered, mostly to exude its own insecticide, as is about half of the
cotton crop (including some grown for edible cottonseed oil) and a smaller
percentage of potatoes. Half of all U.S. soybeans are genetically modified
as well, mostly to produce a chemical that makes the plants impervious to
weed-killing sprays.

So with the exception of explicitly organic food, which flows through
independent "identity-preserved" food streams, nearly everything made with
soy, corn or cotton in this country ends up containing at least some
gene-altered ingredients.

That's a lot of different foods. Soy protein can be found in about 60
percent of all processed food, including frozen meals, baby food, yogurt
and other products. And corn, in addition to being the main ingredient in
tortilla chips and corn starch, provides the high-fructose sweeteners found
in many "natural" sodas, fruit drinks and other products.

U.S. regulators and industry representatives argue that engineered food is,
if anything, safer than conventional food. Old-fashioned plant breeding
involves the random and uncontrolled reassortment of thousands of genes
with every mating, they note. By contrast, biotechnology allows the precise
transfer of a single well-understood gene into a plant, leaving little to
chance.

Moreover, they say, since 1992 the FDA has required allergy tests like the
ones Taylor did for all new food made with genes taken from milk, eggs,
wheat, fish, shellfish, legumes or nuts, foods that account for perhaps 90
percent of American food allergies. The agency also insists that
gene-altered food be nutritionally equivalent to its conventional
counterparts.

Most important, advocates say, the FDA can demand extensive safety testing
if the new gene "differs substantially" from those generally found in other
food. But critics call that a hollow promise. They note that all 44 crops
that so far have gained FDA marketing approval have avoided that scrutiny
because the agency has accepted the industry's claims that they are
"substantially equivalent" to conventional food.

That is, they claim, because the Food, Drug and Cosmetic Act demands safety
testing on all new additives not "generally recognized as safe." Now
activists are suing the FDA in federal court to force such testing on the
bacterial and other genes being added to food crops.

Safety testing can be difficult, as researchers found with the Flavr Savr
tomato, which was given a gene to make it ripen more slowly. When Calgene
and Zeneca Plant Science developed that tomato in the early 1990s, no FDA
rules were in place. So the companies voluntarily agreed to conduct a full
range of tests.

When scientists tried to feed rodents the tomatoes, however, the animals
wouldn't eat them, recalled Roger Salquist, one of the scientists involved
in creating the Flavr Savr. "I gotta tell you, you can be Chef Boyardee and
mice are still not going to like them."

The researchers went so far as to force-feed the tomatoes to rodents
through gastric tubes and stomach washes. The procedure made the rodents
sick, of course, and revealed nothing about the food's safety. The tomato
ultimately won approval from the FDA but failed in the market in part
because it was so expensive.

Safety testing is also difficult because there's no widely accepted way to
predict a new food's potential to cause an allergy. The FDA is now five
years behind in its promise to develop guidelines for doing so. With no
formal guidelines in place, it's largely up to the industry to decide
whether and how to test for the allergy potential of new food not already
on the FDA's "must test" list.

That means there is a small chance that someone will suffer an allergic
reaction, and perhaps a serious one, but science can never assure safety
with 100 percent certainty, said University of Wisconsin professor Robert
Bush, chief of allergies at the Veterans Affairs Hospital in Madison. And
when deciding how much effort and expense should be rallied to minimize
that risk, Bush said, people should remember that new foods are introduced
all the time from other parts of the world without regulators demanding
studies on their allergy potential.

"I don't think there was a hue and cry about introducing kiwis onto the
U.S. market," Bush said, even though many Americans have proven allergic to
them.

The effects of gene-altered crops on the environment are at least as
complicated as those on the human body. The EPA requires companies to
conduct limited ecological impact tests before marketing gene-altered
crops. But while the agency has promised to spell out in detail what crop
developers should do to ensure that their gene-altered plants won't damage
the environment, it has failed to do so for the past five years.

Meanwhile, several recent scientific studies have highlighted a range of
potential problems that may be arising from engineered crops.

The most publicized of those was the recent finding that pollen from corn
that has been engineered to produce an insecticide called Bt is toxic not
only to the caterpillar pest it is aimed at, but also to the monarch
butterfly. The laboratory study leaves unresolved whether monarchs are
actually being harmed around cornfields. But it inspired a coalition of
national environmental groups, including several that had not weighed in on
agricultural biotechnology before, to ask the EPA to stop its registration
of new varieties of Bt corn until the agency comes up with a more complete
ecological safety plan.

At the same time, recent studies have pointed to a variety of other
problems that seem to be emerging from Bt corn. One report, for example,
suggests that the EPA's primary strategy for preventing the emergence of
Bt-resistant insects-a plan that calls for planting "refuges" of
conventional corn in nearby fields-may be doomed to fail because Bt
resistance genes in insects behave differently than scientists had thought.

Another study showed that Bt can alter the time it takes an insect to reach
adulthood. That could dash the EPA's hopes that Bt-resistant insects will
mate with Bt-susceptible ones and give birth to offspring still vulnerable
to the chemical.

Still other studies suggest that Bt corn may be inadvertently killing
beneficial insects such as ladybugs and lacewings, which eat insect pests.
If true, then the insecticidal crops may be giving reprieves to as many
insect pests as they are killing.

And scientists are finding that some engineered crops, such as
herbicide-resistant canola in Canada, are cross-pollinating with wild
relatives more widely than had been predicted, creating hardy weeds that
can survive herbicidal sprays.

Now, the EPA faces a potentially larger problem: whether to approve a new
kind of Bt corn called Bt cry9C. It's a decision that many observers see as
a test case of just where the agency will draw the line on the degree of
risk it is willing to accept.

While other versions of Bt break down harmlessly in the human digestive
tract, the cry9C protein remains stable in the human stomach. And because
the protein can survive digestion, it has increased potential to cause
allergies.

The FDA demands extra allergy testing for new food that contains such
stable proteins. And AgrEvo, the German company that is seeking approval
for cry9C corn, has conducted some additional tests, including a comparison
of cry9C's molecular structure with known allergy-causing proteins.
Reassuringly no similarities exist.

But as the agency considers whether to approve the corn for human
ingestion, it is up against the reality that there is no surefire way of
testing a new protein like cry9C for its potential to cause allergies in
people.

"We all wish there was a test where you plug in a protein and out pops a
'yes' or 'no' answer," said Sue MacIntosh, a protein chemist with AgrEvo.

But there is no such test, short of giving it to a lot of people and seeing
what happens.

The EPA is considering the company's application and hopes to make a
decision by fall.

© 1999 The Washington Post Company

** NOTICE: In accordance with Title 17 U.S.C. Section 107, this material is
distributed for research and educational purposes only. **

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