Washington Post-Genetically Altered Food

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To: Undisclosed-recipients:;

Date: Mon, 19 Mar 2001 11:48:51 -0500 (EST)

My husband just sent me this article from today's Washington Post. It

really expands upon the issues involved in food allergies and genetically

altered food.

Sharon in Virginia

To view the entire article, go to

http://washingtonpost.com/wp-dyn/articles/A23092-2001Mar18.html

Biotech Corn Is Test Case For Industry

Grace Booth had just finished a chicken enchilada lunch with some

co-workers when she began to feel hot and itchy. Her lips began to swell,

she developed severe diarrhea and soon she was having trouble breathing.

Colleagues called an ambulance.

Booth, 35, was rushed from the California youth center where she works

to a nearby hospital, apparently suffering from anaphylactic shock.

Doctors quickly injected her with anti-allergy medicine, gave her some

Benadryl to swallow and put her on an IV. The treatment worked, and after

five hours Booth walked out of the hospital.

Several days later, Booth learned that taco shells and other corn

products had been recalled nationwide because they were found to contain

a genetically modified type of corn called StarLink. The corn had been

approved only for animal consumption because of concerns that it might

trigger dangerous allergic reactions in people.

Because there was corn in the tortillas Booth had eaten -- and because

tests for!

all other food allergies had been negative -- she contacted the Food and

Drug Administration. She reported that she might have had an allergic

reaction to StarLink.

Booth is among several dozen people nationwide who believe they suffered

allergic reactions from eating StarLink corn last fall. Their cases are

being investigated by the FDA and the federal Centers for Disease Control

and Prevention. The outcome of that investigation could have enormous

ramifications for the future of biotech food.

Allergic reactions have been viewed for years as the primary threat to

human health posed by genetically engineered foods, which typically have

proteins from other organisms spliced into them for various reasons. But

the health complaints about StarLink are the first lodged by consumers

against an engineered food.

If researchers determine the unsuspecting diners did have allergic

reactions to a protein in the corn, then the already troubled world of

agricultural biotechnology wil!

l suffer another damaging blow. Despite widespread concern over the

possibility that genetically engineered crops could damage the

environment or cause human health problems, there has been little

evidence that either has occurred. Allergic responses to StarLink would

mark the first documented instances of people suffering health problems

because of engineered food.

But if the results come back negative, the industry will regain some

credibility. Company scientists have argued that StarLink could not cause

severe, or even minor, allergic reactions, and that the corn is safe.

That's why they say it should have been approved for human use (rather

than only animal feed) several years ago.

It has taken months for the FDA to develop a test for that potential

allergic reaction, but officials say they believe they have one. It has

not been fully checked and double-checked, and researchers warn the test

will not give a definitive answer.

But officials said they are far enough al!

ong to seek blood samples from people like Booth collected last year by

the CDC. The samples were scheduled to arrive in Washington last week,

and testing is expected to begin this month.

Karl Klontz, a medical officer with the FDA's Center for Food Safety and

Applied Nutrition, said the test will determine whether the people had

produced antibodies to the genetically modified protein in StarLink corn,

called Cry9C, which protects plants against the European corn borer.

" This is the first time a test like this has been developed, and nobody

is claiming that it is a gold standard, " Klontz said. " But the presence

of [the antibody] would suggest the possibility of an allergic

phenomenon, and the lack of [the antibody] would go a long way to

reassure that there is no allergic issue. "

If the antibody to Cry9C is found in the blood samples, he said, then

skin-prick tests and even " food challenges " -- the feeding of food

containing StarLink to possible allergy sufferers -- coul!

d follow.

Regulators have been especially concerned about engineering foreign

proteins into food because consumers have no way of knowing they might be

present. People allergic to peanuts know to avoid certain products, but

genetically engineered proteins are not labeled and so can't be avoided.

The issue surfaced in 1995, when researchers found that a Brazil nut

gene introduced into a soybean could cause allergic reactions. The

problem was discovered before the soybean went to market, and research on

the seeds was stopped.

StarLink corn was supposed to be kept from human food, but all involved

acknowledge the system for doing that didn't work.

The corn was discovered last fall to have been inadvertently mixed with

corn destined for the human food supply, prompting a massive and costly

recall of corn and foods made with corn, including tacos, beer and, most

recently, corn dogs. But since the recalls began, federal and industry

officials have emphasized that no signific!

ant health hazard was involved.

In fact, in November, Aventis CropScience, which makes the corn, once

again asked the Environmental Protection Agency to approve StarLink for

human consumption, pointing to new research it said showed there was no

risk of allergic reactions. Aventis had returned its license to sell the

corn in the future but wanted the variety approved for past seasons to

limit disruptions in the corn market -- and, some contend, its own

financial liability.

The company argued then that the quantities of StarLink in processed

food are too small to cause allergic reactions and that its research

showed that the Cry9C protein was destroyed in producing food such as

tacos. The Cry9C found in tests of tacos was from cell DNA rather than

actual protein, the company said, and so could not cause an allergic

reaction.

An EPA expert panel concluded several weeks later that there was a

" medium likelihood " StarLink protein could cause an allergic reaction but

that the!

re was a " low probability " that people had developed the needed

sensitivity because of the limited amount of the corn in the food supply.

However, the panel recommended that the EPA not act on the Aventis

request until a test was created and used to evaluate reports of allergic

reactions to StarLink.

The FDA has received 48 such reports, and the CDC has focused on the 35

that came in before the November advisory committee meeting. At that

time, the FDA said about a dozen of the complaints appeared to involve

bona fide allergic reactions.

StarLink is suspected of causing allergies because Cry9C has a

heightened ability to resist heat and gastric juices -- giving more time

for the body to overreact. The molecular weight of the protein is also

consistent with something that can trigger an allergic reaction, the

panel said.

The StarLink issue has spawned several lawsuits, including a class

action suit filed in Chicago, accusing Aventis and others of negligence

and consumer f!

raud for producing or selling corn products that weren't approved for

human use. The plaintiffs contend that they suffered allergic reactions,

and include people who filed reports with the FDA and some who did not.

Biotechnology officials minimize the suits, saying that some people are

trying to take advantage of the situation. They also say that given the

huge effort and cost involved in buying up StarLink corn and recalling

products found to contain it, the industry response should be applauded

rather than attacked.

Finger, a Florida optometrist, is a plaintiff in one suit, and

like Booth, he reported suffering a serious allergic reaction. Finger ate

a dinner of tortillas, beans and rice in September, and 15 minutes later

got a terrible stomachache and diarrhea. Soon after, he started to itch

all over, his tongue began to swell and he had difficulty breathing --

all the symptoms of anaphylactic shock.

Finger called in a prescription for a fast injection of an ant!

i-allergy medicine and gobbled some Benadryl; gradually, the symptoms

subsided. If he hadn't acted quickly, he said, he could have died.

Several days later, he learned about StarLink corn, and went back to see

whether there was corn in his tortillas. There was, and he filed a report

with the FDA.

Finger said that he talked several weeks ago to an Aventis lawyer and

offered to eat some food with StarLink to see whether he would have

another allergic reaction. He said the lawyer was initially interested

but declined.

" At this point, I just want to know if people like me can have an

allergic reaction to StarLink, " Finger said. " It's scary to think people

might have reactions to something they don't even know is in their food.

This needs to get cleared up soon. "