Titel: Genetically Engineered Corn Cleared in 17 Food Reactions
Datum: 14 juni 2001
Bron: Washington Post
Via: "GENTECH" email 18 juni 2001
Full report: http://www.cdc.gov/nceh/ehhe/Cry9cReport/

Genetically Engineered Corn Cleared in 17 Food Reactions
Product Did Not Trigger Allergies, Health Officials Report

DATE: June 14, 2001

Genetically engineered StarLink corn did not cause allergic reactions in 17 people who had reported sometimes severe reactions after eating corn tacos and tortillas last fall, federal health officials said yesterday.

Blood tests failed to find any signs of antibodies to the protein in the genetically engineered corn, indicating none of those tested had experienced an allergic reaction, the federal Centers for Disease Control and Prevention said. All had complained to federal agencies last year of reactions ranging from rashes to anaphylactic shock after eating products made of yellow corn that might have contained StarLink.

The results were applauded by advocates of biotechnology as confirming the safety of StarLink in particular and modified crops in general. But environmental groups called the federal effort limited and insufficient to answer the question of whether StarLink can cause dangerous allergic reactions.

Carol Rubin, an epidemiologist with the CDC's National Center for Environmental Health, said that while the test results were "only a first step" in answering questions about the safety of the corn, "it can be seen as good news for consumers."

"Based on the test methods used, it is highly unlikely that the people had an allergic reaction to" StarLink, she said. "They may have experienced allergic reactions to some food, but not the protein that was tested."

But one of the people who suffered anaphylactic shock after eating an enchilada made of yellow corn, Californian Grace Booth, said she was still convinced she had a reaction to StarLink.

"Everything else I ate in the 72 hours before I got so sick, I've eaten again with no problem," she said. "Frankly, I don't trust the tests."

StarLink is a variety of corn engineered to contain a protein, called Cry9c, that can protect crops against several insects. While many similar modified corns have been approved for general use, StarLink was approved only for animal feed because of concerns that it broke down more slowly than many proteins and might cause allergic reactions. The corn nonetheless inadvertently entered the human food supply, triggering the recall of about 300 corn products.

The developer of the corn, Aventis CropSciences of Research Triangle, N.C., has asked the Environmental Protection Agency for retroactive approval to allow small amounts of StarLink corn in food for people. The tests results announced yesterday were requested by a scientific advisory panel convened by the EPA to help determine whether to issue that approval. The advisory panel is set to meet again on the StarLink issue next month.

Val Giddings of the Biotechnology Industry Organization said that yesterday's results meant that the case was "slam-dunk closed."

"We are pleased, but not the least bit surprised, that the data released by the CDC today is consistent with the vast body of data we have had all along showing the safety of StarLink corn," he said. "If the protein was allergenic, they would not have found these negative reactions."

The tests were done at a Food and Drug Administration laboratory, and required new research into how to test for possible reactions to foods containing genetically modified crops. The blood samples, which included some taken before StarLink was developed and some from highly allergic people, were sent with number codes to prevent bias.

Rebecca Goldburg, a scientist with Environmental Defense, said that the CDC sample was too small to be meaningful, and that the EPA should not approve StarLink for human use based on the results. She said a wider test of people, especially children and those who eat enough yellow corn products to develop a sensitivity, is needed.

"The results are comforting, but hardly definitive," she said. "This is not something that could be published in a scientific journal and be accepted as conclusive. They didn't target the right people to test."

Mark Helm of Friends of the Earth, an environmental group that first brought the issue of StarLink in taco shells to public attention, said it was "borderline irresponsible to say this stuff is safe. It still has not been rigorously tested."

According to the CDC's Rubin, 51 people had reported experiencing adverse reactions in the weeks after StarLink was found in tacos and other corn products.

Of those, she said, 28 fit the definition of having suffered a food allergy, and 17 of them agreed to provide a blood sample. Some of the reactions had been quite severe, and Rubin said that all will receive reports on what the researchers learned about their blood.

Allergy experts generally agree that if antibodies to StarLink had been found in the blood of the 17, that still would not have meant the people had allergic reactions to the modified corn. That determination could be made only after completing skin prick tests or food challenges.

Booth, 35, who works at a youth center, said that she remained willing to have a skin test with StarLink protein or even eat something made with StarLink under a doctor's supervision. "I still feel like I haven't gotten to the bottom of this, and very much want to do that," she said.

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TITLE: CDC involvement in investigating adverse health effects associated with eating corn products potentially contaminated with the Cry9C Protein in StarLink(TM) corn
SOURCE: Centers for Disease Control and Prevention, USA
DATE: June 13, 2001

----------------- archive: http://www.gene.ch/genet.html -----------------

Contact: CDC, Division of Media Relations (404) 639Ð3286


CDC involvement in investigating adverse health effects associated with eating corn products potentially contaminated with the Cry9C Protein in StarLink(TM) corn

In May 1998, the U.S. Environmental Protection Agency (EPA) granted a limited license for the production of StarLink(TM) corn containing the protein Cry9c. This protein has pesticidal properties and was inserted into StarLink(TM) corn to protect the crop against several insects. The EPA did not license StarLink(TM) for use in food intended for human consumption because the Cry9c protein shared several molecular properties with proteins that are known food allergens.

In response to a request from EPA in October of 2000 the U.S. Food and Drug Administration (FDA) requested assistance from the Centers for Disease Control and Prevention (CDC) in investigating possible adverse health effects among people who had reported to FDA that they may have had an allergic reaction to eating corn products contaminated with the Cry9c protein in StarLink(TM) corn.

CDCÕs investigation did not find any evidence that hypersensitivity to the Cry9c protein was responsible for the self-reported allergic responses that people experienced last fall.

Our field investigation included the following:

1. Reviewing the adverse event reports (AERs) that FDA/Center for Food Safety and Applied Nutrition received from consumers in the United States or its territories who reported adverse health events between July 1, 2000, and November 30, 2000, and involving a product suspected of containing corn meal contaminated with StarLinkª corn.

2. Contacting persons who gave permission to the FDA for CDC to speak with them. CDC field investigators asked basic questions about food consumption and signs and symptoms that each person recalled experiencing when they consumed corn products. CDC obtained medical records and collected blood specimens from each person for later laboratory tests.

An FDA laboratory developed a laboratory method to detect the type of antibody (IgE) that would indicate hypersensitivity to the Cry9c protein that was inserted into StarLinkª corn.

CDC asked FDA to evaluate the case report samples as well as other reference samples using this developmental method. To avoid bias in the laboratory analysis, all samples were provided to FDA with just a simple code number.

FDA returned the data to CDC and CDC analyzed it to compare case values with control values.

Although the study participants may have experienced allergic reactions, based upon the results of this study alone, we cannot conclude that a reported illness was a Cry9c allergic reaction.

An independent laboratory analyzed the same set of coded samples that CDC sent to FDA and confirmed the results.

CDC reviewed this data and issued individual reports to the study participants. CDC has also sent a report of the investigation and study results to FDA, and FDA will provide this information to EPA. EPA will consider the results of the CDC study and other data as it makes recommendations about the use of Cry9c.

CDC is continuing to work with FDA to evaluate the AER system for identifying potential health outcomes.

To access the full report, log onto http://www.cdc.gov/nceh/ehhe/Cry9cReport/