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US science panel rejects StarLink in human food

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Download EPA's final report and related documents.

Source: Planet Ark. US science panel rejects StarLink in human food

USA: July 30, 2001

WASHINGTON - A science advisory panel last week urged the Environmental Protection Agency to maintain its ban on StarLink biotech corn in human food, saying too many questions remain about whether the gene-spliced corn can cause rashes, breathing problems or other allergic reactions.

StarLink, originated by the European drug giant Aventis SA , caused a massive U.S. food recall last autumn when traces of the bio-corn were discovered in taco shells. The vast U.S. corn supply was accidentally contaminated when farmers, shippers and grain handlers mixed small amounts of StarLink with other varieties of yellow corn.

The EPA asked a panel of 16 physicians and independent scientists to evaluate if a "tolerance level" - or maximum allowable amount of StarLink - could be established for StarLink in human food.

The agency approved StarLink in 1998 for livestock feed and ethanol, but banned it in human food because of uncertainties about health effects. At issue is StarLink's unique Cry9C protein, which protects the growing plant from pests.

STARLINK A POTENTIAL ALLERGEN

The science panel concluded in its 40-page report that "no evidence has been presented that demonstrates StarLink Cry9C's protein allergenic potential is diminished."

It also reaffirmed an earlier finding that the gene-spliced corn has a "medium likelihood" of being a human allergen.

The panel's recommendation to the EPA is a setback for Aventis, which faces several lawsuits and is trying to sell its agricultural division.

The scientists, led by University of Florida toxicologist Stephen Roberts, questioned the reliability of laboratory tests used by the Food and Drug Administration and the Centers for Disease Control. The panel expressed concern about the FDA's use of an alternate form of Cry9C protein in its testing, rather than the authentic Starlink-produced Cry9C protein.

The CDC tested blood samples of 17 consumers who claimed to have allergic reactions to StarLink from food products. All 17 tested negative.

Other safety tests should be conducted with farmers and grain mill workers to identify any allergic reactions, the scientists recommended. And private physicians specializing in allergies and immunology should be alerted to report food reactions to the government for further investigation.

Sponsors

MOST STARLINK GONE

The panel also noted that virtually all StarLink corn would be gone from the U.S. corn supply by 2002 because of aggressive efforts by the U.S. Agriculture Department and Aventis to remove StarLink from the market.

Major food makers have also begun testing their corn supplies for StarLink contamination.

The wet-milling corn process used by food makers for corn-based snack foods and flours diminishes StarLink's Cry9C protein and risk to public health, the panel said.

The EPA, which will consider the panel's recommendations before issuing a final decision, said the new report showed there was little risk to the public from StarLink.

"This supports the agency's determination that there is no public health risk from eating products manufactured from StarLink corn through the wet-milling process, provided that corn utilized in the wet-milling process does not contain significant levels of StarLink," the EPA said in a statement.

EPA TO MAKE FINAL DECISION

The scientific review of StarLink was prompted after Aventis asked the EPA to set a tolerance level of 20 parts per billion for StarLink in processed food.

Aventis contends StarLink poses no risk of allergic reactions and is safe to eat.

"Aventis will fulfill its commitments to continue direct Cry9C-containing corn to approved feed and nonfood industrial uses," the company said in a statement. "We will continue to support the grain handlers and millers with their testing programs."

The EPA, which typically follows the advice of its science advisory panels, did not say how soon it would issue a decision on Aventis' request.

"EPA sincerely appreciates the high level of scientific expertise this panel has provided on this important issue," Stephen Johnson, EPA assistant administrator, said in a statement.

"Bringing the best science to the table, and evaluating it in a transparent manner is fundamental as we continue the important work of ensuring protection of public health and maintaining consumer confidence in the integrity of the food supply," Johnson added.

The panel's recommendation was a victory for environmental groups, which have urged regulators to go slow with biotech food approvals until more research is done.

They cited the case of a Florida optometrist who documented with photographs his skin rash after eating corn chips containing a small amount of StarLink.

"The passive allergy reporting measures that the EPA and FDA have enlisted to date have been insufficient," said the Genetically Engineered Food Alert, a coalition of green and consumer groups. "American consumers have the right to know what they are eating and that the food they are eating is safe."

Story by Julie Vorman

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