WASHINGTON, DC, June 21, 2002 (ENS) - The science needed for government regulators to assess allergies in genetically engineered foods is not being adequately researched, according to a new report issued June 11 from the Pew Initiative on Food and Biotechnology.

The report, "A Snapshot of Federal Research on Food Allergy: Implications for Genetically Modified Food," found that nine federal agencies or institutes now supervise 33 food allergy research projects totaling between $4.2 and $7 million, but those funds are spread thin and there is little coordination among federal agencies or between research teams.

Dr. Lynn Goldman and Dr. Luca Bucchini of the Johns Hopkins Bloomberg School of Public Health conducted the study. The authors reviewed food allergy research funded by the federal government and aimed at investigating food safety.

Genetically modified corn (Photos courtesy Monsanto)

The increasing use of genetically modified crops such as corn and soybeans raises several issues relevant to food allergies.

On one hand, biotechnology may help remove or change proteins that can cause allergies, but genetically modified foods could also introduce new proteins into foods that could cause allergic reactions. Without prior experience with the new protein, the Pew report says, it is difficult for regulators to predict the potential of the protein to be a serious allergen.

Unless a product can be shown not to be an allergen, federal regulators cannot approve it for human consumption.

The existing research focuses on known allergens such as peanuts and milk, and almost no studies examine the allergenicity of novel proteins potentially introduced by foods created through biotechnology, the study found.

Food allergy is an immune mediated disease caused by food antigens. It occurs only among people who are sensitive to those antigens.

As many as 10 million Americans are estimated to have allergies to one or more foods, and for them, reactions to those foods can result in illness or even death. Little is known today about why some people have reactions to food in general.

It is impossible for allergy prone consumers to determine whether the food they purchase is or is not genetically engineered. It is not labeled, and citizen pressure for labeling laws has been rejected by the federal government.

Genetically modified oil rapeseed, also known as canola. The oil from this crop is widely used in baked goods.

The U.S. Food and Drug Administration (FDA) considers that genetically engineered foods as a class do not require premarket review and approval of a food additive petition.

This view was upheld by a federal court. On September 29, 2000, the U.S. District Court for the District of Columbia dismissed the challenge to the FDA regulatory policies concerning genetically engineered foods brought by The Alliance for Bio-Integrity and other public interest and religious groups.

The court also accepted FDA's view that special labeling for genetically engineered foods as a class is not required solely because of consumer demand or because of the process used to develop these foods.

GM foods currently on the market have been screened for possible allergenicity problems. But some new GM foods may be difficult to judge with current science, as illustrated recently in the case of StarLink, a type of genetically modified corn genetically engineered to be toxic to insects. It was approved for use only in animal feed because it could not be shown that the new protein in the corn was not an allergen.

"Almost two years ago, Starlink accidentally made its way into the human food supply," said Michael Rodemeyer, executive director of the Pew Initiative.

"After massive consumer product recalls, lawsuits, buybacks from farmers and a disruption to American farm export markets that continues today, we still lack answers to the basic science questions posed by government regulators whether StarLink was or was not an allergen," he said. "Was the Starlink recall even necessary for allergy reasons? We just don't know."

The FDA maintains that federal food law requires premarket approval for food additives, whether or not they are the products of biotechnology. FDA treats substances added to food products through recombinant DNA techniques as food additives if they are "significantly different in structure, function or amount than substances currently found in food."

"However, if a new food product developed through biotechnology does not contain substances that are significantly different from those already in the diet, it does not require premarket approval," the agency says.

One year ago, the federal Centers for Disease Control found no evidence that eating corn products contaminated with an unapproved genetically engineered variety can make people sick. The report on the health effects of StarLink corn, which was licensed only for animal feed, met heavy criticism from environmental and public interest groups who say the engineered corn has been linked to severe allergic reactions in dozens of people who complained to federal agencies.

Bill Freese of Friends of the Earth said the CDC's study did not test a large enough group of people. "The EPA's scientific advisors specifically said that the investigation should be broadened, yet FDA chose to ignore that advice. A thorough investigation is exactly what the public deserves."

Rodemeyer agrees. "Unfortunately, this lack of scientific knowledge is hindering both the government as well as the private sector. We need to invest in the science to give regulators the tools and information they need to evaluate new products and protect the public."

For a copy of Pew Initiative study, go to: http://www.pewagbiotech.org/research/allergy.pdf

The Pew Initiative on Food and Biotechnology is a nonprofit, nonpartisan research project whose goal is to inform the public and policymakers on issues about genetically modified food and agricultural biotechnology, including its importance, as well as concerns about it and its regulation. It is funded by a grant from The Pew Charitable Trusts to the University of Richmond.

Copyright Environment News Service (ENS) 2002. All rights reserved.