The science needed for government regulators to assess allergies in genetically engineered foods could be greatly improved, according to a new report issued today 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 currently supervise 33 food allergy research projects totaling between $4.2 and $7 million, but that those funds are spread thin and with little coordination among federal agencies or between research teams. Moreover, the study found that the existing research focuses on known allergens such as peanuts and milk, and that almost no studies examine the allergenicity of novel proteins potentially introduced by foods created through biotechnology. In other words, the funds that have been committed to address the problem are not being strategically allocated to ensure research needs and opportunities are fully met.

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. In addition, the increasing use of genetically modified (GM) crops raises several issues relevant to food allergies. On the 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, 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.

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 that 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," noted Michael Rodemeyer, executive director of the 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.

"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," he concluded Drs. Lynn R. Goldman and 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. Research abstracts were sourced from CRISP (Computer Retrieval of Information on Scientific Projects), a database of research supported by the Department of Health and Human Services, and CRIS (Current Research Information System), a database supported by the US Department of Agriculture as well as additional sources. Because of the way CRISP and CRIS are maintained, the study is a snapshot in time; it captures research projects that were active in Q3 2001 and does not account for studies that may have just been completed or that will soon be approved. The study also does not include research undertaken by the private sector, NGOs or states, which all may have an impact on the advancement of food allergy research but are not easily investigated. The study did not include ongoing federal research projects that more generally investigate allergy and may, in time, produce results that contribute to understanding of food allergy.

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