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Modern biotechnology has dramatically increased our ability to alter the agronomic traits of plants. Among the novel traits that biotechnology has made available, an important group includes Bacillus thuringiensis-derived insect resistance. This technology has been applied to potatoes, cotton, and corn. Benefits of Bt crops, and biotechnology generally, can be realized only if risks are assessed and managed properly. The case of Starlink corn, a plant modified with a gene that encodes the Bt protein Cry9c, was a severe test of U.S. regulatory agencies. The U.S. Environmental Protection Agency had restricted its use to animal feed due to concern about the potential for allergenicity. However, Starlink corn was later found throughout the human food supply, resulting in food recalls by the Food and Drug Administration and significant disruption of the food supply. Here we examine the regulatory history of Starlink, the assessment framework employed by the U.S. government, assumptions and information gaps, and the key elements of government efforts to manage the product. We explore the impacts on regulations, science, and society and conclude that only significant advances in our understanding of food allergies and improvements in monitoring and enforcement will avoid similar events in the future. Specifically, we need to develop a stronger fundamental basis for predicting allergic sensitization and reactions if novel proteins are to be introduced in this fashion. Mechanisms are needed to assure that worker and community aeroallergen risks are considered. Requirements are needed for the development of valid assays so that enforcement and post market surveillance activities can be conducted.

Talk of genetically engineered organisms (GEOs) has moved from the hushed corridors of life science corporations to the front pages of the world's major newspapers. As Europeans began rejecting genetically engineered foods in the marketplace, the StarLink corn incident exploded in the United States and farmers set fire to genetically modified crops in India

This article briefly describes incidents of food crop & seed contamination from genetically modified (GM) varieties: indigenous land maize contamination from GM corn varieties in Oaxaca, Mexico; contamination of US domestic corn supplies with a GM trait called Starlink; plots of oilseed rape (canola) in Alberta, Canada, rendered resistant to common herbicides by GM contamination; "geographically dispersed & random" contamination of long-grain rice in the southeastern US from small (one acre) field tests of GM rice; pharmaceutical contamination of soy & corn in the US Midwest from a GM variety produced for a drug for cystic fibrosis; contamination of wild & organic papaya in HI from a GM variety; & contamination of seed for non-GM varieties of corn, canola, & soybeans sold in the US Midwest. ASD. Adapted from the source document.

Agricultural biotechnology offers substantial benefits to farmers, consumers, and the environment. However, the American people have not embraced this new technology. Spurred by such events as the StarLink™ corn contamination and European rejection of genetically modified foods, there is an increasingly visible and contentious debate in this country about the potential risks and benefits of agricultural. If we want to realize the potential benefits of agricultural biotechnology, we must achieve agreement and compromise. We must appreciate some of the factors that contribute to continuing public concern, and consider changes in government regulation that might increase public trust.

Technology has improved the food supply since the first cultivation of crops. Genetic engineering facilitates the transfer of genes among organisms. Generally, only minute amounts of a specific protein need to be expressed to obtain the desired trait. Food allergy affects only individuals with an abnormal immunologic response to food--6% of children and 1.5-2% of adults in the United States. Not all diseases caused by food allergy are mediated by IgE. A number of expert committees have advised the U.S. government and international organizations on risk assessment for allergenicity of food proteins. These committees have created decision trees largely based on assessment of IgE-mediated food allergenicity. Difficulties include the limited availability of allergen-specific IgE antisera from allergic persons as validated source material, the utility of specific IgE assays, limited characterization of food proteins, cross-reactivity between food and other allergens, and modifications of food proteins by processing. StarLink was a corn variety modified to produce a (Italic)Bacillus thuringiensis(/Italic) (Bt) endotoxin, Cry9C. The Centers for Disease Control and Prevention investigated 51 reports of possible adverse reactions to corn that occurred after the announcement that StarLink, allowed for animal feed, was found in the human food supply. Allergic reactions were not confirmed, but tools for postmarket assessment were limited. Workers in agricultural and food preparation facilities have potential inhalation exposure to plant dusts and flours. In 1999, researchers found that migrant health workers can become sensitized to certain Bt spore extracts after exposure to Bt spraying.

Intro -- INSPECTING GRAIN IN THEUNITED STATES: PROCEDURES AND DISEASES -- INSPECTING GRAIN IN THE UNITED STATES: PROCEDURES AND DISEASES -- CONTENTS -- PREFACE -- Chapter 1 INSPECTING GRAIN-PRACTICALPROCEDURES FOR GRAIN HANDLERS -- INTRODUCTION -- Inspecting Grain in the United States -- Official United States Standards for Grain -- Federal Grain Inspection Service -- Official Grain Inspections -- Official Agencies -- Inspection Services -- Review Inspections -- SECTION I. SAMPLING GRAIN -- The Importance of Proper Sampling -- Sampling Grain at Rest -- Hand Probes -- Mechanical Probes -- Sampling Moving Grain -- Diverter-Type Mechanical Samplers -- Woodside-Type Mechanical Samplers -- Pelican Samplers -- Truck (Tailgate) Samplers -- Ellis Cup Samplers -- SECTION II. INSPECTING GRAIN -- The Inspection Process -- Portion Sizes -- Harmful Substances -- Objectionable Odors -- Heating -- Insect Infestation -- Moisture -- Test Weight -- Dockage -- Foreign Material -- Damaged Kernels -- Protein, Oil, and other Intrinsic Characteristics -- Starlink -- Stress Crack Analysis in Corn -- Aflatoxin -- DON -- Fumonisin -- Zearalenone -- Ochratoxin A -- Other Factors -- SECTION III. GRADING GRAIN -- Grades and Grade Designations -- Special Grades and Special Grade Designations -- Barley -- Canola -- Corn -- Flaxseed -- Mixed Grain -- Oats -- Rye -- Sorghum -- Soybeans -- Sunflower Seed (Oil-Type) -- Triticale -- Wheat -- SECTION IV. NOT STANDARDIZED GRAINAND COMMODITIES -- Factor Analysis -- Buckwheat -- Confectionary Sunflower Seed -- Cracked Corn -- Crambe Seed -- Hulless Barley -- Hulless Oats -- Khorasan Seed -- Millet Seed -- Mustard Seed and Rapeseed -- Popcorn -- Safflower Seed -- Specialty Type Corn -- Whole Buckwheat Groats -- APPENDIX I. SELECTED REFERENCES -- APPENDIX II. GRADES AND GRADE REQUIREMENTS

The promise of biotechnology, especially as it relates to food, is about shared responsibility and trust. Merging healthful eating with medicines in our foods is part of the promise of biotechnology and food-based products that may have medicinal capacity. Biotechnology and agriculture also offer new ways to make vaccines, more cheaply, more effectively, and with greater capacity, actually growing medicines, or "pharming." Agriculture and health have always been linked, and a new relationship is evolving requiring interdisciplinary approaches and new thinking. There is also the need to share responsibility for safety and for the accountability of the progresses. Promises regarding agricultural biotechnology must be realistic and objective and must be evaluated with an eye to political and moral and must be kept throughout the whole chain from producers to consumers. ; How do we assure that the public understands what the risks and benefits? We cannot assure them until we ourselves understand the risks to human health, especially that of our children, and to the environment. Until we do, we must at least provide objective and creditable information. We have to educate people keeping in mind cultural aspect to food. Rituals and traditions are not to be trifled with when we talk about genetically modifying food. ; If the consumers of genetically modified foods don't trust it, they won't buy it no matter what health claims are made and even delivered. Trust in the regulatory agencies is generally strong where medicines are concerned, but not so much for genetically modified foods. Only transparency can help, even if it means to address problems such as the Starlink™ corn. Producers must be sure that they can sell their products and they must be trusted by the public that the food they produce is safe.