Academic journal article Environmental Health Perspectives

Starlink Corn: A Risk Analysis. (Commentaries)

Academic journal article Environmental Health Perspectives

Starlink Corn: A Risk Analysis. (Commentaries)

Article excerpt

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 (Bt)-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. Key words: allergens, biotechnology, corn, food hypersensitivity, pesticides, risk assessment. Environ Health Perspect 110:5-13 (2002). [Online 10 December 2001]


Selective breeding of plants has been one of the most significant achievements of human civilization; it has resulted in major agronomic improvements and in an ability to adequately provide food to large human populations. Conventional plant breeding involves genetic manipulation via crosses of sexually compatible plants and selection for the offspring that have desirable characteristics (such as fruit quantity and quality, pest resistance, and agricultural requirements). More recently, conventional plant breeding has also involved use of technologies such as irradiation that randomly induce mutations that can allow plant breeders to select for new, desirable traits. Biotechnology-based breeding involves direct transfer of specific genetic information in its pure DNA form; unlike radiation, it is a selective process, in that the desired trait and the genetic code that expresses the protein responsible for the trait have been identified and characterized in the parent organism. The process of gene transfer often involves modification of the transferred DNA for better functioning in the new host. Because only a well-characterized segment of DNA is transferred, biotechnology-based breeding is considered to be more precise than conventional breeding, which involves many uncharacterized linked genes. Nonetheless, uncertainties still surround genomic alterations due to the insertion site of the DNA (which is random) and metabolic changes due to the new proteins expressed (which are difficult to predict).

A report of an international academy of sciences panel on biotechnology in agriculture recently concluded that

   foods can be produced through the use of GM [genetic modification]
   technology that are more nutritious, stable in storage, and in principle
   health promoting--bringing benefits to consumers in both industrialized and
   developing nations (1; p. 1).

At the same time, they also said,

   public health regulatory systems need to be put in place in every country
   to identify and monitor any potential adverse human health effects of
   transgenic plants, as for any other new [plant] variety (1; p. … 
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