Starlink corn: a risk analysis.

Abstract

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.

Genetically Engineered Crops for Biofuel Production: Regulatory Perspectives

“…This suggests that there was no human health risk associated with StarLink corn, supporting EPA's own assessment that Cry9C had a low probability of allergenicity (Bucchini, 2002). In contrast, there have been numerous examples during the 20 th century of foods imported into countries that have led to lifethreatening allergic responses, such as the case with kiwi fruit (Lucas et al, 2003).…”

“…The best known case in the United States is of Aventis' StarLink corn containing the Bt gene Cry9C. StarLink was approved by the EPA for animal feed but not for human consumption due to concerns that the stability of the protein under low pH might lead to allergic reactions (Bucchini, 2002). When traces of Cry9C were identified during 2000 in food products made from corn, there were rapid recalls of almost three hundred corn based products and Aventis spent approximately $100 million buying back corn that might have commingled with StarLink at a premium to try and remove StarLink from the market (Bucchini, 2002).…”

Clinical and laboratory investigation of allergy to genetically modified foods.

“…In September 2000, it was reported and confirmed that StarLink had contaminated the human food supply. The basis for the approval process of StarLink only for animals was that it contained Cry9c, a protein from Bacillus thuringiensis (Bt), that appeared to be heat stable when compared with other Bt proteins and thus could not be excluded as an allergen (because allergenicity could not be ruled out), using an earlier version of the decision tree (Bucchini and Goldman 2002).…”

Quantitative exposure assessment for confinement of maize biogenic systems

“…Despite their rapid adoption by producers, some public and regulatory questions remain regarding the long term impacts of these products (NRC, 2002). In order to manage uncertainties surrounding these technological innovations, and in response to earlier breakdowns in the management of transgenic trait deployment and distribution (Bucchini and Goldman, 2002), considerable care has been taken to ensure confinement of products lacking full regulatory approval. Despite these efforts, incomplete compliance with regulatory conditions for confinement of transgenic crop field experiments can occur (USDA, 2004;USEPA, 2002).…”