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Key Regulatory Issues » Post-Release Monitoring

Title: Post-Market Oversight of Biotech Foods: Is the System Prepared?
Source: Pew Initiative on Food and Biotechnology/Resources for the Future
Publication date: April 24, 2003
Posting date: June 23, 2004

Executive Summary

The September 2000 discovery of StarLink corn in taco shells caught the public and much of the American food system by surprise. StarLink was one of several varieties of corn that had been genetically modified to produce its own insecticide. The U.S. Environmental Protection Agency (EPA) had approved StarLink only for animal feed because tests had suggested that the specific insecticidal protein in the genetically modified corn might be a human allergen. StarLink was therefore not approved for use in human food.

The discovery of StarLink where it was not supposed to be caused a public uproar. The group that first reported it, Genetically Engineered Food Alert, used the finding to argue for stronger government regulation of biotech crops and foods. The food industry recalled foods containing StarLink from the market out of concern about the possible impact of StarLink on the safety and public acceptance of their products. Corn traders faced disruption of their export markets. And commentators suggested the U.S. regulatory system had failed by not preventing the problem from occurring in the first place. A chronology of the StarLink case is provided in Appendix A.

The government also acted, declaring StarLink’s presence in human food unlawful, working with the food industry to accomplish the necessary recalls and attempting to calm grain markets and the concerns of foreign trading partners. In addition, EPA announced that it would no longer approve the registration of pesticidal traits in genetically modified plants if the plants were not also approved for human food use. This action would appear to preclude future StarLink-type episodes by ensuring that all pesticide-producing genetically-modified crops on the market would be approved as safe for humans to eat.

Such a perspective on the StarLink incident, however, would be far too simple. StarLink may prove to be a one-time experience—and it has not been linked conclusively to any adverse effects—but its importance extends well beyond the specific facts. StarLink put a public spotlight on the regulatory system for biotech food. It raised questions about how the system works today and whether it is prepared for the challenges it will face in the future. These challenges were underscored again recently with a “near miss”: material from a variety of corn engineered to produce an animal vaccine, made by a company named ProdiGene, turned up in soybeans destined for the food supply. Fortunately, the corn was detected by government inspectors in time to keep it out of the food supply.

This report addresses a subset of the questions about biotechnology regulation. This report is one of several reports on aspects of the U.S. regulatory system for biotechnology prepared by the Pew Initiative on Food and Biotechnology. Much of the public debate about biotechnology prior to StarLink focused on whether, and under what circumstances, biotech products should enter the environment and marketplace: what standards, testing, and review procedures should be required prior to biotech crops being planted and biotech foods sold? This report addresses issues that arise after the products enter the environment or the marketplace—when the crop is in the field, commodities are in commerce, and foods are being prepared and marketed to consumers:

Is the regulatory system prepared to ensure compliance with use restrictions or other conditions imposed by regulators to protect health or the environment?
More broadly, what is the appropriate degree of control over biotech foods and crops after they enter the environment or the marketplace?
What role can and should the government play in achieving this control?
How do the postrelease and postmarket oversight issues posed by biotech crops and foods compare with those posed by conventionally produced ones?
This report is intended to inform the public, policymakers, and other interested parties in the biotechnology debate. The report identifies issues and provides factual background and analysis, rather than offering policy recommendations. There are no “right” answers or single solutions to the issues presented. The issues involve subjective values and a range of competing considerations and interests that should be sorted out in public processes.

The Pew Initiative on Food and Biotechnology commissioned Resources for the Future (RFF) to prepare this report. We would like to acknowledge authors Michael R. Taylor and Jody S. Tick, of RFF for their collaboration and thoughtful examination of these issues.

We hope that our analysis contributes to an informed debate and, in the end, to good public policy. This report, like all of our projects, is made possible through a grant from The Pew Charitable Trusts to the University of Richmond. The opinions expressed in this report are those of the authors and do not necessarily reflect the views of The Pew Charitable Trusts.

Michael Rodemeyer
Executive Director
Pew Initiative on Food and Biotechnology
April 2003

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