The Illusion of Care: Regulation, Uncertainty, and Genetically Modified Food Crops

Abstract

Examining the degree to which environmental concerns have or have not been incorporated into the registration requirements of Bt crops, it becomes clear that the regulatory process suffers from many ills. In approving these genetically engineered crops for market, the United States Department of Agriculture (USDA) and Environmental Protection Agency (EPA) repeatedly disregarded significant but unresolved scientific questions about these GM crops. Seed companies agreed to environmentally protective measures in their crop registrations, but assumed no responsibility for implementing those measures. Instead, the implementation burden fell exclusively on growers who, as third parties to the genetically modified organisms' registrations, were not directly subject to regulatory jurisdiction. No regulatory framework existed (or, for that matter, exists) to monitor and enforce these registration restrictions. I suggest that these defects grow directly from ill-advised fragmentation of the regulatory role and a squeamish unwillingness to engage in necessary, but politically charged, direct regulation that might slow the development of a high-tech industry. These serious regulatory deficiencies call into question the soundness of the entire biotechnology regulatory process, a question ultimately much broader than any particular GMO.

Using the actual behavior of regulators and the regulated community as a case study, this article evaluates whether the Coordinated Framework facilitates relatively safe development and introduction of these new crops. Specifically, I examine how regulatory decisions have used available scientific information and have responded to scientific uncertainty. Without advocating the elimination of Bt crops, or discounting the potential benefits of biotechnology, I conclude that the Bt case study reveals significant regulatory failures that can be remedied only through systemic changes to the regulatory process.

Keywords: genetically modified organisms, environmental law, agriculture, precautionary principle, uncertainty, risk assessment

Keywords: GM crop, GMO, LMO, genetically modified organism, genetically engineered, genetic engineering, Starlink, Coordinated Framework, substantial equivalence, biopharming, administrative law, agriculture, biotechnology, FDA, USDA, EPA, precautionary principle, uncertainty, risk assessment, transgenic

JEL Classification: K32, K42, K40, Q1, Q18, Q28