Gaps, inexperience, inconsistencies, and overlaps: crisis in the regulation of genetically modified plants and animals.

TABLE OF CONTENTS INTRODUCTION I. OVERVIEW OF GENETIC MODIFICATION A. The History and Science of Genetically Modified Products B. Current Status of Genetically Modified Products II. BENEFITS AND RISKS OF GENETICALLY MODIFIED PLANTS AND ANIMALS A. Potential Benefits of Genetic Engineering 1. Agricultural Benefits 2. Human Health and Consumer Benefits 3. Environmental and Ecological Benefits 4. Next-Generation Biotechnology Benefits B. Potential Risks of Genetic Engineering 1. Human Health Impacts 2. Environmental and Ecological Concerns 3. Next-Generation Biotechnology Concerns III. GENETICALLY MODIFIED PRODUCT CASE STUDIES A. StarLink Corn B. Genetically Modified Salmon C. Threat to Monarch Butterflies D. ProdiGene Pharmaceutical-Producing Corn IV. CURRENT REGULATION OF GENETICALLY MODIFIED PLANTS AND ANIMALS A. The Coordinated Framework B. The Food and Drug Administration C. The Environmental Protection Agency D. The U.S. Department of Agriculture V. REGULATORY GAPS, INCONSISTENCIES, INEXPERIENCE, AND OVERLAPS A. Regulatory Gaps 1. Gaps in Environmental Review 2. Gaps Beyond Environmental Review B. Regulatory Inconsistencies C. Regulatory Inexperience D. Regulatory Overlaps VI. THE CAUSE AND THE CURE OF THE REGULATORY DEFICIENCIES A. The Coordinated Framework Revisited B. Proposed Statutory and Regulatory Changes 1. Closing Regulatory and Statutory Gaps 2. Overhauling the Division of Regulatory Responsibility C. Debunking Common Critiques of Regulatory Change 1. Are Genetically Modified Product Risks New? 2. Should Regulation Be Based upon the Product or the Process? 3. Should Protection Be Left to the Market? CONCLUSION ABSTRACT The regulation of genetically modified products pursuant to statutes enacted decades prior to the advent of biotechnology has created a regulatory system that is passive rather than proactive about risks, has difficulty adapting to biotechnology advances, and is highly fractured and inefficient--transgenic plants and animals are governed by at least twelve different statutes and five different agencies or services. The deficiencies resulting from this piecemeal approach to regulation unnecessarily expose society and the environment to adverse risks of biotechnology and introduce numerous inefficiencies into the regulatory system. These risks and inefficiencies include gaps in regulation, duplicative and inconsistent regulation, unnecessary regulatory expense, agencies acting outside their areas of expertise, and unnecessary increases in the cost of and delay in the development and commercialization of new biotechnology products. These deficiencies also increase the risk of further unnecessary biotechnology scares, which may cause public overreaction against biotechnology products, preventing the maximization of social welfare. With science and society poised to soar from first-generation biotechnology (focused on crops modified for agricultural benefit), to next-generation developments (including transgenic fish, insects, and livestock, and pharmaceutical-producing and industrial compound-producing plants and animals), it is necessary to establish a comprehensive, efficient, and scientifically rigorous regulatory system. This Article details how to achieve such a result through fixing the deficiencies in, and risks created by, the current regulatory structure. Ignoring many details, the solutions can be summarized in two categories. First, statutory and regulatory gaps that are identified must be closed with new legislation and regulation. Second, regulation of genetically modified products must be shifted from a haphazard model based on statutes not intended to cover biotechnology to a system based upon agency expertise in handling particular types of risks. …