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

• Author: Mandel, Gregory N.

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.

INTRODUCTION

Biotechnology may help ameliorate some of the greatest crises currently facing the United States and the world, including hunger and malnutrition, environmental degradation, and widespread disease. Genetically modifying crops through the use of biotechnology potentially allows for greater agricultural efficiency, increased nutritional content of food, and reduced environmental impacts. Genetically engineering animals may create cheaper food, reduce pressures on wild animal populations, and provide organs or tissues for human transplant. Modifying plants and animals to produce pharmaceuticals could provide for widespread, inexpensive dissemination of critical pharmaceuticals and vaccines throughout the United States and the world.

On the other hand, biotechnology could have harmful consequences. Potential problems include human health impacts resulting from the introduction of new allergens or toxins, widespread environmental and ecological damage resulting from the introduction of invasive species or loss of biodiversity, and unforeseen injury arising from the unintentional release of pharmaceuticals or industrial compounds into the food supply.

Most discussion concerning biotechnology takes place in a polarized debate between biotechnology proponents who focus only on biotechnology's advantages and generally deny its risks, and biotechnology opponents who focus only on biotechnology's risks and generally deny its advantages. A review of the data and information available concerning genetically modified products demonstrates that both camps are right, and wrong. There is now strong evidence that genetic engineering can provide substantial health, environmental, and economic benefits. There is also strong evidence that some genetically modified products pose certain human health and environmental risks. This Article stakes out a middle ground in the polarized biotechnology debate: Society simultaneously should promote the development and use of biotechnology while instituting necessary protection against its risks.

Adequate federal regulation of biotechnology is the tool that can best achieve both results at once. Effective and efficient regulation is the mediator that will determine whether society reaps the spectacular advantages of biotechnology or succumbs to its potential dangers. Without proper regulation, society will face unnecessary risks, the benefits of biotechnology will be slowed severely and made more expensive, and the public will lack confidence in biotechnology products.

Though the history of biotechnology is relatively short, it already is filled with numerous regulatory lapses. An examination reveals that most problems and concerns arising in this field are the result of a deficient statutory and regulatory structure. Considering that genetically modified products are regulated pursuant to statutes enacted decades prior to the advent of biotechnology itself, these deficiencies are not entirely surprising. This default system has led to a regulatory approach that is passive rather than proactive about risks, has difficulty adapting to biotechnology advances, and is highly fractured--genetically modified 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 the adverse risks of biotechnology and introduce numerous inefficiencies into the regulatory system. These risks and inefficiencies include gaps in regulation and regulatory authority, duplicative and inconsistent regulation, unnecessary regulatory expense, regulatory 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 result in a further risk: the failure to properly regulate biotechnology has led to unnecessary scares (StarLink corn contamination is the most infamous example), (1) which in turn cause a public overreaction against biotechnology products, preventing society from fully utilizing their potential benefits. Thus far, biotechnology scares primarily are all that have occurred; deficient regulation, however, creates the risk of more serious consequences, ones that could retard the biotechnology industry and impair social welfare.

This Article provides solutions to the deficiencies in, and the risks created by, the current regulatory structure. Ignoring many details for the moment, the solutions can be summarized in two categories. First, numerous statutory and regulatory gaps that are identified in this Article must be closed with new legislation and regulation. Second, regulation of genetically modified products must be shifted from a haphazard model based on archaic statutes not intended to cover biotechnology to a regulatory system based on agency expertise in handling particular types of risks. This shift would remove from the current system numerous inefficient instances of regulatory overlap, regulatory inconsistency, and agencies acting outside their areas of expertise. This proposal also would result in a regulatory structure that is both more protective of human health and the environment and less expensive for industry and taxpayers.

Science and society are poised to soar from first-generation biotechnology, focused on crops genetically modified for agricultural benefits, to next-generation developments including: transgenic fish, insects, and livestock; nutrient-enriched foods; and pharmaceutical-producing and industrial compound-producing plants and animals. In order to maximize the social benefit from these advances it is necessary to establish a comprehensive, efficient, and scientifically rigorous regulatory system to ensure adequate protection of human health and the environment. It is critical at this juncture to get the regulatory house in order so that society can harvest the benefits of future biotechnological advances without unduly suffering their risks. This Article explains and analyzes the steps necessary to achieve this result.

Part I of this Article provides a short history of...