Genomics and Environmental Regulation: Science, Ethics, and Law

Preface

PREFACE Genomics is hardly a modest science. From the early planning of the Human Genome Project, advocates of genomic research have maintained that a comprehensive understanding of genetic contributions to biological processes will explain the many mysteries of human disease and revolutionize the practice of medicine. Yet, while biomedical applications of genomics have garnered much attention, it is perhaps the nonclinical uses of genomics that will generate the most contentious social debates. Examples include applications of genomics in the workplace, in setting dietary recommendations based on an individual’s genomic pro- file (nutrigenomics), and in identifying criminals from crime-scene samples using genetic markers (DNA forensics). This book is about another major new application of genomics outside medical contexts—the use of genomic data and technologies to inform environmental policy and regulation. There are many potential applications of genomic information in environmental decision making, many of which will raise profound ethical, legal, and policy challenges. For example , whereas in the past environmental regulators have conceptualized the population as a relatively uniform whole, at most characterizing risks for large, biologically heterogeneous groups such as children, genomics holds the promise of understanding biological features of much smaller subpopulations. Recent advances in genomics suggest that certain individuals and groups may have genetic profiles associated with increased susceptibility to the harmful effects of environmental toxins. As those susceptibilities are better understood—and it becomes possible to identify individuals who are at risk of developing significant health problems when exposed to pollutant levels below levels deemed “safe” for the general population—regulators will be confronted with a dilemma. Do they provide a level of protection that is greater than that necessary for other citizens—a goal that may be economically burdensome, if not altogether impossible? Or, as genetically susceptible individuals and subpopulations are identified, do regulators exclude such individuals and groups from the guarantee of environmental protection and face a troublesome , if not untenable, political and ethical situation? Another important application of genomic data in the environmental context will be identifying genetic changes that may be markers of early toxicity in exposed individuals. Although this potentially more precise and sensitive information may hold promise for crafting more effective regulatory interventions, it will also raise enormously challenging scientific, legal, and policy questions. One such question is whether or when the detection of molecular genetic changes from exposure to toxic substances, unaccompanied by any detectable clinical effects, should trigger legal liabilities or regulatory requirements for reducing such exposures. As we gain greater knowledge of genetic susceptibilities and markers relating to the harmful effects of environmental exposures, genomic information may create public expectations of environmental protection that cannot be delivered under existing laws and regulations. Yet if laws are modified, who should bear the enhanced costs of maintaining environmental quality, particularly where the risks fall disproportionately on a limited subset of the population? And will a shifting focus on subclinical genetic changes rather than subsequent toxic injuries lead to more effective and targeted environmental regulations, or will it simply inflate the costs and burdens of environmental protection without corresponding improvements in environmental health? This book addresses these and other related issues of social justice and public policy raised by the application of genomics to environmental regulation . The chapters that follow are organized into four parts. The first examines the manner in which genomic technologies may shape environmental -policy debates. In chapter 1, Gary Marchant surveys how one important type of toxicogenomic data, that generated by gene expression assays, are likely to be applied in environmental regulation and the policy opportunities and challenges such data present. More rapid screening of environment chemicals, a more sensitive assay for adverse effects used to trigger regulatory requirements, and real-time monitoring of exposed populations and ecosystems are some of the potential applications discussed in the chapter. These promising applications raise important xii P R E F A C E policy issues relating to data and methods validation, appropriate levels of regulatory stringency, avoidance of false positives, and reporting requirements. In the second chapter by Kerry Dearfield, William Benson, Kathryn Gallagher, and Jeremy Johnson, these and other potential regulatory applications highlighted by Marchant are discussed from the perspective of policy makers at the U.S. Environmental Protection Agency. The chapter covers several EPA-supported activities and policy initiatives, including the Agency’s Interim Policy on Genomics and its technical framework for developing methods and standardizing...