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Genomics and Environmental Regulation

Science, Ethics, and Law

edited by Richard R. Sharp, Gary E. Marchant, and Jamie A. Grodsky

Publication Year: 2008

To reduce the deleterious effects of environmental contamination, governments across the world have enacted regulations broadly conceived for entire populations. Information arising out of the Human Genome Project and other cutting-edge genetic research is shifting the policymaking process. This fascinating volume draws on experts from academia, government, industry, and nongovernmental organizations to examine the science of genomic research as applied to environmental policy. The first section explores environmental policy applications, including subpopulation genetic profiling, industrial regulations, and standardizing governmental evaluation of genomic data. The second section assesses from multiple angles the legal framework involved in applying genomics to environmental regulation. In the third section, the contributors review closely the implications of genomic research for occupational health, from disease prevention and genetic susceptibility to toxicants, to workers’ rights and potential employment discrimination. A fourth section explores the bioethical and philosophical complications of bringing genetic data and research into nonclinical regulatory frameworks. Genomics and Environmental Regulation points to ways in which information on toxicology and genetics can be used to craft more precise and efficient regulations.

Published by: The Johns Hopkins University Press


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pp. vii-ix

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pp. xi-xvii

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. ...

List of Contributors

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pp. xix-xxiv

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Introduction: Environmental Policy in the Age of Genomics

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pp. 1-8

For decades, scientists have recognized that individuals can differ significantly in their susceptibility to environmental toxicants. Using information and tools produced by recent genomic initiatives such as the Human Genome Project, risk assessors may soon be able to conduct far more systematic investigations of individual susceptibilities to toxic substances, potentially transforming environmental risk assessment. ...


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1 Toxicogenomics and Environmental Regulation

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pp. 11-24

Toxicogenomics seeks to better understand toxic substances and their effects on living systems, with the ultimate objective of improving human health and environmental protection. This objective will in large part be accomplished through environmental regulation, and thus environmental regulation is an important context for the application of toxicogenomics. ...

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2 Addressing Genomic Needs at the U.S. Environmental Protection Agency

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pp. 25-34

The data and information emanating from the various genomic technologies (speaking generally here as encompassing all aspects of genomics, proteomics, metabolomics, and systems biology) present many exciting opportunities as well as challenges for the U.S. Environmental Protection Agency (EPA). To deal efficiently and fairly with the information generated by genomic technologies, EPA has initiated many activities. The agency has taken measures to address policy positions; to ...

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3 Application of Genomics for Health and Environmental Safety of Chemicals: An Industry Perspective

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pp. 35-45

The advent of genomic technologies has facilitated major advances in our understanding of the molecular details of normal biology and holds the promise of providing new insights into molecular mechanisms of a variety of toxicities. These “-omics“ technologies provide many potential benefits for assessment of chemical safety. Among the more promising areas are opportunities for more effective screening and priority setting for chemicals. ...

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4 Toxicogenomics and the Public Interest: Technical and Sociopolitical Challenges

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pp. 46-64

New scientific tools spawned by the genomics revolution promise to improve our ability to identify causative factors in human diseases. Transcriptomics (the analysis of messenger RNA transcripts), proteomics (the global analysis of cellular or biofluid proteins), and metabolomics (the global analysis of tissue, cellular, or biofluid metabolites) all share the potential to examine early processes in the pathways to toxicity in a comprehensive fashion. These tools are expected to allow more rapid ...


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5 Challenges in Applying Toxicogenomic Data in Federal Regulatory Settings

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pp. 67-80

Both the legal and the scientific literatures are replete with assessments of the implications of toxicogenomics for many aspects of human and ecological health. Based on a review of the research and writings in this area, there is consensus that toxicogenomic data will find their greatest application in at least three areas: susceptibility—identifying subpopulations and life stages uniquely susceptible to environmental ...

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6 Genetic Data and Toxic Torts: Intimations of Statistical Reductionism

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pp. 82-97

Rapid advances in our knowledge about genomics are affecting many areas of legal policy and practice. This knowledge encompasses the structure and function of genes and their products and also the impacts of genes on conditions and behavior. The condition component includes both etiological accounts for how conditions arise and predictions about avoiding harmful outcomes and promoting beneficial outcomes. ...

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7 Genomics and Environmental Justice: Some Preliminary Thoughts

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pp. 98-115

Environmental justice is concerned with the disparate impact of environmental exposures on particular communities or subsets of the population. Genetic research recently has identified variations in the human genome that may make some individuals more susceptible than others to certain environmental pollutants (Kelada et al., 2003; Marchant, 2003; Grodsky, 2005). Differential genetic susceptibility to environmental exposures would seem to trigger environmental justice concerns. ...

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8 Setting Air Quality Standards in the Postgenomic Era

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pp. 116-138

The sequencing of the human genome revealed that humans are more genetically homogeneous than previously appreciated. Any two humans differ on average only once in every thousand DNA base pairs, representing a striking 99.9 percent genetic alikeness (Venter et al., 2001). Notwithstanding this overall genetic homogeneity, one category of genes that are highly variable (“polymorphic”) between individual humans are ...


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9 Genetics and Workplace Issues

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pp. 141-168

Attention to genetic issues in the workplace is a relatively recent occurrence (Schulte, 1987; Office of Technology Assessment [OTA], 1990). Historically, genetic factors have not been considered to any extent in occupational safety and health research, practice, regulation, or litigation. This was, in part, due to the overwhelming and relatively ...

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10 Advances in Human Genome Epidemiology: Implications for Occupational Health and Disease Prevention

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pp. 169-182

The convergence of information technology and biology helped accelerate the mapping of the human genome, creating the possibility that advances in knowledge about human biology may follow the same exponential trajectory witnessed in information technology. Uncertain, however, is whether this accelerated rate of growth will translate into a comparable increase in the speed of development of new diagnostic tools and clinical therapies. ...

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11 Occupational Health and Discrimination Issues Raised by Toxicogenomics in the Workplace

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pp. 183-201

Scientists have long recognized the connection between genetic factors and illnesses caused by workplace exposures. In 1938, geneticist J.B.S. Haldane first suggested the possibility of using genetic screening to exclude workers who were more likely to become ill from occupational exposures. “The majority of potters do not die of bronchitis. It is quite possible that if we understood the causation of this disease, we should find that only a fraction of potters are of a constitution which ...

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12 Genetic Susceptibility and Radiological Health and Safety

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pp. 202-216

With the publication of the complete human genome in 2001, the door has been pushed wide open to explore fully the genetic basis of human disease. DNA specimens from many individuals can now be examined to identify variants in the 25,000 to 30,000 genes now believed to make up the human genome. Today, DNA chip technology is capable of scanning ...


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13 Conceptual and Normative Dimensions of Toxicogenomics

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pp. 219-241

Toxicogenetics and toxicogenomics are widely seen to offer considerable promise for environmental risk assessment and rational, knowledge-based environmental policy. As the proponents of such research clearly understand, “it is only through the development of a profound knowledge base that toxicology and environmental health can rapidly advance” (Waters, Olden, and Tennant, 2003, p. 349). But what ...

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14 Environmental Disease, Biomarkers, and the Precautionary Principle

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pp. 242-257

The commonsense wisdom “an ounce of prevention is worth a pound of cure” provides a basis for a rule for decision making known as the precautionary principle (PP). Scientists, scholars, policy analysts, politicians, and others have invoked the PP as a reason for taking effective action to prevent significant harms from occurring, even when scientific certainty is lacking. The PP has played a role in debates about ...

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15 Rights and the Exceptionally Vulnerable

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pp. 258-266

Let’s say that the holder of a legal right is exceptionally vulnerable when that person’s condition or circumstances make it unusually difficult and expensive to respect or implement his or her right.1 For example, people who live in neighborhoods with high levels of crime may be exceptionally vulnerable in regard to their right to safety against crime. ...

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16 (Almost) Equal Protection for Genetically Susceptible Subpopulations: A Hybrid Regulatory-Compensation Proposal

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pp. 267-289

What would it be like to have legal procedures that exemplify thoroughgoing protection of all the public from harm caused by toxic substances? The moral views we use to guide our deliberations about law and regulatory policy can greatly shape the proposals we make. This is not a surprise, because, if our arguments are persuasive, our recommendations follow from the moral premises that support them. I, thus, argue ...

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17 Protecting People in Spite of—or Thanks to—the “Veil of Ignorance”

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pp. 290-342

When society determines that an action to protect public health or the environment is warranted because its benefits exceed its costs, many of us probably conjure up a mental picture of a balance between two discrete quantities, tipping positive. Presumably, all but the most self-contradictory forms of the precautionary principle (discussed by Resnik earlier in this volume) share this mental construct: that is, that ...

Appendix: Executive Summary of National Research Council Report, Applications of Toxicogenomic Technologies to Predictive Toxicology and Risk Assessment

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pp. 343-353


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pp. 355-364

E-ISBN-13: 9780801895159
E-ISBN-10: 0801895154
Print-ISBN-13: 9780801890222
Print-ISBN-10: 0801890225

Page Count: 392
Illustrations: 8 line drawings
Publication Year: 2008