Environmental Risk Assessment Reports - Chapter 30

CHAPTER 30 Historical Toxicology and Risk Assessment David A. Belluck, Mark W. Rattan, and Sally L. Benjamin CONTENTS I. Introduction.................................................................................................537 II. Historical Toxicology and Risk Assessment .............................................538 A. Selecting the Proper Analysis.......................................................538 B. Historical Toxicology ...................................................................539 C. Alcohol Consumption: How Simple Observations Lead to Complex Toxicological Understandings.........................539 III. Application of Historical Toxicology in Insurance Law...........................541 IV. Historical Toxicology in Litigation............................................................542 A. Analysis: Manufactured Gas Plant Industry................................543 1. The Legal Setting.........................................................543 2. A Historical Toxicology Review of the MGP Industry....................................................543 B. Using a Historical Toxicology Review in Litigation...................546 V. Conclusion..................................................................................................547 References...................................................................................................548 I. INTRODUCTION* Since the invention of the risk assessment paradigm in the early 1980s, the risk assessment process and its products have become key elements in public and envi-ronmental health decision making. Although risk assessment methods and policies have changed since the early 1980s, the basic risk assessment paradigm has remained relatively stable. This makes it possible to generate a risk assessment appropriate * The authors are indebted to Desiree Savage, Esq., who researched the technical information that forms the basis for this chapter. 537 © 2001 by CRC Press LLC 538 A PRACTICAL GUIDE TO ENVIRONMENTAL RISK ASSESSMENT REPORTS for any given time period since the 1980s by using risk assessment methods and data inputs from that time and, thus, to reconstruct what risk assessors and other professionals of that period knew or should have known about the human health or environmental risks posed by a facility, activity, or site. Court cases can be won or lost on the basis of characterizations of what a litigant knew or should have known about the environmental or human health effects of their activities. Attorneys and their technical experts expend considerable time and resources to make this determination. Risk assessment is a useful tool in this endeavor. Since modern risk assessment did not exist as a regulatory construct until the early 1980s, however, it can be argued that modern risk assessment principles and methods are not useful to infer knowledge of risks before that time. II. HISTORICAL TOXICOLOGY AND RISK ASSESSMENT If it is anachronistic to use modern risk assessment-based methods to gauge the understanding of human health and environmental impacts of environmental releases before the early 1980s, is there another way? Instead of using modern risk assess-ment, we suggest an in-depth analysis using disciplines that existed at the time of an environmental release to ascertain what individuals or organizations did know, or should have known, about the effects of such releases. We term this analysis “historical risk assessment and toxicology.” A. Selecting the Proper Analysis Before starting a project it is essential to determine which research standard applies to the analysis; “historical risk assessment and toxicology” or “modern” risk assess-ment. While the historical method described in detail below is appropriate for reconstructing what a technical person in a given discipline should have known at a critical point in time, certain laws use a different standard. Although CERCLA, for example, imposes liability for pollution resulting from the polluter’s activities in the past, the cleanup standards it requires the polluter to meet are based upon current scientific knowledge of the hazardous properties of the chemicals involved and their behavior in the environment. Persons working on modern risk assessments will recognize that historical risk assessment and toxicology involves several fundamental tools of their profession. Historical risk assessment and toxicology reviews are essential for cutting edge risk assessments, to ensure that outdated toxicological values and methods are not used in their reports. Data obtained by historical risk assessment and toxicology reviews are also used in modern risk assessment reports (i.e., 1980s onward). Searching records and reviewing the literature and databases are part of modern risk assessment, as well as historical risk assessment and toxicology. The rest of this book discusses how to obtain and use current risk assessment resources and tools. This primer describes the use of historical toxicology. Although © 2001 by CRC Press LLC HISTORICAL TOXICOLOGY AND RISK ASSESSMENT 539 historical toxicology reviews are valid for all periods of time in which toxicology has been an established profession, as discussed above, this primer deals with uses of historical toxicology in the period prior to the current risk assessment paradigm. B. Historical Toxicology How can researchers reasonably determine risk understandings of the past for use in current litigation? Historical toxicologists do so by asking the following three simple questions. What did they know? What should they have known? When should they have known it? Although the questions are simple, answering them can require in-depth historical research. Rigorous review of media reports, letters, memoranda, books, journals, and technical reports of the time period in question can (through what we term a “weight-of-evidence” approach) marshall logically consistent, detailed, and compelling proof concerning what a given industry knew at critical points in time about the hazardous propensities of byproducts from its manufacturing operations, or what the industry should have known if it had made reasonable, prudent, and responsible inquiry. The application of historical toxicology to a given industry, therefore, involves painstaking investigation of the medical, scientific, and technical knowledge con-cerning the byproducts from the manufacturing operations and their chemical con-stituents. When evaluating the three pivotal questions, researchers must resist the temptation to evaluate past actions and understandings in light of modern methods and standards of professional behavior. After contaminants have been identified and their impact on the environment evaluated, the parties must resolve the legal question of who is responsible for paying the cleanup costs. Polluters who have been held liable for cleanup costs by regulatory agencies often assert that the loss should be covered by their liability insurance policies. The insurance companies in turn assert that the cleanup costs are either not covered by the insuring language of the policy, or are excluded from coverage by various policy exclusions. The resolution of the dispute often turns on the factual information obtained in the historical toxicology review concerning what the polluter knew or should have known during the time period when the contaminants were released into the environment. There are a wide range of observation types that can be used to determine the effects of chemical exposures to humans or the environment from a process, activity, or a facility. They can range from a simple observation recorded in a diary, or noted in a file memo, to the traditional scientific method of data collection, interpretation, and hypothesis testing. How simple observations can lead to complex toxicological understandings is illustrated by the decision to consume alcohol. C. Alcohol Consumption: How Simple Observations Lead to Complex Toxicological Understandings People conduct qualitative risk assessments concerning the risks of alcohol con-sumption without formal risk assessment and toxicology training. Persons consum- © 2001 by CRC Press LLC 540 A PRACTICAL GUIDE TO ENVIRONMENTAL RISK ASSESSMENT REPORTS ing alcoholic beverages know that there are potential health problems associated with consuming alcoholic beverages (i.e., hazard evaluation); that the hazards are related to the amount consumed in a given period of time (i.e., exposure assessment); that the various chemicals and process impurities can be toxic by themselves or in combination with pharmaceuticals or other drugs (i.e., toxicity assessment); and that the combination of these factors results in a certain level of risk (i.e., risk characterization). This type of analysis, conducted by many people on Friday evenings on the way to Happy Hour, illustrates that almost everyone has a basic grasp of the main components of risk assessment and that the results of individual assessments can actually influence individual behavior. Characterizing risks allows a person to per-form a cost-benefit analysis and decide what level of risk to accept and what risk-reduction measures (e.g., take a cab home) to employ to reduce short- or long-term risks. Knowledge of the toxic effect of a component of a complex mixture (e.g., alcohol in alcoholic beverages) can be successfully applied to all other alcoholic beverages. A person might not be able to express the exact toxicity of a given alcoholic beverage, but common sense indicates that any alcoholic beverage will, at some point, induce the toxic effects, even though the point differs according to the type of alcoholic drink. Personal experience with every alcoholic beverage is not required to know this. The above risk analysis reveals simple truths about alcohol consumption. These simple truths enable the individual to make choices to control the risks. In a similar fashion, historical toxicology reviews reveal awareness of simple scientific correla-tions (e.g., exposure to chemical A causes effect B) long before a definitive treatise is published quantifying the fact and explaining its precise mechanism of action. Historical toxicology reviews usually reveal the same general pattern of awareness and scientific analysis: · An ongoing exposure is identified as the possible cause of a toxic effect that is observed repeatedly in humans. · This awareness leads to data collection on the phenomenon (case studies) and initiation of testing (epidemiological or animal studies). · Results of systematic information gathering, in turn, spur more detailed research into the phenomenon. · A cause and effect relationship is established. · Research turns to quantifying the dose-response relationship and to determining the mechanism of action. The point is that human awareness grows and becomes more refined over time, but even simple observations are valuable clues for the historical toxicologist’s quest to understand what could or should have been known at a given point in time about human or environmental health effects of some human action. © 2001 by CRC Press LLC HISTORICAL TOXICOLOGY AND RISK ASSESSMENT 541 III. APPLICATION OF HISTORICAL TOXICOLOGY IN INSURANCE LAW * In 1980 the passage of Superfund** fostered an explosion of litigation between insurers and their policyholders concerning the issue whether the expense associated with environmental clean-ups, often referred to as “response costs” or “remediation,” is covered under one or more of the insurance industry standard form Comprehensive General Liability (CGL) insurance policies issued to businesses since the 1950s. As the Supreme Court of Minnesota noted in the recent case, Northern States Power Co. v. Fidelity and Gas. Co. of New York, 521 N.W.2d 21, 31 (1994), “The stakes in these cases are extremely high.” Quoting law review articles by Kenneth S. Abraham, the Supreme Court of Minnesota further noted: The average cost of remedying hazardous conditions at a site on the Superfund “National Priority List” now exceeds $30 million (Abraham, 1993). The cost of hazardous waste cleanup under the federal superfund program and analogous state regimes ... is likely to be several hundred billion dollars before these programs are completed (Abraham, 1991) (521 N.W.2d at 3l). Given the ruinous liability which can be imposed on a polluter under CERCLA and comparable state statutes, the polluter looks to its insurers to pay or at least share in the remediation cost. The language of a standard CGL policy typically provides that the insurer agrees to pay on the policyholder’s behalf the amounts that a policyholder is legally obligated to pay in “damages” as the result of unintentional conduct by the policyholder which causes property damage to a third person. Insurers contend that the amounts government regulators order a policyholder to pay under CERCLA to cover the “response costs” necessary to cleanup pollution to the envi-ronment are not “damages” within the meaning of the policy language, and were never intended to be covered by a CGL policy Insurers further assert that, to the extent the courts construe CERCLA “response costs” to constitute “damages” within the meaning of the insuring agreement, an exclusion introduced into CGL insurance policies in about 1973 precludes coverage for all liability associated with discharges of contaminants into the environment unless the discharges were sudden and accidental. That exclusion is known as the “sudden and accidental” pollution exclusion. Since contamination on most of the CERCLA cleanup sites results from repeated and gradual discharges of pollutants over the course of several years, as opposed to a “sudden and accidental” event, insurers contend that the sudden and accidental pollution exclusion precludes cov-erage for the cost necessary to remedy the contamination.*** * This section is not intended and does not pretend to be a complete or exhaustive discussion of the law of insurance coverage in the environmental context. Rather, it is designed to give the reader an overview of some environmental insurance law issues and how they relate to historical risk assessment and toxicology reviews. ** The Comprehensive Environmental Response, Compensation, and Liability Act, §9601 (CERCLA). *** As the result of court decisions in some states which weakened the sudden and accidental pollution exclusion (see, for example, Just v. land Reclamation, 155 Wis.2d 737, 456 N.W.2d 570 [1990], amended, recons. den’d., 157 Wis.2d 507 [1990], the insurance industry introduced the “absolute pollution exclu-sion” into CGL policies in 1985 which, among other things, excluded coverage for even sudden and accidental polluting events. © 2001 by CRC Press LLC ... - tailieumienphi.vn