CHAPTER 2 RISK ASSESSMENT METHODOLOGIES AND CONSIDERATIONS FOR THEIR APPLICATION TO ENVIRONMENTAL ISSUES BEYOND U.S. BOUNDARIES

• Jurisdiction: United States

International Environmental Law for Natural Resources Practitioners
(Mar 1997)
CHAPTER 2
RISK ASSESSMENT METHODOLOGIES AND CONSIDERATIONS FOR THEIR APPLICATION TO ENVIRONMENTAL ISSUES BEYOND U.S. BOUNDARIES
Richard L. Degrandchamp Devraj Sharma
Terranext
Lakewood, Colorado

I. INTRODUCTION

For many years, the U.S. EPA has relied on numerical standards as benchmark cleanup levels for environmental restoration conducted by the regulatory community. In order to be able to apply these standards to any hazardous waste site in the U.S., it was necessary to use a "least common denominator" approach. With this approach, standards were intentionally set based on worst-case conditions. If standards were set to target worst-case conditions and were applied consistently to all hazardous waste sites, the regulatory community could be confident that no site would pose a health threat to public health after cleanup was completed. There is little question that this approach can reduce health hazards to negligible levels, but at what cost? It is becoming increasingly clear that this approach may be overly protective and too expensive to employ on a national level simply because worst-case conditions do not exist at many hazardous waste sites. As a solution to this dilemma, many stakeholders are promoting a risk-based corrective action (RBCA) approach as the logical alternative and a panacea for all U.S. environmental problems. Unfortunately, most risk assessments conducted for regulatory purposes are themselves based on "national standards" and cannot be truly considered site specific. Although it is a laudable goal to make hazardous waste site cleanups less time consuming and costly, this goal cannot be achieved until risk assessments are made scientifically tenable and based on site-specific conditions.

There is consensus on the fact that tremendous amounts of money have been and will be spent on regulatory compliance and environmental restoration in the U.S. Nearly $190 billion was spent on environmental problems in the U.S. in 1994. By contrast, all other countries spent an estimated $400 billion.¹ The EPA estimates that approximately $150 billion is spent annually to comply with environmental regulations. Environmental expenditures in the U.S. are expected to increase annually by 7 percent until the year 2000. In fact, based on existing technologies, it is estimated that costs will escalate to more than $1.7 trillion to remediate hazardous waste sites identified as of 1995.²

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Clearly, environmental restoration will require a significant portion of the U.S. national budget. Prompted by growing costs and increased competition for limited funds and resources, stakeholders have begun to question "how clean is clean?" With this question forefront in the national debate, current environmental restoration practices are being reexamined. Most discussions are centered on spending money earmarked for environmental restoration more wisely. Although the debate continues and a consensus has not been reached, most experts agree that significant cost savings can only be realized through a scientific RBCA approach. Ultimately, the goal is to spend less money to achieve the same level of protection to public health.

Risk-based environmental restoration is more cost-effective than automatically applying national standards because remedial decisions can be tailored to site-specific conditions and risk. Moreover, a RBCA approach allows risk managers to make meaningful decisions based on the results of risk/benefit analyses incorporating cost/mitigated risk evaluations. However, just as the application of national standards (based on worst case conditions) to all hazardous waste sites can lead to injudicious, expensive, and unnecessary remediation, standardized risk assessments often lead to ineffective risk management decisions. In other words, flawed risk assessments will inexorably lead to flawed risk management. For risk assessments to be cost-effective and lead to meaningful decisions, risk assessments must be conducted in a scientifically tenable manner. They must also incorporate recent scientific improvements in risk assessment methodology. Otherwise, risk assessments will predict "phantom," or nonexistent, risks. Risk assessments that estimate phantom risks are typically referred to as "policy-based" risk assessments, which are in contrast to "science-based" risk assessments.

Policy-based risk assessments often exacerbate, rather than solve, problems. For example, one of the most recent developments in risk management is to use risk as the criterion to prioritize federal hazardous waste sites for funding (which is finite and shrinking). The Department of Defense is currently remediating and closing hundreds of Navy installations in the U.S. in preparation for civilian use. This is a Herculean task, and with limited environmental restoration funds appropriated by the U.S. Congress, it is possible that high-risk installations will not receive adequate funding unless funding is based on risk. Clearly, it is of national importance to remediate high-risk sites first. Accordingly, the Navy has committed itself to this ambitious goal and has begun a risk prioritization program. However, if phantom risks are unknowingly estimated and relied on for ranking purposes, the Navy's well-intentioned goals will be subverted.

On a national level, remediating phantom risks can also lead to a diversion of financial resources that could be used to reduce other health-related risks, such as providing childhood immunizations and conducting research on cancer and AIDS.

It is equally important to conduct science-based risk assessments in order to make meaningful risk management decisions in the private sector. There are thousands of hazardous waste sites, and some companies are in such precarious financial positions that expensive and unnecessary remediation could force them into bankruptcy. In these cases,

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the taxpayers would ultimately have to fund remediation. It may not be possible to remediate all hazardous waste sites if a clear distinction cannot be made between phantom and real risk. There are over 1,000 sites currently on the National Priorities List in the Superfund program, and with an estimated average cleanup cost per site, it is possible that funds will be insufficient to treat all sites equally.³

The advantage of RBCA is that it can be used to set cleanup priorities, develop target cleanup levels, decide "how clean is clean," and to evaluate risk/cost-benefits. Despite the tremendous potential that RBCA promises for real cost savings and expedited cleanup, this potential will only be realized when remediation is based on "real" risks. This paper highlights specific aspects of the risk assessment and risk management process that can make a major difference in how sites are remediated. An attempt has been made to provide anecdotes or illustrative examples to facilitate a clear understanding of arcane concepts or difficult technical issues. This paper focuses exclusively on human health risk assessments that are used to make remedial decisions at hazardous waste sites.

The goal of this paper is to provide some insight into the current practice of risk assessment in U.S. environmental restoration and how risk is used in the process. It is hoped that some of the recommendations can enable countries currently developing environmental policies to develop practical and cost-effective solutions to environmental problems. The discussion that follows should not be viewed as an indictment of the current U.S. policy, as this was not the intent. Rather, specific areas have been highlighted because they are confounding factors in estimating risk and making practical remedial decisions.

II. RISK ASSESSMENT VERSUS RISK MANAGEMENT

Before discussing risk and risk assessment, it is important to clearly distinguish the scientific process used to quantify risks and the process of mitigating those risks during risk management. While there is benefit in conducting these two processes in parallel, it is critical to conduct the risk assessment independent from risk management. All too often, risk managers (unitentionally) interfere in the science of risk assessment by setting preconditions or limiting the scope. The introduction of risk management into risk assessments usually occurs insidiously in the planning phase and may be invisible to all stakeholders, which is all the more reason to be vigilant.

Introducing risk management into the risk assessment process is similar to allowing a patient undergoing a physical examination to actively participate in the examination process with his or her physician. Obviously, it is inappropriate for a patient to conduct medical tests or limit the medical examination (even if the patient knows how to conduct the tests and is a physician). Limiting the examination in any way could compromise the

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physician's diagnosis of the patient's health problem. After the medical results are in, however, it is vital that the patient take the lead in managing the medical problem. For example, whether or not to have elective surgery is a risk management decision only the patient can make after carefully reviewing all the risks.

In a speech before the U.S. National Academy of Sciences, U.S. EPA Administrator Ruckelshaus (who was the first U.S. EPA administrator) described the processes of risk assessment and risk management as follows⁴ :

"Scientist assess a risk to find out what the problems are. The process of deciding what to do about the problems is risk management. The second procedure involves a much broader array of disciplines, and is aimed toward a decision about control. Risk management assumes we have assessed the risks of a suspect chemical. We must factor in its benefits, the costs of the various methods available for its control, and the statutory framework for...