Risk Analysis, Decision Analysis, Causal Analysis, and Economics: A Personal Perspective from More Than 40 years Experience.

I entered the field of risk analysis forty years ago from a background in physics followed by doctoral training and experience in decision analysis. I came into the Society for Risk Analysis (SRA) after participating as a committee member in the 1983 National Academies report, Risk Assessment in the Federal Government: Managing the Process. The insights and recommendations from this report, and successor reports from 1996 and 2008, merit revisiting on this 40th anniversary. Risk analysis includes risk assessment, a process of summarizing applicable science to inform decisions; and risk management, a process of making informed choices, usually involving multiple stakeholders. Inherent in both is the need to deal with complexity, uncertainty, and differing perspectives and goals. The lessons I have learned include the need for a conceptual separation of risk management from risk assessment, the benefit of an iterative dialogue between these activities, and the wisdom of articulating and assessing what we know, what we want, and what we can do as we seek to understand and manage risks affecting ourselves and those we advise.

Whither Risk Assessment: New Challenges and Opportunities a Third of a Century After the Red Book.

Six multi-decade-long members of SRA reflect on the 1983 Red Book in order to examine the evolving relationship between risk assessment and risk management; the diffusion of risk assessment practice to risk areas such as homeland security and transportation; the quality of chemical risk databases; challenges from other groups to elements at the core of risk assessment practice; and our collective efforts to communicate risk assessment to a diverse set of critical groups that do not understand risk, risk assessment, or many other risk-related issues. The authors reflect on the 10 recommendations in the Red Book and present several pressing challenges for risk assessment practitioners.

Public and stakeholder participation for managing and reducing the risks of shale gas development.

Emerging technologies pose particularly strong challenges for risk governance when they have multidimensional and inequitable impacts, when there is scientific uncertainty about the technology and its risks, when there are strong value conflicts over the perceived benefits and risks, when decisions must be made urgently, and when the decision making environment is rife with mistrust. Shale gas development is one such emerging technology. Drawing on previous U.S. National Research Council committee reports that examined risk decision making for complex issues like these, we point to the benefits and challenges of applying the analytic-deliberative process recommended in those reports for stakeholder and public engagement in risk decision making about shale gas development in the United States. We discuss the different phases of such a process and conclude by noting the dangers of allowing controversy to ossify and the benefits of sound dialogue and learning among publics, stakeholders, industry, and regulatory decision makers.

Risks and risk governance in unconventional shale gas development.

A broad assessment is provided of the current state of knowledge regarding the risks associated with shale gas development and their governance. For the principal domains of risk, we identify observed and potential hazards and promising mitigation options to address them, characterizing current knowledge and research needs. Important unresolved research questions are identified for each area of risk; however, certain domains exhibit especially acute deficits of knowledge and attention, including integrated studies of public health, ecosystems, air quality, socioeconomic impacts on communities, and climate change. For these, current research and analysis are insufficient to either confirm or preclude important impacts. The rapidly evolving landscape of shale gas governance in the U.S. is also assessed, noting challenges and opportunities associated with the current decentralized (state-focused) system of regulation. We briefly review emerging approaches to shale gas governance in other nations, and consider new governance initiatives and options in the U.S. involving voluntary industry certification, comprehensive development plans, financial instruments, and possible future federal roles. In order to encompass the multiple relevant disciplines, address the complexities of the evolving shale gas system and reduce the many key uncertainties needed for improved management, a coordinated multiagency federal research effort will need to be implemented.

Can Sisyphus succeed? Getting U.S. high-level nuclear waste into a geological repository.

The U.S. government has the obligation of managing the high-level radioactive waste from its defense activities and also, under existing law, from civilian nuclear power generation. This obligation is not being met. The January 2012 Final Report from the Blue Ribbon Commission on America's Nuclear Future provides commendable guidance but little that is new. The author, who served on the federal Nuclear Waste Technical Review Board from 1989 to 1994 and subsequently on the Board on Radioactive Waste Management of the National Research Council from 1994 to 1999, provides a perspective both on the Commission's recommendations and a potential path toward progress in meeting the federal obligation. By analogy to Sisyphus of Greek mythology, our nation needs to find a way to roll the rock to the top of the hill and have it stay there, rather than continuing to roll back down again.

Critical considerations in evaluating scientific evidence of health effects of ambient ozone: a conference report.

The U.S. Environmental Protection Agency (EPA), under the authority of the Clean Air Act (CAA), is required to promulgate National Ambient Air Quality Standards (NAAQSs) for criteria air pollutants, including ozone. Each NAAQS includes a primary health-based standard and a secondary or welfare-based standard. This paper considers only the science used for revision of the primary standard for ozone in 2008. This paper summarizes deliberations of a small group of scientists who met in June 2007 to review the scientific information informing the EPA Administrator's proposed revision of the 1997 standard. The Panel recognized that there is no scientific methodology that, in the absence of judgment, can define the precise numerical level, related averaging time, and statistical form of the NAAQS. The selection of these elements of the NAAQS involves policy judgments that should be informed by scientific information and analyses. Thus, the Panel members did not feel it appropriate to offer either their individual or collective judgment on the specific numerical level of the NAAQS for ozone. The Panel deliberations focused on the scientific data available on the health effects of exposure to ambient concentrations of ozone, controlled ozone exposure studies with human volunteers, long-term epidemiological studies, time- series epidemiological studies, human panel studies, and toxicological investigations. The deliberations also dealt with the issue of background levels of ozone of nonanthropogenic origin and issues involved with conducting formal risk assessments of the health impacts of current and prospective levels of ambient ozone. The scientific issues that were central to the EPA Administrator's 2008 revision of the NAAQS for ozone will undoubtedly also be critical to the next review of the ozone standard. That review should begin very soon if it is to be completed within the 5-year cycle specified in the CAA. It is hoped that this Report will stimulate discussion of these scientific issues, conduct of additional research, and conduct of new analyses that will provide an improved scientific basis for the policy judgment that will have to be made by a future EPA Administrator in considering potential revision of the ozone standard.

The naphthalene state of the science symposium: objectives, organization, structure, and charge.

This report provides a summary of the objectives, organization, structure and charge for the naphthalene state of the science symposium (NS(3)), Monterey, CA, October 9-12, 2006. A 1-day preliminary conference was held followed by a 3-day state of the science symposium covering four topics judged by the Planning Committee to be crucial for developing valid and reliable scientific estimates of low-dose human cancer risk from naphthalene. The Planning Committee reviewed the relevant scientific literature to identify singularly knowledgeable researchers and a pool of scientists qualified to serve as expert panelists. In two cases, independent scientists were commissioned to develop comprehensive reviews of the relevant science in a specific area for which no leading researcher could be identified. Researchers and expert panelists alike were screened for conflicts of interest. All policy issues related to risk assessment practices and risk management were scrupulously excluded. NS(3) was novel in several ways and provides an innovative model for the effective use of peer review to identify scientific uncertainties and propose research strategies for reducing or eliminating them prior to the conduct of risk assessment.

A review of whole animal bioassays of the carcinogenic potential of naphthalene.

This report provides a summary of deliberations conducted under the charge for members of Module A participating in the Naphthalene State-of-the-Science Symposium (NS3), Monterey, CA, October 9-12, 2006. Whole animal bioassays have been performed by the National Toxicology Program in mice and rats to ascertain the carcinogenic potential of naphthalene by inhalation exposure. A statistically significant increased incidence of pulmonary alveolar/bronchiolar adenoma (a benign lesion), was observed among female mice; an observed increase among the males did not reach statistical significance. No nasal tumors were observed in either sex. A tumorigenic response was observed in both sexes of rats, in males an increased incidence of nasal respiratory epithelium adenoma (a benign rather than malignant lesion) and in females, olfactory epithelial neuroblastoma. Interpretations of these studies vary. On the one hand, evidence of extensive non-neoplastic response in both sexes of both species indicates cytotoxicity occurred at all doses, and strongly suggests that cytotoxicity played a significant role in the tumor responses observed in the target tissues. On the other hand, olfactory epithelial neuroblastoma has rarely been observed in NTP bioassays. This review seeks to develop a consensus understanding of the scientific evidence provided by these studies, taking into account that they have been used as the basis for quantitative human cancer risk assessment, and suggests scientific studies that, if performed, could resolve scientific uncertainties.

A discussion of findings and their possible implications from a workshop on bioterrorism threat assessment and risk management.

In November 2001, the Monterey Institute of International Studies convened a workshop on bioterrorism threat assessment and risk management. Risk assessment practitioners from various disciplines, but without specialized knowledge of terrorism, were brought together with security and intelligence threat analysts to stimulate an exchange that could be useful to both communities. This article, prepared by a subset of the participants, comments on the workshop's findings and their implications and makes three recommendations, two short term (use of threat assessment methodologies and vulnerability analysis) and one long term (application of quantitative risk assessment and modeling), regarding the practical application of risk assessment methods to bioterrorism issues.