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We compare how several forms of multicriteria decision analysis (MCDA) can enhance the practice of alternatives assessment (AA). We report on a workshop in which 12 practitioners from US corporations, government agencies, NGOs, and consulting organizations applied different MCDA techniques to 3 AA case studies to understand how they improved the decision process. Participants were asked to select a preferred alternative in each case using a different decision analysis approach: their unaided decision-making method, individual or lightly facilitated group multiattribute value theory (MAVT), and more extensively facilitated group structured decision making (SDM). Surveys conducted after each exercise revealed that participants were positive toward the use of formal decision-making methods for AA, reporting meaningful increases in their understanding of the trade-offs involved and their own values. Participants also reported challenges with each approach. While the MCDA techniques were reported to enhance transparency and communication, they did not consistently lead to higher satisfaction with a decision and/or outcome, and they were not more likely to be adopted within their organizations than unaided approaches. More formal decision-making methods have promise in the context of AA, but practitioners will need more guidance to use such tools successfully. Practitioners will also need to define what "success" constitutes; different approaches may be called for depending on whether the objective is increased understanding, satisfaction with the outcome, satisfaction with the process, or something else. Integr Environ Assess Manag 2021;17:27-41. © 2020 SETAC.

Chemical hazard assessment (CHA), which aims to investigate the inherent hazard potential of chemicals, has been developed with the purpose of promoting safer consumer products. Despite the increasing use of CHA in recent years, finding adequate and reliable toxicity data required for CHA is still challenging due to issues regarding data completeness and data quality. Also, collecting data from primary toxicity reports or literature can be time consuming, which promotes the use of secondary data sources instead. In this study, we evaluate and characterize numerous secondary data sources on the basis of 5 performance attributes: reliability, adequacy, transparency, volume, and ease of use. We use GreenScreen for Safer Chemicals v1.4 as the CHA framework, which defines the endpoints of interest used in this analysis. We focused upon 34 data sources that reflect 3 types of secondary data: chemical-oriented data sources, hazard-trait-oriented data sources, and predictive data sources. To integrate and analyze the evaluation results, we applied 2 multicriteria decision analysis (MCDA) methodologies: multiattribute utility theory (MAUT) and stochastic multiobjective acceptability analysis (SMAA). Overall, the findings in this research program allow us to explore the relative importance of performance criteria and the data source quality for effectively conducting CHA. Integr Environ Assess Manag 2019;00:1-14. © 2019 SETAC.

Contaminated stormwater runoff from oil and gas (O&G) operations can pose a significant threat to surface waters. The purpose of this study is to examine the extent of this threat and identify more specific permitting requirements to protect surface waters. To better understand the extent of the threat, this paper identified and characterized the use of waste surface impoundments at O&G facilities as well as the threat level from O&G spills in California. To assess the efficacy of the current federal and California state-permitting regime, the paper evaluated stormwater permit compliance in two California counties. It also reviewed selected spill cases and associated Spill Prevention, Control and Countermeasure Plans and Stormwater Pollution Prevention Plans to identify the adequacy of current industry practices. The analysis showed that contaminated stormwater from O&G facilities can be better regulated. The U.S. Environmental Protection Agency does not require O&G facilities to file for an Industrial Stormwater General Permit even though many O&G industry practices have the potential to contaminate stormwater runoff from the site. When O&G facilities discharge a Reportable Quantity of a hazardous chemical or violate a water quality standard, they are required to enroll in the National Pollutant Discharge Elimination System permit program. Spills, although not a direct indication of stormwater runoff, can highlight polluted runoff discharges that should have been regulated. Medium and large spills that reached waterways were such a risk for which operators did not file for a permit. In California new filing requirements for the oil and gas industry require all facilities that discharge stormwater that has come into contact with any overburden, raw material, or intermediate products located on the site, to file for an Industrial Stormwater General Permit. As this study showed, there has been an increase in enrollment since the enactment of the new requirements. Having all facilities enroll in the general permit program, as done in California, would require minimum monitoring and maintenance that could help prevent spills. A further step to ensure better protocol is to require specific pollution control practices in addition to the current general permit requirements. Such permitting regimes not only can be implemented on the US federal level but also internationally.

Alternatives analysis (AA) is a method used in regulation and product design to identify, assess, and evaluate the safety and viability of potential substitutes for hazardous chemicals. It requires toxicological data for the existing chemical and potential alternatives. Predictive toxicology uses in silico and in vitro approaches, computational models, and other tools to expedite toxicological data generation in a more cost-effective manner than traditional approaches. The present article briefly reviews the challenges associated with using predictive toxicology in regulatory AA, then presents 4 recommendations for its advancement. It recommends using case studies to advance the integration of predictive toxicology into AA, adopting a stepwise process to employing predictive toxicology in AA beginning with prioritization of chemicals of concern, leveraging existing resources to advance the integration of predictive toxicology into the practice of AA, and supporting transdisciplinary efforts. The further incorporation of predictive toxicology into AA would advance the ability of companies and regulators to select alternatives to harmful ingredients, and potentially increase the use of predictive toxicology in regulation more broadly. Integr Environ Assess Manag 2017;13:915-925. © 2017 SETAC.

In 2006, the European Union (EU) enacted the Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) to address growing concerns of hazardous chemicals in the EU market. Under REACH, companies seeking authorization to use priority substances identified as substances of very high concern (SVHCs) and included in the authorization list must apply and submit health and environmental effects data in analyses of alternatives (AoAs) to the European Chemicals Agency (ECHA). To assess safer alternatives, especially in AoA hazard assessment cases where vital information could be missing or insufficient, quantitative structure-activity relationship (QSAR) nontesting methods have gained increasing acceptance and importance. This article assesses AoA applicants' use of QSAR sources and documentation while looking for meaningful trends. In this assessment, usage and frequency of QSAR sources were evaluated in 189 analyses of alternatives for 15 physicochemical properties and 19 human health and environmental endpoints to determine the scope of purpose of QSAR use in AoAs. We found that only 24 out of 189 applications cited QSAR sources to rank or evaluate the safety of their alternative substances relative to the REACH Annex XIV chemical. For human health and environmental hazard endpoints, applicants cited the Danish (Q)SAR Database (n = 63) and unidentified QSARs (n = 36) most frequently. While QSARs were not used to eliminate an alternative, 7.9% and 1.4% per maximum opportunity (MOP) of hazard endpoint and physicochemical QSAR predictions reported background information on alternatives using weight of evidence (WoE). In addition, 3.0% per MOP of hazard endpoint QSAR predictions supported the safety of the alternative while 0.7% per MOP of physicochemical QSAR predictions gave mixed support for their alternative's safety. Documentation regarding QSARs was absent in all 24 AoAs that used QSARs. Limited QSAR use and missing documentation may be the result of several factors, including inconsistent regulatory guidance. Integr Environ Assess Manag 2020;16:745-760. © 2020 SETAC.

Although toxicity data is critical to effective risk prevention and management, comprehensive health and safety data is not available for the vast majority of chemicals in use today. Rapid development of new engineered nanomaterials exacerbates the dilemma even further. Emerging alternative testing approaches offer a solution to this dilemma. Traditional toxicity testing predicts human disease based upon its occurrence in other species such as rodents and rabbits. Alternative testing strategies (ATS) seek to reduce, refine or replace the use of animals, minimize cost and diminish uncertainty by placing greater reliance upon mechanistically-based in vitro and in silico methods. While significant advances have recently been made in the science of alternative testing, little of that science has worked its way into regulatory actions by EPA. Recent reforms to the federal Toxic Substances Control Act include provisions meant to advance regulatory use of ATS. This article asks whether the legislation will make any appreciable difference in the adoption of ATS for regulatory purposes. Recognizing that the scope and speed of adoption will depend on the specific legal-institutional environment in question, we present and apply a conceptual model that takes that environment into account in the context of the federal Environmental Protection Agency's (EPA) regulation of chemicals. We use that model to explore EPA's historical usage of alternative testing strategies, identifying certain features of the legal-institutional environment that influenced EPA usage. We then turn to the reform legislation and consider whether it is likely to alter the relevant features of the legal-institutional environment.

Background: Ten years ago, leaders in the field of toxicology called for a transformation of the discipline and a shift from primarily relying on traditional animal testing to incorporating advances in biotechnology and predictive methodologies into alternative testing strategies (ATS). Governmental agencies and academic and industry partners initiated programs to support such a transformation, but a decade later, the outcomes of these efforts are not well understood. Objectives: We aimed to assess the use of ATS and the perceived barriers and drivers to their adoption by toxicologists and by others working in, or closely linked with, the field of toxicology. Methods: We surveyed 1,381 toxicologists and experts in associated fields regarding the viability and use of ATS and the perceived barriers and drivers of ATS for a range of applications. We performed ranking, hierarchical clustering, and correlation analyses of the survey data. Results: Many respondents indicated that they were already using ATS, or believed that ATS were already viable approaches, for toxicological assessment of one or more end points in their primary area of interest or concern (26–86%, depending on the specific ATS/application pair). However, the proportions of respondents reporting use of ATS in the previous 12 mo were smaller (4.5–41%). Concern about regulatory acceptance was the most commonly cited factor inhibiting the adoption of ATS, and a variety of technical concerns were also cited as significant barriers to ATS viability. The factors most often cited as playing a significant role (currently or in the future) in driving the adoption of ATS were the need for expedited toxicology information, the need for reduced toxicity testing costs, demand by regulatory agencies, and ethical or moral concerns. Conclusions: Our findings indicate that the transformation of the field of toxicology is partly implemented, but significant barriers to acceptance and adoption remain. https://doi.org/10.1289/EHP1435

Regulators are implementing new programs that require manufacturers of products containing certain chemicals of concern to identify, evaluate, and adopt viable, safer alternatives. Such programs raise the difficult question for policymakers and regulated businesses of which alternatives are “viable” and “safer.” To address that question, these programs use “alternatives analysis,” an emerging methodology that integrates issues of human health and environmental effects with technical feasibility and economic impact. Despite the central role that alternatives analysis plays in these programs, the methodology itself is neither well-developed nor tailored to application in regulatory settings. This study uses the case of Pb-based bar solder and its non-Pb-based alternatives to examine the application of 2 multi-criteria decision analysis (MCDA) methods to alternatives analysis: multi-attribute utility analysis and outranking. The article develops and evaluates an alternatives analysis methodology and supporting decision-analysis software for use in a regulatory context, using weighting of the relevant decision criteria generated from a stakeholder elicitation process. The analysis produced complete rankings of the alternatives, including identification of the relative contribution to the ranking of each of the highest level decision criteria such as human health impacts, technical feasibility, and economic feasibility. It also examined the effect of variation in data conventions, weighting, and decision frameworks on the outcome. The results indicate that MCDA can play a critical role in emerging prevention-based regulatory programs. Multi-criteria decision analysis methods offer a means for transparent, objective, and rigorous analysis of products and processes, providing regulators and stakeholders with a common baseline understanding of the relative performance of alternatives and the trade-offs they present. Integr Environ Assess Manag 2013;9:652–664. © 2013 SETAC

• We express our satisfaction with the responding author's agreement with our call to action to require clinical studies in the U.S. Environmental Protection Agency registration of antimicrobial surfaces.

Power-frequency electric and magnetic fields (EMFs) have been present in industrialized countries since the late 19th century and a considerable amount of knowledge has been accumulated as to potential health effects. The mainstream scientific view is that even if there is a risk, it is unlikely to be of major public-health significance. EMFs from cellular communications and other radio-frequency technologies have increased rapidly in the last decade. This technology is constantly changing, which makes continued research both more urgent and more challenging. While there are no persuasive data suggesting a health risk, research and particularly exposure assessment is still immature. The principal risk-governance issue with power frequencies is how to respond to weak and uncertain scientific evidence that nonetheless causes public concern. For radio-frequency electromagnetic fields, the issue is how to respond to large potential consequences and large public concern where only limited scientific evidence exists. We survey these issues and identify deficits in risk governance. Deficits in problem framing include both overstatement and understatement of the scientific evidence and of the consequences of taking protective measures, limited ability to detect early warnings of risk, and attempted reassurance that has sometimes been counterproductive. Other deficits relate to the limited public involvement mechanisms, and flaws in the identification and evaluation of tradeoffs in the selection of appropriate management strategies. We conclude that risk management of EMFs has certainly not been perfect, but for power frequencies it has evolved and now displays many successful features. Lessons from the power-frequency experience can benefit risk governance of the radio-frequency EMFs and other emerging technologies.

Background Given increasing pressures for hazardous chemical replacement, there is growing interest in alternatives assessment to avoid substituting a toxic chemical with another of equal or greater concern. Alternatives assessment is a process for identifying, comparing, and selecting safer alternatives to chemicals of concern (including those used in materials, processes, or technologies) on the basis of their hazards, performance, and economic viability. Objectives The purposes of this substantive review of alternatives assessment frameworks are to identify consistencies and differences in methods and to outline needs for research and collaboration to advance science policy practice. Methods This review compares methods used in six core components of these frameworks: hazard assessment, exposure characterization, life-cycle impacts, technical feasibility evaluation, economic feasibility assessment, and decision making. Alternatives assessment frameworks published from 1990 to 2014 were included. Results Twenty frameworks were reviewed. The frameworks were consistent in terms of general process steps, but some differences were identified in the end points addressed. Methodological gaps were identified in the exposure characterization, life-cycle assessment, and decision–analysis components. Methods for addressing data gaps remain an issue. Discussion Greater consistency in methods and evaluation metrics is needed but with sufficient flexibility to allow the process to be adapted to different decision contexts. Conclusion Although alternatives assessment is becoming an important science policy field, there is a need for increased cross-disciplinary collaboration to refine methodologies in support of the informed substitution and design of safer chemicals, materials, and products. Case studies can provide concrete lessons to improve alternatives assessment. Citation Jacobs MM, Malloy TF, Tickner JA, Edwards S. 2016. Alternatives assessment frameworks: research needs for the informed substitution of hazardous chemicals. Environ Health Perspect 124:265–280; http://dx.doi.org/10.1289/ehp.1409581

There has been considerable public interest regarding the toxicity of chemicals used in hydraulic fracturing, but little is known about its sister technique, acidizing. Little to no research has been done on what the chemicals of acidization are and what impact they could have on humans and the environment. This paper discusses the differences between three acidizing techniques (acid maintenance, matrix acidization, and acid fracturing) and quantifies the amounts of the chemicals used for each. Washington State's Quick Chemical Assessment Tool is used to identify F-graded toxins, which are known carcinogens, mutagens, reproductive toxins, developmental toxins, endocrine disruptors, or high acute toxicity chemicals. The analysis of the present data shows that there have been over 600 instances of acidizing in urbanized Southern and Central California from April 2013 to August 2015. Although most of the chemicals of acidizing are similar to hydraulic fracturing, those used most frequently are different. There are close to 200 specific chemicals used in acidization, with at least 28 of them being F-graded hazardous chemicals. Some are used frequently in the range of 100–1000 kg per treatment, such as hydrofluoric acid, xylene, diethylene glycol, and ethyl benzene. Close to 90 more chemicals are identified using non-specific names as trade secrets or reported with no quantity. Unlike hydraulic fracturing the chemical concentrations in acidizing are high, ranging from 6% to 18%, and the waste returns can be highly acidic, in the range of pH 0–3. With this paper it is hoped that acidization becomes part of the larger discussion on concerns with oil exploration and be evaluated by appropriate authorities.

Background: Decision analysis—a systematic approach to solving complex problems—offers tools and frameworks to support decision making that are increasingly being applied to environmental challenges. Alternatives analysis is a method used in regulation and product design to identify, compare, and evaluate the safety and viability of potential substitutes for hazardous chemicals. Objectives: We assessed whether decision science may assist the alternatives analysis decision maker in comparing alternatives across a range of metrics. Methods: A workshop was convened that included representatives from government, academia, business, and civil society and included experts in toxicology, decision science, alternatives assessment, engineering, and law and policy. Participants were divided into two groups and were prompted with targeted questions. Throughout the workshop, the groups periodically came together in plenary sessions to reflect on other groups’ findings. Results: We concluded that the further incorporation of decision science into alternatives analysis would advance the ability of companies and regulators to select alternatives to harmful ingredients and would also advance the science of decision analysis. Conclusions: We advance four recommendations: a) engaging the systematic development and evaluation of decision approaches and tools; b) using case studies to advance the integration of decision analysis into alternatives analysis; c) supporting transdisciplinary research; and d) supporting education and outreach efforts. https://doi.org/10.1289/EHP483

Most people dread being the subject of interest for doctors, scientists, regulators, and lawyers. While we may joke about the arrogance of the medical profession and the aggressiveness of the legal field, both lie at the core of environmental public health (EPH). They are inseparable, sometimes complementary and other times in tension. The role of medicine and science in EPH is clear, but their relationship with law is often opaque. Yet in no other area of public health, from infectious and chronic disease prevention to providing health care in underserved communities, is law so central as an instrument and partner. In this article we explore the relationship of law and science in the broader context of EPH, beginning with an overview of potential goals and challenges. We then offer three organizing principles that inform and guide the integration of law, science and policy in EPH.

This chapter asks what is needed to craft effective legal frameworks that take the notion of sustainable production seriously. Getting to an answer requires consideration of three questions. First, what do we mean by “sustainable production” in terms of a definition and fundamental principles? Here the chapter adopts a definition and examines three central principles: life cycle thinking, integration of environmental, social and economic concerns, and a preventive orientation. Second, what types of mandatory regulation can be used to advance sustainable production in accord with the fundamental principles? In response the chapter provides an overview of forms of sustainability-based regulation, and maps them onto five existing regulatory programs that to various degrees reflect sustainable production concepts. Third, which of those forms of regulation should be used to advance sustainable production? Recognizing the breadth of this normative question, the chapter does not attempt to identify the optimal regulatory approach. Instead it offers a set of factors that may influence regulatory design in this context.

There is little question that we face substantial challenges in the 21st century: climate change, disease, poverty, natural resource depletion and degradation, war and terrorism — the list goes on. Emerging technologies will likely be integral in resolving or mitigating many of these challenges; prominent examples include renewable energy technologies, green chemistry, biotechnology, nanotechnology, and informatics. Government policies often play a significant or even central role in advancing the development and diffusion of such technologies. Yet, these policies typically fail to account for the unintended adverse health, environmental, social and other consequences that may flow from those technologies. This chapter starts with the premise that the United States’ technology policy ought to integrate principles of protection and promotion so as to ensure the availability of truly beneficial technologies. It examines the extent to which this integration can be accomplished through technology assessment at the legislative stage of policy formulation. For these purposes, technology assessment refers to the systematic assessment and evaluation of the positive and negative impacts of an ostensibly beneficial technology. Technology assessment has a decades-long history, starting primarily in the United States and more recently establishing itself in Europe. It takes many forms, not all of which will be appropriate for use in legislative settings in the United States.After some definitional matters regarding the notion of technological change, the chapter turns to two specific aspects of government technology policy. Promotional policies actively support the development and use of emerging technologies through research funding, direct subsidies and other strategies. Regulatory policies create a demand for emerging technologies by removing market competitors, creating a need for the emerging technology, or even requiring its use. Next, the chapter examines the problem of unintended consequences by identifying potential causes and exploring the historical example of methyl tertiary-butyl ether (MTBE) and the Clean Air Act. The chapter then briefly surveys the field of technology assessment, and considers how it could mitigate the problem of unintended consequences in the legislative setting. It concludes that, given the institutional structure and dynamics of Congress, technology assessment can address some, but not all, causes of such unintended consequences.

There has been a conceptual shift in toxicological studies from describing what happens to explaining how the adverse outcome occurs, thereby enabling a deeper and improved understanding of how biomolecular and mechanistic profiling can inform hazard identification and improve risk assessment. Compared to traditional toxicology methods, which have a heavy reliance on animals, new approaches to generate toxicological data are becoming available for the safety assessment of chemicals, including high-throughput and high-content screening (HTS, HCS). With the emergence of nanotechnology, the exponential increase in the total number of engineered nanomaterials (ENMs) in research, development, and commercialization requires a robust scientific approach to screen ENM safety in humans and the environment rapidly and efficiently. Spurred by the developments in chemical testing, a promising new toxicological paradigm for ENMs is to use alternative test strategies (ATS), which reduce reliance on animal testing through the use of in vitro and in silico methods such as HTS, HCS, and computational modeling. Furthermore, this allows for the comparative analysis of large numbers of ENMs simultaneously and for hazard assessment at various stages of the product development process and overall life cycle. Using carbon nanotubes as a case study, a workshop bringing together national and international leaders from government, industry, and academia was convened at the University of California, Los Angeles, to discuss the utility of ATS for decision-making analyses of ENMs. After lively discussions, a short list of generally shared viewpoints on this topic was generated, including a general view that ATS approaches for ENMs can significantly benefit chemical safety analysis. © 2013 American Chemical Society.

Regulators are implementing new programs that require manufacturers of products containing certain chemicals of concern to identify, evaluate, and adopt viable, safer alternatives. Such programs raise the difficult question for policymakers and regulated businesses of which alternatives are "viable" and "safer." To address that question, these programs use "alternatives analysis," an emerging methodology that integrates issues of human health and environmental effects with technical feasibility and economic impact. Despite the central role that alternatives analysis plays in these programs, the methodology itself is neither well-developed nor tailored to application in regulatory settings. This study uses the case of Pb-based bar solder and its non-Pb-based alternatives to examine the application of 2 multi-criteria decision analysis (MCDA) methods to alternatives analysis: multi-attribute utility analysis and outranking. The article develops and evaluates an alternatives analysis methodology and supporting decision-analysis software for use in a regulatory context, using weighting of the relevant decision criteria generated from a stakeholder elicitation process. The analysis produced complete rankings of the alternatives, including identification of the relative contribution to the ranking of each of the highest level decision criteria such as human health impacts, technical feasibility, and economic feasibility. It also examined the effect of variation in data conventions, weighting, and decision frameworks on the outcome. The results indicate that MCDA can play a critical role in emerging prevention-based regulatory programs. Multi-criteria decision analysis methods offer a means for transparent, objective, and rigorous analysis of products and processes, providing regulators and stakeholders with a common baseline understanding of the relative performance of alternatives and the trade-offs they present.

There appears to be consensus on the notion that the hazards of nanotechnology are a social problem in need of resolution, but much dispute remains over what that resolution should be. There are a variety of potential policy tools for tackling this challenge, including conventional direct regulation, self-regulation, tort liability, financial guarantees, and more. The literature in this area is replete with proposals embracing one or more of these tools, typically using conventional regulation as a foil in which its inadequacy is presented as justification for a new proposed approach. At its core, the existing literature raises a critical question: What is the most effective role of government as regulator in these circumstances? This article explores that question by focusing upon two policy approaches in particular: conventional regulation and self-regulation, often described as hard law and soft law, respectively. Drawing from the sociology of social problems, the article examines the soft law construction of the nanotechnology problem and the associated solutions, with emphasis on the claims-making strategies used. In particular, it critically examines the rhetoric and underlying grounds for the soft law approach. It also sets out the grounds and framework for an alternative construction and solution-the concept of iterative regulation.

Power-frequency electric and magnetic fields (EMFs) have been present in industrialized countries since the late 19th century and a considerable amount of knowledge has been accumulated as to potential health effects. The mainstream scientific view is that even if there is a risk, it is unlikely to be of major public-health significance. EMFs from cellular communications and other radio-frequency technologies have increased rapidly in the last decade. This technology is constantly changing, which makes continued research both more urgent and more challenging. While there are no persuasive data suggesting a health risk, research and particularly exposure assessment is still immature. The principal risk-governance issue with power frequencies is how to respond to weak and uncertain scientific evidence that nonetheless causes public concern. For radio-frequency electromagnetic fields, the issue is how to respond to large potential consequences and large public concern where only limited scientific evidence exists. We survey these issues and identify deficits in risk governance. Deficits in problem framing include both overstatement and understatement of the scientific evidence and of the consequences of taking protective measures, limited ability to detect early warnings of risk, and attempted reassurance that has sometimes been counterproductive. Other deficits relate to the limited public involvement mechanisms, and flaws in the identification and evaluation of tradeoffs in the selection of appropriate management strategies. We conclude that risk management of EMFs has certainly not been perfect, but for power frequencies it has evolved and now displays many successful features. Lessons from the power-frequency experience can benefit risk governance of the radio-frequency EMFs and other emerging technologies.

Technological innovation almost always comes at a price in terms, of environmental health. In large part, this equation can be traced to one of the fundamental differences between technological innovation and regulatory innovation. The former can often occur swiftly, coming from numerous diffuse sources within the market. The latter, with rare exceptions, moves slowly, flowing from centralized state, national or international sources. (1) Thus, regulatory response typically lags well beyond the introduction of new products and technology. Nanotechnology, defined for these purposes as the use, manipulation or control of materials at the nanometer scale, is yet another case in point. Nanomaterials already are present in hundreds of consumer and industrial applications, yet are subject to minimal regulation in the United States and elsewhere. Despite the paucity of comprehensive testing of nanomaterials, there is a growing body of evidence that exposure to some types of nanoparticles may pose significant health risks to workers and the general public. (2) The very properties that make engineered nanomaterials valuable--small size, large surface area and highly variable physical and chemical characteristics--both complicate our ability to monitor exposures to nanomaterials and increase the potential that some categories of nanomaterials will prove harmful. Notwithstanding the expected benefits of emerging nanotechnologies and nanomaterials, the hazards associated with them have lead to a cacophony of appeals for various types of regulatory response, ranging from a moratorium to industry self-regulation and virtually everything in between. With this background in mind, the UCLA Working Conference on Nanotechnology Regulatory Policy commissioned a series of papers to form the centerpiece of pragmatic discussion regarding the way forward. Commentators often characterize nanotechnology as "disruptive," meaning it is a form of radical technological innovation that fundamentally challenges the existing product/technology market and leads to new competitive opportunities. (3) Yet this new technology is disruptive in three other significant ways as well. It presents difficult technical issues regarding toxicity testing and hazard assessment so central to conventional regulatory policy. Likewise, it highlights the limits of existing risk governance approaches in use in the United States and abroad, particularly with respect to the role of third parties and the general public in policymaking. Lastly, it strains an already overburdened--and some might say obsolete--regulatory system, raising calls for innovative approaches more suited to managing this strange new technology. The papers that follow deal thoughtfully with these three themes, providing useful background and provocative prescriptions for policymakers, industry and academia alike. THE NEED FOR A NEW TOXICOLOGY In The Scientific Basis for the Regulation of Nanoparticles: Challenging Paracelsus and Pare, Dr. Bernard Goldstein describes how the unique attributes of nanomaterials can turn commonly accepted laws of toxicology on their head. Consequently, he argues, conventional toxicity testing and assessment are neither protective nor cost-effective. He appeals for substantial investment in new approaches to toxicology, including new toxicological testing modalities, improved exposure assessment, and post-marketing surveillance of nanomaterials in products. Dr. Goldstein's emphasis on developing a new toxicology for nanotechnology is consistent with the growth of predictive toxicology more generally, (4) and with work currently underway at universities and other research centers. (5) Dr. Goldstein sees a direct link between the new toxicological science and regulatory policy, arguing that better science is required for appropriate risk management. He cautions against embracing the precautionary principle, concerned about the likelihood of incurring unreasonably high social costs. …

I. INTRODUCTION II. THE PERFECT STORM A. Natural Accidents B. Climate Change C. Industrial Terrorism III. DUELING PARADIGMS: MANAGEMENT VS. PREVENTION A. Implementing the Dominant Paradigm B. Inherently Safer Design IV. ADAPTATION: INTEGRATION OF ISD V. CONCLUSION I. INTRODUCTION A Category four hurricane is bearing down upon the Gulf Coast. Managers at the Trident Oil refinery in Pascagoula, Mississippi, invoke shutdown procedures three days prior to expected landfall. All crude oil, sulfuric acid, hydrofluoric acid, and other hazardous materials are drained from the process units and the nearby storage tanks and pumped to a more distant emergency storage area at the facility. Most equipment is shut down, although some steam boilers, power generating units, and cooling systems continue to run in order to maintain temperature and pressure in tanks and to support safety devices. A skeleton crew remains at the facility to deal with emergencies and to restart the facility after the storm passes. The storm arrives, lashing the plant with thick sheets of rain and howling 125 mile per hour winds. Heavy rains have overwhelmed the storm water drains throughout the plant, flooding various buildings. The automatic monitoring system associated with Tank 213, which contains a highly toxic liquid material, is located in one of the flooded buildings. High winds rip Tank 213 from its foundations, causing a massive spill of the contents. The facility operator is unaware of the release due to the failure of the submerged monitoring system, and takes no action until after the released material has reached a nearby channel to the gulf. Just south of downtown Philadelphia, the Atlantic Refining Company's facility is nestled among several working class neighborhoods. A sprawling complex on 25 acres, the Atlantic refinery produces 350,000 barrels per day of gasoline, diesel, and jet fuel each year. In the alkylation process unit, light hydrocarbons react with a catalyst to create alkylate, an important additive used to produce high octane gasoline. At the Atlantic refinery hydrofluoric acid is the catalyst of choice. The hydrofluoric acid is stored in a large green cylindrical tank located adjacent to the alkylation process unit. One July morning the neighborhoods surrounding the Atlantic refinery are slowly rousing. Dogs sniff grass, weeds, and flowers on morning walks or in backyards. Children rush to depart for daycare, or play in the street or in small green patches behind their homes. Distracted parents finish coffee on the run, packing up for a day of work. Unnoticed, a lone figure carrying a large duffle bag emerges from the stairs leading to the roof of a weathered apartment building. He sets it down by the roof's edge facing the refinery, and methodically removes dark machined items from the bag. Once assembled, he lifts the tubular contraption to his shoulder, sighting the dull green cylinder at the refinery some 500 yards away. A projectile erupts from the tube, streaking towards the refinery. A large puff of smoke and flame appear on the face of the cylinder, and an orange-tinted haze slowly oozes out, drifting in silence towards the neighborhood. As the 21st century unfolds, regulators charged with overseeing chemical production and use in the United States face a perfect storm of sorts. Three important phenomena with critical implications for chemical management policy are converging at once. First, production and use of toxic chemicals continue to proliferate. Eighty thousand chemicals are in commerce in the United States, with 1,000 added each year. (1) Although current government and industrial codes are in place to minimize known risks, there are troubling gaps in our understanding of the use and impacts of these chemicals. (2) Despite best efforts, even under normal circumstances chemical releases regularly occur. "Normal accident" theory posits that unanticipated human and system failures are inevitable at complex facilities like oil refineries and chemical plants. …