Benjamin D. Trump

Emerging Technologies for Environmental Remediation: Integrating Data and Judgment.

Emerging technologies present significant challenges to researchers, decision-makers, industry professionals, and other stakeholder groups due to the lack of quantitative risk, benefit, and cost data associated with their use. Multi-criteria decision analysis (MCDA) can support early decisions for emerging technologies when data is too sparse or uncertain for traditional risk assessment. It does this by integrating expert judgment with available quantitative and qualitative inputs across multiple criteria to provide relative technology scores. Here, an MCDA framework provides preliminary insights on the suitability of emerging technologies for environmental remediation by comparing nanotechnology and synthetic biology to conventional remediation methods. Subject matter experts provided judgments regarding the importance of criteria used in the evaluations and scored the technologies with respect to those criteria. The results indicate that synthetic biology may be preferred over nanotechnology and conventional methods for high expected benefits and low deployment costs but that conventional technology may be preferred over emerging technologies for reduced risks and development costs. In the absence of field data regarding the risks, benefits, and costs of emerging technologies, structuring evidence-based expert judgment through a weighted hierarchy of topical questions may be helpful to inform preliminary risk governance and guide emerging technology development and policy.

Integrating legal liabilities in nanomanufacturing risk management.

Among other things, the wide-scale development and use of nanomaterials is expected to produce costly regulatory and civil liabilities for nanomanufacturers due to lingering uncertainties, unanticipated effects, and potential toxicity. The life-cycle environmental, health, and safety (EHS) risks of nanomaterials are currently being studied, but the corresponding legal risks have not been systematically addressed. With the aid of a systematic approach that holistically evaluates and accounts for uncertainties about the inherent properties of nanomaterials, it is possible to provide an order of magnitude estimate of liability risks from regulatory and litigious sources based on current knowledge. In this work, we present a conceptual framework for integrating estimated legal liabilities with EHS risks across nanomaterial life-cycle stages using empirical knowledge in the field, scientific and legal judgment, probabilistic risk assessment, and multicriteria decision analysis. Such estimates will provide investors and operators with a basis to compare different technologies and practices and will also inform regulatory and legislative bodies in determining standards that balance risks with technical advancement. We illustrate the framework through the hypothetical case of a manufacturer of nanoscale titanium dioxide and use the resulting expected legal costs to evaluate alternative risk-management actions.

Risk-Based and Prevention-Based Governance for Emerging Materials.

T emergence of new materials and technologies such as engineered nanomaterials or synthetic biology pose significant challenges to regulatory bodies. Similarly, policymakers continue to grapple with the regulation of incumbent technologies. This exercise is known as risk governance, which is defined by the International Risk Governance Council as the institutions, rules conventions, processes, and mechanisms by which decisions about risks are taken and implemented. For decades, risk governance for chemicals adopted a conventional risk management approach in which risks are quantified in absolute units and controlled to acceptable levels. The conventional risk management approach can be effective where (i) hazards are well understood, (ii) the set of potential effects is known, and (iii) exposure can be quantified and reliably controlled. However, where any of these three conditions are missing, a different approach to risk governance is required in order to facilitate the development of beneficial materials. One potential alternative is prevention-based governance, which seeks to avoid or minimize hazard, effects, and exposure by mandating, directly incentivizing, or encouraging the adoption of inherently safer alternative technologies. Although legislators and regulatory agencies have expressed a preference for prevention over control for decades, the notion of prevention has rarely been incorporated into mainstream enforceable regulation or governance more broadly. In large part this is due to the lack of tractable, rigorous and transparent methods for comparative analysis of potentially safer alternatives. We argue that developing decision analytic tools to facilitate and guide risk governance would make preventionbased risk governance practical and achievable. The traditional approach of risk assessment and risk management suffers from several limitations when applied to the governance of emerging materials and technologies. These methodologies were developed in the 1970s and 1980s in order to account for risk in the engineered and well-controlled nuclear and aerospace industries, and subsequently adopted in the environmental and occupational health regulatory regimes under assumption that uncertainty in risk predictions can be quantified and exposure reliably controlled. Such assumptions are challenged within present-day decision scenarios where information regarding potential hazards and exposures are limited such as with the cases of exposure assessment for novel nanomaterial production. Likewise, knowledge about the set of consequences that may result from hazards is often incomplete, where unpredictable effects may emerge from the complex, interconnected interaction of emerging materials in the biological systems and environment. Even probabilistic risk assessment, which is designed to take uncertainty and variability into account, is unable to adequately quantify hazard or assess exposure and effects for highly complex and uncertain emerging threats. In contrast to the conventional risk management, preventionbased risk governance requires the evaluation of alternative courses of action against which the regulated system is to be compared (Figure 1). Comparative assessment methods need to evaluate the relative performance of alternatives with respect to the decision-maker’s criteria, such as human health, environmental impacts, technical viability, and cost. As illustrated in Figure 1, decision-making in the risk prevention paradigm begins with comparative assessment of the incumbent material or technology and its alternatives across a range of relevant criteria. In the subsequent evaluation/option selection process, the decision-maker uses the results of the comparative assessment to identify a safer viable alternative and either require, incentivize, or encourage its adoption. Where there are no safer feasible alternatives, or where it leaves residual risks, prevention is supplemented with more conventional risk management measures. Because it focuses on excising the inherent danger presented by materials or technologies, the prevention-based approach minimizes the

Comparative, collaborative, and integrative risk governance for emerging technologies

Various emerging technologies challenge existing governance processes to identify, assess, and manage risk. Though the existing risk-based paradigm has been essential for assessment of many chemical, biological, radiological, and nuclear technologies, a complementary approach may be warranted for the early-stage assessment and management challenges of high uncertainty technologies ranging from nanotechnology to synthetic biology to artificial intelligence, among many others. This paper argues for a risk governance approach that integrates quantitative experimental information alongside qualitative expert insight to characterize and balance the risks, benefits, costs, and societal implications of emerging technologies. Various articles in scholarly literature have highlighted differing points of how to address technological uncertainty, and this article builds upon such knowledge to explain how an emerging technology risk governance process should be driven by a multi-stakeholder effort, incorporate various disparate sources of information, review various endpoints and outcomes, and comparatively assess emerging technology performance against existing conventional products in a given application area. At least in the early stages of development when quantitative data for risk assessment remain incomplete or limited, such an approach can be valuable for policymakers and decision makers to evaluate the impact that such technologies may have upon human and environmental health.

Nanotoxicology and nanomedicine: making development decisions in an evolving governance environment

The fields of nanomedicine, risk analysis, and decision science have evolved considerably in the past decade, providing developers of nano-enabled therapies and diagnostic tools with more complete information than ever before and shifting a fundamental requisite of the nanomedical community from the need for more information about nanomaterials to the need for a streamlined method of integrating the abundance of nano-specific information into higher-certainty product design decisions. The crucial question facing nanomedicine developers that must select the optimal nanotechnology in a given situation has shifted from “how do we estimate nanomaterial risk in the absence of good risk data?” to “how can we derive a holistic characterization of the risks and benefits that a given nanomaterial may pose within a specific nanomedical application?” Many decision support frameworks have been proposed to assist with this inquiry; however, those based in multicriteria decision analysis have proven to be most adaptive in the rapidly evolving field of nanomedicine—from the early stages of the field when conditions of significant uncertainty and incomplete information dominated, to today when nanotoxicology and nano-environmental health and safety information is abundant but foundational paradigms such as chemical risk assessment, risk governance, life cycle assessment, safety-by-design, and stakeholder engagement are undergoing substantial reformation in an effort to address the needs of emerging technologies. In this paper, we reflect upon 10xa0years of developments in nanomedical engineering and demonstrate how the rich knowledgebase of nano-focused toxicological and risk assessment information developed over the last decade enhances the capability of multicriteria decision analysis approaches and underscores the need to continue the transition from traditional risk assessment towards risk-based decision-making and alternatives-based governance for emerging technologies.

Leveraging stakeholder knowledge in the innovation decision making process

Organisations must make decisions regarding how to best bridge existing societal challenges or market gaps with innovative technologies and business practices. However, many organisations turn to ad hoc decision-making. Within the contemporary environment of accelerating technological change, this is particularly problematic due to the inability of stakeholders to consider the full breadth of information that must be taken into account during the innovation process, and fosters the potential for inefficient outcomes. We propose an integrated mental modelling and multi-criteria decision analysis framework to provide a structured approach to innovation decision-making. Using formal and transparent decision rules to systematically extract the relevant knowledge from experts, one can efficiently map emergent challenges and assess value tradeoffs associated with competing objectives and investments. This process can assist in the identification of emerging societal, technical, and economic risks, and point to how different types of innovations may resolve such concerns.

Diplomacy for science: strategies to promote international collaboration

Technology innovation is an increasingly globalized exercise with dramatic consequences for scientific and diplomatic goals alike, and requires enhanced participation and integration of scientists and science-minded diplomats within diplomatic missions to advance shared policy goals. This more general problem is addressed in the present article by focusing on recent collaborations between U.S. and German scientists, including several of the coauthors.

A decision-analytic approach to predict state regulation of hydraulic fracturing

BackgroundThe development of horizontal drilling and hydraulic fracturing methods has dramatically increased the potential for the extraction of previously unrecoverable natural gas. Nonetheless, the potential risks and hazards associated with such technologies are not without controversy and are compounded by frequently changing information and an uncertain landscape of international politics and laws. Where each nation has its own energy policies and laws, predicting how a state with natural gas reserves that require hydraulic fracturing will regulate the industry is of paramount importance for potential developers and extractors. We present a method for predicting hydraulic fracturing decisions using multiple-criteria decision analysis. The case study evaluates the decisions of five hypothetical countries with differing political, social, environmental, and economic priorities, choosing among four policy alternatives: open hydraulic fracturing, limited hydraulic fracturing, completely banned hydraulic fracturing, and a cap and trade program.ResultsThe result is a model that identifies the preferred policy alternative for each archetypal country and demonstrates the sensitivity the decision to particular metrics. Armed with such information, observers can predict each country’s likely decisions related to natural gas exploration as more data become available or political situations change.ConclusionsDecision analysis provides a method to manage uncertainty and address forecasting concerns where rich and objective data may be lacking. For the case of hydraulic fracturing, the various political pressures and extreme uncertainty regarding the technology’s risks and benefits serve as a prime platform to demonstrate how decision analysis can be used to predict future behaviors.

Risk Assessment and Decision Analysis Within Surgical Applications

Risk is an omnipresent and recurring concern within any surgical application. Even within routine procedures with a high likelihood of success and a limited probability of complications, intra- and postoperative complications may arise that place patients at risk for substantial health consequences. Equally challenging includes the task of communicating such risks to patients, where even slight changes to how risk is conveyed can substantially alter a patient’s perspective and wishes for potential surgical procedures in various applications. As such, physicians must be mindful not only of the likelihood and consequences of risk inherent within surgical applications, but also how such risks are discussed with patients and their families when discussing surgical and non-surgical options to address set health concerns. This chapter seeks to provide an overview and introduction to risk for such physicians, and offer insight regarding how tools of decision analysis may facilitate surgical decision making and frame the likelihood and consequence of potential complications to occur during and after such procedures are undertaken. Additional comments will be centered on the impact that risk communication may have upon patient decision making when considering surgical options. While introductory in nature, this chapter may serve as a helpful outline of how to understand, derive, and communicate risks that remain an intrinsic piece of all medical decision making.

Munitions and explosives of concern: international governance and applications for the United States

A combination of 20th century warfare alongside the storage of and frequent testing of munitions by various national armed forces has contributed to a legacy of unexploded ordnance, munitions, and explosives of concern (MEC). The presence of such latent munitions has potentially debilitating or even fatal effects upon a generally unsuspecting stakeholders where communities may be unaware of the risks posed by buried shells, bombs, and other ordnance on both public and privately held properties. As such, various governments have undertaken differing initiatives to assess, mitigate, and manage the risks associated with these munitions. MEC remediation is generally tailored to each nations unique historical experience with munitions and ordnance and is highly dependent not only on the type and quantity of MEC but also on the existing or proposed land use of the parcel as well. This paper compares the MEC management efforts of the United States, the United Kingdom, Germany, and Canada with regard to their MEC monitoring, detection, and removal methods in order to identify successful policies and procedures that can inform international MEC management.