Timothy F. Malloy

Nanomaterial categorization for assessing risk potential to facilitate regulatory decision-making

For nanotechnology to meet its potential as a game-changing and sustainable technology, it is important to ensure that the engineered nanomaterials and nanoenabled products that gain entry to the marketplace are safe and effective. Tools and methods are needed for regulatory purposes to allow rapid material categorization according to human health and environmental risk potential, so that materials of high concern can be targeted for additional scrutiny, while material categories that pose the least risk can receive expedited review. Using carbon nanotubes as an example, we discuss how data from alternative testing strategies can be used to facilitate engineered nanomaterial categorization according to risk potential and how such an approach could facilitate regulatory decision-making in the future.

A Multi-Stakeholder Perspective on the Use of Alternative Test Strategies for Nanomaterial Safety Assessment

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.

Nanotechnology Regulation: A Study in Claims Making

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.

Alternatives Assessment Frameworks: Research Needs for the Informed Substitution of Hazardous Chemicals

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

Risk Governance for Mobile Phones, Power Lines, and Other EMF Technologies

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.

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.

Toxicity of acidization fluids used in California oil exploration

ABSTRACT 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 States 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.

Policy reforms to update chemical safety testing

TSCA reform empowers EPA to use modernized safety testing in the United States Toxicological evaluation of chemicals and newly emerging substances, such as engineered nanomaterials, is essential to protect human health and the environment (1). Traditional approaches for chemical safety assessment often use high-dose animal studies, human exposure estimates, linear dose extrapolations, and uncertainty factors to determine the circumstances under which human exposure is safe. But in 2016, major bipartisan reform of the antiquated Toxic Substances Control Act (TSCA) in the United States embraced a new paradigm emerging across the globe (2). This paradigm, relying largely on nonanimal, alternative testing strategies (ATS), uses mechanism-based in vitro assays and in silico predictive tools for testing chemicals at considerably less cost (3). We provide a cautious but hopeful assessment of this intersection of law and science. Although the law generally takes a sensible approach to using ATS for regulatory purposes, commitment by the U.S. Environmental Protection Agency (EPA) and its partner agencies remains the key to successful integration of ATS in TSCA.

It is time to revise our approach to registering antimicrobial agents for health care settings

• In this manuscript, we provide a critical assessment of the process that is currently used by the U.S. Environmental Protection Agency to register antimicrobial products and focus on the recent registration of copper and copper alloys as antimicrobial surfaces.