Margaret MacDonell

Nano Risk Analysis: Advancing the Science for Nanomaterials Risk Management

Scientists, activists, industry, and governments have raised concerns about health and environmental risks of nanoscale materials. The Society for Risk Analysis convened experts in September 2008 in Washington, DC to deliberate on issues relating to the unique attributes of nanoscale materials that raise novel concerns about health risks. This article reports on the overall themes and findings of the workshop, uncovering the underlying issues for each of these topics that become recurring themes. The attributes of nanoscale particles and other nanomaterials that present novel issues for risk analysis are evaluated in a risk analysis framework, identifying challenges and opportunities for risk analysts and others seeking to assess and manage the risks from emerging nanoscale materials and nanotechnologies. Workshop deliberations and recommendations for advancing the risk analysis and management of nanotechnologies are presented.

An approach for assessing human exposures to chemical mixtures in the environment

Humans are exposed daily to multiple chemicals, including incidental exposures to complex chemical mixtures released into the environment and to combinations of chemicals that already co-exist in the environment because of previous releases from various sources. Exposures to chemical mixtures can occur through multiple pathways and across multiple routes. In this paper, we propose an iterative approach for assessing exposures to environmental chemical mixtures; it is similar to single-chemical approaches. Our approach encompasses two elements of the Risk Assessment Paradigm: Problem Formulation and Exposure Assessment. Multiple phases of the assessment occur in each element of the paradigm. During Problem Formulation, analysts identify and characterize the source(s) of the chemical mixture, ensure that dose-response and exposure assessment measures are concordant, and develop a preliminary evaluation of the mixtures fate. During Exposure Assessment, analysts evaluate the fate of the chemicals comprising the mixture using appropriate models and measurement data, characterize the exposure scenario, and estimate human exposure to the mixture. We also describe the utility of grouping the chemicals to be analyzed based on both physical-chemical properties and an understanding of environmental fate. In the article, we also highlight the need for understanding of changes in the mixture composition in the environment due to differential transport, differential degradation, and differential partitioning to other media. The Results section describes the application of the method to various chemical mixtures, highlighting issues associated with assessing exposures to chemical mixtures in the environment.

Priorities for mixtures health effects research.

In order to better inform scientific decision making in the occupational environment, we need a better understanding of the toxicology of mixed exposures. In particular, we need an understanding of the dose-response relationship from the level of individual or population exposure down to the molecular level (and then back up again from the molecular level to the specific health-related response of the organism as a whole). Mixtures toxicology is proving to be different from single-chemical toxicology in several fundamental but barely recognized ways: Knowledge gained in mixtures research should be able to improve current risk assessment and mitigation or intervention methods. In NIOSHs National Occupational Research Agenda (NORA) three priority areas have been identified:

Advancing Risk Analysis for Nanoscale Materials: Report from an International Workshop on the Role of Alternative Testing Strategies for Advancement

The Society for Risk Analysis (SRA) has a history of bringing thought leadership to topics of emerging risk. In September 2014, the SRA Emerging Nanoscale Materials Specialty Group convened an international workshop to examine the use of alternative testing strategies (ATS) for manufactured nanomaterials (NM) from a risk analysis perspective. Experts in NM environmental health and safety, human health, ecotoxicology, regulatory compliance, risk analysis, and ATS evaluated and discussed the state of the science for in vitro and other alternatives to traditional toxicology testing for NM. Based on this review, experts recommended immediate and near-term actions that would advance ATS use in NM risk assessment. Three focal areas-human health, ecological health, and exposure considerations-shaped deliberations about information needs, priorities, and the next steps required to increase confidence in and use of ATS in NM risk assessment. The deliberations revealed that ATS are now being used for screening, and that, in the near term, ATS could be developed for use in read-across or categorization decision making within certain regulatory frameworks. Participants recognized that leadership is required from within the scientific community to address basic challenges, including standardizing materials, protocols, techniques and reporting, and designing experiments relevant to real-world conditions, as well as coordination and sharing of large-scale collaborations and data. Experts agreed that it will be critical to include experimental parameters that can support the development of adverse outcome pathways. Numerous other insightful ideas for investment in ATS emerged throughout the discussions and are further highlighted in this article.

Cumulative risk assessment toolbox: methods and approaches for the practitioner.

The historical approach to assessing health risks of environmental chemicals has been to evaluate them one at a time. In fact, we are exposed every day to a wide variety of chemicals and are increasingly aware of potential health implications. Although considerable progress has been made in the science underlying risk assessments for real-world exposures, implementation has lagged because many practitioners are unaware of methods and tools available to support these analyses. To address this issue, the US Environmental Protection Agency developed a toolbox of cumulative risk resources for contaminated sites, as part of a resource document that was published in 2007. This paper highlights information for nearly 80 resources from the toolbox and provides selected updates, with practical notes for cumulative risk applications. Resources are organized according to the main elements of the assessment process: (1) planning, scoping, and problem formulation; (2) environmental fate and transport; (3) exposure analysis extending to human factors; (4) toxicity analysis; and (5) risk and uncertainty characterization, including presentation of results. In addition to providing online access, plans for the toolbox include addressing nonchemical stressors and applications beyond contaminated sites and further strengthening resource accessibility to support evolving analyses for cumulative risk and sustainable communities.

Integrating information for better environmental decisions.

As more is learned about the complex nature and extent of environmental impacts from progressive human disturbance, scientists, policy analysts, decision makers, educators, and communicators are increasingly joining forces to develop strategies for preserving and protecting the environment. The Eco-Informa Foundation is an educational scientific organization dedicated to promoting the collaborative development and sharing of scientific information. The Foundation participated in a recent international conference on environmental informatics through a special symposium on integrating information for better environmental decisions. Presentations focused on four general themes: (1) remote sensing and data interpretation, including through new knowledge management tools; (2) risk assessment and communication, including for radioactively contaminated facilities, introduced biological hazards, and food safety; (3) community involvement in cleanup projects; and (4) environmental education. The general context for related issues, methods and applications, and results and recommendations from those discussions are highlighted here.

Facing the environmental risk issues of the cold war legacy.

During World War II and the Cold War, the United States developed a complex of industrial facilities for the research, production, and testing of nuclear weapons. In addition, the United States government supported the development of nuclear energy for commercial applications and conducted research in high-energy physics and other basic sciences, as well as medical diagnostics and treatment. These activities required the use of a vast array of facilities that included mines, mills, chemical plants, metal machining plants, maintenance shops, research laboratories, nuclear reactors, and test sites.

Environmental Impacts of Hydraulic Fracturing

The environmental concerns associated with hydraulic fracturing for oil and gas production are outlined. Most environmental concerns are not specific to hydraulic fracturing but are common to all oil and gas activity. Hydraulic fracturing has increased oil and gas activity, however, and thus exacerbated these concerns. The most likely environmental issues include spills and leaks of hydrocarbons or formation waters in the near subsurface and during management at the surface. There are also concerns about the availability of water for hydraulic fracturing in water scarce areas and this could be partially offset by increased reuse of produced water. Increased reuse would simultaneously reduce the potential for seismic activity due to disposal of produced waters through deep well injection. Effective management of these environmental concerns is necessary to achieve the full benefits of hydraulic fracturing for oil and gas including greater energy independence and increased supplies of relatively low carbon footprint natural gas.

Data dialogues: critical connections for designing and implementing future nanomaterial research

Individuals and organizations in the engineered nanomaterial (ENM) community have increasingly recognized two related but distinct concerns: (1) Discordant data due to differences in experimental design (e.g., material characteristics, experimental model, and exposure concentration) or reporting (e.g., dose metric and material characterization details), and (2) a lack of data to inform decisions about ENM environmental, health, and safety (EHS). As one way to help address these issues, this Commentary discusses the important role of “data dialogues” or structured discussions between ENM researchers in EHS fields (e.g., toxicology, exposure science, and industrial hygiene) and decision makers who use the data researchers’ collect. The importance of these structured discussions is examined here in the context of barriers, solutions, and incentives: barriers to developing research relevant for human and ecological risk assessments; potential solutions to overcome such barriers; and incentives to help implement these or other solutions. These barriers, solutions, and incentives were identified by a group of expert stakeholders and ENM community members at the December 2013 Society for Risk Analysis panel discussion on research needed to support decision making for multiwalled carbon nanotubes. Key topics discussed by experts and ENM community members include: (1) The value of researchers collaborating with EHS decision makers (e.g., risk analysts, product developers, and regulators) to design research that can inform ENM EHS-related decisions (e.g., occupational exposure limits and product safety determinations), (2) the importance of funding incentives for such collaborative research, (3) the need to improve mechanisms for data sharing within and between sectors (e.g., academia, government, and industry), and (4) the critical need to educate the “next generation” of nanotechnology researchers in EHS topics (e.g., risk assessment, risk management). In presenting these outcomes, this Commentary is not intended to conclude the conversation that took place in December 2013 but rather to support a broader dialogue that helps ensure important risk assessment questions are answered for ENMs.

Regulating Under Uncertainty: Newsboy for Exposure Limits

Setting action levels or limits for health protection is complicated by uncertainty in the dose-response relation across a range of hazards and exposures. To address this issue, we consider the classic newsboy problem. The principles used to manage uncertainty for that case are applied to two stylized exposure examples, one for high dose and high dose rate radiation and the other for ammonia. Both incorporate expert judgment on uncertainty quantification in the dose-response relationship. The mathematical technique of probabilistic inversion also plays a key role. We propose a coupled approach, whereby scientists quantify the dose-response uncertainty using techniques such as structured expert judgment with performance weights and probabilistic inversion, and stakeholders quantify associated loss rates.