BackgroundGiven 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.ObjectivesThe 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.MethodsThis 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.ResultsTwenty 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.DiscussionGreater consistency in methods and evaluation metrics is needed but with sufficient flexibility to allow the process to be adapted to different decision contexts.ConclusionAlthough 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.CitationJacobs 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

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.

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.

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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.