To achieve the ultimate goal of sustainable chemicals management policy–the transition to safer chemicals, materials, products, and processes–current chemicals management approaches could benefit from a broader perspective. Starting with considerations of function, rather than characterizing and managing risks associated with a particular chemical, may provide a different, solutions-oriented lens to reduce risk associated with the uses of chemicals. It may also offer an efficient means, complementing existing tools, to reorient chemicals management approaches from time-intensive risk assessment and risk management based on single chemicals to comparative evaluation of the best options to fulfill a specific function. This article describes a functional approach to chemicals management we call “functional substitution” that encourages decision-makers to look beyond chemical by chemical substitution to find a range of alternatives to meet product performance. We define functional substitution, outline a rationale for greater use of this concept when considering risks posed by uses of chemicals, and provide examples of how functional approaches have been applied toward the identification of alternatives. We also discuss next steps for implementing functional substitution in chemical assessment and policy development.
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.
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
Alternatives assessment has emerged as a science policy field that supports the evaluation and adoption of safer chemistries in manufacturing processes and consumer products. The recent surge in the development and practice of alternatives assessment has revealed notable methodological challenges. Spurred by this need, we convened an informal community of practice comprising industry experts, academics, and scientists within government and nongovernmental organizations to prioritize a research and practice agenda for the next 5 years that, if implemented, would significantly advance the field of alternatives assessment. With input from over 40 experts, the agenda outlines specific needs to advance methods, tools, and guidance in 5 critical areas: hazard assessment, comparative exposure characterization, life cycle considerations, decision making, and professional practice. Fifteen research and practice needs were identified, ranging from relatively simple efforts to define a minimum hazard data set to the development of more complex performance and decision-analytic methods and data integration tools. Some research needs involve adapting existing approaches to the alternatives assessment context, while others will require the development of entirely new methods and tools. The proposed research and practice agenda is ambitious. Implementing it will require expanding the current network of researchers from academia, government, and industry, as well as increased funding for methodological, application, and evaluation research. Integr Environ Assess Manag 2018;00:000-000. © 2018 SETAC.
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.
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