Advancing safer alternatives through functional substitution.

To achieve the ultimate goal of sustainable chemicals management policy­the transition to safer chemicals, materials, products, and processes­current 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.

The Architecture of Chemical Alternatives Assessment.

Chemical alternatives assessment is a method rapidly developing for use by businesses, governments, and nongovernment organizations seeking to substitute chemicals of concern in production processes and products. Chemical alternatives assessment is defined as a process for identifying, comparing, and selecting safer alternatives to chemicals of concern (including those in materials, processes, or technologies) on the basis of their hazards, performance, and economic viability. The process is intended to provide guidance for assuring that chemicals of concern are replaced with safer alternatives that are not likely to be later regretted. Conceptually, the assessment methods are developed from a set of three foundational pillars and five common principles. Based on a number of emerging alternatives assessment initiatives, in this commentary, we outline a chemical alternatives assessment blueprint structured around three broad steps: Scope, Assessment, and Selection and Implementation. Specific tasks and tools are identified for each of these three steps. While it is recognized that on-going practice will further refine and develop the method and tools, it is important that the structure of the assessment process remain flexible, adaptive, and focused on the substitution of chemicals of concern with safer alternatives.

Alternatives assessment: An analysis on progress and future needs for research and practice.

Alternatives assessment is a science-policy approach to support the informed substitution of chemicals of concern in consumer products and industries, with the intent of avoiding regrettable substitution and facilitating the transition to safer, more sustainable chemicals and products. The field of alternatives assessment has grown steadily in recent decades, particularly after the publication of specific frameworks and the inclusion of substitution and alternatives assessment requirements in a number of policy contexts. Previously, 14 research and practice needs for the field were outlined across five critical areas: comparative hazard assessment, comparative exposure characterization, lifecycle considerations, decision-making and decision analysis, and professional practice. The aim of the current article is twofold: to highlight methodological advances in the growing field of alternatives assessment based on identified research and practice needs and to propose areas for future developments. We assess advances in the field based on the analysis of a broad literature review that captured 154 sources published from 2013 to 2022. The results indicate that research conducted advanced many of the needs identified, but several remain underaddressed. Although the field has clearly grown and taken root over the past decade, there are still research and practice gaps, most notably on the hazard assessment of mixtures or different forms of chemicals, the integration of lifecycle considerations, and the development of practical approaches to address trade-offs in decision-making. We propose modifications to four of the prior research and practice needs in addition to new needs, including the development of standardized hazard assessment approaches for chemical mixtures as well as better integration of equity and/or justice considerations into assessments. Integr Environ Assess Manag 2024;20:1337-1354. © 2023 The Authors. Integrated Environmental Assessment and Management published by Wiley Periodicals LLC on behalf of Society of Environmental Toxicology & Chemistry (SETAC).

The use of alternatives assessment in chemicals management policies: Needs for greater impact.

Alternatives assessment is a methodology used to identify, evaluate, and compare potential chemical and nonchemical solutions with a substance of concern. It is required in several chemicals management regulatory frameworks, with the objective of supporting the transition to safer chemistry and avoiding regrettable substitutions. Using expert input from symposium presentations and a discussion group hosted by the Association for the Advancement of Alternatives Assessment, four case examples of the use of alternatives assessment in regulatory frameworks were evaluated and compared: (1) the US Environmental Protection Agency Significant New Alternatives Policy (USEPA SNAP), (2) authorization provisions in the EU REACH (Registration, Evaluation, Authorisation, and Restriction of Chemicals) regulation, (3) the California (CA) Safer Consumer Products (SCP) Program, and (4) the Safer Products for Washington (WA) Program. Factors such as the purpose of the alternatives assessment, the timeline of actions, who completes the assessment, the role of stakeholder engagement, and the regulatory response options for each policy are outlined. Through these presentations and expert discussions, four lessons learned about the use of alternatives assessments in regulatory policy emerged: (1) the goal and purpose of the regulatory framework significantly affects its ability to result in safer substitution, (2) existing frameworks struggle with data access and insufficient stakeholder engagement, (3) some frameworks lack clear decision rules regarding what is a safer and feasible alternative, and (4) regulatory response options provide limited authority for enforcement and do not adequately address options where alternatives are unavailable or limited. Five recommendations address these lessons as well as how the application of alternatives assessment in regulatory settings could have greater impact in the future. This synthesis is not meant to be a comprehensive policy analysis, but rather an assessment based on the perspectives from experts in the field, which should be supplemented by formal policy analysis as policies are implemented over time. Integr Environ Assess Manag 2023;00:1-11. © 2023 The Authors. Integrated Environmental Assessment and Management published by Wiley Periodicals LLC on behalf of Society of Environmental Toxicology & Chemistry (SETAC).

Advancing alternatives assessment for safer chemical substitution: A research and practice agenda.

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.

Lessons from the 2018 International Symposium on Alternatives Assessment: Advances and Reflections on Practice and Ongoing Needs to Build the Field.

Alternatives assessment is gaining traction as a systematic method to support the informed substitution of chemicals of concern. The 2nd International Symposium on Alternatives Assessment, on 1-2 November 2018, convened nearly 150 professionals from government agencies, industry, consultant firms, academia, and advocacy organizations to advance a greater understanding of the evolving methods, practices, and challenges in the use of alternatives assessment. This article reviews highlights and lessons from the symposium, including 1) notable advances in methods, 2) shared insights from practitioners on best practices as well as inherent tensions and challenges, and 3) research and practice needs in the field that can be addressed by organizations such as the newly launched Association for the Advancement of Alternatives Assessment. Being interdisciplinary in nature, the establishment of educational frameworks across disciplines and inclusion of diverse expertise in hazard and exposure assessments, life cycle impacts considerations, design principles, and economic and engineering evaluations will ensure continued growth of the field. Integr Environ Assess Manag 2019;00:1-8. © 2019 SETAC.

The applicability of chemical alternatives assessment for engineered nanomaterials.

The use of alternatives assessment to substitute hazardous chemicals with inherently safer options is gaining momentum worldwide as a legislative and corporate strategy to minimize consumer, occupational, and environmental risks. Engineered nanomaterials represent an interesting case for alternatives assessment approaches, because they can be considered both emerging "chemicals" of concern, as well as potentially safer alternatives to hazardous chemicals. However, comparing the hazards of nanomaterials to traditional chemicals or to other nanomaterials is challenging, and critical elements in chemical hazard and exposure assessment may have to be fundamentally altered to sufficiently address nanomaterials. The aim of this paper is to assess the overall applicability of alternatives assessment methods for nanomaterials and to outline recommendations to enhance their use in this context. The present paper focuses on the adaptability of existing hazard and exposure assessment approaches to engineered nanomaterials as well as strategies to design inherently safer nanomaterials. We argue that alternatives assessment for nanomaterials is complicated by the sheer number of nanomaterials possible. As a result, the inclusion of new data tools that can efficiently and effectively evaluate nanomaterials as substitutes is needed to strengthen the alternatives assessment process. However, we conclude that with additional tools to enhance traditional hazard and exposure assessment modules of alternatives assessment, such as the use of mechanistic toxicity screens and control banding tools, alternatives assessment can be adapted to evaluate engineered nanomaterials as potential substitutes for chemicals of concern and to ensure safer nanomaterials are incorporated in the design of new products. Integr Environ Assess Manag 2017;13:177-187. © 2016 SETAC.

Advancing alternatives analysis: The role of predictive toxicology in selecting safer chemical products and processes.

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.

What does the precautionary principle mean for evidence-based dentistry?

The precautionary principle calls for preventive actions in the face of uncertain information about risks. It serves as a compass to better guide more health-protective decisions in the face of complex risks. Applying precaution requires thinking more broadly about risks, taking an interdisciplinary approach to science and policy, and considering a wide range of alternatives to potentially harmful activities. While often criticized as antiscientific, the precautionary principle represents a challenge to scientists and public health professionals to develop newer and more effective tools for characterizing and preventing complex risks, in addition to being more explicit about uncertainties. This article examines the role and application of precaution in the context of dental practice, where activities that may convey risks also have public health benefits, and risk trade offs are a possibility. We conclude that the precautionary principle is not at odds with, but rather complements evidence-based practice in situations of scientific uncertainty and complex risks.

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.

Community-initiated breast cancer and environment studies and the precautionary principle.

The precautionary principle implies the need for research paradigms that contribute to "strength of the evidence" assessments of the plausibility of health effects when scientific uncertainty is likely to persist and prevention is the underlying goal. Previous discussions of science that inform precautionary decision making are augmented by examining three activist-initiated breast cancer and environment studies--the Long Island, New York, and Cape Cod, Massachusetts, studies and the National Institute of Environmental Health Sciences breast cancer and environment centers. These studies show how the choice of research questions affects the potential of results to inform action. They illustrate a spectrum of public involvement, population- and individual-level epidemiologic study designs, and the crucial importance of developing and applying new exposure assessment methods. The exposure studies are key because they are critical in assessing plausibility (without exposure to a causal agent, there is no health effect), are prerequisite to health studies, and identify preventable exposures that could be reduced by precautionary policies, even in the absence of strong evidence of harm. The breast cancer studies have contributed to environmental and biological sampling programs for endocrine-disrupting compounds in drinking water and household air and dust and the application of geographic information systems for surveillance and historical exposure assessment. They leave unanswered questions about when to invest in large epidemiologic studies, when negative results are sufficient, and how to pursue ambiguous positive results in further research and policy.

The U.S. experience in promoting sustainable chemistry.

BACKGROUND, AIM AND SCOPE: Recent developments in European chemicals policy, including the Registration, Evaluation and Authorization of Chemicals (REACH) proposal, provide a unique opportunity to examine the U.S. experience in promoting sustainable chemistry as well as the strengths and weaknesses of existing policies. Indeed, the problems of industrial chemicals and limitations in current regulatory approaches to address chemical risks are strikingly similar on both sides of the Atlantic. We provide an overview of the U.S. regulatory system for chemicals management and its relationship to efforts promoting sustainable chemistry. We examine federal and state initiatives and examine lessons learned from this system that can be applied to developing more integrated, sustainable approaches to chemicals management. MAIN FEATURES: There is truly no one U.S. chemicals policy, but rather a series of different un-integrated policies at the federal, regional, state and local levels. While centerpiece U.S. Chemicals Policy, the Toxic Substances Control Act of 1976, has resulted in the development of a comprehensive, efficient rapid screening process for new chemicals, agency action to manage existing chemicals has been very limited. The agency, however, has engaged in a number of successful, though highly underfunded, voluntary data collection, pollution prevention, and sustainable design programs that have been important motivators for sustainable chemistry. Policy innovation in the establishment of numerous state level initiatives on persistent and bioaccumulative toxics, chemical restrictions and toxics use reduction have resulted in pressure on the federal government to augment its efforts. RESULTS AND CONCLUSIONS: It is clear that data collection on chemical risks and phase-outs of the most egregious chemicals alone will not achieve the goals of sustainable chemistry. These alone will also not internalize the cultural and institutional changes needed to ensure that design and implementation of safer chemicals, processes, and products are the focus of the future. Thus, a more holistic approach of 'carrots and sticks'--that involves not just chemical producers but those who use and purchase chemicals is necessary. Some important lessons of the US experience in chemicals management include: (1) the need for good information on chemicals flows, toxic risks, and safer substances.; (2) the need for comprehensive planning processes for chemical substitution and reduction to avoid risk trade-offs and ensure product quality; (3) the need for technical and research support to firms for innovation in safer chemistry; and (4) the need for rapid screening processes and tools for comparison of alternative chemicals, materials, and products.

Developing scientific and policy methods that support precautionary action in the face of uncertainty--the Institute of Medicine Committee on Agent Orange.

To be precautionary, decisions must be made to prevent the impacts of potentially harmful activities even though the nature and magnitude of harm have not been proven scientifically. The Institute of Medicine's Committee on the Health Effects in Vietnam Veterans of Exposures to Herbicides provides a novel example of science and policy structures that support precautionary action in the face of uncertainty. What makes this example unique is the clear set of precautionary decision rules that lowered the standard for evidence, which formed the basis for policy. These rules, established by Congress, strongly influenced the way scientific information was weighed and the subsequent compensation decisions. They encouraged committee members to think outside the confines of their disciplines and develop new tools and methods to fit their unique mandate. The result was a methodology, supported by strong institutional structures, that allowed scientists to discuss the evidence as a whole, reach decisions as a group, and clarify uncertainties.

Commentary: barriers and opportunities to changing the research agenda to support precaution and primary prevention.

Conceptual research to define the Precautionary Principle and its role in science, science policy, and public health is making substantial progress. In September 2001, participants at the International Summit on Science and the Precautionary Principle developed a vision for science to address the complexity of contemporary health risks in a way that could lead to more precautionary, preventive decisions under uncertainty. Its components include: 1) a more effective linkage between research on hazards and research on primary prevention; 2) increased use of interdisciplinary approaches including better integration of qualitative and quantitative data; 3) innovative methods for analyzing cumulative and interactive effects, populations and systems and vulnerable sub-populations; 4) systems for continuous monitoring to avoid unintended consequences of actions and to identify early warnings of risks; 5) more comprehensive techniques for analyzing and communicating hazards and uncertainties; and 6) a more dynamic interface between science and policy. This article addresses barriers and opportunities to the practical application of this vision for science. Scientists in many fields have recognized the need for innovative approaches and tools to address increasingly complex, uncertain risks of a global scale. While opportunities to apply precautionary concepts in the research agenda exist, public health scientists must be cognizant of current and emerging barriers in the research agenda that balance the research focus on characterizing proximate causal mechanisms of disease, to the detriment of research and policy to support primary prevention.

The sustainability solutions agenda.

Progress toward a more sustainable society is usually described in a "knowledge-first" framework, where science characterizes a problem in terms of its causes and mechanisms as a basis for subsequent action. Here we present a different approach-A Sustainability Solutions Agenda (SSA)-which seeks from the outset to identify the possible pathways to solutions. SSA focuses on uncovering paths to sustainability by improving current technological practice, and applying existing knowledge to identify and evaluate technological alternatives. SSA allows people and organizations to transition toward greater sustainability without sacrificing essential technological functions, and therefore does not threaten the interests that depend on those functions. Whereas knowledge-first approaches view scientific information as sufficient to convince people to take the right actions, even if those actions are perceived as against their immediate interests, SSA allows values to evolve toward greater attention to sustainability as a result of the positive experience of solving a problem.