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).

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.

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.

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.

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.

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.

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.

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 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.

Reforming state-level chemicals management policies in the United States: status, challenges, and opportunities.

During the last several years there has been increasing public concern about chemicals in everyday products. Scientific studies are increasingly revealing the build-up of some substances in ecosystems and in our bodies and new findings are linking exposures to hazardous chemicals to a range of adverse human health effects. Despite these trends, there has been little federal initiative in the United States on reforming chemicals management policies for well over two decades, even though a variety of analyses have identified significant gaps in the regulatory structure. As has historically been the case, states are beginning to fill the holes in federal leadership. This article explores this emerging state leadership and establishes a vision for and elements of policies to reduce hazardous chemicals in the products we buy and the places we go. It examines international efforts to reform chemicals management policies, such as the European REACH legislation and corporate leadership in advancing safer products. Finally, it outlines specific challenges states face in developing integrated, comprehensive chemicals management policies. We conclude that while there are plenty of challenges to implementation of chemicals policy reforms, it is a propitious time for states to become leaders in policy innovation that can help achieve safer production systems and products for future generations. This article is part of a Lowell Center for Sustainable Production report entitled "Options for State Chemicals Policy Reform" that provides in-depth analysis of the pros and cons of policy options to address a range of aspects of state-level chemicals policy reform. The article has been edited slightly for use in New Solutions. The report has been widely distributed to policy-makers, advocates, and others across the United States.

Human exposure to PBDEs: associations of PBDE body burdens with food consumption and house dust concentrations.

This study was designed to determine the body burden of polybrominated diphenyl ethers (PBDEs) among first-time mothers in the Greater Boston, Massachusetts area and to explore key routes of exposure. We collected breast milk samples from 46 first-time mothers, 2-8 weeks after birth. We also sampled house dust from the homes of a subset of participants by vacuuming commonly used areas. Data on personal characteristics, diet, home furniture, and electrical devices were gathered from each participant using a questionnaire. Breast milk and dust samples were analyzed for PBDEs using gas chromatography/ mass spectrometry. PBDE concentrations were log-normally distributed in breast milk and dust. We found statistically significant, positive associations between PBDE concentrations in breast milk and house dust (r = 0.76, p = 0.003, not including BDE-209), as well as with reported dietary habits, particularly the consumption of dairy products (r = 0.41, p = 0.005) and meat (r = 0.37, p = 0.01). Due to low detection rates, it was not possible to draw conclusions about the association between BDE-209 in milk and dust. Our results support the hypothesis that the indoor environment and diet both play prominent roles in adult human exposure to PBDEs.

Categorizing mistaken false positives in regulation of human and environmental health.

One of the concerns often voiced by critics of the precautionary principle is that a widespread regulatory application of the principle will lead to a large number of false positives (i.e., over-regulation of minor risks and regulation of nonexisting risks). The present article proposes a general definition of a regulatory false positive, and seeks to identify case studies that can be considered authentic regulatory false positives. Through a comprehensive review of the science policy literature for proclaimed false positives and interviews with authorities on regulation and the precautionary principle we identified 88 cases. Following a detailed analysis of these cases, we found that few of the cases mentioned in the literature can be considered to be authentic false positives. As a result, we have developed a number of different categories for these cases of "mistaken false positives," including: real risks, "The jury is still out," nonregulated proclaimed risks, "Too narrow a definition of risk," and risk-risk tradeoffs. These categories are defined and examples are presented in order to illustrate their key characteristics. On the basis of our analysis, we were able to identify only four cases that could be defined as regulatory false positives in the light of today's knowledge and recognized uncertainty: the Southern Corn Leaf Blight, the Swine Flu, Saccharin, and Food Irradiation in relation to consumer health. We conclude that concerns about false positives do not represent a reasonable argument against future application of the precautionary principle.