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A Framework to Guide Selection of Chemical Alternatives (2014)

Chapter: 3 The Committee's Framework

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Suggested Citation:"3 The Committee's Framework." National Research Council. 2014. A Framework to Guide Selection of Chemical Alternatives. Washington, DC: The National Academies Press. doi: 10.17226/18872.
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3

The Committee’s Framework

To develop its framework, the committee assessed the frameworks and tools [Lowell (Rossi et al. 2006); TURI 2006a; UNEP 2009; REACH (ECHA 2011); UCLA MCDA (Malloy et al. 2011); German Guide (Reihlen et al. 2011); BizNGO (Rossi et al. 2012); CA SCP (CA DTSC 2013a); IC2 2013; DfE (EPA 2014c)] identified in Chapter 2 to determine whether they included the elements identified in the committee’s statement of task. Most of the frameworks included some, but not all, elements in the task statement. Thus, the committee viewed its role as developing a framework that captures common elements of the frameworks, which reflect more than 20 years of experience in this field, while ensuring that its framework included all the elements identified in the task statement. On the basis of its assessment, the committee made several decisions that influenced the development of its final framework. These decisions are summarized below.

  • The statement of task specifically states that the framework should address safer chemical substitution. Therefore, the committee’s alternatives assessment framework represents a structured approach for comparing human health and environmental hazards associated with different chemicals or chemical-dependent processes. Although changes to materials or designs might also provide alternatives to chemicals of concern, the framework does not focus on this option.
  • The framework is intended to be used by a multidisciplinary team that has training and expertise in toxicology (human health and ecotoxicology), chemistry, materials science, exposure assessment, and life cycle assessment. Additional expertise in engineering, social sciences, economics, and cost analysis might also be required. Assessors without such expertise, such as small- and medium-sized firms, may need user-friendly assessment tools or technical support to carry out parts of the assessment.
  • The framework should identify critical elements to be included in all chemical alternatives assessments but also provide flexibility to adopt different steps and tools, when appropriate. The committee emphasizes that the framework outlines the core considerations that should be included in a thorough alternatives assessment. In many cases, an assessor will not have the resources to conduct the most comprehensive assessment options as outlined in this report. However, the framework is meant to be sufficiently flexible so a particular user can at least thoughtfully consider each step of the process and undertake the assessment as information, time, and resources allow. The case study of decabromodiphenyl ether in Chapter 12 demonstrates how the framework might be applied by a user with limited resources.
  • The framework is focused on the technical aspects of evaluating alternatives rather than establishing values that inform decisions and policies. For example, the framework does not select the factors to be used to determine whether an alternative is safer than the chemical of concern because this decision is context-dependent and based on value judgments. Those decisions are left to the discretion of the entity conducting the assessment.
  • Certain activities, although important to evaluating alternatives, were deemed to be beyond the scope of the current project. The committee provides sufficient information for an understanding of the general approach, but if more information is needed, the references supplied should be used. Those topics that may warrant more information include criteria and approaches for identifying and prioritizing chemicals of concern, a full discussion of life cycle analysis (LCA) practice, and detailed guidance on conducting performance, economic, or social impact assessments.

In addition to the frameworks, the committee also considered principles intended to inform the assessment process (Chapter 2) and other relevant references. Although some of the principles are not necessarily scientific ones, they are meant as a guide to a thoughtful, scientific review process for evaluating alternatives to chemicals of concern.

Suggested Citation:"3 The Committee's Framework." National Research Council. 2014. A Framework to Guide Selection of Chemical Alternatives. Washington, DC: The National Academies Press. doi: 10.17226/18872.
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Therefore, the committee adopted some of them and applied them when constructing its framework. Those principles that fall in this category include the following:

  • The goal of chemical alternatives assessments conducted using the committee’s framework is to identify safer alternatives that can be used to replace chemicals of concern in products or processes, thereby protecting and enhancing human health and the environment.10 It is understood that the safer alternatives would also meet other requirements, such as cost and performance. An approach for replacing chemicals of concern with safer chemicals or non-chemical alternatives is what the EPA refers to as “informed substitution” (EPA 2014c). As EPA notes, practicing informed substitution is meant to “minimize the likelihood of unintended consequences, which can result from a precautionary switch away from a chemical of concern without fully understanding the profile of potential alternatives, and to enable a course of action based on the best information—on the environment and human health—that is available or can be estimated” (EPA 2012d). Although no approach can completely eliminate the possibility of unintended consequences of chemical substitutions, the committee’s framework is intended to provide a structured, thoughtful evaluation of the advantages and disadvantages of alternatives, helping to support informed transition to safer chemicals.
  • To be considered safer, an alternative will, for pragmatic reasons, need to be an improvement over, or no worse than, the original chemical of concern in the domain that prompted the alternatives assessment. However, a focus on a key end point does not eliminate the need for an assessment of the full range of human health hazard end points and ecotoxicity, or consideration of the life cycle of alternatives, and the alternative should also have a lower overall negative impact on worker and public health and the environment than the chemical of concern.11 Addressing the original areas of concern can be achieved by the direct improvement or elimination of the hazardous attributes of the chemical of concern. It could also include reducing exposure potential, such as by replacing an aquatic toxicant with another chemical that has some aquatic toxicity, but breaks down quickly or has low solubility. The definition of “lower overall negative impact to human health and the environment” is context-dependent and based on value judgments; therefore, the selection of hazard end points for comparison and their relative importance are left to the discretion of the entity conducting the assessment.
  • Expected exposures should be understood to help assessors determine the relevance of certain hazards, identify areas of potential concern, identify cases in which an alternative could end up in the environment or vulnerable populations, and identify the need for and appropriate type of monitoring that would be required after implementation of an alternative.
  • It is important to integrate knowledge from multiple sources and disciplines to support informed substitution and to document assumptions, data, and methods clearly.
  • Even safer alternatives might present some risk to human health or the environment, so chemical alternatives assessments should identify relevant trade-offs and mitigation options or continuous improvement goals that would minimize the potential for unintended consequences.
  • Chemical alternatives assessments should be an iterative and flexible process so that they can be adapted to different decision contexts, goals, and conditions.
  • Stakeholder engagement should occur throughout the chemical alternatives assessment.
  • The chemical alternatives assessment framework should encourage innovation in chemical and process design to meet a particular chemical function for situations in which no alternatives are available, the currently

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10 This objective is different from that of a safety assessment, where the primary goal is to ensure that the exposure to a particular substance is below a prescribed safety standard.

11 Requiring alternatives to offer improvements that address the original areas of concern as part of the definition of safer might sometimes result in excluding potential alternatives that offer substantial improvements in other impact areas while only offering marginal improvements in the original areas. This approach might limit the adoption of incrementally better alternatives that could act as interim solutions while better solutions are developed. These situations could be handled on a case-by-case basis as long as the acceptance of such an interim solution is consistent with the entity’s values.

Suggested Citation:"3 The Committee's Framework." National Research Council. 2014. A Framework to Guide Selection of Chemical Alternatives. Washington, DC: The National Academies Press. doi: 10.17226/18872.
×
  • available options do not perform as well as the chemical of concern, or alternatives present their own significant hazards.

  • The framework should encourage the direct initiation of chemical alternatives assessments for innovative green chemistry alternatives and sustainable designs, instead of only conducting chemical alternatives assessments when there is a chemical of interest to replace.

This concept is consistent with the NRC report, Science for Environmental Protection: The Road Ahead, which states: “the focus on problem identification sometimes occurs at the expense of efforts to use scientific tools to develop safer technologies and solutions. Defining problems without a comparable effort to find solutions can diminish the value of applied research efforts” (NRC 2012, p.7).

Considering these frameworks, decisions, and principles, the committee developed its own framework, as shown in Figure 3-1. The committee’s framework identifies critical elements as steps, and places them at key points in the assessment process. At the same time, however, the framework allows flexibility in that other elements may be included in a less rigid order. Indeed, in some cases, those elements might not be needed.

Thus, the proposed framework can be reconfigured, rearranging the simultaneous steps into an order chosen by the user. Figure 3-1 is a diagram of the framework. The discussion that follows provides an overview of each of the framework’s steps. For each step, the goal, inputs, outputs, and other frameworks that contain a similar step are described. In subsequent chapters, each step is described in more detail.

STEP 1: IDENTIFY CHEMICAL OF CONCERN

Although four frameworks (DfE, BizNGO, Lowell, and German Guide) address the identification or prioritization of chemicals of concern, this topic was outside of the scope of the committee’s task. Therefore, Step 1 is merely the entry point for a chemical of concern into the alternatives assessment process. A chemical might enter the framework because concerns have been raised about it, resulting in a regulatory requirement, obligation, market, or policy incentive to substitute or evaluate alternatives for it. The framework might also be used to help design or evaluate new chemicals that could be potential alternatives for chemicals of concern.

STEP 2: SCOPING AND PROBLEM FORMULATION

Goal: Establish scope of assessment and plan for assessment. This step should determine appropriate stakeholder engagement; identify goals, principles, and decision rules that will guide the assessment; gather information on the chemical of concern; and determine assessment methods that will be used.

Input: Identity of the chemical12 of concern.

Outputs: Information and parameters needed for the assessment, including goals, principles, and decisions rules for the assessment; stakeholder-engagement plan; information on the chemical of concern; methods and tools for each assessment step; and procedures on how data gaps and uncertainty will be handled.

Frameworks: BizNGO, CA SCP, DfE, German Guide, IC2, Lowell, REACH, TURI, UNEP, and UCLA MCDA

All the frameworks include some preparatory work before beginning the technical portion of an assessment. The 2009 NRC report, Science and Decisions: Advancing Risk Assessment, also recommends scoping and problem formulation. Scoping is a discussion between decision makers and stakeholders in which assessors have a supporting role, and problem formulation is a discussion between decision makers and assessors (and technically-oriented stakeholders) to develop a detailed technical plan for the assessment that reflects the broad conceptual design developed in the scoping stage. The committee incorporates scoping and problem formulation into its framework as Steps 2a and 2b.

Step 2a: Scoping—Determine Appropriate Stakeholder Engagement and Describe Goals, Principles, and Decision Rules

Seven frameworks (IC2, DfE, Lowell, UCLA MCDA, TURI, UNEP, and German) advise consulting stakeholders as part of an assessment. The committee included this activity within Step 2a because stakeholder engagement helps ensure that the assessment will address a broad range of concerns, improve stakeholder understanding and

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12Chemical of concern could be a chemical that is used in a manufacturing process or a chemical in an end product.

Suggested Citation:"3 The Committee's Framework." National Research Council. 2014. A Framework to Guide Selection of Chemical Alternatives. Washington, DC: The National Academies Press. doi: 10.17226/18872.
×
Suggested Citation:"3 The Committee's Framework." National Research Council. 2014. A Framework to Guide Selection of Chemical Alternatives. Washington, DC: The National Academies Press. doi: 10.17226/18872.
×

support of the outcomes, and provide additional review for technical information, analytical methods, and other data. These benefits will improve the overall quality and accuracy of the assessment.

Formal external stakeholder engagement might not be necessary when the assessment is conducted within a single business. In that case, it can still be useful to consult employees with different roles within the company, such as product design and procurement, to capture different perspectives and priorities with respect to the assessment. It might be advisable to engage a broader range of stakeholders when a state or federal agency intends to use a chemical alternatives assessment to inform regulations or policy. A more complete discussion of stakeholder engagement can be found in Chapter 4.

Five frameworks (IC2, DfE, BizNGO, Lowell, and German Guide) provide principles that are intended to influence the assessment process. Although some regulatory frameworks (CA SCP, REACH, and UNEP) do not explicitly articulate principles, their approaches and requirements reflect implicit values of the regulators. Framework developers have attempted to embed organizational or corporate values into the frameworks because different entities can have different opinions of what would be considered a good outcome, and in many instances, developers would like to influence the outcome so that it aligns with their own values. Therefore, the committee has included within the assessment process the activity of describing or establishing goals, principles, and decision rules expected to affect basic assumptions or constraints. The reason this activity has been included is that many aspects of substitution decisions are not purely technical, but rather are value-driven or context-dependent. It is important to explicitly articulate and document those assumptions and constraints because they can strongly influence the conclusions and recommendations of an assessment, especially with respect to trade-off resolution. Also, thorough documentation allows for more effective critical evaluation of chemical alternatives assessment results and comparability across assessments.

Assessors themselves typically will not establish the goals, principles, and decision rules. The agency, organization, or corporation usually determines them, but assessors will need to document them. A more complete discussion of goals, principles, and decision rules and their impacts on alternatives assessments can be found in Chapters 4 and 9.

Step 2b: Problem Formulation—Gather Information on the Chemical of Concern and Determine Assessment Methods

All the frameworks include the collection of preliminary information about the original chemical to facilitate the assessment. This activity also has been included in the committee’s framework. Information to be collected includes the following:

  • The identity of the chemical of concern (and any relevant structurally-related chemicals) must be clearly established because the scope of the assessment and the range of potential alternatives can be affected by this determination. For example, if the flame-retardant pentabromodiphenyl ether was the chemical of concern, decabromodiphenyl ether could be considered as a potential alternative, but it would not be considered a viable alternative if all polybrominated diphenyl ethers were defined as the chemicals of concern.
  • The function that a chemical serves or the properties that it gives to a product or process must be defined because viable alternatives must produce acceptable functional results (Lavoie et al. 2010). Clearly defining the chemical’s functional and performance requirements can lead to the identification of options for achieving the desired result through non-chemical means, such as material substitutions or design changes. And finally, if the chemical of concern does not perform a necessary function, simple elimination of the chemical might be considered as an alternative, and a formal chemical alternatives assessment would not be necessary. Use scenarios need to be defined to evaluate comparative exposure.
  • To determine human health and ecological effects, use scenarios, exposure pathways, and life cycle segments that warrant particular attention in light of socioeconomic, environmental, or other impacts. As described in Chapter 4, any issues about the chemical of concern should be documented before starting an assessment. Defining those elements provide a baseline for comparisons of potential alternatives. Clearly articulating the negative effects of the original substance also helps in establishing human health and ecological goals for the alternatives. A more complete discussion of the information that should be gathered in this step, and the benefits of doing so can be found in Chapter 4.
Suggested Citation:"3 The Committee's Framework." National Research Council. 2014. A Framework to Guide Selection of Chemical Alternatives. Washington, DC: The National Academies Press. doi: 10.17226/18872.
×

Formal assessment planning is included in four frameworks (IC2, CA SCP, Lowell, and UCLA MCDA) and has been included in the committee’s framework. Specific tools and steps will need to be selected for the assessment, and decisions will need to be made about how to handle data gaps and uncertainty. A more complete discussion of the planning activities associated with this step can be found in Chapter 4.

STEP 3: IDENTIFY POTENTIAL ALTERNATIVES

Goal: Identify chemical, material, and design alternatives on the basis of the requirements established in Step 2. If needed, conduct initial screening to identify alternatives that are clearly not viable substitutes to narrow the number of alternatives to evaluate.

Inputs: Scope established in Step 2 and results of research and consultation with stakeholders.

Output: List of potential alternatives to be evaluated.

Frameworks: BizNGO, CA SCP, DfE, German Guide, IC2, Lowell, REACH, TURI, UNEP, and UCLA MCDA

All the frameworks include a process for identifying potential chemical, material, and design alternatives on the basis of the established requirements in Step 2. Alternatives identification is critical in any framework to establish the alternatives to be assessed relative to the chemical of concern. Therefore, this step has been included in the committee’s framework.

BizNGO, CA SCP, DfE, IC2, Lowell, and TURI also include some level of initial screening (i.e., prescreening) of certain factors, such as predicted performance or presence on restricted chemical lists. Reducing the list of potential alternatives for assessment might be needed when resources for conducting assessments are limited, when the list of potential alternatives is too large, or when certain selection criteria can be used to exclude obviously nonviable alternatives. Initial screening also might involve some data gathering on alternatives, but would not normally be considered a complete assessment of any domain. When initial screening is used in an assessment, care must be taken to ensure that overly conservative predictions of alternatives’ performance do not lead to the elimination of potentially viable alternatives that could be further developed to meet technical and economic goals. Likewise, promising alternatives should not be disqualified because of data gaps that could be filled later. Alternatives eliminated from consideration at this step should be documented both for transparency purposes and in case it is determined that they should be re-examined at later stages of the assessment. Chapter 4 includes a more complete discussion on identifying and screening potential alternatives.

STEP 4: DETERMINE IF ALTERNATIVES ARE AVAILABLE; REFER CASES WITH LIMITED OR NO ALTERNATIVES TO RESEARCH AND DEVELOPMENT

Goal: Initiate research to develop new alternatives or improve existing ones when no (or limited) alternatives are available.

Inputs: List of potential alternatives from Step 3 and results of initial screening, if available.

Output: Information on how each alternative failed to meet the requirements established in Step 2, which should help research and development efforts.

Frameworks: BizNGO, CA SCP, REACH, and UNEP

This step is an early decision point to determine if alternatives to evaluate further are available. Four frameworks allow or encourage the development of new or improved alternatives when alternatives are not available or those available could be improved. Similarly, this early step has been included in the committee’s framework to address those situations so that the process for developing safer substitutes (Step 13) can be initiated earlier. Chapter 13 has a more complete discussion on innovation and the design of safer chemical substitutes.

STEP 5: ASSESS PHYSICOCHEMICAL PROPERTIES

Goal: Gather information on physicochemical properties to facilitate steps that evaluate hazard and exposure.

Inputs: List of potential alternatives from Step 4.

Outputs: Physicochemical properties for each alternative (and for the chemical of concern, if not already determined in Step 3).

Frameworks: BizNGO, CA SCP, DfE, German Guide, IC2, Lowell, REACH, TURI, UNEP, and UCLA MCDA

Suggested Citation:"3 The Committee's Framework." National Research Council. 2014. A Framework to Guide Selection of Chemical Alternatives. Washington, DC: The National Academies Press. doi: 10.17226/18872.
×

All the frameworks include a step to gather information about the physicochemical properties of alternatives. These properties contribute to the inherent hazards of a chemical, including its ability to interfere with normal biological processes. Physicochemical properties also define a chemical’s physical hazards and influence its environmental fate, such as degradation and persistence. The committee’s framework includes a step to determine the physicochemical properties of alternatives and those of the chemical of concern, if not already established in Step 3. Determining physicochemical properties is done early in the assessment because these data can be obtained quickly and inexpensively in the initial stages, and they can potentially be used to screen out chemicals likely to exhibit particular physical and toxicological hazards. Those characteristics are likely to be similar among structurally related chemicals, so such information can help focus later hazard and exposure evaluations on end points and pathways of greatest concern. Chapter 5 has a complete discussion about determining the physicochemical properties of alternatives.

STEP 6: ASSESS HUMAN HEALTH, ECOTOXICITY, AND COMPARATIVE EXPOSURE

This step includes the following three parts:

  • Step 6.1: An assessment of hazards to human health
  • Step 6.2: An assessment of ecotoxicity hazards
  • Step 6.3: An assessment of comparative exposure

Steps 6.1, 6.2, and 6.3 could be completed concurrently because the findings are interrelated, and assessments or conclusions from one step may affect the conclusions from other steps.

Goal: Evaluate human health and ecological hazards and assess comparative exposures.

Inputs: List of potential alternatives and preliminary data on each alternative from Step 3 and physicochemical properties from Step 5. The magnitude of Step 6.3 may also be influenced by results of Life Cycle Thinking performed in Step 8.

Output: Human health and ecological hazards, exposures, and data gaps for each alternative.

Frameworks: BizNGO, CA SCP, DfE, German Guide, IC2, Lowell, REACH, TURI, UNEP, and UCLA MCDA

Every framework includes a step that evaluates human health and ecological hazards associated with the chemical of concern and identified alternatives. Four frameworks (BizNGO, CA SCP, IC2, REACH) include exposure assessment as a part of their chemical alternatives assessment. In line with the committee’s belief that understanding exposure is important to understanding the relevance of hazards, a comparative exposure assessment step has been included (Step 6.3). This step includes further evaluation of the exposure potential and impacts of hazards through qualitative or quantitative exposure assessment methods.

The committee’s task statement also requires evaluation of “potentially safer substitute chemicals as determined by human health and ecological risks.” Therefore, the committee’s framework includes steps to examine the human health and ecological hazards and exposures.

Step 6.1: Assess Human Health Hazards

This step identifies the types of adverse effects on human health that are potentially caused by exposure to the chemical of concern and its alternatives and characterizes the quality and relevance of the supporting evidence. Chapter 8 includes a complete discussion of assessing the human health hazards of alternatives.

Step 6.2: Assess Ecotoxicity

This step assesses ecological hazards associated with alternatives and compares them across alternatives. Depending on where the chemical might partition in the environment, this step can include the determination of toxicity to aquatic, sediment, or terrestrial organisms. If not completed in Step 5, this step might also include an evaluation of the persistence of chemicals in the environment and their potential to bioaccumulate in the food chain. Chapter 7 has a more complete discussion about assessing the ecological hazards of alternatives.

Step 6.3: Conduct Comparative Exposure Assessment

This step assesses whether the expected exposures from the chemical of concern and the alternatives would be substantially equivalent. If the expected exposures are not substantially equivalent, then a more detailed exposure assessment might be needed. Understanding the expected exposure is

Suggested Citation:"3 The Committee's Framework." National Research Council. 2014. A Framework to Guide Selection of Chemical Alternatives. Washington, DC: The National Academies Press. doi: 10.17226/18872.
×

useful when interpreting the relevance of hazards identified in Steps 6.2 and 6.1. Chapter 6 has a more complete discussion of exposure assessment within the context of chemical alternatives assessment.

STEP 7: INTEGRATION OF INFORMATION TO IDENTIFY SAFER ALTERNATIVES

Goals: Identify safer alternatives on the basis of information compiled in previous steps. If no alternatives are considered safer than the chemical of concern, initiate research to develop new alternatives or improve existing alternatives.

Inputs: Results of evaluations of each alternative from Steps 5, 6.1, 6.2, and 6.3.

Outputs: List of safer alternatives and supporting documentation for each, including actions needed to offset trade-offs or detect unintended consequences. List of unacceptable alternatives, including information on how each alternative failed to meet the requirements established in Step 2 or the tradeoffs that made the alternatives unacceptable. This information can inform additional research and development efforts.

Frameworks: BizNGO, CA SCP, DfE, German Guide, IC2, Lowell, REACH, TURI, UNEP, and UCLA MCDA

Every framework explicitly or implicitly integrates the findings from human health and ecological assessments to provide decision makers with the potential impacts of the alternatives. The committee’s framework also includes a step to integrate human health and ecological information from Step 6. Step 7 acts as a decision point, meaning that if there are no safer alternatives for further assessment, additional research can be initiated to develop new alternatives or improve existing ones. The research will be informed by information on how each alternative failed to meet the requirements established in Step 2 or on the tradeoffs that made the alternatives unacceptable. Chapter 9 explains how to integrate information from Steps 6.1, 6.2, and 6.3 to identify safer alternatives, including strategies for making decisions when there is uncertainty in the data and trade-offs to resolve.

STEP 8: LIFE CYCLE THINKING

Goal: Determine whether risks to human health, the environment, or society exist at a place or time beyond the point of use or application, and if those risks are expected to differ between the chemical of concern and proposed alternatives, to determine if additional analysis is needed to inform a substitution decision.

Inputs: List of alternatives from Step 7.

Outputs: Decision about whether further life cycle assessment is needed to inform a substitution decision and areas of concern identified.

Frameworks: BizNGO, CA SCP, German Guide, IC2, REACH, and UCLA MCDA

Step 8 addresses the portion of the statement of task related to whether resource use is considered a potential issue. This step aligns the committee’s framework with several other frameworks with regard to this concern. In addition, this step is intended to determine whether human health, environmental, and social equity impacts might occur at a place or time other than the point of use of the chemical of concern. This consideration will serve to determine whether additional assessments are required to compare alternatives. IC2, BizNGO, and the German Guide evaluate whether life cycle concerns indicate a need for a more formal life cycle assessment. Additionally, three other frameworks (CA SCP, REACH, and MCDA) suggest or consider factors, such as greenhouse gas emissions, that would normally be addressed through a life cycle assessment. The committee’s framework uses Life Cycle Thinking to complete this analysis.

Life Cycle Thinking is also used to determine whether a more detailed evaluation of social impact is needed to inform a substitution decision. It does so by considering whether there are worker issues (such as child labor or forced labor), consumer issues (such as end-of-life responsibility), local issues (such as respect of indigenous rights), and society-wide issues (such as preventing and mitigating armed conflicts and reducing corruption) that are not addressed by other steps and whether the differences between alternatives are expected to be significant.13 Five frameworks and tools (IC2, Lowell, REACH, UNEP, and UCLA MCDA) support an option to consider such social impacts beyond those already addressed in other steps. Despite the fact that these impacts are not being routinely included in many assessments currently being performed, this consideration was included in the committee’s framework in recognition of growing interest in

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13 The UNEP/SETAC Guidelines for Social Life Cycle Assessment of Products (UNEP/SETAC 2009) contain a list of stakeholder groups and impact categories that might be useful to consider.

Suggested Citation:"3 The Committee's Framework." National Research Council. 2014. A Framework to Guide Selection of Chemical Alternatives. Washington, DC: The National Academies Press. doi: 10.17226/18872.
×

environmental justice issues and social life cycle assessments.

Many social impacts, such as worker health and safety, will also be addressed by other steps in the framework. However, it might be necessary to consider whether there are worker impacts, local community impacts, or societal issues that have not been addressed by other steps. Chapter 10 presents a more complete discussion of this step.

STEP 9: OPTIONAL ASSESSMENTS

At a minimum, Steps 1-8 of the framework shown in Figure 3-1 should be considered in each assessment. At this stage, the committee’s framework includes several optional assessments, identified in the bullets listed above. Whether or not a particular assessment is within the scope and capability is determined during the scoping and problem formulation stage and is also influenced by the outcome of preceding steps.

Step 9 includes the following three optional parts:

  • Step 9.1: Additional Life Cycle Assessment
  • Step 9.2: Performance Assessment
  • Step 9.3: Economic Assessment

Step 9.1: Additional Life Cycle Assessments, Including Evaluation of Broader Environmental and Social Impacts

Goal: Use additional life cycle assessment methods to estimate energy consumed and materials emitted and consumed by a product. This can be done by incorporating different alternatives over part or all of a product’s life cycle and estimating the broader environmental impacts associated with these flows. Use life cycle assessment methods to assess potential social and socioeconomic impacts of each alternative over its life cycle.

Inputs: List of alternatives from Step 7 and result of Life Cycle Thinking (Step 8).

Outputs: Assessment of the relative life cycle impacts of alternatives.

Frameworks: BizNGO and IC2

Broader environmental impacts of alternatives can be informed by comparing the life cycles of the alternatives and their implications for how alternatives differ in resource consumption and materials emitted. Two frameworks (BizNGO and IC2) support conducting full life cycle analyses within an alternatives assessment. Also, CA SCP requires the consideration of factors, such as greenhouse gas emissions, that could be addressed through a life cycle analysis. A life cycle assessment step has been included in the committee’s framework to support conducting such analyses when needed (as determined in Step 8) and to meet the objective in the task statement, which states that the framework should be able to balance other relevant considerations, such as resource use, with human health and ecological hazards. This step is also consistent with other frameworks.

It should be noted that the goal of this step is to assess the relative life cycle impacts of alternatives to uncover trade-offs that might need to be considered and resolved in later decision steps (Step 10). Therefore, the scope of additional life cycle assessment might be adjusted on the basis of topics of concern identified in Step 8.

Potential social and socioeconomic impacts of each alternative over its life cycle may also be assessed, but providing detailed guidance on conducting social impact assessments is outside the scope of the committee. If a social impact assessment is needed, two of the reviewed frameworks (IC2 and REACH) provide specific guidance; however, the most current literature at the time of the assessment should be consulted for the latest in methodological guidance and best practices. Once relevant social issues are identified for alternatives, either in this step or in Step 8 (Life Cycle Thinking), a qualitative assessment might be sufficient to inform substitution decisions. Chapter 10 has a more complete discussion of this step.

Step 9.2: Performance Assessment

Goal: Assess the performance of alternatives against the requirements set in Step 2.

Inputs: List of alternatives from Step 7 and performance requirements from Step 2.

Outputs: Assessment of the performance of each alternative.

Frameworks: BizNGO, CA SCP, IC2, REACH, TURI, and UNEP

Given the critical importance of performance to the viability of an alternative, all the frameworks include some level of performance analysis. Six frameworks include it as a key step, and the other frameworks allow for it elsewhere. The task statement specifically instructs the committee to

Suggested Citation:"3 The Committee's Framework." National Research Council. 2014. A Framework to Guide Selection of Chemical Alternatives. Washington, DC: The National Academies Press. doi: 10.17226/18872.
×

consider product function and efficacy, so a performance assessment is also included as a possible step in the committee’s framework. A performance assessment can range from a simple verification that an alternative can meet the requirements determined in Step 2 to a full characterization of each alternative’s performance. If detailed performance requirements have not been established in Step 2, they should be established in this step. Chapter 10 has a more complete discussion of this step. The committee notes that there will be situations in which alternatives’ performance cannot be evaluated, such as when a regulator, consortium, or public-private partnership performs the chemical alternatives assessment.

Step 9.3: Economic Assessment

Goal: Assess economic impacts associated with each alternative if an economic analysis is within the scope/formulation (Step 2), is needed to inform a substitution decision, and if there is sufficient information available to complete an economic assessment.

Inputs: List of alternatives from Step 7.

Outputs: Assessment of the economic impacts of each alternative.

Frameworks: BizNGO, CA SCP, IC2, REACH, TURI, and UNEP

Although the task statement does not require the committee to address economic factors, understanding the potential financial impacts of alternatives is important in most substitution decisions. Frameworks considered by the committee include an economic analysis, and this step has been included in the committee’s framework.

In cases when regulators require an economic assessment, as with CA SCP or REACH, this step must be completed. However, there will be situations in which financial analyses are not necessary (for example, when alternatives are already in the market or simple calculations show an economic benefit) or cannot be completed (for example, when there is insufficient financial information for a thorough economic evaluation, such as when a regulator, consortium, or public-private partnership conducts the alternatives assessment). In those cases, economic analyses can be deferred to later stages of the assessment or delegated to users of the final report. Providing detailed guidance on conducting economic assessments is outside the scope of the committee, but a more complete discussion of this step can be found in Chapter 10.

STEP 10: IDENTIFY ACCEPTABLE ALTERNATIVES AND REFER CASES WITH NO ALTERNATIVES TO RESEARCH AND DEVELOPMENT

Goals: Identify acceptable alternatives on the basis of information compiled in previous steps, and document findings. Address situations where no alternatives are currently viable by initiating research and development to develop new alternatives or improve existing ones.

Inputs: Results of evaluations of each alternative.

Outputs: List of acceptable alternatives and supporting documentation for each, including actions needed to offset trade-offs or detect unintended consequences. If no alternatives are acceptable, document the information describing why each alternative failed to meet the requirements. That information is used to inform additional research to develop alternatives.

Frameworks: BizNGO, CA SCP, DfE, German Guide, IC2, Lowell, REACH, TURI, UNEP, and UCLA MCDA

Each framework that was considered by the committee includes a step for integrating information across different domains to identify acceptable alternatives. In fact, one framework (UCLA MCDA) is a tailored form of decision analysis, which is a logical procedure for balancing factors from different domains to make decisions (Belton and Stewart 2002). A step to integrate information across different domains to enable identification of acceptable alternatives has also been included in the committee’s framework. Inclusion of this step is not only consistent with other frameworks, but also the task statement, which states that the framework should be able to consider the full range of benefits and shortcomings of substitutes, including balancing such factors as product functionality, product efficacy, process safety, and resource use.

Another important aspect of this step is that it is a critical point for documenting the findings of all the analyses performed throughout the assessment. As noted at the beginning of this chapter, thorough documentation of findings allows for a more effective critical evaluation of alternatives assessment results and comparability across assessments. This step also acts as a decision point, meaning if there are no acceptable alternatives, additional research can be

Suggested Citation:"3 The Committee's Framework." National Research Council. 2014. A Framework to Guide Selection of Chemical Alternatives. Washington, DC: The National Academies Press. doi: 10.17226/18872.
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initiated to develop new alternatives or improve existing ones that is informed by information on how each alternative failed to meet the requirements established in Step 2. Chapter 11 has a more complete discussion of this step.

STEP 11: COMPARE OR RANK ALTERNATIVES

Goal: Select a single alternative for implementation or differentiate between acceptable alternatives by applying the preferred comparison method.

Input: List of acceptable alternatives from Step 10.

Output: A selected alternative or a ranked or categorized list of alternatives.

Frameworks: CA SCP, IC2, Lowell, and UCLA MCDA

Several frameworks include ranking or categorizing alternatives to select the best ones for the specific application (CA SCP, IC2, Lowell, and UCLA MCDA). For example, CA SCP requires the comparison of the original priority product to each of the alternatives under consideration. Although some frameworks do not explicitly require a ranking step, several imply that a ranking or categorization step will be completed as the assessment process concludes and implementation begins. A ranking step has been included as an option in the committee’s framework because it might be necessary to differentiate between potential alternatives to a greater extent than is accomplished in Step 10 to make a substitution decision. Chapter 11 includes a more complete discussion of this step.

STEP 12: IMPLEMENT ALTERNATIVES

Goal: Plan and execute the transition to alternatives, including mitigating trade-offs and monitoring for unintended consequences, as needed.

Input: List of acceptable alternatives and their associated mitigation and monitoring requirements.

Output: Implementation plan created and executed.

Frameworks: BizNGO, CA SCP, Lowell, REACH, and UNEP

Several frameworks either include a step to create a substitution plan after successfully identifying safer alternatives (CA SCP, Lowell, REACH, and UNEP) or stress that assessments should result in the implementation of the identified safer alternatives (BizNGO). California’s Safer Consumer Product Regulation not only requires an implementation plan but also requires confirmation that the plan has been executed. An implementation step has been included in the committee’s framework to ensure that safer substitutes are implemented (when supported by the findings of the assessment), that those implementations are successful (even when unanticipated challenges are encountered during the transition), and that any unintended consequences are quickly identified once a substitution has been fully implemented. In cases where alternatives have been assessed through consortia or public-private partnerships rather than through the entity that will ultimately implement the change, this step can be adjusted to include other actions that would support implementation, such as creating industry-wide voluntary phase-out dates for the original chemical of concern, market-based incentives for phase-out (such as labeling or approved ingredient lists), or even potential recommendations for regulatory action. Chapter 11 includes a more complete discussion of this step.

STEP 13: RESEARCH / DE NOVO DESIGN

Goal: Create new designs and safer solutions to support replacing chemicals of concern and improving the overall safety of chemical products.

Inputs: Design objectives or list of potential alternatives from Step 3 and information on how each failed to meet the requirements from Step 2.

Output: New chemicals, materials, or designs for assessment.

Frameworks: BizNGO, CA SCP, Lowell, and TURI

Four frameworks (BizNGO, CA SCP, Lowell, and TURI) encourage the development of new or improved alternatives. In addition, new chemicals, materials, or designs under development might need to be evaluated for their potential health and ecological impacts early in the chemical design process. The committee anticipates that situations will arise where replacements for a chemical of concern do not exist, or existing alternatives are not viable in their current form. To address those situations, a step involving research and de novo design has been included in its framework. There are two paths to Step 13: (a) research might be initiated when no alternatives are available at the end of Step 4, 7, or 10, or (b) a new chemical might be in development. Chapter 13 has a more complete discussion on de novo design.

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Historically, regulations governing chemical use have often focused on widely used chemicals and acute human health effects of exposure to them, as well as their potential to cause cancer and other adverse health effects. As scientific knowledge has expanded there has been an increased awareness of the mechanisms through which chemicals may exert harmful effects on human health, as well as their effects on other species and ecosystems. Identification of high-priority chemicals and other chemicals of concern has prompted a growing number of state and local governments, as well as major companies, to take steps beyond existing hazardous chemical federal legislation. Interest in approaches and policies that ensure that any new substances substituted for chemicals of concern are assessed as carefully and thoroughly as possible has also burgeoned. The overarching goal of these approaches is to avoid regrettable substitutions, which occur when a toxic chemical is replaced by another chemical that later proved unsuitable because of persistence, bioaccumulation, toxicity, or other concerns.

Chemical alternative assessments are tools designed to facilitate consideration of these factors to assist stakeholders in identifying chemicals that may have the greatest likelihood of harm to human and ecological health, and to provide guidance on how the industry may develop and adopt safer alternatives. A Framework to Guide Selection of Chemical Alternatives develops and demonstrates a decision framework for evaluating potentially safer substitute chemicals as primarily determined by human health and ecological risks. This new framework is informed by previous efforts by regulatory agencies, academic institutions, and others to develop alternative assessment frameworks that could be operationalized. In addition to hazard assessments, the framework incorporates steps for life-cycle thinking - which considers possible impacts of a chemical at all stages including production, use, and disposal - as well as steps for performance and economic assessments. The report also highlights how modern information sources such as computational modeling can supplement traditional toxicology data in the assessment process.

This new framework allows the evaluation of the full range of benefits and shortcomings of substitutes, and examination of tradeoffs between these risks and factors such as product functionality, product efficacy, process safety, and resource use. Through case studies, this report demonstrates how different users in contrasting decision contexts with diverse priorities can apply the framework. This report will be an essential resource to the chemical industry, environmentalists, ecologists, and state and local governments.

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