Examining opportunities to support the transition to safer chemicals in Canada

International landscape on chemical substitution and alternatives assessment

This report was developed by the University of Massachusetts Lowell, Lowell Center for Sustainable Production under contract with Environment and Climate Change Canada

October 2017

Table of Contents

• Executive summary
• Background and purpose – informed substitution and alternatives assessment
• Findings
  • Review of policies and approaches taken by authorities internationally
  • Review of methods and tools for alternatives assessment
• Challenges and data gaps in alternatives assessment and chemical substitution processes – policies and methods
  • Needs and challenges – policy landscape
  • Challenges and data gaps in alternatives assessment and chemical substitution process
• Lessons learned for the development of alternatives assessment methods and program design
  • Alternatives assessment program/policy design – considerations
  • Alternatives assessment methods and guidance – considerations
• Conclusion
• Annex 1: Methodology
• Annex 2: Landscape and review
• Annex 3: Landscape of alternatives assessment tools and methods

Executive summary

Effectively mitigating the impact of toxic chemicals on human health and the environment requires not only taking regulatory action on chemicals of concern, but also supporting the informed transition to safer, alternative chemicals and technologies. Chemical substitution – defined as "the replacement or reduction of hazardous substances in products or processes by less hazardous or non-hazardous substances, or by achieving an equivalent functionality via technological or organizational measures" – focuses on reducing chemical risks at the product or process design stage by eliminating the hazards associated with a chemical of concern, rather than relying on exposure control strategies that may fail or shift risks. Substitution is different than chemical restrictions, bans, or a de-selection approach, where chemicals may be eliminated without consideration of what may replace them.

Alternatives assessment has emerged as an important science policy field to help guide the informed transition to the use of chemicals that are inherently safer for the environment and human health. Alternatives assessment is defined as a "process for identifying and comparing potential chemical and non-chemical alternatives that could replace chemicals of concern on the basis of their hazards, performance, and economic viability. Alternatives assessment does not replace the evaluation of risk in regulatory decision-making, as it asks a fundamentally different question. Alternatives assessment helps to answer: what alternative is safer and feasible with regard to cost and performance? Risk assessment considers hazard, dose-response, and exposure and helps to answer: Is it safe enough?

The Canadian government is currently reviewing the Canadian Environmental Protection Act, 1999 (CEPA 1999) and will reach the end of its Chemicals Management Plan (CMP) in 2020/21. As the government begins to consider revisions to CEPA 1999 and its post-2020 chemicals management strategy, it is considering placing an increased focus on informed substitution and is looking to align its efforts with those occurring internationally. Given this context, Environment and Climate Change Canada (ECCC) commissioned the Lowell Center for Sustainable Production (LCSP) at the University of Massachusetts Lowell to conduct a review of international substitution policies and alternatives assessment methods, tools, and frameworks in order to better understand lessons learned to help inform Canadian discussions and policy and program development (see Annex 1 for the detailed research methodology).

Over 30 international regulatory and non-regulatory policies and programs that include informative substitution provisions were identified and analyzed (see Annex 2). Government efforts to drive chemical substitution are not new and can be found in policies focused on environmental protection, chemicals management, consumer health, worker health, pollution prevention and procurement. The vast majority of these policy examples are from the European Union (EU) or the United States (U.S.) However, international treaties, such as the Stockholm Convention on Persistent Organic Pollutants (POPs) are guiding substitution efforts globally. Key findings from this review include:

• Few substitution policies have detailed alternatives assessment requirements. Although substitution is being promoted in a range of policies, only a handful include specific provisions related to alternatives assessment, including the authorisation and restriction requirements under the EU Registration, Evaluation, and Authorisation of Chemicals (REACH), and the Safer Consumer Products regulation in California.
• A narrow policy approach is inadequate for ensuring a broad transition to safer chemicals. Regulation is necessary, but not sufficient to drive substitution and the use of alternatives assessment. Substitution does not occur regularly in practice due to a lack of incentives, guidance, technical support and tools for implementation.
• Government and industry face different challenges when conducting alternatives assessments. Some policies require governments to conduct alternatives assessments while others give industry this responsibility. Governments and firms have different capacity limitations and associated data challenges. Firms need toxicological expertise within their companies or may need to hire consultants with this knowledge. Government agencies face challenges in assessing technical feasibility and cost, as performance and market data are often not publicly available.
• Most chemical substitution and alternatives assessment requirements in policies to date have focused primarily on individual chemicals or chemical classes and product types rather than on functional uses of chemicals. Although consideration of chemical function or functional use may be used to frame the scoping or technical evaluation in alternatives assessments, the concept has not traditionally been used as a starting point for policies focused on substitution. While the concept of function may not be a key consideration in chemicals assessment and management today, chemists and designers regularly focus on function when identifying cost-effective, high performing options for a particular product or manufacturing process.

Driven by government policies and market demands, over the past decade, researchers and practitioners have developed a variety of methods and tools to assist in evaluating chemical hazards and identifying safer substitutes. Four categories of alternatives assessment tools were reviewed: chemical screening, comparative chemical hazard evaluation, economic and technical assessment, and frameworks for alternatives assessment (see Annex 3). Notable challenges in alternatives assessment processes that emerged in this review include:

• Data gaps. The most serious challenge for conducting comprehensive alternatives assessments is the lack of adequate toxicity data. To help fill these critical data gaps, there is considerable interest in the use of predictive toxicology data and other methods such as structure activity analysis. However, methods are needed to incorporate these approaches into existing hazard assessment tools.
• Chemical mixtures. Currently, alternatives assessment methods and tools focus on chemical-to-chemical assessments and associated replacements. However, many chemical functions and products are not dependent upon a single chemical but upon a formulation. Methods to evaluate chemical to material changes are in their infancy.
• Environmental toxicity. Most alternatives assessment methods use acute and chronic aquatic toxicity as a surrogate for evaluating all types of environmental toxicity. Currently, non-aquatic species are considered although some methods are beginning to incorporate terrestrial endpoints such as avian or bee toxicity where data permit.
• Exposure assessment. The 2014 U.S. National Research Council's (U.S. NRC) report recommended an increased emphasis on comparative exposure assessment in alternatives assessment.^{Footnote 1} Prior to this, most alternatives assessment frameworks focused on the characterization of inherent hazard with minimal consideration of exposure, with the exception of physiochemical properties such as persistence and bioaccumulation. Methods are currently being developed to provide guidance on how to use exposure information during the screening and scoping step of an alternatives assessment and how to integrate this information with evidence related to human and ecological toxicity.
• Life cycle considerations. Many product manufacturers seek to avoid negative consequences of chemical substitutions beyond human health and environmental impacts, including "upstream" or "downstream" impacts associated with resource depletion, energy use or climate change. However, methods for integrating life cycle considerations, what the U.S. NRC termed "lifecycle thinking," into alternatives assessment processes in a systematic and consistent manner have not been developed, yet efforts are underway.
• Decision-making approaches. The ultimate goal of alternatives assessment is the selection and adoption of a safer, feasible alternative, where one is available. Methods development is needed to guide decision processes and identify decision rules to resolve trade-offs among attributes as well as make the values that underlie those trade-offs more transparent.
• Training and education. Training is needed on the basics of alternatives assessment, including approaches to navigate the difficult question of scoping decisions about the array of attributes to consider during the assessment process. In addition, practitioners need to stay abreast of new developments in the multi-disciplinary field of alternatives assessment.
• Economic and technical performance tools. Tools for economic and technical feasibility assessment are not well developed for evaluating alternatives. Many economic costing tools, developed in the context of pollution prevention, could be useful in substitution processes, including methods for full cost accounting. Technical performance evaluation can be very specific to a particular business process and may not be able to be developed as a generalised tool, though development of general processes and questions to ask in the context of an alternatives assessment may be possible.
• Resource needs. Conducting a comprehensive alternatives assessment can be quite resource intensive. Although tools have been developed to streamline the process, the requirements for conducting a comprehensive alternatives assessment can be burdensome to small and medium-sized businesses and to government agencies without significant technical resources.
• Protecting vulnerable populations. Current alternative assessment methods/tools do not explicitly address how to ensure protection of vulnerable populations, which include, but are not limited to, those that are exposed to toxic chemicals in their workplaces; low-income communities; communities of color; fence line neighbourhoods; communities that rely on subsistence for at least a portion of their food sources; and infants, children, and pregnant women.

Taken altogether, this review highlights many lessons learned that are instructive for the future development in the policies, methods and tools that promote informed substitution and the use of alternatives assessment.

Program/policy design – considerations

1. A mix of regulatory and non-regulatory policy tools is needed to stimulate and support the broad transition to safer chemicals. Experience suggests that a single policy approach will not achieve the goals of informed substitution. A multi-pronged approach of policy incentives and disincentives is needed.
2. The use of alternatives assessment should be promoted to guide informed substitution long before agencies initiate restrictive risk management actions. Early regulatory signals on substances of concern are critical as they help to initiate innovation and informed substitution activities ahead of regulatory mandates.
3. Regulations are needed to send a firm signal to the market to substitute. Regulation remains the primary driver for substitution, based on EU and U.S. experience. However, capacity and opportunities for change need to be supported by a broader substitution/alternatives assessment policy and program infrastructure.
4. Regulatory actions that restrict the use of priority toxic chemicals of concern should be linked to provisions for an evaluation of alternatives to avoid regrettable substitution. Whether industry or government undertakes alternatives assessments, there is a clear responsibility to avoid potential unintended consequences of chemical restrictions, which can be accomplished through thoughtful alternatives assessment requirements. Criteria about what is considered "safer" should be explicit in policy.
5. Regulatory risk management actions should be supplemented with government programs that support the transition to safer chemicals. Although many firms may wish to adopt a safer technology, technical or institutional barriers may inhibit adoption. Capacity for informed substitution can be enhanced through government initiatives that include research and evaluation, support, guidance, information on alternatives, demonstration projects, technical assistance, databases, training, and supply chain networking of firms.

Alternatives assessment methods and guidance – considerations

1. There is a need for consistent, yet flexible alternatives assessment methods and guidance. Lack of consistency may make it difficult for alternatives assessments produced in one region to be applicable in or transferrable to other regions. Having clear guidance and criteria that define a thorough alternatives assessment, including the types of data required and how data gaps are to be addressed is critical.
2. There should be consistency in the minimum set of endpoints/elements evaluated in alternatives assessment processes. While there is a need to prioritize flexibility in the practice of alternatives assessment given that each assessment may vary given the particular context, there is a growing consensus about the need to establish a set of "core" attributes/endpoints that are consistently evaluated.
3. Thorough scoping should be undertaken at the beginning of alternatives assessment processes. Scoping can also help with narrowing and focusing an alternatives assessment and is important for identifying life cycle impacts of concern.
4. A range of key stakeholders should be engaged throughout the alternatives assessment process. Engaging stakeholders at the scoping phase of an alternatives assessment and continuing their engagement throughout the process can help in ensuring that the analysis asks the right questions, identifies a broad range of options, and is sufficiently comprehensive. Stakeholders may be internal (different divisions or units) or external to an organisation including representatives from government, business, workers, and potentially impacted communities. In the case of alternatives assessments conducted by enterprises, engagement of stakeholders may also include downstream customers or upstream suppliers.
5. Transparency is a necessary element in alternatives assessment processes. Transparency is an essential element of alternatives assessment given that there are many places in the process that require judgment, such as when scoping, determining decision rules, or making data choices.
6. Alternatives assessment findings should be used to identify and implement the use of safer chemicals. The goal of alternatives assessment is to drive the design and selection of safer chemicals. The data derived from alternatives assessment processes should be used to facilitate informed decision-making.

Increased drivers for informed chemical substitution have led to a rapid evolution in alternatives assessment frameworks and methods, along with substitution policies. Nonetheless, most of these efforts are in their early stages. With vision, coordination, strategic interventions, and resource commitments, Canada has the potential to take a leading role in shaping informed substitution practices both nationally and globally.

Background and purpose – informed substitution and alternatives assessment

Scientific and consumer concern about the impacts of chemicals released from products and manufacturing processes on human and ecosystem health is turning regulatory and market attention towards avoiding such chemicals, where feasible. However, removing a chemical of concern from a process or product without adequate consideration of its replacements could result in regrettable substitutions. Effectively mitigating the impact of toxic chemicals on human health and the environment requires not only taking regulatory action on chemicals of concern, but also supporting the informed transition to safer, alternative chemicals and technologies.

Chemical substitution is commonly defined as "the replacement or reduction of hazardous substances in products or processes by less hazardous or non-hazardous substances, or by achieving an equivalent functionality via technological or organizational measures." ^{Footnote 2} Substitution is part of a strategy aimed at reducing chemical risks at the product or process design stage by eliminating the hazards associated with a chemical of concern, rather than relying on exposure control strategies that may fail or shift risks. Substitution is different than chemical restrictions, bans, or a de-selection approach, where chemicals may be eliminated without consideration of what may replace them.

Whenever a hazardous chemical is restricted, there is the potential for the chemical to be replaced with a substitute chemical or redesigned process or product that poses new and potentially greater risks or results in risk-shifting from one group to another. Examples of such regrettable substitutions include chlorinated solvents and flame retardants.^{Footnote 3} The goal of informed substitution, as defined by the U.S. Environmental Protection Agency (U.S. EPA) is "to minimize the likelihood of unintended consequences, which can result from a precautionary switch away from a hazardous chemical without fully understanding the profile of potential alternatives, and to enable a course of action based on the best information that is available or can be estimated." Informed substitution approaches focus on identifying alternatives and evaluating their health, safety, and environmental hazards, potential trade-offs and technical and economic feasibility.

Alternatives assessment has emerged as an important science policy field to help guide this informed transition. Alternatives assessment is defined as a "process for identifying and comparing potential chemical and non-chemical alternatives that could replace chemicals of concern on the basis of their hazards, performance, and economic viability."^{Footnote 4} Alternatives assessment examines the pros and cons of a range of options that could replace the specific function provided by a priority chemical of concern in an application and includes 6 general steps as outlined in Table 1. Options that are evaluated can include chemical, process or technology changes. Eliminating the use of the substance or chemical can also be an option, where the function provided is not essential or can be achieved by another means. For example, mechanical stripping techniques are an alternative to chemical-based paint stripping formulations.

Although substitution is identified in many policies as an important risk management strategy, it is not usually accompanied by incentives or requirements to conduct an alternatives assessment. Indeed, risk management is often viewed as synonymous with controlling exposure to a chemical of concern to a "safe" level as informed by risk assessment. The U.S. National Research Council (U.S. NRC), in its 2014 Framework to Guide the Selection of Chemical Alternatives, notes the difference between alternatives assessment and risk assessment:

"Alternatives assessment is a process for comparing alternatives, usually to a chemical of concern and identifying those that are safer. It is different from a safety assessment, where the primary goal is to ensure that exposure is below a prescribed standard; different from risk assessment, where risk associated with a given level of exposure is calculated; and different from a sustainability assessment, which considers all aspects of a chemical's life cycle, including energy and material use."^{Footnote 5}

Table 1: Alternatives assessment – a snapshot of its components

Component	What it involves
1. Scoping, problem formulation, identifying alternatives for consideration	Establishes the scope of and plan for assessment. Identifies stakeholders to engage and decision rules that will guide the assessment; gathers data on chemical of concern, its function and application; determines assessment methods and identifies alternatives to be considered
2. Hazard/comparative exposure assessment	Evaluates human health and ecological hazards and assesses comparative exposures
3. Technical feasibility assessment	Assesses the performance of alternatives against the requirements established during the problem formulation step above
4. Economic feasibility assessment	Assesses the economic feasibility of alternatives against the requirements established during the problem formulation step above
5. Other life cycle considerations	Addresses additional factors critical for determining risks to human health and the environment beyond those included in the hazard/exposure assessment component to avoid risk trade-offs (for example, energy, climate change impacts, etc.)
6. Decision-making	Identifies acceptable alternatives on the basis of information compiled in previous steps. Addresses situations where no alternatives are currently viable by initiating R&D to develop new alternatives or improve existing ones and establishes an implementation and adoption plan to identify potential trade-offs during adoption

Alternatives assessment does not replace the evaluation of risk in regulatory decision-making as it asks a fundamentally different question.

• Alternatives assessment helps to answer: what alternative is safer and feasible with regard to cost and performance?
• Risk assessment considers hazard, dose-response, and exposure and helps to answer: Is it safe enough?

In the context of alternatives assessment and chemicals management policy in general, there has been significant debate regarding a "hazard" versus "risk"-based approach. Consistent with the principles of green chemistry and pollution prevention, alternatives assessment and informed substitution focus on comparing options that reduce the intrinsic hazards and exposure properties (for example, persistence, volatility) associated with a chemical of concern – in essence, designing out the hazardous properties. While alternatives assessment focuses primarily on comparing the hazard profiles associated with a chemical of concern and those of its alternatives, intrinsic exposure characteristics are considered part of the assessment and are important to understanding potential trade-offs. The 2014 U.S. NRC report states that considerations of exposure should be included in alternatives assessments, "not to demonstrate 'safe' levels of exposure" but as an additional basis for comparing and selecting safer alternatives that is "focused on the intrinsic potential for exposure without physical or administrative controls." The U.S. NRC recommended the inclusion of information on potential exposure (from simple models, physiochemical properties or exposure measures) when comparing toxicity information on chemical alternatives to ensure that any substantive changes to the routes, levels and patterns of exposure to alternatives are identified and accounted for in the assessment of hazard. Further, risk information can provide important signals as to priority applications and uses for substitution, where a chemical of concern may have multiple applications.

Nonetheless, some jurisdictions, such as the European Union (EU), and many marketplace actors are making decisions to prioritize chemicals for substitution based primarily on intrinsic hazard properties, such as carcinogenicity and endocrine disruption. For example, the 2008 European Commission regulation on Classification, Labeling and Packaging of Substances and Mixtures (CLP), updated the European classification and labeling process, including processes for harmonized classifications, in line with the Globally Harmonized System of Classification and Labeling (GHS). While the concept of substitution is not directly addressed in the harmonized classification and labeling process, hazard classifications are directly linked to chemical restrictions and substitution provisions in EU policy and many Member State regulations. These provisions provide a strong incentive to industry to substitute on their own. Integrating consideration of alternatives into risk management processes can incentivize the transition to safer chemicals, processes, and products by opening up consideration of a range of alternatives that may eliminate exposures in the first place, saving money and improving performance. In the U.S., market drivers as opposed to policy drivers have spurred a growth in the field of alternatives assessment as a corporate risk management tool. For example, leading U.S. retailers including Walmart and Target have launched chemicals management programs that will restrict the sale of certain consumer products, such as household cleaners and cosmetics that contain priority toxic chemicals. These retailers and U.S. companies with complex supply chains including Hewett Packard, Nike and Seagate are similarly taking proactive approaches to manage toxic chemicals in their manufacturing streams through the identification, evaluation and adoption of safer alternatives.

Although restrictions and pollution prevention plans are part of the risk management options available to (HC) and Environment and Climate Change Canada (ECCC) under the Canadian Environmental Protection Act (CEPA 1999), there is currently no formal, systematic government-mandated program or approach in place in Canada for the identification and assessment of safer alternatives. Internationally, there are a number of policies and market demands driving attention to informed substitution and alternatives assessment. As a result, there has been a growth in the development of policies that require alternatives assessment as well as in the development of frameworks and tools for supporting informed chemical substitution.

ECCC commissioned the Lowell Center for Sustainable Production (LCSP) at the University of Massachusetts Lowell to conduct a review of international substitution policies and alternatives assessment methods, tools, and frameworks to better understand lessons learned in order to inform Canadian discussions and policy and program development.

In response to the Statement of Task from ECCC, this report aims to:

1. Provide a comprehensive review of policies and approaches taken by authorities internationally to support substitution among chemical manufacturers and users.
2. Provide a comparative overview of tools and methods applied to alternatives assessment.
3. Characterize global challenges and critical data gaps for chemical substitution.
4. Characterize lessons learned to support the development of a policy approach for alternatives assessment in Canada.

A detailed research methodology is included in Annex 1.

Findings

Review of policies and approaches taken by authorities internationally

Policies reviewed are characterized in detail in Annex 2: landscape and review of international policies that promote substitution and include an evaluation of alternatives, and listed in Table 2. Over 30 international regulatory and non-regulatory policies and programs were identified that include informative substitution provisions, yet only a small subset of these require or promote the use of alternatives assessment.

International treaties. There are several international agreements that include substitution requirements as a primary means to achieve the goal of the treaty (Table 2). However, the majority provides limited details about how alternatives should be evaluated to avoid regrettable substitutes. The most notable exception is the Stockholm Convention on Persistent Organic Pollutants (POPs). The treaty requires the use of substitutes or modified materials, products, and processes to prevent the formation and release of POPs. The Persistent Organic Pollutants Review Committee is in charge of conducting risk management evaluations of substances, which includes an evaluation of alternatives. The committee has published a detailed guidance on steps for the alternatives assessment process, which includes broad considerations of hazards, economic feasibility, exposure considerations including use characteristics, emissions and environmental fate, and other socioeconomic factors.

For many countries in Asia, South America as well as Australia and New Zealand, implementation of international treaties drives national program attention to substitution as a chemicals management option. In the EU and the U.S., substitution provisions are written into national and regional policies.

Regulatory policies requiring alternatives assessment vary in terms of their focus and are reviewed below.

Alternatives assessment specific regulatory provisions. Under the California Safer Consumer Products Regulations, companies must undertake alternatives assessments (called alternatives analysis in the regulation) for Priority Products containing Chemicals of Concern, after which the state's Department of Toxic Substances Control (DTSC) may impose regulatory restrictions. While no alternatives analysis has been conducted under the law, DTSC's draft guidance for the alternatives assessment process indicates that the regulation will require a more comprehensive alternatives assessment than any other policy to date. The EU Registration, Evaluation, and Authorization of Chemicals (REACH) legislation requires companies to seek authorization to continue use of a Substance of Very High Concern (SVHC). SVHCs include substances with hazard profiles that are classified as carcinogenic, mutagenic or reproductive toxicants (CMRs); persistent, bioaccumulative and toxic (PBTs); or have effects of "equivalent concern," which can include endocrine disruption and neurotoxicity. SVHCs that are subject to authorisation require an alternatives assessment (called analysis of alternatives) to ensure that these highly hazardous substances are progressively replaced by safer alternative substances or technologies where economically and technically feasible. To obtain authorization, companies must demonstrate lack of feasibility of alternatives or adequate control in their analysis.

The EU Biocides Directive requires a similar process for biocides and pesticides. Also under REACH, Member State authorities use alternatives assessment in their proposals to restrict SVHCs. These proposals include detailed characterizations of the risk posed by the SVHCs and require examining the availability of safer, feasible alternatives for specific functions/applications to make a determination as to whether specific uses that lack alternatives should be excluded from the proposal. The European Chemicals Agency (ECHA) has developed guidance documents outlining the information that must be incorporated into alternatives assessments used in authorization and restriction processes. Other than requiring the assessment of technical feasibility, economic feasibility and risk, these do not outline key elements that are required to be assessed, with the exception of evaluating CMR or PBT endpoints for alternatives in the hazard evaluation.

Table 2: Snapshot of policies reviewed in Annex 2

International treaties
Aarhus Protocols on heavy metals and POPs Geneva Protocol Montreal Protocol Rotterdam Convention Stockholm Convention
Regulatory
Alternatives Assessment Specific Regulatory Provisions U.S. California Safer Consumer Products EU REACH (Authorisation and Restrictions) EU Biocidal Products Directive Classification-Based Substitution Requirements EU OSHA (Chemical Agents Directive, Carcinogens and Mutagens at Work Directive) EU Classification, Labelling and Packaging of Substances and Mixtures Requirements for Use of Acceptable Substitutes U.S. Clean Air Act § 612 Significant New Alternatives Rule Requirements for Use of Safer Alternatives in Procurement U.S. Federal Executive Order 13514 U.S. New York State Order No. 4 Single or Multiple Chemical Restrictions with Alternatives Assessment Requirements Maine Act to Protect Children's Health and the Environment from Toxic Chemicals in Toys and Children's Products Minnesota Act on Products Containing Poly-Brominated Diphenyl Ether Norwegian Environmental Agency – Norwegian Product Control Act, Section 3A Restriction on Hazardous Substances Directive (RoHS) (China, EU, Japan, Korea) Vermont Act Relating to Phthalates in Products for Young Children Pollution Prevention Chinese Law on Promotion of Clean Production EU Integrated Pollution Prevention Control (IPPC) Directive EU End of Life Directive Massachusetts Toxics Use Reduction Act (MA TURA) New Jersey Pollution Prevention Act
Non-regulatory
China's State Recommended Catalogue of Alternatives Materials for Toxic and Hazardous Substances and Products Director General (DG) Environment's Non-Toxic Environment Initiative – The 7th Environmental Action Programme Massachusetts Toxics Use Reduction Institute Sweden, KEMI's Environmental Quality Objectives, "A Non-Toxic Environment" U.S. Environmental Protection Agency (EPA) Safer Choice Program U.S. OSHA Transitioning to Safer Chemicals Washington State's Reducing Toxics Threat Initiative

Classification-based substitution requirements. Several European Commission (EC) directives (occupational health and consumer) on chemicals derive from European and now (GHS) classifications, particularly for CMRs, and require evaluation of alternatives for continued use of such substances. For example, the EC Chemical Agents Directive (EC CAD) and the EC Carcinogens and Mutagens Directive (EC CMD) – 2 directives focused on workplace chemical exposures – include a hierarchy of chemical risk reduction measures. Substitution with safer alternatives is the measure at the top of this prevention-oriented hierarchy followed by engineering and exposure control methods. These directives are codified in the legislation of EU Member States, which may go beyond the requirements of the EU directive that only contains minimal guidance regarding how substitution should be implemented in practice. For example, Germany has developed guidelines, tools, and additional requirements to support substitution of chemicals of concern in response to these directives. While the concept of substitution is not directly addressed in the harmonized classification and labeling process, hazard classifications are directly linked to chemical restrictions and substitution provisions in EU policy and many Member State regulations and provide a strong incentive to industry for substitution.

Requirements for use of acceptable substitutes. The Clean Air Act Significant New Alternatives Program rule implemented by the U.S. EPA requires that companies substituting an ozone depleting substance ensure that alternatives are safer. Companies must seek approval for substitution of ozone-depleting substances and provide data to demonstrate they will not deplete the ozone layer or present other significant risks. The U.S. EPA identifies and publishes lists of acceptable and unacceptable substitutes for ozone-depleting substances.

Requirements for the use of safer alternatives in procurement. Governments are large-scale purchasers and can significantly influence the marketplace. Some state and federal executive orders and legislation in the U.S. require that government agencies "lead by example" regarding using the least toxic chemicals/products in specific product classes. Most procurement programs focus on particular product categories (for example, janitorial cleaning products) and do not necessarily look at functional uses of chemicals or restrict classes of chemicals, with some exceptions such as PBT purchasing restrictions in some locations.

Single or multiple chemical restrictions with alternatives assessment requirements.  Several European countries initiated activities to restrict chemicals and classes of concern in the late 1990s through Member State policies and the use of action plans. At the EU level, the RoHS directive and the Volatile Organic Compounds (VOC) directive require substitution for particular chemicals, chemical classes and product types. Legislation modeled on RoHS is now found in other countries, including China, Japan and Korea. In the past 10 years, several U.S. states have passed single chemical restrictions on a number of chemicals of concern (for example, phthalates, flame retardants, mercury and bisphenol A). In many cases these single and multiple chemical restrictions do not require any evaluation of substitutes. However, more recent legislation, including Maine's Act to Protect Children's Health and the Environment from Toxic Chemicals in Toys and Children's Products and Minnesota's Toxic Free Kids Act require more comprehensive coverage of multiple chemicals of concern, and require government (state) agencies to evaluate alternatives for such chemicals to demonstrate availability or lack of alternatives and to avoid regrettable substitutions.

Pollution prevention planning. Several U.S. states (and the province of Ontario) have laws requiring materials accounting and toxics use reduction planning for chemicals of concern. These laws generally require manufacturing firms to characterize chemical use in manufacturing processes and evaluate alternatives to reduce or eliminate toxics use and waste. Under its Toxics Use Reduction Act, the State of Massachusetts has developed guidance, tools, training, and technical support to assist firms in transitioning to safer chemicals, including specific guidance on the use of alternatives assessment. China is also using its law on Promoting Clean Production to use research, fiscal and administrative measures to advance substitution strategies.

Non-regulatory policies and programs. Non-regulatory programs can provide important incentives, guidance, direction and support to firms seeking to substitute safer chemicals. They are most effective, and incentivize more than just leader companies, when supplemented with a regulatory or market driver. A number of voluntary government initiatives have focused on conducting alternatives assessments for chemicals of concern, such as the U.S. EPA's Safer Choice Program (formerly the U.S. EPA Design for the Environment program). These alternatives assessments have informed firms that are seeking to voluntarily replace chemicals of concern with safer substitutes in response to regulatory or consumer demands. The Safer Choice program's current efforts focus on stimulating market demand for safer chemicals by recognizing preferred products with its Safer Choice label and promoting the adoption of safer chemistries through its Safer Chemical Ingredients list (SCIL). To achieve the label, ingredients are evaluated by a third-party certifier using stringent human health and environmental criteria. Similar in concept to U.S. EPA's SCIL, China's Ministry of Industry and Information Technology has created the Catalogue of Encouraged Substitutes to Toxic and Hazardous Raw Materials. The catalogue identifies recommended chemicals that can serve as alternatives to hazardous chemicals. Although the list is not legally binding, companies that comply may benefit from lower taxes or other incentives.^{Footnote 6} The Massachusetts Toxics Use Reduction Institute (MA TURI) has also conducted alternatives assessments to guide substitution efforts by industry. And the U.S. Occupational Safety and Health Administration (U.S. OSHA) developed a Toolkit to Guide the Transition to Safer Chemicals and training modules for industry to implement the toolkit. In the EU, there are several government-led voluntary efforts to advance substitution.

Different drivers for substitution activities in industry

The drivers for companies to substitute chemicals of concern vary across nations and are reflected in the types of policies implemented. For example, the EU has been the most active region in terms of regulatory requirements promoting substitution. Through a variety of directives and regulations, in the past 2 decades, the EU has restricted over 1,000 chemicals (many of which are petroleum derivatives). In a recent survey of industry and industry consultants inquiring about drivers of substitution in the EU, regulation was by far identified as the most important driver of substitution – the REACH regulation in particular, but also the various EC directives.^{Footnote 7}

Regulatory action driving substitution in the U.S., in contrast has been much more limited. Federal approaches to substitution have been mostly voluntary, through programmatic activities, such as the Safer Choice Program. State regulations and NGO activism that increase consumer demand for safer chemicals have been more important drivers for substitution. U.S. companies have voluntarily phased out certain chemicals, such as perfluorooctanoic acid (PFOA) and certain flame retardants. Moreover, due to the lack of federal action, a number of U.S. states have established safer chemicals policies – most notably California.

Substitution policies in other regions are poorly documented, if they do exist. Despite the significant presence of chemical manufacturing operations in Asia, no legislation other than RoHS (Chinese, Korean and Japanese versions of RoHS) includes specific substitution requirements or provisions. Although early drafts of South Korea's K-REACH included language requiring authorities to consider substitutes when designating banned or restricted chemicals, no such provisions made it into the final legislation.

Review of methods and tools for alternatives assessment

Driven by government policies and market demands, over the past decade, researchers and practitioners have developed a variety of methods and tools to assist in evaluating chemical hazards and identifying safer substitutes. Below, we review the landscape of these methods and tools. We outline 4 categories of tools: chemical screening, comparative chemical hazard evaluation, economic and technical assessment, and frameworks for alternatives assessment. We analyze the strengths and limitations of each category.

Annex 3 summarizes the 4 categories of methods and tools and includes a brief description of each with additional relevant information (such as hazard endpoints addressed), and a summary of strengths and limitations.

Chemical screening tools (Annex 3 and Table 3) are useful for quickly identifying known chemicals of concern. These tools include chemicals that have been well characterized in the scientific literature. They do not include chemicals that are not well studied and therefore are not listed on authoritative lists of chemicals of concern (i.e., lists established by either regulatory authorities (for example, U.S. EPA, REACH) or scientific bodies (for example, the International Agency for Research on Cancer, the U.S. National Toxicology Program). As summarized in Annex 3, these tools consider a wide range of hazard endpoints. Some tools include an evaluation of potential exposure pathways and others are purely hazard focused. PRIO and the GreenScreen List Translator include a decision-framework to guide decisions (hazard benchmarking) based on the health hazards that are identified, whereas ChemHat and RISCTOX provide the data and leave decision-making to the user. A major limitation of chemical screening tools is that they do not evaluate chemicals that are not on authoritative lists and therefore are limited in providing assistance in identifying safer alternatives and avoiding regrettable substitutions (particularly for less well-characterized chemicals), though can be useful to identify chemicals to avoid as substitutes.

Table 3: Chemical hazard screening tools

Tool	Developer
Green Screen List Translator	U.S.-based NGO Clean Production Action
ChemHat	U.S.-based NGO BlueGreen Alliance in partnership with several unions
PRIO	Swedish Chemicals Inspectorate (KEMI)
RISCTOX	Spanish Trade Union Institute of Health, Work and Environment and the European Trade Union Institute

Many companies initiate their chemicals management programs by developing a Restricted Substances List (RSL), which is a basic screening tool to identify chemicals to avoid that is specific to a company or industry sector. A RSL may include chemicals that are currently restricted by a government body in the markets where a company sells its products, or the RSL may be more wide reaching, including chemicals that are restricted globally (whether or not the company sells in that region). Some companies maintain a separate "watch list" of chemicals under scrutiny by scientists and environmental advocates that are not yet regulated (or may include these chemicals in its RSL). Some industry sectors, including the automotive, apparel, and electronic sectors, have developed sectoral RSLs. In addition to RSLs developed by the private sector, NGOs have created lists of chemicals of concern to raise awareness about toxic chemicals in commercial use. For example, ChemSec, a non-profit organisation based in Sweden, has created the SIN (Substitute IT Now) List. The SIN List includes chemicals that meet REACH criteria for SVHCs and is being used by a number of companies in their RSL programs. ChemSec has developed additional tools to identify structurally similar chemicals to those on the SIN list, providing additional indicators for chemicals to avoid in substitution processes.

In addition to RSLs, some companies have developed their own tools to screen ingredients being considered for their product formulations and identified those that are preferred. For example, SC Johnson has developed the Greenlist™, a tool that scores chemical ingredients used in SC Johnson products on the basis of health and environmental profiles. Levi Strauss & Company has created its Screened Chemistry Program, to help shift the company and the apparel industry to an approach aimed at avoiding chemicals of concern in the supply chain by screening chemical formulations against human and environmental health hazard endpoints before chemicals enter the supply chain.^{Footnote 8}

In recent years, many companies have developed software systems to assist manufacturers in evaluating chemicals in their supply chains. These service providers serve as third parties that can protect confidential business information about formulations. For example, a manufacturer may require that its suppliers provide chemical ingredient information to this third party, which reviews ingredient data for chemical hazards and risks without sharing this information directly with the requester. Users generally adapt the weighting of hazard categories to their specifications and pay a subscription fee that varies based on the services provided. Some examples of these "software-as-service" tools include the Scivera Lens and the UL, Purview Platform.

In addition, some sectors, such as the automotive industry, have developed platforms for suppliers to commonly report on restricted substances and some additional chemicals of concern. The purpose of the automotive industry program is to facilitate communication and exchange of information regarding the use of certain substances of potential concern in automotive products throughout the supply chain. The auto industry's data management system is called the International Material Data System (IMDS). Auto suppliers are required to use the IMDS for reporting on the Global Automotive Declarable Substance List. This list includes substances that are expected to be present in a material or part that remains in a vehicle at point of sale.

All of these tools are valuable in screening out known high hazard chemicals. However, they are not designed to directly compare chemical alternatives. In addition, they do not include chemicals that do not appear on authoritative lists because of limited data, but may still pose risks to human health and the environment.

Comparative chemical evaluation tools (Table 4 and detailed in Annex 3) are designed to explicitly compare alternatives and therefore provide a basis for informed substitution and avoiding the selection of regrettable substitutes. Of the tools/methods that have been developed for alternatives assessment, those that focus on assessing and comparing hazards of chemical alternatives are the most developed. Those tools identified in Table 4 utilize a comparative ranking or categorization scheme to determine differences in the levels of severity among the hazard endpoints (for example, high, moderate, or low). Metrics for each of the ranks are based on specific data sources, ranging from continuous values (such as an LD50), to presence on an authoritative list, or categorization based on specific decision logic such as GHS criteria. Use of GHS criteria and related testing methodologies from the Organization for Economic Cooperation and Development (OECD) that are used help to standardize the assessment process. Professional judgment is needed to evaluate the merits of specific toxicological studies reviewed in the assessment. Thus, assessments are typically performed by toxicologists or trained analysts. GreenScreen^®has developed a program to certify assessors that includes an auditing program to ensure consistency and quality.

Table 4: Comparative chemical hazard evaluation tools

Tool	Developer
GreenScreen®for Safer Chemicals	U.S.-based NGO Clean Production Action
Quick Chemical Assessment Tool (QCAT)	Washington State Department of Ecology
P2OASys	Massachusetts Toxics Use Reduction Institute
U.S. EPA	Alternatives Assessment Criteria for Hazard Evaluation
Column Model	German Institute for Occupational Safety and Health
Chemical Hazard Data Commons	U.S.-based NGO Healthy Building Network

The more comprehensive tools, such as GreenScreen^®, used by a number of government agencies and companies, evaluate a wide range of hazard endpoints for human and environmental health (18 in total). The Washington Department of Ecology's Quick Chemical Assessment Tool (QCAT), developed as a tool for small businesses, is somewhat more limited in that it includes an evaluation of 9 hazard endpoints. As with the chemical screening tools, some of the comparative tools provide guidance for decision-making (for example, GreenScreen^®benchmarks), whereas other tools array the data and leave the decision-making about alternatives to the user. Some of these tools may include an evaluation of exposure potential and may give some consideration to life cycle impacts. The Chemical Hazard Data Commons is a new collaborative tool developed by the Healthy Building Network in its pilot phase. It includes a feature that allows for quick comparison of chemical hazards. It also is a repository of publicly available, third-party assessed GreenScreen^®evaluations and provides link to many databases on chemical hazards.

These methods go beyond chemical screening tools as they require the user to conduct a review of toxicological literature to identify potential human health and environmental hazards, rather than rely only on authoritative lists of chemicals of concern. If these data are lacking, the user may need to use measured data on analogs or estimated data from predictive modeling to characterize potential hazards. These methods/tools require a user that has some expertise in both toxicology and chemistry and can be quite time consuming and resource intensive.

A major limitation of these tools is data gaps on chemicals. The GreenScreen^®method addresses data quality by assigning a high or low level of confidence for each hazard level assigned to an endpoint. If the hazard level is determined based on high confidence sources, it is assigned "high." If the hazard level is determined using equivocal results, measured data for a weak analog, and/or modeled data it is assigned "low" confidence. If studies are truly inadequate for characterizing some aspect of a chemical, GreenScreen^®identifies it as a data gap, defined as follows: "when measured data and authoritative and screening lists have been reviewed, and expert judgment and estimation such as modeling and analog data have been applied, and there is still insufficient information to assign a hazard level to an endpoint."^{Footnote 9}

The third category of tools is those that address economic and technical feasibility of alternatives (Annex 3), as listed in Table 5.

For a chemical alternative to be successfully adopted by a manufacturer, it must be technically feasible, which generally means that it performs as well or better than the existing chemical, and it must be economically profitable. This category of tools is relatively undeveloped by alternatives assessment researchers and practitioners in comparison to hazard assessment tools.

The economic tools that are summarized in Table 5 were primarily developed by pollution prevention programs in the 1990's and have not been updated for use in alternatives assessment. While seemingly out of date, these tools include some concepts that are useful currently such as total cost assessment: "the process of integrating environmental costs into a capital budgeting analysis and has been defined as the long-term, comprehensive financial analysis of the full range of private costs and savings of an investment."^{Footnote 10} The European Chemicals Agency has developed guidance on preparing a socio-economic analysis as part of an application for Authorization under REACH. This type of analysis is complex, requires specialized expertise and therefore is difficult for small and medium-sized businesses to conduct. California DTSC's Alternatives Analysis Guidance has put forth the most comprehensive and complex economic assessment requirements as dictated by the Safer Consumer Products regulation, "The responsible entity shall evaluate, monetize, and compare for the relevant exposure pathways and life cycle segments the following impacts of the Priority Product and the alternatives: (1) Public health and environmental costs; and (2) costs to governmental agencies and non-profit organizations that manage waste, oversee environmental cleanup and restoration efforts, and/or are charged with protecting natural resources, water quality, and wildlife."^{Footnote 11} However, methods and tools to achieve this comprehensive economic assessment are currently lacking.

Table 5: Economic and technical feasibility tools

Tool	Developer
Toxics Use Reduction Act (TURA) Planners Guide, Section IVB8: Economic Assessment	Massachusetts Toxics Use Reduction Institute
Cost Calculator	U.S.-based: National Pollution Prevention Roundtable
Cost Analysis for Pollution Prevention	Washington State Department of Ecology
Financial Assessment of Pollution Prevention Investments	Northeast Waste Management Officials' Association (NEWMOA)
Technical Rules for Hazardous Substance (TRGS) 600	German Institute for Occupational Safety and Health (BaUA)
Safer Consumer Product Analysis of Alternatives Guidance	California Department of Toxics Substances Control
Guidance on preparation of Socioeconomic analysis as part of an application for Authorization	European Chemicals Agency
Toxics Use Reduction Act (TURA) Planners Guide, Section IVB7: Technical Assessment	Massachusetts Toxics Use Reduction Institute

Facility-specific knowledge is needed to conduct a meaningful technical assessment of alternatives. The Massachusetts Toxics Use Reduction Institute (MA TURI) has developed some guidelines for Toxics Use Reduction (TUR) Planners to use in assessing costs and technical feasibility. In addition, the Interstate Chemicals Clearinghouse (IC2) Alternatives Assessment guide provides users with qualitative approaches for considering economic costs and technical feasibility.

The last category of tools included in Annex 3 is alternatives assessment frameworks (see Table 6). To be included in this review, the frameworks needed to encompass a comparative assessment of alternatives (chemicals or technologies) on the basis of hazard, performance and economics, at minimum. The frameworks listed are an updated but smaller inventory of alternatives assessment frameworks as reviewed earlier by Jacobs et al.^{Footnote 12} The table includes 7 frameworks associated with regulatory/policy initiatives and 7 non-regulatory frameworks.

Table 6. Alternatives assessment frameworks^{Footnote a}

Framework	Source/Developer
Alternatives Analysis Guide, Version 1.0 (regulatory)	CA Department of Toxic Substances and Control
Minimizing Chemical Risk to Workers Health and Safety through Substitution (regulatory)	European Commission, DG Employment
Alternatives Assessment Guide V1.1	Interstate Chemicals Clearinghouse (IC2)
Outlined in 2 publicationsFootnote b	MA Toxics Use Reduction Institute
A Framework to Guide the Selection of Chemical Alternatives	U.S. National Research Council
Assessing Safer Chemical Alternatives (regulatory)	Ontario Toxics Use Reduction Program
Guidance on the Preparation for an Application for Authorization (regulatory)	European Chemicals Agency
Guidance for the Preparation of an Annex XV Dossier for Restrictions (regulatory)	European Chemicals Agency
General Guidance on Considerations Related to Alternatives and Substitutes for Listed Persistent Organic Pollutants and Candidate Chemicals	United Nations Environment Program, Stockholm Convention
TRGS 600 (regulatory)	German Institute for Occupational Safety and Health (BaUA)
Alternatives Assessment Criteria V2. Also see Lavoie et al.Footnote c	U.S. EPA Safer Choice Program (formerly Design for Environment Program)
Cleaner Technologies Substitute Assessment: A Methodology and Resource Guide	U.S. Environmental Protection Agency,
Instructions for the Significant New Alternatives Policy (SNAP) Program TSCA/SNAP Addendum (regulatory)	U.S. Environmental Protection Agency Significant New Alternatives (SNAP) Policy Program
Transitioning to Safer Chemicals: A Toolkit for Employers and Workers	U.S. Occupational Safety and Health Administration
Footnote a Frameworks in response to regulatory requirements are specifically indicated Return to footnote a referrer Footnote b (1) Massachusetts Toxics Use Reduction Institute. Five Chemicals Alternatives Assessment Study. 2006. (2) Eliason P and G Morose. Safer alternatives assessment: the Massachusetts process as a model for state governments. J Cleaner Prod. 2011;19:517-526. Return to footnote b referrer Footnote c Lavoie E., et al. Chemical alternatives assessment: enabling substitution to safer chemicals. Environ Sci Technol. 2010; 44:9244-9249. Return to footnote c referrer

These frameworks provide broad guidance for conducting alternatives assessment but are not prescriptive protocols as most lack details on methods for evaluating alternatives. Some frameworks, such as the California, Department of Toxic Substances Control (CA DTSC) Alternatives Analysis Guidance are very comprehensive, but as a result, are quite resource intensive and therefore difficult for small and medium-sized businesses to implement. The framework developed by the IC2 is useful as it includes options for increasing levels of detail and comprehensiveness so that a user with limited resources could choose to conduct a more limited assessment. Several of these frameworks are helpful in guiding the user in addressing data gaps. The U.S. NRC framework includes an in-depth discussion about using novel high throughput in vitro data and in silico modelling to address data gaps. There is an increasing need for collaboration at the international level on validation of such novel data streams to enhance their use in alternatives assessment.

Challenges and data gaps in alternatives assessment and chemical substitution processes – policies and methods

Needs and challenges – policy landscape

Our analysis of existing policy models reveals a number of needs and associated challenges for integrating informed substitution and alternatives assessment requirements into policy.

Few substitution policies have detailed alternatives assessment requirements. Government efforts to drive chemical substitution are not new and there over 20 informative policy approaches identified and characterized in Section 2 and Annex 2. However, the majority of these policies do not include alternatives assessment requirements. Among those that do, the required elements for assessment include a small set of endpoints, typically CMRs. Decision thresholds for action – what is not acceptable or preferred – are not well defined. Even for those policies that are more comprehensive, such as the REACH authorization requirements, the main evaluation metric is demonstrating that the alternative under review is not more hazardous than the chemical on the authorization list, at least for the specific endpoint of concern. Such a limited review is consistent with the legal requirements under REACH, but may not protect against regrettable substitutes where the substitute has a different hazard profile (for example, substituting a neurotoxicant for a carcinogen). In addition, it is assumed that the analysis ensures that no other hazard would qualify the alternative as an SVHC. A more thorough evaluation of the hazards associated with alternatives would assist applicants and others reviewing the merit of such applications, particularly for alternatives that will become feasible in the future due to economies of scale and advances in technological research and development. The California Safer Consumer Products regulation requires the applicant to determine "relevant impact" factors and thus can be more comprehensive in coverage of endpoints to minimize risk trade-offs. However, it remains to be seen how applicants are to determine the "relevant" impacts for the specific priority product/chemical under scrutiny.

A narrow policy approach is inadequate for a broad transition to safer chemicals. Regulation is necessary, but not sufficient to drive substitution and the use of alternatives assessment. In an analysis of implementation of the EC CAD, researchers found that despite the policy mandate to substitute certain chemicals where feasible, substitution does not occur regularly in practice due to a lack of incentives, guidance and tools for implementation.^{Footnote 13} Yet regulations that restrict certain chemicals (or make those chemicals unacceptable in the market place) can lead to chemical de-selection. When combined with alternatives assessment guidance, support or requirements, restriction policies such as REACH and RoHS can help leverage informed substitution, leading to enhanced competitiveness for firms. Sector-wide collaborations to identify and evaluate alternatives for lead, prohibited in electronics under EU RoHS, shows how restriction–focused policies can drive substitution.

The strongest policy models that promote alternatives assessment as part of efforts to substitute chemicals of concern include REACH and the California Safer Consumer Product regulations. But even these have their limits. For example, the REACH authorization process requires alternatives assessment to justify continued use of an SVHC chemical, favoring a "no feasible alternative" outcome of the assessment. At this point, all requests for authorization under REACH have been granted. It may be true that in some cases, feasible alternatives are not available for the function needed in a given application. However, this type of policy framework on its own may be inadequate for a broad transition to safer chemicals.

Government and industry face different challenges when conducting alternatives assessments. Some policies require governments to conduct alternatives assessments while others give industry this responsibility. The REACH authorization process and California Safer Consumer Products regulations require firms to conduct the assessment. Restriction policy models under REACH and U.S. state-level policies in Maine and Minnesota focused on chemicals in children's products require government agencies to conduct the alternatives assessments to identify whether specific applications should be excluded from restriction mandates because of a lack of alternatives. Voluntary program models such as MA TURI's alternatives assessments and U.S. EPA's Safer Choice program depend on government staff conducting the alternatives assessments.

Governments and firms have different capacity limitations and associated data challenges.^{Footnote 14} Firms, specifically small and medium-sized ones, may have information on chemical uses but not the expertise to generate or evaluate toxicological information or address gaps in data. As a result, they often need external expertise to complete assessments. Government agencies face challenges in assessing technical feasibility and cost, as performance and market data are often not publicly available.

Most chemical substitution and alternatives assessment requirements in policies to date have focused primarily on individual chemicals or chemical classes and product types rather than on functional uses of chemicals. Although consideration of chemical function or functional use may be used to frame the scoping or technical evaluation of alternatives assessments, the concept has not traditionally been used as a starting point for policies focused on substitution. Starting with considerations of function (for example, solvent, preservative, surfactant, flame retardant) – a "functional substitution" approach – rather than simply comparing risks of drop-in chemical alternatives offers an efficient means to identify a broad range of options to meet a particular functional need and reorients chemicals management approaches from time-intensive risk assessment and risk management based on single chemical substances to comparative evaluations of the best options to fulfill a specific function.^{Footnote 15} While the concept of function may not be a key consideration in chemicals assessment and management today, chemists and designers regularly focus on function when identifying cost-effective, high performing options for a particular product or manufacturing process.

Challenges and data gaps in alternatives assessment and chemical substitution processe

As the field of alternatives assessment has developed over the last decade and new frameworks, methods, and tools are developed, researchers and practitioners have identified a range of challenges. The need for a research agenda that advances both alternatives assessment methods and implementation in practice has been the topic of several conferences and workshops over the last few years.^{Footnote 16} In March 2015, the LCSP convened an international symposium on alternatives assessment. Out of this meeting an informal alternatives assessment community of practice comprised of academic researchers, industry experts, and scientists within government and non-governmental organizations have been working to develop a research agenda to fill gaps in knowledge and methods. Although methodological advances and research are needed to help build the scientific assessment aspects of alternatives assessment, there are also important needs related to building the professional base of practitioners. As alternatives assessment develops, there is a growing need to develop standards to help align practice in the field. The challenges outlined below are drawn largely from this research and practice agenda effort.

Data gaps. The most significant challenge for both governments and industry in conducting comprehensive alternatives assessments is the lack of adequate toxicity data. There are tens of thousands of chemicals in commerce and only a fraction of them have been assessed for the range of human health and ecological health endpoints that are evaluated in alternatives assessments.^{Footnote 17} To help fill these critical data gaps, there is considerable international interest in the use of predictive toxicology data and other methods such as structure activity analysis. Rather than relying upon standard in vitro assays, predictive toxicology uses high-throughput screening, in vivo assays, knowledge of the mechanisms of toxicity, and advanced computational methods to evaluate and predict toxicity. There is a critical need to advance these methods to augment available data for alternatives assessment.^{Footnote 18} The 2014 U.S. NRC Framework to Guide the Selection of Chemical Alternatives notes the need for tools to combine data from multiple types of testing (traditional toxicology, in-silico methods and high throughput screening) to develop a robust comparative evaluation of alternatives. The influx of chemical data from policies such as REACH may help alleviate some data gaps, though additional use of predictive tools will likely still be necessary.

Chemical mixtures. Currently, alternatives assessments primarily focus on chemical-to-chemical replacements. Although this is appropriate in many applications, many chemical functions and products are not dependent upon a single chemical but upon a formulation. Replacement of one chemical in a product may require replacement of other chemicals in the formulation. To further the development and use of alternatives assessment, methods are needed to evaluate and compare chemical mixtures. An additional challenge is when an alternative is not a chemical alternative but a material or process alternative. Methods to evaluate chemical to material changes are just beginning to be developed.

Environmental toxicity. Most alternatives assessment methods use acute and chronic aquatic toxicity as a surrogate for evaluating all types of environmental toxicity. However, this approach does not differentiate chemicals that are extremely toxic to aquatic organisms from those that are less toxic. In addition, this approach does not include non-aquatic species and therefore may not reveal a negative impact on a terrestrial species, for example. In many cases, data are not available on non-aquatic species. GreenScreen^®has begun to include additional ecotoxicity endpoints such as avian or bee toxicity when available and relevant.^{Footnote 19}

Exposure assessment. The 2014 U.S. NRC report recommended an increased emphasis on comparative exposure assessment in alternatives assessment.^{Footnote 20} Prior to this report, most alternatives assessment frameworks focused on the characterization of inherent hazard with minimal consideration of exposure, with the exception of physiochemical properties such as persistence and bioaccumulation.^{Footnote 21} The U.S. NRC suggests the inclusion of a comparative exposure assessment when integrating evidence related to human and ecological toxicity among alternatives to: ensure that any substantive changes to the routes and any substantive increases to the levels of exposure [of alternatives] are identified; and to allow for consideration of the routes (dermal, oral, inhalation, etc.) patterns (acute, chronic) and levels of exposure (irrespective of any exposure controls). Methods are needed to provide guidance on how to use exposure information during the screening and scoping step of an alternatives assessment and how to integrate this information with evidence related to human and ecological toxicity.

Life cycle considerations. Many product manufacturers seek to avoid negative consequences of chemical substitutions beyond human health and environmental impacts, including "upstream" or "downstream" impacts associated with resource depletion, energy use or climate change. However, methods for integrating life cycle considerations, what the U.S. NRC termed "lifecycle thinking," into alternatives assessment processes in a systematic and consistent manner have not been developed. Efforts are underway to develop approaches that identify relevant life cycle stages and impact categories that are comparatively different during the initial scoping and problem formulation stage of the alternatives assessment to better address this issue.

Decision-making approaches. The ultimate goal of alternatives assessment is the selection and adoption of a safer, feasible alternative, where one is available. The decision-making process in the face of data gaps and uncertainties can be challenging and there are difficult trade-offs to be made among human health, ecological concerns, economic and social impacts and other factors. Methods development is needed to guide decision processes and identify decision rules to resolve trade-offs among attributes and to make the values that underlie those trade-offs more transparent.

Training and education. Training is needed on the basics of alternatives assessment, including approaches to navigate the difficult question of scoping decisions about the array of attributes to compare and consider during the assessment process. In addition, the knowledge base of practitioners needs to stay abreast of new developments in the fields of toxicology, life cycle assessment, exposure assessment, and socio-economic assessment among others, and how new methods and data sources can be integrated into the practice of alternatives assessment.

Economic and technical performance tools. As described above, these tools are not well developed for alternatives assessment. Many of the economic costing tools were developed in the context of pollution prevention. While they may be relevant for alternatives assessment, they have not been updated for this purpose. Although some guidelines exist for technical performance evaluation, this area is also underdeveloped. Technical performance evaluation can be very specific to a particular business process and may not be able to be developed as a generalized tool, though development of general processes and questions to ask in the context of an alternatives assessment may be possible.

Resource needs. Conducting a comprehensive alternatives assessment can be quite resource intensive. Although tools have been developed to streamline the process (for example, QCAT), the requirements for conducting a comprehensive alternatives assessment can be burdensome to small and medium-sized businesses and to government agencies without significant technical resources.

Protecting vulnerable populations. Current alternative assessment methods/tools do not explicitly address how to ensure protection of vulnerable populations. A new report by the Natural Resources Defense Council (NRDC) entitled "Selecting Safer Alternatives to Toxics Chemicals and ensuring the Protection of the Most Vulnerable: A Discussion Draft" explores how alternatives assessment practices could begin to address this issue.^{Footnote 22} NRDC defines "vulnerable populations" as those that: have been disproportionately impacted by toxic chemicals, and/or; have an increased likelihood of adverse health effects from toxic chemicals due to greater susceptibility and/or exposure, and/or: have been, and continue to be, marginalized and excluded from processes and decisions that affect them. These populations include, but are not limited to, those that are exposed to toxic chemicals in their workplaces; low-income communities; communities of color; fence line neighborhoods; communities that rely on subsistence for at least a portion of their food sources (such as indigenous people of the Arctic); and infants, children, and pregnant women."

Lessons learned for the development of alternatives assessment methods and program design

In this section, we identify lessons learned for the development of alternatives assessment methods and informed substitution program/policy design. These lessons are gleaned from our review of existing policies, methods and examples, experience conducting alternatives assessments, and discussions of a growing community of practice for alternatives assessment throughout North America and in the EU. We outline considerations for alternatives assessment methods and guidance, and for policy and program design. In the context of alternatives assessment methods and guidance, these lessons learned can help inform development of guidance and tools for both government and industry. These could then be incorporated into a specific government policy or program or become the basis for sectorial or firm-based policies.

Alternatives assessment program/policy design – considerations

A mix of regulatory and non-regulatory policy tools is needed to stimulate and support the broad transition to safer chemicals. Experience suggests that a single policy approach will not achieve the goals of informed substitution. A multi-pronged approach of policy incentives and disincentives is needed. This includes requirements for alternatives assessment for chemicals of concern as well as support structures that facilitate adoption of safer alternatives.^{Footnote 23}

The use of alternatives assessment should be promoted to guide informed substitution long before agencies initiate restrictive risk management actions. Early regulatory signals on substances of concern are critical as they help to stimulate innovation and informed substitution activities ahead of regulatory mandates. Risk assessment and management processes are resource and time intensive, measured in years and sometimes decades, while market decisions or policies in other jurisdictions may impact chemical choices at a much earlier stage. The number of chemicals identified as being of concern, for example, the SVHC list under REACH, is much larger than the number of chemicals subject to risk management actions (including authorization and restriction). The SVHC list (also called the Candidate List) serves as an early regulatory signal. Anecdotal evidence from interviews with industry representatives in Europe suggest that firms have undertaken substitution efforts because a chemical was listed on the SVHC list (far ahead of being listed for authorisation).^{Footnote 24} However, alternatives assessment under REACH is required of firms submitting an application for authorisation. Thus, additional policy and/or program incentives are needed to promote informed substitution outside of regulatory mandates given concerns about regrettable substitution. ECHA is currently considering a range of options to support broader use of alternatives assessment and informed substitution efforts outside the regulatory domain.^{Footnote 25Footnote 26}

The U.S. EPA's Safer Choice's SCIL is one such program example that is seeking to stimulate the marketplace for safer alternatives. As described above, this U.S. EPA model supports market innovation by establishing clear criteria for defining safer or "preferred" chemicals. Substitution planning policy models offer another approach outside of regulatory mandates to substitute, such as those used by the Ontario and MA TURA programs. In Massachusetts firms are required by law to submit Toxic Use Reduction (TUR) plans, which include substitution among the strategies. Program experience has shown that once firms go through the TUR and substitution planning process, many firms proceed to implement the identified strategies, although not required, because the plans demonstrate the feasibility and cost savings that could be achieved. For example, trichloroethylene is not banned in the U.S. or in Massachusetts, and the U.S. EPA has only recently proposed restrictions on some trichloroethylene (TCE) uses. Yet, TCE has been a chemical of concern in the state for more than 20 years and through TUR planning requirements and performance and testing of alternatives for Massachusetts companies by MA TURI's Surface Solutions Laboratory, use of TCE in the state has declined 92%.^{Footnote 27}

Regulations are needed to send a firm signal to the market to substitute. Regulation remains the primary driver for substitution, based on international experience.^{Footnote 28} Although chemical restrictions are useful to laggards to remove a chemical of concern from a production process or product, the resulting change may be a shallow substitute – one that can be dropped-in and is devoid of innovations in green/sustainable chemistry and may present trade-off risks. Ashford^{Footnote 29} and O'Rourke and Lee^{Footnote 30} note that technological innovation in safer chemicals requires 3 elements: motivation, capacity and opportunities for change. Regulation (or another strong market driver such as procurement) fulfills the motivation need, but capacity and opportunities for change need to be supported by a broader substitution/alternatives assessment policy and program infrastructure.

Regulatory actions that restrict the use of priority toxic chemicals of concern should be linked to provisions for an evaluation of alternatives to avoid regrettable substitution. There are a number of examples of regrettable substitutions that came about due to chemical ban or restriction regulations that did not include provisions about evaluating and adopting safer alternatives. For example, when U.S. OSHA tightened regulations for methylene chloride, industry users were quick to substitute with an unregulated solvent, 1-bromopropane that was catastrophic for exposed workers. U.S. state (and Canadian) restrictions of bisphenol-A are another example.^{Footnote 31} Industry users have often substituted with the easiest drop-in replacement, bisphenol-S or bisphenol-F, which have now been shown to cause endocrine disruption impacts similar to those associated with bisphenol-A.^{Footnote 32} Whether alternatives assessments are undertaken by industry or government, there is a clear responsibility to avoid potential unintended consequences of chemical restrictions, which can be accomplished through thoughtful alternatives assessment requirements. Criteria about what is considered "safer" should be explicit in policy. California's Safer Consumer Product's regulation should be considered a move in this direction.

Regulatory risk management actions should be supplemented with government programs that support the transition to safer chemicals. Although many firms may wish to adopt a safer technology, technical or institutional barriers may inhibit adoption. Capacity for informed substitution can be enhanced through government initiatives that include research and evaluation support, guidance, information on alternatives, demonstration projects, technical assistance, databases, training, and supply chain networking of firms. Massachusetts' experience with toxics use reduction indicates that policies that require an evaluation of alternatives is more successful when linked to technical support structures to facilitate adoption. Voluntary initiatives – without a regulatory or market driver - have varied participation, and tend to include only leading edge enterprises and those with a willingness and interest in sustainability and transitioning to safer chemicals/products.^{Footnote 33}

Alternatives assessment methods and guidance – considerations

There is a need for consistent, yet flexible alternatives assessment methods and guidance. Lack of consistency may make it difficult for alternatives assessments produced in one region to be applicable in or transferrable to other regions. As such, having clear guidance and criteria at an international level that define a 'thorough' alternatives assessment, including the types of data required for alternatives assessment and how data gaps are addressed is important. However, as alternatives assessment is an action-oriented process designed to facilitate informed substitution decision-making (and considering that drivers for chemical de-selection are continuing), it is important that the alternatives assessment process remain flexible and adaptable to different contexts. An assessment process that is overly resource-intensive, costly, or slow will likely not be widely adopted and may overburden regulators, which would undermine the goal of alternatives assessment in supporting an informed transition to safer, feasible alternatives. For example, the alternatives assessment requirements under the California Safer Consumer Product regulations are very detailed and may make compliance difficult for many companies. Such a 'locked down' specification of the design and conduct of alternatives assessments can not only reduce broad and creative thinking about substitutes, but also can convert the tool into a formulistic, compliance-oriented device that encourages a routinized exercise that is neither substantive, innovation generating, nor respected. While incorporating a broader set of considerations in alternatives assessment methods to account for lifecycle impacts or comparative exposures that may result in trade-offs is important, it is critical that methods be developed that can be readily used and facilitate thoughtful and efficient decision-making. International discussion on consistent approaches to alternatives assessment could be achieved through organizations such as the OECD. Current efforts by the OECD have focused on the creating repositories of alternatives assessment tools and case studies.^{Footnote 34}

There should be consistency in the minimum set of endpoints/elements evaluated in alternatives assessment processes. Although there is a need to prioritize flexibility in the practice of alternatives assessment given that each assessment may vary based on the particular context, there is a growing consensus about the need to establish a set of "core" attributes/endpoints that are consistently evaluated.^{Footnote 35} This is particularly true for the hazard assessment component of alternatives assessment. A consistent set of endpoints to consider could be, at a minimum, the 18 endpoints outlined in GreenScreen^®.^{Footnote 36} Development of a minimum set of endpoints to consider and the data hierarchy (including how data gaps should be filled with estimated data from predictive modeling) could be undertaken internationally through organizations such as OECD.

Thorough scoping should be undertaken at the beginning of alternatives assessment processes. Scoping can be one of the most challenging steps in an alternatives assessment. Scoping should begin with an understanding of the functional use of the chemical of concern. By starting here, researchers and practitioners can search for alternatives beyond "drop-in" substitutes, which rarely exist and may result in a regrettable substitution if a chemical of a similar class is selected. The solution may lie in a different product design, production process or a material that avoids the use of the chemical or removes the need for the chemical altogether. Thoughtful scoping is also important for identifying life cycle impacts of concern. Scoping can also help with narrowing and focusing an alternatives assessment.

A range of key stakeholders should be engaged throughout the alternatives assessment process. Engaging stakeholders at the scoping phase of an alternatives assessment and continuing their engagement throughout the process can help in ensuring that the analysis asks the right questions, identifies a range of options, and is sufficiently comprehensive. Stakeholders may be internal (different divisions or units) or external to an organization including representatives from government, business, workers, and potentially impacted communities. In the case of alternatives assessments conducted by enterprises, engagement of stakeholders could also include downstream customers or upstream suppliers. Communication and engagement across the supply chain is critical for identifying potential alternatives and for better understanding the functional needs/requirements of the alternative from a customer use perspective. MA TURA requires that workers be involved in the toxics use reduction planning process, as they can be instructive in identifying and applying alternatives as well as potential risk trade-offs. The recent NRDC report noted that vulnerable populations are often not engaged in the alternatives assessment process and articulated a strong need for affected communities to be engaged throughout. At the stage of alternatives implementation, it is critical to engage workers in testing and evaluating performance and any risk trade-off issues that may arise from making a process change.

Transparency is a necessary element in alternatives assessment processes. Transparency is an essential element of alternatives assessment given the decision-rules, data choices and assumptions involved. This includes transparency in scoping (including decision-rules underlying the assessment), data collection, identification of data gaps and data confidence/uncertainty, and in decision-making. Throughout the steps of an alternatives assessment, there are many junctures where expert judgment is needed. The decisions made at these points are often not transparent. Some tools include benchmarks for decision-making to determine the acceptability of potential alternatives. These benchmarks aid the user but may reduce transparency.

Once an alternatives assessment is completed and the results are being used in decision-making, there is also a need for transparency. Having transparent guidelines about what trade-offs are/are not acceptable (for example, PBTs, CMRs that are known high hazard chemicals) is important. The NRDC report notes the need for explicit accounting of the consequences of trade-off decisions including the relative weighting of different health and environmental impact factors and consideration of differential exposures, including legacy exposures.

Alternatives assessment findings should be used to identify and implement the use of safer chemicals. The goal of alternatives assessment is to drive the design and selection of safer chemicals. The data derived from alternatives assessment and hazard assessment processes can be used to facilitate informed decision-making, particularly for smaller firms without significant resources by identifying "preferred chemicals." Some good examples are CleanGredients and the U.S. EPA Safer Chemical Ingredients List (SCIL). CleanGredients^®is an online database of cleaning product ingredients that meet the EPA Safer Choice criteria for safer ingredients for specific functional classes.^{Footnote 37} Its goal is to encourage the design of cleaning products that are safer with respect to human and ecological health and safety and to provide a market-based incentive for chemical manufacturers to invest in green chemistry research and development. U.S. EPA's SCIL was developed to assist manufacturers in finding safer chemical alternatives. It includes chemical ingredients, arranged by functional-use class, that have been determined to be safer than traditional chemical ingredients. These databases are particularly helpful for manufacturers of cleaning and personal care products. Expanding these databases or developing new databases that address additional functions of chemicals and chemical classes is greatly needed to guide manufacturers toward safer alternatives.

There are few lessons learned for including exposure and life cycle considerations in alternatives assessment as these methods are currently evolving. Similarly, methods for evaluating economic costs and technical feasibility in alternatives assessment are evolving though it is important for all 4 components of an alternatives assessment, at a minimum, to include a qualitative assessment of lifecycle implications, potential exposure trade-offs, socioeconomic costs and technical feasibility.

Conclusion

Increased drivers for informed chemical substitution have led to a rapid evolution in alternatives assessment frameworks and methods, along with substitution policies. Nonetheless, most of these efforts are in their early stages. Many challenges remain, but significant opportunities exist to advance the informed substitution of toxic chemicals. Our review reveals lessons learned that can guide developments in the field, including methods, guidance and policies. With vision, coordination, strategic interventions, and resource commitments, Canada has the potential to take a leading role in shaping informed substitution practices both nationally and globally.

Annex 1: Methodology

The methodology undertaken for this landscape analysis consisted of:

1. A comprehensive review of policies and approaches taken by authorities internationally (government programmes, non-governmental organisations (NGOs) and other stakeholders in public institutions and industry) to support substitution among chemical manufacturers and users, the different drivers that exist between countries and their impact on the process of alternatives identification and substitution.

Policies and approaches untaken by authorities internationally were identified using a number of sources, including reports, peer-reviewed literature, on-line resource tools, including Subsport, the IC2 U.S. State Chemicals Policy Database, and the Safer State Policy database – that are compendia of international and U.S.-focused substitution policies, respectively – and the OECD substitution and alternatives assessment tool box. Our comparative review focused on the subset of policies that included an evaluation of alternatives/alternatives assessment provisions, given the primary objective of this project. Strengths and limitations related to each policy approach were characterized based on the project team's chemical management policy and alternatives assessment expertise. Where more information was needed for such characterizations, additional policy research was conducted.

2. A comparative overview of tools and methods applied to alternatives assessment.

Alternatives assessment methods and tools were identified using similar sources as in task 1. The project team's peer-reviewed publications^{Footnote 38} and participation in an informal alternatives assessment community of practice were also used to identify relevant methods and tools, and this expertise was used to characterize strengths and limitations.

3. Characterize global challenges and critical data gaps for chemical substitution.

Gaps and challenges were identified based on assessments conducted by the project team within the last 18 months and discussed during team meetings to identify issues most relevant to the Canadian context. This included a detailed review of alternatives assessment practice and research needs as convened by the project team in 2015 with participation of approximately 50 stakeholders from academia, government agencies, industry and NGOs and is the basis of a forthcoming paper.

4. Characterize lessons learned to support the development of a policy approach for alternatives assessment in Canada.

Characterization of lessons learned was based on the project team's expert knowledge on chemicals policy and alternatives asessment, specifically, rather than a formal best practice evaluations as no such evaluation is currently available.

Annex 2: Landscape and review

Table 1: Landscape and review of international policies that promote substitution

Policies	Substitution/AA-specific policy provisions	Responsible entity that conducts the AA?	AA guidance?	Strengths	Limitations
International treaties
Aarhus Protocols on (a) metals and (b) POPs http://www.unece.org/info/ece-homepage.html	Considers substitution as a primary measure to achieve its goals and targets of controlling emissions of (a) heavy metals of concern (for example, cadmium, lead and mercury) and (b) POPs	n/a	n/a	Supports transition to safer chemicals via substitution	No requirements for analysis of alternatives
Geneva Protocol http://www.unece.org/info/ece-homepage.html	The protocol specifies reduction targets for VOC emissions from stationary and mobile sources and suggests measures to be applied, including substitution of targeted VOCs with alternatives (chemicals or technologies)	n/a	n/a	Supports transition to safer chemicals via substitution	No requirements for analysis of alternatives
Montreal Protocol http://ozone.unep.org/en/treaties-and-decisions	Requests the phase out and elimination of specified ozone depleting substances and stimulates the search for substitute substances and technologies All parties have to elaborate their strategies and plans to comply with the provisions, targets and timetables of the Protocol, while finding and making available safer alternatives	n/a [where alternatives are reviewed, assessed by the Technology and Assessment Panel] All	No detailed guidance, but Technology and Economic Assessment Panel addresses issues concerning alternatives. Implemented in policy at country level.	TEAP considers technical and economic feasibility of alternatives	TEAP does not comprehensively address hazards. Assessment of alternatives primarily considers ozone depleting potential (ODP) and global warming potential (GWP)
Rotterdam Convention http://www.pic.int/Portals/5/download.aspx?d=RC_Convention_Text_2011_English.pdf	Inclusive of the Rotterdam convention is the opportunity to take informed risk-based decisions supported by measures to facilitate information exchange regarding hazardous chemicals, including information on safer alternatives and information on alternatives and their relative risks	n/a	n/a	Supports transition to safer chemicals via substitution	No requirements for analysis of alternatives
Stockholm Convention http://chm.pops.int/TheConvention/Overview/TextoftheConvention/tabid/2232/Default.aspx	Prohibits the most hazardous POPs and restricts or recommends the reduction of others. It establishes the requirement to use substitute or modified materials, products, and processes to prevent the formation and release of POPs POPs review committee (POPRC) reviews information on alternatives substances	Signatories requesting listing of new POPs, reviewed and supported by the POPRC	UNEP POPs Review Committee. 2009. Available: http://chm.pops.int/Default.aspx?tabid=592	Detailed guidance on steps for an alternatives assessment Broad considerations of hazards, economic feasibility and socioeconomic factors	Use of the alternatives assessment guidance is not required in POPs process
Regulatory actions
Alternatives assessment specific regulatory provisions
U.S. California Safer Consumer Products https://dtsc.ca.gov/LawsRegsPolicies/Regs/upload/Text-of-Final-Safer-Consumer-Products-Regulations-2.pdf	Requires responsible entities (manufacturers, importers, assemblers, and/or retailers) of a "priority product" * (a consumer product containing a prioritized chemical of concern) to complete an AA to determine whether feasible alternatives are available * priority product classifications derived from chemicals listed on the "candidate chemicals list" http://www.dtsc.ca.gov/SCP/CandidateChemicals.cfm	Industry	DRAFT guidance (2/22/2017) http://www.dtsc.ca.gov/SCP/upload/Draft-Alternatives-Analysis-Guide.pdf	Link to potential regulatory actions by the state Evaluation of product level alternatives for a particular functional use Detailed evaluation of economic and technical feasibility and life cycle factors	Focuses only on chemicals in consumer products Link to regulation may inhibit thoughtful assessment of alternatives or adoption AA requirements are quite prescriptive Requires assessment of relevant impacts where methods have not been developed
EU REACH (Authorization and Restrictions) http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2006:396:0001:0849:EN:PDF	AA required among firms seeking authorization for continued use of a restricted substance AA required among Member State authorities submitting restriction proposals for substances of very high concern (SVHCs)	REACH Authorization: Industry REACH Restriction: Member State Authorities	Authorization AA guidance: https://www.echa.europa.eu/documents/10162/13637/authorisation_application_en.pdf Restriction AA guidance: http://echa.europa.eu/documents/10162/13641/restriction_en.pdf	Link to potential regulatory actions [authorizations granted or denied; restrictions enacted or not] Evaluation of product level alternatives for a particular functional use Detailed evaluation of economic and technical feasibility	Authorization: rationale for the AA (defending continued use of chemical can result in over-specifying prescribing performance attributes Resource intensive for business and for agencies to review each assessment Guidance documents do not require a "minimal set" of evaluative hazard endpoint requirements
EU Biocidal Products Directive EU528/2012 http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:1998:123:0001:0063:EN:PDF	Prohibits CMRs, sensitizers and bioacumulative chemicals from use as active ingredients in biocidal products Active ingredients in biocidal products identified as candidates for substitution are subject to a comparative assessment of alternatives at the time of their authorization If safer, feasible products are available, the biocidal product shall not be authorized	Industry	No	The biocidal authorizations are "prospective" – required to put a product on the market, not defending its continued use	The extent to which use of alternatives assessment is used by industry remains to be seen
Classification-based substitution requirements
EU Cosmetics Directive (EC 1223/2009)	Applies EU GHS classifications for CMRs to identify chemicals that should be substituted, where feasible in specific uses with exemptions for low concentration uses Requires alternatives analysis for continued use in some cases Substitution not required if alternatives are not feasible	Industry	No	Uses GHS classification to identify groups of chemicals of concern that must be substituted Rapid decisions on multiple chemicals	Little focus on assessing safety of substitutes Permits continued use in some cases when low exposure potential is demonstrated
EU OSHA Chemical Agents Directive (98/24/EC) http://eur-lex.europa.eu/legal-content/en/TXT/?uri=CELEX:31998L0024 Carcinogens and Mutagens at Work Directive (2004/37/EC) http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02004L0037-20140325	Applies EU GHS classifications for CMRs to identify chemicals that should be substituted, where feasible in specific uses Requires alternatives analysis for continued use in some cases Substitution not required if alternatives are not feasible Member States have issued their own regulations in response to these directives; examples include: German Hazardous Substance Ordinance http://www.baua.de/en/Topics-from-A-to-Z/Hazardous-Substances/Hazardous-Substances-Ordinance.html UK Health and Safety Executive, Control of Substances Hazardous to Health (COSHH) regulations [2002] http://www.hse.gov.uk/coshh/index.htm	Industry	No* *Some Member States have developed AA/ substitution guidance to fulfill these directives. Example: Germany's TRGS 600 http://www.baua.de/en/Topics-from-A-to-Z/Hazardous-Substances/TRGS/pdf/TRGS-600-619-Summaries.pdf?__blob=publicationFile	Uses GHS classification to identify groups of chemicals of concern that must be substituted Rapid decisions on multiple chemicals	Legal preference in EC Directives for substitution does not include a detailed definition of how substitution should be implemented and no direction on assessing the safety of substitutes; details are left up to member states to implement Permits continued use in some cases when low exposure potential is demonstrated
EU Classification, Labeling and Packaging of Substances and Mixtures (CLP Regulation) http://subsport.eu/wp-content/uploads/2011/01/61-clp-regulation-11.pdf	Hazard classifications are directly linked to priorities for chemical restrictions and substitution provisions in specific EU policies and many Member State regulations	n/a	No	Provides a strong incentive to industry to substitute on their own before regulatory requirements (for example, authorizations/ restrictions)	No requirements for analysis of alternatives
Requirements for use of acceptable substitutes
U.S. Clean Air Act § 612 Significant New Alternatives Rule	Requires EPA to publish list of acceptable and unacceptable alternatives to chemicals of concern and requires manufacturers to demonstrate safety of alternatives Federal research facilities should assist users in identifying and developing alternatives and in achieving a transition Fulfills" Safe alternatives policy" of the Clean Air Act	Industry submits the information, but gov't agency conducts the assessment	Yes – for industry submission of alternatives to SNAP program https://www.epa.gov/sites/production/files/2015-09/documents/tsca-snapaddenduminstruction2014.pdf	Allows agency to get strong data from industry in order to review alternatives to avoid regrettable substitutions Considers acceptability of substitute in use-specific applications	Risk-based evaluation can be resource intensive and often completed in absence of good data Media focus (atmospheric) have missed human health impacts in the consideration of acceptable substitutes
Requirements for use of safer alternatives in procurement
U.S. Federal Executive Order 13514 Federal Leadership in Env., Energy, and Economic Performance https://www.fedcenter.gov/programs/eo13514	Outlines a target of 95% of all new contracts, including non-exempt contract modifications, require products and services that are energy-efficient, water-efficient, biobased, environmentally preferable, non-ozone depleting, contain recycled-content, non-toxic or less-toxic alternatives	Government agencies	No	Labels provide easy decision for purchaser/decision-maker Market based driver of alternative without having to demonstrate risk threshold	No clear guidance/criteria on assessing safer (may vary) and criteria may not be transparent EO was revoked
U.S. New York State Executive Order No. 4, Establishing a State Green Procurement and Agency Sustainability Program http://www.dec.ny.gov/energy/71389.html	Considers the hazardous substances when establishing "green" procurement lists and specifications that are required when developing new gov't solicitations and contracts for the procurement of commodities, services and technology, and for the procurement of commodities, services and technology under existing gov't contracts	Government agencies	No	Preferred procurement standards provide clear decision rules for gov't purchasers Market based driver of alternative without having to demonstrate risk threshold	No clear guidance on assessing safer chemicals/technologies (may vary by label) and criteria may not be transparent Often focus on simple decision tools (labels) limits number of product/chemicals considered
Single or multiple chemical restrictions with alternatives assessment requirements
EU – VOC Directive (1999/13/EC)	Calls for substitution of VOCs at specific installations that operate above consumption thresholds Special attention is paid to the substitution of CMRs	Government agencies	Provides guidance documents and resources for substitutes in various VOC-containing products	NA	No clear guidance on assessing safer chemicals/technologies (may vary by label) and criteria may not be transparent
Maine Act to Protect Children's Health and the Environment from Toxic Chemicals in Toys and Children's Products: http://www.mainelegislature.org/legis/bills/bills_123rd/billpdfs/HP143201.pdf	Requires the Department of Environmental Protection to publish a list of chemicals of high concern. Permits the Commissioner of Environmental Protection to designate a chemical of high concern as a priority chemical if the chemical meets certain criteria. Requires manufacturer notification if using priority chemical. Permits the Department to request additional information from the manufacturer or distributor including: information on the likelihood that the chemical will be released from the children's product; information on the extent to which the chemical is present in the environment or human body; and an assessment of the availability, cost, feasibility, and performance of alternatives to the priority chemical and the reason the priority chemical is used in the manufacture of the children's product in lieu of identified alternatives.	Government makes determination as to the availability of safer alternatives for one or more specific uses of at least one priority chemical in a children's product Manufacturers can be asked to do an assessment of the availability, cost, feasibility, and performance of alternatives to the priority chemical.	No	Legislation goes beyond chemical restriction and includes identification of safer alternatives by government and industry	Guidance on alternatives assessment guidance is not provided
Minnesota Act on Products Containing Poly-Brominated Diphenyl Ether https://www.revisor.mn.gov/statutes/?id=325e.385	Restriction on individual substances or group with requirement for government or industry to evaluate and/or use safer alternatives	Government or industry	No	Supports transition to safer chemicals while seeking to avoid regrettable substitutions	Single chemical approach Few criteria for defining safer alternatives other than types of endpoints to avoid (primarily developmental/ reproductive toxicity)
Norwegian Environmental Agency, Norwegian Product Control Act, Section 3A https://www.regjeringen.no/en/dokumenter/product-control-act/id172150/	Requires evaluation of alternatives for chemicals of concern in products for occupational purpose and substitution if feasible alternatives exist The Act applies to production, including testing, and to the import, placing on the market, use and other handling of products and consumer services The Norwegian Environment Agency has published a list of priority chemicals of concern that pertain to various regulations http://www.environment.no/topics/hazardous-chemicals/lists-of-hazardous-substances/list-of-priority-substances/	Industry	General guidance available: http://www.miljodirektoratet.no/old/klif/publikasjoner/kjemikalier/2007/ta2007.html	Supports transition to safer chemicals via substitution	Does not specify how alternatives should be evaluated
Restrictions on certain Hazardous Substances (RoHS) [China, EU, Japan, Korea]	Several countries have followed the EU's lead and issued restrictions related to specific chemicals in electronic products, including lead, cadmium, hexavalent chromium, pBDEs, etc. Substitution is mentioned in these policies, but not AA specifically. However, it is well-known that RoHS regulations have been a driver for the growing use of alternatives assessment Examples w/ links to legislation in English: EU RoHS Directive – Directive 2002/95/EC http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32002L0095 Chinese RoHS http://english.mofcom.gov.cn/aarticle/policyrelease/domesticpolicy/200605/20060502132549.html	Industry	No	Supports substitution as a means to comply with the chemical restrictions RoHs regulations have been described by firm (for example, Hewett Packard) as a driver for their use of alternatives assessment	Restriction policies alone are not sufficient to promote use of alternatives assessment and to avoid regrettable substitutions
Vermont Act Relating to Phthalates in Products for Young Children www.leg.state.vt.us/docs/legdoc.cfm?URL=/docs/2008/acts/ACT171.HTM	Restriction on individual substances or group with requirement for government or industry to evaluate and/or use safer alternatives	Industry	No	Supports transition to safer chemicals while seeking to avoid regrettable substitutions by ensuring substitutes are not carcinogens, reproductive toxicants or developmental toxicants	Single chemical approach Few criteria for defining safer alternatives other than a few high hazard endpoints to avoid
Pollution prevention
Chinese Law on Promoting Clean Production http://english.mep.gov.cn/Policies_Regulations/laws/envir_elatedlaws/200710/t20071009_109966.htm	Substituting hazardous substances with safer ones is part of the clean production measures, presented by the law. General provisions meant to promote clean production are applicable also for substitution of chemicals. Research, fiscal and administrative measures, and guides are meant to help the implementation and enforcement of clean production rules, including the use of safer alternatives to hazardous substances.	n/a	n/a	Links pollution prevention and substitution	AA not specified
EU Integrated Pollution Prevention Control (IPPC) Directive 2008/1/EC http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2008:024:0008:0029:EN:PDF	Several EU directives that are focused on pollution prevention to control emissions and release of hazardous substances associated end-of-life include substitution and assessment of alternatives and the use of "less hazardous substances" as a pollution prevention strategy. Another directive example: EU DG Environment End of Life Vehicles Directive 2000/53/EC http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02000L0053-20130611&qid=1405610569066&from=EN	n/a	No	Links pollution prevention and substitution Useful driver for substitution associated with end of life	AA not specified Decision to substitute up to firms
MA Toxics Use Reduction Act http://www.turi.org/About/Toxics_Use_Reduction_Act2	Requirement that firms conduct process level material accounting and planning to evaluate safer process alternatives Companies required to identify potential alternatives and conduct evaluation of the technical and economic feasibility of alternatives using good engineering and accounting practices Alternatives that result in shifting of risks not considered acceptable	Regulated firms consider substitution as part of TURA plans	TUR Planning guidance describes how to assess alternatives: http://www.mass.gov/eea/docs/dep/toxics/laws/planguid.pdf	Planning requires companies to understand chemical use and examine alternatives Companies trained on the concepts of AA Technical assistance supports adoption	Focus primarily on manufacturing process chemicals and not products Decision to substitute up to companies Comprehensiveness of AA varies by company
New Jersey Pollution Prevention Act http://www.nj.gov/dep/enforcement/opppc/rules/1991%20NJ%20Pollution%20Prevention%20Act.pdf	Requirement that firms conduct process level material accounting and planning to evaluate safer process alternatives	n/a	n/a	Planning requires firms to understand chemical use and examine alternatives Technical assistance supports adoption	Focus primarily on manufacturing process chemicals and not products. Decision to substitute up to firms Level of assessment varies by firm
Non-regulatory actions
China's State Recommended Catalog of Alternative Materials for Toxic and Hazardous Substances and Products [no url available]	The list provides recommended chemicals that can serve as alternatives to hazardous chemicals List is not legally binding, yet companies who comply may benefit from lower taxes or other incentives This effort is an attempt to fulfill some of the obligations to support substitution within China's Law on Promoting Clean Production	Government	No	Promotes adoption of safer chemicals through its recommended list. Model use of taxes and other incentives to improve substitution efforts	Not legally binding
DG Environment Non Toxic Environment Initiative - The 7th Environment Action Programme (EAP) http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32013D1386	The 7th EAP program is a guide for European environment policy until 2020. The 3rd objective focuses on challenges to human health and well-being and includes an initiative to "tackle hazardous chemical, including nanomaterials, chemicals that interfere with the endocrine system and chemicals in combination, as part of a broader, strategic approach for a non-toxic environment." DG Environment has sponsored several "sub-studies" to inform the strategy, to address needs and opportunities relating to the grouping of chemicals and measures to support substitution.	n/a	No	Visionary initiative that has broad implications to enhance substitution programs across regulatory and non-regulatory programs w/in the EC and member states	Ability and willingness to address recommended actions via policy remains to be seen
MA Toxics Use Reduction Institute www.turi.org	Conducts alternatives assessment to identify safer, feasible substitutes to enhance the economic competiveness of MA businesses. Reviews the hazard, cost/performance and availability of alternatives as part of the TURA program's policy analysis when proposing to categorize specific chemicals as higher-hazard substances	Government (MA TURI)	Massachusetts Toxics Use Reduction Institute conducts AAs. Five chemicals alternatives assessment study: http://www.turi.org/TURI_Publications/TURI_Methods_Policy_Reports/Five _Chemicals_Alternatives_Assessment_Study._2006/Full_Report Eliason P, Morose G. 2011. J Clean Prod 19: 517–526.	TURI is a pioneer in the methods and practice of alternatives assessment, which continues to guide developments in the field	Decision to utilize TURI's AA findings re: substitution is up to companies – findings are not legally binding
Sweden, KEMI Environmental Quality Objectives, "A Non-Toxic Environment"	One of the 16 environmental quality objectives includes a 'non-toxic environment.' Includes interim targets that may involve regulatory measures	n/a	No	Visionary	Guide for policy and regulatory actions only
U.S. EPA Safer Choice Program https://www.epa.gov/saferchoice	Alternatives assessments are conducted for Action Plan chemicals for either broad or specific end uses Focuses on comparative hazard screening. Identifies safer substitutes for chemicals in specific applications in its Safer Choice Program and also publishes a safer chemical ingredient list [SCIL) that is searchable by function (i.e., preservative, solvent)	Government	Yes http://www2.epa.gov/sites/production/files/2014-01/documents/aa_criteria_v2.pdf Environ Sci Technol 2011; 44:9244–9249.	Promotes alternatives assessment and adoption of safer chemicals through its SCIL list	Safer Choice program is not currently conducting alternatives assessments The agency is focused on conducting hazard assessments only for their Safer Choice product labelling program and the SCIL list
U.S. OSHA Transitioning to Safer Chemicals https://www.osha.gov/dsg/safer_chemicals/	Issued advisory recommendations to assist businesses in identifying and adopting safer chemicals as a means to reduce hazardous chemical use	Industry	Yes https://www.osha.gov/dsg/safer_chemicals/	Promotes alternatives assessment and adoption of safer chemicals through its alternatives assessment guidance Guidance has been used as the basis for worker education/training	Lack of legally binding requirements
Washington State's Reducing Toxics Threat Initiative http://www.ecy.wa.gov/toxics/	Focuses on preventing the use of toxic substances by encouraging safer alternatives and promoting green chemistry	Government (and has developed AA guide for industry)	General guidance is available https://fortress.wa.gov/ecy/publications/SummaryPages/1504002.html	Promotes alternatives assessment AND the development of safer chemistry Model state-level commitment to use of alternatives assessment	Lack of legally binding requirements

Note: This review should not be considered exhaustive, but rather inclusive of policy provisions that are most instructive for the consideration of alternatives assessment (AA) in regulation.

Annex 3: Landscape of alternatives assessment tools and methods

Table 1. Chemical hazard screening tools
Table 2. Comparative hazard evaluation tools
Table 3. Economic and technical feasibility assessment tools
Table 4. Alternative assessment frameworks

Table 1: Chemical hazard screening tools

Method/tool and description (with url)	Hazard endpoints considered	Other attributes considered	Decision-making framework	Strengths	Limitations
ChemHAT (the Chemical Hazard and Alternatives Toolbox) http://www.chemhat.org/en Developed by the BlueGreen Alliance in partnership with several unions. ChemHAT is an online database created to help workers identify safer chemicals so that they are protected on the job	A wide range of hazard endpoints is considered The chemical hazard information in ChemHAT is from the Chemical and Material Library (CML) created by the Healthy Building Network for its Pharos database of chemicals and materials in building products; CML evaluates over 22,000 chemicals and materials against 30 authoritative chemical hazard lists and restricted substances lists developed by governmental agencies and other reputable, science-based non-governmental organizations	Information on likely exposure routes is provided	No guidance for Decision-making but information is provided on: Potential health and environmental hazards; how workers may be exposed; safer alternatives, if available	Rapid screening of known chemical hazards; information provided is accessible and relevant to workers	Tool does not evaluate safety of chemicals that are not on authoritative lists
Chemical Hazard Data Commons – Pilot https://commons.healthymaterials.net/ Developed by Healthy Building Network and other members of the Chemicals Common Helps users find resources and work collaboratively to understand the chemical hazards and identify alternatives	Hazard endpoints considered in the Data Commons are consistent with those considered in the GreenScreen tool	No	For each endpoint, the criteria define "High," "Moderate," and "Low" concern (in some cases "very high" and "very low" Results are provided in table and color-coded according to high, moderate, low ranking The results are not aggregated	User can find hazard information on an individual chemical or a group and view evidence of human and environmental health impacts from authoritative hazard lists and GreenScreen assessments Additional tabs provide a deeper hazard review, and a discussion forum about the substance and its hazard listings	Biggest limitation is data gaps; Chemical Hazard Data Commons is currently in pilot phase only
Column Model http://www.dguv.de/ifa/ praxishilfen/hazardous-substances/ghs-spaltenmodell-zur-substitutionspruefung/index.jsp Developed by the Institute for Occupational Safety and Health (IFA) of the German Social Accident Insurance. A matrix tool designed for industry's use to identify alternative substances. The tool allows for the comparison of chemicals/ substances or materials/ mixtures based on 6 hazard endpoints.	Human Health Hazards Exposure potential Acute health hazards Chronic health hazards Environmental Hazards Chemical/Physical Properties Physicochemical hazards Process-related hazards	Exposure potential is qualitatively evaluated	Compares the 5 columns for each product evaluated: acute and chronic health hazards environmental hazards physico-chemical effects hazards from release behaviour hazards caused by procedures If the proposed substitute ranks as a lower risk in all columns, then the decision to make this change is straightforward. If the potential substitute ranks higher in some columns and lower in others, the user must evaluate which hazards are of greatest concern in a particular production process	Users must consult external data sources (for example safety data sheets) and compare against the Column Model's internal standards databases Users can assess the significance of each potential hazard (qualitative weighting factor) for each situation. Column Model is easy for non-professional users and facilitates a quick assessment on possible substitutes and alternatives	Data derived primarily from SDS which may not provide sufficient information for comprehensive evaluation
GreenScreen List Translator http://www.greenscreenchemicals.org/method/greenscreen-list-translator Developed by Clean Production Action A rapid assessment tool for chemical substances that utilizes authoritative lists of chemicals of concern. The screening evaluation results in 3 outcomes: of high concern, possibly of high concern, and unknown	Human Health Hazards Human health group 1 (carcinogenicity, developmental toxicity, endocrine activity, mutagenicity and genotoxicity, reproductive toxicity) Human health group 2 (acute mammalian toxicity, systemic toxicity and organ effects, eye irritation, neurotoxicity, respiratory sensitization, skin irritation, skin sensitization) Environmental Hazards (Acute and chronic aquatic toxicity) Environmental Fate (Bioaccumulation; Persistence Chemical/Physical Properties (Flammability; Reactivity)	No	LT-1 - hazard classifications meet one or more GreenScreen Benchmark-1 criteria; determined using authoritative lists LT-P1 - hazard classifications meet one or more GreenScreen Benchmark-1 criteria; determined using screening lists and/or there is some uncertainty about the classification for key endpoints. Further research is needed LT-UNK - chemical is present on a list, but information is insufficient to apply scoring algorithm	GSLT can be used for identifying chemicals that should be avoided	GSLT is not intended for fully evaluating the relative safety of substances or alternatives not on authoritative lists
PRIO – A tool for Risk Reduction of Chemicals http://www.kemi.se/en/prio-start/ search-in-the-database Developed by the Swedish Chemical Inspectorate (Kemi) to help eliminate high hazard chemicals from products to meet the Swedish government's goal of a "non-toxic environment" by 2020	Human Health Hazards Acute and chronic toxicity Allergenicity Carcinogenicity, mutagenicity, and reproductive toxicity Endocrine disruption Environmental Hazards Aquatic toxicity Metals (Hg, Cd, Pb, and compounds) Ozone depletion Environmental Fate PB and vPvB substances	Recommends that exposure be evaluated for "risk reduction" substances Has questions to qualitatively assess potential worker exposure: http://www.kemi.se/en/prio-start/chemicals-in-practical-use/risk-analysis	Contains a database of chemicals of high concern to human health and the environment, which are divided into "phase-out" or "priority risk reduction" chemicals. For chemicals identified as "phase-out" substances, the tool provides a 7-step process for identifying safer alternatives Phase-out substances should be avoided or substituted: CMR (1A and 1B); PBT/vPvB); endocrine disruptive; Ozone-depleting. For "priority risk reduction" chemicals, assessing additional health/env endpoints recommended to ensure risk minimization	Rapid screening of chemicals according to hazard criteria; information provided is accessible and relevant to environmental managers, purchasers and product developers	Tool does not evaluate safety of chemicals that are not well characterized in the scientific literature Hazards such as explosiveness, flammability are not evaluated
RISCTOX http://www.istas.net/risctox/en/ Developed by the Spanish Trade Union Institute of Health, Work and Environment (ISTAS) and the European Trade Union Institute (ETUI) and includes over 100,000 chemicals and provides information on substance classification and labeling under EU Regulation 1272/2008, health and environmental impacts and risks, and environmental and health regulations	Human Health Hazards Carcinogenicity/ mutagenicity Endocrine disruption Neurotoxicity Sensitization Ototoxicity Occupational disease related Reproductive toxicity Environmental Hazards Aquatic toxicity Atmospheric pollutants Soil pollutants Environmental Fate PBTs Persistent organic pollutants Chemical/Physical Properties Volatile organic compounds	Provides information on hazard according to exposure route (for example, oral, dermal, inhalation)	User is provided with R-phrases, H-phrases and pictograms indicating different types of hazard Decision about use is left to user	Users can search by hazard endpoint or specific substance Users can assess and compare alternative products using a tool in the database that is based on the Column Model RISCTOX is designed for users with no scientific or engineering background	Tool does not evaluate safety of chemicals that are not well characterized in the scientific literature RISCTOX includes information on individual substances and does not evaluate chemical mixtures Database is in Spanish Depending on the level of interpretation required, a toxicology or chemistry background may be necessary Explanatory texts are available

Table 2: Comparative hazard evaluation tools

Method/tool and description (with url)	Hazard endpoints considered	Other attributes considered	Decision-making framework	Strengths	Limitations
GreenScreen for Safer Chemicals http://www.greenscreenchemicals.org/ Developed by Clean Production Action to promote the use of safer chemicals and to support more informed decision-making on the use of chemicals in products and processes	Human Health Hazards Human health group 1 (carcinogenicity, developmental toxicity, endocrine activity, mutagenicity and genotoxicity, reproductive toxicity) Human health group 2 (acute mammalian toxicity, systemic toxicity and organ effects, eye irritation, neurotoxicity, respiratory sensitization, skin irritation, skin sensitization) Environmental Hazards Acute aquatic toxicity Chronic aquatic toxicity Environmental Fate Bioaccumulation Persistence Chemical/Physical Properties Flammability Reactivity	Environmental transformation products are considered to determine the final Benchmark score of the parent chemical	Chemicals are classified in one of 4 Benchmark categories: Benchmark 1 – Avoid - is chemical of high concern; Benchmark 2 – use but search for safer substitutes; Benchmark 3 – use but still opportunity for improvement; Benchmark 4 – Prefer – is considered to be a safer chemical	GreenScreen®can be used to compare organic, inorganic, and polymeric chemicals/ substances and materials/ mixtures	Evaluation of ecotoxicity endpoints is limited Biggest limitation in this methodology is data gaps
QCAT (Quick Chemical Assessment Tool) http://www.ecy.wa.gov/ greenchemistry/qcat.html Developed by the Washington State Department of Ecology Developed as a tool for small businesses to evaluate chemicals to determine their toxicity and assess alternatives. Requires the assessment of chemical hazard for 9 endpoints.	Human Health Hazards Human Health Group 1 (carcinogenicity, developmental toxicity, endocrine activity, mutagenicity and genotoxicity, reproductive toxicity) Human Health Group 2 (acute mammalian toxicity) Environmental Hazards Acute aquatic toxicity Environmental Fate Bioaccumulation Persistence	No	Chemicals are rated based on an aggregated score, but toxicity can also be assessed based on individual endpoints. Ratings are as follows: Grade A – Few concerns, i.e., safer chemical - Preferable Grade B – Slight concern - Improvement possible Grade C – Moderate concern - Use but search for safer Grade F – High concern - Avoid	QCAT focuses on important hazard endpoints, lowers data requirements, and provides a significant amount of information with a relatively low investment of resources.	Because only a limited number of hazard endpoints are evaluated, QCAT does not provide a comprehensive evaluation of alternatives.
P2OASys (Pollution Prevention Options Assessment System) http://www.turi.org/ p2oasys Developed by the Toxic Use Reduction Institute (TURI) at the University of Massachusetts, Lowell to assist companies assess and compare environmental, worker, and public health impacts of alternative technologies. The tool automatically compares current processes to alternatives based on 11 endpoints using an aggregated score, which is dependent upon the proportion of chemical present	Human Health Hazards Acute human effects Chronic human effects Exposure potential Environmental Hazards Aquatic hazards Atmospheric hazards Disposal hazards Energy and resource use Environmental Fate Bioaccumulation Persistence Chemical/Physical Properties Chemical hazards Physical hazards Product hazards	P2OASys worksheet allows user to consider exposure potential and life cycle issues including atmospheric hazard, disposal hazard, energy and resource use, product hazard (upstream effects, consumer hazard and disposal hazard)	User can set data certainty and weighting factors for each endpoint The tool automatically calculates an aggregated score for each alternative. User can manually compare alternatives based on individual endpoint categories NOTE: P2OASys is currently undergoing revision to better align with other tools such as GreenScreen and GHS	User collects data from external sources and inputs both quantitative and qualitative data on chemical toxicology, ecological effects, physical properties, and likely changes in work organisation as a result of a proposed option Tool includes data associated with the process in which the chemical is used, to help determine potential occupational exposures. Tools allows user to weigh specific characteristics of the alternatives to address the company's concerns	Requires significant effort from user to research and input data Likely inconsistencies in application of "professional judgment" create limitations in using tool across organisations, unless significant explanation of assumptions made is provided
U.S. EPA DfE Alternatives Assessment Criteria for Hazard Evaluation https://www.epa.gov/ saferchoice/alternatives-assessment-criteria-hazard-evaluation Devloped by U.S. EPA DFE Program as a transparent tool for evaluating and differentiating among chemicals based on their human health and environmental hazards Criteria document was last updated in August 2011	Human Health Effects: Acute Mammalian Toxicity Carcinogenicity Mutagenicity/Genotoxicity Reproductive and Developmental Toxicity (including Developmental Neurotoxicity) Neurotoxicity Repeated Dose Toxicity Respiratory and Skin Sensitization Eye and Skin Irritation/Corrosivity Endocrine Activity Environmental Toxicity and Fate: Aquatic Toxicity Environmental Persistence Bioaccumulation	Life cycle thinking includes consideration of potential worker, consumer, and environmental exposures Degradation or metabolism of a chemical into a hazardous by-product is considered in the hazard assessment	For each endpoint, the criteria define "High," "Moderate," and "Low" concern (in some cases "very high" and "very low." Results are provided in table and color-coded according to high, moderate, low ranking Results are not aggregated	The tool uses existing primary data and predictive modeling to determine human health and environmental hazards of each chemical under evaluation Summary table arrays the hazard classifications of each chemical for human health effects, ecotoxicity, environmental impacts, and potential routes of exposure allowing for easy comparison of alternatives	Biggest limitation in this methodology is data gaps Developing this tool required significant stakeholder input and there are significant costs associated with filling data gaps

Table 3: Economic and technical feasibility assessment tools

Method/tool (with url)	Brief description	Metrics considered	Decision-making framework	Strengths	Weaknesses
Economic feasibility assessment
Cost accounting methods established by pollution prevention programs
Massachusetts Toxics Use Reduction Program TURA Planners Guide, Section IVB 8: Economic Assessment http://www.mass.gov/eea/docs/dep/toxics/laws/planguid.doc	Required of facilities regulated under TURA that are developing TUR plans Economic assessment of TUR options, which can include substitution, must be considered in the required TUR plans	Indirect and direct labor and materials costs Purchase or manufacturing cost of the toxic chemical and its alternative chemical Capital and equipment costs	"A good faith and reasonable business decision" that the technique is either (a) clearly economically infeasible or (b) economically feasible	Outlines a minimal set of cost parameters to consider in an options analysis	No detailed methods, or suggested use of long-term cost assessment (for example, NPV)
National Pollution Prevention Roundtable Cost Calculator http://www.p2.org/2014/07/p2-data-calculators/	An Excel spreadsheet with macros, designed to walk a user through the costs associated with hazardous waste management, air emissions (Title V pollutants or HAPs), water pollution (BOD/COD, TSS, toxics, nutrients), water use, fuel use (heating source and transportation), electricity use (conventional vs green), non-hazardous inputs and solid waste	Cost per unit Considers reduction/ savings as well as use Provides for some state-specific input	"The tool is designed to track annual savings or conservation"	Helps identify various costs associated with the use of toxics and their alternatives; provides an aggregate overview of various inputs to the overall cost; developed by Pacific Northwest PPRC and updated by EPA OPPT	Requires significant data input; hasn't been updated in 7 years – no entity "owns" it
Washington Department of Ecology Cost Analysis for Pollution Prevention https://fortress.wa.gov/ecy/publications/documents/95400.pdf	Publication provides a list of important costs to consider when evaluating pollution prevention projects (assessment of current costs and costs of alternative) as well as summary economic measures (for example, net present value, pay-back periods)	Production costs (capital equipment, operating expenses (for example, chemical costs, maintenance, utilities) Compliance and oversight costs (for example, emissions control, hazardous waste, permits, industrial hygiene training) Potential liabilities Intangible/externalized costs	Suggests to use summary economic measures, for example net present value (NPV), pay-back period, return on investment (ROI) to arrive at a single summary economic figure to use for financial comparisons	Many of these cost/financial assessments endpoints and methods are standard facility accounting techniques	Most direct/facility-specific costs will be difficult for gov't entities to quantify. These methods are best achieved if industry/facilities are conducting the assessment
New England Waste Management Organization Financial Assessment of Pollution Prevention Investments http://www.newmoa.org/publications/competitive.pdf	Comprehensive training manual that thoroughly reviews Environmental Full Cost Accounting methods	Operating costs (for example, capital equipment, operating expenses, chemical costs, waste management, maintenance, utilities, labor, regulatory compliance) Potential liabilities Intangible/externalized costs	Suggests to use summary profitability measures, for example net present value (NPV), pay-back period, return on investment (ROI)	Comprehensive manual Includes provisions on including "qualitative" information	Most direct/facility-specific costs will be difficult for gov't entities to quantify. These methods are best achieved if industry/facilities are conducting the assessment
Informative economic assessment methods/tools in alternatives assessment frameworks
BaUA TRGS 600 http://www.baua.de/en/Topics-from-A-to-Z/Hazardous-Substances/TRGS/pdf/TRGS-600.pdf?__blob=publicationFile&v=3	This alternatives assessment framework includes a table on comparative economic assessment that outlines a method/model (page 16 of the pdf)	Material costs Equipment costs Labor costs Insurance Technical/Worker protective measures Transportation Storage Disposal Nontangible/externalized costs and benefits	Relative cost differences (for example: ++/+/0/-/--) are used to help compare costs across the range of metrics	Outlines a qualitative method for assessing costs it is difficult to quantify
California Safer Consumer Product Analysis of Alternatives Guidance http://www.dtsc.ca.gov/SCP/AlternativesAnalysisGuidance.cfm	Section 8 describes the economic impact evaluation requirements, which includes assessment of internal costs and external costs (costs to human health, the environment and gov't agencies"	Internal Costs (manufacturing, marketing, materials and equipment acquisition, and resource consumption costs) External costs (environmental impact, human health impact, impact to gov't agencies)		Reviews a series of external cost analysis approaches (for example, willingness to pay, use of environmental attributable fractions to calculate health costs; DALYs, etc) Provides links to available data sources	Complicated array of external cost assessment methods, which reflects the lack of standardized approaches in this field for alternatives assessment
European Chemicals Agency - Guidance on the Preparation of Socio-Economic Analysis as Part of an Application for Authorization https://echa.europa.eu/documents/10162/13637/sea_authorisation_en.pdf	Provides approaches steps to estimate health and environmental costs which is required of applications where the AoA has determined no feasible alternative; The SEA is used by the applicant to justify that continued benefit of using the substance outweighs the risk to health and environment	External costs: human impacts, environmental impacts, social impacts, economic impact, trade and economic development impacts		Methods easier for those with nationalized health care with easier access to health impact and cost data on a national basis. Detailed guidance and review of methodological options	Methods are limited in the valuation of health impacts. Cancer is among the only impact that is calculated in terms of societal costs
Technical/performance feasibility assessment
Massachusetts Toxics Use Reduction Program TURA Planners Guide, Section IVB 7: Technical Assessment http://www.mass.gov/eea/docs/dep/toxics/laws/planguid.doc	Required of facilities regulated under TURA that are developing TUR plans. Technical assessment of TUR options, which can include substitution, must be considered in the required TUR plans.	Does it reduce use or byproduct per unit of product? Does it avoid shifting risk? Is it legal? Can customer and quality specifications be met? Is it reliable and stable? Is there adequate physical space? Can workers gain necessary expertise?	"There are no explicit criteria for a technical evaluation. Facilities may go about the evaluation in whatever way they generally evaluate projects, as long as they do the analysis in good faith, use good engineering practices, and document the assumptions and work performed in the analysis."	Optional chart to help determine tech. feasibility provided Requires technical evaluation be conducted prior to economic evaluation	Specific metrics not provided – requires facility-specific knowledge

Table 4: Alternative assessment frameworks*
*Defined as including a comparative assessment of alternatives (chemicals or technologies) of hazard, performance and economics, at minimum. This list is an updated, but smaller inventory of alternatives assessment frameworks as reviewed by Jacobs M et al. Environ Health Perspect. 2016;124(3):265-80 and considered most instructive for CEPA 1999 considerations.

Alternatives assessment framework	Description/purpose	Strengths	Limitations
Draft Alternatives Analysis Guide California Department of Toxic Substances and Control, 2016 (draft)	Guidance for enterprises that are required to complete an AA based on regulatory requirements. Consumer product-level focus	Comprehensive Includes thoughtful inclusion of a life cycle perspective Scoping phase useful to determine relevant factors/endpoints to consider in assessment Includes the concept of "necessity" in the evaluation of functional use requirements	Resource Intensive Complicated for SMEs to use
Minimising Chemical Risk to Workers Health and Safety Through Substitution European Commission, DG Employment, 2012	Guidance for enterprises to help comply with various Commission-level directives (for example, CMD and CAD directives)	Helpful for SMEs; easy format to use/follow Includes options for increasing levels of comprehensiveness (resource-intensive data sources, and data outputs increases as the level increases) Includes the concept of "necessity" in the evaluation of functional use requirements Helpful tables to show how comparisons can be made across attributes and across alternatives	Limited evaluation/consideration of environmental/ecological endpoints
Alternatives Assessment Guide V1.1 Interstate Chemicals Clearinghouse, 2017	Developed for enterprises but of use to government authorities. AA guidance developed by NGO comprised of state environmental/hazardous waste agencies	Comprehensive Includes options for increasing levels of comprehensiveness (resource-intensive data sources, and data outputs increases as the level increases) Outlines methods for the consideration of data gaps Detailed decision-making approach framework Parallels elements in the NRC framework, but more detailed on performance and economic assessment	Long guidance document; not user friendly for SMEs
MA Toxics Use Reduction Institute (MA TURI 2006; Eliason et al. 2011)	Internal protocol for the agency to provide information to enterprises on alternatives	Comprehensive and detailed, yet flexible	Limited utility for evaluation at the product-level
A Framework to Guide the Selection of Chemical Alternatives National Research Council, 2014	Guidance for enterprises, NGOs and government authorities	Authoritative body of experts Comprehensive and detailed guidance Outlines methods for the consideration of data gaps (elevates the use of predictive toxicology data streams)	Limited utility for the evaluation of costs and performance
Assessing Safer Chemical Alternatives Ontario Toxics Use Reduction Program, 2012)	Guidance for enterprises	Strong life-cycle perspective Clear comparative ranking methodology	Limited utility for evaluation at the consumer product-level
Guidance on the Preparation for an Application for Authorisation European Chemicals Agency, 2011)	Guidance for enterprises that are required to complete an AA based on regulatory requirements.	Comprehensive guidance	Hazard endpoints to be considered are undefined with the exception of CMRs
Guidance for the Preparation of an Annex XV Dossier for Restrictions European Chemicals Agency, 2007	Guidance for government authorities complete an AA in support of a chemical restriction proposal	Coverage of basic elements for an alternatives assessment	Dependent on readily available data, limits comprehensiveness possible for evaluation of cost and performance
General Guidance on Considerations Related to Alternatives and Substitutes for Listed Persistent Organic Pollutants and Candidate Chemicals Stockholm Convention, UNEP 2009	Guidance for enterprises/ authorities	Basic coverage of alternatives assessment components	Limited utility for worker safety and health considerations
TRGS 600 BAuA, 2008	Guidance for enterprises to help comply with the German Hazardous Substances Ordinance (which complies with EC directives (for example, CMD and CAD directives)	Created for SMEs Comprehensive consideration of worker safety and health attributes Outlines methods for the consideration of data gaps Includes use of physicochemical data to help evaluate intrinsic exposure Includes hazard assessment tools (for example, column model) and economic assessment framework	Limited evaluation of environmental/ ecological endpoints Limited utility for evaluation at the consumer product-level
U.S. EPA - Safer Choice (formerly DFE) Program (Lavoie et al. 2010; U.S. EPA 2011)	Internal protocol for the agency to provide information to enterprises on alternatives	Comprehensive consideration of hazard attributes with clear comparative ranking methodology Includes the concept of "necessity" in the evaluation of functional use requirements	Limited utility for evaluation of performance and cost Primarily focused on hazard evaluation No longer being used
Cleaner Technologies Substitute Assessment: A Methodology and Resource Guide U.S. EPA, 1996	Internal protocol for the agency to provide information to enterprises on alternatives	Comprehensive and detailed	No longer being used
Instructions for the Significant New Alternatives Policy (SNAP Program) TSCA/SNAP Addendum U.S. EPA, 2011	Internal protocol for the agency and guidance for enterprises to submit information on alternatives	Basic coverage of alternatives assessment components	Dependency on use of OELs as a means to cover a range of health hazards Elevates concern for environmental endpoints over human health (potential risk tradeoffs)
Transitioning to Safer Chemicals: A Toolkit for Employers and Workers U.S. OSHA, 2013	Guidance for enterprises	Easy to use Includes the concept of "necessity" in the evaluation of functional use requirements	Limited utility for ecological endpoints Light on specific methods to use