This appendix provides a brief overview of methods for addressing ecological and environmental evaluation used by chemical alternatives assessment frameworks.
- BizNGO Alternatives Assessment Protocol (Rossi et al. 2012)
- California Safer Consumer Products Regulation (CA DTSC 2013)
- EPA’s Design for the Environment (DfE) Chemical Alternatives Assessments (EPA 2011)
- Lowell Center Alternatives Assessment Framework (Rossi et al. 2006)
- REACH Authorization Analysis of Alternatives (ECHA 2011)
- TURI Alternatives Assessment Process Guidance (TURI 2006a)
- UNEP Persistent Organic Pollutants Review Committee General Guidance on Alternatives (UNEP 2009)
- Interstate Chemicals Clearinghouse (IC2) Alternatives Assessment Guidance (IC2 2013)
- German Guide on Sustainable Chemicals (Reihlen et al. 2011)
- UCLA Multi-Criteria Decision Analysis (Malloy et al. 2011)
Table B-1 summarizes the ecological assessment approach for the 10 chemical alternatives assessment frameworks.
|Level of Specificity||Risk Assessment Elements||Environmental Assessment Elements|
|Hazard Assessment||Hazard End Points||Exposure Assessment||Exposure Criteria|
|Aquatic End Points||Terrestrial End Points||Other End Points||Bioaccumulation||Persistence||Mobility|
|BizNGO||Non-specific, defers to other methods for specifics of analysis.||Precedes technical and economic feasibility.||Defers details of analysis to other methods.||None recommended||Assumes that where use patterns are similar, exposure will be equal.||None recommended||None recommended||Defers to vaguely defined “Life Cycle Thinking” to address assessment of potential for global warming, end-of-life management, and worker exposure.|
|EPA DfE||Provides explicit end points for assessing hazard.||This is largely a Hazard Evaluation Method.||See Table 7-1.||End points based on EPA Office of Pesticide Programs Ecotoxicity Categories for Terrestrial Organisms||Other toxicological end points to consider if data are available: epigenetic toxicity, lactational or transplacental transfer. Specific target organ toxicity—single exposure, wildlife developmental impairment, wildlife growth impairment, wildlife survival impairment, wildlife reproductive impairment, immunotoxicity.||Not robustly considered other than to provide criteria for assessing general aspects of environmental fate: persistence in water, sediment, and soil, and bioaccumulation.||See Table 5-2.||Based on data on ultimate degradation and persistence of degradation products. In absence of measured data, the requirement is to use information on analogs or estimated valued from models (EPA Suite or SPAEC). Considers persistence in soil, sediment, and water. Categorizes persistence into four categories based on half-life ranging from "readily biodegradable to 180 days half-life.||Not separately considered||Lists various end points to consider if data are available, including: domestic animal toxicity, mobility in the environmental media, ozone formation, eutrophication, global warming potential, loss of genetic diversity/biodiver sity, non-target phytotoxicity.|
|German Guide on Sustainable Chemicals||A guide for selecting sustainable chemicals based on exposure as much as hazard.||The Guide uses the term “problematic properties related to the environment.”||See Table 7-1.||None||None||Exposure is emphasized and assess in some detail as a “problematic property” of a chemical. With two categories: persistent, bioaccumulative and toxic and very persistent and very bioaccumulative.||Two categories of bioconcentration factors >2000 and >5000 (bioacummulatable vs very bio-acummulatable).||Half-life criteria on the same order but not exactly the same as GHS criteria. Parsed by freshwater/estuarine vs marine (no explanation given).||Explicit evaluations that include release potential (solubility, vapor pressure) and sub criteria for short- and long- range transport and transport as a “dusty” chemical.||Use of resources; greenhouse gas potential as mass of carbon dioxide per kg of substance produced. “Origin of raw materials,” including some value-laden criteria such as “supplier doesn't care about environmental protection” and social responsibility; Numerous “use of resources criteria” - such as renewability, energy consumption, water consumption, and waste production.|
|Interstate Chemicals Clearinghouse (IC2) Alternatives Assessment Guidance||A detailed method for assessing chemicals through a long series of questions. The document specifies other tools that can be used to answer these questions (GreenScreen, GreenScreen® Plus), but does not offer its own methods for assessment.||Based on GreenScreen ® and GreenScreen ® Plus||See Table 7-1.||Lists wildlife development growth, reproductive, and survival impairment. Phytotoxicity recommended as end points but provides no method for assessment.||Lists eutrophication but offers no evaluative scheme.||Recognizes six levels of exposure from exposure assessment evaluation to full exposure assessment as found in risk assessment guidance.||See Table 5-2.||Uses GreenScreen® Criteria||Not explicitly addressed.||Not explicitly addressed.|
|Level of Specificity||Risk Assessmen||Elements||Environmental Assessment Elements|
|Hazard Assessment||Hazard End Points||Exposure Assessment||Exposure Criteria|
|California Safer Consumer Products Regulation||A listing and brief description of various hazard assessment and exposure assessment tools with no specific recommendations.||Refers the reader to other specific evaluation methods.||Refers the reader to other specific evaluation methods.||Refers the reader to other specific evaluation methods.||Refers the reader to other specific evaluation methods.||Refers the reader to other specific evaluation methods.||Refers the reader to other specific evaluation methods.||Refers the reader to other specific evaluation methods.||Refers the reader to other specific evaluation methods.||Refers the reader to other specific evaluation methods.|
|Lowell Center Alternatives Assessment Framework||A high-level, general framework in flowchart format that includes three “core elements”: Alternatives Assessment Foundation; Alternatives Assessment Process; and Evaluation modules. One of these modules is “Human Health and the Environment.”||Refers the reader to other specific evaluation methods.||Refers to various other methods.||Refers to various other methods.||Refers to various other methods.||Refers to various other methods.||One of the decision- making rules in this alternatives framework is to “Avoid alternatives that are the direct source of persistent, bioaccumulative toxics (PBTs) across their lifecycle.”||One of the decision- making rules in this alternatives framework is to “Avoid alternatives that are the direct source of persistent, bioaccumulative toxics (PBTs) across their lifecycle.”||Refers to various other methods.||Refers to various other methods.|
|REACH Authorisation Analysis of Alternatives||Requires the use of a predicted no effect concentration.||Requires the use of a predicted no effect concentration.||Requires the use of a predicted no effect concentration, such as food chain effects.||If a substance is shown to be PBT or vPvB, then an exposure assessment and risk characterization is required.||Uses the concept of vPvB with described substances that are characterized by high persistence and high bioavailability but not necessarily by proven toxicity.||Uses the concept of vPvB with described substances that are characterized by high persistence and high bioavailability but not necessarily by proven toxicity.||None||None|
|TURI Alternatives Assessment Process Guidance P2OASys||TURI provides a review of methods for alternatives assessment, including the P2OSys, which it developed.||Uses a numerical scoring system (2,4,6,8) to characterize acute and chronic aquatic toxicity.||See Table 7-1.||None||None||Scores exposure potential environmental and worker impacts.||See Table 5-2.||Scored based on hydrolysis half- life ranging from 4 to 500 days||None|
|UCLA MCDA||Compendium of approaches that refer the reader to various assessment methods or software for evaluating environmental effects.||Provides summary of various methods.||Provides summary of various methods.||Provides summary of various methods.||Provides summary of various methods.||Provides summary of various methods.||Provides summary of various methods.||Provides summary of various methods.||Provides summary of various methods.|
|UNEP Persistent Organic Pollutants Review Committee General Guidance on Alternatives||High-level framework that specifies general steps to be taken in the environmental assessment of risk from persistent organic pollutants.||Recommended but not specified.||None||None||None||Recommends assessment of release to environment, especially for those chemicals that may be used in “dispersive” products, such as paint or possibly dispersed products such as lubricating oil.||Not considered||Not considered||Consideration of environmental exposures for POPs used in dispersive or possibly dispersive products.|
Relative to ecological risk and environmental assessment, BizNGO presents a broad, step-by-step protocol to compare the safety of chemical alternatives. Although it is labeled as a protocol, it does not provide the level of methodological detail that allows the user to conduct a comparative evaluation. Rather, it offers seven broad steps to be taken in series when conducting a chemical alternatives assessment. The protocol explicitly emphasizes hazard assessment over exposure assessment and requires hazard assessment to occur in advance of technical or economic analysis of the chemicals that are being compared. The following discussion points show how the BizNGO steps are relevant to ecological risk or environmental assessment.
Step 1: Identify chemicals of concern. BizNGO generally relies on specific lists to complete this step. This approach does not conform to methods that ecologists usually use to identify chemicals of concern for purposes of environmental assessment or risk assessment. Ecologists generally rely on functional attributes of chemicals that characterize its potential for persistence, bioaccumulation, or toxicity.
Steps 2 and 3: Characterize end uses and function and identify alternatives. There is no ecological assessment involved at these steps. BizNGO defers human and ecological assessment to other resources.
Step 4: Assess chemical hazards. BizNGO directs the reader to other methods (for example, EPA DfE or GreenScreen® “benchmarking”) and depends on GreenScreen® to assess and classify human and environmental health based on 17 end points into one of four benchmarks. GreenScreen® includes assessment of breakdown products. BizNGO also references other screening methods, such as Washington State DEP Quick Chemical Assessment Tool (WA Department of Ecology 2014) and Massachusetts Toxics Use Reduction Institutes Five Chemicals Alternative Assessment Study (TURI 2006b).
Step 5: Technical and economic performance. No ecological aspects included.
Step 6: Apply Life Cycle Thinking. This step suggests the use of Life Cycle Thinking (an undefined term) to assess “other human health and environmental impacts such as global warming, end-of-life management, and worker exposure.”
DESIGN FOR THE ENVIRONMENT (DfE)
EPA’s DfE assessment framework is a hazard-based assessment protocol that incorporates six general requirements into the alternatives assessment:
- Data for all relevant exposure routes are evaluated.
- The review of toxicological data uses the U.N. Globally Harmonized System of Classification and Labelling of Chemicals (GHS) criteria and EPA risk-assessment guidance to identify no observed adverse effect level (NOAEL) or no observed adverse effect concentration (NOAEC) and lowest observed adverse effect level (LOAEL) or lowest observable adverse effect concentration (LOEAC) data where possible.
- EPA High Production Volume (HPV) Challenge Program and OECD HPV Programme data guidelines are used.
- Peer-reviewed studies, government reports, and confidential sources of information are incorporated into the characterization of toxicity.
- The sensitivity of test species is considered in the evaluation of data.
- The hazard assessment considers degradation or metabolism of a chemical into a by-product that might itself be hazardous.
The hazard assessment parses end points into four hazard designations (very high, high, moderate, and low level of concern) on the basis of certain criteria (see Table 7-1 and Tables 5-2 to 5-5). Relevant environmental end points include acute aquatic toxicity (in water) based on LC50 or EC50 data; chronic aquatic toxicity (in water) based on NOEC or LOEC data; avian acute toxicity based on an acute oral dose or concentration in the diet; acute bee toxicity; persistence in water, soil, or sediment based on half-life; persistence in air based on a qualitative assessment of data; and bioaccumulation based on BAF or BCF or Kow. The framework recognizes that other end points might be applicable if data are available. They include domestic animal toxicity, epigenetic toxicity, mobility in environmental media, ozone formation, eutrophication, global warming potential, lactational or transplacental transfer, loss of genetic diversity or biodiversity, non-target phytotoxicity, specific target organ toxicity from a single exposure, wildlife developmental impairment, wildlife growth
impairment, wildlife survival impairment, wildlife reproductive impairment, and immunotoxicity.
GERMAN GUIDE ON SUSTAINABLE CHEMICALS
The Guide on Sustainable Chemicals (Reihlen et al. 2011) is for selecting sustainable chemicals on the basis of lists, dangerous chemical properties, human health toxicity, “problematic properties related to the environment, mobility,” origin of raw materials, greenhouse-gas emissions, and resource consumption. It uses a color-coded system (green, yellow, red) and white (for insufficient information). This guidance emphasizes exposure to a greater degree than most other frameworks and incorporates mobility in terms of release potential, criteria for short- and long-range transport, and Aeolian transport as a dusty chemical.
INTERSTATE CHEMICALS CLEARINGHOUSE ALTERNATIVES ASSESSMENT GUIDANCE
IC2 (2013) is a detailed method for assessing chemicals through a long series of questions posed within two general types of modules: scoping modules and assessment modules. The assessment modules include performance evaluation, hazard, cost and availability, exposure assessment, materials management, social impact, and Life Cycle Thinking. The hazard module uses GreenScreen® and GreenScreen® Plus to assess hazard but does not offer its own methods for assessment. The method categorizes end points as low, moderate, or high based on the ranges shown in Table 7-1 and Tables 5-2 to 5-5. This framework recognizes the potential importance of terrestrial ecological hazards and eutrophication but offers no specific evaluative methods.
CALIFORNIA SAFER CONSUMER PRODUCTS REGULATION
California regulation (Safer Consumer Products, Regulations, R-20011-02) specifies that the California Department of Toxics Substances Control (the Department) shall provide on its website guidance materials for conducting alternatives assessment and that the assessment shall evaluate “environmental fate” and “adverse environmental impacts,” among other topics. Subsequently, the Department (CA DTSC 2012) published a list and brief descriptions of the following:
- Hazard assessment methods that include GreenScreen®, Globally Harmonized System, EPA Source Ranking Database, EPA Cluster Scoring System, and OECD Screening Information Data Set.
- Exposure assessment methods that include EPA PBT profiler, EPA ChemSTEER, EPA E-FAST, and EPA EPI Suite (with the caution that the programs in this suite provide screening values and should not be used when direct property measurements are available); EPA PIRAT, EPA ReachScan, EPA ECOSAR (which the document recognizes as a predictor of toxicity but lists as an exposure assessment method), NIOSH Control Banding (human health only), UK COSHH (human health only), CleanGredients, UC Berkley PLUM, SUBSPORT Portal, P2OASys, and Pharos (human health only).
Neither the regulations nor the published descriptions make specific recommendations regarding the use of the hazard assessment or exposure assessment tools noted.
LOWELL CENTER ALTERNATIVES ASSESSMENT FRAMEWORK
The Lowell Center Alternatives Assessment (LCSP) Framework (Rossi et al. 2006) is in flowchart format and includes three core elements: alternatives assessment foundation, alternatives assessment process, and evaluation modules. One of the evaluation modules is “Human Health and the Environment.” The LCSP framework prefers methods that present disaggregated data in their actual values for comparison across evaluation categories or hazards (as opposed to creating a single number to compare across options). That approach is used to increase transparency and the ability to identify trade-offs among categories. The framework promotes “creating summary tables from the evaluation modules to support the selection process.”
The Human Health and the Environment module does not provide a framework-specific method for evaluating environmental effects. Rather, it directs the reader to various assessment methods or software that can serve that purpose. They include:
- The “Evaluation Matrix” developed for the German Federal Environmental Agency;
- “Quick Scan” developed by The Netherlands;
- PRIO” developed by the Swedish Chemicals Inspectorate;
- “The Column Model” developed by the German Institute for Occupational Safety;
- The “Pollution Prevention Options Analysis System” (P2OASys) developed by the Massachusetts Toxics Use Reduction Institute;
- The “Cradle to Cradle Design Protocol” developed by McDonough Braungart Design Chemistry;
- The “Chemicals Assessment and Ranking System” designed by the Zero Waste Alliance;
- The “P2 Framework Models” developed by EPA;
- EPA DfE Program;
- EPA’s chemical alternatives assessment developed in Furniture Flame Retardancy Partnership; and
- The “GreenList” process developed by the SC Johnson Company.
REACH AUTHORISATION ANALYSIS OF ALTERNATIVES
The REACH framework is published by the European Chemicals Agency and is used to conduct chemical safety assessments. It follows the familiar risk paradigm, incorporating hazard assessment and exposure assessment into a risk characterization. If a substance is shown to be a persistent, bioaccumulative, and toxic (PBT) chemical or a very persistent and very bioaccumulative (vPvB) chemical, an exposure assessment and risk characterization are required. The exposure assessment addresses operational conditions, such as duration and frequency of use, amount used, concentration in the product, and process temperature and local measures, such as ventilation, air filtering, wastewater treatment, and personal protection equipment.
TURI ALTERNATIVES ASSESSMENT PROCESS GUIDANCE
The Massachusetts Toxics Use Reduction Institute report (Edwards et al. 2005) is a survey of methods and tools used in alternatives assessment. It provides an appendix that summarizes more than 100 various methods and tools available for use in chemical assessment. The report reviews nine methods for alternatives assessment of chemicals and divides them into hazard display methods (several of which aggregate data to create a risk index for comparing substances) and screening methods that evaluate a range of hazards and recommend elimination of those that “are deemed to be a high risk.” The hazard display methods include:
- Pollution Prevention Options Analysis System developed by the Institute;
- The Column model;
- Five-Step Evaluation Matrix created by the
- German Federal Environmental Agency; and
- Chemicals Assessment and Ranking System designed by the Zero Waste Alliance, a private consulting organization based in Oregon.
The screening methods contain built-in decision rules to determine priorities for eliminating a chemical on the basis of inherent hazard. The screening methods include Quick Scan, PRIO, Norwegian Guidelines, and C2C protocol and the PBT profiler. Among those methods, P2OASys is the software tool developed by TURI to determine the potential environmental, worker, and public-health impacts of alternative technologies. Table B-1 shows the categorization system used in P2OASys.
UNITED NATIONS ENVIRONMENT PROGRAM PERSISTENT ORGANIC POLLUTANTS REVIEW COMMITTEE GENERAL GUIDANCE ON ALTERNATIVES
UNEP (2009) provides a general description of the issues to be considered in identifying and evaluating alternatives to listed persistent organic pollutants and candidate chemicals. In assessing risks, it considers the hazardous properties of persistent organic pollutants. UNEP requires the collection of information on the release of a chemical into the environment if it is to be used in dispersive products (such as paints) and that some release to the environment should be considered for non-dispersive products (such as lubricants). The guidance requires at least a simple risk assessment, taking into account the weight of available evidence. This high-level guidance does not provide specific recommendations, categorization protocols, or endpoint ranges to characterize ecological toxicity, environmental impact, or exposure.
UNIVERSITY OF CALIFORNIA LOS ANGELES MULTI-CRITERIA DECISION ANALYSIS
The MCDA method provides a comparative alternatives assessment based on a wide range of criteria, including physicochemical hazards; human health, ecological, and environmental impacts, as well as technical and economic feasibility. The method recognizes two categories of ecological impacts: adverse effects (aquatic animal or plant species, aquatic and terrestrial ecosystems, endangered or threatened species, and environmentally sensitive habitats) and exposure (volume in manufacturing, volume in consumer use, extent of dispersive use, persistence, and bioaccumulation). Environmental impacts include three broadly populated categories: adverse air quality effects, adverse water quality effects, and adverse soil quality effects.
CA DTSC (California Department of Toxic Substances Control). 2012. Alternative Analysis Workshop Tools, Methodologies and Frameworks [online]. Available: www.dtsc.ca.gov/PollutionPrevention/upload/WorkshopTables.pdf [accessed July 22, 2014].
CA DTSC (California Department of Toxic Substances Control). 2013. Safer Consumer Products [online]. Available: https://dtsc.ca.gov/LawsRegsPolicies/Regs/SCPA. cfm [accessed June 26, 2014].
ECHA (European Chemical Agency). 2011. Guidance on the Preparation of an Application for Authorization. European Chemical Agency, Helsinki, Finland. January 2011 [online]. Available: http://echa.europa.eu/documents/10162/13643/authorisation_application_en.pdf [accessed June 26, 2014].
Edwards, S., M. Rossi, and P. Civie. 2005. Alternatives Assessment for Toxic Use Reduction: A Survey of Methods and Tools. Toxic Use Reduction Institute [online]. Available: http://www.turi.org/TURI_Publications/TURI_Methods_Policy_Reports/Alternatives_Assessment_for_Toxics_Use_Reduction_A_Survey_of_Methods_and_Tools._2005 [accessed July 22, 2014].
EPA (U.S. Environmental Protection Agency). 2011. Design for the Environment Program Alternatives Assessment Criteria for Hazard Evaluation, Version 2.0. Office of pollution Prevention and Toxics, U.S. Environmental Protection Agency [online]. Available: http://www.epa.gov/dfe/alternatives_assessment_criteria_for_hazard_eval.pdf [accessed July 22, 2013].
IC2 (Interstate Chemicals Clearinghouse). 2013. Interstate Chemicals Clearinghouse Alternatives Assessment Guide, Version 1.0. November 2013 [online]. Available: http://www.newmoa.org/prevention/ic2/IC2_AA_Guide-Version_1.pdf [accessed June 26, 2014].
Malloy, T.F., P.J. Sinsheimer, A. Blake, and I. Linkov. 2011. Developing Regulatory Alternatives Analysis Methodologies for the California Green Chemistry Initiative. Sustainable Technology and Policy Program, University of California, Los Angeles, CA. October 20, 2011[online]. Available: http://www.stpp.ucla.edu/sites/default/files/Final%20AA%20Report.final%20rev.pdf [accessed June 26, 2014].
Reihlen, A., D. Bunke, R. Gross, and D. Jepsen, eds. 2011. Guide on Sustainable Chemicals: A Decision Tool for Substance Manufacturers, Formulators and End Users of Chemicals. Federal Environmental Agency, Dessau-Rosslau, Germany. April 2011 [online]. Available: http://www.umweltbundesamt.de/sites/default/files/medien/publikation/long/4169.pdf [accessed June 26, 2014].
Rossi, M., J. Tickner, and K. Geiser. 2006. Alternatives Assessment Framework of the Lowell Center for Sustainable Production. Version 1.0. July 2006 [online]. Available: http://www.chemicalspolicy.org/downloads/FinalAltsAssess06.pdf [accessed June 26, 2014].
Rossi, M., C. Peele, and B. Thorpe. 2012. BizNGO Chemical Alternatives Assessment Protocol: How to Select Safer Alternatives to Chemicals of Concern to Human Health or to the Environment. The Business-NGO Working Group, April 12, 2012 [online]. Available: http://www.bizngo.org/static/ee_images/uploads/resources/BizNGOChemicalAltsAssessmentProtocol_V1.1_04_12_12-1.pdf [accessed June 25, 2014].
TURI (Toxics Use Reduction Institute), 2006a. Five Chemicals Study: Alternatives Assessment Process Guidance. March 2006 [online]. Available:
TURI (Toxics Use Reduction Institute), 2006b. Five Chemicals Alternatives Assessment Study. University Massachusetts Lowell. June 2006 [online]. Available: http://www.turi.org/TURI_Publications/TURI_Methods_Policy_Reports/Five_Chemicals_Alternatives_Assessment_Study._2006/Full_Report [accessed June 26, 2014].
UNEP (United Nations Environment Programme). 2009. General Guidance on Considerations Related to Alternatives and Substitutes for Listed Persistent Organic Pollutants and Candidate Chemicals. UNEP/POPS/POPRC.5/10/Add.1. Persistent Organic Pollutants Review Committee, Fifth Meeting, October 12-16, Geneva [online]. Available: http://www.subsport.eu/images/stories/pdf_archive/substitution_tools/7_guidance_alt_pop_en.pdf [accessed June 26, 2014].
WA Department of Ecology. 2014. The Quick Chemical Assessment Tool [online]. Available: http://www.ecy.wa.gov/programs/hwtr/chemalternatives/QCAT.html [accessed July 23, 2014].