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Chemicals Alternatives Assessments
Chemicals Alternatives Assessments MH Whittaker, ToxServices LLC, Washington, DC, USA Ó 2014 Elsevier Inc. All rights reserved.
Introduction Chemical alternatives assessment (CAA) is a process for identifying and comparing potential chemical and nonchemical alternatives to replace chemicals or technologies of concern on the basis of hazard, performance, and economic viability. CAAs are used to evaluate and manage hazards and subsequent health risks through the informed choice of safer chemicals. The CAA process is integral to the advancement of green chemistry, which can be defined as the design of chemical products and processes that reduce or eliminate the use and generation of hazardous substances. Historically, materials or chemicals have been selected during the design process based on the assessment and subsequent reduction of human health or environmental risks, as opposed to avoiding hazards or promoting continuous improvement in a chemical, material, product, system, production process, or function. CAA began its development in the late 1990s in the United States as a framework on which to avoid such hazards and promote safer alternatives. Prior to the inception of CAA, life cycle assessment (LCA) and risk assessment were the two primary tools used to select safer alternatives. Ideally, a CAA provides a science-based solution that identifies and characterizes chemical hazards, promotes the selection of less hazardous chemical ingredients, and avoids unintended consequences of switching to a poorly characterized and more hazardous chemical substitute or technology. A number of regulatory initiatives at the state level in the United States (notably, in California, Washington, and Maine), voluntary hazard reduction initiatives such as the US Environmental Protection Agency’s (EPA) Design for the Environment (DfE) Program, and EU and European-country funded initiatives such as SUBSPORT have contributed to the growth of CAA. CAA can be used as a process for identifying alternatives to a hazardous chemical, screening out alternatives of equal or greater hazard, and selecting a less hazardous alternative that is technically and economically viable.
Overview of CAA Frameworks There are three primary CAA paradigms currently in use: The Lowell Center for Sustainable Production’s Alternatives Assessment Framework (Figure 1), BizNGO’s Chemical Alternatives Assessment Protocol (Figure 2), and DfE’s Alternatives Assessment Criteria for Hazard Evaluation (Figure 3). More recently, the Interstate Chemicals Clearinghouse (IC2), an association of state, local, and tribal governments in the United States, has drafted Guidance for Alternatives Assessment and Risk Reduction. Internationally, the Austrian Environment Agency has proposed a draft methodology for the identification and assessment of substances that should be considered for restriction under the European Directive on the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment.
782
These CAA paradigms share many of the same attributes by placing initial emphasis on the assessment of hazards, with LCA and risk-related metrics such as exposure assessment, occurring later in the process. Core elements of a CAA comprise chemical hazard assessment (CHA), life cycle thinking, exposure assessment, technical/functional assessment, economic assessment, and social impact assessment. Examples of CAAs published to date include the following: l
The University of Massachusetts at Lowell Toxics Use Reduction Institute’s Five Chemicals Alternatives Assessment Study (2006) B This set of CAAs assessed the availability of technically and economically feasible safer alternatives for five hazardous chemicals (i.e., lead, formaldehyde, perchloroethylene, hexavalent chromium, and di(2-ethylhexyl)phthalate) l DfE’s Alternatives Assessment Project on Alternatives to Decabromodiphenyl ether (decaBDE) (2012) B This project assessed the toxicity and environmental fate of flame retardant chemicals that are potential alternatives to decaBDE when used in materials and products where decaBDE currently is, or previously was, used as a flame retardant.
Overview of CHA Frameworks CHAs evaluate and manage human health and environmental hazards through the informed choice of safer chemicals. CHAs are based on primary data, data on chemical surrogates, and/or predictive modeling. Each CHA comprises literature search, identification of critical health and environmental effects, identification of data gaps, chemical analog selection and/or use of predictive modeling, including the use of QSAR software (when needed), and assignment of endpoint-specific hazard classifications (usually following the United Nation’s Globally Harmonized System of Classification and Labeling of Chemicals (GHS)). All of these factors are applied to a broad set of toxicological and environmental hazard endpoints. The overall goal of a CHA is to determine whether a proposed chemical alternative is less hazardous to human health and the surrounding environment. Two primary CHA paradigms in use today are the US EPA’s DfE Alternatives Assessment (AA) protocol and Clean Production Action’s GreenScreenÔ. Both CHA methods assess a broad range of health effects and environmental endpoints. As an example, the EPA’s DfE AA paradigm estimates hazards for 17 individual health effects and environmental fate and toxicity endpoints, while GreenScreen assigns hazard classifications to 18 human health, environmental toxicity and fate, and physical characteristics of a chemical. GreenScreen has grown in favor among those who perform CHA because it assigns a quantitative GreenScreen benchmark
Encyclopedia of Toxicology, Volume 1
http://dx.doi.org/10.1016/B978-0-12-386454-3.01239-2
Chemicals Alternatives Assessments
1 Alternatives assessment foundation
Goals and measurable objectives For example • Achieve nontoxic environment by 2020 • Use materials that can be closed loop recycled or composted into healthy nutrients • Use renewable feedstocks and energy
Guiding principles For example • Prevention • Precaution • Substitution • Life cycle perspective
Comparative assessment of existing chemicals materials, or products
783
Decision making rules For example • Prefer solutions that eliminate the function of problematic chemicals • Prefer methods that present disaggregated data
Design assessment for new chemicals, materials, or products
2 Alternatives assessment processes
Identify target(s) for action
Define desired attributes including environmental and human health attributes, and social justice concerns
Characterize end uses and functions Identify alternatives Review selection continuous improvements
Identify alternatives to targeted end uses and functions
Review selection continuous improvements
Evaluate and compare alternatives e.g., chemicals, materials, or products
3 Evaluation
Human health and the environment
Social justice
Economic feasibility
Technical performance
modules
Select and implement preferred alternatives
Figure 1 Lowell Center for Sustainable Production’s alternatives assessment framework. Reproduced with permission from Rossi, M., Tickner, J., Geiser, K., 2006. Alternatives Assessment Framework of the Lowell Center for Sustainable Production. http://www.chemicalspolicy.org/downloads/ FinalAltsAssess06.pdf.
score ranging from 1 to 4 according to specific combinations of hazard classifications, as shown in Figure 4:
l
A GreenScreen score of 1 corresponds to ‘Avoid. Chemical of High Concern’ l A GreenScreen score of 2 corresponds to ‘Use But Search for Safer Substitutes’ l A GreenScreen score of 3 corresponds to ‘Use But Still Opportunity for Improvement’
GreenScreen scores can be compared for individual chemicals or materials, assisting in the selection of less hazardous chemicals or materials during the design process. As an example, acetic acid received a GreenScreen benchmark score of 2 based on very high (vH) hazard scores for Group II and II* human toxicity endpoints, comprising system toxicity/organ
l
A GreenScreen score of 4 corresponds to ‘Prefer. Safer Chemical’
784
Chemicals Alternatives Assessments
1.
Identify chemical(s) of concern
2. Characterize end uses and function
3a. Implement best practices to reduce worker and community exposure
No
3. Identify alternatives: are there potential alternatives including chemicals, material, products, or new designs?
3b. Continue to research alternatives
Yes 4. Assess chemical hazards Evaluate human and environmental health impacts of chemicals and deselect options of greatest concern
5. Evaluate technical and economic performance Yes 6a. Life cycle concerns?
6. Apply life cycle thinking Is there potential for significant life cycle or exposure concerns?
Life cycle evaluation Depending on resources and needs complete partial or fill evaluation of life cycle impacts
Yes
Risk assessment (RA) 6b. Exposure concerns?
Yes No
Depending on resources and needs complete partial or full RA to assess risks
7. Select and implement safer alternatives
Figure 2 BizNGO Chemical Alternatives Assessment Protocol (v.1.1) screening logic for selecting safer alternatives to chemicals of concern to human health or the environment*. Reproduced with permission from BizNGO, 2011. BizNGO Chemical Alternatives Assessment Protocol (v.1.1). November 2011. http://www.bizngo.org/safer.php.
1
Determine that an alternatives assessment is needed
Figure 3
2
Gather available information on alternatives
3
Invite stakeholders, refine the project’s scope, and consider economic reality
US EPA’s DfE alternatives assessment criteria for hazard evaluation.
4 Hazard assessment – conduct literature search, identify data gaps, apply SAR and expert judgment, and determine hazard levels for the alternatives
5
Develop the report
6
Apply the information in decision making for safer substitutes
785
Chemicals Alternatives Assessments
Figure 4 GreenScreen™ benchmarks. Reproduced with permission from Clean Production Action (CPA), 2011. GreenScreenTM Benchmarks. http://www.cleanproduction.org/library/greenScreenv1-2/GreenScreen_v1-2_Benchmarks_REV.pdf.
effects, skin and eye irritation, neurotoxicity, and skin and respiratory sensitization. Acetic acid’s GreenScreen hazard rating table is illustrated in Table 1. Additional GreenScreen assessments can be viewed through Clean Production Action’s GreenScreen website. Acetic acid received a GreenScreen benchmark score of 2 based on hazard scores of very high (vH) for the following endpoints: systemic toxicity (single dose) (ST), skin irritation/corrosivity (IrS), eye irritation/corrosivity (IrE). This corresponds to benchmark classification 2f (very high for any ecotoxicity or Group II and II* human health endpoint) on the GreenScreen benchmarking scheme as shown in Figure 4.
Table 1
GreenScreen™ hazard ratings for acetic acid (2013)
Group I human C L
M L
Acetic acid is classified as a GHS Category 1 specific target organ toxicity chemical based on an inhalation effect level of 1.1 mg l 1 following a single dose, 4 h inhalation exposure in an acute inhalation study in rats. In addition, acetic acid is present on the GHS-Japan screening list as a Category 1 substance (blood) for single exposure systemic toxicity. According to GHS criteria, a specific target organ toxicant following single exposure is categorized as a Category 1 substance (‘have the potential to produce significant toxicity in humans’) in instances where significant toxicity is seen in humans or from studies in experimental. Specifically, the GHS guidance concentration value for a substance to be categorized as a Category 1 single dose inhalation toxicant (vapor form) is
R DG
D L
Group II and II* human E L
ST
AT M
(AA) acute aquatic toxicity (AT) acute mammalian toxicity (B) bioaccumulation (C) carcinogenicity (CA) chronic aquatic toxicity
Single vH
Repeated* L
(E) endocrine activity (F) flammability (P) persistence (N) neurotoxicity (Rx) reactivity
N Single L
Repeated* L
Ecotox
Fate
Physical
SnS*
SnR*
IrS
IrE
AA
CA
P
B
Rx
F
DG
M
vH
vH
M
L
vL
vL
M
M
(IrE) eye Irritation/corrosivity (IrS) skin irritation/corrosivity (M) mutagenicity and genotoxicity (R) reproductive toxicity (SnS) sensitization – skin
(SnR) sensitization – respiratory (ST) systemic/organ toxicity (Cr) corrosion/irritation (skin/eye) (D) developmental toxicity (DG) data gap
Note: Hazard levels – Very High (vH), High (H), Moderate (M), Low (L), Very Low (vL) in italics reflect estimated values and lower confidence. Hazard levels in BOLD font reflect values based on test data (See Guidance). Group II Human Health endpoints differ from Group II* Human Health endpoints in that they have four hazard scores (i.e., vH, H, M, and L) instead of three (i.e., H, M, and L), and are based on single exposures instead of repeated exposures.
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Chemicals Alternatives Assessments
equal to or less than 10 mg l 1 following a 4 h period of exposure. GreenScreen criteria states that any GHS Category 1 substance, or one that is listed on a screening list such as GHS-Japan, is automatically assigned a hazard score of very high (vH) for systemic toxicity (single dose). Acetic acid is associated with the EU Risk Phrase R:35 (‘Causes severe burns’). Risk phrases are categorized as an authoritative list that Clean Production Action (CPA) considers to be based on a comprehensive expert review by a recognized authoritative body (CPA, 2013). Any chemical assigned the EU R-phrase 34 or 35, which correspond to ‘causes burns’ and ‘causes severe burns,’ respectively, will automatically be assigned a hazard score of very high (vH) for IrS. Finally, data from human and animal studies indicate that acetic acid at concentrations equivalent to or higher than 3% in an aqueous solution is likely to be a severe eye irritant. In addition, the ocular damage induced by acetic acid is irreversible. GHS criteria for eye irritation indicate that any substance shown to produce irreversible ocular damage is classified as a Category 1 eye irritant (UN, 2009). CPA criteria state that any GHS Category 1 substance will automatically be assigned a hazard score of very high (vH) for IrE. Acetic acid was assigned a score of moderate (M) for acute aquatic toxicity.
CAA Tools Another set of tools that industry can use to drive sustainability are online databases, such as Pharos, CleanGredients, and SUBSPORT, which promote safer chemical selection and hazardous chemical elimination. The Pharos Building Product Library evaluates more than 1000 products used in buildings, and scores materials and products on endpoints, including volatile organic compound content, toxic content, manufacturing toxics, renewable materials, and renewable energy. The Pharos Chemical and Material Library profiles health and environmental hazards of chemicals throughout various life cycle phases. CleanGredients is an online database that identifies less hazardous chemicals divided by functional use categories, such a less hazardous chelants, solvents, surfactants, among other functional classes. SUBSPORT is an EU, Germany, and Austrian-funded website designed to provide information about, and tools relating to, the substitution of hazardous chemicals. SUBSPORT developed a substitution steps paradigm companies can follow to phase out hazardous chemicals, and it also features an overview and electronic links to substitution/alternative assessment models and tools available around the world, such as the German GHS Column Model, Clean Production Action’s GreenScreen, the Swedish Chemicals Inspectorate’s PRIO database and tool, among others.
See also: Sustainability; Green Chemistry; Hazard Ranking; The Globally Harmonized System for Classification and Labeling of the GHS; Chemicals in Consumer Products.
Further Reading BizNGO, November 2011. BizNGO Chemical Alternatives Assessment Protocol (v.1.1). http://www.bizngo.org/safer.php. BizNGO, 2012. BizNGO Guide to Safer Chemicals. Version 1.0. http://www.bizngo.org/ pdf/GuideToSaferChemicals-v1_2.pdf. Clean Production Action (CPA), 2011. GreenScreen™ Benchmarks. http://www. cleanproduction.org/library/greenScreenv1-2/GreenScreen_v1-2_Benchmarks_ REV.pdf. Clean Production Action (CPA), 2013. The GreenScreen™ for Safer Chemicals Hazard Assessment Procedure. Version 1.2 Guidance. Dated: August 31, 2013. Available: http://www.cleanproduction.org/Greenscreen.php. Clean Production Action (CPA), 2012a. GreenScreen™ Version 1.2 (2e) Hazard Criteria. Dated: November 2012 http://www.cleanproduction.org/library/ GreenScreen_v1_2-2e_CriteriaDetailed_2012_10_10w_all_Lists_vf.pdf. Clean Production Action (CPA), 2012b. GreenScreen™ for Safer Chemicals. Version 1.2 Specified Lists. February 2012 http://www.cleanproduction.org/library/greenscreentranslator-benchmark1-possible%20benchmark1.pdf. Geiser, K., 2001. Materials Matter: Toward a Sustainable Materials Policy (Urban and Industrial Environments). MIT Press. Interstate Chemicals Clearinghouse (IC2), March 2013. Draft Guidance for Alternatives Assessment and Risk Reduction. http://www.newmoa.org/prevention/ic2/ aaguidance.cfm. Lavoie, E.T., Heine, L.G., Holder, H., Rossi, M.S., Lee, R.E., Connor, E.A., Vrabel, M.E., DiFiore, D.M., Davies, C.L., 2010. Chemical alternatives assessment: enabling substitution to safer chemicals. Environ. Sci. Technol. 44 (24), 9244–9249. http:// pubs.acs.org/doi/abs/10.1021/es1015789. O’Brien, M., 2000. Making Better Environmental Decisions. An Alternative to Risk Assessment. MIT Press. Rossi, M., Tickner, J., Geiser, K., 2006. Alternatives Assessment Framework of the Lowell Center for Sustainable Production. http://www.chemicalspolicy.org/ downloads/FinalAltsAssess06.pdf. United Nations, 2011. The Globally Harmonized System of Classification and Labelling of Chemicals (GHS), fourth revised ed. http://www.unece.org/trans/danger/publi/ ghs/ghs_rev04/04files_e.html. United States Environmental Protection Agency (U.S. EPA), August 2011. Design for the Environment Program Alternatives Assessment Criteria for Hazard Evaluation. Version 2.0. http://www.epa.gov/dfe/alternatives_assessment_criteria_ for_hazard_eval.pdf. Whittaker, M.H., Heine, L., 2013. Chemicals alternatives assessment (CAA): tools for selecting less hazardous chemicals. In: Chemicals Alternatives Assessments (Issues in Environmental Science and Technology). RSC Publishing, London.
Relevant Websites http://www.cleanproduction.org/Greenscreen.php – Clean Production Action (CPA). 2013. GreenScreen™ for Safer Chemicals version 1.2 website. http://www.epa.gov/dfe/alternative_assessments.html – Design for the Environment (DfE). 2013. Alternatives Assessments. www.subsport.eu – European SUBSPORT. 2013. European Substitution Portal (SUBSPORT). http://www.cleangredients.org/home – GreenBlue. 2013. CleanGredients database. http://www.ecy.wa.gov/programs/hwtr/ChemAlternatives/index.html – State of Washington. 2013. Assessing the Safety of Chemical Alternatives. Department of Ecology. http://www.turi.org/Our_Work/Research/Alternatives_Assessment – Toxics Use Reduction Institute (TURI). Alternatives Assessment. University of Massachusetts Lowell.
Introduction Chemical alternatives assessment (CAA) is a process for identifying and comparing potential chemical and nonchemical alternatives to replace chemicals or technologies of concern on the basis of hazard, performance, and economic viability. CAAs are used to evaluate and manage hazards and subsequent health risks through the informed choice of safer chemicals. The CAA process is integral to the advancement of green chemistry, which can be defined as the design of chemical products and processes that reduce or eliminate the use and generation of hazardous substances. Historically, materials or chemicals have been selected during the design process based on the assessment and subsequent reduction of human health or environmental risks, as opposed to avoiding hazards or promoting continuous improvement in a chemical, material, product, system, production process, or function. CAA began its development in the late 1990s in the United States as a framework on which to avoid such hazards and promote safer alternatives. Prior to the inception of CAA, life cycle assessment (LCA) and risk assessment were the two primary tools used to select safer alternatives. Ideally, a CAA provides a science-based solution that identifies and characterizes chemical hazards, promotes the selection of less hazardous chemical ingredients, and avoids unintended consequences of switching to a poorly characterized and more hazardous chemical substitute or technology. A number of regulatory initiatives at the state level in the United States (notably, in California, Washington, and Maine), voluntary hazard reduction initiatives such as the US Environmental Protection Agency’s (EPA) Design for the Environment (DfE) Program, and EU and European-country funded initiatives such as SUBSPORT have contributed to the growth of CAA. CAA can be used as a process for identifying alternatives to a hazardous chemical, screening out alternatives of equal or greater hazard, and selecting a less hazardous alternative that is technically and economically viable.
Overview of CAA Frameworks There are three primary CAA paradigms currently in use: The Lowell Center for Sustainable Production’s Alternatives Assessment Framework (Figure 1), BizNGO’s Chemical Alternatives Assessment Protocol (Figure 2), and DfE’s Alternatives Assessment Criteria for Hazard Evaluation (Figure 3). More recently, the Interstate Chemicals Clearinghouse (IC2), an association of state, local, and tribal governments in the United States, has drafted Guidance for Alternatives Assessment and Risk Reduction. Internationally, the Austrian Environment Agency has proposed a draft methodology for the identification and assessment of substances that should be considered for restriction under the European Directive on the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment.
782
These CAA paradigms share many of the same attributes by placing initial emphasis on the assessment of hazards, with LCA and risk-related metrics such as exposure assessment, occurring later in the process. Core elements of a CAA comprise chemical hazard assessment (CHA), life cycle thinking, exposure assessment, technical/functional assessment, economic assessment, and social impact assessment. Examples of CAAs published to date include the following: l
The University of Massachusetts at Lowell Toxics Use Reduction Institute’s Five Chemicals Alternatives Assessment Study (2006) B This set of CAAs assessed the availability of technically and economically feasible safer alternatives for five hazardous chemicals (i.e., lead, formaldehyde, perchloroethylene, hexavalent chromium, and di(2-ethylhexyl)phthalate) l DfE’s Alternatives Assessment Project on Alternatives to Decabromodiphenyl ether (decaBDE) (2012) B This project assessed the toxicity and environmental fate of flame retardant chemicals that are potential alternatives to decaBDE when used in materials and products where decaBDE currently is, or previously was, used as a flame retardant.
Overview of CHA Frameworks CHAs evaluate and manage human health and environmental hazards through the informed choice of safer chemicals. CHAs are based on primary data, data on chemical surrogates, and/or predictive modeling. Each CHA comprises literature search, identification of critical health and environmental effects, identification of data gaps, chemical analog selection and/or use of predictive modeling, including the use of QSAR software (when needed), and assignment of endpoint-specific hazard classifications (usually following the United Nation’s Globally Harmonized System of Classification and Labeling of Chemicals (GHS)). All of these factors are applied to a broad set of toxicological and environmental hazard endpoints. The overall goal of a CHA is to determine whether a proposed chemical alternative is less hazardous to human health and the surrounding environment. Two primary CHA paradigms in use today are the US EPA’s DfE Alternatives Assessment (AA) protocol and Clean Production Action’s GreenScreenÔ. Both CHA methods assess a broad range of health effects and environmental endpoints. As an example, the EPA’s DfE AA paradigm estimates hazards for 17 individual health effects and environmental fate and toxicity endpoints, while GreenScreen assigns hazard classifications to 18 human health, environmental toxicity and fate, and physical characteristics of a chemical. GreenScreen has grown in favor among those who perform CHA because it assigns a quantitative GreenScreen benchmark
Encyclopedia of Toxicology, Volume 1
http://dx.doi.org/10.1016/B978-0-12-386454-3.01239-2
Chemicals Alternatives Assessments
1 Alternatives assessment foundation
Goals and measurable objectives For example • Achieve nontoxic environment by 2020 • Use materials that can be closed loop recycled or composted into healthy nutrients • Use renewable feedstocks and energy
Guiding principles For example • Prevention • Precaution • Substitution • Life cycle perspective
Comparative assessment of existing chemicals materials, or products
783
Decision making rules For example • Prefer solutions that eliminate the function of problematic chemicals • Prefer methods that present disaggregated data
Design assessment for new chemicals, materials, or products
2 Alternatives assessment processes
Identify target(s) for action
Define desired attributes including environmental and human health attributes, and social justice concerns
Characterize end uses and functions Identify alternatives Review selection continuous improvements
Identify alternatives to targeted end uses and functions
Review selection continuous improvements
Evaluate and compare alternatives e.g., chemicals, materials, or products
3 Evaluation
Human health and the environment
Social justice
Economic feasibility
Technical performance
modules
Select and implement preferred alternatives
Figure 1 Lowell Center for Sustainable Production’s alternatives assessment framework. Reproduced with permission from Rossi, M., Tickner, J., Geiser, K., 2006. Alternatives Assessment Framework of the Lowell Center for Sustainable Production. http://www.chemicalspolicy.org/downloads/ FinalAltsAssess06.pdf.
score ranging from 1 to 4 according to specific combinations of hazard classifications, as shown in Figure 4:
l
A GreenScreen score of 1 corresponds to ‘Avoid. Chemical of High Concern’ l A GreenScreen score of 2 corresponds to ‘Use But Search for Safer Substitutes’ l A GreenScreen score of 3 corresponds to ‘Use But Still Opportunity for Improvement’
GreenScreen scores can be compared for individual chemicals or materials, assisting in the selection of less hazardous chemicals or materials during the design process. As an example, acetic acid received a GreenScreen benchmark score of 2 based on very high (vH) hazard scores for Group II and II* human toxicity endpoints, comprising system toxicity/organ
l
A GreenScreen score of 4 corresponds to ‘Prefer. Safer Chemical’
784
Chemicals Alternatives Assessments
1.
Identify chemical(s) of concern
2. Characterize end uses and function
3a. Implement best practices to reduce worker and community exposure
No
3. Identify alternatives: are there potential alternatives including chemicals, material, products, or new designs?
3b. Continue to research alternatives
Yes 4. Assess chemical hazards Evaluate human and environmental health impacts of chemicals and deselect options of greatest concern
5. Evaluate technical and economic performance Yes 6a. Life cycle concerns?
6. Apply life cycle thinking Is there potential for significant life cycle or exposure concerns?
Life cycle evaluation Depending on resources and needs complete partial or fill evaluation of life cycle impacts
Yes
Risk assessment (RA) 6b. Exposure concerns?
Yes No
Depending on resources and needs complete partial or full RA to assess risks
7. Select and implement safer alternatives
Figure 2 BizNGO Chemical Alternatives Assessment Protocol (v.1.1) screening logic for selecting safer alternatives to chemicals of concern to human health or the environment*. Reproduced with permission from BizNGO, 2011. BizNGO Chemical Alternatives Assessment Protocol (v.1.1). November 2011. http://www.bizngo.org/safer.php.
1
Determine that an alternatives assessment is needed
Figure 3
2
Gather available information on alternatives
3
Invite stakeholders, refine the project’s scope, and consider economic reality
US EPA’s DfE alternatives assessment criteria for hazard evaluation.
4 Hazard assessment – conduct literature search, identify data gaps, apply SAR and expert judgment, and determine hazard levels for the alternatives
5
Develop the report
6
Apply the information in decision making for safer substitutes
785
Chemicals Alternatives Assessments
Figure 4 GreenScreen™ benchmarks. Reproduced with permission from Clean Production Action (CPA), 2011. GreenScreenTM Benchmarks. http://www.cleanproduction.org/library/greenScreenv1-2/GreenScreen_v1-2_Benchmarks_REV.pdf.
effects, skin and eye irritation, neurotoxicity, and skin and respiratory sensitization. Acetic acid’s GreenScreen hazard rating table is illustrated in Table 1. Additional GreenScreen assessments can be viewed through Clean Production Action’s GreenScreen website. Acetic acid received a GreenScreen benchmark score of 2 based on hazard scores of very high (vH) for the following endpoints: systemic toxicity (single dose) (ST), skin irritation/corrosivity (IrS), eye irritation/corrosivity (IrE). This corresponds to benchmark classification 2f (very high for any ecotoxicity or Group II and II* human health endpoint) on the GreenScreen benchmarking scheme as shown in Figure 4.
Table 1
GreenScreen™ hazard ratings for acetic acid (2013)
Group I human C L
M L
Acetic acid is classified as a GHS Category 1 specific target organ toxicity chemical based on an inhalation effect level of 1.1 mg l 1 following a single dose, 4 h inhalation exposure in an acute inhalation study in rats. In addition, acetic acid is present on the GHS-Japan screening list as a Category 1 substance (blood) for single exposure systemic toxicity. According to GHS criteria, a specific target organ toxicant following single exposure is categorized as a Category 1 substance (‘have the potential to produce significant toxicity in humans’) in instances where significant toxicity is seen in humans or from studies in experimental. Specifically, the GHS guidance concentration value for a substance to be categorized as a Category 1 single dose inhalation toxicant (vapor form) is
R DG
D L
Group II and II* human E L
ST
AT M
(AA) acute aquatic toxicity (AT) acute mammalian toxicity (B) bioaccumulation (C) carcinogenicity (CA) chronic aquatic toxicity
Single vH
Repeated* L
(E) endocrine activity (F) flammability (P) persistence (N) neurotoxicity (Rx) reactivity
N Single L
Repeated* L
Ecotox
Fate
Physical
SnS*
SnR*
IrS
IrE
AA
CA
P
B
Rx
F
DG
M
vH
vH
M
L
vL
vL
M
M
(IrE) eye Irritation/corrosivity (IrS) skin irritation/corrosivity (M) mutagenicity and genotoxicity (R) reproductive toxicity (SnS) sensitization – skin
(SnR) sensitization – respiratory (ST) systemic/organ toxicity (Cr) corrosion/irritation (skin/eye) (D) developmental toxicity (DG) data gap
Note: Hazard levels – Very High (vH), High (H), Moderate (M), Low (L), Very Low (vL) in italics reflect estimated values and lower confidence. Hazard levels in BOLD font reflect values based on test data (See Guidance). Group II Human Health endpoints differ from Group II* Human Health endpoints in that they have four hazard scores (i.e., vH, H, M, and L) instead of three (i.e., H, M, and L), and are based on single exposures instead of repeated exposures.
786
Chemicals Alternatives Assessments
equal to or less than 10 mg l 1 following a 4 h period of exposure. GreenScreen criteria states that any GHS Category 1 substance, or one that is listed on a screening list such as GHS-Japan, is automatically assigned a hazard score of very high (vH) for systemic toxicity (single dose). Acetic acid is associated with the EU Risk Phrase R:35 (‘Causes severe burns’). Risk phrases are categorized as an authoritative list that Clean Production Action (CPA) considers to be based on a comprehensive expert review by a recognized authoritative body (CPA, 2013). Any chemical assigned the EU R-phrase 34 or 35, which correspond to ‘causes burns’ and ‘causes severe burns,’ respectively, will automatically be assigned a hazard score of very high (vH) for IrS. Finally, data from human and animal studies indicate that acetic acid at concentrations equivalent to or higher than 3% in an aqueous solution is likely to be a severe eye irritant. In addition, the ocular damage induced by acetic acid is irreversible. GHS criteria for eye irritation indicate that any substance shown to produce irreversible ocular damage is classified as a Category 1 eye irritant (UN, 2009). CPA criteria state that any GHS Category 1 substance will automatically be assigned a hazard score of very high (vH) for IrE. Acetic acid was assigned a score of moderate (M) for acute aquatic toxicity.
CAA Tools Another set of tools that industry can use to drive sustainability are online databases, such as Pharos, CleanGredients, and SUBSPORT, which promote safer chemical selection and hazardous chemical elimination. The Pharos Building Product Library evaluates more than 1000 products used in buildings, and scores materials and products on endpoints, including volatile organic compound content, toxic content, manufacturing toxics, renewable materials, and renewable energy. The Pharos Chemical and Material Library profiles health and environmental hazards of chemicals throughout various life cycle phases. CleanGredients is an online database that identifies less hazardous chemicals divided by functional use categories, such a less hazardous chelants, solvents, surfactants, among other functional classes. SUBSPORT is an EU, Germany, and Austrian-funded website designed to provide information about, and tools relating to, the substitution of hazardous chemicals. SUBSPORT developed a substitution steps paradigm companies can follow to phase out hazardous chemicals, and it also features an overview and electronic links to substitution/alternative assessment models and tools available around the world, such as the German GHS Column Model, Clean Production Action’s GreenScreen, the Swedish Chemicals Inspectorate’s PRIO database and tool, among others.
See also: Sustainability; Green Chemistry; Hazard Ranking; The Globally Harmonized System for Classification and Labeling of the GHS; Chemicals in Consumer Products.
Further Reading BizNGO, November 2011. BizNGO Chemical Alternatives Assessment Protocol (v.1.1). http://www.bizngo.org/safer.php. BizNGO, 2012. BizNGO Guide to Safer Chemicals. Version 1.0. http://www.bizngo.org/ pdf/GuideToSaferChemicals-v1_2.pdf. Clean Production Action (CPA), 2011. GreenScreen™ Benchmarks. http://www. cleanproduction.org/library/greenScreenv1-2/GreenScreen_v1-2_Benchmarks_ REV.pdf. Clean Production Action (CPA), 2013. The GreenScreen™ for Safer Chemicals Hazard Assessment Procedure. Version 1.2 Guidance. Dated: August 31, 2013. Available: http://www.cleanproduction.org/Greenscreen.php. Clean Production Action (CPA), 2012a. GreenScreen™ Version 1.2 (2e) Hazard Criteria. Dated: November 2012 http://www.cleanproduction.org/library/ GreenScreen_v1_2-2e_CriteriaDetailed_2012_10_10w_all_Lists_vf.pdf. Clean Production Action (CPA), 2012b. GreenScreen™ for Safer Chemicals. Version 1.2 Specified Lists. February 2012 http://www.cleanproduction.org/library/greenscreentranslator-benchmark1-possible%20benchmark1.pdf. Geiser, K., 2001. Materials Matter: Toward a Sustainable Materials Policy (Urban and Industrial Environments). MIT Press. Interstate Chemicals Clearinghouse (IC2), March 2013. Draft Guidance for Alternatives Assessment and Risk Reduction. http://www.newmoa.org/prevention/ic2/ aaguidance.cfm. Lavoie, E.T., Heine, L.G., Holder, H., Rossi, M.S., Lee, R.E., Connor, E.A., Vrabel, M.E., DiFiore, D.M., Davies, C.L., 2010. Chemical alternatives assessment: enabling substitution to safer chemicals. Environ. Sci. Technol. 44 (24), 9244–9249. http:// pubs.acs.org/doi/abs/10.1021/es1015789. O’Brien, M., 2000. Making Better Environmental Decisions. An Alternative to Risk Assessment. MIT Press. Rossi, M., Tickner, J., Geiser, K., 2006. Alternatives Assessment Framework of the Lowell Center for Sustainable Production. http://www.chemicalspolicy.org/ downloads/FinalAltsAssess06.pdf. United Nations, 2011. The Globally Harmonized System of Classification and Labelling of Chemicals (GHS), fourth revised ed. http://www.unece.org/trans/danger/publi/ ghs/ghs_rev04/04files_e.html. United States Environmental Protection Agency (U.S. EPA), August 2011. Design for the Environment Program Alternatives Assessment Criteria for Hazard Evaluation. Version 2.0. http://www.epa.gov/dfe/alternatives_assessment_criteria_ for_hazard_eval.pdf. Whittaker, M.H., Heine, L., 2013. Chemicals alternatives assessment (CAA): tools for selecting less hazardous chemicals. In: Chemicals Alternatives Assessments (Issues in Environmental Science and Technology). RSC Publishing, London.
Relevant Websites http://www.cleanproduction.org/Greenscreen.php – Clean Production Action (CPA). 2013. GreenScreen™ for Safer Chemicals version 1.2 website. http://www.epa.gov/dfe/alternative_assessments.html – Design for the Environment (DfE). 2013. Alternatives Assessments. www.subsport.eu – European SUBSPORT. 2013. European Substitution Portal (SUBSPORT). http://www.cleangredients.org/home – GreenBlue. 2013. CleanGredients database. http://www.ecy.wa.gov/programs/hwtr/ChemAlternatives/index.html – State of Washington. 2013. Assessing the Safety of Chemical Alternatives. Department of Ecology. http://www.turi.org/Our_Work/Research/Alternatives_Assessment – Toxics Use Reduction Institute (TURI). Alternatives Assessment. University of Massachusetts Lowell.