Domain 1: Assessment, Impact Analysis, and Risk Management Flashcards

1
Q

Define “Product Stewardship”

Domain 1: 101

A

“Product Stewardship” describes the responsible management of the health, safety, and environmental aspects of raw materials, intermediate, and consumer products throughout their lifecycle and across the value chain in order to prevent or minimize negative impacts and maximize value.

Core comp for PS page 4

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2
Q

What are the four ways product stewardship can add value to the product design process?

Domain 1: 102

A
  1. Avoid hidden costs
  2. Future-proofing the product
  3. Enabling addressable markets
  4. Providing market differentiation

Professional Practices p. 163-164

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3
Q

Name three commonly used design thinking frameworks.

Domain 1: 103

A

Triple bottom line,
Cradle to cradle design,
And circular economy

Prof Practices p. 165-166

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4
Q

Define “Design for Environment” (DFE).

Domain 1:104

A

DFE aims to reduce the overall human health and environmental impact of a product, process, or service across its lifecycle cycle.

Prof Practices p. 167

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5
Q

Define “green chemistry”

Domain 1: 105

A

Green chemistry is the design of chemical products and processes that reduce or eliminate the use or generation of hazardous substances.

Prof Practices p. 170

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6
Q

Define “life cycle”

Domain 1: 106

A

“Life cycle” describes the entire process of existence of a product including development, manufacture, distribution, use, and disposal/reuse.

Prof Practices p. 15

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7
Q

Define “hazard of a chemical.”

Domain 1: 107

A

The hazard of a chemical is the inherent capability of a chemical to cause harm.

Prof Practices p. 56

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8
Q

Most regional, national, and international transportation regulations are based on what regulatory framework?

Domain 1: 108

A

United Nations Recommendations on the Transport of Dangerous Goods (TDG Model Regulations)

Prof practices p. 224

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9
Q

What are the five key considerations when performing a product exposure assessment?

Domain 1: 109

A
  1. Product attributes
  2. Product use(s)
  3. Environmental factors
  4. Potential hazards
  5. Potential receptors

Prof practices p. 97

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10
Q

How do exposure assessments work?

Domain 1: 110

A

Exposure assessments use qualitative, quantitative, or semi quantitative approaches that vary by agent, hazard, route of exposure, and exposed population to characterize the potential exposure of various populations to hazards of concern.

Prof practices p. 94-96

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11
Q

What process is used to characterize the likelihood of chemical, physical, biological, and other stressors to cause harm to birds, fish, and wildlife?

Domain 1: 111

A

Ecological risk assessment

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12
Q

What are the 3 Rs for humane animal use during the conduct of toxicological studies?

Domain 1: 112

A
  1. Replacement
  2. Reduction
  3. Refinement
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13
Q

The core concept of green chemistry echoes some aspects of which other control system?

Domain 1: 113

A

Hazard control

Prof practices p. 170

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14
Q

Green chemistry is also called what?

Domain 1: 114

A

Sustainable chemistry

Prof practices p. 170

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15
Q

What is the “hierarchy of hazard controls”?

Domain 1: 115

A

The hierarchy of hazard controls is a system used in industry to reduce or eliminate worker exposure to hazards.

Prof practices p. 170

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16
Q

What is a chemical alternatives assessment (AA)?

Domain 1: 116

A

A chemical alternatives assessment (AA) is a process for identifying and comparing chemical alternatives to chemicals of concern based on their hazards, performance, and economic viability.

Prof practices p. 170-171

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17
Q

The International Organization for Standardization (ISO) has defined standards around which three types of environmental labeling and declarations?

Domain 1: 117

A
  1. Type I: Environmental labeling
  2. Type II: Self-declared environmental claims
  3. Type III: Environmental declarations

Prof practices p. 173

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18
Q

Define “life cycle assessment (LCA).”

Domain 1: 118

A

A life cycle assessment (LCA) is a formal practice that delivers information and insight to allow a more considered view of the relative consequences of making a particular choice that takes into account the full product life cycle.

Prof practices p. 181

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19
Q

Which assessment do product stewards use to elevate the environmental performance of a product or service throughout its life cycle?

Domain 1: 119

A

Life cycle assessment (LCA)

Prof practices p. 181

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20
Q

A life cycle assessment (LCA) consists of which four phases?

Domain 1: 120

A
  1. Goal and scope definition
  2. Inventory analysis
  3. Impact assessment
  4. Interpretation

Prof practices p. 183

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21
Q

Define “life cycle inventory analysis.”

Domain 1: 121

A

The process for estimating the consumption of resources and generation of quantities of emissions, wastes, and energy throughout the life cycle of the system or product.

Prof practices p. 187

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22
Q

A life cycle inventory analysis includes which five factors?

Domain 1: 122

A
  1. Raw materials/energy needs
  2. Manufacturing processes
  3. Transportation, storage, and distribution requirements
  4. Use and reuse
  5. Recycle and end of life scenarios such as incineration and land filling

Prof practices p. 187

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23
Q

What do “flows” in the context of life cycle assessment refer to?

Domain 1: 123

A

Inputs and outputs to and from a process, group of processes, or product system, such as natural resources, materials, energy, products, waste, and emissions.

Prof practices p. 187

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24
Q

How do we set the boundary of the product life cycle?

Domain 1: 124

A

By defining the life cycle stages, processes, and flows to be included within the system to be appraised.

Prof practices p. 187

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25
Q

What three steps does defining a system usually involve?

Domain 1: 125

A
  1. Drawing a simple diagram of life cycle stages with generic inputs and outputs from the life cycle stages
  2. Data gathering and discussions to specify in more detail the activities within each life cycle stage and the inputs and outputs of each stage
  3. Exclusion of insignificant or unnecessary elements of the product system

Prof practices p. 187

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26
Q

Define an “impact category indicator.”

Domain 1: 126

A

An impact category indicator is the final result of converting the life cycle inventory data into common units, such as carbon dioxide equivalents, and then adding the common units up.

Prof practices p. 190

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27
Q

The selection of impacts reported in a life cycle assessment (LCA) is decided based on what?

Domain 1: 127

A

The goal of the study and understanding of the environmental issues related to the product system being studied.

Prof practices p. 190

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28
Q

What should you look for when choosing a characterization model to perform a life cycle assessment?

Domain 1: 128

A

Completeness, practicality, objectiveness, lack of bias, environmental relevance, and scientific method.

Prof practices p. 190

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29
Q

Define “sensitivity analysis.”

Domain 1: 129

A

A sensitivity analysis is a systematic procedure for estimating effects of chose. Methods and data on inventory and impact assessments results and the study outcome.

Prof practices p. 194

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30
Q

How is a sensitivity analysis conducted?

Domain 1: 130

A

By assessing the effects of varying data and assumptions within expected ranges on the inventory results, impact assessments, and conclusions.

Prof practices p. 195

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31
Q

Name three ways to check the influence of varying multiple data points.

Domain 1: 131

A
  1. Data distribution evaluation
  2. Monte Carlo assessment
  3. Probability density functions

Prof practices p. 195

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32
Q

Should reporting and critical review requirements be defined before, during, or after the life cycle assessment study?

Domain 1: 132

A

At the beginning of the life cycle assessment study.

Prof practices p. 196

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33
Q

The results of a life cycle assessment should be interpreted in the context of what?

Domain 1: 133

A

The particular study, which defines a particular product system, function unit, and scope.

Prof practices p. 196

34
Q

Define “product risk assessment (PRA).”

Domain 1: 134

A

A product risk assessment (PRA) is a systematic scientific evaluation that is used to characterize the likelihood and severity of potential adverse effects from exposure to chemical, biological, and/or physical agents in products under expected product use conditions.

Prof practices p. 56

35
Q

Define “hazard assessment.”

Domain 1: 135

A

A hazard assessment is the process used to identify the hazards from a chemical, physical, biological, or radiological agents.

Prof practices p. 59

36
Q

What does a hazard assessment involve?

Domain 1: 136

A

Identifying potential hazards that a product may present through the entire life cycle, which includes characterizing relevant exposure-response relationships for identified hazards.

Prof practices p. 60

37
Q

The Globally Harmonized System (GHS) includes which two major elements?

Domain 1:137

A
  1. Harmonized criteria for classifying substances and mixtures according to their health, environmental, and physical hazards.
  2. Harmonized hazard communication elements, including requirements for labeling and safety data sheets (SDSs).

Prof practices p. 61

38
Q

Define “Exposure assessment.”

Domain 1:138

A

An exposure assessment is the risk assessment process that is used to characterize the potential exposure of various populations to hazards of concern (e.g., chemical, physical, biological, or ergonomic) based on measuring or estimating the magnitude, frequency, and duration of exposure to the hazard.

Prof practices p. 94-96

39
Q

Exposure assessments can utilize which three approaches that vary by agent, hazard, route of exposure, and exposed population?

Domain 1:139

A
  1. Qualitative
  2. Quantitative
  3. Semiquantitative

Prof practices p. 94

40
Q

What are the five varying types of hazards evaluated in exposure assessments?

Domain 1:140

A
  1. Chemical
  2. Chemical-physical
  3. Physical
  4. Ergonomic
  5. Biological

Prof practices p. 94

41
Q

A risk matrix considers what?

Domain 1:141

A

A risk matrix considers the inherent hazards of a product and the expected potential degree of exposure (PDE) that may be experienced under conditions of the product’s intended use and/or foreseeable misuse or abuse of that product over its service life and through end of life (i.e., disposal, potential recycling, or reuse).

Prof practices p. 127

42
Q

What does a risk matrix involve?

Domain 1:142

A

A risk matrix involves assessing the severity of each hazard and estimating the potential degree of exposure.

Prof practices p. 127

43
Q

What is the purpose of an ecological risk assessment (ERA)?

Domain 1:143

A

The purpose of an ecological risk assessment (ERA) is to characterize the likelihood of chemical, physical, biological, and other stressors in the environment to cause harm to ecological receptors, including birds, fish, and wildlife.

44
Q

Ecological risk assessment (ERA) can consider effects on which groups?

Domain 1:144

A

Individuals in a single species
A population
Life stages (e.g., juveniles or adults)
Population subgroups
Multiple species in an ecosystem

45
Q

What are the stages of the product development cycle?

Domain 1:145

A
  1. Scoping
  2. Building the Business Case
  3. Development
  4. Testing and Validation
  5. Launch

Prof practices p. 156

46
Q

Define “ideation.”

Domain 1:146

A

Ideation is the process by which a company generates new product concepts.

Prof practices p. 155

47
Q

What’s the focus of the building the business case stage of product development?

Domain 1:147

A

The building the business case stage focuses on technical and market research needed to define the business case for the product.

Prof practices p. 156

48
Q

What does product stewardship during the development stage involve?

Domain 1:148

A
  1. Testing
  2. Hazard/risk assessments
  3. Regulatory submittals necessary to support compliance and market access needs

Prof practices p. 156

49
Q

What does product stewardship during launch involve?

Domain 1:149

A
  1. Ensuring that customer support documentation (e.g., safety data sheets [SDSs], environmental claims documents) is in place
  2. Managing country-specific compliance obligations and/or volume restrictions
  3. Managing hazard and risk considerations

Prof practices p. 156

50
Q

What does product stewardship during use involve?

Domain 1:150

A
  1. Tracking customer feedback/poison center calls
  2. Responding accordingly based on risk
  3. Responding to customer inquiries regarding the product

Prof practices p. 156

51
Q

Documentation of the raw materials and components to verify compliance should take place during which stages?

Domain 1:151

A

Testing and validation

52
Q

Ideally, a product’s use in terms of electricity, water, and other inputs is considered during which stages?

Domain 1:152

A

The Scoping and Building the Business Case stages.

Prof practices p. 157

53
Q

In addition to being verified during development, material content should be verified during which events?

Domain 1:153

A

Supplier or manufacturing processes change
Raw materials or components change
Market or manufacturing locations change
Applications/end uses change

54
Q

How should product stewards participate in the product design process, regarding end-of-life (EOL)?

Domain 1:154

A
  1. Gain knowledge of end-of-life (EOL) treatments to decide which is the most appropriate for the product
  2. Influence EOL decisions made by end users through appropriate product and business model design and labeling/information
  3. Ensure that the product design is optimized for the chosen EOL treatment (and, to a lesser extent, the other possible EOL treatments that the product may be subject to)
55
Q

Industry design standards are usually consulted during which stage?

Domain 1:155

A

The Building the Business Case stage of the product development cycle

Prof practices p. 155-156

56
Q

How do internal audits differ from evaluation of compliance?

Domain 1:156

A

The auditor should be independent of the activity being audited to provide an objective assessment of performance.

Prof practices p. 376

57
Q

What are the seven important elements of internal audits?

Domain 1:157

A
  1. Sponsorship
  2. Scope
  3. Auditor selection
  4. Audit protocol
  5. Pre-audit preparation
  6. Audit
  7. Post-audit

Prof practices p. 376-377

58
Q

Define “root cause analysis (RCA).”

Domain 1:158

A

A step-by-step method that traces the cause-and-effect trail from the end failure to the root cause, beyond just the symptoms.

Prof practices p. 380

59
Q

What are five important tools to perform a root cause analysis (RCA)?

Domain 1:159

A
  1. 5-whys
  2. Fishbone analysis
  3. Pareto charts
  4. Scatter diagrams
  5. Failure mode and effects analysis

Prof practices p. 381

60
Q

Name the four broad approaches to mitigating risk.

Domain 1:160

A
  1. Take
  2. Transfer
  3. Terminate
  4. Treat

Prof practices p. 134

61
Q

To ensure the rights, safety, and welfare of human subjects during clinical investigations, which requirements must be followed?

Domain 1:161

A

Obtaining informed consent

62
Q

What are the legal and ethical considerations for the conduct of animal-based toxicology studies?

Domain 1:162

A

The studies should be designed to minimize pain and distress of the animals as much as possible.

63
Q

What does LD50 mean?

Domain 1:163

A

The amount of material, given all at once, that causes the death of 50% of a group of test animals within days to weeks. It is used to measure the short term (acute toxicity) of a material.

64
Q

Define “additive effect.”

Domain 1:164

A

When exposure to more than one toxic agent results in the same effect as would be predicted by the sum of the effects of exposure to the individual agents.

65
Q

What are the three approaches of Design for Dematerialization?

Domain 1:165

A
  1. Design for Energy and Material Conservation
  2. Design for Source Reduction
  3. Design for Servicization

Prof practices p. 167

66
Q

What are the three approaches of Design for Detoxification?

Domain 1:166

A
  1. Design for Release Reduction
  2. Design for Hazard Reduction
  3. Design for Benign Waste Disposition

Prof practices p. 167-168

67
Q

What are the three approaches of Design for Revalorization?

Domain 1:167

A
  1. Design for Product Recovery
  2. Design for Product Disassembly
  3. Design for Recyclability

Prof practices p. 167

68
Q

What are the three approaches of Design for Capital Protection and Renewal?

Domain 1:168

A
  1. Design for Human Capital
  2. Design for Natural Capital
  3. Design for Economic Capital

Prof practices p. 168

69
Q

What is the objective of Green Chemistry’s “prevent waste” principle?

Domain 1:169

A

Design chemical synthesis to prevent waste. Leave no waste to treat or clean up.

Prof practices p. 169

70
Q

What is the objective of Green Chemistry’s “maximize atom economy” principle?

Domain 1:170

A

Design synthesis so that the final product contains the maximum proportion of the starting materials. Waste few or no atoms.

Prof practices p. 169

71
Q

What is the objective of Green Chemistry’s “design less hazardous chemical synthesis” principle?

Domain 1:171

A

Design synthesis to use and generate substances with little or no toxicity to either humans or the environment.

Prof practices p. 169

72
Q

What is the objective of Green Chemistry’s “design safer chemicals and products” principle?

Domain 1:172

A

Design chemical products that are fully effective yet have little or no toxicity.

Prof practices p. 169

73
Q

What is the objective of Green Chemistry’s “use safer solvents and reaction conditions” principle?

Domain 1:173

A

Avoid using solvents, separation agents, or other auxiliary chemicals. If you must use these chemicals, use safer ones.

Prof practices p. 169

74
Q

What is the objective of Green Chemistry’s “increase energy efficiency” principle?

Domain 1:174

A

Run chemical reactions at room temperature and pressure whenever possible.

Prof practices p. 169

75
Q

What is the objective of Green Chemistry’s “use renewable feedstocks” principle?

Domain 1:175

A

Use starting materials (also known as feedstocks) that are renewable rather than depletable. The source of renewable feedstocks is often agricultural products or the wastes of other processes; the source of depletable feedstocks is often fossil fuels (petroleum, natural gas, or coal) or mining operations.

Prof practices p. 169

76
Q

What is the objective of Green Chemistry’s “avoid chemical derivatives” principle?

Domain 1:176

A

Avoid using blocking or protecting groups or any temporary modifications, if possible. Derivatives use additional reagents and generate waste.

Prof practices p. 169

77
Q

What is the objective of Green Chemistry’s “use catalysts, not stoichiometric reagents” principle?

Domain 1:177

A

Minimize waste by using catalytic reactions. Catalysts are effective in small amounts and can carry out a single reaction many times. They are preferable to stoichiometric reagents, which are used in excess and carry out a reaction only once.

Prof practices p. 169

78
Q

What is the objective of Green Chemistry’s “design chemicals and products to degrade after use” principle?

Domain 1:178

A

Design chemical products to break down to innocuous substances after use so that they do not accumulate in the environment.

Prof practices p. 169

79
Q

What is the objective of Green Chemistry’s “analyze in real time to prevent pollution” principle?

Domain 1:179

A

Include in-process, real-time monitoring and control during synthesis to minimize or eliminate the formation of byproducts.

Prof practices p. 169

80
Q

What is the objective of Green Chemistry’s “minimize the potential for accidents” principle?

Domain 1:180

A

Design chemicals and their physical forms (solid, liquid, or gas) to minimize the potential for chemical accidents, including explosions, fires, and releases to the environment.

Prof practices p. 169