Domain 1: Assessment, Impact Analysis, and Risk Management Flashcards
Define “Product Stewardship”
Domain 1: 101
“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
What are the four ways product stewardship can add value to the product design process?
Domain 1: 102
- Avoid hidden costs
- Future-proofing the product
- Enabling addressable markets
- Providing market differentiation
Professional Practices p. 163-164
Name three commonly used design thinking frameworks.
Domain 1: 103
Triple bottom line,
Cradle to cradle design,
And circular economy
Prof Practices p. 165-166
Define “Design for Environment” (DFE).
Domain 1:104
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
Define “green chemistry”
Domain 1: 105
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
Define “life cycle”
Domain 1: 106
“Life cycle” describes the entire process of existence of a product including development, manufacture, distribution, use, and disposal/reuse.
Prof Practices p. 15
Define “hazard of a chemical.”
Domain 1: 107
The hazard of a chemical is the inherent capability of a chemical to cause harm.
Prof Practices p. 56
Most regional, national, and international transportation regulations are based on what regulatory framework?
Domain 1: 108
United Nations Recommendations on the Transport of Dangerous Goods (TDG Model Regulations)
Prof practices p. 224
What are the five key considerations when performing a product exposure assessment?
Domain 1: 109
- Product attributes
- Product use(s)
- Environmental factors
- Potential hazards
- Potential receptors
Prof practices p. 97
How do exposure assessments work?
Domain 1: 110
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
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
Ecological risk assessment
What are the 3 Rs for humane animal use during the conduct of toxicological studies?
Domain 1: 112
- Replacement
- Reduction
- Refinement
The core concept of green chemistry echoes some aspects of which other control system?
Domain 1: 113
Hazard control
Prof practices p. 170
Green chemistry is also called what?
Domain 1: 114
Sustainable chemistry
Prof practices p. 170
What is the “hierarchy of hazard controls”?
Domain 1: 115
The hierarchy of hazard controls is a system used in industry to reduce or eliminate worker exposure to hazards.
Prof practices p. 170
What is a chemical alternatives assessment (AA)?
Domain 1: 116
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
The International Organization for Standardization (ISO) has defined standards around which three types of environmental labeling and declarations?
Domain 1: 117
- Type I: Environmental labeling
- Type II: Self-declared environmental claims
- Type III: Environmental declarations
Prof practices p. 173
Define “life cycle assessment (LCA).”
Domain 1: 118
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
Which assessment do product stewards use to elevate the environmental performance of a product or service throughout its life cycle?
Domain 1: 119
Life cycle assessment (LCA)
Prof practices p. 181
A life cycle assessment (LCA) consists of which four phases?
Domain 1: 120
- Goal and scope definition
- Inventory analysis
- Impact assessment
- Interpretation
Prof practices p. 183
Define “life cycle inventory analysis.”
Domain 1: 121
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
A life cycle inventory analysis includes which five factors?
Domain 1: 122
- Raw materials/energy needs
- Manufacturing processes
- Transportation, storage, and distribution requirements
- Use and reuse
- Recycle and end of life scenarios such as incineration and land filling
Prof practices p. 187
What do “flows” in the context of life cycle assessment refer to?
Domain 1: 123
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
How do we set the boundary of the product life cycle?
Domain 1: 124
By defining the life cycle stages, processes, and flows to be included within the system to be appraised.
Prof practices p. 187
What three steps does defining a system usually involve?
Domain 1: 125
- Drawing a simple diagram of life cycle stages with generic inputs and outputs from the life cycle stages
- Data gathering and discussions to specify in more detail the activities within each life cycle stage and the inputs and outputs of each stage
- Exclusion of insignificant or unnecessary elements of the product system
Prof practices p. 187
Define an “impact category indicator.”
Domain 1: 126
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
The selection of impacts reported in a life cycle assessment (LCA) is decided based on what?
Domain 1: 127
The goal of the study and understanding of the environmental issues related to the product system being studied.
Prof practices p. 190
What should you look for when choosing a characterization model to perform a life cycle assessment?
Domain 1: 128
Completeness, practicality, objectiveness, lack of bias, environmental relevance, and scientific method.
Prof practices p. 190
Define “sensitivity analysis.”
Domain 1: 129
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
How is a sensitivity analysis conducted?
Domain 1: 130
By assessing the effects of varying data and assumptions within expected ranges on the inventory results, impact assessments, and conclusions.
Prof practices p. 195
Name three ways to check the influence of varying multiple data points.
Domain 1: 131
- Data distribution evaluation
- Monte Carlo assessment
- Probability density functions
Prof practices p. 195
Should reporting and critical review requirements be defined before, during, or after the life cycle assessment study?
Domain 1: 132
At the beginning of the life cycle assessment study.
Prof practices p. 196
The results of a life cycle assessment should be interpreted in the context of what?
Domain 1: 133
The particular study, which defines a particular product system, function unit, and scope.
Prof practices p. 196
Define “product risk assessment (PRA).”
Domain 1: 134
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
Define “hazard assessment.”
Domain 1: 135
A hazard assessment is the process used to identify the hazards from a chemical, physical, biological, or radiological agents.
Prof practices p. 59
What does a hazard assessment involve?
Domain 1: 136
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
The Globally Harmonized System (GHS) includes which two major elements?
Domain 1:137
- Harmonized criteria for classifying substances and mixtures according to their health, environmental, and physical hazards.
- Harmonized hazard communication elements, including requirements for labeling and safety data sheets (SDSs).
Prof practices p. 61
Define “Exposure assessment.”
Domain 1:138
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
Exposure assessments can utilize which three approaches that vary by agent, hazard, route of exposure, and exposed population?
Domain 1:139
- Qualitative
- Quantitative
- Semiquantitative
Prof practices p. 94
What are the five varying types of hazards evaluated in exposure assessments?
Domain 1:140
- Chemical
- Chemical-physical
- Physical
- Ergonomic
- Biological
Prof practices p. 94
A risk matrix considers what?
Domain 1:141
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
What does a risk matrix involve?
Domain 1:142
A risk matrix involves assessing the severity of each hazard and estimating the potential degree of exposure.
Prof practices p. 127
What is the purpose of an ecological risk assessment (ERA)?
Domain 1:143
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.
Ecological risk assessment (ERA) can consider effects on which groups?
Domain 1:144
Individuals in a single species
A population
Life stages (e.g., juveniles or adults)
Population subgroups
Multiple species in an ecosystem
What are the stages of the product development cycle?
Domain 1:145
- Scoping
- Building the Business Case
- Development
- Testing and Validation
- Launch
Prof practices p. 156
Define “ideation.”
Domain 1:146
Ideation is the process by which a company generates new product concepts.
Prof practices p. 155
What’s the focus of the building the business case stage of product development?
Domain 1:147
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
What does product stewardship during the development stage involve?
Domain 1:148
- Testing
- Hazard/risk assessments
- Regulatory submittals necessary to support compliance and market access needs
Prof practices p. 156
What does product stewardship during launch involve?
Domain 1:149
- Ensuring that customer support documentation (e.g., safety data sheets [SDSs], environmental claims documents) is in place
- Managing country-specific compliance obligations and/or volume restrictions
- Managing hazard and risk considerations
Prof practices p. 156
What does product stewardship during use involve?
Domain 1:150
- Tracking customer feedback/poison center calls
- Responding accordingly based on risk
- Responding to customer inquiries regarding the product
Prof practices p. 156
Documentation of the raw materials and components to verify compliance should take place during which stages?
Domain 1:151
Testing and validation
Ideally, a product’s use in terms of electricity, water, and other inputs is considered during which stages?
Domain 1:152
The Scoping and Building the Business Case stages.
Prof practices p. 157
In addition to being verified during development, material content should be verified during which events?
Domain 1:153
Supplier or manufacturing processes change
Raw materials or components change
Market or manufacturing locations change
Applications/end uses change
How should product stewards participate in the product design process, regarding end-of-life (EOL)?
Domain 1:154
- Gain knowledge of end-of-life (EOL) treatments to decide which is the most appropriate for the product
- Influence EOL decisions made by end users through appropriate product and business model design and labeling/information
- 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)
Industry design standards are usually consulted during which stage?
Domain 1:155
The Building the Business Case stage of the product development cycle
Prof practices p. 155-156
How do internal audits differ from evaluation of compliance?
Domain 1:156
The auditor should be independent of the activity being audited to provide an objective assessment of performance.
Prof practices p. 376
What are the seven important elements of internal audits?
Domain 1:157
- Sponsorship
- Scope
- Auditor selection
- Audit protocol
- Pre-audit preparation
- Audit
- Post-audit
Prof practices p. 376-377
Define “root cause analysis (RCA).”
Domain 1:158
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
What are five important tools to perform a root cause analysis (RCA)?
Domain 1:159
- 5-whys
- Fishbone analysis
- Pareto charts
- Scatter diagrams
- Failure mode and effects analysis
Prof practices p. 381
Name the four broad approaches to mitigating risk.
Domain 1:160
- Take
- Transfer
- Terminate
- Treat
Prof practices p. 134
To ensure the rights, safety, and welfare of human subjects during clinical investigations, which requirements must be followed?
Domain 1:161
Obtaining informed consent
What are the legal and ethical considerations for the conduct of animal-based toxicology studies?
Domain 1:162
The studies should be designed to minimize pain and distress of the animals as much as possible.
What does LD50 mean?
Domain 1:163
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.
Define “additive effect.”
Domain 1:164
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.
What are the three approaches of Design for Dematerialization?
Domain 1:165
- Design for Energy and Material Conservation
- Design for Source Reduction
- Design for Servicization
Prof practices p. 167
What are the three approaches of Design for Detoxification?
Domain 1:166
- Design for Release Reduction
- Design for Hazard Reduction
- Design for Benign Waste Disposition
Prof practices p. 167-168
What are the three approaches of Design for Revalorization?
Domain 1:167
- Design for Product Recovery
- Design for Product Disassembly
- Design for Recyclability
Prof practices p. 167
What are the three approaches of Design for Capital Protection and Renewal?
Domain 1:168
- Design for Human Capital
- Design for Natural Capital
- Design for Economic Capital
Prof practices p. 168
What is the objective of Green Chemistry’s “prevent waste” principle?
Domain 1:169
Design chemical synthesis to prevent waste. Leave no waste to treat or clean up.
Prof practices p. 169
What is the objective of Green Chemistry’s “maximize atom economy” principle?
Domain 1:170
Design synthesis so that the final product contains the maximum proportion of the starting materials. Waste few or no atoms.
Prof practices p. 169
What is the objective of Green Chemistry’s “design less hazardous chemical synthesis” principle?
Domain 1:171
Design synthesis to use and generate substances with little or no toxicity to either humans or the environment.
Prof practices p. 169
What is the objective of Green Chemistry’s “design safer chemicals and products” principle?
Domain 1:172
Design chemical products that are fully effective yet have little or no toxicity.
Prof practices p. 169
What is the objective of Green Chemistry’s “use safer solvents and reaction conditions” principle?
Domain 1:173
Avoid using solvents, separation agents, or other auxiliary chemicals. If you must use these chemicals, use safer ones.
Prof practices p. 169
What is the objective of Green Chemistry’s “increase energy efficiency” principle?
Domain 1:174
Run chemical reactions at room temperature and pressure whenever possible.
Prof practices p. 169
What is the objective of Green Chemistry’s “use renewable feedstocks” principle?
Domain 1:175
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
What is the objective of Green Chemistry’s “avoid chemical derivatives” principle?
Domain 1:176
Avoid using blocking or protecting groups or any temporary modifications, if possible. Derivatives use additional reagents and generate waste.
Prof practices p. 169
What is the objective of Green Chemistry’s “use catalysts, not stoichiometric reagents” principle?
Domain 1:177
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
What is the objective of Green Chemistry’s “design chemicals and products to degrade after use” principle?
Domain 1:178
Design chemical products to break down to innocuous substances after use so that they do not accumulate in the environment.
Prof practices p. 169
What is the objective of Green Chemistry’s “analyze in real time to prevent pollution” principle?
Domain 1:179
Include in-process, real-time monitoring and control during synthesis to minimize or eliminate the formation of byproducts.
Prof practices p. 169
What is the objective of Green Chemistry’s “minimize the potential for accidents” principle?
Domain 1:180
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
