General principles for risk assessment of chemical exposure Flashcards
(32 cards)
What is the scientific core activity of risk assessment?
Toxicologic research and toxicity testing conducted by toxicologists
This includes the steps of hazard identification, dose–response assessment, exposure analysis, and risk characterization.
What are the four key steps of risk assessment?
- Hazard identification
- Dose–response assessment
- Exposure assessment
- Risk characterization
These steps create a consistent framework for risk assessment across agencies.
What does risk management refer to?
The process by which policy actions are chosen to control hazards identified in the risk assessment stage
It involves considering scientific evidence, risk estimates, and various factors.
What is the definition of risk communication?
The process of making risk assessment and risk management information comprehensible to various stakeholders
Effective communication requires listening to the fears and perceptions of stakeholders.
What is the role of biomarkers in toxicology?
They link the presence of a chemical to specific sites of action in target organs and host responses
Biomarkers of exposure, effect, or individual susceptibility are crucial for risk assessment.
What types of studies are used to assess the toxicity of chemicals?
- Structure–activity relationships (SARs)
- In vitro or short-term studies
- In vivo animal bioassays
- Human epidemiologic studies
These studies provide essential data for toxicity assessments.
What is the primary focus of Structure–Activity Relationships (SARs) in toxicology?
To provide initial hazard identification and inform decisions about chemical development
SARs evaluate chemical properties like solubility and stability.
What are the advantages of in vitro and short-term tests?
- Fast and inexpensive compared to lifetime bioassays
- Can provide information about mechanisms of effects
These tests improve the assessment of potential health effects.
What is the precautionary principle in risk assessment?
Regard chemicals and mixtures with sufficient evidence of carcinogenicity in animals as presenting a carcinogenic risk to humans
This principle emphasizes caution in the absence of human data.
List the three types of epidemiologic study designs.
- Cross-sectional studies
- Cohort studies
- Case–control studies
Each design serves different purposes in evaluating exposure and disease relationships.
What criteria are used to judge epidemiologic findings in risk assessment?
- Strength of association
- Consistency of observations
- Specificity
- Appropriateness of temporal relationship
- Dose–response
- Biological plausibility and coherence
- Verification
- Analogy
These criteria help assess the validity of the findings.
What are the key criteria for evaluating epidemiologic study designs?
Key criteria include:
* Consistency of observations
* Specificity
* Appropriateness of temporal relationship
* Dose–response
* Biological plausibility and coherence
* Verification
* Analogy
What is the power of detection in epidemiologic studies?
Power of detection is calculated using:
* Study size
* Variability
* Accepted detection limits for endpoints
* Specified significance level
How does meta-analysis contribute to epidemiologic studies?
Meta-analysis combines results from different studies using weighting of results to account for sample size across studies
What advancements have resulted from the human genome project in epidemiology?
Advancements include increased sophistication of molecular biomarkers and improved mechanistic bases for epidemiologic hypotheses
What are some examples of biomarkers used in epidemiological studies?
Examples include:
* Single-nucleotide polymorphisms (SNPs)
* Genomic profiling
* Transcriptome analysis
* Proteomic analysis
What is the purpose of qualitative assessment in risk assessment?
Qualitative assessment considers consistency and concordance of findings across species, experimental conditions, and adequacy of experiments
What are common evidence classifications used by agencies in risk assessment?
Common classifications include:
* Sufficient
* Limited
* Inadequate
* No evidence
What is a critical effect in dose-response assessment?
A critical effect is the significant adverse biological effect occurring at the lowest exposure level
What are tolerable daily intakes (TDIs)?
TDIs describe intakes for chemicals that are not ‘acceptable’ but are ‘tolerable’ as they are below levels thought to cause adverse health effects
What is the difference between threshold and nonthreshold dose–response models?
Threshold models assume a dose below which no adverse effects occur, while nonthreshold models assume any exposure carries some risk
How does the one-hit linear model apply to cancer modeling?
The one-hit model suggests that a single molecule of a genotoxic carcinogen has a chance of causing a mutational event
What are toxicokinetic (TK) and toxicodynamic (TD) considerations?
TK refers to processes like absorption and metabolism, while TD refers to the actions and interactions of the toxicant within the organism
What is the primary goal of exposure assessment in risk assessment?
To determine the source, type, magnitude, and duration of contact with chemicals
Exposure assessment is crucial for understanding potential health risks associated with chemicals.