Risk Analysis in Toxicology Flashcards
For risk to be present, there must be two things. What are they?
- Exposure
2. A consequence arising out of exposure (adverse effect)
Risk assessment adheres to a 4-step process. What are those 4 steps?
- Problem formulation
- Effects characterization
- Exposure characterization
- Risk characterization
If you were given exposure and effect, how would you calculate risk?
Effect / exposure
True or False: Dose = exposure.
TRUE
True or False: Toxicity = risk.
FALSE: toxicity = effect
What does this define: the likelihood of harm to be manifested under relevant conditions of exposure?
Risk
What does this define: systematic scientific evaluation of potential adverse effects from exposures to hazardous agents or situations?
Risk assessment
What does this define: intrinsic toxic properties?
Hazard
What does this define: process by which policy actions are chosen to address and mitigate risk?
Risk management
What does this define: making risk assessment outcomes and risk management decisions comprehensible to interested and affected parties?
Risk communication
What does this define: the interrelated activities of risk assessment, management, communication, and perception?
Risk analysis
What is risk in relation to exposure and effect?
Risk is the joint probability of exposure and effect = f(exposure, effect)
Which part of the risk assessment process is the toxicology and biology?
Effects characterization
Which part of the risk assessment process involves source, route, duration, and intensity?
Exposure characterization
Which part of the risk assessment process is the confluence of exposure and effect?
Risk characterization
Which part of the risk assessment process are the likelihoods, uncertainties, and mitigation options?
Risk conclusion
Which part of the risk assessment process are the physical, chemical, or biological entities that can induce an adverse response?
Stressors
What is the hierarchy of the weight of evidence with risk assessment?
- Qualitative & quantitative
- Deterministic & probabilistic
- Partially stochastic & fully stochastic
What are the Bradford Hill Criteria for the weight of evidence?
- Strength of association
- Consistency of findings
- Biological gradient
- Temporal sequence
- Plausibility
- Coherence with existing knowledge
- Specificity of cause-effect association
Measure the effect of a source stressor (toxicant). Is this a form or prospective or retrospective risk assessment?
Prospective
Observe the consequence of exposure. Is this a form of prospective or retrospective risk assessment?
Retrospective
Which generally uses toxicological principles, prospective or retrospective risk assessment?
Prospective
What type of principles does retrospective risk assessment use?
Epidemiological principles
Which is a forward prediction, prospective or retrospective risk assessment?
Prospective
Which is a backward prediction, prospective or retrospective risk assessment?
Retrospective
What does EED stand for?
Estimated environmental dose
What is percent reference dose (%RfD) equal to?
100 x Rfd/EED
If EED is greater than RfD, what does that indicate?
A regulatory concern
What does MOE stand for?
Margin of exposure
What is the equation for MOE?
MOE = NOAEL / EED
If MOE is greater than the safety factors (UF and MF), what does that indicate?
There is a health/performance concern
Drug residues are analyzed, regulated, and monitored by _____, _____, _____, and ____.
- FDA-CFSAN/CVM
- USDA-FSIS
- State milk ordinances
- JEFCA
Regulatory toxicology is a confluence of ____ and ____.
Science and government
