Term
| *Things to think about in risk (8): |
|
Definition
-What is the problem?
-Hazard
-Severity of effect
-Effective dose
-Population exposure
-vulnerability and susceptibility
-prevention
-risk management |
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Term
|
Definition
-Probability that an event will "occur"
-"Risk is the measure of the probability and severity of adverse effects" |
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Term
| *What does the decision maker do? |
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Definition
| Weigh scientific uncertainty versus acceptability of risk |
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Term
| *5 steps of risk assessment: |
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Definition
1. Problem formulation
2. Hazard Identification
3. Dose Response
4. Exposure assessment
5. Risk characterization |
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Term
| *Components of hazard identification |
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Definition
-Review and analyze toxicity data
-weight the evidence that a substance causes various toxic effects
-evaluate whether toxic effects in one setting will occur in other settings |
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Term
| *Dose Response Assessments |
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Definition
-assess relevance of animal and human data to target situation
-Review data for shape and form of dose-response relationship
-extrapolate from high to low dose
-extrapolate from species, age, and route to target |
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Term
| *Exposure assessment questions: |
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Definition
-WHERE is agent found?
-Through what ROUTES?
-How many people are exposed?
-WHO is exposed?
What is the magnitude, duration, and timing of exposure? |
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Term
| *Risk characterization components: |
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Definition
-integrate and summarize the hazard identification, dose-response assessment, and exposure assessment
-Develop public health risk estimates
-develop a framework to define the significance of the risk
present assumptions, uncertainties, scientific judgments |
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Term
| *Preparing for interviews: |
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Definition
-Ask who is conducting the interview
-Ask what subject they want to cover
-Caution them when you are not the correct person to interview
-Inquire about the format and duration
-Ask who else will be interviewed
-Prepare & practice |
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Term
| *Don't do these in an interview: |
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Definition
-Lie
-Improvise
-Fail to think it through ahead of time
-Guess
-Raise issues you don't want to see in the story
-Use jargon or assume the facts speak for themselves
-Speculate
-Say "no comment" |
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Term
|
Definition
| Risk = Hazard + Outrage (fear) |
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Term
| *Risk is more accepted when: |
|
Definition
perceived to be:
-voluntary
-under individuals control
-has clear benefits
-fairly distributed
-of natural causes |
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Term
| *Risk is more accepted when (part 2): |
|
Definition
perceived to be:
-statistical
-generated by a trusted source
-familiar
-affect adults |
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Term
| *Determinants of toxicity: |
|
Definition
-Dose
-Individual exposed
-Species
-Presence or absence of receptors
-frequency of dosing (once or repeated)
-Duration of exposure
-Route of exposure
-Absorption/metabolism
-physical form (liquid, solid, solution)
-presence of other agents (additive or synergistic effects) |
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Term
| *Microbial hazard identification: |
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Definition
-includes both ID of agent and spectrum of illness and disease associated with the organism
-Data comes from clinical literature & studies
-endemic and epidemic disease investigations |
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Term
| *Microbial Hazard ID Considerations: |
|
Definition
-pathogenicity and virulence
-transmission
-host response regarding immunity
-molecular epidemiology to track specific organisms |
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Term
|
Definition
-characterizes the evidence from human studies and from animal studies
-summarizes key evidence, type of effect and target organ, mode of action |
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Term
|
Definition
Absorption
Distribution
Metabolism
Excretion |
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Term
| *Experimental Design variables |
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Definition
| -Route -Species -Controls -sample size -dose selection -duration of study -observations to be made |
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Term
|
Definition
Maximum Tolerated Dose
-group treated with increasing dose until effects are seen
-second group dosed at this level to ensure consistent results
MTD or slightly lower is used as the high dose of hte study |
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Term
| *National Tox Program Cancer Bioassay standards |
|
Definition
-4 animal groups (MTD, 1/2 MTD, 1/4MTD, 0)
-60m/60f
-rats or mice
-2 years in duration
-40 tissues/organs examined from each animal |
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Term
|
Definition
No Observed Effect Level
No Observed Adverse Effect Level
Lowest Observed Adverse Effect Level |
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Term
| *Human Evidence Factors (increase weight) |
|
Definition
most causal criteria satisfied:
-temporal relationship
-Strong association
-reliable exposure data
-dos response relationship
-freedom from bias and confounding
-biological plausibility
-high statistical significance |
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Term
| *Dose-response relationship: |
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Definition
| relationship between a quantified exposure (dose) and the proportion of subjects demonstrating specific, biological changes (response) |
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Term
| *Dose-response from animal bioassays: |
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Definition
-typically done at high doses (limited precision at lower doses)
-relevance of animal model (nature of response: uptake, metabolism, organ distribution, species variation in target site susceptibility)
-Mixture problem (studies usually single agent) |
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Term
| *Source of data: short-term tests (pro/con) |
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Definition
Strength:cheap, quickly performed
Weakness: uncertain relevance |
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Term
| *Source of data: animal bioassays (pro/con) |
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Definition
Strengths:dose controlled, outcome assessment, experimental
Weaknesses: species wrong, expensive, mixtures difficult |
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Term
| *Source of data: epidemiologic data (pro/con) |
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Definition
Strengths: species right, real-world exposures, population heterogeneity
Weaknesses: misclassification of exposure/outcome, confounding, precision of estimates |
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Term
| *EPA defaults for data selection in hazard and dose response: |
|
Definition
-Human data over animal data
-Animal data when human data inadequate
-Select animal species most similar to human
-Select most sensitive animal species/strain |
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Term
| *EPA defaults for Dose-Response |
|
Definition
-Combine benign and malignant tumor count for carcinogens
-apply standard factor to scale between species (surface area)
-assume no threshold for carcinogens
-assume a threshold for non-carcinogens
-apply linearized multistage model for low dose extrapolation for carcinogens. use upper statistical confidence limit. |
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Term
|
Definition
-Command
-Control
-Coordination
-Communication |
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Term
| *Understanding the challenges (command structure): |
|
Definition
-environmental hazard ID
-hazards consultation
-epidemiologic services
-health and medical needs assessment
-identificatino of affected individuals
-contamination control
-health surveillance |
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Term
|
Definition
| ED = weeks/weeks * days/days * hours/hours * years |
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Term
|
Definition
ADD = (C*IR*EF)/BW
used for acute, sub-chronic and chronic exposures |
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Term
|
Definition
|
|
Term
| 6 sources of human exposure to Environmental Hg |
|
Definition
1. Air
2. Food
3. water
4. Medications
5. Medical devices
6. Ritual use |
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Term
|
Definition
-worker health issues
-poisonings
-ecological & environmental impacts
-toxicology
-epidemiology
-exposure assessment |
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Term
| Define Risk Characterization |
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Definition
| brings together assessments and characterizations of hazard, dose response, and exposure to make risk estimates for the exposure scenarios of interest. |
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Term
| Challenge of risk assessment is... |
|
Definition
characterization of risks that is -scientifically sound
-useful to decision makers
-understandable and credible to the public |
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Term
| *Tools in risk characterization |
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Definition
| NOAEL, LOAEL, RfD, RfC, TLV, MOE, MOS, Bench Mark Dose, ID50, LD50 |
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Term
|
Definition
| traditionally 1/100 of rodent NOAEL |
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Term
|
Definition
| RfD = NOAEL/uncertainty factors (UF) |
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Term
|
Definition
Risk = probability of developing cancer
LADD = lifetime average daily dose (mg/kg/day)
q1 = slope factor (mg/kg/day) |
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Term
| *Margin of Safety Equation |
|
Definition
|
|
Term
|
Definition
HI = exposure/RfD
(we want this to be small) |
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Term
| *Margin of Exposure definition |
|
Definition
MOE = BMDL (benchamark dose limit)/exposure
-examines difference between actual human exposure and BMDL |
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Term
| *Margin of Exposure eqn 2 |
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Definition
| MOE = NOAEL or BMDL / Exposure |
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Term
| risk characterization values are: |
|
Definition
| transparency, clarity, consistency, reasonableness |
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Term
|
Definition
| have at least one dimension smaller than 100 nanometers |
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Term
| EPA Classification of nanomaterials |
|
Definition
-Carbon based
-Metal based materials
-nanosized polymers
-nano clays |
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Term
|
Definition
no health benchmarks, very little data
most nanomaterials are common materials and no reporting required |
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Term
| three groups of microorganisms |
|
Definition
bacteria
parasites (can last months in environment)
viruses (alst weeks to month; enveloped degrade, nonenveloped persist) |
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Term
| **treatment of drinking water (this IS on the exam) |
|
Definition
1. coagulation, floculation, sedimentation
2. filtration
3. disinfection
4. distribution |
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Term
| *Risk Assessment - microbial paradigm |
|
Definition
-pathogens may grow or die in water
-can mutate and become more pathogenic
-different strains of same species have varying potential to infect & cause disease
-human health effects can vary based on age, preexisting immunity, general health of the exposed population |
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Term
| *Risk assessment - microbial paradigm (part 2) |
|
Definition
-once infected, a person may spread infectious disease to others
-person may suffer serious after effects of disease (chronic) |
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Term
| *Risk assessment - microbial paradigm (part 2) |
|
Definition
-once infected, a person may spread infectious disease to others
-person may suffer serious after effects of disease (chronic) |
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Term
| *Summary Microbial Paradigm |
|
Definition
-wash your hands
-microbial risk assessment differs from chemical risk assessment
-human dose response data limited for microorganisms
-microbial detection techniques are not perfect
-more research needed to obtain more accurate microbial risk characterizations |
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Term
| *EPA statement: when did tests show that it is safe for workers to go back in NY financial district |
|
Definition
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|
Term
| *Political conflicts concerning the potential costs of risk management should influence which of the following? |
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Definition
| A: the choice of risk management options |
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Term
| Look over DR curve in lecture 13 |
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Definition
| Observable range & range of inference |
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|
Term
*Improving the utility of risk assessment:
(know one of these) |
|
Definition
-what is the problem and what is its souce?
-how can the assessments be used to support decisions?
-what impacts other than health and ecosystem threats will be considered? |
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|
Term
|
Definition
-natural disasters
-food safety
-infectious disease
-terrorism
-chronic disease
-health care
-lifestyle |
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|
Term
|
Definition
| a process in which information is analyzed to determine if a hazard may cause harm. |
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|
Term
| Purpose of Risk Assessment: |
|
Definition
-to inform risk manager's decision making
-NOT to recommend any particular decision |
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|
Term
| Factors in risk decision: |
|
Definition
-economic
-laws & legal
-social factors
-technological factors
-political factors
-public values |
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|
Term
| 7 cardinal rules of Risk Comm. |
|
Definition
1. accept and involve the public as a partner
2. plan carefully and evaluate performance
3. listen to your audience
4. be honest, frank, and open
5. coordinate and collaborate with other credible sources
6. meet the needs of the media
7. speak clearly and with compassion |
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Term
| 7 realities of Risk Comm. |
|
Definition
1. involuntary risks are unacceptable
2. once minds are made up, it is hard to change them
3. trust and credibility require long term effort
4. unfamiliarity breeds contempt
5. health risks may be secondary in environmental controversy
6. communitiy values/perceptions can outweigh science in shaping policy
7. best communication can't reverse bad risk management decisions |
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Term
| Why use animal studies for Hazard ID? |
|
Definition
-Good correlation with human disease
-acutely toxic doses are similar in human and a variety of animals
-accepted by the scientific community
-among mammals, anatomical, physiological and biochemical parameters are similar |
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Term
|
Definition
-exposure
-potency
-susceptibility |
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|
Term
| Margin of Exposure (aka Margin of Safety) |
|
Definition
| MOE = NOAEL OR BMDL / population exposure |
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|
Term
| *The public health response: |
|
Definition
-prepardness
-surveillance
-coordination
-communication
-emergency response
-exposure assessment
-diagnosis & triage
-psycho-social response
-remediation
-consequence management |
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