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Risk Assessment Flashcards

1
Q

what is risk assessment

A

systematic scientific characterization of potential adverse health effects resulting from human exposure to hazardous agents or situations

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2
Q

what is risk

A

the probability of an adverse outcome under specified conditions

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3
Q

what is risk management

A

process by which policy actions are chosen to control hazards

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4
Q

who decides policy decisions and actions

A

potilics

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5
Q

what are the 3 main components of risk determination/ judgement

A

research, risk assessment, risk management

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6
Q

what are 4 main things that happen in risk assessment

A
  • hazard identification
  • dose response assessment
  • exposure assessment
  • risk characterization
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7
Q

what are 4 objectives for risk assessment

A
  • protect human and ecological health
  • balance risks and benefits
  • set target levels of risk (food contaminants, water pollutants)
  • set priorities for program activities (manufacturers, agencies)
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8
Q

what are the 4 four types of testing done to assess toxicity

A
  • structure/ activity relationships
  • in vitro and short term tests (cell culture, isolated tissue)
  • in vivo animal bioassays
  • epidemiological studies
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9
Q

what is a con for in vivo animal bioassays

A

expensive and long term

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10
Q

what is a pro for structure/ activity relationships

A

inexpensive

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11
Q

what is QSAR

A

quantitative structure activity relationships

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12
Q

what do QSARs do (GENERAL)

A

identify potential toxicities

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13
Q

what kind of things do they look at with QSAR

A

structure, solubility, stability, pH sensitivity, electrophilicity, volatility and reactivity

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14
Q

what is an example of a structural property that QSAR would flag

A

amine group on aromatic

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15
Q

so why would QSAR flag an amine group on aromatic

A

because experience shows that chemicals like this have been previously linked to cancer and DNA mutation in general

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16
Q

why might QSAR have mixed results

A
  • difficult to predict activity across diff chemical classes

- difficult to predict multiple toxic outcomes based on limited testing (so many diff types of diseases)

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17
Q

what is a good way to increase QSAR accuracy

A

incorporate expert evaluation into the screening process

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18
Q

what is Ames test

A

bacterial to see ability to cause mutation

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19
Q

what is the best way to find evidence for toxicity in humans

A

epidemiological studies

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20
Q

what do epidemiological studies show

A

association between exposure and disease

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21
Q

what are the 3 kinds of epidemiological studies

A

cohort, case-control, cross-sectional

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22
Q

what is the initial classification in cohort studies (who is in it and how many)

A

exposure vs non exposure (large population)

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23
Q

what is the initial classification in case-control studies (who is in it and how many)

A

disease vs non disease (small group)

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24
Q

what is the initial classification in cross-sectional studies (who is in it and how many)

A

either exposure vs non exposure or disease vs non disease, often large populations

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25
what is the time sequence in cohort studies
prospective (follow them for some time, check back for decades)
26
what is the time sequence classification in case control studies
retrospective (starting with people who already have disease, ask about the past)
27
what is the time sequence in cross sectional studies
present time
28
what is the comparison in cohort studies
exposed that develop the disease vs non exposed that develop disease
29
what is the comparison in case control studies
people with disease that were exposed vs. non-diseased people that were exposed
30
what is the comparison in cross sectional studies
people with disease that were exposed vs. non-diseased people that were exposed OR exposed that develop the disease vs non exposed that develop disease
31
what is the advantages in cohort studies
lack of bias in exposure(people choose what they do), powerful statistics that can support causation
32
what is the advantages in case control studies
inexpensive, small n, no attrition, good for rare diseases
33
which epidemiological study can support causation
cohort
34
what is the advantages in cross sectional studies
quick results, can determine prevalence (proportion of population with a disease/condition), can do studies with info gathered for other purposes
35
what is the disadvantages in cohort studies
long follow up, attrition, costly, large populations, poor for rare diseases (not big enough sizes to catch rare diseases)
36
what is the disadvantages in case control studies
biased recall, problems obtaining good controls, population enriched with survivors(toxin may seem better than it is, you cant interview dead people), cannot support causation
37
what is the disadvantages in cross sectional studies
population enriched with survivors, poor for rare diseases, hard to know if disease or exposure came first
38
why is it a disadvantage to have "population enriched with survivors"
it means that the toxin may seem better than it is, you cant interview dead people
39
why is it hard to get good controls in case control studies
cause you want people to have lived very similar lives, but some dont have the disease - hard to find
40
which epidemiological study can be good for rare diseases
case control
41
which epidemiological study can do prospective studies
cohort
42
which epidemiological study can do retreospective studies
case control
43
what does threshold approach mean
assuming a compound is safe below a certain concentration
44
what are 2 examples of threshold approaches
NOAEL and LOAEL
45
what does LOAEL stand for
lowest observed adverse effect level
46
what does NOAEL stand for
no observed adverse effect level
47
what is NOAEL
the highest non statistically significant dose tested (usually like 10% above background)
48
what is LOAEL
lowest dose tested to produce a statistically significant dose (usually like 10% above background)
49
what is the point of departure (definition)
point on dose response curve established rom experimental or observational data generally corresponding to an estimated low effect level or no-effect level (marks beginning of extrapolation) usually NOAEL
50
what does the point of departure usually signify
NOAEL
51
is NOAEL or LOAEL higher on the graph
LOAEL
52
what does it mean if a dose response curve intersects with the Y axis
there is a natural incidence of this response in the natural population
53
why is it hard to test for thresholds in animals
you want to test low doses, but at very low doses, chemicals rarely induce a disease state so large numbers of animals must be tested
54
what are 2 measurements that use NOAEL
RfD and ADI
55
what does RfD stand for
reference dose
56
what is RfD
estimates of a daily exposure to an agent that is assumed to be without adverse health impact on the human population
57
what is ADI
daily intake over an entire lifetime which appears to be without appreciable risk on the basis of all known facts
58
what is the equation for RfD
NOAEL / UF*MF
59
what is the equation for ADI
NOAEL / UF*MF
60
what is UF
uncertainty factor
61
what is MF
modifying factor to alter UF
62
what happens if you wanna calculate RfD or ADI but theres to NOAEL
use LOAEL
63
what is UF if data is from another species
10
64
what is UF if intraspecies variation
10
65
what is UF if data only LOAEL is available
10
66
what is UF if study is not chronic
10
67
what are 4 examples of things that would add 10s to UF
- data from another species - intraspecies variation - data only LOAEL is available - study is not chronic
68
what do you do to MF if calculating for children
use factor of 10
69
what is an example of something that would change MF
if using in kids
70
what is RfD if 500 animals, subchronic, NOAEL=5
5/ ((1000)(0.8)) = 0.006 rats +10 variation +10 not chronic+10 good confidence cause high number MF=0.8
71
what does MOE stand for
margin of exposure
72
what is MOE
ratio of NOAEL compared to level which humans may be exposed
73
what # of MOE gets flagged for potential toxicity
if its under 100
74
what does a large MOE mean
safer, means you are far from toxic dose
75
what does a small MOE mean
more dangerous, closer to toxic dose
76
what is BMD
benchmark dose
77
what is the main goal of calculating BMD
use it to estimate daily oral or dermal exposure level to the human population that is likely without risk in lifetime
78
what is a new preferred way of figuring out reference dose
using BMD instead of NOAEL
79
what is BMR
benchmark response
80
what is BMD
a dose that produces a predetermined increase in the rate of response, BMR (you are more working backwards, find dose that gives response like 5-10%)
81
what are the default BMR values
5% to 10% changes in response rate of an adverse effect relative to a control group
82
what kind of data can be used to find BMD
quantal or continuous data
83
what do you need to know in order to do benchmark dose
the upper and lower confidence limits of the data points
84
what is the confidence limit
confidence that true value lies somewhere within that boundary of values, usually at 95%
85
how are BMR and BMD related
the dose at which BMR occurs is the BMD
86
statistically, what is the BMD
a range of values bordered by upper and lower confidence limits
87
what is chosen as the BMD (BMDL)
the lowest dose defined by the confidence limit
88
how do you calculate RfD using BMD
same, just use it instead of NOAEL
89
what are 4 advantages of BMD over NOAEL
- not limited to experimental dose - less dependent on dose spacing - compare diff chemical responses (all response levels at 10%) - flexibility in determining biologically significant rates (if BMR is 5% and causes small increase, can be dangerous)

PMCOL 303 (25 decks)

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