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PMCOL 303 > Risk Assessment > Flashcards

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
Q

what is the time sequence in cohort studies

A

prospective (follow them for some time, check back for decades)

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26
Q

what is the time sequence classification in case control studies

A

retrospective (starting with people who already have disease, ask about the past)

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27
Q

what is the time sequence in cross sectional studies

A

present time

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28
Q

what is the comparison in cohort studies

A

exposed that develop the disease vs non exposed that develop disease

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29
Q

what is the comparison in case control studies

A

people with disease that were exposed vs. non-diseased people that were exposed

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30
Q

what is the comparison in cross sectional studies

A

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

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31
Q

what is the advantages in cohort studies

A

lack of bias in exposure(people choose what they do), powerful statistics that can support causation

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32
Q

what is the advantages in case control studies

A

inexpensive, small n, no attrition, good for rare diseases

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33
Q

which epidemiological study can support causation

A

cohort

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34
Q

what is the advantages in cross sectional studies

A

quick results, can determine prevalence (proportion of population with a disease/condition), can do studies with info gathered for other purposes

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35
Q

what is the disadvantages in cohort studies

A

long follow up, attrition, costly, large populations, poor for rare diseases (not big enough sizes to catch rare diseases)

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36
Q

what is the disadvantages in case control studies

A

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
Q

what is the disadvantages in cross sectional studies

A

population enriched with survivors, poor for rare diseases, hard to know if disease or exposure came first

38
Q

why is it a disadvantage to have “population enriched with survivors”

A

it means that the toxin may seem better than it is, you cant interview dead people

39
Q

why is it hard to get good controls in case control studies

A

cause you want people to have lived very similar lives, but some dont have the disease - hard to find

40
Q

which epidemiological study can be good for rare diseases

A

case control

41
Q

which epidemiological study can do prospective studies

A

cohort

42
Q

which epidemiological study can do retreospective studies

A

case control

43
Q

what does threshold approach mean

A

assuming a compound is safe below a certain concentration

44
Q

what are 2 examples of threshold approaches

A

NOAEL and LOAEL

45
Q

what does LOAEL stand for

A

lowest observed adverse effect level

46
Q

what does NOAEL stand for

A

no observed adverse effect level

47
Q

what is NOAEL

A

the highest non statistically significant dose tested (usually like 10% above background)

48
Q

what is LOAEL

A

lowest dose tested to produce a statistically significant dose (usually like 10% above background)

49
Q

what is the point of departure (definition)

A

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
Q

what does the point of departure usually signify

A

NOAEL

51
Q

is NOAEL or LOAEL higher on the graph

A

LOAEL

52
Q

what does it mean if a dose response curve intersects with the Y axis

A

there is a natural incidence of this response in the natural population

53
Q

why is it hard to test for thresholds in animals

A

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
Q

what are 2 measurements that use NOAEL

A

RfD and ADI

55
Q

what does RfD stand for

A

reference dose

56
Q

what is RfD

A

estimates of a daily exposure to an agent that is assumed to be without adverse health impact on the human population

57
Q

what is ADI

A

daily intake over an entire lifetime which appears to be without appreciable risk on the basis of all known facts

58
Q

what is the equation for RfD

A

NOAEL / UF*MF

59
Q

what is the equation for ADI

A

NOAEL / UF*MF

60
Q

what is UF

A

uncertainty factor

61
Q

what is MF

A

modifying factor to alter UF

62
Q

what happens if you wanna calculate RfD or ADI but theres to NOAEL

A

use LOAEL

63
Q

what is UF if data is from another species

A

10

64
Q

what is UF if intraspecies variation

A

10

65
Q

what is UF if data only LOAEL is available

A

10

66
Q

what is UF if study is not chronic

A

10

67
Q

what are 4 examples of things that would add 10s to UF

A
  • data from another species
  • intraspecies variation
  • data only LOAEL is available
  • study is not chronic
68
Q

what do you do to MF if calculating for children

A

use factor of 10

69
Q

what is an example of something that would change MF

A

if using in kids

70
Q

what is RfD if 500 animals, subchronic, NOAEL=5

A

5/ ((1000)(0.8)) = 0.006

rats +10
variation +10
not chronic+10
good confidence cause high number MF=0.8

71
Q

what does MOE stand for

A

margin of exposure

72
Q

what is MOE

A

ratio of NOAEL compared to level which humans may be exposed

73
Q

what # of MOE gets flagged for potential toxicity

A

if its under 100

74
Q

what does a large MOE mean

A

safer, means you are far from toxic dose

75
Q

what does a small MOE mean

A

more dangerous, closer to toxic dose

76
Q

what is BMD

A

benchmark dose

77
Q

what is the main goal of calculating BMD

A

use it to estimate daily oral or dermal exposure level to the human population that is likely without risk in lifetime

78
Q

what is a new preferred way of figuring out reference dose

A

using BMD instead of NOAEL

79
Q

what is BMR

A

benchmark response

80
Q

what is BMD

A

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
Q

what are the default BMR values

A

5% to 10% changes in response rate of an adverse effect relative to a control group

82
Q

what kind of data can be used to find BMD

A

quantal or continuous data

83
Q

what do you need to know in order to do benchmark dose

A

the upper and lower confidence limits of the data points

84
Q

what is the confidence limit

A

confidence that true value lies somewhere within that boundary of values, usually at 95%

85
Q

how are BMR and BMD related

A

the dose at which BMR occurs is the BMD

86
Q

statistically, what is the BMD

A

a range of values bordered by upper and lower confidence limits

87
Q

what is chosen as the BMD (BMDL)

A

the lowest dose defined by the confidence limit

88
Q

how do you calculate RfD using BMD

A

same, just use it instead of NOAEL

89
Q

what are 4 advantages of BMD over NOAEL

A
  • 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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