week 2 risk assessment/managment Flashcards

1
Q

What is a hazard?

A

threat to human health or the environment; could be chemical, physical, biological, or cultural

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2
Q

What is risk?

A

probability of harm (there is no such thing as zero risk)

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3
Q

What is safety?

A

freedom from danger, risk, or injury (there is no such thing as 100% safe)

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4
Q

What is risk assessment?

A

determination of probability that an adverse effect will result from a define exposure (this is a scientific process)

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5
Q

What are the four steps of risk assessment?

A

Hazard identification, dose-response assessment, exposure assessment, risk characterization

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6
Q

What is risk management?

A

Process of weighing policy alternatives and selecting the most appropriate regulatory actions based on the results of risk assessment and social, economic, and political concern; science and value judgement; “what do we do about it?”

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7
Q

What are the components of risk? How is risk calculated?

A
  • Existence and severity of a hazard
  • likelihood or probablity of exposure

RISK= (SEVERITY OF HAZARD) X (PROBABILITY OF EXPOSURE)

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8
Q

What factores influence risk perception?

A
  • trust
  • control
  • dread
  • risk vs. benefit
  • human-made vs. natural
  • “could it happen to me?
  • new or familiar
  • children
  • uncertainty
  • age
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9
Q

How does controllabity and observability affect risk?

A
  • observable & controllable= low risk
  • not observable & controllable/ observavble & not controllable= medium risk
  • not observable or controllable= high risk
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10
Q

What level of risk is acceptable?

A

Arbitrary number, depends on situation; see slides for examples

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11
Q

What is the purpose of risk assesment?

A
  • weigh the harms and benefits (risk/rewards)
  • set target exposure/dose levels
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12
Q

What is hazard identification?

A

Looking at if a hazard is having an impact on health; might use observational or experimental data

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13
Q

How do we weigh evidence in hazard identification?

A
  • Human data prefered (relevant species, capture genetic variation, real-world exposures)
  • Animal data (more controlled, similar physiological patterns, some correlation with human effects, accepted by scientific community, require by regulatory community)
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14
Q

What is the dose-resposnse assesment?

A
  • characterization or quantification of the relationship between exposure/dose and effect
  • describes how likelihood/severity of adverse health effects are related to amount/condition of exposure to agent
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15
Q

What are the two steps in dose-response assessment?

A
  • Model the shape of the dose-response curve in observable range
  • Extrapolate the dose-response curve to estimate dose that starts to cause increased risk in population of interest
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16
Q

When and why is linear extrapolation used?

A

Used for carcinogens, suggests there is NOT a safe level

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17
Q

When and is nonlinear extrapolation used?

A

curved line is used for carcinogens, suggests there is no safe level

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18
Q

What is NOAEL?

A
  • No Observable Adverse Effect Level
  • Highest expoure level at which no statistically or biologically increases are seen
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19
Q

What is LOAEL?

A
  • Lowest Observable Adverse Effect Level
  • lowest expoure level at which no statistically or biologically increases in frequency or severity of adverse effects
20
Q

What is BMD?

A
  • Benchmark Mark Dose
  • dose or concentration that produces a predetermined change in response rate of an adverse effect compared to background
21
Q

What is BMDL?

A
  • Benchmark Dose Lower Level
  • a statistical lower confidence limit on the dose or concentration at the BMD
22
Q

What do you use to graph non-carcinogens?

A

NOAEL, LOAEL, or threshold (BMD/BMDL)

23
Q

What do you use to graph carcinogens?

A

slope (q*) and point of departure (POD)

24
Q

What is the end-product of dose-response step for carcinogens and non-carcinogens?

A

Carcinogens: slope factor

Noncarcinogens: NOAEL, LOAEL, BMDL

25
Q

What is exposure assesment?

A
  • who, where, to how much
  • media, routes
  • special populations
  • exposure pathways
26
Q

What is exposure population? exposure media? exposure routes?

A

population= affected group of people

media: air, soil, food, water
routes: inhalation, ingestion, dermal

27
Q

What is LADD?

A

Lifetime Average Daily Dose

28
Q

How is LADD calculated?

A

LADD (mg/kg-day)= (concentration X intake rate X exposure duration) / (body weigh X lifespan)

29
Q

What is LADD used for?

A

Calculating exposure/dose for carcinogens

30
Q

What is ADD (measurement, not attention deficit disorder…)?

A

Average Daily Dose

31
Q

How is ADD calculated?

A

ADD= (concentration X intake rate X frequency X duration) / (body weight X averaging time)

32
Q

What is ADD used for?

A

estimating exposure/dose for noncarcinogens (for time of interest, not whole lifetime)

33
Q

What is risk characterization?

A

summarizing and intergrating information from the preceeding steps of risk assesment to synthesize an overall conclusion about risk

34
Q

What are the end products of risk characterization?

A

Carcinogens: estimate of increase in the number of cancer cases per year due to chemical (UCL)

Non-carcinogens: RfD or MOE

35
Q

How do you deterime the UCL risk for carcinogens?

A

UCL (mg/kg/day)-1= Slope facotr (q*) X LADD (mg/kg/day)

units should all cancel out and you end up with unitless number that tells you probability of harm

36
Q

What is the difference between RfD and RfC?

A

RfD= reference dose; RfC= reference concentration

dose= inside body (ingestion), concentration= outside body (inhlation)

37
Q

What is the goal of an RfD?

A

determine a safe level, estimated daily dose that is likley to have no appreciable adverse effects during a lifetime exposure

38
Q

How is RfD calculated?

A

RfD= (NOAEL or LOAEL or BMDL) / (UF1X UF2X UF3…)

39
Q

What are sources of uncertainty?

A
  • dose-response: lack of data, especially at real world dose
  • exposure assesment: lack of data, ambient monitoring rather than personal exposure assesment, modeling instead of data, occupational rather than environmental
40
Q

List uncertainty factors (UF).

A
  • human variability
  • extrapolation from human to animal
  • extrapolation from high to low dose
  • short study duration
  • use of LOAEL instead of NOAEL
  • incomplete database
  • children

* all are UF of 10

41
Q

What is MOE?

A

Margin of exposure

42
Q

What is MOE used for?

A
  • non-linear endpoints (so for non-carcinogens)
  • compare “safe levels” to levels humans are actually exposed to (use exposure level from highly exposed group to be safe
43
Q

How is MOE calculated? How do you know if the MOE is good?

A
  • MOE= (NOAEL or LOAEL or BMDL)/ human exposure level
  • want the # to be big (greater than 100 or the combination of uncertainty factors)
44
Q

What is the precautionary principle?

A
  • 1992 Rio Declaration
  • “where there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost-effective measure to prevent environmental degradation”
  • philosiphy towards being conservative
45
Q

What is risk communication?

A

process of making risk assesment and management info understandable to public, lawyers, politicians, media, public interest groups