Risk Assessment

Question 1

Define Risk assessment

Answer 1

The systematic scientific characterization of potential adverse health effect from (human) exposures

Question 2

Define Risk

Answer 2

Probability of an adverse outcome under specified conditions

Question 3

True/False? Something is always a risk, but how much of a hazard it is depends on potential exposure.

Answer 3

False, opposite is true

Question 4

List 4 methods of hazard identification

Answer 4

Structure-Activity Relationships
In vitro/short term tests
Animal Bioassays
Epidemiologic data

Question 5

Define different types of Structure/activity relationships (9)

Answer 5

Structure
Solubility
Stability
pH sensitivity
electrophilicity
reactivity
endpoint(s)
read across
3D molecular modelling

Question 6

What is the read across approach?

Answer 6

Using data from similar chemical(s) to predict endpoint or property information for one or more substances that lack empirical data (qualitative or quantitative)

Question 7

Name the different in vitro/short term tests (3)

Answer 7

Bacterial/cell mutagenicity assays
Cell free corrosivity test
Pathway based cell assays

Question 8

Name the different animal bioassays (3)

Answer 8

Acute/chronic toxicity tests
Carcinogenicity (2 species, both sexes, near lifetime exposure)
Reproductive and developmental toxicity

Question 9

What can you get from epidemiologic data? (7 things)

Answer 9

Strength of association, consistency of observations, specificity, temporal relationship, dose response, biological plausibility, biomarkers

Question 10

What is the weight of evidence apporach

Answer 10

Quantity and quality of the data: consideration of all available lines of evidence, each line of evidence is weighted depending on quality, strength of inference and relevance

Question 11

True/False? A high quality, weak symbol is equivalent to a low quality, strong symbol.

Answer 11

True

Question 12

What are two types of mode of action pathways?

Answer 12

Key events and processes

Development of Adverse Outcome Pathways (AOPs)

Question 13

What are AOPs?

Answer 13

Central element of a toxicological knowledge framework being built to support chemical risk assessment based on mechanistic reasoning
Adverse Outocome Pathways

Question 14

What are three factors relating to a “safe” level of exposure?

Answer 14

Reference dose (RfD)
Acceptable daily intake (ADI)
Threshold of toxicological concern (TTC)

Question 15

What are the two measurements you can use as a point of departure?

Answer 15

NOAEL or BMD

Question 16

How can you reduce uncertainty?

Answer 16

Additional investigation

Question 17

What does uncertainty account for?

Answer 17

Experimental inadequacies (eg intraspecies or interspecies differences)

Question 18

What is the difference between uncertainty and variability?

Answer 18

Uncertainty: Group
Variability: individual

Question 19

How do you calculate ADI?

Answer 19

ADI = NOAEL/UF*MF

Question 20

How do you assess the cumulative hazard index?

Answer 20

By chemical or by pathway

Question 21

True/False? There aren’t many exposure pathways

Answer 21

V. False

Question 22

What is the Margin of Exposure?

Answer 22

The “distance” between expected exposures and the level exposure associated with harm (assuming there is a threshold)

Question 23

True/False? A high MOE is good

Answer 23

True

Question 24

When was the Chemicals management plan created?

Answer 24

2006

Question 25

When was the CEPA passed?

Answer 25

Canadian Environmental protection Act, 1999

Question 26

What does it mean to be CEPA toxic?

Answer 26

Having a Substantial combination of Toxicity, Persistence, and Bioaccumulation

Question 27

True/False? CEPA can ban a toxicant as a precaution without sufficient evidence

Answer 27

True (eg. BPA)

Question 28

True/False? TTC can be used to see if a toxicant is worth looking into.

Answer 28

True

Question 29

Define Risk Management

Answer 29

The process by which policy actions are chosen to control hazards

Question 30

Define the different CEPA approach types

Answer 30

type 1 - maybe of interest
type 2 - Fast but not detailed
Types 3 - 500 pages, very detailed.