Workshop "Traffic Light Model" Norbert Rupprich Dortmund May 2011 1
To grant or
not to grant
...
The basic topics
Traffic light model
Authorisation process
Non-threshold carcinogen (MDA) Socio-economic route
No suitable alternatives
Risk characterisation (science) Risk evaluation (policy)
DMEL = science + policy
Workshop "Traffic Light Model" Norbert Rupprich Dortmund May 2011 3
No time to waste …
Application of authorisation
ECHA‘s draft opinion (10 m)
Industry comment (2 m)
Final opinion (2 m)
Draft decision by the Commission Commission (3 m)
17 m
to think about
risk evaluation and DMELs
Working lifetime risk (I)
1.000 workers
Workshop "Traffic Light Model" Norbert Rupprich Dortmund May 2011 5
Working lifetime risk (II)
1.000 workers
identically exposed to a carcinogen
for their working lifetime of 40 years
Working lifetime risk
One of these 1.000 workers gets cancer
because of a specified 40-year exposure to the carcinogen:
Working lifetime risk of 1 : 1.000
It is an
excess risk
Workshop "Traffic Light Model" Norbert Rupprich Dortmund May 2011 7
High and low risk areas
R
E
?
Hi gh ris k a re a
A true dose response in the low risk area
R
E 1
Hi gh ris k a re a
Low risk area
Workshop "Traffic Light Model" Norbert Rupprich Dortmund May 2011 9
A black cloud covering the low risk area
R
E Hi gh ris k a re a
Low risk area
Probability of probability of getting cancer
Low risk area R
E Mode of action
1
3
2
Hi gh ris k a re a
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Reach guidance
Reach regulation
A qualitative assessment of the likelihood that effects are avoided when implementing the exposure scenario should be carried out …
Guidance document Two methodologies to characterise and evaluate risks:
Linear approach
Large assessment factor approach
MDA in the high risk area
Genotoxic
Liver tumours in rats Control: 1/50
9 mg/kg/d: 13/50 16 mg/kg/d: 26/50
Point
of departure for
both approaches:
T25
45.7 mg/m³
An extra cancer risk for workers of 25:100 at 45.7 mg/m³ With
R to R
extrapolation
Workshop "Traffic Light Model" Norbert Rupprich Dortmund May 2011 13
MDA in the low risk area
Reference value for LAFA
14.6 µg/m³
? Reference value
linear approach
45.700 / 3.125
2.5 in case of starting with T25 2.5
Point of comparison 10
Nature of carc.
process 10
Intraspecies 5
Interspecies 2.5
Large assessment factor approach T25 of 45,7 mg/m³
Linear approach T25 of 45,7 mg/m³
o
o
4:100.000 at 7,3 µg/m³
4:1.000
at 731 µg/m³
MDA (comparing both approaches)
Large assessment factor approach T25
45,7
mg/m³
14.6 µg/m³
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MDA (comparing both approaches)
T25 45,7 mg/m³ Linear
approach
Large assessment factor approach T25
45,7
mg/m³
14.6 µg/m³
MDA (comparing both approaches)
T25 45,7 mg/m³ Linear
approach
Large assessment factor approach Level of
acceptance o
T25 45,7 mg/m³ 14.6 µg/m³
7,3 µg/m³
4:100.000
Workshop "Traffic Light Model" Norbert Rupprich Dortmund May 2011 17
MDA (comparing both approaches)
T25 45,7 mg/m³ Linear
approach
Large assessment factor approach Level of
acceptance o
T25 45,7 mg/m³ 14.6 µg/m³
7,3 µg/m³ 4:100.000
8:100.000
Reach elements of decision finding
To grant or not to grant the authorisation
To conclude whether socio-
economic benefits outweigh the risk
To consider socio-economic aspects
To consider the appropriateness and effectiveness of RMM
To describe the risks posed by the uses
Risk
evaluation !?
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Responsibilities
x
o Decision
o ? Opinion
o SE versus RE
o Socio-economics (SE)
o ? o
Risk evaluation (RE)
o Risk characterisation
o Dose response
o Exposure
COM ECHA
SEAC RAC
X = large assessment factor approach
Traffic light model for MDA (linear approach)
Risk
4 : 100.000
7.3 µg/m³
4 : 1.000
731 µg/m³
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Traffic light model and authorisation process
Risk
Do not grant the authorisation !
Be satisfied with risk reduction ! Don‘t invest in socio-economics Grant the authorisation !
Do the socio-economic benefits
outweigh
the risk?
DMEL as target level Prohibitive level
PPE?
How to compare ?
… ideally you need to have the same weight unit on both sides of the balance …
Socio-economic benefits
Burden of risk
To grant
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