Risk Assessment
Helena Parkman, 15 Sept.
Helena Parkman, September 2009
Contents
• Definitions – general principles
• Effects assessment
• Risk characterisation – Ex. Existing chemicals/REACH
• Mention Biocides and Plant Protection Products
The Global Risk Assessment
1. Hazard identification
2. Dose-Response
3. Exposure assessment
4. Risk Characterisation
1+2. Hazard Assessment
(Effect Assessment)
5. Conclusions
Risk reduction/management”Other factors”
REACH
Environmental Risk Assessment
according to ”Existing substances”
≈ Chemical Safety Report required in REACH if the
substance is classified as dangerous or PBT, vPvB
or substance evaluation by a member state
REACH guidance documents:
http://guidance.echa.europa.eu/docs/guidance_document/information_require
ments_en.htm?time=1252871010
• PEC = Predicted Environmental Concentration
(the concentration in the environment)
• PNEC = Predicted No Effect Concentration
(No adverse effects are expected below this
concentration)
• Risk characterisation:
PEC/PNEC >1, Risk!Risk reduction measures
General concepts
www.kemi.se
“TGD”Technical Guidance Document for Risk Assessment of
new and existing chemicals and biocides
http://ec.jrc.ec.europa.eu/risk-assessment/
Principle
.
.
Inherent properties
Exposure assessment
PEC
Effects Assessment
PNEC
Risk Characterization
PEC/PNEC
More infor-mation
No further action
Risk Reduction
Environmental effects
assessment - principle1. Identify critical effects
2. Dose – response endpoint (L(E)C50 or NOEC)
in combination with
Assessment (uncertainty) Factor
=> PNEC (predicted no effect concentration)
o
“Base-set”: Minimum requirements for hazard
assessment and classification and labelling
Environmental data:
acute toxicity to fish, daphnia and algae,
primary degradation studies
In addition, possibly:
•studies from the open litterature
•non test data: (Q)SAR (Qualitative Structure
Analysis Relationships)
Available effects data
Additional data requirements at
higher tonnage within REACH
Ecotoxicity data
• Level 1 (>10/100 tpa)
e.g. prolonged Daphnia and fish test, plant and
earthworms toxicity test, bioaccumulation –
fish, degradation
• Level 2 (> 1000 tpa)
e.g. additional bioaccumulation, degradation
(simulation), sediment organisms, birds, etc
Target organisms - medium
Target Exposure medium
(PEClocal/PECregional)
PNEC
Aquatic organisms Surface water PNECwater
Benthic organisms Sediment PNECsediment
Terrestrial organisms Agricultural soil PNECsoil
Fish-eating predators Fish PNECoral from
NOALavain/mammalian
Worm-eating predators Earthworms PNECoral as above
Microorganisms STP aeration tank PNECmicoorganisms
Marine Top-predator Predator (fish) PNECoral as above
Surface water - PNECaquatic
•Assessment Factor (AF) – method
PNEC= (lowest LC50 or NOEC)/AF
• Species sensitivity distribution (SSD)
PNEC=SSD5/AF (for data rich substances)
Species Sensitivity Distribution (SSD)
logNOECSSD5%
(HC5)
•More than ten species•Most sensitive ’end-point’ for a species•Geometric mean if many data from comparable studies•Mainly used for metals
PNEC= SSD5%/AF (5-1)
Helena Parkman, 15 Sept.
Effects in Sewage treatment plants -
PNECmicroorganisms/STP
NOEC (ECx)/AF
PNECsediment and PNECsoil
• No toxdata for sediment/ soil => equilibrium partition
method:
• Toxdata available => calculate PNEC= NOEC/AF
PNECair
• No available methods for quantitative risk
characterisation
• Biotic effects: acute effect are not likely, some examples
exist with long-term effects on plants.
• Abiotic effects: global warming, effects on ozone layer,
acidification
PNECoral, predator for aquatic and terrestrial food chain
PNECoral, predator= TOXoral /Aforal
NOECbird/mammal=NOALbird/mammal*CONVbird/mammal
where CONVbird/mammal: species specific conversion factor: 8-40
Risk
characteri-
zation
PEC/PNEC for
- air
- water
- sediment
- soil
- STP
- predators
decrease AF refine PEC,
emission scenarios
Risk
controlled?
Overview of PEC/PNEC ratios considered
for inland risk assessment
Helena Parkman, 15 Sept.
Comp. Local regional
Water PEClocalwater/PNECwater PECregionalwater/PNECwater
Sediment PEClocalsediment/PNECsediment PECregionalsediment/PNECsediment
soil PEClocalsoil/PNECsoil PECregionalagr.soil/PNECsoil
STP PECstp/
PNECmicroorganisms
Predator,
fish –
eating
(0.5 . PEClocal,oralfish + 0.5 . PECregional,oralfish)/PNECoral
Predator,
worm-
eating
(0.5 . PEClocal,oralworm + 0.5 . PECregional,oralworm)/PNECoral
Conlusions from the risk
characterization (1)Performe local and regional risk characterization
for all identified uses and all compartments =>
Within ”existing substances”, the characterization
resulted in conclusions:
i) there is a need for further information/testing
ii) at present no need for further
information/testing and no need for risk
reduction measures beyond these that are being
applied already
III) There is a need for limiting the risk
Helena Parkman, 15 Sept.
Conlusions from the risk
characterization (2)
Helena Parkman, 15 Sept.
Within REACH
Risk controlled? If not:
•Improve hazard information
•Improve exposure information and/or
consider to introduce sufficient RMMs
•Conclude that it is not possible to
demonstrate control of risk, and
provide the necessary documentation
that uses are advised against.
PBT assessment
Persistant, Bioaccumulating and Toxic or
very Persistant and very Bioaccumulating
To protect systems where risks are difficult to
estimate e.g. long range transport of
accumulating/biomagnifying substances
If PBT or vPvB
• No exposure assessment is needed,
• Exposure assessment should be performed
• Rsk reduction measures should be performed
• Substance is put on candidate list for SVHC
substances => limitations/ authorisation
EU Risk assessment on Biocides
Directive 98/8/EG give the principles.
Detailed test requirements and guidance
are given in Technical Notes on the
ECB Web site :
http://ecb.jrc.it/biocides/
In accordance with TGD
(Environment) for new and
existing chemicals
+ ”Emission scenario documents” for
calculation of PEC for different
product types http://ecb.jrc.it/tgd/
EU Risk assessment on
Plant Protection Products (PPP)
• Directive 91/414/EG give the principles
• Annex 6 gives guidance on risk assessment (“uniform principles”)
• Annex 2&3: Data requirements, much more specific and comprehensive compared to Existing/REACH-chemicals
• Some differences to TGD/REACH principles (egTER=Toxcity to Exposure ratio instead of PEC/PNEC)
• The directive will be replaced by a new regulation (soon)
Guidance can be found on DG SANCO home page.
http://ec.europa.eu/dgs/health_consumer/index_en.htm
and exposure models on: http://focus.jrc.ec.europa.eu/
EFSA: http://www.efsa.europa.eu/en.html
Plant Protection Products
• Risk assessment Toxicity Exposure Ratio = TER
TER = Toxicity endpoint / PEC
E.g. TER long term (TERlt): NOEC (bird) / PEC (in feed)
TER acute fish(TERac): LC50 (Fish)/PECsurface water
Both toxicity tests and the calculation of PEC should be carried out
on both active ingredient and major metabolites (≥10% of parent
compound)
EU Guidance documents on assessments for aquatic and terrestrial
environment at DG SANCO web site.
Helena Parkman, 15 Sept.
Risk assessment PPP
• Risk (TER) is calculated for :Aquatic environment:
- Algae; growth inhibition
- Higher plant – Lemna; acute / long term risk (growth inhibition)
- Daphnia – acute and reproductive risk
- Fish (2 species) – acute and long term risk (reproduction)
- Sediment living organism – long term risk
• Terrestrial organism:
- Earthworm - acute and reproductive risk
- Birds – acute, dietary and reproduction risk
- Mammals – acute and reproductive risk
- Bees and other non-target arthropods
- soil microorganisms
Helena Parkman, 15 Sept.
PPP - risk criteria
For PPP there are specific criteria set for each set of organisms belonging to a compartment. These are found in AnnexVI to directive 91/41/EG. The criteria have to be met for an approval.
Example, birds and mammals:
TER (Toxicity Exposure Ratio): Acute: LD50 / PEC < 10 risk is indicatedLong term exp.: NOEC / PEC < 5 risk is indicated
Groundwater: shall be <0.1 µg/l (not risk based) (active ingredient and relevant metabolites
Helena Parkman, 15 Sept.
Helena Parkman, 15 Sept.
THANK YOU FOR
YOUR ATTENTION!
Web sites
• www.epa.gov
• www.oecd.org
• www.epa.gov/ordntrnt/ORD/WebPubs/ecorisk/
• ecb.jrc.it/existing-chemicals/
• ecb.jrc.it/biocides
• europa.eu.int/comm/food/plant/protection/resources/p
ublications_en.htm
• puck.sourceoecd.org (Links to OECD Test
Guidelines)
Literature
Ballantyne B, Marrs T, Syversen T (eds) General and Applied Toxicology, 2nd ed., vol. 1-3, MacMilllan Reference Ltd., 1999.
Cockerham, L.G., and Shane, B.S. (eds) Basic Environmental Toxicology, CRC press 1994.
Klaassen (ed) Casarett and Doull´s Toxicology – The Basic Science of Poisons, 6th ed., McGraw-Hill, 2001
Hoffman, Barnett, Burton and Cairns (eds) Handbook of ecotoxicology, 2nd ed., Lewis Publishers, 2003.
Wexler P (ed-in-chief) Encyclopedia of Toxicology, 2nd ed., vol. 1-4, Elsevier Academic Press, 2005