risk assessment - sustainicum · the global risk assessment 1. hazard identification 2....
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Risk Assessment
Helena Parkman, 15 Sept.
Helena Parkman, September 2009
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Contents
• Definitions – general principles
• Effects assessment
• Risk characterisation – Ex. Existing chemicals/REACH
• Mention Biocides and Plant Protection Products
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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”
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REACH
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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
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• 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
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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/
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Principle
.
.
Inherent properties
Exposure assessment
PEC
Effects Assessment
PNEC
Risk Characterization
PEC/PNEC
More infor-mation
No further action
Risk Reduction
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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)
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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
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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
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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
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Surface water - PNECaquatic
•Assessment Factor (AF) – method
PNEC= (lowest LC50 or NOEC)/AF
• Species sensitivity distribution (SSD)
PNEC=SSD5/AF (for data rich substances)
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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.
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Effects in Sewage treatment plants -
PNECmicroorganisms/STP
NOEC (ECx)/AF
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PNECsediment and PNECsoil
• No toxdata for sediment/ soil => equilibrium partition
method:
• Toxdata available => calculate PNEC= NOEC/AF
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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
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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
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Risk
characteri-
zation
PEC/PNEC for
- air
- water
- sediment
- soil
- STP
- predators
decrease AF refine PEC,
emission scenarios
Risk
controlled?
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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
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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.
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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.
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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
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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
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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/
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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
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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.
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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.
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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.
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Helena Parkman, 15 Sept.
THANK YOU FOR
YOUR ATTENTION!
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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)
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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