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