Environmental risk assessment

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Environmental risk assessment
Margrit Grimm
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Environmental risk assessment

• Definition of risk

Risk
Exposure
Hazard
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Environmental risk assessment

• Exposure
• Depends on Product-type Kind of
  application Fate and behaviour of the active
  substance
• Can be calculated for the active
  ingredient biocidal product
• Is expressed as PEC (predicted environmental
  concentration) for the use of a product

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Environmental risk assessment

• Hazard effects of concern
• Effects are evaluated in several tests
• Tests are requested for these protection goals of
  the environment were exposure is possible
• Tests are mainly done with the active ingredient,
  but also with the product
• A PNEC has to be established for each
  environmental compartment using an assessment
  factor
• The assessment factor reflects the degree of
  uncertainty in extrapolation from laboratory
  toxicity test data to the real environment

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Environmental risk assessment

• Pointing out the riskPNEC is regarded as the
  concentration below which an unacceptable effect
  will most likely not occurPEC for the intended
  use is compared with thePNEC for the particular
  environmental compartmentPEC/PNEC ratio gt1
  indicates a risk The higher the value, the
  higher the risk

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Environmental risk assessment

• Quantitative estimation
• PEC/PNEC lt1 for protection of the following goals
  (protection of non-target organisms)
• aquatic fresh water and marine ecosystem
  (including the sediment)
• terrestrial ecosystem (for example other
  non-target arthropods)
• micro-organisms in sewage treatment plants
• top-predators (secondary poisoning)

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Environmental risk assessment

• Qualitative estimation
• Compartment air A substance should be carefully
  considered if it
• is volatile and stable in the atmosphere
• is measured at elevated levels in remote regions
• has the potential to cause adverse effects, e.g.
  on the atmospheric environment contributing to
• degrading air quality
• tropospheric ozone building
• acidification
• ozone layer depletion
• global warming
• long range transport

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Environmental risk assessment

• Qualitative and quantitative estimation
• Compartment soilA substance should be carefully
  considered if it
• has the potential to persist and accumulate in
  soil
• Compartment surface waterIf the surface water is
  envisaged to use it for drinking water
  abstraction
• the corresponding regulations have to be followed
  (e.g. Council Directive 98/83/EC on the quality
  of water intended for human consumption)
• Compartment ground water
• the maximum permissible concentration laid down
  by Directive 80/778/EEC, as amended by 98/83/EC
  should not be exceeded

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Environmental risk assessment

• Unless clausesEnvironmental criteria for
  exclusion in Annex I
• Non-target organisms
• Soil, accumulation
• Water, drinking water quality
• Bioaccumulation (BCF gt1000 for readily
  biodegradableBCF gt100 for not-readily
  biodegradable substances)
• .... are valid unless it is scientifically
  demonstrated that under relevant field conditions
  there is no unacceptable effect.

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Environmental risk assessment

• PBT-assessment (persistent, bioaccumulative,
  toxic substances)
• Substances, which fulfil the selection criteria
  under the POPs convention (persistent organic
  pollutants) shall not be included in Annex I
• Substances which are persistent in water and
  sediment (DT50 gt 60 and 180 d, resp.) and have a
  high potential to bioaccumulate (BCF between 2000
  and 5000) should not be included in Annex I if
  they are released into the environment (PBTs)
• Substances with a BCF gt 5000 should not be
  included in Annex I

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Environmental risk assessment

• PEC/PNEC ratio lt1
• Active substance and its transformation
  products? Inclusion of an active substance in
  Annex I, IA, IB
• Product (multi-component mixtures) ?
  Authorisation/registration of a biocidal product

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Environmental risk assessment

• PEC/PNEC ratio gt1? Refinement of PEC/PNEC
  ratio
• PEC (based on worst case scenarios)
• further, more realistic data on fate and
  behaviour
• more realistic exposure data (measured conc.)
• refinement on model inputs (likelihood)
• monitoring programs
• PNEC
• additional data
• long term tests
• bioaccumulation tests
• tests with species from tropic levels not yet
  tested

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Environmental risk assessment

• PEC/PNEC ratio gt1 and further testing cannot
  decrease the ratio below 1 further tests should
  not be required
• ? Risk reduction measures ? calculation of
  new PECs

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Environmental risk assessment

• Further tests with the most relevant organism
• Aquatic compartment
• long-term fish test (effects on reproduction and
  growth)
• long-term test on invertebrates
• long term test on sediment dwelling organisms
• tests on aquatic plant growth
• tests with estuarine or marine organisms
• The assessment factor can be lowered to 10

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Environmental risk assessment

• Further tests on the terrestrial compartment
• inhibition on microbial activity
• acute toxicity on earthworms
• acute toxicity to other non-target soil organisms
• acute toxicity to plants
• long-term test on plants
• reproduction study on earthworms
• long-term study on other soil macro-organisms
• short-term tests on birds or mammals
• long-term tests on birds or mammals
• toxicity tests on honeybees or other beneficial
  arthropods

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Environmental risk assessment

• Further tests on bioaccumulation
• bioaccumulation study in a fish species
• bioaccumulation study in an invertebrate species
• bioconcentration study in a soil dwelling
  organism

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Environmental risk assessment
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Environmental risk assessment

• Comparative risk assessmentProcedure to
  determine whether there is an alternative active
  substance in Annex I intended for the same
  purpose which
• presents significantly less risk
• can be used for sufficient control of the target
  organisms
• can be used without significant economic or
  practical disadvantages for the user

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Environmental risk assessment

• Candidates for comparative assessment
• PEC/PNEC ratio lt 1 and gt 0.1
• Any of the unless clauses has been applied
• The substance is restricted within directive
  76/769/EEC
• ? Substitution of a substance with an identified
  alternative

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Environmental risk assessment

• Biocidal productsmulti-component mixtures
• Active substances
• other components (vehicles, solvents)
• Influence
• Additive effects
• Synergistic or antagonistic effects
• Other effects (e.g.fate and behaviour)
• degradation
• exposure (e.g. aerosol)

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Environmental risk assessment

• Product evaluation
• Data of active substances (fate and behaviour)
• Data of product (if information cannot be
  extrapolated from the active substance itself)
• Ecotoxicology testing might be required where a
  direct release of a product to a compartment is
  possible

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Environmental risk assessment

• Product PEC/PNEC gt 1
• Further information and/or testing are required
  to clarify the concern
• Conditions or restrictions of use can be applied
  to reduce the risk to an acceptable level
• The product cannot be authorised