Miljøvurdering af midlerne. Datakrav og Risikovurdering. Ole Christian Hansen. Dialogmøde den 29. september 2009

Transkript

1 Miljøvurdering af midlerne Datakrav og Risikovurdering Ole Christian Hansen Dialogmøde den 29. september 2009

2 Præsentationer Introduktion Rodenticider, PT 14 Datakrav Eksponeringsscenarier Insektmidler, PT 18 Datakrav Eksponeringsscenarier Repellanter og attraktanter, PT 19 Datakrav Eksponeringsscenarier

3 Environmental Risk Assessment: Basic Framework Exposure assessment Data evaluation Data set Effects assessment Emissions TGD Single species toxicity data Distribution EUSES Extrapolation PEC Risk characterization PEC/PNEC PNEC

4 Emission Scenario Document, ESD A set of conditions about sources, pathways, production processes and use patterns that quantify the emissions (or releases) of a chemical from production, formulation, processing, private use (or use in the household) and recovery/disposal into water, air and solid waste (OECD 2000) In general, an ESD should cover all aspects of the lifecycle. An ESD may cover only some parts of the lifecycle, if remaining parts are not relevant or covered by another ESD. ESD EUSES

5 Datakrav, core data The general guidance given on the information to be provided on the ecotoxicological profile of the active substance applies also here. The information provided for the product, and that provided for the active substance, should be sufficient to: Specify the hazard symbols, and relevant risk and safety phrases for the protection of the environment Predict the distribution, fate, and behaviour in the environment as well as the time involved (e.g. whether exposure is short or long-term), Identify non-target species and populations for which concern arise because of potential exposure, and Justified estimates must be made of the predicted environmental concentrations (PEC) of the active substance and relevant metabolites and degradation products, in soil, groundwater, surface water (including marine, if relevant) and air following use as proposed or already occurring. In addition a realistic worst-case estimation must be made.

6 Datakrav Additional data (Annex II B) 7.1 Foreseeable routes of entry into the environment on the basis of the use envisaged 7.2 Information on the ecotoxicology of the active substance in the product, where this cannot be extrapolated from the information on the active substance itself 7.3 Available ecotoxicological information relating to ecotoxicological relevant non-active substances (i.e. substances of concern), such as information from safety data sheets

7 Datakrav Additional data (Annex III B) Where relevant all the information on fate and behaviour required in data set for the active substance) if the composition or the application technique of the product is suspected to influence the degradation and transformation or mobility and adsorption properties of an active substance or a substance of concern in a way that may considerably alter the conclusions of the risk characterisation. Further ecotoxicological data could be required, if the data on the active substance cannot give sufficient information, and there are indications of risk due to specific properties of the biocidal product. It must be underlined that normally this information, if relevant, is available from the active substance.

8 Gnavermidler / rodenticider

9 Rodenticider, Datakrav Additional data For products to be used in animal housing, releases to manure storage facilities are possible. An anaerobic biodegradation study is necessary: Anaerobic biodegradation If used outside of buildings in the form of baits, granulates or powder, avian toxicity tests are necessary with the product. Secondary poisoning is tested on the product Acute oral toxicity

10 Rodenticider, eksponering Emission Scenario Dokument Scenarier: Kloak med voksblokke I og omkring bygninger Rottegiftkasser (bait boxes) Drikkegift (liquid concentrates) Udendørs (open areas) Giftpiller og korn (pellets and grain) Kontaktpudder (contact powder) Gasning i jord (fumigation soil) Deponi / losseplads (waste dumps)

11 rodenticider, anvendelsesform Scenario: Sewer Buildings Open fields Waste dumps Wax blocks Grain / pellets Bait box Contact powder Liquid Fumigation

12 rodenticider, eksponering ved anvendelse Scenario: Sewer Buildings Open fields Waste dumps STP Surface water Soil Air Primary poisoning Secondary poisoning

13 Rodenticider, Beregning af PEC / PNEC Baseret på produktdata (evnt. omregnet fra aktivstofdata) Anvendelse af scenarier efter ESD PT14 Beregningseksempler på ECB hjemmeside Anvendelse af EUSES Anvendelse af målte data til erstatning af default værdier

14 Primary poisoning: Estimated Daily Intake FIR EDI = C AV PT BW PD ( mg/ kgbw/ d) FIR: Food intake rate of indicator species (gram fresh weight per day) BW: Body weight (g) C: Concentration of compound in fresh diet (mg/kg) AV: Avoidance factor (0 to 1) PT: Fraction of diet obtained in treated area (0 to 1) PD: Fraction of food type in diet (0 to 1)

15 Secondary poisoning Predators (mammals or birds) feeding on poisoned rodents Oral exposure (PEC oral,predator ) depends on EC n : Estimated Concentration in rodent on day n ETE: Estimated daily uptake on day n F rodent : Fraction of poisoned rodent in diet of predator EC n depends on fraction bait consumption PEC = ( EC + ETE) oral, predator n F rodent

16 Insektmidler

17 Insektmidler, datakrav Som for andre midler i princip de samme som for aktivstof. Data skal give mulighed for klassificering og mulighed for at finde de rette risiko og sikkerhedssætninger til beskyttelse af miljø Data skal anvendes til vurdering af skæbne og opførsel i miljø Data skal give mulighed for beregning af eksponeringen i miljø (predicted environmental concentrations, PEC) af aktivstof, relevante metabolitter og nedbrydningsprodukter i vand, grundvand, sediment, jord og luft efter anvendelsen af midlet som påtænkt. Desuden beregnes et realistisk worst case.

18 Insekticider etc (PT 18), additional data For products used outside buildings as well as products to be used by gassing, fogging or fumigation, release to soil is possible. It is necessary to perform initial terrestrial tests with the product: Inhibition to microbial activity Acute toxicity to earthworms or other soil non-target macro-organisms Acute toxicity to plants If used outside of buildings in the form of baits, granulates or powder, an acute avian toxicity test is necessary with the product: Acute oral toxicity Furthermore, a test with bees is necessary: Acute toxicity to honeybees and other beneficial arthropods, for example predators

19 Insektmidler, PT 18 ESD scenarier: Stalde og husdyrgødning Indendørs (Products used in areas in which animals are housed, kept or transported in order to kill pests by treating the structure but not the animal, including situations where the products are intended to be active while animals are in the structures) Udendørs Møddinger, gylletanke, osv. Andre bygninger Indendørs Boliger, fabrikker, institutioner) Udendørs Omkring bygninger

20 Insektmidler i stalde og husdyrgødning Stalde Kvæg, grise, fjerkræ (18 staldtyper) Skadedyr / gener: fluer og andre insekter og arthropoder (voksne og larver), mider Anvendelsesmetoder: Sprøjtning, påsmøring, pensling, lokkedåser, tågesprøjtning, osv. Gødning: fast gødning, våd gødning, gylle, affaldsvand, osv

21 Insektmidler, scenarier

22 Insektmidler i stalde og møddinger

23 Insektmidler, etc PT 18

24 Insektmidler, etc PT 18

25 Insektmidler, emissionsbegrænsninger Bekendtgørelse anvendelse af affald til jordbrugsformål Bkg. nr af 13/12/2006 (Slambekendtgørelsen): Arealer må max. tilføres affald og husdyrgødning sv.t. 170 kg N total og 30 kg P total pr. ha pr. år. P beregnes som et gennemsnit over 3 år, i skove 10 år. Der må ikke tilføres jorden mere end 7 tons tørstof pr. ha pr. år beregnet som et gennemsnit over 10 år. I parker og skove, hvor der ikke dyrkes fortærbare afgrøder, må der tilføres 15 tons tørstof pr. ha pr. år, beregnet som et gennemsnit over 10 år. Erhvervsmæssigt dyrehold anvender dyreenheder, hvor 1 dyreenhed svarer til max.100 kg N og 20 kg P. (1,4-1,7 dyreenheder/ha/år over 3-10 år)

26 Introduction of insecticides in and around buildings Different types of buildings: - Private houses: Typical size for house and surrounding garden (area and volume) - Larger building: 5 x private house assumed typically for restaurants, schools, offices etc. Simultaneity factor: - Release of insecticides has a diffuse character (large no. of small point sources) - All releases are collected in STP -> unique point source - Necessary to determine how many houses are simultaneously treated

27 Insecticides in and around buildings Different release pathways: - Indoor via treated surfaces and residues on applicator to STP via treated air to outdoor air - Outdoor: Via leaching/run-off from treated area Spilling Overspray For outdoor applications a distinction is made between rural and urban areas - Urban areas: assumed that surface is impermeable -> run-off to the sewer system -> STP (point source) - Rural areas: assumed that surface is unpaved -> soil and groundwater are most important compartments

28 Indoor and outdoor application For both indoor and outdoor applications releases during different stages are taken into account : - Mixing and loading - Application - Cleaning (only indoor for area treated and applicator) For the different types of application - Spraying - Gel application - Diffusers, powders and bait stations

29 Secondary poisoning to wild birds and mammals Secondary poisoning can take place through: - 1. Consumption of worms from contaminated soil - 2. Consumption of contaminated vegetation - 3. Eating affected insects that have accumulated the biocide

30 Repellanter og attraktanter

31 Repellanter og attraktanter (PT 19) For products used outside buildings as well as products to be used by gassing, fogging or fumigation, release to soil is possible. It is necessary to perform initial terrestrial tests with the product: Inhibition to microbial activity Acute toxicity to earthworms or other soil non-target macro-organisms Acute toxicity to plants If used outside of buildings in the form of baits, granulates or powder, an acute avian toxicity test is necessary with the product: Acute oral toxicity Furthermore, a test with bees is necessary: Acute toxicity to honeybees and other beneficial arthropods, for example predators

32 Repellanter og attraktanter PT 19 ESD forefindes ikke Få allerede under vurdering i EU her refereres til TGD, IC 5 Personal/domestic use and UC 9 cleaning/washing agents (vaske-/ rengøringsmidler)?? eller PT 18 indendørs anvendelse som spray eller OECD Pesticides monografi nr. 12 (Guidance for Registration Requirements for Pheromones and other Semiochemicals Used for Arthropod Pest Control)

33 Miljøvurdering PT 14 Rodenticider PT 18 Insektmidler, midemidler og midler mod andre arthropoder PT 19 Repellanter og attraktanter Spørgsmål????