1. National Institute for Public Health and the Environment Thanks to Fiji Government Risk Assessment for BWMS Jan Linders, RIVM-SEC, Bilthoven GESAMP37, Bangkok, Thailand February 2010

2. National Institute for Public Health and the Environment February 2010 Risk Assessment for BWMS | Jan Linders Contents Introduction GESAMP-BWWG Ballast Water Management Convention Approval Process Risk Assessment -Environment -Human -Ship Emission Scenario Document Conclusions Recommendations

3. National Institute for Public Health and the Environment February 2010 Risk Assessment for BWMS | Jan Linders Acknowledgement: the BWWGroup

4. National Institute for Public Health and the Environment February 2010 Risk Assessment for BWMS | Jan Linders GESAMP-BWWG Technical Group, advisory body to MEPC GESAMP-BWWG (WG34) evaluates the systems for risks to humans, crew, ship and environment and reports the recommendations to MEPC MEPC decides on Basic or Final Approval based on the report of GESAMP-BWWG GESAMP-BWWG evaluates the additional testing with whole effluent before FA GESAMP-BWWG develops evaluation and risk assessment methodology, to be approved by MEPC Current guidance: acceptable (eco)toxicological effects at discharge of BW

5. National Institute for Public Health and the Environment February 2010 Risk Assessment for BWMS | Jan Linders The ship’s ballast tanks DARK Full of STOW-AWAY POCKETS often ANOXIC Variation in organic load Global total of discharge volume of BW: 3E9 tpa

6. National Institute for Public Health and the Environment February 2010 Risk Assessment for BWMS | Jan Linders Ballast Water Management Convention (1) International Convention, intended for global protection of ecosystems from bio-invasion Aim is to control and manage all kinds of organisms in the ship’s ballast water Procedure G9 deals with the discharge of BW containing residues of active substances, disinfection byproducts and dead biota -Quote from Article 2, point 5 of the Convention: Parties undertake to encourage the continued development of Ballast Water Management and standards to prevent, minimize and ultimately eliminate the transfer of Harmful Aquatic Organisms and Pathogens through the control and management of ships’ Ballast Water and Sediments Safeguarding crew, ship and environment

7. National Institute for Public Health and the Environment February 2010 Risk Assessment for BWMS | Jan Linders Ballast Water Management Convention (2) Additional important points: Not yet entered into force Deadline of introduction of BWMS is now 2011, was 2009 Port of Entry may set additional requirements

8. National Institute for Public Health and the Environment February 2010 Risk Assessment for BWMS | Jan Linders Approval Process (1) All BWMS using active substances should be evaluated by the Administration in accordance with Guideline (G8) and Procedure (G9) and approved by IMO in accordance with Procedure (G9) For the approval of active substances (G9): -Data requirements (dossier) defined -Risk assessment methods and PBT evaluation -2 step approach in Basic and Final Approval based on the evaluation of all available data including ecotoxicological testing of discharged BW (whole effluent test) Last item illustrates the difference with other RA-methods, like EU and US

9. National Institute for Public Health and the Environment February 2010 Risk Assessment for BWMS | Jan Linders Approval Process (2) Active Substance Basic Approval Land based type approval Whole effluent test Shipboard type approval Final approval Final Product YesNo Guideline G8 Procedure G9 Applicant/ Administration GESAMP/ MEPC

10. National Institute for Public Health and the Environment February 2010 Risk Assessment for BWMS | Jan Linders Basic Approval Only laboratory scale data is necessary, and discharge time is predicted in simplified dilution model The Member of the Organization Evaluate as confidential Dossiers of existing registration may be submitted Risk Characterization and Analysis Basic Approval by, and report to Organization For approved Active Substances the Organization circulates the list to the Parties Request for additional data set Submit Submit application Data set Discharge Test - data Discharge Time Etc. Manufacturer Organization IMO Technical Group Organization (MEPC) The Member of the Organization

11. National Institute for Public Health and the Environment February 2010 Risk Assessment for BWMS | Jan Linders Using Active Substances that have received basic approval Type Approval according to relevant IMO guidelines Confirm residual toxicity of discharged ballast water with the evaluation under the basic approval Approve the Ballast Water Management systems that make use of Active Substances Publish list of approvals Request for additional data set Data set Discharge Test - data Discharge Time The Member of the Organization Organization IMO Technical Group Organization (MEPC) The Member of the Organization Discharge test with whole system on the test bed Manufacturer Final Approval

12. National Institute for Public Health and the Environment February 2010 Risk Assessment for BWMS | Jan Linders Various Active Substances used in BWMS Flag state BWMSActive SubstancesBy-productsBA/FA GermanyC 2 H 4 O 3, H 2 O 2 -BA Republic of KoreaCl 2, HOCl, OCl –, OHTHMBA JapanO 3, BrO 3 - CHBr 3, TROBA SwedenCl 2, HOCl, OCl –, OHTHM, TROBA Sweden/NorwayUV-lightfree radicals, THMFA Republic of KoreaO3O3 CHBr 3, TRO, THMBA JapanFe 3 O 4, PAC, PASAacryl amide monomerBA South AfricaO3O3 BrO 3 -, CHBr 3, TROBA Republic of KoreaUV-lightfree radicals, THMBA GermanyC 2 H 4 O 3, H 2 O 2 -FA NorwayCl 2, O 3, H 2 O 2 HOCl, THMBA

13. National Institute for Public Health and the Environment February 2010 Risk Assessment for BWMS | Jan Linders Risk Assessment (1) Data evaluation Data set Exposure estimation Emission rates Environmental distribution Exposure levels, con- centrations, intakes Hazard identification Dose-response assessment Toxicity data single species Extrapolation No-effect levels Riskcharacterisation PEC/PNEC, MOS

14. National Institute for Public Health and the Environment February 2010 Risk Assessment for BWMS | Jan Linders Risk Assessment (2) A thorough assessment of the behavior and fate of active substances and relevant chemicals BEFORE released into the marine environment: -This should include reaction products of the substance with the different components, i.e. organic matter, sediment and water of the receiving aquatic environment of treated BW. An assessment of the fate of the discharged ballast water in the receiving waters Evaluation methodology Risk Assessment tools

15. National Institute for Public Health and the Environment February 2010 Risk Assessment for BWMS | Jan Linders Risk Assessment (3) Environment: Determination of PEC, PNEC and ratio PEC/PNEC -Relevant substances and treated BW -Water and sediment, -Fish, Daphnia and algae -Marine organisms -PBT Humans, treated BW Crew -Unit operations, pipe rupture, ventilation, storage, temperature Ship -Corrosion (not really RA)

16. National Institute for Public Health and the Environment February 2010 Risk Assessment for BWMS | Jan Linders Environmental Risk Assessment PBT (hazards) Exposure calculation (PEC using MAMPEC) Effects assessments (using extrapolation to ecosystem) Determination of PEC/PNEC

17. National Institute for Public Health and the Environment February 2010 Risk Assessment for BWMS | Jan Linders PBT Hazards CriterionPBT criteria PersistenceHalf-life: > 60 days in marine water, or > 40 days in fresh water, * or > 180 days in marine sediments, or > 120 days in freshwater sediments BioaccumulationExperimentally determined BCF > 2,000, or if no experimentally BCF has been determined, Log Pow≥3 Toxicity Incl. CMR Chronic NOEC < 0.01 mg/l

18. National Institute for Public Health and the Environment February 2010 Risk Assessment for BWMS | Jan Linders PEC calculation Using MAMPEC Developed for antifouling products Advantages -Freely available -User friendly Disadvantages -Insufficient guidance -Locked database Adjustment for Ballast Water -Harbor definition -Tidal exchange rate

19. National Institute for Public Health and the Environment February 2010 Risk Assessment for BWMS | Jan Linders MAMPEC model Substance definition Environment definition Emission definition

20. National Institute for Public Health and the Environment February 2010 Risk Assessment for BWMS | Jan Linders Substance definition

21. National Institute for Public Health and the Environment February 2010 Risk Assessment for BWMS | Jan Linders Environment definition

22. National Institute for Public Health and the Environment February 2010 Risk Assessment for BWMS | Jan Linders Emission definition

23. National Institute for Public Health and the Environment February 2010 Risk Assessment for BWMS | Jan Linders Results

24. National Institute for Public Health and the Environment February 2010 Risk Assessment for BWMS | Jan Linders Assessment Factor Data ‑ set PNEClongPNECshort Freshwater assessment Lowest short-term L(E)C 50 from freshwater species representing three trophic levels 100010-100 Lowest chronic NOEC from three freshwater or saltwater species representing three trophic levels 10 Saltwater assessment Lowest short-term L(E)C 50 from marine species representing three trophic levels 100010-100 Lowest chronic NOEC from three freshwater or saltwater species representing three trophic levels 100 Lowest chronic NOEC from three saltwater species representing three trophic level 100 Lowest chronic NOEC from three freshwater or saltwater species representing three trophic levels + at least two chronic NOECs from additional marine taxonomic groups 10 Extrapolation fresh water

25. National Institute for Public Health and the Environment February 2010 Risk Assessment for BWMS | Jan Linders Data-setAssessment factor Freshwater sediment assessment Three chronic sediment tests with species representing different living and feeding conditions 10 Saltwater sediment assessment Three chronic sediment tests with species representing different living and feeding conditions 50 Lowest chronic NOEC from three freshwater or saltwater species representing different living and feeding conditions including at least two chronic NOECs from marine species 10 Extrapolation fresh water sediment

26. National Institute for Public Health and the Environment February 2010 Risk Assessment for BWMS | Jan Linders Jan Linders, 20 February 2008 Human Exposure Scenarios (HES) - development Exposure assessment At GESAMP-BWWG WS 2 (Oct 2009) information from 10 meetings available and report of the WS1 Collaboration with US EPA to develop HES template Qualitative and/or quantitative exposure assessments based on a screening-level approach: Tier 1 assessments when there is a general lack of exposure data, taking into account conservative default values and no Personal Protective Equipment (PPE) Tier 2 assessments triggered when the Tier 1 assessment indicates a potential risk concern

27. National Institute for Public Health and the Environment February 2010 Risk Assessment for BWMS | Jan Linders HES in BWMS Two types of Human Exposure Scenarios can be associated with operating BWMS: Occupational: -who operate directly the system (crew, BWMS technicians) or perform tasks associated with system (port-state control functionaries) – primary/direct exposure; -by-standers (crew or other personnel) - secondary/indirect exposure. General Public: -people who can be exposed indirectly via environment e.g. beachgoers, eating seafood from the ballast water discharge area. Jan Linders, 20 February 2008

28. National Institute for Public Health and the Environment February 2010 Risk Assessment for BWMS | Jan Linders Jan Linders, Occupational HES (modeling is possible) 1.To build the HES: detailed description of the relevant processes/unit operations associated with the system and the working activities resulting in exposure; 2.to identify the exposure routes of concern (normally dermal or inhalatory) taking into account the phys/chem. characteristics and toxicological hazard profile of the chemicals involved; 3.taking the above information, to carry out the exposure assessment based on a tiered approach and using realistic worst-case assumptions (concentration, quantity, frequency and duration, etc.).

29. National Institute for Public Health and the Environment February 2010 Risk Assessment for BWMS | Jan Linders Key quantitative occupational HES (source HES Template-WS2) Jan Linders, 20 February 2008 Crew manually mixing, adding or loading chemicals to the BWMS –dermal exposure to concentrate formulation; Ballast water sampling during discharge –inhalation of air in the headspace and dermal exposure through contact with treated water; Periodic sediment cleaning in ballast tanks –inhalation of air in the ballast water tank and dermal exposure due to close contact to sludge and sediment; Ballast tank inspections and crew carrying out on deck –inhalation to volatile components arising from ballast water treatment.

30. National Institute for Public Health and the Environment February 2010 Risk Assessment for BWMS | Jan Linders General Public HES – exposed to ballast water effluent chemicals Jan Linders, 20 February 2008 Recreational swimming in ballast water released from vessels –ingestion of water and dermal uptake are the key elements to be considered in the outdoor environment (e.g. default values used in US EPA SWIMODEL). Eating fish from the coastal area –exposure through the food chain taking into consideration PEC fish derived from BCF and PEC MAMPEC (e.g. ECHA Guidance R15 – consumer exposure assessment).

31. National Institute for Public Health and the Environment February 2010 Risk Assessment for BWMS | Jan Linders Human Risk Assessment General Public -Bathing Oral: unintended drinking during swimming Dermal: whole body exposure Inhalatory: breathing potential volatile substances (minor) US SWIMODEL -Food consumption Sea food Defining appropriate equations and parameters (e.g.) -Number of events -Amount drunk -Absorption factor through skin -Bioconcentration factor

32. National Institute for Public Health and the Environment February 2010 Risk Assessment for BWMS | Jan Linders Bathing Dermal exposure Inhalatory exposure (minor route) Oral exposure (main route)

33. National Institute for Public Health and the Environment February 2010 Risk Assessment for BWMS | Jan Linders Food consumption Cfish = BCF x PEC Ufish = Mfish x Cfish x BIOoral Concentration in fish: Amount consumed:

34. National Institute for Public Health and the Environment February 2010 Risk Assessment for BWMS | Jan Linders Crew Risk Assessment (part of HES) Unit operations -Piping (including connections and valves) -Reactors Pipe rupture Ventilation Storage Temperature Assumptions: -Number of times -Amount -Duration

35. National Institute for Public Health and the Environment February 2010 Risk Assessment for BWMS | Jan Linders Guidance for WET tests Procedure G9 Methodology GESAMP-BWWG General part of GESAMP-BWWG reports OECD Test Guidelines or other equivalent tests for -Algae testing: OECD TG201, TG204, TG210, TG215 -Daphnia testing: OECD TG202, TG211 -Fish testing: OECD TG203, TG221 Including validity guidance -Algae: factor 16 growth in control group -Daphnia: immobilization 3 mg/L -Fish: mortality 60% saturation, maintaining test substance concentration (> 80% of nominal) GLP / QA/QC where appropriate

36. National Institute for Public Health and the Environment February 2010 Risk Assessment for BWMS | Jan Linders Tools to be finalized Stock taking Workshops Modeling PEC with MAMPEC -Scenario definition Testing HES template for: -General public -Unit operations Database -Active substances -Relevant chemicals -Calculations Emission Scenario Document Short term scenario

37. National Institute for Public Health and the Environment February 2010 Risk Assessment for BWMS | Jan Linders Conclusions (1) GESAMP-BWWG -Building up experience -Trying to achieve transparency and consistency Increasing guidance available Development in methodology Development in risk assessment -Environment -Human health Crew General public

38. National Institute for Public Health and the Environment February 2010 Risk Assessment for BWMS | Jan Linders Jan Linders, Conclusions (2) Hazard profiles database – under construction by WG1 Human exposure scenarios (HES) – HES template from WS 2 needs to be tested in practice The guidance on risk characterization (RC) needs to be further developed based on validated RC methodologies (e.g. Margin of Safety (MOS) and Risk Characterization Ratio (RCR)) Developing working tools to address human health risks associated with specific BWMS is the main goal

39. National Institute for Public Health and the Environment February 2010 Risk Assessment for BWMS | Jan Linders Recommendations Use available guidance as much as possible -Toxicity testing -QA/QC -Measurement technologies -Corrosion -Risk Assessment Environment Human Exposure Scenario -Crew -General public If not possible, provide scientific reasoning

40. National Institute for Public Health and the Environment February 2010 Risk Assessment for BWMS | Jan Linders Closure Thank you for your attention Any questions Your input is very much appreciated