Risk Assessment for BWMS

1. Risk Assessment for BWMS Jan Linders, RIVM-SEC, Bilthoven GESAMP37, Bangkok, Thailand February 2010

2. Contents • Introduction • GESAMP-BWWG • Ballast Water Management Convention • Approval Process • Risk Assessment • Environment • Human • Ship • Emission Scenario Document • Conclusions • Recommendations Risk Assessment for BWMS | Jan Linders

3. Acknowledgement: the BWWGroup Risk Assessment for BWMS | Jan Linders

4. 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 Risk Assessment for BWMS | Jan Linders

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

6. 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 Risk Assessment for BWMS | Jan Linders

7. 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 Risk Assessment for BWMS | Jan Linders

8. 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 Risk Assessment for BWMS | Jan Linders

9. Active Substance Yes No Guideline G8 Procedure G9 Basic Approval Whole effluent test Land based type approval Final approval Shipboard type approval GESAMP/ MEPC Applicant/ Administration Final Product Approval Process (2) Risk Assessment for BWMS | Jan Linders

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

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

12. Various Active Substances used in BWMS Risk Assessment for BWMS | Jan Linders

13. Data evaluation Exposure estimation Hazard identification Dose-response assessment Data set Emission Toxicity data rates single species Environmental Extrapolation distribution Exposure levels, con- No-effect centrations, intakes levels Risk characterisation PEC/PNEC, MOS Risk Assessment (1) Risk Assessment for BWMS | Jan Linders

14. 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 Risk Assessment for BWMS | Jan Linders

15. 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) Risk Assessment for BWMS | Jan Linders

16. Environmental Risk Assessment • PBT (hazards) • Exposure calculation (PEC using MAMPEC) • Effects assessments (using extrapolation to ecosystem) • Determination of PEC/PNEC Risk Assessment for BWMS | Jan Linders

17. PBT Hazards Risk Assessment for BWMS | Jan Linders

18. 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 Risk Assessment for BWMS | Jan Linders

19. MAMPEC model • Substance definition • Environment definition • Emission definition Risk Assessment for BWMS | Jan Linders

20. Substance definition Risk Assessment for BWMS | Jan Linders

21. Environment definition Risk Assessment for BWMS | Jan Linders

22. Emission definition Risk Assessment for BWMS | Jan Linders

23. Results Risk Assessment for BWMS | Jan Linders

24. Extrapolation fresh water Risk Assessment for BWMS | Jan Linders

25. Extrapolation fresh water sediment Risk Assessment for BWMS | Jan Linders

26. 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 Risk Assessment for BWMS | Jan Linders Jan Linders, 20 February 2008

27. HES in BWMS Risk Assessment for BWMS | Jan Linders 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. Occupational HES (modeling is possible) To build the HES: detailed description of the relevant processes/unit operations associated with the system and the working activities resulting in exposure; 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; 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.). Risk Assessment for BWMS | Jan Linders Jan Linders,

29. Key quantitative occupational HES (source HES Template-WS2) • 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. Risk Assessment for BWMS | Jan Linders Jan Linders, 20 February 2008

30. General Public HES – exposed to ballast water effluent chemicals • Recreational swimmingin 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 PECfish derived from BCF and PECMAMPEC (e.g. ECHA Guidance R15 – consumer exposure assessment). Risk Assessment for BWMS | Jan Linders Jan Linders, 20 February 2008

31. 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 Risk Assessment for BWMS | Jan Linders

32. Bathing • Dermal exposure • Inhalatory exposure (minor route) • Oral exposure (main route) Risk Assessment for BWMS | Jan Linders

33. Food consumption • Concentration in fish: Cfish = BCF x PEC • Amount consumed: Ufish = Mfish x Cfish x BIOoral Risk Assessment for BWMS | Jan Linders

34. 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 Risk Assessment for BWMS | Jan Linders

35. 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 < 10% in control group, DO>3 mg/L • Fish: mortality < 10% in control group, maintaining constant conditions, DO > 60% saturation, maintaining test substance concentration (> 80% of nominal) • GLP / QA/QC where appropriate Risk Assessment for BWMS | Jan Linders

36. 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 Risk Assessment for BWMS | Jan Linders

37. 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 Risk Assessment for BWMS | Jan Linders

38. 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 Risk Assessment for BWMS | Jan Linders Jan Linders,

39. 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 Risk Assessment for BWMS | Jan Linders

40. Closure • Thank you for your attention • Any questions • Your input is very much appreciated Risk Assessment for BWMS | Jan Linders