Risk Assessment for BWMS

National Institutefor Public Healthand the Environment

Thanks toFijiGovernment

Risk Assessment for BWMS

Jan Linders, RIVM-SEC, Bilthoven

GESAMP37, Bangkok, Thailand

February 2010

February 2010 Risk Assessment for BWMS | Jan LindersNational Institutefor Public Healthand the Environment

Contents

• Introduction

• GESAMP-BWWG

• Ballast Water Management Convention

• Approval Process

• Risk Assessment

- Environment

- Human

- Ship

• Emission Scenario Document

• Conclusions

• Recommendations


Acknowledgement: the BWWGroup


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


The ship’s ballast tanks

DARKDARK

Full of STOW-AWAY POCKETS

often ANOXIC

Variation in organic load

Global total of discharge volume of BW: 3E9 tpa


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


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


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


Approval Process (2)

Active Substance

Basic Approval

Land based type approval

Whole effluent test

Shipboard type approval Final approval

Final Product

Yes NoGuideline G8Procedure G9

Applicant/Administration

GESAMP/ MEPC


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 setDischarge Test-dataDischarge TimeEtc.

Manufacturer

Organization

IMO Technical Group

Organization (MEPC)



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 setDischarge Test-dataDischarge Time


Organization

IMO Technical Group

Organization (MEPC)


Discharge test with whole system on the test bed

Manufacturer

Final Approval


Various Active Substances used in BWMSFlag state BWMS Active Substances By-products BA/FA

Germany C2H4O3, H2O2 - BA

Republic of Korea Cl2, HOCl, OCl–, OH• THM BA

Japan O3, BrO3- CHBr3, TRO BA

Sweden Cl2, HOCl, OCl–, OH• THM, TRO BA

Sweden/Norway UV-light free radicals, THM FA

Republic of Korea O3 CHBr3, TRO, THM BA

Japan Fe3O4, PAC, PASA acryl amide monomer BA

South Africa O3 BrO3-, CHBr3, TRO BA

Republic of Korea UV-light free radicals, THM BA

Germany C2H4O3, H2O2 - FA

Norway Cl2, O3, H2O2 HOCl, THM BA


Risk Assessment (1)

Data evaluation

Data setExposure estimation

Emissionrates

Environmentaldistribution

Exposure levels, con-centrations, intakes

Hazard identificationDose-response assessment

Toxicity datasingle species

Extrapolation

No-effectlevels

Risk characterisation

PEC/PNEC, MOS


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 (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)


Environmental Risk Assessment

• PBT (hazards)

• Exposure calculation (PEC using MAMPEC)

• Effects assessments (using extrapolation to ecosystem)

• Determination of PEC/PNEC


PBT Hazards

Criterion PBT criteria

Persistence Half-life:> 60 days in marine water, or> 40 days in fresh water,* or> 180 days in marine sediments, or> 120 days in freshwater sediments

Bioaccumulation Experimentally determined BCF > 2,000, or if no experimentally BCF has been determined, Log Pow≥3

ToxicityIncl. CMR

Chronic NOEC < 0.01 mg/l


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


MAMPEC model

• Substance definition

• Environment definition

• Emission definition


Substance definition


En

viro

nm

ent

def

init

ion


Emission definition


Results


Assessment Factor

Data‑set PNEClong PNECshort

Freshwater assessment

Lowest short-term L(E)C50 from freshwater species

representing three trophic levels

1000 10-100

Lowest chronic NOEC from three freshwater or saltwater species representing three trophic levels

10

Saltwater assessment

Lowest short-term L(E)C50 from marine species

representing three trophic levels

1000 10-100

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


Data-set Assessment 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


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


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,

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.).


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.


General Public HES – exposed to ballast water effluent chemicals


• 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 PECfish derived from BCF and PECMAMPEC (e.g. ECHA Guidance R15 – consumer exposure assessment).


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


Bathing

waterair CTR

HC

BW

PECTHnAU mampecdermalswimskin

sd

BW

CnW wswim soU

• Dermal exposure

• Inhalatory exposure (minor route)

• Oral exposure (main route)


Food consumption

Cfish = BCF x PEC

Ufish = Mfish x Cfish x BIOoral

• Concentration in fish:

• Amount consumed:


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


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


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


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


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


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


Closure

• Thank you for your attention

• Any questions

• Your input is very much appreciated

Risk Assessment for BWMS

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