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MARINE ENVIRONMENT PROTECTION COMMITTEE 61st session Agenda item 2 MEPC 61/2/1 18 March 2010 Original: ENGLISH

HARMFUL AQUATIC ORGANISMS IN BALLAST WATER

Application for Basic Approval of AquaStar Ballast Water Management System

Submitted by the Republic of Korea

SUMMARY

Executive summary: This document contains the non-confidential information related to the application for Basic Approval of the AquaStar Ballast Water Management System developed by AQUA Eng. Co., Ltd. in accordance with the "Procedure for approval of ballast water management systems that make use of Active Substances (G9)" adopted by resolution MEPC.169(57). The AquaStar BWMS consists of Smart Pipe, electrolysis and neutralization units to treat ballast water.

Strategic direction: 7.1

High-level action: 7.1.2

Planned output: 7.1.2.4

Action to be taken: Paragraph 6

Related documents: BWM/CONF/36; MEPC 57/21; MEPC 58/2/4 and BWM.2/Circ.24

Introduction

1 Regulation D-3.2 of the International Convention for the Control and Management of Ships' Ballast Water and Sediments stipul ates that ballast water management systems which make use of Active Substances to comply with the Convention shall be approved by the Organization, based on a procedure developed by the Organization.

2 The "Procedure for approval of ballast water management systems that make use of Active Substances (G9)", adopted by resolution MEPC.169(57), defines the principal aspects to be documented by data or testing (MEPC 57/21, annex 1, paragraph 4.2.1) and some basic principles for risk evaluation (MEPC 57/21, annex 1, paragraph 5.3). According to section 6 of Procedure (G9), the Organization should evaluate the information provided in the application.MEPC 61/2/1 Page 2

I:\MEPC\61\2-1.doc 3 According to BWM.2/Circ.24, proposals for approval of ballast water management systems that make use of Active Substances are to be submitted to the Marine Environment Division of the Organization to be reviewed by the GESAMP-Ballast Water Working Group. In the meantime, a document on the proposal for approval containing all the non-confidential data related to the respective ballast water management systems that make use of Active Substances needs to be submitted to MEPC 61.

4 The competent authority in the Republic of Korea has verified the application dossier prepared by AQUA Eng. Co., Ltd. and believes it to satisfy the data requirements of Procedure (G9) adopted by resolution MEPC.169(57).

5 Therefore, the Republic of Korea submits the non-confidential part of the applicant's dossier in the annex of this document to the Organization for evaluation according to Procedure (G9). The complete dossier will be made available to the experts of the GESAMP-BWWG with the understanding of confidential treatment.

Action requested of the Committee

6 The Committee is invited to consider the proposal for Basic Approval and decide as appropriate.

***MEPC 61/2/1 Annex, page 1

I:\MEPC\61\2-1.doc ANNEX

NON-CONFIDENTIAL INFORMATION ON AquaStar BALLAST WATER MANAGEMENT SYSTEM

Contents

1 INTRODUCTION

2 DESCRIPTION OF THE AquaStar SYSTEM

2.1 General description of the AquaStar system 2.2 The components of the AquaStar system 2.3 Preliminary test facility 2.4 Laboratory-scale test facility for Basic Approval

3 PRINCIPLE OF THE AquaStar SYSTEM

3.1 Disinfection principles of hypochlorite and sodium hypochlorite 3.2 Principle of electrolysis of seawater 3.3 Principle of neutralization

4 GENERAL REQUIREMENTS

4.1 Identification of the Active Substances, Relevant Chemicals and Other Chemicals 4.2 Data-set for Active Substances and preparations 4.3 Assessment report

5 RISK CHARACTERIZATION

5.1 Screening for Persistency, Bioaccumulation and Toxicity (PBT) 5.2 Toxicity testing 5.3 Risk characterization and analysis

6 EVALUATION CRITERIA

6.1 Ship and personnel safety

7 REGULATION OF THE USE OF ACTIVE SUBSTANCES AND PREPARATION

7.1 Handling of Active Substances and Preparations 7.2 Hazard documentation and labelling (Safe procedure and use for hazard incidents)

8 REFERENCES

9 APPENDICESMEPC 61/2/1 Annex, page 2

I:\MEPC\61\2-1.doc List of Abbreviations

Abbreviation Description °C Degrees Celsius AS Active Substance BWM Ballast Water Management BWMS Ballast Water Management System cm Centimetre CRO Combined Residual Oxidant d Day DOC Dissolved Organic Carbon DOT U.S. Department of Transportation EC 50 Effect Concentration, 50% (median effective concentration) EPA (U.S.) Environmental Protection Agency FRO Free Residual Oxidant g Gram g/h Gram per hour hr Hour ISO International Standard Organization Koc Partition coefficient L Litre LC 50 Median lethal dose LOAEL Lowest Observed Adverse Effect Level μg Microgram μm Micrometre m3/hr Cubic metres per hour MAMPEC Marine Antifouling Model to Predict Environment Concentration mg Milligram MOS Margin Of Safety mV Millivolt N/A Not Applicable ND Not Detected NOAEL No Observable Adverse Effect Level NOEC No-Effect Concentration NTU Nephelometric Turbidity Unit OECD Organization for Economic Cooperation and Development ORP Oxidation and Reduction Potential PEC Predicted Environmental Concentration pH Measure of the acidity or alkalinity of a solution PNEC Predicted No-effect Concentration PLC Programmable Logic Control POC Particulate Organic Carbon Pow Octanol-water Partition Coefficient RC Relevant Chemical SMILES Simplified Molecular Input Line Entry Specification TEST WATER Raw seawater including viable organisms, heterotrophic bacteria, starch, glucose to correspond with Guidelines (G8)MEPC 61/2/1 Annex, page 3

I:\MEPC\61\2-1.doc THM Trihalomethanes TOC Total Organic Carbon TRO Total Residual Oxidant TSS Total Suspended Solids WHO World Health Organization

This report is structured in accordance with the headlines in the "Procedure for approval of ballast water management systems that make use of Active Substances (G9)".

1 INTRODUCTION

The transportation of ballast water on the oceans amounts to 10 billion tonnes per year, and aquatic organisms more than 3,000 individuals are unavoidably transported. Non-indigenous aquatic species of animals, plants, and bacteria have been introduced into new environments through discharge of ballast water with severe impact on native ecosystems (Hayes and Sliwa, 2003). In 2004, the International Maritime Organization (IMO) adopted the International Convention for the Control and Management of Ship's Ballast Water and Sediments and prepared a quality standard for discharge of ballast water. From next 2011, the International Convention will be applicable in sequence. As of 2011, the Convention will be implemented for new ships holding less than 5,000 m 3 of ballast water capacity.

2 DESCRIPTION OF THE AquaStar SYSTEM

2.1 General description of the AquaStar system

The AquaStar Ballast Water Management System being developed by AQUA Eng. Co., Ltd. is an electrolytic system. The Active Substanc es (AS) are produced from electrolysis of natural seawater. The AS include chlorine (Cl 2 ), sodium hypochlorite (NaOCl), hypochlorous acid (HOCl), hypochlorite (OCl - ), hypobromous acid (HOBr), and hypobromite (OBr - ). These disinfectants are used to remove aquatic organisms in seawater or brackish water (Jeong et al. , 2002; Yoon et al. , 2005). The system design is simple with the ballasting water passing directly through the electrolyzer unit.

During ballasting, AquaStar is possible to produce and control the maximum 30 mg/L of TRO (AS) in seawater or brackish water through electrolysis, also has the efficient range to remove aquatic organisms. After AquaStar is installed on ship, AquaStar is feasible to generate the suitable TRO (AS) concentration during ballasting.

The AQUA Eng. Co., Ltd. has developed the AquaStar Ballast Water Management System (BWMS) as an eco-friendly and efficient treatment of the ballast water based on principles of electrolysis. The AquaStar system is simple with the ballasting water passing directly through the electrolyzer, and aims at a compact design to be installed easily also in smaller ships. In other words, AquaStar that is directly set up at ballast line of a ship is working efficiently and economically than the general disinfection equipment. The aim of AquaStar is that harmful aquatic organisms in the ballast water are simply treated.

2.2 The components of the AquaStar system

The AquaStar system is composed of a Smart Pipe unit, an electrolyzer unit, a neutralization unit and a system control unit (Figure1). When ballasting, the seawater passes through the Smart Pipe unit which has a number of filt ration compartments with mesh sizes of 30 μm ~ 50 μm. Aquatic organisms larger than 50 μm are here removed or damaged and thereby increasing their sensitivity to the AS when introduced into the electrolyzer unit.MEPC 61/2/1 Annex, page 4

I:\MEPC\61\2-1.doc Thus the construction of the Smart Pipe unit increases the efficiency of the electrolyzer unit and reduces the amount of AS needed for disinfection. Organisms smaller than 50 μm are disinfected by the AS in the electrolyzer unit. Active Substances, Relevant Chemicals (see section 4.1), and possibly impact of electric al currents produced by the electrolyzer unit may all contribute to the disinfection of aquatic organisms. The treated water satisfies the requirements of regulation D-2 of the International Convention for the Control and Management of Ships' Ballast Water and Sediments, 2004. When de-ballasting, the treated water passes through the neutralization unit. The TRO concentration of the neutralized de-ballasting water is similar to that of natural seawater. The operation of the AquaStar system is automatically monitored and controlled by the system control unit.

Figure 1: Diagram of AquaStar system

2.2.1 Smart Pipe unit

The Smart Pipe unit is constructed with a number of filtration compartments with filtration units varying between 30 μm - 50 μm in mesh size. A detailed description of the construction of the pipe is given in appendix 1 of the application dossier. When ballasting water flows through the Smart Pipe unit, most aquatic organisms > 50 μm are removed or cell structures (such as membranes, appendages, etc.) are possibly damaged; and damaged cells are assumed to be more vulnerable and sensitive to the treatment in the electrolyzer unit. The efficacy of the Smart Pipe unit at different flow rates is shown in appendix 1 of the application dossier.

AQUA Eng. Co. Ltd. will conduct Computational Flow Dynamic (CFD) to determine the flow conditions of the ballast water and to estimate effects of removal aquatic organism for pilot-scale land-based and shipboard tests in the future.

2.2.2 Electrolyzer unit

The electrolyzer unit of the AquaStar system is in stalled directly in the main of ballast pipe. The TRO concentration of the treated water is monitored automatically by the control unitMEPC 61/2/1 Annex, page 5

I:\MEPC\61\2-1.doc with a feed-back system for control of the power supply in order to regulate the production of chlorine (Cl 2 ), and in turn the TRO concentration. During voyage, the disinfectants inhibit re-growth of harmful aquatic organisms and protect the ballast water from possible pollutants.

A ventilation system, also monitored by the c ontrol unit, continuously removes hydrogen gas (H 2 ) and chlorine gas (Cl 2 ) developed during the electrolysis process.

A detailed description of electrolyzer unit is given in appendix 1 of the application dossier.

2.2.3 Neutralization unit

During de-ballasting, the neutralization unit of AquaStar removes or reduces TRO of the treated water to concentration levels similar to those of natural seawater. The TRO concentration is continuously monitored during de-ballasting, and a feed-back system controls the injection of the neutralizing agent, sodium thiosulfate (Na 2 S 2 O 3 ). The concentration of TRO in the de-ballasting water is kept below 0.2 mg/L as Cl 2

. A detailed description of neutralization unit is given in appendix 1 of the application dossier.

2.2.4 System control unit

The system control unit automatically monitors and controls the operation of the AquaStar system during ballasting and de-ballasting. TRO sensors are installed at two points (Figure 4); the first TRO sensor is installed immediately after the electrolyzer with feed-back control of the electric current of the power supply in order to regulate the TRO of the treated water, and control the gas ventilation system; the second TRO sensor is installed in the de-ballasting pipe for control of the neutralization process.

A detailed description of system control unit is given in appendix 1 of the application dossier.

2.3 Preliminary test facility

In the early development stage of the AquaSta r system, AQUA Eng. Co., Ltd. conducted preliminary experiments with a small-scale elec trolyzer during six months. The aim of these experiments was to test the efficiency of improvements to the anode and the cathode of the electrolyzer unit as well as the control of the unit.

2.3.1 Small-scale test facility

Figure 2: Small-scale test equipmentMEPC 61/2/1 Annex, page 6

I:\MEPC\61\2-1.doc The small-scale test unit is composed of a small- scale electrolyzer with power supply, test water tank, test water pump and flowmeter (Figure 2). TRO and pH are also analysed.

2.3.2 Operating conditions

Test water flow rate 0.2 ± 0.2 m 3 /hr
Test water volume about 0.2 m 3
Salinity 34 psu (NaCl solution)

2.4 Laboratory-scale test facility for Basic Approval

2.4.1 Overview of laboratory-scale test facility

The laboratory-scale test facility of AquaStar is located at Dalsan-ri, Jeonggwan-myeon, Gijang-gun, Busan, Republic of Korea (Figure 3). The maximum capacity of the facility is 7.0 m 3 /hr, but only 5.0 m 3 /hr were treated for the performance test, chemical analysis and toxicity tests. The capacity of the test water tank, the control water tank, and the treated water tank is 10 m 3 , 2 m 3 and 4 m 3 , respectively. The material of all tanks is resistant to seawater (PE and FRP). Pumps are placed on the bottom of the test water tank, the control tank, and the treated water tank to ensure homogeneity of the water samples.

Figure 3: Laboratory-scale test facility of AquaStar at AQUA Eng. Co., Ltd., Busan, the Republic of KoreaMEPC 61/2/1 Annex, page 7

I:\MEPC\61\2-1.doc 2.4.2 Operating condition

Test water flow rate 5.0 ± 0.2 m 3 /hr Treated water flow rate 5.0 ± 0.2 m 3 /hr

Treated water volume about 4.0 m 3
Salinity 34 psu (Seawater), 20 psu (Brackish water)

2.4.3 Laboratory-scale test facility

The AquaStar laboratory-scale test system is s hown schematically in Figure 4. Tests were performed with seawater and brackish water in accordance with Guidelines (G8). Efficacy tests, chemical analysis and acute toxicity tests were conducted by KOMERI, KTR and MEI, respectively.

Figure 4: Schematic flow diagram of the laboratory-scale test of AquaStar

2.4.3.1 Sampling and measurement

All activities related to the AquaStar project were carried out according to the quality assurance project plan (QAPP), which was prepared by AQUA Eng. Co., Ltd., KOMERI and KTR (appendices 2 and 3 of the application dossier). The QAPP is prepared in accordance with Guidelines (G8).

In the AquaStar laboratory-scale test system, there are six sampling sites, S1-S6 (Figure 4). S1 is placed in the raw seawater tank to which has been added viable organisms, heterotrophic bacteria, starch and glucose in accordance with (G8). S2 is placed in the control water tank and S3 is placed in the tank with treated water for sampling on day 0 afterMEPC 61/2/1 Annex, page 8

I:\MEPC\61\2-1.doc ballasting, day 1 for chemical analysis, and day 5 before neutralization. S4 is placed in the Smart Pipe system, but this sampling site was not used for laboratory-scale test. S5 is placed in the discharge pipe for sampling of treated water after 5 days and after neutralization. S6 is placed in the ventilation system located after the electrolyzer for sampling of gases which may develop during ballasting.

The control water tank, the treated water tank, and the test water tank have vertical sampling ports, and samples are taken to confirm water homogeneity (Figure 5). Results are shown in appendix 7 of appendix 2 of the application dossier.

Figure 5: Vertical sampling port of tank

Tables 1 and 2 show the sampling protocol.

Table 1: Sampling tag and sampling sites of AquaStar

Test water Control water Treated water Treated water before neutralization Gas sampling

Sample tag AE-S33S1D0* AE-S33S2D0 /AE-S33S2D5 AE-S33S3D0 /AE-S33S5D5 AE-S33S3D5 AE-S33S6D0
Sampling site S1 S2 S3/S5 S3 S6

*AE, Aqua Eng; S33, Salinity >33 psu; S1, Sampling port 1; D0, 0 Day.MEPC 61/2/1 Annex, page 9

I:\MEPC\61\2-1.doc Table 2: Sample information for efficacy testing of AquaStar
Location of sampling ports
Treated water Sample for Test water Control water Smart Pipe Gas

sampling Before N After N On-siteMeasurements Off-siteMeasurements

Day 0 S1 S2 - S6 S3 -

Day 1 - S2 - - S3 - Chemical Analysis (By KTR a ) Day 5 - S2 - - S3 S5 - DO

- ORP

- pH

- Salinity

- TRO

- Turbidity

- Temp. DOC POC Chemicals

Day 0 S1 S2 S4 - S3 - Efficacy Analysis (By KOMERI b ) Day 5 - S2 - - - S5 - DO

- ORP

- pH

- Salinity

- Turbidity

- Temp. Organisms
≥ 50 um
≥ 10-50 um

- Bacteria

- TSS

Toxicity (By MEI c ) Day 5 - S2 - - - S5 - Acute toxicity

* a KTR: Korea Testing & Research Institute.
b KOERI: Korea Marine Equipm ent Research Institute.

c MEI: Marine Eco-Technology Institute.

2.4.3.2 Basic parameters of test water and results of efficacy test of AquaStar

Table 3 shows the test water conditions. Organisms, heterotrophic bacteria, starch and glucose have been added to the test water in accordance with requirements of Guidelines (G8) (appendix 2 – identifies the quantities of added materials in appendix 7 of appendix 2 of the application dossier).

Table 3: Basic parameters of test water for 34 psu and 20 psu Salinity

(psu) Temp. (°C) pH DO (mg/L) ORP (mV) Turbidity (NTU) 34 psu 33.88 23.53 8.17 6.84 597 3.54 20 psu 20.87 19.84 8.04 7.96 527 15.2MEPC 61/2/1 Annex, page 10

I:\MEPC\61\2-1.doc Table 4: Concentrations of organisms, dissolved and particulate matter in test water

Viable organisms Salinity ≥ 50 μ m (inds./m 3 ) ≥ 10-50 μ m (inds./mL) Heterotrophic bacteria (cells/mL) DOC (mg/L) POC* (mg/L) TSS (mg/L)

34 psu 1,191,000 (6 div. 11 spp.) 4,562 (4 phy. 10 spp.) > 12,045 2.73 0.75 78.7

20 psu 1,165,000 (5 div. 11 spp.) 1,358 (4 phy. 5 spp.) 22,045 6.33 13.5 55.7

* POC is estimated from TOC (total organic carbon).

The concentration of viable organisms and heterotrophic bacteria satisfied the requirements of Guidelines (G8) (Table 4).

All results of the efficacy test satisfied the regulation D-2 (Table 5).

Table 5: Data summary for the laboratory-scale test result of AquaStar

Salinity 34 psu 20 psu

Elapsed time Day 0 Day 5 Day 0 Day 5

Test item Test water Control water Treated water Control water Treated water* Test water Control water Treated water Control water Treated water*

DOC (mg/L) 2.73 2.90 3.03 1.79 3.53 6.33 5.99 6.17 1.89 6.59 POC (mg/L) 0.75 0.88 1.30 0.04 0.25 13.5 15.0 6.85 1.89 1.45 TSS (mg/L) 78.7 73.6 67.5 58.7 55.7 55.7 50.5 41.7 11.7 10 FRO (mg/L as Cl 2 ) 0 0 6.50 0 0.05 0 0 12.5 0 0

TRO (mg/L TRO) 0 0 7.23 0 0.10 0 0 13.5 0 0

Viable organism ( ≥ 50 μ m) (inds./m 3 ) 1,191,000 1,355,000 420 2,400 0 1,165,000 785,000 102,130 637,500 10

Viable organism ( ≥ 10 – 50
μ m) (inds./mL) 2,562 2,657 1 285 0 1,358 1,398 1 184 0

Heterotrophic bacteria (cells/mL) >12,045 >14,955 0 1,820 42 22,045 32,364 3 22,409 1,520

Escherichia coli (cfu/100 mL) 8 14 0 1 0 1 0 0 0 0

Intestinal Enterococci (cfu/100 mL) 192 209 0 0 0 18 23 0 0 0

Vibrio cholerae (cfu/100 mL) 0 0 0 0 0 0 0 0 0 0

* The treated water was neutralized by a sodium thio sulfate solution at discharge stage after 5 days.MEPC 61/2/1 Annex, page 11

I:\MEPC\61\2-1.doc 3 PRINCIPLE OF THE AquaStar SYSTEM

3.1 Disinfection principles by hypochlorite and sodium hypochloride

Sodium hypochlorite (NaOCl) as the main disinfectant is generated by reaction to chlorine (Cl 2 ) produced from anode and sodium hydroxi de (NaOH) produced from cathode during electrolysis process. Besides sodium hypochlorite (NaOCl), the disinfectants are hypochlorous acid (HOCl) as water-solution from chlorine (Cl 2 ) gas, hypochlorite ion (OCl - ) ionized from sodium hypochlorite (NaOCl) or hypochlorous acid (HOCl) and hydroxide ion (OH - ) dissolved from the cathode in water. These di sinfectants are also strongly oxidative. The disinfection mechanism of chlorine and chlorine-compounds is to destroy enzymes in cell or the cell membrane of aquatic organisms. Finally, aquatic organisms are killed.

Hypochlorous acid (HOCl) exists in a pH -dependent equilibrium with hypochlorite ion (OCl - ) (Figure 6). The disinfection effect of hypochlorous acid (HOCl) is approximately 80~100 times that of hypochlorite ion (OCl - ). Because the cell membrane of organisms is a negative charge, the affinity of the hypochlorite ion (OCl - ) is lower than that of hypochlorous acid (HOCl).

Figure 6: The equilibrium of free chlorine with pH.

If the pH in water is low, the concentration of ratio of hypochlorous acid (HOCl) is high, and the disinfection effect is increased. Therefore, the pH in the water is an important factor of electrolysis process, and appropriate conditions should be controlled. Ballast water management system using electrolysis method is also suitable to disinfection effect of chlorine.

3.2 Principle of electrolysis in seawater

During electrolysis of seawater, chlorine (Cl 2 ) is produced at the anode, see reactions below. Cl 2 reacts immediately with water to produce hypochlorous acid (HOCl) and hypochlorite (OCl - ), (reactions 2 and 3 below). Also ozone (O 3 ) and oxygen (O 2 ) may be generated at the anode.MEPC 61/2/1 Annex, page 12

I:\MEPC\61\2-1.doc At the cathode, hydrogen (H 2 ) is generated, see cathode reaction below:

Anode reaction: 2Cl - → Cl 2 + 2e -

Cathode reaction: 2H 2 O + 2Na + + 2e - → 2NaOH + H 2
The overall reaction of the electrolysis is shown in the reaction 1.

(reaction 1) 2NaCl (2Na + + 2Cl - ) + 2H 2 O → 2NaOH (2Na + + 2OH - )+ Cl 2 + H 2
During the electrolysis process, hypochlorous acid (HOCl) and sodium hypochlorite (NaOCl) is generated (reaction 2).

(reaction 2) Cl 2 + HOH → HOCl + HCl

Cl 2 + NaOH → NaOCl + HCl

Hypochlorous acid (HOCl) exists in a pH-dependent, reversible equilibrium with hypochlorite (OCl - ) (reaction 3).

(reaction 3) HOCl ↔ OCl - + H +

Natural seawater contains approximately 65 mg/L~70 mg/L of bromine (Br), which exists as bromide (Br - ) (Lee and Yang, 1998). Under alkaline conditions, bromide (Br - ) also is oxidized by hypochlorous acid (HOCl) to hypobromous acid (HOBr) (reaction 4)

. (reaction 4) HOCl + Br - → HOBr + Cl Hypobromous acid (HOBr) dissociates in water in reactions similar to those of hypochlorous acid (HOCl) (reaction 5).

(reaction 5) HOBr ↔ OBr - + H +

3.3 Principle of neutralization

During de-ballasting the treated water is neutralized to contain TRO concentrations as found in natural seawater. The neutralizing agent is sodium thiosulfate (Na 2 S 2 O 3 ).

The neutralizing reactions of sodium thiosulfate (Na 2 S 2 O 3 ) and sodium hypochlorite (NaOCl) are shown in reactions 6 and 7.

(reaction 6) Na 2 S 2 O 3 + 3NaOCl → 3NaCl + Na 2 S 2 O 6
(reaction 7) Na 2 S 2 O 3 + 4NaOCl + 2NaOH → 4NaCl + 2Na 2 SO 4 +H 2 O

4 GENERAL REQUIREMENTS

4.1 Identification of the Active Substances (AS), Relevant Chemicals (RCs) and Other Chemicals

Active Substances (AS) act to disinfect viable organisms in the ballast water. In AquaStar, AS are produced in situ by electrolysis of natural seawater. This electrolytic process produces chlorine, Cl 2 , at the anode, and Cl 2 reacts immediately with water to produce HOCl and OCl -MEPC 61/2/1 Annex, page 13

I:\MEPC\61\2-1.doc which exist in equilibrium in the seawater (see also section 3.2). Similar processes takes place for bromine. These compounds are free residual oxidants (FRO). Chloramines and bromines are also produced by the electrolytic process and are here referred to as combined residual oxidants (CRO). The FRO and CRO together are referred to as total residual oxidants (TRO). All TRO compounds may have disinfectant effects; hence, they are here regarded as Active Substances (AS).

AQUA Eng. Co., Ltd. controls and measures the TRO concentration using on-line type equipment adopted DPD-method.

In addition to the AS, the electrolytic proces s produces certain by-products here regarded as Relevant Chemicals (RCs). The RCs include bromated, halogenated organic compounds, halogenated acetonitriles (HANs) and halogenated acetic acids (HAAs).

Sodium thiosulfate for neutralizing agent and gases such as hydrogen gas (H 2 ), ozone gas (O 3 ) and chlorine gas (Cl 2 ) are classified as "Other Chemicals".

Table 6 summarizes the AS, RCs and Other Chem icals produced by the AquaStar system. The AS, RC and Other Chemicals were analysed by the Korea Testing and Research Institute (KTR).

Table 6: Active Substances (AS), Relevant Chemicals (RCs) and Other Chemicals in the AquaStar

Substance SMILES CAS NO. Detect Limit Unit

Active Substances TRO N/A N/A 0.03 mg/L

FRO N/A N/A

Chlorine ClCl 7782-50-5

Bromine BrBr 7726-95-6 Hypochlorous acid(HOCl) ClO 7790-92-3 Hypobromous acid(HOBr) BrO 13517-118 Sodium hypochlorite (NaOCl) NaClO 7681-52-9 Sodium hypobromite (NaOBr) NaBrO 13824-96-9 Ozone (O 3 ) O=O=O 10028-15-6
CRO N/A N/A
Chloramine CN(H)(Cl)(CCCl)CCCl 55-86-7 Bromamine N/A N/A

Relevant Chemicals Bromate Br 15541-45-4 0.52 μ g/L Halogenated organic compounds 1,1-dichloroethane C(Cl)(Cl)C 75-34-3 0.02 Trichloromethane C(Cl)(Cl)Cl 67-66-3 0.01 1,2-dichloroethane ClCCCl 107-06-2 0.02 Dibromomethane BrCBr 74-95-3 0.05 μ g/LMEPC 61/2/1 Annex, page 14

I:\MEPC\61\2-1.doc Dichlorobromomethane BrC(Cl)Cl 75-27-4 0.02 Dibromochloromethane BrC(Br)Cl 124-48-1 0.02 Tribromomethane BrC(Br)Br 75-25-2 0.03 Halogenated acetonitriles (HANs) Dichloroacetonitrile ClC(Cl)C(#N) 3018-12-0 0.001 Chloropicrin N(=O)(=O)C(Cl)(Cl)Cl 76-06-2 0.001 Dibromoacetonitrile C(#N)C(Br)Br 3252-43-5 0.001 μ g/L

Halogenated acetic acids (HAAs) Monochloroacetic acid O=C(O)CCl 79-11-8 0.16 Monobromoacetic acid O=C(O)CBr 79-08-3 0.10 Dalapon O=C(O)C(Cl)(Cl)C 75-99-0 0.17 Trichloroacetic acid O=C(O)C(Cl)(Cl)Cl 76-03-9 0.04 Bromochloroacetic acid O=C(C(Cl)Br)O 5589-96-8 0.09 Dibromoacetic acid O=C(O)C(Br)Br 631-64-1 0.05 Tribromoacetic acid O=C(O)C(Br)(Br)Br 75-96-7 0.33 μ g/L

Other Chemicals Sodium thiosulfate (neutralizing agent) S(=S)(=O)(O[Na]O[Na]) 7772-98-7 0.04 mg/L
Hydrogen gas HH 1333-74-0 0.05 % Ozone gas O=O=O 10028-15-6 0.05 Gas Chlorine gas ClCl 7782-50-5 0.10 μ L/L

4.1.1 Active Substances (AS)

The electrolyzer produces Cl 2 and this reacts immediately with water to produce hypochlorous acid (HOCl) in equilibrium with hypochlorite (OCl - ) and hypobromous acid (HOBr) in equilibrium with hypobromite (OBr - ) (see also section 3.2). In the analysis of the test water, the concentrations of AS (TRO) are given as Cl 2 (Table 7).

Table 7: Active Substances of AquaStar Concentration (mg/L TRO) 34 psu Day 0 Day 1 Day 5

a Treated water Substance Test water Control water Treated water Control water Treated water Control water Before N After N

b TRO 0 0 7.23 0 4.07 0 2.54 0.10

Concentration (mg/L TRO) 20 psu Day 0 Day 1 Day 5

a Treated water Substance Test water Control water Treated water Control water Treated water Control water Before N After N

b TRO 0 0 13.5 0 11.2 0 8.78 0

a Treated water is divided into two types, befor e neutralization and after neutralization. b The analyses were performed according to Drinking Water Quality Standard and Test ES 05310, Korea (2007, OT -method) and/or US EPA 330.3 (1978).MEPC 61/2/1 Annex, page 15

I:\MEPC\61\2-1.doc 4.1.2 Relevant Chemicals (RCs)

The production of TRO and FRO by the electrolysis process from chloride in natural water leads to the formation of Relevant Chemicals, such as halogenated organic compounds, chlorinated phenols, brominated phenols, halogenated acetic acid (HAA) and halogenated acetonitrile (HAN). The applicant has tested the formation of by-products in the laboratory-scale test facility in accordance with Guidelines (G8) and Procedure (G9) for 34 psu and 20 psu water. Results are reported for test water; control water and treated water on day 0 (ballasting); control water and treated water on day 1; control water, treated water before neutralization, and treated water after neutralization on day 5 (de-ballasting) (34 psu: Table 8; 20 psu: Table 9).

Table 8: Relevant Chemicals of AquaStar in 34 psu Concentration ( μ g/L) Day 0 Day 5 Treated water b Substance DL a ( μ g/L) Test water Control water Before Neutralization After Neutralization Bromat e c 0.39 ND ND ND ND Halogenated organic compounds d Absorbable organic halogens (AOX) 10 0.36 0.36 0.96 1.02
1,1-Dichloroethene 0.03 ND ND ND ND Dichloromethane 0.03 7.62 ND ND ND trans-1,2- Dichloroethene 0.04 ND ND ND ND
1,1-Dichloroethane 0.02 ND ND ND ND cis-1,2- Dichloroethene 0.02 ND ND ND ND

Bromochloromethan

e 0.03 ND ND ND ND

Trichloromethane 0.01 0.14 ND ND ND 1,2-Dichloroethane 0.02 ND ND ND ND 1,1,1- Trichloroethane 0.02 ND ND ND ND

Tetrachloromethane 0.01 ND ND ND ND Dibromomethane 0.05 ND ND 4.13 3.17 1,2-Dichloropropane 0.02 0.05 ND 0.04 ND Dichlorobromometh

ane 0.02 ND ND 0.34 0.27
1,1,2- Trichloroethane 0.02 ND ND ND ND

Dibromochlorometh

ane 0.02 ND ND 13.5 12.9

Tetrachloroethene 0.01 ND ND ND ND 1,1,1,2- Tetrachloroethane 0.01 ND ND ND ND
1,2,3- Trichloropropane 0.05 ND ND ND ND

Chlorobenzene 0.01 ND ND ND ND Tribromomethane 0.03 0.85 ND 592 585MEPC 61/2/1 Annex, page 16

I:\MEPC\61\2-1.doc 1,1,2,2- Tetrachloroethane 0.02 ND ND ND ND

Bromobenzene 0.01 ND ND ND ND 2-Chlorotoluene 0.02 ND ND ND ND 4-Chlorotoluene 0.02 ND ND ND ND 1,2-Dibromo-3- chloropropane 0.03 ND ND ND ND
1,2,4- Trichlorobenzene 0.04 ND ND ND ND
1,2,3- Trichlorobenzene 0.04 ND ND ND ND
1,3,5- Tribromobenzene 0.02 ND ND ND ND
1,2,4- Tribromobenzene 0.02 ND ND ND ND

Haloacetonitriles e Trichloroacetonitrile 0.004 ND ND ND ND Dichloroacetonitrile 0.001 ND ND ND ND Chloral hydrate 0.002 ND ND ND ND Chloropicrin 0.001 ND ND 0.49 0.40 Bromochloroacetoni trile 0.002 ND ND ND ND

Dibromoacetonitrile 0.001 ND ND 16.8 16.5 Haloacetic acid f
Monochloroacetic acid 0.16 4.63 3.23 513 430

Monobromoacetic acid 0.10 ND ND 18.6 16.2

Dichloroacetic acid 0.13 ND ND ND ND Dalapon 0.17 ND ND 9.51 4.20 Trichloroacetic acid 0.04 6.04 4.86 8.36 2.61 Bromochloroacetic acid 0.09 16.0 12.5 409 390

Dibromoacetic acid 0.05 ND ND 160 45.8 Bromodichloroaceti c acid 0.08 ND ND ND ND

Tribromoacetic acid 0.33 21.4 ND 166 140 Chlorinated phenols g 2-Chlorophenol 0.5 ND ND ND ND 3-Chlorophenol 0.5 ND ND ND ND 4-Chlorophenol 0.5 ND ND ND ND 2,6-Dichlorophenol 0.4 ND ND ND ND 2,5-Dichlorophenol 0.4 ND ND ND ND 2,4-Dichlorophenol 0.5 ND ND ND ND 3,5-Dichlorophenol 0.4 ND ND ND ND 2,3-Dichlorophenol 0.4 ND ND ND ND 3,4-Dichlorophenol 0.4 ND ND ND ND 2,4,6-Trichlorophenol 0.4 ND ND ND ND 2,3,6-Trichlorophenol 0.4 ND ND ND ND 2,4,5-Trichlorophenol 0.6 ND ND ND ND 2,3,5-Trichlorophenol 0.6 ND ND ND ND 2,3,4-Trichlorophenol 0.4 ND ND ND NDMEPC 61/2/1 Annex, page 17

I:\MEPC\61\2-1.doc 3,4,5- Trichlorophenol 0.4 ND ND ND ND
2,3,5,6- Tetrachlorophenol 0.4 ND ND ND ND
2,3,4,6- Tetrachlorophenol 0.4 ND ND ND ND
2,3,4,5- Tetrachlorophenol 0.4 ND ND ND ND
Pentachlorophenol 0.5 ND ND ND ND Bromonated Phenol g 2,6-Dibromophenol 0.6 ND ND ND ND 2,4-Dibromophenol 0.4 ND ND ND ND 2,4,6-Tribromphenol 0.8 ND ND ND ND

a DL, detection limit. b Treated water is divided into two types, befor e neutralization and after neutralization.

c The analyses were performed according to ISO 15061 (2001, HPLC/Agilent/USA) and US EPA 300.1 (1997, IC/DX-500/Dionex/USA). d The analyses were performed according to ISO 9562 (2004, Cl 10/Behr Labor-Technik/Germany) and US EPA 524.2 (1995, Purge-trap GC-MS/Agilent/USA).

e The analyses were performed according to US EPA 551.1 (1995, microECD-GCMS/Agilent/USA). f The analyses were performed according to US EPA 552.2 (1995, microECD-GCMS/Agilent/USA).
g The analyses were performed according to US EPA 8041A (2007, microECD-GCMS/Agilent/USA).

Table 9: Relevant Chemicals of AquaStar in 20 psu Concentration ( μ g/L) Day 0 Day 5 Treated water b Substance DL a ( μ g/L) Test water Control water Before Neutralization After Neutralization Bromate c 0.39 ND ND ND ND Halogenated organic compounds d Absorbable organic halogens (AOX) 10 0.39 0.42 0.78 0.82
1,1-Dichloroethene 0.03 ND ND ND ND Dichloromethane 0.03 ND ND ND ND trans-1,2- Dichloroethene 0.04 ND ND ND ND
1,1-Dichloroethane 0.02 ND ND 0.13 ND cis-1,2- Dichloroethene 0.02 ND ND ND ND

Bromochloromethane 0.03 ND ND ND ND Trichloromethane 0.01 5.48 3.17 6.64 5.71 1,2-Dichloroethane 0.02 0.38 0.23 0.40 0.39 1,1,1- Trichloroethane 0.02 ND ND ND ND

Tetrachloromethane 0.01 ND ND ND ND Dibromomethane 0.05 ND ND ND NDMEPC 61/2/1 Annex, page 18

I:\MEPC\61\2-1.doc 1,2-Dichloropropane 0.02 0.08 ND ND ND Dichlorobromometh

ane 0.02 4.71 3.50 6.34 5.92
1,1,2- Trichloroethane 0.02 ND ND ND ND

Dibromochlorometh

ane 0.02 5.52 2.55 15.2 14.4

Tetrachloroethene 0.01 ND ND ND ND 1,1,1,2- Tetrachloroethane 0.01 ND ND ND ND
1,2,3- Trichloropropane 0.05 ND ND ND ND

Chlorobenzene 0.01 ND ND ND ND Tribromomethane 0.03 3.75 1.96 290 280 1,1,2,2- Tetrachloroethane 0.02 ND ND ND ND

Bromobenzene 0.01 ND ND ND ND 2-Chlorotoluene 0.02 ND ND ND ND 4-Chlorotoluene 0.02 ND ND ND ND 1,2-Dibromo-3- chloropropane 0.03 ND ND ND ND
1,2,4- Trichlorobenzene 0.04 ND ND ND ND
1,2,3- Trichlorobenzene 0.04 ND ND ND ND
1,3,5- Tribromobenzene 0.02 ND ND ND ND
1,2,4- Tribromobenzene 0.02 ND ND ND ND

Haloacetonitriles e
Trichloroacetonitrile 0.004 ND ND ND ND
Dichloroacetonitrile 0.001 1.45 0.62 3.98 1.04 Chloral hydrate 0.002 ND ND ND ND Chloropicrin 0.001 0.45 0.10 1.94 1.74 Bromochloroacetonit rile 0.002 ND ND ND ND

Dibromoacetonitrile 0.001 0.41 ND 19.5 17.4 Haloacetic acid f
Monochloroacetic acid 0.16 54.6 46.8 292 289

Monobromoacetic acid 0.10 ND ND ND ND

Dichloroacetic acid 0.13 ND ND ND ND Dalapon 0.17 2.06 ND 22.4 18.2 Trichloroacetic acid 0.04 2.15 ND 3.41 1.85 Bromochloroacetic acid 0.09 ND ND 205 184

Dibromoacetic acid 0.05 ND ND 2.63 2.11 Bromodichloroacetic acid 0.08 ND ND ND ND

Tribromoacetic acid 0.33 ND ND 192 174MEPC 61/2/1 Annex, page 19

I:\MEPC\61\2-1.doc Chlorinated phenols g 2-Chlorophenol 0.5 ND ND ND ND 3-Chlorophenol 0.5 ND ND ND ND 4-Chlorophenol 0.5 ND ND ND ND 2,6-Dichlorophenol 0.4 ND ND ND ND 2,5-Dichlorophenol 0.4 ND ND ND ND 2,4-Dichlorophenol 0.5 ND ND ND ND 3,5-Dichlorophenol 0.4 ND ND ND ND 2,3-Dichlorophenol 0.4 ND ND ND ND 3,4-Dichlorophenol 0.4 ND ND ND ND 2,4,6- Trichlorophenol 0.4 ND ND ND ND
2,3,6- Trichlorophenol 0.4 ND ND ND ND
2,4,5- Trichlorophenol 0.6 ND ND ND ND
2,3,5- Trichlorophenol 0.6 ND ND ND ND
2,3,4- Trichlorophenol 0.4 ND ND ND ND
3,4,5- Trichlorophenol 0.4 ND ND ND ND
2,3,5,6- Tetrachlorophenol 0.4 ND ND ND ND
2,3,4,6- Tetrachlorophenol 0.4 ND ND ND ND
2,3,4,5- Tetrachlorophenol 0.4 ND ND ND ND
Pentachlorophenol 0.5 ND ND ND ND Bromonated Phenols g 2,6-Dibromophenol 0.6 ND ND ND ND 2,4-Dibromophenol 0.4 ND ND ND ND 2,4,6-Tribromphenol 0.8 ND ND ND ND

a DL, detection limit. b Treated water is divided into two types, befor e neutralization and after neutralization.

c The analyses were performed according to ISO 15061 (2001, HPLC/Agilent/USA) and US EPA 300.1 (1997, IC/DX-500/Dionex/USA). d The analyses were performed according to ISO 9562 (2004, Cl 10/Behr Labor-Technik/Germany) and US EPA 524.2 (1995, Purge-trap GC-MS/Agilent/USA).

e The analyses were performed according to US EPA 551.1 (1995, microECD-GCMS/Agilent/USA). f The analyses were performed according to US EPA 552.2 (1995, microECD-GCMS/Agilent/USA).
g The analyses were performed according to US EPA 8041A (2007, microECD-GCMS/Agilent/USA).MEPC 61/2/1 Annex, page 20

I:\MEPC\61\2-1.doc 4.1.3 Other Chemicals

Sodium thiosulfate is injected into the ballast water before discharge in order to neutralize any residual oxidants that may be present. This is not an AS and the sodium thiosulfate is not produced by the AquaStar. Therefore, it is considered as "Other Chemicals".

Tables 10 and 11 show "Other Chemicals" including gases of AquaStar in 34 psu and 20 psu seawater, respectively.

Sulfide was analysed according to Standard Method 4500-S -2 -D (2005, Iodometric method).

Gases (H 2 , O 3 , Cl 2 ) were analysed according to GC-TCD for H 2 , and Detector tube for O 3 and Cl 2 . These gases were analysed immediately after electrolysis on day 0.

Table 10: Other Chemicals of AquaStar in 34 psu

Concentration Day 0 Day 5 Treated water b Substance DL a Test water Control water Treated water Control water Before N After N Sulfide (S 2- ) (mg/L) 0.04 ND ND ND ND ND ND
Hydrogen (gas) (%) 0.05 - c - 78.4 - - -

Ozone (gas) ( μ L/L) 0.05 - - ND - - -

Cl 2 (gas) ( μ L/L) 0.10 - - ND - - -

a DL, detection limit. b Treated water is divided into two types, bef ore neutralization and after neutralization.

c -, not required.

Table 11: Other Chemicals of AquaStar in 20 psu

Concentration Day 0 Day 5 Treated water b Substance DL a Test water Control water Treated water Control water Before N After N Sulfide (S 2- ) (mg/L) 0.04 ND ND ND ND ND ND

Hydrogen (gas) (%) 0.05 - c - 74.6 - - -

Ozone (gas) ( μ L/L) 0.05 - - ND - - -

Cl 2 (gas) ( μ L/L) 0.10 - - ND - - -

a DL, detection limit. b Treated water is divided into two types, befor e neutralization and after neutralization.

c -, not required.MEPC 61/2/1 Annex, page 21

I:\MEPC\61\2-1.doc 4.2 Data-set for Active Substances and Preparations

4.2.1 Data on effects on aquatic plant, invertebrate and fish including sensitive and representative organisms

4.2.1.1 Acute aquatic toxicity

The most sensitive organism for ballast water treated by AquaStar was the algae, Skeletonema costatum, that gave the EC 50 value of 94.29% for the 20 psu water from aquatic toxicity test results. The other test organisms showed no significant acute toxicity (see report in appendix 4 of the application dossier, section 3.1). The results are summarized in Tables 12 and 13.

Algae: For the study to assess the effects of discharged ballast water on the diatom, Skeletonema costatum , during 72 hours, NOEC and LOEC values from Hypothesis Test and EC 50 values based on the cell densities at the end of the test were calculated for both 34 psu and 20 psu.

Invertebrate (Crustacean): For the study to assess the effects of discharged ballast water on the copepod, Tigriopus japonicus, during 48 hours, EC 50 and LC 50 values based on mobility and survival data at the end of the test were calculated for both 34 psu and 20 psu.

Fish: For the study to assess the effects of discharged ballast water on the olive flounder, Paralichthys olivaceus , during 96 hours, LC 50 values based on survival data at the end of the test were calculated for both 34 psu and 20 psu.

Table 12: Acute aquatic toxicity of AquaStar in 34 psu

EC 50 and/or LC 50 Species End point Conc. (%) Reference/Comments/ justification for

missing data

Algae Skeletonema costatum EC 50 72 h > 100 OECD 201

Invertebrate (Crustacean) Tigriopus japonicus EC 50 48 h LC 50 48 h > 100 > 100 OECD 202

Fish Paralichthys olivaceus LC 50 96 h > 100 OECD 203

Table 13: Acute aquatic toxicity of AquaStar in 20 psu

EC 50 and/or LC 50 Species End point Conc. (%) Reference/Comments/ justification for

missing data

Algae Skeletonema costatum EC 50 72 h 94.29 OECD 201

Invertebrate (Crustacean) Tigriopus japonicus EC 50 48 h LC 50 48 h > 100 > 100 OECD 202

Fish Palalichthys olivaceus LC 50 96 h > 100 OECD 203MEPC 61/2/1 Annex, page 22

I:\MEPC\61\2-1.doc 4.2.1.2 Chronic aquatic organism toxicity, endocrine disruption and sediment toxicity

Chronic toxicity tests were not carried out for Basic Approval. Instead, endocrine disruption and sediment toxicity is described based on related material, see Material Safety Data Sheet (MSDS), appendix 5 of the application dossier. Tests of chronic toxicity will be undertaken in the full-scale land-based test facility for Final Approval.

4.2.1.3 Bioavailability/Biomagnification/Bioconcentration

Tests were not carried out. However, the bio-concentration is described using the EPI Suite (regressed log K OW based BCF model in BCFWIN TM , 2009) (Table 14).

Table 14: Bio-concentration of chemicals

Substance log Kow a Bioconcentration b (R/A) c (L/Kg wet-weight) Bromate -7.18 3.162/1.13 Trichloromethane 1.52 9.264/8.706 Dibromomethane 1.52 6.147/5.046 Dichlorobromomethane 1.61 9.696/10.01 Dibromochloromethane 1.70 12.36/12.78 Tribromomethane 1.79 17.8/19.49 Chloropicrin 1.32 11.12/11.95 Dibromoacetonitrile 0.47 3.162/1.085 Monochloroacetic acid 0.34 3.162/1.038 Monobromoaceti acid 0.43 3.162/1.102 Dalapon 1.68 3.162/5.624 Bromochloroacetic acid 0.61 3.162/1.244 Dibromoacetic acid 0.70 3.162/1.286 Tribromoacetic acid 1.71 3.162/5.185 Sodium thiosulfate -4.53 3.162/0.8931

a log Kow is obtained by KOWWIN v.1.67 of EPI Suite (2009). b Bio-concentration is obtained by BCFBAF v.3.00 of EPI Suite (2009).

c R-value by regression-based estimate; A-value by Arnot-Gobas method.

4.2.1.4 Food web/population effects

Information about these was not found anywhere.

4.2.2 Data on mammalian toxicity

Tests were not carried out. However, related material is described in MSDS; see appendix 5 of the application dossier.MEPC 61/2/1 Annex, page 23

I:\MEPC\61\2-1.doc 4.2.3 Data on environmental fate and effects under aerobic and anaerobic conditions

4.2.3.1 Mode of degradation, bioaccumulation, partition coefficient and octanol/water coefficient

Tests were not carried out. However, related material is described in MSDS; see appendix 5 of the application dossier.

4.2.3.2 Persistence and identification of the main metabolites in the relevant media (ballast water, marine and fresh water, reaction with organic matter, potential physical effects on wildlife and benthic habitats, potential residues in seafood and any known interactive effects

Information about these was not found anywhere.

4.2.4 Physical and chemical properties for the Active Substances and Preparations and the treated ballast water

Oxidation and Reduction Potential (ORP) of test water, control water and treated water is shown in Table 15, see also appendix 2 of the application dossier.

Table 15: Oxidation and Reduction Potential (ORP) changes of AquaStar ORP (mV) Time Test sample 34 psu 20 psu Test water 597 527 Control water 597 593 Day 0 Treated water 944 980 Control water 626 - a Day 1 Treated water 931 - a Control water 625 469 Before neutralization 919 - b Day 5 Treated water After neutralization 712 677

a Because of a lack of equipment, ORP was not analysed. b ORP was not analysed.

4.3 Assessment report

All analyses were carried out according to standard methods. Quality control processes were followed strictly at all times (see appendices 2 and 3 of the application dossier).

All of the chemicals discharged from the AquaS tar were evaluated with regard to effects on aquatic organisms, mammalian toxicity and environmental effect and were non-PBT according to Procedure (G9) criteria (see Table 16, section 5).

- It is concluded that the chemical compounds, discharged from AquaStar, do not accumulate in the tissue of marine organisms.MEPC 61/2/1 Annex, page 24

I:\MEPC\61\2-1.doc - The test results indicate that there are no harmful effects on aquatic organisms, the algae Skeletonema costatum , the invertebrate Tigriopus japonicus, and the fish Palalichthys olivaceus caused by the chemical compounds (Active Substances, Rele vant Chemicals) produced by AquaStar in the de-ballasting water. Therefore, no adverse health effects would be expected to derive from direct or indirect exposure to de-ballasted water, see appendix 4 of the application dossier.

The evaluation of mammalian toxicity using several databases (ECOTOX, EPA, EPI Suite, HSDB, OECD SIDS, PBT Profiler and WHO database by way of accredited laboratories and commercial institutions) involves assessing the AS and RC for various endpoints, including acute and chronic toxicity, carcinogenicity , developmental and reproductive effects. There are a wide range of effects including acute and chronic toxicity, carcinogenicity, mutagenicity, and reproductive toxicity caused by AS and RCs as follows:

- Most of newly generated AS and RCs have potential effects on mammals, but it is expected that the concentrations presented in the neutralized de-ballasting water by AquaStar are not influential.

- Evaluation criteria (section 6.1.1) show that chloropicrin will probably affect the environment including health of humans. However chloropicrin is readily formed from nitromethane during chlorination and its formation is increased in the presence of nitrates. Also, concentrations of chloropicrin in drinking water are usually less than 5 μ g/L from the limited data in the United States and concentrations of chloropicrin in wells 35 m and 65 m from site where chloropicrin was buried were 2.1 ppm and 0.001 ppm, respectively (Spectrum Laboratories Inc. 2003, WHO 2010). Therefore, a concentration of 1.74 μ g/L (= 0.00174 ppm) of chloropicrin detected in the treated water after neutralization (Table 19) is not considered harmful to human health (see also section 6.1.2).

5 RISK CHARACTERIZATIONS

5.1 Screening for Persistency, Bioaccumulation and Toxicity (PBT)

De-ballasting water after neutralization was screened for Persistency, Bioaccumulation and Toxicity (PBT), see Table 16.

Data for persistence and bioaccumulation (log Pow) are obtained from the EPI Suite (2009), and toxicity data are obtained from MSDS (Material safety data sheet), appendix 5 of the application dossier. All compounds have low persistency, bioaccumulation and toxicity as shown in Table 16.MEPC 61/2/1 Annex, page 25

I:\MEPC\61\2-1.doc Table 16: PBT evaluation of de-ballasting water

Criterion Substance Evaluation Persistence a (V/T) b Bioaccumulative c (B/P) d Toxic e

Bromate No 2.9143/15 d 1.13/0.63 176 mg/L/24 hr (Acute LC 50 , crustacea)

Trichloromethane No 2.4158/38 d 8.706/1.52 3.4 mg/L/7-10 d (NOEC, crustacea)
Dibromomethane No 2.8729/15 d 5.046/1.52 N/A

Dichlorobromomethane No 2.5197/38 d 10.01/1.61 1.424 mg/L/9

mon (LC 50 , fish)

Dibromochloromethane No 2.6386/38 d 12.78/1.70 34 mg/L/3-50 d (LC 50 , fish)

Tribromomethane No 2.7275/38 d 19.49/1.79 4.8 mg/L/28 dph f (NOEC, fish)
Chloropicrin No 2.1043/60 d 11.95/1.32 0.0165 mg/L/4 d (Acute LC 50 , fish)

Dibromoacetonitrile No 2.7353/38 d 1.085/0.47 0.55 mg/L/4 d (Acute LC 50 , fish)

Monochloroacetic acid No 3.1818/15 d 1.038/0.34 32 mg/L/21 d (NOEC, crustacea)

Monobromoacetic acid No 3.2857/8.67 d 1.102/0.43 1.6 mg/L/21 d (LC 50 , crustacea)

Dalapon No 2.6894/38 d 5.624/1.68 6 mg/L/1.083 d (Acute LC 50 , crustacea)
Bromochloroacetic acid No 3.0364/15 d 1.244/0.61 N/A

Dibromoacetic acid No 3.1403/15 d 1.286/0.70 69 mg/L/4 d (Acute LC 50 , fish)
Tribromoacetic acid No 2.7827/15 d 5.185/1.71 N/A

Sodium thiosulfate No 2.9469/15 d 0.8931/-4.53 50 mg/L/0.003 d (Acute NOEC, algae)

a Persistence Half life: > 60 days in marine wate r or > 40 days in fresh water or > 180 days in marine sediment or > 120 days in fresh water sediment. b V, numerical value from ultimate biodegradatio n timeframe model; T, total degradation time.

c Bioaccumulation: BCF > 2,000 or log Pow ≥ 3. d B, BCF from Arnot-Gobas Method; P, log Pow.

e Toxicity: Chronic NOEC < 0.01 mg/L. f Days post-hatch.MEPC 61/2/1 Annex, page 26

I:\MEPC\61\2-1.doc 5.2 Toxicity testing

For Basic Approval, tests on acute aquatic toxicity have been performed only in discharged neutralized 34 psu and 20 psu ballast water. Test species (algae, invertebrate and fish) showed slightly low toxicity for the microalga, Skeletonema costatum (EC 50 value is 94.29% in 20 psu); but the invertebrate, Tigriopus japonicus and the fish, Palalichthys olivaceus showed no acute toxicity to the discharged neutralized ballast water (see section 4.2.1).

5.3 Risk characterization and analysis

The predicted environmental concentrations (PEC) of chemicals are estimated using the Marine Anti-foulant Model to Predict Environm ental Concentrations (MAMPEC version 2.0). The model was developed to estimate leaking of anti-fouling from the surface of ships and worst case scenario applied. For the calculation of the PEC in this dossier, the highest concentrations of chemicals were used from the neutralized de-ballasting water of either 34 psu or 20 psu; and in an amount of 396,922 tonnes/day corresponding to the load of discharged ballast water in the OECD commercial harbour of Rotterdam. The results are shown in Table 17. All input data and results of the MAMPEC calculations are presented in appendix 6 of the application dossier.

Table 17: PEC in the OECD-EU commercial harbour from AquaStar

Total concentration in water ( μ g/L) Substance Highest concentration a ( μ g/L) k b Max. Average Min. Bromate c 0.52 0.046 7.43E-03 2.94E-03 2.16E-04 Trichloromethane 5.71 0.018 9.78E-02 3.76E-02 2.41E-03 Dibromomethane 3.17 0.046 5.45E-02 2.09E-02 1.34E-03 Dichlorobromomethane 5.92 0.018 1.12E-01 4.23E-02 2.53E-03 Dibromochloromethane 14.4 0.018 3.06E-01 1.14E-01 6.21E-03 Tribromomethane 585 0.018 1.34E+01 4.92E+00 2.54E-01 Chloropicrin 1.74 0.012 6.01E-02 2.11E-02 7.75E-04 Dibromoacetonitrile 17.4 0.018 5.90E-01 2.07E-01 7.74E-03 Monochloroacetic acid 430 0.046 1.32E+01 4.70E+00 1.90E-01 Monobromoacetic acid 16.2 0.077 4.52E-01 1.62E-01 7.12E-03 Dalapon 18.2 0.018 6.18E-01 2.17E-01 8.10E-03 Bromochloroacetic acid 390 0.046 1.20E+01 4.26E+00 1.73E-01 Dibromoacetic acid 45.8 0.046 1.41E+00 5.00E-01 2.03E-02 Tribromoacetic acid 174 0.046 5.36E+00 1.90E+00 7.70E-02 Sodium thiosulfate c 40 0.046 1.23E+00 4.37E-01 1.77E-02

a The worst case applied. The values in the gr ay fields are taken from the 20 psu water as these values were higher t han the values from the 34 psu water. Load amount estimated from the OECD-EU commercial harbour (Rotterdam), 396,922 m 3 per day of discharge. b k is obtained the followed evaluation; k = ln(2)/half-life. And these values input for degradation rate.

c These chemicals were not detected. Theref ore, the detection limit is used as maximum concentration.MEPC 61/2/1 Annex, page 27

I:\MEPC\61\2-1.doc Based on MAMPEC results of AquaStar, Table 18 shows PEC/PNEC ratio.

Table 18: PEC/PNEC ratios from MAMPEC modelling results

Substance Toxicity (mg/L) PNEC a ( μ g/L) PEC b ( μ g/L) PEC/PNEC ( μ g/L)

Bromate 176 176 7.43E-03 4.22E-05 Trichloromethane 3.4 3.4 9.78E-02 2.88E-02 Dibromomethane N/A N/A 5.45E-02 N/A Dichlorobromomethane 1.424 1.424 1.12E-01 7.87E-02 Dibromochloromethane 34 34 3.06E-01 9.00E-03 Tribromomethane 4.8 4.8 1.34E+01 2.79E+00 Chloropicrin 0.0165 0.0165 6.01E-02 3.64E+00 Dibromoacetonitrile 0.55 0.55 5.90E-01 1.07E+00 Monochloroacetic acid 32 32 1.32E+01 4.13E-01 Monobromoacetic acid 1.6 1.6 4.52E-01 2.83E-01 Dalapon 6 6 6.18E-01 1.03E-01 Bromochloroacetic acid N/A N/A 1.20E+01 N/A Dibromoacetic acid 69 69 1.41E+00 2.04E-02 Tribromoacetic acid N/A N/A 5.36E+00 N/A Sodium thiosulfate 50 50 1.23E+00 2.46E-02

a PNEC = (Toxicity value/Assessment factor) x 1000, 1000 of Assessment factor is applied. b PEC values were used maximum values of total concentration in water.

The PEC/PNEC ratios are >1 for tribromomethane, chloropicrin and dibromoacetonitrile.

However, PEC values of tribromomethane and dibromoactonitrile are not in excess of the WHO's drinking water standards of 100 μ g/L. In addition, these are non-PBT substances and no effect on human health through MOS approach is anticipated.

Chloropicrin is no guideline on drinking water standards and is able to influence human health through MOS approach even though it is a non-PBT substance.

Therefore, it is concluded that tribromomethane and dibromoacetonitrile maybe have no effect but chloropicrin in the de-ballasting water after neutralization are unlikely to affect the environment including health of humans. Chloropicrin must be treated carefully in accordance with regulation (see section 6.1.2).

6 EVALUATION CRITERIA

6.1 Ship and personnel safety

6.1.1 Human Exposure Scenario

In this section, estimates of levels of exposure and risk assessments will be conducted for various exposure scenarios. Concentrations, which used MOS approach, are the highest value of all water (test water, control water, treated water before neutralization and treated after neutralization). Consequently, the highest concentrations are in the treated ballast water both before neutralization and after neutralization. These concentrations can be expected toMEPC 61/2/1 Annex, page 28

I:\MEPC\61\2-1.doc be further diluted when discharged into the natural environment. Margin of safety (MOS) has been estimated in accordance with a worst-case scenario, in which no dilution occurs (MEPC 56/2/2, GESAMP-BWWG 3/9, annex 9). Table 19 shows the theoretical exposure to the various compounds of a person weighing 60 kg and drinking 2 L of water per day.

Since these MOS values, except for chloropicrin (MOS of chloropicrin is 12), are substantially higher than the MOSref (100), it is conc luded that chemical compounds except for chloropicrin in the treated water after neutralization are unlikely to affect the environment including health of humans. Chloropicrin must be treated carefully in accordance with regulation (see section 6.1.1.1).

Table 19: Results of the Margin of Safety (MOS) Approach

Substance a Highest concentration (mg/L) Exposure b (mg/kg/day) NOAEL or LOAEL value c (mg/kg) MOS d

Bromate 0.00052 1.73E-05 7.7 444,231

Trichloromethane 0.00664 1.90E-04 145 655,120

Dibromomethane 0.00413 1.06E-04 N/A N/A

Dichlorobromomethane 0.00634 1.97E-04 13.4 63,407

Dibromochloromethane 0.0152 4.80E-04 18.3 36,118
Tribromomethane 0.592 1.95E-02 56.4 2,858 Chloropicrin 0.00503 5.80E-05 0.002 12

Dibromoacetonitrile 0.0195 5.80E-04 8.2 12,615
Monochloroacetic acid 0.513 1.43E-02 193 11,287
Monobromoacetic acid 0.0186 5.40E-04 50 80,645 Dalapon 0.0224 6.07E-04 15 20,089
Bromochloroacetic acid 0.409 1.30E-02 41 3,007
Dibromoacetic acid 0.16 1.53E-03 25 4,688

Tribromoacetic acid 0.192 5.80E-03 N/A N/A

Sodium thiosulfate 0.04 1.33E-03 N/A N/A

a The values in the gray fields are taken fr om the 20 psu water as these values were higher than the values from the 34 psu water. b Exposure = {(Highest concentr ation) x 2 L/day}/60 kg.

c NOAEL, no observable adverse effect level; LO AEL, low observable ad verse effect level. d MOS = (NOAEL or LOAEL value)/Exposure value.

6.1.1.1 Crew and general public exposure/human exposure via environment

In normal condition, AquaStar should pose no unacceptable risk to crew and general population. Also, through the MOS values of AquaStar, there will be no unacceptable risk to the general population and the crew, in case of accident (spill or leak of ballast water tank).

However, MOS value of chloropicrin is 12. This value is lower than the MOSref (100). Therefore, chloropicrin must be treated carefully in accordance with regulation.MEPC 61/2/1 Annex, page 29

I:\MEPC\61\2-1.doc Chloropicrin is hazardous and colourless liquid with an intensely irritating tear gas odour. It may cause severe eye irritation with corneal injury, which may result in permanent impairment of vision, or even blindness. Chloropi crin causes painful irritation of the eyes at concentration of 1 ppm or less, and a concentration of 15 ppm or more for longer than one minute is intolerable to humans. Chloropicrin may cause severe skin burns and this is classified as corrosive according to DOT guidelines. Chloropicrin is also toxic to fish and other aquatic organisms.

In case of accidental spill or leak of treated ballast water, the affected area should be evacuated immediately. Appropriate personal pr otective equipment such as a NIOSH/MSHA approved self-contained breathing apparatus should be used by personnel entering the affected area for repairing the system. Work upwind if possible. Persons without protective equipment should not be permitted to enter the spill or clean-up area.

Personnel who might get in contact with the treated ballast water during, e.g., maintenance or sampling should wear protective clothing including breathing apparatus, and should avoid eye, skin, and clothing contact as well as inhaling of aerosols by breathing. Containers should be opened only in well-ventilated areas.

6.1.2 Ship

AquaStar designed by AQUA Eng. Co., Ltd. is directly installed in the main ballast pipeline and is operated to the electrolysis method. By-products of electrolysis are chloro- or bromo-compounds such as sodium hypochlorite, sodium hypobromite, trichloromethane, etc. Because these substances are the strong oxidant, by-products could corrode the ballast pipeline and tank. Therefore, the long-term (> 6 months) corrosion test will be performed by using treated water containing these substances. During land-based test, the comprehensive long-term corrosion test will be performed at the AquaStar system according to IMO Performance Standard for Protective Coating (PSPC) guideline. All tests related to corrosion test will base on document MEPC 59/2/16. The results of corrosion test will be presented to the Final Approval application. Generally, hydrochloric acid (HCl) is used as the washing substance of electrode attachments of electrolyzer unit, and is a hazard chemical. But the washing of electrode attachments of AquaStar electrolyzer unit does not use hydrochloric acid (HCl), and electrode attachm ents are easily removed as the high-pressure washing method used fresh water or seawater. AquaStar electrolyzer unit is also designed to simply separate electrodes.

7 REGULATION OF THE USE OF ACTIVE SUBSTANCES AND PREPARATIONS

7.1 Handling of Active Substances and Preparations

The electrolyzer unit of the AquaStar system devel oped by AQUA Eng. Co. Ltd. is installed in ballast pipeline pumping water directly from the sea. When ballasting, the water flows directly through the AquaStar system and into the ballast t anks. This means that the ships crew will not get in contact with AS or other chemicals. This also applies to ballasting during voyage. The presented results indicate that the neutralized de-ballasting water is unlikely to cause any hazards to the marine ecosystem.MEPC 61/2/1 Annex, page 30

I:\MEPC\61\2-1.doc 7.2 Hazard documentation and labelling (Safe procedure and use for hazard incidents)

If all operators and crew follow the manuals of AquaStar, there is no hazard to human health and marine ecosystems. Accidental leaking should be treated as described in section 6.1.2. For the safe operation of the AquaStar system, the pressure gauges and TRO sensors are installed and continuously monitoring and controlling the system during operation. If the problems occur, the warning system of the cont rol unit will automatically indicate the type of problem encountered and appropriate action can be taken. In case of severe failure or malfunction, the control unit will shot down the system. A detailed description of the manuals of AquaStar is given in appendix 1 of the application dossier.

During de-ballasting, sodium thiosulfate (Na 2 S 2 O 3 ) is used to neutralize the treated ballast water. This chemical is stored in a tank, and it is regarded as non-hazardous. The detailed description of the MSDS of sodium thiosulfate (Na 2 S 2 O 3 ) is given in appendix of the application dossier.

8 REFERENCES

Hayes K. R. and Sliwa C., Identifying potential marine pests-a deductive approach applied to Australia, Marine Pollution Bulletin, 46, 91-98, 2003.

Jeong H. J., Kim H. R., Kim K. I., Kim K. Y., Park K. H., Kim S. T., Yoo Y. D., Song J. Y., Kim J. S., Seong K. A., Yih W. H., Pae S. J., Lee C. H., Huh M. D. and Lee S. H., NaOCl produced by electrolysis of natural seawater as a potential method to control marine red tide dinoflagellates, Phycologia, 41, 643-656, 2002.

Lee K. W. and Yang H. S., Chemical Oceanography, pp 35, 1998.

Yoon B. S. Rho J. H. Kim K. I. Park K. S. and Kim H. R., Development of ballast water treatment technology (Feasibility study of NaOC l produced by electrolysis), Journal of the Korean Society, Vol 8, No 4, 174-178, 2005.

9 APPENDICES

The following appendices referred to in this document are contained in the application dossier:

Appendix 1 System description of AquaStar BWMS Appendix 2 QAPP and Efficacy test report Appendix 3 QAPP, COC records and test results for chemicals Appendix 4 COC records and test results for aquatic toxicity Appendix 5 Material safety data sheet Appendix 6 MAMPEC result Appendix 7 MSDS reference articles

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