I:\MEPC\61\2-4.doc 

# E

MARINE ENVIRONMENT PROTECTION

COMMITTEE

61st session Agenda item 2 MEPC 61/2/4

22 March 2010 Original: ENGLISH

HARMFUL AQUATIC ORGANISMS IN BALLAST WATER

Application for Final Approval of BalClor TM ballast water management system

Submitted by China

SUMMARY

Executive summary: This document contains the non-confidential information for Final Approval of BalClor TM Ballast Water Management System 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 complete application

dossier will be submitted to the Marine Environment Division of IMO for review by the GESAMP-Ballast Water Working Group in accordance with Procedure (G9).

Strategic direction: 7.1

High-level action: 7.1.2

Planned output: 7.1.2.4

Action to be taken: Paragraph 7

Related documents: BWM/CONF/36; MEPC 57/21/Add.1; BWM.2/Circ.13, BWM.2/Circ.24;

MEPC 60/2/3 and MEPC 60/2/12

Introduction

1 Regulation D-3.2 of the International Convention for the Control and Management of Ships' Ballast Water and Sediments stipulates that ballast water management systems that make use of Active Substances to comply with the Convention shall be approved by the Organization.

2 The Procedure for approval of ballast water management systems that make use of Active Substances (G9) contains the information that should be included into a proposal for approval (MEPC 57/21/Add.1, annex 1, paragraph 4.2.1) and provisions for risk characterization and analysis (MEPC 57/21/Add.1, annex 1, paragraph 5.3). According to section 6 of Procedure (G9), the Organization should evaluate the information provided in the application.MEPC 61/2/4 Page 2

I:\MEPC\61\2-4.doc 3 Sunrui Corrosion and Fouling Control Company, Qingdao (China) has developed a ballast water management system to treat ballast water using electrolysis. The name of "Sunrui BWMS" was used in the application for Basic Approval (MEPC 60/2/3). After that, the applicant decided to register its ballast water management system under the name of

"BalClor TM BWMS" and to apply for Final Approval under the new name.

4 According to BWM.2/Circ.24, 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 shall be submitted to MEPC 61.

5 The competent authority in China has verified the application dossier and believes it satisfies the data requirements of Procedure (G9) adopted by resolution MEPC.169(57).

6 China therefore submits the non-confidential part of the manufacturer's application 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

7 The Committee is invited to consider the proposal for approval and decide as appropriate.

***MEPC 61/2/4 Annex, page 1

I:\MEPC\61\2-4.doc ANNEX

NON-CONFIDENTIAL INFORMATION ON BALCLOR TM BALLAST WATER MANAGEMENT SYSTEM (CHINA)

This information related to the application for Final Approval of BalClor TM BWMS (the name of "Sunrui BWMS" was previously used in the application for Basic Approval (MEPC 60/2/3)) is prepared in accordance with the Procedure for approval of ballast water management systems that make use of Acti ve Substances (G9) (MEPC.169(57)) and the Methodology for information gathering and t he conduct of work of the GESAMP-BWWG (BWM.2/Circ.13).

1 INTRODUCTION

1.1 Background 1.2 Response to the GESAMP-BWWG's review of the application for Basic Approval

2 DESCRIPTION OF BALCLOR TM BALLAST WATER MANAGEMENT SYSTEM

2.1 Overview 2.2 Principle of chlorine disinfection

2.3 BalClor TM BWMS configuration and characters

3 LAND-BASED TYPE APPROVAL TESTS OF BALCLOR TM BWMS

3.1 Introduction 3.2 Test facility 3.3 Test cycles and test water

3.4 Test results

4 IDENTIFICATION OF THE SUBSTANCE, RELEVANT CHEMICALS AND OTHER CHEMICALS (G9: 4.1)

4.1 Active Substances

4.2 Relevant Chemicals

4.3 Other Chemicals 4.4 Chemical analysis results

5 DATA SET FOR ACTIVE SUBSTANCE AND PREPARATION (G9: 4.2)

5.1 Data on effects on aquatic plants, invertebrates and fish, and other biota, including sensitive and representative organisms (G9: 4.2.1.1) 5.1.1 Acute aquatic toxicity 5.1.2 Chronic aquatic toxicity 5.1.3 Endocrine disruption 5.1.4 Sediment toxicity 5.1.5 Bioavailability/biomagnification/bioconcentration 5.1.6 Food web/population effectsMEPC 61/2/4 Annex, page 2

I:\MEPC\61\2-4.doc 5.2 Data on mammalian toxicity (G9: 4.2.1.2) 5.2.1 Acute mammalian toxicity 5.2.2 Effects on skin and eye, and sensitization effects 5.2.3 Repeated-dose toxicity 5.2.4 Chronic toxicity 5.2.5 Developmental and reproductive toxicity 5.2.6 Carcinogenicity 5.2.7 Mutagenicity/genotoxicity

5.2.8 Toxicokinetics

5.3 Data on environmental fate and effect under aerobic and anaerobic conditions (G9: 4.2.1.3) 5.3.1 Modes of degradation (biotic; abiotic) 5.3.2 Bioaccumulation, partition coefficient, octanol/water partition coefficient

5.3.3 Persistence and identification of the main metabolites in the relevant media (ballast water, marine and fresh waters) 5.3.4 Reaction with organic matter 5.3.5 Potential physical effects on wildlife and benthic habitats

5.3.6 Potential residues in seafood 5.3.7 Any known interactive effects

5.4 Physical and chemical properties for the Active Substances, Relevant Chemicals and treated ballast water (G9: 4.2.1.4) 5.5 Analytical methods at environmentally relevant concentrations (G9: 4.2.1.5)

6 USE OF THE ACTIVE SUBSTANCE (G9: 4.2.6)

6.1 Manner of application 6.2 TRO dosage monitoring and control 6.3 Neutralizing unit and TRO monitoring at discharge

6.4 Retention time

7 MATERIAL SAFETY DATA SHEETS (G9: 4.2.7)

8 RISK CHARACTERIZATION

8.1 Screening for persistence, bioaccumulation and toxicity (G9: 5.1) 8.1.1 PBT criteria for Active Substance (G9: 5.1.1.1) 8.1.2 Assessment of Persistence (P), Bioaccumulation (B) and toxicity (T) (G9: 5.1.1.2) 8.2 Evaluation of the treated ballast water (G9: 5.2) 8.2.1 Toxicity test of the treated ballast water 8.2.2 Determination of holding time (G9:5.2.7) 8.3 Risk characterization and analysis (G9: 5.3) 8.3.1 Reaction with organic matter (G9: 4.2.1.3) 8.3.2 Characterization of degradation route and rate (G9: 5.3.5) 8.3.3 Prediction of discharge and environmental concentrations (G9: 5.3.8) 8.3.4 Assessment of potential for bioaccumulation (G9: 5.3.7)

8.3.5 Effects assessment 8.3.6 Effects on aquatic organisms

8.3.7 Effects on sediment 8.3.8 Comparison of effect assessment with discharge toxicityMEPC 61/2/4 Annex, page 3

I:\MEPC\61\2-4.doc 9 RISK ASSESSMENT

9.1 Risk to safety of ship 9.1.1 Flooding

9.1.2 Corrosion 9.1.3 Fire and explosion 9.1.4 Hydrogen gas and chlorine gas 9.1.5 Storage and handling of the substances

9.1.6 Noise

9.2 Risks to human health 9.3 Risks to the aquatic environment

10 ASSESSMENT REPORT (G9: 4.3)

10.1 Test report and data quality

REFERENCESMEPC 61/2/4 Annex, page 4

I:\MEPC\61\2-4.doc 1 INTRODUCTION

1.1 Background

Sunrui Corrosion and Fouling Control Company ( ) Sunrui CFCC has developed a ballast water management system (BalClor TM BWMS) to treat ballast water on board through pre-filtration followed by disinfection with Active Substances (AS) produced by an electrolytic process during ballasting, and neutralization at de-ballasting. In applying for Basic Approval, the name of "Sunrui BWMS" was used (MEPC 60/2/3). After that, the applicant decided to register its ballast water management system in the name of "BalClor TM BWMS" and to apply for Final Approval of BalClor TM BWMS.

BalClor TM BWMS has been developed on the basis of land-based electrolytic technology applied by Sunrui CFCC for many years, and the core technique is to electrolyze seawater on board directly to produce sodium hypochlorite solution for sterilization. Sunrui CFCC owns the proprietary rights of core components, such as cell design, electrode material etc.

Application for Basic Approval of the BalClor TM BWMS (in the name of "Sunrui BWMS") was submitted to IMO in August 2009 and review ed by the GESAMP-BWWG at its eleventh meeting held at IMO Headquarters from 19 to 24 October 2009. Based on the recommendation by the GESAMP-BWWG (MEPC 60/2/12), Basic Approval has been granted to the BWMS by the Marine Environment Protection Committee at MEPC 60.

The system has run the land-based type approval testing in accordance with the IMO Guidelines (G8) from September to December 2009. The results of land-based tests showed that the biological efficacy of BalClor TM BWMS meet the performance standards of Regulation D-2. Meanwhile, as part of la nd-based type approval process, the discharge toxicity tests, on the samples drawn from the land-based test set-up were conducted according to Procedure (G9). The results of the Procedure (G9) tests, including the toxicity and chemical testing required for Final Approv al, are reported in the application dossier.

1.2 Response to the GESAMP-BWWG's review of the application for Basic Approval

All the comments and recommendations made by the GESAMP-BWWG at its eleventh meeting have been carefully considered and addressed by the applicant. The response to individual recommendations is given below:

1.2.1 Human Exposure Assessment (MEPC 60/2/12, annex 6, paragraph 9.4)

The Group recommended that the Human Exposure Scenario (HES) general public via aggregated exposure (oral, skin and inhalation) when bathing in the areas close to the discharged ballast water should be provided by the applicant if the system is to be reviewed for Final Approval. The applicant should also identify and describe the unit operations associated with this system and information regarding the Human Exposure Scenario (MEPC 56/2/2, annex 9).

Response:

Assessment on potential risk of treated ballast water by the BWMS to human health has been conducted in accordance with the Methodology for information gathering and conduct of work of the GESAMP-BWWG contained in BWM.2/Circ.13. The full assessment report is contained in appendix 10 of the confidential dossier.MEPC 61/2/4 Annex, page 5

I:\MEPC\61\2-4.doc In the assessment, identification/description of the unit operations associated with the BWMS was carried out as a basic step to identify which individual system component is likely to lead to human exposure to the BWMS related c hemicals. The Human Exposure Scenarios were developed according to the guidance in annex 2 of BWM.2/Circ.13. The descriptions on unit operations and the information regarding the HES are included in the assessment report.

Regarding the general public/human exposure via environment, in addition to the food chain that was addressed in Basic Approval, the HES general public via aggregated exposure (oral, skin and inhalation) when bathing in the areas close to the discharged ballast water

was included in the risk assessment.

1.2.2 Corrosion Tests (MEPC 60/2/12, annex 6, paragraph 9.5)

The Group recommended that the comprehensive corrosion testing be conducted in accordance with the guidance provided in section 5.1 of the "Report of the eighth meeting of

the GESAMP-BWWG" contained in MEPC 59/2/16. Where intermittent exposures are utilized to predict long-term corrosion rates, as proposed by the applicant, the TRO in the sample containers should be recorded and reported over the period of the exposure. In addition, the Group recommended that some indication, with supporting data, of the long-term corrosion rates under a constant level of TRO at the maximum allowable dosage concentration should be provided to allow the potential impact on exposed ship systems to be assessed.

Response:

The comprehensive corrosion testing has been conducted in accordance with the guidance provided in section 5.1 of the "Report of the eighth meeting of the GESAMP-BWWG" contained in document MEPC 59/2/16. The testing includes two kinds of low carbon steel, i.e. stainless steel and Cu alloy, respectively, and one non-metal. In addition, corrosion of marine epoxy-coated steel and the coating properties of the specimens exposed to the

treated water were also tested. The test duration lasted for six months.

Corrosion tests are described in section 9.1.2. The full reports are provided in appendix 5 of

the confidential dossier.

1.2.3 Monitor and control of TRO in discharge (MEPC 60/2/12, annex 6, paragraph 9.6)

The Group recommended that the neutralization system should include appropriate monitoring and control to ensure efficient reduction of TRO in the ballast water discharge and this should be fully described in an application for Final Approval.

Response:

The neutralization system has included two sets of TRO analysers to monitor and control the residual TRO in the ballast water discharge. The full description of the monitoring and control system is presented in section 6.3.MEPC 61/2/4 Annex, page 6

I:\MEPC\61\2-4.doc 2 DESCRIPTION OF BALCLOR TM BALLAST WATER MANAGEMENT SYSTEM

2.1 Overview

The BalClor TM BWMS is a complete ballast water management system composing of the following main functional components:

.1 self-cleaning filter with 50 μm screen to remove large plankton and solid particles;

.2 electrolytic unit (including electrolytic cells and accessory dosing and degassing units) to produce sodium hypochlorite solution which is injected back into the main ballast pipe to the ballast tanks to kill the residual planktons, pathogens, larva or spores;

.3 neutralizing unit to add sodium thiosulfate solution into the treated ballast water at de-ballasting to neutralize the residual TRO; and

.4 control and auxiliary equipment.

The flow chart of treatment of BalClor TM BWMS is shown in Figure 2-1.

When ballasting, seawater is filtrated by self-cleaning filter with precision of 50 μ m, then a side stream of seawater is pumped into an el ectrolytic unit to generate sodium hypochlorite solution, which is injected back into the main ballast stream after degas, making a complete mixture with the main stream. The TRO level is measured by a TRO analyser (TRO analyser 1) and controlled at a pre-set concentration value (ranging from 7.5 mg/L to 9.5 mg/L).

On discharge of the treated ballast water, the BalClor TM system monitors the levels of TRO in ballast water. Discharge does not start until the sensors are operational and the neutralizer feed system is in operation. The neutralization system is activated with the neutralizer dose, which is calculated based on the concentration of TRO measured at the location just in front of the neutralizer injection point, to offset all TRO residuals. The sodium thiosulfate solution is injected into the suction of the ballast pump by a metering pump. Another TRO sensor is installed after the neutralizer injection point to monitor the TRO level to ensure that during discharge TRO concentration does not exceed 0.1 mg/L at any time.MEPC 61/2/4 Annex, page 7

I:\MEPC\61\2-4.doc (a) Ballasting

(b) De-ballasting

Figure 2-1: Flow chart of BalClor TM BWMS

2.2 Principle of chlorine disinfection

Chlorination is a mature technique for water treatment and has been widely used for the sterilizations of potable water, waste wa ter and swimming pools for many years. The chlorination technique applied in BalClor TM BWMS is to directly electrolyze seawater to produce the sodium hypochlorite solution in situ. The principle of electrolysing seawater is: when a certain amount of seawater flows through the electrolytic cells, decomposition reactions take place on the electrode surfaces, with chlorine produced at the anode and hydrogen gas at the cathode. The reaction mechanism is as follows:

Anode: 2Cl
- → Cl 2 + 2e

Cathode: 2H 2 O + 2e → 2OH
- + H 2 ↑MEPC 61/2/4 Annex, page 8

I:\MEPC\61\2-4.doc Chlorine dissolves into water and produces hypoc hlorous acid (HOCl) in equilibrium with hypochlorite ion (OCl
- ); and a part of HOCl reacts with bromine ion in seawater and generates hypobromous acid (HOBr) in equilibrium with hypobromous ion (OBr
- ). HOCl/OCl
and HOBr/OBr
- are usually called free available halogen (FAH).

Both HOCl and HOBr are strong oxidizers and halogenation agents, which react with nitrogen compounds such as ammonia, urea, aminoacids, etc., present in fresh water or seawater, generating chloramines and/or bromamines, collectively called haloamines.

All the substances mentioned above are biocide, including HClO/ClO
- /Cl 2 , HOBr/OBr
- /Br 2 , chloramines and bromamines, which are called by a joint name Total Residual Oxidants (TRO) in this document.

2.3 BalClor TM BWMS configuration and characters

BalClor TM BWMS consists of the following functional modules:

- Self-cleaning filter;

- Electrolytic unit (including electrolytic cells and accessory dosing and degassing units);

- Rectifier;

- Controller;

- TRO analyser;

- Neutralizing unit;

- Sampling unit; and

- Hydrogen gas/chlorine gas alarm.

Accessory units include flow-meters, pumps and valves, etc. Figure 2-2 shows a typical

BalClor TM BWMS.

Figure 2-2: BalClor TM BWMS

The functional modules of the system can be in stalled either as an integrated system in one space or installed separately in different places on the ship. The integrated BWMS is more suitable for new buildings, while different factional modules installed in different place may be more practicable for existing ships.MEPC 61/2/4 Annex, page 9

I:\MEPC\61\2-4.doc The BalClor TM BWMS has some special characters, in particular, in the following aspects:

Friendly to environment

No wastes like fume and dust that may pollute the environment are produced when the system operates. The substances pr oduced by the system leave no harmful

influences on natural environment.

Safe for ships and crew

The system does not produce any substances that do harm to the crew. All electrical and electronic sections that crew shall operate are safe. Adequate alarm system is designed, so that protective action could be taken in time to eliminate potential dangers for ships and crew.

Easy operation

The calibration and setting of the system have been completed in the factory and the operation of the system can be performed in fully automatic mode. It is easy for operators to monitor the operational status of the system on the Human-Machine Interface (HMI) on the touch screen.

Low cost for operating and maintenance

For the operation of the system, only power consumption and a small amount of inexpensive reagent is needed.

The ballast water with salinity above 3 PSU can be directly electrolyzed to produce Active Substances as disinfecting agents. When ship is ballasting in fresh water areas with salinity below 3 PSU, there are two options: one is to add salt to increase the salinity in the water for electrolysis; the other option is that the ship in question retain a certain amount of seawater in the ballast tanks from her previous voyage (about 1%-2% of the ballast water needed for the voyage), which can be used as the electrolytic water. For either option, specific design can be tailored to the particular ship according to shipowner's choice.

3 LAND-BASED TYPE APPROVAL TESTS OF BALCLOR TM BWMS

3.1 Introduction

Land-based type approval tests were conducted from September to December 2009 at the test site located in Qingdao, China. The full-scale BalClor TM BWMS tested during the land-based testing was manufactured and installed in accordance with the requirements of Guidelines (G8) and the relevant class requirements. Its rated treatment capacity is 250 m 3 /h. According to the requirements of Guidelines (G8), pre-test evaluation of the system was carried out and approved by China Classification Society (CCS) prior to the land-based type approval testing. The tests were attended and verified by the CCS.

3.2 Test facility

The test facility was built in 2008. It was arranged and established in accordance with the requirements of Guidelines (G8) and was also used for the tests for Basic Approval of

BalClor TM BWMS. The facility includes two feed tanks (Culture tanks) used for preparing the inlet water to be tested, one control tank (Control ballast tank) for keeping control water andMEPC 61/2/4 Annex, page 10

I:\MEPC\61\2-4.doc one treated ballast tank (Treated ballast tank) for storing treated water before discharge, each tank with a capacity of 250 m 3 . Rated flow rate of the land-based set-up is 250 m 3 /h.

3.3 Test cycles and test waters

According to section 2.3.17, part 2 of Guidelines (G8), the tests of five cycles with high salinity and five cycles with medium salinity were performed. Each cycle lasted for a period of at least 5 days. In one test cycle for each salinity range, treated waters were also sampled for the toxicity tests and chemical analysis required in Procedure (G9). In addition, one test cycle (TC20) on fresh water (salinity< 3PSU) was conducted to analyse the chemicals in the water treated by electrolyzing artificial saltwater.

Test water was prepared in the culture tanks for two different sets of test cycles. The test water fulfilled the influent water criteria in sections 2.3.17 to 2.3.20 of Guidelines (G8). Detailed information is provided in appendix 1 "Testing plans and QAPPs" and appendix 2 "Test reports for biological efficacy analysis and physical and chemical properties test of treated water in land-based testing" to the confidential dossier.

3.4 Test results

Biological efficacy

The biological analysis results of ten valid land-based test cycles proved that the biological efficacy of BalClor TM BWMS met the performance standards of Regulation D-2. The full reports of biological analysis results of test cycles TC07 (with high salinity) and TC08 (medium salinity) are provided in appendix 2 of the confidential dossier.

Chemical analysis

Samples for chemical analysis were taken from the treated water in test cycles TC07, TC08 and TC20 (fresh water). The test results and analysis are reported in sections 4.4 and 4.5 and appendix 3 of the confidential dossier.

Toxicity tests

In test cycles TC07 and TC08, the discharge water was sampled immediately after treatment (after neutralizing) and after storage in tank for 48 hours (after neutralizing) for acute and chronic toxicity tests. The results and analysis of toxicity tests are reported in section 8.2.1 and appendix 4 of the confidential dossier.MEPC 61/2/4 Annex, page 11

I:\MEPC\61\2-4.doc TRO concentration in treated tanks

The concentration of TRO in treated tank were measured and recorded daily. The data collected in the test cycles TC07, TC08 and TC20 are presented in Figure 3-1.

0 12 24 36 48 60 72 84 96 108 120 0 2 4 6 8TRO (mg/L)

Time (h) Test Cycle 07 Test Cycle 08 Test Cycle 20

Figure 3-1: TRO concentration in treated ballast water of test cycles TC07, TC08 and TC20

4 IDENTIFICATION OF THE SUBSTANCE, RELEVANT CHEMICALS AND OTHER CHEMICALS (G9: 4.1)

4.1 Active Substances

BalClor TM BWMS utilizes the technology of electrolyzing seawater directly to generate biocides in situ on board. In the disinfection step, a side stream of filtered seawater flows through the electrolytic cells, in which electrochemical reactions take place at the anode and cathode, with chlorine and certain short-life oxygenated chemical compounds and oxygen gas at the anode, and hydrogen gas generated at the cathode. Chlorine dissolves into water and results in the formation of hypochlorous acid (HOCl) in equilibrium with hypochlorite ion (OCl
- ); and a part of HOCl reacts with bromine ion in seawater and generates hypobromous acid (HOBr) in equilibrium with hypobromous ion (OBr
- ). Both HOCl/OCl
- and HOBr/OBr
- are effective biocides, usually called free available halogen (FAH).

Hydrogen gas and oxygen gas are completely removed in the degas tank, therefore, they are considered as by-products and not Relevant Ch emicals. The short-life oxygenated chemical species, possibly including hydrogen peroxide and ozone, present in the side-stream will decompose. For example, hydrogen peroxide w ill be reduced to water by free available chlorine and ozone will decompose into oxygen gas with chlorine acting as a catalyst. Therefore, these oxygenated species will not be c onsidered as either Active Substances or

Relevant Chemicals.

Both HOCl and HOBr are strong oxidizers and halogenation agents, which react with nitrogen compounds such as ammonia, urea, aminoacids, etc., present in fresh water or seawater, generating chloramines and/or bromam ines, collectively called haloamines. Both chloramines and bromamines are also biocides. Although the germicide efficiency ofMEPC 61/2/4 Annex, page 12

I:\MEPC\61\2-4.doc haloamines are much weaker than that of FAH, it becomes evident that those haloamines also have biocide effect, especially on certain pathogens, and have longer term effect.

Chlorine and bromine based compounds are typically analysed together and reported as Free Available Halogen (FAH) for total HOCl /OCl- and HOBr/OBr- or as Total Residual Oxidant (TRO) for total HOCl/OCl-, HOBr/OBr-, chloramines and bromamines. It is virtually impossible to provide a further breakdown for the concentration of chloramines and bromamines in TRO, as these are unstable compounds and there are no calibration standards available to ensure their reliable analysis.

Based on the above, for this application, HOCl/O Cl- , HOBr/OBr-, chloramines together with bromamines, regarded as TRO, are defined as Active Substances.

4.2 Relevant Chemicals

During the process of disinfection by chlorine in seawater, trihalomethanes (THM), haloacetic acids (HAA), haloacetonitriles (HAN) and bromate ion are considered as main potential chemicals , therefore are defined as Relevant Chemicals.

4.3 Other Chemicals

On discharge of the treated ballast water, the TRO in ballast water is neutralized with sodium thiosulphate, which is defined as Other Chemical.

4.4 Chemical analysis results

The potential by-products in the seawater treated by BalClor TM BWMS have been tested and analysed. Based on the analysis results, the Active Substance, Relevant Chemicals and

Other Chemicals identified are listed in Table 4-1. From the test results, it was observed that the chemicals detected in the treated water in land-based type approval testing are the same as those found in the previous tests for Basic Approval, and the quantity of each substance is at the similar level, some are slightly lower than the previous test results.

The full chemical analysis report is provided in appendix 3 of the confidential application

dossier.

Table 4-1: Identified Active Substances, Relevant Chemicals and Other Chemicals

Chemicals CAS No. Molecular weight Formula AS/RC/

OC (bio)degradation

rate or half-life Hypochlorous acid/ hypochlorite 7681-52-9 74.44 NaOCl AS 1.4 hour (at pH 8)
Hypobromous acid/ hypobromite 13824-96-9 118.89 NaOBr AS Biodegrades fast

Chloramines/Bromamines Not available 51.48 NH 2 Cl AS 9 to 420 hours(as Monochloramine)

Dibromochloromethan e 124-48-1 208.28 CHBr 2 Cl RC Water: 38 days Soil: 75 days

Sediment: 340 days Air: 280 daysMEPC 61/2/4 Annex, page 13

I:\MEPC\61\2-4.doc Chemicals CAS No. Molecular weight Formula AS/RC/

OC (bio)degradation

rate or half-life

Tribromomethane 75-25-2 252.73 CHBr 3 RC 1.7 years (Fresh water, at

an aqueous concentration

of 1X10 -17 mole/l hydroxyl radicals)

Monobromoacetic acid 79-08-3 167.01 CH 2 BrC

OOH RC Half-life: Water: 8.7 days Soil: 17 days

Sediment: 78 days Air: 22 days

Bromochloroacetic acid 5589-96-8 138.95 CHBrClC

OOH RC Half-life: Water: 15 days Soil: 30 days

Sediment: 140 days Air: 24 days

Dibromoacetic acid 631-64-1 217.86 CHBr 2 C

OOH RC Half-life: Water: 15 days Soil: 30 days

Sediment: 140 days Air: 25 days

Dibromochloroacetic

acid 5278-95-5 252.36 CClBr 2 C

OOH RC No data available

Tribromoacetic acid 75-96-7 296.74 CBr 3 CO

OH RC Half-life: Water: 15 days Soil: 30 days

Sediment: 140 days Air: 31 days

Dibromoacetonitrile 3252-43-5 198.86 CHBr 2 C

N RC Half-life: Water: 38 days Soil: 75 days

Sediment: 340 days Air: 540 days

Bromate 7758-01-2 167.01 KBrO 3 RC Half-life:

Seawater:

12 hours

Sodium thiosulfate 7772-98-7 158.09 Na 2 S 2 O 3 OC Biodegrades fast

5 DATA SET FOR ACTIVE SUBSTANCE AND PREPARATION (G9: 4.2)

Note: The data sets of the substances listed in Table 4-1 were provided in the forms in accordance with the requirements of Procedure (G9) and BWM.2/Circ.13 in the application for Basic Approval (MEPC 60/2/3). Since the inform ation for this section (from 5.1 to 5.5) is the same as those in section 4 of document MEPC 60/2/3, it was not reproduced.MEPC 61/2/4 Annex, page 14

I:\MEPC\61\2-4.doc 6 USE OF THE ACTIVE SUBSTANCE OR PREPARATION (G9: 4.2.6)

6.1 Manner of application

As reported in section 2, in disinfection process, the BalClor TM BWMS utilizes the technology of electrolyzing seawater directly to generate Ac tive Substances as biocides in situ on board. A side stream of filtered seawater flows through the electrolytic cells, in which electrochemical reactions take place to generate Active Substances, including HClO/ClO -

, HOBr/OBr
- , chloramines and bromamines, which are called by a joint name Total Residual Oxidants (TRO). After degas, the TRO solution is injected back into the main ballast pipe and mixed with incoming ballast water in the pipe. The initial TRO concentration value in the treated ballast water is pre-set in the system, and the dose range in the BalClor TM BWMS is between 7.5 mg/L and 9.5mg/L.

The production of TRO is determined by the magnitude of DC current of the electrolytic cells and the salinity of ballast water. The salinity of ballast water is measured by sensors prior to the electrolytic cells, and the signal is transmitted to controller. Because the production of TRO is a function of electrolytic current and the salinity of water, controller will determine the current output of rectifier to generate required amount of TRO, according to preset value of TRO concentration and the salinity of water.

The actual TRO concentration in ballast water is continuously monitored by an online TRO analyser when ballasting. After the TRO solution is injected into the main ballast water stream from electrolytic unit and fully mixed, water samples will be taken to the TRO analyser to measure the TRO concentration, and the signals will be transmitted back to the controller, which will regulate the current output of the rectifier to maintain the TRO concentration at the preset level (7.5 mg/L – 9.5 mg/L), according to the difference between the measured concentration and preset value. The flow chart of treatment of BalClor TM BWMS is shown in Figure 2-1(a). During electrolysis, hydrogen gas is produced, whic h is a hazard to safety of ships. In the system, hydrogen gas is fully separated and diluted in a degas tank, and then discharged to atmosphere outside ships. Risk management measures in this regard are described in detail

in section 9.1.4.

6.2 TRO dosage monitoring and control during ballasting

There are two TRO analysers in the BalClor TM BWMS. During ballasting operation, TRO analyser 1 is responsible for measuring the TRO concentration in the treated ballast water in main pipe. As mentioned above, the si gnal from the TRO analyser is transmitted to the controller, which will compare the TRO concentrations measured by TRO analyser with the preset values and regulate the current output of rectifier to maintain the TRO concentration at the preset value.

6.3 Neutralizing unit and TRO monitoring and control at discharge

When de-ballasting, neutralizer (sodium thiosulfate solution) is added into the treated ballast water to neutralize the residual TRO. The chemical reaction equation is as follows:

Na 2 S 2 O 3 + 4NaCl O + 2NaOH → 4NaCl + 2Na 2 SO 4 + H 2 O

NaCl and Na 2 SO 4 produced in the neutralization reaction are the substances already existing in seawater, they will not cause any risk to the marine environment.MEPC 61/2/4 Annex, page 15

I:\MEPC\61\2-4.doc The neutralization step will be always employed prior to discharge to ensure the safety of the marine environment in receiving water. The dosage of the neutralizer depends on the TRO concentration in the ballast water for discharge and ballast water flow rate, and is controlled automatically. Flow chart of neutralization at discharge is shown in Figure 6-1.

In neutralization process, filter and electrolytic unit are bypassed. At discharge, two TRO analysers (No.1 and No.2) are used to control and monitor the residual TRO in ballast water during neutralizing process; first one (TRO analyser 1) measures the residual TRO in

treated ballast water before neutralization in order to calculate the amount of sodium thiosulfate solution needed to offset all remaining TRO, while second one (TRO analyser 2), which is located at downstream of the dosing point of the neutralizer, monitors the residual TRO in the discharge water after neutralization to ensure that during discharge TRO does not exceed 0.1 mg/L at any time.

Figure 6-1: Flow chart of neutralization when discharging

The BalClor TM BWMS is interlocked with the ballast system of the ship, and ballast water discharge will not start until the TRO analysers and the neutralization system are in operation. During deballasting, if the TRO concentration detected by TRO analyser 2 exceeds 0.1 mg/L, an audible and visual alarm will be triggered, and the controller will send signals to ship ballast system to stop de-ballasting process. Instructions on how to carry out the inspection and take remedy actions will be shown on human-machine interface (HMI) at control station (see Technical Specification and Manual in appendix 11 of the confidential dossier). Discharge will not restart until the malfunction has been corrected.

6.4 Retention time

Retention time in the BalClor TM BWMS was determined based on the biological efficacy tests. According to the test results, 24 hours of storing of ballast water in the ballast tanks after treatment can ensure effective disinfection to the Regulation D-2 and no re-growth of organisms were found in the treated water after 10 days.MEPC 61/2/4 Annex, page 16

I:\MEPC\61\2-4.doc In conclusion, in order to meet the requirements in Regulation D-2, the treated ballast water should be kept in ballast tanks for 24 hours before de-ballasting.

7 MATERIAL SAFETY DATA SHEETS (G9: 4.2.7)

Material Safety Data Sheets (MSDS) for Active Substances, Relevant Chemicals and Other Chemical are provided in appendix 7 of the confidential dossier.

8 RISK CHARACTERIZATION

8.1 Screening for persistence, bioaccumulation and toxicity (G9: 5.1)

8.1.1 PBT criteria for Active Substance (G9: Table 1)

Table 8-1 shows the criteria for identification of PBT substances.

Table 8-1: Criteria for identification of PBT substances

Criterion PBT criteria

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

Bioaccumulation BCF > 2,000 or

LogPoctanol/water ≥ 3

Toxicity Chronic NOEC < 0.01 mg/l

8.1.2 Assessment of Persistence (P), Bioaccumulation (B), and Toxicity (T)

Table 8-2 shows Persistence (P), bioaccumulation (B), and toxicity (T) data for the Active Substances, Relevant Chemicals and Ot her Chemicals. According to PBT evaluation, all of the Active Substances, Relevant Chem icals and Other Chemicals are not considered to

be PBT substances.

Table 8-2: Persistence (P), bioaccumulation (B), and toxicity (T) data for the Active Substances, Relevant Chemicals and Other Chemicals

Chemical Persistence(Y/N) Bioaccumulation(Y/N) Toxicity(Y/N) HOCl(NaClO) No

Half-life:1.4 hour (at pH 8) No

BCF: 3.162 Log Pow: -3.42 Yes

NOEC:0.003 mg/l HOBr(NaBrO) No Biodegrades fast No

BCF: 1.24 Log Pow: -1.03 N. A.

Monochloramine No Abiotic Degradation:

Chloramine half-lives ranging from 9

to 420 hours N. A. N. A.MEPC 61/2/4 Annex, page 17

I:\MEPC\61\2-4.doc Chemical Persistence(Y/N) Bioaccumulation(Y/N) Toxicity(Y/N)

Tribromomethane Yes Fresh water, Half-life: 1.7 years (at an aqueous concentration

of 1X10 -17 mole/l hydroxyl radicals) No

BCF: 14 Log Pow: 2.4 No

NOEC: 4.8 mg/l/28d

Dibromochloromethane Yes

Half-life: Watetr: 38 days Soil: 75 days Sediment: 340 days Air: 280 days No BCF: 0.74-1.47 L/kg Log Pow: 2.24 No

NOEC: 3.2 mg/L/21day

Bromoacetic acid No

Half-life: Watetr: 8.7 days Soil: 17 days Sediment: 78 days Air: 22 days No

BCF: 3.2 Log Pow: 0.41 No

NOEC: 1.6 mg/l/21days

Dibromoacetic acid No

Half-life: Watetr: 15 days Soil: 30 days Sediment: 140 days Air: 25 days No

BCF: 0.17 Log Pow: 0.70 No

PBT Profiler

Tribromoacetic acid No

Half-life: Watetr: 15 days Soil: 30 days Sediment: 140 days Air: 31 days No

BCF: 0.63 Log Pow: 1.71 No

PBT Profiler

Bromochloroacetic acid No

Half-life: Watetr: 15 days Soil: 30 days Sediment: 140 days Air: 24 days No

BCF: 3.2 Log Pow: 0.61 No

PBT Profiler

Dibromochloroacetic

acid No Activated sludge: 100%(aerobic), 28 days No Log Pow: 1.62 N. A.

Dibromoacetonitrile No

Half-life: Watetr: 38 days Soil: 75 days Sediment: 340 days Air: 540 days No

BCF: 3 Log Pow: 0.47 No

PBT Profiler

Bromate No

Half-life:

Seawater: 12 hours No

BCF: 3.7×10 -7
Log Pow: -7.18 No

NOEC:8 mg/l/7d

Sodium thiosulfate No Biodegrades fast No

BCF: 3.162 Log Pow: -4.53 No

NOEC: 600 mg/l/18monthMEPC 61/2/4 Annex, page 18

I:\MEPC\61\2-4.doc 8.2 Evaluation of the treated ballast water (G9: 5.2)

8.2.1 Toxicity test of the treated ballast water

According to the requirements of Procedure (G9) and BWM.2/Circ.13, the aquatic toxicity tests of three trophic levels using the treated ballast waters sampled from the land-based type approval testing of BalClor TM BWMS were performed by Supervision and Test Center for Pesticide Safety Evaluation and Quality Control.

The aquatic toxicity tests results are summarized in Table 8-3

, and the complete report of the aquatic toxicity tests is provided in appendix 4 of the confidential dossier.

Table 8-3: Aquatic toxicity test results

Samples Tests Organisms Results Algae Growth inhibition Test Skeleonema

costatum NOAEC > 100%

Marine Invertebrate Acute Toxicity

Test NOAEC > 100%

Marine Invertebrate Chronic Toxicity Test Neomysis

awatschenis NOEC > 100%

LOEC > 100% Marine Fish Acute Toxicity Test NOAEC > 100% 20091101-

TC07T-0h-N

Marine Fish Chronic Toxicity Test Ctenogobius gymnauchen NOEC > 100%

LOEC > 100%

Algae Growth inhibition Test Skeleonema

costatum NOAEC > 100%

Marine Invertebrate Acute Toxicity

Test NOAEC > 100%

Marine Invertebrate Chronic Toxicity Test Neomysis

awatschenis NOEC > 100%

LOEC > 100% Marine Fish Acute Toxicity Test NOAEC > 100% 20091103-

TC07T-48h-N

Marine Fish Chronic Toxicity Test Ctenogobius gymnauchen NOEC > 100%

LOEC > 100% Algae Growth inhibition Test Skeleonema

costatum NOAEC > 100%

Marine Invertebrate Acute Toxicity

Test NOAEC > 100%

Marine Invertebrate Chronic Toxicity Test Neomysis

awatschenis NOEC > 100%

LOEC > 100% Marine Fish Acute Toxicity Test NOAEC > 100% 20091109-

TC08T-0h-N

Marine Fish Chronic Toxicity Test Ctenogobius gymnauchen NOEC > 100%

LOEC > 100% Algae Growth inhibition Test Skeleonema

costatum NOAEC > 100%

Marine Invertebrate Acute Toxicity

Test NOAEC > 100%

Marine Invertebrate Chronic Toxicity Test Neomysis

awatschenis NOEC > 100%

LOEC > 100% Marine Fish Acute Toxicity Test NOAEC > 100% 20091111-

TC08T-48h-N

Marine Fish Chronic Toxicity Test Ctenogobius gymnauchen NOEC > 100%

LOEC > 100%MEPC 61/2/4 Annex, page 19

I:\MEPC\61\2-4.doc From the results of aquatic toxicity tests, it is concluded that all the ecotoxicity of discharged ballast water is acceptable.

8.2.2 Determination of holding time (G9:5.2.7)

The holding time is the time that the treated ballast water has to be retained in the tanks to ensure there is no adverse effect concentration upon discharge. Since the neutralization step will be always employed in BalClor TM BWMS treatment process prior to discharge, treated water can be discharged anytime as long as the required disinfection level is achieved.

For the BalClor TM BWMS, whether that level is achieved is determined by the contact time between Active Substances and organisms. According to a series of biological efficacy tests, the retention time of 24 hours is considered to be adequate to meet Regulation D-2.

8.3 Risk characterization and analysis (G9: 5.3)

8.3.1 Reaction with organic matter (G9: 4.2.1.3)

Major reactions of chlorine with organic matter in polluted water were described in section 5.3.4. THM and HAA identified as the major by-products of these reactions are directly related to the total organic carbon in the water being treated and the chlorine dose level used for disinfection. As these by-pr oducts may bring risk to the environment, they

should be reduced to the minimum.

8.3.2 Characterization of degradation route and rate (G9: 5.3.5)

Degradation of TRO has two major routes: (1) through a quick consumption or decomposition by the chlorine demand in the polluted water (organic and nitrogen compounds, ions of Fe, Ni, Co that decompose TRO); and (2) through a slow decay via photolytic or heat decomposition.

Chlorine and all of its derived species are ox idative and very reactive compounds. Chlorine gas is a more efficient oxidizer than hypochl orous acid (HOCl), and hypochlorous acid is more efficient than the hypochlorite ion (ClO
- ). The balance between HOCl and ClO
- can be studied in polluted water with pH between 4 and 10. In this case, the kinetic of the reactions and the final products obtained depend, to a large extent, on the percentage of each of the two species (HOCl, ClO-). The main reaction routes can be described as follows:

.1 chlorination with amines R-NH 2 or ammonium NH 4 + is very rapid and explains the very fast disappearance of available chlorine in waste water;

.2 oxidation reactions occur with many inorganic or organic compounds; and

.3 chlorination of C atoms from organic molecules is easier for molecules with

a shorter carbon skeleton.

Three typical reactions are: Reaction with phenol giving monochlorophenols; Reaction with molecules containing two carbon atoms: acetaldehyde, acetonitrile, and acetic acid, which

are chlorinated on the CH 3 , and give chloroacetaldehydes, chloroacetonitriles and chloroacetic acids; Reaction with final degradation of the carbon chain giving THMs.

HOBr/OBr
- is removed from seawater by several mechanisms. HOBr/OBr
- reacts with natural organic matter to form tribromomethane by the haloform reaction. In fact, a number of disinfection products and other halogen containing compounds are reported when bromide is present in natural waters. Therefore, organic matter in ballast water could lead to theMEPC 61/2/4 Annex, page 20

I:\MEPC\61\2-4.doc disappearance of the TRO. Sunlight can reduce HOBr/OBr
- to Br - through a complex series of photochemical reactions. In some cases, where high concentrations of Cl
- are present, it may be that sunlight-mediated photolysis of HOBr/OBr - leads to the formation of bromate ion. Therefore, photolysis may also lead to the loss of TRO. After the neutralization and before the discharging, the concentrations of Active Substances and the bromate were 0 μg/L.

THMs are extensively removed in sewage treat ment, probably primarily by volatilization as well as by degradation. All trihalomethanes are volatile, the volatility decreasing in the order

CHCl 3 > CHBrCl 2 > CHBr 2 Cl > CHBr 3 . Brominated acetic acids are generally more biodegradable than their chlorinated counterparts. Relevant Chemicals and Other Chemicals are expected to be naturally degradable by natural biotic or abiotic paths.

8.3.3 Prediction of discharge and environmental concentrations (G9: 5.3.8)

8.3.3.1 Introduction

The MAMPEC Model of version 2.0 was used to calculate the PEC of Relevant Chemicals and Other Chemicals in the port. MAMPEC was originally programmed to calculate environmental concentrations of anti-fouling biocides released from ship coatings.

In a modified way it can be used to calculate the concentrations that are released constantly into the water by other processes like for example ballast water treatment. The applicability of the model to any chemical substance made it a useful tool for environmental impact

studies.

8.3.3.2 Parameterization of the model

To calculate the environmental concentration of the released compound in the harbour water and the sediment, several parameters are ne cessary. These parameters define the harbour and its characteristics, the compound that is being released and the amount of the specified compound released by ships. In the calculat ion, the OECD-EU commercial harbour was chosen with the default setting given by MA MPEC. Physico-chemical property data for Relevant Chemicals and Other Chemicals were taken from Key Data Summary or calculation of the EPI suit. The input parameters were the same as those of EUSES 2.1 which was used for human exposure assessment. The emission load was calculated from ballast water concentration for Relative chemicals and Other Chemical and average amount of ballast

water in the OECD-EU commercial harbour.

According to information contained in document BLG 13/INF.4, the daily ballast water discharge in port of Rotterdam (twice the size of the OECD-EU commercial harbour) is about 100,000 m 3

.

8.3.3.3 Half-life

Within MAMPEC, it was not possible to include the decay of the compound of interest during emptying the ballast water tank. In this case, a worst case scenario was used assuming that

the water released from the ballast tanks has the same concentration at the start and at the end of discharge.

The ballast water was treated by filter and electrolytic unit, and held in simulated tank for several days and then neutralized by sodium thiosulfate. After the neutralization the concentration of Active Substances and the Bromate measured was 0 μg/L in the ballast water, so the PEC of Active Substances and the Bromate in the harbour are 0 μg/L.MEPC 61/2/4 Annex, page 21

I:\MEPC\61\2-4.doc In the calculation of this dossier, using the worst-case scenario, it is assumed that all chemicals will not decay in water of the har bour after discharging. Predicted environmental concentrations (PEC) of the chemicals calculated by the MAMPEC model is based on the worst-case scenario of 100,000 m 3 ballast water discharge.

The concentrations of Active Substances, Relevant Chemicals and Other Chemicals after the neutralization were measured during the analytic testing, as shown in Table 8-4.

Table 8-4: Maximum concentration of chemicals detected in treated water at discharge

Chemicals Concentration, μg/L HOCl(NaOCl) 0 HOBr(NaOBr) 0

Chloramine 0

Tribromomethane 42.21

Dibromochloromethane 2.15

Monobromoacetic acid 2.89

Dibromoacetic acid 8.98

Tribromoacetic acid 4.09

Bromochloroacetic acid 0.46

Dibromochloroacetic acid 2.96

Dibromoacetonitrile 5.58

Bromate 0 Sodium thiosulphate 870

8.3.3.4 Harbour definitions

For all runs, the OECD-EU commercial harbour was chosen with the default settings given by MAMPEC. The modelling of the harbour is shown in Figure 8-1.

Figure 8-1: The modelling of the OECD-EU commercial harbour

Where: x1 = 1,000 m y1 = 1,000 m x2 = 5,000 m y2 = 500 m depth = 15 m x3 = 2,500 m flow velocity 1 m·s -1MEPC 61/2/4 Annex, page 22

I:\MEPC\61\2-4.doc 8.3.3.5 Background concentration

The background concentration of HOCl(NaOCl), HOBr(NaOBr), Chloramine, Monobromoacetic acid, Tribromoacetic acid, Di bromochloroacetic acid, Dibromoacetonitrile, Bromate, Sodium thiosulphate were measured to be 0 μg/L and Tribromomethane, Dibromochloromethane, Dibromoacetic acid, Br omochloroacetic acid were measured to be 0.16 μg/L, 0.04 μg/L, 0.22 μg/L and 0.12 μg/L, respectively.

8.3.3.6 Results of Modelling

The PEC results from the MAMPEC calculation are shown in Table 8-5. Maximum concentration was used in PEC/PNEC calculation. The data sheets are provided in the relevant parts of appendix 8 in the confidential application dossier.

Table 8-5: Estimated total concentrations for Active Substance and Relevant Chemicals by MAMPEC (VER. 2.0 model)

Chemical name Maximum

Concentration ( μ g/L) 95%

Concentration ( μ g/L) Average

Concentration ( μ g/L) Median

Concentration ( μ g/L) Minimum

Concentration ( μ g/L) HOCl(NaOCl) 0 0 0 0 0 HOBr(NaOBr) 0 0 0 0 0

Chloramine 0 0 0 0 0

Tribromomethane 3.48E-01 3.40E- 01 2.28E-01 1.83E-01 1.63E-01

Dibromochloromethane 3.99E-02 3.98E-02 3.73E -02 3.91E-03 3.25E-04

Monobromoacetic acid 2.65E-02 2. 59E-02 9.22E-03 2. 42E-03 3.25E-04

Dibromoacetic acid 3.02E-01 3. 01E-01 2.49E-01 2. 28E-01 2.21E-01

Tribromoacetic acid 3.74E-02 3. 67E-02 1.31E-02 3. 43E-03 4.60E-04

Bromochloroacetic acid 1.24E-01 1.24E-01 1.21E-01 1.20E-01 1.20E-01

Dibromochloroacetic

acid 2.71E-02 2.66E-02 9.44E -03 2.48E-03 3.33E-04

Dibromoacetonitrile 5.10E-02 5. 00E-02 1.78E-02 4. 67E-03 6.28E-04

Bromate 0 0 0 0 0 Sodium thiosulphate 7.96E+00 7. 81E+00 2.78E+00 7. 30E-01 9.79E-02

8.3.4 Assessment of potential for bioaccumulation (G9:5.3.7)

As the logarithm octanol/water partition coefficients (log Pow) of all Active Substances, Relevant Chemicals and Other Chemicals in the treated ballast water by BalClor TM BWMS

are < 3 and the BCFs of all chemicals are below 500 L/kg, the potential for bioaccumulation is not accessed in marine or freshwater organisms in accordance with G9:5.3.7.

8.3.5 Effects assessment

The toxicity data sets indicate that the risk of the Active Substances of HOCl is significant for most fresh water and saltwater predators (fish) and primary producer (alga) based on a chronic NOEC <0.01 mg/L.

The ecological risk of the Relevant Chemicals to aquatic organisms is less than the risk from the Active Substances because much less chronic NOEC toxicity data are available. Chronic data of two trophic levels used in this dossier are available for tribromomethane and bromate to conclude that the compounds would not bring risk to predators and alga because all of the NOECs are 2-3 orders of magnitude above 0. 01 mg/L. Likewise, one chronic crustaceansMEPC 61/2/4 Annex, page 23

I:\MEPC\61\2-4.doc value (1.6 mg/L) is available for monobromoacetic acid. An NOEC of 600 mg/L was found for fish exposed to sodium thiosulphate which indicates that the risk of sodium thiosulphate is negative. Because of the lack of a complete chronic database (i.e. one or more of the three chronic trophic levels used in this dossier are no t available), a great deal of uncertainty exists for some of the THMs and HAAs. In addition, one must also consider the fact that it is unlikely that only one chemical will be discharged in the ballast water. Additional risks are likely when a mixture of the relevant chemicals is discharged.

8.3.6 Effects on aquatic organisms

In chemical testing, no potential ecotoxic substance was found in the treated water. Predicted No-Effect Concentrations (PNEC) values were calculated using the aquatic toxicity data set endpoints and the appropriate assessment factor. The calculation results are shown

in Table 8-6.

Table 8-6: PNEC for the Active Substances and Relevant Chemicals in fresh water and saltwater according to data set endpoint

Chemical name Toxicity

(mg/L) Information Assessment

factor PNEC

(mg/L)
HOCl(NaOCl) 0.003 Lowest L(E)C 50 from a fish, crustacean and alga and lowest NOEC from a algae,

crustaceans and fish 100 0.00003

Chloramine 0.012 Lowest LC 50 from a fish and

crustacean 1000 0.000012

Tribromomethane 4.8 Lowest L(E)C 50 from a fish, crustacean and alga and Lowest NOEC from a algae and fish 100 0.048

Dibromochloromethane 3.2 Lowest L(E)C 50 from a fish, crustacean and alga and Lowest

NOEC from fish 100 0.032

Monobromoacetic acid 0.2 Lowest L(E)C 50 from a crustacean and alga and Lowest

NOEC from crustacean 1000 0.0002

Dibromoacetic acid 6.9 Lowest LC50 from a fish 1000 0.0069

Tribromoacetic acid 6.9 PNEC was assumed to be the

same value as that for

dibromoacetic acid 1000 0.0069

Bromochloroacetic acid 6.9 PN EC was assumed to be the

same value as that for

dibromoacetic acid 1000 0.0069

Dibromochloroacetic acid 6.9 PN EC was assumed to be the

same value as that for

dibromoacetic acid 1000 0.0069

Dibromoacetonitrile 0.55 Lowest L(E)C 50 from a fish, crustacean and alga 1000 0.00055

Bromate 8 Lowest L(E)C 50 from a fish, crustacean and alga and Lowest NOEC from fish and alga 100 0.08

Sodium thiosulphate 64 Lowest L(E)C 50 from a fish and alga and Lowest NOEC from

fish 1000 0.064MEPC 61/2/4 Annex, page 24

I:\MEPC\61\2-4.doc Risk to aquatic environment by chemicals in ba llast water was carried out by calculating PEC/PNEC ratio. If PEC/PNEC ratio is less than or equal to 1, the chemical is of no immediate concern. In PEC/PNEC ratio is greater than 1, the substance should be of

concern. Active Substances were not detected in treated ballast water so that risk assessment to aquatic environment for Active S ubstance was not considered. PNEC values are normally derived from short-term and/or long- term aquatic toxicity results for relevant aquatic species by dividing the lowest available effect concentration with an appropriate

assessment factor.

The PEC/PNEC calculated for chemicals are all less than 1, so the ballast water treated by

BalClor TM BWMS has low potential risk for aquatic environment. Risk assessment results for aquatic environment are summarized in Table 8-7.

Table 8-7: Risk assessment results for aquatic environment

Chemicals PEC/PNEC

Tribromomethane 0.00725

Dibromochloromethane 0.00125

Monobromoacetic acid 0.13250

Dibromoacetic acid 0.04377

Tribromoacetic acid 0.00542

Bromochloroacetic acid 0.01800

Dibromochloroacetic acid 0.00393

Dibromoacetonitrile 0.09270

Sodium thiosulphate 0.12440

8.3.7 Effects on sediment

As stated in section 5.1.4, the Koc values of all chemicals range from 2.7×10 -8 to 468, which are smaller than 500 l/kg, which indicate that the chemicals will not readily partition to sediment and thus be of concern to benthic organisms residing in the sediment, so the risk to infaunal sediment organisms is low.

8.3.8 Comparison of effect assessment with discharge toxicity

The concentration of Active Substance, Relevant Chemicals and Other Chemicals in the ballast water were measured by analytical methods and the aquatic toxicity tests were conducted using the same ballast water. From the toxicity test results, no mortality and adverse effects were observed, so the toxic effects of the ballast water treated by BalClor TM BWMS to aquatic organisms would be low.MEPC 61/2/4 Annex, page 25

I:\MEPC\61\2-4.doc 9 RISK ASSESSMENT

9.1 Risk to safety of ship

9.1.1 Flooding

The BalClor TM BWMS is connected to the ship balla st piping system by hard rubber lined steel pipes, together with a number of electromagnetic and manual valves. The piping to connect the BWMS with ship ballast piping system is designed and arranged in accordance with the classification rules. The BWMS is so designed that in case of any failure of the components or function module, the system w ill be stopped automatically to isolate the BWMS from the ship ballast piping. Manual valves are also fitted in the system so that the BWMS can be closed by the manual valves if there is a failure of the automatic valves.

9.1.2 Corrosion

Further to the corrosion test on two kinds of low carbon steels, as reported in the application for Basic Approval, comprehensive corrosion testing has been conducted in accordance with the guidance provided in section 5.1 of the "Report of the eighth meeting of the

GESAMP-BWWG" contained in document MEPC 59/2/16.

The corrosion tests include two kinds of low car bon steels, i.e. stainless steel and Cu alloy respectively, and the test on one non-metal. In addition, corrosion of marine epoxy-coated steel and the coating properties of the specimens exposed to the treated water were also tested. The test duration was six months. All the tests have completed except the long-term test on stainless steel and Cu alloy. The full corrosion testing reports are provided in appendix 5 to the confidential dossier. Based on these tests the following conclusions were

obtained:

- For uncoated steel exposure, the corrosion rates of bare steels were tested using the method of mass loss. No localized corrosion was found on the samples of 360 steel and CCS B steel both in the treated water and in the control water. The corrosion tests show that the corrosion morphology of the bare samples subjected to the treated water are same with those subjected to natural seawater, i.e. all are uniform corrosion. The results of corrosion rate

calculation indicate that the corrosion rate of the bare steels in the ballast water treated by BalClor TM BWMS is at the similar level with that of the steels in

nature seawater.

- Regarding coated steel, the corrosion rating of coated specimens was

evaluated in accordance with the rule of ASTM D1654-08. While the corrosion rating of the specimen exposed in natural seawater was rating 7, the rating of the specimen in the treated seawater was rating 8. That implies that the corrosion on the coated specimens exposed in the treated water is lighter than

that in natural seawater.

- The effect of the treated water on the epoxy painted specimens was tested, and no significant difference was found in coating properties compared to

natural seawater.

- The effect of the treated water on non-metal was evaluated, and Nitrile butadiene rubber (NBR, gasket material) was used for testing. The results show that the main properties of NBR immersed in treated water for six months

was at the similar level to that immersed in natural seawater.MEPC 61/2/4 Annex, page 26

I:\MEPC\61\2-4.doc - For steel and Cu alloy, the interim report on corrosion testing was included in the application dossier based on the results of two months exposure. Long-term testing was still ongoing at the time of submission for Final Approval, and the final report will be submitted as part of Type Approval requirements.

9.1.3 Fire and explosion

The only chemical carried on board is sodium thiosulfate for neutralizing residual TRO during de-ballasting. The solution is stored in a sealed PVC container, which is neither flammable nor explosive.

9.1.4 Hydrogen gas and Chlorine gas

Hydrogen gas

Hydrogen gas is generated during the electrolytic process. Theoretically, under the condition of the TRO concentration of 9.5 mg/L (the maximum allowable dosage of TRO), 133.8 mol of hydrogen gas (H 2 ) is generated in the electrolyzed water with concentrated TRO for treating 1,000 tonnes of ballast water, which equals 267.6 g.

The electrolysed water entraining H 2 gas flows into the degas tank. H 2 gas is fully separated inside the tank, and diluted by air blowers to the level below Lower Explosive Limit (LEL). Then, the diluted gas is released overboard. A spark arrestor is fitted on the discharge end of vent pipe.

Rated air flow of the blowers is calculated according to the relevant specifications to ensure that the volume of air provided is adequate to dilute H 2 gas to the level below LEL. Considering it is important to supply air continuously, two air blowers are fitted in the degas unit. Should the one in operation fail, another will continue to operate automatically. As a further safety measure, an air pressure sens or is installed at the discharge side of the blowers, and the sensor will send an acousto-optic alarm if air supply is insufficient. The air blower will continue to work for 10 minutes after electrolytic process finishes.

During the land-based type approval tests, H 2 gas was monitored. No hydrogen gas was ever detected in the area around the electrolytic unit or in the headspace of treated tank throughout the electrolytic process. The concentration of hydrogen gas measured near the outlet of the vent pipe of degas tank was not higher than 0.28 v/v % during the whole electrolytic process, and then it went down to below 0.04 v/v % two hours after completion of the electrolytic process.

The technology for venting hydrogen gas has been employed by Sunrui Company in the design and manufacture in relation to electrolytic process for several hundreds of the installations either on board (sewage water treatm ent system by electrolytic method) or in land-based systems (anti-fouling of seawater cooling system). These installations have been in operation safely and reliably for many years.

Chlorine gas

The chlorine gas produced by electrolysis dissolv es into seawater rapidly, generating active substances (TRO). The short-term exposure limit of chlorine gas is known to be 1 mg/m 3
(MSDS, approximately 0.78 ppm). Under normal oper ation, there is no leakage of chlorine gas from the BWMS. During land-based type approval tests, no chlorine gas was detected in the area around the electrolytic unit. The concentration of chlorine gas measured in theMEPC 61/2/4 Annex, page 27

I:\MEPC\61\2-4.doc headspace of treated tank was not higher than 0.3 mg/m 3 during the whole electrolytic treatment, and after that it clears away rapidly.

To monitor the accidental leakage of hydrogen gas and chlorine gas, sensors and alarms are included in the BWMS to detect any leakage online. Acousto-optic alarms will be sent when

the concentrations of H 2 and Cl 2 exceed 2 v/v % and 0.4 ppm, respectively. If the

concentrations of H 2 and Cl 2 exceed 3 v/v % and 0.55 ppm, respectively, the electrolytic units will be immediately shut down automatically. Meanwhile, air blowers will keep ventilation

continuous to dilute H 2 to the level below Lower Explosive Limit.

When there is an alarm signal, relevant information and instructions on the remedy measures will be shown on the human-machine interface (HMI).

9.1.5 Storage and handling of the substances

The only chemical substance carried on board is sodium thiosulfate. The substance is widely used in dechlorination in water, such as halt bleaching in the paper-making industry. It is also used in smelting silver ore, in producing leat her goods and to set dyes in textiles. Sodium thiosulfate is also used to fix black and white photography negatives after the developing stage.

Sodium thiosulfate is kept in a tightly closed container, stored in a cool, dry, ventilated area; therefore, there is no any risk to the safety of ships during storage and handling.

When the sodium thiosulfate is handled and mixed by crew, it is required that the operators should wear neoprene or rubber gloves and other protective clothing, wear safety glasses or chemical goggles with face shield and wear respirator. Safety procedure for handling of sodium thiosulfate is detailed in "Technical Specification and Manual", in appendix 11 of the confidential application dossier.

9.1.6 Noise

The BalClor TM BWMS operates in engine room of ships using standard pumps and valves that meet relevant specifications. The noise of BalClor TM BWMS in operation was tested in accordance with the relevant specifications of the Class, and confirmed to remain within the permitted levels.

9.2 Risks to human health

9.2.1 Introduction

The assessment on potential risks of ballast water treated by the BalClor TM BWMS was carried out by China Classification Society (CCS) together with the applicant in accordance with the IMO Methodology for Information gathering and conduct of work of the

GESAMP-BWWG contained in BWM.2/Circ.13.

The human health risk assessment of the BalClor TM BWMS includes assessment of risks to human health due to potential exposure of crew, dock workers and PSC inspectors to

chemicals associated with BalClor TM BWMS during normal operation and in accident situations, as well as general public exposure to the discharge treated ballast water. The full assessment report is provided in appendix 10 of the confidential dossier.MEPC 61/2/4 Annex, page 28

I:\MEPC\61\2-4.doc 9.2.2 Occupational exposure (HES) and quantitative risk evaluation

As recommended by the GESAMP-BWWG, identification/description of the unit operations

associated with BalClor TM BWMS has been carried out as a basic step to identify which individual system component is likely to lead to human exposure to the BWMS related chemicals. Each unit was assessed for the potential risk of human exposure to the BWMS

related chemical substances.

The BalClor TM BWMS is designed to operate automatically, and under normal operating conditions, the system is to be considered as a closed system, therefore, the crew's exposure to the treated water is highly unlikely.

During ballasting, the air in the empty ballast tanks will gradually be vented out of the tanks as the air is replaced by the rising water. The air can contain chemical substances found in the ballast water that could imply a health ri sk if inhaled. Crew on deck can be exposed to the vented tank air. To minimize the exposure to the vented tank air, crew should avoid staying in the area near to the vent heads when the BWMS is operating.

Although it is considered to be highly unlikely, crew or dock workers could have contact with treated ballast water during maintenance and sediment cleaning in ballast tanks. Ship's crew and PSC officers could have contact with treated ballast water when sampling during discharge.

Following the identification of operation units in BalClor TM BWMS, the occupational exposure to chemicals associated with the system was assessed for the following HES assumptions:

- carrying out work on deck near to the vent heads of ballast tanks;

- entering ballast tanks for cleaning or maintenance; and

- sampling from the BWMS at discharge.

All routes of exposure were thoroughly evaluated based on very conservative assumptions, and the calculated results show that there is no unacceptable risk to human health, without consideration of wearing personal protective equipment (PPE). Therefore, it is not necessary

for the crew to wear PPE as a routine when wo rking on deck. Notwithstanding, to minimize the potential risk, PPE is recommended when people enter empty ballast tanks for cleaning, maintenance or sampling.

Human risk in accident situations was also addressed. Though human exposure to TRO or neutralizer due to accidental leakage is considered to be highly unlikely, safety precautions and mitigating measures are provided to protect the crew in case of any incident (refer to the full assessment report in the confidential dossier).

9.2.3 General public/human exposure via environment

The following two scenarios are identified as possible scenarios of exposure to the general population through environment and food chain:

- exposure to sea bathers in surrounding areas (oral, inhalational or dermal exposure by way of bathing in areas near the harbours); and

- exposure to the general population through the food chain (oral intake by way of marine foods).MEPC 61/2/4 Annex, page 29

I:\MEPC\61\2-4.doc As worst scenarios, the calculation results for human health risk to general public via swimming near port (oral route) and through eating marine food from the ballast water discharge areas are listed in Tables 9-6 and 9-7.

Table 9-6: MRR values for seawater ingestion during swimming

Chemical MOS MOSref MRR(MOS/MOSref)

Tribromomethane 1.724 E+05 100 1.724 E+03

Dibromochloromethane 1.8 E+06 100 1.8 E+04

Monobromoacetic acid 3.182 E+05 100 3.182 E+03

Bromochloroacetic acid 2.51 E+05 100 2.51 E+03

Dibromoacetic acid 3.18 E+04 100 3.18 E+02

Dibromochloroacetic

acid 3.23 E+06 100 3.23 E+04

Tribromoacetic acid 2.34 E+06 100 2.34 E+04

Dibromoacetonitrile 5.22 E+04 100 5.22 E+02 Sodium thiosulphate 1.206 E+05 100 1.206 E+03

Table 9-7: Calculated MRR(MOS/MOSref) values (Human health risk via eating marine food from the ballast water discharge areas)

Chemical MOS MOSref MRR(MOS/MOSref)

Tribromomethane 2.68E+04 100 2.68 E+02

Dibromochloromethane 2.67E+06 100 2.67E+04

Monobromoacetic acid 2.15E+05 100 2.15E+03

Bromochloroacetic acid 1.71E+05 100 1.71E+03

Dibromoacetic acid 4.07E+05 100 4.07E+03

Dibromochloroacetic acid 2.225E+06 100 2.225E+04

Stribromoacetic acid 8.075E+06 100 8.075E+04

Dibromoacetonitrile 4.44E+04 100 4.44E+02

Sodium thiosulphate 8.28 E+04 100 8.28 E+02

As shown in the above tables, all MRR values are much higher than 1, it can be judged that there is no unacceptable risk to the general public.

9.3 Risks to the aquatic environment

Risk to aquatic environment by chemicals in ba llast water was carried out by calculating PEC/PNEC ratio. If PEC/PNEC ratio is less than or equals to 1, the chemical is of no immediate concern. If PEC/PNEC ratio is greater than 1, the substance should be of

concern.

The PEC/PNEC calculated for chemicals are all less than 1, so the ballast water treated by BalClor TM BWMS of Sunrui Company has low potential risk for aquatic environment.

Detailed results are shown in section 8.3.6.MEPC 61/2/4 Annex, page 30

I:\MEPC\61\2-4.doc 10 ASSESSMENT REPORT (G9: 4.3)

10.1 Test report data quality

The ballast water treated by BalClor TM BWMS have been tested by the following organizations in accordance with the relevant international recognized guidelines, and the data obtained from the testing were used in the dossier for the application of Final Approval:

.1 Aquatic toxicity tests were conducted by Supervision and Test Center for Pesticide Safety Evaluation and Quality Control (PSEC) in Shenyang. PSEC is accredited for toxicological safety evaluations of drugs, pesticides, and other fine chemicals by the Ministry of Agriculture of the People's Republic of China.

.2 The chemical analysis was performed by PONY Testing International Group in Qingdao and Beijing laboratory (PONY TEST).

.3 The measuring of environmental parameters of the seawater and the physical and chemical properties of the treated ballast water were carried out by the Centre of Marine Environmental Measurement, the First Institute of Oceanography, State Oceanic Administration.

.4 The corrosion tests were conducted by Qingdao Laboratory, Xiamen Laboratory and Luoyang Laboratory of Testing and Verifying Centre for Ship Materials of China Shipbuilding Industry (TCSI), respectively. TCSI is a famous organization on corrosion test in China. In 2002, the TCSI obtained accreditation of China Class Society (CCS).

The above four organizations are accredited by China National Accreditation Service for Conformity Assessment (CNAS, eqv . to ISO/IEC 17025) and China Metrology Accreditation (CMA). And PSEC is registered as a GLP laboratory in China and run in accordance with the requirements of GLP lab.

These organizations are all qualified testing organizations, and have their own Quality Management Plan (QMP). The testing plans and QAPPs were developed and strictly followed through the testing.MEPC 61/2/4 Annex, page 31

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