For reasons of economy, this document is pr inted in a limited number. Delegates are kindly asked to bring their copies to mee tings and not to request additional copies.

I:\MEPC\59\2.doc

INTERNATIONAL MARITIME ORGANIZATION

IMO 

# E

MARINE ENVIRONMENT PROTECTION
COMMITTEE
59th session Agenda item 2 MEPC 59/2
28 November 2008 Original: ENGLISH

HARMFUL AQUATIC ORGANI SMS IN BALLAST WATER

Application for Final Approval of the RWO Ballast Water Management System (CleanBallast)

Submitted by Germany

SUMMARY

Executive summary: This document contains the non-conf idential information related to the application for Final Approval of the RWO Ballast Water Management System (CleanBall ast) under the “Procedure for approval of ballast water managment systems that make use of Active Substances (G9)” a dopted by resolution MEPC.169(57)

Strategic direction: 7.1

High-level action: 7.1.2

Planned output: 7.1.2.4

Action to be taken: Paragraph 5

Related documents: BWM/CONF/36; MEPC 53/24/Add.1; MEPC 55/23; MEPC 57/2/3; MEPC 57/2; MEPC 57/21; BW M.2/Circ.13 and BWM.2/Circ.15

1 Regulation D-3.2 of the International Conve ntion for the Control and Management of Ships’ Ballast Water and Sediments stipulates th at ballast water management systems that make use of Active Substances to comply with the Convention shall be appr oved by the Organization.

2 Germany submits herewith an application fo r Final Approval accordi ng to the “Procedure for approval of ballast water management system s that make use of Active Substances (G9)”. This procedure stipulates that the required information (MEPC 57/21, annex 1, paragraph 4.2.1), which, according to section 6, should be ev aluated by the Organization. In accordance with BWM.2/Circ.15, this document contains th e non-confidential part of the manufacturer’s application dossier in the annex. The complete do ssier will be made ava ilable to the experts of the GESAMP-BWWG with the understanding of confidential treatment.MEPC 59/2 - 2 -

I:\MEPC\59\2.doc 3 Basic Approval of the Active Substance used has been granted at MEPC 55 (MEPC 55/23, paragraph 2.16). Final Approval as applied for in document MEPC 57/2/3 has not been granted at MEPC 57 (MEPC 57/21, paragraph 2.12).

4 After carefully taking into account the recommendations contained in annex 6 of the Report of the fourth meeting of the GESA MP-BWWG (MEPC 57/2) the receiving competent authority has verified the applic ation dossier and believes it to satisfy the requirements of the Procedure (G9) adopted by resolution MEPC.169(57).

Action requested of the Committee

5 The Committee is invited to consider the pr oposal for approval and decide as appropriate.

***MEPC 59/2

I:\MEPC\59\2.doc ANNEX

NON-CONFIDENTIAL INFORMATIO N ON THE RWO BALLAST WATER MANAGEMENT SYSTEM (GERMANY)

1 INTRODUCTION

The applicant is proposing a combined system usi ng disc filtration for me chanical separation and the advanced EctoSys ® electrolysis for disinfection as a complete system for ballast water treatment. Previously this complete ballast water treatment system was described as Technology No. 1 in annex 1 of document MEPC 55/2/17 and of document MEPC 56/2/10 and in an oral presentation on October 7, 2008 during MEPC 58. The CleanBallast system was developed and is manufactured by RWO GmbH Marine Water Technology (Bremen, Germany), which is part of Veolia Water. It is commercia lized under the name of Cl eanBallast (please note
that in contrast to earlier nomi nation CleanBallast is written now without an exclamation mark at the end for marketing and re adability reasons). The appl icant hereby proposes the complete CleanBallast system to receive Fi nal Approval under Proce dure (G9) adopted by resolution MEPC.169(57).

1.1 Status of the CleanBallast sy stem and type approval testing

The development of the CleanBallast system st arted in 2003 as a publicly funded R&D project. Hereby, different treatment devices for mechani cal separation and disi nfection (including the advanced EctoSys ® electrolysis) were tested in parallel , achieving a direct comparison of their performance at the naturally changing inlet water quality. Based on these comparative tests, the best technology was evaluated and consequently the full-scale CleanBallast system was designed. After scaling-up to 500 m 3 /h flow rate, the full-scale Clea nBallast system underwent again a rigorous testing at the containe r pier in Bremerhaven (Germany) since January 2007, in close proximity to container ships car rying out ballasting operations.

The advanced EctoSys ® electrolysis received Basic Appr oval of Active Substances at the MEPC 55 in Oct 2006 (MEPC 55/2/4 and MEPC 55/2/16, annex 7). On March 1, 2007, RWO GmbH purchased the EctoSys ® technology from the former owner Permascand (Sweden) including all rights (BWM.2/Circ.11).

In summer 2007, the CleanBallast system ran successfully the land-based type approval procedure on a barge set up at two locations offering brackish and fresh water salinities: the harbours of Bremerhaven and Bremen. As require d by Procedure (G9), tests related to the application for Final Approval were carried out in parallel. A worst-case approach was chosen concerning the operation (i.e. the use of Active Subs tances) of the CleanBallast system as well as the water quality (i.e. realistic ballasting conditions) for the tes ting. The application for Final Approval was submitted to MEPC 57 (MEPC 57/2/3), but following the recommendations of the GESAMP-BWWG (MEPC 57/2, annex 6) the Final Approval was not granted by MEPC 57 (MEPC 57/21, paragraph 2.12).

Thereupon, the applicant considered the recommenda tions by GESAMP-BWWG (cf. MEPC 57/2, annex 6) and repeated complete ly the testing for the land-based type approval and for the Final Approval at nominal worki ng conditions of the CleanBallast system at the NIVA test facility in Solbergstrand (N orway). Det Norske Veritas (DNV) was the verification organization of the testing and repor ting according to Guidelines (G8) and Procedure (G9) at the test facility NIVA. The German Administration BSH (Federal Maritime and Hydrographic Agency) involving the Competen t Authorities approved the test programme,MEPC 59/2
ANNEX Page 2

I:\MEPC\59\2.doc set-up and the CleanBallast system as well as fi nal reports as the certifyi ng authority of Germany for the applicant. The full Quality Assurance Project Plan (QAPP) of the test facility NIVA, can be found in Appendix E of the application dossier.

For the shipboard type approval, a 500 m3/h CleanBallast system was installed on a container ship (2890 TEU) owned by one of the world-largest container fleet owners (due to a confidential agreement the name of the ship and the owner cannot be revealed currently). The shipboard type approval procedure is planned to be fi nalized in spring 2009. Fu rthermore, the first four CleanBallast systems were delivered for newbuildings (20,000 dwt Multipurpose Heavy Lift Carriers) since early summer 2008.

1.2 Short description of the Clea nBallast system and control

1.2.1 CleanBallast unit operation s and system components

The ballast water treatment process performed by the CleanBallast system comprises two main unit operations: mechanical separation (filtering ) and disinfection (advanced electrochemical oxidation). The CleanBallast system contains th e following main components: ballast water disc filters, EctoSys ® electrochemical cell, gas tr ap and de-aeration pipe, re ctifier, control cabinet with Panel PC, monitoring equipment, e.g., conduc tivity sensor, TRO (Total Residual Oxidants) sensor, Algae Monitor, hydrogen gas sensor , pressure sensors (please refer to the confidential Appendix A of the application dossier).

A neutralization system for furthe r decrease of the TRO concentra tion if required in high salinity seawater before discharge at deballasting is an optional component (Please see TRO data in
section 6.2 and in the confid ential part of the applica tion dossier Appendix N).

1.2.2 Operation of the CleanBallast system

The CleanBallast system is operated inline using disc filtration (50 μm filter fineness) and the advanced EctoSys ® electrolysis for disinfection during ballast water uptake.

Treatment at ballast water uptake:

- In the first step, the disc filters remove particles, sediments and organisms of the larger size classes. This allows the following disinfection step to minimize the use
of Active Substances.

- In the second step, organisms of the sma ller size class and bacteria remaining in the filtrate are effectively disi nfected by the advanced EctoSys ® electrolysis.

A controlled limited current input from the rectifier to the EctoSys ® cell assures that the Maximum Dosage Disinfectant Concentration propor tional to the volume flow rate is kept at all times. In marine waters, this maximum is 2 mg/L Total Residual Oxidant (TRO). In fresh water any residual oxidants (Activ e Substances) are not detectable due to the fact that the only Active Substance species formed is th e short-lived hydroxyl radical (compare to section 2.1.2). Thereafter, th e treated water is pumped in to the ballast water tanks.MEPC 59/2
ANNEX

Page 3

I:\MEPC\59\2.doc Whilst the ship is en route to the next port of ca ll, potential regrowth of organisms in the ballast
water tank must be considered. To ensure that the IMO Ballast Water Pe rformance Standard is met when discharging the ballast water from the ship, the disinfection process is used a second time at deballasting.

Treatment at ballast water discharge:

- The disc filters are bypassed.

- The water from the ballast water tanks is treated once more by the advanced EctoSys ® electrolysis. At this trea tment during deballasting, the maximum input current applied to the EctoSys ® electrodes is limited at all times ensuring the Maximum Dosage Concentrati on of < 2 mg/L TRO in marine waters. Furthermore, in waters of all salinities the applied current is mitigated by using the Algae Monitor (see also section 2.1.4, appe ndix and the confidential Appendix C) to monitor and only allow generating the level of disinfectants necessary at deballasting (if needed at all). By using this measure the TRO discharge
concentration is minimized in marine wa ter qualities, and use of hydroxyl radicals
is minimized in fresh water.

The correct term reflecting the EctoSys ® disinfection would be maximum producible concentration; nevertheless, th e common term Maximum Dosage C oncentration is used in this application, although no dosing of chemicals is applied for the operation and production of Active Substances by the EctoSys ® electrolysis – please see for fu rther information below.

1.2.3 Active Substances produced by the advanced EctoSys ® electrolysis

The main electrochemical r eactions producing Active Substa nces are described below. Previously, a full description of the electroche mical reactions was given in the application for Basic Approval in paragraphs 4.3 and 5.2.3 of document MEPC 55/2/4.

The EctoSys ® cell produces disinfectants inline within the main pipe using an electrochemical process, whereby flows of up to 500 m 3 /h can be disinfected from or ganisms and bacteria using a single EctoSys ® module of a footprint < 1 m2. For this , the rectifier rece ives AC power and supplies a direct current to the electrodes of the EctoSys ® cell.

Due to the specific properties of the anodes, th e production of hydroxyl radicals is favoured with high selectivity in the whole sa linity range from river water to seawater. By favouring the formation of hydroxyl radicals simultaneously the production of oxyge n is suppressed.

In contrast to conventional chlori ne electrolysis, where the addition of salt or a brine solution is necessary to low salinity waters, the advanced EctoSys ® electrolysis functi ons in river water comparably to seawater without loss of immediat e disinfection efficiency. This is due to its ability to form hydroxyl radicals as disinfectant directly from wa ter and the direct oxidation of
contaminants on the electrodes. In river and fr esh water (< 3 psu), the only Active Substance (disinfectant) produced by the EctoSys ® are hydroxyl radicals. Equa tion (1) gives the anodic
reaction:

H 2 O → OH * + H + + e - (1)MEPC 59/2
ANNEX Page 4

I:\MEPC\59\2.doc Hydroxyl radicals are extremely shor t-living (life time of approx. 10 -9 s – please refer to the Basic Approval application dossier MEPC 55/2/4) and th erefore give no residual , long-lasting effect
after the treatment.

In brackish and seawater, the EctoSys ® produces simultaneously the hydroxyl radicals according to Equation (1) and chlorine according to Equation (2):

2 Cl - → Cl 2 + 2 e - (2)

Due to the strong pH dependency of the three chlorine species Cl 2 , HOCl and OCl - , the formed chlorine gas Cl 2 is immediately converted into hypochl oric acid HOCl in water above pH 4

− please see equation (3) a nd in document MEPC 55/2/4, Figure 1 on page 14.

Cl 2 + H 2 O → HCl + HOCl (3)

This conversion of chlorine gas Cl 2 is facilitated further by the strong water mixing effect caused by the arrangement of the electrodes in the EctoSys ® cell.

Especially in marine waters, hypochlo ric acid HOCl is reduced by bromide Br - in an irreversible reaction (Harp 2002) to chloride Cl - under the formation of the more stable hypobromic
acid HOBr.

HOCl + Br - → HOBr + Cl - (4)

Hydroxyl radicals and Free Ac tive Chlorine (HOCl/OCl - ) are regarded as Active Substances and the secondarily formed Free Active Bromine HOBr/OBr - as a Relevant Chemical. For details, please refer to section 3.2.

Besides chlorine and bromine, also other compounds such as manganese (Mn 2+ ) and hydrogen peroxide (H 2 O 2 ) give a response to the DPD-me thod commonly used to determine
the concentration of Total Residual Oxidan ts (TRO; Harp 2002). All concentrations of Total Residual Oxidants are given as equivalent chlorine in this appli cation dossier for reasons of better comparability. For example, resolutio n MEPC.159(55) requires 0.5 mg/L chlorine for the discharge of treated effluents by sewage treatment plants on board ships.

Furthermore, the applicant would like to stress th at during testing at different locations, relative high blank TRO concentrations between 0.1 - 0.3 mg/L were found in th e untreated raw and control waters. Such values are in the range of the residual concentration as applied in drinking water treatment. At least part of the blank conc entration can be attribut ed to phytoplankton such as dinoflagellates and green algae, which are capable of producing superoxide O 2 - and hydrogen peroxide H 2 O 2 , etc. (Marshall et al. 2005 a and b) as well as volatile halocarbons (Crane et al. 1980). Superoxide and hydroge n peroxide formed by algae give a response to
the DPD-method for the determination of TRO.

1.2.4 Control of the CleanBallast sy stem and disinfection process

In normal operation the CleanBallast system is automatically controlled by a PLC (Programmable Logic Controller). The syst em maybe supervised locally by means of a panel PC or remotely for instance on the bridge of the ship. This allows the operation sequences, status messages and alarms to be monitored.MEPC 59/2
ANNEX

Page 5

I:\MEPC\59\2.doc TRO and hydroxyl radicals additional to the background level are solely formed in the CleanBallast disinfection unit, the EctoSys ® (MEPC 55/2/4). The EctoSys ® electrochemical reaction is controlled by varying the input curre nt to the electrode sets. The maximum permitted input current is calculated c ontinuously using real-time data for both water flow rate and conductivity measurements. Decrea sing flow rate and increasing conductivity (i.e. salinity) adjusts the permitted current down. Signals from flow measurements and conductivity measurements are processed within the PLC and th en used to adjust the current set-point on the rectifier supplying the current to the EctoSys ® electrochemical cell.

Throughout the ballasting and deballasting process, the Algae Monitor continuously measures the content of viable phytoplankton in the water. If during deballasting the measured level of viable phytoplankton is below a specific va lue, then the system is desi gned to allow th e algae control loop to reduce the total current output set point . This prevents an unnecessary discharge of excess Active Substances into the output stre am, and efficiently reduces the impact on the receiving environment to an absolute minimum.

In addition to the mitigating function of the Algae Monitor, a final fail-safe in the form of a TRO
measurement device is installed. This TRO meas urement device continuously monitors the TRO concentration after the EctoSys ® disinfection unit and ensures that the actual concentration does not exceed the set limit. As soon as the preset wa rning limit, which can be set to any value up to the Maximum Allowable Dosage limit of 2 mg/L TRO at ballasting treatment, is reached, the TRO control loop immediately reduces the tota l current output set point further in marine waters above 3 psu.

The system control software allows a number of the limit values to be adjusted. Certain values are able to be set by the manufacturer only and others remain changeable by a suitably qualified user. To ensure that system values are not changed by unaut horized personnel, a number of password protected security leve ls have been implemented.

Several pressure/flow rate sensors are installed, which safely automatically shut down the system and open the bypass in case of leakage. Likewise, the system is automatically shut down in a safe manner and the bypass opened if the hydrogen gas concentration measured in the de-aeration pipe after the EctoSys ® cell exceeds 2 Vol. %. For further information please see the application
dossier in confidential Appendix A. The comprehensive co ntrol philosophy of the CleanBallast is described in confidential Appendi x D in the application dossier.

1.3 Contents of the application for Final Approval

The application for Final Approval consists of two parts: the non-confidential application document, which contains a summary of results a nd conclusions of the complete dossier and is also submitted by the Member directly to the MEPC, as well as the confidential part of the application dossier, which include s additional information such as complete test reports and references. Besides covering the requirements of Procedure (G9), the dossier also includes data, justifications and answers to the questions raised by the GESAMP-BWWG in the review (MEPC 57/2, annex 6) of previous application of Final Approval (MEPC 57/2/3). The summary document has, to the widest extent possible, been arranged according to the “Methodology for information gathering and the conduct of work of GESAMP-BWWG” (MEPC 58/2/7, annex 4) regarding paragraph referen ces in order to simplify the review by the GESAMP-BWWG.MEPC 59/2
ANNEX Page 6

I:\MEPC\59\2.doc The confidential part of the dossier includes:

Appendix A: Manual of the CleanBallast system Appendix B: Process diagram of the CleanBallast system Appendix C: Detailed description of the Algae Monitor

- Functional description of the Algae Monitor - Patent description of the Algae Monitor

- Certificate on Environmental Testin g of the Algae Monitor according to Guidelines (G8), Part 3

Appendix D: Description of the control ph ilosophy of the CleanBallast system Appendix E: Quality Assurance Project Pl an (QAPP) of test facility NIVA Appendix F: Report on the tes ting for Final Approval by NIVA Appendix G. Data set on land-based type approval testing in fresh water

- Physical and chemical parameters

- TRO concentrations

- Concentrations of di sinfection by-products - Results of aquatic toxicity testing

Appendix H: Data on hydrogen and oxygen gas c oncentrations from CleanBallasts’ data recording system (according to Guidelines (G8), paragraph 4.1.3) Appendix I: Data on long-term corrosion tests

- Certificate on compatibility of the CleanBallast system with epoxy-based ballast water tank coating systems issued by the Germanischer Lloyd - Technical Report “Testing of the infl uence of CleanBallast on coated and uncoated steel” by Germanischer Lloyd - Full corrosion test report by a pproved corrosion test institute

Appendix J: Discharge modelling Appendix K: Human Exposure Scenario (HES) Appendix L: Key Data Summaries Appendix M: Substance Data and Fate Properties of Active Substances and Relevant Chemicals Appendix N: Data on an optional neutralization system. Included as a contingency measure in case the TRO discharge concentration exceeds the allowable concentration Appendix O: LiteratureMEPC 59/2
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I:\MEPC\59\2.doc 2 GENERAL

2.1 Response to the recommendations made by the GESAMP-BWWG at its fourth meeting (MEPC 57/2, annex 6)

2.1.1 MEPC 57/2, annex 6, paragraph 9.4. 2: Ac tive Substances and Relevant Chemicals

The Group noted that the proposed system tr eat the ballast wate r both on uptake and at discharge. The use of a secondary treatment at discharge is to address any potential for re-growth of organisms in the ballast tank. At upt ake the ballast water is filtered and then treated by electrolysis directly in the ballast water pipe. At discharge the ballast water is treated by electrolysis only. Chemicals are not required to be stored on board. However, it was noted that, e.g., Hydroxyl radicals, Chlorine gas and Hy drogen gas are produced and should be regarded
as Active Substances and Relevant Chemicals. In addition a number of Disinfection By-Products (DPB) were identified by the Applicant and should be regarded as Relevant chemicals.

Response:

All Active Substances and Relevant Chemicals including brominated DBPs (Disinfection By-Products) are identified by th is application, and have been quantitatively analysed in whole-effluent samples of treated water of several qualities (e.g., fresh, brackish and full salinity). Please refer to s ection 6.2 of this document.

2.1.2 MEPC 57/2, annex 6, paragraph 9.4.3: Maximu m Allowable Discharge Concentration

The required concentrations of Active Substances in seawater, measured as Total Residual Oxidants, are given by the submission as maximu m 2 mg/L. The Group noted that no such levels were given for fresh water. Therefore, the Group considers the concentration of 2 mg/L as both the Maximum Dosage and the Maximum Allowabl e Discharge Concentr ation according to the G9-evaluation, respectively.

Response:

In freshwater (< 3 psu), e.g., river water and lake harbours, the only Active Substance formed by the EctoSys ® is the hydroxyl radical (compare equation (1)). Because of the extremely short life time of approximately 10 -9 s which is equivalent to a distan ce of less than 1 nanometre (< 10 -9 m) at the designed flow rate of 500 m3/h hydroxyl radicals will evidently not be released from the EctoSys ® cell to the water flow. Particularly due to their extremely short lifetimem hydroxyl
radicals are not residual a nd therefore give no response to the common DPD-method for measuring Total Residual Oxidants. Consequen tly, no TRO concentrations additional to the background level (section 1.2.3) can be detected in case of CleanBallast trea tment of fresh water.
As shown in section 6.2 as well as in Appendix G of the application dossier,
the TRO concentrations in fresh water of the tr eated water are identical to the control and the
natural concentrations in the raw (untreated) water. Since hydroxyl radicals are the only Active Substances formed during fresh water treatment, the concentrations of disinfection by-products are close to the limits of quantific ation in fresh water (compare section 6.2.1.1 and full data in Appendix G of the confidentia l dossier). Consequently, terms such as Maximum Dosage and Maximum Allowable Di scharge Concentration concerning hydroxyl
radicals are not relevant in the case of CleanBallast operation in fresh water.MEPC 59/2
ANNEX Page 8

I:\MEPC\59\2.doc 2.1.3 MEPC 57/2, annex 6, paragraph 9.4.4: Risks to the safety of the ship

The Group noted that the Applicant had explained that high levels of disinfection by-products such as THM were due to the fact that the EctoSys ® system was run differently in the land-based tests than it will be in normal operation on board ships. The Group further considered that a full chemical characterization of water treated by the CleanBallast! system run in normal mode should be provided together with to xicity tests with the same water.

Response:

For the previous submission for Final Approval (MEPC 57/2/3) in summer 2007, the CleanBallast system was operated taking a wo rst case approach, i.e. the maximum current was applied to the electrodes, consequently generating concentra tions close to the maximum TRO limit of 2 mg/L in marine waters at all times. This was done both at ballasting and at deballasting treatment in order to allow a worst case approach in the subsequent risk assessment. This procedure was applied regardle ss of an actual need for such high maximum concentration to achieve the biological efficiency defined by Guidelines (G8).

In this new application, the CleanBallast system including the EctoSys ® electrolysis was run according to normal operation conditions, whereby the TRO concentration/ current applied at deballasting treatment is minimized by control, nevertheless fulfilling the performance criteria given by the Guidelines (G8). Ta bles in section 3.6 provide a full chemical characterization of water treated by the CleanBallast system. The toxi city studies were done with the same water from full-scale land-based type approval testing. The summary results are presented in section 3.3 and the full study is reported in th e confidential Appendix F of the application
dossier. Concentrations of disi nfection by-products a nd aquatic toxicity are lower at normal operation of the CleanBallast presented in this do ssier compared to the worst case testing data submitted earlier (MEPC 57/2/3). The results of the toxicity tests are also in compliance with, or considerably lower, than results presen ted during the evaluation for Basic Approval (summarized in MEPC 55/2/4).

2.1.4 MEPC 57/2, annex 6, paragraph 9.4.5: TRO control scheme

The Group noted that no detailed information about the control system which could ensure that the maximum designed TRO-concentration is ma intained was included in the CleanBallast! system. However, the dossier indicated that an al gae monitor sensor is to be included in the industrialized version of the system installe d on board ships. This sensor was still under development and the Group therefore concludes that the control system wa s not fully developed and therefore not an integrated part of the system under evaluation by the Group.

Response:

The Maximum Dosage Concentration of 2 mg/L TR O in marine waters is ensured by restricting
the current distributed from the rectifier to the electrodes depending on the flow rate and conductivity. Thus, it is in no way linked to the function or operation of the Algae Monitor.

Furthermore, the recommendation of GE SAMP-BWWG on maintaining the maximum
TRO concentration was considered and an ad ditional TRO online sensor was included in the CleanBallast system for monitoring and co ntrolling the produced TRO concentration in
marine waters.MEPC 59/2
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I:\MEPC\59\2.doc Thus, the Algae Monitor is not used for the m easurement of the chemical properties of the effluent such as TRO levels. The Algae Monitor is used to conti nuously analyse the direct effect of the treatment on phytoplankton and, by a feedback loop to th e disinfection unit operation system (EctoSys ® ), to minimize the use of Active S ubstances at concentrations below the Maximum Dosage of 2 mg/L TRO. The Al gae Monitor is a mitigation measure for the second EctoSys ® treatment, reducing disinfection at de ballasting only to a level needed for achieving the G8 efficiency (please refer to sect ion 1.2.4 for control of th e CleanBallast system). As shown in section 6.2.2, the actually discharg ed TRO concentration is maximum 1.2 mg/L in seawater, below 0.5 mg/L in brackish water, and in fresh water no TRO additional to the background level is formed at the treatment during deballasting.

The function and features of the Algae Monitor are described in detail in Appendix C of the confidential part of the application dossier, and summarized in the appendix to this non-confidential document. The detailed control ph ilosophy of the CleanBallast system using the EctoSys ® disinfection step, verifying the Maximum Dosage Concentr ation of 2 mg/L TRO, is found in Appendix D of the confidentia l part of the application dossier.

2.1.5 MEPC 57/2, annex 6, paragraph 9.4.6: Recommendations for hydrogen and oxygen

measurements

The Applicant carried out hydrogen measurements in a full-scale system. The lowest explosion limit for hydrogen gas is 4% under standard co nditions. The highest measured value was 0.25%, which is 16 times below the explo sion limit. It is also noted t hat a de-aeration component has been added immediately following the electrolys is phase and that a hydrogen content monitor
has been included to monitor th e discharge from the de-aerati on pipe that will shut down the system should hydrogen concentrations at this point reach dangerous levels. The Group considers that the information provided together with the mitigation measures incorporated are acceptable in addressing this identified risk. The group recognized that the formation of oxygen in a full-scale test has not been investigated.

As well as in MEPC 57/2, annex 6, paragraph 9.4.10: recommendation concerning risk for the crew and ship:

The Group noted that the risk of explosion due to the generation of Hydrogen gas in the electrolysis process identified dur ing the assessment for Basic Appr oval of this system had been fully considered by the applicant. A de-aerator ha s been incorporated to the system that includes a hydrogen monitor in its vent arrangement that will shut down the system should dangerous level of hydrogen be detected as an additional risk mitigation measur e. The Group therefore considers that this risk has been adequat ely addressed and controlled by the applicant.MEPC 59/2
ANNEX Page 10

I:\MEPC\59\2.doc Response:

During normal operation of the CleanBallast system, the hydrogen gas measurements were repeated by an online gas analyser installed in the de-aeration pipe after the EctoSys ® electrolysis (for details see MEPC 57/2/3, paragraph 3.5.2.2.2 and Appendices A, B) as well as with a portable analyser at different locations, e.g., the storage tanks. All analysed hydrogen gas
concentrations were far below 0.25 Vol. %. Be sides the measurements of the dissolved oxygen concentration in water, an addi tional oxygen gas analyser was inst alled in the de-aeration pipe, likewise, in the testing for the Final Approval. A slight increase of the dissolved oxygen
concentration was measured in the effluent wate r of the CleanBallast system, which was in the range of the dissolved oxygen saturation concen tration (see section 6.2.3). In accordance with the still low dissolved oxygen concen tration, the measured oxygen gas concentrations were in the normal range of 20 Vol. % (for full data please see in the confidential part of the application dossier, Appendices F and H).

Together with the hydrogen gas formed as by-product, the by-produce d oxygen gas is also removed by the deaerator. In the above-mentioned shipboard installations th e de-aeration pipe is installed through the chimney directly to the ambi ent air well above the main deck or through the deck with the pipe ending well above the height of a human.

2.1.6 MEPC 57/2, annex 6, paragraph 9.4.7: Recommendations on corrosion testing

The Group noted that the long-term corrosi on testing that had been advised in the Basic Approval evaluation has not yet commenced.

As well as in MEPC 57/2, annex 6, paragraph 9.4.11: Recommendations on corrosion testing:

The Group noted that tests to determine the corro sive properties of the tr eated ballast water had yet to commence, and therefore th e level of the potential risk of accelerated corrosion to the ballast water piping and structure that may be ra ised by use of this system remains to be
assessed.

Response:

Comprehensive corrosion studies have been comme nced in co-operation w ith a leading European corrosion institute and under supervision of Germanischer Lloyd as the accredited quality controlling authority (please refe r to section 7.1.1). The result showed that the CleanBallast system does not have any negative influence on the tested coating systems, which are intended for the use in seawater ballast tanks on ships. Consequently, Germanischer Lloyd has issued the “Certificate on compatibility of the CleanBallast system with epoxy-based ballast water tank coating systems” for use on board ships. The certificate and tec hnical report issued by Germanischer Lloyd as well as the full report of the performing institute covering the test methodology, ISO standards used, raw data, etc ., can be found in the application dossier, confidential Appendix I.MEPC 59/2
ANNEX Page 11

I:\MEPC\59\2.doc 2.1.7 MEPC 57/2, annex 6, paragraph 9.4.8: Recomme ndations on chronic aquatic toxicity

The Group noted that chronic aquatic toxicity studies were not carrie d out in a land-based installation as required by the G9 guideline, but in a lab-based installation. The Applicant emphasizes that it is the TRO concentration which is relevant in relation to the toxicity of the
treated water and not the scale of the installation. The Group c onsiders both the level of TRO and organic matter essential for the quantity of halogenated by-products (DBP) and therefore also for the toxicity of the treated water. Toxi city tests with water samples from the land-based efficacy tests as required by the G8 and G9 guide lines will ensure that adequate levels of TRO and organic matter is used in all tests and the ch emical characterization of treated water.

Response:

Acute and chronic aquatic toxicity studies with six different species on three trophic levels and five phyla were carried out using water treated in the full-scale Clean Ballast system during land-based type approval testing at the test facility NIVA. The tests and equipment were fulfilling the criteria given by the Guidelines (G8), as required by Procedure (G9). Water quality also fulfilled the inlet criteria. The full-scale land-based CleanBallast unit was operated according to normal procedures, similar as on boar d a ship. The treatment efficiency fulfilled the
D-2 standard criteria.

A summary of the whole-efflue nt toxicity data including endpoints and other relevant
information can be found in section 3 of this docum ent. Chemical characterization of inlet water, treated water (including by-products, oxygen) can be found in section 6.2. The complete description and data-set of the toxicity studies and chemical characterization of the water can be found in the confidential part of the application dossier in A ppendices E and F, respectively.

2.1.8 MEPC 57/2, annex 6, paragraph 9.4.9: Human Exposure Scenario

The Group considered that Bromin ated DBPs (Disinfection By-Pr oducts) are the toxicological relevant compounds generated by the process. As th e applicant couldn’t provide information concerning the Human Exposure Scenario (3.9. MEPC 57/2/3), the Group noted that an adequate conclusion as to the outcome of the Hu man Risk Assessment c ould not be achieved. Therefore, the Group recommended that human exposure when handling ballast water treatment operations should be restri cted and RMM put in place.

Response:

Human Exposure Scenarios (HES) of Active Subs tances and Relevant Chemicals, including brominated disinfection by-produ cts, originating from treate d ballast water have been evaluated according to guidance given by the GESAMP-BWWG (MEPC 58/2/7, annex 4, paragraph 7.2.3) and elaborated from templates and principles used in the available TGD (Technical Guidance Document, issued by the EU Commission) as well as reflecting the recommendations given by the GESAMP-BWWG c oncerning HES (i.e. MEPC 58/2/7, annex 4, appendix 2). Occupational as well as exposures via the environment have been addressed. Inhalation, dermal route as well as oral route have been evaluate d. Please refer to the conclusion summaries in section 7.2.3 of this document, and more thoroughly the comprehensive study on HES in the confidential part of the applic ation dossier Appendix K, performed by external relevant expertise.MEPC 59/2
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I:\MEPC\59\2.doc During normal handling of ballast water operations on board the ship such as ballasting, ballast water storage and ballast water discharge, th ere is no dermal or oral exposure route
of Active Substances or Relevant Chemicals to the crew, due to the in situ production principle of EctoSys ® cell in the CleanBallast system directly in the main ballast pipe. The inhalation route has raised concern, since brominated and other disinfection by-products mi ght enter into the gas phase. Therefore, especial attention was taken to this potential risk when developing the HES. The HES concludes that the predicted concentr ation in the air for inhalation is far below existing OEL (occupational exposure limit) - values . Thus, no risk to the crew on the ships is expected. Also, as the predicted daily uptake cons idering all uptake routes simultaneously is far below existing TDI values, no risk to the public from the TRO, its degradation products or by-products is expected from the environment.

In case of damage to any equipment carrying trea ted ballast water (e.g., the ballast water piping), the CleanBallast system is automatically shut do wn. However, a leakage will provide a possible exposure route. The Maximum Dosage Concentrat ion of 2 mg/L Active Substances (MEPC 57/2, annex 6, paragraphs 0.3 and 9.4.3) will never be ex ceeded in any step of the process, thus the acute toxicity of treated water is evaluated to have no dermal effect on humans, should there be a direct exposure outside normal operation, i.e. leakag e. The exposure dose (l ow concentrations well below acute dermal toxicity levels, based on data provided by MSDS for each substance), duration and frequency of such events are asse ssed as neglectable to the risk assessment. For human exposure risk assessment at these c oncentrations of the Active Substances and
relevant concentrations of Relevant Chemical s, please refer to sec tion 7.2 of this document and Appendix K of the confidential part of the application dossier.

2.1.9 MEPC 57/2, annex 6, paragraph 9.4.12: Risk for the environment

Based on information provided in the applicat ion for Basic approval, a PEC/PNEC ratio of discharged ballast water in Rotterdam harbour can be calculated to 0.85. Based on this ratio the Group concludes that under the conditions of the test there would be low risk for the environment. For a final risk assessment to th e environment the Group needs, however, a better explanation of the presence and performance of the algae m onitor and inform ation on the validity and applicability of the model used. For reference reas ons also calculations with the MAMPEC-model are recommended using as many as possible the same parameter values. Under the assumptions of the applicant there s eems no risk for the environment but the Group needs more confidence in the applied tools and methods.

Response:

Meeting the recommendation by th e Group, the applicant has used MAMPEC (ver. 6) in addition to previous custom-made simulatio ns to assess conservative PEC TRO values for large commercial harbours comparable to Rotterd am. Using (as far as possible) the same input parameters (i.e. standard commercial harbour + EU OECD commercial harbour) as fo r previous evaluations, the PEC/PNEC ratios for TRO as derived by MAMPEC for discharge concentrations relevant for normal operation of the Clean Ballast operated in natural waters are <1. The risk characterization is further based on input parameters varying over the whole range from the unrealistically conservative default assumptions on, e.g., discharge quantities to a more balanced assessment of the discharge into the receiving environment. Please refer to se ction 6.3.3, where also a summary of PEC/PNEC ratios for Relevant Chemicals can be found.MEPC 59/2
ANNEX Page 13

I:\MEPC\59\2.doc In addition to calculatin g predicted steady-state concentra tions (using MAMP EC, see above), plume modelling has been adopted to examin e the acute exposure of receiving waters
to Active Substances and Relevant Chemicals. Properly defined real cas e harbours have been used in order to simplify future comparisons. Immediate exposure during discharge as well as
dilution/diffusion over time has been considere d. The results have been compared to the outcome of the acute toxicity studies, calcul ated NOEC of the most sensitive species and literature references (please refer to the summary in section 6.3 of this document and Appendix J of the application dossier).

3 APPLICATION DATA SET

3.1 General

3.1.1 The dossier contains the information sp ecified in Procedure (G9). In cases where information requested in accordance with Procedur e (G9) has not been submitted, it is either not applicable or a justification is provided.

3.1.2 For Active Substances and Relevant Ch emicals, data on physical, chemical and environmental fate properties have been includ ed, if applicable, and can be found in the form of Key Data Summaries in Appendix L of th e application dossier, or in report form
“Theoretical evaluation of the fate and effect of disinfecti on by-products” found in Appendix M.

3.1.3 Fate and effect evaluation on Active Substa nces and Relevant Ch emicals (G9: 5.3.1, including degradation, bioaccumulation, etc.) have been performed using theoretical methods and
literature. Justification for not testing each chemical is given by the nature of the disinfection process where the Active Substances and Relevant Chemicals are formed. The Active Substances and Relevant Chemicals are not dosed, but formed in situ in the ballast water by an electrochemical process. Furthermore, the form ed Active Substances and Relevant Chemicals (and their concentrations) are depending on the water quality (e.g., seawat er, brackish water or fresh water). Thus, fate (i.e. by-product formation) and effect studies (i .e. toxicity) directly testing whole-effluents of treated ballas t water of different origins, including
the 100% concentration in the dilu tion series, are more suitable.

3.1.4 Acute and chronic toxicity data have been provided for treated ballast water (G9: 5.2.2). The discharge toxicity tests include chronic test methods performed as part of the land-based type approval process with test specie s (fish, invertebrate, algae) that address the sensitive life stage (G9: 5.2.4). The results include acute LC50 valu es and chronic NOECs or similar endpoints, respectively (G9: 5.2.5). Dilution series including 100% concentrations of samples of ballast water discharge have been used (G9: 5.2.6). Acute toxicity data for brackish and fresh water have also been provided for treated ba llast water whole-effluent sample s taken at full-scale land-based type approval process tests whic h were performed at locations of real ballasting operation. Tests on additional taxonomic groups have been added, as requested by the GESAMP-BWWG (MEPC 58/2/7, annex 4).MEPC 59/2
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I:\MEPC\59\2.doc 3.2 Identification of the Substa nce or Preparation (G9: 4.1)

Active Substances used by the CleanBallast are solely formed in and by the electrochemical disinfection process. The disinfection unit operation is performed by the advanced electrochemical EctoSys ® technology, which received Basic Approval at MEPC 55 (MEPC 55/2/4). Active Substan ces were identified in documen t MEPC 55/2/4, paragraph 3, as
follows:

.1 Hydroxyl Radicals (OH·)

.2 Free Active Chlorine (HOCl/OCl - )

These Active Substances are primarily formed in the electrochemical disinfection process. Secondary by-products, degradatio n products, etc. (some of wh ich may have an oxidative “active” effect) are regarded as Relevant Chemicals as defined by paragraph 1.1.6 “Relevant Chemicals” of the Methodology which can be detected in discharged ballast water (or in the gas phase above the treated water) treated by the CleanBallast are:

.1 Free Active Bromine (HOBr/OBr - )

.2 Dibromochloromethane CHClBr 2 .3 Tribromomethane, Br 3 CH

.4 Dichloroacetic acid (DCAA)

.5 Trichloroacetic acid (TCAA)

.6 Dibromoacetic acid (DBAA)

.7 Bromochloroacetic acid (BCAA)

.8 1.2.3-trichloropropane

.9 Bromate

.10 Hydrogen

Other components such as by-products formed and chemical sum parameters that may be influenced by the CleanBallast disinfection process are:

.1 Oxygen

.2 AOX (Adsorbable organically bound halogens)

.3 EOX (Extractable organohalogen compounds)

3.2.1 Preparations: The CleanBallast system does not include the addition of any chemicals or chemical preparations. The Active Substances used by and Relevant Chemicals related to
the CleanBallast disinfec tion process are produced in situ from the components of natural waters and electrical direct current. Thus, Prep arations as defined by paragraph 1.1.3 of the Methodology are not relevant for the CleanBallast system or the application for Final Approval.MEPC 59/2
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I:\MEPC\59\2.doc 3.2.2 Active Substances:

3.2.2.1 Hydroxyl radical

Trade name N/A Chemical (IUPAC) name Hydroxyl radical
CAS number 3352-57-6 UN number/Proper shipping name N/A Molar mass (g/mol) 17.01 Empirical formula HO
Structural formula H*O Classification (UN GHS) N/A Purity/Identification of impurities N/A Stabilizers/Necessary additives N/A

3.2.2.2 Free Active Chlorine (OCl-/HOCl, in the form of sodium hypochlorite)Trade name Sodium hypochlorite

Chemical (IUPAC) name Sodium hypochlorite
CAS number 7681-52-9 UN number/Proper shipping name 1791 Molar mass (g/mol) 74,5 Empirical formula NaOCl
Structural formula

Purity/Identification of impurities N/A Stabilizers/Necessary additives N/AMEPC 59/2
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I:\MEPC\59\2.doc 3.2.3 Relevant Chemicals (G9: 2.1.4)

3.2.3.1 Free Active Bromine (OBr-/HOBr, in the form of Sodium hypobromite)

Chemical (IUPAC) name Sodium hypobromite
CAS number 7726-95-6 Molar mass (g/mol) 159.8 Empirical formula NaOBr
Structural formula

3.2.3.2 Dibromochloromethane

Chemical (IUPAC) name Dibromochloromethane
CAS number 124-48-1 Molar mass (g/mol) 208.3 Empirical formula CHClBr 2 Structural formula

3.2.3.3 Bromoform

Chemical (IUPAC) name Tribromomethane
CAS number 75-25-2 Molar mass (g/mol) 252.7 Empirical formula Br 3 CH
Structural formula

3.2.3.4 Dichloroacetic acid (DCAA)

Chemical (IUPAC) name Dichloroacetic acid
CAS number 79-43-6 Molar mass (g/mol) 128.9 Empirical formula CHCl 2 COOH
Structural formulaMEPC 59/2
ANNEX Page 17

I:\MEPC\59\2.doc 3.2.3.5 Trichloroacetic acid (TCAA)

Chemical (IUPAC) name Trichloroacetic acid
CAS number 76-03-9 Molar mass (g/mol) 163.4 Empirical formula CCl 3 COOH
Structural formula

3.2.3.6 Dibromoacetic acid (DBAA)

Chemical (IUPAC) name Dibromoacetic acid
CAS number 631-64-1 Molar mass (g/mol) 217.8 Empirical formula CHBr 2 COOH
Structural formula

3.2.3.7 Bromochloroacetic acid (BCAA)

Chemical (IUPAC) name Bromochloroacetic acid
CAS number 5589-96-8
Molar mass 173.39 Empirical formula CHBrClCOOH
Structural formula

3.2.3.8 1.2.3-Trichloropropane

Chemical (IUPAC) name 1.2.3-Trichloropropane
CAS number 96-18-4 Molar mass (g/mol) 147
Molecular formula C 3 H 5 Cl 3 Structural formula

3.2.3.9 Bromate (in the form of sodium bromate)

Chemical (IUPAC) name Sodium bromate
CAS number 7789-38-0 Molar mass (g/mol) 150.89
Molecular formula NaBrO 3 Structural formulaMEPC 59/2
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I:\MEPC\59\2.doc 3.2.3.10 Hydrogen (g)

Chemical (IUPAC) name Hydrogen
CAS number 1333-74-0 Molar mass (g/mol) 2.02
Molecular formula H 2 Structural formula H-H

The new measurements of hydrogen gas during the re peated land-based type approval testing at the test facility NIVA showed that all an alysed hydrogen gas con centrations were far below 0.25 Vol. % in the de-aeration pipe installed after the EctoSys ® disinfection as well as at different locations of the storag e tank (cf. NIVA report in Appendix F and data on hydrogen and oxygen gas concentrations from CleanBallasts’ data recording system (according to Guidelines (G8) in Appendix H).

3.2.4 Other chemicals

3.2.4.1 Oxygen

Oxygen (O 2 , gaseous) is formed as a by-product of the electrochemical process (MEPC 55/2/4, paragraph 4.3.2). The oxygen dissolves in the trea ted water until the dissolved oxygen saturation concentration is reached and surplus oxygen will leave the water in the form of gas via the deaerator. This is installed after the EctoSys ® disinfection and allows free gases to be removed after the CleanBallast system, leaving the ship via the de-aeration pipe to the atmosphere. By this measure, no hazards are posed to the crew, ship or environment. The changes in dissolved oxygen content of water treated by the CleanBalla st system have been analysed during the land-based type approval procedure as well as oxygen gas measured in the de-aeration pipe. These results can be found paragraphs 6.2.3.1 to 6.2.3.3 and in Appendix H of the application dossier. Due to the high natural occurrence of oxygen in natural waters and in the atmosphere/biosphere, the substance is not regard ed as a Relevant Chemical by the applicant.

3.2.4.2 AOX

AOX (Adsorbable Organic Halogen; also Total Organic Halogen TOX) is a sum parameter, which is widely used in waste water and envi ronmental analysis for the quantification of organically bound halogens. The AOX includes chlorinated and brom inated adsorbable organics, e.g., trihalomethanes (THM), which were analys ed separately as single compounds during the land-based type approval procedur e. While AOX concentration was al so analysed in addition to single disinfection by-products, the sum para meter AOX as such is not regarded as a Relevant Chemical by the applicant. The ma ximum AOX concentration after the deballasting treatment, with 0.07 mg/L (also se e section 6.2.1), was relatively lo w compared to concentrations between 0.02 - 0.28 mg/L TOX analysed in supp lied drinking water in the United States (Reemtsma and Jekel, 2002). These low AOX concen trations are in accord ance with previous results (see MEPC 57/2/3, Table 1).MEPC 59/2
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I:\MEPC\59\2.doc 3.2.4.3 EOX

Likewise, the EOX (Extractable Organic Halogen) is a sum parameter for the quantification of organically bound halogens, which can be extracted from solids. Ther efore, it is mostly used to characterize soil or seldom for particles in wa ter. Similar to AOX, the EOX concentration was analysed during the land-based type approval te sting and rather in a low concentration range (maximum 0.03 mg/L; see also section 6.2.1). Theref ore, the sum parameter EOX as such is not regarded as a Relevant Chem ical by the applicant.

3.3 Data on effects on aquatic plants, invert ebrates and fish, and other biota, including sensitive and representative organisms (G9: 4.2.1.1)

3.3.1 For every Active Substance and Relevant Ch emical data are presented and discussed either on the basis of toxicological tests (tre ated ballast water) or existing toxicological knowledge for separate Active Substa nces and Relevant Chemicals.

3.3.2 Acute aquatic toxicity

3.3.2.1 Short-term L(E)Cx from fr eshwater or saltwater repres entatives of three taxonomic groups (algae, crustaceans and fish ) representing three trophic leve ls are provided, if available.

3.3.2.2 In the case of whole effluent testing (paragraph 3.3.2.3.4 “Treated ballast water”) short-term methods deemed qualitatively equivalent to US EPA for estimating the acute toxicity
have been used.

3.3.2.3 Acute aquatic toxicity for Preparations, Active Substances, Relevant Chemicals and
treated ballast water.

3.3.2.3.1 Preparations is not an appli cable term to the CleanBallast process or the toxicity tests related hereto (paragraph 3.2.1).

3.3.2.3.2 Active Substances

Due to the nature of the electrochemical disi nfection process, indivi dual Active Substances cannot be separately obtained in order to perform toxicity studies. Acute t oxicities of individual substances have been reviewed using literature , and further used for PNEC evaluations. For Active Substances, data on individual acute toxi city is provided and evaluated for Free Active Chlorine. Please refer to the complete risk assessment previously submitted for Basic Approval, paragraphs 3.3.2.3.2.1 and 3.3.2.3.2.2 below and Appe ndix L of the application dossier.

3.3.2.3.2.1 Hydroxyl radical

Due to the nature of radical spec ies, toxicity studies cannot be performed specifically using such. The toxic effect caused by radical mediated oxidati on has been investigated and discussed in the submitted application dossier for Basic Approval and summarized in document MEPC 55/2/4, paragraph 5.1.1.3. Toxicity of sepa rate degradation and disinfec tion by-products generated by the electrochemical process is provide d in the Key Data Summaries in Appendix L, where such data
is available.MEPC 59/2
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I:\MEPC\59\2.doc 3.3.2.3.2.2 Free Active Chlorine

The toxicity of free active chlo rine (FAC) has been thoroughly in vestigated by many scientists over a long period of time. A vast number of species from > 3 taxonomic groups and many methods have been used. A comprehensive summ ary of the toxicity studies performed was compiled and presented in the submitted dossier for Basic Approval (MEPC 55/2/4, paragraph 5.2.9). A complete ri sk assessment on sodium hypochlor ite was also included in the submission. Toxicity of degradation and disinfection by-products generated by the electrochemical process is summ arized in further sections. Th e sodium hypochlorite PNEC for brackish water and seawater organisms was determined at 0.04 μ g FAC/L, including the safety factor of 50 (MEPC 55/2/4, paragraph 5.2.10). Also see Appendix M of the application dossier, the report “Theoretical evaluati on of the fate and effect of disinfection by-products” where almost the same PNEC value (0.06 μ g FAC/L) was derived based on available ecotoxicity data. The ecotoxicity data on most sensitive specie s selected for PNEC cal culation are summarized in Table 1 below. Acute aquatic toxicity data on most sensitive species from three taxonomic groups are summarized in th e key data summary sheet.

Table 1: Summary of ecotoxicity data se lected for the determination of the sodium hypochlorite PNEC for brackis h and seawater organism

Specie Endpoint Result Reference/Justification of missing data
Fish Leiostomus
xanthurus 96 h LC50 0.09 mg/L Bellanca & Bailey (1977)
Fish Oncorhynchus
kisutch 96 h LC50 0.032 mg/L Thatcher (1978)

Other Crassostrea virginica (Mollusc, Bivalve) 48 h EC50 0.026 mg/L Robert and Gleeson (1978)

Fish Menidia peninsulae 28 d NOEC 0.04 mg/L Goodman et al. (1983)

Other Crassostrea virginica (Mollusc, Bivalve) 15 d NOEC 0.007 mg/L (TRC) Liden et al. (1980)

Table 2: Acute toxicity data for s odium hypochlorite, three trophic levels

Specie Endpoint Result Reference/Justification of missing data
Fish Leiostomus
xanthurus 96 h LC50 0.09 mg/L Bellanca & Bailey (1977)
Crustacea Crangon nigricauda 96 h LC50 0.134 mg/L Thatcher (1978)

Algae Thalassiosira pseudonana 24 h LC50 0.075 mg/L Gentile (1976)MEPC 59/2
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I:\MEPC\59\2.doc 3.3.2.3.3 Relevant Chemicals

Due to the nature of the electrochemical disinf ection process, individual Relevant Chemicals cannot be separately produced in order to perfor m toxicity studies. Acute toxicity of individual
substances has been reviewed using literature, where avai lable, and can be found in the Key Data Summaries (Appendix L) and in Appendix M report “T heoretical evaluation of the fate and effect of disinfection by-products”. Th e data is further used for the PNECs derived in Appendix M of the application do ssier, the report “Theoretical ev aluation of the fate and effect of disinfection by-products”.

3.3.2.3.4 Treated ballast water (G9: 5.2.3)

In accordance with paragraph 5.2.1 of Procedure (G9) for Final Approval, the discharge testing has been performed as part of the land-based t ype approval process using the treated ballast water discharge. All toxi city data disclosed were obtained at land-based type approval test cycles meeting Ballast Water Performance Standard c oncerning biological e fficiency. Tests were
carried out with water from several consecutiv e cycles and the most conservative values are reported in the summary tables below.

3.3.2.3.4.1 Fresh water (0.4 psu)

Table 3: Acute aquatic acute toxicity in treated fresh water (cf. Appendix G)

Specie Endpoint Result Reference/Justification of missing data
Fish Danio rerio LC50 (ml/L) n.r. * DIN 38415-T6

Crustacea Daphnia magna EC50 (ml/L) n.r. * DIN 38412-L30

Algae Scenedesmus sp. EC50 (ml/L) n.r. * DIN 38412-L33

Other Vibrio fisheri (Microtox © ) EC50 (ml/L) n.r. * ISO 11348-2

* n.r. = not reached

3.3.2.3.4.2 Brackish water (22 psu)

Table 4: Acute aquatic acute toxicity in treated brackish water (cf. Appendix F)

Specie Endpoint Result Reference/Justification of missing data
Fish Scopthalmus

maximus LC50, % * >100 OECD 203

Crustacea Acartia tonsa LC50, % * >100 ISO 14669 Algae Skeletonema

costatum EC10, % *
EC50, % * 61
>100 ISO 10253

( * percentage of treated ballast water diluted in control water)MEPC 59/2
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I:\MEPC\59\2.doc 3.3.2.3.4.3 Sea water (32-35 psu)

Table 5: Acute aquatic acute toxicity in treated sea water (cf. Appendix F)

Specie Endpoint Result Reference/Justification of missing data
Fish Scopthalmus

maximus LC50, % * 74 OECD 203

Crustacea Acartia tonsa LC50, % * 60.5 ISO 14669 Algae Skeletonema

costatum EC10, % *
EC50, % * 14
19 ISO 10253

( * percentage of treated ballast water diluted in control water)

3.3.3 Chronic aquatic toxicity

3.3.3.1 Long-term NOECs or ECx from three fres hwater or saltwater species representing three trophic levels have been provided, if avai lable. Justifications for missing data have
been made.

3.3.3.2 In the case of whole effluent testing (paragraph 3.3.3.3.4 “Treated ballast water”) short-term methods deemed equivalent to US EPA for estimating the chronic toxicity are provided, since the identification of the sensitive sub-leth al endpoints and vulne rable life-stages is the ultimate aim of the long-term testing.

3.3.3.3 Chronic aquatic toxicity for Preparations , Active Substances, Re levant Chemicals and
Treated ballast water.

3.3.3.3.1 Preparations is not an appli cable term to the CleanBallast process or the toxicity tests related hereto (paragraph 3.2.1).

3.3.3.3.2 Active Substances

Due to the nature of the electrochemical disi nfection process, indivi dual Active Substances cannot be separately obtained in order to perform toxicity studies . Chronic toxicity of individual substances has been reviewed using literature.

3.3.3.3.2.1 Hydroxyl radical

Due to the nature of radical spec ies, toxicity studies cannot be pe rformed specifically using such. The toxic effect caused by radical mediated oxidati on has been investigated and discussed in the submitted application dossier for Basic Approval and summarized in document, MEPC 55/2/4, paragraph 5.1.1.3. Toxicities of degradation a nd disinfection by-products generated by the electrochemical process are summarized in further sections.MEPC 59/2
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I:\MEPC\59\2.doc 3.3.3.3.2.2 Free Active Chlorine (HOCl/ OCl - , in the form of sodium hypochlorite)

Table 6: Chronic aquatic acute toxicity for sodium hypochlorite

Species NOEC (mg/ L/duration) Reference/Comments/ Justification for missing data

Fish Menidia peninsulae 0.04 (28d NOEC) Goodman et al. (1983)

Crustacea Crassostrea virginica 0.11 (60d NOEC) Scott et al. (1979)

Algae N/A N/A Supportive information on long-term algae toxicity studies
can be found in MEPC 55/2/4
reference

3.3.3.3.3 Relevant Chemicals

Due to the nature of the electrochemical disinf ection process, individual Relevant Chemicals cannot be separately produced in order to perfor m toxicity studies. Chroni c toxicity of individual
substances has been reviewed using literature, where avai lable, and can be found in the Key Data Summaries (Appendix L) and in Appendix M report “T heoretical evaluation of the fate and effect of disinfection by-products”. Th e data is further used for the PNECs derived in Appendix M of the application dossier, report “The oretical evaluation of the fate and effect of disinfection by-products”.

3.3.3.3.4 Treated ballast water (G9: 5.2.3)

In accordance with paragraph 5.2.1 of Procedure (G9) for Final Approval, the discharge testing has been performed as part of the land-based t ype approval process using the treated ballast water discharge. All toxicity data di sclosed are obtained at land-base d type approval test cycles meeting Ballast Water Performance Standard con cerning efficiency. Tests were carried out with water from several consecutive cycles and the mo st conservative values are disclosed in the summary tables below.

Chronic toxicity in treated fresh water was not ev aluated due to the results of the acute tests and in view of the fact that no poten tially toxic Active Substances need to be expected , and only very low concentrations of disinfection by-products (clo se to the limit of quantif ication) were detected in fresh water (compare to section 6.2.1.1).MEPC 59/2
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I:\MEPC\59\2.doc 3.3.3.3.4.1 Brackish water (22 psu)

Table 7: Chronic aquatic toxicity in treated brackish water (cf. Appendix F)

Specie Endpoint Result Reference/Justification of missing data
Fish Scopthalmus

maximus NOEC, % 56 OECD 215

Crustacea Nitocra spinipes NOEC, % >32 * Danish standard reproduction test Algae Skeletonema

costatum EC10, % *
EC50, % * 61
> 100 ISO 10253

Other Brachionus plicatilis EC50, % NOEC, % > 100
> 100 ISO/DC 20666
Chronic rotifer test

* Highest tested concentration was 32%

3.3.3.3.4.2 Sea water (32-35 psu)

Table 8: Chronic aquatic toxicity in treated sea water (cf. Appendix F)

Specie Endpoint Result Reference/Justification of missing data
Fish Scopthalmus

maximus NOEC, % 56 OECD 215

Crustacea Nitocra spinipes NOEC, % >32 * Danish standard reproduction test Algae Skeletonema

costatum EC10, % *
EC50, % * 14
19 ISO 10253

Other Crassostrea gigas

Brachionus plicatilis LC50, % NOEC, % EC50, % NOEC, % 62
46
> 100
56 ASTM E724 Chronic oyster embryo test
ISO/DC 20666
Chronic rotifer test

* Highest tested concentration was 32%

3.3.4 Endocrine disruption

3.3.4.1 There are no indications, e.g., from the stru cture of the substance or results of other available studies that any of Active Substances or Releva nt Chemicals causes endocrine disruption. None are found listed as endocrine disruptors (US EPA EDSP, Danish EPA, EU Priority list).

3.3.5 Sediment toxicity

3.3.5.1 Active Substances and Relevant Chemical s have been assessed for persistence in natural waters and concerning accumulation potential in sediments. All substances have log Kow values < 3 and thus very low accu mulation potential in sediments.MEPC 59/2
ANNEX Page 25

I:\MEPC\59\2.doc 3.3.6 Bioavailability/biomagnification/bioconcentration

3.3.6.1 Reviewing log Pow values for Active Subs tances and Relevant Chemicals, it is concluded that the bioaccumulation poten tial should be considered very low.

3.3.7 Food web/population effects

3.3.7.1 Biomagnification and persistence in the food web is not considered as a potential risk
based on the results from a quatic toxicity testing, low PE C values, mammalian toxicity evaluation and bioaccumulation and biodegradation data.

3.3.7.2 Secondary poisoning from Active Substances and Relevant Chemicals are considered of no concern based on the very low bioaccumulation potential.

3.4 Data on mammalian toxicity (G9: 4.2.1.2)

3.4.1 General

Mammalian toxicity studies have not been performed separately for Active Substances or Relevant Chemicals formed during or after a pplication of the CleanBallast system. Testing
with vertebrate animals should be avoided if other type of informa tion is available that allows an
assessment of hazards and risks to humans. Te sting the Active Substances hydroxyl radical for mammalian toxicity is not feasible due to its short lif etime (half-life = approx. 10 -9 sec) and a high reactivity. For details, please refer to the section on biological impact of radical species submitted for Basic Approval, summarized in document MEPC 55/2/4, paragraph 5.1.1.3. Free Active Chlorine, also defined as an Active S ubstance in marine waters , has been extensively studied for mammalian toxicity, due to its wide use and many applications in the industry. The worst-case maximum concentration (2 mg/L) fr om CleanBallast effluents in marine water is below the WHO Drinking Water Guideline Value (5 mg/L). In view of the rapid decay of FAC and TRO in natural waters (see paragraphs 6.2.2.1 to 6.2.2.3 and MEPC 55/2/4, paragraph 5.2.7),
the in situ generation of Active Substances in the ba llast water and the resulting worst-case maximum concentration of TRO (2 mg/L) in mari ne water the conduct of new animal toxicity
studies is not consider ed to be required. For explicit da ta, please refer to the separate comprehensive Risk Assessment for sodium h ypochlorite submitted for the Basic Approval.
The formation of detectable disinfection by-products, which are therefore identified as Relevant Chemicals, are in the range of in ternationally recognized drinking water guidelines and are thus not considered justifying the c onduct of separate tests for mammalian toxicity. For explicit data (where available) please re fer to the MSDSs for each Relevant Chemical provided in Appendix M of the application dossier.

3.5 Data on environmental fate and effect under aerobic and anaerobic conditions (G9: 4.2.1.3)

3.5.1 General

Data on the rate and r oute of abiotic and/or biotic degr adation of the Active Substances and Relevant Chemicals have been retrieved (G 9: 5.3.4). Please refer to the evaluation reported in Appendix M of the application dossier, “Theor etical evaluation of the fate and effect of disinfection by-products”. Half-lifes of Active S ubstances and Relevant Chemicals have been assessed conservatively being in the order of na noseconds up to two years depending on the
substance.MEPC 59/2
ANNEX Page 26

I:\MEPC\59\2.doc 3.5.2 Biodegradability

The Active Substances are assessed for biodegr adability (Appendix M, report: “Theoretical
evaluation of the fate and effect of disinfection by-products”).

3.5.3 Bioaccumulation, partition coefficient, octanol/water partition coefficient

Partition coefficient, octanol/water par tition coefficients have been assessed
for Active Substances and Relevant Chemicals. Part ition coefficients were used in the evaluation of environmental fate. A summary of fate propert ies used, including partition coefficients, can be found in Appendix M, report “Theor etical evaluation of the fate and effect of disinfection by-products”, Table 2.2.

3.5.4 Reaction with organic matter

The reaction of the Active Subs tances produced by the electrochemical process with organic matter has been addressed by identifying main reac tion routes, so as to identify if products of
concern to the environment would form. Please re fer to Appendix M of th e application dossier.

3.5.5 Potential residues in seafood

Potential risks arising from residues of the Ac tive Substances or Relevant Chemicals ending up in seafood have been evaluated within the HES, please refer to Appendix K of the application dossier. It was concluded that impact on, e .g., consumer safety need not be expected.

3.5.6 Any known interactive effects

No knowledge on interactive effects of the Active Substances or Relevant Chemicals associated with CleanBallast system can be reported.

3.6 Physical and chemical properties for th e Active Substances, Relevant Chemicals and treated ballast water (G9: 4.2.1.4)

3.6.1 Data on physical and chemical properties ar e retrieved, if appli cable, and submitted for
the Active Substances and Relevant Chemicals to allow for the identification of hazards to the crew, the ship and the environment. Such data are submitted for each substance in the form of key summary sheets, and repo rt tables including source material in Appendices L (Key Data Summaries) and M (Substance Data and Fate Properties of Active Substances and Relevant Chemicals). “Preparations” is not an applicable term for the use of the CleanBallast system (section 3.2.1). Physical and chemical para meters of treated balla st water of different salinities used in the land-based type approval process are provided together with the quantification of formed Active Substances a nd Relevant Chemicals (T ables 9, 10 and 11). Reactivity towards container material has been assessed in an extensive corrosion study, please refer to Appendix I.MEPC 59/2
ANNEX Page 27

I:\MEPC\59\2.doc 3.6.2 The summarized physical and chemi cal properties on Ac tive Substances
and Relevant Chemicals can be found in the ke y data summary sheets provided in Appendix L of the application dossier and in clude (where applicable):

.1 melting point

.2 boiling point

.3 flammability (flash point)

.4 density (relative density)

.5 vapour pressure, vapour density

.6 water solubility/dissociation constant

.7 oxidation/reduction potential

.8 corrosivity

.9 auto-ignition temperature

.10 explosive properties

.11 oxidizing properties

.12 surface tension

.13 viscosity

3.6.3 The summarized physical and chemical properti es on treated ballast wa ter can be found in the following paragraphs and include:

.1 pH

.2 salinity

.3 TOC

.4 DOC

.5 POC

3.6.3.1 Physical and chemical properties of fresh water used in the full- scale land-based type approval tests.MEPC 59/2
ANNEX Page 28

I:\MEPC\59\2.doc Table 9: Physical and chemical propertie s of treated fresh water and control from in the full-scale land-based type approval tests

Parameter Unit Method Mean Raw

Water 6 7 8 9 10 Mean 6-10 6 7 8 9 10 Mean 6-10

Temperature °C instrument manual 18.2 21.5 16.5 18.0 19.4 15.1 18.1 19.6 17.6 20.0 19.6 16.5 18.7

pH-value

- DIN 38404-C 5 1984

- 01 ( A ) * 7.45 7.26 7.41 7.19 7.33 7.21 7.28 7.29 7.30 7.13 7.30 7.11 7.23

Practical salinity

units psu DIN EN 27888 (C8) 1993-11(A)* 0.4 0.5 0.4 0.4 0.4 0.4 0.4 0.6 0.5 0.4 0.4 0.4 0.5

Total Suspended

Solids (TSS) mg/L

C DIN 38409-H2 1987- 03(A)* 71 11 5 9 5 9 8 12 8 13 7 16 11

Total Organic Carbon (TOC) mg/L

C DIN EN 1484 (H3)1997-08(A)* 87.8 7.8 3.9 5.4 6.2 7.6 6.2 6.7 5.1 9.3 6.8 9.4 7.5

Dissolved Organic

Carbon (DOC) mg/L

C DIN EN 1484 (H3)1997-08(A)* 50.9 5.6 3.0 5.0 5.4 7.2 5.3 4.1 3.2 5.9 4.8 9.1 5.4

Particular Organic

Carbon (POC) mg/L

C DIN EN 1484 (H3)1997-08(A)* 36.9 2.1 0.8 0.3 0.8 0.4 0.9 2.6 2.0 3.4 2.0 0.3 2.0 Effluent treatment deballasting Effluent control deballasting

LBTA cycle

For further physical and chemical parameters ex tensively analysed during the land-based type approval please also see Appendix G.

3.6.3.2 Physical and chemical properties of brackis h water used in the full-scale land-based type approval tests.

Table 10: Physical and chemical propert ies of treated brackish water and control from in the full-scale land-based type approval tests

Parameter Unit 6 7 8 9 10 Mean 6-10 6 7 8 9 10 Mean 6-10

Temperature oC Instrument manual 10.9 10.3 10.9 10.1 9.4 9.5 10.0 10.2 10.9 11.5 10.3 9.4 10.5
pH - Instrument manual 8.1 7.8 7.7 7.6 7.8 7.7 7.7 8.0 7.9 8.2 8.1 7.9 8.0
Salinity PSU Instrument manual 20.9 20.2 21.4 20.9 20.9 21.1 20.9 20.3 21.4 21.0 20.9 21.1 20.9

Total Suspended Solids (TSS) mg/L NIVA (method B1/2)

in accordance to NSEN 872 and NS 4733 60.7 20.2 24.3 25 15 13.2 19.6 9.3 18.3 12.7 10 13.3 12.7

Dissolved Organic Carbon (DOC) mg/L C Norwegian Standard NS-ISO 8245 (NIVA

method G5-3 ) 6.4 5.9 6 5.6 5.6 6.3 5.9 5.6 5.7 5.7 5.9 6.4 5.9

Particular Organic Carbon (POC) mg/L C NIVA (method G6) 7.5 1.2 1.4 1.4 1.0 0.9 1.2 0.9 1.2 1.1 1.3 1.4 1.2

Total Organic Carbon (TOC) mg/L C Norwegian Standard NS-ISO 8245 (NIVA

method G5-3 ) 13.9 7.1 7.4 7.0 6.6 7.2 7.1 6.5 6.9 6.8 7.2 7.8 7.0 Mean raw

water LBTA cycle Effluent treatment deballasting Effluent control deballasting

For further physical and chemical parameters an alysed during land-based type approval please also see Appendix F.MEPC 59/2
ANNEX Page 29

I:\MEPC\59\2.doc 3.6.3.3 Physical and chemical properties of seawat er used in the full-scale land-based type approval tests.

Table 11: Physical and chemical propertie s of treated seawater and control from in the full-scale land-based type approval tests

Parameter Unit Method 1a (12) 2 3 4 5 Mean 1a (12) 2 3 4 5 Mean Temperature oC Instrument manual 9.5 9.5 11.0 10.3 9.4 8.6 9.8 6.8 10.8 10.4 9.5 8.7 10.3 pH - Instrument manual 7.98 8.12 7.87 7.83 8.00 7.96 7.9 8.09 7.93 7.83 7.92 7.95 7.89 Salinity PSU Instrument manual 32.8 32.2 32.3 32.6 32.9 33.4 32. 8 32.2 32.5 32.6 32.9 33.0 32.8

Total Suspended Solids (TSS) mg/L C NIVA (method B1/2)

in accordance to NSEN 872 and NS 4733 14.2 7.40 5.5 5.5 8.9 10.60 7 .6 6.10 5.6 5.4 7.2 6.7 6.225

Dissolved Organic

Carbon (DOC) mg/L C Norwegian Standard NS-ISO 8245 (NIVA method G5-3) 2.36 2.50 3.3 3.3 2.7 2.50 3 .0 2.10 2.2 2.8 2 1.9 2.2

Particular Organic

Carbon ( POC ) mg/L C NIVA (method G6) 2.28 0.90 0.7 0 .7 0.7 0.70 0.7 0.60 0.7 0 0.7 0.7 0.5

Total Or g anic

Carbon (TOC) mg/L C Norwegian Standard NS-ISO 8245 (NIVA method G5-3) 4.6 3.4 4 4 3.4 3.2 3.7 2.7 2.9 2.8 2.7 2.6 2.8 Mean

Raw LBTA cycle Effluent treatment deballasting Effluent control deballasting

For further physical and chemical parameters an alysed during land-based type approval, please also see Appendix F.

3.7 Analytical methods at environmentally rele vant concentrations (G9: 4.2.1.5) are provided. See also separate reports of respective perf orming institute in Appendices F and G.

4 USE OF THE ACTIVE SUBSTA NCE OR THE PREPARATION

4.1 The application technique

4.1.1 Active Substances are applied by an elect rochemical disinfection process, whereby Active Substances are produced in situ from electrical current an d the components of natural waters. Disinfection is achieved by multiple mechanisms, including also direct oxidation, which will differ for different salinities. Concerning TRO, the Maximum Allowable Discharge/Dosage
Concentrations for marine waters should be 2 mg/L as recommended by the GESAMP-BWWG. The terms “Required dosage” and “retention time” (G9: 4.2.6) are not applicable. As discussed previously, no Maximum Allowabl e Discharge/Dosage Concentrations for the Active Substance hydroxyl radical can be given for freshwater becau se this specie is not discharged to the environment due to its extremely short half-life (s ee section 2.1.2).

5 MATERIAL SAFETY DAT A SHEETS (G9: 4.2.7)

5.1 The term Preparation is not applicable to the CleanBallast system (paragraph 3.2.1) and MSDS can consequently not be provided acco rding to Procedure (G9), paragraph 6.3.2.

5.2 MSDSs are submitted for Active Substances a nd Relevant Chemicals. These can be found in Appendix M.MEPC 59/2
ANNEX Page 30

I:\MEPC\59\2.doc 6 RISK CHARACTERIZATION

6.1 Screening for persistence, bioaccu mulation and toxicity (G9: 5.1)

6.1.1 Persistence (G9: 5.1.1.1)

None of Active Substances is considered to fulfil the persistence criteria. Some Relevant Chemicals (1.2.3-Tr ichloropropane, bromate, trichl oroacetic acid) are considered to fulfil the persistence criteria due to their predicted overall half-life >60 days, see further Appendix M, the report “Theoretical eval uation of the fate and effect of disinfection by-products”, Table 2.2.

6.1.2 Bioaccumulation (G9: 5.1.1.2)

The assessment of the bioaccumulation potential cons idering log Pow values did not give rise to any concern, thus the bioaccumulation criter ia is not met by any Active Substances
or Relevant Chemicals.

6.1.3 Toxicity tests (G9: 5.1.2.3)

Acute and/or chronic ecotoxicity data coveri ng the sensitive life stages was used for the assessment of the toxicity criteri on. The toxicity criteri on consequently was not considered to be met by Active Substances and Relevant Chemicals.

6.1.4 Consequently, none of Active Substanc e or Relevant Chemicals related to the CleanBallast treatment of different water qualities meets all three criteria for PBT (Procedure (G9), Table 1).

6.2 Evaluation of the treated ballast water (G9: 5.2)

6.2.1 Toxicity tests and chemical analysis wi th samples of ballast water treated with the CleanBallast system from the land-based test set-up were done (G9: 5.2.1.2 and 5.2.3), the test fully meeting the requirements of G8. Toxici ty results are summarized in section 3.3; also see Appendix F for the full results in brackish and seawater. For summaries of disinfection by-products formed in different water qualities, see paragraphs 6.2.1.1 to 6.2.1.3

In order to study the TRO decay in the effluent of the CleanBallast system after the second deballasting treatment, samples from the effluent were taken at all three salinities and stored in the dark. Sub-samples were analysed for TRO after different storage times. These samples represent the water before discharge to a nd before dilution in the receiving water.

Disinfection by-products as Relevant Chemicals were analysed for te st cycles in samples from all three salinities. Furthermore, chemical fate analysis was carried ou t for the disinfection by-products formed in brackish water and seawat er (see Appendix F). For the latter, different sub-samples of the stored efflue nt after the deballasting treatment were taken in one test cycle and the reaction was stopped by dosing sodium thio sulphate to each sample after different storage times (see Appendix E, paragraph 4.7), which allows to reco rd the disinfection by-product concentration over the time after the deballasting treatment.MEPC 59/2
ANNEX Page 31

I:\MEPC\59\2.doc Furthermore, the by-product oxygen was measured as dissolved oxygen concentration in the water during ballasting and deba llasting treatment as well as in the control. As given by the Henry-coefficient the dissolved oxygen concentra tion in the water is in equilibrium with the oxygen gas concentration. In addition to the meas urement of the dissolved oxygen concentration, the oxygen gas concentration was measured in the de-aeration pipe after the gas trap, which is installed after the EctoSys ® cell to remove free gases formed by the electrochemical process.
In accordance with the still low dissolved oxygen concentration (ple ase see below), the measured oxygen gas concentrations were in the normal range of 20 Vol. % (for full gas concentration data please see Appendix H).

6.2.1.1 Active Substances and Relevant Chemicals formed in fresh water

Table 12: Active Substances and Relevant Chem icals formed in fresh water (cf. Appendix G)

Parameter Unit DL Effluent treatment Effluent control WHO Method

Trichloromethane

Cl 3 CH μg/L 0.3 0.38 (<0.3-0.7) 0.32 (<0.3-0.40) 300 DIN EN ISO 10301 (F4) 1997-08

Dichlorobromomethane

CHBrCl 2 μg/L 0.1 0.38 (0.2-0.6) <0.1 (<0.1-<0.1) 60 DIN EN ISO 10301 (F4) 1997-08

Dibromochloromethane

CHClBr 2 μg/L 0.1 0.82 (0.3-1.10) <0.1 (<0.1-<0.1) 100 DIN EN ISO 10301 (F4) 1997-08

Tribromomethane

Br 3 CH μg/L 0.1 1.44 (0.44-3.40) <0.1 (<0.1-<0.1) 100 DIN EN ISO 10301 (F4) 1997-08

Sum THM μg/L 3.02 (0.9-5.8) 560 DIN EN ISO 10301 ( F4 ) 1997-08

Monochloroacetic acid ( MCAA ) μg/L 0.1 0.21 (<0.1-0.38) <0.1 (<0.1-<0.1) 20 DIN 38407-25-F25

Dichloroacetic acid ( DCAA ) μg/L 0.1 0.87 (0.46-1.40) 0.14 (<0.1-0.28) 50 DIN 38407-25-F25

Trichloroacetic acid ( TCAA ) μg/L 0.05 0.5 (<0.05-2.00) 0.08 (<0.05-

0.23 ) 200 DIN 38407-25-F25

Monobromoacetic acid ( MBAA ) μg/L 0.1 0.15 (<0.1.-0.22) <0.1 (<0.1-<0.1) DIN 38407-25-F25

Dibromoacetic acid ( DBAA ) μg/L 0.1 1.28 (0.21-2.20) <0.1 (<0.1-<0.1) DIN 38407-25-F25

Bromochloroacetic acid ( BCAA ) μg/L 0.1 1.07 (0.50-1.6) <0.1 (<0.1-<0.1) DIN 38407-25-F25

Sum HAA μg/L 4.08 (1.42-7.8)

Bromate μg/L 1 2.6 (<1-4.4) <1 (<1-<1) 10 Laboratory method*

AOX mg/L

C 0.02 0.14 (0.04-0.2) 0.1 (0.03-0.15) DIN EN 1485 (H 14)

1996-11 ( A )
Mean TRO mg/L 0.22 0.12 Deballasting LBTA 6 - 10, 0.4 psu Mean concentration (Min - Max)

* Customized laboratory method (based on IC-ICP-MS technique) to avoid chloride interference in high salinity

water.

In compliance with the production of hydroxyl radicals specified as Active Substance the concentrations of disinfection by-products were very low; they were mostly close to the limit of quantification (LOQ) in fresh water treated by the CleanBallast system.MEPC 59/2
ANNEX Page 32

I:\MEPC\59\2.doc 6.2.1.2 Active Substances and Relevant Chem icals formed in brackish water:

Table 13: Active Substances and Relevant Chemi cals formed in brackish water (cf. Appendix F)

Parameter Unit LOQ Drinking

Water Limits

Mean 6-10 min max Mean 6-10 min max WHO Method

Trichloromethane

Cl3CH <0.50 <0.50 <0.50 <0.50 <0.50 <0.50 300 DIN EN ISO 10301-

F4:1997

Dichlorobromometh

ane CHBrCl2 <0.50 <0.50 <0.50 <0.50 <0.50 <0.50 60 DIN EN ISO 10301-

F4:1997

Dibromochlorometh

ane CHClBr2 6 3.5 7.7 <0.50 <0.50 <0.50 100 DIN EN ISO 10301-

F4:1997

Tribromomethane

Br3CH 147 96 240 1.05 <0.5 1.4 100 DIN EN ISO 10301-

F4:1997

SUM THM <155 <100 <249 <6 <2.0 <2.9 560 DIN EN ISO 10301-

F4:1997

Monochloroacetic acid (MCAA) <0.50 <0.50 <0.50 <0.50 <0.50 <0.50 20 ISO 23631 (2006)- Water quality

Dichloroacetic acid (DCAA) <0.30 <0.30 <0.30 <0.30 <0.30 <0.30 50 ISO 23631 (2006)- Water quality

Trichloroacetic acid (TCAA) <0.20 <0.20 <0.20 <0.20 <0.20 <0.20 200 ISO 23631 (2006)- Water quality

Monobromoacetic acid (MBAA) <0.20 <0.20 <0.20 <0.20 <0.20 <0.20 ISO 23631 (2006)- Water quality

Dibromoacetic acid (DBAA) 22 2.2 120 <0.47 <0.10 1.7 ISO 23631 (2006)- Water quality

Bromochloroacetic acid (BCAA) <0.6 <0.10 1.1 <0.10 <0.10 <0.10 ISO 23631 (2006)- Water quality

SUM HAA <8.8 <6.2 <19.3 <1.74 <1.4 <3.0 ISO 23631 (2006)- Water quality Bromate (BrO3) μg/L 1.0 26 24 29 <1.0 <1.0 <1.0 10 Laboratory method*

AOX 0.06 0.03 0.07 <0.010 <0.01 <0.01 DIN EN ISO

9562:2004

EOX 0.01 0.01 0.015 <0.010 <0.01 <0.01 DIN 38409-H8:1984

Mean TRO mg/L

Cl2 0.40 0.39 0.42 0.06 0.01 0.12 DPD-method (American Public Health Association, 1989) Test Cycle 6 -10 Salinity <22 psu

μg/L

μg/L 0.1-0.5 0.5

mg/L 0.01 Effluent control deballasting Effluent treatment deballasting

* Customized laboratory method (based on IC-ICP-MS technique) to avoid chloride interference in high salinity water.

In the normal operation of the CleanBallast system the disinfection by-product concentrations are significantly lower than reported earlier for the worst-case operation in brackish water (compare to Table 1 in MEPC 57/2).

The drinking water standard limits of the Wo rld Health Organization (WHO) is provided for comparison to existing guidelines. However th e relevance of drinking water standards to concentrations in treated ballast water, which as such is not used for drinking purposes but is discharged to the environment, can be discussed. In cases where the maximum detected level
of DBPs exceeds the WHO Drinki ng Water Standard (as well as for all detected disinfection by-products), attention has been taken in the fo rm of developing Human Exposure Scenarios and evaluating the environmental risk using PEC/PNEC ratios. Please refer to Appendix M, report
“Theoretical evaluation of the fate a nd effect of disinf ection by-products”.MEPC 59/2
ANNEX Page 33

I:\MEPC\59\2.doc 6.2.1.3 Active Substances and Relevant Chemicals formed in seawater

Table 14: Active Substances and Relevant Chem icals formed in seawater (cf. Appendix F)

Parameter Unit LOQ Drinking

Water

Limits

Mean 1a-5 Min Max Mean 1a-5 Min Max WHO Method

Trichloromethane

Cl3CH <0.50 <0.50 <0.50 <0.50 <0.50 <0.50 300 DIN EN ISO 10301-

F4:1997

Dichlorobromometh

ane CHBrCl2 <0.50 <0.50 <0.50 <0.50 <0.50 <0.50 60 DIN EN ISO 10301-

F4:1997

Dibromochlorometh

ane CHClBr2 5.3 4.3 6.5 <0.50 <0.50 <0.50 100 DIN EN ISO 10301-

F4:1997

Tribromomethane

Br3CH 135 86 190 <1.43 <0.51 4.0 100 DIN EN ISO 10301-

F4:1997

SUM THM <141 <91.3 <197.5 <2.9 <2 <5.5 560 DIN EN ISO 10301-

F4:1997

Monochloroacetic acid (MCAA) <0.50 <0.50 <0.50 <0.50 <0.50 <0.50 20 ISO 23631 (2006)- Water quality

Dichloroacetic acid (DCAA) <0.30 <0.30 <0.30 <0.30 <0.30 <0.30 50 ISO 23631 (2006)- Water quality

Trichloroacetic acid (TCAA) <0.20 <0.20 <0.20 <0.20 <0.20 <0.20 200 ISO 23631 (2006)- Water quality

Monobromoacetic acid (MBAA) <0.20 <0.20 <0.20 <0.20 <0.20 <0.20 ISO 23631 (2006)- Water quality

Dibromoacetic acid (DBAA) 5.0 2.7 9.3 <0.22 <0.10 0.43 ISO 23631 (2006)- Water quality

Bromochloroacetic acid (BCAA) <0.17 <0.1 0.43 <0.10 <0.10 <0.10 ISO 23631 (2006)- Water quality

SUM HAA <6.4 <4 <10.9 <1.52 <1.4 <1.73 ISO 23631 (2006)- Water quality

Bromate (BrO3) μg/L 1.0 9.9 6.0 19.0 <1.0 <1.0 <1.0 10 Laboratory method*

AOX 0.05 <0.01 0.07 0.012 <0.01 0.02 DIN EN ISO

9562:2004

EOX 0.03 <0.01 0.06 <0.010 <0.01 <0.01 DIN 38409-H8:1984

Mean TRO mg/L

Cl2 1.10 0.84 1.47 0.08 0.01 0.18 DPD-method (American Public Health Association, 1989) mg/L 0.01 μg/L 0.1-0.5 Effluent treatment deballasting Effluent control deballasting

μg/L 0.5 Test Cycle 1a (12)-5 Salinity > 32 psu

* C us t o m i zed l a b o ra t o ry m e t hod ( b as e d on I C -I C P

- M S t ec h n i q u e) t o a vo i d c h l o r i de i n t e rf e rence i n h i g h sa li n it y
water.

6.2.2 The decay rate and degradation curve of TR O is different for diffe rent water qualities. TRO has a major impact on aquatic acute toxicit y. TRO decay curves from the land-based type approval tests from three different water quali ties are shown in paragraphs 6.2.2.1 to 6.2.2.3 after five days’ tank storage and deballasting treatment . During the previous ballasting treatment the highest mean TRO concentration of 1.90 ± 0.09 mg /L was determined for the test cycles in seawater by the TRO online measurement of th e CleanBallast system (cf. Control philosophy in Appendix D), which was recorded according to Guidelines (G8), paragraph 4.1.3 with data storage rate of 10 seconds. This mean concentr ation is slightly below the Maximum TRO Dosage Concentration of 2 mg/L in seawater at ballas ting treatment, which is limited due to the limited current applied to the EctoSys ® electrodes.MEPC 59/2
ANNEX Page 34

I:\MEPC\59\2.doc The relation (i.e. the ratio) between the differe nt Active Substances (i.e. hydroxyl radicals and TRO) formed in the EctoSys ® disinfection unit has a strong de pendency on the salinity of the
treated ballast water (see further MEPC 55/2/4, paragraph 4.3.2). The relative formation of hydroxyl radicals increases when the salinity decrea ses, while the formation of TRO is at the same time lowered. Reflecting this, the mean TRO concentration formed during ballasting treatment in brackish water was 1.16 mg/L (for all test cycles measured by the TRO online measurement) and thus lower compared to the test cycles carried out in full salinity seawater.

6.2.2.1 Decay curve of TRO in fresh water

TRO as Total Chlorine in treated fresh water and control

0 0.2 0.4 0.6 0.8

1 1.2 1.4 1.6 1.8

2

0 10 20 30 40 50 60 70 80

Minutes after deballastingTRO as Total Chlorine mg/L Cl2

Mean treated effluent

Mean Control

Figure 1: Decay curve of TRO in treated fresh water and control before discharge to receiving water (mean of five test cycles 1-6)

As described above, the only Active Substa nce is the hydroxyl ra dical formed by the CleanBallast system in fresh water, which gives no response to th e analysis of TRO in effluent water, since it will never exist outside the disinfection unit reaction zone. Considering
the standard deviations of the treated and control sample s, no differences between the TRO
concentrations of treated and control water can be stated. In both cases, the TRO concentrations are in the range of natu ral TRO concentrations of 0.1 - 0.3 mg /L TRO found at different locations (compare to section 1.2.3).MEPC 59/2
ANNEX Page 35

I:\MEPC\59\2.doc 6.2.2.2 Decay curve of TRO in brackish water

TRO as Total Chlorine in treated brackish water and control

0 0.2 0.4 0.6 0.8

1 1.2 1.4 1.6 1.8

2

0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 34 36 38 40 42 44 46 48 50
Hours after deballastingTRO as Total Chlorine mg/L Cl2

Mean treated effluent

Control

Figure 2: Decay curve of TRO in treated brackish water and control before discharge to receiving water (mean of five test cycles 6 to 10)

6.2.2.3 Decay curve of TRO in seawater

TRO as Total Chlorine in tr eated seawater and control

0 0.2 0.4 0.6 0.8

1 1.2 1.4 1.6 1.8

2

0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 34 36 38 40 42 44 46 48 50

Hours after deballastingTRO as Total Chlorine mg/L Cl2
Mean treated effluent

Control

Raw water

Figure 3: Decay curve of TRO in treate d seawater and control before discharge to receiving water (mean of five test cycles 1a (12)-5)MEPC 59/2
ANNEX Page 36

I:\MEPC\59\2.doc In seawater the mean discharge concentration is 1.04 ± 0.22 mg/L TRO as analysed by the test facility NIVA (cf. Appendix F). Compared to the TRO decay curve for brackish water in Figure 2, the high standard deviat ions of the TRO concentrations in the treated water at each sampling time is noticeable. Furthermore, the rather slow decay of TRO in Figure 3 is in contradiction to previously re ported results, where half-life of TRO was 30 min in a polluted harbour (compare to Figure 3 in MEPC 57/2/3).

Simultaneously to the manual TRO analysis show n in Figure 3, the TRO wa s measured online in the effluent of the CleanBallast system (cf. Control philosophy in Appe ndix D) and recorded according to Guidelines (G8), paragraph 4.1.3, wher eby a data storage rate of 10 seconds was used. For the five test cycles the mean TR O concentration after deballasting treatment was 0.88 ± 0.39 mg/L, thus in the mean lower than the discharge concentration mentioned above.

6.2.2.4 Holding time

Due to the direct formation of the disinfectants in situ , the EctoSys ® disinfection unit of the CleanBallast system provides an immediate disinfec tant effect based on the principles and mechanisms described in the app lication for Basic Appr oval (MEPC 55/2/4, pa ragraph 4.3), thus requiring no holding ti me. Furthermore, it operates also in fresh water wher e no residual oxidants (TRO) are formed, hence no residual effect is ob tained. Ballast water is treated by the EctoSys ® disinfection unit a second time directly before discharge. For these reasons, the determination of requested holding time of the treate d ballast water is not applicable.

6.2.3 Dissolved oxygen concentrations

6.2.3.1 Dissolved oxygen concentrations in fresh water

Table 15: Dissolved oxygen concentrations in fres h water (raw water, treated water and control) during ballasting and deballasting

Bremen 2007, 0.4 psu, mean LBTA 6-10 Ballasting Deballasting

20°C Raw water Treatment Control Treatment Control Dissolved oxygen mg/L 5.6 7.4 6.1 6.5 4.1

Only a slight increase of the dissolved oxygen co ncentration was measured in the effluent water of the CleanBallast system after ballasting and deballasting treatment. The slight increase in dissolved oxygen concentration, which is formed by the electrochemical EctoSys ® cell, is always below the dissolved oxygen satura tion concentration, which is 9 mg/L at 20°C and atmospheric pressure. At deballasting the dissolved oxygen c oncentration in the cont rol was significantly lower than in the original raw water and af ter the second treatment, due to the stronger microbiological activity consuming dissolved oxygen during the five days storage in the
control tank.MEPC 59/2
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I:\MEPC\59\2.doc 6.2.3.2 Dissolved oxygen concentr ations in brackish water

Table 16: Dissolved oxygen concentrations in brackish water (raw water, treated water and control) during balla sting and deballasting

NIVA 2008, 21 psu, mean LBTA 6-10 Ballasting Deballasting

10°C Raw water Treatment Control Treatment Control Dissolved oxygen mg/L 8.6 8.7 8.7 7.3 8.1

For comparison the dissolved oxygen saturation con centration is 9.9 mg/L at 10°C and atmospheric pressure.

6.2.3.3 Dissolved oxygen concen trations in seawater

Table 17: Dissolved oxygen concentrations in seawater (raw water, treated water and control) during balla sting and deballasting

NIVA 2008, 33 psu, mean LBTA 1 - 5 Ballasting Deballasting

10°C Raw water Treatment Control Treatment Control Dissolved oxygen mg/L 10.1 9.7 9.7 10.1 8.7

For comparison, the dissolved oxygen saturation con centration is 9.2 mg/L at 10°C and atmospheric pressure.

Concerning both brackish water (Table 16) a nd seawater results (Tab le 17), the difference
between treatment and control is not so distinctiv e in these trials compared to the fresh water results (Table 15). In brackish water and seawater testing, the observed increase in the dissolved oxygen concentration cannot be attributed to the formation by electrochemical EctoSys ® cell alone. The reasons are given as follows:

- a mixing device was used in the stor age tanks directly before sampling (see Appendix E, QAPP NIVA, paragraph 3.1.3), which could have increased the dissolved oxygen concentr ations in all tanks;

- due to the lower water temperature the micr obiological activity in the control tank was probably lower; and

- in general the oxygen gas formation by the electrochemical EctoSys® cell is lower with increasing salinity.

However, at all salinities the dissolved oxygen sa turation concentration is not reached in the treated effluent indicating a low formati on of oxygen by the electrochemical EctoSys ® cell in the CleanBallast system. In acco rdance with the still low dissolved oxygen concentration, the measured oxygen gas concentrations were in the normal range of 20 Vol. % (for full data please see the confidential part of the app lication dossier, Appendices F and H).MEPC 59/2
ANNEX Page 38

I:\MEPC\59\2.doc 6.3 Risk characterization and analysis

6.3.1 Aquatic toxicity tests with samples of ballast water treated with th e CleanBallast system from the land-based test set-up have been conducted (G9: 5.2.1.2 and 5.2.3). The reaction of Active Substances with orga nic matter has been addressed by their chemical properties (e.g., oxidation potential) in order to identify potential further Releva nt Chemicals that may be of concern to the environment; please refer to Appendix M in the application dossier.
Active Substances and Relevant Chemicals have been analysed during whole effluent testing during land-based type approval.

6.3.2 Routes and rate of degradation (G9: 5.3.5) have been assessed and characterized, where applicable. Please refer to the separate report “The oretical evaluation of the fate and effect of disinfection by-products ”, Table 2.2, in Appendix M in the application dossier.

6.3.3 Prediction of discharge and environmental concentrations

Discharge concentrations of Activ e Substances and Relevant Chemicals at selected time intervals can be predicted (G9: 5.3.8), usin g the literature degradation data (section 6.3.2), measured discharge concentrations in different waters (sec tion 6.2) and measured decay rates from the tests (paragraphs 6.2.2.1 to 6.2.2.3, please refer to Appendices F and G) . Ballast water discharge customized PEC evaluations for different generic scenarios, and realistic case studies including the land-based type approval test location were performed during the evaluations undertaken for Basic Approval (MEPC 55/2/4) and previous submission for Final Approval (MEPC 57/2/3). According to the recommendation of th e GESAMP-BWWG, this was supplemented with MAMPEC simulations, please re fer to paragraph 6.3.5 for details.

6.3.3.1 Discharge concentrations of Active Substances

6.3.3.1.1 Due to the short half-life of the Active S ubstance hydroxyl radical, this species will
never occur outside the electrochemical reaction zone and the discharge concentration will thus be zero after treatment of water of all qualities.

6.3.3.1.2 Discharge concentrations of the Active Substance HOCl/OCl - are aggregated into the generally known TRO parameter together with the Relevant Chemical HOBr/OBr - (due to the limited specificity of the analysis methods available). Fr om the land-based type approval testing, the TRO decay curves in effluent s after the second treatment at deballasting (see paragraphs 6.2.2.1 to 6.2.2.3) represent the TRO concentrations in st ored samples without discharge to the receiving water and without dilution in the receivi ng water. Based on these data
it can be concluded that:

- in fresh water (< 3 psu) the discharge TRO concentration (given as chlorine) is within the natural background range of approximately 0.1 – 0.3 mg/L , thus always below the discharge limit of 0.5 mg/L chlorine as regulated by resolution MEPC.159(55) for sewage treatment plants on board ships;

- in brackish water the mean TRO concentration directly after the deballasting treatment was 0.40 ± 0.02 mg/L (Table 13). Thus , it can be conclude d that the effluent of the CleanBallast system is below the di scharge limit of 0.5 mg/L chlorine regulated by resolution MEPC.159(55) for sewage tr eatment plants on board ships; andMEPC 59/2
ANNEX Page 39

I:\MEPC\59\2.doc - in seawater (> 32 psu), as discussed above, drawing a clear conclusion on the TRO discharge concentration is hampered due to the large standard deviation of the TRO measurements (see Figure 3). Us ing the TRO limit of 0.5 mg/L this could already be achieved after 4 h or later without di lution in the receiv ing water. Due to the large standard deviation of the TRO measurements and scarcity of sample points between 4 and 48 hours, theoretical calcula tions were done also on the TRO decay. Based on the physical and fate properties of each substance (please refer to the report “Theoretical evaluation of the fate and effect of disinfection by-products” in Appendix M) a generally accepted half -life of TRO (both hypochlorite and hypobromite) of 0.5 h has been determined. Th eoretical calculations show that an
initial concentration of 1.2 mg/L TRO (mean concentra tion with upper standard deviation, see section 6.2.2.) reached the limit concentration of 0.5 mg/L TRO within 40 min, based on a half-life of 30 mi n without dilution. The half-life of 30 min is in full compliance with previous result s (see Figure 3 in MEPC 57/2/3): The limit of 0.5 mg/L TRO was reached af ter 40 min in polluted harbou r water at real ballasting locations (Bremerhaven). For comparabilit y, the half-life value of 0.5 h for TRO was
also used in the MAMPEC si mulations (see paragraph 6.3.5).

Overall, before discharge of the deballastin g water to the receiving water and dilution therein, TRO concentrations in water treated by the CleanBallast system are in most cases immediately below the discharge limit set by resolution MEPC.159(55) for sewage treatment plants on board ships of 0.5 mg/L chlorine. In acco rdance with earlier results ( cf. MEPC 55/2/4 and MEPC 57/2/3) as well as considering the earlie r evaluation of the concen tration of 2 mg/L as both the Maximum Dosage and the Maximum Allowable Discharge Concentration by the GESAMP-BWWG (MEPC 57/2, paragraph 9.4.3), th e applicant is of the opinion that an additional neutralization system is not necessary at regular operation for de stroying the remaining TRO concentration before discharge.

Specifically, the only case where the TRO discha rge concentration might exceed 0.5 mg/L is treating unpolluted seawater inoculated with test organisms at very high densities, in which the mean TRO discharge concentra tions have been shown to be always below 1.2 mg/L during land-based type approval testing. In nature such high organism densities are unlikely to be found in natural seawater, especially due to the low le vel of nutrients in seaw ater for phytoplankton growth (cf. also MEPC 57/2/12). This is refl ected by Guidelines (G8) requiring for shipboard type approval only > 100 viable organisms per mL for the size ≥ 10 μm and < 50 μm, and 100 per m3 for the size ≥ 50 μm in the inlet to the treatmen t system: in contrast, densities as high as at least 1,000 per ml and 100,000 per m3 are required for land-based type approval testing. However, since ballast water treatment already takes place at ballast water uptake on board using the maximum TRO concentration of 2 mg/L in seawater, it results in effective reduction of organisms density a nd little or no regrowth in the ballast tanks during the voyage. Therefore numbers of still viable organisms at de ballasting are expected to be very low, thus requiring application of only a fraction of the maximum TRO concentration. Because the Algae Monitor as a mitigation measure reduces the EctoSys ® disinfection at deballasting only to the level actually needed (if needed at all), the TRO discharge concentration will be much lower than the 1.2 mg/L found in seawater in oculated with test organisms during land-based type approval testing.

For comparison, the maximum dosage chlorine concentration allowe d for drinking water treatment is 1.2 mg/L in Germany and according USPH EPA (2005) even 5 mg/L for drinking water treatment on board ships. Reflecting th e rather low Maximum Dosage and similar maximum Discharged Concentration of 1.2 mg/L in land-based type a pproval testing, treatingMEPC 59/2
ANNEX Page 40

I:\MEPC\59\2.doc seawater the level will be in the range of the discharge limit of 0.5 mg/L chlorine regulated by resolution MEPC.159(55) for sewage treatment plan ts on board ships by a dilution of 1:1 at discharge.

Furthermore, the applicant is c oncerned that the fine-tuning by the Algae Monitor would become
redundant in case an additional ne utralization system has to be fitted in the effluent of the CleanBallast system. The main advantage of the Algae Monitor is that disinfection is controlled directly by its biological eff ect on phytoplankton, because ballast water is characterized by the great variability and dive rsity of marine organisms and water qualities worldwide (refer further to the appendix at the end of this document an d “Functional description of the Algae Monitor” in Appendix C of the confidential part of the dossier).

However, because of the ongoing debate on acceptable TRO discharge levels, the full-scale CleanBallast system was also tested during land-based type approval testing at the test facility NIVA according to Guidelines (G8) us ing an additional neutralization system after deballasting. The full data set from this test cy cle can be found in Appendix F and more details on the neutralization system in Appendix N for evaluation of the GESAMP-BWWG.

6.3.3.2 Discharge concentrations of Relevant Chemicals

The quantitative formation of Relevant Chem icals (by-products of the electrochemical disinfection process) is linked to the formation of Active Substances. The qua litative formation is also linked to dissolved species (reactants) in the water. Thus, discharge concentrations
of Relevant Chemicals are evaluated based on th e highest measured concentrations found during the land-based type approval tests in all three wa ter qualities, reaching from fresh water to full salinity marine water. Risk assessment, PEC cal culations (section 6.3.4), etc. have also been performed using these levels of the Relevant Chemicals.

6.3.3.2.1 In fresh water discharge con centrations of disinfection by-pr oducts are very low, close to the limit of quantification and far below the WHO Drinking Water Guideline Values.

6.3.3.2.2 In brackish water and seawater, the sum concentration of trihalomethane THM and
haloacetic acids HAA is below the sum WHO Dri nking Water Guideline Value. Here, the single compound bromoform can exceed its respec tive WHO Drinking Water Guideline Value of 100 μg/L in brackish water and seawat er, and bromate can exceed its respective WHO Drinking Water Guideline Value of 10 μg/L in brackish water approximately by a factor of 2. Therefore, by a dilution of 1:1 at discharg e to seawater, the level will be in the range accepted for drinking water (cf. NIVA report, Appendix F).

6.3.3.2.3 Discharged concentrations of dissolved oxygen as well as oxyge n gas concentrations are in the range of natural fluctuations a nd are therefore not considered further in
the Risk Assessment.MEPC 59/2
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I:\MEPC\59\2.doc 6.3.4 Effects on aquatic organisms

6.3.4.1 Appropriate freshwater and marine Predic ted No-Effect Concentrations (PNEC) have
been derived for Active Substances and Re levant chemicals. A summary can be found in Table 18 below. For details, please refer to the report “Theoretical evaluation of the fate and effect of disinfection by-produc ts” found in Appendix M, including the complete underlying data sets, the assessment factors used including justification and th e derivation of the proposed PNEC values of Active Substances a nd Relevant Chemicals. The magnitude of the assessment factor applied has been set to between 50 and 10,000, depending on amount and quality of available data.

Table 18: PNEC values of Active Substances and Relevant Chemicals

CAS Name PNEC (Fresh)

μg/l PNEC (Marine) μg/l

7681-52-9 Sodium Hypochlorite 0.06 0.06
13824-96-9 Sodium Hypobromite 0.06 0.06

124-48-1 Dibromochloromethane 1 0.1
75-25-2 Tribromomethane 70 70
7789-38-0 Sodium Bromate 14 1,4
10102-75-7 Calcium Bromate 14 1.4
7758-01-02 Potassium Bromate 4 0.4

79-43-6 Dichloroacetic Acid 23 2
76-03-9 Trichloroacetic Acid 0.2 0.02
631-64-1 Dibromoacetic Acid 62 6
5589-96-8 Bromochloroacetic Acid 39 * 3 *

96-18-4 1,2,3-Trichloropropane 50 5 ( * = Calculated assuming same molar ecotoxic ity of chlorine and bromine compound)

6.3.4.2 PNEC values have been derived for any substa nces that were detect ed in treated ballast water at concentrations that may be of concern for the aquatic environment.

6.3.4.3 Available data for additional taxonomic gr oups, for example, rotifers, echinoderms or molluscs, have also been used in a previous at tempt to derive a PNEC for the Active Substance free active chlorine (MEPC 55/2/4). The outcome of this previous PNEC calculation (0.04 μg/L) was very close to the latest result (0.06 μg/L)

6.3.5 PEC values calculated using MAMPEC

In addition to the custom-made ballast water discharge modelling work conducted for Basic Approval and the previous subm ission for Final Approval, PEC values
for Active Substances and Relevant Chemical s have been derived for two generic cases
in MAMPEC ver. 2.0: the “Comme rcial harbour scenario” and the “OECD-EU Commercial
harbour”. The “commercial harbour” scenario of MAMPEC is a greater harbour based on and comparable to the Rotterdam harbour in the Netherlands. Noting th at the water quality of Rotterdam is not full salinity, the max imum discharge TRO con centration should beMEPC 59/2
ANNEX Page 42

I:\MEPC\59\2.doc rather < 500 μg/L in the real case (please refer to sectio n 6.3.7). The OECD-EU Commercial harbour (for smaller harbours) is essentially th e same as the “commercial harbour” scenario
of MAMPEC but differs in dimensions and the size of the harbour. The results are summarized
in Table 19 below. MAMPEC outcome on the TRO species hypochlorite and hypobromite has been provided for different effluent concentr ations at and below the unrealistic 2 mg/L (2000 μg/L) TRO, for comparison to the m odelling presented previously (MEPC 55/2/4 and MEPC 57/2/3). Therefore, the applicant would like to point out that in the normal operation of the CleanBallast system the TRO discharge concentration is maximum 1.2 mg/L (1200 μg/L) in seawater, below 0.5 mg/L (500 μg/L) in brackis h water, and in fresh water no TRO additional to the background level is form ed at the treatment during deballasting (mean 200 μg/L). Disinfection by-product concentratio ns used in MAMPEC were th e highest concentration found during the normal operation of the CleanBallast system in the land -based type approval testing. For methods, input parameters, assumptions on tra ffic, etc. see Appendix J of the application
dossier.

Table 19: PEC values of Active Substan ces and Relevant Chemicals, calculated by MAMPEC v.6.0 for two standard harbours

Name Initial
concentrations in discharged marine water, μg/L Commercial (Marine) Harbour, μg/l OECD-EU
Commercial

(marine) Harbour, μg/l Initial
concentrations in discharged fresh water, μg/l OECD-EU
Commercial (fresh water) Harbour, μg/l

2000 0.23 0.222 0 ---

1200 0.135 0.133 0 ---

500 0.056 0.055 0 --- Sodium Hypochlorite

200 0.023 0.022 0 ---

2000 0.23 0.222 0 ---

1200 0.135 0.133 0 ---

500 0.056 0.055 0 --- Sodium Hypobromite

200 0.023 0.022 0 ---

Dibromochloromethane 8.2 0.05 0.030 1.1 0.0039

Tribromomethane 190 1.25 0.708 3 0.0112

Bromate 19 0.47 0.136 4.4 0.0314

Dichloroacetic Acid 0.97 0.00 0.005 1.4 0.0085

Trichloroacetic Acid 0.28 0.01 0.003 2 0.0141

Dibromoacetic Acid 9.3 0.17 0.062 2.2 0.0145

Bromochloroacetic Acid 0.43 0.01 0.003 1.6 0.0105 1,2,3-Trichloropropane 1 0.01 0.005 0 0.0000

6.3.6 Plume modelling

Besides MAMPEC modelling and in addition to previous customized plume modelling work conducted for Basic Approval (MEPC 55/2/4) a nd previous submission for Final Approval (MEPC 57/2/3), dispersion (plume) modelling using software (“MIKE 3” + “ECOLAB”) developed by the engaged the third party external relevant expertise was performed. MIKE 3 is a three-dimensional hydraulic model, enabling the de scription of the water movements on the basis of information on amount of water exchange , wind, and bathymetry of the water body. The hydraulic model was combined with a fate model for the TRO and its degradation products in as it is called an ECOLAB template. The ou tput of the model is predicted environmentalMEPC 59/2
ANNEX Page 43

I:\MEPC\59\2.doc concentrations (PEC) varying in time and space cl ose by as well as more distant areas from the outlet of the ship. The derived PECs was then compared with the PNEC values
of Active Substances and Relevant Chemicals for the risk assessment. Described in this document is only the general set-up and conclusi ons. The full description of the model set-up, assumptions, results and conclusions can be found in Appendix J, as well as set in the context of the complete risk assessment in Appendix M, repor t “Theoretical evaluation of the fate and effect of disinfection by-products”.

The harbour basin chosen for the study was one of the basins of the Esbjerg port complex. Esbjerg port is a Danish port located in the Ho Bay on the North of the Walden Sea, in the southern part of Denmark.

The amount of ballast water and the flow disc harge depends on the ship size. In the study, five different sizes of ships – or discharge rates were modelled:

- Ship type 1: from 50 m to 100 m with a flow discharge of 0.083 m 3 /s (300 m3/h);

- Ship type 2: from 100 m to 150 m with a flow discharge of 0.3056 m 3 /s (1,100 m3/h);

- Ship type 3: from 150 m to 200 m with a flow discharge of 0.5278 m 3 /s (1,900 m3/h);

- Ship type 4: from 200 m to 250 m with a flow discharge of 0.75 m 3 /s (2,700 m3/h); and

- Ship type 5: from 250 m to 300 m with a flow discharge of 0.9722 m 3 /s (3,500 m3/h).

These five sources were distributed in the basin depending of the sh ips size (Figure 4).

Figure 4: 2D location of the sources (ships type 1-5) in Esbjerg portMEPC 59/2
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I:\MEPC\59\2.doc The behaviour of the plume depe nds on the salinity of the discha rged water. Three types of
ballast water were simulated:

- fresh water
- brackish water
- saline water

The simulation was carried out in the very cons ervative way that all ships were assumed to discharge the same type (same salinity) of ballast water during one complete day.

The hydrodynamic model was combined with a fate model. The same degradation rates and
concentrations in the ballast water as were used in the MAMPEC modelling were applied.

The study resulted in a vast amount of data. Only a few selected results of the simulations are presented here. Films showing results of the plume modelling in more details have been prepared and an example is given in Appendix J4.

Figures 5 to 8 show the predicted risk quot ients (RQ) for TRO for different assumed concentration in the ballast water: 2 mg/L, 1.2 mg/L, 0.5 mg/L and 0.2 mg/L. Only results from the discharge of saline ballast water are shown (most cons ervative approach). The RQ was calculated by dividing the average concentration of TRO during the comple te day of ballasting, on which the discharge takes place, by the PNEC for TRO (HOCl/OCl - , HOBr/OBr - ). Please note again that a discharge concentration of 2 mg/L is much higher than from the normal operation of the CleanBallast system at deballasting.MEPC 59/2
ANNEX Page 45

I:\MEPC\59\2.doc Figure 5: Discharge TRO concentration: 2 mg/L Layer 1: Bottom Figure 6: Discharge TRO concentration: 2 mg/L Layer 8: Surface

Figure 7: Discharge TRO concentration: 0.5 mg/L, Layer 1: Bottom Figure 8: Discharge TRO concentration.: 0.5 mg/L, Layer 8: Surface

From the plots it was concluded that:

- the area of impact increases with discharge ra te, as the area of impact for the large ships tends to be bigger than for the smaller ships;

- the risk quotients increases w ith depth. This is not surprisi ng, as the discharge takes place below water line closer to the bottom of the basin; and

- the risk quotients are well be low 1 outside the basin area.MEPC 59/2
ANNEX Page 46

I:\MEPC\59\2.doc Figure 9: Risk quotient scale

As can be seen, even under these unrealistic a ssumptions of discharge concentrations and total discharge periods, the acute risks for th e environment are droppi ng very rapidly with distance away from the point of discharge. Thus , no harm to immediate receiving environment is expected.

6.3.7 Deriving PEC/PNEC ratios

PEC/PNEC ratios were calculated for Active S ubstances and Relevant Chemicals, based on the values given in Tables 18 and 19. The results are summarized in Table 20. Please refer to the section “Risk Assessment” below, paragraph 7.3.2.

Table 20: PEC/PNEC ratios for Active Substances and Relevant Chemicals

Name Initial
concentrations in discharged marine water, μg/l Commercial (Marine)
Harbour OECD-EU
Commercial

(marine)
Harbour Initial
concentrations in discharged fresh water, μg/l OECD-EU
Commercial (fresh water)
Harbour

2000 5.64 5.54 0 ---

1200 3.39 3.32 0 ---

500 1.41 1.39 0 --- Sodium Hypochlorite

200 0.56 0.55 0 ---

2000 5.64 5.54 0 ---

1200 3.39 3.32 0 ---

500 1.41 1.39 0 --- Sodium Hypobromite

200 0.56 0.55 0 ---

Dibromochloromethane 8.2 0.51 0.30 1.1 0.004

Tribromomethane 190 0.02 0.01 3 0.000

Bromate 19 0.34 0.10 4.4 0.010

Dichloroacetic Acid 0.97 0.00 0.00 1.4 0.000

Trichloroacetic Acid 0.28 0.29 0.14 2 0.071

Dibromoacetic Acid 9.3 0.03 0.01 2.2 0.000

Bromochloroacetic Acid 0.43 0.003 0.001 1.6 0.00027 1,2,3-Trichloropropane 1 0.00 0.00 0 0.000MEPC 59/2
ANNEX Page 47

I:\MEPC\59\2.doc Hereby, the PEC/PNEC of 5.64 do es not represent the normal operation of the CleanBallast system. As shown above, please note that in the normal operation of the CleanBallast system in land-based type approval testing, the TRO (c hlorine/bromine) discha rge concentration is maximum 1.2 mg/L (1200 μg/L) in seawater, belo w 0.5 mg/L (500 μg/L) in brackish water, and
in fresh water no TRO additiona l to the background level is formed at the treatment during deballasting (mean 200 μg/L). Similarly, disinfection by-pr oduct concentrations used in MAMPEC were the highest concentrat ion found during the normal operation of the CleanBallast system in the land-based ty pe approval testing. While MAMPEC assumes a salinity of 34 psu for Rotterdam harbour, in rea lity the salinity is in the range of 0.3 - 28.6 psu (DNV, 2005). Nijs et al. (2008) in a time series over 1.5 months found a salinity in the range of 5-25 psu at Hook of Holland, of 0 - 18 psu at Botlek Harbour (a bout 16 km up-estuary of Hook of Holland), whereby the water 3 m below the surface was freshwater with around 2 psu, and a salinity of 0 - 10 psu at Lek Harbour (about 25 km up-estuary of Hook of Holland). Therefore in reality, due to presen ce salinities ranging from brackish water to
freshwater in the Rotterdam harbour maxi mum discharge TRO concentration should be < 500 μg/L giving a PEC/PNEC value < 1.

7 RISK ASSESSMENT

The potential risks to the safety of the ship, cr ew and environment raised by the operation of the CleanBallast system have been assessed by an i ndependent expert institution, also taking into account the identified risk mitigation measur es and brominated disinfection by-products.

7.1 Risk to safety of ship

7.1.1 Corrosion tests

Extensive long-term corrosion test s advised in the Basic Approval evaluation have been finalized (MEPC 57/2, annex 6, paragrap h 9.4.7). No risk of increas ed corrosion induced by the CleanBallast system could be found. Thus, th e level of the potential risk of accelerated corrosion to the ballast water piping and structure that ma y be raised by use of this system can be properly assessed (MEPC 57/2, annex 6, paragraph 9.4.11) as being zero.

The corrosion evaluation of th e CleanBallast effluent was developed and performed in co-operation with the classifi cation society Germanischer Ll oyd (GL) and a well-recognized independent third party corrosion institute in northern Europe. The test included an accelerated comparative exposure phase (using full salinity sea water) and thereafte r an evaluation phase.
GL concluded a number of ISO/ASTM standard co rrosion test methods which were used for the evaluation phase. After evaluati on, a certificate was is sued by GL concerning shipboard use of the CleanBallast system, recognizing no increased risk for corrosion.

The full documentation, in cluding reports from the performing corrosio n institute, from GL (also the certificate), and from coating and material su b-suppliers, etc. can be found in Appendix I.

The influence of the CleanBallast system on comm on sealing material such as EPDM used in ballast water piping was evaluated. EPDM is known as a sealing material being highly resistant to seawater, various chemicals, acids and bases. Therefore, it is assumed that the EPDM seals are durable to the disinfection pr oducts produced by the CleanBallast system. Neither hypochloric nor hypobromic acid is assessed to ha ve an effect on EPDM material properties. As discussed inMEPC 59/2
ANNEX Page 48

I:\MEPC\59\2.doc section 2.1.2, due to their extremely short lifeti me hydroxyl radicals cannot come into contact with the sealing material.

7.1.2 Fire and explosion

The CleanBallast equipment and process does not contain any component or step increasing the risk of fire. Like all electroly tic processes in water solutions , a small by-production of hydrogen gas (RC) will occur. Hydrogen and oxygen mixtures can be explosive in a certain concentration range, whereby the lowest explosion limit is 4 Vol. % hydrogen gas. The potential hydrogen formation, along with the extensive testing and monitoring, was discussed and submitted through the previous application for Fi nal Approval (MEPC 57/2/3). A de- aeration component is included immediately following the EctoSys ® electrolysis as well as a hydr ogen content sensor monitoring the discharge from the de-aeration pipe, which is directed to the ambient air outside the ship. The system will immediately be shut down if hydroge n concentrations at this point reach a level
of 2 Vol. %. The GESAMP-BWWG considered that the information provided together with the mitigation measures incorporated was accepta ble for addressing this identified risk (MEPC 57/2/2, paragraph 9.4.6).

The new measurements of hydrogen gas during the re peated land-based type approval testing at the test facility NIVA showed that all anal ysed hydrogen gas concen trations were far below 0.25 Vol. % in the de-aeration pipe as well as at different locations of the storage tank. Oxygen gas concentrations were in the normal range of 20 Vol. % (f or full data please refer to the confidential part of the appli cation dossier, Appendices F and H).

7.1.3 Storage and handling of the substances

Active Substances and Relevant Chemicals are produced in situ during the electrochemical disinfection process in the closed cell housing and will neither be stored nor handled by the crew, thus posing no threat to the ship.

7.1.4 Contact with, or inhalation of, process products

Potential skin contact, or inhalation of, process products have been evaluated (using literature studies) in the human exposure assess ment (section 7.2.3 and Appendix K).

7.1.5 Noise

The CleanBallast system does not generate any specific noise, which could exceed the high noise level common in machinery rooms.

7.2 Risks to human health

7.2.1 The human health risk assessment is based on the Human Exposure Scenario (HES), please refer to section 7.2.3. Risks are not consider ed to be relevant wh ere no exposure routes exist. The acute toxicity of treated water is ev aluated to have no dermal effect on humans, should there be a direct exposure outside normal opera tion, i.e. leakage, because the exposure dose (low concentrations well below acute dermal toxicity levels, based on data provided by MSDS for each substance), duration and frequency of such events are assessed as neglectable. Direct oral exposure of treated water is not considered as a realistic case. Furthermore, evaluation of indirect oral exposure did not give rise to any concern (e.g., none of Active Substances or Relevant Chemicals will persist or accumulate in sea food at detectable quantities), pleaseMEPC 59/2
ANNEX Page 49

I:\MEPC\59\2.doc refer to the Human Exposure S cenario provided in Appendix K of the application dossier. Disinfection by-products detected in non-diluted treated water were furthermore below or in the range of drinking water standards, e.g., WHO. In the Human Exposure Scenario (HES) special focus was laid on the inhalative uptake of brominated THM, according to the main concern raised by the GESAMP-BWWG

− please refer to the conclusi on in section 7.2.3 below and the HES in Appendix K of the application dossier.

7.2.2 The effects assessment of the Active Substances and Relevant Chemicals including the screening for carcinogenic , mutagenic and endocrine disruptive properties did no t give rise to concerns at concentrations corresponding to 100% discharge water. This screening was performed using literature data separate MSDS, please refer to Appendix M of the application
dossier. No further effects assessment was considered necessary (G9: 5.3.12).

7.2.3 A Human Exposure Scenario (HES) was develo ped in co-operation with an independent third party, a leading European environmental in stitute. The HES is provided by the applicant as part of the risk assessment procedure for th e CleanBallast system. (G9: 6.3.3). The complete HES, including the calculated data for humans from respective exposure route, is submitted as Appendix K of the application dossier.

7.2.3.1 Occupational exposure

The occupational exposure to TRO, degradatio n products and DBPs was assessed based on the following assumptions:

- Sampling from the system. Sampling is expected to be carried out only to a very limited extent and only by technicians appoi nted by the applicant/manufacturer of the CleanBallast system, thus no exposure to the crew on the ship due to sampling is expected.

- Upon loading of the ballast tanks with water, the excessive air in the ballast tanks is replaced by water in the ballast tanks, re sulting in potential inhalation exposure of humans to the exhaust air mixing with the outside air mass on board the ship.

The predicted equilibrium concentrations (without dilution/venting) in air were first compared
with the OEL-values found for the various subs tances for various countries, and a potentially required dilution in order to obtain concentrations in air below the OEL was calculated. A simple model for predicting the average concentration in inhaled air, further described in the HES, was set up.

Regarding inhalation of exhaust air emitted from the ballast tanks (occupational exposure), it was concluded that the predicted concentration in the air is far below existing OEL-values. Thus, no risk to the crew on the ships is expected

7.2.3.2 Exposure via the environment

Human exposure to TRO and its degradation products related to the use of the CleanBallast system may occur as:

- oral intake due to bioaccumulation of th e substances in bivalves and fish; and

- oral, inhalative and dermal exposure during bathing in areas close to the ballast
water outlet.MEPC 59/2
ANNEX Page 50

I:\MEPC\59\2.doc All routes of exposure were thoroughly evaluated based on ve ry conservative assumptions. The risks related to exposure vi a the environment due to eating the fish from the harbour area and due to swimming in the harbour area were eval uated. As the predicted daily uptake considering all uptake routes simultaneously is far below existing TDI values, no risk to the general public from the TRO, its degradation produ cts or by-products is expected.

7.2.4 The quantitative risk assessment, taki ng into account identification of hazardous substances, dose response relationships, exposure routes and frequency, etc., did not give any
indications of concern for human health.

7.2.5 The unit operations used in the whole Clean Ballast process are identified as a first mechanical separation step (filtration) and a disinfection step (the EctoSys ® advanced electrolysis). Assessment of Human exposure to Active Substances and Re levant Chemicals is only relevant after the unit operation of disinfecti on (but not filtration), where the substances are produced in situ

.

7.2.6 The risk assessment for human health wa s conducted under full consideration of the technical description of the ballast water treatm ent process – please refe r to Appendices A and B of the application dossier. For each system component, including connecting piping, possible routes of exposure were evalua ted. No Personal Protective Equipm ent especially related to the operation or use of the CleanBallast sy stem was deemed to be necessary.

7.2.7 Maintenance, equipment failure and accident s ituations were considered separately from conditions of normal operation. No Personal Prot ective Equipment, especi ally related to the above-mentioned special cases, was deemed to be necessary.

7.2.8 Taking into account the above, risks on human health related to treatment by the CleanBallast system are considered to have been thoroughly addressed. No potential risks
could be identified.

7.3 Risks to the aquatic environment

7.3.1 The potential risks to the aquatic environm ent during experimental development and type approval testing were assessed, based on t oxicity studies and evaluations undertaken during Basic Approval, first submission for Fi nal Approval (MEPC 57/2/3) and the tests and evaluations undertaken for this application for Final Approval. The specifically developed plume model for the land-based type approval test set-up used 2007 was adopted to assess the risks associated with further type appr oval testing and evaluations for Final Approval. The validity of the model was confirmed by experimental tests of the water (MEPC 57/2/3, Table 10), where the predictions of environmental concentrations made by the model were confirmed by on-site sampling and analysis. The risk assessment for the further tests related to the approval process according to the Guidelines (G8) and Pr ocedure (G9) did not raise any concern.

7.3.2 Acute and chronic aquatic toxi city of the treated ballast wa ter at discharge was found to be considerably lower than the level repor ted during the evaluati on for Basic Approval (MEPC 55/2/4). The risks of sepa rate Active Substances and Relevant Chemicals were assessed using estimated ratios between predicted concentrations (PECs, using MAMPEC in the
standardized OECD-EU commercial harbour) of the Active Substa nces or Relevant Chemicals and the respective PNEC values. The PEC/PNEC ra tio (including appropriat e assessment factors) for the Active Substance hydroxyl radical is neither relevant nor possible to calculate, due to theMEPC 59/2
ANNEX Page 51

I:\MEPC\59\2.doc properties (short half-life) of the substance (MEPC 55/2/4). The PEC/PNEC ratio for TRO is estimated using calculated values for hypochl orite and hypobromite (i ncluding appropriate assessment factors). Using MAMPEC and the same unrealistic conservative worst-case assumptions made for previous submission fo r Final Approval (MEPC 57/2/3, paragraph 3.8.3)
the PEC/PNEC ratio is ca lculated at <1 fo r initial TRO concentrations of < 0.4 mg/L. This can be compared to the results from the custom-made ba llast water discharge modelling undertaken for previous submissions; at an initial TRO concen tration of 2 mg/L the PEC/PNEC ratio equals to 0.4. The PEC/PNEC ratios (inc luding appropriate assessment f actors) for Relevant Chemicals are below 1, thus no further assessment of dir ect toxic effects to the aquatic environment is considered to be necessary (s ection 6.3.7). In seawater matri x, bromate concentrations in the μg/L range are extremely diffi cult to analyse. Specialized equipment and methods are needed.
It is noted that bromate wa s not considered by the applic ants to raise any concern using conventional chlorination as a disi nfection step in BW systems submitted for Basic and Final Approval, since this substance was not detected during th e approval process.

7.3.3 Dilution and/or degradation of toxic subs tances is necessary to ensure that the PNEC values are not exceeded following direct rele ase of treated ballast water to the receiving aquatic environment. PECs have been calculated using several appropri ate models (including MAMPEC as recommended by the Group) for releva nt controlled use and discharge scenarios during deballasting.

7.3.4 The potential risks to the aquatic envir onment resulting from full-scale application on board ships and discharge of treated ballast water under representativ e conditions have been assessed using several models a nd calculations throughout the approva l process. Case studies of the port of Rotterdam, together with representa tive plume modelling on the port of Esbjerg of ballast water discharge based on worst case scen arios concerning concentrations have been submitted. Even under unrealistically high assumptions of discharge concentrations and total discharge periods, the acute risks for th e environment are droppi ng very rapidly with distance away from the point of discharge. Thus , no harm to immediate receiving environment is expected. The extensive material provided by the a pplicant can be regarded as the first stage of a tiered approach to the development of a full Emission Scenario Document (ESD) for ballast water treatment systems, when more data on pot ential discharges and technologies becomes available (G9: 6.4.4).

7.3.5 Taking into account the above, the risks for the environment related to treatment by the CleanBallast system are considered to be thoroughly addressed. Proper mitigation measures to prevent unnecessary stress to receiving environment have been implemented, e.g., specifically the use of the Algae Monitor (see secti ons 1.2 and 2.1.4, appendix of this document and Appendix C of the confidential part) at deba llasting, and the fail-safe mechanism of the TRO measurement before discharge.

8 ASSESSMENT REPORT (G9: 4.3)

A risk assessment was carried out for the prev ious submission for Final Approval (MEPC 57/2/3)
based on the worst-case data submitted in the contex t of this application. The risk assessments for crew, ship and environment, respectively, is base d on data and evaluations as summarized in the following paragraphs 8.1 to 8.5.

8.1 The data and endpoints on which the risk characterization according to section 6 of Procedure (G9) is based are considered sufficien t. The quality of test reports are judged to be satisfactory and in compliance with th e guidelines given in Procedure (G9).MEPC 59/2
ANNEX Page 52

I:\MEPC\59\2.doc 8.2 The assessments of risks to the safety of sh ips, crew (human health), the environment and natural resources (e.g., fisheries) in accordance with section 6 of Proc edure (G9) have been performed. Conclusions from these assessm ents can be found in sections 7.1 to 7.3.

8.3 The available data on environmental e xposure and the estimates of environmental concentrations obtained upon application of mathematical models using all available environmental fate parameters, along with an identification or description of the modelling methodology, are consider ed sufficient for assessment. For details please refer to Appendices J, K and M of the application dossier.

8.4 The qualitative statements of and the level of uncertainty in the ev aluations performed by the test facilities and institute performing the theoretical assessments are considered to be
sufficient.

8.5 A review of risk management possibiliti es, e.g., emergency shut down of the system, de-aeration pipe for removal of potentially formed hydrogen, fail-safe monitoring of TRO concentration, mitigation by the Algae Mon itor, etc. has been given. Because of the ongoing debate on acceptable TRO discharge levels, the full-scale CleanBallast system was also tested during land-based type appr oval testing at the test facility NIVA according to Guidelines (G8) using an additional neutraliz ation system. The full data set from this test cycle can be found in Appendix N for the evaluation of the GESAMP-BWWG.

8.6 In conclusion, it is considered that all potential risks to crew, ship or environment are covered by the respective risk assessments.

9 MODIFICATIONS TO THE APPLICATION

9.1 The manufacturer will report a ny modifications in names, in cluding trade and technical name, composition or use of the Active Substan ces in the ballast water management systems approved by the Organization, to the Memb ers of the Organization. The Members of the Organization will inform the Or ganization accordingly (G9: 8.4.1).

9.2 If the manufacturer intends to significantly change any part of a ballast water management system that has been approved by the Organization or the Active Substances and Preparations used in it, a new ap plication will be submitted (G9: 8.4.2).

10 FINAL APPROVAL

10.1 Tests of treated ballast water

In accordance with paragraph 5.2.1 of Procedure (G9) for Final Approval, the discharge testing has been performed as part of the land-based ty pe approval process using the discharged treated
ballast water.MEPC 59/2
ANNEX Page 53

I:\MEPC\59\2.doc 10.2 Criteria met to obtain Final Approval

In accordance with section 8.2 of Procedure (G9), the following criteria were met by the applicant:

.1 Basic Approval have been given (MEPC 55/2/4).

.2 The Members of the Organization have conducted the Type Approval tests
in accordance with Guidelines for a pproval of ballast water management systems (G8). The results have been conveyed to the Organization for
confirmation that the residual toxicity of the discharge conforms to the evaluation undertaken for Basic Approval.

.3 The results of the residual toxicity tests are include d in the proposal for Final Approval in accordance with Procedure (G9).

.4 If Final Approval under the Procedure (G9) is given, th en the applicant should not have to retrospectively submit new data if there is a change in the Methodology as agreed by the Organization (G9: 8.2.3).

.5 Toxicity testing has been done on three t ypes of seawater at two appropriate time intervals after treatment. Organisms nor mally found in the se lected types of seawater were used for toxicity testing. Several additional toxicity studies have been performed as submitted in the previous application for Final Approval.

.6 Information related to Total Residual Oxidants (TROs) and the chemicals included in such groupings, including th eir concentrations, was provided to the GESAMP-BWWG for Final Approval as recommended in its evaluation for Basic Approval.

.7 In addition to the basic data set needed for the treated ballast water and the individual chemicals produced by the system – as identified in the Methodology for Basic Approval – estimated PEC/PNEC ratios were submitted for Final Approval.

.8 The application for Fina l Approval reflects the concerns identified during consideration of Basic Approva l. It also reflects the concerns that were raised during first consideration for Final Appr oval. The data for acute and chronic ecotoxicity was required and consequently submitted.

11 TERMS AND DEFINITIONS

11.1 Definitions

Definitions used in this document are intend ed to supplement those in the Ballast Water Management Convention:

.1 Ballast Water Management Convention means the International Convention for the Control and Manageme nt of Ships’ Ballast Water and Sediments, 2004.

.2 Ballast Water Management means mechan ical, physical, chemical and biological processes – either singularly or in combination – to remove, render harmless, or avoid the uptake or discharge of harmfu l aquatic organisms and pathogens within
ballast water and sediments.MEPC 59/2
ANNEX Page 54

I:\MEPC\59\2.doc .3 Preparation means any commercial formulation containing one or more Active Substances including any additives. This term also includes any Active Substances generated on boa rd for purposes of ballast water management and any relevant chemicals fo rmed in the ballast water management system that makes use of Active Substa nces to comply w ith the Convention.

.4 Active Substance means a substance or organism, including a virus or a fungus that has a general or specific action on or against harmful aquatic organisms and pathogens.

.5 Other components of a preparation means any other substances in a preparation, other than the Active Substance(s) or Relevant Chemicals, produced during the
treatment of ballast water.

.6 Relevant Chemicals means transformati on or reaction products that are produced during and after employment of the ballast water management system in the ballast water or in the receiving environmen t that may be of concern to the ship’s safety, aquatic environmen t and/or human health.

.7 Basic Approval means the preliminary approval of Active Substances and the ballast water management system making us e of them in order to comply with the Ballast Water Management Convention.

.8 Final Approval means the approval of a ballast water management system using an Active Substance or Preparation to comply with the Convention, including a review of the Type Approval tests in accordance with Guidelines for approval of ballast water management systems (G8).

.9 GESAMP–Ballast Water Working Group (GESAMP-BWWG) means the Technical Group consisting of independe nt experts acting in their individual capacity reviewing the proposals for a pproval of ballast water management systems making use of Active Substances submitted by the Administration and report, through GESAMP, to MEPC.

11.2 Abbreviations used in the text

Abbreviations:

AC alternating current AOX adsorbable organic halogen
BW ballast water °C degree Celsius (Centigrade)
CAS Chemical Abstract Service d day(s) DIN Deutsches Institut für Normung (German Institute for Standardization) DOC dissolved organic carbon dwt deadweight tonnage EC50 effect concentration, 50% (median effective concentration) EOX extractable organic halogen EPDM ethylene propylene diene M-class rubber
FAC Free Active ChlorineMEPC 59/2
ANNEX Page 55

I:\MEPC\59\2.doc g gram GHS Globally Harmonized System GL Germanischer Lloyd G9 Procedure for approval of ballast wate r management systems that make use of Active Substances (G9), as revised, adopted by resolution MEPC.169(57) in April 2008.
h hour
HAA Haloacetic acids IMO International Maritime Organization ISO International Organi zation for Standardization
IUPAC International Union of Pure and Applied Chemistry kg kilogram Koc organic carbon-water partition coefficient
L litre LBTA land-based type approval LC50 lethal concentration, 50% LD50 lethal dose, 50% Log Pow logarithm of the octanol /water partition coefficient LOQ limit of quantification
MEPC Marine Environment Protection Committee

m metre m2 square metre
m3 cubic metre mg milligram
mL millilitre
n.r. not reached N/A not applicable
NOEC No-observed-effect concentration OECD Organization for Economic Co- operation and Development Organization OEL Occupational Exposure Limit PC personal computer PEC predicted envir onmental concentration PLC programmable logic controller PNEC predicted no-e ffect concentration POC particulate organic carbon Pow Octanol/water partition coefficient psu practical salinity units QAPP Quality Assurance Project Plan RQ risk quotient
s second TDI Tolerable Daily Intake
TGD Technical Guidance Document
THM trihalomethane
TRO Total Residual Oxidants
US EPA United States Envi ronmental Protection Agency WHO World Health Organization wt weightMEPC 59/2
ANNEX Page 56

I:\MEPC\59\2.doc APPENDIX

NON-CONFIDENTIAL SHORT DESCRI PTION OF THE ALGAE MONITOR

The Algae Monitor is a fundamental part of the Cl eanBallast system used to continuously analyse the direct effect of the treatment on phytoplankt on and, by a feedback loop to the disinfection system (EctoSys ® ), to minimize the use of Active Substances at concentrations below the maximum concentration of 2 mg/L Total Residual Oxidant (TRO). The Algae Monitor is a key mitigation measure for the second EctoSys ® treatment during deballasting, ensuring a reduction of disinfection down to only the level absolute ly necessary to reac h adequate biological efficiency.

The advantage of the Algae Monitor is that it meas ures directly the effect of the disinfection on phytoplankton. This is important:

- because the residual disinfectan t concentration (TRO) is not su fficient to indicate if the disinfection was completed succ essfully in ballast water, because it does not correspond
to the actual biological effect of the disinfecti on. No correlation exists between the TRO concentration and disinfection for the gr eat variability and diversity of marine organisms and water qualities worldwide; and

- specifically for the CleanBallast system, where the EctoSys ® disinfection is only producing hydroxyl radicals as Active Substance in fresh water. Thus, no additional Total Residual Oxidant (TRO) is formed and consequently the TRO concentration can not at all be used as a controlling parameter.

Mainly after efficient ballast wa ter treatment, the number of dead organisms is high and therefore common biomass parameters such as chlorophyll- a or the Genty-parameter, which gives also a response for dead cells, cannot give an indication on the success of the disinfection performance. A unique design characteristic of the algae monito r is that the measurement is specific only for living phytoplankton and therefore not aff ected by dead cells, sediment, etc.

The base of the algae monitor is a flow-through fluorometer using well-established photometrical principles, which is installed after EctoSys ® disinfection in a bypass to the effluent of CleanBallast system. Both inlet water to the Cl eanBallast system as well as the effluent after the EctoSys ® disinfection can be supplied to and anal ysed by the Algae Monitor. If living phytoplankton remains in the sample, this light se rves to drive photosynth etic reactions and the phytoplankton cells respond to the introduced light by emitting certain fluorescence light. The differentiation between viable and dead phyt oplankton cells is achieved by the specific features of the measurement. Its output signa l is forwarded to the PLC (Programmable Logic Controller) of the Cl eanBallast system.

The Algae Monitor allows that the EctoSys ® disinfection is controlled directly by its effect on phytoplankton and minimizes the use of disinf ectants by a feedback loop to the EctoSys ®

. Importantly, during deballasting this allows to monitor and only generate the level of disinfectants that are necessary (if needed at all). By using this m easure the TRO discharge
concentration is minimized in ma rine water qualities, and use of hydroxyl radicals is minimized
in fresh water.MEPC 59/2
ANNEX Page 57

I:\MEPC\59\2.doc The quality assurance is secured by a techni cal and a biological calibration. For each Algae Monitor the optical properties ar e checked before the first use in a technical ca libration. After a certain operation time within regular surveys on boa rd, it is checked by st andard solutions that
the technical calibration is sti ll valid and no ageing of the opt ical properties occurred.

For the biological calibration viable cells of the reference organisms Tetraselmis sueccica is used with a minimum length around 10 μm, representing the lower limit of the smaller size class regulated by the IMO Ballast Water Performance Standard. The biological calibration is carried out according to a Standard Operation Procedure (SOP) by an approved institute for handling and analysing phytoplankton.

Tetraselmis sueccica was chosen as a reference organism, because from testing and operation of the CleanBallast system at different locations it was experienced that Tetraselmis sueccica is one of the last organisms that die. This is in accordance with the literature, e.g.. Gregg and Hallegraeff (2007), who published that the green flagellate Tetraselmis sueccica was found to be considerably more resistant to treatment by biocides than the vegetative dinoflagellates.

Although the Algae Monitor is calibra ted to the reference organism Tetraselmis sueccica

, certainly also smaller and larger phytoplankton species are measured by the Algae Monitor as well. The special feature is that viable phytopl ankton smaller than 10 μm give also in higher numbers a lower response to the measurement, while phytoplankton bigger than 10 μm but in numbers below 10 viable organisms per ml give a higher response. By this a safe monitoring is
achieved.

The Algae Monitor has successfully passed the requirements of the specification for Environmental Testing according to Part 3 of Guidelines (G8).

Important note:

The Algae Monitor is not a measuring device to check if the number of organisms in the effluent is in compliance with IMO Ballast Water Performance Standard. Due to the fact that two
different size classes and different indicator bacteria are regulate d, a marine biologist needs to analyse and decide on the co mpliance with the standard.

The Algae Monitor is designed to give only an indication on the disinfecting effect on phytoplankton and allow minimizing the use of Activ e Substances. This is comparable to the oil/water monitors, which are widely used with bilge water separators on board. The oil/water-monitors measure the scattering of the light as an indicator for the 15 ppm oil discharge limit.

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