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\2-5.doc

INTERNATIONAL MARITIME ORGANIZATION

IMO 

# E

MARINE ENVIRONMENT PROTECTION COMMITTEE 59th session Agenda item 2 MEPC 59/2/5 11 December 2008 Original: ENGLISH

HARMFUL AQUATIC ORGANI SMS IN BALLAST WATER

Application for Final Approval of the Hitachi Ballast Water Purification System (ClearBallast)

Submitted by Japan

SUMMARY

Executive summary: This document contains non-confidential information related to the application for Final Approval of the Hitachi Ballast Water Purification System (ClearBallast) in accordance with the “Procedure for approval of ballast water management systems that make use of Active Substances (G9)” adopt ed 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 7

Related documents: BWM/CONF/36; MEPC 57/2, MEPC 57/2/2, MEPC 57/21; BWM.2/Circ.13 and BWM.2/Circ.15

Introduction

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

2 The Procedure for approval of ballast water management systems that make use of Active Substances (G9) stipulates the information that should be included into a proposal for approval and provisions for risk characterization and analys is. According to sectio n 6 of Procedure (G9), the Organization should evaluate the in formation provided in the application.

3 According to BWM.2/Circ.15, a document on th e proposal for approval containing all the non-confidential data related to the respective ballast water management systems that make use of Active Substances needs to be submitted to MEPC 59.MEPC 59/2/5 - 2 -

I:\MEPC\59\2-5.doc 4 This document contains non-confidential in formation related to the application for Final Approval of the Hitachi Ballast Water Pu rification System (ClearBallast) in accordance with the “Procedure for approval of ballast wate r management systems that make use of Active Substances (G9)” adopted by resolution MEPC .169(57). The system is developed by Hitachi Plant Technologies, Ltd., using enhanced wa ter treatment technology based on coagulation magnetic separation method.

5 The competent authority in Japan has verified the application dossier and believes that it satisfies the data require ments of Procedure (G9).

6 Japan therefore submits the non-confidentia l part of the manufacturer’s application dossier, as set out in the annex to this document, to the Organization for evaluation according to Procedure (G9). The complete dossier will be made available to the experts of the GESAMP-BWWG with the understanding of confidential treatment.

Action requested of the Committee

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

***MEPC 59/2/5

I:\MEPC\59\2-5.doc ANNEX

NON-CONFIDENTIAL INFORMATION ON THE HITACHI BALLAST WATER PURIFICATION SYSTEM (JAPAN)

1 Introduction

1.1 Features of the Hitachi Balla st Water Purification System 1.2 Test results 1.3 Glossary

2 Summary of the recommendations of the GESAMP-BWWG in the review of proposal for Basic Approval a nd the applicant’s responses

3 Outline of Hitachi Ballas t Water Purification System

3.1 Additive concentration of coagulant chemicals 3.2 Purification process 3.3 Purification system 3.4 System specifications 3.5 General specifications of electrical devices 3.6 Constituents machines 3.7 Operation procedure 3.8 Actions in case of problems or emergency 3.9 Scale up 3.10 Quality assurance 3.11 Measures to reduce risks to humans and ships 3.12 Maintenance 3.13 Supply and storage of chemicals

4 Assessment of treated water

4.1 Water sampling 4.2 Quality of collected floc

5 Ecotoxicity test of treated ballast water

5.1 Acute toxicity test 5.2 Chronic toxicity test 5.3 Study on effects of treated water under higher concentration of Active Substances

6 Risk characterization and risk assessment

6.1 Summary of critical information of substances 6.2 Risk assessment with regard to ship safety 6.3 Risk to human health 6.4 Risk assessment on aquatic organisms 6.5 Establish the maximum allowa ble discharge concentration 6.6 Conclusion on risk to the aquatic environmentMEPC 59/2/5 ANNEX Page 2

I:\MEPC\59\2-5.doc 1 Introduction

Hitachi Ballast Water Purification System (Cle arBallast) was granted Basic Approval by the Marine Environment Protection Committee at it s 57th session in April 2008. This application dossier is for Final Approval in accordance with the Procedure for approval of ballast water management systems that make use of Active Substances (G9).

This system employs conventional drinking wate r purification technology to form flocs using triiron tetraoxide, PAC, PASA a nd the like to coagulate organi sms and other suspended matters in ballast water. Strong magnetic force is us ed to quickly remove flocs, thereby making it unnecessary to use biocides. The chemicals used in this system are the same as those used in drinking water purification process, and have been extensively ci ted in literatures relating to human health and the environment (including Worl d Health Organization (W HO) guidelines), so there is plenty of evidence to show that they are safe.

This application is prepared by Hitachi Plan t Technologies Ltd. although the application of Basic Approval was prepared by joint name of H itachi Ltd. and Hitachi Plant Technologies Ltd.

1.1 Features of the Hitachi Balla st Water Purification System

The system coagulates target organisms and othe r suspended materials using a coagulating agent during the ballast water intake , and cleans the ballast water by efficiently separating and removing aquatic organisms through a combination of magnetic separati on and filter separation techniques.

1.2 Test results

From September 2006 through March 2008, tests using a prototype test set- up (treatment rated capacity of 50 m3/h) in Tokyo Bay are performed. After the Basic Approval granted, from April to October 2008, shipboard testing of this system with a treatme nt rated capacity of 50 m3/h mounted on board an LPG carrier belonging to Yuyo Steamship Co., Ltd. and built by Mitsubishi Heavy Industries, Ltd., was performed. From April of the same year, land-based tests were also performed in Tokyo Bay, using a land-based test set-up (treatment rated capacity of 200 m 3 /h). Figure 1-1 shows the onboard test set-up and Fi gure 1-2 shows the land-based test set-up.MEPC 59/2/5 ANNEX

Page 3

I:\MEPC\59\2-5.doc Figure 1-1

− Overview of onboard test set-up

Figure 1-2

− Overview of land-based test set-up

1.3 Glossary

Chemical Injector: A device to inject chemicals (triiron tetraoxide, PAC, or PASA), which is a part of the Hitachi Ballast Water Purification System.
Coagulator: A device to transform chemicals into flocs cont aining SS, plankt on, bacteria, and so on, which is a part of the Hitach i Ballast Water Purification System.
Collected Flocs Storage Tank: A tank for storing the removed flocs containing chemicals, SS (suspended solids), plankton, bacteria, and so on, which is a part of the Hitachi Ballast Water Purification System.
Filter Separator: A device which removes flocs from the ballast water using a rotating filter drum, as a part of the Hitachi Ba llast Water Purification System.
Floc: Gelatinous matter made up of fine partic les such as a suspen sion colloid in water (suspended solids) formed by an inorganic coagulant or high-polymer coagulant.MEPC 59/2/5 ANNEX Page 4

I:\MEPC\59\2-5.doc Inorganic Coagulant: A chemical containing meta llic ions of aluminiu m or iron that forms a larger floc of fine particles dispersed in wate r such as a suspension colloid by neutralizing the charge on their surfaces.
Magnetic Disk: A component of the magnetic separator. A disk in which magnets (permanent magnets) are embedded.
Magnetic Disk Array: A component of the magnetic separator. An assembly consisting of several magnetic disks arranged coaxially.
Magnetic Separator: A device whic h removes flocs from the ballast water using a magnetic disk array, as a part of the Hitachi Ba llast Water Purification System.
PAC: Poly Aluminium Chloride. An inorganic co agulant consisting of poly aluminium chloride and referring to basic aluminium chloride.
PASA: Poly Acrylamide Sodium Acrylate. A cro sslinking chemical consisting of high molecular weight polymer particles with a negatively char ged surface, which forms a coagulation of fine particles suspended in water such as a suspension colloid. It is a kind of Anionic High-Polymer Coagulant.

2 Summary of the recommendations of the GESAMP-BWWG in the review of proposal for Basic Approval and the applicant’s responses

The recommendations of the GESAMP-BWWG in the review report of the application for Basic Approval, which the applicant s hould pay careful attention at th e application for Final Approval (MEPC 57/2, annex 5, Summary 0 and Conclusions 9) , and the applicant’s responses to them are summarized as follows;

Summary 0.4.1/Conclusions 9.4.1

An adequate quality assurance programme needs to be developed for the entir e system (including the quality of PASA at industrial production).

Hitachi Plant Technologies, Ltd. will assume c ontrol and responsibility for the quality of the entire system (design, construction and mainte nance of equipment main unit, and supply of consumable chemicals).

Summary 0.4.2/Conclusions 9.4.2

For Final Approval, the human health risks of the system will be evaluated by the GESAMP-BWWG on the basis of its individual unit operations, i.e. each component of the system requiring operator attention. The manufacturer is th erefore requested to describe separately the potential human health risks associated with each major component of the system and to describe the measures necessary to prevent human exposure for each such component. In particular, the methods employed for the colle ction, treatment and disposal of floc and their potential for occupational exposure need to be described. Additionally, the r ecommended risk reduction measures need clear explanation and documentation, e.g., for each procedure such as floc collection, dewatering, drying, incineration, steriliz ation, storage and disposal in whatever form.MEPC 59/2/5 ANNEX

Page 5

I:\MEPC\59\2-5.doc In the assessment of crew exposure, the risks of each component of the system associated with the unit operations have been identified and clearly indicated. To eliminate the material risks, the equipment settings have been reviewed from the viewpoint of crew safety, and statements regarding the use of suitable protective gear and safety gear have been added. On the basis of this review, the risks associated with operations for th e collection, storage and disposal of flocs have been identified, and measures to reduce th ese risks are consider ed and described.

Summary 0.4.3/Conclusions 9.4.5

The storage and handling of the three Active Substances on board needs to be carefully controlled and the proposed safety measures adequately documented, particularly bearing in mind the corrosive properties of poly aluminium chloride.

The physical and chemical states of the three Ac tive Substances are specif ied, the risks they pose to the ship’s hull are characterized and assesse d, and then the guidelines for their storage and handling are proposed. In particular , with regard to PAC which is slightly corrosive to metals, measures are in place for the prevention and avoidance of hull corrosion by using resin coatings at surfaces in contact with this material.

Summary 0.4.4/Conclusions 9.4.6

One major human health issue regarding the Active Substances relates to the residual acrylamide monomer contained in the polyacrylam ide, which has a range of associated human health hazards and which, in parallel to best prac tices in drinking water pur ification, needs to be maintained at appropriately low concentratio ns. The quality of the polyacrylamide Active Substance needs to be strictly controlled a nd included in the QA programme to ensure acceptably low concentrations of acrylamide monomer.

The maximum allowable discharge concentration is based on the collected data on the hazards to human health and aquatic organisms by residua l acrylamide monomers in polyacrylamide. Polyacrylamide of sufficient quality to satisfy these design concen trations is supplied by Hitachi Plant Technologies, Ltd.

Summary 0.4.5/Conclusions 9.4.7

The BWM system appears from the technical desc ription to be partly open, allowing for possible occupational exposure to the crew to system pro cesses and waste. This is a potential weakness of the system that remains to be adequately addressed.

The constituent equipment of this system has a fully closed structure in order to prevent the leakage or escape of liquid or dus t particles. With regard to the possibility of exposure to crewmembers while carrying out their work, th e assessment and measures are included in a response to the points raised in Summary 0.4.2/Conclusions 9.4.2.

Summary 0.4.6/Conclusions 9.4.8

Human health issues related to the potential con centration of pathogens in the flocs need to be examined and assessed in detail. The flocs c ould, under heavily pollute d intake conditions, have the potential to form a biohazard.MEPC 59/2/5 ANNEX Page 6

I:\MEPC\59\2-5.doc Considering the possibility of pathogenic bacteria contained in the intake water, safety measures for human health have been established agai nst the potential risks of pathogenic bacteria exposure risks to ship crew.

To promote careful handling of coll ected flocs in preparation of b acteria captured in floc, labels are affixed to the collected flocs storage tank s and carrying containers recommending the use of protective gear and promoting care with regard to pathogenic bacteria in the floc storage and landing processes, and stating that the storage tanks and transportation contai ners are to be kept closed.

Summary 0.4.7/Conclusions 9.4.9

Adequate separation of the flocs from the treated water is crucial to the successful operation for the system. When scaling up to la rger treatment capacities, this aspect must be addressed by the applicant, to ensure the human and environmenta l risks of the treated ballast water remains acceptable.

When the equipment is scaled up, its processing performance does not change and th ere is no risk on scaling up this system. In a ddition, the human and environmen tal risks via tr eated ballast water and operations relating to the system rema in acceptable with appropriate measures. This is not only backed up by theory, but has also been clearly demonstrated from the results of comparative verification tests of prototype test set-up a nd land-based test set-up.

Summary 0.4.8/Conclusions 9.4.10

The positioning and operation of the proposed pre-fi ltration, as well as post-filtration and its residue feedback system must be better de scribed and documented. The procedures and processes for routine system maintenance, emergency procedur es, filter and sludge conveyor cleaning, and the treatment and handling of the sludge must be defined and detailed.

The flow paths of water and flocs including the in stallation point of the filter separator unit, the flow of treated water, and the flow of filter residu es trapped in the filter separator unit have been explicitly indicated. Daily and periodic main tenance, recovery procedures for error and emergency situations, cleaning of the filter unit of filter separator, and cleaning of floc collection mechanism of magnetic separator have been expressed clearly in the correspondi ng descriptions concerns regarding. The treatmen t and handling of collected fl ocs have been addressed the concerns raised in Summary 0.4.2/Conclusions 9.4.2.

Summary 0.4.9/Conclusions 9.4.11

The risk to the marine envi ronment from the residual Activ e Substances must be assessed. Concentrations of heavy meta ls, aluminium, iron, acrylami de monomer, VOCs, and faecal coliforms must be measured in the intake wa ter, collected sludge and the discharged ballast water from the representative ballast waters associated with testing under G8. The environmental risks of dischar ging polyacrylamide, a non-biodegradable pol ymer to shore and any subsequent disposal rest rictions must be assessed.

The results of analysing the content of toxi c heavy metals, aluminium, iron, acrylamide monomers, VOCs and faecal coliforms in treated ba llast water and flocs have been presented. The potential risks and hazards have been asse ssed on the basis of those results. The method ofMEPC 59/2/5 ANNEX

Page 7

I:\MEPC\59\2-5.doc measuring polyacrylamide in the treated water and influent has been devel oped, and the results of this chemical analysis have been reported.

Summary 0.4.10/Conclusions 9.4.12

Disposal of the collected sludge to shore-based waste reception facilities should be according to the relevant IMO regulations. The availability of suit able harbour reception faci lities needs to be considered.

Concerns regarding the disposal and handling of colle cted flocs have addr essed the concerns raised in Summary 0.4.2/Conclusions 9.4.2. The pro cess of unloading and di sposing flocs should be performed in accordance with the domestic law and the MARPOL Convention.

Summary 0.4.11/Conclusions 9.4.14/ENVIR ONMENTAL RISK ASSESSMENT 8.1.2

Additional toxicity testin g of the treated Ballast Water shou ld be performed using an appropriate range of conditions. (ENVIRON MENTAL RISK ASSESSMENT 8.1.2: Furthermore, the group recommends that the applicant should conduct the additional toxicity testing under higher concentration of PAC and PASA at the laboratory scale, e.g., usi ng samples taken before the post filtering.)

To address this recommendation, a couple of expe riments have been carri ed out and the results have been described in section 5.3 entitled “Study on effects of treated water under high concentration of Active Substan ces”. The upper limit of the concen tration of added chemicals for toxicity tests have been determined on the basis of tests in which the chemicals were added at twice and three times the standard quantities in order to study the flo cculating performance. Consequently the upper limit of chemicals concen tration for adequate coagulation performance has been detected as approximately twice the st andard amounts. From this result, the maximum amount of chemicals to be added under the cond ition of higher concentration of chemicals was taken to be twice the standard am ount. The results of toxicity test s performed using this effluent are shown.

In addition, to evaluate the effect of seawater with a higher con centration of the residual Active Substances on marine organisms, ecotoxicity tests were carried out using seawater containing flocs generated by this system. Th e test results indicate that fl ocs in such water at the rated condition of chemicals had no effect on aquatic organisms such as zooplankton and fish. These experiments were conducted by a GLP compliant laboratory.

Summary 0.4.12/Conclusions 9.4.13

The risk assessment carried out by the applicant in the submissi on cannot be accepted by the GESAMP-BWWG, as it is unclear how the risk assessment was performed and how both the PEC and PNEC of concentration for Aluminium-i ons and other relevant chemicals have been established. The Group therefore recommends to th e MEPC to request the applicant to prepare a revised risk assessment for consideration in any application for Final Approval.

In addition to the hazard data at the time of the application for Basic Approval, other reference, research and academic reports have been surveyed, subsequently risk assessment has been performed with reference to typi cal risk assessments report.MEPC 59/2/5 ANNEX Page 8

I:\MEPC\59\2-5.doc Summary 0.4.13/Conclusions 9.4.15

The maximum allowable discharge concentration should be set against the parameters that can be measured at such low levels. According to the applicant, it is difficult to measure the amount of PASA directly, if its concentration in water is low. This situation is considered to be unsatisfactory by the Group and an acceptable analytical method should be developed for confirming the maximum allowable discharge concentration for re levant parameters.

The PASA analysis method and measurement results have been developed according to the points raised in Summary 0.4.9/Conclusions 9.4.11. On the basis of the an alytical results and other studies, the maximum allowable discharg e concentration has been established with considering the risk assessment in acco rdance with the points raised in Summary 0.4.12/Conclusions 9.4.13.

3 Outline of Hitachi Ballas t Water Purification System

3.1 Additive concentration of coagulant chemicals

In the standard operation of the ballast water pu rification process using the coagulation magnetic separation method, the amounts of chemicals adde d are 5 mg/L of PAC (as Al), 30 mg/L of triiron tetraoxide (Fe 3 O 4 ) and 1 mg/L of PASA. PAC and PASA are widely used in drinking water purification plants so the safety of these chemicals has been confirmed. Triiron tetraoxide, whose composition is Fe 3 O 4 , is a natural resource that exists broadly in nature. Table 3-1 shows the rated concentration of each chemical used in the coagulation magnetic separation method.

Table 3-1

− Rated concentration of chemicals

Additive agent Additive concentration (mg/L) Triiron tetraoxide 30 PAC 5 (as Al)
PASA 1

3.2 Purification process

Figure 3-1 schematically shows the ballast water purification process in this system. First, triiron tetraoxide and PAC are added to intake water containing plankton, bacter ia, and SS. Next, PASA is added to form flocs of about 1 mm in diameter . These flocs are then se parated from the ballast water using permanent magnets. Finally, any fl ocs that were not removed by the magnetic separation are removed by filtering to produce purified water.

Magnetic separation is appropria te for large-scale continuous high-speed treatment because it is fast, highly efficient sepa ration using magnetic force to re move flocs and enables compact design, which satisfies the requirement fo r ballast water management systems. The SS concentration of the water treated by magnetic separation is low. Consequently, the SS concentration of the water after magnetic sepa ration flowing into the filter is also low, which reduces the load on the filter and enables high-speed, high-efficiency filtering. Th e filter is continuously washed and revitalized during the filtering proceeds. The residue from filter washing is returned to the ballast feed pipes before the first chemical (triiron tetraoxide) injection point through a filter wa shing residue tank and treated together with untreated water to maintain clear water processing.MEPC 59/2/5 ANNEX

Page 9

I:\MEPC\59\2-5.doc With this system, the ballast wa ter can be purified eith er during storage in the ballast tank, during intake, or during discharge. Purification during inta ke is the most effective way to ensure that a minimal amount of organisms and SS enter the balla st tanks and thus reduces sediment build-up in the tanks. Therefore, this application focuse s on the system components and operations for purification during intake.

Hitachi ballast water purification system

Magnetic
seprator

Coagulator Filter
separator

Filter residue from filter washing (to be treated with seawater)

Collected flocs storage tank Treated water (to ballast tank)

Ballast

pump Ballast water PASA

Landing and waste
treatment, etc. Flash
mixer Flocculator Triiron tetraoxide
PAC

Residue tank
from filter

washing Chemical injectors

Figure 3-1 – Purification process

3.3 Purification system

This system consists of chemical injectors, a coag ulator, a magnetic separator, a filter separator, a tank for storing collected flocs, a filter washing residue tank and a control system.

The operation and monitoring of this system is au tomated, so no operators or crew are required. Some manual operations are required for refilling the chemicals into the storage tank, unloading the collected flocs, and maintenance checks; thes e manual operations need to be performed every several weeks or years, dependi ng on usage and water route. Figure 3-2 shows the diagram of this system.MEPC 59/2/5 ANNEX Page 10

I:\MEPC\59\2-5.doc Chemical injectors

Coagulator Magnetic Separator Filter separator

To ballast tank

To collected flocs storage tank

From ballast pump FIC LvS

PL C Power supply Local control panel

Compressed air

Operation panel Central console room

Detection point signal Gravity

or
pump

:Pump

:Motor

:Flow indicator controller

:Level switch

:Programable controller

:Detection point LvS FIC M

PLC LvS LvS

fi

l ter w ashi ng resi due tank (tem porari l y used)

source

Figure 3-2 – Purifi cation process diagram

3.4 System specifications

3.4.1 Environment settings

The environment settings of this system are shown below assuming that the system is installed in an engine room, a steering gear room or an upper deck. If the system is installed in a place such as an upper deck, which does not meet the conditions mentioned here, it is necessary to install the system in a closed casing with thermal insula tion, ventilation, etc., to achieve the environment settings shown below.

Environment settings Temperature: 0 to 50 degrees Celsius Humidity: less than 90 % Slant: less than 22.5 degrees

3.4.2 Facilities line-up

This section describes the facilities line-up (as of October, 2008) of th e Hitachi Ballast Water Purification System “ClearBallast” as follows.

Type1 Treatment rated capacity: 200 m 3 /h Facility size: 20 ft bulk container Power consumption: 20 kW

Type2 Treatment rated capacity: 400 m 3 /h Facility size: 40 ft bulk container Power consumption: 40 kW

Type3 Treatment rated capacity: 800 m 3 /h Facility size: 40 m 2 Foot Print *1) Power consumption: 60 kWMEPC 59/2/5 ANNEX Page 11

I:\MEPC\59\2-5.doc Type4 Treatment rated capacity: 1,200 m 3 /h Facility size: 58 m 2 Foot Print *1) Power consumption: 120 kW

Type5 Treatment rated capacity: 1,600 m 3 /h Facility size: 77 m 2 Foot Print *1) Power consumption: 130 kW

* 1): This shows the installation area of this system.

3.5 General specifications of electrical devices

Table 3-2 lists the standard specification of electrical devices used in this system.

Table 3-1

− General specifications of electrical devices

Term Specification Class of insulation F or B Ingress protection IP22 or P44

3.6 Constituents machines

This section explains the ma in pieces of equipment.

All equipment comes in a closed-structure, pre ssure resistant casing to prevent leakage and scattering of liquid and powder. Figure 3-3 shows the main equipment used in the land-based test set-up (treatment rated capacity of 200 m 3 /h) as an example.

Flash mixer

Flocculator Magnetic separat Filter separator

Control panel

Ballast water Treated water

Figure 3-2

− Overview of land-based test set- up and main constituent machinesMEPC 59/2/5 ANNEX Page 12

I:\MEPC\59\2-5.doc 3.7 Operation procedure

Hitachi Ballast Water Purification System (ClearBallast) is automatically operated by the controlled, and no operator is requ ired on site. An operator opera tes the control panel in the centre console room to issue a remote comma nd for starting the equipment and monitors the operational status indicated on th e control panel’s display during operation. If no problems occur, the operator is only required to issue a re mote command for stopping the equipment.

Figure 3-4 shows the operational pr ocedures for the ballast water purifying system. These consist of “Set-up mode”, “Operational mode” and “Shutdown mode”.

In “Set-up mode”, chemicals required for this sy stem are prepared automatically and the system automatically checks that the devices operate normally.

In “Operation mode”, the system starts and st ops operation corresponding to ballast water pump operation.

In “Shutdown mode”, upon receiving the stop co mmand from the centre console room, the machines in this system are stopped automaticall y, the inside of the ballast water purification system (constituents machines) is cleaned, and preparations for the next operation are performed.

Figure 3-4 – Schematic pro cedure of system operation

3.8 Actions in case of problems or emergency

3.8.1 Corrective actions

Problems stated in this system are classified into three categories related to flow rate, water level (water height in tanks and cas ings) and equipment. These pr oblems are detected by sensors which are controlled and monitored by the control system. If any problems are detected in this system by the sensor, the equipment is automatic ally controlled corresponding to its error level by the control system while a warning buzzer and indication lamp provides safety.

After an error is detected and the equipment stops automatically, the operator should check the control panel’s display to identif y the error and perform inspecti on and recovery work. Since the equipment is not automatically reset after an e rror is solved, the operator should issue a command to re-start operation after checking that the oper ation/control panel in th e centre console room does not indicate any error. Set-up m ode

Operation mode

Shutdown mode Preparation of chemicals

Operation and temporary stop

End stop and system washingMEPC 59/2/5 ANNEX Page 13

I:\MEPC\59\2-5.doc 3.8.2 Actions in case of blackout

If a blackout occurs while the equipment is operating, the equipment stops operations, and automatically controlled valves are reset to st arting position. The intake valve automatically closes when the power supply stops, preventing ba llast water leakage from pipe or others.

Since the equipment does not auto matically reset after the power supply is re stored, the operator should issue the start command to re start operations after checking that the status display in the centre control room or on the local control pane l does not indicate any error. And since this system is equipped with interlocking of start conditions, a restart command does not work unless a safety check has been conducted to prevent human errors.

3.8.3 Actions in case of emergency

Operation of the equipments in this Hitachi Ballast Water Purification System can be stopped urgently by using the emergency stop switch on the control panel in the cen tre control room or local. When this is done, operations stop and the intake valve closes, so ballast water does not leak out. Warning buzzers and indicating lamps in the centre console room or on the local control panel indicate an emergency stop to the operator.

3.9 Scale up

The performance of this system is assured by keeping the water flow velocity in piping and constituents machines (coagulator, magnetic separato r and filter separator) within a certain range, and so can be scaled up while keeping the rated flow velocity. This method of scaling up is the same as general centrifugal pumps and pi ping, and so poses no specific risks.

3.10 Quality assurance

This system is produced in a designated factor y (ISO9001 certified factor y) of Hitachi Plant Technologies Ltd., which has a strict quality cont rol programme, and meets the required quality by the Guidelines for approval of Ballast Water Management Systems (G8) . The factory controls quality according to the quality control programme in the respective stages of production.

3.11 Measures to reduce risks to humans and ships

The measures to reduce risks in the Hitachi Ballast Water Purification System are described below.

3.11.1 Measures to prevent chemical leakage

Prevention of chemical leakage is important to protect the safety of humans and the ships. The following preventive measures are taken in this system to substantially reduce the risk of chemical leakage.

(1) Measures for preventing leakage from the chemical storage tank

Plastics such as PE (polyethylene) are used for the wetted surface of the storage tank and the injection line of PAC, which is slightly corrosive to metals, to avoid the risk of leakage caused by corrosion. The closed structure of the respective chemical tanks reduces the risk s of chemicalMEPC 59/2/5 ANNEX Page 14

I:\MEPC\59\2-5.doc leakage and scattering. Each chemi cal storage tank is placed in co amings with level sensors to detect chemical leakage and aler t crew. The leaked chemicals are sent to the filter washing residue tank, and are tr eated appropriately.

(2) Measures for preventing liquid leak age in the chemical injection line

The causes of chemical leakage from the chem ical injection line are corrosion, an unusual pressure rise in the piping and degradation of pa cking gland of flange junc tion, so special care is taken for the materials and structure of the chemi cal injection line. The injection line is equipped with a pressure safety valve to safeguard ag ainst unusual pressure increase and the increased pressure, and the chemicals are returned to th e chemical injection storage tank. Increased pressure is relieved in the chemi cal storage tank. Therefore, the po ssibility of chemical leakages from unusual pressure increases is eliminated. The packing gla nd on flange junction is checked and replaced periodically.

3.11.2 Measures for preventing water leakage

(1) Measures for preventing water leakage from the equipment

The causes of water leakage are corrosion and equi pment defect, so special care is taken for the painting and structure of the equipment and ope ration control at the time of any problems.

(2) Measures for preventing water leakage from the piping

The causes of water leakage from the piping ar e corrosion and unusual pressure rises in the piping, so special care is taken for surface treatm ent of the wetted surface and operation control in the event the piping becomes occluded.

3.11.3 Measures for preventing leakage of collected flocs

Sufficient care is taken for the painting and stru cture of the equipment a nd operation control at the time of any error to prevent floc leakage.

3.11.4 Preventive measures for electric accidents

The causes of electric accidents ar e overcurrent, electrif ication and electrical leak, so safety devices are provided for the local control panel and equipment.

3.12 Maintenance

The Hitachi Ballast Water Purification System is operated automatically as already described, and so no individual operation by ship crew is required and no dedicated operators are needed. This section describes the inspection work to be performed by the operator. The check results are to be record in a blotter and managed.

3.12.1 Daily inspection

Daily inspection requires only visual inspection of the following items before and after operation:

- checking of error display; - storage quantity of chemicals;MEPC 59/2/5 ANNEX Page 15

I:\MEPC\59\2-5.doc - leakage from the equipment and piping; - appearance of the equipment and instruments; and - loose nuts and bolts.

3.12.2 Periodic inspection/maintenance

The outline is described below:

- checking the operation of the devi ces (operation, vibration, abnormal sound, deformation, damage and oil leakage): monthly;

- checking the storage status of chemicals (check the powder supply opening and liquid storage tank interior): monthly;

- inspection and refilling of lubricant: monthly;

- cleaning of the st rainer: monthly;

- replacement of the lubricant: yearly;

- inspection/replacement of consumables: yearly;

- cleaning of the chemical storage tank: yearly;

- inspection and cleaning of the local c ontrol panel (looseness, contact status, damage on the insulated section, defo rmation and discoloration): yearly;

- checking of insulation resistance for the cable and transformer: at docking;

- checking of sequence: at docking;

- checking of the painting a nd lining: at docking; and

- disassembly for maintenance: every 5 years.

3.12.3 Safety measures for humans and hull

Safety precautions are required for inspectio n, recovery and maintenance work because chemicals, collected flocs or lubricant may leak and humans could be expos ed to it. Basic safety precautions and actions in case of leakag e or exposure are described below.

(1) Safety precautions

When supplying/inspecting chemicals and perform ing recovery work for leakage, operators should wear protective gear and take measures to pr event the leaked chemical from spreading and reduce the associated risks, because the ch emicals could cause injury to operators and damage to the ship.MEPC 59/2/5 ANNEX Page 16

I:\MEPC\59\2-5.doc (2) Emergency treatment for exposure and measures in case of leakage

If any chemicals or collected flocs leak, and a person are exposed to it, MSDS counter measures should be taken. As eye exposure poses the hi ghest risk, a portable eye washer should be equipped nearby the working area.

3.13 Supply and storage of chemicals

3.13.1 Chemicals used in the system

The following chemicals are used in this system.

(1) Triiron tetraoxide

Name of substance (IUPAC): triiron tetraoxide Synonyms: Ferriferous oxide (Fe 3 O 4 ), Ferrosoferric oxide, Iron ferrite, Iron oxide, Iron oxide black, Magnetic iron oxide, Magnetite (EU, 2000a) Molecular formula or structural formula: Fe 3 O 4 Main use: Copier toner, Pigmen t, Coating material, Cosmetics

(2) PAC

Name of substance (IUPAC): Basic aluminium chloride Synonyms: Aluminium chlorhydrate, Aluminium chloride hydroxide, Aluminium chloride hydroxide oxide, basic, Aluminium chloride oxide, polyalu minium chloride, (EU, 2000b) Molecular formula or structural formula: [Al 2 (OH) n Cl 6-n ] m (1 ≤ n ≤ 5, m ≤ 10) Main use: Coagulant chemical for water pr ocessing (drinking water, sewage water, industrial waste water)

(3) PASA

Name of substance (IUPAC): Acryla mide sodium acrylate copolymer Synonyms: 2-Propenoic acid, sodium sa lt, polymer with 2-propenamide, 2-Propenamide, polymer with sodium 2-propenoate, Acrylamide Sodium Acrylate Copolymer Molecular formula or structural formula

CH 2 CH CH 2 n CH

m

CONH 2 COONa Main use: Flocculant chemical for water pro cessing (drinking water, sewage water, industrial waste water), Gel for electrophoresis

3.13.2 Method of supplying chemicals

The stable supply of chemicals is very important for this system, and so the supply bases and system should be established.MEPC 59/2/5 ANNEX Page 17

I:\MEPC\59\2-5.doc 3.13.3 Storage of chemicals

Chemicals are stored in the environment settings specified in section 3.4.1. The chemicals used in this system do not have a risk of ignitability or self-reaction, and the pr eventive measures for leakage described in section 3.11.1 assure the safe ty of humans and the hu ll structure. Material Safety Data Sheets (MSDS) for each chemical mu st be indicated in the same or adjacent area on board the ship, in which the chemical is stored.

4 Assessment of treated water

4.1 Water sampling

Table 4-1 shows the rated treatment dose conditions for the chemicals, which are used for all analyses described in this section.

Table 4-1

− Amount of additive chemi cals (rated concentration)
(Unit: mg/L)

Additive chemical Addition concentration (mg/L) Triiron tetraoxide 30 PAC 5 (as Al)
PASA 1

Tokyo

Bay Intake
pump Treatment equipment Simulated Ballast Water Tank Tokyo Bay

Untreated water is sampled. Treated water is sampled at the outlet of the rotary filter separator, which is the final stage of the system. Feed Tank

Treated water is s sampled after 5 days’ storage.

Figure 4-1 – Schematic diagram of water sampling positions

Samples of untreated water and treated water were taken from the appropriate sampling positions indicated in Figure 4-1.

4.1.1 Measurement of pH and SS concentration

Table 4-2 shows the average pH values of treated water and untreated water. These analyses were carried out with both the prototype in 2007 and the land-based set-up in 2008. The pH of treated water is lower than that of untreated water, but differs only slightly. The pH reduction is limited in the ambient water environment due to the mechanism of equilibrium, as described in the Basic Approval Application. Therefore no pH-reducing effect is expected in the aqueous environment, considering that the treated wate r is discharged immediately af ter treatment. The treated water has no corrosivity to ballast water tank s or other equipment in the ship.MEPC 59/2/5 ANNEX Page 18

I:\MEPC\59\2-5.doc Table 4-2 – Average pH value of treated water
Treatment system Sample pH Untreated water 8.5 Land-based set-up Treated water 7.1 Untreated water 8.3 Prototype Treated water 7.0 (n=10)

Table 4-3 shows the average SS concentration in treated water and untreat ed water. The results show that the SS concentration in the treated water of the loaded test was lower than 1 mg/L, as it also was in the control test.

Table 4-3 – SS concentration of treated water
(Unit: mg/L)
SS concentration Treatment system Test Before
treatment After Treatment LOD

Control 1) 5 or < 5 < 1 Land-Based Test Equipment Loaded test 2) 50 ~ 60 < 1 1

Control 1) 5 or < 5 < 1 Prototype Equipment Loaded test 2) 50 ~ 60 < 1 1

1) Actual seawater taken from Tokyo BayLOD: Limit of Detection; (n=10) 2) Kaolin was added to the actual seawater before the treatment

The above test results s how that this system is appropriate for use in large-scale treatment in terms of its pH and SS removing performance.

4.1.2 Compliance with regulation D-2 of the BWM Convention

This section evaluates the qualities of water tr eated by the land-based tr eatment test equipment and shipboard test equipment with respect to regulation D-2. All of the results satisfy regulation D-2, verifying that this technology is reliable under both land-based and shipboard conditions.

Table 4-4 shows a typical example of analysis of water treated by the land-based treatment test equipment and Table 4-5 shows another typical re sult produced by the shipboard test equipment in accordance with Guidelines (G8).MEPC 59/2/5 ANNEX Page 19

I:\MEPC\59\2-5.doc Table 4-4

− Typical example of an alysis of treated water (Land-based test set-up)

Item Unit Untreated
water a) Treated
water b) Control c) Criteria
Viable organisms

50 μm or larger Units/m 3 5,700,000 0 7,200,000 <10
Viable organisms 10 – 50 μm Units/ml 15,000 <1 1,100 <10

E. coli cfu/100mL 18,000 <1 1,600 <250 Toxicogenic Vibrio cholerae (O1 and O139) cfu/100mL <1 <1 <1 <1

Intestinal enterococci cfu/100mL <1 <1 <1 <100

Test conducted in September 2008 (a) Analysed sample taken immediately before the treatment equipment (b) Analysed at discharge after holding period (c) Analysed at discharge after holding period

Table 4-5 – Typical example of analysis of treated water (Shipboard test set-up)

Item Unit Untreated
water a) Treated
water b) Control c) Criteria
Viable organisms

50 μm or larger Units/m 3 31,603 0 8,392 <10
Viable organisms 10 – 50 μm Units/ml 155 <1 15 <10

E. coli cfu/100mL <1 <1 <1 <250 Toxicogenic Vibrio cholerae (O1 and O139) cfu/100mL <1 <1 <1 <1

Intestinal enterococci cfu/100mL <1 <1 <1 <100

Test conducted in May 2008 (a) Analysed sample taken immediately before the treatment equipment (b) Analysed at discharge after holding period (c) Analysed at discharge after holding period

4.1.3 Quantities of substances derived from additive chemicals in treated water

(1) Samples

The quantities of substances in the sample wa ter treated by the land-based test set-up on reclaimed land in Tokyo Bay (tr eatment rated capacity of 200 m 3 /hr) have been determined by analysis.

(2) Dosage concentration

The quantities of chemicals us ed in this test matched th e rated operating conditions (see Table 4-1).MEPC 59/2/5 ANNEX Page 20

I:\MEPC\59\2-5.doc 4.1.4 Result of analysis

4.1.4.1 Active Substances

(1) Aluminium

Table 4-6 shows the results.

Table 4-6 – Aluminium c oncentration of treated water

(Unit: mg/L) Sample Value Limit of Detection
Untreated Water 0.048

Treated Water 0.022 0.001

(2) Iron

Table 4-7 indicates that iron was not detected in treated water.

Table 4-7 – Iron concentr ation of treated water

(Unit: mg/L) Sample Value Limit of Detection
Untreated Water 0.05

Treated Water Not detected 0.01

(3) Acrylamide monomers

Table 4-8 indicates that no acryla mide monomers were detected in either treated or untreated

water.

Table 4-8 – Acrylamide monome rs concentration of treated water

(Unit: mg/L) Sample Value Limit of Detection
Untreated Water Not detected

Treated Water Not detected 0.0001

(4) PASA

PASA concentration was measured by PGC-MS. Table 4-9 shows that PA SA was not detected in either untreated water or treated water.MEPC 59/2/5 ANNEX Page 21

I:\MEPC\59\2-5.doc Table 4-9 – PASA con centration of treated water

(Unit: mg/L)

Sample Untreated Water Treated Water Limit of Detection 1 Not detected Not detected 0.1 2 Not detected Not detected 0.1

4.1.4.2 Others

(1) Harmful heavy metals

Table 4-10 shows the result of harmful heavy meta ls analysis (CERI, 2008 g). No harmful heavy metals were detected in treated water.

Table 4-1 – Harmful Heavy Meta ls concentration of treated water

(Unit: mg/L)

Metal Value Limit of Detection Cadmium (Cd) Not detected 0.002 Lead (Pb) Not detected 0.005 Mercury (Hg) Not detected 0.0001 Chromium [VI] (Cr[VI]) Not detected 0.02 Arsenic (As) Not detected 0.001 Selenium (Se) Not detected 0.001

(2) VOCs

Table 4-11 shows the VOC quantities in treat ed water, measured by purge-and-trap gas chromatograph-mass spectrometry as quantitativ e and qualitative analysis. No VOCs were detected in treated water (CERI, 2008h).MEPC 59/2/5 ANNEX Page 22

I:\MEPC\59\2-5.doc Table 4-11 – VOCs of treated water
(Unit: mg/L)
VOC Value 1,1-dichloroethylen e Not detected

Dichloromethane Not detected Trans-1,2- dichloroethylene Not detected Cis-1,2- dichloroethylene Not detected

Chloroform Not detected 1,1,1-trichloroethane Not detected

Carbon tetrachloride Not detected

Benzene Not detected 1,2-dichloroethane Not detected Trichloroethylene Not detected 1,2-dichloropropane Not detected

Bromodichloromethane Not detected Cis-1,3-dichloropropene Not detected

Toluene Not detected Trans-1,3-dichloropropene Not detected 1,1,2-trichloroethane Not detected Tetrachloroethylene Not detected

Dibromochloromethane Not detected m,p-xylene Not detected O-xylene Not detected

Bromoform Not detected

P-dichlorobenzene Not detected Limit of Detection: 0.0001 mg/L as converted into toluene

4.2 Quality of collected floc

The potential concentration of naturally present s ubstances of intake water and chemicals in the collected flocs needs to be examined and assesse d in detail. Therefore identification of heavy metal, VOC, and acrylamide monomers was perf ormed. The analysis identification used the collected flocs produced in processing seawater at the land-based test set-up and/or prototype test set-up on reclaimed land in Tokyo Bay.

4.2.1 Analysis and results

(1) Harmful heavy metal

Hence the analysis employed elution analysis, which is conventionally used for solids such as mud, to identify heavy metals in the collected flocs (HPS, 2008b). As stated in Table 4-12, the analysis results show that the heavy metals surveyed were not detected.MEPC 59/2/5 ANNEX Page 23

I:\MEPC\59\2-5.doc Table 4-12 – Elution analysis of heavy metal in floc
(Unit: mg/L)

Metal Value Limit of Detection Mercury (Hg) Not detected 0.0005 Cadmium (Cd) Not detected 0.001 Lead (Pb) Not detected 0.001 Chromium [VI] (CrV I]) Not detected 0.005 Selenium (Se) Not detected 0.001

(2) VOC

Purge and trap gas chromatography mass spectrome try was used to quantify VOC in flocs. The results show that no VOC was detected as shown in Table 4-13.

Table 4-2 – VOCs in floc
(Unit: mg/kg)

Item Value

Benzene Not detected Tetrachloroethylene Not detected Trichloroethylene Not detected 1,2-dichloroethane Not detected

Dichloromethane Not detected 1,1,1-trichloroethane Not detected

Carbon tetrachloride Not detected 1,1-dichloroethylene Not detected Cis-1,2- dichloroethylene Not detected 1,1,2-trichloroethane Not detected 1,3-dichloropropene Not detected Limit of Detection: 0.0001mg/L as conversion into Toluene

(3) Acrylamide monomers

Table 4-14 shows analysis results from chromatography mass spectrometry to quantify acrylamide in flocs. The results show that no acrylamide monomer was detected as shown in Table 4-14.

Table 4-3 – Acrylamide monomers in floc
(Unit: mg/kg)

Substance Value Limit of Detection Acrylamide monomers Not detected 0.02MEPC 59/2/5 ANNEX Page 24

I:\MEPC\59\2-5.doc 4.2.2 Conclusions of analysis

As stated above, flocs collected from processing seawater in rated con centration of chemical concentrations as shown in Table 4-1 were found to contain no harmful heavy metal, acrylamide monomers, or VOC (the detected value is lower than the detection limit).

5 Ecotoxicity test of treated ballast water

In this section, the result s of ecotoxicity st udies with treated ballast water as a test substance are presented in accordance with the Procedure for approval of ballast water management systems that make use of Active Substances (G9).

5.1 Acute toxicity test

In accordance with the Methodology for inform ation gathering and the conduct work of the GESAMP-BWWG (IMO circular BWM.2/Circ.13), th e acute toxicity te sts for high and low salinity water were performed using water treated by this system (IDEA, 2008f, 2008g).

5.1.1 Test set-up

The land-based treatment test with high and low salinity water was performed using a land-based test set-up of the Hitachi Ballast Water Purification System in accordance with the IMO Guidelines for approval of Ballast Water Management Systems (G8). The treated-water discharge (hereinafter “TWD”) samples (i.e. s imulated ballast water discharge) were produced and subjected to toxicity tests.

5.1.2 Toxicity test results for high salinity water

Acute toxicity tests of 1-day-hold and 5-day-hol d TWD samples (high salin ity range; >32 psu) on algae, invertebrates, and fish were conducted by a GLP compliant laboratory. From the results shown in Table 5-1, it is concluded that 100 % treated ballast water, which is a non-diluted sample of treated water, by this system ha s no toxicity impact on these aquatic species (IDEA, 2008f).

Table 5-1 – NOEC of treated ba llast water for high salinity water

Test sample Classification Species End point NOEC

Algae Skeletonema
costatum Growth inhibition 72-h NOEC 100% treated ballast water *

Invertebrate Hyale barbicornis Mortality 96-h NOEC 100% treated ballast water * 1-day-hold treated water discharge sample

Fish Oryzias javanicus Mortality 96-h NOEC 100% treated ballast water *

Algae Skeletonema
costatum Growth inhibition 72-h NOEC 100% treated ballast water *

Invertebrate Hyale barbicornis Mortality 96-h NOEC 100% treated ballast water * 5-day-hold treated water discharge sample

Fish Oryzias javanicus Mortality 96-h NOEC 100%treated ballast water *

* No effects were observed in 100% treated ballast wa ter which is a non-diluted sample of treated water.MEPC 59/2/5 ANNEX Page 25

I:\MEPC\59\2-5.doc 5.1.3 Toxicity test results for low salinity water

Acute toxicity tests of 1-day-hold and 5-day-hol d TWD samples (low salinity range; <22 psu) on algae, invertebrates, and fish were conducted by a GLP compliant laboratory. From the results shown in Table 5-2, it is concluded that 100 % treated ballast water, which is a non-diluted sample of treated water, by this system ha s no toxicity impact on these aquatic species (IDEA, 2008g).

Table 5-2

− NOEC of treated ballast water for low salinity water

Test sample Classification Species End point NOEC

Algae Skeletonema
costatum Growth inhibition 72-h NOEC 100% treated ballast water *

Invertebrate Hyale barbicornis Mortality 96-h NOEC 100% treated ballast water * 1-day-hold treated water discharge sample

Fish Oryzias javanicus Mortality 96-h NOEC 100% treated ballast water *

Algae Skeletonema
costatum Growth inhibition 72-h NOEC 100% treated ballast water *

Invertebrate Hyale barbicornis Mortality 96-h NOEC 100% treated ballast water * 5-day-hold treated water discharge sample

Fish Oryzias javanicus Mortality 96-h NOEC 100% treated ballast water *

* No effects were observed in 100% treated ballast wa ter which is a non-diluted sample of treated water.

As stated above, no effects were observed in all sp ecies in 100% treated ballast water, which is a non-diluted sample of tr eated water, for high a nd low salinity water.

5.2 Chronic toxicity test

5.2.1 Test set-up

Seawater was treated with the prototype test set-up installed on reclaimed land in Tokyo Bay which simulates the ballast water purification system (treatment rate d capacity of 50 m 3 /hr) and the samples of treated water were analysed.

5.2.2 Materials and methods

In order to evaluate the hazards of Active Substa nces to aquatic organisms, the substances were injected into seawater collect ed from Tokyo Bay to produce fi nal concentrations two times higher than those of the rated processing conditions for this system (Table 5-3) and the treated water samples collected by this system were analysed.MEPC 59/2/5 ANNEX Page 26

I:\MEPC\59\2-5.doc Table 5-3 – Final concentrations of chemi cals after injection for chromic toxicity test

(Unit: mg/L)

Active Substance Concentration in untreated
seawater Triiron tetraoxide 60 PAC 10 (as Al)
PASA 2

Approximately 20 L of the treated water was sampled from the effluent in the outfall of the filter separator when the processing ha d been carried out for 16 to 32 minutes (see section 4.1). The sample of treated water was put in a 20-L polyethyl ene bottle and transported to the test facility in cool, shaded conditions. All the samples of treated water were carried into the test facility the next day and were used in the toxicity tests.

5.2.3 Test results

The chronic toxicity tests using the water treated by this system on algae, invertebrates, and fish were conducted by a GLP compliant laboratory. Fr om the results shown in Table 5-4, it is concluded that 100% treated ballast water, which is a non-diluted sample of treated water, by this system has no toxicity impact on thes e aquatic species (IDEA, 2007a, b, c).

Table 5-1 – NOEC on chronic toxicity of tr eated ballast water for high salinity water

Test sample Classification Species End point NOEC

Algae Skeletonema
costatum Growth inhibition 72-h NOEC 100% treated ballast water *

Invertebrate Hyale barbicornis Mortality 21-days NOEC 100% treated ballast water * Treated ballast
water Fish Oryzias javanicus Post-hatch mortality 40-days NOEC 100% treated ballast water *

* No effects were observed in 100% treated ballast wate r which is a non-diluted sample of treated water.

As stated above, no chronic toxici ty effects were observed in all species in 100% treated ballast water, which is a non-diluted sample of treated water.

5.3 Study on effects of treated water under hi gher concentration of Active Substances

5.3.1 Ecotoxicity tests of water with flocs

Concerning water containing flocs generated in th e rated additive concentration of chemicals by this system, ecotoxicity tests were carried out to evaluate the effect of water treated with a high concentration of Active Substances on organisms.

The test results indicate that flocs in treated water (100% floc water) generated by the Hitachi Ballast Water Purification System at the rated condition of chemicals had no physical effect on aquatic organisms such as zooplankton and fish.MEPC 59/2/5 ANNEX Page 27

I:\MEPC\59\2-5.doc 5.3.2 Conclusions of study on water treated at high concentration conditions of Active Substances

As stated in the previous sections, ecotoxicity tests of water containing flocs generated by this system to evaluate the upper limit of additive ch emical concentrations, and the adverse effect (including physical and ecotoxici ty) of water treated with a high concentration of Active Substances on organisms were carried out. The re sults indicate that the water treated with the rated amounts of chemicals, the water treated with double the amounts of chemicals, and flocs themselves have no toxic effect on organisms. The safety of treated water provided by this system is thus verified.

6 Risk characterization and risk assessment

6.1 Summary of critical information of substances

6.1.1 Physical chemical properties of Acti ve Substances and treated ballast water (G9:4.2.1.4)

The relevant physical chemical prop erties in Table 6-1 show that al l the substances listed are well known and that the chemicals employed are re latively harmless except for undiluted PAC solution, which is acidic and slightly corrosive, as stated in the application for Basic Approval.

In water, the chemical characteri stics of the listed materials othe r than PAC are relatively simple. However, dissolved aluminium compounds, incl uding PAC, show complicated chemical characteristics.

Table 6-1 – Physical chemical properties

Property Triiron tetraoxide PAC PASA Acrylamide

monomers Treated ballast
water CAS No. 1317-61-9 1327-41-9 25085-02-3 79-06-1 None Melting point (°C) 1,538 1) About -12 2) Not Applicable 84.5 1) NR 9)

Boiling point (°C) Not Applicable About 103 2) Not Applicable 125 at 3kPa 1) NR

Flammability (Flash point for liquids; °C) Not Applicable Non-combustible 5) None #1, 4) 138 (closed method) 3) NR

Density (20°C; kg/m 3 ) 5,200 (5.2g/cm 3 ) 1) 1,340 (1.34g/cm 3 ) 2) Bulk specific gravity; 0.55-0.65 4) 1,130(1.13g/cm 3 ) 3) NR

Vapour pressure (20°C; Pa) Not Applicable Non-evaporable 5) Nonevaporable #2 1 3) NR

Vapour density (air = 1) Not Applicable Not Applicable Not Applicable 2.46 (calculated value) NR

Water solubility g/L Insoluble 6) Soluble 1) Mixing with water forms highly viscous gel-like material 4) 2,040 (25°C) NRMEPC 59/2/5 ANNEX Page 28

I:\MEPC\59\2-5.doc Property Triiron tetraoxide PAC PASA Acrylamide

monomers Treated ballast
waterOxidationreduction potential Not Applicable None 5) None 4) None 7) None

Corrosivity to materiaequipment None Corrosive to metals None None None

Autoignition temperature (°C) Not Applicable Non-combustible 5) None 4) 424 3) NR

Explosive properties Not Applicable None None None 7) NR

Oxidizing properties Not Applicable None 5) None 4) None 7) NR

Surface tension None Equal to water because of aqueous solution None None NR

Viscosity (mPa.s) None 28 mPa·s (25°C) 2) Mixing with water forms highly viscous gel-like material 4) 2.71 mPa·s (25°C) (50%

aqueous solution) 8) 1.55cP (16°C)

Thermal stability Transformed into iron oxide (Fe 2 O 3 ) by heating in air 1) Non-flammable Combustible by heating at high temperature Violently polymerizes when heated to over 85°C or when exposed to of light or oxidizing agents. When heated to decomposition, fumes and nitrogen oxide are generated. 3),
8) NR

Reactivity to storage tank material None None None None NR

pH in solution NR NR 4.3 (15%) 1) NR NR 7 - 7.3

Salinity N.D.

Conductivity 4.5 S/m

TOC 1.3 mg/L
DOC N.D.MEPC 59/2/5 ANNEX Page 29

I:\MEPC\59\2-5.doc Property Triiron tetraoxide PAC PASA Acrylamide

monomers Treated ballast
waterOther physicochemical properties None None None Because acrylamide readily polymerizes,

common products contain polymerization inhibitors 1) None

Dissociation constant (pKa) Not Applicable No dissociable

group No dissociable

group No dissociable

group NR

1) Merck, 2006, 2) EU, 2000b, 3) IPCS, 2000, 4) Dia-Nitrix, 2004, 5) Asad a Chemical Industry, 2003, 6) Dean,1999, 7) EU, 2002, 8) HSDB, 2007, 9) NR: not required for G9 #1 Non-combustible under conditions of no rmal use (normal pressure, 0-50°C). #2 Non-evaporable under normal pressure and normal temperature because of high molecular weight polymers (several million or more).

6.2 Risk assessment with regard to ship safety

Specific countermeasures that can be employed in this system to deal with envisaged problems during the ballast water purifica tion have been discussed.

6.3 Risk to human health

6.3.1 Data on NOAELs to be used in th e assessment of risk to human health

Data from key studies which can be utilized in th e assessment of risk to human health are shown in Table 6-2.MEPC 59/2/5 ANNEX Page 30

I:\MEPC\59\2-5.doc Table 6-2 – Key studies utilized in the assessment of risk to human health

Substance Test Species Route Duration Result References
Iron oxide (Reference) Occupation Human Inhalation - TLV-TWA: 5 mg/m 3 1) ACGIH, 2005

Triiron tetraoxide Repeated toxicity - Oral (drinking

water) - - -

PAC Repeated toxicity Rat Inhalation 6 months LOAEL: 0.25 mg/m 3 Steinhagen et al., 1978

PAC Repeated toxicity - Oral (drinking

water) - - -

Aluminium (Reference) Repeated toxicity Human Oral (drinking

water) 0.1 mg/L or less 2) 0.2 mg/L or less WHO, 2003b

PASA Repeated toxicity - Inhalation - - -

PASA Repeated toxicity - Oral (drinking

water) - - -

PASA Repeated toxicity Rat, dog Oral (feeding) 2 years NOAEL: >5% Cosmetic Ingredient

Review,

2005 Acrylamide

monomers Occupation Human Inhalation - TLV-TWA: 0.03 mg/m 3 3) ACGIH, 2005

Acrylamide

monomers Repeated toxicity Rat Oral (drinking

water) 90 days NOAEL: 0.2 mg/kg/day EU, 2002;NTPCERHR,

2005 1) Measured as respirable fraction of the aerosol. 2) Owing to the uncertainty surrounding the human data and the limitations of the animal data as a model for humans, a health-based guideline value for aluminium cannot be derived at this time (WHO, 2003b). Therefore, the practicable level is derived based on optimization of the coagulation process in drinking-water plants using aluminium-based coagulants, to minimize aluminium levels in finished water. Concentrations of aluminium of 0.1 mg/L or less ar e achievable in large water treatment facilities. For small facilities (e.g., those serving fewer than 10,000 people), 0.2 mg/L or less is a practicable level for aluminium in finished water (WHO, 2003b). 3) Measured as inhalable fraction and vapour.

6.3.2 Assessment of exposure and risk to humans

The target populations of exposure and risk asse ssment are ships’ crew who may be at risk of occupational exposure [1] in Figur e 6-1 as well as people in th e general population who may be subjected to indirect exposure by way of sea bathing or through the environment [2] in Figure 6-1.MEPC 59/2/5 ANNEX Page 31

I:\MEPC\59\2-5.doc 

### [1] Ship Crew

Aquatic Organisms 

### [2] General Population Air Ballast Water Discharge

Aquatic Environment

Food, Drinking Water 

### [1] Ship Crew

Aquatic Organisms 

### [2] General Population Air Ballast Water Discharge

Aquatic Environment

Food, Drinking Water

Figure 6-1 – Schematic diagram of target populations of exposure and risk assessment for this system

In the Technical Guidance Document on Risk Assessment (ECB, 2003) and the Methodology for information gathering and the conduct work of the GESAMP-BWWG (IMO circular BWM.2/Circ.13, Appendix 2, “Human Exposure Asse ssment”) the following procedures for the assessment of exposure and risk to huma n health have been recommended:

.1 identification of exposure routes and development of exposure scenarios for respective exposure routes; and

.2 estimation of the amounts of exposur e (intake) and risk assessment.

Specifically, risk assessment is to be conducted by comparing the margin of safety (MOS), which can be calculated by dividing th e NOAEL (no observed adverse eff ect level) in humans or experimental animals by the estimated amount of exposure, with MOSref (100) in compliance with the “Human Exposure Assessment” mentioned above.

MOS = NOAEL/estimated exposure amount

Among the data on NOAELs to be used in the asse ssment of risk to human health, as shown in Table 6-2, those obtained in toxicity studies in mammals which have been judged to be applicable to the present risk as sessment are shown in Table 6-4.

Table 6-3 – Results of assays of chemicals in treated ballast water

(Unit: mg/L)

Substance Concentration in discharged ballast water Limit of Detection

Aluminium 0.022 0.002 PASA n.d. 0.1 Acrylamide monomers n.d. 0.0001 Iron n.d. 0.01MEPC 59/2/5 ANNEX Page 32

I:\MEPC\59\2-5.doc Table 6-4 – Data on toxicity studies in mammals utilized in risk assessment

Substance Test Route Species Duration Result References

PASA Repeated toxicity Oral (feeding) Dog 2 years NOAEL: >1,250 mg/kg/day 1) Cosmetic Ingredient Review, 2005

Acrylamide

monomers Repeated toxicity Oral (drinking

water) Rat 90 days NOAEL: 0.2 mg/kg/day EU, 2002;NTPCERHR,

2005

Aluminium (Guideline for drinking water treatment facility) 0.2 mg/L (small facility)

0.1 mg/L (large facility) WHO, 2003b

1) convert mixing ratio 5% of dose level into dose amount per kilogram of body weight(food intake data referred to Lehman, A.J. (1954) )

6.3.3 Assessment of exposure to ships’ crew

6.3.3.1 Identification of exposure routes and exposure scenarios

In this section, recalling the recommendations of the GESAMP-BWWG (see section 2), work operations to be performed in this system that ma y serve as routes of exposure to humans will be identified, and exposure scenarios for the re spective exposure routes are examined.

6.3.3.2 Estimation of the amount of exposure and risk assessment

Exposure scenarios for the respective operation pro cesses were examined. It was confirmed that measures adopted in this system make it possi ble to minimize the risk of human exposure to chemicals to be used in this system and fl ocs through all of the ex posure routes assessed including percutaneous, oral and inhalation.

Risk to human health (i.e. workers in this case) of exposure to floc is judged to be very low based on the facts that measures, such as washing in nearby washing facilitie s, can be taken in preparation that accidental exposure to the eyes or skin occurs.

6.3.4 Exposure of general population through the environment

In this section, exposure routes and exposure scen arios will be examined for possible exposure of general population through the en vironment that may occur af ter the discharge of active chemicals from this system.

6.3.4.1 Identification of exposure routes and exposure scenarios

Possible scenarios of exposure to the general population through the environment are limited to the following:

Scenario 1: Oral exposure (through water dr inking) of sea bather s and workers in the surrounding water areas; and

Scenario 2: Oral exposure to the general popu lation through the food chain (by way of marine foods).MEPC 59/2/5 ANNEX Page 33

I:\MEPC\59\2-5.doc 6.3.4.2 Estimation of the amounts of exposure and risk assessment

In this section, estimation of the amounts of e xposure and risk assessment will be conducted for the respective expos ure scenarios.

(1) PAC

As shown in paragraph 4.1.4.1 (1), the concentrati on of aluminium in treated ballast water was found to be 0.022 mg/L. This value is substantially smaller than the feasible target concentration of aluminium in tap water specified by WHO, that is, 0.1 mg/L or 0.2 mg/L (for large and small drinking water treatment plants, respectively). Therefore, there is no risk of exposure by the oral route (water drinking) to aluminium contained in treated ballast water.

In the assessment of risk to the general popul ation of oral exposure through the food chain by way of marine products, bioconcentr ation in marine organisms does no t need to be considered for PAC, and there may be no risk to the general population of oral exposure to PAC through the food chain.

(2) PASA

While the concentration of PASA in treated ballast water was found to be less than 0.1 mg/L, as shown in Table 4-9, its concentration is expected to be further diluted in discharged water area. MOS has been estimated in accordance with a worst-case scenario, in which no dilution in water is assumed to occur, under the assumption that the water concentration of PASA derived from treated ballast water is 0.1 mg/L.

MOS = 1,250 mg/kg/day/(0.0003 mg/kg/day) = 4.2 x 10 6

Since this MOS value is substa ntially higher than the MOSref (100), it can be judged that exposure through water drinking to PASA derived from discharged treated ballast water will not affect the health of sea bathers or workers in surrounding water areas.

In the assessment of risk to the general popul ation of oral exposure through the food chain by way of marine products, bioconcentr ation in marine organisms does no t need to be considered for PASA, and it would appear that ther e is no risk to the health of humans (the general population) by the oral route through the food chain.

(3) Acrylamide monomers

While the concentration of acrylamide monomers in treated ballast wate r was found to be less than 0.0001 mg/L, as shown in Table 4-8, its concentr ation is expected to be further diluted in discharged water area. MOS has been estimated in accordance with a worst-case scenario, in which no dilution in water is assumed to occur. Under this assumption, the concentration of acrylamide monomers derived from tr eated ballast wate r is 0.0001 mg/L.

MOS = 0.2 mg/kg/day/(3.3 x 10 -6 mg/kg/day) = 6.1 x 10 4MEPC 59/2/5 ANNEX Page 34

I:\MEPC\59\2-5.doc Since this MOS value is substa ntially higher than the MOSref (100), it can be judged that exposure through water drinking to acrylamide m onomers derived from discharged treated ballast water will not affect the health of sea bathers or workers in surrounding water areas.

In the assessment of risk to the general popul ation of oral exposure through the food chain by way of marine products, bioconcentr ation in marine organisms does no t need to be considered for PASA, and it would appear that ther e is no risk to the health of humans (the general population) by the oral route through the food chain.

(4) Triiron tetraoxide

While the concentration of iron in treated ballast water was found to be less than 0.01 mg/L, as shown in Table 4-7, its concentration is expected to be further diluted in discharged water area. On the other hand, the concentration of iron in wa ter has been reported to be 10 μg/L (0.01 mg/L) in seawater and 1 mg/L in river water (OECD, 2007). These findings indica te that iron concentration in treated ballast water is similar to or less than that in the water areas into which treated ballast water is to be disc harged, and that iron in discharg ed treated ballast water will not alter the iron concentration in the environment. Therefore, it can be judged that the amount of iron, which is derived from discharged treated ballast water, ingested by sea bathers or workers in surrounding water areas through water dr inking is very small (negligible).

In the assessment of risk to the general popul ation of oral exposure through the food chain by way of marine products, as has been clarified in the Basic A pproval application dossier, the accumulation of iron in the marine organisms doe s not need to be considered. Taken together, it would appear that there is no risk to the hea lth of humans (the gene ral population) by the oral route through the food chain.

6.3.5 Conclusion of risk assessment for ex posure to ships’ crew and the general population

In this system, the risk to ships’ crew is j udged to be appropriately managed based on the facts that chemicals themselves to be used, that is, triiron tetraoxide, PAC and PASA, have low toxicity, and that the percenta ge of the content of acrylamide monomers, which is a hazardous substance present in PASA as an impurity, is maintained at a low level, as well as that system components are adopted that are expected to minimize the exposure risk of ships’ crew to chemicals and ballast water before/after treatment.

In addition, it is reasonably consid ered that the system has no risk to the health of the general population in light of the facts that exposure r outes are very limited and that the amounts of possible exposure are very small.

In conclusion, it is reasonably considered that the system has no risk to human health including ships’ crew and the general population.

6.4 Risk assessment on aquatic organisms

The chemical characteristics in water of the subs tances used in this system other than PAC are relatively simple. However, dissolved aluminiu m compounds, including PAC, show complicated chemical characteristics. Therefore, aluminium is separately discussed from the other chemical additives (section 6.4.2). Triiron tetraoxide, PASA, and acrylamid e monomers are discussed in section 6.4.3.MEPC 59/2/5 ANNEX Page 35

I:\MEPC\59\2-5.doc 6.4.1 PBT assessment (G9: 6.4.1)

As corroborated at the Basic Approval, none of the triiron tetraoxi de, PAC, PASA, and acrylamide monomers are classified as PBT substances.

6.4.2 Risks of aluminium to the aquatic environment

Aluminium is the most abundant metallic elemen t on earth and constitute s 8.13% of the earth’s crust. Natural sources of aluminium released to aquatic systems include weathering of rocks, glacial deposits and soils and their derivative mine rals and atmospheric deposition of dust particles (WHO, 1997; EC and HC, 2000). It is not recogn ized as a toxic substance in natural marine environment due to the high concentration of it found in clay particles in marine waters and its relatively constant pH of approximately 8.2. Cl ay particles tend to bind rapidly with aluminium and form large colloids, thus removing aluminium from the water column. Therefore, the concentrations of dissolved aluminium in seawater remain low in accordance with the equilibrium of aluminium speciations, in spite of the existence of a wi de variety of natural aluminium sources (WHO, 1997; CCME, 2003; EC and HC, 2000).

6.4.2.1 Previous risk assessment of aluminium in reports of intern ational bodies and governmental bodies

The following is a summary of representative ev aluations of aluminium effects as previously reported by international bodies and governmental bodies.

(1) WHO, Environmental Health Criteria, 194 Aluminium, 1997

Hazards posed to human health by aluminium have been systematically identified in a number of previous studies. However, no evidence has ye t been produced that supports the primary causative role of aluminium in Alzheimer’s disease that has been suggested. Nor is there any indication that aluminium is carcino genic. Taking these facts togeth er, it has been concluded that there is insufficient health-related evidence to justify revising the existing WHO Drinking-Water Guidelines with respect to aluminium.

(2) WHO, Guideline for drinking water quality, 2006

Owing to the limited amount of data relevant to the effects of aluminium on animals and the uncertainty surrounding available data on its effect on humans, no accurate health-based guideline values on it can be derived. However, practicable levels base d on optimization of the coagulation process in drinking-water plants using aluminium-based coagulants have been derived as 0.1 mg/L or less in large water treatment facilities, and 0.2 mg/L or less in small facilities.MEPC 59/2/5 ANNEX Page 36

I:\MEPC\59\2-5.doc (3) EC and HC (2000), Canadian Envi ronmental Protection Act 1999, Priority Substances List Assessment Report for Aluminium Chloride, Aluminium Nitrate, Aluminium Sulfate

This report characterized the environmental ri sk of aluminium posed to pelagic organisms. Environmental exposure to aluminium in water is a ssumed to be greatest in areas in proximity to places where process wastewater (backwash water) is directly released to aquatic environments from drinking water treatment plants. Table 5 of EC and HC (2000) presents estimated total aluminium concentrations in backwash waters for 13 drinking water treatment plants, including those with the highest estimated levels of con centration. The total aluminium levels present in effluent from drinking water treatment plan t wastewater were measured (Table 5 of EC and HC, 2000; 0.76~115mg/L). In order to estimate the amount of bioavailable aluminium present in rivers, the repor t performed speciation with MINEQL + and WHAM models. These models calculated the concentration leve ls of dissolved inorga nic monomeric forms of aluminium following the releases of wastewater fr om selected drinking water treatment plants, using the estimated aluminium level in effluents and assuming a 1:10 dilution.

The possibility that modelled concentrations over estimate actual values is further supported by measured data. The report concluded that organism s are unlikely to be exposed to harmful levels of aluminium as a result of us ing aluminium to treat water.

In a study done with collected flocs, it was conc luded that all the collect ed flocs tested were non-toxic using a microbial test and acutely and subacutely non-toxic to rainbow trout.

6.4.2.2 Risk assessment of alum inium on aquatic organisms

(1) Assessment of aluminium ion concentr ation in the natural environment water

As a prerequisite for assessing the influence of al uminium contained in treated ballast water, the literature of aluminium concentration in natura l water areas was surveyed especially where intake/discharge of ball ast water is conducted.

Consideration of natural backgr ound concentration in risk asse ssment has been recommended in guidance for the risk assessment of various metals, and this recommendation has been carried out (ICMM, 2007a, b; EA 2008, etc.).

(2) Analysis of aluminium concentrat ions in treated water and influent

Concentrations of aluminium in treated water and influent are compared in this section. As shown in section 4.1.4.1, aluminium was detected in influent (seawater) collected in Tokyo Bay, and concentrations of total aluminium in treated water were constantly lower than that in the influent as shown in Table 6-5

Table 6-5 – Results of quali tative analysis of aluminium (Case where influent was seawater) (Unit: mg/L)
Seawater Treated water Detection limit
0.048 0.022 0.001MEPC 59/2/5 ANNEX Page 37

I:\MEPC\59\2-5.doc In addition, tests were performed using influent (seawater) to whic h kaolin was added to increase the SS concentration and the concentrations of al uminium in the influent were higher than in actual seawater. The test results ar e shown in this section. Kaolin is a natural mineral containing aluminium so the concentrations of total aluminiu m in the influent were several times higher than in actual seawater. Table 6-6 shows that the tota l aluminium concentrations in the treated water were lower than in influent (seawater).

Table 6-6 – Results of qualit ative analysis of aluminium (Case where kaolin was added to influent (seawater))
(Unit: mg/L)
Influent* Treated water Detection limit
0.34 0.044 0.001

As shown above, it is verified that this system removes aluminium in the influent. Consequently, the treated water has almost no e ffect on aluminium concentration in the water area discharged.

(3) Risk assessment from a quantitative e valuation of aluminium risk according to EC and HC (2000)

Tables 6-7 and 6-8 show the key study of the acute t oxicity and chromic t oxicity of aluminium selected from the hazard data on aluminium for aquatic organisms. Considering that the total aluminium concentration in the treated ballast water using this system was 1/10 to 1/10000 smaller than that in the effluent described in the report (0.76 to 115 mg /L, EC and HC, 2000), it can be reasonably concluded that organisms are unlikely to be exposed to harmful levels of aluminium resulting from the use of aluminium for ballast water treatment.

Table 6-1

− Key study of the acute toxicity of aluminium

Substance Biological classification Organism species End point Toxicity (mg/L) Skeletonema costatum

, SW Growth inhibition 72-h EC 50 4.65 mg Al Algae

Pseudokircheneriella subcapitata, FW Growth inhibition 96-h EC 50 0.57 mg Al

Invertebrates Nitocra spinipes , SW Mortality 96-h LC 50 10 mg Al

Shellfish Physa sp. , FW Mortality 96-h LC 50 30.6 mg Al Aluminium ions

Amphibia Bufo americanus , FW Mortality 96-h LC 50 0.86 mg Al Abbreviations: SW: marine species, FW: fresh water speciesMEPC 59/2/5 ANNEX Page 38

I:\MEPC\59\2-5.doc Table 6-2

− Key study of chronic toxicity of aluminium

Substance Biological classification Organism species End point Toxicity (mg/L) Skeletonema costatum

, SW Growth inhibition 72-h NOEC 1.04 mg Al Algae

Pseudokircheneriella subcapitata, FW Growth inhibition 96-h NOEC < 0.4 mg Al Aluminium ions

Invertebrates Ceriodaphnia sp. , FW Mortality 8-day NOEC 4.9 mg Al

Abbreviations; SW: marine species, FW: fresh water species.

(4) Effects of aluminium accumulated in sediments in discharge water areas

The report on aluminium assessment by EC a nd HC (2000) of Canada revealed that they conducted toxicity studies of flocs collect ed in the process of drinking water treatment and found no significant toxicity either in studies using micro-organisms or in acute or subacute toxicity studies using rainbow trout (fish). In a simulation using the MAM-PEC model, the contents of aluminium in sediments after 10 years of accumulation have been calculated at 0.000777-0.0349 mg/g. Since this range of simulated contents is substantia lly smaller than the aluminium content in natural soil, aluminium adsorbed to sediments may not exert adverse effects on living organisms.

6.4.2.3 Summary of the risk assessment of aluminium on aquatic organisms

It is concluded that organisms are quite unlikely to be exposed to harmful levels of aluminium as a result of the metal being used for water treatment processes that produce residual aluminium in the treated water or flocs.

6.4.3 Risk assessment of the triiron tetraoxi de, PASA, and acrylamide monomers on aquatic organisms

6.4.3.1 Key Study of acute toxicity and chronic toxicity

Tables 6-9 and 6-10 show the key studies of acu te toxicity and chronic toxicity respectively extracted from the hazard data those are used fo r calculation of PNEC values of substances employed for Hitachi Ballast Water Purification System.MEPC 59/2/5 ANNEX Page 39

I:\MEPC\59\2-5.doc

Table 6-9 – Key study of acute toxicity of tr iiron tetraoxide, PASA, and acrylamide monomers

Test substance Biological classification Organism species End point Toxicity (mg/L) Algae n.a. n.a. No data Invertebrates n.a. n.a. No data Triiron tetraoxide Fish Leuciscus idus , FW Mortality 48-h LC 0 * > 1,000 Algae n.a. n.a. No data Invertebrates Ceriodaphnia dubia

, FW Mortality 48-h LC 50 218 Girella punctata , SW Mortality 48-h LC 50 840 PASA

Fish

Oryzias latipes , FW Mortality 48-h LC 50 180 Algae Pseudokirchneriella subcapitata , FW Growth inhibition 72-h EC 50 33.8 Mysidopsis bahia , SW Mortality 96-h LC 50 78 Invertebrates

Daphnia magna , FW Swimming inhibition 48-h EC 50 98 Acrylamide

monomers

Algae Danio rerio , FW Mortality 96-h LC 50 59

Abbreviations: SW: marine speci es, FW: fresh water speci es, n.a.: not available

* This evaluation is using LC 0 in which no lethality occurs, because this evaluation stands safer value than using LC 50
.
Table 6-3 – Key study of chronic toxicity of tr iiron tetraoxide, PASA, and acrylamide monomers

Substance Biological classification Organism species End point Toxicity (mg/L) Algae n.a. n.a. No data Invertebrates n.a. n.a. No data Triiron tetraoxide
Fish n.a. n.a. No data Algae n.a. n.a. No data Invertebrates n.a. n.a. No data PASA

Fish Salvelinus namaycush

, FW Mortality 30-day NOEC 75 Algae Pseudokirchneriella subcapitata , FW Growth inhibition 72-h NOEC 16

Invertebrates Mysidopsis bahia , SW Mortality 28-day NOEC 2.04 Acrylamide

monomers

Fish n.a. n.a. No data Abbreviations; SW: marine species, FW: fresh water species, n.a.: not available

6.4.3.2 Derivation of predicted no-e ffect concentration (PNEC)

The PNEC values for triiron tetraoxide, PASA and acrylamide monomers are derived based on hazard data (see Tables 6-9 and 6-10). These values were used in the Basic Approval (Table 6-11, the details are desc ribed in section 8.3.6.3 in the a pplication of Basic Approval).MEPC 59/2/5 ANNEX Page 40

I:\MEPC\59\2-5.doc Table 6-4 – PNECs for triiron tetr aoxide, PASA and acrylamide monomers

Substance Toxicity (mg/L) Assessment factor PNEC (mg/L) Triiron tetraoxide 48-h LC 0 (acute) > 1,000 1,000 > 1 PNECshort

48-h LC 50 (acute) 180 1,000 0.18 PNECshort PASA 30-day NOEC (chronic) 75 100 0.75 PNEClong

96-h LC 50 (acute) 59 1,000 0.059 PNECshort Acrylamide

monomers 28-day NOEC (chronic) 2.04 100 0.02 PNEClong

6.4.3.3 Prediction of discharge and enviro nmental concentrations (G9: 5.3.8)

Table 6-5 shows the analytical results of treated water, which are examined and stated in section 4, and the predicted discharge concentr ations of Active Substances. As for triiron tetraoxide, PASA and acrylamide monomers, PNEC values stated in se ction 6.4.3.2 are used for risk assessment.

Table 6-5 – Analysis results and PECs
(Unit: mg/L)

Substance Analysis result (Detection limit) PEC
Triiron tetraoxide N.D (0.01) <0.01 Aluminium 0.022 0.022 PASA N.D (0.1) <0.1 Acrylamide monomers N.D (0.0001) <0.0001

6.4.3.4 Assessment for triiron tetraoxide, PASA and acrylamide monomers by PEC/PNEC ratio

As shown in Table 6-13, PEC/PNEC ratio is lowe r than 1.0 for all these three Active Substances. Therefore, there is virtually no risk to aquati c organisms from these three Active Substances related to this system.

Table 6-6 – PEC/PNEC ratio for triiron tetraoxide, PASA and acrylamide monomers

Substance PEC (mg/L) PNEC (mg/L) PEC/PNEC ratio Triiron tetraoxide < 0.01 > 1 < 0.01
PASA < 0.1 0.18 * < 0.56 Acrylamide monomers < 0.0001 0.02 < 0.005

6.5 Establish the maximum allowable discharge concentration

Considering the PNEC values calculated in section 6.4.3.2, assessment reports evaluated by international bodies and governmental bodies, and dosage concentration of each substance, the maximum allowable discharge concentration in the ballast water is established.MEPC 59/2/5 ANNEX Page 41

I:\MEPC\59\2-5.doc The substances employed in the Hitachi Ballast Water Purification System forming floc which will be collected virtually all as flocs, may re main in the ballast water in minute amounts with taking into account mechanism of Hitachi Ballast Water Purification System. The amounts of each substance remaining in ballast water will not cause any risks under good operating conditions. The maximum allowable discharge concentration can be used as a kind of indicative value, in case of trouble, to estima te the performance of the system.

6.5.1 Establishing the maximum allowable discharge concentration

6.5.1.1 Aluminium

(1) Environmental criteria for aluminium

It is practical to manage the total concen tration of dissolved m onomeric aluminium and particulate aluminium for risk ma nagement with respect to human species and aquatic organisms. In the United States and Canada, relevant water quality criteria have been established, but there are no criteria in Japan and th e United Kingdom (Table 6-14).

Table 6-7 – Criteria for aluminium in water

Country Environmental Criteria Notes

Canada 0.074 mg/L Minimum criterion for fresh water. Aluminium is not expected to be toxic in the natural marine environment.

USA CMC: 0.75 mg/L (Criteria Maximum Concentration) CCC: 0.084 mg/L (Criteria Continuous Concentration) Both criteria are freshwater criteria. No criteria for seawater.

UK n.a. - Japan n.a. -
n.a.: no established criteria

(2) Establishing the maximum allowable discharge concentration

The maximum allowable discharge concentration for aluminium is calculated on the basis of Canada’s 0.074 mg/L, which is the strictest criterion stated in the above Table 6-14.

At a background concentration of 0.074 mg/L, the maximum allowable discharge concentration of aluminium is 0.22 mg/L according to the MAM-PEC (VER. 1.6 model) simulation (CERI, 2008e). The default commercial harbour of the MAM-PEC model is half the size of Rotterdam Port, and other conditions were used without change.

Considering this simulation, at a background con centration less than 0.074 mg/L, it may be clear that the calculated result of MAM-PEC is to be less than 0.074 mg/L in the case of an emission load of 0.22 mg/L. On the other hand, at a background concentration larger than 0.074 mg/L, aquatic organisms living in the area are expected to have some tolerance to such concentrations of aluminium. In this case, the result calculated with MAM-PEC is less than the background concentration (larger than 0.074 mg/L) when the emission load is 0.22 mg/L, so it is concluded that the discharged ballast water has little impact on the aquatic environment. Considering all ofMEPC 59/2/5 ANNEX Page 42

I:\MEPC\59\2-5.doc the above, the maximum allowable discharge con centration of aluminium in all situations is 0.22 mg/L.

6.5.1.2 Iron

Iron is one of the most abundant me tals in the Earth’s cr ust and is found in natural fresh waters at levels ranging from 0.5 to 50 mg/L. Iron is known as an essential element in human and other organisms’ nutrition and th ere is no data on biotoxic forms of iron. Therefore, it is difficult to establish the maximum allowable discharge concentr ation from an ecotoxic ity point of view as specified in Metals Environmen tal Risk Assessment Guidance (UK, International Council of Mining & Metals). In Hitachi Ballast Water Purifi cation System, triiron tetraoxide is added as slurry and NOT a solution, so that dissolution of iron ions into either ballast water or the ecosystem may not occur. Therefore, the maximu m allowable discharge c oncentration of iron has been established as 30 mg/L.

6.5.1.3 PASA

Table 6-11 shows the PNEC of PASA as 0.18 mg/L and the maximum allowable discharge concentration of PASA can be established accor ding to the PNEC value. According to water quality guidelines of Canada’s CCME, the US EP A and similar bodies in other countries, dilution may be considered because, for the most part, th e immediate concentration of substances at the discharge point will not be an adequate representa tion of the concentration of the substance in the water body as a whole. For instance, for the most part, aquatic life will not be exposed to the concentration of the substance in the pipe but rather to the receiv ing waters mixed with effluent.

There is no simulation model to examine dilution similar to MAM-PEC, and which is specialized for a macromolecular organic compound such as PASA , so an alternative a pproach is considered such as the use of dilution f actors. Canada’s CCME has establ ished a framework of Effluents Discharge Objectives considering dilution factor s. For lakes and enclosed bays, the default dilution factor is a maximum of 1 in 10. Following this framework as an example, it is concluded that the maximum allowable discharge concentration of PASA is 1.8 mg/L.

6.5.1.4 Acrylamide monomers

Table 6-11 shows the PNEC of acrylamide monomers to be 0.02 mg/L. Some parameters required to simulate the discharge load by MA M-PEC are unclear, so that a dilution factor of 10 may be applied as for PASA. Thus cal culated, the maximum allowable discharge concentration of acrylamide monomers is 0.2 mg/L.

6.6 Conclusion on risk to the aquatic environment

PAC and PASA are materials used in drinking water treatment plants, so these risk assessments have been carried out worldwide. Considering th at the dosage concentrations of PAC and PASA equal to those of drinking water treatment plants, and the gathered data or assessment reports by international authorities, it is concluded that PA C and PASA have a low environmental impact.

Taking into consideration well known data, its a bundance in the natural environment, and its insolubility in water, triiron tetra oxide has a low environmental impact.MEPC 59/2/5 ANNEX Page 43

I:\MEPC\59\2-5.doc It is known that unpolymerized acrylamide m onomers present a toxic liability. However, considering the gathered data including the c ontent of acrylamide monomers in PASA, the measured concentration of acrylamide monomers in treated water, an d the estimated amount discharged in ballast water, acrylamide monome rs have a low environmental impact as well.

Each substance can comply with the established maximum allowable discharge concentrations taking into account the properties of each substan ce and the specifications and mechanisms of the Hitachi Ballast Water Purification System. It was concluded that this system presents no risk to the aquatic environment.

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