I:\MEPC\61\2-11.doc 

# E

MARINE ENVIRONMENT PROTECTION

COMMITTEE

61st session Agenda item 2 MEPC 61/2/11

29 March 2010 Original: ENGLISH

HARFMUL AQUATIC ORGANISMS IN BALLAST WATER

Application for Basic Approval of the ERMA FIRST Ballast Water Management System

Submitted by Greece

SUMMARY

Executive summary: This document contains the non-confidential information related to the application for Basic Approval of the ERMA FIRST Ballast Water Management System submitted in accordance with the "Procedure for approval of ballast water management systems that make use of Active Substances (G9)" adopted by resolution MEPC.169(57)

Strategic direction: 7.1

High-level action: 7.1.2

Planned output: 7.1.2.5

Action to be taken: Paragraph 6

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

Introduction

1 Regulation D-3.2 of the International Convention for the Control and Management of Ships' Ballast Water and Sediments 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)" determines the required information (MEPC 57/21, annex 1, paragraph 4.2.1) and provides details for the risk characterization and analysis (MEPC 57/21, annex 1, paragraph 5.3). In accordance with the section 6 of the above-mentioned Procedure, the Organization shoul d evaluate the information provided in the application.

3 The competent authority in Greece has verified the application dossier prepared by ERMA FIRST S.A. and believes it to satisfy the data requirements of Procedure (G9) adopted by resolution MEPC.169(57).MEPC 61/2/11 Page 2

I:\MEPC\61\2-11.doc 4 According to BWM.2/Circ.24, proposals made for the approval of ballast water management systems that make use of Active Substances are to be submitted to the Marine Environment Division of the Organization to be reviewed by the GESAMP-Ballast Water Working Group. In the meantime, a document on the above-mentioned proposals containing all the non-confidential information on the specific ballast water management systems that make use of Active Substances must be submitted to MEPC 61.

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

Action requested of the Committee

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

***MEPC 61/2/11 Annex, page 1

I:\MEPC\61\2-11.doc ANNEX

NON-CONFIDENTIAL INFORMATION ON THE ERMA FIRST BALLAST WATER

MANAGEMENT SYSTEM

Contents

1 PREFACE

2 IDENTIFICATION OF THE SUBSTANCES OR PREPARATIONS

3 EFFECTS ON AQUATIC TOXICITY

4 DATA ON MAMMALIAN TOXICITY

5 DATA ON ENVIRONMENTAL FATE AND EFFECT UNDER AEROBIC AND

ANAEROBIC CONDITIONS

6 PHYSICAL AND CHEMICAL PROPERTIES OF THE ACTIVE SUBSTANCES,

RELEVANT CHEMICALS AND TREATED BALLAST WATER

7 ANALYTICAL METHODS AT ENVIRONMENTALLY RELEVANT CONCENTRATIONS

8 USE OF ACTIVE SUBSTANCE

9 MATERIAL SAFETY DATA SHEETS AND CLASSIFICATION OF HAZARDS

10 RISK CHARACTERIZATION AND ANALYSIS

11 EVALUATION OF TREATED BALLAST WATER

12 RISK ASSESSMENT

13 ASSESSMENT REPORTMEPC 61/2/11 Annex, page 2

I:\MEPC\61\2-11.doc 1 PREFACE

1.1 Profile of the manufacturer

ERMA FIRST E.S.K. Engineering Solutions S.A., the manufacturer of the ballast water management system, presented in this dossier is a new company stemming from the Environmental Protection Engineering S.A., a Greek designer and producer of shipboard and industrial liquid waste treatment equipment. In particular, type-approved oily water separating (filtering) equipment and sewage treatment plants have been produced for more than 25 years serving the needs of the Greek and foreign shipping industry.

Environmental Protection Engineering S.A. was one of the partners that co-operated on the materialization of the three-year project " Ο nboard Treatment of Ballast Water and Application of Low Sulphur Marine Fuel – MARTOB" carried out from April 2001 to June 2004, in the context of the Competition and Sustainable Growth Programme funded by the European Commission. The objectives of this project relating to ballast water management were to investigate the various possible methods for controlling the transfer of non-indigenous organisms through ballast water and develop technologically and economically viable solutions to the problem by testing and assessing safe and environmentally friendly treatment methods that have a minimum impact on ship operations.

Following the research carried out for development and optimization of the system, toxicity testing of ballast water was carried out in the Institute of Marine Resources and Ecosystems Studies Wageningen (IMARES) in the Netherlands in February 2010. Pre-certification and land-based testing of a 100 m 3 /h pilot treatment system commenced in March 2010 in the Royal Netherlands Institute for Sea Research (NIOZ) which is the National Oceanographic

Institution of the Netherlands.

1.2 Outline of the ERMA FIRST ballast water management system

The ERMA FIRST Ballast Water Management Sy stem is an integrated, autonomous and modular treatment system for ballast water, jointly developed by a group of scientists and engineers with a long experience in the design and production of equipment for ship-generated liquid waste treatment. The nominal treatment capacity of each module is 100 m 3 /hr. Basic drawings illustrating typical arrangements of the system are presented in appendix 1 of the

confidential dossier.

The treatment process includes two distinctive stages, a primary one that enables the separation of coarser suspended materials and relatively larger living organisms in ballast water and a secondary one, in which electrolytic disinfection takes place to meet the required biological efficacy standard for treated ballast water as stipulated in the BWM Convention. At the primary stage of the process, removal of material with size larger than 20 μ m is accomplished by means of an advanced cyclonic separator made from frictionless material. To prevent blocking of the separator from large particles that might pass though the sea chests and strainers of the vessel, a 500 μ m self cleaning basket filter has been installed prior to the separator. The benefits offered from the pre-filtering and the cyclonic separation towards the removal of coarse inorganic and organic material present in ballast water relate to a lower disinfectants concentration demand which in turn results in less energy and electrodes coatings consumption.

Electrolysis of ballast water for producing in situ up to 10 mg/L of free active chlorine constitutes the second stage of treatment which takes place during ballasting. The products of this process flow into the ballast tanks of the vessel, so that the residual oxidants disinfect any harmful organisms taken onboard. Integral components of the system are the controlMEPC 61/2/11 Annex, page 3

I:\MEPC\61\2-11.doc and monitoring equipment that ensure its proper operation as well as the neutralization process of treated ballast water prior to its eventual discharge into the sea. The operational status of the system is continuously monitored at a central data logger, located into the central control panel of the system. Data logging includes the operation status of the system, operation, flow and temperature at the electrolytic cell, pressure difference across the self-cleaned filter and the cyclonic separator, the operational status of the neutralizing agent dosing pump as well as the chlorine level of the system. The control panel can be positioned into the cargo control room of the vessel. All major components including pressure difference sensors, flow sensors, chlorine sensors, the neutralizing agent dosing pump, etc., described in detail in the section 8 of the confidential dossier, transmit and/or receive their output and/or input as 4-20 mA signals.

During de-ballasting, neutralization of the total residual chlorine takes place by adding aqueous solution sodium bisulfite solution. At this mode, the pre-filtering equipment, the cyclonic separator and the electrolytic cell of the system is by-passed with the exception of the second free chlorine sensor. When de-ballasting begins, the dosing pump of sodium bisulfite starts operating at a pre-set value of 20 mg/L

. This is based on the worst case scenario, which is the need for de-ballasting the water directly after the ballasting process,

with minimum retention time.

2 IDENTIFICATION OF THE SUBSTANCES OR PREPARATIONS

Electrolysis of ballast water results in the formation of hypochlorous acid (HOCl) in equilibrium with hypochlorite ion (OCl
- ) and due to the presence of bromide ions in seawater also to the formation of hypobromous acid (HOBr ) in equilibrium with hypobromite ion (OBr

- ) supplementing the deactivation of harmful aquatic organisms. The chlorine and bromine based Active Substances produced in the electrolytic cell eventually flow to the ballast water tanks where residual concentration is maintained to ensure complete and effective deactivation of invasive species and eliminate t heir re-growth. Electrolysis of ballast water takes place only during ballasting operation, the products of which flow in the ballast tanks of the vessel so that the residual oxidants deactivate any harmful organisms taken on board.

Both hypochlorous acid and hypochlorite ion have very distinctive behaviour in terms of their killing and inactivating effect to micro-organisms as well as to other marine organisms. In general, the effectiveness of disinfection is dependent on the pH of the water and disinfection with chlorine is optimized when the pH is between 5.5 and 7.5. Free available chlorine is defined as the concentration of the following three forms of chlorine present in the water: dissolved gas Cl 2 , hypochlorous acid (HOCl) and/or hypochlorite ion (OCl
- ) which exist together in equilibrium. Their relative proportions are strongly dependent on pH and also on temperature, ionic strength as well as the total (initial) concentration of chlorine present.

Between pH 2 and 7, the equilibrium is in favour of HOCl while at pH below 2, the predominant

form is Cl 2 . At 25 ° C and pH 7.4, HOCl and OCl - are about equal while above this value,

OCl
is the predominant form of free chlorine. It is noted that ocean pH varies from about 7.90 to 8.20 but along the coastline, larger variations from 7.3 in estuaries or in up welling zones exist to 8.6 in productive coastal plankton blooms might be measured. At the anode of the cell, where chlorine ions migrates, chlorine gas dissolves rapidly in the water and hydrolyses to produce hypochlorous acid (HOCl), which in turn, depending on the pH of the water, forms hypochlorite ions (OCl
- ). The Active Substances and Relevant Chemicals generated during the ballast water treatment as well as sodium bisulfite (used in the neutralization of treated ballast water prior to its discharge into the sea) identified as Other Chemicals, are summarized in the following table:MEPC 61/2/11 Annex, page 4

I:\MEPC\61\2-11.doc Table 1: List of AS, RC and OCs

Chemical Name CAS Number AS, RC or OC

Sodium Hypochlorite (HOCl, OCl - ) 7681-52-9 AS

Sodium Hypobromite (HOBr, OBr - ) 13824-96-9 AS

Chlorodibromomethane 124-48-1 RC

Tribromomethane 75-25-2 RC

Trichloromethane 67-66-3 RC

Dichlorobromomethane 75-27-4 RC

Sodium Bromate 7789-38-0 RC

Monobromoacetic acid 79-08-3 RC

Dichloroacetic acid 79-43-6 RC

Dibromoacetic acid 631-64-1 RC

Bromochloroacetic acid 5589-96-8 RC

Trichloroacetic acid 76-03-9 RC

Hydrogen 1333-74-0 RC

Sodium Bisulfite 7631-90-5 OC

Note: AS – Active Substances; RC – Relevant Chemicals; OC

– Other Chemicals

3 EFFECTS ON AQUATIC TOXICITY

Short-term LCs and NOECs from toxicity test ing mainly on seawater species representing three trophic levels, identified from various literature sources are summarized in the section 3 of the application dossier for each one of the Active Substances generated during the ballast water treatment process.

Endocrine disruptors encompass a variety of chemical classes, including natural and synthetic hormones, plant constituents, and pestici des as well as other industrial by-products and pollutants. Endocrine disruptors have been defined as "exogenous substances that alter function(s) of the endocrine system and consequently cause adverse health effects in an intact organism, or its progeny" (WHO, 2002). Sear ch into various literature sources showed no indication that the Active Substances, Relevant Chemicals or Other Chemicals may be regarded as endocrine disruptors.

The organic carbon-water partitioning coefficient (Koc) is the ratio of the mass of a chemical that is adsorbed in the sediment per unit mass of organic carbon in the sediment per the equilibrium chemical concentration in solution. None of the Active Substances, Relevant Chemicals and Other Chemicals appears to have the potential to be adsorbed to surface sediments to a significant extent based, on the one hand, on the Koc values identified from various literature sources and, on the other hand, on the information on bioavailability/ biomagnification/bioconcentration provided in the following paragraph.MEPC 61/2/11 Annex, page 5

I:\MEPC\61\2-11.doc Table 2: Koc values for the identified AS, RC and OC

Chemical Name Koc (l/kg) Reference

Sodium Hypochlorite 14.3 MEPC 60/2/3

Chlorodibromomethane 84 HSDB Database

Tribromomethane 116-126 HSDB Database

Trichloromethane 65 HSDB Database

Dichlorobromomethane 54.38 Epi Suite

Sodium Bromate 31.8 Epi Suite

Monobromoacetic acid 39.8 HSDB Database

Dichloroacetic acid 75 HSDB Database

Dibromoacetic acid 1.5 HSDB Database

Bromochloroacetic acid 1.9 HSDB Database

Trichloroacetic acid 130 HSDB Database

Sodium Bisulfite 2.2 MEPC 60/2/3

The ability of a chemical to bioaccumulate through the food chain is measured by the Bioconcentration Factor (BCF). Log Kow, defined as the ratio of the equilibrium concentration of a dissolved substance in a two-phase system comprising two largely immiscible solvents, n-octanol and water, with the first substance representing the fatty tissues of the living organism, is recognized as that physiochemical property that can be used to indicate the potential of a chemical to bioaccumulate.

However, some products that have a high Log Kow may be metabolized quickly in reality and so do not actually bioaccumulate. Others, such as long chain alkanes are rapidly metabolized into natural body compounds (fatty acids) and become incorporated into other natural compounds. According to the revised GESAMP Hazard Evaluation Procedure, for log Kow

values of ≥ 4, a measured BCF is required to provide definitive information on the potential of a substance to bioaccumulate under steady stat e conditions. The substances most likely to pose a hazard to aquatic organisms thro ugh bioaccumulation typically have log Kow values ranging from 4 to 7. The log Kows fo r the Active Substances, Relevant Chemicals and Other Chemicals are less than 3, indicating their low potential to bioaccumulate. In addition, measured BCF values are less than 100, as shown in the following table:

Table 3: Bioconcentration Factors for identified Active Substances

and Relevant Chemicals

Chemical Name BCF (l/kg) Reference

Sodium Hypochlorite -2.19 MEPC 60/2/3

Sodium Hypobromite 1.24 MEPC 60/2/3

Chlorodibromomethane 9 HSDB, 2009

Tribromomethane 14 HSDB, 2009

Trichloromethane 2.9 – 10.35 MEPC 59/2/11

Dichlorobromomethane 7.0 HSDB, 2009

Sodium Bromate No data available No data available

Monobromoacetic acid 3.2 HSDB, 2009

Dichloroacetic acid 3 TOXNET 2008

Dibromoacetic acid 0.17 HSDB, 2009

Bromochloroacetic acid 3.2 HSDB, 2009

Trichloroacetic acid 0.4 – 1.7 TOXNET 2008

Sodium Bisulfite 3.2 MEPC 60/2/9MEPC 61/2/11 Annex, page 6

I:\MEPC\61\2-11.doc The above-mentioned substances that might be present in the water overlying surface sediments would not readily be absorbed into them due to the relatively low organic carbon-water partitioning coefficient values. In parallel, the values of Bioconcentration Factors presented in section 3.5 indicate that little bioconcentration/bioaccumulation will occur in aquatic organisms and that little biomagnification across the aquatic and mammalian food web is expected.

Long-term NOECs or ECs mainly from seawater species representing three trophic levels identified from various literature sources, are summarized in section 3.2 of the application dossier for each one of the Active Substances generated during the ballast water treatment process. The data provided are the lowest toxicity values found for fish, crustaceans, and algae. It must be noted that no data were found for dibromochloromethane, dibromoacetic

acid and bromochloroacetic acid.

4 DATA ON MAMMALIAN TOXICITY

Similarly, data on mammalian toxicity including acute toxicity, effects on skin and eye sensitization effects, repeated dose toxicity, development and reproductive toxicity, chronic toxicity, carginogenicity/mutagenicity/reprotoxicity and toxicokinetics are also presented in section 4 of the application dossier.

5 DATA ON ENVIRONMENTAL FATE AND EFFECT UNDER AEROBIC AND

ANAEROBIC CONDITIONS

5.1 Modes of degradation

Biotic degradation could be held under aerobic or anaerobic conditions. Degradation of compounds is conducted also by anaerobic conditions. Furthermore, chemicals in aquatic environments, soil and air may be transformed by abiotic processes such as hydrolysis, oxidation and photolysis. According to literatur e, Actives Substances such as hypochlorous acid and hypobromous acid decay within se conds and produce an oxidizing environment. Under these environment trihalomethanes and haloacetic acid are produced (Relevant Chemicals). Section 5.1 of the confidential dossier summarizes the modes of environmental degradation in biotic and abiotic conditions fo r Active Substances and Relevant Chemicals generated by the ballast water treatment system.

5.2 Bioaccumulation, partition coefficient, octanol/water partition coefficient

Bioconcentration factor (BCF) is the concentration of test substance in/on the fish or specified tissues thereof divided by the concentration of the chemical in the surrounding medium at steady state (as L/kg). Bioconcentration factors (BCFs) are used to relate pollutant residues in aquatic organisms to the pollutant concentration in ambient waters. Many chemical compounds, especially those with a hydrophobic component, partition easily into the lipids and lipid membranes of organisms and bioaccumul ate. Generally a high potential BCF is greater than 1000, a moderate potential BCF is less than 100 but greater than 250 and a low potential BCF is less than 250. BCF values are presented in section 3.5 of the confidential dossier. Organic carbon partition coefficient (Koc) is a measure of the tendency for organic substances to be absorbed by soil or sediment. The Koc is substance-specific and is largely independent of soil properties. Koc values are presented in section 3.4 of the confidential dossier. Octanol/water partition coefficient (Kow ) is a measure of the equilibrium concentration of a compound between octanol and water that indicates the potential for partitioning into soil organic matter. A high Kow indicates a compound which will preferentially partition into soil organic matter rather than water. Kow value is inversely related to the solubility of a compound in water. Log Kow is used in models to estimate plant and soil invertebrate bioaccumulation factors. Table 4 presents logKow values of the compounds.MEPC 61/2/11 Annex, page 7

I:\MEPC\61\2-11.doc Table 4: Values log Kow for chemicals

Chemical Name log Kow Reference/comments

Sodium hypochlorite -0.87 Ko wWin v.167/EpiSuite (EPA)

Sodium hypobromite - No data found

Chlorodibromomethane 1.7 KowW in v.167/EpiSuite (EPA)

Tribromomethane 1.79 KowW in v.167/EpiSuite (EPA)

Trichloromethane 1.52 KowW in v.167/EpiSuite (EPA)

Dichlorobromomethane 1.61 Ko wWin v.167/EpiSuite (EPA)

Sodium Bromate -7.18 KowW in v.167/EpiSuite (EPA)

Monobromoacetic acid 0.43 Ko wWin v.167/EpiSuite (EPA)

Dichloroacetic acid 0.52 Ko wWin v.167/EpiSuite (EPA)

Dibromoacetic acid 0.7 KowW in v.167/EpiSuite (EPA)

Bromochloroacetic acid 0.61 KowWin v.167/EpiSuite (EPA)

Trichloroacetic acid 1.44 Ko wWin v.167/EpiSuite (EPA)

Sodium Bisulfite -7.51 KowW in v.167/EpiSuite (EPA)

5.3 Persistence and identification of the main metabolites in the relevant media

Due to log Kow and BCF values, it is unlikely that these will be accumulated through the aquatic organisms and metabolites.

5.4 Reaction with organic matter

Active Substances such as hypochlorous ac id and hypobromous acid could react with the organic matter naturally present in water and/or other organic substances to yield disinfection by-products. Trihalomethanes and haloacetic acids are the most dominant species of chlorination by-products. Concentration of free chlorine and bromine, pH, temperature and the level of organic matter are parameters that control the production of disinfection by-products. For Relevant Chemicals there are no available data on reaction with organic matter.

5.5 Potential physical effects on wildlife and benthic habitats

No data were found indicating that Active Substances, Relevant chemicals and Other Chemicals could cause potential physical effects to wildlife.

5.6 Potential residues in seafood

There is a little possibility for significant residue s to accumulate in tissues which could impact the consumption of seafood based on low Log POWs and BCFs of the Active Substances,

Relevant Chemicals and Other Chemicals.

5.7 Any known interactive effects

No interactive effects of the Active Substances, Relevant Chemicals and other chemicals

have been identified.

6 PHYSICAL AND CHEMICAL PROPERTIES OF THE ACTIVE SUBSTANCES,

RELEVANT CHEMICALS AND TREATED BALLAST WATER

Physical and chemical properties of the Active Substances, Relevant Chemicals as well as of sodium bisulfite and of treated ballast water are presented in section 6 of the application dossier.MEPC 61/2/11 Annex, page 8

I:\MEPC\61\2-11.doc 7 ANALYTICAL METHODS AT ENVIRONMENTALLY RELEVANT

CONCENTRATIONS

The analytical methods for each Active Substanc e, Relevant and Other Chemicals with their associated reporting limits are provided in section 7 of the application dossier.

8 USE OF ACTIVE SUBSTANCE

8.1 Manner of application

The treatment process includes two distinctive stages, a primary one that enables the separation of coarser suspended materials and relatively larger living organisms in ballast water and a secondary one in which disinfection takes place to meet the required biological efficacy standard for treated ballast water as stipulated in the BWM Convention. At the primary stage of the process, removal of material with size larger than 20 μ m is accomplished by means of an advanced cyclonic separator made from frictionless material. To prevent blocking of the separator from large particles that might pass though the sea chests and strainers of the vessel, a 500 μ m self cleaning basket filter has been installed prior to the separator. This filter is made of glass reinforced plastic while the basket is made duplex stainless steel. The benefits offered fr om the pre-filtering and cyclonic separation with the removal of coarse inorganic and organic material present in ballast water is a lower

disinfectants concentration demand which in turn results in lower concentrations of disinfection by-products, less energy and electrodes coatings consumption.

Electrolysis of ballast water for producing in situ up to 10 mg/L of free active chlorine constitutes the second stage of treatment which takes place during ballasting. The products of this process flow into the ballast tanks of the vessel, so that the residual oxidants disinfect any harmful organisms taken onboard. Integral components of the system are the control and monitoring equipment that ensure its proper operation as well as the neutralization process of treated ballast water prior to its eventual discharge into the sea. The operational status of the system is continuously monitored at a central data logger, located into the central control panel of the system. Data logging includes the operation status of the system,operation, flow and temperature at the electrolytic cell, pressure difference across the selfcleaned filter and the cyclonic separator, the operational status of the neutralizing agent dosing pump as well as the chlorine level of the system. The control panel can be positioned into the cargo control room of the vessel. All major components including pressure difference sensors, flow sensors, chlorine sensors, the neutralizing agent dosing pump, etc., described in detail in the section 8 of the confidential dossier, transmit and/or receive their output and/or input as 4-20 mA signals.

During de-ballasting, neutralization of the total residual chlorine takes place by adding aqueous solution sodium bisulfite solution.At this mode, the pre-filtering equipment, the cyclonic separator and the electrolytic cell of the system is by-passed with the exception of the second free chlorine sensor. When de-ballasting begins, the dosing pump of sodium bisulfite starts operating at a pre-set value of 20 mg/L

. This is based on the worst case scenario, which is the need for de-ballasting the water directly after the ballasting process, with minimum retention time. Performance tests carried out during the development of the system have shown that the biological e fficacy required by the D-2 standard of the Convention can be achieved in less than 24 hours, however this should be verified during the ongoing land-based testing.MEPC 61/2/11 Annex, page 9

I:\MEPC\61\2-11.doc 8.2 Process flow description

The ERMA FIRST Ballast Water Management Sy stem is an autonomous fully automatic operational unit. The system has two different operational modes, one during ballasting and one during the discharge of treated ballast water. The two operation modes are described in the following paragraphs. A process and instrumentation diagram is presented in the appendix 1 of the confidential dossier. During ballasting, ballast water will pass through

the 500 μ m pre-filter and then into the cyclonic separator. The rich of sediments and coarse

material underflow stream from the latter will return back into the sea via a drain line. The overflow will enter the electrolytic cell. A flow sensor, installed upstream of the cell will provide a signal to the cell through the PLC of the system to apply DC current to the electrodes in order to initiate the electrochemical process and the production of the Active Substances. A free chorine sensor, located downstream of the cell, monitors the free chlorine concentration.

The production rate of the Active Substances is continuously tuned, to the ballast flow rate and the measurement of the free chlorine at the sensor. Depending on the flow rate and the free chlorine measurement, the voltage at the cell changes in order to maintain the pre-set free chorine concentration. The electrolytic cell of the system has been specifically designed to produce the identified Active Substances at temperatures as low as 5 o C and water salinity > 0.5 PSU. The ability of the cell to produce free chlorine in such conditions is based on the special coating material of its electrodes, and also to its design that enables sufficient contact time of chlorides in the water stream with the electrodes, thus providing enough

contact time to convert into Active Substances.

Similarly, the electrolytic cell of the system can operate effectively in salinities above 32 PSU, due to the fact that water of such salinity results to low electrical resistance and thus the PLC of the system will adjust the voltage at the electrodes in such manner in order to keep the production of free chlorine at the pre-set values. The whole unit is current driven controlled by the chlorine sensor arranging for the set concentration and current applies to the electrodes result in a specific amount of Ac tive Substance production. By monitoring the operating Amperes on the electrodes of the cell and adjusting the applied voltage, the PLC of the system ensures a constant production rate of Active Substances in an extended salinity and temperature range.

A schematic diagram of the operation of the system during ballasting is illustrated:

Figure 1: Operation mode during ballastingMEPC 61/2/11 Annex, page 10

I:\MEPC\61\2-11.doc During de-ballasting, neutralization of the total residual oxidants takes place by adding aqueous solution sodium bisulfite solution (38% w/w). At this mode, pre-filtering equipment, the cyclonic separator and the electrolytic cell of th e system are by-passed with the exception of the free chlorine sensor. When deballasting begins, the dosing pump of sodium bisulfite starts operating at a pre-set value of 20 mg/L. This is based on the worst case scenario, which is the need for de-ballasting the water directly after the ballasting process, with minimum retention time. From the stoichiometry of the reaction for the neutralization of 1 mg/L of chlorine required 1.5-1.7 mg/L (Metcalf & Eddy, 2003) of sodium bisulfite, i.e. for the 10 mg/L of total residual oxidants, 17 mg/L of NaHSO 3 required. By using a safety margin of 15% the dosing pump of the neutralizing agent will be set at a point to deliver 20 mg/L sodium bisulfite.

Based on the 38% w/w solution used by the system, the flow rate of the dosing unit will be

set at 5.3 L/h. A second free chlorine sensor of the de-ballasting system will monitor the total chlorine level to ensure a maximum concentration in the discharged water of 0.1 mg/L. In case that the total chlorine level at the discharge will reach the 0.1 mg/L then the dosing rate of the pump of the neutralization unit will be increased in order to reduce the total chlorine level under the 0.1 mg/L set- limit. It is expected that during the ongoing land-based testing of the system, a more accurate neutralization dosing rate will be identified.

A schematic diagram of the operation of the system during ballasting is illustrated:

Figure 2: Operation mode during deballasting

8.3 Storage, handling and management measures for Other Chemicals

As mentioned before, aqueous solution of sodium bisulfite will be used for neutralizing ballast water prior to its discharge into the sea. The quantity that will be stored on board varies in relation to the ballast water capacity of the vessel and should be adequate for the effective neutralization of total residual oxidants with minimum refilling requirements. As far as engineering controls are concerned, process enclosures, local exhaust ventilation or other controls should be used to keep airborne levels below recommended exposure limits. The storage means will be placed in a cool, dry, ventila ted, protected area, away from sources of heat, moisture and incompatibilities.MEPC 61/2/11 Annex, page 11

I:\MEPC\61\2-11.doc The exact location will be specif ied for each individual vessel a ccording to space availability and the applicable statutory and Classification Society rules. Specifically the storage means should be protected from water ingress, and maintained structurally in a safe and reliable condition. Storage tanks can be constructed from polyethylene, polypropylene, fibreglass-reinforced plastic, cross-linked polyethylene (XLPE), or 316 stainl ess steel to avoid corrosion. The chemical will be dosed directly in the deballasting line through a rubber lined carbon steel or stainless steel piping. Upon the completion of the deballasting cycle, the piping will be rinsed with water.

It is recommended that only familiarized personnel should handle the chemical. The manner of handling could be integrated into the vessel operational ballasting/deballasting procedures while during refilling and handling, the personnel should wear appropriate personal protection equipment. The storage means will be kept closed when not in use and all necessary equipment for fires, spills, etc., must be readily available. The sodium bisulfite is a non-flammable and non-combustible product. In case that the storage means are in contact with excessive heat caused by a fire that oc curs in that area, sulphur oxides might be formed. Exposed containers to flame must be cooled with streams of water until fire suppression is achieved. Appropriate self-contained breathing apparatus and full protective clothing must be used in order to protect the personnel engaged in the fire-fighting. All other personnel must be evacuated from the area while only trained personnel will be allowed to approach the containers and the area they are placed. The recommended fire extinguishing media is, for small fires, dry chemical, carbon dioxide or water spray while for large fires, dry chemical or carbon dioxide must be used. In case of a spill, use of appropriate means must be made to collect it so that prevention of its release into the sea is accomplished. Hydrogen generated at the cathode of the electrolytic cell has been identified as one of the by-products of the second stage of ballast water treatment. Hydrogen is non-toxic but can act as a simple asphyxiant by displacing the oxygen in the air. Effects of oxygen deficiency may include diminished mental alertness, impaired muscular coordination, faulty judgement, depression of all sensations, etc. The whole flow of the ballast water will be treated into the electrolytic cell, eliminating the accumulation of hydrogen into the ballast tanks. Monitoring of hydrogen generation has been planned to be carried out during both land-based and shipboard testing to verify the theoretical calculations presented in section 12.

9 MATERIAL SAFETY DATA SHEETS AND CLASSIFICATION OF HAZARDS

To ensure consistency with the classification of hazards in the MSDS of commercially available products found for the Active Substances, Relevant Chemicals, and Other Chemicals where use of Risk and Safety phrases was made, it was not attempted to provide the "hazard statements" and "precautionary statements" that have been introduced in the United Nations Globally Harmonized System of Classificati on and Labelling of Chemicals (GHS) and also into the Regulation (EC) No.1272/2008 replacing Risk and Safety phrases.

Table 5: Hazard Classification

AS, RC, OC CAS Number Hazard Classification
Sodium Hypochlorite (less than 10% wt. concentration) 7681-52-9 R31, R36/38 S28, S36/37/39, S45 Chlorodibromomethane 124-48-1 R22, R36/37/38 S26, S37/39 Tribromomethane 75-25-2 R22, R36/38, R40 S28A, S45, S61 Trichloromethane 67-66-3 R20/22, R38, R40

S36/37 Dichlorobromomethane 75-27-4 R/22, R36/37/38, R40 S26, S 36/37/39 Sodium Bromate 7789-38-0 R38, R41

S24/25MEPC 61/2/11 Annex, page 12

I:\MEPC\61\2-11.doc AS, RC, OC CAS Number Hazard Classification

Monobromoacetic acid 79-08-3 R23/24/25, R35, R50 S36/37/39, S45
Dichloroacetic acid 79-43-6 R21, R35 S26, S45, S61 Dibromoacetic acid 631-64-1 R20/21/22, R34 S26, S36/37/39, S45 Bromochloroacetic acid 5589-96-8 R34, R40, R36/37/38 S26, S27, S36/37/39, S45

Trichloroacetic acid 76-03-09 R35 S24/25, S26, S45 Hydrogen 1333-74-0 R12 S9, S16, S33 Sodium Bisulfite 7631-90-5 R22, R31, R41 S26, S39, S46

10 RISK CHARACTERIZATION AND ANALYSIS

10.1 Screening for persistence, bioaccumulation and toxicity

The Active Substances, Preparations and Relevant Chemicals need to be assessed for Persistency, Bioaccumulation potential and Toxicity (PBT). Table 10.1 lists the persistence data as determined by Omegam Laboratories in the Netherlands, Bioaccumulation potential as bioconcentration Factors (BCF) and the lowest available toxicity value. These values were screened against the criteria set by Procedure (G9).

None of the substances exceed all three PBT criteria. Hence they should not be considered as PBT. Toxicity data were collected from the US EPA ECOTOX database and supplemented with data from other sources (e.g., IUCLID). When the most sensitive toxicity values were based on a flow-through experiment it was excluded in this analysis as such an experimental setup is not representative for momentary ballast water discharges.

Table 6: Persistence, Bioaccumulation and Toxicity of the AS, RC and OCs

Chemical Name Persistence

Half-life in marine

water >60 days Bioaccumulation BCF > 2,000 Toxicity

Chronic NOEC < 0.01 mg/L

Value (days) Exceeds

criterion Value (-) Exceeds

criterion Value (mg/L) Exceeds

criterion Hypochlorous acid – hypochlorite (Sodium Hypochlorite) 0.041 No -2.19 No 0.026 No

Hypobromous acid – hypobromite (Sodium Hypobromite) - - 1.24 No - -

Chlorodibromomethane 38 No 9 No 3.2 No

Tribromomethane 38 No 14 No 2.9 No

Trichloromethane 38 No 2.9 – 10.35 No 0.006 Yes

Dichlorobromomethane 38 No 7.0 No 0.78 No

Sodium Bromate - Yes - 32 No

Monobromoacetic acid 8.7 No 3.2 No 0.2 No

Dichloroacetic acid 15 No 3 No 23 No

Dibromoacetic acid 15 No 0.17 No 69 No

Bromochloroacetic acid 15 No 3.2 No - -

Trichloroacetic acid 38 No 0.4 – 1.7 No 1.2 No

Sodium Bisulfite - Yes 3.2 No 59 NoMEPC 61/2/11 Annex, page 13

I:\MEPC\61\2-11.doc 11 EVALUATION OF TREATED BALLAST WATER

11.1 General

Tests with the ballast water management system were performed in the laboratory of IMARES, Den Helder, the Netherlands. A 6 m 3 /h model system was placed in a temperature control room (15±2°C) and seawater originating from the Oosterschelde, the Netherlands and stored in the cellars of the laboratory was used (salinity 30±2‰).

Picture 1: The model treatment system used in toxicity testing

Production of free chlorine was checked using a colorimetric DPD-method directly after production. For comparison, sodium hypochlorite was used in the tests as well. Bioassays were initiated immediately after the treated water was processed. Depending on the expected toxicity for each organism, two chlorine production settings were used (2 and 10 mg/l Cl 2 ). With the treated water, dilution series were made by mixing treated

ballast water with untreated ballast water.

Toxicity of sodium bisulphite as a component used to neutralize ballast water during deballasting, using the maximum expected concentration as highest concentration in the

dilution series was also tested.

11.2 Analysis of total residual oxidants

Chemical Name T=0

Conc.

(μg/L Cl) T=2

Conc.

(μg/L Cl) T=5

Conc.

(μg/L Cl) T=5

Dechlorinated

Conc. (μg/L Cl)

Total available chlorine 9,000 4,500 740 40MEPC 61/2/11 Annex, page 14

I:\MEPC\61\2-11.doc 11.3 Disinfection by-products in treated ballast water

Concentrations in treated ballast water during the toxicity testing as measured by OMEGAM Laboratories are listed in the table below. Maximum concentrations are printed in bold face.

Chemical Substance T=0 Conc. (μg/L) T=2 Conc. (μg/L) T=5

Conc. (μg/L) T=5

Dechlrorination Conc. (μg/L)

Chlorodibromomethane <0.5 8.3 6.0 <0.5

Tribromomethane 100 180 210 130

Trichloromethane <0.1 <0.1 <0.1 <0.1

Dichlorobromomethane <0.5 <0.5 <0.5 <0.5

Bromate <10 25 48 44

Monobromoacetic acid 10 21 6.1 6.2

Dichloroacetic acid <1 <1 <1 <1

Dibromoacetic acid 120 200 140 150

Bromochloroacetic acid 5.5 13 6.6 8.1

Trichloroacetic acid <1 <1 <1 <1

Sulfite (SO 3 2

- ) <400 <400 720 540

11.4 Toxicity testing of treated ballast water

11.4.1 Algal growth inhibition test with Phaeodactylum tricornutum

Algal growth inhibition by exposure to a sample is determined by the so-called algal growth inhibition test according to ISO10253 (2006) and OECD201 (1984) procedures. A known quantity of algae ( Phaeodactylum tricornutum ) from an exponentially growing culture was exposed to a dilution series. After 24, 48 and 72 hours, the growth of algae was tested with means of fluorescence readings. Each concentrat ion was replicated eight times and every well contained a total of 0.25 mL in volume. Each test concentration was inoculated with algae from a log-phase growing culture. The start concentration was approximately 10,000 cells/ml, determined microscopically. The 96-well plate was incubated under continuous light at 18°C and shaken at 130 rpm. Algae were expected to be very sensitive for chlorine; therefore production of ballast water has been performed with 2 mg/L settings.

Table 7: Results of the algal growth inhibition tests with sodium hypochlorite (NaOCl), produced ballast water (TRO) and sodium bisulphate (NaHSO 3 )

Phaeodactylum

tricornutum NaOCl TRO NaHSO 3

(mg/L) (mg/L Cl 2 ) (mg/L)

NOEC (72h) 0.121 0.030 25

LOEC (72h) 0.215 0.053 >25

EC 50 (72h) 0.249 (0.174-0.356) 0.158 (0.150-0.166) >25

11.4.2 Crustacean mortality test with Artemia franciscana

The test was performed in a multiwell testplate using instar II-III larvae of the brine shrimp

Artemia franciscana , obtained as dried cysts from Microlan B.V., The Netherlands, conforming to the Standard Operational Procedure for ARTOXKIT MTM (MicroBioTests Inc. V100603).MEPC 61/2/11 Annex, page 15

I:\MEPC\61\2-11.doc Cysts were incubated in artificial seawater (salinity 35‰) 30 h prior to the start of the tests at 25°C with continuous illumination. After 30 h, most cysts were hatched and the larvae developed into instar II-III stages. Approximately 50 larvae were transferred to a rinsing well containing test medium. From the rinsing well, 10 larvae were transferred to the three test wells per concentration/dilution for the test. The well plate was incubated at 25°C in the dark. After 24 hours, living and dead larvae in the test wells were counted.

Artemia were expected not to be sensitive for chlorine, therefore production of ballast water (TRO) has been performed with 10 mg/L settings. The highest concentration in the test was 9.7 mg/L Cl 2 measured directly after production.

Table 8: Results of the crustacean mortality tests with sodium hypochlorite (NaOCl), produced ballast water (TRO) and sodium bisulphate (NaHSO 3 )

Artemia franciscana NaOCl TRO NaHSO 3

(mg/L) (mg/L Cl 2 ) (mg/L)

NOEC (24h) 0.6 0.97 25

LOEC (24h) 1.2 4.9 >25

LC 50 (24h) 2.37 (0.05-105.5) 5.60 (4.58-6.84) >25

11.4.3 Rotifer mortality test with Brachionus plicatilis

The test applied is commercially available as Testkit at MicroBiotest Innc., Belgium under the name ROTOXKIT M and performed according to the Standard Operational Procedure provided by the manufacturer. Cysts were incubated in artificial seawater (salinity 20‰) 28 to 30 hours prior to the start of the tests at 25°C with continuous illumination. After 28 to 30 hours, most cysts were hatched. Approximately 50 larvae we re transferred to a rinsing well containing test medium. From the rinsing well, 5 larvae were transferred to the six wells per concentration/ dilution for the test. The well plate was incubated at 25°C in the dark. After 24h living and

dead larvae in the test wells were counted.

Rotifers were expected to be sensitive for ch lorine; therefore production of ballast water (TRO) has been performed with 2 mg/L settings. The highest concentration in the test was 2.0 mg/L Cl 2 measured directly after production.

Table 9: Results of the rotifer mortality tests with sodium hypochlorite (NaOCl), produced ballast water (TRO) and sodium bisulphate (NaHSO 3 )

Brachionus plicatilis NaOCl TRO NaHSO 3 (mg/L) (mg/L Cl 2 ) (mg/L)

NOEC (24h) 1.2 0.50 25

LOEC (24h) 6 0.66 >25

LC 50 (24h) 2.51 (2.50-2.52) 0.881 (0.861-0.900) >25

11.4.4 Fish larvae test with Solea solea

The test protocol is based upon OECD203 (1992). Freshly fertilized eggs of the sole ( Solea

solea ) were obtained from SOLEA/IMARES, IJmui den, from a batch produced February, 2010. The eggs were incubated at 12-13°C and slight aeration until use in the tests. After 96 h most eggs were hatched. The test was performed in 100 mL glass beakers, containing 50 mL of theMEPC 61/2/11 Annex, page 16

I:\MEPC\61\2-11.doc test concentration. Each concentration was replicated 4-fold. To each test beaker 10 yolk-sac larvae were transferred. The test beakers were covered with parafilm to prevent evaporation, and put away at 12-13°C with a 16 h light – 8 h dark regime. Surviving organisms were counted daily in each beaker and dead animals were removed. After 4 days exposure, the

test was terminated.

Sole were expected not to be very sensitive for chlorine; therefore production of ballast water (TRO) has been performed with high settings. The highest concentration in the test was 16.8 mg/L Cl 2 measured directly after production.

Table 10: Results of the fish mortality tests with sodium hypochlorite (NaOCl) and produced ballast water (TRO)

Solea solea NaOCl TRO

(mg/L) (mg/L Cl 2 )

NOEC (96h) 2.13 2.99

LOEC (96h) 3.79 5.31

LC 50 (96h) 3.00 (0.770-11.7) 3.23 (0.018-597)

11.5 Determination of holding time

As neutralization of the residual oxidants in the treated ballast water stored on board is an integral component of the whole process in the ERMA FIRST BWMS, the discharge can be carried out as soon as the indented treatment has been accomplished. Toxicity testing that was carried out with samples of treated simulated ballast water before and after neutralization with sodium bisulfite, demonstrated that the discharge had no adverse effect after the neutralization process with the exception of algae, for which the NOEC might be lower than the residual chlorine level. Chemical analysis of ballast water treated with 9 mg/L of free active chlorine showed that the concentration of total residual chlorine was 0.04 mg/L on the 5th day following its electrolytic production and after its has been neutralized.

11.6 Reaction with organic matter

As it was discussed in section 2.3 of the confidential dossier, organic matter is a minor but important component of seawater affecting am ong others, the primary production, chemical and geological processes in the sea. Organic matter may be broadly categorized as either Figure 3: Impact of neutralization to total chlorine concentrationMEPC 61/2/11 Annex, page 17

I:\MEPC\61\2-11.doc particulate or dissolved matter. The dissolved organic carbon in the sea is strongly related to the balance between the rate at which dissolved organic carbon is formed by decay, excretion, etc., and the rate at which it is removed by decomposition or utilization. Particulate organic matter includes both living and non-living material in the sea and generally refers to particles larger than 0.5 – 1.0 μ m diameter although in reality seawater contains a continuous range of particle sizes from the smallest colloids up to larger organic aggregates (E. Duursma & R. Dawson, 1981).

The principal source of organic matter in seawater is in situ biological activity such as photosynthesis and excretion with external input coming from the land through surface run-off, as well as, human activities that produce industrial, agricultural and urban waste water. The highest concentrations of organic carbon will usually be found in areas of high productivity or in coastal areas under the influence of land-based input where invariably ships perform ballasting operations during cargo unloading and transfer. The disinfection by-products generated during various reactions between the Active Substances with the organic material present in the sea have been outlined in section 2.3 of the confidential dossier. In the first stage of treatment immediately after the pre-filtration of ballast water through a self cleaning basket filter (> 500 μ m), removal of coarse matter with size larger than 20 μ m takes place in the cyclonic separator. The removal of this material results on the one hand to a lower total organic carbon level in the ballast water that will be eventually treated in the second stage

with a lower disinfectant concentration demand and on the other hand to a reduction of the concentrations of disinfection by-products and in particular of trihalomethanes and haloacetic

acids. The levels of trihalomethanes and haloacetic acids in treated ballast water at the dose of 10 mg/L of free active chlorine is presented in section 11.3. The concentrations of these groups of substances in treated ballast water will be monitored further during land-based testing at NIOZ so that the results are reported in the application for Final Approval.

11.7 Characterization of degradation route and rate

Several half-life values are reported for hypochlorous acid and hypochlorite ions, ranging from 0.75 up to 1.4 hour. In the presence of organic material, FAC disappears very quickly, forming mainly halomethanes and haloacetic acids. Halomethanes are relatively stable as they are insensitive towards hydrolysis. As these are volatile, evaporation is a likely elimination route in water. A half-life of 38 days is estimated by the PBT-Profiler ( www.pbtprofiler.net ). Haloacetic acids are not very volatile but are more readily degradable through other routes than halomethanes. Haloacetic acids are more susceptible towards hydrolysis than halomethanes. The PBT-Profiler (www.pbtprofiler.net) estimates half-life values ranging from 8.7 up to 38 days in water for these acids.

Compound Biodegradation rate

or half-life Reference

Hypochlorous acid – hypochlorite (Sodium Hypochlorite) 1.4 hour (at pH 8) MEPC 60/2/3

Hypobromous acid – hypobromite (Sodium Hypobromite) Biodegrades fast MEPC 60/2/3

Chlorodibromomethane Half-life 69.951 years at 25°C pH=8 Epi Suite (Hydrowin)

Tribromomethane Half-life 340.755 years at 25°C pH=8 Epi Suite (Hydrowin)

Trichloromethane Half-life 601.994 years at 25°C pH=8 Epi Suite (Hydrowin)

Dichlorobromomethane Half-life 18.569 years at 25°C pH=8 Epi Suite (Hydrowin)

Sodium Bromate Half-life in seawater: 12 hours MEPC 60/2/3MEPC 61/2/11 Annex, page 18

I:\MEPC\61\2-11.doc Compound Biodegradation rate

or half-life Reference

Monobromoacetic acid Half-life Water: 8.7 days Soil: 17 days Sediment: 140 days Air: 25 days PBT profile

Dichloroacetic acid Half-life Water: 15 days Soil: 30 days Sediment: 140 days Air: 22 days PBT profile

Dibromoacetic acid Half-life Water: 15 days Soil: 30 days Sediment: 140 days Air: 25 days PBT profile

Bromochloroacetic acid Half-life Water: 15 days Soil: 30 days Sediment: 140 days Air: 24 days PBT profile

Trichloroacetic acid Half-life Water: 15 days PBT profile

11.8 Prediction of discharge and environmental concentrations

For the calculation of Predicted Environmental Concentrations (PECs), the freely available

Marine Anti-foulant Model to Predict Envir onmental Concentrations (MAMPEC v2.0) was used. For the current calculations, standard settings of the MAMPEC model were used; namely, the OECD-EU harbour (exchange volume 51,117,000 m 3 per tidal period of 12.1 hours). Concentrations outside the harbour and in the shipping lane are not resented here as they are all lower than the concentrations inside the harbour area).

Figure 4: MAMPEC Environment inputMEPC 61/2/11 Annex, page 19

I:\MEPC\61\2-11.doc Table 11: MAMPEC Compound input (* no data available)

Compound Molecular

Mass (g/mol) Saturized

vapour

pressure at 20 or 25 deg C (Pa) Solubility

at 20/25/30 deg C (gr/m 3 ) Koc (10logKoc) Melting Temp (deg C) Acid

dissociation

constant pKa (-)

Chlorodibromomethane 208.29 7. 38E+02 2.70E+03 1.92 -20 *

Tribromomethane 252.77 7.46E+02 3.10E+03 1.94 8 *

Trichloromethane 119.38 2.63E +04 7.95E+03 1.81 -63.6 *

Dichlorobromomethane 163.83 6. 67E+03 3.03E+03 1.74 -57 8

Monobromoacetic acid 138.95 1.59E +01 9.38E+04 1.60 50 2.89

Dichloroacetic acid 128.94 2.39E +01 1.00E+06 1.88 13.5 1.26

Dibromoacetic acid 217.84 3.07E +00 2.11E+06 0.176 49 1.48

Bromochloroacetic acid 173.39 1. 87E+01 2.50E+05 0.279 31.5 1.4

Trichloroacetic acid 163.4 8.00E +00 4.40E+04 2.11 57.5 0.512

Sodium bromate 150.89 1. 00E-10 3.60E+05 * 381 *

Hypochlorous acid – hypochlorite (Sodium Hypochlorite) 74.44 2.00E+03 2.93E+05 0.0627 18 *

Sodium bisulfite 104.061 7. 33E+02 4.20E+05 1.92 * *

A critical input parameter is the emission that corresponds to the amount of compounds (g) discharged per day and defined in model as load. These amounts are calculated from the concentration of the substances in the discharged ballast water and the volume being discharged. Estimates of discharged volumes range from 50,000 up to 396,000 m 3 /day, where 50,000m 3 /day is likely to be more realistic. We used three scenarios of 50,000, 100,000 and 200,000 m 3 /day as a realistic worst-case assumption. Concentrations measured in treated ballast water by OMEGAM (see section 7) after neutralization with sodium bisulfite are used as discharged concentrations in the calculations (PEC neutralization ).

In MAMPEC the load/emission is calculated (d ischarge of ships * maximum concentration of the compounds). Results from the above equation are presenting in Table 12. Values that correspond to three scenarios are in gr/day units while maximum concentration of amounts is

in μ g/L.

Table 12: MAMPEC Emission input

Scenarios :Discharge of ships (m 3 /day)

Compound name Max Concentration of the compounds ( μ g/L) 50000 100000 200000

Chlorodibromomethane 8.3 2.50E+01 5.00E+01 1.00E+02

Tribromomethane 210 6.50E+03 1.30E+04 2.60E+04

Trichloromethane 0.1 5. 00E+00 1.00E+01 2.00E+01

Dichlorobromomethane 0.5 2.50E+01 5.00E+01 1.00E+02

Monobromoacetic acid 21 3.10E+02 6.20E+02 1.24E+03

Dichloroacetic acid 1 5.00E+01 1.00E+02 2.00E+02

Dibromoacetic acid 200 7.50E+03 1.50E+04 3.00E+04

Bromochloroacetic acid 13 4.05E+02 8.10E+02 1.62E+03

Trichloroacetic acid 1 5.00E+01 1.00E+02 2.00E+02

Sodium bromate 51.9 2. 60E+03 5.19E+03 1.04E+04 Hypochlorous acid – hypochlorite (Sodium Hypochlorite) 84 4.20E+03 8.40E+03 1.68E+04

Sodium bisulfite 701.9 3. 51E+04 7.02E+04 1.40E+05MEPC 61/2/11 Annex, page 20

I:\MEPC\61\2-11.doc As indicated in the table below, three measured concentrations had to be converted using molar masses, in order to be able to compare these concentrations with the PNEC:

Table 13: Convert concentrations for comparison

Chemical name Measured

as Measured concentration (T=5 dechlorination) (μg/L) PNEC

based on Converted concentration (T=5 dechlorination) (μg/L)

Hypochlorous acid – hypochlorite (Sodium Hypochlorite) Cl 40 NaOCl 51.9

Sodium bromate BrO 3 - 44 NaBrO 3 84

Sodium bisulfite SO 3 2

- 540 NaHSO 3 701.9

The model was running for every compound and the maximum concentration in water was defined ( μ g/L). All data corresponds to PEC values. The following table contains the PECs

calculated as described above with MAMPEC.

Table 14: PEC calculations from MAMPEC

PEC neutralized (μg/L)

Chemical Name 50,000 m 3 / day 100,000 m 3 / day 200,000 m 3 / day

Chlorodibromomethane 0.00131 0.00262 0.00525

Tribromomethane 0.0372 0.745 1.49

Trichloromethane 0.000 217 0.000435 0.000869

Dichlorobromomethane 0.00119 0.00238 0.00476

Monobromoacetic acid 0.0121 0.00242 0.0485

Dichloroacetic acid 0.00375 0.0075 0.015

Dibromoacetic acid 0.343 0.686 1.37

Bromochloroacetic acid 0.0177 0.0355 0.071

Trichloroacetic acid 0.00229 0.00458 0.0917

Sodium bromate 0.238 0.475 0.95

Hypochlorous acid – hypochlorite (Sodium Hypochlorite) 0.0092 0.0184 0.0368

Sodium bisulfite 3.21 6.42 12.8

11.9 Assessment of potential for bioaccumulation

As indicated in section 10.1 all the Active Substances and Relevant Chemicals have a bioconcentration factor of less than 10.35, meaning that it is unlikely that the substances will

accumulate in the food web.

11.10 Effects assessment

In the previous sections the substances were screened for intrinsic PBT properties. In the next sections potential effects will be identified based on Predicted Environmental Concentrations (PECs) and Predicted No Effect Concentrations (PNECs).

11.11 Effects on aquatic organisms

In order to assess effects of the treated ballast water on aquatic organisms, Predicted No Effect Concentrations (PNECs) are derived for the Active Substances, Preparations and Relevant Chemicals. PNECs are concentration thresholds below which unacceptable effectsMEPC 61/2/11 Annex, page 21

I:\MEPC\61\2-11.doc on organisms will most likely not occur. Although there are different approaches to determine the PNEC, the procedure described in the Methodology for information gathering and the conduct of work of the GESAMP-BWWG is followed here. In this procedure, the most sensitive aquatic toxicity endpoint is di vided by an assessment factor. The assessment factor reflects the degree of uncertainty in extrapolation from laboratory toxicity test data for a limited number of species to the "real" environment.

Assessment factors applied for long-term tests are smaller as the uncertainty of the extrapolation from laboratory data to the natural environment is reduced. For this reason long-term data are preferred to short-term data. Using these assessment factors and the collected toxicity data PNEC values are derived as listed in the table below. Toxicity values reported here are from the most sensitive endpoint available. Toxicity experiments using flow through exposure systems were not used as most sensitive endpoint as such an exposure route is not representative for ballast water treatment.

Chemical Name Toxicity (μg/L) Number of chronic

NOECs in distinct taxonomical groups BWM.2/Circ.13

Assessment

Factor PNEC (μg/L)

Hypochlorous acid – hypochlorite (Sodium Hypochlorite) 26 2 100 0.26

Hypobromous acid – hypobromite (Sodium Hypobromite) - - - -

Chlorodibromomethane 3,200 1 1,000 3.2

Tribromomethane 2,900 2 1,000 2.9

Trichloromethane 5.5 3 10 0.55

Dichlorobromomethane 780 2 1,000 0.78

Sodium Bromate 32,000 1 1,000 32

Monobromoacetic acid 200 1 1,000 0.2

Dichloroacetic acid 23,000 0 1,000 23

Dibromoacetic acid 69,000 0 1,000 69

Bromochloroacetic acid - - - -

Trichloroacetic acid 1,200 1 1,000 1.2

Sodium Bisulfite 59,000 0 1,000 59

11.12 Effects on sediment

The EU-TGD states that substances with a soil/water partitioning constant normalized to organic carbon (Koc) less than 500 – 1,000 l/kg are not likely to adsorb to the sediment. As all the Active Substances, Preparations and Relevant Chemicals have a Koc < 196 and thus much smaller than 500, they will not likely adsorb to the sediments.

11.13 Comparison of effect assessment with discharge toxicity

The results of the chemical analyses of treated seawater show that a direct toxic effect of chlorine (FAC) can be expected in the discharged water. Especially for unicellular organisms, such as micro algae, the NOEC may be lower than the residual chlorine after dechlorination (40 μg/L). In the laboratory tests with treated water performed by IMARES, a NOEC of 30 μg/L was found for the marine diatom Phaeodactylum tricornutum (see section 11.4). Due to the contact with suspended organic matter in the water,MEPC 61/2/11 Annex, page 22

I:\MEPC\61\2-11.doc the residual levels of chlorine will rapidly decrease. Therefore, the effect is expected to be temporarily. The concentrations of by-products in the discharged water are much lower than known toxicity values for these substances. It is not expected that these by-products will result in any aquatic toxicity when discharged.

Toxicity of sodium bisulfite was tested by IMARES with concentrations ranging up to 25 mg/L, which is the maximum dosage for neutralization. No effects where observed in these experiments for any of the tested concentrations and species ( P. tricornutum

, A. franciscana

, B. plicatilis and S. solea ) (see section 11.4). Therefore, ecological effects are not expected for the bisulfite when the treated ballast water is discharged.

12 RISK ASSESSMENT

12.1 Risk to safety of ship

The potential risk to the safety of the ship and her crew raised by the operation of the ballast water treatment system has been evaluated, taking into account the identified risk mitigation measures to be implemented and certain require ments of the legislative framework dealing with safety and pollution prevention matters.

During the development of the system, the ma nufacturer pursued an exchange of views with Greek shipping companies with the aim to collect information on a number of issues regarding the compartments of the ship where the individual components of the system might be installed during from a safety and easy to operate point of view, the minimization of risks to the crew posed during surveys and maintenance as well as the changes, if any, to the standard procedures performed by the crew in cases of emergency situations.

12.1.1 Corrosion

Most data on the effects that the products of electrolyzed seawater might have on the corrosion of steel used in storage tanks or their associated piping come from the pulp and paper industry in contrast to data referring to ballast water treatment which are comparatively less and new. The oxidizing action of hypochlorite ion to the increase of steel corrosion depends on the concentration of this agent and a number of environmental parameters such as acidity, temperature, etc. It should be noted that the maximum concentration of sodium hypochlorite produced by the ERMA FIRST BWMS will not exceed 10 ppm and the materials used in the cyclonic separator are synthetic to prevent corrosion basically from seawater since the electrolyzed water has no contact at all with it. The electrolytic cell itself and its associated connecting piping are fully protect ed by special coatings against corrosion.

A series of field trials and laboratory tests were performed in 2002 to establish the effects of using copper ion and sodium hypochlorite as bioc ides in ballast water, in the context of a study contracted by the Michigan Department of Environmental Quality to BMT Fleet Technology to help determine whether these chemicals could be recommended for use as biocides in ballast water for ships on the Great Lakes. As far as the use of sodium hypochlorite was concerned, the tests attempted to identify its effect on typical coating systems of exposure as well as the effect on typical corrosion rates of ship steel when exposed.

In the same project, tests were conducted using the ASTM standard "Test Method for evaluation of Painted or Coated Specimens Subjected to Corrosive Environments D 1654 92" and its rating system, to investigate and rate the damage arising from exposure to two levels of hypochlorite exposure for four different coating systems using five identical test coupons. While no quantifiable analysis is possible with respect to life expectancy from laboratory testing, the observation that damage is increased by the presence of chlorine isMEPC 61/2/11 Annex, page 23

I:\MEPC\61\2-11.doc mitigated by the observation this increase can only be statistically verified in the highly aggressive environment. During the life of the ship, the period when tank structure is submerged and subject to repeated abrasion i.e. the splash zone of the tank, represents a fraction of its total life. This level of aggressivity is also only seen when the ship experiences some extraordinary motion when operating in the ballast condition or in the bottom of the tanks when residual ballast water is present.

Protective coating systems are applied in dedicated ballast tanks of ships in service to protect the shipbuilding steel from corrosion. Following coating breakdown it is extremely difficult, if not impossible, to repair or reinstate the coating to new building standard and therefore it is important that such coatings be correctly applied according to sound practices. Regulation 3-2 of SOLAS Chapter II-1 referring to corrosion prevention of seawater ballast tanks in oil tankers and bulk carriers, require all dedicated water ballast tanks to be coated with an efficient corrosion prevention system, su ch as hard protective coatings or equivalent.

Performance standards for protective coatings for the ballast tanks in all types of ships have been adopted with the resolution MSC.215(82) with detailed specifications and technical requirements which intend to provide a 15 years good coating life from its initial application to a ship. The specification of a coating or a multi-coat system does not include only the type of the individual coating but also steel preparation, surface preparation, surface cleanliness, environmental conditions, the application proce dure as well as the acceptance criteria and inspection. Today, epoxy based coatings are mainly used for the protection of ballast tanks of ships and any other systems that might be also applied should comply with the performance standards.

In the context of the same project, and with the aim to establish whether there is any increase in corrosion due to the presence of hypochlorite in the concentrations likely to be found in a treated ballast tank, up to 90 days long testing was conducted in simulated

ballast tank conditions with three different env ironments to replicate conditions in a ballast tank, which are the following in terms of incr easing aggressivity: (a) in the damp humid space replicating an empty ballast tank, (b) fully submerged to replicate a full ballast tank, and (c) rotating on a wheel with cyclic immersion into the test solution to replicate the splash zone in the head space of a partially full tank. TRC levels were being maintained at 10 ppm and 40 ppm. Summarizing the results of the above-mentioned tests, it must be noted that there is no significant increase in corrosion rate due to the addition of hypochlorite at either 10 or 40 ppm in the short exposure ex periments. In the longer exposure experiments and less aggressive conditions, mean corrosion rates increased but there is a low confidence

in the difference of the statistical distribution of these data.

Corrosion rates of bare steel are increased by the presence of hypochlorite at the biologically effective dose rates under constant exposure conditions. However, the amount of corrosion increase is not considered significant over the life of a ship due to the relatively small amount of time that elevated hypochlorite concentrations would be present. An evaluation of the corrosion impacts to the ballast tanks will be conducted during land-based testing, at the maximum treatment concentration of 10 mg/L of free active chlorine taking also into account the anticipated decay of the residual chlorine. This evaluation will be based on the recommendations of the GESAMP-Ballast Water Working Group on corrosion testing delivered during its 8th meeting (MEPC 59/2/16).

This testing should have a time horizon of not less than 6 months and include uncoated substrates and marine epoxy coated steel. The testing and the evaluation of both uncoated and coated materials will be carried out in accordance with the applicable standards and methodologies recommended in the above-mentioned document.MEPC 61/2/11 Annex, page 24

I:\MEPC\61\2-11.doc 12.1.2 Fire and explosion

In section 2 of the dossier, hydrogen that is generated at the cathode of the electrolytic cell has been identified as one of the by-products of the second stage of ballast water treatment. Hydrogen is non-toxic but can act as a simple asphyxiant by displacing the oxygen in the air.

Effects of oxygen deficiency may include dimi nished mental alertness, impaired muscular coordination, faulty judgement, depression of al l sensations, etc. The whole flow of the ballast water pumped on board a ship will be treated into the electrolytic cell, eliminating the accumulation of hydrogen into the ballast tanks. The amount of hydrogen produced at the cathode of the electrolytic cell is directly proportional to the amount of electric current that passes through the cell. See below:

Theoretical calculations showed that in the nominal flow rate of 100 m 3 /h (based on the modular design and construction of the system) and the maximum operating current (200 Amps), the concentration of hydrogen in ballast tanks is extremely lower than its lowest explosive level, that means the lowest gas concentration that can support an explosion when mixed with air (4%).

The calculation of the amount of electrical c harge passing through the seawater, considering operating current of 200 Amps for 1 hour, is presented below:

Moles of electrons that carry the above calculated charge are as follows:

For every two moles of electrons, a mole of H 2 is formed, thus 3.73 mole H 2 . See below:

According to the above calculations, theoretically, 8.06 gr H2 gas per 200 Amps and hour of operation are produced by the electrolytic cell. At a treatment flow rate of 100 m 3 /hour, the hydrogen concentration would be less than 0.1 ppm, a value that is considerably lower low than the hydrogen lower explosivity level. However, it is intended that monitoring of hydrogen generation be carried out during both land-based and shipboard testing to verify this conclusion.

12.1.3 Storage and handling of chemical substances

The only chemical substance that needs to be stored on board is the aqueous solution of sodium bisulfite that will be injected into the ballast piping to neutralize the residual oxidants present in the treated ballast water before its eventual discharge into the sea. Sodium bisulfite solution 38 – 44% can be stored in 316 stainless steel, fibreglass or HDPE tanks while same material is recommended for the associated piping, pumps and valves. It must be noted that

sodium bisulfite is non-flammable and theref ore does not present any fire risk. The damage of human tissue is the most dangerous characteristic of sodium bisulphite. For that reason, protective equipment must be worn which is appropriate to the degree of risk such as safety goggles, face shield, hard hat, PVC jacket and pants, PVC gloves, and rubber boots. Normally, R 8.314 J / mole K 0.08205 L atm /mole K    

(3.73 ) 0.08205 / 293 89.67 V mole l atm mole K K l     

2 =89.67l 0.0899gr/l=8.06gr/200A/hour H  P V n R T

   720,000 1 .

. 96,485 C mol e mol e C     60min 60sec 1 200 1 720000 1 1min 1 sec C A mp hour C hour Amp    MEPC 61/2/11 Annex, page 25

I:\MEPC\61\2-11.doc no respiratory protection is required in handling sodium bisulfite during loading/unloading operations. However, during emergency situations, approved sulphur dioxide gas respirators or self contained breathing apparatus may be required. Containment under the storage tanks placed onboard is recommended. In the event of a leak, sodium bisulphite solution may be neutralized with alkali material such as soda ash, caustic soda, lime or limestone.

12.2 Risks to human health

Normal procedures for risk assessment for hum an health is to compare the exposure levels to which the population is exposed or likely to be exposed with those levels at which no toxic effects are expected to occur. Exposure assessment includes the intensity and the duration or frequency of exposure to a substance. Also, the chemical and physical properties determine the main exposure routes. From the substances that have been identified in section 2 of this dossier, those that are of concern in relation to the exposure risks to the crew of the vessel and technical personnel and discussed here are sodium hypochlorite,

tribromomethane and sodium bisulfite.

Sodium hypochlorite is produced in situ at 10 mg/L prior to its flow into the ballast tanks. The actual disinfection products are hypochlor ous acid – hypochlorite ion and hypobromous acid – hypobromite ion. The data presented for sodium hypochlorite in section 4 have been taken into account to assess the exposure ri sks. Trihalomethanes and haloacetic acids are generated during the reactions of sodium hypochlorite with organic material present in the ballast water. The concentrations of the individual substances of these two groups as well as sodium bromate measured during the toxicity test ing of treated ballast water are provided in section 11. Engineer officers or other personnel of the vessel charged with the operation of the ballast water treatment system are not expected to be exposed in sodium hypochlorite and/or sodium bisulfite during normal operations.

Risks of exposure might exist in case of failures of the system. Concentrations of sodium hypochlorite in aqueous solution more than 12.5% have been reported corrosive for the eyes. According to the MSDS of aqueous solutions of sodium bisulfite, contact with it can cause skin and eye irritation. Appropriate personal protective means should be used when members of the personnel of the vessel or technical personnel deal with its storage or handling on board to minimize the potential for acute health effects.

12.2.1 Free available chlorine

Free available chlorine is produced in situ at 10 mg/l to its flow into the ballast tanks and will give

three forms of chlori ne, dissolved gas Cl 2 , hypochlorous acid (HOCl) and hypochlorite ion (OCl
- ) in equilibrium. The exact concentration of each form is a function of the pH as described in

section 2.1 of the confidential dossier. Al so, hypobromous acid (HOBr) and hypobromite ion (OBr
- ) are produced as part of the TRO. The data presented for sodium hypochlorite in section 4 have been taken into account to assess the exposure risks. It must be noted that regulated safety procedures for the production of hypochlorite do not exist in Europe. National occupational exposure levels are, therefore, used for determining the exposure evaluation. In most European countries, the limit for long term exposure (8 hours TWA) to hypochlorite is 1.5 mg/m 3 . Some countries use a short term exposure limit (15 minutes STEL) of 3 mg/m 3

.

Inhalation exposure of the three forms of chlorine is not likely to occur, except in cases in which an aerosol is formed. Volatilization of the hypochlorite ion and the small fraction of hypochlorous acid present in the ballast water are very low or even absent. Gaseous chlorine can be formed in accidental cases in which strong acids are mixed with the hypochlorite solution. The latter is not likely to occur in ballast water treatment. Oral exposure to free available chlorine and to chlorinated by-products is only possible for the crew and generalMEPC 61/2/11 Annex, page 26

I:\MEPC\61\2-11.doc public by accidental ingestion. Risk for the crew might only be present in case of failures of the system; the general public might be exposed more often but at much lower concentrations. Dermal exposure to free chlorine is the route of exposure most likely to occur.

Engineer officers or other personnel of the vessel charged with the operation of the ballast water management system are not expected to be exposed to sodium hypochlorite during normal operations. Regardless of the type of the vessel, where the system can be installed, the frequency of physical attendance of her machi nery spaces by the crew it was considered that almost during every ballasting and deballasting operation, a visual observation of the ballast water management system may take place. Risks of exposure might exist in case of failures of the system, wherein the observers are posed to the highest risk. In case of failure observers and crew might be exposed at the highest concentration of hypochlorite (10 mg/L) during treatment.

The general public on the other hand is dermal exposed intermittent as users of coastal amenities, beach coastlines and offshore instal lations and harbours (BWM.2/Circ.13). Worst case scenario would be exposure of general public with full contact e.g., through swimming in the harbour. This is however not expected to occur.

Concentrations of sodium hypochlorite in aqueous solution more than 12.5% have been reported to be corrosive for the eyes. This is more than 100 times more concentrated than is produced during treatment. Corrosiveness to eyes is, therefore, no issue. Rates of absorption of hypochlorite through the skin ar e not available from experimental studies. Given the reactivity of the substance to or ganic materials and other proteinaceous material, the potential to be absorbed through the skin is low. In the European Risk Assessment report for hypochlorite (European communities, ECB: 2007) a conservative assumption of 10% for penetration through the skin is used.

12.2.2 Sodium bisulfite

The only chemical stored on board in concentrated form is sodium bisulfite (38-44% solution). Exposure to humans is possible during storage, at injection to ballast water and as surplus in the discharged water. In Europe, the substance is not listed in a priority list (as foreseen under Council Regulation (EEC) No 793/93 on the evaluation and control of the risks of existing substances). On average, the limit for long term exposure (8 hours TWA) to sodium bisulfite is 5 mg/m 3 . Sodium bisulfite decomposes at ambient temperatures and atmospheric pressure giving su lfur dioxide gas. Exposure limits values for sulfur dioxide are 2 mg/m 3 for long term exposure (8 hours TWA) and 5 mg/m 3 is used for the short term exposure limit (15 minutes STEL).

Inhalation exposure of sodium bisulfite solution is negligible, only present in cases where a mist is formed. The decomposed gaseous fraction sulfur dioxide might be inhaled and pose

a risk. Both forms causes irritation and sulfit e-sensitive individuals may experience a severe allergic reaction. Greatest risk for inhalation exposure is while handling the concentrated form. Oral exposure to sodium bisulfite is only possible for the crew and general public by accidental ingestion. Risk for the crew might be present in case of failures in handling or storage; the general public might be exposed more often by the surplus but at much lower

concentrations.

Dermal exposure of the substance to crew is a possibility as the substance needs to be handled on board. The greatest risk is posed when handling the concentrated form of the substance. When handling the concentrated form personal protection should avoid contact with the skin or eyes. Prolonged skin exposure may cause mild irritation. To the eyes, it tends to cause mild irritation and at prolonged exposure severe burns. The general publicMEPC 61/2/11 Annex, page 27

I:\MEPC\61\2-11.doc is dermal exposed intermittent as users of coastal amenities, beach coastlines and offshore installations and harbours (BWM.2/Circ.13). Worst case scenario would be exposure of general public with full contact e.g., through swimming in the harbour.

12.2.3 Tribromomethane

Tribromomethane and dibromochloromethane are formed as by-products in the process. Both substances are not listed in a priority list (as foreseen under Council Regulation (EEC) No 793/93 on the evaluation and control of the risks of existing substances). In natural circumstances the substances are produced in small amounts by plants in the ocean. In water, these chemicals will evaporate to the air and/or be broken down slowly by bacteria. Due to the rapid evaporation rate of the subst ances, inhalation is a likely exposure route. Workers may be exposed to vapours of the substances at the ventilation grills on the deck of the vessel. The ventilation grills on deck are directly connected to open air, indicating rapid ventilation of the vapours. In case of ac cidental release of vapours in closed areas (e.g., machine room) short term exposure may occur. Tribromomethane and

dibromochloromethane are eliminated from the body fairly quickly. The US Occupational Safety and Health Administration (OSHA) set a long term limit of 0.5 ppm for tribromomethane (8 hours TWA). No limits have been set for dibromochloromethane due to its limited use. The DFG (German Research Foundation) reports a MAK for tribromomethane: confirmed animal carcinogen with unknown relevance to humans.

Very small amounts of the substances may enter the body directly through the skin while bathing or swimming. There is no conclusive evidence that tribromomethane or

dibromochloromethane cause cancer in human s as there is no data of humans exposed exclusively to these chemicals. Animal studi es showed liver and kidney cancer after long term exposure. In the USA, the EPA recommends drinking water containing no more than 0.7 ppm of tribromomethane and 0.7 ppm (700 μg/L) of dibromochloromethane. The measured concentrations in the treated water did not exceed these limits, posing no risk for humans. The highest measured values were 210 μg/L tribromomethane after 2 days and 8.3 μg/L of dibromochloromethane after 2 days.

12.3 Risks to the aquatic environment

By comparing Predicted Environmental Concentrations (PEC, section 11.8) with Predicted No Effect Concentrations (PNEC, section 10.11) potential ecological risks can be identified. When the ratio between PEC and PNEC is larger than 1 (in other words: PEC > PNEC) ecological effects cannot be ruled out, based on the underpinning worst-case assumptions.

The table below contains the PEC/PNEC ratios for all Active Substances and Relevant

Chemicals calculated with the PEC and PNEC values determined in this document.

PEC PNEC PEC/PNEC
50,000

m 3 /day 100,000

m 3 /day 200,000

m 3 /day (Literature) 50,000

m 3 /day 100,000

m 3 /day 200,000

m 3 /day

Chlorodibromomethane 0.00131 0.00262 0.0053 3.2 4.09E-04 8.19E-04 1.64E-03

Tribromomethane 0.0372 0.745 1.49 2.9 1. 28E-02 2.57E-01 5.14E-01

Trichloromethane 0.000217 0.000435 0.0009 0.55 3.95E-04 7.91E-04 1.58E-03

Dichlorobromomethane 0.00119 0.00238 0.0048 0.78 1.53E-03 3.05E-03 6.10E-03

Monobromoacetic acid 0.0121 0.00242 0.0485 0.2 6.05E-02 1.21E-02 2.43E-01

Dichloroacetic acid 0.00375 0.0075 0.015 23 1.63E-04 3.26E-04 6.52E-04

Dibromoacetic acid 0.343 0.686 1.37 69 4. 97E-03 9.94E-03 1.99E-02

Trichloroacetic acid 0.00229 0.00458 0.0917 1.2 1.91E-03 3.82E-03 7.64E-02

Sodium bromate 0.238 0.475 0.95 32 7. 44E-03 1.48E-02 2.97E-02
Hypochlorous acid – hypochlorite 0.0092 0.0184 0.0368 0.26 3.54E-02 7.08E-02 1.42E-01

Sodium bisulfite 3.21 6.42 12.8 59 5. 44E-02 1.09E-01 2.17E-01MEPC 61/2/11 Annex, page 28

I:\MEPC\61\2-11.doc Based on the calculated PEC/PNEC ratios, ecological risks to the aquatic environment are not expected due to PEC/PNEC ratios that remain below 1. The calculated PECs are based on continuous discharges.

13 ASSESSMENT REPORT

Aquatic and mammalian toxicity, the potential for bioaccumulation and persistence in the marine environment, as well as the physical and chemical properties of the identified Active Substances and Relevant Chemicals pr oduced during the electrolytic disinfection of ballast water were assessed to evaluate the environmental risks that might exist when discharge of treated ballast water will take place and also the risks to human health and to the safety of the vessel and her crew. Toxicity testing of treated ballast water in combination with the chemical analyses of the Active Subs tances in various time intervals showed that toxicity was not observed in the discharge 96 hours after treatment for the exposed representative species, with the exception of algae, for which the NOEC might be lower than the residual chlorine level following the neutralization process.

The concentration of the identified Relevant Chemicals, generated during the electrolytic disinfection of ballast water, were found to be much lower than the respective toxicity values for these chemicals. Similarly, toxicity of sodium bisulfite used as neutralization agent in concentrations ranging up to the maximum dosage in the system, demonstrated that there were no effects for any of the tested species. Toxicity experiments were performed by the ISO 9001 certified laboratory of IMARES in the Netherlands, following OECD and ISO protocols as closely as possible. The L(E)C50 values determined for sodium hypochlorite are comparable with values found in literature as shown in the table below (showing only static exposure experiments):

Table 15: Comparison of toxicity data

ERMA FIRST BWMS testing results EPA ECOTOX database Species L(E)C50 (mg/L) Species L(E)C50 (mg/L)

P. triconutum 0.249 (72 h) Diatoms 0.075-0.33 (24 - 96 h)

A. franciscana 2.37 (0.05-106) A. franciscana 5.6

Brachionus plicatilis 2.51 Br achionus calyciflorus 0.37

S. solea 3.00 (96 h) Fish 0.2-10 (96 h)

Section 11.8 of the dossier provides an overview of Predicted Environmental Concentrations (PECs) as calculated using the MAMPEC v2.0 model. Section 11.11 gives a list of PNECs

that were used in the risk assessment in section 12.3. Variable PNEC values have been reported in literature. Assessment factors are generally designed to obtain a worst-case impression of the sensitivity of the receiving environmental compartment towards a toxicant. Assessment factors as proposed in BWM.2/Circ.13 were used in this assessment. Major inputs for the MAMPEC model were discharged concentrations (μg/L), discharged amounts (m 3 /day) and half-life values. The PEC/PNEC ratios as presented in section 12.3 indicate that the Active Substances and Relevant Chemicals do not pose an ecological risk when discharged.

Ship's crew charged with the operation of the ballast water treatment system or other personnel dealing with its maintenance are not expected to be exposed in the Active Substances or the neutralizing agent used during normal operations. Risks of exposure might exist in case of failures of the system.

___________