E

MARINE ENVIRONMENT PROTECTION COMMITTEE 62nd session Agenda item 2 MEPC 62/2/10 17 December 2010 Original: ENGLISH

HARMFUL AQUATIC ORGANISMS IN BALLAST WATER Application for Final Approval of the SiCURE Ballast Water Management System Submitted by Germany SUMMARY Executive summary: This document contains the non-confidential information related to the application for Final Approval of the SiCURE Ballast Water Management System under the "Procedure for approval of ballast water management systems that make use of Active Substances (G9)" adopted by resolution MEPC.169(57). This document contains a summary for translation purposes.1 7.1 7.1.2 7.1.2.5 Paragraph 15 BWM/CONF/36; MEPC 57/21; MEPC 60/2/15; BWM.2/Circ.13 and BWM.2/Circ.26

Strategic direction: High-level action: Planned output: Action to be taken: Related documents:

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 Germany herewith submits an application for Final Approval according to the Procedure for approval of ballast water management systems that make use of Active Substances (G9). This procedure stipulates the required information (MEPC 57/21, annex 1, paragraph 4.2.1), which, according to section 6, should be evaluated by the Organization. In accordance with BWM.2/Circ.26, Germany submits the non-confidential part of the manufacturer's application dossier in the annex of this document. The complete dossier will be made available to the experts of the GESAMP-BWWG with the understanding of confidential treatment.
1

The original document is over 20 pages long and can be found in English only in the annex hereto.

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MEPC 62/2/10 Page 2 3 Basic Approval of the Active Substance used has been granted at MEPC 60 (MEPC 60/22, paragraph 2.4.1). 4 After carefully taking into account the recommendations contained in annex 6 of the report of the tenth meeting of the GESAMP-BWWG (MEPC 60/2/11), the competent authority has verified the application dossier and believes it to satisfy the requirements of Procedure (G9) adopted by resolution MEPC 169(57). Summary of non-confidential information on the SiCURE Ballast Water Management System 5 The SiCURE Ballast Water Management System (BWMS) utilizes a proven technology to filter out, oxidize and eliminate aquatic invasive species (AIS) with Sodium Hypochlorite (NaOCl). NaOCl, a chlorine compound, has been used for many years to prevent marine growth in the seawater piping and heat transfer systems of land-based, offshore and shipboard installations. It has been found that the most efficient method of hypochlorination is to produce sodium hypochlorite in situ, electrolytically, on demand, utilizing Concentric Tube Electrode (CTE) technology to produce NaOCl and inject the sodium hypochlorite into the seawater intakes. This technology is well known in the maritime industry under trademark Chloropac. The experience with Chloropac on thousands of shipboard installations worldwide has allowed Siemens to evolve its Chloropac Marine Growth Prevention System into the SiCURE Ballast Water Management System. 6 The SiCURE BWMS is designed to provide a minimum required hypochlorite dose as demanded by the quality of the ballast water being treated. This is done employing filtration and proprietary disinfection control. The electrical current to produce hypochlorite, and therefore its dose level, is controlled by the demand in the receiving waters. The demand is expressed by the oxidation reduction potential (ORP) in the treated water. On-demand biocide dosing is intended to reduce potential for corrosion and formation of disinfection by-products as well as to minimize residual biocide concentration in the ballast water discharge. An optional dechlorination module will be installed for vessels with voyage times shorter than 5 days. In this case sodium sulfite is used to neutralize remaining TRO in the discharge. 7 Siemens has carried out a comprehensive risk assessment analysis of performance of the SiCURE system in accordance with Procedure (G9). Several disinfection by-products such as trihalomethanes, haloacetic acids, haloacetonitriles, chlorate and bromate were identified as Relevant Chemicals along with sodium sulfite used as a dechlorination chemical, when required. All these chemicals were investigated for their toxicity and other critical properties, either based on the results of the public literature search or by direct toxicity testing. These effects were then compared with the toxicity of treated water from fresh water and saltwater sources. 8 Treated water toxicity was evaluated during land-based testing conducted at the Great Ships Initiative (GSI) test facility on fresh water Lake Superior (about 0.1 PSU) in Wisconsin (United States) and at the Maritime Environmental Resource Centre (MERC) in brackish water Chesapeake Bay (7 to 10 PSU) in Maryland (United States). Oxidant residuals in all ten land-based tests with retention time of 5 days were below 0.1 mg/L. As neutralization was not required in these test runs, an additional test using a neutralization agent was undertaken, showing a potential neutralization system to work. Whole Effluent Toxicity (WET) testing showed absence of acute toxicity in both fresh and brackish water tests meaning that discharge of treated water 5 days after treatment will not present any immediate adverse effect to the aquatic environment upon its discharge. WET test results in fresh and brackish water do show some chronic toxicity to algae at 100% effluent but as little as 50% dilution rendered treated water safe to the aquatic environment. There was no toxicity found in a trial with dechlorination, providing NOEC of 100% for all three trophic levels.
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MEPC 62/2/10 Page 3 9 The potential long-term adverse effects due to discharge were addressed using the environmental modelling Marine Anti-foulant Model to predict environmental concentration (MAMPEC Model, version 2) in the OECD-EU commercial harbour port. It was assumed that there were 80 ships anchored in the Port of Rotterdam on an average day, discharging 100,000 (one hundred thousand) m3/day or about 4,167 m3/hour of ballast water into the harbour. Further, it was assumed that all 80 ships present in the harbour are equipped with the SiCURE BWMS with the water characterized by the same holding time (Active Substance and Relevant Chemicals levels). While in land-based tests, Active Substance concentration (TRO) after 5 days was below 0.1 mg/L, it was conservatively assumed here that TRO concentration in discharge was at 0.1 mg/L for all 80 vessels discharging in port. 10 Predicted environmental concentrations (PEC) for every Active Substance and Relevant Chemical were then compared with their Predicted No-Effect Concentrations (PNEC). The PEC/PNEC ratios listed below in the table indicate that no aquatic risk (ratio <1) exists when all 80 ships discharge treated water daily in the Port of Rotterdam after 5-day holding time.
Chemical HOCl Trichloromethane Bromodichloromethane Dibromochloromethane Tribromomethane Monochloroacetic acid Dichloroacetic acid Trichloroacetic acid Monobromoacetic acid Bromochloroacetic acid Dibromoacetic acid Tribromoacetic acid Sodium chlorate Sodium bromate Dichloroacetonitrile Dibromoacetonitrile Sodium sulfite PEC g/L 0.018 1.790 0.096 0.154 1.920 0.159 9 0.385 0.687 0.037 0.054 0.416 2.220 3.010 0.682 0.027 0.153 0.260 PNEC g/L 0.04 15.00 15.00 34.00 12.00 0.58 52.30 785.00 0.58 0.58 978.00 1382.00 62.60 8.00 490.00 490.00 48.00 PEC/PN EC ratio 0.450 0.120 0.006 0.005 0.160 0.270 0.007 0.001 0.060 0.090 0.000 0.002 0.048 0.085 0.000 0.000 0.005

11 Risk assessment was also carried out for the safety of the ship, its crew and other population groups. In order to evaluate the effect of the treatment with SiCURE BWMS on materials of ships' construction, Siemens undertook a comprehensive, real-time six-month long testing programme at their testing facility in Singapore. The study was based on recommendations for corrosion testing by the GESAMP-BWWG published in document MEPC 59/2/16 in April 2009 and was conducted under supervision from Germanischer Lloyd. The corrosion effects from natural seawater were compared to seawater with 6 mg/L hypochlorite (measured as chlorine) which represents the maximum treatment concentration of the SiCURE system. Materials investigated included low carbon steel (shipbuilding steel), stainless steel, copper and nickel alloys as well as gasket materials and epoxy coatings applied in ballast tanks. Testing showed that while sodium hypochlorite can be damaging to some of the shipbuilding materials, SiCURE design and control logic will mitigate any possible risks from corrosion.

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MEPC 62/2/10 Page 4 12 The Human Exposure Assessment section identified various population groups who could potentially be exposed to the chemicals of potential concern (COPCs). The assessment showed a low possibility of exposure for all of the population groups. The technicians/ship's crew have some potential for inhalation exposure as a result of venting from the ballast tanks and inspections that require technicians to go inside the tank. However, the exposures estimated in this risk assessment are likely overstated due to the use of highly conservative exposure assumptions and there are numerous safety mechanisms in place to prevent exposure under these circumstances. In summary, based on the results of the conservative risk assessment, potential risks to on board receptors who may be exposed to ballast water via inhalation or dermal exposures are below or within typical acceptable risk ranges used in risk management decision making around the world. 13 It is important to note that the basic process used in the SiCURE Ballast Water Management System has been used for a long time to disinfect drinking water and bathing water. There have been many toxicology studies conducted on both the Active Substances and the disinfection by-products to develop health-protective guidelines for these chemicals. The potential risks to the safety of ships, human health and the environment are expected to be low because of the low potential for exposure. 14 In conclusion, the risk assessment shows that the SiCURE BWMS treats ballast water safely, in full compliance with the IMO Guidelines. Action requested of the Committee 15 The Committee is invited to consider the proposal for Final Approval and decide as appropriate. ***

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MEPC 62/2/10 Annex, page 1 ANNEX NON CONFIDENTIAL INFORMATION ON THE SICURETM BALLAST WATER MANAGEMENT SYSTEM 1 PREAMBLE

The structure of the dossier for Final Approval for the SiCURE BWMS follows the dossier for Basic Approval as submitted to MEPC in December 2008 and approved by MEPC in March 2010. Changes in this application dossier are related to providing additional information on: treated water properties analysed during land-based tests in fresh water of Lake Superior and brackish water of Chesapeake Bay; acute and/or chronic toxicity data for Relevant Chemicals; boundary conditions; risk to the aquatic environment (MAMPEC modelling); effect on corrosion; and assessment of additional human exposure scenarios.

Siemens' dossier for Final Approval also includes some information on the environmental performance of the SiCURE BWMS when equipped with an optional dechlorination sub-system as it is Siemens intent to receive two type approvals: without the dechlorination system for vessels engaged in long-term voyages and with dechlorination system for the vessels with short voyage times. 2 DESCRIPTION OF THE SIEMENS' SICURE BWMS

The SiCURE Ballast Water Management System (BWMS) utilizes a proven technology to filter out, oxidize and eliminate aquatic invasive species (AIS) with Sodium Hypochlorite (NaOCl). NaOCl, a chlorine compound, has been used for many years to prevent marine growth in the seawater piping and heat transfer systems of land-based, offshore and shipboard installations. It has been found that the most efficient method of hypochlorination is to produce sodium hypochlorite in situ, electrolytically, on demand, utilizing Concentric Tube Electrode (CTE) technology to produce NaOCl and inject the Sodium Hypochlorite into the seawater intakes. This technology is well known in the maritime industry under trademark Chloropac. The experience with Chloropac on thousands of shipboard installations worldwide has allowed Siemens to evolve its Chloropac Marine Growth Prevention System into the SiCURE Ballast Water Management System. SiCURE BWMS is designed to provide a minimum required chlorine dose as demanded by the quality of the ballast water being treated. This is done employing filtration and proprietary disinfection control. Pre-treatment of the ballast water with filtration is incorporated as a part of the SiCURE BWMS to remove or break down AIS and sediments sized at 40 microns and above. This allows reducing NaOCl dose to provide required disinfection efficacy. Proprietary control logic of the SiCURE system monitors the chlorine dose level necessary to provide the
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MEPC 62/2/10 Annex, page 2 required efficacy. Biocide dosing level is variable and depends on the ballast water conditions its physical, chemical and biological characteristics cumulatively called chlorine demand. Matching dose level with the biocide demand allows minimizing unwanted effects sometimes associated with chlorine compounds. The main features of the SiCURE BWMS and process are as follows: filtration (40 micron) to remove zooplankton, some phytoplankton and sediments; in situ produced Sodium Hypochlorite quickly destroys all AIS down to the bacteria level. Sodium hypochlorite oxidation is well documented proven technology in shipboard and offshore applications; sodium hypochlorite decays quickly and will reach environmentally acceptable levels during the ships voyage with little or no residual in the overboard discharge after 5 days holding time; sodium hypochlorite, produced safely and economically in situ, eliminates the need to store and handle hazardous chemicals on board; SiCURE BWMS Sodium Hypochlorite generators employ CTE technology and thus are of low maintenance; centre-tapped electrochemical cells prevent stray currents in the ballast water thus eliminating possible piping corrosion; SiCURE employs "On-Demand" hypochlorite dosing powered by Siemens proprietary ORP based control logic which allows automatic hypochlorite dosing depending on ballast water conditions. This minimizes Active Substance and Relevant Chemicals residuals and corrosion; maximum dose level of NaOCl is limited to 6.0 mg/L; SiCURE employs a modular design that can be expanded to accommodate a wide range of ballast water capacities; SiCURE can be supplied as loose components to accommodate retro-fit applications as required; and as NaOCl decays relatively quickly, vessels with voyage time over 5 days will be able to safely discharge treated water without any additional treatment. Vessels with short voyage times will require a dechlorination system.

2.1

SiCURE BWMS design and configurations

The Siemens SiCURE BWMS employs a two-stage treatment process used only on ballast water intake see a block-diagram below. The first stage is the filtration to remove or damage hard-to-kill zooplankton as well as some part of phytoplankton and sediments. The filter is installed directly into the ballast water main and has a bypass for ballast water discharge operations. The second stage is a proprietary disinfection with a biocide produced on board a ship in situ from saltwater. The Active Substance is produced in a side stream of the ballast water main. Following the electrolyzer unit a degas tank is provided to allow the entrained by-products, hydrogen and oxygen, to vent out upon safe dilution with air. Then NaOCl is injected back into the ballast water main.
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MEPC 62/2/10 Annex, page 3 Most of NaOCl is injected downstream of the filter to provide disinfection for filtered ballast water. The NaOCl dose level is designed not to exceed a maximum of 6 mg/L in the treated water. This maximum is limited by continuous monitoring and control of the DC current drawn through the electrochemical cells. Further, a small NaOCl stream is injected into the main upstream of the filter to provide NaOCl concentration of equal or less than about 0.1 mg/L to prevent it from bio-fouling and to break up the colonies of marine organisms.

Electrochlorination Module Filtration Module BALLASTING Ballast Water Tanks

DE-BALLASTING Optional Dechlorination Module Figure 2.1-1: Block diagram of the SiCURE ballast water management process The core of the system is its Chloropac electrochemical generator. The electrolyzer consists of a pre-determined number of cells arranged in series, called a train. The cells are housed in an enclosure that provides additional personnel protection. To avoid high differential pressure over the cells, several trains installed in parallel are used for high ballast water flows. This increases the size of a side stream. Table 2.1-1 provides an overview of the system configuration as well as the chemical composition of the concentrate that is fed into the ballast water main. The concentration of biocide, as produced, will depend on a size of the system. For example, the systems used for treating 200 m3/h and 900 m3/h will use the same side-stream flow of 5.5 m3/h, however, they will be producing biocide at the concentration levels of about 220 mg/l and 1,000 mg/l, correspondingly. The SiCURE BWMS employs variable biocide dosing. Variable dose is achieved by maintaining the constant side-stream flow and varying the DC current from the transformer-rectifier to meet a specific biocide demand. Therefore, the biocide concentration in the side stream will vary.

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MEPC 62/2/10 Annex, page 4 Table 2.1-1: SiCURE system configurations for different ballast water flows
SiCURE System capacity / Ballast Water Flow m3/h 200 400 500 600 800 900 1000 1500 2000 3000 5000 Required Chlorine Dose kg/h 1.2 2.4 3.0 3.6 4.8 5.4 6.0 9.0 12.0 18.0 30.0 Side Stream Flow m3/h 5.5 5.5 5.5 5.5 5.5 5.5 11.0 11.0 16.5 22.0 33.0 Max NaOCl Concentration in Side Stream mg/L 218 436 545 655 873 982 545 818 727 818 909 Max NaOCl Concentration in Ballast Water Main mg/L 6 6 6 6 6 6 6 6 6 6 6

The current to produce chlorine, and therefore its dose level, is controlled by the demand in the receiving waters. The demand is expressed by the oxidation reduction potential (ORP) in the treated water. On-demand biocide dosing is intended to reduce potential for corrosion and formation of disinfection by-products as well as to minimize residual biocide concentration in the ballast water discharge. An optional dechlorination module will be installed for vessels with voyage times shorter than 5 days. In this case sodium sulfite is used to neutralize remaining TRO in the discharge. Materials of construction are type approved CPVC pipe, FRP, titanium and Hastelloy-C. Filter is built of epoxy-coated carbon steel with a 904L stainless steel screen. Integration with the shipboard ballast system will include startup, shutdown, emergency shutdown and data acquisition communication protocols. The SiCURE BWMS is set up to operate automatically with minimal operator supervision. The unit is controlled by a Siemens Programmable Logic Controller (PLC) programmed to initiate operation when all the system prerequisites for the operation are satisfied. A 3-D rendering of the containerized system is presented in Figure 2.1-2. The system's mechanical equipment is composed of the following: automatic backwash seawater inlet filter with a backwash pump; seawater booster pump; electrochemical generator; degassing equipment; biocide dosing pump; ballast water analyser pump; orp control loop; automatic and manual valves; and optional dechlorination module.

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MEPC 62/2/10 Annex, page 5 The system's electrical equipment is composed of the following: transformer/rectifier; system control panel; and motor control centre.

The system's use of a side stream to produce NaOCl allows for a flexible footprint wherein system's components can be placed wherever the room is available in the engine or a pump room that makes SiCURETM a good fit for retrofits see Figure 2.1-3.

DEGAS TANK WITH AIR BLOWERS DOSING PUMP SEAWATER INLET

ORP CONTROL

CONTROL PANEL

FILTER

BOOSTER PUMP

CHLOROPAC GENERATOR

TRANSFORMER RECTIFIER

Figure 2.1-2: 3-D Model of containerized SiCURE BWMS

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MEPC 62/2/10 Annex, page 6

Control Panel MCC Filter TR Cells

Tank

Figure 2.1-3: 3-D View of the engine room with SiCURE BWMS for 750 m3/h flow 3 IDENTIFICATION OF THE PREPARATION, ACTIVE BY-PRODUCTS AND RELEVANT CHEMICALS (G9: 4.1) SUBSTANCE,

Active Substance and Relevant Chemicals described in this section have been identified during testing of the SiCURE system that had taken place at three separate locations, each with widely differing ecosystems. Bench-top, proof-of-concept testing was carried out by the Royal Netherlands Institute for Ocean Research (NIOZ) in the Netherlands using North Seawater with salinity of about 30 PSU. Land-based testing has been conducted at the Great Ships Initiative (GSI) test facility on fresh water (about 0.1 PSU) Lake Superior in Wisconsin (USA) and at the Maritime Environmental Resource Centre (MERC) in brackish water (6 1-0 PSU) Chesapeake Bay in Maryland (USA). 3.1 Active Substances and Preparations

SiCURE BWMS uses seawater to produce biocides in situ using principles of electrolysis. At the outlet of the electrochemical generator, seawater will contain several products of electrochemical reactions taking place at the anode and cathode surfaces of the CHLOROPAC generator. These are hypochlorous acid (HOCl) in equilibrium with hypochlorite ion (OCl-), hypobromous acid (HOBr) in equilibrium with hypobromous ion (OBr-), certain short-life oxygenated chemical compounds and oxygen gas (O2) generated at the anode and hydrogen gas (H2) generated at the cathode. Hydrogen gas and oxygen gas are completely removed in the degas tank, therefore, they will be considered in this application as irrelevant. The list of Active Substances as produced by the SiCURE BWMS and their expected concentration ranges are presented in Table 3.1-1. Table 3.1-2 below provides an estimate of the relevant concentration of TRO in the treated ballast water at the time zero after their injection into the ballast water.

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MEPC 62/2/10 Annex, page 7 Table 3.1-1: Active Substances as produced Composition of Active Substances as produced Component Chemical Name CAS Number Concentration, mg/l Hypochlorous Acid 7681-52-9 <1000 Hypobromous Acid 13824-96-9 <65 Table 3.1-2: Active Substance as applied at time zero (T0) Component Chemical Name TRO* (as HOCl)
*

AS, RC or Other AS AS

Active Substance as applied (at Time Zero (T0) Concentration, mg/l CAS Number fresh water salt water 6.0 6.0 7681-52-9

AS, RC or Other AS

TRO is a commonly accepted term for measuring biocide concentration when treating water with chlorinebased compounds, especially, in seawater. In the application dossier for Basic Approval, it was shown that TRO is essentially a mix of FAH (HOCl and HOBr), chloramines and bromamines, if any, measured as equivalent chlorine, a term also commonly used in the water treatment industry. It was also shown that HOCl is the most toxic chemical in the mix, therefore only the TRO term will be used in this dossier and it will be conservatively assumed that all TRO is composed of HOCl. The term TRC will be used in this dossier only when referring to the data reported by other sources.

3.2

Other Chemicals

When a dechlorination module is used for vessels with short voyage times, a crew will have to prepare a solution with sodium sulfite see Table 3.2-1 that will be used for dechlorination during treated ballast water discharge when holding time is less than 5 days. Table 3.2-1: Preparation for dechlorination option Component Chemical Name Sodium Sulfite 3.3 Relevant Chemicals CAS Number 7757-83-7 Concentration, % Wt. 5.0 15.0 AS, RC or Other Other

Based on results of analysis Siemens has identified certain trihalomethanes (THM), certain haloacetic acids (HAA), certain haloacetonitriles, sodium chlorate and sodium bromate disinfection by-products as well as remnants of sodium sulfite when dechlorination is used as Relevant Chemicals Table 3.3-1. As seen from the tables below, depending on a source of ballast water (fresh water, brackish water or seawater) composition of these Relevant Chemicals varies.

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MEPC 62/2/10 Annex, page 8 Table 3.3-1: List of Relevant Chemicals

List of by-products produced in ballast water and their concentration in g/L Chemical Name Fresh water Brackish water Saltwater

T0
Trihalomethanes: Trichloromethane Bromodichloromethane Dibromochloromethane Tribromomethane Haloacetic acids: Dichloroacetic acid Trichloroacetic acid Dibromoacetic acid Tribromoacetic acid Sodium Chlorate Sodium Bromate Dibromoacetonitrile Sodium Sulfite* 51.1 6.3 87.1 21.9 < 1.0 < 4.0 404.0 32.1 < 50.0 < 0.5 NA 127.2 34.0 12.2 2.5 0.6 0.1 < 0.5

T5

T0

T5

T0

T5

236.2 20.3 13.9 6.3 0.7 0.1 < 0.5

< 0.5 2.1 1.0 28.8 37.0 68.9 33.0

< 0.5 3.1 1.1 24.9 4.1 201.0 74.3

N/A N/A N/A N/A

< 0.4 < 0.4 2.9 85.0

27.0 28.3 92.2 6.4 < 1.0 < 4.0 406.0 26.1 < 50.0 < 0.5 <5.0

1.3 0.1 < 1.0 45.2 15.0 71.6 71.8 262.5 77.8 < 50.0 22.5 5.0 NA

1.3 < 1.0 23.1 23.3 167.2 122.8 299.5 65.4 < 50.0 12.3 9.7 <5.0

N/A N/A N/A N/A N/A N/A

<3 0 50 60 N/A 76 N/A

NA

<5.0

NOTES:

Data for saltwater at T0 and T5 are limited as tests at NIOZ were of a limited scope. More data in saltwater will be available upon conclusion of the shipboard testing. ** Sodium Sulfite concentration is shown at a maximum possible level.

4 4.1

DATA SET FOR ACTIVE SUBSTANCES AND PREPARATIONS (G9: 4.2) Data sets on effects on aquatic plants, invertebrates and fish (G9: 4.2.1.1)

Acute and chronic toxicity data for both Active Substances and Relevant Chemicals were selected to conform with OECD Guidelines 203 (adopted 17 July 1992), 202 (adopted 13 April 2004), and 201 (adopted 23 March 2006) or USEPA Guidelines, for fish, crustaceans, and algae, respectively. In some cases toxicity data could not be found that followed the OECD Guidelines, then toxicity data non-conforming OECD Guidelines were cited with a note indicating any deviation from OECD. In other cases there was no toxicity data available at all, thus, Siemens initiated a study by the University of Maryland (UMD 2010) listed in Appendix A to obtain the necessary data following OECD guidelines. Still some data points in the tables below are missing. Where possible, such approaches as ACR (acute-tochronic ratio) method were used to compensate for missing data during risk assessment. 4.1.1 Acute aquatic toxicity

The data given in Table 4.1.1-1 are the lowest toxicity values found in the literature or in the UMD 2010 for each of the test substances for fish, crustaceans, and algae.
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MEPC 62/2/10 Annex, page 9 The literature summarized below for acute toxicity shows that TRO, in general, and HOCl, in particular, are more toxic to fish and crustaceans relative to Relevant Chemicals (Table 4.1.1-1). For example, the acute toxicity of TRO and HOCl to fish and crustaceans ranges from 0.032 up to 0.143 mg/L. The acute toxicity values of Relevant Chemicals are 2-3 orders of magnitude higher. No acceptable exposure data for algae (minimum 72-hour exposure; OECD 201 Guideline requirement) were found for TRO and HOCl, however, the indications are that they are toxic to algae. Table 4.1.1-1: Acute Aquatic Toxicity
Test Substance
Active Substances TRO (Fresh water) TRO (Saltwater) HOCl HOBr Relevant Chemicals Bromate Chlorate

F C A
F C A F C A F C A F C A F C A F C A

Species

Test Type

LC50/ EC50 mg/L

0.059 0.032 (<0.1)a 0.143 0.062 (0.075) 0.032 0.144 0.059 0.038 31 46.8

NOEC mg/L
N/A N/A NA N/A N/A N/A N/A N/A N/A N/A 5,277 >784

Reference/ Comments
Fisher et al. (1999) Fisher et al. (1999) Brooks and Liptak (1977) Fisher et al. (1999) Fisher et al. (1999) Videau et al. (1979) Thatcher (1978) Fisher et al. (1994) Fisher et al. (1999) Fisher et al. (1999) No data found Richardson et al. (1981) UMD (2010) UMD (2010) Mark and Hantink-de Rooij, 1991 AQUIRE, 1984 Hutchinson, 1994b Anderson et al. (1979) Foster and Tullis (1984) Kuhn and Pattard (1990) Heitmueller et al. (1981) LeBlanc, G.A. (1980) U.S. EPA (1978) Mattice et al. (1981) UMD (2010) UMD (2010) No data found No data found No data found UMD (2010) Trenel and Kuhn (1982) UMD Study (2010) Dennis et al. (1979) Dennis et al. (1979) UMD (2010) UMD (2010) UMD (2010) UMD (2010) UMD (2010) UMD (2010) UMD (2010) TOXNET (2010) No data found No data found

Oncorhynchus mykiss Daphnia magna Natural phytoplankton Menidia beryllina Mysidopsis bahia Dunaliella primolecta Oncorhynchus mykiss Americamysis bahia Oncorhynchus mykiss Daphnia magna

15-d survival 48-h survival 47-h change in Chlaa 96-h survival 96-h survival b 24-h growth 96-h survival 7-d survival 96-h survival 48-h survival 96-h survival 96-h survival 72-h growth 96 h-survival 48-h survival 72-h growth rate 96-h survival 24-h survival c 48-h growth 96-h survival 48-h immobilization 96-h growth inhibition 72- to 120-h egg fertilization to hatch 96-h survival 72-h growth

Morone saxatilis Daphnia magna Isochrysis galbana Brachidanio rerio Daphnia magna Phaeodactylum tricornutum Lepomis macrochirus Artemia salina Scenedesmus subspicatus Cyprinodon variegatus Daphnia magna Skeletonema costatum Cyprinus carpio Daphnia magna Isochrysis galbana

1,098 444 14 30 (950) 18 46 12.3 34 46.8

100 N/A N/A N/A 2.9 N/A N/A N/A 56.0

Trichloromethane

F C A F C A F C A F C A F C A F C A F C A F C A F C A

Tribromomethane Dibromochloromethane

Bromodichloromethane Dichloroacetic acid Trichloroacetic acid Dibromoacetic acid Tribromoacetic acid Dibromoacetonitrile

Cyprinodon variegatus Daphnia magna Isochrysis galbana Pimephales promelas Daphnia magna Isochrysis galbana Cyprinodon variegatus Daphnia magna Isochrysis galbana Cyprinodon variegatus Daphnia magna Isochrysis galbana Pimephales promelas

96-h survival 24-h immobilization 72-h growth 96-h survival 48-h immobilization 72-h growth 96-h survival 96-h survival 72-h growth 96-h survival 96-h survival 72-h growth 96-h survival

321.6 106 2000 2000 N/A 352.9 259.9 376.4 219.9

N/A 52.3 N/A N/A 250.3 195.5 250.0

490-620

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MEPC 62/2/10 Annex, page 10

Test Substance
Sodium Sulfite

F C A
F C A

Species
golden orfe

Test Type
96-h mortality 48-h survival 72-h growth

LC50/ EC50 mg/L

220-460 89 48.1

NOEC mg/L

Reference/ Comments
BASF MSDS BASF MSDS BASF MSDS

Daphnia magna Isochrysis galbana

NOTES: F = Fish; C = Crustacean; A = Algae. a. Study did not meet OECD 201 Guidelines because the test evaluated a change in chlorophyll at 47 h rather than growth at 72 h. b. Study did not meet OECD 201 Guidelines because the test evaluated a growth at 24 h rather than growth at 72 h. c. Study did not meet OECD 201 Guidelines because the test evaluated growth at 48 h rather than growth at 72 h.

4.1.2

Chronic aquatic toxicity

The data given in Table 4.1.2-1 are the lowest toxicity values found in the literature or in the UMD 2010 for each of the test substances for fish, crustaceans, and algae. The literature summarized below for chronic toxicity shows that TRO, in general, and HOCl, in particular, are more toxic to fish and crustaceans relative to Relevant Chemicals. The chronic toxicity of TRO to fish is 0.04 mg/L. The chronic toxicity of TRO to crustaceans is 0.012 mg/L. The chronic toxicity values of Relevant Chemicals are 2-4 orders of magnitude higher. No acceptable OECD 201 guideline exposure data for algae were found for TRO. No chronic data were found in the literature for hypobromous acid. Relative to the Active Substances, bromate and chlorate are not very toxic to algae (8 and 62.6 mg/L). UMD 2010 study showed HAA NOEC values in the range of 70 to 300 mg/L. Trichloromethane, which ranged from 1.5 up to 216 mg/L, is approximately 2-3 orders of magnitude less toxic than TRO to fish, crustaceans, and algae. The NOEC for tribromomethane to algae was 10 mg/L which is less toxic than TRO. No acceptable data could be found for the chronic toxicity of Tribromomethane to fish and crustaceans. No chronic data could be found for fish, crustaceans or algae exposed to dibromochloromethane, bromodichloromethane, dibromoacetonitrile and sodium sulfite. Table 4.1.2-1: Chronic aquatic toxicity
Test Substance Active Substances F C TRO (Fresh water) A F TRO (Saltwater) C A F HOCl C A F C A Ictalurus punctatus Gammarus pseudolimnaeus Natural algae Menidia peninsula Panaeus kerathurus Natural phytoplankton Oncorhynchus kisutch Americamysis bahia F C A Species Test Type 134-d growtha 70-d fecundity 24-d inhibition of b biomass 32-d egg to posthatch 7-d growth/moltingc 21-d reduction in cell b density d 23-d survival 7-d reproductionc LC50/ NOEC EC50 mg/L mg/L N/A N/A N/A N/A N/A N/A N/A N/A Reference/ Comments

(0.005) Hermanutz et al. (1990) 0.012 Authur et al. (1975) (0.079) Pratt et al. (1988) 0.04 Goodman et al. (1983)

(0.079) Saroglia and Scarano (1979) (0.001) Sanders et al. (1981) 0.042 0.048 Holland et al. (1960) Fisher et al. (1994) No data found No data found No data found No data found

HOBr

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MEPC 62/2/10 Annex, page 11

Test Substance Relevant Chemicals Bromate F C A F C A F C A F C A Morone saxatilis Isochrysis galbana F C A Species Test Type 10-d survival
e

LC50/ NOEC EC50 mg/L mg/L (93) N/A (50) 8

Reference/ Comments Richardson et al. (1981) No data found Erickson and Freeman (1978) No data found No data found Van Wijk et al., 1998 Toussaint et al. (2001) Kuhn et al. (1989) Cowgill et al. (1989) No data found No data found U.S. EPA (1978) No data found No data found No data found No data found No data found No data found No data found No data found No data found UMD (2010) UMD (2010) UMD (2010) UMD (2010) UMD (2010) UMD (2010) UMD (2010) UMD (2010) UMD (2010) No data found No data found No data found No data found No data found No data found

7-d growth inhibition

Chlorate

Trichloromethane

Pseudokirchneriella subcapitata Oryzias latipes Daphnia magna Skeletonema costatum

96-h Growth Inhibition 9-month growth 21-d reproduction 5-d reduction in cell volume 96-h growth inhibition N/A N/A 477

62.6 1.5 13 216

Tribromomethane

Selenastrum capricornutum

N/A

10

F C A F Dibromochloromethane C A F Dichloroacetic acid C A F Bromodichloromethane Trichloroacetic acid C A F C A F C A F C A F C A

Dibromoacetic acid

Tribromoacetic acid

Cyprinodon variegatus Daphnia magna Isochrysis galbana Cyprinodon variegatus Daphnia magna Isochrysis galbana Cyprinodon variegatus Daphnia magna Isochrysis galbana

32-d survival 21-d survival 96-h growth 32-d survival 21-d survival 96-h growth 32-d survival 21-d survival 96-h growth

260.8 235.0 249.5 285.0 78.5 396.6 277.0 244.4 271.0 97.8 590.8 508.5 163.0 138.2 250.0

Dibromoacetonitrile Sodium Sulfite NOTES:

F = Fish; C = Crustacean; A = Algae. a. Study did not meet OECD 210 Guidelines because the test was initiated with juveniles rather than the egg stage. b. Study did not meet OECD 201 Guidelines because the test did not have control culture biomass data. c. Study did not meet OECD 211 Guidelines because the test was not a 21-d reproduction test. The test did follow a portion of the protocol of the U.S. EPA OPPTS 850.1350 mysid chronic toxicity test (U.S. EPA, 1996); however, molting was only observed for 7 days rather than the minimum of 28 days. d. Study did not meet OECD 210 Guidelines because the test exposure was 23 days rather than the required minimum of 28 days. e. Study did not meet OECD 210 Guidelines because the test was initiated with 4-d old larvae (not eggs) and the post-hatch exposure was 10 days rather than the required minimum of 28 days.

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MEPC 62/2/10 Annex, page 12 4.1.3 Endocrine disruption

No reports were found in the literature that indicated the Active Substances (TRO) may be endocrine disrupters in aquatic organisms. Likewise, no reports were found that indicated the Relevant Chemicals listed in the dossier may be endocrine disrupters in aquatic organisms. 4.1.4 Sediment toxicity

Kocs for the Active Substances and Relevant Chemicals are presented in Table 4.1.4-1 of the Confidential Part of the Application Dossier. Neither the Active Substances nor the Relevant Chemicals appear to have the potential to be adsorbed to sediments to a significant extent based on the adsorption coefficients (Kocs) for the chemicals summarized below. All of the Kocs were <500 L/kg which indicate that the chemicals would not readily partition to sediment and thus be of concern to benthic organisms residing in the sediment. Furthermore, as shown in the next section (4.1.5), all of the log Pows for the Active Substances and Relevant Chemicals are <3 which indicate that significant bioconcentration/ bioaccumulation (<100 L/kg wet weight for the whole organism at 6% fat) of the chemicals will not occur. 4.1.5 Bioavailability/biomagnification/bioconcentration

Log Pows and BCFs for the Active Substances and Relevant Chemicals are presented in Table 4.1.5-1 of the confidential part of the application dossier. The log Pows for the Active Substances and Relevant Chemicals are all <3 which indicate that significant bioconcentration/ bioaccumulation (<100 L/kg wet weight for the whole organism at 6% fat) of the chemicals will not occur. Likewise, the BCFs also show that the potential for significant bioconcentration/ bioaccumulation is small in aquatic organisms. Little biomagnifications should occur in a food web since the chemicals are not readily bioconcentrated/bioaccumulated. 4.1.6 Food web/population effects

Little biomagnification and persistence in aquatic and mammalian food webs is anticipated from the Active Substances or Relevant Chemicals. This conclusion is based on the low Kocs and log Pows of the chemicals. All of the Kocs for both the Active Substances and Relevant Chemicals (Section 4.1.4) are <500 L/kg which indicate that the chemicals would not readily absorb to sediment and thus be of concern to benthic populations and their food webs. The log Pows for the Active Substances and Relevant Chemicals are all <3 which indicate that significant bioconcentration/bioaccumulation (<100 L/kg wet weight for the whole organism at 6% fat) of the chemicals will not occur. Likewise for the chemicals that have established BCFs, the BCFs also show that little bioconcentration/bioaccumulation will occur in aquatic organisms. Little biomagnification should occur in an aquatic food webs and bird/mammalian food webs since the chemicals are not readily bioconcentrated/ bioaccumulated. 4.2 Data on mammalian toxicity (G9: 4.2.1.2)

A variety of endpoints for mammalian toxicity for Active Substances and Relevant Chemicals were collected based on the information mainly from toxicology summaries performed by the International Programme on Chemical Safety (which is a consortium including the World Health Organization and United Nations Environment Programme), and the United States sources, such as the National Library of Medicine. In some cases, information from Material Safety Data Sheets was compiled. The studies discussed in these toxicology summaries represent valid and reproducible data.
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MEPC 62/2/10 Annex, page 13 4.2.1 Acute mammalian toxicity

Data for acute mammalian toxicity are presented in Table 4.2.1-1 of the confidential part of the application dossier. The lowest LD50s noted are for trichloromethane (36 to 2,000 mg/kg), bromate and dibromoacetonitrile (280 to 495 mg/kg). The LD50s for the other chemicals are mainly above 500 to 1,000 mg/kg. 4.2.2 Skin, eye and sensitization effects

Data for Skin and Eye Effects are presented in Table 4.2.2-1 of the confidential part of the application dossier. No data could be found for sensitization effects for any of the chemicals. All of the chemicals have the potential to cause irritation to the skin and eyes at sufficient concentrations. Where effects concentrations were provided, they were higher than concentrations typically found in treated ballast water. 4.2.3 Repeated-dose toxicity

Data for Repeated-Dose Toxicity Studies in a form of No-Observed-Adverse-Effects Levels (NOAELs) or Lowest-Observed-Adverse-Effects Levels (LOAELs), when available, are presented in Table 4.2.3-1 of the confidential part of the application dossier. For many of the chemicals, the target organs were the liver and kidney. A typical range of NOAEL/LOAEL values was within 10 100 mg/kg-day. Where effects concentrations are provided, they are higher than concentrations typically found in treated ballast water. 4.2.4 Chronic mammalian toxicity

The results of chronic mammalian toxicity studies are listed in Table 4.2.4-1 of the confidential part of the application dossier. The studies are conducted in rodents over a period of two years. Some of the chemicals report liver and kidney effects, similar to the subchronic studies. Some of the chemicals show an increase in specific tumours, usually in one species. Where effects concentrations are provided, they are higher than concentrations typically found in treated ballast water. 4.2.5 Developmental and reproductive toxicity

Data on developmental and reproductive toxicity in rodents are presented in Table 4.2.5-1 of the confidential part of the application dossier. For many of the chemicals, there were no effects noted on fertility or health of the fetus, even at the relatively high doses used in the studies. 4.2.6 Carcinogenicity

Data on carcinogenicity, including carcinogenic classification for the chemicals by the International Agency for Research on Cancer (IARC) and other agencies in the United States and Canada, are listed in Table 4.2.6-1 of the confidential part of the application dossier. A few of the chemicals were not classified (hypobromous acid, tribromoacetic acid) by IARC, and there is no information in the literature suggesting that they should be classified as potentially carcinogenic. Some of the chemicals are listed in IARC Group 3 not classifiable as to carcinogenicity in humans, while many are suspected as possible or probable carcinogens based on animal studies.

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MEPC 62/2/10 Annex, page 14 4.2.7 Mutagenicity and genotoxicity

Data on mutagenicity and genotoxicity are presented in Table 4.2.7-1 of the confidential part of the application dossier representing the results of various mutagenicity and genotoxicity assays. A wide range of results was observed for the different chemicals, and the different tests. Several studies have shown that sodium hypochlorite produces mutagenic responses in bacterial systems and mammalian cells in vitro. However, there is no evidence of activity in mammalian test systems in vivo. There were some mixed positive/negative results for THMs and chlorate/bromate, mainly negative results for haloacetic acids and positive mutagenicity results in several in vitro and some in vivo assays for dibromoacetonitrile. 4.2.8 Toxicokinetics

Data on toxicokinetics are presented in Table 4.2.8-1 of the confidential part of the application dossier. Most of the chemicals are excreted in the urine over the course of several hours, indicating relatively short half-lives in the human body. Trichloroacetic acid appeared to have the longest half-life. Some of the chemicals metabolize into breakdown products, such as trichloroacetic acid and dichloroacetic acid that are also rapidly eliminated from the body. 4.3 4.3.1 Data on environmental fate and effect under aerobic and anaerobic conditions (G9: 4.2.1.3) Modes of degradation (biotic and abiotic)

Aerobic degradation TRO, hypochlorous acid and hypobromous acid decay in seconds to hours as discussed in section 7.3.2 and in Heltz (1981), thus, little or no aerobic degradation is expected. Biodegradation of the Relevant Chemicals in presented in Table 4.3.1-1 of the confidential part of the application dossier. Most of the Relevant Chemicals degrade slowly, with half-lives in the range of weeks or months. Sodium sulfite degrades quickly with a half-life of about 10 minutes. When no degradation data were available, no degradation was assumed in the risk assessment. Anaerobic degradation TRO, hypochlorous acid and hypobromous acid decay in seconds to hours as discussed in section 7.3.2 and in Heltz (1981), thus, little or no anaerobic degradation is expected. Biodegradation of the Relevant Chemicals in presented in Table 4.3.1-2 of the Confidential Part of the Application Dossier. Most of the Relevant Chemicals degrade slowly, with half-lives in the range of days or weeks. 4.3.2 Bioaccumulation, partition coefficient, octanol/water partition coefficient

The octanol/water partition coefficients (Pows) and bioaccumulation factors (BCFs) for the Active Substances and Relevant Chemicals are given in section 4.1.5 above. The adsorption coefficients (Kocs) for the Active Substances and Relevant Chemicals are given in section 4.1.4. 4.3.3 Persistence and identification of the main metabolites in the relevant media

It is well documented that free available chlorine will react in fresh water to form a number of chloro-organic compounds, oxidation products, and chloride. Likewise, it is well documented that chlorine will react with Br- in saltwater to form free bromine which reacts with nitrogen to form bromamines which in turn form a number of bromo-organic, oxidation products, and Br-. All Relevant Chemicals discussed in this dossier, except for sodium sulfite, are the by-products expected from the chlorination of fresh water and saltwater ballast. The persistence of the above by-products is given in section 4.3.1.
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MEPC 62/2/10 Annex, page 15 4.3.4 Reaction with organic matter

Several oxidant decay reactions have been identified. The principal types of decay reactions which can ultimately react with organic matter are: (1) oxidation of amino-nitrogen (breakpoint reaction) which in turn react with organic matter; (2) oxidation of carbon; and (3) organic substitution. The most important decay reactions are probably those associated with the oxidation of amino-nitrogen which are important in the breakpoint phenomena of the chlorine-ammonia system. The breakpoint reactions are a function of chlorine dose, amino-nitrogen concentration, pH, temperature, and time of reaction. Trihalomethanes are unquestionably ubiquitous products of chlorination. Several variables can affect THM yields which include pH, temperature, chlorine dose, total organic carbon, and type of chlorine residual. Other factors being equal, higher pH tends to produce higher levels of THM after a given contact time. Higher temperatures accelerate the rate of THM appearance, however, it is not clear whether temperature affects the ultimate yield. Increasing chlorine dose increases yield up to point, however, several studies indicate that a plateau is reached. THM yields correlate positively with total organic carbon, but there is a great deal of scatter. Oxidation of carbon can play an important role in oxidant decay when natural water containing various amounts of organic matter are chlorinated. CO2 has been shown to be a major product of chlorination of natural estuarine water. Halocarbons have been shown to occur to a lesser degree by carbon oxidation. The production of halocarbons by substitution reactions also constitutes a decay mechanism for chlorine. However, the literature indicates (Helz, G.R. 1981) that only a few per cent of the chlorine in typical doses is consumed in substitution reactions during the decay process. 4.3.5 Potential physical effects on wildlife and benthic habitats

No data were found that indicated the Active Substances and Relevant Chemicals could cause potential physical effects to wildlife. 4.3.6 Potential residues in seafood

Based on the log Pows and BCFs of the Active Substances and Relevant Chemicals, it is unlikely that significant residues will accumulate in tissues which in turn could impact the consumption of seafood. No data were found that suggest that the Active Substances and Relevant Chemicals impart a foreign flavour or odour in the organisms exposed to the chemicals. 4.3.7 Any known interactive effects

No interactive effects of the Relevant Chemicals with fresh and salt ballast water have been identified. 4.4 Physical and chemical properties of the Active Substances, Relevant Chemicals and treated ballast water (G9: 4.2.1.4)

Please see Table 4.4-1 of the confidential part of the application dossier. MSDS for Active Substances and Relevant Chemicals are presented in appendix B of the confidential part of the application dossier.

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MEPC 62/2/10 Annex, page 16 4.5 Analytical methods at environmentally relevant concentrations

Several accredited environmental laboratories for environmental analytical services were used: Enviroscan Analytical Services, Rothschild, WI (USA); Underwriters Laboratories (UL), South Bend (USA); Analytical Laboratory Services, Inc., Middletown, PA (USA); Weck Laboratories, Inc., City of Industry, CA (USA). USEPA methods, including detection limits, used for analysis of Active Substances and Relevant Chemicals are presented in Table 4.5-1 of the confidential part of the application dossier. 5 5.1 USE OF THE ACTIVE SUBSTANCE (G9: 4.2.6) Manner of application and dosage

The SiCURE system applies Active Substance on intake only. SiCURE BWMS is based on variable dosing necessary to achieve a certain oxidizing power of the treated water its ORP potential. Required chlorine dosing will be determined based on a certain ORP setpoint and controlled by PLC to reduce or increase DC current drawn from the transformer-rectifier to the electrochemical generator as necessary. DC current is limited to produce no more hypochlorite than required to deliver 6 mg/L in ballast water. The SiCURE system is designed for shipboard applications for both new builds and retrofits. The system can be supplied as a skid mount or containerized, fully integrated package or as loose components. SiCURE systems will be manufactured to treat from 200 to 5,000 m3/h ballast water flow; with 6 to 8 standard size systems covering the entire range. The system primary market will be large ocean-going vessels such as tankers, LNG, bulkers and containerships. For vessels with the short voyage time (under 5 days), a dechlorination sub-system will be used for neutralizing treated ballast water on discharge. The system will consist of a storage tank and a dosing pump. Neutralization will be carried out using sodium sulfite solution at a dose rate of up to 5 mg/L. 5.2 Retention time

In addition to the mandatory efficacy testing after 5 days (120 h) retention time specified by the IMO in Guidelines (G8), Siemens also carried out testing with only one day (24 h) retention time. The results of that test showed that the treatment with SiCURE system was effective within the first 24 hours. As Siemens will be offering two alternative models of the SiCURE system, with and without a dechlorination module, therefore the retention time will be: 5 days to allow for TRO to dissipate to below 0.1 mg/L level for vessels with the voyage time of more than 5 days. Land-based tests in Chesapeake Bay and Lake Superior showed (Tables 7.2.1-1 and 7.2.1-2) that after 5 days' retention time, TRO in the treated water was found to be below 0.1 mg/L; and 24 hours for vessels with a short voyage time when dechlorination module is used.

5.3

System monitoring and control, crew interaction

SiCURE BWMS has a data acquisition system. PLC will collect and transmit to the data acquisition system those parameters that are vital for the reliable performance of the filtration and disinfection subsystems. The parameters will include differential pressure setpoint (backwash trigger), differential pressure and backwash duration for the filter and ORP setpoint, ORP value, DC current, DC voltage, electrochemical generator flow, differential pressure in the hydrogen degas tank.
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MEPC 62/2/10 Annex, page 17 Operation of the SiCURE system is provided in a fully automated mode and requires minimum maintenance limited to the following: inspecting all SiCURE equipment prior to operation and after ballasting is completed; tightening any loose item in the system; performing visual checks of the system in operation. Maintain system tidiness and ensure equipment is operating properly. Log any observation; calibrating ORP sensors according to the maintenance requirements; checking the ORP monitor as appropriate. Log extreme changes in reading; checking the system data logger and examining the data recorded. Look for any variation; monitoring any abnormal alarm; and during discharge, in line with the water treatment industry practice, a crew will be required to carry out a TRO grab sample analysis of the water being discharged using hand-held HACH analyser or equal.

NOTE: In accordance with GESAMP-BWWG's recommendations, Siemens will test an inline TRO analyser and/or ORP monitoring during discharge at the time of shipboard testing. However, these instruments are usually unreliable at low TRO levels especially with dirty seawater and in the presence of suspended solids. At this time grab sample analysis using hand-held HACH analyser or equal is considered as a preferred option. 5.4 System locations, considerations and limitations

System locations and considerations Based on Siemens experience with Chloropac shipboard applications, it is expected that every installation will require engineering work together with a shipowner, ship operator and a naval architect to determine the best location and piping configuration for the SiCURE BWMS to provide for its safe operation. A location for each installation will have to be approved by a Classification Society. While electrochlorination part of the SiCURE system can be installed at various locations such as in the engine or pump rooms or on a deck, it is preferred that the filter be installed near the ballast water pumps that are typically designed for low pressure. Limitations Major limitation of the SiCURE BWMS is related to the manner the Active Substances are produced on board the ship. SiCURE system produces Active Substance in a side-stream to a concentration of about 200 to 900 mg/L. This design was selected to eliminate any possibility of the hydrogen gas by-product from accumulating in the ballast tanks. To use the electrodes applied in the SiCURE process effectively the minimal salinity in the side stream directed to the electrolyzer should not be below 14 g/L chloride. For ships that occasionally operate in fresh or brackish water this requirement will be met by feeding the electrolyzer with water with sufficient salinity stored in a dedicated ballast tank before entering the zone of low salinity.

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MEPC 62/2/10 Annex, page 18 6 HAZARD CLASSIFICATION (G9: 4.2.7) AND MATERIAL SAFETY DATA SHEETS

Hazard identification for Active Substances and Relevant Chemicals is provided in Table 6-1 of the confidential part of the application dossier. All referenced MSDS are provided in appendix B of the confidential part of the application dossier. 7 7.1 7.1.1 RISK CHARACTERIZATION Screening for persistence, bioaccumulation, and toxicity (G9: 5.1) Persistence (G9: 5.1.1.1)

The Active Substances and sodium sulfite are not persistent. All other Relevant Chemicals are persistent using Procedure (G9) criteria of a half-life >60 days in marine water or >40 days in fresh water. 7.1.2 Bioaccumulation (G9: 5.1.1.2)

None of the Active Substances or Relevant Chemicals are expected to bioaccumulate using Procedure (G9) criteria of a log Pow <3. 7.1.3 Toxicity tests (G9: 5.1.1.3)

The chronic toxicity database in this dossier (Table 4.1.2-1) indicates that none of the Active Substances appear to be toxic to fish (0.04 mg/L) and crustaceans (0.012 mg/L) based on a chronic NOEC criterion of <0.01 mg/L. The Active Substances may have the potential to be toxic to algae based on unacceptable OECD data when the chronic NOEC criterion of <0.01 mg/L is used. Since the chronic data shown in Table 4.1.2-1 for algae did not meet OECD 201 Guideline acceptability criteria but were included to provide an indication only of potential toxicity, further speculation regarding chronic toxicity of the Active Substances to algae is not warranted. The chronic toxicity database (Table 4.1.2-1) shows the Relevant Chemicals for which acceptable OECD chronic toxicity data are available that these compounds are much less toxic than the Active Substances. For example, the bromate NOEC for algae is 8 mg/L which is almost 3 orders of magnitude above the <0.01 mg/L level set for the Active Substances. The chronic NOECs for trichloromethane range from a low of 1.5 mg/L for fish up to 216 mg/L for algae. A 10 mg/L NOEC for algae exposed to tribromomethane is 3 orders of magnitude higher than the <0.01 mg/L level set for the Active Substances. No chronic data were found for bromodichloromethane and dibromochloromethane. 7.1.4 PBT criteria for Active Substance (G9: Table 1)

PBT analysis is presented in Table 7.1.4-1 of the confidential part of the application dossier. Based on the available data for Active Substances and Relevant Chemicals, these chemicals should not be PBT-classified. 7.2 7.2.1 Evaluation of the treated ballast water (G9: 5.2) Environmental data from the land-based tests

During the land-based tests, treated ballast water was evaluated 5 days after treatment by independent research facilities GSI and MERC (in fresh water, 0.1 PSU and in brackish water, 6 to 10 PSU), respectively. An additional test with a retention time of 24 hours
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MEPC 62/2/10 Annex, page 19 accompanied with dechlorination during discharge was also carried out by MERC. Treated water evaluation involved TRC/TRO analysis and Whole Effluent Toxicity (WET) testing. Both reports are available for review in Appendixes C, D and E, correspondingly, of the confidential part of the application dossier. Endpoints values (EC50, NOEC, LOEC) observed during WET tests are presented in Tables 7.2.1-3 and 7.2.1-4 1 of the confidential part of the application dossier. TRO values in all 10 tests with retention time of 5 days were below 0.1 mg/L. No acute toxicity was observed across all 10 fresh and brackish water trials and all 6 fresh and brackish water taxonomic species through the entire dilution series including 100% effluent. No acute toxicity was found in a 24-hour test with dechlorination. Chronic toxicity was observed in some test trials with 100% effluent, both fresh and brackish water. There were no statistically significant (p<0.05) detectable chronic toxicity effects across organisms and trials in 50% or lower effluent dilutions. Absence of acute toxicity in fresh water tests means that discharge of treated water 5 days after treatment will not present any immediate adverse effect to the aquatic environment upon its discharge. Chronic toxicity observed in 100% effluent in at least one valid trial needs to be evaluated further and is fully addressed in the risk assessment section using environmental modelling in the OECD-EU commercial harbour port. 7.2.2 Determination of holding time (G9: 5.2.7)

Holding time The time the treated ballast water has to be retained in the tanks prior to discharge serves two purposes with the SiCURE system as follows: to provide enough contact time to eliminate AIS in ballast water; and to allow the Active Substances to decay to a level that is environmentally safe for the discharge of treated water.

Bench-top and land-based tests showed that disinfection using the SiCURE system is completed within the first 24 hours after treatment. However, the environmental aspect of the holding time determination is more complex and requires analysis of such parameters as residual concentration and decay of Active Substance and evaluation of PEC/PNEC ratio. The Risk Assessment that was based on results of NaOCl decay obtained to date during land-based tests indicates that holding time of 5 days is sufficient for ensuring a safe discharge. Siemens was unable to investigate NaOCl decay at near freezing temperatures. This will be done during shipboard testing to provide further proof of the sufficiency of a 5-day holding time. Results of this test program will be presented to the Flag Administration prior to Type Approval. While hypochlorite decays slower at the cold temperatures, the ORP-based control logic used by the SiCURE system will provide leverage in maintaining discharge concentration at below 0.1 mg/L 5 days after treatment. According to White, 2010, disassociation of HOCl into weak hypochlorite ion is shifted toward HOCl at lower temperatures. An increase of HOCl between 5C and 20C may reach as high as 30% at the typical pH of seawater. Because HOCl defines the ORP of the treated water, in colder water the required ORP will be reached at a lower chlorine concentration. 7.3 7.3.1 Risk characterization and analysis (G9: 5.3) Reaction with organic matter (G9: 4.2.1.3)

Major reactions of chlorine with organic matter in polluted water were described in the section 4.3.4. The yield of THM and HAA identified as the major by-products of these reactions is directly related to the total organic carbon in the water being treated and the
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MEPC 62/2/10 Annex, page 20 chlorine dose level used for disinfection. As these by-products may present a risk potential to the environment, their yields have to be minimized. Employing a variable, on-demand chlorine dosing will allow minimizing the concentrations of Relevant Chemicals in the treated water and, as a result, in the aquatic environment after discharge. On other hand, the same reactions result in a quick decay of the residual chlorine in the ballast tanks. Use of variable, on-demand chlorine dosing allows minimizing the level of TRO in the treated water. The same reactions will also play a very important role of eliminating chlorine from the treated water being discharged in to the port harbour. 7.3.2 Characterization of degradation route and rate (G9: 5.3.5)

The main removal pathways for chlorine species in water are abiotic degradation (e.g., reaction with other chemicals present in the water), volatilization and photolytic reactions. Biodegradation and bioaccumulation of chlorine species are not important and only chlorinated organic by-products would be bioaccumulated to any extent (Environment Agency, 2007). Abiotic degradation depends on the water quality (chlorine demand) and is difficult to predict. As it was shown in our application dossier for the Basic Approval, the half-life due to abiotic degradation could be as short as seconds and as long as a few hours. Further analysis of the literature and internal testing showed that sunlight-induced photochemical decay of oxidants including chlorine and bromine yields a half-life of about 0.2 to 0.8 hours. 7.3.3 Prediction of discharge and environmental concentrations (G9: 5.3.8)

As it was shown in section 7.2.1, there was no acute toxicity observed during WET tests in all land-based test trials both in fresh and brackish water with six fresh water and saltwater aquatic organisms representing three trophic levels. In order to provide a conservative evaluation of potential chronic toxicity effects on the aquatic environment by the discharge treated with the SiCURE system, in accordance with Procedure (G9), section 5.2.6, the Marine Anti-foulant Model to predict environmental concentration (MAMPEC, version 2) was used in this dossier to predict environmental concentrations of TRO in the OECD-EU commercial harbour port (Port of Rotterdam) water after discharge. As a worst-case scenario, it was assumed in the MAMPEC Model that: all TRO is composed of the free available chlorine (FAC), by far the most toxic halogen compound. Further, the calculations were therefore all based on HOCl (as sodium hypochlorite); and considering unpredictable character of abiotic degradation of HOCl due to variable chlorine demand, only photolytic degradation rate was considered in this modelling study. The half-life of HOCl was selected conservatively at 1 hour.

It was assumed that there were 80 ships anchored in the Port of Rotterdam on an average day, discharging 100,000 (one hundred thousand) m3/day or about 4,167 m3/hour of ballast water into the harbour. These numbers for the Port of Rotterdam were used recently in the publicly available dossiers of other BWMS developers and it is reasonable to maintain the same scenarios in the current calculations (MEPC 61/2/4). Further it was assumed that all 80 ships present in the harbour are equipped with the SiCURE BWMS with the water characterized by the same holding time (TRO level). While in land-based tests TRO concentration after 5 days was below 0.1 mg/L, it was conservatively assumed here that TRO concentration in discharge was at 0.1 mg/L for all 80 vessels discharging in port.

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MEPC 62/2/10 Annex, page 21 Results of modelling are presented in Table 7.3.3-1 as predicated environmental concentration (PEC) based on a 95% concentration value from the MAMPEC output file. Table 7.3.3-1 also lists PECs for all Relevant Chemicals that were calculated using MAMPEC modelling in a similar manner to HOCl modelling. Maximum values in the concentration range for Relevant Chemicals found 5 days after treatment across all fresh water, brackish water and saltwater trials (listed in Tables 3.2-3 and 7.3.3-1) were used in these calculations. All PEC values in Table 7.3.3-1 are based on a 95% concentration value from the MAMPEC output files. All MAMPEC output files are presented in the appendix F of the confidential part of the application dossier. PEC for sodium sulfite had to be calculated using an alternative method as its physical parameters (Koc of 500, no vapour pressure and Henry constant) were outside of the MAMPEC parameters range. Details of PEC calculations for sodium sulfite are also presented in appendix F of the confidential part of the application dossier. Table 7.3.3-1: Results of MAMPEC modelling for 80 ships
Chemical Name Max Concentration in discharge at T5, gl-1 Fresh Brackish Salt water water water <100 256.5 20.2 29.0 275.3 55.3 98.6 46.4 290 432.1 76 <5,000 22.0 <5,000 <5,000 <100 <100 Predicted environmental concentration (95 Percentile), gl-1 0.018 1.790 0.096 0.154 1.920 0.385 0.687 0.416 2.220 3.010 0.682 0.153 0.260

TRO (as HOCl) Trihalomethanes: Trichloromethane Bromodichloromethane Dibromochloromethane Tribromomethane Haloacetic acids: Dichloroacetic acid Trichloroacetic acid Dibromoacetic acid Tribromoacetic acid Sodium Chlorate Sodium Bromate Dibromoacetonitrile Sodium Sulfite

7.3.4

Assessment of potential for bioaccumulation (G9: 5.3.7)

The risk of bioaccumulation in fresh water and saltwater pelagic organisms as well as epifaunal sediment organisms is low based on the log Pows of the Active Substances and Relevant Chemicals which are <3 in all cases. The BCFs for the Active Substances and Relevant Chemicals reflect the low log Pows. All BCFs were <100 L/kg which also indicates that little bioconcentration/bioaccumulation of the chemicals will occur. The risk to infaunal sediment organisms is low as well based on the Kocs which are all <500 L/kg and show that the chemicals will not readily partition to sediment and thus be of concern to benthic organisms residing in the sediment. Likewise, the biomagnification of all chemicals through aquatic food webs, wildlife, and humans is low based on the log Pows and kocs. No data were found that suggest the Active Substances and Relevant Chemicals impart a foreign flavour or odour in the organisms exposed to the chemicals. Thus, consumers of seafood will not reject the seafood because of a flavour problem.

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MEPC 62/2/10 Annex, page 22 7.3.5 Effects assessment

The toxicity data sets indicate that the risk of the Active Substances is negligible for most fresh water and saltwater predators (fish) and consumers (crustaceans) based on a chronic NOEC <0.01 mg/L. However, there was no data available for both the acute and chronic algal NOECs that met OECD 201 Guideline criteria, thus, there is large uncertainty associated with the chronic primary producer data. The ecological risk of the Relevant Chemicals to aquatic organisms is less clear than the risk from the Active Substances because much less chronic NOEC toxicity data are available. Sufficient chronic data are available only for trichloromethane and most of HAAs (TCA, DBA and TBA) to conclude that these compounds should not be a risk to predators, consumers, and plants because all of the NOECs are 2 to 3 orders of magnitude above 0.01 mg/L. Acute-to-chronic ratios (ACRs) have been used in ecological risk assessments to extrapolate from acute responses to NOEC or chronic responses. Bromate does not appear to be a risk to plants (8 mg/L) based on a chronic NOEC <0.01 mg/L. Same applies to chlorate based on a chronic NOEC of 62 mg/L for algae. If one uses an acute-to-chronic ratio (ACR) of 27.5, the acute bromate data for fish, crustaceans and alga have an estimated chronic NOEC >1.0 mg/L which suggests that bromate (as well as chlorate) will not be toxic to any of the three trophic levels considered in this dossier. Tribromomethane, dibromochloromerthane and dichloroacetic acid also do not appear to be a risk using the ACR of 27.5 to estimate chronic NOECs because the NOECs are 1 to 4 orders of magnitude above 0.01 mg/L. Sufficient chronic data and acute data to estimate risk from ACRs are not available for the bromodichloromehane. Only one acute fish value (490 to 620 mg/L) is available for dibromoacetonitrile which indicates that this compound probably is not toxic to fish. No chronic data are available for dibromoacetonitrile to make any conclusions regarding this compound's toxicity towards aquatic organisms. No acceptable acute or chronic data are available for bromodichloromethane to make any conclusions regarding this THM. Based on the available data for acute toxicity for sodium sulfite, it seems to represent low risk to the aquatic organisms. White provides information that sodium sulfite used below 10 mg/l was found to be non-toxic to the marine environment can be supported by the results of MERC-24h test. 7.3.6 Effects on aquatic organisms

The following PNECs were obtained using the assessment factors given in Table 2 of document MEPC 58/2/7, GESAMP-BWWG 6/9, annex 4 (IMO, 2008b).

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MEPC 62/2/10 Annex, page 23 Table 7.3.6-1: Predicted No-Effect Concentration (PNEC) for the Active Substances and Relevant Chemicals in fresh water and saltwater
Chemical Active Substances TRO HOCl Relevant Chemicals Bromate Chlorate THM -Trichloromethane THM -Tribromomethane TTM-Bromodichloromethane THM -Dibromochloromethane HAA -Dichloroacetic acid HAA -Trichloroacetic acid HAA -Dibromoacetic acid HAA -Tribromoacetic acid Dibromoacetonitrile Sodium Sulfite PNEC (g/L) 0.04 0.032 Factor Applied N/A 1000 Comment(s)

EU PNEC of 0.04 g/L for HOCl was used because the value is more conservative than TRO Lowest HOCl L(E)C50 from a fish, crustacean and alga Lowest L(E)C50 from a fish and alga Lowest L(E)C50 and chronic NOEC from a fish, crustacean, and alga Lowest L(E)C50 and NOEC from a fish, crustacean, and alga Lowest acute data from a fish, crustacean, and an alga Insufficient data; thus, aquatic PNEC taken from page 96 in EU (2007) Lowest L(E)C50 and NOEC from a fish, crustacean, and alga Lowest L(E)C50 and NOEC from a fish, crustacean, and alga Lowest chronic NOEC from a fish, crustacean, and alga Lowest chronic NOEC from a fish, crustacean, and alga Lowest chronic NOEC from a fish, crustacean, and alga Lowest L(E)C50 and NOEC from a fish, crustacean, and alga Lowest L(E)C50 from a fish, crustacean and alga

8 62.6 15 12 15 34 52.3 785 978 1382 490 48

1000 1000 100 1000 N/A 1000 1000 100 100 100 1000 1000

7.3.7

Effects on sediment

No acute or chronic whole sediment fresh water or saltwater toxicity data were found in the literature for the Active Substances or Relevant Chemicals. The PNEC data for pelagic organisms can be used to estimate potential risks to epifaunal sediment organisms. As stated in section 7.3.4, the risk to infaunal sediment organisms is low based on the Kocs which are all <500 L/kg which indicate that the chemicals will not readily partition to sediment and thus be of concern to benthic organisms residing in the sediment. 7.3.8 Comparison of effect assessment with discharge toxicity

TRO and some DBP concentrations in the ballast water five days after land-based treatment exceed their corresponding literature based PNECs. Based on the PNECs, the concentrations in the ballast tanks would be judged to be an ecological risk when discharged with no further decay and mixing in the receiving harbour. However, there was no acute toxicity found) across all trials in fresh and brackish water after holding time of 5 days.

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MEPC 62/2/10 Annex, page 24 While there was some chronic toxicity observed in some land-based trials, a 50% dilution of treated water would render discharge after 5-day holding time non-toxic to all three trophic levels. Based on GSI data for TRO in dilution series, TRO NOEC of 22 g/L could be calculated using results of GSI discharge toxicity study. That provides a PNEC value of 0.22 g/L (assessment factor of 100) or about 20 times greater than PNEC listed in Table 7.3.6-1 thus providing a safety margin in PEC/PNEC calculations for TRO in the Risk Assessment of this application. 7.4 Risk to the aquatic environment

No acute toxicity found across the land-based trials in fresh and brackish water with and without dechlorination suggests that there is no immediate risk to the aquatic environment upon discharge. Chronic toxicity observed in some of WET tests during land-based testing suggests that there are some risks present to the aquatic environment in the long term that need to be evaluated. Evaluation of the potential risk to the aquatic environment is based on a series of PEC/PNEC ratios using a worst case scenario. Given below in Table 7.4-1 are the PEC/PNEC ratios for Active Substance and Relevant Chemicals calculated using MAMPEC or Box (for sulfite) models for a scenario of 80 ships simultaneously discharging ballast water treated with the Siemens SiCURE BWMS in the Port of Rotterdam. The PEC/PNEC ratios for Active Substances and Relevant Chemicals indicate that no aquatic risk (ratio <1) exists when all 80 ships discharge treated water daily in the Port of Rotterdam after 5-day holding time. As discussed in the risk characterization section of this dossier, no risk is anticipated to infaunal sediment organisms. Insignificant concentrations of HOCl and Relevant Chemicals are predicted to occur in sediment in the Port of Rotterdam after a year of discharge from 80 ships per day in the harbour. Table 7.4-1: Estimated PEC/PNEC ratios in the Port of Rotterdam for 80 ships Chemical HOCl Trichloromethane Bromodichloromethane Dibromochloromethane Tribromomethane Dichloroacetic acid Trichloroacetic acid Dibromoacetic acid Tribromoacetic acid Sodium chlorate Sodium bromate Dibromoacetonitrile Sodium sulfite PEC g/L 0.018 1.790 0.096 0.154 1.920 0.385 0.687 0.416 2.220 3.010 0.682 0.153 0.260 PNEC g/L 0.04 15 15 34 12 52.3 785 978 1382 62.6 8.0 490 48.0 PEC/PNE C ratio 0.450 0.120 0.006 0.005 0.160 0.007 0.001 0.000 0.002 0.048 0.085 0.000 0.005

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MEPC 62/2/10 Annex, page 25 8 8.1 RISK ASSESSMENT Risk to safety of ship

A risk assessment is a method used to estimate the likelihood of adverse effects to human health and the environment, based on toxicity and exposure information. The risk assessment section discusses potential risks to the safety of the ship, as well as potential exposures and risks to human populations who could potentially come into contact with ballast water containing chemicals from the SiCURE system. 8.1.1 Flooding

The SiCURE system is installed such that the ships ballasting system can run independently of its operation. The connection to the ballast water piping system is made via class-approved automatic valves. In case of catastrophic failure of any of the components of the SiCURE system, the emergency stop would automatically close these valves resulting in complete isolation from the ships ballast water piping. 8.1.2 Corrosion

In order to evaluate effect of the treatment with SiCURE BWMS, Siemens undertook a real-time six-month long testing program at their testing facility in Singapore. The study was based on recommendations for corrosion testing by the GESAMP-BWWG published in document MEPC 59/2/16 in April 2009 and was conducted under supervision from Germanischer Lloyd. As the GESAMP-BWWG recommended, the testing was executed using a flow through setup with full strength seawater as a basis. The corrosion effects from natural seawater were compared to seawater with hypochlorite maintained at 6 mg/L (measured as chlorine) which represents the maximum treatment concentration of the SiCURE system. Materials investigated included low carbon steel (shipbuilding steel), stainless steel, copper and nickel alloys as well as gasket materials and epoxy coating applied in ballast tank coatings. The tests were carried at ambient temperature at about 302C. Evaluation of uncoated metals included: (a) corrosion rate measurement (by mass loss) on a monthly basis per ASTM G31, (b) evaluation of crevice corrosion per ASTM G78 at the end of testing (6 months), (c) evaluation of pitting corrosion at the end of testing per ASTM G46. Evaluation of coated carbon steel included: (a) Interim inspection: examination for blistering per ISO 4628-2 on a bi-monthly basis, (b) final inspection (after 6 months), to examine the specimens for blistering (ISO 4628-2), rusting (ISO 4628-3), cracking i(ISO 4628-4), flaking (ISO 4628-5), delamination around the scribe (4628-8), and coating adhesion (ISO 4624). Evaluation of EPDM and PTFE included: (a) visual by monthly inspections and (b) assessment of tensile strength per ISO 527 at strat and after 3 and 6 months of exposure. Complete results of the corrosion study are presented in the appendix H of the confidential part of the application dossier for Final Approval. Corrosion rate Table 8.1.2-1 below provides results for immersion corrosion testing of shipbuilding carbon steel A36 and other alloys after six months of testing. Equivalent annual corrosion rates were calculated from the measured weight loss of the sample coupons.

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MEPC 62/2/10 Annex, page 26 The test specimen for stainless steel barely experienced any mass loss. Brass and cupro-nickel showed rate in the range of micrometers per year. Only carbon steel A36 showed significant corrosion rates around 0.1 mm/year. The corrosion rate in seawater where NaOCl concentration was maintained at 6 mg/L was about 1.4-fold greater than in untreated seawater. Table 8.1.2-1: Immersion corrosion rate for uncoated coupons Material Carbon Steel Stainless steel Aluminium Brass Cupro-Nickel A36 SS316L C68700 (CuZn20Al2) C71500, ASME SB 171 (CuNi30Mn1Fe) Grade Treatment Seawater 6 mg/L NaOCl Seawater 6 mg/L NaOCl Seawater 6 mg/L NaOCl Seawater 6 mg/L NaOCl Corrosion Rate, mm/year 0.075 0.001 0.108 0.003 0.8E-04 0.3E-04 1.2E-04 0.4E-04 2.7E-03 0.1E-03 2.8E-03 0.1E-03 5.6E-03 0.4E-03 8.9E-03 0.2E-03

The annual corrosion rates found in this study fall within the annual corrosion rate range between 0.1 to 1.2 mm/year (BMT 2002) reported for untreated seawater ballast water tanks by The Tanker Structure Cooperative Forum, the most extensive publicly available database on corrosion rates in maritime industry. Pitting corrosion Carbon steel samples from the corrosion tests were evaluated by Germanischer Lloyd and showed that pitting corrosion was evenly dispersed over the surface. The size and depth of pits were within the lowest category given in ASTM G46. The density of pits in chlorinated seawater was characterized as category A3-A4 (5.0 E+04 to 1.0 E+05 per m2), slightly above the untreated seawater, which was category A2-A3 (1.0 E+04 to 5.0 E+04 per m2). Stainless steel samples showed similar pattern only that in this case the sample exposed to chlorinated seawater showed a lesser pitting density. Germanischer Lloyd stated in their evaluation that there were no significant differences between the test samples exposed to natural seawater and treated seawater, either for carbon or for stainless steel. Crevice corrosion Testing revealed no crevice corrosion for carbon steel, slight crevice corrosion for brass and cupro-nickel but it showed severe crevice corrosion effects on stainless steel, especially in untreated seawater. Stainless steel samples immersed in chlorinated seawater showed less severe crevice corrosion than that of untreated seawater. All samples in untreated seawater had holes fully penetrated through the thickness of test coupons. Coating assessment Two epoxy-based ballast water tank coatings were assessed in accordance with ISO 4628 and ISO 2624.
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MEPC 62/2/10 Annex, page 27 After six months of exposure to 6 mg/L of NaOCl or untreated seawater, all samples with or without the cross-shaped scribe showed no degree of blistering. No defects were detected under 10-fold magnification. No cracking, flaking or delamination was found on any samples. Cyclic potentiodynamic polarization measurement The impact of chlorinated seawater on the stability of shipbuilding materials was investigated by electrochemical measurements. These materials included stainless steel (SS316L), carbon steel (A36), brass (CDA 687) and copper-nickel alloy (CDA715). The polarization measurements were carried out to determine the susceptibility of test specimens to localized corrosion in an environment with or without a presence of sodium hypochlorite (NaOCl concentrations of 0, 1, 2 and 6 mg/L). An indication of the susceptibility to initiation of localized corrosion in the test specimen is given by the potential at which the anodic current increases rapidly (denotes as ELC hereafter). The more noble this potential, the less susceptible the material is to initiation of localized corrosion. Table 8.1.2-2: Short-term corrosion testing: evaluation of susceptibility of test specimens to localized corrosion Material Carbon Steel Stainless steel Aluminium Brass Cupro-Nickel Extent of Localized Corrosion Low High None None Stability against localized corrosion untreated & 1 mg/L > 2 mg/L > 6 mg/L (-0.62 to -0.60 V) (-0.66 V) N/A N/A (-0.74 V) 1 mg/L & 2 mg/L > untreated > 6 mg/L

Assessment For the risk assessment, an operational scenario for a bulker with a round trip of 10 days is assumed. During the voyages, two complete ballast cycles are executed. As shown in the SiCURETM dossier for Basic Approval (IMO, 2008f) the concentration of Active Substance decays within the first 24 hours to levels of about 0.5 to 0.7 mg/L where corrosion becomes insignificant. Under this assumption and based on the laboratory testing, the effective corrosion rate of bare steel (after removal or damage to the coating system) in the ballast tank would result in a corrosion rate less than 0.082 mm/y (0.108 x 20%+0.075 x 80%). This number when compared to the corrosion rate range given in The Tanker Structure Cooperative Forum allows to make a conclusion that the effect that ballast water treated with the SiCURE BWMS has on ballast water tanks is negligible. 8.1.3 Fire/explosion

As the SiCURE system does not require the storage of Active Substance on board, there is no associated fire/explosion risk. The generation of sodium hypochlorite in situ eliminates the need for chemical storage, however, it does result in the generation of hydrogen gas. The system includes a degas tank with air blowers and hydrogen gas detecting instrumentation to ensure that the hydrogen gas has been safely diluted with air prior to venting.

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MEPC 62/2/10 Annex, page 28 8.1.4 Accidental chemical release

Under standard operations, the SiCURE system does not require the storage of any chemicals on board, therefore there is little associated risk of accidental chemical release. The generation of sodium hypochlorite in situ results in the generation of hydrogen gas. Under normal operations, the generator cells do not leak or release any chemicals. The system has built-in safety features that stops the system in case of leakage. 8.2 Risk to human health

This section discusses potential exposure pathways and risk to human populations who could be exposed to chemicals associated with the SiCURE system. This section identifies the chemicals that will be considered, discusses potential exposures to people who may be affected, and discusses the potential of adverse health effects. 8.2.1 Identification of chemicals of potential concern and sources

The chemicals of potential concern (COPCs) related to the SiCURE system include the Active Substances, which are hypochlorous and hypobromous acids, and Relevant Chemicals, which consist of trichloromethane, bromodichloromethane, bromochloroacetic acid, dibromochloromethane, tribromomethane, monochloroacetic acid, dichloroacetic acid, trichloroacetic acid, monobromoacetic acid, dibromoacetic acid, tribromoacetic acid, chlorate, bromated, dichloroacetonitrile, dibromoacetonitrile. The Relevant Chemicals may be formed in small amounts as disinfection by-products. The Active Substances are produced in situ and injected directly into the ballast water piping system. The Relevant Chemicals are produced as by-products in the ballast water. There are no external sources of chemicals except sodium sulfite in case of the dechlorination option. 8.2.2 Exposure assessment

The Exposure Assessment consists of identifying human populations that could be exposed to COPCs, and the exposure pathways through which they could have contact with COPCs. A complete exposure pathway consists of: a source or chemical release from a source; an exposure point where contact can occur; and an exposure route by which contact can occur (such as ingestion, skin contact or inhalation).

All of these components need to be present for a complete exposure pathway. This section discusses potential human populations who could be exposed to COPCs in the ballast water. Potentially exposed human populations On-deck personnel During ballasting (uptake of ballast water to ballast tanks) it was assumed that the air in the headspace of the ballast tank is released through air vents to the deck and that this air may contain vapours of COPCs in the primary treatment water. Therefore, it was assumed that on-deck personnel, including those involved in ship navigation, operation of ship machinery, maintenance activities, and resting crewmen in the ship's quarters, may be indirectly exposed via inhalation of these vapours.
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MEPC 62/2/10 Annex, page 29 The following general assumptions were used to estimate potential exposure and risk to on-deck personnel: ballasting occurs every two or three days (175 days/year); exposure of on-deck personnel only occurs during ballasting (maximum of 20 hours for large tanks); and on-deck personnel are assumed to have an occupational tenure of 6.6 years, based on the median occupational tenure of 6.6 years recommended for men and women 16 years and older in the U.S EPA's Exposure Factors Handbook (EPA, 1997)).

Tank inspector Technicians would not be expected to contact COPCs under normal operations. In the SiCURE system, Active Substances are injected directly into the ballast water piping system. The other COPCs would be formed as by-products in the ballast water. The potential for human exposure to concentrated levels of these COPCs would only exist during a failure of the system or when performing service/maintenance on the system. The risks associated with this scenario is mitigated by numerous system safeties (leak detection, purging of tank, equipment isolation, stray current protection, interlocks, etc.) and by using appropriate personal protective equipment when performing maintenance and/or repair on the system. Under typical circumstances (when proper personal protective equipment is worn and the ballast tank is properly ventilated prior to entry), there is only limited potential for significant exposure of this population because the tank is drained of its contents and purged of vapours prior to entry and portable monitors are used to determine the condition of the atmosphere while inside the ballast tank. However, for the purposes of this risk assessment, it was assumed that several times during the year, a technician could be exposed to ballast water during visual inspection of the internal surface of all ballast tanks. The purpose of this inspection is to check the soundness of the structure and the amount of sludge accumulated in the ballast tanks. The visual inspection is to check the protective coating and look for dents and traces of corrosion. This inspection is normally conducted about twice a year in many large shipping companies and, as such, a 6-month interval is assumed. Exposure via inhalation of vapours that could potentially accumulate in the ballast tank and skin contact with the small quantity of water potentially remaining inside the ballast tank was evaluated. The following general assumptions were made in estimating potential exposure and risk associated with this activity: the inspection of a ballast tank requires two hours; four tanks are inspected during each inspection event; two inspection events are conducted per year; and maintenance technicians are assumed to have an occupational tenure of 6.6 years, based on the median occupational tenure of 6.6 years recommended for men and women 16 years and older in the U.S. EPA's Exposure Factors Handbook (EPA, 1997).

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MEPC 62/2/10 Annex, page 30 Coast guard sampler Boarding Coast Guard officers will measure the various parameters of ballast water (e.g., pH, TRC, salinity, turbidity, organic content, etc.) and collect water samples to assess if the ship is in compliance with ballast water treatment standards. To collect water samples, ballast water is expected to be pumped into a collapsible tank from which samples are collected for biological testing. Exposure via inhalation of vapours in the breathing zone above the collapsible tank and skin contact with the ballast water during sampling was evaluated. The following general assumptions were made in estimating potential risk associated with this activity: sampling of ballast tank requires one hour; twenty sampling events are conducted per month (240/year); and Coast Guards are assumed to have an occupational tenure of 20 years, based on the median occupational tenure of 20.1 years for men and women 65 years and younger in the US EPA's Exposure Factors Handbook (EPA, 1997).

The large difference in the median occupational tenure used for the on-deck personnel/tank inspector and the Coast Guard is due to the significant variability in occupational tenure according to age and educational level. The strength of an individual's attachment to a specific occupation has been attributed to the individual's investment in education (Carey, 1988 as cited in EPA, 1997). Workers with 5 or more years of college have the highest median occupational tenure of 10.1 years. Sea tours in the Coast Guard are approximately 51 months (4 years); however, because Coast Guards receive specialized training/education, it is anticipated that Coast Guard occupational tenure will likely be more lengthy than typical ship crews. Passengers Passengers would not be expected to contact COPCs under normal operations. Since sodium hypochlorite is produced in situ, there is little potential for accidental chemical release. There are numerous system safeties in place to mitigate a system failure. There is little potential for this population group to be exposed directly to treated ballast water. Therefore, no complete exposure pathways were identified for this group. Employees in harbours Employees in harbours have little potential for exposure because of the low possibility of accidental release of sodium hypochlorite vapours and hydrogen gas. There is also little possibility for this group to be exposed directly to ballast water. Therefore, no complete exposure pathways were identified for this group. Bathers Bathers in the harbour areas could potentially be exposed to released ballast water. COPC concentrations in ballast water would be greatly diluted in the seawater to which bathers could be exposed. Even though a complete exposure pathway exists for this group, there is little possibility of adverse health effects since the COPC concentrations would be greatly diluted when treated ballast water is released into the sea. In addition, as discussed in section 8.2.3, the measured ballast water concentrations of various chemicals were generally lower than their respective drinking water guidelines. Therefore, no adverse health effects would be expected from bathers who may occasionally be exposed to diluted concentrations of these chemicals.
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MEPC 62/2/10 Annex, page 31 Consumers of seafood Consumers of seafood from the harbour area where the ballast water may be released are unlikely to be exposed to COPCs, since the COPCs are not expected to biomagnify or bioaccumulate in seafood. The COPCs are not expected to exhibit biomagnifications or bioaccumulations, and subsequently would not be expected to persist in the food web. The United Kingdom Department for Environment Food and Rural Affairs (DEFRA) defines a bioaccumulative chemical as having a log Kow greater than 4 (http://www.defra.gov.uk/ENVIRONMENT/chemicals/csf/criteria/detailed.htm). The COPCs evaluated here all have log Kows less than 4. Therefore, no complete exposure pathways were identified for this population group. Exposure concentrations Pathways evaluated in this risk assessment included direct skin contact with ballast water and inhalation of vapours from COPCs present in the ballast water. Incidental ingestion of ballast water is not reasonably expected to occur for any of the receptor exposure scenarios evaluated. Therefore, ingestion of ballast water is not considered a complete exposure pathway. The methodology used to estimate exposure concentrations for the dermal contact and vapour inhalation pathways is presented below. Direct dermal (skin) contact with ballast water Because the chemical profile of the tank mixture changes with time, exposure needed to be evaluated assuming the chemicals were applied at two times: 1) the same day as the exposure (T0), and 2) five days prior to exposure (T5). For some COPCs, concentrations in water were highest at T0 (trihalomethanes), while for others, the concentrations were highest at T5 (some haloacetic acids and haloacetonitriles). In addition, tests were conducted with fresh and brackish water. To streamline the assessment, the highest COPC concentration measured in ballast water across all test conditions (i.e. T0 fresh water, T5 fresh water, T0 brackish water, and T5 brackish water) was used in evaluating dermal (skin) contact exposure. Maximum measured ballast water concentrations are provided in Table 8.2.2-1. Table 8.2.2-1: Maximum measured ballast water concentrations (g/L) Chemical Trichloromethane Bromodichloromethane Dibromochloromethane Tribromomethane Monochloroaceticacid Dichloroaceticacid Trichloroaceticacid Bromochloroaceticacid Monobromoaceticacid Dibromoaceticacid Tribromoaceticacid Sodiumchlorate Sodiumbromate Dichloroacetonitrile Dibromoacetonitrile
NOTE:

Fresh T0 T5 176 257 14.9 19.4 0.81 0.81 0.5 0.5 5 2 60.3 77.5 107 99.9 4.4 1 1 1 1 1 4 4 450 440 50 50 4.1 0.5 0.5 0.5

Brackish T0 T5 0.54 0.5 4.2 5.3 119.8 30.8 119 268 17.8 2 1.3 1.3 1 1 5.6 5.5 4.5 3.8 72.2 63.4 187 374 370 380 50 50 0.86 0.5 28 29

Detection limits were used for undetected chemicals, which is a conservative (health-protective) approach.

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MEPC 62/2/10 Annex, page 32 Inhalation of vapours Maximum vapour concentrations of COPCs present in ballast water were estimated for three exposure scenarios: exposure of on-deck personnel due to a ballast vent; exposure of a tank inspector (inside ballast tank); and exposure of Coast Guard personnel during sampling and testing.

The estimation of emissions for each scenario was based on the maximum measured T0 and T5 concentrations provided in Table 8.2.2-1 for fresh ballast water and brackish ballast water. 8.2.3 Toxicity assessment

Adverse effects are generally classified as acute (short-term) or chronic (long-term). Chronic effects are further subcategorized as carcinogenic or noncarcinogenic (i.e. potential effects other than cancer). Acute (short-term) evaluation Acceptable levels for the evaluation of potential acute (1-hour) health effects were obtained from the U.S. Department of Energy's (DOE's) current data set of Protective Action Criteria (PAC) values, which are available in an on-line searchable database at http://www.atlintl.com/DOE/teels/teel.html. PACs may assume one of the following forms: Acute Exposure Guideline Levels (AEGLs); Emergency Response Planning Guidelines (ERPGs); and Temporary Emergency Exposure Limits (TEELs).

Chronic (long-term) evaluation For purposes of this evaluation, acceptable levels for noncarcinogens assume one of the following forms: United States Environmental Protection Agency (EPA, 2010) oral reference dose (RfD) in mg/kg-day; United States EPA (EPA, 2010) inhalation reference concentration (RfC) in mg/m3; World Health Organization (WHO, 2006) oral tolerable daily intake (TDI) in mg/kg-day; or WHO (WHO, 2006) total allowable concentration (TAC) in mg/m3.

For the purposes of this risk assessment, the threshold effects levels were assumed to equal the internal dose level that corresponds to a cancer risk of 1 x 10-5 and were derived from the following sources:

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MEPC 62/2/10 Annex, page 33 United States EPA dermal unit risk factor in mg/kg-day (these values were calculated using the oral slope factor due to the lack of dermal toxicity values); United States EPA Risk-Specific Air Concentration (RSC) in mg/m3; WHO oral cancer risk (CR) in mg/kg-day; or WHO inhalation CR in mg/m3.

The 1 x 10-5 target cancer risk represents the mid-point of the cancer risk range targeted by most authoritative organizations. Use of the 1 x 10-5 target cancer risk for establishing acceptable levels corresponds with the German screening levels established under the Bundes-Bodenschutz und Altlastenverordnung (BBodSchV), which stands for Federal Ground Protection and Refuse Dump Regulations. Many other internationally-recognized regulatory bodies, such as the WHO also use this target cancer risk for establishing screening values. Thus, a target cancer risk level of 1 x 10-5 was used to derive risk-specific doses for carcinogens, expressed in units of mg/kg-day. Oral and inhalation reference doses, also expressed in units of mg/kg-day, were used to evaluate COPCs with potential noncarcinogenic effects. 8.2.4 Risk characterization

Risk characterization is the process by which the toxicity information is integrated with quantitative estimates of human exposure derived in the exposure assessment. A risk characterization ratio (RCR) or margin of safety (MOS) for each of the COPCs was calculated as follows: MOS Where: Acceptable Level = Protective Action Criteria (PAC) for the acute (short-term) evaluation and for the chronic (long-term) evaluation, a threshold level for noncarcinogens or concentration level that corresponds to a cancer risk of 1 x 10-5 (see above) for carcinogens Absorbed dose based on predicted concentration in ballast water (mg/L) or air (mg/m3) = Acceptable Level/Exposure Level

Exposure Level

For purposes of this risk assessment, a MOS of one (1) or greater was judged to indicate there is no unacceptable risk. Detailed exposure and MOS calculations are provided in appendix G/attachment 2. Working spreadsheets will be provided upon request. Acute risk Maximum modelled 1-hour air concentrations were compared to PACs to determine the acute MOS for inhalation exposures. The results of those comparisons are provided in Table 9 of appendix G/attachment 1. As can be seen in Table 9 of attachment 1, the 1-hour concentrations for all COPCs were less than their corresponding PACs, resulting in an acute MOS of greater than one for all COPCs. In fact, as summarized in Table 8.2.2-3, the predicted 1-hour concentrations ranged from one to 29 orders of magnitude lower than the corresponding PACs, indicating that potential risks from short-term inhalation exposures are very low.
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MEPC 62/2/10 Annex, page 34 Table 8.2.4-1: Acute margins of safety Chemical Trichloromethane Bromodichloromethane Dibromochloromethane Tribromomethane Monochloroaceticacid Dichloroaceticacid Trichloroaceticacid Bromochloroaceticacid Monobromoaceticacid Dibromoaceticacid Tribromoaceticacid Sodiumchlorate Sodiumbromate Dichloroacetonitrile Dibromoacetonitrile OnDeckPersonnel 2mVent 3mVent 53 1170 3400 1,790,000 33,200 4,300,000 14,600 3,450,000 123,000,000 1E+16 360,000,000 1E+16 NA NA 40,400,000 7.6E+15 NA NA NA NA NA NA NA NA NA NA NA NA NA NA CoastGuard 45,600 5E+10 9.5E+9 6.2E+9 1.4E+23 5E+22 NA 4.8e+23 NA NA NA NA NA NA NA TankInspector 35,500 5E+11 1.6E+10 4.7E+9 2E+28 2E+27 NA 1.6E+29 NA NA NA NA NA NA NA

NOTE: NA Not available (acute inhalation toxicity criteria not available).

Chronic risk Maximum modelled annual concentrations were compared to chronic RfDs or TDIs for noncarcinogens and the dose level corresponding to a 1 x 10-5 cancer risk for carcinogens to determine the chronic MOS. The results of those comparisons are provided in Table 10 of appendix G/attachment 1. As can be seen in Table 10, the dermal MOS for all COPCs and potentially exposed populations are well above one. The chronic estimated dermal exposure estimates range from one to six orders of magnitude below the relevant acceptable level, indicating that potential risk posed by long-term dermal contact with ballast water is low. For the inhalation pathway, the chronic MOS for most COPCs and exposed populations were above one. However, the predicted air concentration for trichloromethane when the ballast vent was assumed to be seven feet (2 m) above the deck and the breathing zone of on-deck personnel was assumed to be 1.6 m was below one (0.6). This sub-unity MOS for trichloromethane is due to carcinogenic effects and it should be noted that this MOS does not exceed the upper end of the acceptable risk range (1 x 10-4) used by US EPA in risk management decision making. When the ballast vent was assumed to be 10 feet (3 m), the trichloromethane MOS for on-deck personnel was greater than one (2.5). In addition, the carcinogenic trichloromethane MOS for the tank inspector was equal to one. The long-term inhalation MOS are summarized in Table 8.2.2-4.

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MEPC 62/2/10 Annex, page 35 Table 8.2.4-2: Chronic inhalation margins of safety
Chemical On-Deck Personnel 2 m Vent NonCancer cancer 0.59 14 NC NC 141 NC NC NC NC NC NC NC NC NC NC NC NC NC 586 NC NC NC NC NC NC NC NC NC NC NC 3 m Vent NonCancer cancer 2.5 58 NC NC NC NC NC NC NC NC NC NC NC NC NC NC NC NC NC NC NC NC NC NC NC NC NC NC NC NC Coast Guard Cancer 1.7 NC NC 1730 NC NC NC NC NC NC NC NC NC NC NC Noncancer 118 NC NC NC NC NC NC NC NC NC NC NC NC NC NC Tank Inspector Cancer 1 NC NC 22 NC NC NC NC NC NC NC NC NC NC NC Noncancer 24 NC NC NC NC NC NC NC NC NC NC NC NC NC NC

Trichloromethane Bromodichloromethane Dibromochloromethane Tribromomethane Monochloroacetic acid Dichloroacetic acid Trichloroacetic acid Bromochloroacetic acid Monobromoacetic acid Dibromoacetic acid Tribromoacetic acid Sodium chlorate Sodium bromate Dichloroacetonitrile Dibromoacetonitrile
NOTE:

NA Not available All dermal MOS were > 1

These results suggest that there is a slight potential for trichloromethane to pose an inhalation risk to on-deck personnel. However, these risks are considered low due to the highly conservative air modelling and exposure assumptions made in the risk assessment. In estimating air concentrations, six combinations of flow rate and vent diameter were evaluated and the one that produced the smallest dilution factor was used in estimating on-deck air concentrations. In addition, the air model (SCREEN3) determines the combination of wind speed and atmospheric stability that maximizes the concentration and reports the overall maximum concentration anywhere on deck. This maximum on-deck concentration was used to estimate exposure. On-deck personnel were assumed to be exposed for 20 hours during ballasting, which was assumed to occur every other day. Unless the ship was very large, ballasting would take less time (1 to 4 hours for containerships) and on-deck personnel exposure would be reduced accordingly (5-fold to 20-fold). None of the crew are likely to remain in the same place (the location where the maximum on-deck concentration occurs) for 20 hours; crewman are expected to move about the ship throughout the day. In addition, the frequency with which ballasting assumed to occur is conservative. The actual ballasting frequency may be considerably less (e.g., every two weeks). Finally, on-deck personnel and tank inspectors were assumed to be exposed in this manner for a period of six-and-a-half years. Although data on occupational tenure of seagoing crew are sparse, ship's crew are expected to have a shorter occupational tenure than six years as they are not typically career jobs. In one survey (Fairbrother and Warn, 2003) of naval officer trainees undergoing sea training, consisting of a group of 100 trainees, comprising 65 males and 35 females, the median length of tenure was three years. There are many potential stressors in sea service (work overload, cramped living/work quarters, lack of privacy, broken
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MEPC 62/2/10 Annex, page 36 periods of sleep, separation from family/friends) that likely contribute to low job satisfaction and relatively short occupational tenure. However, it is worth noting (because of the relationship between age and occupational tenure) that the median age for the group was 21 years and 90 per cent of the group was 25 years or younger. Even though the tank inspector trichloromethane MOS was equal to one, this is not judged to indicate a significant potential for carcinogenic risk because there are numerous safety mechanisms in place to prevent excessive exposure under these circumstances. Summary The exposure assessment section identified various population groups who could potentially be exposed to COPCs. There is a low possibility of exposure for all of the population groups. The technicians/ship's crew have some potential for inhalation exposure as a result of venting from the ballast tanks and inspections that require technicians to go inside the tank. However, the exposures estimated in this risk assessment are likely overstated due to the use of highly conservative exposure assumptions and there are numerous safety mechanisms in place to prevent exposure under these circumstances. In summary, based on the results of the conservative risk assessment, potential risks to on board receptors who may be exposed to ballast water via inhalation or dermal exposures are below or within typical acceptable risk ranges used in risk management decision making around the world. 8.3 Risks to the aquatic environment

WET testing of treated fresh water by GSI and brackish water by MERC, both with the holding time of 5 days showed no acute toxicity of discharge for all three fresh water and three saltwater species. Further, Siemens have identified TRO as the most toxic chemical in the treated water and conducted an environmental risk analysis based on the PEC/PNEC ratios. These ratios were calculated for an OECD-EU commercial harbour port using MAMPEC Model and assuming 80 ships in port, all equipped with the SiCURE BWMS and simultaneously discharging ballast water with the same holding time of 5 days. The PEC/PNEC ratio analysis has shown that even when every ship entering the port is equipped with the SiCURE system and discharges treated water daily and at the same time, discharged water should not bear any risks to the aquatic environment if holding time exceeds 5 days (120 hours). Note that certain chemicals such as monochloroacetic acid, bromochloroacetic acid, monobromoacetic acid and dichloroacetonitrile were excluded from the Relevant Chemicals list due to their minute quantities found in the land-based tests. PEC/PNEC analysis performed for other haloacetic acids and haloacetonitriles shows that their exclusion from risk assessment consideration should not have altered the assessment outcome. The data in the dossier prove that the SiCURE BWMS, in its basic design without dechlorination, is safe to the environment after a holding time greater than 120 hours. This basic design of the system is intended for large ocean-going marine vessels such as oil tankers that have long voyage times. Siemens firmly believe that this is a valid statement as there was no acute toxicity observed in all land-based fresh and brackish water tests that included six fresh water and saltwater species from all three trophic levels. A Procedure (G9) requirement for a conservative review of the discharge toxicity (paragraph 5.2.6) states that "the rationale for taking a conservative approach is that there could be multiple discharges into one location (even though this is not necessarily the case)". This has been thoroughly and conservatively assessed through MAMPEC modelling using Port of Rotterdam as an
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MEPC 62/2/10 Annex, page 37 example of an OECD-EU commercial harbour port and assuming that all 80 vessels anchored in the port discharged ballast water treated with SiCURE on a daily basis. These results show that discharge after 120 hour holding time will present no chronic toxicity issues to the aquatic organisms. In case of the shorter voyages, Siemens will employ an optional dechlorination system. The results of WET testing and MAMPEC modelling also show, that discharge of treated water dechlorinated with sodium sulfite is also safe to the aquatic environment. Siemens believe that the addition of reducing chemicals in cases where oxidant concentrations are already very low and difficult to measure, is not beneficial to the environment and should be avoided where possible. This will also provide better operational flexibilities and reduce the carbon footprint for those large vessels that quite often use gravity discharge. Based on this risk assessment it is Siemens' intent to apply for two type approvals: without the dechlorination sub-system for vessels engaged in long-term voyages and with dechlorination sub-system for the vessels with short voyage times. 9 9.1 ASSESSMENT REPORT Overview of data and endpoints

All Relevant Chemicals were evaluated with regard to aquatic and mammalian toxicity. The evaluation of aquatic toxicity included assessing the chemicals with regard to persistence, bioaccumulation and toxicity. The Active Substances (TRO, hypochlorous and hypobromous acids) are not persistent. All of the Relevant Chemicals are persistent using Procedure (G9) criteria of a half-life >60 days in marine water or >40 days in fresh water. None of the Active Substances or Relevant Chemicals are expected to bioaccumulate using Procedure (G9) criteria of a log Pow <3. Therefore, the chemicals are not expected to accumulate in the tissue of marine organisms. The chronic toxicity database in this dossier indicates that none of the Active Substances appear to be toxic to fish (0.04 mg/L) and crustaceans (0.012 mg/L) based on a chronic NOEC criterion of <0.01 mg/L. The Active Substances may have the potential to be toxic to algae based on unacceptable OECD data when the chronic NOEC criterion of <0.01 mg/L is used. The chronic toxicity database shows for the Relevant Chemicals for which acceptable OECD chronic toxicity data are available that these compounds are much less toxic than the Active Substances. There are no studies indicating the possibility of endocrine disruption for any of these chemicals. The evaluation of mammalian toxicity involved assessing the chemicals for various endpoints, including acute and chronic toxicity, carcinogenicity, and developmental effects. There is a wide range of acute toxicity. Most of the COPCs have the potential to be irritating to the eyes and skin, however these effects were seen at higher concentrations than would be present in ballast water. The toxicity studies show that some of the COPCs result in adverse effects to the liver and kidney at the higher doses, and there are some reproductive effects generally at high doses. It is unlikely that people could be exposed to concentrations that could result in adverse health effects. A comparison of the measured ballast water concentrations of various chemicals to drinking water guidelines showed that the measured concentrations were generally lower than their respective drinking water guidelines. Therefore, no adverse health effects would be expected from exposures that are much less than daily drinking water exposure. The low bioaccumulation potential for these chemicals indicates that consumers of seafood in the harbour areas would not face health risks from consuming seafood containing these chemicals.

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MEPC 62/2/10 Annex, page 38 Therefore, the possibility of exposure health risks for human populations is very low because of the low potential for exposure to the COPCs. The SiCURE system can safely and effectively treat ballast water in compliance with the guidelines. It is important to note that this basic process has been used for a long time to disinfect drinking water and bathing water. There have been many toxicology studies conducted on both the Active Substances and the disinfection by-products to develop health-protective guidelines for these chemicals. The potential risks to the safety of ships, human health and the environment are expected to be low because of the low potential for exposure. In the SiCURE system, sodium hypochlorite is produced in situ and injected directly into the ballast water piping system. The other COPCs would be formed as by-products in the ballast water. Therefore, no Active Substance is stored on board, thereby reducing the possibility of accidental release. 9.2 Test report data quality

The test reports used in this application were from a variety of reputable sources, including the International Programme on Chemical Safety (a consortium of governmental bodies including the World Health Organization and the United Nations Environment Programme), the International Agency for Research on Cancer, and the United States National Library of Medicine. The studies included in reports by these agencies are valid and reproducible studies. The toxicology studies followed standard laboratory practices. ___________

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