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

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INTERNATIONAL MARITIME ORGANIZATION



### IMO 

# E

MARINE ENVIRONMENT PROTECTION COMMITTEE 59th session Agenda item 2 MEPC 59/2/9 16 December 2008 Original: ENGLISH

HARMFUL AQUATIC ORGANISMS IN BALLAST WATER
Application for Final Approval of the Ecochlor® 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 Ecochlor® Ballast Water Management System under the “Procedure for approval of ballast water managment systems that make use of Active Substances (G9)” adopted by resolution MEPC.169(57) Strategic direction: 7.1 High-level action: 7.1.2 Planned output: 7.1.2.4
Action to be taken: Paragraph 6
Related documents: BWM/CONF/36; MEPC 57/21; MEPC 58/2/2, MEPC 58/2/8, MEPC 58/23; BWM.2/Circ.13 and BWM.2/Circ.15

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)”. The Procedure stipulates the required information (MEPC 57/21, annex 1, paragraph 4.2.1) and provisions for risk characterization and analysis (MEPC 57/21, annex 1, section 5) which, according to section 6 of the Procedure, should be evaluated by the Organization. 3 In accordance with BWM.2/Circ.15, this application contains the non-confidential part of the manufacturer’s application dossier in the annex. The complete dossier will be made available to the experts of the GESAMP-BWWG with th e understanding of confidential treatment.

### MEPC 59/2/9 - 2 -

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### 4 Basic Approval of the Active Substance used has been granted at MEPC 58 (MEPC 58/23, paragraph 2.6.3). 5 Taking into account the recommendations contained in annex 5 of the Report of the seventh meeting of the GESAMP-BWWG (MEPC 58/2/8), the receiving competent authority has verified the application dossier and believes it satisfies the requirements of Procedure (G9) adopted by resolution MEPC.169(57).
Action requested of the Committee 6 The Committee is invited to consider the proposal for approval and decide as appropriate.

***

### ANNEX NON-CONFIDENTIAL INFORMATION ON THE Ecochlor® BALLAST WATER MANAGEMENT SYSTEM (GERMANY) PREAMBLE Ecochlor is applying for Final Approval of the Purate ®

### chlorine dioxide generation method utilized with the Ecochlor ®

### BWTS in accordance with the International Maritime Organization (IMO) Guideline 9 (Resolution MEPC.169(57) 1 

### ). This application was compiled using the guidance and format provided in the Methodology for Information Gathering and the Conduct of Work of GESAMP-BWWG (MEPC 58/2/7, Annex 4 2 

### ) Ecochlor submitted a dossier for G9 Basic Approval (MEPC 58/2/2 3 

### ) and was recommended for approval by the GESAMP-BWWG (MEPC 58/2/8, Annex 5 4 

### ). Ecochlor appreciates the comments received by the GESAMP-BWWG, which are summarized below. Per the request of the German Administration, this Final Approval dossier was developed by adding information tothe existing Basic Approval dossier in response to the comments provided by the GESAMPBWWG in the report of its seventh meeting (MEPC 58/2/8, Annex 5 4 

### ). In addition to the response to comments, applicable data from the land based testing according to Guideline 8, as well as other new information per the request of the German Administration has been added. Summary of the GESAMP-BWWG comments received (MEPC 58/2/8, Annex 5): 1. Having considered the information provided, the Group agreed that: a. After the injection of chlorine dioxide to the ballast water, chlorite ion is produced as a reaction between seawater and chlorine dioxide and is considered by the Group to be an Active Substance in addition to the chlorine dioxide in need of full evaluation in the application for Final Approval. (See Sections 2.0.3.2.1, 2.2, 2.2.5, 2.2.6, 2.2.7, 2.2.8) b. Purate ® 

### containing 40% by weight sodium chlorate (NaClO3 

### ) and 8% by weight hydrogen peroxide (H 2 

### O2 

### ) is considered to be a Preparation. (No Response Required) c. Sulfuric acid is considered to be a Relevant Chemical. (See Section 2.0.3.1.1) 2. The maximum allowable discharge level of the Active Substances (chlorine dioxide and chlorite) needs to be defined in the application for Final Approval. (See Section 5.3.3.5) 3. The Group considers the Level of Quantification (LOQ) for the THMs and HAAs used in the analyses of treated ballast water too high. It is common to determine these contaminants in surface waters at levels of 0.01 – 0.05 μg/L. It remains to be confirmed that the potential amount of by-products produced by the system is sufficiently low and meets the international standards on these substances. This uncertainty should be <0.1 μg/L. (See Section 2.0.3.3.1) 4. The Group noted that whole effluent ecotoxicity testing still has to be carried out for Final Approval. Samples should be taken during the land-based efficacy tests to meet G8 standards (Ref. G9, 5.2.1) and should include samples taken at day 0, 2 and 5 after treatment to demonstrate conclusively eventual remaining ecotoxicity at discharge after varying holding time in ballast tanks. Chemical analyses with a sufficient low LOQ should be carried out on the samples in order to identify substances responsible for any toxic effects encountered. (See Sections 2.1, 2.1.1.6 and 2.1.2.4, Tables T2.9a and T2.10a; Section 5.2.2)

1 International Maritime Organization, MEPC 57/21, Annex 1, Resolution MEPC.169(57), April 2008 2 International Maritime Organization, MEPC 58/2/7, GESAMP-BWWG 6/9, Annex 4, May 2008 3 International Maritime Organization, MEPC 58/2/2, March 2008 4 International Maritime Organization, MEPC 58/2/8, Annex 5, July 2008 

### MEPC 59/2/9

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### 5. A full environmental risk assessment is required for the application for Final Approval. This should apply model calculations of environmental concentrations using defined emissions scenarios and include the use of the maximum allowable discharge level of both Active Substances and the relevant chemicals in the treated ballast water as well as the eventual toxicity of the whole effluent sample. (See Section 5.3.3) 6. For Final Approval the Group recommends additional long-term (at least three months duration) corrosion tests with the treated ballast water to be carried out and also to confirm that epoxy ballast tank coatings commonly in use will not be adversely affected by the use of this BWTS. (See Sections 6.1.2.4, 6.1.2.5) 7. The Group recommends the provision of appropriate chemical resistant save-all protection by way of the storage tanks and any other locations considered necessary to provide protection to the ship in the event of leakage or spillage of the chemicals used. (See Section 3.0.7.1) Information in response to other comments in the GESAMP-BWWG Annex 5 report, but not listed in the Annex 5 summary has also been provided. For example, an updated process diagram (Figure F3.2a) has been included that shows the location of the optical sensor (Annex 5, comment 3.1.4). In Section 3.0.8.1.1, Ecochlor provides information in response to the GESAMP-BWWG comment regarding fire mitigation measures (Annex 5, comment 5.7). In addition to ecotoxicity data, Section 2.0.4 of this Final Approval dossier presents chemical analysis (Tables T2.8a, T2.8b, and T2.8c) and water quality data (Tables T2.8e and T2.8f) for treated ballast water discharge from the land based test set up. Based on this new data from the G8 land based testing, the German Administration requested that Ecochlor discuss and present information on dibromoacetic acid (DBAA) as a relevant chemical (see Section 2.0.3.3.2). Also based on chemical analysis of treated water discharge from land based testing, chlorate ion has been added to the list of relevant chemicals (Section 2.0.3.4).

1.0 INTRODUCTION The Ecochlor ®

### Ballast Water Treatment System (BWTS) applies established chlorine dioxide technology to oxidize and disinfect aquatic invasive species (AIS). Chlorine dioxide has a long history (50+ years) of being applied safely and economically for the control of micro-organisms in industrial and municipal waters. What is unique about chlorine dioxide is its ability to be effective against a wide range of troublesome organisms and in a broad range of water quality conditions. A second unique feature of the chlorine dioxide generated with the Ecochlor ®

### BWTS compared to other oxidants (such as chlorine) is the minimization of unwanted by-products. 1.0.1 Technology Overview The Ecochlor ® 

### BWTS uses a two-step treatment process. The first step is pre-treatment filtration with a 40 micron steel mesh filter. The second step is injection of chlorine-free chlorine dioxide into the incoming ballast water stream. A detailed discussion of the technology overview was provided in MEPC 58/2/2.
2.0 IDENTIFICATION OF PREPARATIONS, ACTIVE SUBSTANCES AND RELEVANT CHEMICALS (G9: 4.1) Based on the definitions of Preparations, Active Substances and Relevant Chemicals in the G9 procedure (Resolution MEPC.169(57)), Ecochlor classifies the substances involved in the Ecochlor ®

### BWTS process as follows: MEPC 59/2/9 ANNEX Page 2

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### Preparations: There are two preparation substances used with the Ecochlor ®

### BWTS: 1) Purate ®

### (a proprietary formulation from Eka Chemicals containing 40% by weight sodium chlorate (NaCl0 3 

### ) and 8% by weight hydrogen peroxide (H 2 

### O 2 

### ); and 2) Sulfuric acid (78% by weight). These two preparation substances are used to generate the active substance (chlorine-free chlorine dioxide) onboard and are not themselves active substances.

Purate ®

### is discussed in more detail in Section 2.0.1.1 and sulfuric acid is discussed further in Section 2.0.1.2 below. Active Substance: Chlorine-free chlorine dioxide is the active substance that is generated onboard and has “...specific action on or against harmful aquatic organisms and pathogens” (Guideline 9, 2.1.1). Additional information regarding chlorine dioxide is presented in Section 2.0.2.1 below. Relevant Chemicals: Ecochlor discusses the following substances as Relevant Chemicals in Section 2.0.3: 1) Sulfate ion; 2) Chlorite ion (as sodium chlorite); 3) Dibromoacetic acid; and 4) Chlorate ion. Based on the G9 definition of relevant chemicals, these substances are “...transformation or reaction products that are produced during and after employment of the ballast water management system...” (Guideline 9, 2.1.4). Sulfate ions are discussed as a relevant chemical because a slight excess of sulfuric acid is used during the chlorine dioxide generation process. This is done to ensure high chlorine dioxide production efficiency. As such, additional sulfate ions (19 mg/L) may be added to ballast water treated with chlorine dioxide. Although the addition of sulfate ions to sea water as a result of treatment with the Ecochlor®

### BWTS is inconsequential, Ecochlor presents justifications to fully explain the chemistry associated with the treatment process. Section 2.0.3.1 of the application provides further information regarding sulfate ions that clearly demonstrates that sulfate ions are not added to treated ballast water at environmentally relevant concentrations. Additional clarification regarding sulfuric acid has been added in response to the GESAMP-BWWG comment. See Section 2.0.3.1.1. As the primary reaction by-product in ballast water after disinfection with chlorine-free chlorine dioxide, Ecochlor classifies chlorite ion (ClO 2 - 

### ), or sodium chlorite (NaClO 2 

### ) as a relevant chemical. Detailed information on chlorite ion is presented in Section 2.0.3.2 below. Additional clarification regarding chlorite ion has been added in response to the GESAMP-BWWG comment. See Section 2.0.3.2.1. Chemical analysis and known chemical principles of disinfection using chlorine dioxide that is generated in the chlorine-free method used with the Ecochlor®

### BWTS indicate that no other reaction by-products are present at environmentally relevant concentrations. However, biocide treatment of water can raise questions regarding the formation of THM’s and/or HAA’s. Chemical data and justifications regarding these substances are located in Sections 1.0.1 (above) and 2.0.3.3. Additional clarification regarding THM and HAA analysis has been added in response to the GESAMP-BWWG comment. See Section 2.0.3.3.1.

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### MEPC 59/2/9 ANNEX

Page 3

### Dibromoacetic acid and chlorate ions were measured at concentrations of 0.012 – 0.036 mg/L and 0.98 – 2.42 mg/L, respectively, in treated water discharge samples collected during land based testing. Because these values are higher than previously measured in treated ballast water samples, additional information is provided for these chemicals. See Section 2.0.3.3.2 for DBAA and Section 2.0.3.4 for chlorate. Table T2.1 below provides an overview of the chemicals involved in the Ecochlor® 

### BWTS and descriptions of each chemical follow the table.

Table T2.1 – Overview of Chemical Identification Ingredient (IUPAC Name) Identification Numbers Chemical Formula Structural Formula Molecular Weight Percentage (by weight) AppliedConcentration Preparation Chemicals

1. Purate ®

a. Hydrogen

Peroxide b. Sodium

Chlorate a. CAS # 7722-84-1 b. CAS # 7775-09-9 a. H 2 O 2 b. NaClO 3 a.

b. a. 34.01 b. 106.44 a. <8% b. 40% a. 0.05-2.9 M b. 0.5-3.2 M

2. Sulfuric Acid CAS# 7664-93-9 H2 SO 4 98.08 78% 0.75-4M

Active Substance in Ballast Water
Chlorine dioxide CAS# 10049-04-4 ClO 2 67.45 -- < 5 mg/L in ballast water Relevant Chemicals in Ballast Water

1. Sulfate ion (as sodium sulfate or sulfuric acid) CAS # 7757-82-6
or CAS# 7664-93-9 Na 2 SO 4 or H 2 SO 4 or 142.04

or
98.08 By-product < 20 mg/L

2. Sodium Chlorite (present as chlorite ion) CAS # 7758-19-2 NaClO 2 90.45 By-product 0.24 – 3.83 mg/L (as measured in treated water)

3. Dibromoacetic acid (DBAA) CAS # 631-64-1 Br2 CHCOOH 217.84 By-product .012 – .036 mg/L (as measured in treated water)

4. Sodium Chlorate (present as chlorate ion) See above See above See above See above By-product 0.49 – 2.42 mg/L (as measured in treated water) 

### 2.0.1 Preparations In order to generate chlorine dioxide onboard Ecochlor®

### is utilizing a two precursor chemical approach. The two preparation chemicals, Purate ®

### and sulfuric acid, are mixed under controlled

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### MEPC 59/2/9 ANNEX Page 4

### conditions to generate chlorine dioxide, which is then injected into the ballast water stream. The preparation chemicals are not added to the ballast water directly, and are not the active substance.

2.0.1.1 Purate ® 

### Detailed information regarding Purate ®

### was provided in the Basic Approval dossier (MEPC 58/2/2). Hydrogen Peroxide: Detailed information regarding hydrogen peroxide was provided in the Basic Approval dossier (MEPC 58/2/2).

Sodium Chlorate: Detailed information regarding sodium chlorate was provided in the Basic Approval dossier (MEPC 58/2/2). Chlorate ion was measured at concentrations ranging from 0.98 – 2.42 mg/L, with a mean concentration of 1.39 mg/L, in samples of treated water discharge during land based testing. As such, chlorate ion is also discussed as a relevant chemical in Section 2.0.3.4 below.
2.0.1.2 Sulfuric Acid Detailed information regarding sulfuric acid was provided in the Basic Approval dossier (MEPC 58/2/2).

2.0.2 Active Substance 2.0.2.1 Chlorine Dioxide Detailed information regarding chlorine dioxide was provided in the Basic Approval dossier (MEPC 58/2/2). Additional data generated since the submittal of the Basic Approval dossier is included below. To further define the rapid degradation of chlorine dioxide, additional demand studies where measurements were taken on the minutes time scale were performed in the laboratory using water collected at the NIOZ facility in the Netherlands. The data presented in Figure F2.3a and Table T2.4a below is consistent with previous studies performed to determine the demand/decay of chlorine dioxide.

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### Figure F2.3a – Example of Chlorine Dioxide Demand Curve (NIOZ Water), 20°C

Chlorine Dioxide Demand at Different Concentrations Low Salinity Control Water, Texel, Netherlands (NIOZ) 20C

0.00 0.50 1.00 1.50 2.00 2.50 3.00

0 10 20 30 40 50 60 Time (min)Chlorine Dioxide Concentration (mg/L)

1 mg/L 2 mg/L 3 mg/L



### Table T2.4a – Ecochlor Chlorine Dioxide Demand Study (NIOZ Water), 20oC Ecochlor Ballast Water Chlorine Dioxide Decay Study
Source Water Texel, The Netherlands (NIOZ) Low Salinity Water ClO 2 Dose Nominal 1, 2, and 3 mg/L Water Temp 20oC

Time after ClO 2 treatment (minutes) Remaining ClO 2 Concentration (mg/L), 1 mg/L treatment Remaining ClO 2 Concentration (mg/L), 2 mg/L treatment Remaining ClO 2 Concentration (mg/L), 3 mg/L treatment 0 1.03 2.06 2.97 1 0.70 1.52 2.31 2 0.64 1.45 2.19 3 0.57 1.36 2.13 4 0.54 1.34 2.09 5 0.51 1.30 2.05 6 0.48 1.27 2.00 7 0.44 1.24 1.98 8 0.43 1.22 1.93 9 0.41 1.18 1.91 10 0.40 1.17 1.88 11 0.37 1.14 1.86 12 0.36 1.13 1.83 13 0.35 1.11 1.81 14 0.34 1.09 1.79 15 0.32 1.07 1.77 20 0.26 1.00 1.65 25 0.22 0.92 1.54 30 0.18 0.86 1.42 35 0.15 0.81 1.31 40 0.12 0.76 1.19 45 0.10 0.70 1.07 50 0.08 0.65 0.93 55 0.05 0.60 0.81 60 0.04 0.56 0.68 Note: Demand testing performed by NovaChem Laboratories

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### MEPC 59/2/9 ANNEX Page 6

### 2.0.3 Relevant Chemicals The information provided in the Basic Approval dossier was obtained from laboratory and shipboard analysis of treated water. During land based testing at NIOZ additional chemical analysis was performed on water treated with the Ecochlor® 

### BWTS. Chemical analysis was performed on eight (8) separate discharge sampling events; four during brackish water test cycles and four during sea water test cycles. Water samples were collected on days 0, 1, and 5 from both treatment and control ballast tanks for proper comparison. Tables T2.8a, T2.8b and T2.8c provide a summary of the chemical analysis results from discharge samples collected during land based testing. Chlorate ion and dibromoacetic acid (DBAA) were measured at slightly higher concentrations during land based testing than had been previously measured in treated ballast water. As such, Section 2.0.3.3.2 provides additional information on DBAA and Section 2.0.3.4 provides additional information for chlorate ion.
2.0.3.1 Sulfate Ion and Sulfuric Acid Detailed information regarding sulfuric acid was provided in the Basic Approval dossier (MEPC 58/2/2). Also see Section 2.0.3.1.1 below for additional clarification.

2.0.3.1.1 Additional Clarification on Sulfuric Acid In Ecochlor’s Basic Approval dossier sulfuric acid was classified as a preparation (Section 2.0.1.2), and also discussed as a relevant chemical because of the small excess that is combined with Purate ®

### to generate chlorine dioxide (Section 2.0.3.1 above). Comments from the GESAMP-BWWG suggest that sulfuric acid is considered a relevant chemical. Ecochlor would like to further emphasize that in water sulfuric acid will be completely dissociated into hydrogen ions (H + 

### ) and sulfate ions (SO 4 2- 

### ) as discussed above. Therefore, the slight excess of acid can only be present in treated ballast water as the ions, not as sulfuric acid. The interchangeable use of sulfuric acid and sulfate ions in the discussion of these constituents in treated ballast water unintentionally confused the evaluation of sulfate ion in treated ballast water. Because sulfuric acid completely ionizes in water5 

### , the only potential impacts of the small amount of acid that may remain after the generation of chlorine dioxide are: 1) an addition of sulfate ions to treated ballast water, or 2) lowering the pH of treated ballast water. Section 2.0.3.1 in the Basic Approval dossier (MEPC 58/2/2) provided sulfate ion concentration and pH data for treated ballast water, which demonstrated that neither are present in treated ballast water at levels that could present aquatic or human health concerns. Further, the GESAMP-BWWG agreed that sulfate ion is not considered a relevant chemical (MEPC 58/2/8, Annex 5, Section 3.2.3). Therefore, no additional evaluation of sulfate ions is presented in this application for Final Approval.
2.0.3.2 Chlorite Ion Detailed information regarding chlorite ion was provided in the Basic Approval dossier (MEPC 58/2/2). Additional data generated since the submittal of the Basic Approval dossier is included below. To further define the degradation of chlorite ion, additional demand studies where measurements where taken on the minutes time scale were performed in the laboratory using natural harbor water collected at the NIOZ facility in the Netherlands. The data presented in Figure F2.4a and Table T2.5a below is consistent with previous studies performed to determine the demand/decay of chlorite ion.

5 OECD SIDS, Sulfuric Acid, SIAM 11, January 2001, UNEP Publications

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### Figure F2.4a – Chlorite Ion Demand Curve Texel Harbor (NIOZ) Water, 20°C
Ecochlor Chlorite Ion Demand Study Texel, 4HS-6 June 08-CX, 0.983 mg/L, ambient

0.00 0.20 0.40 0.60 0.80 1.00 1.20

0 0.5 1 1.5 2 2.5 3 3.5 Time (Hr)Concentration (mg/L)

Note: Demand testing on raw water samples performed by NovaChem Laboratories


### Table T2.5a – Ecochlor Chlorite Ion Demand Study (NIOZ Water), 20oC Ecochlor Ballast Water Chlorite Ion Demand Study
Source Water Texel Harbor (NIOZ), The Netherlands Chlorite Dose 0.983 mg/L Water Temp 20 oC (ambient)

Time after ClO 2 - treatment (hour) Chlorite Ion ClO 2 -(mg/L) 0 0.983 0.03 0.40 0.75 0.40 3.25 0.39 Note: Demand testing on raw water samples performed by NovaChem Laboratories


### 2.0.3.2.1 Additional Clarification on Chlorite Ion This section has been added in response to the GESAMP-BWWG comment indicating that chlorite ion is considered an active substance. In Ecochlor’s Basic Approval dossier chlorite ion was classified as a relevant chemical based on the definition provided in the G9 Methodology: “Relevant Chemicals means transformation or reaction products that are produced during and after employment of the ballast water management system in the ballast water or in the receiving environment and that may be of concern to the ship’s safety, aquatic environment or human health.” This definition accurately describes chlorite ion, which is formed after employment of the Ecochlor ®

### BWTS. Chlorite ion is not produced due to the reaction between seawater and chlorine dioxide. Rather, chlorite ion is the primary by-product when chlorine dioxide degrades, regardless of the matrix (fresh or sea water). Known chlorine dioxide disinfection chemistry clearly indicates that chlorite is the primary reaction by-product of chlorine dioxide oxidation

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### MEPC 59/2/9 ANNEX Page 86,7,8,9,10,11 

### rather than an active substance. There are methods of chlorine dioxide generation that utilize sodium chlorite as a preparation or active substance; however, this differs from the chlorate-based method used with the Ecochlor® 

### BWTS. Ecochlor agrees with the GESAMP-BWWG that the content of chlorite ion in treated ballast water must be considered in regards to potential aquatic toxicity. However, based on the G9 definition and the authorities referenced above, evaluation of chlorite ion remains under the relevant chemicals section in this dossier. The Basic Approval dossier included information for chlorite ion in regards to chemical identification (Table T2.1), demand/dilution discussion (section 2.0.3.2), acute and chronic aquatic toxicity (Tables T2.9 and T2.10, Section 5.0), environmental fate and effect (Section 2.3), physical and chemical properties, analytical methods at environmentally relevant concentrations (Section 2.5), risk characterization (Section 5.0), and risks to the aquatic environment (Section 6.4). In response to the GESAMP-BWWG request, additional information to supplement the evaluation of chlorite ion has been included in Sections 2.2, 2.2.5, 2.2.6, 2.2.7, and 2.2.8. During land based testing chlorite ion was measured in treated ballast water at concentrations ranging from 2.26 – 3.83 mg/L, with a mean concentration of 3.16 mg/L. Table T2.8a in Section 2.0.4 provides analytical data for chlorite ion in treated water from land based testing at NIOZ. Chlorite ion was also evaluated in the predicted environmental concentration assessment using hydrodynamic modeling (Section 5.3.3) 2.0.3.3 Trihalomethanes and Haloacetic Acid By-Products Detailed information regarding THMs and HAAs was provided in the Basic Approval dossier (MEPC 58/2/2). Also see Section 2.0.3.3.1 below for additional clarification. 2.0.3.3.1 Additional Clarification on THM and HAA Analysis The GESAMP-BWWG commented that the Level of Quantification (LOQ) associated with the analytical data provided in the Basic Approval dossier was too high to confirm that THMs and HAAs in treated water discharge are at sufficiently low levels to ensure that international discharge standards are not exceeded. Clarification on the LOQ comment was requested from the GESAMP-BWWG because the LOQ suggested was very low (0.01 – 0.05 μg/L). The response provided to the GermanAdministration on 4 November 2008 explained that the detection limits noted by the GESAMPBWWG “...were taken from information provided in previous applications.” Due to the variation in detection limits and terminology that is discussed below, using other applications as “guidance documents” can lead to incorrect data comparisons. Other applicants may have used detection limit terms differently, produced data by varying methods or in differing matrices (fresh vs. sea water), or had possible errors. As noted by other applicants, and acknowledged by the GESAMP-BWWG, chemical analysis in sea water presents challenges due to potential interferences with the analytical methods.

6 US EPA Reregistration Eligibility Decision (RED) for Chlorine Dioxide and Sodium Chlorite (Case 4023), August 2006 7 US EPA Toxicological Review of Chlorine Dioxide and Chlorite, September 2000 8 EPA Guidance Manual, Alternative Disinfectants and Oxidants, Chlorine Dioxide, 1999 9 Simpson, G.D., Miller, R.F., Laxton, G.D., Clements, W.R., A Focus on Chlorine Dioxide: “The Ideal Biocide” 10 OECD SIDS, Sodium Chlorite and Chlorine Dioxide, SIAM 23, October 2006 11 World Health Organization, Guidelines for Drinking-Water Quality, 2006

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### The information presented below demonstrates that the THM and HAA data presented has sufficient detection limits and shows that regulatory standards for these constituents are not exceeded in treated ballast discharge.

Detection Limit Discussion: There are many different “detection limit” terms commonly used in analytical chemistry and each term can refer to different aspects of detection. A few examples of terms used to describe detection limits include: method detection limit (MDL), instrument detection limit (IDL), limit (or level) of quantitation (LOQ), or practical quantitation limit (PQL). Further, the use of similar terminology does not imply equal detection limits due to the inherent differences between methods, analytical equipment and laboratory practices. Ecochlor contends that the THM and HAA methodologies used and the data generated are of similar accuracy and quality to that requested by the GESAMP-BWWG, but the detection limits are reported differently due to the USEPA requirements that the laboratory is required to adhere to. The THM and HAA results are reported as <1 μg/L, which specifies a Minimum Reporting Limit (MRL) rather than an LOQ. The different terms used to report an analytical method’s detection capability causes confusion when attempting to equate LOQs with MRLs. In recent years within the US, there has been movement toward MRLs in an attempt to make direct comparisons between data from different sources possible, and to be sure that the comparisons include equivalent levels of data accuracy. From the USEPA DPB/ICR Analytical Methods Manual 12 

### : “A major issue for comparing results between laboratories is data quality. This includes both accuracy and precision targets in order to meet the data quality objectives required for setting regulatory limits. Maintaining data comparability between laboratories is a necessary requirement if the data are to be successfully used in sophisticated correlational analysis. The recommendations of an expert panel are the source of the data quality objectives discussed in this document. Thus, to ensure that the analytical data are scientifically valid and are of known and acceptable precision and accuracy, laboratories are required to adhere to defined quality assurance procedures. This quality assurance plan at a minimum incorporates the elements of the initial demonstration of capabilities. The Method Detection Limit (MDL) as defined in this document is considered qualitative, because they are not precise enough to meet the data needs for regulation. If accurate and precise data are required, concentrations are not reported below the level at which the necessary precision and accuracy are achieved. Thus, based on recommendations from a panel of technical experts, minimum reporting levels (MRLs) were established .”

12 USEPA, DBP/ICR Analytical Methods Manual (EPA 814-B-96-002), April 1996

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### MEPC 59/2/9 ANNEX Page 10

### EPA Method 524.2 was used to analyze treated ballast water samples for THMs. The method explains: “Method detection limits (MDLs) are compound, instrument and especially matrix dependent and vary from approximately 0.02-1.6 ȝg/L. The applicable concentration range of this method is primarily column and matrix dependent, and is approximately 0.02-200 ȝg/L...” EPA Method 552.2 was used to analyze treated ballast water samples for HAAs. The method explains: “Method Detection Limit (MDL) -- The minimum concentration of an analyte that can be identified, measured and reported with 99% confidence that the analyte concentration is greater than zero.” In a revised version of this method (EPA Method 552.3), the Minimum Reporting Level (MRL) is explained: “The MRL is the threshold concentration of an analyte that a laboratory can expect to accurately quantitate in an unknown sample. The MRL should be established at an analyte concentration that is at least 3x the detection limit or at a concentration which would yield a signal-to-noise (S/N) ratio of greater than or equal to five. Depending upon the study’s data quality objectives it may be set at a higher concentration. The concentration of the lowest calibration standard must be at or below the MRL.” The Ph.D. chemist, Dr. Bubnis, involved with the analysis of Ecochlor’s samples has written an expert opinion on this matter 13 

### : “The MRL incorporates a more demanding accounting of bias and accuracy than the reporting of MDL or LOQ. Thus, the higher MRL value is not an indication of an inferior method. It is simply a more rigorous treatment of potential error and includes both a bias and an accuracy function. In contrast, the MDL and LOQ do not account for the predicted accuracy of a method but rely on the expertise of the laboratory and laboratory personnel .” In summary, an MDL is a compound-, matrix-, and instrument-specific detection level that provides information about the data precision for a specific analytical situation. An MRL takes into account both the precision and the accuracy of the data being produced by testing replicate samples with known concentrations. With the difference between MRLs, MDLs and LOQs clarified, the following information shows both the calculated MDL and the MRL for the methods that were used to analyze the treated water samples.
Table T2.7a – Comparison of MDL and MRL for THM Analysis (EPA Method 524.2) Compound MDL a(μg/L) MRL b (μg/L) Bromdichloromethane (BDCM) 0.08 1.0 Bromoform 0.12 1.0 Chloroform 0.03 1.0 Dibromochloromethane (DBCM) 0.05 1.0

aMDL as determined by the analytical method. b MRL as determined by the laboratory according to EPA requirements.

13 Bubnis, B., The Rationale and Transition of Regulating Agencies Specifying the Reporting of Method Reporting Limits (MRLs) In- Lieu of Method Detection Limits (MDLs), October 2008

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### MEPC 59/2/9 ANNEX Page 11

### Table T2.7b – Comparison of MDL and MRL for HAA Analysis (EPA Method 552.2, MTBE Extraction) Compound MDL a(μg/L) MRL b (μg/L) Monochloroacetic acid (MCAA) 0.17 1.0 Monobromoacetic acid (MBAA) 0.027 1.0 Dichloroacetic acid (DCAA) 0.020 1.0 Trichloroacetic acid (TCAA) 0.019 1.0 Bromochloroacetic acid (BCAA) 0.016 1.0 Dibromoacetic acid (DBAA) 0.012 1.0

aMDL as determined by the analytical method. b MRL as determined by the laboratory according to EPA requirements. 

### The tables above show the calculated MDL values for THMs and HAAs determined by the analytical method. This information demonstrates that the methods are capable of the low detection limits suggested by the GESAMP-BWWG. The above MDL values apply to the previous data submitted by Ecochlor (Table T2.8), as well as the new data generated during the land based testing (Tables T2.8b and T2.8c). The MRL values in the tables above are consistent with the <1.0 μg/L values reported with the THM and HAA data generated during analysis of water samples treated with the Ecochlor system, and are a result of the method detection study performed by the analytical laboratory in accordance with EPA requirements 13



### . Regulatory Standards Discussion: The primary goal of conducting chemical analysis on treated water discharge is to verify that regulatory standards are not exceeded. A search to locate published allowable limits for THMs and HAAs was conducted to verify that utilizing an MRL of <1 μg/L demonstrates that the Ecochlor system does not introduce these constituents to the environment at levels that exceed published standards. Table T2.7c below lists the standards that were located for THMs and HAAs during the search. The only published regulatory standards located are for drinking water and therefore, provide the only alternative to determine if treated water discharge meets the standards.
Table T2.7c – Summary of Published Standards for THMs and HAAs Agency Chemical Regulatory Limit Reference World Health Organization THMs: -Chloroform -Bromoform -Dibromochloromethane (DBCM) -Bromodichloromethane (BDCM)

HAAs: -chloroacetic acid -dichloroacetic acid -trichloracetic acid -brominated acetic acids 0.3 mg/L (300 μg/L) 0.1 mg/L (100 μg/L) 0.1 mg/L (100 μg/L) 0.06 mg/L (60 μg/L)

0.02 mg/L (20 μg/L) 0.05 mg/L (50 μg/L) 0.2 mg/L (200 μg/L) No guideline value established Guidelines for Drinking-water Quality First Addendum to Third Edition, Volume 1 Recommendations

Australian GovernmentPrimary Industries Ministerial Council(PMIC) and THMs

HAAs -chloroacetic acid 0.25 mg/L (250 μg/L)

0.15 mg/L (150 μg/L) Australian and New Zealand Guidelines for Fresh and Marine Water Quality

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### MEPC 59/2/9 ANNEX Page 12Agency Chemical Regulatory Limit Reference Natural Resource Management Ministerial Council (NRMMC) -dichloroacetic acid -trichloracetic acid -brominated acetic acids 0.1 mg/L (100 μg/L) 0.1 mg/L (100 μg/L) No guideline value noted AUSTRALIAN DRINKING WATER GUIDELINES (6) 2004

Canada-Federal Provincial Subcommittee on Drinking Water THMs --Total

HAAs --Total 0.100 mg/L (100 μg/L) 0.080 mg/L (80 μg/L) Guidelines for Canadian Drinking Water Quality - Summary Table

US EPA THMs --Total

HAAs --Total 0.080 mg/L (80 μg/L) 0.060 mg/L (60 μg/L) USEPA National Primary Drinking Water Regulations
California Department of Public Health, Division of Drinking Water and Environmental Management THMs -- Total

HAAs --Total 0.080 mg/L (80 μg/L) 0.060 mg/L (60 μg/L) California Regulations Related to Drinking Water (Title 22 of the California Code of Regulations)

Agency Chemical Limit Approved ReferenceIMO MEPC, GESAMPBWWG – based on levels in treated ballast water that have received G9 approval THMs -Tribromomethane (Bromoform)

-Tribromomethane (Bromoform)

HAAs -Dibromoacetic acid -Tribromoacetic acid 0.230 mg/L (230 μg/L)

0.373 mg/L (373 μg/L)

0.163 mg/L (163 μg/L) 0.183 mg/L (183 μg/L) MEPC 58/2/8, Annex 4 (OceanSaver)
MEPC 58/2/7, Annex 6, (Electroclean)

MEPC 58/2/7, Annex 6, (Electroclean)



### In the table above, the lowest published standard located for a single THM was 60 μg/L (WHO, bromodichloromethane), while the lowest standard for total THMs located was 80 μg/L. Tables T2.8 and T2.8b provide the measured THMs in treated ballast water discharge. In Ecochlor treated ballast water discharge all THMs are <1 μg/L and therefore do not exceed the limits for THMs. In the table above, the lowest published standard located for a single HAA was 20 μg/L (WHO, chloroacetic acid), while the lowest standard for total HAAs was 60 μg/L. No specific standard was located for DBAA which has been measured in treated ballast water. Tables T2.8 and T2.8c list the measured HAAs in treated ballast water discharge. Chloroacetic acid is reported at <1 μg/L for all chemical analysis performed on treated ballast water discharge and therefore the WHO standard for this constituent is not exceeded. The highest total HAAs measured in a single sample was 36 μg/L (DBAA) and therefore the limit for total HAAs is not exceeded. Also in the table above Ecochlor notes that G9 Final Approval has been granted to other technologies who have concentrations of THMs and HAAs at least one order of magnitude higher than that present in Ecochlor treated water discharge. Based on the fact that higher concentrations have been previously approved, Ecochlor presumes that the lower concentrations measured in Ecochlor’s treated ballast water discharge are considered acceptable. Additionally, the results of the hydrodynamic modeling and environmental risk assessment indicate that the discharge will not cause unacceptable risk to the aquatic environment. See Section 5.3.3.

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### MEPC 59/2/9 ANNEX Page 13

### 2.0.3.3.2 Dibromoacetic Acid (DBAA) This section has been added based on the levels of DBAA measured in treated water discharge from the land based testing at NIOZ and comments Ecochlor received from the German Administration. DBAA is a low-level disinfection by-product that has been measured in water treated with the Ecochlor system. Brominated acetic acids are formed during disinfection of water that contains bromide ions and organic matter 11 

### . In regards to drinking water, the WHO reports that brominated acetic acids are generally present in surface water and groundwater distribution systems at mean concentrations below 5 μg/L 11 

### . Data from the USEPA indicates that DBAA has been detected at mean concentrations of 0.82 μg/L and 1.09 μg/L in groundwater and surface water distribution systems, respectively 14



### . DBAA was previously measured at 12 μg/L in ballast water treated onboard the M/V Moku Pahu . During land based testing DBAA was measured at concentrations ranging from 12 - 36 μg/L (Table T2.8c), with a mean concentration of 22.6 μg/L. These values are significantly lower than the DBAA concentrations reported by other ballast water treatment technologies that have received IMO Final Approval. Most importantly, the level of DBAA in treated ballast water does not exceed the regulatory standards as presented above. Information on DBAA is provided in the appropriate sections of this dossier to allow for a proper evaluation. Additionally, to further demonstrate and verify that DBAA potentially present in treated ballast water discharge will not cause unacceptable environmental risk, Ecochlor has included this constituent in the environmental concentration prediction model in Section 5.3.3.

2.0.3.4 Chlorate Ion Ecochlor has added chlorate ion to the discussion of relevant chemicals because higher concentrations were measured during land based testing than had been previously measured during laboratory and shipboard testing. During land based testing at NIOZ chlorate ion was measured at concentrations ranging from 0.98 – 2.42 mg/L (mean concentration of 1.39 mg/L) in samples of treated water discharge. Sodium chlorate (as solid sodium chlorate) is highly soluble in water (802 g/L at 20oC 15 

### ). This high solubility implies that chlorate does not bioaccumulate or easily adsorb to particulates 25



### . There are conflicting opinions published regarding the stability of chlorate in the environment. Examples include three sources that indicate chlorate is unstable and non-persistent in the aquatic environment 17,19,25 

### while the USEPA indicates “...chlorate is stable in finished drinking water” 8



### . However, finished drinking waters cannot be equated to natural waters where treated ballast effluent will be discharged. Natural waters will have physiological properties, organic matter, and biological components that play a role in the degradation of chlorate ion that finished drinking water will not. Through controlled laboratory experiments, an observable degradation of chlorate ion over time in natural sea water has been demonstrated. Similar to chlorine dioxide and chlorite, natural seawater has an observable demand for chlorate. The measured decay rate of chlorate in natural seawater at 20oC is 0.03 mg/L -1 minute



### .

14 World Health Organization, Brominated Acetic Acids in Drinking Water, 2004 15 OECD SIDS, Sodium Chlorate, SIAM 22, April 2006

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### MEPC 59/2/9 ANNEX Page 14

### Figure F2.7 – Example of Chlorate Ion Demand Curve Newark, NJ Water, 20°C

NJ Water Chlorate Ion Demand 1.49 mg/L, 20C

0.00 0.50 1.00 1.50 2.00

0 5 10 15 20 25 Time (hours)Concentration (mg/L)



### Table T2.7d – Chlorate Ion Demand Study, New Jersey. 20oC Ecochlor Ballast Water Chlorate Ion Demand Study

Source Water New Jers ey Ballast Water Chlorite Dose 1.49 mg/L Water Temp 20 oC

Time after ClO 3 - treatment (hour) Chlorate Ion ClO 3 -(mg/L) 0 1.49 0.03 1.41 0.5 1.37 1.0 1.35 20 1.07 Note: Testing performed by NovaChem Laboratories


### To further demonstrate that the measured concentration of chlorate in treated ballast water discharge will not present unacceptable risks to the aquatic environment, chlorate was included hydrodynamic modeling as part of the risk assessment. See Section 5.3.3. Detailed information on chlorate ion (as sodium chlorate) is evaluated and presented in this dossier to allow for an appropriate review.
2.0.4 Overview of Chemical Analysis and Water Quality Data for Treated Ballast Water The tables below present chemical analysis and water quality data for samples of ballast water treated with the Ecochlor®

### Ballast Water Treatment System.

Table T2.8 – Chemical Analysis of Ballast Water Treated Onboard the M/V Moku Pahu , San Francisco Bay Area (Richmond, CA)

Parameter Control Ballast Water Ballast Water Treated Onboard + 3 Day 13 Feb 2008 Ballast Water Treated Onboard + 5 Day 15 Feb 2008 pH 7.6 7.3 7.3 FAC <0.05 mg/L <0.05 mg/L -- ClO 2 -- <0.05 mg/L <0.05 mg/L ClO 2 - <0.05 mg/L 0.91 mg/L 0.24 mg/L

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### MEPC 59/2/9 ANNEX Page 15Parameter Control Ballast Water Ballast Water Treated Onboard + 3 Day 13 Feb 2008 Ballast Water Treated Onboard + 5 Day 15 Feb 2008 ClO 3 - <0.10 mg/L 0.49 mg/L 0.49 mg/L Br - 50 mg/L -- -- BrO 3 - <0.02 mg/L -- <0.02 mg/L (+11 Day) SO 4 -2 1902 mg/L -- 1826 mg/L (+ Day 8) THM’s Bromdichloromethane Bromoform Chloroform Dibromochloromethane <1 μg/L <1 μg/L <1 μg/L <1 μg/L -- <1 μg/L <1 μg/L <1 μg/L <1 μg/L HAA’s Dibromoacetic Acid Dichloroacetic Acid Monobromoacetic Acid Monochloroacetic Acid Trichloroacetic Acid <1 μg/L <1 μg/L <1 μg/L <1 μg/L <1 μg/L -- 12 μg/L <1 μg/L <1 μg/L <1 μg/L <1 μg/L Note: Demand testing on raw water samples performed by NovaChem Laboratories “--“ = not measured 

### Tables T2.8a, T2.8b, and T2.8c summarize the chemical analysis results from treated water discharge samples collected during land based testing. Testing was performed by NovaChem Laboratories and McCoy & McCoy Laboratories 16



### . Table T2.8a – Chemical Analysis of Treated Ballast Water, Land Based Testing at NIOZ

Treated Ballast Water 5 mg/L ClO2 Days AfterTreatment Sample ID pH a FAC a (mg/L) ClO2 b (mg/L) Chlorite a (mg/L) Chlorate a (mg/L) Bromide a (mg/L) Bromate a (mg/L) Nitrate a (mg/L) 4HS 6 June 08 - CX 7.7 <0.05 -- <0.10 <0.10 55 <0.02 6 1 4HS 6 June 08 - TX 6.8 <0.05 0.79 3.6 1.47 52 <0.02 7

5HS 12 June 08 - CX 7.8 <0.05 -- <0.10 <0.10 58 <0.02 5 0 5HS 12 June 08 - TX 6.8 <0.05 >2.5 3.83 2.42 53 <0.02 5

5HS 13 June 08 - CX 7.6 <0.05 -- <0.10 <0.10 58 <0.02 6 1 5HS 13 June 08 - TX 7.0 <0.05 0.85 3.11 1.46 54 <0.02 6

5HS 17 June 08 - CX 7.9 <0.05 -- <0.10 <0.10 57 <0.02 5 Sea Water (average salinity 31.9 ±

1.3 PSU c )

5 5HS 17 June 08 - TX 7.0 <0.05 ND 2.26 1.27 54 <0.02 5

1LS 21 June 08 - CX 8.0 <0.05 -- <0.10 <0.10 63 <0.02 6 1 1LS 21 June 08 - TX 7.0 <0.05 0.22 3.35 1.17 62 <0.02 6

3LS 26 June 08 - CX 8.0 <0.05 -- <0.10 <0.10 55 <0.02 5 0 3LS 26 June 08 - TX 7.1 <0.05 >2.5 3.18 1.24 52 <0.02 5 Brackish

Water (average salinity 23.1 ± 0.65 PSU c )
1 3LS 27 June 08 - CX 8.1 <0.05 -- <0.10 <0.10 54 <0.02 5

16 NovaChem Laboratories, A Data Summary of the Ecochlor Ballast Water Treatment System at the Land-Based Testing Facility Operated by the Royal Netherlands Institute for Sea Research (NIOZ), November 2008

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### MEPC 59/2/9 ANNEX Page 16Treated Ballast Water 5 mg/L ClO2 Days AfterTreatment Sample ID pH a FAC a (mg/L) ClO2 b (mg/L) Chlorite a (mg/L) Chlorate a (mg/L) Bromide a (mg/L) Bromate a (mg/L) Nitrate a (mg/L) 3LS 27 June 08 - TX 7.1 <0.05 0.67 3.12 1.07 51 <0.02 6

3LS 1 July 08 - CX 8.1 <0.05 -- <0.10 <0.10 53 <0.02 5 5 3LS 1 July 08 - TX 7.1 <0.05 ND 2.8 0.98 51 <0.02 5 HS = High Salinity, LS = Low Salinity, CX = Control Sample, TX = Treated Sample, ND = non-detectable

a Analysis performed by NovaChem Labs, USA b Chlorine dioxide residuals measured using the Palintest ChlorDiox-Duo

c Average salinity during land-based test cycles as reported by NIOZ 

### Table T2.8b – Chemical Analysis of Treated Ballast Water for THMs, Land Based Testing at NIOZ
Trihalomethanes (THM) Treated Ballast Water 5 mg/L ClO2 Days After Treatment Sample ID BDCM a (ug/L) Bromoform a (ug/L) Chloroform a (ug/L) DBCM a (ug/L) 4HS 6 June 08 - CX <1 <1 <1 <1 1 4HS 6 June 08 - TX <1 <1 <1 <1

5HS 12 June 08 - CX <1 <1 <1 <1 0 5HS 12 June 08 - TX <1 <1 <1 <1

5HS 13 June 08 - CX <1 <1 <1 <1 1 5HS 13 June 08 - TX <1 <1 <1 <1

5HS 17 June 08 - CX <1 <1 <1 <1 Sea Water (average salinity 31.9 ±

1.3 PSUb )

5 5HS 17 June 08 - TX <1 <1 <1 <1

1LS 21 June 08 - CX <1 <1 <1 <1 1 1LS 21 June 08 - TX <1 <1 <1 <1

3LS 26 June 08 - CX <1 <1 <1 <1 0 3LS 26 June 08 - TX <1 <1 <1 <1

3LS 27 June 08 - CX <1 <1 <1 <1 1 3LS 27 June 08 - TX <1 <1 <1 <1

3LS 1 July 08 - CX <1 <1 <1 <1 Brackish

Water (average salinity 23.1 ± 0.65

PSUb )

5 3LS 1 July 08 - TX <1 <1 <1 <1 HS = High Salinity, LS = Low Salinity, CX = Control Sample, TX = Treated Sample, BDCM = bromodichloromethane, DBCM = dibromochloromethane

aAnalysis performed by McCoy & McCoy Labs, USA b Average salinity during land-based test cycles as reported by NIOZ

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### MEPC 59/2/9 ANNEX Page 17

### Table T2.8c – Chemical Analysis of Treated Ballast Water for HAAs, Land Based Testing at NIOZ
Haloacetic Acids (HAA) Treated Ballast Water 5 mg/L ClO2 Days After Treatment Sample ID DBAA a (ug/L) DCAA a (ug/L) MBAA a (ug/L) MCAA a (ug/L TCAA a (ug/L) 4HS 6 June 08 - CX <1 <1 <1 <1 <1 1 4HS 6 June 08 - TX 20 <1 3 <1 <1

5HS 12 June 08 - CX <1 <1 <1 <1 <1 0 5HS 12 June 08 - TX 23 <1 <1 <1 <1

5HS 13 June 08 - CX <1 <1 <1 <1 <1 1 5HS 13 June 08 - TX 23 <1 3 <1 <1

5HS 17 June 08 - CX <1 <1 <1 <1 <1 Sea Water (average salinity 31.9 ± 1.3 PSUb )

5 5HS 17 June 08 - TX 25 <1 2 <1 <1

1LS 21 June 08 - CX <1 <1 <1 <1 <1 1 1LS 21 June 08 - TX 36 <1 <1 <1 <1

3LS 26 June 08 - CX <1 <1 <1 <1 <1 0 3LS 26 June 08 - TX 21 <1 <1 <1 <1

3LS 27 June 08 - CX <1 <1 <1 <1 <1 1 3LS 27 June 08 - TX 21 <1 <1 <1 <1

3LS 1 July 08 - CX <1 <1 <1 <1 <1 Brackish

Water (average salinity 23.1 ± 0.65

PSUb )

5 3LS 1 July 08 - TX 12 <1 <1 <1 <1 HS = High Salinity, LS = Low Salinity, CX = Control Sample, TX = Treated Sample, DBAA = dibromoacetic acid, DCAA = dichloroacetic acid, MBAA = monobromoacetic acid, MCAA = monochloroacetic acid, TCAA = trichloroacetic acid

aAnalysis performed by McCoy & McCoy Labs, USA b Average salinity during land-based test cycles as reported by NIOZ 

### The GESAMP-BWWG commented that water quality data associated with the shipboard treated ballast water toxicity results presented in Tables T2.9 and T2.10 of the Basic approval dossier was not provided. This was inadvertently left out of the dossier and the information is provided in Table T2.8d below.

Table T2.8d – Water Quality Data from Ship Board Testing

Parameter Atlantic Compass Treatment, August 2006 a Atlantic Compass Treatment, September 2006 a Unit Salinity – control tank 21.3 24.63 ppt Salinity – treatment tank 21.5 23.96 ppt Temperature – control tank 25 20.98 °C Temperature – treatment tank 25.7 21.71 °C DO – control tank 6.9 7.41 mg/L DO – treatment tank 6.5 6.79 mg/L pH – control tank 7.46 7.6 pH pH – treatment tank 7.25 7.13 pH POC – control tank 0.158 0.108 mg-C/L POC – treatment tank 0.290 0.180 mg-C/L

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### MEPC 59/2/9 ANNEX Page 18Parameter Atlantic Compass Treatment, August 2006 a Atlantic Compass Treatment, September 2006 a Unit DOC – control tank 2.68 2.57 mg-C/L DOC – treatment tank 2.17 2.19 mg-C/L

aWater quality measurements 5 days after treatment.


### Tables T2.8e and T2.8f below provide the water quality data for the test water at intake and discharge from land based testing as reported by NIOZ.

Table T2.8e – Water Quality Data from Land Based Testing at NIOZ, Brackish (Low Salinity) Test Cycles
Average Salinity @ Intake [PSU] Average temperature @ Intake [°C] 6 Test cycles 23.1 ± 0.65 16.7 - 18.8

Parameter Intake Standard Deviation Discharge (day 5) Standard Deviation unit

O 2 reference tank 5.7-8.5 a -- 3.5-5.9 a -- mg/L

O 2 treatment tank 10.6-13.3 a -- 9.9-12.0 a -- mg/L DO saturation – reference tank 69-102 b -- 43-70 b -- % DO saturation – treatment tank 90-111 b -- 81-99 b -- % pH - reference tank 7.95 0.09 Not Measured -- pH pH-treatment tank 6.91 c-- 6.92 d -- pH TSS-reference tank 75.3 23.6 14.0 9.8 mg/L TSS-treatment tank 19.3 9.50 13.0 2.1 mg/L POC -reference tank 11.6 1.50 7.60 3.0 mg/L POC-treatment tank 9.0 3.90 6.60 1.4 mg/L DOC -reference tank 3.2 0.47 2.8 0.37 mg-C/L DOC-treatment tank 3.4 0.36 3.5 0.43 mg-C/L

“Reference tank” is the experimental “control” tank.

aRange of values; oxygen concentrations are corrected for the interference of the active substance or derivates. b Measured range of DO percent saturation.

c Measurement taken as soon as possible after treatment. dAverage of measurements throughout the 5 day holding period.


### Table T2.8f – Water Quality Data from Land Based Testing at NIOZ, Sea Water (High Salinity) Test Cycles
Average Salinity @ Intake [PSU] Average temperature @ Intake [°C] 5 Test cycles 31.9 ± 1.3 14.3 - 17.5

Parameter Intake Standard Deviation Discharge (day 5) Standard Deviation unit

O 2 reference tank 4.7-9.2 a -- 2.6-6.1 a -- mg/L

O 2 treatment tank 8.8-12.0 a -- 8.0-10.9 a -- mg/L

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### MEPC 59/2/9 ANNEX Page 19Parameter Intake Standard Deviation Discharge (day 5) Standard Deviation unit DO saturation – reference tank 59-113 b -- 33-73 b -- % DO saturation – treatment tank 76-100 b -- 69-93 b -- % pH - reference tank 8.07 0.05 Not Measured -- pH pH-treatment tank 6.81 c-- 6.89 d -- pH TSS-reference tank 33.9 37.10 9.7 3.10 mg/L TSS-treatment tank 15.6 3.6 9.6 1.3 mg/L POC -reference tank 10.2 5.3 4.8 1.3 mg/L POC-treatment tank 7.8 2.1 4.8 0.5 mg/L DOC -reference tank 4.0 1.02 3.3 0.51 mg-C/L DOC-treatment tank 4.3 0.76 4.3 0.93 mg-C/L “Reference tank” is the experimental “control” tank.

aRange of values; oxygen concentrations are corrected for the interference of the active substance or derivates. b Measured range of DO percent saturation.

c Measurement taken as soon as possible after treatment. dAverage of pH at day 5 discharge over all five test cycles.

2.1 

### DATA ON EFFECTS ON AQUATIC PLANTS, INVERTEBRATES AND FISH, AND OTHER BIOTA, INCLUDING SENSITIVE AND REPRESENTATIVE ORGANISMS (G9: 4.2.1.1) The toxicology data presented in this application varies by topic and is selective by design. To clarify, the toxicology data set required by Guideline 9 involves several categories; 1) aquatic toxicity, 2) mammalian toxicity and 3) environmental fate and effect. These categories relate to the Ecochlor process at different phases of treatment and potential exposure to the substances associated with the Ecochlor®

### BWTS is not the same for each category. As such, each toxicological category was evaluated to determine where a potential exposure existed and what chemicals were of potential concern throughout the treatment process.For example, the acute and chronic aquatic toxicity data submitted is intended to provide a reallife scenario of what chemicals may be present when treated ballast water is discharged. Because Purate ®

### and sulfuric acid are converted into chlorine-free chlorine dioxide and are not present at significant concentrations in treated ballast water, aquatic toxicity data is not provided for these chemicals. However, because treated ballast water may contain chlorine dioxide and chlorite ion (the primary by-product of disinfection with chlorine dioxide), aquatic toxicity data is provided for these chemicals. Dibromoacetic acid (DBAA) and chlorate ion have been added to the list of relevant chemicals in treated ballast water and aquatic toxicity data, when available, is presented in the tables below. Similarly, because Purate ®

### and sulfuric acid are stored onboard and a potential for human exposure (crew or technicians) exists, mammalian toxicity data is provided for these chemicals. However, because treated ballast water is not typically handled by crew or technicians, Ecochlor did not provide mammalian toxicity data on chlorite ion as this does not seem relevant. Even in a situation where human contact with treated ballast water could occur, (i.e. water sample collection) the chemicals that may be present have been determined analytically to be at concentrations that are not of concern to humans. Based on comments received by the GESAMP-BWWG and the German Administration data on chlorite ion, chlorate ion and DBAA has been added to the dossier.

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### MEPC 59/2/9 ANNEX Page 20

### Whole effluent testing of the treated ballast water includes the sum of all substances formed in the treatment process. Therefore, aquatic toxicity testing on treated ballast water discharge reflects the most accurate information on the potential toxicological effects of the treated water a ship will discharge. Toxicity testing on the precursor chemicals and/or intermediate substances is informative, but may not reflect the most realistic toxicological evaluation of treated ballast water. Toxicity tests for chlorine dioxide were performed by Nautilus Environmental and end-points are based on measured concentrations of chlorine dioxide at the start of the exposure periods. Acute toxicity tests were static and chronic tests were static renewal with a daily renewal of test solutions, with the exception of tests with Macrocystis pyrifera, Mytilus sp. and Skeletonema costatum , which were static, and the 96 hr test with Clupea pallasiin which the solution was renewed only after 48 hr of exposure. All tests were conducted according to USEPA guidelines for conducting short term acute and chronic toxicity tests (USEPA 1995, 2002), with the exception of the tests with Skeletonema costatum , which followed ASTM (1998) methodology, and tests with Clupea pallasi , which were based on methodology developed by Dr. Paul Dinnel from the Shannon Point Marine Center. Toxicity tests for chlorite were static, with the exception of 7-day tests with Mysidposis bahia and Atherinops affinis , which were static renewal with daily renewal of solutions. All tests were conducted according to USEPA guidelines for conducting short term acute and chronic toxicity tests (USEPA 1995, 2002). A summary of the toxicity testing methods is provided below.
Table T2.8g – Summary of Aquatic Toxicity Testing Methods Methods Taxonomic Groups Tested Acute Testing Methods EPA-821-R-02-012 Crustaceans (Mysids) EPA-600-R-95-136 Mollusk ( Mytilus ), Marine Algae, Echinoderm EPA FIFRA Guideline 72-3 Fish ( Cyprinodon ), Crustacean (Mysids), 96 hr acute survival, Dr. Dinnel, Shannon Point Marine Center Fish ( Clupe a) OECD 203 Fish ( Cyprinodon ) ISO 14669 Crustacean ( Acartia ) ASTM E724 Mollusk ( Crassostrea ) ISO 11348-3 Microtox ISO 10253 Algae (Phaeodactylum ) Rotox Kit M Rotifers Chronic Methods EPA-821-R-02-014 Fish (Menidia, Atherinops ), Crustacean (Mysids) 18-day Embryo Development, Dr. Dinnel, Shannon Point Marine Center Fish ( Clupea ) ASTM E1218-97a Algae (Skeletonema ) EPA FIFRA Guideline 72-3 Mollusk Development ( Crassostrea ) EPA-600-R-95-136 Mollusk Development ( Mytilus ) ASTM E724 Mollusk Development ( Crassostrea ) 

### According to Section 3.3.2.2 of the G9 Methodology (MEPC 58/2/7, Annex 4 2 

### ), “In the case of whole effluent testing, US EPA or equivalent, short term methods for estimating the acute toxicity of substances and discharge provide acceptable alternatives.”

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### MEPC 59/2/9 ANNEX Page 21

### According to Section 3.3.3.2 of the G9 Methodology (MEPC 58/2/7, Annex 4 2 

### ), “In the case of whole effluent testing, US EPA short term methods for estimating the chronic toxicity of substances and discharge provide acceptable alternatives, since the identification of the sensitive sub-lethal endpoints and vulnerable life-stages is the ultimate aim of the long-term testing.” Sections 2.1.1.6 and 2.1.2.4 along with Tables T2.9a and T2.10a below include results of whole effluent ecotoxicity testing conducted during land based testing for type approval according to IMO Guideline 8 (G8). The land based testing was successfully performed at the Royal Netherlands Institute for Sea Research (NIOZ) from April to July 2008 to demonstrate compliance with IMO Regulation D-2. Ecotoxicity testing for crustaceans, algae, mollusks, rotifers, and marine bacteria was performed by Grontmij|AquaSense in the Netherlands, and fish ecotoxicity testing was performed by Chemex Environmental International in the United Kingdom. Aquatic toxicity testing of treated ballast water discharge from the land based test set up was conducted at two different salinities (brackish and sea water) and two different time points (days 1 and 5 after treatment). These time points were selected to demonstrate that treated ballast water is safe to discharge within 24 hours of treatment (day 1) and also after the holding time of 5 days specified in G8 testing. Ecotoxicity was evaluated for six (6) different taxonomic groups (algae, crustacean, fish, rotifers, mollusks, and marine bacteria). Acute exposure testing was performed on all six taxonomic groups from brackish and sea water test cycles. The most sensitive taxonomic group identified was then tested again with day 5 treated ballast water discharge. To evaluate chronic affects, short-term exposure (sub-lethal endpoint (growth / development)) testing was also evaluated for the most sensitive taxonomic group identified from the acute testing. This approach allowed for testing on a wider range of taxonomic groups and also avoided unnecessary testing on organisms that did not show evidence of toxic effects with acute exposures. This approach for ecotoxicity testing was based on discussions and agreements between Ecochlor and the German Administration. Comments received by the GESAMP-BWWG suggested that samples be taken at day 0, 2 and 5 after treatment to demonstrate ecotoxicity at various holding times. Ecochlor would like to note that chlorine dioxide is a well-known biocide that is highly effective in water treatment systems. Because chlorine dioxide would still be present in treated ballast water at day 0 (i.e. immediately after treatment), conducting toxicity testing at this time point would more accurately reflect efficacy testing. This is due to the fact that the active substance, chlorine dioxide, is injected during ballast uptake and decays over time in the ballast tank(s). Therefore, sampling treated ballast water immediately after chlorine dioxide injection would only be expected to produce mortality of aquatic organisms. Testing a broader range of taxonomic groups at time points that represent more realistic onboard situations (days 1 and 5) demonstrates that treated water is safe to discharge within 24 hours of treatment and provides more useful information than confirming the efficacy of chlorine dioxide by toxicity testing on samples collected immediately after injection.
2.1.1 Acute Aquatic Toxicity 2.1.1.1 Chlorine Dioxide A summary of chlorine dioxide toxicity data was presented in the Basic Approval dossier (MEPC 58/2/2). The data is also summarized in Table T2.9. The GESAMP-BWWG commented that the Nautilus Environmental testing protocols with chlorine dioxide measured the effect concentrations of the active substance at the initiation of the

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### MEPC 59/2/9 ANNEX Page 22

### tests. Ecochlor accepts and understands this criticism of the test results and has applied the lower LC50 of 0.02 mg/L (juvenile Pimephales promelas ) for chlorine dioxide as suggested by the GESAMP-BWWG for the environmental risk assessment.

2.1.1.2 Chlorite Ion A summary of chlorite toxicity data was presented in the Basic Approval dossier (MEPC 58/2/2). The data is also summarized in Table T2.9. Nautilus Environmental performed a number toxicity studies on chlorite ion to evaluate this chemical in treated ballast water. Although data can be found in literature that may present lower end point results, Ecochlor contends that the data generated by Nautilus is the most appropriate to use for this assessment. Studies found in literature were often conducted long ago and there is difficulty in knowing how the chlorite solution was made for a particular study, or the exact method the study was conducted with. Therefore, Ecochlor undertook toxicity testing to ensure that the testing accurately represented this relevant chemical in treated ballast water. In any case, Ecochlor accepts the suggested use of the Mysidopsis bahia LC50 of 0.58 mg/L (Table T2.9) and the higher assessment factor of 1,000 for chlorite ion to derive a PNEC = 0.58 μg/L.

2.1.1.3 Chlorate Ion A literature search was conducted to locate chlorate aquatic toxicity data. Data for both freshwater and marine organisms is presented when available. However, no suitable published data on the effects of chlorate on marine fish or invertebrates is available 17 

### . The data indicate that algae are more sensitive to chlorate than invertebrates or fish. Further, marine brown algae are the most sensitive to chlorate. Research indicates that algal sensitivity to chlorate is related to ambient nitrate levels and the nitrate reductase enzyme system 18,19 

### . Additionally, freshwater microalgae are generally more sensitive to chlorate than marine microalgae, at high nitrate levels 19



### . 2.1.1.4 Dibromoacetic Acid (DBAA) A literature search was conducted to locate DBAA aquatic toxicity data; however, limited data was located. Four LC50 endpoints, with exposure periods of one to four days, were located for the fathead minnow (Pimephales promelas ). The lowest LC50 (69 mg/L) was obtained from the four day exposure. Data for other aquatic species was not located. 2.1.1.5 Treated Ballast Water – Shipboard Testing A summary of treated ballast water toxicity data from shipboard testing was presented in the Basic Approval dossier (MEPC 58/2/2). The data is also summarized in Table T2.9. Water quality data of the test water from shipboard testing are presented in Section 2.0.4, Table T2.8d.

17 Ambient Water Quality Guidelines for Chlorate, Government of British Columbia, Environmental Protection Division, 2002 18 van Wijk, D.J., Kroon, G.M. and Garttener-Arends, C.M., Toxicity of Chlorate and Chlorite to Selected Species of Algae, Bacter ia, and Fungi, 1998 19 Stauber, J.L., Toxicity of Chlorate to Marine Microalgae, 1998

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### MEPC 59/2/9 ANNEX Page 23

### Table T2.9 – Overview of Acute Aquatic Toxicity

Test Substance F C A Species Test Type E(L)C50 mg/L NOEC mg/L Reference/ comments
Preparations

1. Purate ® -- -- -- -- See Section 2.0.1.1 for justification of not providing data

2. Sulfuric Acid -- -- -- -- See Section 2.0.3.1 for justification of not providing data Active Substance

F Menidia beryllina 96 hr survival a(EPA-821-R02-014) >0.4 0.4 Nautilus Env. 2005 20

F Clupea pallasi 96 hr survival (Method by Dr. Dinnel, Shannon Pt. Marine Center) 0.35 0.22 Nautilus Env. 2005 20

F Pimephales promelas 96 hr survival 0.02 -- Wilde et al (1983) as reported in Nautilus Env. 2007 33

C Mysidopsis bahia 48 hr survival a(EPA-821-R02-014) ~ 0.4 0.04 b Nautilus Env. 2005 20 Chlorine Dioxide

A Macrocystis pyrifera 48 hr germination(EPA-600-R95-136) 0.20 0.14 Nautilus Env. 2006 21

Relevant Chemicals

F Cyprinidon variegatus 96 hr survival (EPA FIFRA Guideline 72- 3) 75.0 13.9 Env. Sci. Eng. 1994 22

C Mysidopsis bahia 96 hr survival (EPA FIFRA Guideline 72- 3) 0.58 NR Env. Sci. Eng. 1994 23 Chlorite Ion (Sodium chlorite)

A Macrocystis pyrifera 48 hr germination(EPA-600-R95-136) >15.4 15.4 Nautilus Env. 2008 24

20 Nautilus Environmental, Toxicological Evaluations of Chlorine Dioxide, January 2005 21 Nautilus Environmental, Algal Toxicity Testing using Chlorine Dioxide, May 2006 22 Environmental Science & Engineering, Acute Toxicity of Sodium Chlorite to the Sheepshead Minnow, 1994 23 Environmental Science & Engineering, Acute Toxicity of Sodium Chlorite to Mysid Shrimp, 1994 24 Nautilus Environmental, Supplemental Testing using Chlorite, January 2008

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### MEPC 59/2/9 ANNEX Page 24Test Substance F C A Species Test Type E(L)C50 mg/L NOEC mg/L Reference/ comments

F Oncorhynchus masou (larvae) 24 hr behavior/ survival 7,843 -- Matida et al (1976) As reported in van Wijk and Hutchinson, 1995) 25

F Oncorhynchus mykiss (juvenile) 48 hr survival 2,157 -- Environment Canada (1985) As reported in van Wijk and Hutchinson, 1995) 25

F Pimephales promelas (juvenile) 96 hr survival -- >784 Mark and Arends (1974) As reported in van Wijk and Hutchinson, 1995) 25

F Different Fresh Water Species Geometric Mean 3,815 -- van Wijk and Hutchinson, 1995 25

C Daphnia magna (juvenile) 48 hr (LC50) 1,098 -- AQUIRE (1984) As reported in van Wijk and Hutchinson, 1995) 25

C Asellus hilgendorfi (juvenile) 96 hr (LC50) 5,019 -- Matida et al (1976) As reported in van Wijk and Hutchinson, 1995) 25

C Daphnia pulex (juvenile) 3 hr survival -- >31 Nishiuchi (1982) As reported in van Wijk and Hutchinson, 1995) 25

C Different Fresh Water Species Geometric Mean 2,442 -- van Wijk and Hutchinson, 1995 25

A Phaeodactylum tricornutum 72 hr biomass 289 50 Hutchinson (1994) As reported in Stauber 1998 19 Chlorate Ion (ClO 3 - ) (Tested as sodium chlorate or potassium chlorate)

A Phaeodactylum tricornutum 72 hr growth rate 444 -- Hutchinson (1994b) As reported in van Wijk and Hutchinson, 1995) 25

25 van Wijk, D.J. and Hutchinson T.H., The Ecotoxicity of Chlorate to Aquatic Organisms: A Critical Review, 1995

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### MEPC 59/2/9 ANNEX Page 25Test Substance F C A Species Test Type E(L)C50 mg/L NOEC mg/L Reference/ comments

A Phaeodactylum tricornutum 72 hr growth rate -- 100 Hutchinson (1994b) As reported in van Wijk and Hutchinson, 1995) 25

A Fucus vesiculosus 70 hr net photosynthetic rate (EC66) 4.0 -- Rosemarin et al (1994) As reported in Ambient Water Quality Guidelines 17
A Dunaliella terticolecta 72 hr biomass >1,000 500 Stauber (1998) 19

A Nitzschia closterium 72 hr growth 1.9 -- Stauber (1998) 19

A Different Marine Macroalgae Species Geometric Mean 0.1 0.06 c van Wijk and Hutchinson, 1995 25

A Marine Mesocosms Biomass/ Growth -- 0.005 c van Wijk and Hutchinson, 1995 25
F Pimephales promelas 24 hr survival 160 -- US EPA Ecotox Database 26
F Pimephales promelas 48 hr survival 107 -- US EPA Ecotox Database 26
F Pimephales promelas 72 hr survival 81 -- US EPA Ecotox Database 26 Dibromoacetic Acid

F Pimephales promelas 96 hr survival 69 -- US EPA Ecotox Database 26 Treated Ballast Water – Shipboard Testing

C Mysidopsis bahia 48 hr survival(EPA-821-R02-012) 38.7% 25% Nautilus Env. August 2006 27

C Mysidopsis bahia 48 hr survival(EPA-821-R02-012) 37.7% 25% Nautilus Env. September

2006 28

M Mytilus galloprovencialis 48 hr survival(EPA600-R95-136) >81.3% d 81.3% d Nautilus Env. August 2006 27 5.0 mg/L dose of ClO 2

M Mytilus sp. 48 hr survival(EPA600-R95-136) >84% e84% e Nautilus Env. September

2006 28 F = Fish, C = Crustacean, M = Mollusk, A = Algae, NR = Not Reported EC50 and NOEC values for treated ballast water are presented in % (vol/vol) treated ballast water sample.

aCalculated on the basis of data from the chronic toxicity test with this species. b Reported NOEC is highly conservative because the next concentration tested was 10-times higher (see discussion in Section 2.1. 2.1).

c See discussion regarding this data in Section 5.3.6.2 d81.3% is the highest concentration tested in this Mytilus test.

e84% is the highest concentration tested in this Mytilus test. 

### 2.1.1.6 Treated Ballast Water – Land Based Testing at NIOZ Acute exposure tests were performed with fish, crustaceans, algae, mollusks, rotifers and marine bacteria. Testing was performed for all six (6) taxonomic groups during both brackish and sea

26 US EPA, ECOTOX Database, Aquatic Report for Dibromoacetic Acid, 2008 27 Nautilus Environmental, Toxicological Evaluation of Ballast Water Treated with Chlorine Dioxide, Atlantic Compass Trial, Augus t 2006 28 Nautilus Environmental, Toxicological Evaluation of Ballast Water Treated with Chlorine Dioxide, Atlantic Compass Trial, Septe mber 2006

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### MEPC 59/2/9 ANNEX Page 26

### water test cycles. However, although testing with algae at the higher salinity (sea water) was attempted multiple times, the laboratory control results did not meet quality control criteria to allow the data to be reported with confidence. Ultimately, two separate algae tests were completed successfully in brackish water. Because the G9 methodology indicates that toxicity data from freshwater OR saltwater species should be accepted, algae toxicity testing in brackish water fulfils the data requested by the methodology.

The mollusk Crassostrea gigas was the most sensitive of the six (6) taxonomic groups tested one (1) day after treatment in both brackish and sea water, with EC50 values of 38.1% and 62.3%, respectively. Acute testing results from land based discharges are summarized in Table T2.9a below. Water quality data of the test water from land based testing are presented in Section 2.0.4, Tables T2.8e and T2.8f.
Table T2.9a – Overview of Acute Aquatic Toxicity Data – Land Based Testing

Test Substance F C A Species Test Type E(L)C50 NOEC Reference/ comments Treated Ballast Water – Land Based Testing at NIOZ BRACKISH WATER (average salinity 23.1 ± 0.65 PSU a )

F Cyprinodon variegatus (Sheepshead minnow) 96 hr survival (OECD 203) >100% 100% Chemex Environmental Internt’l, 2008 29

C Acartia tonsa (copepod) 48 hr survival (ISO 14669) >100% 100% Grontmij / AquaSense, 2008 29

M Crassostrea gigas (Pacific oyster) 48 hr develop. (ASTM E724, modified) 38.1% 10% Grontmij / AquaSense, 2008 29

B Vibrio fisheri Microtox (ISO 11348- 3) 83.3% NR Grontmij / AquaSense, 2008 29

A Phaeodactylum tricornutum (diatom) 96 hr growth inhibition (ISO 10253) >100% 100% Grontmij / AquaSense, 2008 29 5.0 mg/L dose of ClO 2 - 1 day after treatment

R Brachionus plicatilis (rotifer) 24 hr survival (Rotox Kit M) >100% 100% Grontmij / AquaSense, 2008 29
SEA WATER (average salinity 31.9 ± 1.3 PSU a )

F Cyprinodon variegatus (Sheepshead minnow) 96 hr survival (OECD 203) >100% 100% Chemex Environmental Internt’l, 2008 29

C Acartia tonsa (copepod) 48 hr survival (ISO 14669) >100% 100% Grontmij / AquaSense, 2008 29 5.0 mg/L dose of ClO 2 - 1 day after treatment

M Crassostrea gigas (Pacific oyster) 48 hr develop. (ASTM E724, modified) 62.3% 18% Grontmij / AquaSense, 2008 29

29 Grontmij | Aquasense, Report of Ecotoxicological Studies, October 2008

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### MEPC 59/2/9 ANNEX Page 27B Vibrio fisheri Microtox (ISO 11348- 3) 70.9% NR Grontmij / AquaSense, 2008 29

R Brachionus plicatilis (rotifer) 24 hr survival (Rotox Kit M) >100% 100% Grontmij / AquaSense, 2008 29
F = Fish, C = Crustacean, A = Algae, M = Mollusk, B = Bacteria, R = Rotifer, NR = Not Reported EC50 and NOEC values for treated ballast water are presented in % (vol/vol) treated ballast water sample.

aAverage salinity during land-based test cycles as reported by NIOZ 

### 2.1.2 Chronic Aquatic Toxicity The GEAMP-BWWG commented (Section 8.1.2 of MEPC 58/2/8, Annex 5 4 

### ) that toxicity tests of 7-day exposures are not recognized as chronic methods. Although Ecochlor has accepted the recommendation of using a higher assessment factor of 1,000 for the environmental risk assessment as recommended by the GESAMP-BWWG, the following discussion is provided to explain the use and validity of short term exposure chronic testing methods. The primary reasons for using short term exposure (sub-lethal endpoint) testing methods is that these methods are commonly recognized by regulatory agencies as acceptable chronic methods, and the physical properties of the chemicals associated with the Ecochlor®

### BWTS indicate that they degrade rapidly. Therefore, long term exposure in the aquatic environment would not be expected. Justification is provided below. As a result of extensive studies that compared “traditional” long term (full life cycle) chronic toxicity test data with the data obtained using short term chronic testing methods, the US EPA and independent scientific experts determined that short term methods provided essentially the same data. The US EPA therefore adopted and recognizes short term chronic testing methods as standard procedures for evaluating toxicity of substances and whole effluents 30 

### . Environment Canada also considers short term testing as standard methods. For example, a  7 day survival and growth test with fathead minnow eggs and larvae is considered a standard long term test31



### . Additionally, a non-lethal endpoint test of  7 days with longer-lived crustaceans is considered a standard long term test method 31



### . Since the late 1960’s scientists have been evaluating the validity of long term chronic toxicity testing methods. From the US EPA Short Term Methods for Estimating Chronic Toxicity Manual 30 

### : “2.1.6 Macek and Sleight (1977) found that exposure of critical life stages of fish to toxicants provides estimates of chronically safe concentrations remarkably similar to those derived from full life cycle toxicity tests. They reported that "for a great majority of toxicants, the concentration which will not be acutely toxic to the most sensitive life stages is the chronically safe concentration for fish, and that the most sensitive life stages are the embryos and fry." Critical life stage exposure was considered to be exposure of the embryos during most, preferably all, of the embryogenic (incubation) period, and exposure of the fry for 30 days post-hatch for warmwater fish with embryogenic periods ranging from one-to-fourteen days, and for 60 days posthatch for fish with longer embryogenic periods. They concluded that in the majority of cases, the maximum acceptable toxicant concentration (MATC) could be estimated from the results of exposure of the embryos during incubation, and the larvae for 30 days post-hatch.

30 US EPA, Short-Term Methods for Estimating the Chronic Toxicity of Effluents and Receiving Waters to West Coast Marine and Estu arine Organisms, EPA/600/R-95-136, August 1995, (Section 2) 31 Canadian Water Quality Guidelines for the Protection of Aquatic Life, A Protocol for the Derivation of Water Quality Guideline s for the Protection of Aquatic Life 2007

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### MEPC 59/2/9 ANNEX Page 282.1.7 Because of the high cost of full life-cycle fish toxicity tests and the emerging consensus that the ELS test data usually would be adequate for estimating chronically safe concentrations, there was a rapid shift by aquatic toxicologists to 30- to 90-day ELS toxicity tests for estimating chronically safe concentrations in the late 1970s. In 1980, USEPA adopted the policy that ELS test data could be used in establishing water quality criteria if data from full life-cycle tests were not available (USEPA, 1980a). 2.1.8 Published reports of the results of ELS tests indicate that the relative sensitivity of growth and survival as endpoints may be species dependent, toxicant dependent, or both. Ward and Parrish (1980) examined the literature on ELS tests that used embryos and juveniles of the sheepshead minnow, Cyprinodon variegatus, and found that growth was not a statistically sensitive indicator of toxicity in 16 of 18 tests. They suggested that the ELS tests be shortened to 14 days posthatch and that growth be eliminated as an indicator of toxic effects. 2.1.9 In a review of the literature on 173 fish full life-cycle and ELS tests performed to determine the chronically safe concentrations of a wide variety of toxicants, such as metals, pesticides, organics, inorganics, detergents, and complex effluents, Woltering (1984) found that at the lowest effect concentration, significant reductions were observed in fry survival in 57%, fry growth in 36%, and egg hatchability in 19% of the tests. He also found that fry survival and growth were very often equally sensitive, and concluded that the growth response could be deleted from routine application of the ELS tests. The net result would be a significant reduction in the duration and cost of screening tests with no appreciable impact on estimating MATCs for chemical hazard assessments. Benoit et al. (1982), however, found larval growth to be the mostsignificant measure of effect and survival to be equally or less sensitive than growth in early lifestage tests with four organic chemicals. 2.1.10 Efforts to further reduce the length of partial lifecycle toxicity tests for fish withoutcompromising their predictive value have resulted in the development of an eight-day, embryolarval survival and teratogenicity test for fish and other aquatic vertebrates (USEPA, 1981; Birge et al.,1985), and a seven-day larval survival and growth test (Norberg and Mount, 1985). 2.1.11 The similarity of estimates of chronically safe concentrations of toxicants derived from short-term, embryo-larval survival and teratogenicity tests to those derived from full life-cycle tests has been demonstrated by Birge et al. (1981), Birge and Cassidy (1983), and Birge et al. (1985). 2.1.12 Use of a seven-day, fathead minnow, Pimephales promelas, larval survival and growth test was first proposed by Norberg and Mount at the 1983 annual meeting of the Society for Environmental Toxicology and Chemistry (Norberg and Mount, 1983). This test was subsequently used by Mount and associates in field demonstrations at Lima, Ohio (USEPA, 1984), and at many other locations (USEPA, 1985c, USEPA, 1985d; USEPA, 1985e; USEPA, 1986a; USEPA, 1986b; USEPA, 1986c; USEPA, 1986d). Growth was frequently found to be more sensitive than survival in determining the effects of complex effluents. 2.1.13 Norberg and Mount (1985) performed three single toxicant fathead minnow larval growth tests with zinc, copper, and DURSBAN®, using dilution water from Lake Superior. The results were comparable to, and had confidence intervals that overlapped with, chronic values reported in the literature for both ELS and full life-cycle tests. 2.1.14 USEPA (1987b) and USEPA (1987c) adapted the fathead minnow larval growth and survival test for use with the sheepshead minnow and the inland silverside, respectively. When daily renewal 7-day sheepshead minnow larval growth and survival tests and 28-day ELS tests were performed with industrial and municipal effluents, growth was more sensitive than survival in seven out of 12 larval growth and survival tests, equally sensitive in four tests, and less sensitive in only one test. In four cases, the ELS test may have been three to 10 times more

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### MEPC 59/2/9 ANNEX Page 29sensitive to effluents than the larval growth and survival test. In tests using copper, the No Observable Effect Concentrations (NOECs) were the same for both types of test, and growth was themost sensitive endpoint for both. In a four laboratory comparison, six of seven tests produced identical NOECs for survival and growth (USEPA, 1987a). Data indicate that the inland silverside is at least equally sensitive or more sensitive to effluents and single compounds than the sheepshead minnow, and can be tested over a wider salinity range, 5-30‰ (USEPA, 1987a). 2.1.15 Lussier et al. (1985) and USEPA (1987e) determined that survival and growth are often as sensitive as reproduction in 28-day life-cycle tests with the mysid, Mysidopsis bahia. ” 

### The toxicity testing results presented in this and the Basic Approval dossier were performed in accordance with the short term chronic toxicity testing methods considered standard in the US, which are also recognized internationally. Section 3.3.3.2 of the G9 Methodology also indicatesthat short-term chronic testing methods are acceptable because identifying the sensitive sublethal endpoints and vulnerable life stages is the goal of long-term exposure testing. As such, and in accordance with widely accepted testing guidelines, US EPA short term chronic testing methods were used during testing with these chemicals as well as treated ballast water discharge. This is the basis for including and evaluating 7-day toxicity tests under the chronic test data section of the dossier. In regard to the chemical properties, it is important to note that long term exposure chronic toxicity testing for both chlorine dioxide and chlorite ion is not the most practical approach due to the rapid degradation of these chemicals. According to the OECD “...the instability of these chemicals suggests that it would not be relevant to perform chronic experiments.” 10 

### Subjecting test organisms to 14, 21 or 28-day test protocols would not reflect realistic exposure times because chlorine dioxide and chlorite ion would not persist in the environment for these durations.

2.1.2.1 Chlorine Dioxide A summary of chlorine dioxide toxicity data was presented in the Basic Approval dossier (MEPC 58/2/2). The data is also summarized in Table T2.10.

2.1.2.2 Chlorite Ion A summary of chlorite toxicity data was presented in the Basic Approval dossier (MEPC 58/2/2). The data is also summarized in Table T2.10. Nautilus Environmental performed a number toxicity studies on chlorite ion to evaluate this chemical in treated ballast water. Although data can be found in literature that may present lower end point results, Ecochlor contends that the data generated by Nautilus is the most appropriate to use for this assessment. Studies found in literature were often conducted long ago and there is difficulty in knowing how the chlorite solution was made for a particular study, or the exact method the study was conducted with. Therefore, Ecochlor undertook toxicity testing to ensure that the testing accurately represented this relevant chemical in treated ballast water. In any case, Ecochlor accepts the suggested use of the Mysidopsis bahia LC50 of 0.58 mg/L (Table T2.9) and the higher assessment factor of 1,000 for chlorite ion to derive a PNEC = 0.58 μg/L. 2.1.2.3 Treated Ballast Water – Shipboard Testing A summary of treated ballast water toxicity data from shipboard testing was presented in the Basic Approval dossier (MEPC 58/2/2). The data is also summarized in Table T2.10.

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### MEPC 59/2/9 ANNEX Page 30

### Water quality data of the test water from shipboard testing are presented in Section 2.0.4, Table T2.8d. Table T2.10 – Overview of Chronic Aquatic Toxicity

Test Substance F C A M Species Test Type EC50 mg/L NOEC mg/L Reference/ comments
Preparations

1. Purate ® -- -- -- -- See Section 2.0.1.1 for justification of not providing data

2. Sulfuric Acid -- -- -- -- See Section 2.0.3.1 for justification of not providing data Active Substance

F Menidia beryllina 7 day surv/growth(EPA-821-R02-014) >0.4 0.4 Nautilus Env. 2005 20

F Clupea pallasi 18 day embryo devpt (Method by Dr. Dinnel, Shannon Pt. Marine Center) >0.33 0.33 Nautilus Env. 2005 20

C Mysidopsis bahia 7 day surv/growth(EPA-821-R02-014) ~ 0.4 0.04 a Nautilus Env. 2005 20

A Macrocystis pyrifera 48 hr germination(EPA-600-R95-136) 0.20 0.14 Nautilus Env. 2006 21

D Skeletonema costatum 96 hr growth (ASTM E1218-97a) 3.09 2.09 Nautilus Env. 2006 21 Chlorine Dioxide

M Mytilus edulis Development(EPA-600-R95-136) 0.22 0.09 Nautilus Env. 2005 20
Relevant Chemicals Sulfate Ion/ Sulfuric Acid -- -- -- -- See Section 2.0.3.1 for justification of not providing data

F Atherinops affinis 7 day surv/growth(EPA-821-R02-014) >13.8 6.9 Nautilus Env. 2008 24

C Mysidopsis bahia 7 day surv/growth(EPA-821-R02-014) 0.26 0.18 Nautilus Env. 2008 24 Chlorite Ion (Sodium chlorite)

A Macrocystis pyrifera 48 hr germination(EPA-600-R95-136) >15.4 15.4 Nautilus Env. 2008 24

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### MEPC 59/2/9 ANNEX Page 31Test Substance F C A M Species Test Type EC50 mg/L NOEC mg/L Reference/ comments

E Strongylocentrotus purpuratus 48 hr germination(EPA-600-R95-136) 10.4 5.0 Nautilus Env. 2008 24

M Crassostrea virginica Development (EPA FIFRA Guideline 72- 3) 21.4 14.3 Env. Sci. Eng. 1994 32

F Oncorhynchus mykiss 56 days -- 48 Matida et al (1975) As reported in Ambient Water Quality Guidelines 17

C Dasycorixa hybrida 10 days -- 100 Dosdall et. al. (1997) As reported in Ambient Water Quality Guidelines 17

C Isoperla transmarina 10 days -- 100 Dosdall et. al. (1997) As reported in Ambient Water Quality Guidelines 17 Fehler!
Textmarke nicht definiert.
A Zostera marina 6 month growth -- >0.29 Rosemarin et al (1994) 41
A Fucus serratus 1 month frond growth 0.13 -- Rosemarin et al (1994) 41
A Fucus vesiculosus 6 month growth -- 0.005 b van Wijk and Hutchinson, 1995 25 Chlorate Ion (ClO 3 - ) (Tested as sodium chlorate or potassium chlorate)

A Fucus vesiculosus 6 month growth 0.08 b -- Rosemarin et al (1994) 41
Dibromoacetic acid No Chronic Aquatic Studies Located for DBAA -- -- -- -- Treated Ballast Water – Shipboard Testing

M Mytilus galloprovincialis Development(EPA-600-R95-136) >81.3 % c 81.3% c Nautilus Env. August 2006 27

M Mytilus sp. Development(EPA-600-R95-136) >84% d 50% Nautilus Env. September 2006 28

C Mysidopsis bahia 48 hr survival(EPA-821-R02-012) -- 12% eNautilus Env. 2007 33 5.0 mg/L dose of ClO 2

C Mysidopsis bahia 48 hr survival(EPA-821-R02-012) -- 11.7% eNautilus Env. 2007 33

F = Fish, C = Crustacean, A = Algae, D = Diatom, M = Mollusk, E = Echinoderm, NR = Not Reported EC50 and NOEC values for treated ballast water are presented in % (vol/vol) treated ballast water sample.

aReported NOEC is highly conservative because the next concentration tested was 10-times higher (see discussion in Section 2.1. 2.1). b See discussion regarding this data in Section 5.3.6.2

c 81.3% is the highest concentration tested in this Mytilus test. d84% is the highest concentration tested in this Mytilus test.

eChronic NOEC calculated using acute-to-chronic ratio of 3.22.

32 Environmental Science & Engineering, Effect of Sodium Chlorite on New Shell Growth in Eastern Oyster ( Crassostrea virginica ), 1994

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### 2.1.2.4 Treated Ballast Water – Land Based Testing at NIOZ Short term exposure (sub-lethal endpoint (growth / development)) testing was evaluated only for the most sensitive taxonomic group identified from the acute testing. This approach allowed for testing on a wider range of six taxonomic groups and also avoided unnecessary testing on organisms that did not show evidence of toxic effects with acute exposures. This approach for ecotoxicity testing was based on discussions and agreements between Ecochlor and the German Administration. During the land based test set up samples of treated ballast water discharge were collected one (1) day (approx. 24 hours) and five (5) days after treatment and evaluated for chronic (short term exposure) aquatic toxicity. From the acute testing series, Crassostrea gigas was identified as the most sensitive taxonomic group and additional tests were performed with this species. Although the Crassostrea gigastesting method uses a short-term exposure, the test evaluates a chronic sublethal end point (development). As such, this test was determined by Grontmij|AquaSense to be the appropriate method to evaluate chronic effects with this species and is consistent with Section 3.3.3.2 of the G9 Methodology. Crassostrea gigas tested with discharge one (1) day after treatment resulted in EC50 values of 43.3% and 50.4% in brackish and sea water, respectively. Testing on day 5 samples with Crassostrea gigas resulted in EC50 values of 36.3% and 73.6% in brackish and sea water, respectively.

One additional test with Phaeodactylum tricornutum was also performed with day 1 brackish water discharge. This test resulted in an EC50 of 75.8%. Poor growth performances of the laboratory controls during algae testing in sea water caused the tests to be invalid, so although testing was performed multiple times, the controls did not meet the criteria to be reported with confidence. Chronic sub-lethal endpoint testing results are summarized in Table T2.10a below. Water quality data of the test water from land based testing are presented in Section 2.0.4, Tables T2.8e and T2.8f.

Table T2.10a – Overview of Chronic (Sub-lethal) Aquatic Toxicity – Land Based Testing

Test Substance F C A Species Test Type E(L)C50 NOEC Reference/ comments Treated Ballast Water – Land Based Testing at NIOZ BRACKISH WATER (average salinity 23.1 ± 0.65 PSU a )

M Crassostrea gigas (Pacific oyster) 48 hr develop. (ASTM E724,

modified) 43.3% 18% Grontmij / AquaSense, 2008 5.0 mg/L dose of ClO 2 - 1 day after treatment A Phaeodactylum tricornutum (diatom) 96 hr growth inhibition (ISO 10253) 75.8% 32% Grontmij / AquaSense, 2008 5.0 mg/L dose of ClO 2 - 5 days after treatment M Crassostrea gigas (Pacific oyster) 48 hr develop. (ASTM E724,

modified) 36.3% 18% Grontmij / AquaSense, 2008
SEA WATER (average salinity 31.9 ± 1.3 PSU a ) 5.0 mg/L dose of ClO 2 - 1 day after treatment M Crassostrea gigas (Pacific oyster) 48 hr develop. (ASTM E724,

modified) 50.4% 32% Grontmij / AquaSense, 2008

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### MEPC 59/2/9 ANNEX Page 335.0 mg/L dose of ClO 2 - 5 days after treatment M Crassostrea gigas (Pacific oyster) 48 hr develop. (ASTM E724,

modified) 73.6% 56% Grontmij / AquaSense, 2008 A = Algae, M = Mollusk EC50 and NOEC values for treated ballast water are presented in % (vol/vol) treated ballast water sample.

aAverage salinity during land-based test cycles as reported by NIOZ 

### 2.1.3 Endocrine Disruption There is no evidence to suggest that Purate ®

### or sulfuric acid would result in endocrine disruption. There is no evidence to suggest that chlorine dioxide or chlorite would result in endocrine disruption 33



### . Sodium chlorate is not known to be an endocrine disrupter 34


### , No data on specific endocrine disruption studies for DBAA were located. However, a reproductive study using daily gavage doses of 10 mg/kg of body weight per day for 79 days showed altered spermiation in male rats 14



### . 2.1.4 Sediment Toxicity 2.1.4.1 Preparations Information was provided in the Basic Approval dossier (MEPC 58/2/2).

2.1.4.2 Active Substance Information was provided in the Basic Approval dossier (MEPC 58/2/2).

2.1.4.3 Relevant Chemicals Information for sulfuric acid and chlorite ion was provided in the Basic Approval dossier (MEPC 58/2/2). Sodium chlorate is discussed above in Section 2.1.4.1, Preparations. DBAA is “very soluble” 14 

### and has a log Kow

### < 3. These chemical properties indicate that DBAA will not adsorb to sediments.

2.1.4.4 Treated Ballast Water The potential substances present in treated ballast water at the time of discharge are chlorine dioxide, chlorite ion, chlorate ion, and DBAA. The capability of these constituents to accumulate in sediments is discussed above. 2.1.5 Bioavailability/Biomagnification/Bioconcentration and Food Web/Population Effects The active substance (chlorine dioxide) and relevant chemicals (chlorite ion, chlorate ion, DBAA) are the constituents potentially present in treated ballast water that will be discharged to the environment. All substances are highly water soluble and are not organic in nature. Neither chlorine dioxide or chlorite ion would be expected to exhibit biomagnification or bioconcentration, and consequently, would not be expected to persist in the food web 33 

### . Sodium chlorate has a low potential to bioaccumulate 15 

### . DBAA is not lipophilic at physiological pH and has a low potential to accumulate in fat 14



### . 2.2 DATA ON MAMMALIAN TOXICITY (G9: 4.2.1.2) Most information provided in this section has not changed from the Basic Approval dossier and is not presented again. However, based on comments received from the GESAMP-BWWG regarding chlorite ion, as well as new analytical chemistry data from land based testing, the data

33 Review of the Environmental Fate and Effects of Chlorine Dioxide and Chlorite, Nautilus Environmental, 2007. 34 European Union, The Footprint Pesticide Properties Database (www.eu-footprint.org/ppdb.html)

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### tables in this section were revised to include information on chlorite ion and DBAA to supplement the evaluation. There are very limited data available on the toxicity of brominated acetic acids 35 

### . Specific data was not always located for DBAA, but data for brominated acetic acids as a group is provided when available. All data tables are contained within the complete confidential dossier for Final Approval. 2.2.1 Acute Mammalian Toxicity Data table was presented in the Basic Approval dossier (MEPC 58/2/2) and is included in the complete confidential dossier for Final Approval. 2.2.2 Effects on Skin and Eye Data table was presented in the Basic Approval dossier (MEPC 58/2/2) and is included in the complete confidential dossier for Final Approval. 2.2.3 Repeated-dose Toxicity Data table was presented in the Basic Approval dossier (MEPC 58/2/2) and is included in the complete confidential dossier for Final Approval. 2.2.4 Chronic Toxicity Data table was presented in the Basic Approval dossier (MEPC 58/2/2) and is included in the complete confidential dossier for Final Approval. 2.2.5 Developmental and Reproductive Toxicity Information for sodium chlorate, hydrogen peroxide, sulfuric acid and chlorine dioxide was provided in the Basic Approval dossier (MEPC 58/2/2). A developmental study with rabbits concluded that sodium chlorite in drinking water was not considered teratogenic or a developmental toxicant 10



### . DBAA was administered via gavage to male rats for 14 daily doses at 0, 10, 30, 90, or 270 mg/kg of body weight per day. The LOAEL for this study was the lowest dose tested, 10 mg/kg of body weight per day 14 

### . DBAA did not exhibit teratogenic potential in the frog embryo ( Xenopus ) assay 14



### . 2.2.6 Carcinogenicity Information for sodium chlorate, hydrogen peroxide, sulfuric acid and chlorine dioxide was provided in the Basic Approval dossier (MEPC 58/2/2). A carcinogenicity study of sodium chlorite in drinking water with mice concluded that sodium chlorite had no carcinogenic potential 10



### . Two-year drinking water studies for carcinogenicity with male and female rats indicate some evidence of carcinogenic activity for DBAA 42



### . 2.2.7 Mutagenicity/Genotoxicity Information for sodium chlorate, hydrogen peroxide, sulfuric acid and chlorine dioxide was provided in the Basic Approval dossier (MEPC 58/2/2).

35 International Programme on Chemical Safety, Environmental Health Criteria 216, World Health Organization, 2000 42 NTP Technical Report on the Toxicology and Carcinogenesis of Dibromoacetic Acid, April 2007

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### Negative in vivo tests with sodium chlorite indicate a low potential for genotoxicity. There were no reliable in vitro mutagenicity tests for sodium chlorite 10



### . In the Ames fluctuation test with S. typhimurium tester strain TA100 DBAA was mutagenic, with and without metabolic activation, but not in S. typhimurium tester strain TA98 14 

### . In the SOS chromotest, DBAA induced DNA repair, with and without metabolic activation, but the number of erythrocyctes with micronuclei in the newt micronucleus test were not increased 14



### . 2.2.8 Toxicokinetics Information for sodium chlorate, hydrogen peroxide, sulfuric acid, chlorine dioxide and chlorite was provided in the Basic Approval dossier (MEPC 58/2/2). In a gavage study with rats, the concentration of DBAA in blood peaked within 1 hour after dosing, suggesting rapid intestinal absorption 14 

### . Further, the metabolites of DBAA appear to be rapidly excreted; however, the urine and fecal excreted contributed minimally to the overall blood clearance of DBAA. This finding suggested that biotransformation was responsible for the rapid disappearance of DBAA from blood 14



### . 2.3 DATA ON ENVIRONMENTAL FATE AND EFFECT UNDER AEROBIC AND ANAEROBIC CONDITIONS (G9: 4.2.1.3) The active substance (chlorine dioxide) and relevant chemicals (chlorite ion, chlorate ion, DBAA) are the constituents potentially present at environmentally relevant concentrations in treated ballast water that may be discharged to the environment. Therefore, environmental fate is evaluated for these substances only.
2.3.1 Modes of Degradation (Biotic, Abiotic) Information for chlorine dioxide and chlorite ion was provided in the Basic Approval dossier (MEPC 58/2/2). Because sodium chlorate is an inorganic substance, it cannot be defined as biodegradable on the basis of mineralization of organic matter 15 

### . However, within anaerobic niches in the soil, biotic degradation occurred where anaerobic biodegradation occurred via non-obligate anaerobes which mineralize chlorate to chloride generally using the same pathway as for nitrate reduction 15 

### . In a water-sediment system the DT50s under anaerobic- and aerobic conditions were 8 days in water and less than 3 days in sediment 15 

### . In the water column, extensive redox reactions are expected to occur in the environment that will reduce the concentration of chlorate 36



### . Haloacetic acids such as (MCAA) monochlororoacetic acid, (DCAA) dichloroacetic acid, (TCAA) trichloroacetic acid, MBAA (monobromoacetic acid) and DBAA (dibromoacetic acid) have been reported to be decomposed by bacterial enzymes called haloacid dehydrogenases 37 

### . In a study of the degradation of haloacetic acids in seawater using mercury chloride to inhibit microbial activity, all of the haloacetic acids nearly disappeared within 9 days holding time, with the exception of TCAA 37 

### . The authors also concluded that brominated acetic acids are better substrates for the bacterial haloacid dehydrogenases than the chloroacetic acids 37 

### . This study indicates that “... degradation patterns of haloacetic acids with and without HgCl2 suggest that, with the exception of TCAA, about one half of the observed decomposition over the 9-d incubations was due to microbial activity 37 

### . Photolytic degradation of DBAA, particularly in the presence of a photocatalyst (titanium dioxide) is also an effective mode of degradation 38



### .

36 US EPA Reregistration Eligibility Decision (RED) for Inorganic Chlorates, Case #4049, July 2006 37 Hashimoto, S., Azuma, T., Otsuki, A., Distribution, Sources and Stability of Haloacetic Acids in Tokyo Bay, Japan, 1998 38 Lifongo, L., Bowden, D., Brimblecombe, P., Photodegradation of haloacetic acids in water, 2004
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### 2.3.2 Bioaccumulation, Partition Coefficient, Octanol/Water Partition Coefficient Information for chlorine dioxide and chlorite ion was provided in the Basic Approval dossier (MEPC 58/2/2). Sodium chlorate has a low log n-octanol/water partition coefficient and high water solubility, which indicate that sodium chlorate has low potential to bioaccumulate 36



### . DBAA has a low log n-octanol/water partition coefficient and high water solubility, which indicate that sodium chlorate has low potential to bioaccumulate 14



### . 2.3.3 Reaction with Organic Matter Information for chlorine dioxide and chlorite ion was provided in the Basic Approval dossier (MEPC 58/2/2). In the environment, chlorate can undergo reduction reactions with organic matter and “...the thermodynamically favored, end reduction product of chlorate in soil and in water is the chloride anion.” 39


### Brominated acetic acids such as DBAA are formed when bromide ion and organic matter is present during water disinfection processes 14 

### . Continued reaction of DBAA with organic matter is not expected.
2.3.4 Potential Physical Effects on Wildlife and Benthic Habitats The chemical and physical properties of the preparation chemicals, active substance, and relevant chemicals (Table T2-15) indicate that physical effects on wildlife and benthic habitats as described and rated in GESAMP Reports and Studies No. 64 would not be expected to occur. Also see Section 2.1.4.

2.3.5 Potential Residues in Seafood No potential for residues in seafood are known or anticipated for the chemicals associated with the Ecochlor ®

### Ballast Water Treatment System.
2.3.6 Any Known Interactive Effects There are no other known or expected interactive effects related to the chemicals associated with the Ecochlor ®

### Ballast Water Treatment System.
2.4 PHYSICAL AND CHEMICAL PROPERTIES FOR THE PREPARATIONS, ACTIVE SUBSTANCE, AND TREATED BALLAST WATER (G9: 4.2.1.4) Data table was provided in the Basic Approval dossier (MEPC 58/2/2) and is also included in the complete confidential Final Approval dossier.

2.5 ANALYTICAL METHODS AT ENVIRONMENTALLY RELEVANT CONCENTRATIONS (G9: 4.2.1.5) Information was provided in the Basic Approval dossier (MEPC 58/2/2) and is also included in the complete confidential Final Approval dossier.
2.6 QUALITY CONTROL/QUALITY ASSURANCE (G9: 4.2.4) 2.6.1 Chemical Quality Control Information was provided in the Basic Approval dossier (MEPC 58/2/2) and is also included in the complete confidential Final Approval dossier.

39 US EPA Memorandum, Revised Inorganic Chlorates, HED Chapter of the Reregistration Eligibility Decision (RED) Case #4049, Janu ary 2006

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### 2.6.2 Test Data Quality Control Information was provided in the Basic Approval dossier (MEPC 58/2/2) and is also included in the complete confidential Final Approval dossier.

3.0 USE OF THE ACTIVE SUBSTANCE 3.0.1 Manner of Application (G9: 4.2.6) A detailed description of the application of chlorine-free chlorine dioxide to treat ballast water was included in the Basic Approval dossier (MEPC 58/2/2). The description has been modified only by the addition of the following:

The Ecochlor ® 

### BWTS uses a two-step treatment process. The first step is pre-treatment filtration with a 40 micron steel mesh filter. The second step is injection of chlorine-free chlorine dioxide into the incoming ballast water stream.
3.0.2 Operational Overview & Process Description Incoming ballast water is pumped onboard as usual (through the sea chest/sea filter) via the ballast water pumps. Ballast water then passes through the pre-filtration step of Ecochlor’s treatment process. Immediately after the pre-filtration step, the Ecochlor®

### BWTS injects chlorine-free chlorine dioxide into the incoming ballast water as it is piped to the ballast tanks. See Figure F3.2 for a process flow overview.

The Ecochlor ®

### BWTS chlorine dioxide generation module consists of two self-contained chemical storage modules, two separate precursor chemical pumps, a chlorine dioxide generation module (housing for the reactor column), a booster pump, a programmable logic controller (PLC), an operator interface terminal (OIT), a system status/start-up panel, and piping to inject chlorine dioxide solution into the ballast water line. Ancillary equipment includes pipelines for chemical vents and re-supply, and in-line sampling valves. For demonstration, engineered drawings of a full scale Ecochlor®

### BWTS and the BallastSafeTM filter unit are included in Appendix D. Figure F3.1 provides a photograph of the Ecochlor ®

### BWTS, Figure F3.1a is a photo of the BallastSafeTM filter unit, and Figures F3.2 and F3.2a outline the Ecochlor®

### BWTS process.

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### Figure F3.1 – Photo of Full Scale Ecochlor ®

### BWTS

Figure F3.1a – Photo of Filtration Unit

Figure F3.2 – Ecochlor ®

### BWTS Process Flow Diagram



### BW Tank(s Sea Chest Sea Filter BW Pump Pretreatment Filtration 

### Cl0 2 

### Generation System ( See Figure F3.2a 

### )

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### Figure F3.2a – Ecochlor Chlorine Dioxide Generation Process

Supply Water

Mixing Chamber ClO 2 solution to ballast line

Purate Sulfuric Acid ClO 2 is mixed in supply water

Venturi ClO 2 Sensor

PLC FT

PT

FT = Flow Transmitter, PT = Pressure Transmitter, PLC = Programmable Logic Controller 

### A detailed discussion of the chlorine dioxide generation process and treatment parameters was presented in the Basic Approval dossier (MEPC 58/2/2).
3.0.3 System Monitoring & Control, Crew Interaction Detailed information was provided in the Basic Approval dossier (MEPC 58/2/2).
3.0.4 System Requirements Detailed information was provided in the Basic Approval dossier (MEPC 58/2/2).
3.0.5 System Locations, Considerations and Limitations Detailed information was provided in the Basic Approval dossier (MEPC 58/2/2).
3.0.6 BWTS Operational Safety Features and Alarms Detailed information was provided in the Basic Approval dossier (MEPC 58/2/2).
3.0.7 Precursor Chemical Storage, Handling and Delivery Ecochlor’s team has accumulated over 100 years of industrial and municipal experience in storing, feeding and re-supplying these and many other chemicals. This experience is utilized in the design, fabrication and installation of the Ecochlor®

### BWTS. Ecochlor also utilizes a team of naval architects and marine engineers from Seaworthy Systems, Inc. to assist with the specifics of shipboard installation and environments. 3.0.7.1 Chemical Storage Detailed information was provided in the Basic Approval dossier (MEPC 58/2/2). Additional clarification based on GESAMP-BWWG comments is provided below. The use of the terms “secondary containment” to describe additional measures to ensure protection to the ship in the unlikely event of a chemical leak is equivalent to the terminology “save-all protection” used by the GESAMP-BWWG. This is an engineered aspect of the BWTS to ensure safe installation. Preparing for BWTS installation onboard a ship requires detailed reviews by Ecochlor’s marine engineers, the vessel engineers, as well as the ship’s classification

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### society. Additional mitigation measures that may be identified for safe BWTS installation on a specific ship during these reviews will be implemented as needed. 3.0.7.2 Chemical Handling Detailed information was provided in the Basic Approval dossier (MEPC 58/2/2). 3.0.7.3 Chemical Delivery Detailed information was provided in the Basic Approval dossier (MEPC 58/2/2).
3.0.8 Various Procedures and Management Measures 3.0.8.1 Fire Detailed information was provided in the Basic Approval dossier (MEPC 58/2/2). Additional clarification based on GESAMP-BWWG comments is provided below. 3.0.8.1.1 Additional Clarification on Fire Mitigation Measures The GESAMP-BWWG provided comments regarding the different fire fighting materials used for Purate ®

### and sulfuric acid. Ecochlor agrees that this is a critical aspect for safe installation of the BWTS. There are two potential scenarios related to the chemicals and fire risk. These are: 1) a fire on the ship that is non-related to the BWTS, but within proximity of the system, or 2) a fire directly involving the chemicals. In an onboard fire situation that is not related to the BWTS or the stored chemicals, but may be within proximity to the chemicals, the primary risk would be that the chemicals could become heated inside the storage tanks. The chemical properties of each substance (non-flammable) as well as the mitigation measures that are engineered into the BWTS to ensure proper chemical storage and ventilation (Sections 3.0.8.1, 6.1.3.1, 6.1.4, and 6.1.5) greatly reduce a chemical fire starting from such a situation onboard. Additionally, although the fire fighting mediums for sulfuric acid and Purate ®

### are different, water can be used on the exterior of both chemical tanks (but not allowed to enter the tanks) to keep the storage tanks cool in the event of a fire situation that may cause the tanks to become heated. This is a practical fire mitigation measure should such a situation arise onboard. Because both chemicals are non-flammable and Ecochlor ensures proper chemical storage, the likelihood of sulfuric acid or Purate ®

### being the direct cause of a fire onboard is extremely low. For sulfuric acid to directly cause a fire would require a combination of a substantial chemical leak and contact with an incompatible, combustible material. For Purate ®

### to directly cause a fire would require the combination of a chemical leak, contact with an incompatible material, plus the addition of a heat and/or ignition source. Therefore, mitigating the risk of chemical fire is directly related to proper chemical storage and avoiding chemical contact with combustible materials. The general mitigation measures outlined in Sections 6.1.3, 6.1.4 and 6.1.5 to prevent chemical spills from contacting incompatible materials include:

 Proper training for both BWTS technicians and ship’s crew;

 Proper system engineering;

 Proper location of the BWTS onboard;

 Use of appropriate chemical storage tanks, piping and construction materials for all aspects of the BWTS;

 Use of chemical secondary containment (i.e. “save-all protection”);

 Proper chemical tank ventilation;

 Chemical storage tank temperature control devices, if necessary;

 Storage of incompatible/combustible materials away from the BWTS;

 Availability of chemical spill containment materials should they be needed; and

 Regular system inspection and maintenance.

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### Additionally, ships typically have both water and CO 2 

### (or other chemical fire suppressants) readily available and installed onboard for fire fighting. Considering the mitigation measures incorporated into the design of the BWTS and the typical fire fighting equipment onboard together with the low potential for the chemicals to be involved in a fire, the risk of fire related to the BWTS chemicals is almost non-existent. The mitigation measures above are general measures used to ensure safe installation of the BWTS. Preparing for BWTS installation onboard a ship requires detailed reviews by Ecochlor’s marine engineers, the vessel engineers, as well as the ship’s classification society. Additional mitigation measures that may be identified for safe BWTS installation on a specific ship during these reviews will be implemented as needed.

3.0.8.2 Accidental Release Measures Detailed information was provided in the Basic Approval dossier (MEPC 58/2/2).

3.0.8.3 Marine Environment Release Detailed information was provided in the Basic Approval dossier (MEPC 58/2/2). 3.0.8.4 Active Substance Waste Management, Reuse, Recycling, Neutralization Detailed information was provided in the Basic Approval dossier (MEPC 58/2/2). 3.0.8.5 Conditions for Controlled Discharge Detailed information was provided in the Basic Approval dossier (MEPC 58/2/2). 3.0.10 Evaluation of Management Measures Information was provided in the Basic Approval dossier (MEPC 58/2/2) and is also included in the complete confidential Final Approval dossier.
4.0 HAZARD CLASSIFICATION & MATERIAL SAFETY DATA SHEETS (G9: 4.2.7) The hazard classifications presented reflect hazards only and do not consider actual potential for exposure.
4.0.1 Purate ® 

### Information was provided in the Basic Approval dossier (MEPC 58/2/2).

4.0.2 Sulfuric Acid Information not changed from that provided in Basic Approval dossier (MEPC 58/2/2).

4.0.3 Chlorine Dioxide Information was provided in the Basic Approval dossier (MEPC 58/2/2).
4.0.4 Sodium Chlorite (Chlorite ion) Information was provided in the Basic Approval dossier (MEPC 58/2/2).

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### 4.0.5 Sodium Chlorate (Chlorate ion) Utilizing a typical MSDS sheet for sodium chlorate solution for hazard classification does not accurately represent the potential hazards at the concentration of chlorate ion that may be present in treated ballast water. Thus, hazard classification is not provided for chlorate ion, but toxicology data is presented in this application.
4.0.6 Dibromoacetic Acid (DBAA) Utilizing a typical MSDS sheet for dibromoacetic acid for hazard classification does not accurately represent the potential hazards at the low concentration of DBAA that may be present in treated ballast water. Thus, hazard classification is not provided for DBAA, but toxicology data is presented in this application.

5.0 RISK CHARACTERIZATION
5.1 SCREENING FOR PERSISTENCE, BIOACCUMULATION, & TOXICITY (G9: 5.1) The chemicals that may be present in treated ballast water discharge 24 hours after treatment include the active substance (chlorine dioxide) and three relevant chemicals (chlorite ion, chlorate ion and DBAA). These constituents are evaluated below for persistence, bioaccumulation and toxicity.
5.1.1 Persistence (G9: 5.1.1.1) Chlorine dioxide, chlorite ion, and chlorate ion demand/decay data presented in Section 2.0 demonstrate that these constituents do not persist for extended periods of time in water, and undergo rapid degradation. These findings are supported by the physical and chemical properties (i.e. high solubility, non-organic) associated with these substances as well as studies conducted by others. For chlorine dioxide, Cooper et al. (2007) demonstrated that chlorine dioxide degradation is photochemically-enhanced 33 

### . Fisher and Burton (1993) reported that at 25°C, 60% of chlorine dioxide decays to chlorite within 15 minutes, and decayed completely within four hours 33 

### . The studies of chlorine dioxide decay in natural seawater presented in Section 2.0.2 compare well with this data. Chlorite is considered more stable in aqueous solution than chlorine dioxide; however, in a similar manner to chlorine dioxide, chlorite also degrades in aqueous solution as a result of oxidative reactions. Residual chlorite ion in treated ballast water will decrease through reactions with organic matter to form chloride, which is non-toxic at the concentrations of interest. Chlorite is not persistent as a result of its degradation pathway to chloride 33



### . Chlorate ion is an oxidant and is expected to be non-persistent in the environment when there are sufficient levels of organic matter present25



### . DBAA is documented to degrade by microbial activity 37 

### as well as photolysis 38 

### . A study of haloacetic acid decomposition in seawater demonstrated that DBAA was degraded within 9 days 37 

### , even when microbial activity was inhibited. These studies, considered with the chemical properties of DBAA suggest non-persistent behavior in the environment.

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### 5.1.2 Bioaccumulation (G9: 5.1.1.2) The estimated log Kow

### of chlorine dioxide is -3.22 and for sodium chlorite is -7.17 6 

### . These values along with the chemical properties (i.e. high solubility, non-organic) of chlorine dioxide and chlorite indicate that bioaccumulation is not expected. The reported log Kow

### for sodium chlorate is -2.9 34 

### and has a low potential to bioaccumulate 15



### . DBAA has a reported log Kow

### of 1.22, is not lipophilic at physiological pH and has a low potential to accumulate in fat 14



### . 5.1.3 Toxicity (G9: 5.1.2.3) 5.1.4 PBT Criteria - Active Substance (G9: Table 1) Table T5.1 – PBT Criteria Evaluation

Substance Persistence (P) Half-life: >60 days in marine water, or >40 days in freshwater, or >180 days in marine sediment >120 days in freshwater sediment Bioaccumulation (B) BCF >2,000 or Log K ow  3 Toxicity (T) Chronic NOEC

<0.01mg/L

Chlorine dioxide 3.9 minutes, clear freshwater at 5 meters 33

5 minutes in seawater at 20oC Criteria fulfilled - No -3.22 6

Criteria fulfilled - No Lowest LC50 = 0.02 mg/L (see Table T2.9) Criteria fulfilled - No

Chlorite Ion <2 minutes in seawater at 20oC Criteria Fulfilled – No -7.17 6 (as sodium chlorite) Criteria fulfilled - No Lowest chronic NOEC = 0.18 mg/L (See Table T2.10) Criteria Fulfilled - No

Chlorate Ion ~1 day in seawater at 20oC Criteria fulfilled - No -2.9 34 (as sodium chlorate) Criteria fulfilled - No NOEC = 0.06 mg/L Criteria Fulfilled - No

Dibromoacetic Acid 14 days (freshwater, 15oC, in presence of titanium dioxide) 38 Criteria fulfilled - No 1.22 14 Criteria fulfilled - No LC50 = 69 mg/L Criteria Fulfilled - No



### None of the chemicals meet the criteria to be classified as PBT substances. In the GESAMP-BWWG review (MEPC 58/2/7, Annex 5) the chlorite ion persistence value from the table above was reported as 4 days in seawater. However, the review contained no information on the basis for this change nor was the reference source of this persistence value for chlorite ion provided. The updated half-life value of <2 minutes in seawater reported above is based on independent laboratory analysis and is considered accurate for this relevant chemical.

5.2 EVALUATION OF THE TREATED BALLAST WATER Section 5.2.1 includes evaluation of treated ballast water toxicity from laboratory and shipboard testing conducted on the Ecochlor ® 

### BWTS and was included in the Basic Approval dossier. Section 5.2.2 provides new information for this Final Approval dossier and evaluates treated ballast water discharge from the land based testing conducted during 2008 at NIOZ.
5.2.1 Determination of Holding Time – Treated Water from Lab and Shipboard Testing 5.2.1.1 Toxicity and Dilution of Treated Ballast Water - Lab and Shipboard Testing Detailed information was provided in the Basic Approval dossier (MEPC 58/2/2).

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### 5.2.2 Determination of Holding Time – Treated Ballast Water from Land-Based Testing 5.2.2.1 Toxicity, Dilution and Holding Time of Treated Ballast Water – Land Based Testing Toxicity testing of treated ballast water discharge from the land-based test unit was performed by Grontmij|AquaSense in the Netherlands (crustaceans, algae, mollusks, rotifers, and marine bacteria testing) and by Chemex Environmental International in the United Kingdom (fish testing). Ecotoxicity was evaluated for six (6) different taxonomic groups (algae, crustacean, fish, rotifers, mollusks, and marine bacteria). Testing of treated ballast water discharge from the land based test unit was conducted at two different salinities (brackish and sea water) and two different time points (1 day and 5 days after treatment). These time points were selected to demonstrate that treated ballast water is safe to discharge within 24 hours (1 day) of treatment and also after the holding time of 5 days specified in G8 testing. Acute exposure testing was performed on all six taxonomic groups from brackish and sea water test cycles. The most sensitive taxonomic group identified was then tested again with day 5 treated ballast water discharge. Short term exposure (sub-lethal endpoint (growth / development)) testing was also evaluated for the most sensitive taxonomic group identified from the acute testing. This approach allowed for testing on a wider range of taxonomic groups and also avoided unnecessary testing on organisms that did not show evidence of toxic effects with acute exposures. This approach for ecotoxicity testing was based on discussions and agreements between Ecochlor and the German Administration. Results of toxicity tests with treated ballast water discharge are presented on the basis of percent by volume (% v/v) of treated water. As shown in Table T2.9a no acute toxicity was observed with Cyprinodon variegatus , Acartia tonsa , Brachionus plicatilis , or Phaeodactylum tricornutum (brackish water only); the E(L)C50 for each species was >100% for discharge testing performed on samples collected 1 day after treatment. Therefore, the NOEC was 100% sample for these four species with day 1 treated water discharge. The EC50 for Vibrio fisheriin day 1 discharge samples was 83.3% in brackish water and 70.9% in sea water. The EC50 for Crassostrea gigas with day 1 discharge samples was 38.1% (NOEC = 10%) in brackish water and 62.3% (NOEC = 18%) in sea water. The results of the testing indicate that Crassostrea gigas was the most sensitive species in day 1 discharge samples. Therefore, based on the agreed testing approach, additional testing for this species was repeated with day 1 and 5 discharge samples for chronic effects using sub-lethal endpoints. Although the Crassostrea gigas testing method uses a short-term exposure, the test evaluates a chronic sub-lethal end point (development). As such this test was determined by Grontmij|AquaSense to be the appropriate method to evaluate chronic effects with this species. Section 3.3.3.2 of the G9 Methodology also indicates that short-term chronic testing methods are acceptable because identifying the sensitive sub-lethal endpoints and vulnerable life stages is the goal of long-term exposure testing. Additional testing with discharge samples 1 day after treatment resulted in EC50s for Crassostrea gigas of 43.3% (NOEC = 18%) in brackish water and 50.4% (NOEC = 32%) in sea water. Additional testing with discharge samples 5 days after treatment resulted in EC50s of 36.3% (NOEC = 18%) in brackish water and 73.6% (NOEC = 56%) in sea water. The average EC50 for all Crassostrea tests is 51% (average NOEC = 31%). Thus, a two-fold dilution is necessary to reach a concentration less than the EC50, and a three-fold dilution is necessary to reach a concentration less than the NOEC value for Crassostrea

.

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### The data are quite consistent when comparing the toxicity results for Crassostre a with discharges on day 1 and day 5 in both brackish and seawater29 

### . Therefore, the data support the conclusion that treated ballast water is safe to discharge within 24 hours of treatment and that a longer holding time is not required.

5.3 RISK CHARACTERIZATION & ANALYSIS 5.3.1 Reaction with Organic Matter (G9: 4.2.1.3) Information for chlorine dioxide and chlorite ion was provided in the Basic Approval dossier (MEPC 58/2/2). In the environment, chlorate can undergo reduction reactions with organic matter and “...the thermodynamically favored, end reduction product of chlorate in soil and in water is the chloride anion.” 39


### Brominated acetic acids such as DBAA are formed when bromide ion and organic matter is present during water disinfection processes 14 

### . Continued reaction of DBAA with organic matter is not expected.
5.3.2 Characterization of Degradation Route & Rate (G9: 5.3.5) Information for chlorine dioxide and chlorite ion was provided in the Basic Approval dossier (MEPC 58/2/2). Chlorate is degraded by both abioitc and biotic mechanisms. In the environment, chlorate can undergo reduction reactions with organic matter and “...the thermodynamically favored, end reduction product of chlorate in soil and in water is the chloride anion.” 39 

### Although reduction reactions of chlorate are said to occur very fast, how fast they occur is not known ( i.e. , the actual rate constants in the environment are not known) 36 

### . Decay studies presented in Section 2.0.3.4 indicate that in natural seawater the degradation of chlorate is on the hours-time scale. It is important to note that in a laboratory setting where the water sample is in a closed system the chlorate ion concentration becomes stable once demand of the water has been met. DBAA is degraded by both abiotic and biotic mechanisms, and a half-life of 14 days in freshwater (in the presence of the catalyst titanium dioxide) has been reported38



### . 5.3.3 Prediction of Discharge & Environmental Concentrations (G9: 5.3.8) The evaluation of predicted environmental concentrations presented in the Basic Approval dossier was based on direct measurements of the active substance and relevant chemicals in treated ballast water from laboratory and shipboard pilot testing. The evaluation did not involve prediction of environmental concentrations using hydrodynamic modeling technology. Therefore, the information provided in this section of Basic Approval dossier has been omitted and replaced with a more refined evaluation based on the results of land based testing and hydrodynamic modeling. 5.3.3.1 Hydrodynamic Modeling Approach Two separate modeling programs were utilized to determine the predicted environmental concentrations (PECs) for the Ecochlor®

### BWTS; MamPec (beta release v2.5) and Delft-3D. Deltares (formerly Delft Hydraulics) is located in the Netherlands and is the firm that developed the MamPec and Delft-3D models. Deltares performed the analysis of the PECs for Ecochlor’s treated ballast water.

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### MamPec Model The MamPec model uses a generalized approach and is considered a rapid assessment tool 40



### . The model was developed for antifouling products from ship’s hulls and therefore evaluates discharges as continuous releases into the environment. This is different than the intermittent and non-continuous nature of ballast water discharges, and therefore MamPec simulations will provide a worst-case estimate of the PEC’s 40 

### . MamPec offers three different schematizations, and the estuarine harbor as shown in Figure F5.1 was selected for this analysis.
Figure F5.1 – Example of MamPec Estuarine Harbor Schematization

Two separate ‘locations’ were simulated with MamPec for the Port of Rotterdam. The first location considered a specific part of the Nieuwe Waterweg, the Maashaven, and is shown in Figure F5.2 below. The circled area in the figure below shows the location of the Maashaven.
Figure F5.2 – Port of Rotterdam and Location of Maashaven

Source: Deltares 

### This location was chosen because the detailed model (discussed below) was also available for the Maashaven and would allow for a comparison between the two models. Details of the Maashaven input values for MamPec are provided in Tables T5.2 and T5.3. Further, within the Maashaven location different emission scenarios (also called ‘environmental conditions’) were evaluated. For example, the modeling was done with and without the effect of flushing within the harbor to determine how this complex harbor characteristic impacts the PEC values. In the Deltares report, scenarios where flushing is considered are referred to as “with salt”, indicating the influence of tides and water density. The scenarios where flushing is not considered are referred to as “no salt”. Although the difference in the PEC values was not significant for the

40 Deltares, Predicted Environmental Concentrations as a result of ballast water discharges in the Rotterdam harbor, 2008

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### simulation of the Maashaven with MamPec, the environmental condition without flushing can be considered the ‘worst-case’ scenario based on the PEC for DBAA. The results are presented in Section 5.3.3.3.
Table T5.2 – Summary of MamPec Model Input Parameters, Maashaven

Parameter Value Unit Tidal period 12.41 h x2 300 m y1 2045 m y2 380 m depth 7.6 m Mouth width x3 200 m Flow velocity F 0.08 m/s Tidal difference 2.55 m Max density difference tide (avg conditions: with salt) 2.29 kg/m3



### Figure F5.3 – Detail of Maashaven Harbor

Source: Deltares 

### Table T5.3 – Summary of MamPec Model Details, Maashaven

Substance Dishcarge Rate Q [m3/s] Chemical Concentration c [g/m3] Discharge Duration Decay Rate [1/d] Emission [g/d]
Chlorate 0.14 1.47 continuous 43.2 17640 Dibromoacetic acid 0.14 0.036 continuous 0 432 Chlorine dioxide 0.14 0.85 continuous 145.4 10200 Chlorite 0.14 3.6 continuous 463.7 43200


### The second MamPec ‘location’ considered the Port of Rotterdam as a whole in which the release of ballast water due to all ships present was simulated40 

### . As stated in the Deltares report, the total ballast water discharge for the whole Port of Rotterdam used in the model was derived from Niekerk (2008) and totaled 2.76 million m3 

### . For the whole Port of Rotterdam modeling, only one approach was utilized where the geometry and flushing characteristics were copied from the MamPec manual. Details of the input values for MamPec simulations for the whole Port of Rotterdam are provided in Tables T5.4 and T5.5. The results of this simulation are presented in Section 5.3.3.3 380

200

300

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### Table T5.4 – Summary of MamPec Model Input Parameters, Port of Rotterdam (Whole)

Parameter Value Unit Tidal period 12.41 h length x1 2000 m x2 20000 m y1 2000 m y2 500 m depth 20 m Mouth width x3 5000 m Flow velocity F 1.5 m/s Tidal difference 1.5 m Max density difference tide (avg conditions: with salt) 0.80 kg/m3 

### Table T5.5 – Summary of MamPec Model Details, Port of Rotterdam (Whole)

Substance Dishcarge Rate Q [m3/s] Chemical Concentration c [g/m3] Discharge Duration Decay Rate [1/d] Emission [g/d]
Chlorate 1.1 1.47 continuous 43.2 139903 Dibromoacetic acid 1.1 0.036 continuous 0 3426 Chlorine dioxide 1.1 0.85 continuous 145.4 80897 Chlorite 1.1 3.6 continuous 463.7 342621 

### Delft 3D Detailed Model The Delft-3D model is a world-leading 2D/3D modeling suite developed by Deltares (formerly Delft Hydraulics). The Delft-3D detailed model was used to provide a precise simulation of treated water discharge within the Maashaven in addition than the general assessment that MamPec provided. Further, the detailed model provided an indication of the overall suitability of the MamPec model to accurately predict ballast water discharge concentrations. The intent is not to validate the MamPec model, but to indicate the suitability / accuracy of the MamPec model to be applied to ballast water discharges 40 

### . The detailed model is a calibrated numerical model that encompasses realistic geometry and complex hydrodynamic behavior in a specific harbor. For this evaluation, the Maashaven, part of the Nieuwe Waterweg, within the Port of Rotterdam was selected. The modeling input parameters are the same as those used for the MamPec model as presented in Tables T5.2 and T5.3 above, with the only difference being that the discharge duration for the detailed model was 24 hours rather than continuous.
Several scenarios were evaluated with the Delft-3D model. Similar to the MamPec simulations, the modeling was done with and without the effect of flushing within the harbor to determine how this complex harbor characteristic impacts the PEC values. It was determined that the environmental condition without flushing provided the ‘worst-case’ scenario. Further, scenarios with one ship at different locations within the harbor, as well as three ships in the harbor discharging simultaneously were simulated. Of all the scenarios simulated with the detailed model, the ‘worst-case’ (where the PECs are the highest) occurred when three ships discharge simultaneously and no flushing is considered in the model. The results are presented in Section 5.3.3.3 below. General Parameters Used for both MamPec and Delft-3D Models To determine the discharge volume and duration, Ecochlor chose vessel parameters to represent a ‘worst case’ scenario within Maashaven. The largest vessel able to enter Maashaven is the 38,650 metric ton SS Rotterdam. Due to the size of this vessel, it can only be docked in the entrance, or front, of the Maashaven harbor. Since this vessel is a cruise ship (reduced ballast

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### water volume), Ecochlor chose to take a ‘worst-case’ approach and assume the vessel was a typical bulker of the identical tonnage. Most bulkers carry and discharge 30% of their tonnage in ballast water. Therefore a volume of 12,000 metric tons of ballast water was assumed for this vessel. In order to incorporate multiple vessels discharging simultaneously in Maashaven, Ecochlor chose to use three vessels with equal (12,000 metric tons) volumes of ballast water. This was done with the knowledge that no vessel of this size could enter the smaller docks in middle and back of the harbor; however, this created an unattainable ‘worst-case’ scenario for the analysis and provided an added level of protection to the PEC values generated. For discharge rate, and given the volumes discussed above, Ecochlor chose to assume a consistent discharge rate for the entire 12,000 metric tons over a 24 hour period for the detailed model. This equaled an hourly discharge of 500 metric tons per hour, for 24 hours, for each vessel used in the different emission scenarios. For the MamPec model the discharge duration is continuous. 5.3.3.2 Determination of Chemical Concentrations and Decay Rates for Modeling Input Due to the rapid degradation of chlorine dioxide, chlorite ion, and chlorate ion, a decay rate was specified for use in the modeling. This was determined as the most realistic approach for these substances. This approach, particularly when considered with the “no salt” flushing parameter, also demonstrates that extensive dilution is not depended upon to make treated ballast water discharge environmentally acceptable. The decay rates are so high that they almost completely determine the PECs 40



### . Prior to initiating the hydrodynamic modeling a decay rate for DBAA was not located. Therefore, no decay rate was specified for DBAA.

Chlorine Dioxide When the Ecochlor ®

### BWTS is utilized on a vessel as directed by Ecochlor, the concentration of chlorine dioxide is expected to be at undetectable levels when treated ballast water is discharged. However, it is also known that various water quality parameters can increase or decrease the demand/decay of chlorine dioxide. During land based testing, detectable levels of chlorine dioxide were measured within 24 hours (1 day) after treatment at concentrations ranging from 0.22 – 0.85 mg/L (mean = 0.63 mg/L). To verify that chlorine dioxide in treated ballast water discharge does not present unacceptable environmental risk, the highest day 1 chlorine dioxide concentration of 0.85 mg/L (See Table T2.8a) was used in the modeling to determine the (PEC). This approach represents the ‘worst-case’ situation for chlorine dioxide in treated ballast water discharge 24 hours after treatment. The decay rate of 145.4 mg/L per day used in the model for chlorine dioxide was derived from laboratory testing results, and was the slowest rate measured. Therefore, the decay rate is considered conservative.

Chlorite Ion During land based testing, chlorite ion was measured at concentrations ranging from 3.11 – 3.6 mg/L (mean = 3.3 mg/L) 1 day after treatment. To verify that chlorite ion in treated ballast water discharge does not present unacceptable environmental risk, the highest day 1 chlorite ion concentration of 3.6 mg/L (See Table T2.8a) was used in the modeling to determine the predicted environmental concentration (PEC). This approach represents the ‘worst-case’ for chlorite ion in treated ballast water discharge 24 hours after treatment. The decay rate of 463.7 mg/L per day used in the model for chlorite ion was derived from laboratory testing results and was the slowest rate measured. Therefore, the decay rate is considered conservative.

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### Chlorate Ion During land based testing, chlorate ion was measured at concentrations ranging from 1.07 – 1.47 mg/L (mean = 1.3 mg/L) 1 day after treatment. To verify that chlorate ion in treated ballast water discharge does not present unacceptable environmental risk, the highest day 1 chlorate ion concentration of 1.47 mg/L (See Table T2.8a) was used in the modeling to determine the predicted environmental concentration (PEC). This approach represents the ‘worst-case’ for chlorate ion in treated ballast water discharge 24 hours after treatment. The decay rate of 43.2 mg/L per day used in the model for chlorine dioxide was derived from laboratory testing results and was the slowest rate measured. Therefore, the decay rate is considered conservative.

DBAA During land based testing, DBAA was measured at concentrations ranging from 20 – 36 μg/L (mean = 25 μg/L) 1 day after treatment. To verify that DBAA in treated ballast water discharge does not present unacceptable environmental risk, the highest day 1 DBAA concentration of 36 μg/L (See Table T2.8c) was used in the modeling to determine the predicted environmental concentration (PEC). This approach represents the ‘worst-case’ for DBAA in treated ballast water discharge 24 hours after treatment. As noted above, no decay rate was entered into the model for DBAA. 5.3.3.3 Results of Modeling and Derived PEC Values MamPec Model For the first simulation using MamPec in Maashaven harbor, the results are presented in Table T5.6. Based on the concentration of dibromoacetic acid (DBAA), the scenario with no salt represents the ‘worst-case’ scenario.
Table T5.6 – Results of MamPec, Maashaven

Substance Average concentration

(with salt)

[g/m3] [Average concentration (with no salt) [g/m3] Chlorate 8.74E-05 8.74E-05 Dibromoacetic acid 3.85E-04 8.74E-04 Chlorine dioxide 1.50E-05 1.50E-05 Chlorite 1.99E-05 1.99E-05 

### The MamPec simulation results for the whole Port of Rotterdam are presented in Table T5.7. This scenario was simulated with the standard flushing and geometry as outlined in the MamPec manual and therefore did not consider the alternate environmental condition of no flushing. The results indicate that the average concentrations of all constituents are lower in this simulation for the whole Port of Rotterdam than within Maashaven harbor.
Table T5.7 – Results of MamPec, Port of Rotterdam (Whole)

Substance MamPec average concentration [g/m3] Chlorate 5.67E-06 Dibromacetic acid 6.94E-04 Chlorine dioxide 9.73E-07 Chlorite 1.29E-06

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### Delft-3D Model The results of the detailed model and the six different scenarios evaluated are presented in Table T5.8.
Table T5.8 – Results of Delft-3D Detailed Model, Maashaven Max average Maashaven concentrations [g/m3] Average (with salt) Worst case (no salt ) 1 ship; located at back of harbour Chlorate 9.67E-05 9.67E-05 Dibromacetic acid 8.53E-05 1.02E-04 Chlorine dioxide 1.66E-05 1.66E-05 Chlorite 2.21E-05 2.21E-05 1 ship; located at front of harbour Chlorate 9.65E-05 9.67E-05 Dibromacetic acid 4.71E-05 7.25E-05 Chlorine dioxide 1.66E-05 1.66E-05 Chlorite 2.21E-05 2.21E-05 3 ships; 3 locations: back, middle and front Chlorate 2.85E-04 2.90E-04 Dibromacetic acid 2.10E-04 2.65E-04 Chlorine dioxide 4.90E-05 4.98E-05 Chlorite 6.51E-05 6.62E-05 

### For the substances that decay (chlorine dioxide, chlorite ion and chlorate ion), the PECs are the same for the simulations ‘with salt’ (flushing) and ‘without salt’ (no flushing). Additionally, the differing location of the discharge within the Maashaven (front or back) does not influence the PECs for these substances. For DBAA, flushing as well location of the discharge within the harbor influences the PEC. The highest PEC for chlorine dioxide, chlorite ion and chlorate ion is generated with the detailed model for the ‘worst-case’ scenario of three ships discharging in the Maashaven simultaneously without the influence of flushing (no salt). These results are 4.98 x 10 -5 

### , 6.62 x 10 -5 

### , and 2.90 x 10 -4 

### , respectively. For DBAA, the highest PEC (8.74 x 10 -4 

### ) is generated with the MamPec model when one ship discharges in the back of the Maashaven without the influence of flushing (no salt). Therefore, since these are the highest PECs derived for all modeling scenarios for both the MamPec and the Delft-3D model, these are the values used for the environmental risk assessment for treated ballast water discharge. 5.3.3.4 General Conclusions from Hydrodynamic Modeling and Derivation of PECs In general the PEC of the substances due to the re lease of treated ballast water is determined by the load, the amount of flushing, and the behavior of the substance (i.e. decay). In regards to chlorine dioxide, chlorite ion, and chlorate ion the decay rates almost completely determine the PECs 40 

### . This conclusion is valid for any type of harbor, independent of the flushing characteristics of the harbor and independent of the location of discharge within the harbor 40



### . The concentration of these three substances drops to 10% of the concentration present in treated ballast water discharge within 1.3 hours after the discharge 40 

### . Compared to the decay ratesderived in the laboratory, which indicated that chlorine dioxide and chlorite ion are at nondetectable levels within minutes, the model is considered conservative in this regard. For substances that decay rapidly, MamPec provides realistic estimates of the PECs for ballast water discharge. This conclusion is based on the comparison between average concentrations derived with MamPec under various environmental conditions using a continuous release, which

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### were very close to the maximum concentrations over a 24 hour discharge period derived with the detailed model 40 

### . For DBAA, a conservative substance (i.e. no decay used in the model), the MamPec model overestimates the PECs from ballast water discharges. This conclusion is based on the concentration of DBAA with MamPec under continuous release being up to one order of magnitude higher than the maximum PEC derived with the detailed model with a 24 hour discharge 40



### . 5.3.3.5 Allowable Discharge Levels The concentrations of chlorine dioxide, chlorite ion, chlorate ion and DBAA in treated ballast water discharge that were entered into the models for PEC derivation were the highest concentrations measured 24 hours after treatment during land based testing. Additionally, the concentrations of these substances measured during land based testing were higher than in all previous laboratory and shipboard studies. As such, the calculated PECs are based on ‘worst case’ scenarios with the highest levels of constituents 24 hours after treatment and are considered conservative. Therefore, the allowable discharge levels in treated ballast water are as follows: Chlorine dioxide – 0.85 mg/L Chlorite ion – 3.6 mg/L Chlorate ion – 1.47 mg/L DBAA - 0.036 mg/L Because the modeling was done using these conservative values, the calculated PECs and PEC/PNEC ratios are considered protective of the aquatic environment.
5.3.4 Assessment of Potential for Bioaccumulation (G9: 5.3.7) Because the substances utilized with the Ecochlor®

### BWTS do not have characteristics that would indicate a potential for bioaccumulation, no bioaccumulation effects are anticipated.

5.3.5 Effects Assessment 5.3.5.1 Chlorine Dioxide Information was provided in the Basic Approval dossier (MEPC 58/2/2).

5.3.5.2 Chlorite Ion Information was provided in the Basic Approval dossier (MEPC 58/2/2).

5.3.5.3 Chlorate Ion With respect to risk, toxicity to aquatic organisms appears to be the most significant potential exposure for chlorate because it is not persistent in the environment and is not expected to bioaccumulate or adsorb to sediments. An effects assessment of secondary poisoning is not relevant. Therefore, the acute and chronic aquatic toxicity results presented in Section 2.1 for chlorate provide the most appropriate evaluation of the potential for adverse effects to aquatic organisms. Acute toxicity data for chlorate ion is presented in Table T2.9, and varies widely across the taxonomic groups. For example, one test with Oncorhynchus masou reported and LC50 of 7,843 mg/L, and another fish test ( Oncorhynchus mykiss ) reported an LC50 of 2,527 mg/L. Toxicity tests with crustaceans had E(L)C50 values ranging from 1,098 – 5,019 mg/L. Although responses varied greatly, algae is clearly the most sensitive group to chlorate with reported EC50 values ranging from 0.1 - >1.000 mg/L, and NOEC values of 0.005 – 500 mg/L. Discussion regarding the NOEC value of 0.005 mg/L is presented in Section 5.3.6.2.

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### Chronic aquatic toxicity data for chlorate is presented in Table T2.10. Overall, the NOEC values are lower than the acute values, with algae clearly being the most sensitive group. Discussion regarding the NOEC value of 0.005 mg/L is presented in Section 5.3.6.2. 5.3.5.4 Dibromoacetic Acid (DBAA) The toxicity data set for dibromoacetic acid is limited for both aquatic and mammalian studies. However, high solubility indicates that DBAA is not expected to be persistent in the environment or adsorb to particles. Adverse reactions with organic matter are not expected. DBAA is not lipophilic and is not expected to bioaccumulate in tissues. Mammalian studies indicate that DBAA did not exhibit teratogenic potential, is readily absorbed and the metabolites are readily excreted. Some evidence suggests DBAA may have carcinogenic and mutagenic potential. Considering the limited data, and because the low level of dibromoacetic acid potentially in treated water discharge will be discharge to the aquatic compartment, the available aquatic toxicity data for Pimephales promelas is considered the most relevant data to use for this assessment. 5.3.6 Effects on Aquatic Organisms 5.3.6.1 Evaluation of Effects Based on Laboratory and Shipboard Toxicity Testing This information was provided in the Basic Approval dossier (MEPC 58/2/2, Section 5.3.6). An updated evaluation of effects is presented below. 5.3.6.2 Updated Evaluation of Effects on Aquatic Organisms The following effects assessment is based on revisions to the earlier assessment, comments received by the GESMAP-BWWG and new data generated since submission of the Basic Approval dossier. Derivation of the PNEC values in Table T5.9 below are based on the toxicity data presented in Tables T2.9 and T2.10. Assessment factors were selected based on the guidance in the G9 Methodology, Section 6.3.6.4, Table 2 2 

### as well as the EU Technical Guidance Document (TGD) on Risk Assessment (2003). Justification for the selected assessment factor for each constituent is provided below.

Chlorine dioxide: The GESAMP-BWWG commented that the Nautilus Environmental testing protocols with chlorine dioxide measured the effect concentrations of the active substance at the initiation of the tests. Ecochlor accepts and understands this criticism of the test results and has applied the lower LC50 of 0.02 mg/L (juvenile Pimephales promelas ) for chlorine dioxide as suggested by the GESAMP-BWWG for the environmental risk assessment. Applying an assessment factor of 1,000 results in a PNEC = 0.02 μg/L for chlorine dioxide.

Chlorite ion: Nautilus Environmental performed a number toxicity studies on chlorite ion to evaluate this chemical in treated ballast water. Although data can be found in literature that may present lower end point data, Ecochlor contends that the data generated by Nautilus is appropriate to use for this assessment. The studies found in literature are often conducted long ago and there is difficulty in knowing how the chlorite solution was made for a particular study, or the exact method the study was conducted with. Therefore, Ecochlor undertook toxicity testing to ensure that the testing accurately represented this relevant chemical in treated ballast water. In any case, Ecochlor accepts the suggested use of the Mysidopsis bahia LC50 of 0.58 mg/L (Table T2.9) and the higher assessment factor of 1,000 for chlorite ion to derive a PNEC = 0.58 μg/L.

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### Chlorate ion: A literature search was done to locate acute and chronic aquatic toxicity data for this chemical. The acute toxicity data set in Table T2.9 presents three data points for fish, four data points for crustaceans and five data points for algae. The chronic toxicity data set in Table T2.10 presents one result for fish, two results for crustaceans, and four results for algae. This justifies the use of an assessment factor of 100. The data indicate that algae are more sensitive to chlorate than invertebrates or fish. Further, marine brown algae are the most sensitive to chlorate. Research indicates that algal sensitivity to chlorate is related to ambient nitrate levels and the nitrate reductase enzyme system 18,19



### . Additionally, freshwater microalgae are generally more sensitive to chlorate than marine microalgae, at high nitrate levels 19



### . The lowest NOEC value reported by van Wijk and Hutchinson25 

### was 0.005 mg/L (5 μg/L ) chlorate. This value was reported in the van Wijk and Hutchinson paper as both the marine mesocosms value and the result of a 6-month study of Fucus vesiculosus . These authors state that this data is from Rosemarin et al . (1994) 41 

### . However, the Rosemarin study does not report NOEC results but instead reports an EC50 of 80 μg/L for Fucus vesiculosus . The Rosemarin study states: “Clear negative effects begin at about 15-20 μg chlorate/L. The level where 50% effect is observed (so-called EC50) is about 80 μg/L.” The lower chlorate concentrations tested in the Rosemarin study were 1, 5, and 20 μg/L. Therefore, it appears that van Wijk and Hutchinson inferred the NOEC for this 6-month Fucus vesiculosus marine mesocosm study to be 5 μg/L, because Rosemarin reported that negative effects start to occur at 15-20 μg/L, and 5 μg/L was the next lowest concentration tested. However, the data presented by these authors are not sufficient to statistically calculate an NOEC value of 5 μg/L since there was no replication of the control, 1 or 5 μg/L exposures in the Rosemarin study. Based on the above discussion, and due to the large variability in toxicity data for chlorate, Ecochlor selected the lowest chronic NOEC geometric mean value of 0.06 mg/L (60 μg/L) for marine macroalgae reported by van Wijk and Hutchinson to derive a PNEC value. This geometric mean value takes into account the very low data point (5 μg/L ) that van Wijk inferred from the Rosemarin study, as well as other data points that are an order of magnitude higher. As such, the NOEC of 0.06 mg/L is more representative of the overall algal toxicity data for various species, yet is lower than the actual EC50 value of 0.08 mg/L for Fucus vesiculosus . This NOEC value for chlorate provides adequate protection for aquatic species when used to derive a PNEC = 0.6 μg/L.

DBAA: The aquatic toxicity data set for dibromoacetic acid is very limited. The lowest LC50 reported for Pimephales promelas was 69 mg/L. Applying the highest assessment factor of 1,000 from Table 2 of the G9 Methodology results in a PNEC = 69.0 μg/L for DBAA.

41 Rosemarin, et.al. Effects of Pulp Mill Chlorate on Baltic Sea Algae, 1994

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### Table T5.9 – Derivation of PNEC Values and PEC/PNEC Ratios

Chemical Name Lowest Observed Effect Concentration (mg/L) Assessment Factor PNEC (μg/L) PEC (μg/L) / PNEC (μg/L) Ratio Chlorine dioxide 0.02 1000 0.02 0.0498/0.02 = 2.49

Chlorite Ion 0.58 1000 0.58 0.0662/0.58 = 0.11 Chlorate Ion 0.06 100 0.6 0.290/0.6 = 0.48 Dibromoacetic acid (DBAA) 69.0 1000 69.0 0.874/69 = 0.013


### For all substances, with the exception of chlorine dioxide, the PEC/PNEC ratio is <1, thereby indicating that no further evaluation or testing is required for chlorite ion, chlorate ion and DBAA at the present time. Because the PECs were calculated based on a ‘worst-case’ scenario that considered the least amount of flushing (i.e. dilution) within the hydrodynamic model, this assessment is considered adequately protective of the aquatic compartment.
For chlorine dioxide, the PEC/PNEC ratio = 2.49. This PEC was calculated for the Maashaven with the detailed model based on a ‘worst-case’ scenario. When the chlorine dioxide PEC result of 0.015 μg/L as calculated with the MamPec model for the Maashaven under a ‘worst-case’ scenario is considered, a PEC/PNEC ratio of 0.75 is achieved. Further, when the chlorine dioxide PEC result of 0.000973 μg/L as calculated with the MamPec model for the whole Port of Rotterdam is considered, a PEC/PNEC ratio of 0.049 is achieved. Therefore, the PEC/PNEC = 2.49 for chlorine dioxide is a conservative value derived under unattainable ‘worst-case’ conditions.

5.3.7 Effects on Sediment Because the substances utilized with the Ecochlor®

### BWTS do not have characteristics that would indicate adsorption to sediment particles, no effects on sediments are anticipated. Further, none of the constituents potentially present in treated ballast water have log K ow

### values >3.
5.3.8 Comparison of Effect Assessment with Discharge Toxicity The original section presented in the Basic Approval dossier was based on discharge toxicity from shipboard pilot studies. This data is still considered valid and remains in Tables T2.9 and T2.10. However, the original section has been replaced with an updated evaluation to include the results of discharge toxicity testing from land based testing. 5.3.8.1 Treated Ballast Water from Land Based Testing The effects assessment for the individual constituents potentially present in treated ballast water indicates that aquatic toxicity rather than bioaccumulation or sediment toxicity is the primary environmental risk. An evaluation of the PEC from hydrodynamic modeling and calculation of a PNEC value from toxicity data for each chemical indicates that chlorite ion, chlorate ion and DBAA have PEC/PNEC ratios <1. Chlorine dioxide has a calculated PEC/PNEC = 2.49 based on a ‘worst-case’ scenario. When more realistic harbor scenarios are considered, the calculated PEC/PNEC ratio is <1. From land based testing, treated ballast water discharge was evaluated for toxicity to six different taxonomic groups. The most sensitive species was Crassostrea gigas with an average EC50 of 51% and an average NOEC of 31%. Therefore, a two-fold dilution is necessary to reach a concentration less than the EC50 and a three-fold dilution is necessary to reach a concentration less than the NOEC value for Crassostrea

.

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### The PEC/PNEC ratio of 2.49 compares very well to the three-fold dilution that would be required to reach a concentration less than the effect concentrations for Crassostrea gigas , which was determined to be the most sensitive species during testing with treated ballast water discharge.

6.0 RISK ASSESSMENT The risks presented by having the Ecochlor®

### BWTS onboard are discussed in Section 6.1, while risks to technicians and/or ships crew are discussed in Section 6.2.

6.1 RISK TO SAFETY OF SHIP As discussed in Section 1.0.1, Ecochlor began testing the BWTS onboard ship in 2004 prior to the availability of land based testing facilities. The years of testing onboard have allowed Ecochlor to identify the risks and develop appropriate mitigations for the safe operation of the BWTS onboard, which are detailed in the sections below. This experience, along with the engineering reviews that are required during the design, approval and installation process for any ship will ensure that appropriate mitigation measures are implemented. Preparing for BWTS installation onboard a ship requires extensive reviews by Ecochlor’s marine engineers, the vessel engineers, as well as the ship’s classification society. Additional mitigation measures that may be identified for safe BWTS installation on a specific ship during these reviews will be implemented as needed.
6.1.1 Ship Integrity and the BWTS Information was provided in the Basic Approval dossier (MEPC 58/2/2).

6.1.2 Corrosion Detailed information was provided in the Basic Approval dossier (MEPC 58/2/2). 6.1.2.1 Effect of pH and Elevated Dissolved Oxygen Concentration on Corrosion Detailed information was provided in the Basic Approval dossier (MEPC 58/2/2). 6.1.2.2 Corrosion Coupon Testing In response to the GESAMP-BWWG comment (Section 5.2 in 58/2/8, Annex 5), additional details of previous corrosion coupon tests are provided below. Corrosion tests have been conducted in ballast tanks treated by the Ecochlor® 

### BWTS to verify the effect of chlorine dioxide treatment on ballast tank corrosion rates. Tests were conducted with C1010 mild steel corrosion test coupons and sent to Metal Samples Company, Inc. for analysis 42



### . In July/August of 2005, corrosion test coupons were placed in one control (untreated) tank and one chlorine dioxide-treated tank that received ballast water from Newark, NJ. The treatment tank received a 5.0 mg/L dose of chlorine dioxide. Two test coupons were placed in each tank; one high (approximately 1.35 m from the bottom of a 1.8 m tank) and one low (approximately 0.9 m from the bottom of a 1.8 m tank), and hung by nylon strings. Both sets of coupons remained in the respective tanks for 672 hours (28 days). Two pre-weighed, standard corrosion coupons were inserted in double bottom ballast tank #DB5P as a control. Two pre-weighed, standard corrosion coupons were inserted in double bottom #DB6P as treated. Each of the coupons were hung in the ballast tanks from modified inspection hatches with non-reactive nylon string.

42 Corrosion Analysis Data Report, Metal Samples, Co., 2005.

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### The control tank was filled at 10:00 am in NJ at the FAPS marine terminal in the Port of Newark on July 25, 2005. The treated tank was also filled at the FAPS marine terminal in the Port of Newark at 12:30 pm on July 25, 2005. The control tank was untreated and the treated tank received an initial dosage of 5.0 mg/L of chlorine dioxide that was confirmed thru chemical draw down calculations. The temperature of the incoming water for both tanks was 24°C. Both tanks were “pressed” (filled above 100%) allowing some water to enter the air vents. A pressed tank eliminates or drastically reduces the turbulence in the ballast tanks and is required for trans-Atlantic voyages. It is highly unlikely that the coupons were ever above the water line even in heavy seas. The Atlantic Compass had the following subsequent port calls: Halifax, Liverpool, Antwerp, Bremerhaven, Gothenburg, Antwerp, Liverpool, Halifax and then back to New Jersey. No ballasting or de-ballasting operations for either #DB5P or #DB6P took place until the return to New Jersey, when the coupons were removed from the tanks. Upon removal, the coupons were sealed in manila envelopes, as dictated by standard analytical procedures and sent via express mail to Metal Samples Company for analysis. In October/November of 2006 a similar test took place in a tank treated with approximately 4.0 mg/L of chlorine dioxide. Two test coupons were placed in the tank; one high (approximately 1.35 m from the bottom of a 1.8 m tank) and one low (approximately 0.9 m from the bottom of a 1.8 m tank), and hung by nylon strings. Both coupons remained in the tank for 768 hours (32 days). Two pre-weighed, standard corrosion coupons were inserted in double bottom #DB5NP which was treated with chlorine dioxide upon ballasting. Each of the coupons was hung in the ballast tank from a modified inspection hatch with non-reactive nylon string. The Atlantic Compass could not guarantee that double bottom #DB5P or #DB6P (as used in the 2005 study) could be filled in NJ and held as a control thru the Atlantic crossing. Only #DB5NP was available for this study. Therefore, no control tank was available for this test.

The treated tank was filled at the FAPS marine terminal in the Port of Newark at 9:00 am on October 21, 2006. The treated tank received an initial dosage of 4.0 mg/L of chlorine dioxide that was confirmed thru chemical draw down calculations. The temperature of the incoming water was 15°C. The deviation from the typical dosage of 5.0 mg/L was due to experimental efficacy testing that was being evaluated on board the vessel during this period. Ecochlor has since abandoned the lower dosage but believes the corrosion data from this study is relevant. As done previously, the treatment tank (#DB5NP) was “pressed” (filled above 100%) allowing some water to enter the air vents. The Atlantic Compass had the following subsequent port calls: Halifax, Liverpool, Antwerp, Bremerhaven, Gothenburg, Antwerp, Liverpool, Halifax and then back to New Jersey. No ballasting or de-ballasting operations for #DB5NP took place until the return to New Jersey. The two coupons from #DB5NP were removed upon the vessels return to New Jersey on November 22, 2006.

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### Upon removal, the coupons were sealed in manila envelopes, as dictated by standard analytical procedures and sent via express mail to Metal Samples Company for analysis. The results of this initial testing are presented in Table T6.1 below, and indicate no adverse effect on corrosion rates from chlorine dioxide treatment. Actually, when the July/Aug 2005 study corrosion rates of test coupons from untreated and treated tanks are compared, a slight decrease in the corrosion rate was observed for test coupons in the treated tanks. Table T6.1 – Comparison of Corrosion Rates Sample Date ClO2 Dosage (mg/L) Exposure time (Hrs) Corrosion Rate (mpy)

Untreated tank (high) Jul/Aug 2005 0 672 9.8389 Untreated tank (low) Jul/Aug 2005 0 672 10.9133 Treated (high) Jul/Aug 2005 5 672 6.0879 Treated (low) Jul/Aug 2005 5 672 7.87 Treated (high) Oct/Nov 2006 4 768 5.0977 Treated (low) Oct/Nov 2006 4 768 5.5624 Corrosion by chlorine dioxide



### Ecochlor’s statement that chlorine dioxide treatment will not adversely affect corrosion rates is supported by this data. Additional verification of these results with continued coupon corrosion studies is presented in Section 6.1.2.4 below. Additionally, visual inspections of piping close to the chlorine dioxide injection point was conducted on the Atlantic Compass during a dry-dock visit in Dunkirk, France in September 2007. Ecochlor and Atlantic Container Lines personnel took this opportunity to visually inspect the internal bare metal piping downstream of the injection point of the chlorine dioxide solution. It was the opinion of all inspectors that there was no appearance of metal loss of this internal piping. This inspection took place 3 years after the installation and commissioning of the Ecochlor system. It is also relevant to note the rapid degradation and the relatively low concentrations of the active substance and relevant chemicals present in Ecochlor’s treated ballast water, particularly when compared with other technologies. The degradation of the active substance in the ballast tanks is on the hours time scale, which further suggests that utilization of this BWTS will not have significant impacts on the rate of corrosion onboard. 6.1.2.3 Corrosion Coupon Analysis Procedure This information is included in the complete confidential Final Approval dossier. 6.1.2.4 Additional Corrosion Coupon Testing As indicated in Section 6.1.2.2 above, additional corrosion coupon testing was conducted since the submittal of the Basic Approval dossier. The testing was done in conjunction with the land based testing at NIOZ.

NIOZ Harbor on Texel Island is located between the North Sea and the Wadden Sea. As in the testing cycles, harbor water was pumped from the harbor into the coated concrete tanks (300 m3 

### volume each) that simulate ballast water tanks. One tank was filled on July 22, 2008 with 250 metric tons of harbor water and used as a “control” (Tank #1) that received no treatment. A separate tank (Tank #2) was also filled on July 22, 2008 with approximately 250 metric tons of harbor water and “treated” with 5 mg/L of chlorine dioxide. Each tank was open to the atmosphere and not “pressed”. Three metal coupons were placed in each tank. One coupon was placed one meter below the air / water interface (high), one coupon was placed two (2) meters below the air / water interface

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### (mid) and one coupon was placed three (3) meters below the air / water interface (low). The low coupon was approximately 1⁄2 meter above the tank bottom. The tanks remained filled during the entire study and the total exposure time was 1680 hours. All coupons were removed on September 20, 2008 and were shipped for analysis on September 21, 2008. The results are presented in Table T6.2 below. Due to the length of the exposure period water quality was not measured for the duration of the study. However, water quality data that is typical for the NIOZ harbor and chlorine dioxide treatment cycles can be found in Section 2.0.4.
Table T6.2 – Comparison of Corrosion Rates, Additional Corrosion Coupon Studies, NIOZ

Sample Date ClO2 Dosage (mg/L) Exposure time (Hrs) Corrosion Rate (mpy) Untreated tank (high) Jul – Sept. 2008 0 1680 2.7246 Untreated tank (mid) Jul – Sept. 2008 0 1680 2.5672 Untreated tank (low) Jul – Sept. 2008 0 1680 0.9385 Treated (high) Jul – Sept. 2008 5 1680 3.2891 Treated (mid) Jul – Sept. 2008 5 1680 2.6375 Treated (low) Jul – Sept. 2008 5 1680 2.4643 

### The corrosion rates were reviewed and interpreted by Brad Krantz, Senior Corrosion Scientist at Corrosion Testing Laboratories, Inc. The report of Corrosion Testing Laboratories confirms the theoretical discussion above regarding the effect that dissolved oxygen can have on the corrosion rate of mild steel in natural seawater. The full text of Mr. Krantz’s review of the NIOZ corrosion study is included in the references of this dossier. Mr. Krantz concluded 43 

### :

“

Although the corrosion rates for the specimens exposed in the treated tank are slightly higher than the untreated controls, all of the corrosion rates are within the range expected for carbon steels in natural seawater”. This additional corrosion work continues to support Ecochlor’s claim that there will be no adverse effects on ship metal surfaces with the use of the Ecochlor treatment methodology. 6.1.2.5 Ballast Tank Coatings Testing Information contained in the complete confidential Final Approval dossier.
6.1.3 Fire and Explosion The fire and explosion risks associated with the Ecochlor®

### BWTS relate to the precursor chemicals stored onboard or electrical components that are part of the system. 6.1.3.1 Preparation Chemicals Information was provided in the Basic Approval dossier (MEPC 58/2/2).

6.1.3.2 Active Substance Information was provided in the Basic Approval dossier (MEPC 58/2/2).

43 Corrosion Testing Laboratories, Inc., Review of Corrosion Test Data, November 2008

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### 6.1.3.3 Other BWTS Components Information was provided in the Basic Approval dossier (MEPC 58/2/2).

6.1.4 Chemical Storage Information was provided in the Basic Approval dossier (MEPC 58/2/2).

6.1.5 Accidental Chemical Release Information was provided in the Basic Approval dossier (MEPC 58/2/2). 6.1.5.1 Storage Tank Failure Information was provided in the Basic Approval dossier (MEPC 58/2/2). 6.1.5.2 Delivery Pipeline Failure Information was provided in the Basic Approval dossier (MEPC 58/2/2).

6.2 RISK TO TECHNICIANS AND/OR SHIP’S CREW 6.2.1 System Interaction – Risks to Technicians and Crew Information was provided in the Basic Approval dossier (MEPC 58/2/2). 6.2.1.1 Normal System Operation Information was provided in the Basic Approval dossier (MEPC 58/2/2). 6.2.1.2 System Maintenance and Chemical Refill Operations Information was provided in the Basic Approval dossier (MEPC 58/2/2).

6.3 RISKS TO HUMAN HEALTH AND HUMAN EXPOSURE SCENARIOS Comments from the GESAMP-BWWG (MEPC 58/2/8, Annex 5, Section 4.9) indicated the information provided for HES and Human Health Risk Characterization were adequately addressed in the Basic Approval dossier. No further analysis has been added to this Final Approval dossier.

6.3.1 Identification of Chemicals of Potential Concern and Sources Information was provided in the Basic Approval dossier (MEPC 58/2/2).
6.3.2 Human Exposure Assessment Information was provided in the Basic Approval dossier (MEPC 58/2/2).
6.3.3 Potential Exposure Health Risks Information was provided in the Basic Approval dossier (MEPC 58/2/2).

6.3.4 Risk Characterization Information was provided in the Basic Approval dossier (MEPC 58/2/2).
6.4 RISKS TO THE AQUATIC ENVIRONMENT Based on the discharge toxicity results from land based testing and the results of the hydrodynamic modeling, treated ballast water from the Ecochlor®

### BWTS will not present unacceptable risks to the aquatic environment. The calculated PEC/PNEC ratios for chlorite ion, chlorate ion and DBAA were <1, indicating no adverse effects from these constituents in treated ballast water discharge. The calculate PEC/PNEC ratio for chlorine dioxide is 2.49, which is considered to be a conservative value that was derived from an unattainable ‘worst-case’ scenario. More realistic modeling approaches yielded PEC/PNEC values <1 for chlorine dioxide.

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### Further, only during the land based testing have residuals of chlorine dioxide been measurable in treated ballast water 24 hours after treatment. This is unlike shipboard testing where chlorine dioxide residuals have not been measured 24 hours after treatment. The longer residual time observed is likely due to the fact that simulated ballast tanks at the land based testing facility did not contain any sediments and/or biofilms that are present within actual ballast tanks onboard ship. The oxidative reactions with sediments and/or biofilms increases the decay rate for chlorine dioxide. Therefore, using the highest chlorine dioxide residual measured 24 hours after treatment during land based testing is also considered a ‘worst-case’ scenario. Discharge toxicity testing from the land based unit resulted in Pacific oyster ( Crassostrea gigas ) being the most sensitive species of six taxonomic groups tested. The average EC50 for all Crassostrea tests was 51% (average NOEC = 31%). Thus, a two-fold dilution is necessary to reach a concentration less than the EC50, and a three-fold dilution is necessary to reach a concentration less than the NOEC value for Crassostrea . This low level of dilution will be achieved immediately upon discharge of treated ballast water. Further, the discharge toxicity testing results from land based testing compare well with previous conclusions regarding the dilution required to reach no-effect concentrations from shipboard discharge toxicity testing. For example, from shipboard discharge toxicity testing, acute toxicity with M. bahia resulted in EC50 values of 38.7% and 37.7% (v/v) and the NOEC for both tests was 25% sample. Thus, a three-fold dilution was necessary to reach a concentration less than the EC50 and a four-fold dilution was necessary to result in no acute toxicity with M. bahia

. Based on this assessment, although the PEC/PNEC value for chlorine dioxide is slightly >1, treated ballast water discharge from the Ecochlor BWTS will not present unacceptable risks to the aquatic environment.
6.5 ASSESSMENT REPORT (G9: 4.3) 6.5.1 Overview of Data and Endpoints As constituents potentially present in ballast water treated with the Ecochlor®

### BWTS, chlorine dioxide, chlorite ion, chlorate ion and dibromoacetic acid (DBAA) were evaluated in regards to persistence, bioaccumulation, and toxicity. In regards to persistence, chlorine dioxide was reported to have a half-life of 3.9 minutes in freshwater 33 

### (5 minutes in seawater), chlorite ion insea water had a measured half-life of <2 minutes in seawater, chlorate ion had a measured halflife of <1 day in seawater, and a half-life of 14 days was reported for DBAA in freshwater. The estimated log Kow

### values for chlorine dioxide and chlorite are -3.22 and -7.17 6 

### , respectively. The measured log Kow

### value for chlorate ion and DBAA are -2.9 34 

### and 1.22 14 

### , respectively. These Kow

### values, the physical and chemical characteristics, along with well-documented degradation behavior, indicate that these substances would not be expected to bioaccumulate. In regards to toxicity, the lowest LC50 for chlorine dioxide was 0.02 mg/L, while the lowest chronic NOEC for chlorite ion was 0.18 mg/L. For chlorate ion the NOEC (geometric mean) value was 0.06 mg/L and for DBAA, the lowest LC50 was 69 mg/L. Therefore, these substances do not meet the criteria to be classified as PBT substances. Prediction of environmental concentrations (PECs) using two separate hydrodynamic modeling programs was performed for each substance that may be present in treated ballast water discharge. The predicted no-effect concentrations (PNECs) were derived by applying an appropriate assessment factor to the lowest toxicity data points for each substance. For all substances, with the exception of chlorine dioxide, the PEC/PNEC ratio is <1, thereby indicating that no unacceptable risks to the aquatic environment can be expected from chlorite ion, chlorate ion and DBAA. Further, because the PECs were calculated based on a ‘worst-case’ scenario that considered the least amount of flushing (i.e. dilution) within the hydrodynamic model, and the

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### highest measured value (rather than the average) for each constituent, this assessment is considered adequately protective of the aquatic compartment.
For chlorine dioxide, the PEC/PNEC ratio = 2.49. This PEC was calculated for the Maashaven with the detailed model based on an unrealistic ‘worst-case’ scenario. When the chlorine dioxide PEC result of 0.015 μg/L as calculated with the MamPec model for the Maashaven under a ‘worst-case’ scenario is considered, a PEC/PNEC ratio of 0.75 is achieved. Further, when the chlorine dioxide PEC result of 0.000973 μg/L as calculated with the MamPec model for the whole Port of Rotterdam is considered, a PEC/PNEC ratio of 0.049 is achieved. Therefore, thePEC/PNEC = 2.49 for chlorine dioxide is a conservative value derived under unrealistic ‘worstcase’ conditions. Evaluation of discharge toxicity results from land based discharge demonstrated that the Pacific oyster ( Crassostrea gigas ) was the most sensitive species of the six taxonomic groups tested. The average EC50 for all Crassostrea tests is 51% (average NOEC = 31%). Thus, a two-fold dilution is necessary to reach a concentration less than the EC50, and a three-fold dilution is necessary to reach a concentration less than the NOEC value for Crassostrea . Additionally, the toxicity results between day 1 and day 5 discharges for Crassostrea were not significantly different, thereby indicating that treated water discharge will not present unacceptable risks when discharged within 24 of treatment and a longer holding time is not required. As presented in Sections 2.3.3 and 5.3.1, chlorine dioxide, chlorite ion and chlorate ion are oxidizing agents that do not produce harmful organic by-products. DBAA is not expected to have adverse reactions with organic matter. Additionally, chlorine dioxide degrades rapidly in marine and fresh waters, predominantly forming chlorite ion as a degradation by-product 33



### . Chlorite ion, chlorate ion, and DBAA are all considered non-persistent. Degradation of chlorine dioxide and chlorite ion both substances is by abiotic mechanisms and is predominantly a result of oxidative reactions. Chlorate ion and DBAA degradation by both abiotic and biotic mechanisms has been demonstrated. Land based testing at NIOZ in the Netherlands successfully demonstrated that the Ecochlor® 

### BWTS can safely and effectively treat ballast water for AIS to comply with the performance standards in Regulation D-2 of the International Convention for the Control and Management of Ship’s Ballast Water and Sediments, as well as standards proposed in the US Ballast Water Management Act of 2005 (Senate Bill S.363). Based on laboratory analysis, shipboard testing, and land based testing of treated ballast water, no related adverse effects from the use of the Ecochlor ®

### BWTS to comply with the Convention can be reasonably anticipated. The level of uncertainty in the data supporting this opinion is low. Additional data continues to be collected on the Ecochlor ®

### BWTS, further increasing the confidence in the results obtained through various analyses. The potential risks to the safety of ships, human health and the environment are mitigated by engineering and constructing systems that are designed for use onboard ships, proper chemical production, dosing, storage and handling, as well as thorough personnel training and use of PPE. The automatic dosing of chlorine dioxide treatment based on the amount of ballast water being brought onboard limits chlorine dioxide production, ensuring safe discharge of treated water to the environment. The substances used with the Ecochlor ®

### BWTS are not expected to persist in the environment or bioaccumulate, thereby presenting no risks to resources (i.e. beaches, fisheries).

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### 6.5.2 Test Report Data Quality Test reports used in this application were from a variety of sources, including, but not limited to, OECD SIDS, Eka Chemicals (performed by independent laboratories), independent research, USEPA, and the National Toxicology Program. The reports were evaluated to ensure that the data presented was generated by accredited laboratories using accepted standard methodologies and laboratory practices. The data met acceptable confidence intervals (i.e. >95%), indicating a low level of uncertainty associated with the data. For example, the following is quoted text from one mammalian toxicity study used in the risk characterization (Barrett, 1987): “Results of the inspections made by the Quality Assurance Unit at BIO/dynamics, Inc. indicate that this study was conducted in compliance with applicable United States Environmental Protection Agency’s Good Laboratory Practice Standards and applicable Standard Operating Procedures. No significant deviates were noted. Minor deviations may be include in the raw data” Proper quality assurance / quality control programs are strictly implemented at each of the laboratories that conducted testing on treated ballast water. These include NovaChem Labs (analytical chemistry), Nautilus Environmental, Chemex Environmental Limited, and Grontmij|AquaSense (toxicology). Documentation of the quality control that these labs adhere to are included in Appendix C of this dossier.

7.0 REFERENCE DOCUMENTS
1 International Maritime Organization, MEPC57/21, Annex 1, Resolution MEPC.169(57), Procedure for Approval of Ballast Water Management Systems That Make Use of Active Substances (G9), April 2008. 2 International Maritime Organization, MEPC 58/2/7, Annex 4, GESAMP-BWWG 6/9, Methodology for Information Gathering and the Conduct of Work of GESAMP-BWWG, May 2008. 3 International Maritime Organization, MEPC 58/2/2, Application for Basic Approval of the Ecochlor ®

### Ballast Water Treatment System, March 2008. 4 International Maritime Organization, MEPC 58/2/8, Annex 5, July 2008. 5 OECD SIDS, Sulfuric Acid, SIAM 11, January 2001, UNEP Publications. 6 US EPA Reregistration Eligibility Decision (RED) for Chlorine Dioxide and Sodium Chlorite (Case 4023), August 2006. 7 US EPA Toxicological Review of Chlorine Dioxide and Chlorite, September 2000. 8 EPA Guidance Manual, Alternative Disinfectants and Oxidants, Chlorine Dioxide, 1999

(http://www.epa.gov/safewater/mdbp/pdf/alter/chapt_4.pdf). 9 Simpson, G.D., Miller, R.F., Laxton, G.D., Clements, W.R., A Focus on Chlorine Dioxide: The “Ideal” Biocide. 10 OECD SIDS, Sodium Chlorite and Chlorine Dioxide, SIAM 23, October 2006. 11 World Health Organization, Guidelines for Drinking-Water Quality, 2006. 12 USEPA, Office of Ground Water and Drinking Water, DBP/ICR Analytical Methods Manual (EPA 814-B-96-002, April 1996. 13 Bubnis, B., The Rationale and Transition of Regulating Agencies Specifying the Reporting of Method Reporting Limits (MRLs) In-Lieu of Method Detection Limits (MDLs), October 2008. 14 World Health Organization, Brominated Acetic Acids in Drinking Water, Background

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### Document for Development of WHO Guidelines for Drinking-water Quality, 2004. 15 OECD SIDS, Sodium Chlorate, SIAM 22, April 2006. 16 NovaChem Laboratories, A Data Summary of the Ecochlor Ballast Water Treatment System at the Land Based Testing Facility Operated by the Royal Netherlands Institute for Sea Research (NIOZ), Nov 2008. 17 Ambient Water Quality Guidelines for Chlorate, Government of British Columbia, Environmental Protection Division, 2002. 18 van Wijk, D.J. Kroon, G.M. and Garttener-Arends, C.M., Toxicity of Chlorate and Chlorite to Selected Species of Algae, Bacteria, and Fungi, 1998. 19 Stauber, J.L., Toxicity of Chlorate to Marine Microalgae, 1998. 20 Nautilus Environmental, Toxicological Evaluations of Chlorine Dioxide, January 2005. 21 Nautilus Environmental, Algal Toxicity Testing using Chlorine Dioxide, May 2006. 22 Environmental Science & Engineering, Acute Toxicity of Sodium Chlorite to the Sheepshead innow (Cyprinodon variegatus), May 1994. 23 Environmental Science & Engineering, Acute Toxicity of Sodium Chlorite to Mysid Shrimp (Mysidopsis bahia), May 1994. 24 Nautilus Environmental, Supplemental Toxicity Testing using Chlorite, January 2008. 25 van Wijk, D.J and Hutchinson T.H., The Ecotoxicity of Chlorate to Aquatic Organisms: A Critical Review, 1995. 26 US EPA, ECOTOX Database, Aquatic Report for Dibromoacetic Acid, 2008. 27 Nautilus Environmental, Toxicological Evaluation of Ballast Water Treated with Chlorine Dioxide, Atlantic Compass Trial, August 2006. 28 Nautilus Environmental, Toxicological Evaluation of Ballast Water Treated with Chlorine Dioxide, Atlantic Compass Trial, September 2006. 29 Grontmij | AquaSense, Report of Ecotoxicological Studies, October 2008. 30 US EPA, Short-Term Methods for Estimating the Chronic Toxicity of Effluents and Receiving Waters to West Coast Marine and Estuarine Organisms, EPA/600/R-95-136 (Section 2), August 1995. 31 Canadian Water Quality Guidelines for the Protection of Aquatic Life, A Protocol for the Derivation of Water Quality Guidelines for the Protection of Aquatic Life, 2007. 32 Environmental Science & Engineering, Effect of Sodium Chlorite on New Shell Growth in Eastern Oyster ( Crassostrea virginica ), May 1994. 33 Review of the Environmental Fate and Effects of Chlorine Dioxide and Chlorite, Nautilus Environmental, 2007. 34 European Union, The Footprint Pesticide Properties Database, www.eu-footprint.org/ppdb.html 35 International Programme on Chemical Safety, Environmental Health Criteria 216, Disinfectants and Disinfectant By-Products, World Health Organization, 2000. 36 Concise International Chemical Assessment Document (CICADS) 37, Chlorine Dioxide (Gas), 2002. 37 Barrett, D.S. (1987) A Subchronic (3 Month) Oral Toxicity Study of Sodium Chlorate in the Rat via Gavage. 38 Barrett, D.S. (1987) A Subchronic (3 Month) Oral Toxicity Study in the Dog via Gavage Administration with Sodium Chlorate.

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### 39 Scientific Committee on Consumer Products (SCCP), Opinion on Hydrogen Peroxide in Tooth Whitening Products, 2005 (SCCP/0844/04). 40 NTP Technical Report on the Toxicology and Carcinogenesis Studies of Sodium Chlorate in F344/N Rats and B6C3F1 Mice (Drinking Water Studies), 2005. NTP TR 517, NIH Publication No. 06-4457. 41 European Chemical Bureau (2003) Hydrogen Peroxide Summary Risk Assessment Report, Special Publication I.03.148. 42 NTP Technical Report on the Toxicology and Carcinogenesis Studies of Dibromoacetic Acid in F344/N Rats and B6C3F1 Mice (Drinking Water Studies), April 2007, NTP TR 537, NIH Publication No. 07-4475. 43 Smith, D.J., Anderson, R. C., Ellig, E.A., and Larsen, G.L. (2005) Tissue Distribution, Elimination, and Metabolism of Dietary Sodium [36Cl}Chlorate in Beef Cattle. 44 Abdel-Rahman, M.S., Couri, D., and Bull, R.J. (1982) Metabolism and Pharmacokinetics of Alternate Drinking Water Disinfectants. Environmental Health Perspectives, v46, pp19-23. 45 US EPA Reregistration Eligibility Decision (RED) for Inorganic Chlorates (Case 4049), July 2006. 46 Hashimoto, S., Azuma, T., Otsuki, A., Distribution, Sources, and Stability of Haloacetic Acids in Tokyo Bay, 1998. 47 Lifongo, L., Bowden, D., Brimblecombe, P., Photodegradation of haloacetic acids in water, 2004. 48 US EPA Memorandum, Revised Inorganic Chlorates, HED Chapter of the Reregistration Eligibility Decision (RED) Case #4049, January 2006 49 Mosser, Mark L., Sermatech International Inc., September 15, 2005. 50 The Sulphur Institute Online, Glossary of Terms (http://www.sulphurinstitute.org/webarticles/anmviewer.asp?a=109&z=30). 51 Deltares, Draft Predicted Environmental Concentrations as a result of ballast water discharge in the Rotterdam harbor, 2008. 52 Rosemarin, A., Lehtinen, K., Notini, M, Mattsson, J., Effects of Pulp Mill Chlorate on Baltic Sea Algae, 1994. 53 Heidersbach, Bob; Dr. Rust, Inc.; Ballast Water Corrosion Rates Using the Ecochlor® 

### Ballast Water Treatment System, May 2007. 54 Corrosion Analysis Data Report, Metal Samples, Co., 2005. 55 Corrosion Testing Laboratories, Inc., Review of Corrosion Test Data, November 2008. 56 Physical and Chemical Characteristics of Purate ® 

### , Case Consulting Laboratories, 2000. 57 Chlorine Dioxide and Chlorite Toxicological Profile, Agency for Toxic Substances and Disease Registry (http://www.atsdr.cdc.gov/toxprofiles/tp160-c4.pdf).

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