marine environment protection committee ......appendix 1: quality control statement of test. 1...

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E

MARINE ENVIRONMENT PROTECTION COMMITTEE 63rd session Agenda item 2

MEPC 63/2/25 August 2011

Original: ENGLISH

HARMFUL AQUATIC ORGANISMS IN BALLAST WATER

Application for Final Approval of MICROFADETM Ballast Water Management System

Submitted by Japan

SUMMARY

Executive summary: This document contains an application for Final Approval of MICROFADE Ballast Water Management System under the Procedure for approval of ballast water management systems that make use of Active Substances (G9) adopted by resolution MEPC.169(57). This document contains a summary for translation purposes.1

Strategic direction: 7.1

High-level action: 7.1.2

Planned output: 7.1.2.6

Action to be taken: Paragraph 7

Related documents: BWM/CONF/36; MEPC 53/24/Add.1; MEPC 57/21; BWM.2/Circ.13 and BWM.2/Circ.31

Introduction 1 Regulation D-3.2 of the International Convention for the Control and Management of Ships' Ballast Water and Sediments stipulates that ballast water management systems that make use of Active Substances to comply with the Convention shall be approved by the Organization. 2 Japan herewith submits an application for Final Approval according to the Procedure for approval of ballast water management systems that make use of Active Substances (G9). This Procedure stipulates that the required information (MEPC 57/21, annex 1, paragraph 4.2.1) which, according to section 6, should be evaluated by the Organization. In accordance with BWM.2/Circ.31, the document in the annex contains the non-confidential part of the manufacturer's application dossier including:

1 This document is over 20 pages long and, in accordance with the provisions of Circular letter No.3087,

only the first three pages will be translated into the working languages with the annex in English only.

MEPC 63/2/2

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.1 a summary of the application dossier of the MICROFADE Ballast Water Management System (BWMS), which received Basic Approval under the name Kuraray BWMS, according to Procedure (G9);

.2 a list of references; and

.3 a quality control statement regarding the test.

The complete dossier will be made available to the experts of the GESAMP-BWWG with the understanding of confidential treatment. 3 The receiving competent authority in Japan has verified the application dossier and believes it to satisfy the data requirements of the Procedure (G9) adopted by resolution MEPC.169(57). Summary of non-confidential information on the MICROFADE Ballast Water Management System 4 The Committee, having considered the recommendations contained in annexes 4 and 5 of the "Report of the thirteenth meeting of the GESAMP-BWWG" (MEPC 61/2/15), as well as the recommendations contained in annex 4 of the "Report of the fourteenth meeting of the GESAMP-BWWG" (MEPC 61/2/21), agreed to grant Basic Approval to Kuraray Ballast Water Management System, proposed by Japan. The Kuraray BWMS developed by KURARAY Co. Ltd. has since been given the new name 'MICROFADE™ Ballast Water Management System'. KURARAY Co. Ltd. has made this application in order to obtain Final Approval for MICROFADE BWMS. This application contains the items recommended by the GESAMP-BWWG and the response. 5 MICROFADE consists of a Filtration Unit, a Chemical Infusion Unit, and a Main Control Unit. After removal of sediment particles and aquatic organisms by the Filtration Unit, KURARAY AS solution is infused to make concentration of TRO in ballast water at 2 mg/L for ballast water treatment. At discharge, TRO in treated ballast water is monitored by sensors. When TRO is at or below 0.2 mg/L, the treated ballast water will be discharged without neutralization. If TRO exceeds 0.2 mg/L, the treated ballast water will be automatically neutralized by infusion of KURARAY NS solution. Applied conditions of MICROFADE are as follows. This Final Approval application is submitted to request deliberation and approval concerning the use of this BWMS under the following conditions:

.1 Ballast water to be treated

All conditions of ballast water, not limited by salt content and temperature.

.2 Number of ballast water treatments

Once at water filling.

.3 Preparation and Active Substance concentration to be used

Preparation is KURARAY AS of which the main component is calcium

hypochlorite. The Active Substance is calcium hypochlorite. The maximum TRO concentration in ballast water is 2 mg/L.

MEPC 63/2/2

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.4 Holding time

Holding time is not set. Ballast water can be discharged immediately after treatment.

.5 Operation of TRO sensor

During discharge of ballast water, the TRO sensor monitors concentration of TRO before discharge. Neutralizing treatment is automatically executed when it detects TRO of more than 0.2 mg/L. Furthermore, the sensor monitors the TRO after neutralization to ensure that TRO at discharge is at or less than 0.2 mg/L.

.6 The maximum allowable discharge concentration

The maximum allowable discharge concentration (mg/L) of TRO and the Relevant Chemicals is as follows:

TRO (as Cl2) 0.2 Dibromoacetic acid 0.022

Bromoform 0.15 Tribromoacetic acid 0.10

Dibromochloromethane 0.0071 Bromochloroacetic acid 0.0011

Dibromomethane 0.0010 Bromodichloroacetic acid 0.0016

Dichloroacetic acid 0.0001 Dibromochloroacetic acid 0.0070

Monobromoacetic acid 0.0031 Dibromoacetonitrile 0.017

6 The safety of the MICROFADE system for the hull and crews can be sufficiently assured by implementing strict safety measures concerning transport, handling and storage of KURARAY AS, which has oxidizing power. In addition, safety is assured regarding the risk to the general public and the environment in the periphery of marine areas exposed to the above substances because the discharged concentration of TRO is at or less than 0.2 mg/L via the neutralizing treatment process. Action requested of the Committee 7 The Committee is invited to consider the proposal for approval and decide as appropriate.

***

MEPC 63/2/2 Annex, page 1

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ANNEX

NON-CONFIDENTIAL INFORMATION ON THE MICROFADETM BALLAST WATER MANAGEMENT SYSTEM

This annex contains the following:

1 INTRODUCTION 2 APPLICATION DATA SET 3 USE OF THE ACTIVE SUBSTANCE 4 MATERIAL SAFETY DATA SHEET 5 RISK CHARACTERIZATION 6 EVALUATION OF THE TREATED BALLAST WATER 7 RISK ASSESSMENT 8 CONCLUSION

REFERENCES APPENDIX 1: Quality control statement of test.

1 INTRODUCTION 1.1 Items pointed out by the GESAMP-BWWG for the Basic Approval application

in accordance with Procedure (G9) (MEPC 61/2/6) (MEPC 61/2/21, annex 4) and responses

Kuraray BWMS has been granted Basic Approval (MEPC 61/2/21), and Final Approval application is submitted under the system name of MICROFADE BWMS. In the Basic Approval application, the items for study until the Final Approval application were pointed out by THE GESAMP-BWWG. The items pointed out, the response to the items and the results of the response are described in detail in appendix 1 of the confidential dossier. A summary of the items pointed out and the responses to the items are shown below (regarding Comment 2, the response is fully described in the Introduction because it is based on toxicity tests and an environmental risk assessment of the Basic Approval. For other comments see chapters 3, 6 and 7 of this application in detail.): Recommendation 1 The TRO total residual oxidant (TRO) should be used for the evaluation of environmental influence. In the Final Approval, the maximum allowable discharge concentration (MADC) of the TRO in the BWMS is to be set at 0.2 mg/L (as Cl2). In addition, discharged ballast water should be monitored by a TRO sensor, and neutralization treatment should be performed, if necessary, to control the TRO concentration in the discharged ballast water. When the TRO concentration exceeds MADC, shutdown should be executed.


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Response 1 To apply for Final Approval, various tests were conducted using a full-scale land-based testing facility with two TRO sensors installed on the discharge line. One of the TRO sensors is intended to monitor the TRO concentration in treated ballast water and perform neutralization when the TRO concentration exceeds 0.2 mg/L. The other TRO sensor was intended to ensure the final TRO concentration of 0.2 mg/L or less. An auto shut-down function (interlock) was provided to forcefully stop ballast water discharge upon detection of a TRO concentration exceeding 0.2 mg/L by the second sensor. The two sensors were confirmed as functioning normally in all tests and performed neutralization upon detection of a TRO concentration exceeding 0.2 mg/L, thereby keeping the TRO concentration in ballast water discharges below the quantitative detection limit of 0.01 mg/L. It was also confirmed that ballast water discharge was shut down when the second sensor detected a TRO concentration exceeding 0.2 mg/L. Thus, MICROFADE is a BWMS that does not discharge ballast water with a TRO concentration exceeding 0.2 mg/L. (See sections 3.2.3, 3.3 and 6.6.) Recommendation 2 Prior to full-scale shipboard testing, follow-up laboratory WET tests shall be conducted using the appropriate dilution series to re-estimate toxicity effect (especially to algae). In particular chloramines shall be re-assessed, with the degradation rates stated in terms of the environmental influence, including the PEC/PNEC ratio. Shipboard testing shall be conducted only after the Administration satisfied with the follow-up laboratory WET tests results. Response 2 Follow-up laboratory WET tests were performed with appropriate QA/QC to clarify the toxicity effect of TRO and CRO. It is confirmed that neutralized ballast waters have no toxicity effect on algae, crustaceans and fish. The PEC/PNEC ratio was re-evaluated as in the Basic Approval stage. The discharged ballast waters from MICROFADE system were sufficiently safe for the marine environment. The result was confirmed by the Administration. (See section 1.1.3.) Recommendation 3 To receive Final Approval, full-scale WET tests shall be conducted with appropriate QA/QC; the relationship between chemical composition and toxicity shall be re-examined based on chemical identification data, MADC value re-setting, PEC value re-calculation, and PEC/PNEC ratio re-estimation shall be performed, and the chemistry of the ballast water treatment process shall be described in detail. Response 3 Full-scale WET tests were performed with appropriate QA/QC. The relationship between chemical composition and toxicity effect was re-examined, the MADC value was reset, and the PEC/PNEC value was recalculated. The treated ballast waters showed toxicity effect according to the TRO concentration. For every Relevant Chemical, the PEC/PNEC ratio, in which the PEC was calculated based on the assumption that maximum detected concentrations in treated ballast water (before neutralization) were set as MADC, was below


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one; thus, it was evaluated that the discharged ballast waters did not affect the marine environment. The TRO after neutralization were all below the quantitative detection limit (0.01 mg/L) and showed no toxicity effect. (See sections 6.4, 6.9 to 6.15.) Recommendation 4 To receive Final Approval, potential safety risks to the crew and the general public in association with the operation of the system and the transportation, storage, and handling of the Active Substance and the neutralizer shall be identified in human exposure scenarios (HES) and shall be properly assessed. Response 4 MICROFADE is under preparation for shipboard testing as per the Guidelines for approval of ballast water management systems (G8). The system design has been completed. Operating procedures, the safety manual covering transportation, storage and handling of the Active Substance and the neutralizer, and system maintenance procedures have also been established. In applying for the Final Approval, the relevant information has been included in the application dossier, along with the HES assessments including potential risks to the crew and the general public. It has been confirmed that MICROFADE is a BWMS capable of the proper control of risks. (See sections 7.1 and 7.2.) 1.2 Definition of TRO In this Final Approval application, the terms TRO, FRO and CRO are defined as follows:

Total Residual Oxidant (TRO) – The TRO is essentially an indicator value for the concentration of calcium hypochlorite, the Active Substance used in MICROFADE. This is measured as the total sum of FRO and CRO and expressed as Cl2 equivalent.

Free Residual Oxidant (FRO) – FRO is derived mainly from calcium hypochlorite. FRO is known to have strong oxidizing power.

Combined Residual Oxidant (CRO) – CRO is produced from the reaction between calcium hypochlorite and other chemical substances in water. Note, however, that the chemical substances constituting CRO (mainly chloramines and bromamines) react rapidly and in a complex manner with each other, and hence separate identification and quantification are impossible. CRO is automatically measured and monitored as a part of the TRO in MICROFADE. Hence, CRO should be regarded as a part of the TRO to properly assess environmental risks. Chloramines were inappropriately classified collectively as an independent Relevant Chemical at the time of the Basic Approval application and are regarded as a part of the TRO in the Final Approval application.

1.3 Follow-up laboratory WET tests and re-evaluation Follow-up laboratory WET tests were performed with proper QA/QC (cf. Recommendation 2). The environmental risk assessment was made on the basis of the test results. Prototype test equipment with 960 L/h flow rate, the same one used at Basic Approval tests, was used for the tests. Natural seawater and brackish water were used as the raw water for the tests.


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The test water was freshly treated ballast water and neutralized ballast water (freshly treated ballast water immediately neutralized with sodium sulfite). Test water was diluted at a common ratio of 3 from 100%, using untreated control water as the diluent. Regarding the raw water quality, brackish water in particular, DOC, POC, and TSS values were lower than the values of the standard test water requirement in Guidelines (G8). Thus, the laboratory WET test clarified the toxicity effect of the Active Substance (TRO) to aquatic life under a condition of lower degradation rate of TRO with less sediments and less organic matter. The above test results are summarized in Table 1-1. Details are described in appendix 3 of the confidential dossier. Re-evaluation of aquatic toxicity of follow-up laboratory WET tests The NOECs in the laboratory WET tests varied according to aquatic life and the lowest were as follows: 11% dilution in the algae growth inhibition and fish acute toxicity tests using seawater and 3.7% dilution in the algae growth inhibition test using brackish water. The above freshly treated ballast water had TRO and CRO concentrations of: 0.66 to 1.1 mg/L-TRO and 0.13 to 0.17 mg/L-CRO for seawater and 0.93 mg/L-TRO and 0.12 mg/L-CRO for brackish water. The detected concentrations were proper and reasonable considering the full-scale land-based WET test results. No toxicity effect was observed in any of the laboratory WET tests using neutralized ballast water. Hence, the NOECs were all 100% (undiluted). The TRO and CRO were both below the quantitative detection limit (0.01 mg/L). In the Basic Approval application, the TRO and CRO were also below the quantitative detection limit in the neutralizing tests; however, NOEC was reported to be 33%. However, the follow-up laboratory WET test with appropriate QA/QC showed reasonable results in both freshly treated waters and neutralized water reflecting the TRO and CRO concentrations. Thus, the follow-up laboratory WET tests provided appropriate toxicity evaluation, showing that the freshly treated ballast waters had an toxicity effect depending on the TRO concentration, while the neutralized ballast waters showed no toxicity effect and the TRO concentrations were below the quantitative detection limit (0.01 mg/L). Thus, the toxicity evaluation was considered appropriate, and neutralization process was confirmed to be effective.


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Table 1-1: Summary of full-scale land-based WET tests, laboratory WET tests and Basic Approval tests

TWD N-TWD TWD N-TWD TWD N-TWD TWD N-TWD TWD N-TWD TWD N-TWD

72h-ECr 50 25.5% >100% 25% >100% 28.3% >100% 16.4% >100% >10% >33% 5.8%

72h-LOEC 20% -- 11% -- 33% -- 11% -- 10% -- 2%72h-NOEC 4% 100% 3.7% 100% 11% 100% 3.7% 100% 2% 33% 0.4%TRO (mg/L) 0.97 ＜0.01 0.82 ＜0.01 0.66 ＜0.01 0.93 ＜0.01 0.2 ＜0.01 0.2 ＜0.01CRO (mg/L) 0.14 ＜0.01 0.12 ＜0.01 0.13 ＜0.01 0.12 ＜0.01 0.1 ＜0.01 0.2 ＜0.01

96h-LC 50 >100% >100% >100% >100% >100% >100% >10% >33% >10% >33%

96h-LOEC 100% -- 100% -- 100% -- -- -- -- --96h-NOEC 20% 100% 33% 100% 33% 100% 10% 33% 10% 33%

TRO (mg/L)0.72

- 0.82＜0.01

0.55- 0.83

＜0.01-0.03

0.89- 1.1

＜0.01＜0.01- 0.3

＜0.01 0.2 ＜0.01

CRO (mg/L)0.13

- 0.16＜0.01

0.12- 0.13

＜0.01-0.03

0.15- 0.16

＜0.01＜0.01- 0.2

＜0.01 0.2 ＜0.01

21d-LOEC 100% -- -- -- 100% -- -- -- -- --21d-NOEC 20% 100% 100% 100% 33% 100% 10% 33% 10% 33%

TRO (mg/L) 1.0-1.2 ＜0.010.11

- 0.16＜0.01

0.87- 1.1

＜0.01＜0.01- 0.4

＜0.01 0.2-0.3＜0.01- 0.1

CRO (mg/L)0.10

- 0.15＜0.01 0.09 ＜0.01

0.13- 0.17

＜0.01＜0.01- 0.2

＜0.01 0.2 ＜0.01

96h-LC 50 44.7% >100% 58% >100% 29.4% >100% >10% >33% >10% >33%96h-LOEC 100% -- 100% -- 33% -- -- -- -- --96h-NOEC 20% 100% 33% 100% 11% 100% 10% 33% 10% 33%

TRO (mg/L)0.77

- 0.97＜0.01

0.72-0.77

＜0.010.92- 1.0

＜0.01＜0.01- 0.4

＜0.01 0.2 ＜0.01

CRO (mg/L)0.14

- 0.15＜0.01

0.10- 0.11

＜0.010.13

- 0.17＜0.01

＜0.01- 0.2

＜0.01 0.2 ＜0.01

28d-LOEC 100% -- -- -- 100% -- -- -- -- --28d-NOEC 20% 100% 100% 100% 33% 100% 10% 33% 10% 33%

TRO (mg/L) 1.0-1.2 ＜0.010.09

- 0.16＜0.01

0.87- 1.1

＜0.01＜0.01- 0.4

＜0.01- 0.4

0.2＜0.01- 0.1

CRO (mg/L)0.09

- 0.15＜0.01

0.07- 0.09

＜0.010.12

- 0.17＜0.01

＜0.01- 0.2

＜0.01- 0.2

0.2 ＜0.01

Fish

Acu

te to

xici

tyC

hron

ic to

xici

t y

Laboratory WET tests

Natural seawaterNatural brackish

water

Cru

stac

ea

Full-scale land-based WET tests

Chr

onic

toxi

city

Acu

te to

xici

ty

G9 Basic Approval

Alg

ae g

row

thin

hibi

tion

test

G8 Brackishwater

G8 SeawaterG8 Brackish

water

Adverseeffect

G8 Seawater

-- : Not measured , / : Not tested TWD: Treated water discharge, N-TWD: Neutralized treated water discharge TRO and CRO are at the beginning of the exposure test (in 100% test water)

PEC/PNEC ratio re-evaluation using the laboratory WET tests (Basic Approval stage) In the Basic Approval application, CRO were all regarded as chloramines and the evaluation made included the PEC calculation and PEC/PNEC ratio calculation based on the laboratory WET test results. The PEC/PNEC ratio was 1.25, exceeding one. Because the chloramine concentration was reduced by neutralization to yield a PEC/PNEC ratio of 0.125 (after neutralization) and because chloramines degrade rapidly, the conclusion was that the resulting environmental risks were in the allowable range. Based on the laboratory WET tests, re-calculation of PEC and re-evaluation of the PEC/PNEC ratio were done for all the Active Substance and Relevant Chemicals. The port of Tokyo was chosen as the target port for the PEC calculation as well as the Basic Approval application in order to make good comparison. The MADC of the Relevant Chemicals were set at the maximum detected concentrations of freshly treated ballast water on follow-up laboratory WET tests. The MADC of the Active Substance was set at 0.2 mg/L-TRO. The physical and chemical properties of the Active Substance and the


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Relevant Chemicals were the same values as in the Basic Approval application, as shown in Tables 2.5-1 to 2.5-4 of the confidential dossier. The degradation of CRO was set at the lowest rate under the lowest temperature condition (see appendix 5 of the confidential dossier). In other words, it is the worst case scenario at the port of Tokyo. For the PEC value re-calculation, MAMPEC model version 2.5 was used. According to the manual, MAMPEC model version 2.5 tends to output higher PEC values than version 2.0. Table 1-2 shows results of PEC re-calculation and PEC/PNEC ratio re-evaluation. The PEC/PNEC ratio of all the Active Substance and the Relevant Chemicals, including chloramines (CRO), were all below one.

Table 1-2: PEC/PNEC ratio re-evaluation using the laboratory WET tests

The PEC/PNEC ratio of CRO was 0.923. The value was calculated setting the MADC at 0.17 mg/L (see Table 1-1). In the practical operation of MICROFADE, when the TRO in discharging ballast water exceeds 0.2 mg/L, neutralization is executed and the TRO becomes lower than the quantitative detection limit (0.01 mg/L). Therefore, it is important to


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clarify that the actual CRO concentration at TRO is 0.2 mg/L to determine that the setting value of 0.17 mg/L-CRO includes a sufficient safety margin. Table 1.2-3 of the confidential dossier shows CRO concentrations of the degradation tests when the TRO was around 0.2 mg/L (0.15 to 0.25 mg/L). Degradation tests were performed using a variety of water qualities and temperatures (see appendix 5 of the confidential dossier). The maximum detected concentration of CRO was 0.09 mg/L at TRO of 0.25 mg/L and the average CRO concentration was ca. 0.05 mg/L. Thus, 0.17 mg/L of CRO was far beyond the actual concentration detected in discharging ballast water and certainly belonged to the case of neutralization. It was thus concluded that the PEC/PNEC ratio of 0.923 for CRO was estimated with an excess of environmental risks. In conclusion, laboratory WET tests were performed with appropriate QA/QC to clarify the toxicity effect and the PEC/PNEC ratio was re-evaluated. Discharging ballast water by MICROFADE was evaluated to be sufficiently safe for the marine environment. The Administration confirmation of follow-up laboratory WET tests results The Administration is satisfied with the results of the above-described follow-up laboratory WET tests; that is, MICROFADE treats ballast water to levels that would not affect the environment. 2 APPLICATION DATA SET Additional data of the four newly-identified Relevant Chemicals (dibromomethane, dichloroacetic acid, bromochloroacetic acid and bromodichloroacetic acid) and various additional tests for Final Approval are provided here. Apart from the additional data, the data sets are identical to that of the Basic Approval application (MEPC 61/2/6); see chapter 2 of the confidential dossier. 2.1 Identification of the Active Substance or Preparation (G9: 4.1) 2.1.1 Preparations (G9: 4.2.2) The preparation that is infused into the ballast line of the MICROFADE BWMS is KURARAY AS, the main component of which is the Active Substance, calcium hypochlorite. See paragraph 2.1.1 of the confidential dossier for details. 2.1.2 Active Substances The Active Substance used in the MICROFADE BWMS is calcium hypochlorite. See paragraph 2.1.2 of the confidential dossier for details. 2.1.3 Relevant Chemicals (G9: 2.1.4) Identification of Relevant Chemicals To identify Relevant Chemicals (hereafter referred to as "RCs") produced during the treatment of seawater and brackish water with the KURARAY AS, i.e., the preparation for MICROFADE, the following tests, the results of which are summarized in Table 2-1, were performed.


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(1) Preliminary tests: with full-scale land-based equipment (250 m3/h), treated ballast water of Guidelines (G8) standard seawater and brackish water (cf. appendix 2-1 of the confidential dossier).

(2) Guidelines (G8) standard tests: with full-scale land-based equipment, treated ballast water of

Guidelines (G8) standard seawater and brackish water (cf. appendix 2-2 of the confidential dossier).

(3) Degradation tests: with full-scale land-based testing equipment, treated ballast water of

Guidelines (G8) standard seawater and brackish water, stored at 5°C and 20°C for 24 and 120 hours, respectively, (cf. section 6.3 and appendix 5-3 of the confidential dossier).

(4) Laboratory WET tests: treated ballast water prepared using prototype equipment

(960 L/h) for repeated WET tests (cf. appendix 3 of the confidential dossier). In preliminary tests, 30 chemicals to analyse were selected according to the known reaction of calcium hypochlorite in seawater and designated RCs in MEPC 59/2/13. In freshly treated water (non-dilution), nine chemicals were detected and classified as RC candidates. In Guidelines (G8) standard tests, 18 chemicals, including dichloromethane that was detected in the Basic Approval application, nine chemicals detected in preliminary tests and designated RCs in MEPC 59/2/13, were analysed. As a result, following 11 chemicals were detected and identified as RCs of MICROFADE in this report:

.1 bromoform

.2 dibromochloromethane

.3 dibromomethane

.4 dichloroacetic acid

.5 monobromoacetic acid

.6 dibromoacetic acid

.7 tribromoacetic acid

.8 bromochloroacetic acid

.9 bromodichloroacetic acid

.10 dibromochloroacetic acid

.11 dibromoacetonitrile

Details are described in appendix 2 of the confidential dossier. Mechanism of formation of Relevant Chemicals When dissolved in water, calcium hypochlorite dissociates into Ca2+ and ClO- ions and the ClO- ion is in equilibrium with HClO in water. Chloride compounds, such as ClO- ions and HClO, react with humic acid substances in water to produce halogenated substances, such as trihalomethanes, halogenated acetic acids and halogenated acetonitriles. Generally, the structure of trihalomethane is represented as CHX3 (X: Cl, Br). Humic acid substances include the acetyl group, carboxyl group, phenol group, alcohol group, carbonyl group, methoxyl group, and so on. Reaction with these humic acid substances proceeds faster at a higher pH. Meanwhile, halogen reacts with amino acids and peptides


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contained in natural water to produce halogenated acetonitriles. The main reaction pathways are oxidation, addition and substitution. While most halogenation by-products are produced by oxidation and substitution, those containing double bonded organic compounds undergo halogen-addition reactions. In seawater with a relatively high concentration of bromine ion, hypochlorous acid undergoes conversion into hypobromous acid via chlorine-bromine substitution in water. Similarly to hypochlorous acid, hypobromous acid reacts with various substances in water to produce brominated/chlorinated by-products. Hypobromous acid is a strong halogenating agent though it has lower oxidizing power than hypochlorous acid. 2.1.4 Other Chemicals

When TRO in ballast water is more than 0.2 mg/L, MICROFADE adds KURARAY NS, sodium sulfite (purity >97%), for neutralization before discharging the ballast water. Sodium sulfite is a highly versatile reducing agent (antioxidant), which can also be used as a food additive. The additives and impurities contained in the KURARAY AS, preparation, are also classified as Other Chemicals. Details are described in 2.1.4 of the confidential dossier.

Table 2-2: Chemical information on Other Chemicals

Chemical Name CAS No. Empirical formula

Molar mass

Proper shipping name

UN No. UN class or

division

Classification based on

Regulation (EC) No

1272/2008

Sodium sulfite 7757-83-

7 Na2SO3 126.04 N/A N/A

Calcium chlorate 10137-

74-3 Ca(ClO3)2 206.98

Calcium chlorate 1452 5.1

N/A

Calcium hydroxide 1305-62-

0 Ca(OH)2 74.09 N/A N/A

Calcium chloride 10043-

52-4 CaCl2 110.98 N/A Eyes Irrit.2

Calcium carbonate 471-34-1 CaCO3 100.09 N/A N/A

Sodium chloride 7647-14-

5 NaCl 58.44 N/A N/A

Sodium polyphosphate

68915-31-1

Na5P3O10 367.86 N/A N/A


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2.2 Data on effects on aquatic plants, invertebrates and fish, and Other biota, including sensitive and representative organisms (G9:4.2.1.1

2.2.1 Acute aquatic toxicity

Table 2-3: Acute aquatic toxicity

RC Species End point Reference

Dibromomethane N/A N/A N/A

Dichloroacetic acid

F Cyprinus carpio, FW 96h-LC50=82– 123mg/L U.S. EPA, 2010f

C Nitocra spinipes, SW 96h-LC50=23mg/L

A N/A N/A N/A

Bromochloroacetic acid N/A N/A N/A

Bromodichloroacetic acid N/A N/A N/A

F: Fish, C: Crustacea, A: Algae FW: Fresh water, SW: Salt water, N/A: Not available 2.2.2 Chronic aquatic toxicity There were no data available on the chronic toxicity of dibromomethane, dichloroacetic acid, bromochloroacetic acid, and bromodichloroacetic acid. 2.2.3 Endocrine disruption There were no reports available that provided evidence of endocrine disruption in environmental organisms caused by any of the four RCs. 2.2.4 Sediment toxicity There was no information on the toxicity effect of the four RCs on the benthos. LogPow values of all the four RCs are smaller than three and thus they are not considered to show sediment toxicity.

Table 2-4: Sediment toxicity

RC logPow BCF Reference

Dibromomethane 1.70 4.06 U.S. NLM: HSDB, 2010m

Dichloroacetic acid 0.92 3.16 U.S. NLM: HSDB, 2010n

Bromochloroacetic acid 0.61 3.16 U.S. NLM: HSDB, 2010b


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2.2.5 Bioavailability/biomagnification/bioconcentration There is low possibility that the four RCs show biomagnification/bioconcentration, considering that the BCF are estimated as small. 2.2.6 Food web/population effects The four RCs have BCF of less than 21. Considering the low bioaccumulation potentials in any of the organisms (algae, invertebrates and fish) constituting the food web, these chemicals are unlikely to affect the food webs or individual populations. 2.3 Data on mammalian toxicity (G9: 4.2.1.2) 2.3.1 Acute toxicity

Table 2-5: Data on acute mammalian toxicity

RC Expo. route

Species End

point Results Reference

DBM Oral Rat LD50 108 mg/kg-bw NITE, 2010

Inhalation Rat LC50 40,000 mg/m3 U.S. NLM: HSDB, 2010mDermal Rabbit LD50 > 4,000 mg/kg- NITE, 2010

DCAA N/A N/A N/A N/A N/A BCAA N/A N/A N/A N/A N/A BDCAA N/A N/A N/A N/A N/A DBM: Dibromomethane, DCAA: Dichloroacetic acid, BCAA: Bromochloroacetic acid, BDCAA: Bromodichloroacetic acid, N/A: Not available

2.3.2 Effects on skin and eye

Table 2-6: Skin/eye/airway corrosion/irritation/sensitization

RC Item Species Method Results Reference/Comments

DBM Skin and

eye Rabbit N/A

Slight irritation

PATTY 5th, 2001

DCAA N/A N/A N/A N/A From their chemical structures, haloacetic acids are expected to decrease their pH in aqueous solution and may become irritating or corrosive depending on their concentrations.

BCAA N/A N/A N/A N/A

BDCAA N/A N/A N/A N/A

DBM: Dibromomethane, DCAA: Dichloroacetic acid, BCAA: Bromochloroacetic acid, BDCAA: Bromodichloroacetic acid, N/A: Not available

2.3.3 Repeated-dose toxicity Information on repeated-dose toxicity is listed in Table 2-7.


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2.3.4 Chronic toxicity

Table 2-8: Chronic toxicity

RC Species Expo. route

Expo. dura- tion

Exposure dose

Results NOAEL/NOEL

Ref.

DBM N/A N/A N/A N/A N/A N/A N/A

DCAA Mouse Ingestion (drinking water)

60 weeks

0, 0.05, 0.5, 3.5 and 5 g/L (0, 7.6, 77,

410 and 486 mg/kg

per day equivalents)

0.5 g/L or more: Relative liver weight gains

3.5 g/L or more: Body weight gain

suppression

Not determined

U.S. EPA: IRIS, 2003

BCAA N/A N/A N/A N/A N/A N/A N/A DBCA N/A N/A N/A N/A N/A N/A N/A


2.3.5 Developmental and reproductive toxicity Information on developmental and reproductive toxicity is listed in Table 2-9.


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2.3.6 Carcinogenicity

Table 2-10: Carcinogenicity

RC Species Method Details Results Ref.

DBM N/A N/A N/A N/A

DCAA Human

Carcinogenicity evaluations by international organization

Classified by IARC into Group 2B (probably carcinogenic to human)

IARC, 2004b

BCAA

Rat, both

sexes

2-year carcinogenicity

study

Increased incidences of malignant mesothelioma (males

only)/colorectal adenoma U.S. NTP 2009 Rat,

both sexes

2-year carcinogenicity

study

Incidences of hepatocellular neoplasia and hepatoblastoma

(males only)

BDCAA N/A N/A N/A N/A


2.3.7 Mutagenicity/genotoxicity Information on mutagenicity/genotoxicity is listed in Table 2-11.


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2.3.8 Toxicokinetics

Table 2-12: Toxicokinetics

RC Results References

DBM Upon inhalation, experimental animals undergo an increase in the blood bromide concentration. Metabolized in the body to carbon monoxide.

PATTY 5th, 2001

DCAA

Metabolized by glutathione S-transferase (GSTzeta) to glyoxylic acid. Glyoxylic acid further undergoes oxidation into oxalic acid, reduction into glycolic acid and amino-transfer to glycine. Discharged as carbon dioxide in exhaled air.

IARC, 2004b

BCAA

When forcefully administered orally to a rat, expected to reach the maximum blood concentration 1.5 hours after administration and then undergo rapid absorption. Exists mainly in free form, unbound to rat plasma protein. It is expected from in vitro experiment results, etc., that many will be metabolized to glyoxylic acid and further to glycolate, oxalate, glycine and carbon dioxide and then rapidly discharged. Supposedly, does not have placental permeability.

U.S. NTP, 2009

BDCAA N/A N/A DBM: Dibromomethane, DCAA: Dichloroacetic acid, BCAA: Bromochloroacetic acid, BDCAA: Bromodichloroacetic acid, N/A: Not available 2.4 Data in environmental fate and effect under aerobic and anaerobic conditions

(G9: 4.2.1.3)

2.4.1 Modes of degradation (biotic; abiotic) Considering the lack of hydrolytic reaction groups in its structure, halogenated acetic acids are not expected to undergo hydrolysis.

Table 2-13: Modes of degradation (biotic and abiotic)

RC Aerobic/

AnaerobicResults Reference

DBM Hydrolysis at pH 5, 7, 9 N/A 2.5×10-8 L/mol-sec

U.S. NLM: HSDB, 2010m

Bio-Degradation N/A Not degrade Half decay period N/A More than decades

DCAA

Hydrolysis at pH 5, 7, 9 N/A N/A U.S. NLM: HSDB,

2010n Bio-Degradation N/A

97% BOD (2 weeks)

Half decay period N/A N/A

BCAA Hydrolysis at pH 5, 7, 9 N/A N/A

U.S. NLM: HSDB, 2010b

Bio-Degradation N/A N/A Half decay period N/A N/A

BDCAA Hydrolysis at pH 5, 7, 9 N/A N/A

N/A Bio-Degradation N/A N/A Half decay period N/A N/A



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2.4.2 Bioaccumulation, partition coefficient, octanol/water partition coefficient The four RCs are expected to have low bioconcentration potential.

Table 2-14: Bioaccumulation

RC logPow BCF Reference

Dibromomethane 1.70 4.06 U.S. NLM: HSDB, 2010m

Dichloroacetic acid 0.92 3.16 U.S. NLM: HSDB, 2010n

Bromochloroacetic acid 0.61 3.16 U.S. NLM: HSDB, 2010b

Bromodichloroacetic acid 1.53 3.16 U.S. NLM: HSDB, 2010c

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

(ballast water, marine and fresh water) The four RCs are persistent as well as other RCs.

Table 2-15: Persistence and identification of principal degradation product

RC Method Result Reference

Dibromomethane N/A Persitent U.S. NLM: HSDB, 2010m Dichloroacetic acid N/A Persistent U.S. NLM: HSDB, 2010n

Bromochloroacetic acid N/A Persistent U.S. NLM: HSDB, 2010b Bromodichloroacetic acid N/A Persistent U.S. NLM: HSDB, 2010c

N/A: Not Available 2.4.4 Reaction with organic matter Having stable chemical structures, the four RCs are considered not to react with the organic matters. 2.4.5 Potential physical effects on wildlife and benthic habitats No data on physical effects on wildlife and benthic habitats were obtained on the four RCs. The conclusion was that halogenated acetic acids have low volatile pressure (less than 1 mmHg) and high water solubility (more than 1 g/L) and mostly remain in water. Therefore, it was determined that there was no physical effect on the wildlife or benthic habitats.


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2.4.6 Potential residues in seafood It was determined that the four RCs as well as other RCs were not accumulated in the seafood considering to solubility in water and the octanol/water partition coefficient. 2.4.7 Any known interactive in effects The four RCs were comparatively stable chemicals and bio-degraded under the habituated condition. 2.5 Physical and chemical properties for the Active Substances and

Preparations and treated ballast water, if applicable (G9: 4.2.1.4) Physical and chemical properties of newly identified Relevant Chemicals, namely dibromomethane, dichloroacetic acid, bromochloroacetic acid and bromodichloroacetic acid, are listed in Table 2-16.

Table 2-16: Physical and chemical properties of newly identified Relevant Chemicals

Chemical

name Dibromo-methane

Dichloroacetic acid

Bromochloro acetic acid

Bromodichloro acetic acid

CAS number 74-95-3 79-43-6 5589-96-8 71133-14-7 Molecular formula

CH2Br2 C2H2Cl2O2 C2H2BrCl2O2 C2HBrCl2O2

Molecular weight

173.84 128.94 173.39 207.84

Melting point -52.5 ℃ (SRC,

2010) 13.5 ℃ (SRC,

2010) 31.5°C（ SRC,

2010） N.A.

Boiling point 97 ℃ 194 ℃ 215°C (SRC,

2010) N.A.

Flammability

Not flammable by standard test in air (U.S. NLM: HSDB, 2010m)

N.A. N.A. N.A.

Density 2.4969 g/cc @

20℃ (U.S. NLM: HSDB, 2010m)

Specific Gravity =1.5634

(U.S. NLM: HSDB, 2010n)

1.9848 g/cm3 (U.S. NLM:

HSDB, 2010b) N.A.

Vapour pressure

44.4 mmHg @ 25℃

(SRC, 2010)

0.179 mmHg @ 25℃

(U.S. NLM: HSDB, 2010n)

0.137 mmHg (SRC, 2010)

0.036 mmHg (SRC, 2010)

Vapour density(air=1)

6.05 (air = 1) (U.S. NLM:

HSDB, 2010n)

4.45 (air = 1) (U.S. NLM:

HSDB, 2010n) N.A. N.A.

Water solubility

11.9 g/L (30 ℃, exp)

(SRC, 2010)

100 g/L (20 ℃, exp)

(SRC, 2010)

24.6 g/L (est, @ 25°C)

(SRC, 2010)

4,870 mg/L (est, @ 25°C)

(SRC, 2010)

Dissociation constant

No dissociable group

pKa = 1.26 (U.S. NLM:

HSDB, 2010n)

pKa = 1.4 (est) (U.S. NLM:

HSDB, 2010b)

pKa = 0.03 (est)(U.S. NLM:

HSDB, 2010c)


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Table 2-16: Physical and chemical properties of newly identified Relevant Chemicals

Chemical

name Dibromo-methane

Dichloroacetic acid

Bromochloro acetic acid

Bromodichloro acetic acid

Oxidation-reduction potential

N.A. N.A. N.A N.A.

Corrosivity to Material

N.A. N.A. N.A N.A.

Auto ignition temperature

(℃)

Not flammable by standard test in air (U.S. NLM: HSDB, 2010m)

N.A. N.A N.A.

Explosive Properties

N.A. N.A. N.A N.A.

Oxidizing properties

N.A. N.A. N.A N.A.

Surface tension

N.A. N.A. N.A N.A.

Viscosity 1.32 mPa @ 0°C

(U.S. NLM: HSDB, 2010m)

N.A. N.A N.A.

Thermal stability and breakdown

product

N.A.

When heated to decomposition, it

emits toxic fumes (U.S. NLM: HSDB,

2010n)

N.A. N.A.

Reactivity to container material

N.A. N.A. N.A. N.A.

pH in solution N.A. N.A. N.A. N.A.

Log Pow 1.7 (exp) (SRC,

2010) 0.92 (exp)

(SRC, 2010) 0.16 (est)

(SRC, 2010) 1.53 (est)

(SRC, 2010) Other physical and chemical

properties N.A. N.A. N.A. N.A.

N.A.: Not Available 3 USE OF THE ACTIVE SUBSTANCE 3.1 Overview of the MICROFADE BWMS MICROFADE is a BWMS developed with careful consideration of size reduction, energy-saving, safety, reliability and easy-handling of its components. MICROFADE is incorporating years of manufacturing and environmental technology experience, and is systematically designed for easy installation into the ballast piping system on board new or existing ships.


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MICROFADE consists of a Filtration Unit, a Chemical Infusion Unit, and a Main Control Unit. After the filtration and removal of sediment particles and aquatic organisms in the ballast water by the Filtration Unit, KURARAY AS solution is infused with the TRO concentration at 2 mg/L (as Cl2, the same hereafter) for water treatment. The treated ballast water will be discharged without neutralization, if the TRO concentration is at or below 0.2 mg/L. If the TRO concentration exceeds 0.2 mg/L, the treated ballast water will be neutralized by infusion of KURARAY NS solution. Thus, MICROFADE treats ballast water to meet the D-2 Standard under the BWM Convention. MICROFADE is designed to minimize the impacts of ballast water on the marine environment. The high-precision filters out most plankton and other large organisms for a return to the waters of origin. What is more, the system requires a minimum amount of the Active Substance to sterilize trace amounts of residual organisms. 3.2 System configuration and main components of MICROFADE 3.2.1 Filtration Unit The Filtration Unit (treatment rated capacity (TRC) = 250 m3/h) basically consists of three filter housings, each loaded with filter elements made of polyolefin nonwoven fabric. To prevent clogged filter elements and ensure long-term stable operation, each housing must programmatically undergo periodic air backwashing. The sediment particles, aquatic organisms, and other impurities removed from the filters by backwashing are discharged with treated water back into the ballast water intake zones during the filtration process. 3.2.2 Chemical Infusion Unit Sterilization performed during ballasting – Seawater filtered by the Filtration Unit then undergoes sterilization by infusion of KURARAY AS solution in the Chemical Infusion Unit. The components involved in the sterilization process during ballasting are as follows: KURARAY AS hopper, KURARAY AS dissolving tank, KURARAY AS solution stock tank, KURARAY AS solution infusion pump (P2), TRO sensor (RC1), and the circulation pump (P1). Neutralization performed during deballasting – The main components of the Chemical Infusion Unit involved in the neutralization of deballast water are basically as follows: KURARAY NS hopper, KURARAY NS dissolving tank, KURARAY NS solution stock tank, KURARAY NS solution infusion pump (P3), TRO sensors (RC2 and RC3), and the circulation pump (P1). 3.2.3 TRO Sensor MICROFADE uses the following two different types of TRO sensors: one for the analysis of KURARAY AS solution with a TRO concentration of 3,000 mg/L, and the other for the TRO analysis of deballast water. Both sensors analyse TRO, combination of FRO and CRO, and have good correlation to the standard DPD (N,N-diethyl-p-phenylenediamine) method (as in, e.g., US EPA METHOD 330.5) (see APPENDICES 6-3 and 7-2). 3.3 Main features MICROFADE has the following features:

.1 It is an environmentally friendly system designed to conserve the environment in the deballasting areas by controlling deballasting properly


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with TRO sensors and an automatic neutralization system, measuring the TRO concentration before and after neutralization, and tripping the interlock to stop deballasting in the case of an excess of the maximum allowable discharge concentration (MADC) of 0.2 mg/L.

.2 The Main Control Unit (MCU) automatically controls device operations and

valve open/close operations. The MCU display screen provides visual access to monitor the operation status of MICROFADE. MICROFADE is an automated system that requires no human intervention during device operations or valve open/close operations, except for emergency maintenance or troubleshooting.

.3 Fully protected against leakage of KURARAY AS solution.

.4 All parts exposed to high-concentrations of KURARAY AS solution are

completely corrosion-proof. In addition, the KURARAY AS solution is infused with the TRO concentration low at 2 mg/L to minimize corrosion of the ship's hull.

.5 Infuses a low-concentration chemical solution and usually requires no

neutralization before deballasting, and hence produces low environmental impacts.

.6 Returns large aquatic organisms (ca. 25 μm or more) back to the waters of

origin.

.7 No holding time prescribed.

.8 Ballast water sterilization-treatment only during ballasting.

.9 Uses solid chemicals for easy storage and has a small footprint.

.10 Has low-pressure loss and usually requires no enhancement of the ballast pump power.

.11 Capable of operation with low power consumption.

3.4 Materials used for the units constituting MICROFADE The Active Substance used in MICROFADE consists primarily of calcium hypochlorite and the oxidizing substances produced are inherently corrosive. Using treated water prepared by a full-scale system, a corrosivity test was performed to reveal that neither the Active Substance nor the oxidizing substances are intolerably corrosive to the internal coating of the ballast water tank nor to the materials exposed to them (cf. section 6.7 of this application and appendix 13 of the confidential dossier). Accordingly, no additional corrosion proofing is required for the ship's hull. It suffices to corrosion-proof only some parts of the units constituting MICROFADE that are exposed to high-concentration hypochlorous acid. The components that prepare, stock, and infuse KURARAY AS solution are exposed to a high TRO concentration of 3,000 mg/L, while the circulation line is exposed to an approximate TRO concentration of 60 mg/L. These components and the circulation line are constructed with anti-corrosive materials. Note that the listed materials were tested by


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exposure to their respective corresponding TRO concentrations and were found to safely withstand the exposure. Note also that the PVC pipes and members used for the parts exposed to a high TRO concentration of 3,000 mg/L are products certified by ClassNK. 3.5 Environmental test results of the units constituting MICROFADE As required by the Guidelines for Approval of Ballast Water Management Systems (hereafter "Guidelines (G8"), environmental testing must be performed on the electrical and electronic components of MICROFADE to guarantee that they meet the safety and reliability requirements for ship equipment. All pieces of equipment listed below are ensured of their safety and reliability by environmental testing. As for any other electronic components not included in the list, the classification society-certified products shall be selected to ensure safety and reliability.

.1 Main Control Unit

.2 Filtration Unit (incl. I/O-F Box)

.3 Chemical Infusion Unit (incl. I/O-C Plate)

.4 Electromagnetic flow meter Additionally, MICROFADE was installed on a general cargo ship to undergo shipboard testing. Prior to installation, application drawings for approval were submitted for review to ClassNK (NK), who classified the ship. In the course of the process, all comments from NK were incorporated into the system to enhance safety. 3.6 The manner of application (G9: 4.2.6 and 7) 3.6.1 Maximum allowable infusion concentration of the Active Substance The KURARAY AS solution (3,000 mg/L) is fed with the TRO concentration of 2 mg/L into ballast water. The infusion volume is automatically controlled proportionally to the ballast flow rate (measured by the electromagnetic flowmeter) and the TRO concentration of the KURARAY AS solution (measured by RC1) prepared in the Chemical Infusion Unit. Thus, the infusion concentration will be kept constant at 2 mg/L regardless of the variations in the ballast flow rate or the TRO concentration (RC1). 3.6.2 Holding time There is no prescribed value for the post-treatment holding time in the ballast water tank. This is because, with a TRO concentration exceeding 0.2 mg/L, ballast water will undergo neutralization, with the TRO concentration reduced down to or below 0.2 mg/L, before overboard discharge. 3.6.3 Handling, use, storage and transport of chemical substances The chemical substances shall be handled according to the IMDG Code and IMO BWM.2/Circ.20.


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4 MATERIAL SAFETY DATA SHEETS (G9: 4.2.7) MSDS of KURRAY AS (preparation) and KURARAY NS (neutralizer) are recorded in the confidential dossier. 5 RISK CHARACTERIZATION 5.1 Screening for persistence, bioaccumulation and toxicity (G9: 5.1) Persistence, bioaccumulation and toxicity of calcium hypochlorite, the Active Substance, and the Relevant Chemicals are summarized in Table 5-1. None of the Active Substance and Relevant Chemicals of MICROFADE correspond to PBT substances. The composition of KURARAY AS, the preparation, and the composition of KURARAY NS (sodium sulfite) are not the object of the risk evaluation because none of their relevant physical and chemical properties are assumed to have an influence on the environment.

Table 5-1: PBT criteria

Persistence Bioaccumulation Toxicity

TRO (Ca(OCl)2) N (half decay period < 2h)

N (can be disregarded due to its aqueous solubility and

reactivity.)

Y (NOEC = 0.005mg TRC/L)

Bromoform Y N (logPow = 2.4) N Dibromochloromethane Y N (logPow = 2.16) N Dibromomethane Y N (logPow = 1.70) N Dichloroacetic acid Y N (logPow = 0.92) N/A Monobromoacetic acid Y N (logPow = 0.41) N Dibromoacetic acid Y N (logPow = 0.70) N/A Tribromoacetic acid Y N (logPow = 1.71) N/A Bromochloroacetic acid Y N (logPow = 0.61) N/A Bromodichloroacetic acid

Y N (logPow = 1.53) N/A

Dibromochloroacetic acid

Y N (logPow = 1.62) N/A

Dibromoacetonitrile Y N (logPow = 0.47) N/A

Y: Yes, N: No, N/A: Not available 6 EVALUATION OF THE TREATED BALLAST WATER (G9: 5.2) 6.1 Quality control of tests The tests performed regarding MICROFADE were all properly quality-controlled. The laboratory WET tests and the full-scale land-based WET tests were performed in accordance with the "OECD Principles of Good Laboratory Practice" (1997) and under the quality control of Idea Consultants, Inc., an environmental project consulting firm certified for ISO/IEC 17025 (JIS Q 17025). The corrosivity tests were performed in accordance with an ISO/IEC 17025-compliant quality assurance program plan (QAPP) prepared on the basis of the ISO 9001 quality management


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system of the National Maritime Research Institute and that of Laboratory of Aquatic Science Consultant Co., Ltd. For the by-product identification tests, degradation tests, and TRO sensor tests, analysis samples were prepared, and some of TRO measurements were made in accordance with Kuraray's own ISO/IEC 17025-compliant QAPP. The calibration of the TRO measuring instruments and the analysis of the Relevant Chemicals were performed under the quality control of the Chemicals Evaluation and Research Institute, Japan, a chemical testing laboratory certified under ISO/IEC 17025 (JIS Q 17025). As a representative, the quality assurance statement of Idea Consultants Inc. for full-scale land-based WET tests is provided in appendix 1. 6.2 By-products identification tests See section 2.1.3 of this application. 6.3 Laboratory WET tests See section 1.1.3 of this application. 6.4 Full-scale land-based WET tests (G9: 5.2.1) (G9: 5.2.2) These tests consisted of acute and chronic toxicity tests. The full-scale MICROFADE system, with a flow rate of 250 m3/h, was used to treat and neutralize seawater and brackish water in accordance with Guidelines (G8) standard for land-based testing. (See appendix 4 of the confidential dossier.) Dilution series of both treated and neutralized test waters were either 100% (undiluted), 20%, 4%, 0.8% and 0.16% or 100% (undiluted), 33%, 11%, 3.7% and 1.2%. Untreated control water was used as the diluent. The test results are summarized in Table 1-1. The freshly treated seawater and brackish water both showed the highest toxicity in the algae growth inhibition tests, with NOECs of 4% and 3.7%, respectively. The brackish water showed lower acute toxicities to crustaceans and fish than the seawater. These results were attributable to the rapid degradation of the TRO in brackish water rich in organic matter with 5 mg/L or more of DOC. In chronic toxicity tests, toxicity (NOEC of 20%) at the same level as acute toxicity tests was observed in seawater, on the other hand no toxicity was observed in brackish water. Considering that the Relevant Chemicals are more likely produced in brackish water rich in organic matter, the main cause of toxicity in ballast water treated by MICFOFADE was considered to be the Active Substance (TRO), not the Relevant Chemicals. The TRO concentrations in the neutralized ballast waters were all below the quantitative detection limit (0.01 mg/L). In addition, no toxicity effect was observed in any of the tests conducted using the neutralized ballast waters. These results, along with those of the above-described laboratory WET tests, indicate that the neutralization function of MICROFADE BWMS reliably ensures ballast water free of toxicity effect. 6.5 Degradation tests Degradation of TRO, CRO and Relevant Chemicals were analysed via the following method. Using full-scale land-based test equipment, treated natural sweater and brackish water as well as treated Guidelines (G8) standard seawater and brackish water were stored in the


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dark at several temperature conditions. The details are described in appendix 5 of the confidential dossier. Basically, both TRO and CRO degrade more rapidly at higher temperatures. Their degradation rates were variable depending on the concentration of organic matter present in treated ballast waters and were observed to increase in ballast waters made richer in organic matter as per Guidelines (G8) land-based testing water requirements relative to general seawater or brackish water. The tests revealed that the TRO had a half decay period of 1 hour at the shortest and 96 hours at the longest while the CRO had a half decay period of 6 hours at the shortest and 96 hours at the longest. The rapid degradation rates observed in organic-rich ballast waters per the brackish water requirements were considered to be the factor responsible for the overall lower aquatic toxicities in the ballast waters per the brackish water requirements than per the seawater requirements for the full-scale land-based WET testing. As suggested by the presented data, ballast waters often show a TRO concentration higher than 0.2 mg/L after treatment followed by low-temperature storage. Thus, TRO concentration monitoring with TRO sensors and neutralization are indispensable for MICROFADE. During storage, the Relevant Chemicals remain at almost constant concentrations or changed within very narrow ranges. The neutralization of these treated ballast waters further reduce the amounts of Relevant Chemicals produced along with narrower ranges of variation during ballast water storage. 6.6 TRO sensor tests Operation tests were conducted for longer hours using the full-scale MICROFADE system to verify the control system by means of TRO sensors. Details are described in appendices 6-5 and 7-3 in the confidential dossier. MICROFADE uses the following three TRO sensors:

– RC1: The TRO sensor for controlling calcium hypochlorite concentrations (TRO) to be infused during ballast water treatment. The sensor monitors the TRO after dissolving calcium hypochlorite so as to make the TRO concentration of 3,000 mg/L. Depending on the actually measured TRO concentration and the ballast water flow rate, the sensor controls the infusion quantity of calcium hypochlorite solution and the TRO concentration in the ballast water is adjusted to 2 mg/L.

– RC2: The TRO sensor for monitoring the TRO in discharged ballast water. The

sensor is located at the upstream side of a neutralizer infusion port and, when the TRO concentration exceeds 0.2 mg/L, transmits a signal for automatic neutralizer infusion.

– RC3: The TRO sensor for final monitoring of the TRO in discharged ballast

water. It is located at the downstream side of a neutralizer infusion port and monitors the TRO at the very end. When this sensor detects a TRO concentration exceeding 0.2 mg/L, the system shuts down ballast water discharge.

As a result of the operation test, it was verified that the above three sensors worked properly, recording the results automatically, controlling the infusion quantity of calcium hypochlorite, performing neutralization treatment, and stopping of ballast water discharge when necessary. And the control system reacted quickly enough to the change of flow rate and TRO concentration.


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6.7 Corrosivity test The corrosion effect of treated ballast waters on the materials of the hull and the system was evaluated. Using full-scale test equipment, various test pieces were exposed to the test waters. The test period was six months, and test water was replaced at intervals of five days. Test temperatures were set at two levels, 23°C and 35°C. Details are described in appendix 13 of the confidential dossier. Test of corrosion effects on hull Test pieces consisting of five types of ballast tank materials (painted steel plate), 10 types of non-painted metal materials, two types of painted metal materials, two types of rubber materials and six types of packing materials were exposed to test water with a TRO concentration of 2 mg/L. Test of corrosion effects on materials used in MICROFADE Six types of materials that are used in MICROFADE and are to be in contact with calcium hypochlorite solution were exposed to test water with their TRO concentration at contact of 3,000, 60 or 2 mg/L. The test results revealed that the corrosion effect of treated water on the hull showed little significant difference in comparison with that of non-treated control water and is thus allowable. Furthermore, since no corrosion effect on materials used in MICROFADE was recognized, the materials were considered to be appropriate. 6.8 Determination of holding time MICROFADE is a ballast water management system (BWMS) that infuses KURARAY NS and neutralizes TRO present in discharged ballast water when the TRO concentration exceeds the maximum allowable discharge concentration (MADC) of 0.2 mg/L. KURARAY NS is infused at a rate sufficient for neutralization of 2.0 mg-TRO/L, the maximum infusion concentration of KURARAY AS. The MADCs of the Relevant Chemicals (see Tables 2-1 and 6-1) were set by the test results of freshly treated ballast water. Therefore, there are no holding time settings for use during the operation of MICROFADE. 6.9 Risk characterization and analysis

6.9.1 Reaction with organic matter (G9: 4.2.1.3)

To observe the reaction between calcium hypochlorite and organic matter, analyses were performed during the tests outlined earlier in sections 6.2 to 6.5. Based on the analysis results, 11 substances were identified and designated as the Relevant Chemicals for the risk assessment. 6.9.2 Characterization of degradation route and rate (G9: 5.3.5)

The degradability of the Active Substance and Relevant Chemicals present in ballast waters treated using MICROFADE were confirmed in the degradation tests described earlier in 6.5. In a high organic concentration environment per Guidelines (G8) standard brackish test water requirements, the reaction between TRO and organic matter reached equilibrium. The concentration of CRO produced under this condition can be regarded as the maximum concentration.


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6.10 Prediction of discharge and environmental concentrations

The predicted environmental concentrations (PECs) of the Active Substance and the Relevant Chemicals present in ballast water discharged from MICROFADE were determined using MAMPEC model ver. 2.5. As a target sea area OECD-EU Commercial harbour was selected. Assuming the worst case scenario the volume of ballast water discharged in designated sea area was estimated to be 100,000 m3/day.

6.11 Assessment of potential for bioaccumulation

The Active Substance and the Relevant Chemicals discharged from MICROFADE had log Pow values below 3, the threshold value for causing bioaccumulation. Therefore, there are no bioaccumulation risks expected to arise from the Active Substance and the Relevant Chemicals.

6.12 Effects assessment Regarding the environmental effects of discharged ballast water by MICROFADE, the acute toxicity effect of the Active Substance (TRO) was the only concern, because MADCs of Relevant Chemicals were all too little to affect the environment. The Active Substance and Relevant Chemicals had a BCF of less than 500, and bioaccumulation was not considered. MICROFADE is a BWMS that monitors the TRO concentration of discharging ballast water, infuses KURARAY NS neutralizer upon detection of a TRO concentration more than 0.2 mg/L, and discharges the ballast water only after ensuring that its TRO concentration is 0.2 mg/L or below. The TRO in deballast water might exceeds both the acute toxicity value (24h-LC50) of 0.005 mg/L and the chronic toxicity value (133d- NOEC) of 0.005 mg/L of calcium hypochlorite (cf. sections 2.2.1.1 and 2.2.2.1 of the confidential dossier). Even so, the discharged water out of the vessel is diluted, diffused and decomposed, and the concentrations soon dropped below the toxicity level (cf. section 6.13 of this application). Therefore, the concerning acute toxicity effect of TRO is considered allowable. From the observations above, it is concluded that the Active Substance and the Relevant Chemicals discharged from MICROFADE will cause neither short-term (acute toxicity) nor long-term (chronic toxicity and bioaccumulation) toxicity effects. 6.13 Effects on aquatic organisms PEC/PNEC ratio is calculated based on PEC of the Active Substance and Relevant Chemicals and listed in Table 6-1. All the values are below one.

Table 6-1: PEC, PNEC and PEC/PNEC ratio

Active Substance and Relevant Chemicals

MADC (mg/L)

PEC (μg/L)

PNEC (μg/L) PEC/PNEC Long Short Long Short

TRO 0.2 0.474 0.5 0.5 0.948 0.948 Bromoform 0.15 0.414 48 710 0.008 0.00005 Dibromochloromethane 0.0071 0.414 0.63 96 0.657 0.004 Dibromomethane 0.0010 0.00208 – –*1 – –*1 – –*1 – –*1 Dichloroacetic acid 0.0001 0.000273 23 230 0.00001 0.000001 Monobromoacetic acid 0.0031 0.00849 0.14 14 0.060 0.0006 Dibromoacetic acid 0.022 0.0617 6.9 69 0.008 0.0008 Tribromoacetic acid 0.10 0.289 – –*1 – –*1 – –*1 – –*1


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Bromochloroacetic acid 0.0011 0.00318 – –*1 – –*1 – –*1 – –*1 Bromodichloroacetic acid 0.0016 0.00463 – –*1 – –*1 – –*1 – –*1 Dibromochloroacetic acid 0.0070 0.0202 – –*1 – –*1 – –*1 – –*1 Dibromoacetonitrile 0.017 0.0269 0.055 0.55 0.489 0.048

*1: Excluded from scope of assessment because PNEC estimation was impossible due to the lack of

aquatic toxicity data. 6.14 Effects on sediment Neither the Active Substance nor the Relevant Chemicals discharged from MICROFADE are expected to be adsorbed to or accumulated in bottom sediments. Hence, there will be no effects on sediments. 6.15 Comparison of effect assessment with discharge toxicity It is confirmed that the acute toxicity of TRO affects the discharged ballast water in various toxicity tests. Toxicity effect of Relevant Chemicals was not confirmed because the PEC/PNEC ratio was much less than one (cf. section 6.13). All the test results confirmed that the post-neutralization TRO concentrations were reduced below the lower quantitative limit (0.01 mg/L). Additionally, in all toxicity tests of post-neutralization the 100% (undiluted) test water did not cause any toxicity. The PEC/PNEC ratio evaluation showed that as long as TRO was not more than 0.2 mg/L, the discharged water was diluted, diffused, and decomposed, and the concentrations soon dropped below the toxicity level. All the results suggest that the risk assessment results are coherent and consistent with the toxicity test results. 7 RISK ASSESSMENT 7.1 Risk to safety of ship 7.1.1 Increased corrosion Parts of MICROFADE exposed to the effects of corrosion caused by its operation were as follows; components involved in the series of processes from KURARAY AS dissolution to infusion into the ballast line, and components downstream of the ballast line, including the hull such as ballast tanks and the system components. A 180-day corrosivity test was conducted to expose these parts to their respective corresponding TRO concentrations (3,000 mg/L, 60 mg/L and 2 mg/L). In the test, the effects of corrosion fell within tolerable ranges or showed no significant differences from the control experiment. Details are described in appendix 13 of the confidential dossier. 7.1.2 Fire and explosion There is no risk that MICROFADE causes fire under the storage and treatment condition described in section 7.1.3. In case of fire in the vicinity, the following safety measures shall be taken to minimize risks:


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.1 In case of fire in a location where KURARAY AS containers are stored, spray plenty of water at and around the containers to lower the temperature. Prepare fire-extinguishing protective gear such as self-contained breathing apparatuses and equipment provided by International Convention for the Safety of Life at Sea (SOLAS) for example, against the possible presence of toxic gases such as chlorine.

.2 In case of fire in a location where KURARAY NS containers are stored,

fight the fire with powder fire extinguishers. Prepare fire-extinguishing protective gear such as self-contained breathing apparatuses and equipment provided by SOLAS for example, against the possible presence of toxic gases such as sulfur oxides.

.3 In case of peripheral fire, immediately move the chemicals to somewhere

else safe. 7.1.3 Storage and handling of the substances KURARAY AS KURARAY AS shall be stored in dedicated containers in a place not exposed to direct sunlight. To ensure segregated storage from chlorinated isocyanuric acids, reducing agents, combustible materials, or acids, the containers shall bear a label indicating the names of these incompatible substances. Ventilation or cold air ducting shall be installed as necessary to keep the internal temperature of the storage at or below 35°C. Ventilation is always working around chemical hopper and chemical outlets through piping out to overboard. The chemical must be stored in drums, each sealed with a top cover. Chlorine gas detectors shall be installed that generate visible and audible alerts in the event of an abnormal condition (chlorine concentration of 0.5 ppm or more). The above-described procedure shall be followed for onboard storage of KURARAY AS to ensure the safety of ship crews. KURARAY AS shall be infused into the hopper via a dedicated adapter hermetically sealed to prevent personal exposure to dust escaping from the container. To ensure maximum safety, long-sleeved and long-legged protective suits, goggle type protective eyewear, chlorine gas/dust masks, and rubber protective gloves shall be worn during hopper charging work. The operation thereafter is fully automatic, precluding personal exposure risks. The above-described procedure shall be followed in the handling of KURARAY AS to ensure the safety of ship crews. KURARAY NS KURARAY NS consists primarily of sodium sulfite (cf. section 3.6.4.2). By definition, sodium sulfite is not classified as any dangerous goods under the UN classification system. Nevertheless, the following safety measures shall be taken to ensure the safety of ship crews:

.1 store in a well-ventilated dry place not exposed to direct sunlight and high temperatures;

.2 store in Kraft paper bags, each with a standard capacity of 25 kg; and


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.3 store in a segregated place to prevent contact with other chemical substances.

Irritation due to exposure of the eyes, nose, throat, or skin or inhalation may result in health problems. Hence, a long-sleeved and long-legged protective suit, goggle type protective eyewear, chlorine gas/dust masks, and rubber protective gloves shall be worn by ship crews involved in the handling of KURARAY NS for their own work safety. 7.1.4 Contact with, or inhalation of, process products The potential risks of KURARAY AS and NS to ship crews during operation of MICROFADE are hazards due to exposure of the eyes, nose, throat, or skin or inhalation that may occur during transfer from a storage container into the hopper. Safety of ship crew can be guaranteed by the use of long-sleeved and long-legged protective suits, protective goggles, gas/dust masks, and rubber gloves during work. Other risks may include spillage/leakage of KURARAY AS from the Chemical Infusion Unit and precautions shall be taken to ensure safety. 7.1.5 Noise MICROFADE consists mainly of a Filtration Unit and a Chemical Infusion Unit for infusing KURARAY AS and NS and does not include components that cause flow velocity fluctuations or cavitations that may induce noise. Therefore, this BWMS is unlikely to emit noise during operation. 7.2 Risk to human health 7.2.1 Health effects in humans (G9: 5.3.12) The following paragraphs provide the outline of health effects to humans (mammalians). The median acute oral LD50 of the Active Substance, i.e., calcium hypochlorite, is 790 mg/kg in rats. The NOAEL value of calcium hypochlorite for humans exposed by inhalation is 0.5 ppm in chlorine equivalent. High concentration exposure may cause dermal and eye corrosion or irritation. The chronic toxicity NOAEL for calcium hypochlorite in animal test subjects is 22.5 mg-chlorine/kg bw per day. There are no reports available on the carcinogenicity, mutagenicity, reproductive toxicity, and endocrine disruption induced by calcium hypochlorite. According to animal test reports, the median acute oral LD50 of bromoform in animals ranged from 1,147 mg/kg to 1,550 mg/kg, and bromoform was observed to induce dermal and eye irritation. According to a report of a chronic exposure test on bromoform, the NOAEL for rats subjected to 13-week oral administration was 25 mg/kg/day. As for the carcinogenicity of bromoform, the IARC stated that it belongs to Group 3 (not classifiable as to carcinogenicity to humans). The results of animal experiments suggest that bromoform may cause mutagenicity and reproductive toxicity at dose levels where maternal toxicities were also observed. Nevertheless, there are no reports available on endocrine disruption induced by bromoform. According to animal test reports, the median acute oral LD50 of dibromochloromethane in animals ranged from 800 mg/kg to 1,200 mg/kg. According to a report of a chronic exposure test on dibromochloromethane, the NOAEL for rats subjected to 13-week oral administration was 30 mg/kg/day. The results of tests at high concentrations suggest that dibromochloromethane may cause reproductive toxicity. As for the carcinogenicity of


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dibromochloromethane, the IARC evaluates that it belongs to Group 3 (not classifiable as to carcinogenicity to humans). As for the mutagenicity of dibromochloromethane, there have been reports of both positive and negative results. There are no data available on endocrine disruption induced by dibromochloromethane. According to animal test reports, the median acute oral LD50 of dibromomethane in animals was 108 mg/kg. While no definitive NOAEC values for dibromomethane have been presented in reports on tests by repeated respiratory administration to rabbits and rats, dibromomethane has been observed to induce hepatic or renal disruption. There are no data available on the carcinogenicity and reproductive toxicity induced by dibromomethane. Among the halogenated acetic acids, which are Relevant Chemicals, monobromoacetic acid is the most acutely toxic, and its oral LD50 in rats is reported as 177 mg/kg. Due to its chemical structure, it is expected that monobromoacetic acid causes dermal, eye, and respiratory system corrosion or irritation. As for the reproductive toxicity and mutagenicity of monobromoacetic acid, there have been reports of both positive and negative results. As for carcinogenicity, dichloroacetic acid is classified by the IARC into Group 2B (probably carcinogenic to humans) and thus may be carcinogenic. Nevertheless, there are no evaluation data available from international institutions on the carcinogenicity of other halogenated acetic acids. There are no data available on endocrine disruption induced by halogenated acetic acids. According to animal test reports, acute oral LD50 of dibromoacetonitrile in animals ranged from 245 to 361 mg/kg, and dibromoacetonitrile was observed to induce dermal, eye, and respiratory system irritation. The NOAEL for rats subjected to a 90-day oral administration test was 11.3 mg/kg/day. There are no data on reproductive toxicity, carcinogenicity, mutagenicity, or endocrine disruption induced by dibromoacetonitrile. 7.2.2 Human Exposure Scenario (HES) (G9: 6.3.3) Figure 7-1 provides an illustrated summary of human exposure scenarios (HES) of crews (shipboard personnel who possibly handle KURARAY AS and KURARAY NS, and other personnel who present in living space or apart from the system) and the general public downstream to treated ballast water for each unit operation in the system flow of MICROFADE. As shown in Figure 7-1, the Other Chemicals contained in KURARAY AS, which consists primarily of calcium hypochlorite, were excluded from the quantitative exposure assessment because their use in MICROFADE does not pose a human health risk due to low toxicities to humans and because the TRO concentration of the Active Substance in ballast water was low at 2.0 mg/L. The paragraphs to follow explain the procedures for assessing the risk of exposure of chemical substances to human populations (crew and the general public) in accordance with exposure scenarios (1) to (5) given below. Note that the human exposure assessment reported in this report was performed in accordance with the requirements under MEPC 57/2/10, annex 4, appendix 2 – Human Exposure Assessment.


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Exposure scenarios:

Exposure scenario (1): Exposure of KURARAY AS during storage, hopper charging (as a granule form), and infusion (solution)

Exposure scenario (2): Exposure during holding time of treated water in ballast tank

Exposure scenario (3): Exposure to general public after discharge of treated

ballast water

Exposure scenario (4): Exposure during storage and infusion of neutralizer into ballast water

Exposure scenario (5): Neutralization of high-concentration Active Substance

The Active Substance, i.e., calcium hypochlorite, is not expected to cause health risks to crews and the general public under any possible exposure scenario. As for the Relevant Chemicals, no health risk to crews and general public is concerned under all possible exposure scenarios. As for Other Chemicals, sodium sulfite is considered unlikely to pose a health risk to workers because worker involved in the operation using high concentration of sodium sulfite are supposed to wear personal protective gear, including protective masks (dust/gas masks), protective gloves, and protective suits. Sodium sulfite is not considered to pose health risks to the general public because it undergoes conversion into sulfuric acid in water and has a low bioconcentration potential.

Figure 7-1: System flow of MICROFADE and Human Exposure Scenarios

Seawater intake

AS (Granule)

AS (solution)

Ballast tanks

(1) ES 1: Storage and infusion of AS

(2)ES 2: Holding in ballast tanks

(3)ES 3: Emission to the environment

TRO < 0 2 mg/L

Discharge Ballast pumps

Filtration Unit

NS (powder)

TRO censor × 2

(4) ES 4: Storage and infusion of NS

Chemical Infusion Unit

(5)ES 5: Neutralization

Discharge after neutralization TRO secsor

(3) ES 3: Emission to the environment

Chemial Infusion Unit

NS (solution)

TRO = 0.2mg/L


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7.3 Risk to the aquatic environment MICROFADE is a system that monitors the TRO concentration of discharged ballast water, performs neutralization by infusion of KURARAY NS in the event of detection of a TRO concentration exceeding 0.2 mg/L, and discharges the deballasting water only after ensuring that the TRO concentration is at or below 0.2 mg/L. The TRO concentration has been confirmed to be lower than the quantitative detection limit (0.01 mg/L) through various tests, as well as other Relevant Chemicals concentrations are confirmed to be reduced. In addition growth inhibition tests on algae, which is one of the most sensitive organisms, shows no toxic effect after neutralization in all toxicity studies performed. Operation of neutralization by TRO sensors have been confirmed to be well performed and the TRO concentration at deballasting water is well controlled. It should be noted that aquatic environmental effects are not assumed in the PEC/PNEC evaluation, where PECs have been calculated using the maximum concentration of Relevant Chemicals without neutralization. Taking into account the above assessment results, deballasting water from MICROFADE is not likely to cause risks to the aquatic environment. 8 CONCLUSION The MICROFADE system will not likely causes health risk for crews and the general public by using KURARAY AS stored and used as instructed by the manufacturer, Relevant Chemicals and KURARAY NS. MICROFADE is a system that monitors the TRO concentration of discharged ballasting water, performs neutralization by infusion of KURARAY NS in the event of detection of a TRO concentration exceeding 0.2 mg/L, and discharges the ballast water only after ensuring that the TRO concentration is at or below 0.2 mg/L. Because of the control system, the TRO and Relevant Chemicals generated in MICROFADE will not cause any short- and long-term health risks. Therefore, MICROFADE is a BWMS that deserves to receive Final Approval in accordance with Procedure (G9). REFERENCES ACGIH (2001) Documentation of the threshold limit values and biological exposure indices, 7th ed. Bromoform ACGIH (2009) TLVs & BEIs Aida, Y., Takada, K., Kobayashi, K., Uchida, O., Yasuhara, K., Yoshimoto, H., Momma, J., Kurokawa,Y. and Tobe, M. (1988) Chronic toxicity studies of TBM, DBCM and BDCM in Wistar rats. J.Toxicol. Sci., 13, 330. Aida et al.,(1992) TOXITIES OF MICROENCAPSULATED TRIBROMOMETHANE, DIBROMOCHLOROMETHANE AND BROMODICHLIROMETHANE ADMINISTERED IN THE DIET TOWISTAR RATS FOR ONE MONTH, The journal of Toxicological Sciences, Vol.17,119-133. Anderson, B.E., Zeiger, E., Shelby, M.D., Resnick, M.A., Gulati, D.K., Ivett, J.L. and Loveday, K.S.(1990) Chromosome aberration and sister chromatid exchange test results with 42 chemicals.Environ. Mol. Mutagen., 16(Suppl. 18), 55-137. ATSDR (2005) Toxicological Profile for Bromoform and Dibromochloromethane. U.S. Department of Health and Human Services.


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Balster and Borzelleca (1982) Behavioral Toxicity of Trihalomethane Contaminants of Drinking Water in Mice, Environmental Health Perspectives Vol, 46, pp 127-136. Benigni et al., (1993) Quantitative structure-activity relationship modes correctly predict the toxic and aneuploidizing properties of six halogenated methanes in Aspergillus nidulans. Bouwer and McCarty, (1983 a) Transformations of 1- and 2-Carbon Halogenated Aliphatic Organic Compounds Under Methanogenic Conditions, APPLIED AND ENVIRONMENTAL MICROBIOLOGY, American Society for Microbiology, p. 1286-1294 Vol. 45, No. 4. Bouwer and McCarty, (1983 b) Transformations Hologenated Organic Compound Under Denitrification Conditions, APPLIED AND ENVIRONMENTAL MICROBIOLOGY, American Society for Microbiology, p. 1295-1299 Vol. 45, No. 4. Carlo and Mettlin, (1980) Cancer Incidence and Trihalomethane Concentrations in a Public Drinking Water System, AJPH , p 523-525 Vol. 70, No. 5. CEPA (2001) Priority Substances List Assessment Report, Inorganic Chloramines. Canadian Environmental Protection Act. Chu et al., (1982) TRIHALOMETHANES: II REVERSUBILITY OF TOXICOLOGICAL CHABGES CHLOROFORM, BROMODICHLOROMRTHANE, CHLORODIBROMO-METHANE AND BROMOFORM IN RATS, J.ENVIRON, SCU. HELTH, B17(3), 225-240. Condie et al., (1983) CAMPARATIVE RENAL AND HEPATOTOXICITY OF DI B HALOMETHANS: BROMODICHLOROMETHANE, BLOMOFORM, CHLOROFORM, ROMOCHLOROMETHANE AND MRTHYLENE CHLORIDE, DRUG AND CHEMICAL TOXICOLOGY, 6(6), 563-578. Cotruvo, (1981) THMS in water drinking, Environmental Science & Technology, p 268-274, Vol. 15, No. 3. Crump, (1983) Chlorinated drinking water and cancer: The strength of the epidemiologic evidence, Water chlorination, chapter 107, p 1481-1491. Fujie et al., (1990) Acute and subacute cytogenetic effects of the trihalomethanes on rat bone marrow cells in vivo, Muauon Research, 242,111-119. GESAMP-BWWG Methodology (MEPC 57/2/10, annex 4, 3.2.4). Gulati et al., (1989) BROMOFORM REPRODUCTION AND FERTILITY ASSESSMENT IN SWISS CD- MICE WHEN ADMINISTERED BY GAVAGE. Hayashi et al., (1988) Micronucleus tests in mice on 39 food additives and eight miscellaneous chemicals. Fd. Chem. Toxicol., 26, 487-500. IARC (1991a) Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to Human. Vol. 52. Chlorodibromomethane. IARC (1991b) Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to Human. Vol. 52. Hypochlorite salts. IARC (1999a) Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to Human. Vol. 71. Bromoform.


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IARC (1999b) Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to Human. Vol. 71. Dibromoacetonitrile. IARC (2004a) Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to Human. Vol. 84. Chloramine. IARC (2004b) Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to Human. Vol. 84. Dichloroacetic acid. ICSC (1994) International Chemical Safety Cards, IPCS (International Programme on Chemical Safety). Bromoform. ICSC (1995) International Chemical Safety Cards, IPCS (International Programme on Chemical Safety). Calcium chloride. ICSC (1997) International Chemical Safety Cards, IPCS (International Programme on Chemical Safety). Calcium dihydroxide. ICSC (1999) International Chemical Safety Cards, IPCS (International Programme on Chemical Safety). Calcium carbonate. ICSC (2005) International Chemical Safety Cards, IPCS (International Programme on Chemical Safety). Calcium hypochlorite. ICSC (2009) International Chemical Safety Cards, IPCS (International Programme on Chemical Safety). Sodium sulfite. IPCS: EHC (2000) Environmental Health Criteria 216. Disinfectants and disinfectant by-products. IPCS (2005) International Programme on Chemical Safety International Chemical Safety cards#108 Bromoform. Isacson,(1983) Relationship of cancer incidence rates in Iowa municipalities to chlorination status of dirinking water, Water chlorination, chapter 97, p 1353-1364. Ishidate,(1987) Data book of chromosome aberration test in vitro. Revised ed., Life-Science Information Center, Tokyo, pp. 421-422. (Refer to IARC, 1991). IUCLID (2000a) EU: IUCLID database. Calcium carbonate. IUCLID (2000b) EU: IUCLID database. Calcium dihydroxide. IUCLID (2000c) EU: IUCLID database. Calcium hypochlorite. IUCLID (2000d) EU: IUCLID database. Sodium chlorate. IUCLID (2000e) EU: IUCLID database. Sodium chloride. IUCLID (2000f) EU: IUCLID database. Sodium sulfite.


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APPENDIX 1

QUALITY CONTROL STATEMENT REGARDING THE TEST


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marine environment protection committee ......appendix 1: quality control statement of test. 1...

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